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 (<1 animal / 10,000 animals treated, including isolated reports) following administration of the veterinary medicinal product.
Section 4.5 (Special precautions to be taken by the person administering the veterinary medicinal product to animals) has also been updated stating If accidental skin exposure occurs, wash the skin immediately with soap and water. If accidental eye exposure occurs, flush eyes immediately with clean water.
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.
