Heparin sodium 5,000 I.U./ml Solution for injection or concentrate for solution for infusion, 5 ml vials

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Heparin sodium

Saadav alates:

Pinewood Laboratories Ltd

ATC kood:

B01AB; B01AB01

INN (Rahvusvaheline Nimetus):

Heparin sodium

Annus:

5000 international unit(s)/millilitre

Ravimvorm:

Solution for injection/infusion

Terapeutiline ala:

Heparin group; heparin

Volitamisolek:

Marketed

Loa andmise kuupäev:

1985-11-14

Infovoldik

PACKAGE LEAFLET: INFORMATION FOR THE USER
HEPARIN SODIUM 5,000 I.U./ML SOLUTION FOR INJECTION OR CONCENTRATE FOR
SOLUTION FOR
INFUSION
CONTAINS PRESERVATIVE
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 heparin sodium 5,000 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 anticoagulants.
These help to stop blood clotting. Heparin injection 5,000 I.U./ml 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 lung operations and during kidney
dialysis.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN HEPARIN INJECTION
THIS MEDICIN

Toote omadused

Health Products Regulatory Authority
04 January 2021
CRN009YTP
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Heparin sodium 5,000 I.U./ml Solution for injection or concentrate for
solution for infusion, 5 ml vials
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Heparin sodium 5,000 I.U./ml (25,000 I.U. in 5 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.
The intravenous injection volume of heparin injection should not
exceed 15ml.
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.
During pregnancy: 5,000 - 10,000 units every 12 hours, subcutaneously,
adjusted according to APTT or anti-Xa assay.
Health Products Regulatory Authority
04 January 2021
CRN009YTP
P