DBL HEPARIN SODIUM (porcine mucous) 35000IU/35mL Injection BP

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

heparin sodium

Available from:

Hospira Australia Pty Ltd

Authorization status:

Registered

Patient Information leaflet

_ _
_Page 1 _
DBL™ HEPARIN SODIUM INJECTION BP
VIAL
Heparin _(HEP-a-rin)_
CONSUMER MEDICINE INFORMATION
_Date of Dispensing_
_Consumer Name _
_ Pharmacist Name _
_Consumer Address _
_ Pharmacist Address _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DBL™ Heparin
Sodium Injection BP vial.
It does not contain all the available
information.
It does not take the place of talking
to your doctor or pharmacist.
All medicines have risks and
benefits
.
Your doctor has weighed
the risks of you being given heparin
against the benefits they expect it
will have for you.
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 is used for the
prevention and treatment of
disorders caused by blood clots,
such as certain heart, blood vessel
and lung conditions. It is also used
to prevent blood clots from forming
during some types of surgery,
dialysis and blood transfusions.
This medicine belongs to a group of
medicines called anticoagulants.
It works by decreasing the clotting
ability of the blood.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have prescribed it
for another reason.
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™
HEPARIN SODIUM INJECTION BP IF
YOU HAVE AN ALLERGY TO:
•
any medicine containing
heparin
•
any of the ingredients listed at
the end of this leaflet.
Some of the symptoms of an
allergic reaction may include
shortness of breath, wheezing or
difficulty breathing; swelling of the
face, lips, tongue or other parts of
the body; rash, itching or hives on
the skin.
YOU SHOULD NOT BE GIVEN THIS
MEDICINE IF YOU HAVE ANY OF THE
FOLLOWING MEDICAL CONDITIONS:
•
conditions where bleeding is or
may be a pr

Summary of Product characteristics

Product Information - Australia
Version 8.0
Page 1
AUSTRALIAN PRODUCT INFORMATION – DBL™ HEPARIN
SODIUM INJECTION BP (HEPARIN SODIUM)
1 NAME OF THE MEDICINE
Heparin sodium
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
DBL™ Heparin Sodium Injection BP 35,000 IU/35 mL: each mL contains
1,000 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
every 4 to 6 hours may be given.
c)
Deep subcutaneous injection: the usual dose is 5,000 units injected
intravenously followed by
subcutaneous injection of 10,000 units 8 hourly or 15,000 units 12
hourly. A c