Heparin sodium 25,000 I.U./ml Solution for injection or concentrate for solution for infusion, 0.2ml ampoules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Heparin sodium

Available from:

Wockhardt UK Limited

ATC code:

B01AB; B01AB01

INN (International Name):

Heparin sodium

Dosage:

25,000 international unit(s)/millilitre

Pharmaceutical form:

Solution injection or concentrate for solution infusion

Prescription type:

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

Therapeutic area:

Heparin group; heparin

Authorization status:

Marketed

Authorization date:

1985-11-14

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
HEPARIN SODIUM 5,000 I.U./ML SOLUTION FOR INJECTION OR CONCENTRATE FOR
SOLUTION FOR
INFUSION
HEPARIN SODIUM 25,000 I.U./ML SOLUTION FOR INJECTION OR CONCENTRATE
FOR SOLUTION FOR
INFUSION
PRESERVATIVE FREE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, please ask your doctor or nurse.
- This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
The name of your medicine is either heparin sodium 5,000 I.U./ml, or
heparin sodium 25,000
I.U./ml solution for injection or concentrate for solution for
infusion. In the rest of this leaflet
it is called heparin injection.
WHAT IS IN THIS LEAFLET
1. What heparin injection is and what it is used for
2. What you need to know before you are given heparin injection
3. How heparin injection is given
4. Possible side effects
5. How to store heparin injection
6. Contents of the pack and other information
1. WHAT HEPARIN INJECTION IS AND WHAT IT IS USED FOR
Heparin belongs to a group of drugs that are called anti-coagulants.
These help to stop blood
clotting. Heparin injection is used in conditions where blood vessels
may become blocked by
blood clots. It is therefore used to treat and prevent:
• blood clots in leg veins (deep vein thrombosis)
• blood clots in the lung (pulmonary embolism)
as well as for:
• the treatment of chest pains resulting from disease of the heart
arteries (unstable angina
pectoris)
• the treatment of severe blockages affecting arteries in the legs
(acute peripheral arterial
occlusion)
• the prevention of blood clots in the heart following a heart
attack (mural thrombosis).
It is also used during heart and lu

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Heparin sodium 25,000 I.U./ml
Solution for injection or concentrate for solution for infusion, 0.2ml
ampoules.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Heparin sodium 25,000 I.U./ml (5,000 I.U. in 0.2 ml)
For the full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection or concentrate for solution for infusion.
A colourless or straw-coloured liquid free from turbidity and from
matter that deposits on standing.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prophylaxis of deep vein thrombosis and pulmonary embolism
Treatment of deep vein thrombosis, pulmonary embolism, unstable angina
pectoris and acute
peripheral arterial occlusion.
Prophylaxis of mural thrombosis following myocardial infarction.
In extracorporeal circulation and haemodialysis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Route of administration_
By continuous intravenous infusion in 5% glucose or 0.9% sodium
chloride or by intermittent intravenous injection, or by
subcutaneous injection.
As the effects of heparin are short-lived, administration by
intravenous infusion or subcutaneous injection is preferable to
intermittent intravenous injections.
_Recommended dosage_
Prophylaxis of deep vein thrombosis and pulmonary embolism
_Adults:_
2 hours pre-operatively:
5,000 units subcutaneously
followed by:
5,000 units subcutaneously every 8-12 hours, for 7-10 days or until
the patient is fully
ambulant.
No laboratory monitoring should be necessary during low dose heparin
prophylaxis.
If monitoring is considered desirable,
anti-Xa assays should be used as the activated partial thromboplastin
time (APTT) is not significantly prolonged.
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