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 is listed, along with the authorisation holder, distribution category and details of which Summary of Product Characteristics (SPC) sections have been revised/changed.
Changes to the SPC, labels and leaflets may change how the medicines should be used. Details can be found on the VMD’s Product Information Database (PID) here.
Due to ongoing assessments, there may be a delay between the point at which a new change is authorised and the updated SPC being available on the PID. There may also be a delay between the point at which any SPC changes are authorised and implementation in the product literature. Unless you have been advised otherwise, the labelling instructions on the pack which is dispensed should be followed.
Food producing animals
Depocillin 300 mg/ml suspension for injection (cattle, horses, sheep, pigs, dogs, cats)
Intervet International B.V. UK POM-V
Section 3.9 of the SPC: The appropriate treatment duration should be chosen based on the clinical needs and individual recovery of the treated animal. Consideration should be given to the accessibility of the target tissue and characteristics of the target pathogen.
Prasequine 1 mg Tablets for Horses
CP Pharma Handelsgesellschaft mbH GB & NI POM-V
Section 3.5 (NI)/4.5 (GB) of the SPC updated user safety precautions: Pergolide, like other ergot derivatives, may cause emesis, dizziness, lethargy or low blood pressure. Severe adverse events such as collapse have been observed. Ingestion may be harmful and associated with severe adverse events, especially in children or people with pre-existing heart conditions. Do not ingest this veterinary medicinal product.
Section 3.6 (NI)/4.6 (GB) updated adverse events:
‘Rare’ frequency, i.e. 1 to 10 animals/10,000 treated: inappetence, transient anorexia and lethargy, central nervous system disorder (e.g., mild central nervous system depression and mild ataxia), diarrhoea, colic.
‘Very rare’ frequency, i.e. <1 animal / 10 000 animals treated, including isolated reports: Increased sweating.
For more information, contact the VMD at postmaster@vmd.gov.uk