DBL HEPARIN SODIUM (porcine mucous) 5000IU/0.2mL Injection BP

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

heparin sodium, Quantity: 25000 IU/mL

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Subcutaneous, Intravenous

Units in package:

50x5000IU/0.2mL, 5x5000IU/0.2mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Heparin is indicated for the prophylaxis and treatment of thromboembolic disorders such as thrombophlebitis, pulmonary embolism and occlusive vascular disease. It is also used to prevent thromboembolic complications arising from cardiac and vascular surgery, frostbite, dialysis and other perfusion procedures. Heparin is also used as an anticoagulant in blood transfusions

Product summary:

Visual Identification: Colourles or straw coloured solution; Container Type: Ampoule; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-10-08

Patient Information leaflet

DBL™ HEPARIN SODIUM
INJECTION BP AMPOULE
_Heparin Sodium_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DBL Heparin
Sodium Injection BP ampoule. 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 being given heparin
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 administered.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT DBL HEPARIN
SODIUM INJECTION BP
IS USED FOR
This medicine belongs to a group of
medicines known as anti-coagulants.
Anti-coagulants work by decreasing
the clotting ability of the blood and
help stop clots dorming in the blood
vessels.
Anti-coagulants 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.
This medicine is used for prevention
and treatment of diseases caused by
blood clots, such as certain blood
vessel, heart and lung conditions. It is
also used to prevent blood clots from
forming during some types of
surgery, dialysis and blood
transfusions.
Heparin 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.
This medicine is available only with
a doctor's prescription.
This medicine is not addictive.
BEFORE YOU ARE GIVEN
DBL HEPARIN SODIUM
INJECTION BP
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU SHOULD NOT BE GIVEN DBL
H

Summary of Product characteristics

Product Information - Australia
pfphephi10321
Superseded: pfphephi10819
Page 1
AUSTRALIAN PRODUCT INFORMATION – DBL™ HEPARIN
SODIUM INJECTION BP AMPOULE (HEPARIN SODIUM)
1 NAME OF THE MEDICINE
Heparin sodium
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
DBL Heparin Sodium Injection BP 1,000 IU/1 mL: each mL contains 1,000
IU Heparin sodium
DBL Heparin Sodium Injection BP 5,000 IU/0.2 mL: 0.2 mL contains 5,000
IU Heparin sodium
DBL Heparin Sodium Injection BP 5,000 IU/1 mL: each mL contains 5,000
IU Heparin sodium
Heparin sodium is prepared from porcine intestinal mucosa and is free
from pyrogenic substances.
3 PHARMACEUTICAL FORM
DBL Heparin Sodium Injection BP is a colourless or straw coloured
sterile solution of heparin sodium in
water for injections. The pH of the injection ranges between 5.0 and
8.0.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Heparin
is
indicated
for
the
prophylaxis
and
treatment
of
thromboembolic
disorders
such
as
thrombophlebitis, pulmonary embolism and occlusive vascular disease.
It is also used to prevent
thromboembolic complications arising from cardiac and vascular
surgery, frostbite, dialysis and other
perfusion procedures. Heparin is also used as an anticoagulant in
blood transfusions.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Low dose prophylaxis against postoperative venous thromboembolism:
heparin sodium may be used. The
usual dose is 5,000 units by deep subcutaneous injection 2 hours
before surgery and repeated every 8 to 12
hours for 7 days or longer until the patient is fully ambulatory.
_ADULTS: _
Treatment of established venous thrombosis or pulmonary embolism. Use
heparin sodium. Treatment
may be given by the following routes:
a)
Continuous intravenous infusion: a bolus dose of 5,000 units may be
given initially followed by an
infusion of 20,000 to 40,000 units in 1 litre of sodium chloride
intravenous infusion or glucose
intravenous infusion over 24 hours.
b)
Intermittent intravenous injection: an initial dose of 10,000 units
followed by 5,000 to 10,000 units
eve