LONDON, June 4 -- The government of the United Kingdom issued the following news:
Following monitoring of pharmacovigilance data, the Summary of Product Characteristics (SPC) for Bravecto 150 mg/ml Powder and Solvent for Suspension for Injection for Dogs has been updated:
Emesis and diarrhoea can occur rarely (1 to 10 animals / 10,000 animals treated) following administration of the veterinary medicinal product. Muscle tremor, ataxia, convulsion, allergic oedema, hypersensitivity reaction and pruritus can occur very rarely (
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 DatabaseProduct Information Database - Homeor on the MAH's website.
You can report directly to the VMD atReport 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 atMonitoring the safety of animal medicines - GOV.UK.Sign up to receive safety updates atUrgent and clinically significant safety updates for veterinary medicines - GOV.UK.
Disclaimer: Curated by HT Syndication.
