This medicines update is provided by the Veterinary Medicines Directorate (VMD) and lists new active substance, new marketing authorisations and changes to authorisations most relevant to vets.
Changes to authorisations most relevant to vets
The changes to authorisations most relevant to vets can be found below. Each product listed, along with the authorisation holder, distribution category and details of which Summary of Product Characteristics sections have been revised/changed.
All entries can be found on the VMD’s Product Information Database.
Changes to the SPC, labels and leaflets may change how the medicines should be used. There may be a delay between these changes being authorised to implementation on product literature. Unless you have been advised otherwise, the labelling instructions on the pack which is dispensed should be followed.
Belavit AD3E solution for injection for horses, cattle, pigs, and dogs
Bela-Pharm GmbH & Co. KG Authorised in UK POM-V
Section 4.3: Do not use in food producing animals with adequate vitamin A supply due to the possibility of accumulation in edible tissues.
Section 4.9: This veterinary medicinal product should not be used by subcutaneous route of administration in food producing species.
For intramuscular use in horses, cattle and pigs.
For subcutaneous or intramuscular use in dogs.
Section 4.11: Cattle: meat and offal: 259 days, milk: 120 hours (5 days).
Horse: meat and offal: 250 days, not authorised for use in horses producing milk for human consumption.
Pig: meat and offal: 194 days.
Kelaprofen 100 mg/ml solution for injection for cattle, horses and pigs
Kela N.V. Authorised in GB POM-V
Section 4.6: Mild inflammatory reactions at the injection site, such as swelling/oedema, without pain in most cases have been reported, based on post-marketing safety experience.
For more information, contact the VMD at postmaster@vmd.gov.uk