DBL™ Heparin Sodium Injection BP

Negara: Selandia Baru

Bahasa: Inggris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Heparin sodium 25000 IU/mL

Tersedia dari:

Pfizer New Zealand Limited

INN (Nama Internasional):

Heparin sodium 25000 IU/mL

Dosis:

25000 IU/mL

Bentuk farmasi:

Solution for injection

Komposisi:

Active: Heparin sodium 25000 IU/mL Excipient: Hydrochloric acid Sodium hydroxide Water for injection

Unit dalam paket:

Ampoule, glass, 5 x 0.2mL, 5 dose units

Kelas:

Prescription

Jenis Resep:

Prescription

Diproduksi oleh:

New Zealand Pharmaceuticals Ltd

Ringkasan produk:

Package - Contents - Shelf Life: Ampoule, glass, 5 x 0.2mL - 5 dose units - 36 months from date of manufacture stored at or below 25°C - Ampoule, glass, 50 x 0.2mL - 50 dose units - 36 months from date of manufacture stored at or below 25°C

Tanggal Otorisasi:

1980-03-06

Karakteristik produk

Version: pfdhephi11221
Supersedes: pfdhephi11119
Page 1 of 12
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
_ _
DBL™ Heparin Sodium Injection BP
Solution for Injection, 1,000 IU/mL, 5,000 IU/mL and 25,000 IU/mL.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Heparin Sodium Injection 1,000 IU/mL, 5,000 IU/mL and 25,000 IU/mL is
prepared from
porcine intestinal mucosa and is free from pyrogenic substances.
EXCIPIENT(S) WITH KNOWN EFFECT
•
Benzyl alcohol (vials only)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
DBL Heparin Sodium Injection is a colourless or straw coloured sterile
solution for injection:
available as ampoules (1,000 IU/mL, 5,000 IU/mL and 25,000 IU/mL) or
vials (1,000 IU/mL
only). The pH of the injection ranges between 5.0 and 8.0.
4.
CLINICAL PARTICULARS 4.1THERAPEUTIC 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
Heparin may be given by intermittent intravenous injection,
intravenous infusion or deep
subcutaneous injection. It should not be given intramuscularly because
of the danger of
haematoma formation.
Low dose prophylaxis against postoperative venous thromboembolism: 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.
Version: pfdhephi11221
Supersedes: pfdhephi11119
Page 2 of 12
ADULTS
Treatment of established venous thrombosis or pulmonary embolism.
Treatment may be given
by the following routes:
1.
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 over 24 hours.
2.
Intermittent intravenous i