Norepinephrine bitartrate injection is indicated to raise blood pressure in adult patients with severe, acute hypotension.

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Correct Hypovolemia

Address hypovolemia before initiation of norepinephrine bitartrate injection therapy. If the patient does not respond to therapy, suspect occult hypovolemia [see Warnings and Precautions (5.1)].

Administration

Dilute norepinephrine bitartrate injection prior to use [see Dosage and Administration (2.3)].

Infuse norepinephrine bitartrate injection into a large vein. Avoid infusions into the veins of the leg in the elderly or in patients with occlusive vascular disease of the legs [see Warnings and Precautions (5.1)]. Avoid using a catheter-tie-in technique.

Discontinuation

When discontinuing the infusion, reduce the flow rate gradually. Avoid abrupt withdrawal.

After an initial dosage of 8 to 12 mcg per minute via intravenous infusion, assess patient response and adjust dosage to maintain desired hemodynamic effect. Monitor blood pressure every two minutes until the desired hemodynamic effect is achieved, and then monitor blood pressure every five minutes for the duration of the infusion.

Typical maintenance intravenous dosage is 2 to 4 mcg per minute.

Visually inspect norepinephrine bitartrate injection for particulate matter and discoloration prior to administration (the solution is colorless). Do not use the solution if its color is pinkish or darker than slightly yellow or if it contains a precipitate.

Add the content of one norepinephrine bitartrate injection ampule (4 mg in 4 mL) to 1,000 mL of 5% Dextrose Injection, USP or Sodium Chloride Injection solutions that contain 5% dextrose to produce a 4 mcg per mL dilution. Dextrose reduces loss of potency due to oxidation. Administration in saline solution alone is not recommended.

Use higher concentration solutions in patients requiring fluid restriction. Prior to use, store the diluted norepinephrine bitartrate injection solution for up to 24 hours at room temperature [20°C to 25°C (68°F to 77°F)] and protect from light.

Avoid contact with iron salts, alkalis, or oxidizing agents.

Whole blood or plasma, if indicated to increase blood volume, should be administered separately.

Injection: 4 mg/4 mL (1 mg/mL norepinephrine base) sterile, colorless solution in a single-dose clear glass ampule.

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None.

{ "type": "p", "children": [], "text": "None." }

Administration of norepinephrine bitartrate injection to patients who are hypotensive from hypovolemia can result in severe peripheral and visceral vasoconstriction, decreased renal perfusion and reduced urine output, tissue hypoxia, lactic acidosis, and reduced systemic blood flow despite “normal” blood pressure. Address hypovolemia prior to initiating norepinephrine bitartrate injection [see Dosage and Administration (2.1)]. Avoid norepinephrine bitartrate injection in patients with mesenteric or peripheral vascular thrombosis, as this may increase ischemia and extend the area of infarction.

Gangrene of the extremities has occurred in patients with occlusive or thrombotic vascular disease or who received prolonged or high dose infusions. Monitor for changes to the skin of the extremities in susceptible patients.

Extravasation of norepinephrine bitartrate injection may cause necrosis and sloughing of surrounding tissue. To reduce the risk of extravasation, infuse into a large vein, check the infusion site frequently for free flow, and monitor for signs of extravasation [see Dosage and Administration (2.1)].

Emergency Treatment of Extravasation

To prevent sloughing and necrosis in areas in which extravasation has occurred, infiltrate the ischemic area as soon as possible, using a syringe with a fine hypodermic needle with 5 to 10 mg of phentolamine mesylate in 10 to 15 mL of 0.9% Sodium Chloride Injection in adults.

Sympathetic blockade with phentolamine causes immediate and conspicuous local hyperemic changes if the area is infiltrated within 12 hours.

Sudden cessation of the infusion rate may result in marked hypotension. When discontinuing the infusion, gradually reduce the norepinephrine bitartrate injection infusion rate while expanding blood volume with intravenous fluids.

Norepinephrine bitartrate injection elevates intracellular calcium concentrations and may cause arrhythmias, particularly in the setting of hypoxia or hypercarbia. Perform continuous cardiac monitoring of patients with arrhythmias.

The following adverse reactions are described in greater detail in other sections:

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The most common adverse reactions are hypertension and bradycardia.

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The following adverse reactions can occur:

{ "type": "p", "children": [], "text": "The following adverse reactions can occur:" }

Nervous system disorders: Anxiety, headache

{ "type": "p", "children": [], "text": "\nNervous system disorders: Anxiety, headache" }

Respiratory disorders: Respiratory difficulty, pulmonary edema

{ "type": "p", "children": [], "text": "\nRespiratory disorders: Respiratory difficulty, pulmonary edema" }

Co-administration of norepinephrine bitartrate injection with monoamine oxidase (MAO) inhibitors or other drugs with MAO-inhibiting properties (e.g., linezolid) can cause severe, prolonged hypertension.

If administration of norepinephrine bitartrate injection cannot be avoided in patients who recently have received any of these drugs and in whom, after discontinuation, MAO activity has not yet sufficiently recovered, monitor for hypertension.

Co-administration of norepinephrine bitartrate injection with tricyclic antidepressants (including amitriptyline, nortriptyline, protriptyline, clomipramine, desipramine, imipramine) can cause severe, prolonged hypertension. If administration of norepinephrine bitartrate injection cannot be avoided in these patients, monitor for hypertension.

Norepinephrine bitartrate injection can decrease insulin sensitivity and raise blood glucose. Monitor glucose and consider dosage adjustment of antidiabetic drugs.

Concomitant use of norepinephrine bitartrate injection with halogenated anesthetics (e.g., cyclopropane, desflurane, enflurane, isoflurane, and sevoflurane) may lead to ventricular tachycardia or ventricular fibrillation. Monitor cardiac rhythm in patients receiving concomitant halogenated anesthetics.

Risk Summary

Limited published data consisting of a small number of case reports and multiple small trials involving the use of norepinephrine in pregnant women at the time of delivery have not identified an increased risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks to the mother and fetus from hypotension associated with septic shock, myocardial infarction and stroke which are medical emergencies in pregnancy and can be fatal if left untreated. (see Clinical Considerations). In animal reproduction studies, using high doses of intravenous norepinephrine resulted in lowered maternal placental blood flow. Clinical relevance to changes in the human fetus is unknown since the average maintenance dose is ten times lower (see Data). Increased fetal reabsorptions were observed in pregnant hamsters after receiving daily injections at approximately 2 times the maximum recommended dose on a mg/m3 basis for four days during organogenesis (see Data).

The estimated background risk for 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 the clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Disease-associated maternal and/or embryo/fetal risk

Hypotension associated with septic shock, myocardial infarction, and stroke are medical emergencies in pregnancy which can be fatal if left untreated. Delaying treatment in pregnant women with hypotension associated with septic shock, myocardial infarction and stroke may increase the risk of maternal and fetal morbidity and mortality. Life-sustaining therapy for the pregnant woman should not be withheld due to potential concerns regarding the effects of norepinephrine on the fetus.

Animal Data

A study in pregnant sheep receiving high doses of intravenous norepinephrine (40 mcg/min, at approximately 10 times the average maintenance dose of 2 mcg/min to 4 mcg/min in human, on a mg/kg basis) exhibited a significant decrease in maternal placental blood flow. Decreases in fetal oxygenation, urine and lung liquid flow were also observed.

Norepinephrine administration to pregnant rats on Gestation Day 16 or 17 resulted in cataract production in rat fetuses.

In hamsters, an increased number of resorptions (29.1% in study group vs. 3.4% in control group), fetal microscopic liver abnormalities and delayed skeletal ossification were observed at approximately 2 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m2 basis at a maternal subcutaneous dose of 0.5 mg/kg/day from Gestation Day 7 to 10).

Risk Summary

There are no data on the presence of norepinephrine in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. Clinically relevant exposure to the infant is not expected based on the short half-life and poor oral bioavailability of norepinephrine.

Safety and effectiveness in pediatric patients have not been established.

Clinical studies of norepinephrine bitartrate injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. 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.

Avoid administration of norepinephrine bitartrate injection into the veins in the leg in elderly patients [see Warnings and Precautions (5.1)].

Overdosage with norepinephrine bitartrate injection may result in headache, severe hypertension, reflex bradycardia, marked increase in peripheral resistance, and decreased cardiac output.

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In case of overdosage, discontinue norepinephrine bitartrate injection until the condition of the patient stabilizes.

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Norepinephrine (sometimes referred to as l-arterenol/Levarterenol or l-norepinephrine) is a sympathomimetic amine which differs from epinephrine by the absence of a methyl group on the nitrogen atom.

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Norepinephrine bitartrate, USP is (-)-α-(aminomethyl)-3,4-dihydroxybenzyl alcohol tartrate (1:1) (salt) monohydrate (molecular weight 337.3 g/mol) and has the following structural formula:

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Norepinephrine bitartrate injection, USP is supplied in a sterile aqueous solution in the form of the bitartrate salt to be administered by intravenous infusion following dilution. Norepinephrine is sparingly soluble in water, very slightly soluble in alcohol and ether, and readily soluble in acids. Each mL contains 1 mg of norepinephrine base (equivalent to 2 mg of norepinephrine bitartrate), sodium chloride for isotonicity. It has a pH of 3 to 4.5. The air in the ampules has been displaced by nitrogen gas.

{ "type": "p", "children": [], "text": "Norepinephrine bitartrate injection, USP is supplied in a sterile aqueous solution in the form of the bitartrate salt to be administered by intravenous infusion following dilution. Norepinephrine is sparingly soluble in water, very slightly soluble in alcohol and ether, and readily soluble in acids. Each mL contains 1 mg of norepinephrine base (equivalent to 2 mg of norepinephrine bitartrate), sodium chloride for isotonicity. It has a pH of 3 to 4.5. The air in the ampules has been displaced by nitrogen gas." }

Norepinephrine is a peripheral vasoconstrictor (alpha-adrenergic action) and an inotropic stimulator of the heart and dilator of coronary arteries (beta-adrenergic action).

The primary pharmacodynamic effects of norepinephrine are cardiac stimulation and vasoconstriction. Cardiac output is generally unaffected, although it can be decreased, and total peripheral resistance is also elevated. The elevation in resistance and pressure result in reflex vagal activity, which slows the heart rate and increases stroke volume. The elevation in vascular tone or resistance reduces blood flow to the major abdominal organs as well as to skeletal muscle. Coronary blood flow is substantially increased secondary to the indirect effects of alpha stimulation. After intravenous administration, a pressor response occurs rapidly and reaches steady state within 5 minutes. The pharmacologic actions of norepinephrine are terminated primarily by uptake and metabolism in sympathetic nerve endings. The pressor action stops within 1 minutes to 2 minutes after the infusion is discontinued.

Absorption

Following initiation of intravenous infusion, the steady state plasma concentration is achieved in 5 min.

Distribution

Plasma protein binding of norepinephrine is approximately 25%. It is mainly bound to plasma albumin and to a smaller extent to prealbumin and alpha 1-acid glycoprotein. The volume of distribution is 8.8 L. Norepinephrine localizes mainly in sympathetic nervous tissue. It crosses the placenta but not the blood-brain barrier.

Elimination

The mean half-life of norepinephrine is approximately 2.4 min. The average metabolic clearance is 3.1 L/min.

Metabolism

Norepinephrine is metabolized in the liver and other tissues by a combination of reactions involving the enzymes catechol-O-methyltransferase (COMT) and MAO. The major metabolites are normetanephrine and 3- methoxyl-4-hydroxy mandelic acid (vanillylmandelic acid, VMA), both of which are inactive. Other inactive metabolites include 3-methoxy-4-hydroxyphenylglycol, 3,4-dihydroxymandelic acid, and 3,4- dihydroxyphenylglycol.

Excretion

Noradrenaline metabolites are excreted in urine primarily as sulphate conjugates and, to a lesser extent, as glucuronide conjugates. Only small quantities of norepinephrine are excreted unchanged.

Carcinogenesis, mutagenesis, and fertility studies have not been performed.

Norepinephrine Bitartrate Injection, USP, contains the equivalent of 4 mg base of norepinephrine per each 4 mL ampule (1 mg/mL), and is available as follows:

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<div class="scrollingtable"><table class="Noautorules" width="100%"> <col width="17%"/> <col width="29%"/> <col width="54%"/> <tbody class="Headless"> <tr> <td align="justify" valign="top"> <p class="First">AIN00610</p> </td><td align="justify" valign="top"> <p class="First">NDC 36000-162-10</p> </td><td align="justify" valign="top"> <p class="First">Ampules of 4 mL in shelf carton of 10</p> </td> </tr> </tbody> </table></div>

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

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Store in original carton until time of administration to protect from light. Discard unused portion.

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Risk of Tissue Damage

{ "type": "p", "children": [], "text": "\nRisk of Tissue Damage\n" }

Advise the patient, family, or caregiver to report signs of extravasation urgently [see Warnings and Precautions (5.1)].

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Manufactured for:

{ "type": "p", "children": [], "text": "Manufactured for:" }

Baxter Healthcare Corporation

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

Deerfield, IL 60015 USA

{ "type": "p", "children": [], "text": "Deerfield, IL 60015 USA" }

Manufactured by:

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

Sintetica S.A., Switzerland

{ "type": "p", "children": [], "text": "Sintetica S.A., Switzerland" }

Baxter is a registered trademark of Baxter International Inc.

{ "type": "p", "children": [], "text": "Baxter is a registered trademark of Baxter International Inc." }

AIN00610 NDC: 36000-162-01

{ "type": "p", "children": [], "text": "AIN00610 NDC: 36000-162-01" }

Norepinephrine Bitartrate Injection, USP

{ "type": "p", "children": [], "text": "\nNorepinephrine Bitartrate Injection, USP\n" }

4 mg/4 mL (1 mg per mL)      Rx Only

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CONTAINS NO SULFITES - PRESERVATIVE FREE

{ "type": "p", "children": [], "text": "\nCONTAINS NO SULFITES - PRESERVATIVE FREE\n" }

Each mL contains: norepinephrine bitartrate equal to 1mg norepinephrine base.

{ "type": "p", "children": [], "text": "Each mL contains: norepinephrine bitartrate equal to 1mg norepinephrine base." }

FOR IV INFUSION ONLY - DILUTE BEFORE USE. PROTECT FROM LIGHT.

{ "type": "p", "children": [], "text": "\nFOR IV INFUSION ONLY - DILUTE BEFORE USE. \n\nPROTECT FROM LIGHT. \n" }

Directions: See Insert.

{ "type": "p", "children": [], "text": "Directions: See Insert." }

BAXTER

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

Deerfield, IL 60015 USA

{ "type": "p", "children": [], "text": "Deerfield, IL 60015 USA" }

68797 02

{ "type": "p", "children": [], "text": "68797 02" }

2018-10-31

{ "type": "p", "children": [], "text": "2018-10-31" }

STERILE INJECTION AIN00610 NDC : 36000-162-10 10 Ampules 4 mL Each

{ "type": "p", "children": [], "text": "STERILE INJECTION AIN00610 NDC : 36000-162-10 10 Ampules 4 mL Each" }

Norepinephrine Bitartrate Injection, USP Rx only

{ "type": "p", "children": [], "text": "\nNorepinephrine Bitartrate Injection, USP Rx only" }

4 mg/4 mL (1 mg per mL)

{ "type": "p", "children": [], "text": "4 mg/4 mL (1 mg per mL)" }

CONTAINS NO SULFITES – PRESERVATIVE FREE

{ "type": "p", "children": [], "text": "CONTAINS NO SULFITES – PRESERVATIVE FREE" }

Warning: This is a potent drug. Dosage should be controlled by frequent determination of blood pressure. Do not leave patient unattended during administration. Avoid extravasation. Read package insert carefully.

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FOR INTRAVENOUS INFUSION ONLY. DILUTE BEFORE USE. DISCARD UNUSED PORTION.

{ "type": "p", "children": [], "text": "\nFOR INTRAVENOUS INFUSION ONLY. DILUTE BEFORE USE. DISCARD UNUSED PORTION.\n" }

Usual Dosage and Dilution Information - See package insert.

{ "type": "p", "children": [], "text": "Usual Dosage and Dilution Information - See package insert." }

Do not use the solution if its color is pinkish or darker than slightly yellow or if it contains a precipitate.

{ "type": "p", "children": [], "text": "Do not use the solution if its color is pinkish or darker than slightly yellow or if it contains a precipitate." }

Avoid contact with iron salts, alkalis, or oxidizing agents.

{ "type": "p", "children": [], "text": "Avoid contact with iron salts, alkalis, or oxidizing agents." }

Each mL contains: norepinephrine bitartrate, equivalent to 1 mg norepinephrine base, sodium chloride for isotonicity.

{ "type": "p", "children": [], "text": "Each mL contains: norepinephrine bitartrate, equivalent to 1 mg norepinephrine base, sodium chloride for isotonicity." }

The air in the ampules has been displaced by nitrogen gas.

{ "type": "p", "children": [], "text": "The air in the ampules has been displaced by nitrogen gas." }

These ampules are Easy Break Ampules.

{ "type": "p", "children": [], "text": "\nThese ampules are Easy Break Ampules.\n" }

Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F)

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[see USP Controlled Room Temperature].

{ "type": "p", "children": [], "text": "\n[see USP Controlled Room Temperature].\n" }

Retain in carton until time of use. PROTECT FROM LIGHT.

{ "type": "p", "children": [], "text": "\nRetain in carton until time of use. PROTECT FROM LIGHT.\n" }

Manufactured by:

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

Sintetica S.A.

{ "type": "p", "children": [], "text": "\nSintetica S.A.\n" }

Switzerland

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

Manufactured for:

{ "type": "p", "children": [], "text": "Manufactured for:" }

Baxter Healthcare Corporation

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

Deerfield, IL 60015 USA

{ "type": "p", "children": [], "text": "Deerfield, IL 60015 USA" }

66797 02

{ "type": "p", "children": [], "text": "66797 02" }

2018-10-31

{ "type": "p", "children": [], "text": "2018-10-31" }

STERILE INJECTION AIN00610 NDC : 36000-162-10 10 Ampules 4 mL Each

{ "type": "p", "children": [], "text": "STERILE INJECTION AIN00610 NDC : 36000-162-10 10 Ampules 4 mL Each" }

Norepinephrine Bitartrate Injection, USP Rx only

{ "type": "p", "children": [], "text": "\nNorepinephrine Bitartrate Injection, USP Rx only" }

4 mg/4 mL (1 mg per mL)

{ "type": "p", "children": [], "text": "4 mg/4 mL (1 mg per mL)" }

CONTAINS NO SULFITES – PRESERVATIVE FREE

{ "type": "p", "children": [], "text": "CONTAINS NO SULFITES – PRESERVATIVE FREE" }

Warning: This is a potent drug. Dosage should be controlled by frequent determination of blood pressure. Do not leave patient unattended during administration. Avoid extravasation. Read package insert carefully.

{ "type": "p", "children": [], "text": "\nWarning: This is a potent drug. Dosage should be controlled by frequent determination of blood pressure. Do not leave patient unattended during administration. Avoid extravasation. Read package insert carefully." }

FOR INTRAVENOUS INFUSION ONLY. DILUTE BEFORE USE. DISCARD UNUSED PORTION.

{ "type": "p", "children": [], "text": "\nFOR INTRAVENOUS INFUSION ONLY. DILUTE BEFORE USE. DISCARD UNUSED PORTION.\n" }

Usual Dosage and Dilution Information - See package insert.

{ "type": "p", "children": [], "text": "Usual Dosage and Dilution Information - See package insert." }

Do not use the solution if its color is pinkish or darker than slightly yellow or if it contains a precipitate.

{ "type": "p", "children": [], "text": "Do not use the solution if its color is pinkish or darker than slightly yellow or if it contains a precipitate." }

Avoid contact with iron salts, alkalis, or oxidizing agents.

{ "type": "p", "children": [], "text": "Avoid contact with iron salts, alkalis, or oxidizing agents." }

Each mL contains: norepinephrine bitartrate, equivalent to 1 mg norepinephrine base, sodium chloride for isotonicity.

{ "type": "p", "children": [], "text": "Each mL contains: norepinephrine bitartrate, equivalent to 1 mg norepinephrine base, sodium chloride for isotonicity." }

The air in the ampules has been displaced by nitrogen gas.

{ "type": "p", "children": [], "text": "The air in the ampules has been displaced by nitrogen gas." }

These ampules are Easy Break Ampules.

{ "type": "p", "children": [], "text": "\nThese ampules are Easy Break Ampules.\n" }

Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F)

{ "type": "p", "children": [], "text": "\nStore at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F)\n" }

[see USP Controlled Room Temperature].

{ "type": "p", "children": [], "text": "\n[see USP Controlled Room Temperature].\n" }

Retain in carton until time of use. PROTECT FROM LIGHT.

{ "type": "p", "children": [], "text": "\nRetain in carton until time of use. PROTECT FROM LIGHT.\n" }

Manufactured by:

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

Sintetica S.A.

{ "type": "p", "children": [], "text": "\nSintetica S.A.\n" }

Switzerland

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

Manufactured for:

{ "type": "p", "children": [], "text": "Manufactured for:" }

Baxter Healthcare Corporation

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

Deerfield, IL 60015 USA

{ "type": "p", "children": [], "text": "Deerfield, IL 60015 USA" }

420100139-01

{ "type": "p", "children": [], "text": "420100139-01" }

2023-04-14

{ "type": "p", "children": [], "text": "2023-04-14" }

Norepinephrine Bitartrate in Dextrose Injection is indicated to raise blood pressure in adult patients with severe, acute hypotension.

{ "type": "p", "children": [], "text": "Norepinephrine Bitartrate in Dextrose Injection is indicated to raise blood pressure in adult patients with severe, acute hypotension. " }

Correct Hypovolemia

Address hypovolemia before initiation of Norepinephrine Bitartrate in Dextrose Injection therapy. If the patient does not respond to therapy, suspect occult hypovolemia [see Warnings and Precautions (5.1)].

Administration

Norepinephrine Bitartrate in Dextrose Injection is a ready to administer product that requires no further dilution prior to infusion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use the solution if its color is pinkish or darker than slightly yellow or if it contains a precipitate.

Infuse Norepinephrine Bitartrate in Dextrose Injection into a large vein. Avoid infusions into the veins of the leg in the elderly or in patients with occlusive vascular disease of the legs [see Warnings and Precautions (5.1)]. Avoid using a catheter-tie-in technique.

The choice of appropriate concentration of Norepinephrine Bitartrate in Dextrose Injection depends on clinical fluid volume requirements. Use higher concentration solutions in patients requiring fluid restriction.

Discontinuation

When discontinuing the infusion, reduce the flow rate gradually. Avoid abrupt withdrawal.

After an initial dosage of 8 to 12 mcg per minute via intravenous infusion, assess patient response and adjust dosage to maintain desired hemodynamic effect. Monitor blood pressure every two minutes until the desired hemodynamic effect is achieved, and then monitor blood pressure every five minutes for the duration of the infusion.

Typical maintenance intravenous dosage is 2 to 4 mcg per minute.

Avoid contact with iron salts, alkalis, or oxidizing agents.

Whole blood or plasma, if indicated to increase blood volume, should be administered separately.

Injection: Norepinephrine bitartrate in 5% dextrose is a colorless to slightly yellow solution for intravenous infusion, supplied in 250-mL single dose containers as:

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None.

{ "type": "p", "children": [], "text": "None." }

Administration of Norepinephrine Bitartrate in Dextrose Injection to patients who are hypotensive from hypovolemia can result in severe peripheral and visceral vasoconstriction, decreased renal perfusion and reduced urine output, tissue hypoxia, lactic acidosis, and reduced systemic blood flow despite “normal” blood pressure. Address hypovolemia prior to initiating Norepinephrine Bitartrate in Dextrose Injection [see Dosage and Administration (2.1)]. Avoid Norepinephrine Bitartrate in Dextrose Injection in patients with mesenteric or peripheral vascular thrombosis, as this may increase ischemia and extend the area of infarction.

Gangrene of the extremities has occurred in patients with occlusive or thrombotic vascular disease or who received prolonged or high dose infusions. Monitor for changes to the skin of the extremities in susceptible patients.

Extravasation of Norepinephrine Bitartrate in Dextrose Injection may cause necrosis and sloughing of surrounding tissue. To reduce the risk of extravasation, infuse into a large vein, check the infusion site frequently for free flow, and monitor for signs of extravasation [see Dosage and Administration (2.1)].

Emergency Treatment of Extravasation

To prevent sloughing and necrosis in areas in which extravasation has occurred, infiltrate the ischemic area as soon as possible, using a syringe with a fine hypodermic needle with 5 to 10 mg of phentolamine mesylate in 10 to 15 mL of 0.9% Sodium Chloride Injection in adults.

Sympathetic blockade with phentolamine causes immediate and conspicuous local hyperemic changes if the area is infiltrated within 12 hours.

Sudden cessation of the infusion rate may result in marked hypotension. When discontinuing the infusion, gradually reduce the Norepinephrine Bitartrate in Dextrose Injection infusion rate while expanding blood volume with intravenous fluids.

Norepinephrine Bitartrate in Dextrose Injection elevates intracellular calcium concentrations and may cause arrhythmias, particularly in the setting of hypoxia or hypercarbia. Perform continuous cardiac monitoring of patients with arrhythmias.

The following serious adverse reactions are described in greater detail in other sections:

{ "type": "p", "children": [], "text": "The following serious adverse reactions are described in greater detail in other sections:" }

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The most common adverse reactions are hypertension and bradycardia.

{ "type": "p", "children": [], "text": "The most common adverse reactions are hypertension and bradycardia." }

The following adverse reactions can occur:

{ "type": "p", "children": [], "text": "The following adverse reactions can occur:" }

Nervous system disorders: Anxiety, headache

{ "type": "p", "children": [], "text": "\nNervous system disorders: Anxiety, headache" }

Respiratory disorders: Respiratory difficulty, pulmonary edema

{ "type": "p", "children": [], "text": "\nRespiratory disorders: Respiratory difficulty, pulmonary edema" }

General disorders and administration site conditions: Extravasation, injection site necrosis [see Warnings and Precautions (5.1)].

{ "type": "p", "children": [], "text": "\nGeneral disorders and administration site conditions: Extravasation, injection site necrosis [see Warnings and Precautions (5.1)].\n" }

Co-administration of Norepinephrine Bitartrate in Dextrose Injection with monoamine oxidase (MAO) inhibitors or other drugs with MAO-inhibiting properties (e.g., linezolid) can cause severe, prolonged hypertension.

If administration of Norepinephrine Bitartrate in Dextrose Injection cannot be avoided in patients who recently have received any of these drugs and in whom, after discontinuation, MAO activity has not yet sufficiently recovered, monitor for hypertension.

Co-administration of Norepinephrine Bitartrate in Dextrose Injection with tricyclic antidepressants (including amitriptyline, nortriptyline, protriptyline, clomipramine, desipramine, imipramine) can cause severe, prolonged hypertension. If administration of Norepinephrine Bitartrate in Dextrose Injection cannot be avoided in these patients, monitor for hypertension.

Norepinephrine Bitartrate in Dextrose Injection can decrease insulin sensitivity and raise blood glucose. Monitor glucose and consider dosage adjustment of antidiabetic drugs.

Concomitant use of Norepinephrine Bitartrate in Dextrose Injection with halogenated anesthetics (e.g., cyclopropane, desflurane, enflurane, isoflurane, and sevoflurane) may lead to ventricular tachycardia or ventricular fibrillation. Monitor cardiac rhythm in patients receiving concomitant halogenated anesthetics.

Risk Summary

Limited published data consisting of a small number of case reports and multiple small trials involving the use of norepinephrine in pregnant women at the time of delivery have not identified an increased risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks to the mother and fetus from hypotension associated with septic shock, myocardial infarction and stroke which are medical emergencies in pregnancy and can be fatal if left untreated. (see Clinical Considerations). In animal reproduction studies, using high doses of intravenous norepinephrine resulted in lowered maternal placental blood flow. Clinical relevance to changes in the human fetus is unknown since the average maintenance dose is ten times lower (see Data). Increased fetal reabsorptions were observed in pregnant hamsters after receiving daily injections at approximately 2 times the maximum recommended dose on a mg/m3 basis for four days during organogenesis (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 2-4% and 15-20%, respectively.

Clinical Considerations

Disease-associated maternal and/or embryo/fetal risk

Hypotension associated with septic shock, myocardial infarction, and stroke are medical emergencies in pregnancy which can be fatal if left untreated. Delaying treatment in pregnant women with hypotension associated with septic shock, myocardial infarction and stroke may increase the risk of maternal and fetal morbidity and mortality. Life-sustaining therapy for the pregnant woman should not be withheld due to potential concerns regarding the effects of norepinephrine on the fetus.

Data

Animal Data

A study in pregnant sheep receiving high doses of intravenous norepinephrine (40 mcg/min, at approximately 10 times the average maintenance dose of 2-4 mcg/min in human, on a mg/kg basis) exhibited a significant decrease in maternal placental blood flow. Decreases in fetal oxygenation, urine and lung liquid flow were also observed.

Norepinephrine administration to pregnant rats on Gestation Day 16 or 17 resulted in cataract production in rat fetuses.

In hamsters, an increased number of resorptions (29.1% in study group vs. 3.4% in control group), fetal microscopic liver abnormalities and delayed skeletal ossification were observed at approximately 2 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m2 basis at a maternal subcutaneous dose of 0.5 mg/kg/day from Gestation Day 7-10).

Risk Summary

There are no data on the presence of norepinephrine in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. Clinically relevant exposure to the infant is not expected based on the short half-life and poor oral bioavailability of norepinephrine.

Safety and effectiveness in pediatric patients have not been established.

Clinical studies of norepinephrine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. 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.

Avoid administration of Norepinephrine Bitartrate in Dextrose Injection into the veins in the leg in elderly patients [see Warnings and Precautions (5.1)].

Overdosage with Norepinephrine Bitartrate in Dextrose Injection may result in headache, severe hypertension, reflex bradycardia, marked increase in peripheral resistance, and decreased cardiac output.

{ "type": "p", "children": [], "text": "Overdosage with Norepinephrine Bitartrate in Dextrose Injection may result in headache, severe hypertension, reflex bradycardia, marked increase in peripheral resistance, and decreased cardiac output." }

In case of overdosage, discontinue Norepinephrine Bitartrate in Dextrose Injection until the condition of the patient stabilizes.

{ "type": "p", "children": [], "text": "In case of overdosage, discontinue Norepinephrine Bitartrate in Dextrose Injection until the condition of the patient stabilizes." }

Norepinephrine Bitartrate in Dextrose Injection contains norepinephrine, a sympathomimetic amine. Norepinephrine is sometimes referred to as l-arterenol/Levarterenol or l-norepinephrine which differs from epinephrine by the absence of a methyl group on the nitrogen atom.

{ "type": "p", "children": [], "text": "Norepinephrine Bitartrate in Dextrose Injection contains norepinephrine, a sympathomimetic amine. Norepinephrine is sometimes referred to as l-arterenol/Levarterenol or l-norepinephrine which differs from epinephrine by the absence of a methyl group on the nitrogen atom." }

Chemically, norepinephrine bitartrate monohydrate is (-)-α-(aminomethyl)-3,4-dihydroxybenzyl alcohol tartrate (1:1) (salt) monohydrate and has the following structural formula:

{ "type": "p", "children": [], "text": "Chemically, norepinephrine bitartrate monohydrate is (-)-α-(aminomethyl)-3,4-dihydroxybenzyl alcohol tartrate (1:1) (salt) monohydrate and has the following structural formula:" }

Norepinephrine is sparingly soluble in water, very slightly soluble in alcohol and ether, and readily soluble in acids.

{ "type": "p", "children": [], "text": "Norepinephrine is sparingly soluble in water, very slightly soluble in alcohol and ether, and readily soluble in acids." }

Norepinephrine Bitartrate in Dextrose Injection is supplied as a sterile aqueous solution administered by intravenous infusion. Each mL contains the equivalent of 16, 32, or 64 micrograms of norepinephrine base supplied as 31.90, 63.80, and 127.60 micrograms per mL of norepinephrine bitartrate monohydrate. It contains dextrose monohydrate (50 mg/mL) and may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. It has a target pH of 3.7. The air in the containers has been displaced by nitrogen gas.

{ "type": "p", "children": [], "text": "Norepinephrine Bitartrate in Dextrose Injection is supplied as a sterile aqueous solution administered by intravenous infusion. Each mL contains the equivalent of 16, 32, or 64 micrograms of norepinephrine base supplied as 31.90, 63.80, and 127.60 micrograms per mL of norepinephrine bitartrate monohydrate. It contains dextrose monohydrate (50 mg/mL) and may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. It has a target pH of 3.7. The air in the containers has been displaced by nitrogen gas." }

Norepinephrine is a peripheral vasoconstrictor (alpha-adrenergic action) and an inotropic stimulator of the heart and dilator of coronary arteries (beta-adrenergic action).

The primary pharmacodynamic effects of norepinephrine are cardiac stimulation and vasoconstriction. Cardiac output is generally unaffected, although it can be decreased, and total peripheral resistance is also elevated. The elevation in resistance and pressure result in reflex vagal activity, which slows the heart rate and increases stroke volume. The elevation in vascular tone or resistance reduces blood flow to the major abdominal organs as well as to skeletal muscle. Coronary blood flow is substantially increased secondary to the indirect effects of alpha stimulation. After intravenous administration, a pressor response occurs rapidly and reaches steady state within 5 minutes. The pharmacologic actions of norepinephrine are terminated primarily by uptake and metabolism in sympathetic nerve endings. The pressor action stops within 1-2 minutes after the infusion is discontinued.

Absorption

Following initiation of intravenous infusion, the steady state plasma concentration is achieved in 5 min.

Distribution

Plasma protein binding of norepinephrine is approximately 25%. It is mainly bound to plasma albumin and to a smaller extent to prealbumin and alpha 1-acid glycoprotein. The volume of distribution is 8.8 L. Norepinephrine localizes mainly in sympathetic nervous tissue. It crosses the placenta but not the blood-brain barrier.

Elimination

The mean half-life of norepinephrine is approximately 2.4 min. The average metabolic clearance is 3.1 L/min.

Metabolism

Norepinephrine is metabolized in the liver and other tissues by a combination of reactions involving the enzymes catechol-O-methyltransferase (COMT) and monoamine oxidase (MAO). The major metabolites are normetanephrine and 3-methoxy-4-hydroxy mandelic acid (vanillylmandelic acid, VMA), both of which are inactive. Other inactive metabolites include 3-methoxy-4-hydroxyphenylglycol, 3,4-dihydroxymandelic acid, and 3,4-dihydroxyphenylglycol.

Excretion

Norepinephrine metabolites are excreted in urine primarily as the sulfate conjugates and, to a lesser extent, as the glucuronide conjugates. Only small quantities of norepinephrine are excreted unchanged.

Carcinogenesis, mutagenesis, and fertility studies have not been performed.

Norepinephrine Bitartrate in Dextrose Injection for intravenous infusion is a colorless to slightly yellow solution available in single-dose, ready-to-use containers in an amber/foil overwrap. Each 250 mL of Norepinephrine Bitartrate in Dextrose Injection , 4 mg/250 mL, 8 mg/250 mL, and 16 mg/250 mL contains the equivalent of 4 mg, 8 mg, and 16 mg of norepinephrine, respectively (provided as norepinephrine bitartrate monohydrate). Norepinephrine Bitartrate in Dextrose Injection is available in the following:

{ "type": "p", "children": [], "text": "Norepinephrine Bitartrate in Dextrose Injection for intravenous infusion is a colorless to slightly yellow solution available in single-dose, ready-to-use containers in an amber/foil overwrap. Each 250 mL of Norepinephrine Bitartrate in Dextrose Injection , 4 mg/250 mL, 8 mg/250 mL, and 16 mg/250 mL contains the equivalent of 4 mg, 8 mg, and 16 mg of norepinephrine, respectively (provided as norepinephrine bitartrate monohydrate). Norepinephrine Bitartrate in Dextrose Injection is available in the following:" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col width="46%"/> <col width="26%"/> <tbody class="Headless"> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Product Description</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">NDC Number</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Twenty containers of 4 mg/250 mL</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">NDC 0338-0112-20</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Twenty containers of 8 mg/250 mL</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">NDC 0338-0108-20</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Twenty containers of 16 mg/250 mL</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">NDC 0338-0116-20</p> </td> </tr> </tbody> </table></div>

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Store at room temperature [20°C to 25°C (68°F to 77°F)], excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light. Once the overwrap is removed, the bag can be stored at room temperature for up to 30 days.

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Risk of Tissue Damage

{ "type": "p", "children": [], "text": "\nRisk of Tissue Damage\n" }

Advise the patient, family, or caregiver to report signs of extravasation urgently [see Warnings and Precautions (5.1)].

{ "type": "p", "children": [], "text": "Advise the patient, family, or caregiver to report signs of extravasation urgently [see Warnings and Precautions (5.1)].\n" }

Manufactured by:Baxter Healthcare CorporationDeerfield, IL 60015 USA

{ "type": "p", "children": [], "text": "Manufactured by:Baxter Healthcare CorporationDeerfield, IL 60015 USA" }

Made in Ireland

{ "type": "p", "children": [], "text": "Made in Ireland" }

Baxter and Viaflo are trademarks of Baxter International, Inc or its subsidiaries.

{ "type": "p", "children": [], "text": "Baxter and Viaflo are trademarks of Baxter International, Inc or its subsidiaries. " }

CB-30-02-920

{ "type": "p", "children": [], "text": "CB-30-02-920" }

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

EZPE7748NDC 0338-0112-20

{ "type": "p", "children": [], "text": "\nEZPE7748NDC 0338-0112-20\n" }

250 mL

{ "type": "p", "children": [], "text": "\n250 mL\n" }

Norepinephrine Bitartrate in 5% Dextrose Injection

{ "type": "p", "children": [], "text": "\nNorepinephrine \nBitartrate in 5% Dextrose Injection" }

4 mg / 250 mL (16 mg / mL) For Intravenous Infusion Only

{ "type": "p", "children": [], "text": "\n4 mg / 250 mL (16 mg / mL)\nFor Intravenous Infusion Only" }

Each 100mL of sterile, nonpyrogenic solution contains: Norepinephrine Bitartrate Monohydrate USP equivalent to 1.6 mg norepinephrine and 5 g Dextrose Monohydrate in Water for Injection, USP. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment.

{ "type": "p", "children": [], "text": "Each 100mL of sterile, nonpyrogenic solution contains: Norepinephrine Bitartrate Monohydrate USP equivalent to 1.6 mg norepinephrine and 5 g Dextrose Monohydrate in Water for Injection, USP. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment." }

Single Dose Only – Discard unused portion. For Intravenous Use.Recommended dosage: See prescribing information.Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15° C to 30°C (59°F to 86° F) [see USP Controlled Room Temperature.] Protect from light. Keep in overwrap until ready to use. Once removed from overwrap, bag can be stored at room temperature and should be used within 30 days.

{ "type": "p", "children": [], "text": "Single Dose Only – Discard unused portion. For Intravenous Use.Recommended dosage: See prescribing information.Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15° C to 30°C (59°F to 86° F) [see USP Controlled Room Temperature.] Protect from light. Keep in overwrap until ready to use. Once removed from overwrap, bag can be stored at room temperature and should be used within 30 days.\n" }

VIAFLO container is not made with natural rubber latex, DEHP, or PVC.Rx Only

{ "type": "p", "children": [], "text": "VIAFLO container is not made with natural rubber latex, DEHP, or PVC.Rx Only" }

Baxter Logo Baxter Healthcare CorporationDeerfield, IL 60015 USAMade in Ireland

{ "type": "p", "children": [], "text": "\nBaxter Logo\n\nBaxter Healthcare CorporationDeerfield, IL 60015 USAMade in Ireland" }

CB-35-05-133

{ "type": "p", "children": [], "text": "CB-35-05-133" }

VIAFLO container

{ "type": "p", "children": [], "text": "VIAFLO container" }

Symbol07 0

{ "type": "p", "children": [], "text": "\nSymbol07\n0" }

Symbol Do not usethis port

{ "type": "p", "children": [], "text": "\nSymbol Do not usethis port \n\n" }

Barcode (01)00303380112203

{ "type": "p", "children": [], "text": "\nBarcode\n(01)00303380112203" }

LOT

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

EXP

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

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

EZPE7788NDC 0338-0108-20 250 mL

{ "type": "p", "children": [], "text": "\nEZPE7788NDC 0338-0108-20 250 mL\n" }

Norepinephrine Bitartrate in 5% Dextrose Injection

{ "type": "p", "children": [], "text": "\nNorepinephrine \nBitartrate in 5% Dextrose Injection" }

8 mg / 250 mL (32 mcg / mL) For Intravenous Infusion Only

{ "type": "p", "children": [], "text": "\n8 mg / 250 mL (32 mcg / mL)\nFor Intravenous Infusion Only" }

Each 100 mL of sterile, nonpyrogenic solution contains: Norepinephrine Bitartrate Monohydrate USP equivalent to 3.2 mg norepinephrine and 5 g Dextrose Monohydrate in Water for Injection, USP. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment.

{ "type": "p", "children": [], "text": "Each 100 mL of sterile, nonpyrogenic solution contains: Norepinephrine Bitartrate Monohydrate USP equivalent to 3.2 mg norepinephrine and 5 g Dextrose Monohydrate in Water for Injection, USP. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment." }

Single Dose Only – Discard unused portion. For Intravenous Use.Recommended dosage: See prescribing information.Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] Protect from light. Keep in overwrap until ready to use. Once removed from overwrap, bag can be stored at room temperature and should be used within 30 days.

{ "type": "p", "children": [], "text": "Single Dose Only – Discard unused portion. For Intravenous Use.Recommended dosage: See prescribing information.Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] Protect from light. Keep in overwrap until ready to use. Once removed from overwrap, bag can be stored at room temperature and should be used within 30 days.\n" }

VIAFLO container is not made with natural rubber latex, DEHP, or PVC.Rx Only

{ "type": "p", "children": [], "text": "VIAFLO container is not made with natural rubber latex, DEHP, or PVC.Rx Only" }

Baxter Logo Baxter Healthcare CorporationDeerfield, IL 60015 USAMade in Ireland

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

VIAFLO container

{ "type": "p", "children": [], "text": "VIAFLO container" }

SymbolDo not usethis port

{ "type": "p", "children": [], "text": "\nSymbolDo not usethis port\n" }

Symbol07 0

{ "type": "p", "children": [], "text": "\nSymbol07\n0" }

CB-35-05-134Symbol 1

{ "type": "p", "children": [], "text": "CB-35-05-134Symbol 1" }

Barcode (01)00303380108206

{ "type": "p", "children": [], "text": "\nBarcode\n(01)00303380108206" }

LOT

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

EXP

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

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

EZPE7758NDC 0338-0116-20 250 mL

{ "type": "p", "children": [], "text": "\nEZPE7758NDC 0338-0116-20 250 mL\n" }

Norepinephrine Bitartrate in 5% Dextrose Injection

{ "type": "p", "children": [], "text": "\nNorepinephrine \nBitartrate in 5% Dextrose Injection" }

16 mg / 250 mL (64 mcg / mL) For Intravenous Infusion Only

{ "type": "p", "children": [], "text": "\n16 mg / 250 mL (64 mcg / mL)\nFor Intravenous Infusion Only" }

Each 100 mL of sterile, nonpyrogenic solution contains: Norepinephrine Bitartrate Monohydrate USP equivalent to 6.4 mg norepinephrine and 5 g Dextrose Monohydrate in Water for Injection, USP. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment.

{ "type": "p", "children": [], "text": "Each 100 mL of sterile, nonpyrogenic solution contains: Norepinephrine Bitartrate Monohydrate USP equivalent to 6.4 mg norepinephrine and 5 g Dextrose Monohydrate in Water for Injection, USP. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment." }

Single Dose Only – Discard unused portion. For Intravenous Use.Recommended dosage: See prescribing information.Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] Protect from light. Keep in overwrap until ready to use. Once removed from overwrap, bag can be stored at room temperature and should be used within 30 days.

{ "type": "p", "children": [], "text": "Single Dose Only – Discard unused portion. For Intravenous Use.Recommended dosage: See prescribing information.Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] Protect from light. Keep in overwrap until ready to use. Once removed from overwrap, bag can be stored at room temperature and should be used within 30 days.\n" }

VIAFLO container is not made with natural rubber latex, DEHP, or PVC.Rx Only

{ "type": "p", "children": [], "text": "VIAFLO container is not made with natural rubber latex, DEHP, or PVC.Rx Only" }

Baxter Logo Baxter Healthcare CorporationDeerfield, IL 60015 USAMade in Ireland

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

VIAFLO container

{ "type": "p", "children": [], "text": "VIAFLO container" }

SymbolDo not usethis port

{ "type": "p", "children": [], "text": "\nSymbolDo not usethis port\n" }

Symbol07 0

{ "type": "p", "children": [], "text": "\nSymbol07\n0" }

CB-35-05-144Symbol 1

{ "type": "p", "children": [], "text": "CB-35-05-144Symbol 1" }

Barcode (01)00303380116201

{ "type": "p", "children": [], "text": "\nBarcode\n(01)00303380116201" }

LOT

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

EXP

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