This medicines update is provided by the Veterinary Medicines Directorate (VMD) and lists 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).
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.
Primopen 300 mg/ml Suspension for Injection for Cattle, Pigs and Horses
Fatro S.p.A. GB and NI POM-V
Section 3.4: Resistance in the target pathogens:
Elevated MIC values or bi-modal distribution profiles suggesting acquired resistance have been reported for the following bacteria:
- Glaesserella parasuis, Staphylococcus spp. causing MMA/PPDS, Streptococcus spp. and S. suis in pigs;
- Fusobacterium necrophorum causing metritis and Mannheimia haemolytica (only in some member states), as well as Bacteroides spp., Staphylococcus chromogenes, Actinobacillus lignieresii and Trueperella pyogenes in cattle.
Use of the veterinary medicinal product may result in a lack of clinical efficacy when treating infections caused by these bacteria.
Strangvac Suspension for Injection for Horses and Ponies
Intervacc AB GB POM-V
Section 4.6: Added injection site swellings exceeding 8 cm.