PANCRELIPASE capsule delayed release

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

PANCRELIPASE LIPASE (UNII: 8MYC33932O) (PANCRELIPASE LIPASE - UNII:8MYC33932O)

Доступна с:

X-GEN Pharmaceuticals, Inc.

ИНН (Международная Имя):

PANCRELIPASE LIPASE

состав:

PANCRELIPASE LIPASE 5000 [USP'U]

Тип рецепта:

PRESCRIPTION DRUG

Статус Авторизация:

New Drug Application Authorized Generic

Характеристики продукта

PANCRELIPASE- PANCRELIPASE CAPSULE, DELAYED RELEASE
X-GEN PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
PANCRELIPASE
X-GEN PHARMACEUTICALS, INC.
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PANCRELIPASE SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR PANCRELIPASE.
[PANCRELIPASE] (PANCRELIPASE) CAPSULE, DELAYED RELEASE FOR ORAL USE
INITIAL U.S. APPROVAL: [2009]
RECENT MAJOR CHANGES
Dosage and Administration, Infants (up to 12 months) (2 ) June 2011
INDICATIONS AND USAGE
PANCRELIPASE TM is indicated for the treatment of exocrine pancreatic
insufficiency due to cystic fibrosis, or other
conditions (1)
DOSAGE AND ADMINISTRATION
_Dosage_
PANCRELIPASE is not interchangeable with any other pancrelipase
product other than Zenpep.
_Infants (up to 12 months)_
Infants may be given 3,000 lipase units (one capsule) per 120 mL of
formula or per breast-feeding. (2.1)
Do not mix PANCRELIPASE capsule contents directly into formula or
breast milk prior to administration. (2.2)
_Children Older than 12 Months and Younger than 4 Years_
Enzyme dosing should begin with 1,000 lipase units/kg of body weight
per meal to a maximum of 2,500 lipase units/kg
of body weight per meal (or less than or equal to 10,000 lipase
units/kg of body weight per day), or less than 4,000
lipase units/g fat ingested per day. (2.1)
_Children 4 Years and Older and Adults_
Enzyme dosing should begin with 500 lipase units/kg of body weight per
meal to a maximum of 2,500 lipase units/kg of
body weight per meal (or less than or equal to 10,000 lipase units/kg
of body weight per day), or less than 4,000 lipase
units/g fat ingested per day.(2.1)
_Limitations on Dosing_
Dosing should not exceed the recommended maximum dosage set forth by
the Cystic Fibrosis Foundation Consensus
Conferences Guidelines (2.1)
_Administration_
PANCRELIPASE should be swallowed whole. For infants or patients unable
to swallow intact capsules, the contents may
be sprinkled on soft acidic food, e.g., applesauce. (2.2)
DOSAGE FORMS AN