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) at www.gov.uk/check-animal-medicine-licensed.
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
Emdofluxin 50 mg/mL, Solution for Injection for Cattle, Pigs and Horses
Emdoka GB POM-V
Multiple sections of the SPC have been significantly revised including 3.2 Indications, 3.3 Contraindications, 3.5 Special precautions for use, 3.6 Adverse events, 3.7 Use during pregnancy, lactation, or lay, 3.8 Interactions, 3.9 Administration routes and dosage, 3.10 Overdosage, and 3.12 Withdrawal periods.
Flunixin 50 mg/ml Solution for Injection for Cattle, Horses and Pigs
Norbrook Laboratories Limited GB & NI POM-V
Multiple sections of the SPC have been significantly revised including 3.2 Indications, 3.3 Contraindications, 3.5 Special precautions for use, 3.6 Adverse events, 3.7 Use during pregnancy, lactation, or lay, 3.8 Interactions, 3.9 Administration routes and dosage, 3.10 Overdosage, and 3.12 Withdrawal periods.
Hipnoton 10 mg/ml Solution for Injection for Horses and Cattle
Vetpharma Animal Health, S.L GB & NI POM-V
Multiple sections of the SPC have been revised including Section 3.6: Additional adverse events in cattle of penile prolapse (transient) at a frequency of very common, uterine contraction, nasal discharge, hyperthermia, and hypothermia at a frequency of common, arrhythmia at a frequency of rare, and heart block at a frequency of very rare.
Additional adverse events in horses of uterine contraction, hyperthermia, and hypothermia at a frequency of very common, hypersalivation, nasal discharge and skin swelling at a frequency of common, and hypersensitivity reaction at a frequency of very rare.
Section 3.9: Addition of dosage instructions for combinations with other active substances.
For more information, contact the VMD at postmaster@vmd.gov.uk