SURE RESULT O3D3 SYSTEM- omega-3-acid ethyl esters kit

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

OMEGA-3-ACID ETHYL ESTERS (UNII: D87YGH4Z0Q) (OMEGA-3 FATTY ACIDS - UNII:71M78END5S)

Доступна с:

International Brand Management, LLC

ИНН (Международная Имя):

OMEGA-3-ACID ETHYL ESTERS

состав:

OMEGA-3-ACID ETHYL ESTERS 1 g in 1 g

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Each capsule contains 1 gram of Omega-3-acid ethyl esters liquid concentrate consisting of at least 900 mg of Omega-3-acid ethyl esters.

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

SURE RESULT O3D3 SYSTEM- OMEGA-3-ACID ETHYL ESTERS
INTERNATIONAL BRAND MANAGEMENT, LLC
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Each capsule contains 1 gram of Omega-3-acid ethyl
esters liquid concentrate consisting of at least 900 mg of
Omega-3-acid ethyl esters.
OMEGA-3-ACID ETHYL ESTERS - omega-3-acid ethyl esters capsule, liquid
filled
International Brand Management, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
omega-3-acid ethyl esters capsules,
USP safely and effectively. See full prescribing information for
omega-3-acid ethyl esters capsules,
USP.
OMEGA-3-ACID ETHYL ESTERS CAPSULES, USP FOR ORAL USE
Initial U.S. Approval: 2004
RECENT MAJOR CHANGES
Indications and Usage, Limitations of Use (1) 06/2013
INDICATIONS AND USAGE
Omega-3-acid ethyl esters, USP is a combination of ethyl esters of
omega 3 fatty acids, principally EPA
and DHA, indicated as an adjunct to diet to reduce triglyceride (TG)
levels in adult patients with severe
(≥500 mg/dL) hypertriglyceridemia (HTG). (1) (1)
Limitations of Use: (1)
• The effect of omega-3-acid ethyl esters capsules, USP on the risk
for pancreatitis has not been
determined. (1)
• The effect of omega-3-acid ethyl esters capsules, USP on
cardiovascular mortality and morbidity has
not been determined. (1)
DOSAGE AND ADMINISTRATION
• The daily dose of omega-3-acid ethyl esters is 4 grams per day
taken as a single 4-gram dose (4
capsules) or as two 2-gram doses (2 capsules given twice daily). (2)
• Patients should be advised to swallow omega-3-acid ethyl esters
capsules whole. Do not break open,
crush, dissolve, or chew omega-3-acid ethyl esters capsules. (2)
DOSAGE FORMS AND
STRENGTHS
Capsules: 1-gram (3) (3)
CONTRAINDICATIONS
Omega-3-acid ethyl esters capsules are contraindicated in patients
with known hypersensitivity (e.g.,
anaphylactic reaction) to omega-3-acid ethyl esters capsules or any of
its components. (4) (4)
WARNINGS AND PRECAUTIONS
• In patients with hepatic impairment, monitor ALT and AST levels
periodically