OMNIPAQUE is indicated for:

OMNIPAQUE is indicated for:

OMNIPAQUE is indicated for:

OMNIPAQUE is indicated for:

OMNIPAQUE is indicated for:

OMNIPAQUE is indicated for:

‡ Specific dosage forms, concentrations, and presentations of OMNIPAQUE are recommended for each type of imaging procedure [see Dosage and Administrations (2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9) and Warnings and Precautions (5.1, 5.2)].

<div class="scrollingtable"><table width="85%"> <caption> <span>Table 1. Recommended Concentrations and Volumes of OMNIPAQUE Injection for Intrathecal Procedures in Adults</span> </caption> <col align="left" valign="middle" width="25%"/> <col align="center" valign="middle" width="25%"/> <col align="center" valign="middle" width="25%"/> <col align="left" valign="middle" width="25%"/> <thead> <tr class="First Last"> <th align="left" class="Lrule Rrule">Imaging Procedure</th><th align="center" class="Rrule">Injection Type</th><th align="center" class="Rrule">Concentration<br/>(mg Iodine/mL)</th><th align="left" class="Rrule">Volume to Administer</th> </tr> </thead> <tfoot> <tr> <td align="left" colspan="4"> <dl class="Footnote"> <dt> <a href="#footnote-reference-1" name="footnote-1">*</a> </dt> <dd>Use single-dose containers or 500 mL Pharmacy Bulk Packages <span class="Italics">[see <a href="#S2.11">Dosage and Administration (2.11)</a>].</span> </dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule" rowspan="2">Lumbar Myelography</td><td align="center" class="Rrule" rowspan="2">Lumbar</td><td align="center" class="Rrule">180<a class="Sup" href="#footnote-1" name="footnote-reference-1">*</a></td><td align="left" class="Rrule">10 mL to 17 mL</td> </tr> <tr class="Botrule"> <td align="center" class="Rrule">240<a class="Sup" href="#footnote-1">*</a></td><td align="left" class="Rrule">7 mL to 12.5 mL</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" rowspan="2">Thoracic Myelography</td><td align="center" class="Rrule" rowspan="2">Lumbar<br/>Cervical</td><td align="center" class="Rrule">240<a class="Sup" href="#footnote-1">*</a></td><td align="left" class="Rrule">6 mL to 12.5 mL</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">300<a class="Sup" href="#footnote-1">*</a></td><td align="left" class="Rrule">6 mL to 10 mL</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" rowspan="5">Cervical Myelography</td><td align="center" class="Rrule" rowspan="2">Lumbar</td><td align="center" class="Rrule">240<a class="Sup" href="#footnote-1">*</a></td><td align="left" class="Rrule">6 mL to 12.5 mL</td> </tr> <tr class="Botrule"> <td align="center" class="Rrule">300<a class="Sup" href="#footnote-1">*</a></td><td align="left" class="Rrule">6 mL to 10 mL</td> </tr> <tr class="Botrule"> <td align="center" class="Rrule" rowspan="3">C1-2</td><td align="center" class="Rrule">180<a class="Sup" href="#footnote-1">*</a></td><td align="left" class="Rrule">7 mL to 10 mL</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">240<a class="Sup" href="#footnote-1">*</a></td><td align="left" class="Rrule">6 mL to 12.5 mL</td> </tr> <tr class="Botrule"> <td align="center" class="Rrule">300<a class="Sup" href="#footnote-1">*</a></td><td align="left" class="Rrule">4 mL to 10 mL</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" rowspan="2">Total Columnar Myelography</td><td align="center" class="Rrule" rowspan="2">Lumbar</td><td align="center" class="Rrule">240<a class="Sup" href="#footnote-1">*</a></td><td align="left" class="Rrule">6 mL to 12.5 mL</td> </tr> <tr class="Botrule"> <td align="center" class="Rrule">300<a class="Sup" href="#footnote-1">*</a></td><td align="left" class="Rrule">6 mL to 10 mL</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" rowspan="2">CT Cisternography</td><td align="center" class="Rrule" rowspan="2">Lumbar</td><td align="center" class="Rrule">180<a class="Sup" href="#footnote-1">*</a></td><td align="left" class="Rrule">10 mL to 17 mL</td> </tr> <tr class="Last"> <td align="center" class="Rrule">240<a class="Sup" href="#footnote-1">*</a></td><td align="left" class="Rrule">7 mL to 12.5 mL</td> </tr> </tbody> </table></div>

The recommended doses for intra-arterial procedures in adults are shown in Table 2.

<div class="scrollingtable"><table width="85%"> <caption> <span>Table 2. Recommended Concentrations and Volumes of OMNIPAQUE Injection for Intra-arterial Procedures in Adults</span> </caption> <col align="left" valign="middle" width="22%"/> <col align="left" valign="middle" width="17%"/> <col align="center" valign="middle" width="14%"/> <col align="left" valign="middle" width="35%"/> <col align="center" valign="middle" width="12%"/> <thead> <tr class="First Last"> <th align="left" class="Lrule Rrule" colspan="2">Imaging Procedure</th><th align="center" class="Rrule">Concentration<br/> (mg Iodine/mL)</th><th align="center" class="Rrule">Volume to Administer per Single Injection for Selective Injection Sites</th><th align="center" class="Rrule">Maximum Cumulative Total Dose</th> </tr> </thead> <tfoot> <tr> <td align="left" colspan="5"> <dl class="Footnote"> <dt> <a href="#footnote-reference-2" name="footnote-2">*</a> </dt> <dd>Use single-dose containers or a 500 mL Pharmacy Bulk Package <span class="Italics">[see <a href="#S2.11">Dosage and Administration (2.11)</a>].</span> </dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule" colspan="2">Cardiac Ventriculography</td><td align="center" class="Rrule">350<a class="Sup" href="#footnote-2" name="footnote-reference-2">*</a></td><td align="left" class="Rrule">40 mL (Range of 30 mL to 60 mL)<br/>may be combined with selective coronary arteriography</td><td align="center" class="Rrule">250 mL</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2" rowspan="2">Aortography and Selective Visceral Arteriography</td><td align="center" class="Rrule">300<a class="Sup" href="#footnote-2">*</a></td><td align="left" class="Rrule" rowspan="2"> <ul> <li>Aorta (aortic arch, ascending aorta): 50 mL to 80 mL</li> <li>Abdominal aorta and its branches (celiac, mesenteric, hepatic, and splenic arteries): 30 mL to 60 mL </li> <li>Renal arteries: 5 mL to 15 mL</li> </ul> </td><td align="center" class="Rrule">290 mL</td> </tr> <tr class="Botrule"> <td align="center" class="Rrule">350<a class="Sup" href="#footnote-2">*</a></td><td align="center" class="Rrule">250 mL</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2">Aortic root and arch study when used alone</td><td align="center" class="Rrule">350<a class="Sup" href="#footnote-2">*</a></td><td align="left" class="Rrule">50 mL (Range of 20 mL to 75 mL)</td><td align="center" class="Rrule">250 mL</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2">Selective Coronary Arteriography</td><td align="center" class="Rrule">350<a class="Sup" href="#footnote-2">*</a></td><td align="left" class="Rrule">5 mL (Range of 3 mL to 14 mL)</td><td align="center" class="Rrule">250 mL</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2">Cerebral Arteriography</td><td align="center" class="Rrule">300<a class="Sup" href="#footnote-2">*</a></td><td align="left" class="Rrule"> <ul> <li>Common carotid artery: 6 mL to 12 mL</li> <li>Internal carotid artery: 8 mL to 10 mL</li> <li>External carotid artery: 6 mL to 9 mL</li> <li>Vertebral artery: 6 mL to 10 mL</li> </ul> </td><td align="center" class="Rrule" valign="middle">290 mL</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" rowspan="4">Peripheral Arteriography</td><td align="left" class="Rrule" rowspan="2">Aortofemoral Runoffs</td><td align="center" class="Rrule">300<a class="Sup" href="#footnote-2">*</a></td><td align="left" class="Rrule">30 mL to 90 mL</td><td align="center" class="Rrule">290 mL</td> </tr> <tr class="Botrule"> <td align="center" class="Rrule">350<a class="Sup" href="#footnote-2">*</a></td><td align="left" class="Rrule">20 mL to 70 mL</td><td align="center" class="Rrule">250 mL</td> </tr> <tr class="Botrule"> <td align="left" class="Rrule" rowspan="2">Selective Arteriogram</td><td align="center" class="Rrule">300<a class="Sup" href="#footnote-2">*</a></td><td align="left" class="Rrule">10 mL to 60 mL</td><td align="center" class="Rrule">290 mL</td> </tr> <tr class="Botrule"> <td align="center" class="Rrule">350<a class="Sup" href="#footnote-2">*</a></td><td align="left" class="Rrule" valign="top">10 mL to 30 mL</td><td align="center" class="Rrule">250 mL</td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule" colspan="2">IA-DSA (head, neck, abdominal, renal, and peripheral vessels)</td><td align="center" class="Rrule">140<a class="Sup" href="#footnote-2">*</a></td><td align="left" class="Rrule" valign="top"> <ul> <li>Aorta: 20 mL to 45 mL at 8 mL/sec to 20 mL/sec</li> <li>Carotid artery: 5 mL to 10 mL at 3 mL/sec to 6 mL/sec</li> <li>Femoral artery: 9 mL to 20 mL at 3 mL/sec to 6 mL/sec</li> <li>Vertebral artery: 4 mL to 10 mL at 2 mL/sec to 8 mL/sec</li> <li>Renal arteries: 6 mL to 12 mL at 3 mL/sec to 6 mL/sec</li> <li>Other branches of aorta (includes subclavian, axillary, innominate, and iliac): 8 mL to 25 mL at 3 mL/sec to 10 mL/sec</li> </ul> </td><td align="center" class="Rrule" valign="middle">250 mL</td> </tr> </tbody> </table></div>

The recommended doses for intravenous procedures in adults are shown in Table 3.

<div class="scrollingtable"><table width="85%"> <caption> <span>Table 3. Recommended Concentrations and Volumes of OMNIPAQUE Injection for Intravenous Procedures in Adults</span> </caption> <col align="left" valign="middle" width="13%"/> <col align="left" valign="middle" width="23%"/> <col align="center" valign="middle" width="16%"/> <col align="left" valign="middle" width="48%"/> <thead> <tr class="First Last"> <th align="left" class="Lrule Rrule" colspan="2">Imaging Procedure</th><th align="center" class="Rrule">Concentration<br/> (mg Iodine/mL)</th><th align="left" class="Rrule">Volume to Administer</th> </tr> </thead> <tfoot> <tr> <td align="left" colspan="4"> <dl class="Footnote"> <dt> <a href="#footnote-reference-3" name="footnote-3">*</a> </dt> <dd>Use single-dose containers or 500 mL Pharmacy Bulk Packages <span class="Italics">[see <a href="#S2.11">Dosage and Administration (2.11)</a>].</span> </dd> <dt> <a href="#footnote-reference-4" name="footnote-4">†</a> </dt> <dd>Use single-dose containers, 500 mL Imaging Bulk Packages or Pharmacy Bulk Packages, or 150 mL single-dose bottles with an automated contrast injection system or contrast management system<span class="Italics"> [see <a href="#S2.10">Dosage and Administration (2.10</a>, <a href="#S2.11">2.11</a>, <a href="#S2.12">2.12)</a>].</span> </dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule" colspan="2" rowspan="2">Excretory Urography</td><td align="center" class="Rrule">300<a class="Sup" href="#footnote-3" name="footnote-reference-3">*</a></td><td align="left" class="Rrule" rowspan="2">0.6 mL/kg to 1.2 mL/kg body weight<br/>(maximum dose is 102 mL)</td> </tr> <tr class="Botrule"> <td align="center" class="Rrule">350<a class="Sup" href="#footnote-3">*</a></td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" rowspan="5">CT</td><td align="left" class="Rrule" rowspan="3">Head</td><td align="center" class="Rrule">240<a class="Sup" href="#footnote-3">*</a></td><td align="left" class="Rrule">120 mL to 250 mL by infusion</td> </tr> <tr class="Botrule"> <td align="center" class="Rrule">300<a class="Sup" href="#footnote-4" name="footnote-reference-4">†</a></td><td align="left" class="Rrule">70 mL to 150 mL by rapid injection</td> </tr> <tr class="Botrule"> <td align="center" class="Rrule">350<a class="Sup" href="#footnote-4">†</a></td><td align="left" class="Rrule">80 mL by rapid injection</td> </tr> <tr class="Botrule"> <td align="left" class="Rrule" rowspan="2">Body</td><td align="center" class="Rrule">300<a class="Sup" href="#footnote-4">†</a></td><td align="left" class="Rrule">50 mL to 200 mL by rapid injection</td> </tr> <tr class="Botrule"> <td align="center" class="Rrule">350<a class="Sup" href="#footnote-4">†</a></td><td align="left" class="Rrule">60 mL to 100 mL by rapid injection</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2" rowspan="2">Peripheral Venography (phlebography)</td><td align="center" class="Rrule">240<a class="Sup" href="#footnote-3">*</a></td><td align="left" class="Rrule">20 mL to 150 mL per leg</td> </tr> <tr class="Botrule"> <td align="center" class="Rrule">300<a class="Sup" href="#footnote-3">*</a></td><td align="left" class="Rrule">40 mL to 100 mL per leg</td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule" colspan="2">IV-DSA (head, neck, abdominal, renal, and peripheral vessels)</td><td align="center" class="Rrule">350<a class="Sup" href="#footnote-3">*</a></td><td align="left" class="Rrule">30 mL to 50 mL at 7.5 mL/sec to 30 mL/sec using a pressure injector<br/>Frequently three or more doses may be required; the maximum cumulative total dose is 250 mL</td> </tr> </tbody> </table></div>

Recommended Dosage for Radiographic Examination of the GI Tract in Adults

The recommended dose for radiographic examination of the GI tract in adults is 50 mL to 100 mL of OMNIPAQUE injection 350 mg iodine/mL administered undiluted orally.

Recommended Dosage for CT of the Abdomen and Pelvis in Conjunction with Intravenous Administration of OMINIPAQUE Injection in Adults

The recommended oral dose using diluted OMNIPAQUE injection or OMNIPAQUE oral solution and concurrent intravenous doses for CT of the abdomen and pelvis in adults are shown in Table 4.

<div class="scrollingtable"><table width="90%"> <caption> <span>Table 4. Recommended Concentrations and Volumes of Diluted OMNIPAQUE Injection or OMNIPAQUE Oral Solution for Oral Administration and Concurrent Intravenous OMNIPAQUE Injection for CT of the Abdomen and Pelvis in Adults</span> </caption> <col align="left" valign="top" width="30%"/> <col align="left" valign="middle" width="25%"/> <col align="left" valign="top" width="45%"/> <thead> <tr class="First Last"> <th align="center" class="Lrule Rrule" valign="middle">Concentration<br/>(mg Iodine/mL)</th><th align="center" class="Rrule">Volume to Administer</th><th align="center" class="Rrule" valign="middle">Administration Instructions</th> </tr> </thead> <tfoot> <tr> <td align="left" colspan="3"> <dl class="Footnote"> <dt> <a href="#footnote-reference-5" name="footnote-5">*</a> </dt> <dd>See <a href="#Table5">Table 5</a> for dilution instructions of OMNIPAQUE injection</dd> <dt> <a href="#footnote-reference-6" name="footnote-6">†</a> </dt> <dd>Use single-dose containers, 500 mL Imaging or Pharmacy Bulk Packages, or 150 mL single-dose bottles with an automated contrast injection system or contrast management system<span class="Italics"> [see <a href="#S2.10">Dosage and Administration (2.10</a>, <a href="#S2.11">2.11</a>, <a href="#S2.12">2.12)</a>].</span> </dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule" colspan="3"><span class="Italics">Oral Dose Using Diluted OMNIPAQUE Injection</span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">6 mg Iodine/mL to 12 mg Iodine/mL of Diluted OMNIPAQUE Injection<a class="Sup" href="#footnote-5" name="footnote-reference-5">*</a></td><td align="left" class="Rrule">500 mL to 1,000 mL</td><td align="left" class="Rrule"> <ul> <li>Administer the oral dose all at once or over a period of up to 45 minutes if there is difficulty in consuming the required volume.</li> <li>Use a higher iodine concentration of the diluted product if a smaller volume needs to be administered (see <a href="#Table5">Table 5</a>).</li> </ul> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="3"><span class="Italics">Oral Dose Using OMNIPAQUE Oral Solution</span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">9 mg Iodine/mL or 12 mg Iodine/mL of OMNIPAQUE Oral Solution</td><td align="left" class="Rrule">500 mL to 1,000 mL</td><td align="left" class="Rrule">Administer the oral dose all at once or over a period of up to 45 minutes if there is difficulty in consuming the required volume.</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="3"><span class="Italics">Intravenous Dose of OMNIPAQUE injection in Conjunction with Oral Administration</span></td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule" valign="middle">300<a class="Sup" href="#footnote-6" name="footnote-reference-6">†</a></td><td align="left" class="Rrule">100 mL to 150 mL</td><td align="left" class="Rrule">Administer up to 40 minutes AFTER consumption of the oral dose.</td> </tr> </tbody> </table></div>

Preparation of Diluted OMNIPAQUE Injection for Oral Administration for CT of the Abdomen and Pelvis in Adults

<div class="scrollingtable"><table width="85%"> <caption> <span>Table 5. Volumes of OMNIPAQUE Injection and Added Liquid to Dilute OMNIPAQUE Injection for Oral Administration for CT of the Abdomen in Adults</span> </caption> <col align="center" valign="top" width="16%"/> <col align="center" valign="top" width="16%"/> <col align="center" valign="top" width="12%"/> <col align="center" valign="top" width="16%"/> <col align="center" valign="top" width="12%"/> <col align="center" valign="top" width="16%"/> <col align="center" valign="top" width="12%"/> <thead> <tr class="First"> <th align="center" class="Lrule Rrule" rowspan="2" valign="top">Concentration of Diluted OMNIPAQUE injection<br/>(mg iodine/mL)</th><th align="center" class="Botrule Rrule" colspan="2">Dilution Method 1</th><th align="center" class="Botrule Rrule" colspan="2">Dilution Method 2</th><th align="center" class="Botrule Rrule" colspan="2">Dilution Method 3</th> </tr> <tr class="Last"> <th align="center" class="Lrule Rrule" valign="middle">Volume of OMNIPAQUE 240 mg Iodine/mL<br/>(mL)</th><th align="center" class="Rrule" valign="middle">Volume of Added Liquid<a class="Sup" href="#footnote-7" name="footnote-reference-7">*</a> <br/> (mL)</th><th align="center" class="Rrule" valign="middle">Volume of OMNIPAQUE 300 mg Iodine/mL<br/>(mL)</th><th align="center" class="Rrule" valign="middle">Volume of Added Liquid<a class="Sup" href="#footnote-7">*</a> <br/>(mL)</th><th align="center" class="Rrule" valign="middle">Volume of OMNIPAQUE 350 mg Iodine/mL<br/> (mL)</th><th align="center" class="Rrule" valign="middle">Volume of Added Liquid<a class="Sup" href="#footnote-7">*</a> <br/> (mL)</th> </tr> </thead> <tfoot> <tr> <td align="left" colspan="7"> <dl class="Footnote"> <dt> <a href="#footnote-reference-7" name="footnote-7">*</a> </dt> <dd>Use water, carbonated beverage, milk, infant formula, or juice.</dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="Botrule First"> <td align="center" class="Lrule Rrule">6</td><td align="center" class="Rrule">25</td><td align="center" class="Rrule">975</td><td align="center" class="Rrule">20</td><td align="center" class="Rrule">980</td><td align="center" class="Rrule">17</td><td align="center" class="Rrule">983</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">9</td><td align="center" class="Rrule">38</td><td align="center" class="Rrule">962</td><td align="center" class="Rrule">30</td><td align="center" class="Rrule">970</td><td align="center" class="Rrule">26</td><td align="center" class="Rrule">974</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">12</td><td align="center" class="Rrule">50</td><td align="center" class="Rrule">950</td><td align="center" class="Rrule">40</td><td align="center" class="Rrule">960</td><td align="center" class="Rrule">35</td><td align="center" class="Rrule">965</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">15</td><td align="center" class="Rrule">63</td><td align="center" class="Rrule">937</td><td align="center" class="Rrule">50</td><td align="center" class="Rrule">950</td><td align="center" class="Rrule">43</td><td align="center" class="Rrule">957</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">18</td><td align="center" class="Rrule">75</td><td align="center" class="Rrule">925</td><td align="center" class="Rrule">60</td><td align="center" class="Rrule">940</td><td align="center" class="Rrule">52</td><td align="center" class="Rrule">948</td> </tr> <tr class="Last"> <td align="center" class="Lrule Rrule">21</td><td align="center" class="Rrule">88</td><td align="center" class="Rrule">912</td><td align="center" class="Rrule">70</td><td align="center" class="Rrule">930</td><td align="center" class="Rrule">60</td><td align="center" class="Rrule">940</td> </tr> </tbody> </table></div>

<div class="scrollingtable"><table width="85%"> <caption> <span>Table 6. Recommended Concentrations and Volumes of OMNIPAQUE Injection for Intraarticular Procedures in Adults</span> </caption> <col align="left" valign="middle" width="14%"/> <col align="left" valign="middle" width="24%"/> <col align="center" valign="top" width="16%"/> <col align="left" valign="middle" width="16%"/> <col align="left" valign="middle" width="30%"/> <thead> <tr class="First Last"> <th align="left" class="Lrule Rrule">Imaging Procedure</th><th align="left" class="Rrule">Location</th><th align="left" class="Rrule">Concentration<br/> (mg Iodine/mL)</th><th align="left" class="Rrule">Volume to Administer</th><th align="left" class="Rrule">Double Contrast/Single Contrast</th> </tr> </thead> <tfoot> <tr> <td align="left" colspan="5"> <dl class="Footnote"> <dt> <a href="#footnote-reference-8" name="footnote-8">*</a> </dt> <dd>Use single-dose containers or 500 mL Pharmacy Bulk Packages <span class="Italics">[see <a href="#S2.11">Dosage and Administration (2.11)</a>].</span> </dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule" rowspan="5">Arthrography</td><td align="left" class="Rrule" rowspan="3">Knee</td><td align="center" class="Rrule">240<a class="Sup" href="#footnote-8" name="footnote-reference-8">*</a></td><td align="left" class="Rrule">5 mL to 15 mL</td><td align="left" class="Rrule" rowspan="5">Lower volumes recommended for double-contrast examinations; higher volumes recommended for single-contrast examinations.</td> </tr> <tr class="Botrule"> <td align="center" class="Rrule">300<a class="Sup" href="#footnote-8">*</a></td><td align="left" class="Rrule">5 mL to 15 mL</td> </tr> <tr class="Botrule"> <td align="center" class="Rrule">350<a class="Sup" href="#footnote-8">*</a></td><td align="left" class="Rrule">5 mL to 10 mL</td> </tr> <tr class="Botrule"> <td align="left" class="Rrule"><span class="XmChange">Shoulder</span></td><td align="center" class="Rrule">300<a class="Sup" href="#footnote-8">*</a></td><td align="left" class="Rrule">10 mL</td> </tr> <tr class="Last"> <td align="left" class="Rrule">Temporomandibular</td><td align="center" class="Rrule">300<a class="Sup" href="#footnote-8">*</a></td><td align="left" class="Rrule">0.5 mL to 1 mL</td> </tr> </tbody> </table></div>

<div class="scrollingtable"><table width="85%"> <caption> <span>Table 7. Recommended Concentrations and Volumes of OMNIPAQUE Injection for Body Cavity Procedures in Adults</span> </caption> <col align="left" valign="middle" width="40%"/> <col align="left" valign="middle" width="30%"/> <col align="left" valign="middle" width="15%"/> <col align="left" valign="middle" width="15%"/> <thead> <tr class="First Last"> <th align="left" class="Lrule Rrule">Imaging Procedure</th><th align="left" class="Rrule">Concentration (mg Iodine/mL)</th><th align="left" class="Rrule">Volume to Administer</th><th align="left" class="Rrule">Route of Administration</th> </tr> </thead> <tfoot> <tr> <td align="left" colspan="4"> <dl class="Footnote"> <dt> <a href="#footnote-reference-9" name="footnote-9">*</a> </dt> <dd>Use single-dose containers or 500 mL Pharmacy Bulk Packages <span class="Italics">[see <a href="#S2.11">Dosage and Administration (2.11)</a>].</span> </dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule">Endoscopic retrograde pancreatography (ERP) and cholangiopancreatography (ERCP)</td><td align="left" class="Rrule">240<a class="Sup" href="#footnote-9" name="footnote-reference-9">*</a></td><td align="left" class="Rrule">10 mL to 50 mL</td><td align="left" class="Rrule">Intraductal</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" rowspan="2">Herniography</td><td align="left" class="Rrule">240<a class="Sup" href="#footnote-9">*</a></td><td align="left" class="Rrule" rowspan="2">15 mL to 20 mL</td><td align="left" class="Rrule" rowspan="2">Intraperitoneal</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">300<a class="Sup" href="#footnote-9">*</a></td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule">Hysterosalpingography</td><td align="left" class="Rrule">240<a class="Sup" href="#footnote-9">*</a></td><td align="left" class="Rrule">50 mL</td><td align="left" class="Rrule">Intrauterine</td> </tr> </tbody> </table></div>

Recommended Dosage for Intrathecal Procedures in Pediatric Patients Aged 2 Weeks and Older

<div class="scrollingtable"><table width="85%"> <caption> <span>Table 8: Recommended Concentrations and Volumes of OMNIPAQUE Injection Based on Age for Intrathecal Procedure in Pediatric Patients Aged 2 Weeks and Older</span> </caption> <col align="left" valign="middle" width="24%"/> <col align="center" valign="middle" width="17%"/> <col align="left" valign="middle" width="24%"/> <col align="center" valign="middle" width="16%"/> <col align="left" valign="middle" width="19%"/> <thead> <tr class="First Last"> <th align="left" class="Lrule Rrule">Imaging Procedure</th><th align="left" class="Rrule">Injection Type</th><th align="left" class="Rrule">Age</th><th align="left" class="Rrule">Concentration<br/>(mg Iodine/mL)</th><th align="left" class="Rrule">Volume to Administer</th> </tr> </thead> <tfoot> <tr> <td align="left" colspan="5"> <dl class="Footnote"> <dt> <a href="#footnote-reference-10" name="footnote-10">*</a> </dt> <dd>Use single-dose containers<span class="Italics">.</span> </dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule" rowspan="5" valign="middle"> <ul class="Disc"> <li>Myelography <ul class="Circle"> <li>Lumbar</li> <li>Thoracic</li> <li>Cervical</li> <li>Total Columnar</li> </ul> </li> <li>CT cisternography</li> </ul> </td><td align="center" class="Rrule" rowspan="5">Lumbar</td><td align="left" class="Rrule">2 weeks up to 3 months</td><td align="center" class="Rrule" rowspan="5">180<a class="Sup" href="#footnote-10" name="footnote-reference-10">*</a></td><td align="left" class="Rrule">2 mL to 4 mL</td> </tr> <tr class="Botrule"> <td align="left" class="Rrule">3 months up to 36 months</td><td align="left" class="Rrule">4 mL to 8 mL</td> </tr> <tr class="Botrule"> <td align="left" class="Rrule">3 years up to 7 years</td><td align="left" class="Rrule">5 mL to 10 mL</td> </tr> <tr class="Botrule"> <td align="left" class="Rrule">7 years up to 13 years</td><td align="left" class="Rrule">5 mL to 12 mL</td> </tr> <tr class="Last"> <td align="left" class="Rrule">13 years to 18 years</td><td align="left" class="Rrule">6 mL to 15 mL</td> </tr> </tbody> </table></div>

Recommended Dosage for Intra-arterial Procedures in Pediatric Patients

The recommended doses for intra-arterial procedures in pediatric patients are shown in Table 9.

<div class="scrollingtable"><table width="85%"> <caption> <span>Table 9. Recommended Concentrations and Volumes of OMNIPAQUE Injection per Body Weight for Intra-arterial Procedures in Pediatric Patients</span> </caption> <col align="left" valign="middle" width="33%"/> <col align="center" valign="middle" width="18%"/> <col align="left" valign="middle" width="28%"/> <col align="left" valign="middle" width="21%"/> <thead> <tr class="First Last"> <th align="left" class="Lrule Rrule">Imaging Procedure</th><th align="center" class="Rrule">Concentration<br/>(mg Iodine/mL)</th><th align="left" class="Rrule">Volume per Body Weight to Administer per Single Injection</th><th align="left" class="Rrule">Maximum Cumulative Volume</th> </tr> </thead> <tfoot> <tr> <td align="left" colspan="4"> <dl class="Footnote"> <dt> <a href="#footnote-reference-11" name="footnote-11">*</a> </dt> <dd>Use single-dose containers or 500 mL Pharmacy Bulk Packages <span class="Italics">[see <a href="#S2.11">Dosage and Administration (2.11)</a>].</span> </dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule" rowspan="2">Cardiac Ventriculography</td><td align="center" class="Rrule">300<a class="Sup" href="#footnote-11" name="footnote-reference-11">*</a></td><td align="left" class="Rrule">1.75 mL/kg<br/>(Range of 1.5 mL/kg to 2 mL/kg)</td><td align="left" class="Rrule">6 mL/kg up to a total volume of 290 mL</td> </tr> <tr class="Botrule"> <td align="center" class="Rrule">350<a class="Sup" href="#footnote-11">*</a></td><td align="left" class="Rrule">1.25 mL/kg<br/>(Range of 1 mL/kg to 1.5 mL/kg)</td><td align="left" class="Rrule">5 mL/kg up to a total volume of 250 mL</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Aortography (aortic root, aortic arch, and descending aorta)</td><td align="center" class="Rrule">350<a class="Sup" href="#footnote-11">*</a></td><td align="left" class="Rrule">1 mL/kg</td><td align="left" class="Rrule">5 mL/kg up to a total volume of 250 mL</td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule">Pulmonary Angiography</td><td align="center" class="Rrule">350<a class="Sup" href="#footnote-11">*</a></td><td align="left" class="Rrule">1 mL/kg</td><td align="left" class="Rrule" valign="top">5 mL/kg up to a total volume of 250 mL</td> </tr> </tbody> </table></div>

Recommended Dosage for Intravenous Procedures in Pediatric Patients

The recommended doses for intravenous procedures in pediatric patients are shown in Table 10.

<div class="scrollingtable"><table width="85%"> <caption> <span>Table 10. Recommended Concentrations and Volumes of OMNIPAQUE Injection per Body Weight for Intravenous Procedures in Pediatric Patients</span> </caption> <col align="left" valign="middle" width="26%"/> <col align="center" valign="middle" width="22%"/> <col align="left" valign="middle" width="52%"/> <thead> <tr class="First Last"> <th align="left" class="Lrule Rrule">Imaging Procedure</th><th align="center" class="Rrule">Concentration<br/>(mg Iodine/mL)</th><th align="left" class="Rrule">Volume per Body Weight to Administer</th> </tr> </thead> <tfoot> <tr> <td align="left" colspan="3"> <dl class="Footnote"> <dt> <a href="#footnote-reference-12" name="footnote-12">*</a> </dt> <dd>Use single-dose containers or 500 mL Pharmacy Bulk Packages <span class="Italics">[see <a href="#S2.11">Dosage and Administration (2.11)</a>].</span> </dd> <dt> <a href="#footnote-reference-13" name="footnote-13">†</a> </dt> <dd>Use single-dose containers, 500 mL Imaging or Pharmacy Bulk Packages, or 150 mL single-dose bottles with an automated contrast injection system or contrast management system <span class="Italics"> [see <a href="#S2.10">Dosage and Administration (2.10</a>, <a href="#S2.11">2.11</a>, <a href="#S2.12">2.12)</a>].</span> </dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule">Excretory Urography</td><td align="center" class="Rrule">300<a class="Sup" href="#footnote-12" name="footnote-reference-12">*</a></td><td align="left" class="Rrule">0.5 mL/kg to 3 mL/kg<br/>(Maximum single dose: 116 mL)</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" rowspan="2">CT of the Head and Body</td><td align="center" class="Rrule">240<a class="Sup" href="#footnote-12">*</a></td><td align="left" class="Rrule" rowspan="2">1 mL/kg to 2 mL/kg (with maximum 3 mL/kg)<br/>(Maximum single dose: 116 mL)</td> </tr> <tr class="Last"> <td align="center" class="Rrule">300<a class="Sup" href="#footnote-13" name="footnote-reference-13">†</a></td> </tr> </tbody> </table></div>

Recommended Dosage for Radiographic Examination of the GI Tract in Pediatric Patients

<div class="scrollingtable"><table width="85%"> <caption> <span>Table 11. Recommended Concentrations and Volumes of OMNIPAQUE Injection Based on Age for Radiographic Examination of the GI Tract in Pediatric Patients</span> </caption> <col align="left" valign="middle" width="24%"/> <col align="center" valign="middle" width="23%"/> <col align="left" valign="middle" width="29%"/> <col align="center" valign="middle" width="24%"/> <thead> <tr class="First Last"> <th align="left" class="Lrule Rrule">Age</th><th align="center" class="Rrule">Concentration<br/>(mg iodine/mL)</th><th align="center" class="Rrule">Oral Volume</th><th align="center" class="Rrule">Rectal Volume</th> </tr> </thead> <tfoot> <tr> <td align="left" colspan="4"> <dl class="Footnote"> <dt> <a href="#footnote-reference-14" name="footnote-14">*</a> </dt> <dd>Use single-dose containers or 500 mL Pharmacy Bulk Packages <span class="Italics">[see <a href="#S2.11">Dosage and Administration (2.11)</a>]</span>.</dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule">Less than 3 months</td><td align="center" class="Rrule">180<a class="Sup" href="#footnote-14" name="footnote-reference-14">*</a></td><td align="left" class="Rrule">5 mL to 30 mL</td><td align="center" class="Rrule" rowspan="4" valign="middle">May be a larger volume than the volume given orally<br/>(up to 300 mL)</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">3 months to 3 years</td><td align="center" class="Rrule" rowspan="3" valign="middle">180<a class="Sup" href="#footnote-14">*</a>, 240<a class="Sup" href="#footnote-14">*</a>, or 300<a class="Sup" href="#footnote-14">*</a></td><td align="left" class="Rrule">Up to 60 mL</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">4 years to 10 years</td><td align="left" class="Rrule">Up to 80 mL</td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule">Greater than 10 years</td><td align="left" class="Rrule">Up to 100 mL</td> </tr> </tbody> </table></div>

Recommended Dosage for CT of the Abdomen and Pelvis in Conjunction with Intravenous Administration of OMNIPAQUE in Pediatric Patients

The recommended oral dose using diluted OMNIPAQUE injection or OMNIPAQUE oral solution and concurrent intravenous dose for CT of the abdomen and pelvis in pediatric patients are shown in Table 12.

<div class="scrollingtable"><table width="85%"> <caption> <span>Table 12. Recommended Concentrations and Volumes of Diluted OMNIPAQUE Injection or OMNIPAQUE Oral Solution for Oral Administration and Concurrent Intravenous OMNIPAQUE Injection for CT of the Abdomen and Pelvis in Pediatric Patients</span> </caption> <col align="left" valign="middle" width="23%"/> <col align="left" valign="middle" width="19%"/> <col align="left" valign="middle" width="32%"/> <col align="left" valign="middle" width="26%"/> <thead> <tr class="First Last"> <th align="center" class="Lrule Rrule">Concentration<br/>(mg Iodine/mL)</th><th align="center" class="Rrule" valign="top">Volume to Administer</th><th align="center" class="Rrule" valign="top">Administration Instructions</th><th align="center" class="Rrule" valign="top">Maximum Dose by Age or Body Weight</th> </tr> </thead> <tfoot> <tr> <td align="left" colspan="4"> <dl class="Footnote"> <dt> <a href="#footnote-reference-15" name="footnote-15">*</a> </dt> <dd>See <a href="#Table13">Table 13</a> for dilution instructions of OMNIPAQUE injection</dd> <dt> <a href="#footnote-reference-16" name="footnote-16">†</a> </dt> <dd>Use single-dose containers, 500 mL Imaging or Pharmacy Bulk Packages, or 150 mL single-dose bottles with an automated contrast injection system or contrast management system<span class="Italics"> [see <a href="#S2.10">Dosage and Administration (2.10</a>, <a href="#S2.11">2.11</a>, <a href="#S2.12">2.12)</a>].</span> </dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule" colspan="4"><span class="Italics">Oral Dose Using Diluted OMNIPAQUE Injection</span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" valign="top">9 mg Iodine/mL to 21 mg Iodine/mL of Diluted OMNIPAQUE Injection<a class="Sup" href="#footnote-15" name="footnote-reference-15">*</a></td><td align="left" class="Rrule">180 mL to 750 mL</td><td align="left" class="Rrule"> <ul> <li>Administer the oral dose all at once or over a period of up to 45 minutes if there is difficulty in consuming the required volume.</li> <li>Use a higher iodine concentration of the diluted product if a smaller volume needs to be administered (see <a href="#Table13">Table 13</a>).</li> </ul> </td><td align="left" class="Rrule"> <ul> <li>less than 3 years old: 5 grams iodine</li> <li>3 years old to 18 years old: 10 grams iodine</li> </ul> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="4"><span class="Italics">Oral Dose Using OMNIPAQUE Oral Solution</span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">6 mg Iodine/mL or 12 mg Iodine/mL of OMNIPAQUE Oral Solution</td><td align="left" class="Rrule">180 mL to 750 mL</td><td align="left" class="Rrule">Administer the oral dose all at once or over a period of up to 45 minutes if there is difficulty in consuming the required volume.</td><td align="left" class="Rrule"> <ul> <li>less than 3 years old: 5 grams iodine</li> <li>3 years old to 18 years old: 10 grams iodine</li> </ul> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="4"><span class="Italics">Intravenous Dose in Conjunction with Oral Administration</span></td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule">240<a class="Sup" href="#footnote-16">†</a> or 300<a class="Sup" href="#footnote-16" name="footnote-reference-16">†</a></td><td align="left" class="Rrule">2 mL/kg body weight (with a range of 1 mL/kg to 2 mL/kg)</td><td align="left" class="Rrule">Administer up to 60 minutes AFTER consumption of the oral dose.</td><td align="left" class="Rrule">3 mL/kg (maximum single dose: 116 mL)</td> </tr> </tbody> </table></div>

Preparation of Diluted OMNIPAQUE Injection for Oral Administration for CT of the Abdomen and Pelvis in Pediatric Patients

<div class="scrollingtable"><table width="85%"> <caption> <span>Table 13. Volumes of OMNIPAQUE Injection and Added Liquid to Dilute OMNIPAQUE Injection for Oral Administration for CT of the Abdomen and Pelvis in Pediatric Patients</span> </caption> <col align="center" valign="top" width="16%"/> <col align="center" valign="middle" width="16%"/> <col align="center" valign="middle" width="12%"/> <col align="center" valign="middle" width="16%"/> <col align="center" valign="middle" width="12%"/> <col align="center" valign="middle" width="16%"/> <col align="center" valign="middle" width="12%"/> <thead> <tr class="First"> <th align="center" class="Lrule Rrule" rowspan="2">Concentration of Diluted OMNIPAQUE injection<br/>(mg iodine/mL)</th><th align="center" class="Botrule Rrule" colspan="2">Dilution Method 1</th><th align="center" class="Botrule Rrule" colspan="2"> Dilution Method 2</th><th align="center" class="Botrule Rrule" colspan="2">Dilution Method 3</th> </tr> <tr class="Last"> <th align="center" class="Rrule">Volume of OMNIPAQUE 240 mg iodine/mL<br/>(mL)</th><th align="center" class="Rrule">Volume of Added Liquid<a class="Sup" href="#footnote-17" name="footnote-reference-17">*</a> <br/> (mL)</th><th align="center" class="Rrule">Volume of OMNIPAQUE 300 mg Iodine/mL<br/>(mL)</th><th align="center" class="Rrule">Volume of Added Liquid<a class="Sup" href="#footnote-17">*</a> <br/>(mL)</th><th align="center" class="Rrule">Volume of OMNIPAQUE 350 mg Iodine/mL<br/> (mL)</th><th align="center" class="Rrule">Volume of Added Liquid<a class="Sup" href="#footnote-17">*</a> <br/> (mL)</th> </tr> </thead> <tfoot> <tr> <td align="left" colspan="7"> <dl class="Footnote"> <dt> <a href="#footnote-reference-17" name="footnote-17">*</a> </dt> <dd>Use water, carbonated beverage, milk, infant formula, or juice.</dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="Botrule First"> <td align="center" class="Lrule Rrule">6</td><td align="center" class="Rrule">25</td><td align="center" class="Rrule">975</td><td align="center" class="Rrule">20</td><td align="center" class="Rrule">980</td><td align="center" class="Rrule">17</td><td align="center" class="Rrule">983</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">9</td><td align="center" class="Rrule">38</td><td align="center" class="Rrule">962</td><td align="center" class="Rrule">30</td><td align="center" class="Rrule">970</td><td align="center" class="Rrule">26</td><td align="center" class="Rrule">974</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">12</td><td align="center" class="Rrule">50</td><td align="center" class="Rrule">950</td><td align="center" class="Rrule">40</td><td align="center" class="Rrule">960</td><td align="center" class="Rrule">35</td><td align="center" class="Rrule">965</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">15</td><td align="center" class="Rrule">63</td><td align="center" class="Rrule">937</td><td align="center" class="Rrule">50</td><td align="center" class="Rrule">950</td><td align="center" class="Rrule">43</td><td align="center" class="Rrule">957</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">18</td><td align="center" class="Rrule">75</td><td align="center" class="Rrule">925</td><td align="center" class="Rrule">60</td><td align="center" class="Rrule">940</td><td align="center" class="Rrule">52</td><td align="center" class="Rrule">948</td> </tr> <tr class="Last"> <td align="center" class="Lrule Rrule">21</td><td align="center" class="Rrule">88</td><td align="center" class="Rrule">912</td><td align="center" class="Rrule">70</td><td align="center" class="Rrule">930</td><td align="center" class="Rrule">60</td><td align="center" class="Rrule">940</td> </tr> </tbody> </table></div>

Recommended Dosage for Voiding Cystourethrography in Pediatric Patients

<div class="scrollingtable"><table width="85%"> <caption> <span>Table 14. Volume Ranges of Diluted OMNIPAQUE Injection for VCU in Pediatric Patients</span> </caption> <col align="center" valign="top" width="50%"/> <col align="left" valign="top" width="50%"/> <thead> <tr class="First Last"> <th align="center" class="Lrule Rrule">Concentration of Diluted OMNIPAQUE Injection<a class="Sup" href="#footnote-18" name="footnote-reference-18">*</a> <br/>(mg iodine/mL)</th><th align="left" class="Rrule">Volume to Administer</th> </tr> </thead> <tfoot> <tr> <td align="left" colspan="2"> <dl class="Footnote"> <dt> <a href="#footnote-reference-18" name="footnote-18">*</a> </dt> <dd>See <a href="#Tb15">Table 15</a> below for dilution instructions of OMNIPAQUE injection.</dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="Botrule First"> <td align="center" class="Lrule Rrule">50</td><td align="left" class="Rrule">50 mL to 600 mL by intravesical administration</td> </tr> <tr class="Last"> <td align="center" class="Lrule Rrule">100</td><td align="left" class="Rrule">50 mL to 300 mL by intravesical administration</td> </tr> </tbody> </table></div>

<div class="scrollingtable"><table width="85%"> <caption> <span>Table 15. Volumes of OMNIPAQUE Injection and Sterile Water for Injection to Dilute OMNIPAQUE Injection for VCU in Pediatric Patients</span> </caption> <col align="center" valign="top" width="16%"/> <col align="center" valign="top" width="16%"/> <col align="center" valign="top" width="12%"/> <col align="center" valign="top" width="16%"/> <col align="center" valign="top" width="12%"/> <col align="center" valign="top" width="16%"/> <col align="center" valign="top" width="12%"/> <thead> <tr class="First"> <th align="center" class="Lrule Rrule" rowspan="2">Concentration of Diluted OMNIPAQUE injection<br/>(mg iodine/mL)</th><th align="center" class="Botrule Rrule" colspan="2">Dilution Method 1</th><th align="center" class="Botrule Rrule" colspan="2"> Dilution Method 2</th><th align="center" class="Botrule Rrule" colspan="2">Dilution Method 3</th> </tr> <tr class="Last"> <th align="center" class="Rrule">Volume of OMNIPAQUE 240 mg Iodine/mL<br/>(mL)</th><th align="center" class="Rrule">Volume of Sterile Water for Injection<br/> (mL)</th><th align="center" class="Rrule">Volume of OMNIPAQUE 300 mg Iodine/mL<br/>(mL)</th><th align="center" class="Rrule">Volume of Sterile Water for Injection<br/>(mL)</th><th align="center" class="Rrule">Volume of OMNIPAQUE 350 mg Iodine/mL<br/> (mL)</th><th align="center" class="Rrule">Volume of Sterile Water for Injection<br/> (mL)</th> </tr> </thead> <tbody> <tr class="Botrule First"> <td align="center" class="Lrule Rrule">50</td><td align="center" class="Rrule">100</td><td align="center" class="Rrule">380</td><td align="center" class="Rrule">100</td><td align="center" class="Rrule">500</td><td align="center" class="Rrule">100</td><td align="center" class="Rrule">600</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">60</td><td align="center" class="Rrule">100</td><td align="center" class="Rrule">300</td><td align="center" class="Rrule">100</td><td align="center" class="Rrule">400</td><td align="center" class="Rrule">100</td><td align="center" class="Rrule">483</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">70</td><td align="center" class="Rrule">100</td><td align="center" class="Rrule">243</td><td align="center" class="Rrule">100</td><td align="center" class="Rrule">330</td><td align="center" class="Rrule">100</td><td align="center" class="Rrule">400</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">80</td><td align="center" class="Rrule">100</td><td align="center" class="Rrule">200</td><td align="center" class="Rrule">100</td><td align="center" class="Rrule">275</td><td align="center" class="Rrule">100</td><td align="center" class="Rrule">338</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">90</td><td align="center" class="Rrule">100</td><td align="center" class="Rrule">167</td><td align="center" class="Rrule">100</td><td align="center" class="Rrule">233</td><td align="center" class="Rrule">100</td><td align="center" class="Rrule">289</td> </tr> <tr class="Last"> <td align="center" class="Lrule Rrule">100</td><td align="center" class="Rrule">100</td><td align="center" class="Rrule">140</td><td align="center" class="Rrule">100</td><td align="center" class="Rrule">200</td><td align="center" class="Rrule">100</td><td align="center" class="Rrule">250</td> </tr> </tbody> </table></div>

Injection and Oral Solution: Colorless to pale yellow solution available in the following presentations:

{ "type": "p", "children": [], "text": "Injection and Oral Solution: Colorless to pale yellow solution available in the following presentations:" }

<div class="scrollingtable"><table width="85%"> <col align="center" valign="middle" width="19%"/> <col align="center" valign="middle" width="19%"/> <col align="left" valign="middle" width="30%"/> <col align="left" valign="middle" width="32%"/> <thead> <tr class="First Last"> <th align="center" class="Lrule Rrule">Dosage Form</th><th align="center" class="Rrule">Concentration<br/> (mg of iodine/mL)</th><th align="center" class="Rrule">Package Size</th><th align="center" class="Rrule">Package Type</th> </tr> </thead> <tfoot> <tr> <td align="left" colspan="4"> <dl class="Footnote"> <dt> <a href="#footnote-reference-19" name="footnote-19">*</a> </dt> <dd>OMNIPAQUE injection 300 mg iodine/mL and OMNIPAQUE injection 350 mg iodine/mL in bottles of 500 mL can be used as either an Imaging Bulk Package or a Pharmacy Bulk Package<span class="Italics"> [see <a href="#S2.10">Dosage and Administration (2.10</a>, <a href="#S2.11">2.11)</a>].</span> </dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="Botrule First"> <td align="center" class="Lrule Rrule" rowspan="9" valign="middle">Injection</td><td align="center" class="Rrule">140</td><td align="left" class="Rrule">50 mL</td><td align="left" class="Rrule">Single-Dose Bottle</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">180</td><td align="left" class="Rrule">10 mL</td><td align="left" class="Rrule">Single-Dose Vial</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" rowspan="2" valign="middle">240</td><td align="left" class="Rrule">10 mL and 20 mL</td><td align="left" class="Rrule">Single-Dose Vial</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">50 mL and 100 mL</td><td align="left" class="Rrule">Sigle-Dose Bottle</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" rowspan="3" valign="middle">300</td><td align="left" class="Rrule">10 mL</td><td align="left" class="Rrule">Single-Dose Vial</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">30 mL, 50 mL, 100 mL, 125 mL, and 150 mL</td><td align="left" class="Rrule">Single-Dose Bottle</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">500 mL<a class="Sup" href="#footnote-19" name="footnote-reference-19">*</a></td><td align="left" class="Rrule">Imaging or Pharmacy Bulk Package</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" rowspan="2" valign="middle">350</td><td align="left" class="Rrule">50 mL, 75 mL, 100 mL, 125 mL, 150 mL, and 200 mL</td><td align="left" class="Rrule">Single-Dose Bottle</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">500 mL<a class="Sup" href="#footnote-19">*</a></td><td align="left" class="Rrule">Imaging or Pharmacy Bulk Package</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" rowspan="2" valign="middle">Oral Solution</td><td align="center" class="Rrule">9</td><td align="left" class="Rrule">500 mL</td><td align="left" class="Rrule">Single-Dose Bottle</td> </tr> <tr class="Last"> <td align="center" class="Lrule Rrule">12</td><td align="left" class="Rrule">500 mL</td><td align="left" class="Rrule">Single-Dose Bottle</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"85%\">\n<col align=\"center\" valign=\"middle\" width=\"19%\"/>\n<col align=\"center\" valign=\"middle\" width=\"19%\"/>\n<col align=\"left\" valign=\"middle\" width=\"30%\"/>\n<col align=\"left\" valign=\"middle\" width=\"32%\"/>\n<thead>\n<tr class=\"First Last\">\n<th align=\"center\" class=\"Lrule Rrule\">Dosage Form</th><th align=\"center\" class=\"Rrule\">Concentration<br/> (mg of iodine/mL)</th><th align=\"center\" class=\"Rrule\">Package Size</th><th align=\"center\" class=\"Rrule\">Package Type</th>\n</tr>\n</thead>\n<tfoot>\n<tr>\n<td align=\"left\" colspan=\"4\">\n<dl class=\"Footnote\">\n<dt>\n<a href=\"#footnote-reference-19\" name=\"footnote-19\">*</a>\n</dt>\n<dd>OMNIPAQUE injection 300 mg iodine/mL and OMNIPAQUE injection 350 mg iodine/mL in bottles of 500 mL can be used as either an Imaging Bulk Package or a Pharmacy Bulk Package<span class=\"Italics\"> [see <a href=\"#S2.10\">Dosage and Administration (2.10</a>, <a href=\"#S2.11\">2.11)</a>].</span>\n</dd>\n</dl>\n</td>\n</tr>\n</tfoot>\n<tbody>\n<tr class=\"Botrule First\">\n<td align=\"center\" class=\"Lrule Rrule\" rowspan=\"9\" valign=\"middle\">Injection</td><td align=\"center\" class=\"Rrule\">140</td><td align=\"left\" class=\"Rrule\">50 mL</td><td align=\"left\" class=\"Rrule\">Single-Dose Bottle</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\">180</td><td align=\"left\" class=\"Rrule\">10 mL</td><td align=\"left\" class=\"Rrule\">Single-Dose Vial</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\" rowspan=\"2\" valign=\"middle\">240</td><td align=\"left\" class=\"Rrule\">10 mL and 20 mL</td><td align=\"left\" class=\"Rrule\">Single-Dose Vial</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\">50 mL and 100 mL</td><td align=\"left\" class=\"Rrule\">Sigle-Dose Bottle</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\" rowspan=\"3\" valign=\"middle\">300</td><td align=\"left\" class=\"Rrule\">10 mL</td><td align=\"left\" class=\"Rrule\">Single-Dose Vial</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\">30 mL, 50 mL, 100 mL, 125 mL, and 150 mL</td><td align=\"left\" class=\"Rrule\">Single-Dose Bottle</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\">500 mL<a class=\"Sup\" href=\"#footnote-19\" name=\"footnote-reference-19\">*</a></td><td align=\"left\" class=\"Rrule\">Imaging or Pharmacy Bulk Package</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\" rowspan=\"2\" valign=\"middle\">350</td><td align=\"left\" class=\"Rrule\">50 mL, 75 mL, 100 mL, 125 mL, 150 mL, and 200 mL</td><td align=\"left\" class=\"Rrule\">Single-Dose Bottle</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\">500 mL<a class=\"Sup\" href=\"#footnote-19\">*</a></td><td align=\"left\" class=\"Rrule\">Imaging or Pharmacy Bulk Package</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\" rowspan=\"2\" valign=\"middle\">Oral Solution</td><td align=\"center\" class=\"Rrule\">9</td><td align=\"left\" class=\"Rrule\">500 mL</td><td align=\"left\" class=\"Rrule\">Single-Dose Bottle</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"center\" class=\"Lrule Rrule\">12</td><td align=\"left\" class=\"Rrule\">500 mL</td><td align=\"left\" class=\"Rrule\">Single-Dose Bottle</td>\n</tr>\n</tbody>\n</table></div>" }

OMNIPAQUE for hysterosalpingography is contraindicated during pregnancy or suspected pregnancy, menstruation or when menstruation is imminent, within 6 months after termination of pregnancy, within 30 days after conization or curettage, when signs of infection are present in any portion of the genital tract including the external genitalia, and when reproductive tract neoplasia is known or suspected because of the risk of peritoneal spread of neoplasm.

{ "type": "p", "children": [], "text": "OMNIPAQUE for hysterosalpingography is contraindicated during pregnancy or suspected pregnancy, menstruation or when menstruation is imminent, within 6 months after termination of pregnancy, within 30 days after conization or curettage, when signs of infection are present in any portion of the genital tract including the external genitalia, and when reproductive tract neoplasia is known or suspected because of the risk of peritoneal spread of neoplasm." }

Use only the iodine concentrations and presentations recommended for intrathecal procedures [see Dosage and Administration (2.2, 2.8)]. Intrathecal administration of OMNIPAQUE of a wrong iodine concentration, even if inadvertent, can cause death, convulsions, seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema.

Adverse reactions such as hemolysis may occur if OMNIPAQUE oral solution is administered intravenously or intraarterially due to low osmolality [see Description (11)]. OMNIPAQUE oral solution is for oral use only.

OMNIPAQUE can cause life-threatening or fatal hypersensitivity reactions including anaphylaxis. Manifestations include respiratory arrest, laryngospasm, bronchospasm, angioedema, and shock. Most severe reactions develop shortly after the start of the injection (within 1 to 3 minutes), but delayed reactions can also occur. There is an increased risk in patients with a history of a previous reaction to contrast agent and known allergic disorders (i.e., bronchial asthma, drug, or food allergies) or other hypersensitivities. Premedication with antihistamines or corticosteroids does not prevent serious life-threatening reactions but may reduce both their incidence and severity.

Obtain a history of allergy, hypersensitivity, or hypersensitivity reactions to iodinated contrast agents and always have emergency resuscitation equipment and trained personnel available prior to OMNIPAQUE administration. Monitor all patients for hypersensitivity reactions.

Acute kidney injury, including renal failure, may occur after parenteral administration of OMNIPAQUE. Risk factors include: pre-existing renal impairment, dehydration, diabetes mellitus, congestive heart failure, advanced vascular disease, elderly age, concomitant use of nephrotoxic or diuretic medications, multiple myeloma/paraproteinaceous diseases, repetitive and/or large doses of an iodinated contrast agent.

Use the lowest necessary dose of OMNIPAQUE in patients with renal impairment. Adequately hydrate patients prior to and following parenteral administration of OMNIPAQUE. Do not use laxatives, diuretics, or preparatory dehydration prior to OMNIPAQUE administration.

Life-threatening or fatal cardiovascular reactions including hypotension, shock, cardiac arrest have occurred with the parenteral administration of OMNIPAQUE. Most deaths occur during injection or five to ten minutes later, with cardiovascular disease as the main aggravating factor. Cardiac decompensation, serious arrhythmias, and myocardial ischemia or infarction can occur during coronary arteriography and ventriculography.

Based on clinical literature, reported deaths from the administration of iodinated contrast agents range from 6.6 per million (0.00066%) to 1 in 10,000 (0.01%). Use the lowest necessary dose of OMNIPAQUE in patients with congestive heart failure and always have emergency resuscitation equipment and trained personnel available. Monitor all patients for severe cardiovascular reactions.

Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke can occur during angiocardiography procedures with iodinated contrast agents including OMNIPAQUE. During these procedures, increased thrombosis and activation of the complement system occurs. Risk factors for thromboembolic events include: length of procedure, catheter and syringe material, underlying disease state, and concomitant medications.

To minimize thromboembolic events, use meticulous angiographic techniques, and minimize the length of the procedure. Avoid blood remaining in contact with syringes containing OMNIPAQUE, which increases the risk of clotting. Avoid angiocardiography in patients with homocystinuria because of the risk of inducing thrombosis and embolism.

Extravasation of OMNIPAQUE during intravenous or intra-arterial injection may cause tissue necrosis and/or compartment syndrome, particularly in patients with severe arterial or venous disease. Ensure intravenous or intra-arterial placement of catheters prior to injection. Monitor patients for extravasation and advise patients to seek medical care for progression of symptoms.

Thyroid storm has occurred after the intravenous or intra-arterial use of iodinated contrast agents in patients with hyperthyroidism, or with an autonomously functioning thyroid nodule. Evaluate the risk in such patients before use of OMNIPAQUE.

Thyroid dysfunction characterized by hypothyroidism or transient thyroid suppression has been reported after both single exposure and multiple exposures to iodinated contrast media (ICM) in pediatric patients 0 to 3 years of age.

Younger age, very low birth weight, prematurity, underlying medical conditions affecting thyroid function, admission to neonatal or pediatric intensive care units, and congenital cardiac conditions are associated with an increased risk of hypothyroidism after ICM exposure. Pediatric patients with congenital cardiac conditions may be at the greatest risk given that they often require high doses of contrast during invasive cardiac procedures.

An underactive thyroid during early life may be harmful for cognitive and neurological development and may require thyroid hormone replacement therapy. After exposure to ICM, individualize thyroid function monitoring based on underlying risk factors, especially in term and preterm neonates.

Hypertensive crisis has occurred after the use of iodinated contrast agents in patient with pheochromocytoma. Monitor patients when administering OMNIPAQUE intravenously or intra-arterially if pheochromocytoma or catecholamine-secreting paragangliomas are suspected. Inject the minimum amount of contrast necessary, assess the blood pressure throughout the procedure, and have measures for treatment of a hypertensive crisis readily available.

Iodinated contrast agents when administered intravenously or intra-arterially may promote sickling in individuals who are homozygous for sickle cell disease. Hydrate patients prior to and following OMNIPAQUE administration and use OMNIPAQUE only if the necessary imaging information cannot be obtained with alternative imaging modalities.

Severe cutaneous adverse reactions (SCAR) may develop from 1 hour to several weeks after intravenous or intra-arterial contrast agent administration. These reactions include Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous pustulosis (AGEP) and drug reaction with eosinophilia and systemic symptoms (DRESS). Reaction severity may increase and time to onset may decrease with repeat administration of contrast agents; prophylactic medications may not prevent or mitigate severe cutaneous adverse reactions. Avoid administering OMNIPAQUE to patients with a history of a severe cutaneous adverse reaction to OMNIPAQUE.

OMNIPAQUE can interfere with protein-bound iodine test [see Drug Interactions (7.2)].

Focal and generalized motor seizures have been reported after intrathecal use of iodinated contrast agents. In several of the cases, higher than recommended doses were administered.

Use of medications that may lower the seizure threshold (phenothiazine derivatives, including those used for their antihistaminic properties; tricyclic antidepressants; MAO inhibitors; CNS stimulants; analeptics; antipsychotic agents) should be carefully evaluated. Consider discontinuing these agents at least 48 hours before and for at least 24 hours following intrathecal administration of OMNIPAQUE.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Intrathecal Administration

Adults

Adverse reactions (≥1%) in 1,531 adult patients following intrathecal administration of OMNIPAQUE in clinical trials are presented in Table 16.

<div class="scrollingtable"><table width="85%"> <caption> <span>Table 16. Adverse Reactions (≥1%) in in Adult Patients Following Intrathecal Administration of OMNIPAQUE in Clinical Trials</span> </caption> <col align="left" valign="middle" width="44%"/> <col align="left" valign="middle" width="46%"/> <col align="center" valign="middle" width="10%"/> <thead> <tr class="First Last"> <th align="left" class="Lrule Rrule">System Organ Class</th><th align="center" class="Rrule">Adverse Reaction</th><th align="center" class="Rrule" valign="top">Incidence<br/>N=1,531</th> </tr> </thead> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule">Nervous system disorders</td><td align="left" class="Rrule">Headaches</td><td align="center" class="Rrule">18%</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Musculoskeletal and connective tissue disorders</td><td align="left" class="Rrule">Pain including backache, neckache, stiffness, neuralgia</td><td align="center" class="Rrule">8%</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" rowspan="2" valign="middle">Gastrointestinal disorders</td><td align="left" class="Rrule">Nausea</td><td align="center" class="Rrule">6%</td> </tr> <tr class="Botrule"> <td align="left" class="Rrule">Vomiting</td><td align="center" class="Rrule">3%</td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule">Nervous System disorders</td><td align="left" class="Rrule">Dizziness</td><td align="center" class="Rrule">2%</td> </tr> </tbody> </table></div>

Other adverse reactions (<1%) were:

Pediatric Patients

The adverse reactions reported in pediatric patients following intrathecal administration of OMNIPAQUE were generally similar to those reported in adults. A total of 152 pediatric patients were administered OMNIPAQUE 180 mg iodine/mL intrathecally by lumbar puncture for pediatric myelography in clinical trials. Adverse reactions (≥1%) are presented in Table 17.

<div class="scrollingtable"><table width="85%"> <caption> <span>Table 17. Adverse Reactions (≥1%) in Pediatric Patients Following Intrathecal Administration of OMNIPAQUE 180 mg iodine/mL by Lumbar Puncture for Myelography in Clinical Trials</span> </caption> <col align="left" valign="middle" width="44%"/> <col align="left" valign="top" width="40%"/> <col align="center" valign="middle" width="16%"/> <thead> <tr class="First Last"> <th align="left" class="Lrule Rrule">System Organ Class</th><th align="center" class="Rrule" valign="middle">Adverse Reaction</th><th align="center" class="Rrule" valign="top">Incidence<br/>N=152</th> </tr> </thead> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule">Nervous system disorders</td><td align="left" class="Rrule">Headache</td><td align="center" class="Rrule">9%</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Gastrointestinal disorders</td><td align="left" class="Rrule">Vomiting</td><td align="center" class="Rrule">6%</td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule">Musculoskeletal and connective tissue disorders</td><td align="left" class="Rrule">Backache</td><td align="center" class="Rrule">1.3%</td> </tr> </tbody> </table></div>

Other adverse reactions (<1%) were:

Intra-arterial or Intravenous Administration

Adults

Adverse reactions (≥1%) in 1,485 adult patients following intra-arterial or intravenous administration of OMNIPAQUE in clinical trials are presented in Table 18.

<div class="scrollingtable"><table width="85%"> <caption> <span>Table 18. Adverse Reactions (≥1%) in Adult Patients Following Intra-arterial or Intravenous Administration of OMNIPAQUE in Clinical Trials </span> </caption> <col align="left" valign="middle" width="34%"/> <col align="left" valign="middle" width="50%"/> <col align="center" valign="middle" width="16%"/> <thead> <tr class="First Last"> <th align="left" class="Lrule Rrule">System Organ Class</th><th align="center" class="Rrule">Adverse Reaction</th><th align="center" class="Rrule" valign="top">Incidence<br/>(N=1,485)</th> </tr> </thead> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule">Cardiac disorders</td><td align="left" class="Rrule">Arrhythmias including PVCs and PACs</td><td align="center" class="Rrule">2%</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" rowspan="3" valign="middle">Nervous system disorders</td><td align="left" class="Rrule">Pain</td><td align="center" class="Rrule">3%</td> </tr> <tr class="Botrule"> <td align="left" class="Rrule">Vision abnormalities including blurred vision and photomas</td><td align="center" class="Rrule">2%</td> </tr> <tr class="Botrule"> <td align="left" class="Rrule">Taste perversion</td><td align="center" class="Rrule">1%</td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule">Gastrointestinal disorders</td><td align="left" class="Rrule">Nausea</td><td align="center" class="Rrule">2%</td> </tr> </tbody> </table></div>

Other adverse reactions (<1%) were:

Pediatric Patients

Adverse reactions reported in pediatric patients following intra-arterial or intravenous administration of OMNIPAQUE were generally similar in quality and frequency to those reported in adults. A total of 391 pediatric patients in clinical trials were administered OMNIPAQUE 240 mg iodine/mL, 300 mg iodine/mL, or 350 mg iodine/mL by intra-arterial or intravenous injection for pediatric cardiac ventriculography, excretory urography, and CT head imaging.

Adverse reactions (≥1%) were vomiting (2%) and nausea (1%).

Other adverse reactions (<1%) were:

Oral or Rectal Administration for Examination of the Gastrointestinal Tract

Adults

A total of 54 adult patients were administered undiluted OMNIPAQUE 350 mg iodine/mL by oral route for radiographic examination of the gastrointestinal tract in clinical trials. Adverse reactions (≥1%) are presented in Table 19.

<div class="scrollingtable"><table width="85%"> <caption> <span>Table 19. Adverse Reactions (≥1%) in Adult Patients Following Oral Administration of Undiluted OMNIPAQUE 350 mg Iodine/mL in Clinical Trials</span> </caption> <col align="left" valign="middle" width="31%"/> <col align="left" valign="top" width="54%"/> <col align="center" valign="top" width="15%"/> <thead> <tr class="First Last"> <th align="left" class="Lrule Rrule">System Organ Class</th><th align="center" class="Rrule" valign="middle">Adverse Reaction</th><th align="center" class="Rrule" valign="middle">Incidence<br/>N=54</th> </tr> </thead> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule" rowspan="5" valign="middle">Gastrointestinal disorders</td><td align="left" class="Rrule">Diarrhea</td><td align="center" class="Rrule">42%</td> </tr> <tr class="Botrule"> <td align="left" class="Rrule" valign="top">Nausea</td><td align="center" class="Rrule">15%</td> </tr> <tr class="Botrule"> <td align="left" class="Rrule" valign="top">Vomiting</td><td align="center" class="Rrule">11%</td> </tr> <tr class="Botrule"> <td align="left" class="Rrule" valign="top">Abdominal Pain</td><td align="center" class="Rrule">7%</td> </tr> <tr class="Botrule"> <td align="left" class="Rrule" valign="top">Flatulence</td><td align="center" class="Rrule">2%</td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule">Nervous system disorders</td><td align="left" class="Rrule">Headache</td><td align="center" class="Rrule">2%</td> </tr> </tbody> </table></div>

Pediatrics Patients

A total of 58 pediatric patients were administered OMNIPAQUE by oral or rectal administration in clinical trials. Adverse reactions (≥1%) are presented in Table 20.

<div class="scrollingtable"><table width="85%"> <caption> <span>Table 20. Adverse Reactions (≥1%) in Pediatric Patients Following Oral or Rectal Administration of OMNIPAQUE in Clinical Trials</span> </caption> <col align="left" valign="middle" width="31%"/> <col align="left" valign="middle" width="54%"/> <col align="center" valign="top" width="15%"/> <thead> <tr class="First Last"> <th align="left" class="Lrule Rrule">System Organ Class</th><th align="center" class="Rrule">Adverse Reaction</th><th align="center" class="Rrule">Incidence<br/>N=58</th> </tr> </thead> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule" rowspan="4" valign="middle">Gastrointestinal disorders</td><td align="left" class="Rrule">Diarrhea</td><td align="center" class="Rrule">36%</td> </tr> <tr class="Botrule"> <td align="left" class="Rrule">Vomiting</td><td align="center" class="Rrule" valign="top">9%</td> </tr> <tr class="Botrule"> <td align="left" class="Rrule">Nausea</td><td align="center" class="Rrule" valign="top">5%</td> </tr> <tr class="Botrule"> <td align="left" class="Rrule">Abdominal pain</td><td align="center" class="Rrule" valign="top">2%</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" valign="top">General disorders and administration site conditions</td><td align="left" class="Rrule">Fever</td><td align="center" class="Rrule">5%</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" valign="top">Skin and subcutaneous tissue disorders</td><td align="left" class="Rrule">Urticaria</td><td align="center" class="Rrule">2%</td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule" valign="top">Vascular disorders</td><td align="left" class="Rrule">Hypotension</td><td align="center" class="Rrule">2%</td> </tr> </tbody> </table></div>

Oral Administration for CT of the Abdomen in Conjunction with Intravenous Administration

Adults

A total of 44 adult patients received diluted OMNIPAQUE (4-9 mg iodine/mL) by oral route in conjunction with intravenously injected OMNIPAQUE 300 mg iodine/mL for CT examination of the abdomen in clinical trials. Adverse reactions (≥1%) were limited to a single report of vomiting (2.3%).

Pediatric Patients

A total of 69 pediatric patients received diluted OMNIPAQUE (9-29 mg iodine/mL) by oral route in conjunction with intravenously administered OMNIPAQUE 240 mg iodine/mL or OMNIPAQUE 300 mg iodine/mL for CT examination of the abdomen in clinical trials. Adverse reactions (≥1%) were limited to a single report of vomiting (1.4%).

Intraarticular Administration

Arthrography in Adults

A total of 285 adult patients received OMNIPAQUE 240 mg iodine/mL, 300 mg iodine/mL, or 350 mg iodine/mL for various body cavity examinations in clinical trials. The most frequent adverse reactions (≥1%) were administration site pain (26%) and swelling (22%) in arthrography. Patients also experienced heat (7%).

Body Cavity Use

VCU in Pediatric Patients

No new adverse reactions associated with the use of OMNIPAQUE for VCU procedures were reported in 51 pediatric patients studied.

The following adverse reactions have been identified during post-approval use of OMNIPAQUE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

General

Immune system disorders: Hypersensitivity reactions, anaphylactic or anaphylactoid reactions, anaphylactic or anaphylactoid shock including life-threatening or fatal anaphylaxis

General disorders and administration site conditions: Pyrexia, chills, pain and discomfort, asthenia, administration site conditions including extravasation

Intrathecal Administration

Nervous system disorders: Meningism, aseptic meningitis, seizures or status epilepticus, disorientation, coma, depressed or loss of consciousness, transient contrast-induced toxic encephalopathy (including amnesia, hallucination, paralysis, paresis, speech disorder, aphasia, dysarthria), restlessness, tremors, hypoesthesia

Musculoskeletal and connective tissue disorders: Pain, muscle spasms or spasticity

Psychiatric disorders: Confusional state, agitation, anxiety

Eye disorders: Transient visual impairment including cortical blindness

Renal and urinary disorders: Acute kidney injury

Intra-arterial or Intravenous Administration

Cardiac disorders: Severe cardiac complications (including cardiac arrest, cardiopulmonary arrest), shock, peripheral vasodilatation, palpitations, vasospasm including spasm of coronary arteries, myocardial infarction, syncope, cyanosis, pallor, flushing, chest pain

Vascular disorders: Vasospasm and thrombophlebitis following intravenous injection

Blood and lymphatic system disorders: Neutropenia

Nervous system disorders: Disorientation, coma, depressed or loss of consciousness, transient contrast-induced toxic encephalopathy (including amnesia, hallucination, paralysis, paresis, speech disorder, aphasia, dysarthria), restlessness, tremors, hypoesthesia

Psychiatric disorders: Confusional state, agitation

Eye disorders: Eye irritation or itchiness, periorbital edema, ocular or conjunctival hyperemia, lacrimation

Renal and urinary disorders: Acute kidney injury, toxic nephropathy (CIN), transient proteinuria, oliguria or anuria, increased serum creatinine

Gastrointestinal disorders: Abdominal pain, pancreatitis aggravated, salivary gland enlargement

Endocrine disorders: Hyperthyroidism, hypothyroidism

Respiratory, thoracic and mediastinal disorders: Respiratory distress, respiratory failure, pulmonary edema, bronchospasm, laryngospasm, throat irritation, throat tightness, laryngeal edema, wheezing, chest discomfort, asthmatic attack

Skin and subcutaneous tissue disorders: Contrast media reactions range from mild (e.g., pleomorphic rashes, drug eruption, erythema and skin discoloration, blisters, hyperhidrosis, angioedema, localized areas of edema) to severe (e.g., Stevens-Johnson syndrome and toxic epidermal necrolysis [SJS/TEN], bullous or exfoliative dermatitis, acute generalized exanthematous pustulosis [AGEP] and drug reaction with eosinophilia and systemic symptoms [DRESS])

Oral Administration

Gastrointestinal disorders: Dysphagia, abdominal pain

Body Cavity Administration

Gastrointestinal disorders: Pancreatitis

Musculoskeletal and connective tissue disorders: Arthritis (arthrography)

Hysterosalpingography: Injection of OMNIPAQUE for hysterosalpingography is associated with immediate, transient pain. Monitor injection pressure and volume instilled to minimize pain and to avoid disruptive distention of the uterus and fallopian tubes. Fluoroscopic monitoring is recommended.

Nervous system disorders: Pain (49%), somnolence and fever each with an individual incidence of 3%

Gastrointestinal disorders: Nausea (3%)

Metformin

In patients with renal impairment, metformin can cause lactic acidosis. Iodinated contrast agents appear to increase the risk of metformin-induced lactic acidosis, possibly as a result of worsening renal function. Stop metformin at the time of, or prior to, OMNIPAQUE administration in patients with an eGFR between 30 and 60 mL/min/1.73 m2; in patients with a history of hepatic impairment, alcoholism or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure, and reinstitute metformin only after renal function is stable.

Radioactive Iodine

OMNIPAQUE may interfere with thyroid uptake of radioactive iodine (I-131 and I-123) and decrease therapeutic and diagnostic efficacy. Avoid thyroid therapy or testing for up to 6 weeks post OMNIPAQUE.

Protein-Bound Iodine Test

Iodinated contrast agents, including OMNIPAQUE, will temporarily increase protein-bound iodine in blood. Do not perform protein-bound iodine test for at least 16 days following administration of OMNIPAQUE. However, thyroid function tests that do not depend on iodine estimation, e.g., T3 resin uptake or direct thyroxine assays, are not affected.

Risk Summary

Hysterosalpingography is contraindicated in pregnant women due to the potential risk to the fetus from an intrauterine procedure [see Contraindications (4)]. There are no data with iohexol use in pregnant women to inform any drug-associated risks. Iohexol crosses the placenta and reaches fetal tissues in small amounts (see Data). In animal reproduction studies, no developmental toxicity occurred with intravenous iohexol administration to rats and rabbits at doses up to 0.4 (rat) and 0.5 (rabbit) times the maximum recommended human intravenous dose (see Data).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Data

Human Data

Literature reports show that intravenously administered iohexol crosses the placenta and is visualized in the digestive tract of exposed infants after birth.

Animal Data

Iohexol was neither embryotoxic nor teratogenic in either rats or rabbits at the following dose levels tested: 1.0, 2.0, 4.0 g iodine/kg in rats, administered intravenously to 3 groups of 25 dams once daily during days 6 through 15 of pregnancy; 0.3, 1.0, 2.5 g iodine/kg in rabbits, administered intravenously to 3 groups of 18 rabbits dosed once a day during days 6 through 18 of pregnancy.

Risk Summary

Published literature reports that breast feeding after intravenous iohexol administration to the mother would result in the infant receiving an oral dose of approximately 0.7% of the maternal intravenous dose; however, lactation studies have not been conducted with oral, intrathecal, or intracavity administration of iohexol. There is no information on the effects of the drug on the breastfed infant or on milk production. Iodinated contrast agents are excreted unchanged in human milk in very low amounts with poor absorption from the gastrointestinal tract of a breastfed infant. Exposure to iohexol to a breastfed infant can be minimized by temporary discontinuation of breastfeeding (see Clinical Considerations). The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for OMNIPAQUE and any potential adverse effects on the breastfed infant from OMNIPAQUE or from the underlying maternal condition.

Clinical Considerations

Interruption of breastfeeding after exposure to iodinated contrast agents is not necessary because the potential exposure of the breastfed infant to iodine is small. However, a lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk for 10 hours (approximately 5 elimination half-lives) after OMNIPAQUE administration to minimize drug exposure to a breastfed infant.

Intrathecal Use

The safety and effectiveness of OMNIPAQUE have been established in pediatric patients aged 2 weeks and older for myelography and CT myelography (lumbar, thoracic, cervical, total columnar) and for CT cisternography. Use of OMNIPAQUE is supported by controlled clinical studies in adults for myelography, in addition to clinical studies in pediatric patients undergoing myelography.

The safety and effectiveness of OMNIPAQUE have not been established for intrathecal use in pediatric patients less than 2 weeks of age.

The safety and effectiveness of OMNIPAQUE for CT cerebral ventriculography have not been established in pediatric patients.

Intra-arterial or Intravenous Use

Cardiac Ventriculography, Aortography, and Pulmonary Angiography

The safety and effectiveness of OMNIPAQUE have been established in pediatric patients from birth to 17 years of age for cardiac ventriculography, aortography, and pulmonary angiography. Use of OMNIPAQUE is supported by controlled clinical studies in adults for cardiac ventriculography and aortography, in addition to controlled clinical studies in pediatric patients undergoing cardiac ventriculography, including aortography.

Excretory Urography

The safety and effectiveness of OMNIPQUE have been established in pediatric patients from birth to 17 years of age for excretory urography. Use of OMNIPAQUE is supported by controlled clinical studies in adults for urography, in addition to controlled clinical studies in pediatric patients undergoing urography and clinical safety data in pediatric patients down to birth.

CT of the Head and Body

The safety and effectiveness of OMNIPAQUE have been established in pediatric patients from birth to 17 years of age for CT imaging of the head and body. Use of OMNIPAQUE is supported by controlled clinical studies in adults for head and body CT, in addition to clinical studies in pediatric patients undergoing head CT and in 69 pediatric patients undergoing CT of the abdomen after oral administration of diluted OMNIPAQUE plus intravenous administration of OMNIPAQUE.

Selective Coronary Arteriography, Cerebral and Peripheral Arteriography, Intra-arterial Digital Subtraction Angiography, Peripheral Venography, and Intravenous Digital Subtraction Angiography

The safety and effectiveness of OMNIPAQUE have not been established in pediatric patients for selective coronary arteriography, cerebral or peripheral arteriography, intra-arterial digital subtraction angiography, peripheral venography, and intravenous digital subtraction angiography.

Oral or Rectal Use

Examination of the GI Tract

The safety and effectiveness of OMNIPAQUE have been established in pediatric patients, from birth to 17 years of age for examination of the GI tract. Use of OMNIPAQUE is supported by controlled studies in adults for examination of the GI tract, in addition to clinical studies in pediatric patients undergoing examination of the GI tract.

CT of the Abdomen and Pelvis in Conjunction with Intravenous Use

The safety and effectiveness of OMNIPAQUE for CT of the abdomen and pelvis have been established in pediatric patients from birth to 17 years of age. Use is supported by clinical trials in adults, in addition to clinical studies in 69 pediatric patients undergoing CT of the abdomen.

Intraarticular Use

The safety and effectiveness of OMNIPAQUE have not been established in pediatric patients for arthrography.

Body Cavity Use

Voiding Cystourethrography

OMNIPAQUE is indicated for use in pediatric patients from birth to 17 years of age for voiding cystourethrography (VCU). Use for voiding cystourethrography is supported by clinical studies in 51 pediatric patients undergoing VCU.

ERCP, Herniography, and Hysterosalpingography

The safety and effectiveness of OMNIPAQUE have not been established in pediatric patients for ERCP, herniography, or hysterosalpingography.

In general, the frequency of adverse reactions in pediatric patients was similar to that seen in adults [see Adverse Reactions (6.1)]. Pediatric patients at higher risk of experiencing adverse events during contrast-medium administration may include those having asthma, a sensitivity to medication and/or allergens, congestive heart failure, a serum creatinine greater than 1.5 mg/dL or those less than 12 months of age.

Thyroid function tests indicative of thyroid dysfunction, characterized by hypothyroidism or transient thyroid suppression have been reported following iodinated contrast media administration in pediatric patients, including term and preterm neonates. Some patients were treated for hypothyroidism. After exposure to iodinated contrast media, individualize thyroid function monitoring in pediatric patients 0 to 3 years of age based on underlying risk factors, especially in term and preterm neonates [see Warnings and Precautions (5.9) and Adverse Reactions (6.2)].

In clinical studies of OMNIPAQUE for CT of the head and body, 52 (17%) of patients were 70 and over. No overall differences in safety were observed between these patients and younger patients. Other reported clinical experience has not identified differences in safety and effectiveness between the elderly and younger patients.

Iohexol is substantially excreted by the kidney, and the risk of adverse reactions to iohexol may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

The clearance of iohexol decreases with increasing degree of renal impairment and results in delayed opacification of the urinary system. In addition, preexisting renal impairment increases the risk for acute kidney injury [see Warnings and Precautions (5.4)]. Iohexol can be removed by dialysis.

The adverse effects of overdosage in intra-arterial or intravenous administration are life-threatening and affect mainly the pulmonary and cardiovascular systems. The symptoms include: cyanosis, bradycardia, acidosis, pulmonary hemorrhage, convulsions, coma, and cardiac arrest. Treatment of an overdosage is directed toward the support of all vital functions, and prompt institution of symptomatic therapy. Iohexol can be dialyzed.

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Iohexol is a nonionic radiographic contrast agent available as:

{ "type": "p", "children": [], "text": "Iohexol is a nonionic radiographic contrast agent available as:" }

{ "type": "ul", "children": [ "OMNIPAQUE (iohexol) injection for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular, and body cavity use", "OMNIPAQUE (iohexol) oral solution for oral use" ], "text": "" }

The chemical name of iohexol is Bis(2,3-dihydroxypropyl)-5-[N-(2,3-dihydroxypropyl)-acetamido]-2,4,6- triiodoisophthalamide with a molecular weight of 821.14 (iodine content 46.36%). Iohexol has the following structural formula:

{ "type": "p", "children": [], "text": "The chemical name of iohexol is Bis(2,3-dihydroxypropyl)-5-[N-(2,3-dihydroxypropyl)-acetamido]-2,4,6- triiodoisophthalamide with a molecular weight of 821.14 (iodine content 46.36%). Iohexol has the following structural formula:" }

OMNIPAQUE injection is a sterile, pyrogen-free, colorless to pale yellow solution available in five concentrations of iodine:

{ "type": "p", "children": [], "text": "OMNIPAQUE injection is a sterile, pyrogen-free, colorless to pale yellow solution available in five concentrations of iodine:" }

{ "type": "ul", "children": [ "OMNIPAQUE 140 mg iodine/mL: Each mL contains 302 mg iohexol (providing 140 mg organically bound iodine) and the following inactive ingredients: 0.1 mg edetate calcium disodium and 1.21 mg tromethamine.", "OMNIPAQUE 180 mg iodine/mL: Each mL contains 388 mg iohexol (providing 180 mg organically bound iodine) and the following inactive ingredients: 0.1 mg edetate calcium disodium and 1.21 mg tromethamine.", "OMNIPAQUE 240 mg iodine/mL: Each mL contains 518 mg iohexol (providing 240 mg organically bound iodine) and the following inactive ingredients: 0.1 mg edetate calcium disodium and 1.21 mg tromethamine.", "OMNIPAQUE 300 mg iodine/mL: Each mL contains 647 mg iohexol (providing 300 mg organically bound iodine) and the following inactive ingredients: 0.1 mg edetate calcium disodium and 1.21 mg tromethamine.", "OMNIPAQUE 350 mg iodine/mL: Each mL contains 755 mg iohexol (providing 350 mg organically bound iodine) and the following inactive ingredients: 0.1 mg edetate calcium disodium and 1.21 mg tromethamine." ], "text": "" }

OMNIPAQUE oral solution is a sterile, pyrogen-free, colorless to pale yellow solution available in two concentrations of iodine:

{ "type": "p", "children": [], "text": "OMNIPAQUE oral solution is a sterile, pyrogen-free, colorless to pale yellow solution available in two concentrations of iodine:" }

{ "type": "ul", "children": [ "OMNIPAQUE oral solution 9 mg iodine/mL: Each mL contains 19 mg iohexol (providing 9 mg organically bound iodine) and the following inactive ingredients: 0.1 mg edetate calcium disodium and 1.21 mg tromethamine.", "OMNIPAQUE oral solution 12 mg iodine/mL: Each mL contains 26 mg iohexol (providing 12 mg organically bound iodine) and the following inactive ingredients: 0.1 mg edetate calcium disodium and 1.21 mg tromethamine." ], "text": "" }

The pH is adjusted between 6.8 and 7.7 with hydrochloric acid or sodium hydroxide. OMNIPAQUE injection and OMNIPAQUE oral solution contain no preservatives and no ingredient made from a gluten-containing grain (wheat, barley, or rye).

{ "type": "p", "children": [], "text": "The pH is adjusted between 6.8 and 7.7 with hydrochloric acid or sodium hydroxide. OMNIPAQUE injection and OMNIPAQUE oral solution contain no preservatives and no ingredient made from a gluten-containing grain (wheat, barley, or rye)." }

OMNIPAQUE injection and OMNIPAQUE oral solution have the following physical properties:

{ "type": "p", "children": [], "text": "OMNIPAQUE injection and OMNIPAQUE oral solution have the following physical properties:" }

<div class="scrollingtable"><table width="85%"> <caption> <span>Table 21. Physicochemical Properties of OMNIPAQUE</span> </caption> <col align="center" valign="middle" width="19%"/> <col align="center" valign="top" width="18%"/> <col align="center" valign="top" width="18%"/> <col align="center" valign="top" width="14%"/> <col align="center" valign="top" width="14%"/> <col align="center" valign="top" width="17%"/> <thead> <tr class="First"> <th align="center" class="Lrule Rrule" rowspan="2">Dosage Form</th><th align="center" class="Rrule" rowspan="2" valign="middle">Concentration<br/>(mg iodine/mL)</th><th align="center" class="Rrule" rowspan="2" valign="middle">Osmolality<a class="Sup" href="#footnote-20" name="footnote-reference-20">*</a> <br/>(mOsmol/kg water)</th><th align="center" class="Botrule Rrule" colspan="2" valign="middle">Absolute Viscosity<br/>(cP)</th><th align="center" class="Botrule Rrule" valign="middle">Specific Gravity</th> </tr> <tr class="Last"> <th align="center" class="Rrule">20°C</th><th align="center" class="Rrule" valign="middle">37°C</th><th align="center" class="Rrule" valign="middle">37°C</th> </tr> </thead> <tfoot> <tr> <td align="left" colspan="6"> <dl class="Footnote"> <dt> <a href="#footnote-reference-20" name="footnote-20">*</a> </dt> <dd> <span class="Italics">By vapor-pressure osmometry.</span> </dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="Botrule First"> <td align="center" class="Lrule Rrule" rowspan="5">Injection</td><td align="center" class="Rrule">140</td><td align="center" class="Rrule">322</td><td align="center" class="Rrule">2.3</td><td align="center" class="Rrule">1.5</td><td align="center" class="Rrule">1.164</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">180</td><td align="center" class="Rrule">408</td><td align="center" class="Rrule">3.1</td><td align="center" class="Rrule">2.0</td><td align="center" class="Rrule">1.209</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">240</td><td align="center" class="Rrule">520</td><td align="center" class="Rrule">5.8</td><td align="center" class="Rrule">3.4</td><td align="center" class="Rrule">1.280</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">300</td><td align="center" class="Rrule">672</td><td align="center" class="Rrule">11.8</td><td align="center" class="Rrule">6.3</td><td align="center" class="Rrule">1.349</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">350</td><td align="center" class="Rrule">844</td><td align="center" class="Rrule">20.4</td><td align="center" class="Rrule">10.4</td><td align="center" class="Rrule">1.406</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" rowspan="2">Oral solution</td><td align="center" class="Rrule">9</td><td align="center" class="Rrule">38</td><td align="center" class="Rrule">1.1</td><td align="center" class="Rrule">0.8</td><td align="center" class="Rrule">1.011</td> </tr> <tr class="Last"> <td align="center" class="Rrule">12</td><td align="center" class="Rrule">45</td><td align="center" class="Rrule">1.1</td><td align="center" class="Rrule">0.8</td><td align="center" class="Rrule">1.014</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"85%\">\n<caption>\n<span>Table 21. Physicochemical Properties of OMNIPAQUE</span>\n</caption>\n<col align=\"center\" valign=\"middle\" width=\"19%\"/>\n<col align=\"center\" valign=\"top\" width=\"18%\"/>\n<col align=\"center\" valign=\"top\" width=\"18%\"/>\n<col align=\"center\" valign=\"top\" width=\"14%\"/>\n<col align=\"center\" valign=\"top\" width=\"14%\"/>\n<col align=\"center\" valign=\"top\" width=\"17%\"/>\n<thead>\n<tr class=\"First\">\n<th align=\"center\" class=\"Lrule Rrule\" rowspan=\"2\">Dosage Form</th><th align=\"center\" class=\"Rrule\" rowspan=\"2\" valign=\"middle\">Concentration<br/>(mg iodine/mL)</th><th align=\"center\" class=\"Rrule\" rowspan=\"2\" valign=\"middle\">Osmolality<a class=\"Sup\" href=\"#footnote-20\" name=\"footnote-reference-20\">*</a>\n<br/>(mOsmol/kg water)</th><th align=\"center\" class=\"Botrule Rrule\" colspan=\"2\" valign=\"middle\">Absolute Viscosity<br/>(cP)</th><th align=\"center\" class=\"Botrule Rrule\" valign=\"middle\">Specific Gravity</th>\n</tr>\n<tr class=\"Last\">\n<th align=\"center\" class=\"Rrule\">20°C</th><th align=\"center\" class=\"Rrule\" valign=\"middle\">37°C</th><th align=\"center\" class=\"Rrule\" valign=\"middle\">37°C</th>\n</tr>\n</thead>\n<tfoot>\n<tr>\n<td align=\"left\" colspan=\"6\">\n<dl class=\"Footnote\">\n<dt>\n<a href=\"#footnote-reference-20\" name=\"footnote-20\">*</a>\n</dt>\n<dd>\n<span class=\"Italics\">By vapor-pressure osmometry.</span>\n</dd>\n</dl>\n</td>\n</tr>\n</tfoot>\n<tbody>\n<tr class=\"Botrule First\">\n<td align=\"center\" class=\"Lrule Rrule\" rowspan=\"5\">Injection</td><td align=\"center\" class=\"Rrule\">140</td><td align=\"center\" class=\"Rrule\">322</td><td align=\"center\" class=\"Rrule\">2.3</td><td align=\"center\" class=\"Rrule\">1.5</td><td align=\"center\" class=\"Rrule\">1.164</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\">180</td><td align=\"center\" class=\"Rrule\">408</td><td align=\"center\" class=\"Rrule\">3.1</td><td align=\"center\" class=\"Rrule\">2.0</td><td align=\"center\" class=\"Rrule\">1.209</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\">240</td><td align=\"center\" class=\"Rrule\">520</td><td align=\"center\" class=\"Rrule\">5.8</td><td align=\"center\" class=\"Rrule\">3.4</td><td align=\"center\" class=\"Rrule\">1.280</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\">300</td><td align=\"center\" class=\"Rrule\">672</td><td align=\"center\" class=\"Rrule\">11.8</td><td align=\"center\" class=\"Rrule\">6.3</td><td align=\"center\" class=\"Rrule\">1.349</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\">350</td><td align=\"center\" class=\"Rrule\">844</td><td align=\"center\" class=\"Rrule\">20.4</td><td align=\"center\" class=\"Rrule\">10.4</td><td align=\"center\" class=\"Rrule\">1.406</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\" rowspan=\"2\">Oral solution</td><td align=\"center\" class=\"Rrule\">9</td><td align=\"center\" class=\"Rrule\">38</td><td align=\"center\" class=\"Rrule\">1.1</td><td align=\"center\" class=\"Rrule\">0.8</td><td align=\"center\" class=\"Rrule\">1.011</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"center\" class=\"Rrule\">12</td><td align=\"center\" class=\"Rrule\">45</td><td align=\"center\" class=\"Rrule\">1.1</td><td align=\"center\" class=\"Rrule\">0.8</td><td align=\"center\" class=\"Rrule\">1.014</td>\n</tr>\n</tbody>\n</table></div>" }

OMNIPAQUE injection has osmolalities from approximately 1.1 to 3 times that of plasma (285 mOsmol/kg water) or cerebrospinal fluid (301 mOsmol/kg water) as shown in the above table and are hypertonic .

{ "type": "p", "children": [], "text": "OMNIPAQUE injection has osmolalities from approximately 1.1 to 3 times that of plasma (285 mOsmol/kg water) or cerebrospinal fluid (301 mOsmol/kg water) as shown in the above table and are hypertonic ." }

OMNIPAQUE oral solution is hypotonic.

{ "type": "p", "children": [], "text": "OMNIPAQUE oral solution is hypotonic." }

The iodine atoms in iohexol provide attenuation of X-rays in direct proportion to the concentration of iohexol. Since concentration changes over time, iohexol provides time-dependent image contrast which may assist in visualizing body structures.

Intrathecal Administration

The initial concentration and volume of the contrast medium, in conjunction with patient manipulation and the volume of cerebrospinal fluid (CSF) into which the contrast medium is placed, will determine the extent of the contrast that can be achieved. Following intrathecal injection in conventional radiography, OMNIPAQUE 180 mg iodine/mL, 240 mg iodine/mL, and 300 mg iodine/mL will continue to provide contrast for at least 30 minutes. Slow diffusion of iohexol takes place throughout the CSF with subsequent absorption into the bloodstream. At approximately 1 hour following injection, contrast will no longer be sufficient for conventional myelography.

After administration into the lumbar subarachnoid space, computerized tomography shows the presence of contrast medium in the thoracic region in about 1 hour, in the cervical region in about 2 hours, and in the basal cisterns in 3 to 4 hours.

Intravenous or Intra-arterial Administration

Following intravenous or intra-arterial administration of OMNIPAQUE, the degree of contrast enhancement is directly related to the iodine concentration of an administered dose; peak iodine blood concentrations occur immediately (15 seconds to 120 seconds) following rapid intravenous injection. The time to maximum contrast enhancement can vary, depending on the organ, from the time that peak blood iodine concentrations are reached to one hour after intravenous bolus administration. When a delay between peak blood iodine concentrations and peak contrast is present, it suggests that radiographic contrast enhancement is at least in part dependent on the accumulation of iodine containing agent within the lesion and outside the blood pool.

Oral Administration

Orally administered OMNIPAQUE produces visualization of the gastrointestinal tract. Less than 1% of orally administered iohexol is recovered in the urine, suggesting minimal amounts are absorbed from the normal gastrointestinal tract. This amount may increase in the presence of bowel perforation or bowel obstruction.

Intraarticular Administration

Visualization of the joint spaces can be accomplished by direct injection of contrast medium. For intraarticular cavities, the injected iohexol is absorbed into the surrounding tissue and subsequently absorbed into systemic circulation.

Body Cavity Administration

For most body cavities, the injected iohexol is absorbed into the surrounding tissue and subsequently absorbed into systemic circulation. Examinations of the uterus (hysterosalpingography) and bladder (voiding cystourethrography) involve the almost immediate drainage of contrast medium from the cavity upon conclusion of the radiographic procedure.

Following the intravenous administration of iohexol (between 500 mg iodine/kg to 1,500 mg iodine/kg) to 16 adult subjects, apparent first-order terminal elimination half-life was 12.6 hours and total body clearance was 131 (98 to 165) mL/min. Clearance was not dose dependent.

Absorption

As evidenced by the amount recovered in urine, <1% of orally administered iohexol is absorbed from the normal gastrointestinal tract. This amount may increase in the presence of bowel perforation or bowel obstruction.

Distribution

In 16 adult subjects (receiving between 500 mg iodine/kg to 1,500 mg iodine/kg intravenous iohexol) the plasma volume of distribution was165 (108 to 219) mL/kg.

In five adult patients receiving 16 mL to 18 mL of OMNIPAQUE (180 mg iodine/mL) by lumbar intrathecal injection the plasma volume of distribution was 559 (350 to 849) mL/kg.

Elimination

Metabolism

No significant metabolism, deiodination or biotransformation occurs.

Excretion

Following intravenous, intra-arterial or intrathecal administration, iohexol is excreted unchanged by glomerular filtration. Approximately 90% of the intravenously injected iohexol dose is excreted within the first 24 hours. Following intravenous or intraarterial administration, peak urine concentration occurs in the first hour after injection.

Long-term animal studies have not been performed with iohexol to evaluate carcinogenic potential. Iohexol was not genotoxic in a series of studies, including the Ames test, the mouse lymphoma TK locus forward mutation assay, and a mouse micronucleus assay. Iohexol did not impair the fertility of male or female rats when repeatedly administered at intravenous dosages up to 4 g iodine/kg.

The safety and effectiveness of OMNIPAQUE for CT of the head were evaluated in three clinical studies. Each study also used an ionic high-osmolar iodinated contrast agent as a comparator. A total of 280 patients were randomized to administration of either OMNIPAQUE (n=142) or the comparator (n=138). OMNIPAQUE patients had a mean age of 52 years (range 16 to 85), 41% were women, and were administered a mean of 692 mg iodine/kg (range 337 to 1,250 mg iodine/kg) by intravenous injection with OMNIPAQUE 240 mg iodine/mL (1 study) or 300 mg iodine/mL (2 studies).

{ "type": "p", "children": [], "text": "The safety and effectiveness of OMNIPAQUE for CT of the head were evaluated in three clinical studies. Each study also used an ionic high-osmolar iodinated contrast agent as a comparator. A total of 280 patients were randomized to administration of either OMNIPAQUE (n=142) or the comparator (n=138). OMNIPAQUE patients had a mean age of 52 years (range 16 to 85), 41% were women, and were administered a mean of 692 mg iodine/kg (range 337 to 1,250 mg iodine/kg) by intravenous injection with OMNIPAQUE 240 mg iodine/mL (1 study) or 300 mg iodine/mL (2 studies)." }

Efficacy was determined from investigator ratings of quality of contrast enhancement (none, poor, good, or excellent; only scans rated as good or excellent were considered diagnostic).

{ "type": "p", "children": [], "text": "Efficacy was determined from investigator ratings of quality of contrast enhancement (none, poor, good, or excellent; only scans rated as good or excellent were considered diagnostic)." }

The percentage of OMNIPAQUE-enhanced scans rated as good or excellent was 100% in the two studies using OMNIPAQUE 300 mg iodine/mL, and 79% in the third study using OMNIPAQUE 240 mg iodine/mL.

{ "type": "p", "children": [], "text": "The percentage of OMNIPAQUE-enhanced scans rated as good or excellent was 100% in the two studies using OMNIPAQUE 300 mg iodine/mL, and 79% in the third study using OMNIPAQUE 240 mg iodine/mL." }

How Supplied

OMNIPAQUE (iohexol) injection and OMNIPAQUE (iohexol) oral solution are colorless to pale yellow solutions available in the following presentations:

<div class="scrollingtable"><table width="85%"> <col align="left" valign="middle" width="16%"/> <col align="center" valign="middle" width="17%"/> <col align="center" valign="middle" width="16%"/> <col align="center" valign="middle" width="17%"/> <col align="center" valign="middle" width="17%"/> <col align="center" valign="middle" width="17%"/> <thead> <tr class="First Last"> <th align="center" class="Lrule Rrule">Dosage Form</th><th align="center" class="Rrule">Concentration <br/>(mg iodine/mL)</th><th align="center" class="Rrule">Package Size</th><th align="center" class="Rrule">Package Type &amp; Material</th><th align="center" class="Rrule">Sale Unit</th><th align="center" class="Rrule">NDC</th> </tr> </thead> <tfoot> <tr> <td align="left" colspan="6"> <dl class="Footnote"> <dt> <a href="#footnote-reference-21" name="footnote-21">*</a> </dt> <dd>OMNIPAQUE injection 300 mg iodine/mL and OMNIPAQUE injection 350 mg iodine/mL in bottles of 500 mL can be used as either an Imaging Bulk Package or a Pharmacy Bulk Package<span class="Italics"> [see <a href="#S2.10">Dosage and Administration (2.10</a>, <a href="#S2.11">2.11)</a>]</span>.</dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule" rowspan="20" valign="middle">Injection</td><td align="center" class="Rrule">140</td><td align="center" class="Rrule">50 mL</td><td align="center" class="Rrule">Single-Dose Polymer Bottles</td><td align="center" class="Rrule">Boxes of 10</td><td align="center" class="Rrule">0407-1401-52</td> </tr> <tr class="Botrule"> <td align="center" class="Rrule">180</td><td align="center" class="Rrule">10 mL</td><td align="center" class="Rrule">Single-Dose Glass Vials</td><td align="center" class="Rrule">Boxes of 10</td><td align="center" class="Rrule">0407-1411-10</td> </tr> <tr class="Botrule"> <td align="center" class="Rrule" rowspan="4" valign="middle">240</td><td align="center" class="Rrule">10 mL</td><td align="center" class="Rrule">Single-Dose Glass Vials</td><td align="center" class="Rrule">Boxes of 10</td><td align="center" class="Rrule">0407-1412-10</td> </tr> <tr class="Botrule"> <td align="center" class="Rrule">20 mL</td><td align="center" class="Rrule">Single-Dose Glass Vials</td><td align="center" class="Rrule">Boxes of 10</td><td align="center" class="Rrule">0407-1412-20</td> </tr> <tr class="Botrule"> <td align="center" class="Rrule">50 mL</td><td align="center" class="Rrule">Single-Dose Polymer Bottles</td><td align="center" class="Rrule">Boxes of 10</td><td align="center" class="Rrule">0407-1412-30</td> </tr> <tr class="Botrule"> <td align="center" class="Rrule">100 mL</td><td align="center" class="Rrule">Single-Dose Polymer Bottles</td><td align="center" class="Rrule">Boxes of 10</td><td align="center" class="Rrule">0407-1412-33</td> </tr> <tr class="Botrule"> <td align="center" class="Rrule" rowspan="7" valign="middle">300</td><td align="center" class="Rrule">10 mL</td><td align="center" class="Rrule">Single-Dose Glass Vials</td><td align="center" class="Rrule">Boxes of 10</td><td align="center" class="Rrule">0407-1413-10</td> </tr> <tr class="Botrule"> <td align="center" class="Rrule">30 mL</td><td align="center" class="Rrule">Single-Dose Polymer Bottles</td><td align="center" class="Rrule">Boxes of 10</td><td align="center" class="Rrule">0407-1413-59</td> </tr> <tr class="Botrule"> <td align="center" class="Rrule">50 mL</td><td align="center" class="Rrule">Single-Dose Polymer Bottles</td><td align="center" class="Rrule">Boxes of 10</td><td align="center" class="Rrule">0407-1413-61</td> </tr> <tr class="Botrule"> <td align="center" class="Rrule">100 mL</td><td align="center" class="Rrule">Single-Dose Polymer Bottles</td><td align="center" class="Rrule">Boxes of 10</td><td align="center" class="Rrule">0407-1413-63</td> </tr> <tr class="Botrule"> <td align="center" class="Rrule">125 mL</td><td align="center" class="Rrule">Single-Dose Glass Bottles</td><td align="center" class="Rrule">Boxes of 10</td><td align="center" class="Rrule">0407-1413-53</td> </tr> <tr class="Botrule"> <td align="center" class="Rrule">150 mL</td><td align="center" class="Rrule">Single-Dose Polymer Bottles</td><td align="center" class="Rrule">Boxes of 10</td><td align="center" class="Rrule">0407-1413-65</td> </tr> <tr class="Botrule"> <td align="center" class="Rrule">500 mL<a class="Sup" href="#footnote-21" name="footnote-reference-21">*</a></td><td align="center" class="Rrule">Imaging or Pharmacy Bulk Package Polymer Bottles</td><td align="center" class="Rrule">Boxes of 10</td><td align="center" class="Rrule">0407-1413-72</td> </tr> <tr class="Botrule"> <td align="center" class="Rrule" rowspan="7" valign="middle">350</td><td align="center" class="Rrule">50 mL</td><td align="center" class="Rrule">Single-Dose Polymer Bottles</td><td align="center" class="Rrule">Boxes of 10</td><td align="center" class="Rrule">0407-1414-89</td> </tr> <tr class="Botrule"> <td align="center" class="Rrule">75 mL</td><td align="center" class="Rrule">Single-Dose Polymer Bottles</td><td align="center" class="Rrule">Boxes of 10</td><td align="center" class="Rrule">0407-1414-90</td> </tr> <tr class="Botrule"> <td align="center" class="Rrule">100 mL</td><td align="center" class="Rrule">Single-Dose Polymer Bottles</td><td align="center" class="Rrule">Boxes of 10</td><td align="center" class="Rrule">0407-1414-91</td> </tr> <tr class="Botrule"> <td align="center" class="Rrule">125 mL</td><td align="center" class="Rrule">Single-Dose Glass Bottles</td><td align="center" class="Rrule">Boxes of 10</td><td align="center" class="Rrule">0407-1414-76</td> </tr> <tr class="Botrule"> <td align="center" class="Rrule">150 mL</td><td align="center" class="Rrule">Single-Dose Polymer Bottles</td><td align="center" class="Rrule">Boxes of 10</td><td align="center" class="Rrule">0407-1414-93</td> </tr> <tr class="Botrule"> <td align="center" class="Rrule">200 mL</td><td align="center" class="Rrule">Single-Dose Polymer Bottles</td><td align="center" class="Rrule">Boxes of 10</td><td align="center" class="Rrule">0407-1414-94</td> </tr> <tr class="Botrule"> <td align="center" class="Rrule">500 mL<a class="Sup" href="#footnote-21">*</a></td><td align="center" class="Rrule">Imaging or Pharmacy Bulk Package Polymer Bottles</td><td align="center" class="Rrule">Boxes of 10</td><td align="center" class="Rrule">0407-1414-72</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" rowspan="2" valign="middle">Oral Solution</td><td align="center" class="Rrule">9</td><td align="center" class="Rrule">500 mL</td><td align="center" class="Rrule">Single-Dose Polymer Bottles</td><td align="center" class="Rrule">Boxes of 10</td><td align="center" class="Rrule">0407-1415-09</td> </tr> <tr class="Last"> <td align="center" class="Rrule">12</td><td align="center" class="Rrule">500 mL</td><td align="center" class="Rrule">Single-Dose Polymer Bottles</td><td align="center" class="Rrule">Boxes of 10</td><td align="center" class="Rrule">0407-1416-12</td> </tr> </tbody> </table></div>

The container closure system components (bottle, vial, stopper, and cap) of OMNIPAQUE injection and OMNIPAQUE oral solution are not made with natural rubber latex.

Storage and Handling

Protect from light. Do not freeze. Discard any product that is inadvertently frozen, as freezing may compromise the closure integrity of the immediate container.

Hypersensitivity Reactions

Advise the patient concerning the risk of hypersensitivity reactions that can occur both during and after OMNIPAQUE administration. Advise the patient to report any signs or symptoms of hypersensitivity reactions during the procedure and to seek immediate medical attention for any signs or symptoms experienced after discharge [see Warnings and Precautions (5.3)].

Advise patients to inform their physician if they develop a rash after receiving OMNIPAQUE [see Warnings and Precautions (5.12)].

Acute Kidney Injury

Advise the patient concerning appropriate hydration to decrease the risk of contrast-induced acute kidney injury [see Warnings and Precautions (5.4)].

Extravasation

If extravasation occurs during injection, advise patients to seek medical care for progression of symptoms [see Warnings and Precautions (5.7)].

Lactation

Advise a lactating woman that interruption of breastfeeding is not necessary. However, to avoid any exposure, a lactating woman may consider pumping and discarding breast milk for 10 hours after OMNIPAQUE administration [see Use in Specific Populations (8.2)].

Thyroid Dysfunction

Advise parents/caregivers about the risk of developing thyroid dysfunction after OMNIPAQUE administration. Advise parents/caregivers about when to seek medical care for their child to monitor for thyroid function [see Warnings and Precautions (5.9)].

Distributed by GE Healthcare Inc., Marlborough, MA 01752 U.S.A.

{ "type": "p", "children": [], "text": "Distributed by GE Healthcare Inc., Marlborough, MA 01752 U.S.A." }

OMNIPAQUE is a trademark of GE HealthCare or one of its subsidiaries.GE is a trademark of General Electric Company used under trademark license.

{ "type": "p", "children": [], "text": "OMNIPAQUE is a trademark of GE HealthCare or one of its subsidiaries.GE is a trademark of General Electric Company used under trademark license." }

© 2024 GE HealthCare

{ "type": "p", "children": [], "text": "© 2024 GE HealthCare" }

NDC 0407-1401-5250 mL

{ "type": "p", "children": [], "text": "NDC 0407-1401-5250 mL" }

OMNIPAQUE™ (iohexol) Injection

{ "type": "p", "children": [], "text": "OMNIPAQUE™ (iohexol) Injection" }

140 mgI/mL

{ "type": "p", "children": [], "text": "140 mgI/mL" }

NOT FOR INTRATHECAL USE

{ "type": "p", "children": [], "text": "NOT FOR INTRATHECAL USE" }

in +PLUSPAK™ (polymer bottle)

{ "type": "p", "children": [], "text": "in +PLUSPAK™ (polymer bottle)" }

GE HealthcareNDC 0407-1411-2020 mL

{ "type": "p", "children": [], "text": "GE HealthcareNDC 0407-1411-2020 mL" }

OMNIPAQUE™ (iohexol) Injection

{ "type": "p", "children": [], "text": "OMNIPAQUE™ (iohexol) Injection" }

180 mgI/mL

{ "type": "p", "children": [], "text": "180 mgI/mL" }

Single-Dose Vial Sterile Aqueous Solution

{ "type": "p", "children": [], "text": "Single-Dose Vial Sterile Aqueous Solution" }

Each 1 mL contains 388.3 mg of iohexol (180 mg organically bound iodine), 1.21 mg tromethamine, and 0.1 mg edetate calcium disodium.

{ "type": "p", "children": [], "text": "Each 1 mL contains 388.3 mg of iohexol (180 mg organically bound iodine), 1.21 mg tromethamine, and 0.1 mg edetate calcium disodium." }

NDC 0407-1412-34150 mL

{ "type": "p", "children": [], "text": "NDC 0407-1412-34150 mL" }

OMNIPAQUE™ (iohexol) Injection

{ "type": "p", "children": [], "text": "OMNIPAQUE™ (iohexol) Injection" }

240 mgI/mL

{ "type": "p", "children": [], "text": "240 mgI/mL" }

in +PLUSPAK™ (polymer bottle)

{ "type": "p", "children": [], "text": "in +PLUSPAK™ (polymer bottle)" }

Single-Dose Bottle. Sterile Aqueous Solution For Injection or Oral Use.

{ "type": "p", "children": [], "text": "Single-Dose Bottle. Sterile Aqueous Solution For Injection or Oral Use." }

DO NOT USE IF TAMPER-EVIDENT RING IS BROKEN OR MISSING

{ "type": "p", "children": [], "text": "DO NOT USE IF TAMPER-EVIDENT RING IS BROKEN OR MISSING" }

NDC 0407-1413-65150 mL

{ "type": "p", "children": [], "text": "NDC 0407-1413-65150 mL" }

OMNIPAQUE™(iohexol) Injection

{ "type": "p", "children": [], "text": "OMNIPAQUE™(iohexol) Injection" }

300 mg Iodine/mL

{ "type": "p", "children": [], "text": "300 mg Iodine/mL" }

For Injection or Oral Use

{ "type": "p", "children": [], "text": "For Injection or Oral Use" }

Single-Dose BottleSterile Aqueous Solution

{ "type": "p", "children": [], "text": "Single-Dose BottleSterile Aqueous Solution" }

DO NOT USE IF TAMPER-EVIDENT RING IS BROKEN OR MISSING

{ "type": "p", "children": [], "text": "DO NOT USE IF TAMPER-EVIDENT RING IS BROKEN OR MISSING" }

NDC 0407-1414-93150 mL

{ "type": "p", "children": [], "text": "NDC 0407-1414-93150 mL" }

OMNIPAQUE™(iohexol) Injection

{ "type": "p", "children": [], "text": "OMNIPAQUE™(iohexol) Injection" }

350 mg Iodine/mL

{ "type": "p", "children": [], "text": "350 mg Iodine/mL" }

For Intravascular, Oral,Intraarticular, andBody Cavity Use Only

{ "type": "p", "children": [], "text": "For Intravascular, Oral,Intraarticular, andBody Cavity Use Only" }

Single-Dose BottleSterile Aqueous Solution

{ "type": "p", "children": [], "text": "Single-Dose BottleSterile Aqueous Solution" }

NOT FOR INTRATHECAL USE

{ "type": "p", "children": [], "text": "NOT FOR INTRATHECAL USE" }

DO NOT USE IF TAMPER-EVIDENTRING IS BROKEN OR MISSING

{ "type": "p", "children": [], "text": "DO NOT USE IF TAMPER-EVIDENTRING IS BROKEN OR MISSING" }

NDC 0407-1415-09500 mL

{ "type": "p", "children": [], "text": "NDC 0407-1415-09500 mL" }

OMNIPAQUE™(iohexol)Oral Solution

{ "type": "p", "children": [], "text": "OMNIPAQUE™(iohexol)Oral Solution" }

9 mg iodine/mL

{ "type": "p", "children": [], "text": "9 mg iodine/mL" }

FOR ORAL USE ONLY

{ "type": "p", "children": [], "text": "FOR ORAL USE ONLY" }

Single-Dose Bottle - Discard Unused PortionSterile Aqueous Solution - No Dilution Required

{ "type": "p", "children": [], "text": "Single-Dose Bottle - Discard Unused PortionSterile Aqueous Solution - No Dilution Required" }

DO NOT USE IF TAMPER-EVIDENT RING IS BROKEN OR MISSING

{ "type": "p", "children": [], "text": "DO NOT USE IF TAMPER-EVIDENT RING IS BROKEN OR MISSING" }

NDC 0407-1416-12500 mL

{ "type": "p", "children": [], "text": "NDC 0407-1416-12500 mL" }

OMNIPAQUE™(iohexol)Oral Solution

{ "type": "p", "children": [], "text": "OMNIPAQUE™(iohexol)Oral Solution" }

12 mg iodine/mL

{ "type": "p", "children": [], "text": "12 mg iodine/mL" }

FOR ORAL USE ONLY

{ "type": "p", "children": [], "text": "FOR ORAL USE ONLY" }

Single-Dose Bottle - Discard Unused PortionSterile Aqueous Solution - No Dilution Required

{ "type": "p", "children": [], "text": "Single-Dose Bottle - Discard Unused PortionSterile Aqueous Solution - No Dilution Required" }

DO NOT USE IF TAMPER-EVIDENT RING IS BROKEN OR MISSING

{ "type": "p", "children": [], "text": "DO NOT USE IF TAMPER-EVIDENT RING IS BROKEN OR MISSING" }