Protamine sulfate Injection 10mg/ml

Land: Armenië

Taal: Engels

Bron: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Werkstoffen:

protamine sulfate

Beschikbaar vanaf:

Swiss Parenterals Pvt. Ltd.

INN (Algemene Internationale Benaming):

protamine sulfate

Dosering:

10mg/ml

farmaceutische vorm:

solution for injection

Prescription-type:

Prescription

Productkenmerken

PRODUCT NAME: PROTAMINE SULFATE INJECTION 10 MG/ML, 5ML
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DOSAGE FORM: SOLUTION FOR INJECTION
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_Confidential _
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, 5ML
_ _
DOSAGE FORM: SOLUTION FOR INJECTION
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_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