Prosulf 10mg/ml Solution for Injection, Protamine Sulphate 10mg/ml solution for injection

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PROTAMINE SULFATE

Available from:

Wockhardt UK Limited Ash Road North, Wrexham, LL13 9UF, United Kingdom

ATC code:

V03AB14

INN (International Name):

PROTAMINE SULFATE 10 mg/ml

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

PROTAMINE SULFATE 10 mg/ml

Prescription type:

POM

Therapeutic area:

ALL OTHER THERAPEUTIC PRODUCTS

Authorization status:

Withdrawn

Authorization date:

2006-08-23

Patient Information leaflet

PACKAGE LEAFLET: 
INFORMATION FOR THE USER
PROTAMINE SULPHATE
®
 10MG/ML 
SOLUTION FOR INJECTION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START 
TAKING THIS MEDICINE.
- Keep this leaflet. You may need to read it again while  
  you are receiving your treatment.
- If you have any further questions, please ask your 
  doctor or nurse.
- This medicine has been prescribed for you. The 
  contents of your vial of Protamine Sulphate 10mg/ml 
  Solution for Injection should not be shared with other 
 patients.
The name of your medicine is Protamine Sulphate 
10mg/ml Solution for Injection. In the rest of this leaflet 
it is called Protamine Sulphate Injection.
IN THIS LEAFLET: 
1. What Protamine Sulphate Injection is and what it is 
   used for
2. Before you are given Protamine Sulphate Injection
3. How Protamine Sulphate Injection should be given
4. Possible side effects
5. How to store Protamine Sulphate Injection
6. Further information 
1. WHAT PROTAMINE SULPHATE INJECTION IS  
    AND WHAT IT IS USED FOR
The name of your medicine is Protamine Sulphate 
Injection. The active ingredient in Protamine Sulphate 
Injection is protamine sulphate.  
HOW DOES YOUR MEDICINE WORK?
Protamine Sulphate Injection contains protamine 
sulphate which is a heparin antidote which neutralises 
the anti blood-clotting effect of heparin and prevents it 
from thinning the blood too much.
It is used before surgery, after kidney dialysis, after open 
- heart surgery, if you bleed during heparin treatment or 
if too much heparin has been given to you by accident.
2. BEFORE YOU ARE GIVEN PROTAMINE 
    SULPHATE INJECTION
Protamine Sulphate Injection should only be given as an 
antidote to heparin. It is not suitable for use as an 
antidote to other medicines that are used to thin the 
blood that are taken by mouth.
Protamine Sulphate Injection should not be used if you 
have ever had a reaction or been told that you are allergic 
to protamine sulphate or any of the other

Summary of Product characteristics

_Page _1 of 5_ _

1          NAME OF THE MEDICINAL PRODUCT 

Prosulf® 10mg/ml Solution for Injection 
            Protamine Sulphate 10mg/ml Solution for Injection 

2          QUALITATIVE AND QUANTITATIVE COMPOSITION 

Protamine Sulphate 10mg/ml 

3          PHARMACEUTICAL FORM 

Solution for injection 

A clear, colourless solution. 

4          CLINICAL PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 

Protamine sulphate 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 sulphate 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 sulphate will usually neutralise at least 100 international units of mucous 
heparin or 80 units of lung heparin.  The dose of protamine sulphate 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-
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