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

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PROTAMINE SULFATE

Available from:

LEO Pharma A/S Industriparken 55, 2750-DK Ballerup, Denmark

ATC code:

V03AB14

INN (International Name):

PROTAMINE SULFATE 10 mg/ml

Pharmaceutical form:

SOLUTION FOR INJECTION/INFUSION

Composition:

PROTAMINE SULFATE 10 mg/ml

Prescription type:

POM

Therapeutic area:

ALL OTHER THERAPEUTIC PRODUCTS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2021-11-23

Patient Information leaflet

Page 1 of 6
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

Summary of Product characteristics

Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
Page
2
of
8
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 relativel