VMD medicines update for October
The VMD are now publishing 6 months’ worth of medicines update information on their VMD connect website which went live earlier this year
Their website enhances the guidance and services already available on gov.uk/vmd and provides a deeper insight into the work of the VMD.
New medicines update resource: a rolling 6-month of summaries of changes of new marketing authorisations and changes to existing authorisations that relate to the safe use of the product is at www.vmdconnect.uk/medicines-update. You can find it under the ‘vet practice & supply’ tab at the top of the page.
RAMAs/SQPs, vets and other prescribers and para-professionals can access links directly to updated SPCs and easily pass on publicly available information to clients.
Please do check the site for relevant updates.
There have been some VPS-specific amends and registrations over the summer including...
Deltafort 10 mg/ml Pour-on Solution for Cattle and Sheep
Sections 4.5, 4.6 and 4.8 of the SPC have been updated. The following statement has been added to section 4.6, 'Application site reactions, including squamosis and pruritus have been very rarely seen in cattle during the 48 hours after treatment'. The following statement has been added to section 4.8, ' Do not use with any other insecticide or acaricide. Especially, in combination with organo-phosphorous compounds, the toxicity of deltamethrin is enhanced'.
Molemec Plus Paste for Horses 15.5 mg/g / 77.5 mg/g Oral Paste
The following statement has been added to section 4.6 of the SPC, 'Digestive discomfort (colic, loose stool) has been observed in very rare cases based on post-marketing surveillance data'.
Prazitel 230/20 mg Flavoured Film-coated Tablets for Cats
Section 4.6 of the SPC has been updated to include hypersalivation as a possible gastrointestinal adverse event observed in very rare frequency following administration of Prazitel for cats.
RSPCA FLEAaway Combo 50 mg/60 mg Spot-on Solution for Cats
RSPCA FLEAaway Combo 67 mg/ 60.3 mg Spot-on Solution for Small Dogs
RSPCA FLEAaway Combo 134 mg/ 120.6 mg Spot-on Solution for Medium Dogs
RSPCA FLEAaway Combo 268 mg/ 241.2 mg Spot-on Solution for Large Dogs
RSPCA FLEAaway Combo 402 mg/ 361.8 mg Spot-on Solution for Extra Large Dogs
Minor amendments due to a change in the distribution category from POM-V to AVM-GSL.
Frontline Tri-Act Spot-on Solution for Dogs 2-5 kg / 5-10 kg / 10-20 kg / 20-40 kg / 40-60 kg
Section 4.5: Warnings in relation to foetotoxicity, teratogenicity and pregnant women have been updated (for the three highest strength products only): 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.
Section 4.7 has been updated for all five products to: “Laboratory studies using fipronil or permethrin have not produced any evidence of teratogenic (capable of causing embryonic or foetal malformation) or embryotoxic (capable of causing toxicity to the embryo) effects. The safety of the veterinary medicinal product has not been established in dogs during pregnancy and 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.