Heparin sodium 10,000units/10ml solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Heparin sodium

Available from:

Wockhardt UK Ltd

ATC code:

B01AB01

INN (International Name):

Heparin sodium

Dosage:

1000unit/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02080100; GTIN: 5012727745695

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
HEPARIN INJECTION SHOULD NOT BE GIVEN IF YOU:
•
are allergic to heparin or any of the other ingredients of this
medicine (listed i

Summary of Product characteristics

OBJECT 1
HEPARIN SODIUM 1,000 I.U./ML SOLUTION FOR
INJECTION OR CONCENTRATE FOR SOLUTION FOR INFUSION
(WITHOUT PRESERVATIVE)
Summary of Product Characteristics Updated 11-Apr-2018 | Wockhardt UK
Ltd
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 composition
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 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
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.
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) i