Protamine sulphate LEO Pharma 1400 anti-heparin IU/ml solution for injection and infusion

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Protamine sulphate

Disponible depuis:

LEO Pharma A/S

Code ATC:

V03AB; V03AB14

DCI (Dénomination commune internationale):

Protamine sulphate

Dosage:

1400 international unit(s)/millilitre

forme pharmaceutique:

Solution for injection/infusion

Type d'ordonnance:

Product subject to prescription which may not be renewed (A)

Domaine thérapeutique:

Antidotes; protamine

Statut de autorisation:

Marketed

Date de l'autorisation:

2006-11-27

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PROTAMINE SULPHATE LEO PHARMA 1400 ANTI-HEPARIN IU/ML
(CORRESPONDS TO 10 MG/ML)
SOLUTION FOR INJECTION AND INFUSION
Protamine sulphate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

A doctor or nurse usually administers this product. If you have any
further questions ask your doctor,
nurse or pharmacist.

If you get any side effects, talk to your doctor, nurse or pharmacist.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Protamine sulphate LEO Pharma is and what it is used for
2.
What you need to know before you use Protamine sulphate LEO Pharma
3.
How to use Protamine sulphate LEO Pharma
4.
Possible side effects
5.
How to store Protamine sulphate LEO Pharma
6.
Contents of the pack and other information
1.
WHAT PROTAMINE SULPHATE LEO PHARMA IS AND WHAT IT IS USED FOR
The active ingredient is protamine sulphate, which is used as an
anti-heparin, to block the action of heparin
and low molecular weight heparins, and to reduce the effect of these
substances on the body.
Heparins are used to prevent your blood from clotting and they may
cause bleeding.
You may be given this medicine:

To help stop bleeding which has been caused by heparin/low molecular
weight heparin

To prevent a lot of bleeding if you have been treated with heparin/low
molecular weight heparin and
are going to have surgery

To reverse the effect of heparin used for some types of heart surgery
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE PROTAMINE SULPHATE LEO PHARMA
DO NOT USE PROTAMINE SULPHATE LEO PHARMA:
if you are allergic to protamine sulphate or any of the other
ingredients of this medicine (listed in section 6)
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using Protamine
sulphate LEO Pharma

if you are a diabetic using insulin (particularly protamine insulin)


Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Protamine sulphate LEO Pharma 1400 anti-heparin IU/ml solution for
injection and infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Protamine sulphate 1400 anti-heparin IU/ml (corresponds to 10 mg/ml)
extracted from the sperm of_ Onchorhynchus_
_keta_ (salmon).
1 ml contains 1400 anti-heparin IU protamine sulphate (10 mg)
5 ml contains 7000 anti-heparin IU protamine sulphate (50 mg)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection and infusion.
Clear, colourless solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Protamine sulphate can be used
- in the treatment of overdosage or haemorrhage during heparin or Low
Molecular Weight Heparin (LMWH) therapy
- to counteract the anticoagulant effects of heparin or LMWH before
emergency surgery.
- to reverse the anticoagulant effects of heparin in cardiopulmonary
bypass procedures.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Protamine sulphate is administered as a slow intravenous injection
over a period of about 10 minutes or as a constant,
slow intravenous infusion. The largest single injection (bolus dose)
should not exceed 5 ml (7000 anti-heparin IU/50
mg protamine sulphate). Ideally the dose should be guided by blood
coagulation studies. The activated partial
thromboplastin time (APTT) activated clotting time (ACT), anti Xa and
bedside protamine neutralisation test are
adequate for this purpose. Coagulation tests are usually performed 5
to 15 minutes after protamine sulphate
administration. Further doses may be needed because protamine sulphate
is cleared from the blood more rapidly than
heparin and especially LMWH. The prolonged absorption after
subcutaneous administration of heparin or LMWH
might also indicate that repeated doses must be given.
_NEUTRALISATION OF HEPARIN_:
1 ml of Protamine sulphate LEO Pharma (10 mg protamine sulphate) will
neutralise approximately 1400 IU of heparin.
As heparin has a relatively short half-life when giv