Change to the information provided on adverse events in the Summary of Product Characteristics (SPC).
Following monitoring of pharmacovigilance data, the Summary of Product Characteristics (SPCs) for the following have been updated:
Librela 5mg Solution for Injection for Dogs
Librela 10mg Solution for Injection for Dogs
Librela 15mg Solution for Injection for Dogs
Librela 20mg Solution for Injection for Dogs
Librela 30mg Solution for Injection for Dogs
Section 4.6 now additionally states that in very rare cases, paresis, paralysis and immune-mediated polyarthritis have been reported.
A special precaution for use has also been added to Section 4.5 stating that caution should be used when treating patients with the following pre-existing conditions:
- immune-mediated haemolytic anaemia
- immune-mediated polyarthritis
- immune-mediated thrombocytopenia
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).
These updates to SPCs are published in the medicine updates section of VMD Connect .
