Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
Fish oil (UNII: XGF7L72M0F) (Fish oil - UNII:XGF7L72M0F)
Fresenius Kabi USA, LLC
INTRAVENOUS
PRESCRIPTION DRUG
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 the prevention of PNAC. It has not been demonstrated that Omegaven prevents PNAC in parenteral nutrition (PN)-dependent patients [see Clinical Studies (14)]. - It has not been demonstrated that the clinical outcomes observed in patients treated with Omegaven are a result of the omega-6:omega-3 fatty acid ratio of the product [see Clinical Studies (14)]. 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 hemorrhagic disorders due to a potential effect on platelet aggregation. - Severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride concentrations greater than 1,000 mg/dL) [see Warnings and Precautions (5.6)]. Risk Summary There are no av
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: The stopper used as the bottle closure is not made with natural rubber latex, PVC, or DEHP. Storage and Handling Store below 25°C (77°F). Avoid excessive heat. Do not freeze. If accidentally frozen, discard product. Once the bottle is connected to the infusion set, use Omegaven immediately. Complete infusion within 12 hours when using a Y-connector [see Dosage and Administration (2.1)] . Infuse admixtures containing Omegaven immediately. If not used immediately, admixtures can be stored for up to 6 hours at room temperature or up to 24 hours under refrigeration. Complete the infusion within 24 hours after removal from storage [see Dosage and Administration (2.2)] .
New Drug Application
OMEGAVEN - FISH OIL INJECTION, EMULSION FRESENIUS KABI USA, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE 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 EMULSION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 2018 RECENT MAJOR CHANGES Dosage and Administration (2.1, 2.3) 5/2023 Warnings and Precautions (5.1) 5/2023 INDICATIONS AND USAGE Omegaven is indicated as a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC). (1) Limitations of Use: Omegaven is not indicated for the prevention of PNAC. It has not been demonstrated that Omegaven prevents PNAC in parenteral nutrition (PN)-dependent patients. (1) It has not been demonstrated that the clinical outcomes observed in patients treated with Omegaven are a result of the omega-6:omega-3 fatty acid ratio of the product. (1) DOSAGE AND ADMINISTRATION For infusion into a central or peripheral vein. (2.1) See full prescribing information for administration and admixing instructions. (2.1, 2.2) Protect the admixed PN solution from light. (2.2) Recommended dosage depends on age, energy expenditure, clinical status, body weight, tolerance, ability to metabolize, and consideration of additional energy sources given to the patient. The recommended daily dose (and the maximum dose) in pediatric patients is 1 g/kg/day. (2.3) For information on infusion rate when initiating dosing and in patients with elevated triglyceride levels, see the full prescribing information. (2.3, 5.1, 5.6) The recommended duration for infusion is between 8 and 24 hours, depending on the clinical situation. (2.3) DOSAGE FORMS AND STRENGTHS Injectable Emulsion: 5 g/50 mL and 10 g/100 mL (0.1 g/mL) in a single-dose bottle (3) CONTRAINDICATIONS Known hypersensitivity to fish or egg protein or to any of the active ingredients or excipients. (4) Severe hemorrhagic disorders. (4) Severe disorders of lipi Belgenin tamamını okuyun