PROSULF

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PROTAMINE SULFATE

Available from:

PROPHARM LTD

ATC code:

V03AB14

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

PROTAMINE SULFATE 50 MG / 5 ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

CP PHARMACEUTICALS LTD, U.K.

Therapeutic group:

PROTAMINE

Therapeutic area:

PROTAMINE

Therapeutic indications:

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.

Authorization date:

2022-10-31

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
PROSULF
®
1.
NAME OF THE MEDICINAL PRODUCT
Prosulf
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Protamine sulfate 10mg/ml
3.
PHARMACEUTICAL FORM
Solution for injection
A clear, colourless solution.
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:_
Prosulf
®
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 elapsed since heparin was injected
intravenously, 0.5-0.75mg protamine sulfate per
100 units of mucous heparin is recommended. If two hours or more have
elapsed, 0.25-0.375mg per 100 units of
mucous heparin should be administered.
If the patient is receiving an intravenous infusion of heparin, the
infusion should be stopped and 25-50mg of protamine
sulfate given by slow intravenous injection.
If heparin was administered subcutaneously, 1mg protamine sulfate
should be given per 100 units of mucous heparin -
25-50mg by slow intravenous injection and the balance by i