Label: OMEGAVEN- fish oil injection, emulsion
- NDC Code(s): 63323-205-00, 63323-205-21, 63323-205-31, 63323-205-50
- Packager: Fresenius Kabi USA, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated July 19, 2023
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use OMEGAVEN safely and effectively. See full prescribing information for OMEGAVEN. OMEGAVEN (fish oil triglycerides) injectable ...
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Table of ContentsTable of Contents
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1 INDICATIONS AND USAGE
Omegaven is indicated as a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC). Limitations of Use: Omegaven is not indicated for ...
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2 DOSAGE AND ADMINISTRATION
2.1 Administration Instructions - Omegaven can be administered alone or as part of a PN admixture. Omegaven is for central or peripheral intravenous infusion. When administered with ...
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3 DOSAGE FORMS AND STRENGTHS
Injectable Emulsion: 5 g/50 mL and 10 g/100 mL (0.1 g/mL) sterile, white, homogenous emulsion in a 50-mL and 100-mL single-dose bottle.
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4 CONTRAINDICATIONS
Use of Omegaven is contraindicated in patients with: Known hypersensitivity to fish or egg protein or to any of the active ingredients or excipients [see Warnings and Precautions (5.2)]. Severe ...
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5 WARNINGS AND PRECAUTIONS
5.1 Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants - In the postmarket setting, serious adverse reactions including acute respiratory ...
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6 ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling: Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants ...
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7 DRUG INTERACTIONS
7.1 Antiplatelet Agents and Anticoagulants - Some published studies have demonstrated prolongation of bleeding time in patients taking antiplatelet agents or anticoagulants and oral omega-3 ...
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8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy - Risk Summary - There are no available data on Omegaven use in pregnant women to establish a drug- associated risk of major birth defects, miscarriage, or adverse maternal or ...
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10 OVERDOSAGE
In the event of an overdose, serious adverse reactions may occur [see Warnings and Precautions (5.1, 5.4)]. Stop the infusion of Omegaven until triglyceride levels have normalized and any symptoms ...
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11 DESCRIPTION
Omegaven (fish oil triglycerides) is a sterile, nonpyrogenic, white, homogenous emulsion for intravenous infusion as a supply of calories in patients with PNAC. Each mL of Omegaven contains 0.1 g ...
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12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action - Omegaven provides a biologically utilizable source of calories and essential fatty acids. Fatty acids serve as an important substrate for energy production. The most ...
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13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - No studies have been performed with fish oil triglycerides to evaluate the carcinogenic potential or its effect on fertility. Fish ...
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14 CLINICAL STUDIES
The efficacy of Omegaven was evaluated in two open-label single-center clinical trials (Study 1, NCT00910104, and Study 2, NCT00738101) in pediatric patients with PNAC (defined as direct or ...
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16 HOW SUPPLIED/STORAGE AND HANDLING
Omegaven (fish oil triglycerides) injectable emulsion, 5 g/50 mL and 10 g/100 mL (0.1 g/mL) is a white, homogenous, sterile emulsion supplied as follows: 50 mL single-dose glass bottle - NDC ...
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17 PATIENT COUNSELING INFORMATION
When initiating Omegaven administration, discuss the following information: Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants - Inform ...
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PRINCIPAL DISPLAY PANELPACKAGE LABEL- PRINCIPAL DISPLAY – Omegaven 50 mL Vial Label - NDC 63323-205-21 255050 - Omegaven - ® (fish oil triglycerides) Injectable emulsion - 5 grams per 50 mL - (0.1 grams per ...
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PRINCIPAL DISPLAY PANELPACKAGE LABEL- PRINCIPAL DISPLAY – Omegaven 50 mL Vial Carton Label - NDC 63323-205-50 255050 - Omegaven - ® (fish oil triglycerides) Injectable emulsion - 5 grams per 50 mL - (0.1 grams per ...
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PRINCIPAL DISPLAY PANELPACKAGE LABEL- PRINCIPAL DISPLAY – Omegaven 100 mL Vial Label - NDC 63323-205-31 255100 - Omegaven - ® (fish oil triglycerides) Injectable emulsion - 10 grams per 100 mL - (0.1 grams per ...
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PRINCIPAL DISPLAY PANELPACKAGE LABEL- PRINCIPAL DISPLAY – Omegaven 100 mL Vial Carton Label - NDC 63323-205-00 255100 - Omegaven - ® (fish oil triglycerides) Injectable emulsion - 10 grams per 100 mL - (0.1 grams per ...
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INGREDIENTS AND APPEARANCEProduct Information