Heparin sodium 1,000 I.U./ml Solution for injection or concentrate for solution for infusion, 5ml ampoules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Heparin sodium

Available from:

Pinewood Laboratories Ltd

ATC code:

B01AB; B01AB01

INN (International Name):

Heparin sodium

Dosage:

1000 international unit(s)/millilitre

Pharmaceutical form:

Solution for injection/infusion

Therapeutic area:

Heparin group; heparin

Authorization status:

Marketed

Authorization date:

1985-11-14

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
HEPARIN SODIUM 1,000 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 heparin sodium 1,000 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:
• 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)
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 MEDICINE SHOULD NOT BE INJECTED INTO YOUR MUSCLES
THIS MEDICINE SHOULD NOT BE USED AFTER MAJOR TRAUMA
HEPARIN INJECTION SHOULD N

Summary of Product characteristics

Health Products Regulatory Authority
04 January 2021
CRN009YTP
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Heparin sodium 1,000 I.U./ml Solution for injection or concentrate for
solution for infusion, 5ml ampoules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Heparin sodium 1,000 I.U./ml (5,000 I.U. in 5ml)
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 matter
that deposits on standing.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of deep vein thrombosis, pulmonary embolism, unstable angina
pectoris and acute peripheral arterial occlusion.
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.
As the effects of heparin are short-lived, administration by
intravenous infusion is preferable to intermittent intravenous
injections.
_Recommended dosage _
TREATMENT OF DEEP VEIN THROMBOSIS, PULMONARY EMBOLISM, UNSTABLE ANGINA
PECTORIS, ACUTE PERIPHERAL ARTERIAL OCCLUSION:
_Adults:_
Loading dose: 5,000 units intravenously (10,000 units may be required
in severe pulmonary embolism)
Maintenance: 1,000-2,000 units/hour by intravenous infusion, or
5,000-10,000 units 4-hourly by intravenous injection.
_Elderly: _
Dosage reduction may be advisable.
Health Products Regulatory Authority
04 January 2021
CRN009YTP
Page 2 of 8
_Children and small adults: _
Loading dose: 50 units/kg intravenously
Maintenance: 15-25 units/kg/hour by intravenous infusion, or 100
units/kg 4-hourly by intravenous injection.
DAILY LABORATORY MONITORING (IDEALLY AT THE SAME TIME EACH DAY,
STARTING 4-6 HOURS AFTER INITIATION OF TREATMENT) IS
ESSENTIAL DURING FULL-DOSE HEPARIN TREATMENT, WITH ADJUSTMENT OF
DOSAGE TO MAINTAIN AN APTT VALUE 1.5-2.5 X MIDPOINT
OF NORMAL RANGE OR CONTROL VALUE