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VMD Medicines Update - September 2021

News Medicines
12 Nov 2021 BEVA

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.

Novel combination of actives

Ekyflogyl 1.8mg/ml + 8.7mg/ml gel for horses is the first product containing the active substances prednisolone acetate and lidocaine to be authorised.  The product is presented as a topically applied gel, indications for use are the alleviation of pain and inflammation associated with localised musculoskeletal disorders in non-food producing horses.

Other new authorisations:

Alfadexx 2 mg/ml solution for injection for horses, cattle, pigs, dogs and cats containing Dexamethasone, MAH Alfasan Nederland B.V., Authorised in GB, POM-V, an Anti Inflammatory corticosteroid

Strangvac suspension for injection for horses and ponies containing Sreptococcus equi, MAH Intervacc AB, Authorised for GB, POM-V, an Inactivated Bacterial Vaccine

Changes:

Depocillin 300 mg/ml suspension for injection

Intervet International BV, Authorised in UK, POM-V

For use in cattle, horses, pigs, sheep and cats, dogs

Section 4.6: Hypersensitivity reactions may occur in very rare cases. Such reactions may evolve to a more severe condition (anaphylaxis), which may be life-threatening. Potentially fatal reactions associated with the administration of procaine penicillin in horses have been observed. If such reactions occur appropriate treatment is recommended.

In sucking and fattening pigs, vomiting has been observed in very rare cases.

Injection site reactions such as swelling and pain have been recorded with post-marketing data in very rare cases.

Ketabel 100 mg/ml solution for injection

Bela-Pharm GmbH & Co. KG, Authorised in GB & NI, POM-V

For use in cattle, horses, pigs, sheep, cats, dogs, guinea pigs, hamsters, mice, rabbits, rats

Section 4.6: In anaesthetised animals, mainly during and after the awakening phase, cardio-respiratory disorders (cardiac arrest, hypotension, dyspnoea, bradypnoea, pulmonary oedema) associated or not with neurological disorders (convulsions, prostration, trembling) and systemic disorders (hypersalivation, pupillary anomaly) have been observed in rare cases.

Salivation has been very rarely reported in cats.

An increase in skeletal muscle tone has been very rarely reported in cats, dogs, horses, rabbits, cattle and goats.

Dose-dependent respiratory depression, which may lead to respiratory arrest, has been very rarely reported in cats, dogs, rabbits, cattle and goats. The combination of respiratory depressant products may amplify this effect.

An increase in heart rate has been very rarely reported in cats and dogs. An increase in blood pressure with an increased tendency to bleed has been very rarely reported in dogs.

Muscular twitching and tonic convulsions have been reported in the cat at the recommended dose rates.

In cats, in very rare cases, the eyes remain open, with mydriasis and nystagmus.

Reactions during awakening - ataxia, hypersensitivity to stimuli, excitement - have been rarely and very rarely reported in horses and dogs, respectively.

Pain on intramuscular injection has been very rarely reported in cats.

All adverse reactions and frequencies are from spontaneous reports (pharmacovigilance).

More information, contact the VMD at postmaster@vmd.gov.uk