Data on a number (637) of exposed pregnancies indicate no additional risk of tinzaparin on pregnancy or on the health of the foetus/new-born child. No transplacental passage was demonstrated in two (2) clinical studies. Data from sequential pharmacokinetic monitoring in 55 pregnancies suggest that pharmacokinetic properties of tinzaparin do not differ from the non-pregnant state. Tinzaparin is not recommended for use in pregnant women with prosthetic heart valves.
Caution should be exercised when prescribing tinzaparin to pregnant women. There are no data available concerning lactation.
For vials only: Cases of 'Gasping Syndrome' have occurred in premature infants when large amounts of benzyl alcohol have been administered (99-404 mg/Kg/day). Despite the low content of benzyl alcohol in the vials (10 mg per ml), as it may cross the placenta the use of innohep formulations containing benzyl alcohol is not recommended during pregnancy.