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.
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 at www.gov.uk/check-animal-medicine-licensed.
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.
Flunixin 50 mg/ml solution for injection for cattle, horses and pigs
Norbrook Laboratories Limited, Authorised in NI, POM-V
Section 4.6: Rare cases of anaphylactic reaction have been reported. In horses (rare) and cattle (very rare) anaphylaxis type reactions can include neurological signs such as convulsion, loss of consciousness and ataxia. Such reactions may be exacerbated by intra-arterial injection.
In pigs (very rare), transient irritation may occur at the injection site, this resolves spontaneously within 14 days.
Mepidor 20mg/ml solution for injection
Richter Pharma AG, Authorised in GB & NI, POM-V for use in horses
Section 4.7: The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Mepivacaine crosses the placenta. There is no evidence that mepivacaine is associated with reproductive toxicity or teratogenic effects. However, there is a potential for anaesthetics of the amide group such as mepivacaine to accumulate in the equine foetus resulting in neonatal depression and interfering with resuscitation efforts. Therefore, use in obstetric anaesthesia only according to the benefit/risk assessment of the responsible veterinarian.
More information, contact the VMD at postmaster@vmd.gov.uk