PROTAMINE SULPHATE LEO

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PROTAMINE SULFATE

Available from:

Leo Laboratories Limited

Dosage:

10 mg/ml Mg/Ml

Pharmaceutical form:

Solution for Injection

Authorization date:

1983-04-01

Summary of Product characteristics

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Protamine Sulphate LEO 10 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Protamine sulphate 10 mg/ml.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless liquid.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
As a heparin antagonist to
neutralise the haemorrhagic effects of heparin. 
To counteract overdosage with tinzaparin.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
No more than 50mg of Protamine Sulphate should be administered in
a 10 minute period and the rate of administration 
should not exceed 5mg/minute.
TO NEUTRALISE THE EFFECTS OF HEPARIN:
The usual dosage is up to 5ml (50 mg) administered by
slow intravenous injection. Dosage depends on patient’s blood 
coagulability. Each 1mg of protamine sulphate is stated to
neutralise 100 IU of heparin. 
If given after a period of 30 minutes following
heparin administration, dosage requirements may be reduced
because of 
heparin metabolism.
TO COUNTERACT OVERDOSAGE OF TINZAPARIN:
Limited evidence suggests that a dose of 1mg
protamine sulphate per 100 anti-Xa IU tinzaparin
neutralises 65-80% of 
the anti-Xa activity. The protamine sulphate dose should
be given intermittently or as a slow continuous intravenous 
infusion for at least 24 hours to maintain neutralisation
of tinzaparin.
4.3 CONTRAINDICATIONS
Hypersensitivity to protamine sulphate or the excipients.
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Excessive dosage may prolong the coagulation
time because protamine itself has anticoagulant activity.
The thrombocytopoenia associated with extracorporeal circulation
during cardiac surgery may be aggravated by 
protamine.
IRISH MEDICINES BOARD
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