Following monitoring of pharmacovigilance data, the Summary of Product Characteristics (SPC) for Senvelgo 15 mg/ml Oral Solution for Cats has been updated
The indication has been changed to ‘For the reduction of hyperglycaemia in cats with non-insulin-dependent diabetes mellitus’.
Additional information has been added to section 3.5 ‘Special precautions for use’, particularly regarding selection of patients for treatment.
The adverse events section (3.6) now contains vomiting under the common frequency category (in 1 to 10 animals / 100 animals treated) with an associated footnote stating ‘Vomiting is usually sporadic and resolves without specific therapy. Acute or more frequent vomiting may also be a sign of clinical Diabetic ketoacidosis (DKA) or other severe disease conditions and should be investigated accordingly’.
Further details are provided in the footnote associated with ‘Diabetic ketoacidosis (DKA)’, which states ‘May be fatal’.
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).
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 Product Information Database – Home 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.
