Fraxiparine

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Nadroparin calcium 9500 anti-Xa IU/mL

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Nadroparin calcium 9500 anti-Xa IU/mL

Dosage:

9500 anti-Xa IU/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Nadroparin calcium 9500 anti-Xa IU/mL Excipient: Calcium hydroxide Hydrochloric acid Water for injection

Units in package:

Syringe, glass, prefilled syringe 0.6ml x 2, 2 dose units

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Glaxo Wellcome Production

Therapeutic indications:

Prophylaxis against thromboembolic disorders, especially those associated with general or orthopaedic surgery. Treatment of thromboembolic disorders. Prevention of clotting during haemodialysis.

Product summary:

Package - Contents - Shelf Life: Syringe, glass, prefilled syringe 0.6ml x 2 - 2 dose units - 36 months from date of manufacture stored at or below 25°C - Syringe, glass, prefilled syringe 0.4ml x 2 - 2 dose units - 36 months from date of manufacture stored at or below 25°C - Syringe, glass, prefilled syringe 0.3ml x 2 - 2 dose units - 36 months from date of manufacture stored at or below 25°C - Syringe, glass, prefilled syringe 0.2ml x 2 - 2 dose units - 36 months from date of manufacture stored at or below 25°C - Syringe, glass, prefilled syringe 0.3ml x 10 - 10 dose units - 36 months from date of manufacture stored at or below 25°C - Syringe, glass, prefilled syringe 1ml x 10 - 10 dose units - 36 months from date of manufacture stored at or below 25°C - Syringe, glass, prefilled syringe 0.8ml x 10 - 10 dose units - 36 months from date of manufacture stored at or below 25°C - Syringe, glass, prefilled syringe 0.6ml x 10 - 10 dose units - 36 months from date of manufacture stored at or below 25°C - Syringe, glass, prefilled syringe 0.4ml x 10 - 10 dose units - 36 months from date of manufacture stored at or below 25°C - Syringe, glass, prefilled syringe 0.2ml x 10 - 10 dose units - 36 months from date of manufacture stored at or below 25°C

Authorization date:

1994-02-09

Summary of Product characteristics

Medsafe Logo
The sponsor (pharmaceutical company) of this
product has advised Medsafe that this product has
either been discontinued or is no longer marketed in
New Zealand.
Therefore this Data Sheet may not be up to date.
Medsafe has elected to leave it on this web site
because supplies of this product may still be
available, and health professionals should continue
to have access to this product information in the
interim.
You may be able to find a more current Data Sheet
containing the same medicine by returning to the
main Data Sheet page and searching by ingredient
name.
INFORMATION FOR
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Data Sheet
Fraxiparine
®
INJECTION
Nadroparin Calcium 9,500 IU anti-Xa
(AXa) per 1.0 mL solution for injection.

Presentation
Fraxiparine is a sterile, clear preservative-free solution usually for subcutaneous injection containing
Nadroparin Calcium 9,500 IU AXa per 1.0 mL dissolved in water for injections.
Fraxiparine is a low molecular weight heparin made by depolymerisation of standard heparin. It is a
glycosaminoglycan with a mean molecular weight around 4,500 daltons. It possesses a high ratio of
anti-Xa activity to anti-IIa activity. Fraxiparine has both immediate and prolonged antithrombotic action.
Uses
Actions
Low molecular weight heparin.
Pharmacokinetics
Pharmacokinetics have been determined by measurement of plasma anti-Xa activity. The plasma peak
Pharmacokinetics have been determined by measurement of plasma anti-Xa activity. The plasma peak
occurs about 3 hours after subcutaneous injection. The elimination half-life is about 3.5 hours. Anti-Xa
activity persists for at least 18 hours after injection.
Bioavailability is almost complete (around 98%).
A