Dextrose Injection is indicated as source of water and calories and may also be used as diluent for reconstitution of a powdered or liquid (up to 10 mL) drug product packaged in a vial with a 20 mm closure.

{ "type": "p", "children": [], "text": "Dextrose Injection is indicated as source of water and calories and may also be used as diluent for reconstitution of a powdered or liquid (up to 10 mL) drug product packaged in a vial with a 20 mm closure. " }

The choice of dextrose concentration, rate and volume depends on the age, weight, clinical and metabolic conditions of the patient and concomitant therapy. Electrolyte supplementation may be indicated according to the clinical needs of the patient.

The administration rate should be governed, especially for premature infants with low birth weight, during the first few days of therapy, by the patient’s tolerance to dextrose.

Increase the infusion rate gradually as indicated by frequent monitoring of blood glucose concentrations [see Warnings and Precautions (5.1), Use in Specific Populations (8.4)].

To Open

Preparation for Administration

To Add Medication

Storage

Dextrose Injection, USP is a clear, sterile, non-pyrogenic solution of 5 grams of dextrose hydrous per 100 mL (0.05 grams/mL) in 50 mL and 100 mL single-dose, flexible containers.

{ "type": "p", "children": [], "text": "Dextrose Injection, USP is a clear, sterile, non-pyrogenic solution of 5 grams of dextrose hydrous per 100 mL (0.05 grams/mL) in 50 mL and 100 mL single-dose, flexible containers." }

The use of Dextrose Injection is contraindicated in patients with:

{ "type": "p", "children": [], "text": "The use of Dextrose Injection is contraindicated in patients with:" }

{ "type": "", "children": [], "text": "" }

The use of dextrose infusions in patients with impaired glucose tolerance may worsen hyperglycemia. Administration of dextrose at a rate exceeding the patient’s utilization rate may lead to hyperglycemia, coma, and death.

Hyperglycemia is associated with an increase in serum osmolality, resulting in osmotic diuresis, dehydration and electrolyte losses [see Warnings and Precautions (5.5)]. Patients with underlying CNS disease and renal impairment who receive dextrose infusions, may be at greater risk of developing hyperosmolar hyperglycemic state.

Monitor blood glucose levels and treat hyperglycemia to maintain levels within normal limits while administering Dextrose Injection. Insulin may be administered or adjusted to maintain optimal blood glucose levels during Dextrose Injection administration.

Hypersensitivity and infusion reactions including anaphylaxis, have been reported with Dextrose Injection [see Adverse Reactions (6)]. Stop infusion immediately and treat patient accordingly if signs or symptoms of a hypersensitivity reaction develop. Appropriate therapeutic countermeasures must be instituted as clinically indicated.

Peripheral administration of 5% Dextrose Injection is generally acceptable, however, consider central vein when administering more than 5% dextrose or with an osmolarity of ≥ 900 mOsm/L or when there is peripheral vein irritation, phlebitis, and/or associated pain [see Dosage and Administration (2.1)]. The infusion of hypertonic solutions into a peripheral vein may result in vein irritation, vein damage, and/or thrombosis. The primary complication of peripheral access is venous thrombophlebitis, which manifests as pain, erythema, tenderness or a palpable cord. Remove the catheter as soon as possible, if thrombophlebitis develops.

5% Dextrose Injection is an isotonic solution [see Description, Table 1 (11)]. In the body, however, glucose containing fluids can become extremely physiologically hypotonic due to rapid glucose metabolization. Monitoring of serum sodium is particularly important for hypotonic fluids.

Depending on the tonicity of the solution, the volume and rate of infusion, and depending on a patient’s underlying clinical condition and capability to metabolize glucose, intravenous administration of glucose can cause electrolyte disturbances, most importantly hypo- or hyperosmotic hyponatremia. Monitor serum sodium to minimize the risk of hyponatremia.

The risk for hyponatremia is increased in pediatric patients, elderly patients, postoperative patients, those with psychogenic polydipsia, and in patients treated with medications that increase the risk of hyponatremia (such as diuretics, certain antiepileptic and psychotropic medications). Close clinical monitoring may be warranted.

Acute hyponatremia can lead to acute hyponatremic encephalopathy characterized by headache, nausea, seizures, lethargy and vomiting. Patients with brain edema are at particular risk of severe, irreversible and life-threatening brain injury. Patients at increased risk for developing complications of hyponatremia, such as hyponatremic encephalopathy include pediatric patients; women, in particular, premenopausal women; patients with hypoxemia; and in patients with underlying central nervous system disease [see Use in Specific Populations (8.4, 8.5)].

Avoid Dextrose Injection in patients with or at risk for hyponatremia. If use cannot be avoided, monitor serum sodium concentrations.

Rapid correction of hyponatremia is potentially dangerous with risk of serious neurologic complications. Brain adaptations reducing risk of cerebral edema make the brain vulnerable to injury when chronic hyponatremia is too rapidly corrected, which is known as osmotic demyelination syndrome (ODS). To avoid complications, monitor serum sodium and chloride concentrations, fluid status, acid-base balance, and signs of neurologic complications.

High volume infusion must be used with close monitoring in patients with cardiac or pulmonary failure, and in patients with non-osmotic vasopressin release (including SIADH), due to the risk of hospital-acquired hyponatremia

Electrolyte deficits, particularly in serum potassium and phosphate, may occur during prolonged use of concentrated dextrose solutions.

Depending on the volume and rate of infusion, the intravenous administration of dextrose solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations (including hypoosmotic hyponatremia, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations in the administered solution. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations in the solution.

Avoid Dextrose Injection in patients with or at risk for fluid and/or solute overloading. If use cannot be avoided, monitor fluid balance, blood electrolyte levels, concentration of glucose, acid-base balance, correct fluid and electrolyte imbalances during prolonged parenteral therapy or whenever the condition of the patient or the rate of administration warrants such evaluation. Additional monitoring is recommended for patients with water and electrolyte disturbances that could be aggravated by increased glucose, insulin administration and/or free water load.

Patients at increased risk for developing hyponatremic encephalopathy include pediatric patients; elderly patients, women, in particular premenopausal women; patients with hypoxemia; and patients with underlying CNS disease [see Use in Specific Populations (8.4,8.5)].

Refeeding severely undernourished patients may result in refeeding syndrome, characterized by the intracellular shift of potassium, phosphorus, and magnesium as the patient becomes anabolic. Thiamine deficiency and fluid retention may also develop. To prevent these complications, monitor severely undernourished patients and slowly increase nutrient intakes.

The following adverse reactions associated with the use of dextrose injection were identified in clinical trials or post-marketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure.

{ "type": "p", "children": [], "text": "The following adverse reactions associated with the use of dextrose injection were identified in clinical trials or post-marketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure. " }

The following clinically significant adverse reactions are described elsewhere in the labeling:

{ "type": "p", "children": [], "text": "The following clinically significant adverse reactions are described elsewhere in the labeling:" }

{ "type": "", "children": [], "text": "" }

Dextrose Injection can affect glycemic control, vasopressin and fluid and/or electrolyte balance [see Warnings and Precautions (5.1, 5.4, 5.5)]. Monitor blood glucose concentrations, fluid balance, serum electrolyte concentrations and acid-base balance when using Dextrose Injection in patients treated with other substances that affect glycemic control, vasopressin or fluid and/or electrolyte balance.

Risk Summary

Appropriate administration of Dextrose Injection during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. Animal reproduction studies have not been conducted with injectable dextrose solutions.

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.

Risk Summary

There are no data on the presence of dextrose in human milk, the effects on a breastfed infant, or the effects on milk production. The lack of clinical data during lactation precludes a clear determination of the risk of Dextrose Injection to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Dextrose Injection and any potential adverse effects on the breastfed infant from Dextrose Injection or from the underlying maternal condition.

The safety profile of Dextrose Injection in pediatric patients is similar to adults.

Neonates, especially premature infants with low birth weight, are at increased risk of developing hypo- or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose infusions to ensure adequate glycemic control in order to avoid potential long-term adverse effects.

Closely monitor plasma electrolyte concentrations in pediatric patients who may have impaired ability to regulate fluids and electrolytes. In very low birth weight infants, excessive or rapid administration of Dextrose Injection may result in increased serum osmolality and risk of intracerebral hemorrhage.

Children (including neonates and older children) are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy [see Warnings and Precautions (5.4)].

Clinical studies of Dextrose Injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Elderly patients are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy [see Warnings and Precautions (5.4)]. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Dextrose is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug 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.

An increased infusion rate of Dextrose Injection or administration of dextrose solutions can cause hyperglycemia, hyperosmolality, and adverse effects on water and electrolyte balance [see Warnings and Precautions (5.1, 5.5)].

{ "type": "p", "children": [], "text": "An increased infusion rate of Dextrose Injection or administration of dextrose solutions can cause hyperglycemia, hyperosmolality, and adverse effects on water and electrolyte balance [see Warnings and Precautions (5.1, 5.5)]." }

Severe hyperglycemia and severe dilutional hyponatremia, and their complications, can be fatal. Discontinue infusion, reduce dose and institute appropriate corrective measures such as administration of exogenous insulin.

{ "type": "p", "children": [], "text": "Severe hyperglycemia and severe dilutional hyponatremia, and their complications, can be fatal. Discontinue infusion, reduce dose and institute appropriate corrective measures such as administration of exogenous insulin." }

Discontinue infusion and institute appropriate corrective measures in the event of overhydration or solute overload during therapy, with particular attention to CNS, respiratory and cardiovascular systems.

{ "type": "p", "children": [], "text": "Discontinue infusion and institute appropriate corrective measures in the event of overhydration or solute overload during therapy, with particular attention to CNS, respiratory and cardiovascular systems." }

If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage.

{ "type": "p", "children": [], "text": "If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage." }

Dextrose Injection, 5% USP is a clear, sterile, non-pyrogenic solution of Dextrose, USP in Water for Injection in a polyvinylchloride flexible plastic container for intravenous administration after admixture with a single dose powdered or liquid (up to 10 mL) drug vial [see Dosage and Administration (2.1)].

{ "type": "p", "children": [], "text": "Dextrose Injection, 5% USP is a clear, sterile, non-pyrogenic solution of Dextrose, USP in Water for Injection in a polyvinylchloride flexible plastic container for intravenous administration after admixture with a single dose powdered or liquid (up to 10 mL) drug vial [see Dosage and Administration (2.1)]." }

Flexible containers, designed to facilitate admixture, are available in 50 mL and 100 mL sizes. See Table 1 for the content and characteristics of this solution.

{ "type": "p", "children": [], "text": "Flexible containers, designed to facilitate admixture, are available in 50 mL and 100 mL sizes. See Table 1 for the content and characteristics of this solution." }

The solution contains no bacteriostatic, antimicrobial agent or added buffer and is intended only for use as a single-dose injection. The pH range is 4.0 (3.2 to 6.5).

{ "type": "p", "children": [], "text": "The solution contains no bacteriostatic, antimicrobial agent or added buffer and is intended only for use as a single-dose injection. The pH range is 4.0 (3.2 to 6.5)." }

Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly.

{ "type": "p", "children": [], "text": "Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly." }

<div class="scrollingtable"><table width="442.8pt"> <caption> <span>Table 1. Contents and Characteristics of Dextrose Injection 5%, USP</span> </caption> <col width="19%"/> <col width="19%"/> <col width="19%"/> <col width="19%"/> <col width="19%"/> <thead> <tr class="First"> <th align="left" colspan="5" valign="top"></th> </tr> <tr class="Last"> <th align="center" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Strength</span></th><th align="center" class="Botrule Lrule Rrule Toprule" valign="top"><span class="Bold">Fill Volume</span></th><th align="center" class="Botrule Lrule Rrule Toprule" valign="top"><span class="Bold">Amount of Dextrose Hydrous per Container</span></th><th align="center" class="Botrule Lrule Rrule Toprule" valign="top"><span class="Bold">kcal</span><a class="Sup" href="#footnote-1" name="footnote-reference-1">*</a><span class="Bold"> per Container</span></th><th align="center" class="Botrule Lrule Rrule Toprule" valign="top"><span class="Bold">mOsmol per liter</span></th> </tr> </thead> <tfoot> <tr> <td align="left" colspan="5"> <dl class="Footnote"> <dt> <a href="#footnote-reference-1" name="footnote-1">*</a> </dt> <dd>Caloric value calculated on the basis of 3.4 kcal/g of dextrose, hydrous</dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="First"> <td align="center" class="Botrule Lrule Rrule" rowspan="2" valign="middle"> <p class="First"> <span class="Bold">Dextrose Injection 5%, USP<br/>(0.05 grams/mL)</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">100 mL</span> </p> <p> <span class="Bold">Single Pack</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">5 grams</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">17</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">252</span> </p> </td> </tr> <tr class="Last"> <td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">50 mL</span> </p> <p> <span class="Bold">Single Pack</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">2.5 grams</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">8.5</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">252</span> </p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"442.8pt\">\n<caption>\n<span>Table 1. Contents and Characteristics of Dextrose Injection 5%, USP</span>\n</caption>\n<col width=\"19%\"/>\n<col width=\"19%\"/>\n<col width=\"19%\"/>\n<col width=\"19%\"/>\n<col width=\"19%\"/>\n<thead>\n<tr class=\"First\">\n<th align=\"left\" colspan=\"5\" valign=\"top\"></th>\n</tr>\n<tr class=\"Last\">\n<th align=\"center\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">Strength</span></th><th align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><span class=\"Bold\">Fill Volume</span></th><th align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><span class=\"Bold\">Amount of Dextrose Hydrous per Container</span></th><th align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><span class=\"Bold\">kcal</span><a class=\"Sup\" href=\"#footnote-1\" name=\"footnote-reference-1\">*</a><span class=\"Bold\"> per Container</span></th><th align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><span class=\"Bold\">mOsmol per liter</span></th>\n</tr>\n</thead>\n<tfoot>\n<tr>\n<td align=\"left\" colspan=\"5\">\n<dl class=\"Footnote\">\n<dt>\n<a href=\"#footnote-reference-1\" name=\"footnote-1\">*</a>\n</dt>\n<dd>Caloric value calculated on the basis of 3.4 kcal/g of dextrose, hydrous</dd>\n</dl>\n</td>\n</tr>\n</tfoot>\n<tbody>\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Lrule Rrule\" rowspan=\"2\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">Dextrose Injection 5%, USP<br/>(0.05 grams/mL)</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">100 mL</span>\n</p>\n<p>\n<span class=\"Bold\">Single Pack</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">5 grams</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">17</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">252</span>\n</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">50 mL</span>\n</p>\n<p>\n<span class=\"Bold\">Single Pack</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">2.5 grams</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">8.5</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">252</span>\n</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 • H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula:

{ "type": "p", "children": [], "text": "Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 • H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula:" }

Water for Injection, USP is chemically designated H2O.

{ "type": "p", "children": [], "text": "Water for Injection, USP is chemically designated H2O." }

Dextrose is derived from corn.

{ "type": "p", "children": [], "text": "Dextrose is derived from corn." }

The MINI-BAG Plus Container is a standard diluent container with an integral drug vial adaptor. It allows for drug admixture after connection to a single dose powdered or liquid (up to 10 mL) drug vial having a 20 mm closure. A breakaway seal in the tube between the vial adaptor and the container is broken to allow transfer of the diluent into the vial and reconstitution of the drug. The Mini-Bag Plus product mechanically prohibits the transfer of contaminants into and out of the system during and after docking, minimizing environmental and personal exposure. The reconstituted drug is then transferred from the vial into the container diluent and mixed to result in an admixture for delivery to the patient.

{ "type": "p", "children": [], "text": "The MINI-BAG Plus Container is a standard diluent container with an integral drug vial adaptor. It allows for drug admixture after connection to a single dose powdered or liquid (up to 10 mL) drug vial having a 20 mm closure. A breakaway seal in the tube between the vial adaptor and the container is broken to allow transfer of the diluent into the vial and reconstitution of the drug. The Mini-Bag Plus product mechanically prohibits the transfer of contaminants into and out of the system during and after docking, minimizing environmental and personal exposure. The reconstituted drug is then transferred from the vial into the container diluent and mixed to result in an admixture for delivery to the patient." }

The VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). VIAFLEX Plus on the container indicates the presence of a drug additive in a drug vehicle. The VIAFLEX Plus plastic container system utilizes the same container as the VIAFLEX plastic container system. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.

{ "type": "p", "children": [], "text": "The VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). VIAFLEX Plus on the container indicates the presence of a drug additive in a drug vehicle. The VIAFLEX Plus plastic container system utilizes the same container as the VIAFLEX plastic container system. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies." }

Dextrose oxidized to carbon dioxide and water, yielding energy.

Dextrose Injection 5%, USP is a clear, sterile solutions of dextrose supplied in single-dose, flexible containers.

{ "type": "p", "children": [], "text": "Dextrose Injection 5%, USP is a clear, sterile solutions of dextrose supplied in single-dose, flexible containers." }

<div class="scrollingtable"><table width="100%"> <col width="32%"/> <col width="18%"/> <col width="18%"/> <col width="20%"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Product Description</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Code</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Size</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">NDC</span> </p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" rowspan="2" valign="middle"> <p class="First">Dextrose Injection 5%, USP<br/>(0.05 grams/mL)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">EZPB0040</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">50 mL</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">0338-9143-30</p> </td> </tr> <tr class="Last"> <td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">EZPB0041</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">100 mL</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">0338-9147-30</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col width=\"32%\"/>\n<col width=\"18%\"/>\n<col width=\"18%\"/>\n<col width=\"20%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Product Description</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Code</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Size</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">NDC</span>\n</p>\n</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\" rowspan=\"2\" valign=\"middle\">\n<p class=\"First\">Dextrose Injection 5%, USP<br/>(0.05 grams/mL)</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">EZPB0040</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">50 mL</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">0338-9143-30</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">EZPB0041</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">100 mL</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">0338-9147-30</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Do not remove container from the overwrap until intended for use.

{ "type": "p", "children": [], "text": "\nDo not remove container from the overwrap until intended for use." }

Use the product immediately after mixing and the introduction of additives.

{ "type": "p", "children": [], "text": "Use the product immediately after mixing and the introduction of additives." }

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C/77°F).

{ "type": "p", "children": [], "text": "Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C/77°F)." }

Inform patients, caregivers, or home healthcare providers of the following risks of Dextrose Injection:

{ "type": "p", "children": [], "text": "Inform patients, caregivers, or home healthcare providers of the following risks of Dextrose Injection:" }

{ "type": "", "children": [], "text": "" }

Manufactured by, Packed by, Distributed by:

{ "type": "p", "children": [], "text": "Manufactured by, Packed by, Distributed by:" }

Baxter Healthcare Corporation Deerfield, IL 60015 USAPrinted in Ireland

{ "type": "p", "children": [], "text": "\nBaxter Healthcare Corporation\nDeerfield, IL 60015 USAPrinted in Ireland" }

CB-30-02-662

{ "type": "p", "children": [], "text": "CB-30-02-662" }

Baxter, Mini-Bag Plus, and Viaflex are trademarks of Baxter International Inc.

{ "type": "p", "children": [], "text": "Baxter, Mini-Bag Plus, and Viaflex are trademarks of Baxter International Inc." }

{ "type": "", "children": [], "text": "" }

BREAK SEAL AND MIX BEFORE USE

{ "type": "p", "children": [], "text": "\nBREAK SEAL AND MIX BEFORE USE\n" }

EZPB0041 NDC 0338-9147-30

{ "type": "p", "children": [], "text": "\nEZPB0041\n\nNDC 0338-9147-30\n" }

100 mL

{ "type": "p", "children": [], "text": "\n100 mL\n" }

5% Dextrose Injection USP MINI-BAG Plus Single Dose Container

{ "type": "p", "children": [], "text": "\n5% Dextrose\n\nInjection USP\n\nMINI-BAG Plus Single Dose Container\n" }

Each 100 mL contains 5 g DextroseHydrous USP Sterile See prescribinginformation Additive compatibility consultpharmacist For intravenous use Do notadminister simultaneously with bloodStore at Room Temperature (25°C) AvoidExcessive Heat Rx Only

{ "type": "p", "children": [], "text": "Each 100 mL contains 5 g DextroseHydrous USP Sterile See prescribinginformation Additive compatibility consultpharmacist For intravenous use Do notadminister simultaneously with bloodStore at Room Temperature (25°C) AvoidExcessive Heat Rx Only\n" }

Baxter Logo

{ "type": "p", "children": [], "text": "\nBaxter Logo\n" }

Baxter Healthcare Corporation Deerfield IL 60015 USAMade in Ireland

{ "type": "p", "children": [], "text": "\nBaxter Healthcare Corporation\nDeerfield IL 60015 USAMade in Ireland" }

CB-35-04-637 (1)

{ "type": "p", "children": [], "text": "CB-35-04-637 (1)" }

LotExp

{ "type": "p", "children": [], "text": "LotExp" }

Bar Code(01)00303389147305

{ "type": "p", "children": [], "text": "Bar Code(01)00303389147305" }

{ "type": "", "children": [], "text": "" }

BREAK SEAL AND MIX BEFORE USE

{ "type": "p", "children": [], "text": "\nBREAK SEAL AND MIX BEFORE USE\n" }

EZPB0040 NDC 0338-9143-30

{ "type": "p", "children": [], "text": "\nEZPB0040\n\nNDC 0338-9143-30\n" }

50 mL

{ "type": "p", "children": [], "text": "\n50 mL\n" }

5% Dextrose Injection USP MINI-BAG PLUS SINGLE DOSE CONTAINER

{ "type": "p", "children": [], "text": "\n5% Dextrose\n\nInjection USP\n\nMINI-BAG PLUS SINGLE DOSE CONTAINER\n" }

EACH 50 ML CONTAINS 2.5 G DEXTROSE HYDROUS USP STERILE SEE PRESCRIBINGINFORMATION ADDITIVE COMPATIBILITY CONSULT PHARMACIST FOR INTRAVENOUS USE DO NOT ADMINISTER SIMULTANEOUSLY WITH BLOOD STORE AT ROOM TEMPERATURE (25°C) AVOID EXCESSIVE HEAT RX ONLY

{ "type": "p", "children": [], "text": "EACH 50 ML CONTAINS 2.5 G DEXTROSE HYDROUS USP STERILE SEE PRESCRIBINGINFORMATION ADDITIVE COMPATIBILITY CONSULT PHARMACIST FOR INTRAVENOUS USE DO NOT ADMINISTER SIMULTANEOUSLY WITH BLOOD STORE AT ROOM TEMPERATURE (25°C) AVOID EXCESSIVE HEAT RX ONLY" }

BAXTER LOGO

{ "type": "p", "children": [], "text": "\nBAXTER LOGO\n" }

BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USAMADE IN IRELAND

{ "type": "p", "children": [], "text": "\nBAXTER HEALTHCARE CORPORATION\nDEERFIELD IL 60015 USAMADE IN IRELAND" }

CB-35-04-791

{ "type": "p", "children": [], "text": "CB-35-04-791" }

1 symbol

{ "type": "p", "children": [], "text": "1 symbol" }

LotExp

{ "type": "p", "children": [], "text": "LotExp" }

Bar Code(01)00303389143307

{ "type": "p", "children": [], "text": "Bar Code(01)00303389143307" }

Dextrose Injection (5% and 10%) is indicated as a source of water and calories in adult and pediatric patients, and may also be used as a diluent for reconstitution of a powder or liquid drug product.

{ "type": "p", "children": [], "text": "Dextrose Injection (5% and 10%) is indicated as a source of water and calories in adult and pediatric patients, and may also be used as a diluent for reconstitution of a powder or liquid drug product." }

Dextrose Injection (5% and 10%) is intended for intravenous use.

Visually inspect the Dextrose Injection (5% and 10%) for particulate matter and discoloration. Do not administer Dextrose Injection (5% and 10%) if the solution is cloudy, there are precipitates, or the container is damaged.

To reduce the risk of air embolism, adhere to the following preparation instructions for Dextrose Injection (5% and 10%):

To Open:

Tear outer wrap at notch and remove solution container. If supplemental medication is desired, follow directions below before preparing for administration.

To Add Medication:

Preparation for Administration

(Use aseptic technique)

The choice of dextrose concentration, rate, and volume depends on the age, weight, clinical and metabolic conditions of the patient and concomitant therapy.

Dextrose Injection (5% and 10%) administration rate should be based on the patient's tolerance of dextrose, especially for premature infants with low birth weight.

Increase the infusion rate gradually as needed; frequently monitor blood glucose concentrations to avoid hyperglycemia [see Warnings and Precautions (5.2), Use in Specific Populations (8.4)].

Injection:

{ "type": "p", "children": [], "text": "Injection:" }

{ "type": "ul", "children": [ "5% (5 g/100 mL) (50 mg/mL) of dextrose hydrous in a clear, sterile, and nonpyrogenic solution in single-dose flexible containers: 25 mL, 50 mL, 100 mL, 150 mL, 250 mL, 500 mL, and 1000 mL", "10% (10 g/100 mL) (100 mg/mL) of dextrose hydrous in a clear, sterile, and nonpyrogenic solution in single-dose flexible containers: 250 mL, 500 mL, and 1000 mL" ], "text": "" }

Dextrose Injection (5% and 10%) is contraindicated in patients with:

{ "type": "p", "children": [], "text": "Dextrose Injection (5% and 10%) is contraindicated in patients with:" }

{ "type": "ul", "children": [ "\nClinically significant hyperglycemia [see Warnings and Precautions (5.2)].\n", "\nKnown hypersensitivity to dextrose [see Warnings and Precautions (5.3)].\n" ], "text": "" }

Neonates, especially preterm neonates with low birth weight, are at increased risk of developing hypoglycemia. Closely monitor blood glucose concentration during treatment with Dextrose Injection (5% and 10%) to ensure adequate glycemic control in order to avoid potential long-term adverse effects.

The use of Dextrose Injection (5% and 10%) in patients with impaired glucose tolerance may worsen hyperglycemia. Administration of dextrose at a rate exceeding the patient's utilization rate may lead to hyperglycemia, coma, and death.

Hyperglycemia is associated with an increase in serum osmolality, resulting in osmotic diuresis, dehydration and electrolyte losses [see Warnings and Precautions (5.6), Use in Specific Populations (8.4)]. Patients with underlying CNS disease and renal impairment who receive dextrose infusions may be at greater risk of developing hyperosmolar hyperglycemic state.

Monitor blood glucose levels and treat hyperglycemia to maintain levels within normal limits while administering Dextrose Injection (5% and 10%). Insulin may be administered or adjusted to maintain optimal blood glucose levels during Dextrose Injection (5% and 10%) administration.

Hypersensitivity reactions, including anaphylaxis, have been reported with Dextrose Injection (5% and 10%) administration [see Adverse Reactions (6)]. Stop administration of Dextrose Injection (5% and 10%) immediately if signs or symptoms of a hypersensitivity reaction develop. Initiate appropriate treatment as clinically indicated.

The infusion of hypertonic solutions into a peripheral vein may result in vein irritation, vein damage, and/or thrombosis [see Dosage and Administration (2.1)]. If thrombophlebitis develops, remove the catheter as soon as possible.

Dextrose Injection (5% and 10%) may cause hyponatremia. Hyponatremia can lead to acute hyponatremic encephalopathy characterized by headache, nausea, seizures, lethargy, and vomiting. The risk of hospital-acquired hyponatremia is increased in younger pediatric patients, geriatric patients, patients treated with diuretics, and patients with cardiac or pulmonary failure or with the syndrome of inappropriate antidiuretic hormone (SIADH) (e.g., postoperative patients, patients concomitantly treated with arginine vasopressin analogs or certain antiepileptic, psychotropic, and cytotoxic drugs) [see Drug Interactions (7.1), Use in Specific Populations (8.4)].

Avoid Dextrose Injection (5% and 10%) in patients with or at risk for hyponatremia. If use cannot be avoided, closely monitor serum sodium concentrations, chloride concentrations, fluid status, acid-base balance, and neurologic status [see Warnings and Precautions (5.6)].

Electrolyte deficits, particularly serum potassium and phosphate, may occur during prolonged use of Dextrose Injection (5% and 10%).

Depending on the administered volume and the infusion rate, Dextrose Injection (5% and 10%) can cause fluid overload, including pulmonary edema.

Avoid Dextrose Injection (5% and 10%) in patients at risk for fluid and/or solute overload. If use cannot be avoided in these patients, monitor fluid balance, electrolyte concentrations, and acid-base balance, especially during prolonged use. Additional monitoring is recommended for patients with water and electrolyte disturbances that could be aggravated by increased glucose, insulin administration and/or free water load.

Refeeding severely undernourished patients may result in refeeding syndrome, characterized by the intracellular shift of potassium, phosphorus, and magnesium as the patient becomes anabolic. Thiamine deficiency and fluid retention may also develop. To prevent these complications, monitor severely undernourished patients and slowly increase nutrient intake.

The following clinically significant adverse reactions are described elsewhere in the labeling:

{ "type": "p", "children": [], "text": "The following clinically significant adverse reactions are described elsewhere in the labeling:" }

{ "type": "ul", "children": [ "Neonatal Hypoglycemia [see Warnings and Precautions (5.1)]\n", "Hyperglycemia and Hyperosmolar Hyperglycemic State [see Warnings and Precautions (5.2)]\n", "Hypersensitivity Reactions [see Warnings and Precautions (5.3)]\n", "Phlebitis and Thrombosis [see Warnings and Precautions (5.4)]\n", "Hyponatremia [see Warnings and Precautions (5.5)]\n", "Electrolyte Imbalance and Fluid Overload [see Warnings and Precautions (5.6)]\n", "Refeeding syndrome [see Warnings and Precautions (5.7)]\n" ], "text": "" }

The following adverse reactions associated with the use of Dextrose Injection (5% and 10%) were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

{ "type": "p", "children": [], "text": "The following adverse reactions associated with the use of Dextrose Injection (5% and 10%) were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure." }

Administration site conditions: blister, erythema, extravasation, pain, phlebitis, vein damage, thrombosis

{ "type": "p", "children": [], "text": "\nAdministration site conditions: blister, erythema, extravasation, pain, phlebitis, vein damage, thrombosis" }

Immune system disorders: anaphylaxis, angioedema, bronchospasm, chills, hypotension, pruritis, pyrexia, rash

{ "type": "p", "children": [], "text": "\nImmune system disorders: anaphylaxis, angioedema, bronchospasm, chills, hypotension, pruritis, pyrexia, rash" }

Cardiovascular disorders: cyanosis, volume overload

{ "type": "p", "children": [], "text": "\nCardiovascular disorders: cyanosis, volume overload" }

Dextrose Injection (5% and 10%) can affect glycemic control, vasopressin, and fluid and/or electrolyte balance [see Warnings and Precautions (5.1, 5.2, 5.4, 5.5)]. Monitor patients' blood glucose concentrations, fluid balance, serum electrolyte concentrations, and acid-base balance.

Concomitant administration of Dextrose Injection (5% and 10%) with drugs associated with hyponatremia may increase the risk of developing hyponatremia. Drugs associated with hyponatremia include diuretics and those that cause SIADH (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), arginine vasopressin analogs, certain antiepileptic, psychotropic, and cytotoxic drugs). Avoid use of Dextrose Injection (5% and 10%) in patients receiving drugs associated with hyponatremia. If use cannot be avoided, closely monitor serum sodium concentrations during concomitant use [see Warnings and Precautions (5.5)].

Risk Summary

Dextrose Injection (5% and 10%) has been used for decades during labor and delivery. Although there are a few case reports that describe adverse effects of dextrose use in other stages of pregnancy, exposure during pregnancy in general is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with dextrose.

The 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.

Risk Summary

Dextrose Injection (5% and 10%) has been used for decades and is not expected to cause harm to a breastfed infant. There are no data on the effects of Dextrose Injection (5% and 10%) on levels of glucose in human milk, on the breastfed infant, or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Dextrose Injection (5% and 10%) and any potential adverse effects on the breastfed infant from Dextrose Injection (5% and 10%) or from the underlying maternal condition.

Dextrose Injection (5% and 10%) is indicated in pediatric patients as a source of water and calories, and may also be used as a diluent for reconstitution of a powder or liquid drug product.

Neonates, especially premature infants with low birth weight, are at increased risk of developing hypo-or hyperglycemia. Therefore, they need close monitoring during treatment with intravenous glucose infusions to ensure adequate glycemic control in order to avoid potential long-term adverse effects.

Dextrose Injection (5% and 10%) can cause imbalances in fluid and electrolytes in pediatric patients and requires close monitoring of volume status and plasma electrolyte concentrations, particularly in pediatric patients who may have impaired ability to regulate fluids and electrolytes. Pediatric patients are at increased risk for developing hyponatremic encephalopathy [see Warnings and Precautions (5.5, 5.6)].

In very low birth weight neonates, excessive or rapid administration of Dextrose Injection (5% and 10%) may result in increased serum osmolality and risk of intracerebral hemorrhage.

Dextrose Injection (5% and 10%) has not been studied in sufficient number of patients aged 65 and over to determine whether they respond differently from younger patients. Geriatric patients are at increased risk of developing hyponatremia and hyponatremic encephalopathy [see Warnings and Precautions (5.5)]. Other reported clinical experience has not identified differences in responses between the geriatric and younger adult patients. In general, the infusion rate for geriatric patients should start slow and be titrated up cautiously, reflecting their greater risk for electrolyte abnormalities and fluid overload.

Dextrose is known to be substantially excreted by the kidney, and the risk of adverse reactions to Dextrose Injection (5% and 10%) may be greater in patients with impaired renal function. Because geriatric patients are more likely to have impaired renal function, care should be taken in selection of infusion rate and patients should be closely monitored during Dextrose Injection (5% and 10%) treatment.

A medication error resulting in a high infusion rate of Dextrose Injection (5% and 10%) can cause hyperglycemia, hyperosmolality, and adverse effects on fluid and electrolyte balance [see Warnings and Precautions (5.2, 5.6)].

{ "type": "p", "children": [], "text": "A medication error resulting in a high infusion rate of Dextrose Injection (5% and 10%) can cause hyperglycemia, hyperosmolality, and adverse effects on fluid and electrolyte balance [see Warnings and Precautions (5.2, 5.6)].\n" }

Severe hyperglycemia and severe dilutional hyponatremia, and their complications, can be fatal. In the event of overdosage (overhydration or solute overload) during Dextrose Injection (5% and 10%) treatment, discontinue the infusion. Institute corrective measures such as administration of exogenous insulin, and treat adverse effects on the CNS, respiratory, and cardiovascular systems [see Warnings and Precautions (5.2, 5.6)].

{ "type": "p", "children": [], "text": "Severe hyperglycemia and severe dilutional hyponatremia, and their complications, can be fatal. In the event of overdosage (overhydration or solute overload) during Dextrose Injection (5% and 10%) treatment, discontinue the infusion. Institute corrective measures such as administration of exogenous insulin, and treat adverse effects on the CNS, respiratory, and cardiovascular systems [see Warnings and Precautions (5.2, 5.6)]." }

Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6 ∙ H2O), a hexose sugar freely soluble in water.

{ "type": "p", "children": [], "text": "Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6 ∙ H2O), a hexose sugar freely soluble in water." }

The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula:

{ "type": "p", "children": [], "text": "The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula:" }

Water for Injection, USP is chemically designated H2O.

{ "type": "p", "children": [], "text": "Water for Injection, USP is chemically designated H2O." }

Dextrose Injection, USP (5% and 10%) solutions are sterile and nonpyrogenic. They are parenteral solutions containing various concentrations of dextrose in water for injection intended for intravenous administration.

{ "type": "p", "children": [], "text": "Dextrose Injection, USP (5% and 10%) solutions are sterile and nonpyrogenic. They are parenteral solutions containing various concentrations of dextrose in water for injection intended for intravenous administration." }

Each 100 mL of 5% Dextrose Injection, USP, contains dextrose, hydrous 5 g in water for injection. The caloric value is 170 kcal/L. The osmolarity is 252 mOsmol/L (calc.), which is slightly hypotonic.

{ "type": "p", "children": [], "text": "Each 100 mL of 5% Dextrose Injection, USP, contains dextrose, hydrous 5 g in water for injection. The caloric value is 170 kcal/L. The osmolarity is 252 mOsmol/L (calc.), which is slightly hypotonic." }

Each 100 mL of 10% Dextrose Injection, USP, contains dextrose, hydrous 10 g in water for injection. The caloric value is 340 kcal/L. The osmolarity is 505 mOsmol/L (calc.), which is hypertonic.

{ "type": "p", "children": [], "text": "Each 100 mL of 10% Dextrose Injection, USP, contains dextrose, hydrous 10 g in water for injection. The caloric value is 340 kcal/L. The osmolarity is 505 mOsmol/L (calc.), which is hypertonic." }

The pH for both concentrations is 4.3 (range is 3.2 to 6.5).

{ "type": "p", "children": [], "text": "The pH for both concentrations is 4.3 (range is 3.2 to 6.5)." }

The solutions contain no bacteriostatic, antimicrobial agent or added buffer and each is supplied as single-dose containers.

{ "type": "p", "children": [], "text": "The solutions contain no bacteriostatic, antimicrobial agent or added buffer and each is supplied as single-dose containers." }

Dextrose is derived from corn.

{ "type": "p", "children": [], "text": "Dextrose is derived from corn." }

Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.

{ "type": "p", "children": [], "text": "Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period." }

Dextrose provides a source of carbohydrate calories and is used to supplement nutrition by providing glucose parenterally.

The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of dextrose have not been fully characterized.

Dextrose is oxidized to carbon dioxide and water.

Studies with dextrose to evaluate the drug's carcinogenic potential, mutagenic potential, or effects on fertility have not been performed.

Storage and Handling

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

Protect from freezing.

IFU0000541

{ "type": "p", "children": [], "text": "IFU0000541" }

icumedical

{ "type": "p", "children": [], "text": "\nicumedical" }

100 mL NDC 0990-7923-37

{ "type": "p", "children": [], "text": "100 mL NDC 0990-7923-37" }

5% Dextrose Injection, USP

{ "type": "p", "children": [], "text": "5% Dextrose Injection, USP" }

EACH 100 mL CONTAINS DEXTROSE, HYDROUS 5 g. 252 mOsmol/LITER (CALC). pH 4.3 (3.2 to 6.5). DEXTROSE SOLUTIONS WITHOUTSALTS SHOULD NOT BE USED IN BLOODTRANSFUSIONS BECAUSE OF POSSIBLEROULEAU FORMATION. ADDITIVES MAY BEINCOMPATIBLE. SINGLE-DOSE CONTAINER.FOR I.V. USE. USUAL DOSAGE: SEE INSERT.STERILE, NONPYROGENIC. USE ONLY IFSOLUTION IS CLEAR AND CONTAINER ISUNDAMAGED. MUST NOT BE USED INSERIES CONNECTIONS.

{ "type": "p", "children": [], "text": "EACH 100 mL CONTAINS DEXTROSE, HYDROUS 5 g.\t\t\t\t\t\t252 mOsmol/LITER (CALC). pH 4.3 (3.2 to 6.5).\t\t\t\t\t\tDEXTROSE SOLUTIONS WITHOUTSALTS SHOULD NOT BE USED IN BLOODTRANSFUSIONS BECAUSE OF POSSIBLEROULEAU FORMATION. ADDITIVES MAY BEINCOMPATIBLE. SINGLE-DOSE CONTAINER.FOR I.V. USE. USUAL DOSAGE: SEE INSERT.STERILE, NONPYROGENIC. USE ONLY IFSOLUTION IS CLEAR AND CONTAINER ISUNDAMAGED. MUST NOT BE USED INSERIES CONNECTIONS." }

Rx ONLY

{ "type": "p", "children": [], "text": "Rx ONLY" }

ICU Medical, Inc., Lake Forest, Illinois, 60045, USA IM-4313

{ "type": "p", "children": [], "text": "ICU Medical, Inc., Lake Forest, Illinois, 60045, USA IM-4313" }

3 V CONTAINS DEHP

{ "type": "p", "children": [], "text": "3 V CONTAINS DEHP" }

icumedical

{ "type": "p", "children": [], "text": "icumedical" }

250 mL NDC 0990-7922-53

{ "type": "p", "children": [], "text": "250 mL NDC 0990-7922-53" }

5% DEXTROSE Injection, USP

{ "type": "p", "children": [], "text": "5% DEXTROSE Injection, USP" }

EACH 100 mL CONTAINS DEXTROSE,HYDROUS 5 g IN WATER FORINJECTION. 252 mOsmol/LITER (CALC.)pH 4.3 (3.2 to 6.5) DEXTROSE SOLUTIONS WITHOUTSALTS SHOULD NOT BE USED INBLOOD TRANSFUSIONS BECAUSE OFPOSSIBLE ROULEAU FORMATION. ADDITIVES MAY BE INCOMPATIBLE.CONSULT WITH PHARMACIST, IFAVAILABLE. WHEN INTRODUCINGADDITIVES, USE ASEPTIC TECHNIQUE,MIX THOROUGHLY AND DO NOTSTORE. SINGLE-DOSE CONTAINER.FOR I.V. USE. USUAL DOSAGE: SEEINSERT. STERILE, NONPYROGENIC.USE ONLY IF SOLUTION IS CLEARAND CONTAINER IS UNDAMAGED.MUST NOT BE USED IN SERIESCONNECTIONS.

{ "type": "p", "children": [], "text": "EACH 100 mL CONTAINS DEXTROSE,HYDROUS 5 g IN WATER FORINJECTION.\t\t\t\t\t\t252 mOsmol/LITER (CALC.)pH 4.3 (3.2 to 6.5)\t\t\t\t\t\tDEXTROSE SOLUTIONS WITHOUTSALTS SHOULD NOT BE USED INBLOOD TRANSFUSIONS BECAUSE OFPOSSIBLE ROULEAU FORMATION.\t\t\t\t\t\tADDITIVES MAY BE INCOMPATIBLE.CONSULT WITH PHARMACIST, IFAVAILABLE. WHEN INTRODUCINGADDITIVES, USE ASEPTIC TECHNIQUE,MIX THOROUGHLY AND DO NOTSTORE. SINGLE-DOSE CONTAINER.FOR I.V. USE. USUAL DOSAGE: SEEINSERT. STERILE, NONPYROGENIC.USE ONLY IF SOLUTION IS CLEARAND CONTAINER IS UNDAMAGED.MUST NOT BE USED IN SERIESCONNECTIONS." }

Rx ONLY

{ "type": "p", "children": [], "text": "Rx ONLY" }

3 V CONTAINS DEHP

{ "type": "p", "children": [], "text": "3 V CONTAINS DEHP" }

IM-4428 Manufactured for ICU Medical, Inc.,Lake Forest, Illinois, 60045, USA

{ "type": "p", "children": [], "text": "IM-4428 Manufactured for ICU Medical, Inc.,Lake Forest, Illinois, 60045, USA" }

icumedical

{ "type": "p", "children": [], "text": "icumedical" }

500 mL NDC 0990-7930-03

{ "type": "p", "children": [], "text": "500 mL NDC 0990-7930-03" }

10% DEXTROSEInjection, USP

{ "type": "p", "children": [], "text": "10% DEXTROSEInjection, USP" }

EACH 100 mL CONTAINS DEXTROSE, HYDROUS 10 g INWATER FOR INJECTION. 505 mOsmol/LITER (CALC.) pH 4.3 (3.2 to 6.5) DEXTROSE SOLUTIONS WITHOUT SALTS SHOULDNOT BE USED IN BLOOD TRANSFUSIONS BECAUSEOF POSSIBLE ROULEAU FORMATION. ADDITIVES MAYBE INCOMPATIBLE. CONSULT WITH PHARMACIST,IF AVAILABLE. WHEN INTRODUCING ADDITIVES, USEASEPTIC TECHNIQUE, MIX THOROUGHLY AND DO NOTSTORE. SINGLE-DOSE CONTAINER. FOR INTRAVENOUSOR SUBCUTANEOUS USE. USUAL DOSAGE: SEE INSERT.STERILE, NONPYROGENIC. USE ONLY IF SOLUTION ISCLEAR AND CONTAINER IS UNDAMAGED. MUST NOT BEUSED IN SERIES CONNECTIONS.

{ "type": "p", "children": [], "text": "EACH 100 mL CONTAINS DEXTROSE, HYDROUS 10 g INWATER FOR INJECTION.\t\t\t\t\t\t505 mOsmol/LITER (CALC.) pH 4.3 (3.2 to 6.5)\t\t\t\t\t\tDEXTROSE SOLUTIONS WITHOUT SALTS SHOULDNOT BE USED IN BLOOD TRANSFUSIONS BECAUSEOF POSSIBLE ROULEAU FORMATION. ADDITIVES MAYBE INCOMPATIBLE. CONSULT WITH PHARMACIST,IF AVAILABLE. WHEN INTRODUCING ADDITIVES, USEASEPTIC TECHNIQUE, MIX THOROUGHLY AND DO NOTSTORE. SINGLE-DOSE CONTAINER. FOR INTRAVENOUSOR SUBCUTANEOUS USE. USUAL DOSAGE: SEE INSERT.STERILE, NONPYROGENIC. USE ONLY IF SOLUTION ISCLEAR AND CONTAINER IS UNDAMAGED. MUST NOT BEUSED IN SERIES CONNECTIONS." }

Rx ONLY

{ "type": "p", "children": [], "text": "Rx ONLY" }

3 V CONTAINS DEHP

{ "type": "p", "children": [], "text": "3 V CONTAINS DEHP" }

icumedical

{ "type": "p", "children": [], "text": "icumedical" }

ICU Medical, Inc., Lake Forest, Illinois, 60045, USA IM-4454

{ "type": "p", "children": [], "text": "ICU Medical, Inc., Lake Forest, Illinois, 60045, USA IM-4454" }