OMEGAVEN- fish oil injection, emulsion

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

Fish oil (UNII: XGF7L72M0F) (Fish oil - UNII:XGF7L72M0F)

Доступна с:

Fresenius Kabi USA, LLC

Администрация маршрут:

INTRAVENOUS

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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

Обзор продуктов:

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)] .

Статус Авторизация:

New Drug Application

Характеристики продукта

OMEGAVEN - FISH OIL INJECTION, EMULSION
FRESENIUS KABI USA, LLC
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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