Change to the information provided on adverse events in the Summary of Product Characteristics for Alizin 30 mg/ml Solution for Injection.
Following monitoring of pharmacovigilance data, sections 4.5 and 4.6 of the Summary of Product Characteristics (SPC) for Alizin 30 mg/ml Solution for Injection have been updated:
Bitches that remain pregnant despite treatment (experiencing lack of efficacy) should be monitored, as viability of the puppies may be compromised. In rare cases of abortion failure (frequency > 1/10000 and < 1/1000) this could lead to dystocia or uterine rupture and very rarely to fatal outcome.
Any veterinary medicinal product which is authorised for marketing in the United Kingdom will have its Summary of Product Characteristics (SPC) available on our Product Information Database .
No medicine is 100% risk free, the SPC includes information on what adverse events have been known to occur following administration of a particular product, these can be found in either section Adverse events (3.6) or Adverse reactions (4.6).
All updates to SPCs other than template changes, are published in the medicine updates section of VMD Connect .
