Heparin Injection 25000IU/5mL heparin sodium injection (porcine mucous)

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

heparin sodium, Quantity: 5000 IU/mL

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections; hydrochloric acid; sodium hydroxide

Administration route:

Intravenous, Subcutaneous

Units in package:

5mL x 50

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 26 NOVEMBER 2001: Prophylaxis and treatment of thromboembolic disorders such as thrombophlebitis, pulmonary embolism, coronary or venous thrombosis and occlusive vascular disease. As a low-dose regimen for the prevention of thromboembolic complications arising as a result of cardiac and arterial surgery. As an anticoagulant during blood transfusions, extracorporeal circulation, dialysis and other perfusion techniques and in blood samples for laboratory purposes.

Product summary:

Visual Identification: Clear, colourless or straw coloured solution, free from visible impurities.; Container Type: Ampoule; Container Material: LDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1994-06-22

Patient Information leaflet

HEPARIN INJECTION
_Heparin sodium_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Heparin Injection. It
does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you using Heparin Injection
against the benefits they expect it
will have for you.
This medicine is likely to be used
while you are at the clinic or in
hospital. If possible, please read this
leaflet carefully before this medicine
is given to you. In some cases, this
leaflet may be given to you after the
medicine has been used.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT HEPARIN
INJECTION IS USED FOR
Heparin Injection belongs to a group
of medicines known as
anticoagulants. Anticoagulants work
by decreasing the clotting ability of
your blood and help stop clots
forming in the blood vessels.
Anticoagulants are sometimes called
"blood thinners", although they do
not actually thin the blood. Heparin
will not dissolve blood clots that
have already formed, but it may
prevent any clots that have already
formed from becoming larger and
causing serious problems.
Heparin Injection is used for
prevention and treatment of diseases
caused by blood clots such as in
certain blood vessel, heart and lung
conditions. It is also used to prevent
blood clots from forming during
surgery, dialysis or blood
transfusions.
Heparin Injection may be used for
the treatment of other conditions that
are not mentioned above. Your
doctor will be able to tell you about
the specific condition for which you
have been prescribed Heparin
Injection.
This medicine is available only with
a doctor's prescription.
This medicine is not addictive.
BEFORE YOU ARE GIVEN
HEPARIN INJECTION
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DO NOT USE HEPARIN INJECTION IF
YOU:
•
have an allergy to heparin or pork
products
•
have, or may

Summary of Product characteristics

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AUSTRALIAN
PRODUCT
INFORMATION
–
HEPARIN
INJECTION
(HEPARIN
SODIUM
(PORCINE MUCOUS))
1.
NAME OF THE MEDICINE
Heparin sodium
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Heparin Injection contains Heparin sodium 5,000 IU/5 mL or 25,000 IU/5
mL
For the full list of excipients, see Section 6.1 List of excipients.
Heparin sodium is a preparation containing the sodium salt of a
sulphated glucosaminoglycan
present in mammalian tissues. It is prepared from the lungs or from
the intestinal mucosae of
pigs. Heparin sodium is a white or almost white powder, moderately
hygroscopic, freely
soluble in water.
3.
PHARMACEUTICAL FORM
Solution for injection.
Heparin Injection is a clear, colourless to straw coloured, sterile,
preservative-free solution.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
•
prophylaxis
and
treatment
of
thromboembolic
disorders
such
as
thrombophlebitis,
pulmonary embolism, coronary or venous thrombosis and occlusive
vascular disease.
•
as a low-dose regimen for the prevention of thromboembolic
complications arising as a
result of cardiac and arterial surgery.
•
as an anticoagulant during blood transfusions, extracorporeal
circulation, dialysis and other
perfusion techniques and in blood samples for laboratory purposes.
4.2 DOSE AND METHOD OF ADMINISTRATION
Heparin Injection contains no antimicrobial agent and is therefore
intended for single use only.
Heparin may be given by intermittent intravenous injection,
intravenous infusion or deep
subcutaneous injection. It should not be given intramuscularly due to
the risk of haematoma
formation at the injection site. There is a wide variation between
individuals in the dose
required to control thromboembolism and heparin dose is usually
determined empirically by
adjustment according to the results of laboratory tests.
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THE DOSAGE OF HEPARIN SODIUM SHOULD BE ADJUSTED ACCORDING TO THE
PATIENT'S COAGULATION
TEST RESULTS.
When hep