Change to the information provided in the Summary of Product Characteristics (SPC).
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'.
