Source: United Kingdom – Executive Government & Departments
Zermex 100 mg/ml LA Solution for Injection for Cattle and Zermex 20 mg/ml LA Solution for Injection for Sheep – 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 (SPCs) for Zermex 100 mg/ml LA Solution for Injection for Cattle and Zermex 20 mg/ml LA Solution for Injection for Sheep have been updated.
Zermex 100 mg/ml LA Solution for Injection for Cattle: Section 4.6 now states that on very rare occasions, hypersensitivity reactions and/or neurological disorders (such as collapse, convulsion, paralysis, and blindness) may occur. Severe reactions may be fatal.
Zermex 20 mg/ml LA Solution for Injection for Sheep: Section 4.6 now states that on very rare occasions, neurological disorders such as collapse, convulsion, and paralysis may occur. Severe reactions 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).
All updates to SPCs other than template changes, are published in the medicine updates section of VMD Connect