INNOHEP 10,000 anti-Factor Xa IU/ml Solution for injection Ref.[7477] Active ingredients: Tinzaparin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: LEO Laboratories Limited, Horizon, Honey Lane, Hurley, Maidenhead, Berkshire, SL6 6RJ, UK

Pharmacodynamic properties

Pharmacotherapeutic group: Antithrombotic Agents
ATC code: B01AB10

innohep is an antithrombotic agent. It potentiates the inhibition of several activated coagulation factors, especially Factor Xa, its activity being mediated via antithrombin III.

Pharmacokinetic properties

The pharmacokinetics/pharmacodynamic activity of innohep is monitored by anti-Factor Xa activity.

innohep has a bioavailability of around 90% following a subcutaneous injection. The absorption half-life is 200 minutes, peak plasma activity being observed after 4 to 6 hours. The elimination half-life is about 90 minutes.

The half-life of innohep in patients with renal insufficiency given a bolus intravenous dose of 2,500 anti-Factor Xa IU is about 2.5 hours.

There is a linear dose response relationship between plasma activity and the dose administered.

Paediatric population

Preliminary data on the use of tinzaparin suggest that younger children including neonates and infants clear tinzaparin faster and therefore might require higher doses than older children. However, data are not sufficient to allow for dosing recommendations, see section 4.2.

Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SmPC.

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