Solensia 7 mg/ml Solution for Injection for Cats – SPC change
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 (SPC) for Solensia 7 mg/ml Solution for Injection for Cats has been updated:
Ataxia, polyuria, and polydipsia can occur very rarely (<1 animals / 10,000 animals treated, including isolated reports) following administration of the veterinary medicinal product.
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. Once approved by the VMD, the updated SPC that supplies the label text will be available on the Product Information Database almost immediately. However, it may take up to 12 months for these changes to appear on marketed packaging.
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.
Reporting of adverse events
We strongly encourage anyone who is aware of an adverse event to report to the Marketing Authorisation Holder (pharmaceutical company, MAH) or the VMD. Provide all relevant information, including the batch number.
Contact details for the MAH can be found on the product leaflet, on the Product Information Database or on the MAH’s website. You can report directly to the VMD at Report a suspected problem with an animal medicine - GOV.UK.
You only need to report once, either to the VMD or the MAH. Reporting to both may create duplicate reports which affects the efficiency of our data handling or the quality of the data we hold.
The reporting of adverse events is critical to our ongoing monitoring activities in order to protect animal health, public health, and the environment. Find out more about pharmacovigilance at Monitoring the safety of animal medicines - GOV.UK. Sign up to receive safety updates at Urgent and clinically significant safety updates for veterinary medicines - GOV.UK.