Change to the information provided on adverse events in the Summary of Product Characteristics for Osurnia Ear Gel for Dogs.
Following monitoring of pharmacovigilance data, the Summary of Product Characteristics (SPC) for Osurnia Ear Gel for Dogs has been updated.
Information relating to the occurrence of eye disorders, despite no direct ocular contact, has been removed from section 4.5.
Instead, section 4.6 (Adverse reactions) has been updated to indicate that, in very rare cases, the following eye disorders have been reported in treated dogs:
- neurogenic keratoconjunctivitis sicca
- keratoconjunctivitis sicca
- corneal ulcer
- blepharospasm
- eye redness
- ocular discharge
Additionally, the following have been reported in very rare cases:
- ataxia
- internal ear disorders (mainly head tilt)
- facial paralysis
- nystagmus
The frequency of adverse reactions is defined using the following convention:
very common (more than 1 in 10 animals treated displaying adverse reaction(s))
common (more than 1 but less than 10 animals in 100 animals treated)
uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
rare (more than 1 but less than 10 animals in 10,000 animals treated)
very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
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 .
