Heparin sodium 125,000units/5ml solution for injection vials

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Heparin sodium

Beschikbaar vanaf:

Wockhardt UK Ltd

ATC-code:

B01AB01

INN (Algemene Internationale Benaming):

Heparin sodium

Dosering:

25000unit/1ml

farmaceutische vorm:

Solution for injection

Toedieningsweg:

Subcutaneous; Intravenous

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 02080100; GTIN: 5012727743851

Bijsluiter

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
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 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
anticoagulants.
These help to stop blood clotting. Heparin
injection 5,000 I.U./ml or 25,000 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).
I

Productkenmerken

OBJECT 1
HEPARIN SODIUM 25,000 I.U./ML SOLUTION FOR
INJECTION OR CONCENTRATE FOR SOLUTION FOR INFUSION
(WITH PRESERVATIVE) (PL 29831/0108)
Summary of Product Characteristics Updated 08-May-2018 | Wockhardt UK
Ltd
1. Name of the medicinal product
Multiparin 25,000 I.U./ml solution for injection or concentrate for
solution for infusion or Heparin
sodium 25,000 I.U./ml solution for injection or concentrate for
solution for infusion
2. Qualitative and quantitative composition
Heparin sodium 25,000 I.U./ml (125,000 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 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 pr