Innohep

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Tinzaparin sodium 20000 anti-Xa IU/mL

Available from:

Seqirus (NZ) Ltd

INN (International Name):

Tinzaparin sodium 20000 anti-Xa IU/mL

Dosage:

20000 anti-Xa IU/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Tinzaparin sodium 20000 anti-Xa IU/mL Excipient: Benzyl alcohol Sodium hydroxide Sodium metabisulfite Water for injection

Units in package:

Vial, glass, 2ml, 10 dose units

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Wexport Limited

Product summary:

Package - Contents - Shelf Life: Vial, glass, 2ml - 10 dose units - 24 months from date of manufacture stored at or below 25°C

Authorization date:

1994-05-26

Summary of Product characteristics

PRESENTATION
Innohep
®
contains tinzaparin sodium (low molecular weight heparin of porcine
origin) in a sterile solution for
subcutaneous injection, presented in unit-dose prefilled syringes, and
multi-dose vials.
Innohep
®
unit dose syringes contain:
•
tinzaparin sodium 10,000 anti-Xa IU/mL in 0.45mL without preservative
•
tinzaparin sodium 20,000 anti-Xa IU/mL in 0.5mL with sodium
metabisulfite
•
tinzaparin sodium 20,000 anti-Xa IU/mL in 0.7mL with sodium
metabisulfite
•
tinzaparin sodium 20,000 anti-Xa IU/mL in 0.9mL with sodium
metabisulfite
Innohep
®
2mL vials contain 20,000 anti-Xa IU/mL with sodium metabisulfite,
benzyl alcohol and water for
injections (see also PACKAGING QUANTITIES at the end of this
document).
Not all presentations may be available.
USES
_ACTIONS _
Innohep
®
is an antithrombotic agent. It potentiates the inhibition of several
activated coagulation factors,
especially Factor Xa, its activity being mediated via Antithrombin
III.
_PHARMACOKINETICS _
The pharmacokinetics/pharmacodynamics of Innohep
®
are monitored by anti-Xa activity. Innohep
®
has a
bioavailability of around 90% following subcutaneous injection. The
absorption half-life is 200 minutes, peak
plasma activity being observed after 4-6 hours. The elimination
half-life is about 90 minutes. There is a
linear dose response relationship between plasma activity and the dose
administered.
The pharmacokinetic activities of Innohep
®
have been studied in pregnancy. Data from sequential
pharmacokinetic monitoring in 55 pregnancies suggests that
pharmacokinetic properties do not differ from
the non-pregnant state. There was a small, but non-statistically
significant, decrease in anti-Xa levels with
advancing gestation.
INDICATIONS
For prevention of thromboembolic events including deep vein
thrombosis, in patients undergoing general
and orthopaedic surgery, treatment of deep vein thrombosis, treatment
of pulmonary embolism and
prevention of coagulation of blood in extra-corporeal circulation,
such as haemodialysis.
DOSAGE AN