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.
Butador 10 mg/ml solution for injection for horses, dogs and cats
Richter Pharma AG NI POM-V
Section 4.6 HORSE: Gastrointestinal motility may be reduced. This effect is mild and transient.
Colvasone 0.2% w/v solution for injection
Norbrook Laboratories Limited UK POM-V
Authorised for use in cats, cattle, dogs, horses
Section 4.5: This product contains dexamethasone which can cause allergic reactions in some people. People with known hypersensitivity to dexamethasone should avoid contact with the veterinary medicinal product.
Section 4.6: Gastrointestinal ulceration has been reported in animals treated with corticosteroids.
In very rare cases, hypersensitivity reactions might occur.
Dexadreson 2 mg/ml solution for injection
MSD Animal Health UK Limited UK POM-V
Authorised in cats, cattle, dogs, horses, pigs
Section 4.5: This product contains dexamethasone which can cause allergic reactions in some people. People with known hypersensitivity to dexamethasone should avoid contact with the veterinary medicinal product.
Duphacort Q 0.2% w/v solution for injection
Norbrook Laboratories Limited UK POM-V
Cats, Cattle, Dogs, Horses
Section 4.5: This product contains dexamethasone which can cause allergic reactions in some people. People with known hypersensitivity to dexamethasone should avoid contact with the veterinary medicinal product.
Section 4.6: Gastrointestinal ulceration has been reported in animals treated with corticosteroids.
In very rare cases, hypersensitivity reactions might occur.
Finadyne 50 mg/ml solution for injection
MSD Animal Health UK Limited UK POM-V
Authorised for use in cattle, horses, pigs
Section 4.5: Inject slowly as life-threatening symptoms of shock can occur due to the content of propylene glycol. The product should have a temperature close to body temperature. Stop injection immediately if first symptoms of shock occur and start treatment for shock if necessary.
Section 4.6: Anaphylactic-type reactions have been reported in horses and cattle, resulting in collapse following intravenous injection. Such reactions, on very rare occasions have been life-threatening in spontaneous pharmacovigilance reports.
For more information, contact the VMD at postmaster@vmd.gov.uk