Change to the information provided in the Summary of Product Characteristics (SPC) for Ataxxa Spot-on Solution for Dogs.
The Summary of Product Characteristics (SPCs) have been been updated for:
- Ataxxa 200 mg/40 mg Spot-on Solution for Dogs up to 4 kg
- Ataxxa 500 mg/100 mg Spot-on Solution for Dogs Over 4 kg up to 10 kg
- Ataxxa 1250 mg/250 mg Spot-on Solution for Dogs over 10 kg up to 25 kg
- Ataxxa 2000 mg/400 mg Spot-on Solution for Dogs Over 25 kg
Section 3.7/4.7 Use during pregnancy, lactation or lay Pregnancy and lactation now states:
"The safety of the veterinary medicinal product has not been established in dogs during pregnancy, lactation or in animals intended for breeding. Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. Use only according to the benefit-risk assessment by the responsible veterinarian."
In addition, the SPC section 3.5/4.5 for Ataxxa 2000 mg/400 mg Spot-on Solution for Dogs Over 25 kg now states:
"Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. The veterinary medicinal product should not be administered by pregnant women and women suspected of being pregnant. Personal protective equipment consisting of gloves should be worn when handling the veterinary medicinal product by women of childbearing age."
No medicine is 100% risk free, the SPC includes information on special precautions for use, and includes special precautions to be taken by the person administering the veterinary medicinal product to animals.
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 .
All updates to SPCs other than template changes, are published in the medicine updates section of VMD Connect .
