Monoparin or Heparin Sodium

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

HEPARIN SODIUM

Available from:

Wockhardt UK Limited

ATC code:

B01AB

INN (International Name):

HEPARIN SODIUM

Pharmaceutical form:

SOLUTION FOR INFUSION OR INJECTION

Composition:

HEPARIN SODIUM 1000 IU/ml

Prescription type:

POM

Therapeutic area:

ANTITHROMBOTIC AGENTS

Authorization status:

Authorised

Authorization date:

2006-08-23

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.
- 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. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.
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.
IN THIS LEAFLET:
1. What heparin injection is and what it is used for
2. Before you are given heparin injection
3. How heparin injection is given
4. Possible side effects
5. How to store heparin injection
6. Further 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. BEFORE YOU ARE GIVEN HEPARIN INJECTION
HEPARIN INJECTION SHOULD NOT BE GIVEN IF YOU:
• are allergic to heparin or any of the other ingredients in your
medicine, (see ‘What heparin
injection contains’ section 6)
• drink large amounts of alcohol
• are currently bleeding from anywhere in the body, (apart from your
normal periods which
does not stop you being given heparin injection)
• have haemophilia (a genetic disorder which may cause you to b

Summary of Product characteristics

Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Monoparin 1,000 I.U./ml Solution for injection or concentrate for
solution for
infusion or Heparin sodium 1,000 I.U./ml Solution for injection or
concentrate for
solution for infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSTION
Heparin sodium 1,000 I.U./ml (1,000 I.U./ml in 1ml, 5,000 I.U. in 5ml,
10,000
I.U in 10ml and 20,000 I.U in 20ml)
For a 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
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:
Page 2 of 8
_ _
_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.
_ _
_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 o