DBL HEPARIN SODIUM INJECTION BP (PORCINE) 1000 iuml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

HEPARIN SODIUM (PORCINE MUCOUS)

Available from:

PFIZER PRIVATE LIMITED

ATC code:

B01AB01

Dosage:

1000 iu/ml

Pharmaceutical form:

INJECTION

Composition:

HEPARIN SODIUM (PORCINE MUCOUS) 1000 iu/ml

Administration route:

INTRAVENOUS, SUBCUTANEOUS

Prescription type:

Prescription Only

Manufactured by:

Siegfried Hameln GmbH

Authorization status:

ACTIVE

Authorization date:

1988-06-13

Summary of Product characteristics

DBL
™ HEPARIN SODIUM INJECTION BP
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/1 mL: each mL contains 5,000
IU Heparin sodium
DBL Heparin Sodium Injection BP 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
concent