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

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Heparin sodium

Saadav alates:

LEO Pharma

ATC kood:

B01AB01

INN (Rahvusvaheline Nimetus):

Heparin sodium

Annus:

1000unit/1ml

Ravimvorm:

Solution for injection

Manustamisviis:

Intravenous; Subcutaneous

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 02080100; GTIN: 5702191004595

Infovoldik

120 mm
320 mm
189 mm
20 mm
(centred)
WHAT IS IN THIS LEAFLET
1.
What heparin is and what it is used for
2.
What you need to know before you have heparin
3.
How to use heparin
4.
Possible side effects
5.
How to store heparin
6.
Contents of the pack and other information
1. WHAT HEPARIN IS AND WHAT IT IS USED FOR
Heparin contains the active substance known as
heparin sodium. Heparin belongs to a group of
medicines called anticoagulants.
These medicines affect how the blood clots. Heparin
prevents clotting, allowing normal blood flow through
the arteries and veins.
Heparin is used to help:
• stop harmful blood clots in your veins growing
bigger (treatment).
• stop harmful blood clots forming in your veins
(prevention).
• stop harmful blood clots forming in the tubing of an
artificial kidney machine during kidney dialysis
(haemodialysis).
An example is a harmful blood clot that has been
formed in a deep vein (deep vein thrombosis, DVT).
This usually happens in a leg. Another example is a
clot that has travelled to the lung and caused a
blockage (pulmonary embolism, PE). This can cause
breathing difficulties and chest pain.
It is more likely these clots will form if you are either
overweight, pregnant, have certain blood disorders
or have already had a PE, DVT, heart attack or stroke.
They may also happen if you do not move around for
long periods of time. This could be because you have
had surgery or you have another illness.
2. WHAT YOU NEED TO KNOW BEFORE YOU HAVE HEPARIN
DO NOT HAVE HEPARIN
• If you are allergic (hypersensitive) to heparin
sodium or any of the other ingredients in this
medicine (listed in section 6).
• If you have ever had a reaction to heparin that
caused a severe drop in the number of your
clotting cells (platelets); a reaction called
heparin-induced thrombocytopenia.
• If you have a major bleed (for instance in the brain,
spine, eye, stomach, into a muscle or womb) or any
condition which makes you bleed severely, such as
haemophilia.
•
If you have very high blood pressure.
•
If

Toote omadused

OBJECT 1
HEPARIN (MUCOUS ) INJECTION BP
Summary of Product Characteristics Updated 26-Sep-2016 | Leo
Laboratories Limited
1. Name of the medicinal product
Heparin (Mucous) Injection BP
2. Qualitative and quantitative composition
Heparin (Mucous) Injection BP 1000 Units/ml: each ml contains Heparin
Sodium 1,000 IU.
Heparin (Mucous) Injection BP 5000 Units/ml: each ml contains Heparin
Sodium 5,000 IU.
Excipients with known effect:
Benzyl alcohol
Methylhydroxybenzoate (E218)
Propylhydroxybenzoate (E216)
Sodium chloride
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection
A clear, colourless or pale yellowish liquid, free from turbidity and
from matter that deposits on standing.
4. Clinical particulars
4.1 Therapeutic indications
For the treatment of thrombo-embolic disorders such as deep vein
thrombosis, acute arterial embolism or
thrombosis, thrombophlebitis, pulmonary embolism and fat embolism.
For prophylaxis against deep vein thrombosis and thrombo-embolic
events in susceptible patients.
For the prevention of clotting in the extracorporeal circuit during
haemodialysis.
4.2 Posology and method of administration
Posology
FOR THE TREATMENT OR PREVENTION OF THROMBO-EMBOLIC DISORDERS:
TREATMENT DOSAGE:
INTRAVENOUS ADMINISTRATION
5,000-10,000 IU every 4 hours or 500 IU/kg bodyweight daily as a
continuous infusion in sodium
chloride injection or dextrose injection. Doses should be individually
adjusted according to coagulation
tests.
SUBCUTANEOUS ADMINISTRATION
The initial dose is 250 IU/kg bodyweight. Further doses should be
given every 12 hours and individually
adjusted according to coagulation tests.
DOSAGE ADJUSTMENT
It is recommended that dosages be adjusted to maintain a thrombin
clotting time, whole blood clotting
time or activated partial thromboplastin time 1.5 to 2 times that of
control on blood withdrawn 4 - 6 hours
after the first injection or commencement of infusion and at similar
intervals until the patient is stabilised.
PROPHYLACTIC DOSAGE:
Administration is b