Protamine sulfate Injection 10mg/ml solution for injection

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

protamine sulfate

Доступна с:

Swiss Parenterals Ltd.

код АТС:

V03AB14

ИНН (Международная Имя):

protamine sulfate

дозировка:

10mg/ml

Фармацевтическая форма:

solution for injection

Штук в упаковке:

(5) ampoules 5ml

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2019-09-06

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Protamine Sulfate Injection 10 mg/ml, 5ml
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
QUALITATIVE DECLARATION
Protamine Sulfate Injection 10 mg/ml, 5ml
QUANTITATIVE DECLARATION
Each ml contains :
Protamine Sulfate.........10 mg
Excipients :
Sodium Chloride..........9.0 mg as tonicity adjustment
Sulfuric acid ...............q.s. for pH adjustment
Dibasic Sodium phosphate Heptahydrate..............q.s. for pH
adjustment
Water for Injections................ q.s.
DESCRIPTION
Protamine Sulfate Injection is clear, colourless solution filled in a
glass ampoule.
3. PHARMACEUTICAL FORM
Sterile Solution for Injection
PRODUCT NAME: PROTAMINE SULFATE INJECTION 10 MG/ML, 5 ML
DOSAGE FORM: SOLUTION FOR INJECTION
_Confidential _
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Protamine sulfate is used to counteract the anticoagulant effect of
heparin: before
surgery; after renal dialysis; after open-heart surgery; if excessive
bleeding occurs and
when an overdose has inadvertently been given.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS:
Protamine sulfate injection should be administered by slow intravenous
injection over a
period of about 10 minutes. No more than 50mg of protamine sulfate
should be given in
any one dose.
The dose is dependent on the amount and type of heparin to be
neutralised, its route of
administration and the time elapsed since it was last given, since
heparin is continuously
being excreted. Ideally, the dose required to neutralise the action of
heparin should be
guided by blood coagulation studies or calculated from a protamine
neutralisation test. In
gross excess, protamine itself acts as an anticoagulant.
NEUTRALISATION OF UNFRACTIONATED (UF) HEPARINS:
1mg of protamine sulfate will usually neutralise at least 100
international units of mucous
heparin or 80 units of lung heparin. The dose of protamine sulfate
should be reduced if
more than 15 minutes have elapsed since intravenous injection.
For example, if 30-60 minutes have ela