New MAs and changes made and published to end of January 2021
The points below highlight changes in marketing authorisations (MAs) that may have a significant impact on veterinary surgeons’ prescribing decisions.
Changes made to authorisations
Repose 500 mg/ml solution for injection
(Pentobarbital Sodium) (Le Vet Beheer B.V.)
Authorised for cats, cattle, dogs, goats, horses, mink, pigs, rabbits, rodents, sheep
Deletion of: 'In large animal species (horses, cattle, sheep, goats and pigs) lower dosages may be used, especially in case of euthanasia of adult animals' from section 4.9 of the SPC.
Introduction of a table outlining possible routes of administration by target species.
Somulose solution for injection
(Cinchocaine hydrochloride, Secobarbital sodium) (Dechra Limited)
Authorised for use in cats, cattle, dogs, horses
Section 4.3 of the SPC has been updated to include: ‘The combination product must not be used for anaesthesia, it is non-sterile. Do not use the carcass for animal consumption due to the risk of secondary intoxication.’
Section 4.6 of the SPC has been updated to include: ‘The recommended dose may be insufficient to achieve rapid euthanasia in some horses and this has been rarely reported. Excitation, muscle tremor and convulsion after injection has been very rarely observed in horses. Sedation prior to euthanasia is recommended in horses (see also section 4.9).’
Section 4.11 of the SPC has been updated to include: ‘Not to be used in animals intended for human or animal consumption due to the risk of secondary intoxication.
Treated animals may never be slaughtered for human or animal consumption.
Horses must have been declared as not intended for human consumption under national horse passport legislation.’
In prescribing these veterinary medicines, veterinary surgeons should be aware that changes to the Summary of Product Characteristics (SPC), labels and leaflets may, in certain cases, change how the medicines should be used. The timing of when such changes have to be taken into account will depend on the circumstances, but as a general rule unless a prescriber has been advised otherwise by the manufacturer or the VMD the labelling instructions on the pack from which the product is dispensed should be followed.
VMD contact for this article: Vivienne Saville; v.saville@vmd.gov.uk