VMD Medicines Update - October 2021

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 actives

Novocillin LC 1000 mg intramammary suspension for lactating cow

This is the only authorised product containing oxacillin sodium.  The product is indicated for treatment of clinical mastitis caused by Staphylococcus spp. (including β-lactamase producing strains) and Streptococcus spp. susceptible to oxacillin in lactating cattle.

StromEase 25 mg/ml eye drops, solution for dogs and cats 

This product contains acetylcysteine, a novel active substance.  The product is indicated for the supportive treatment of corneal ulcers in dogs and cats. 

New marketing authorisations

Table 1 shows the new marketing authorisations for October 2021.

TABLE 1: New marketing authorisations in October 2021

See the VMD’s Product Information Database for more information on each of these products. This includes separate links for the authorisation territories of Great Britain and Northern Ireland.

Please note, there may be a delay between the issuing of a marketing authorisation and the product being placed on the market.

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 at www.gov.uk/check-animal-medicine-licensed.

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.

Food producing animals

Aqupharm 1 (9 mg/ml) solution for injection/infusion

Animalcare Ltd, Authorised in GB & NI, POM-V

For use in Cats, Cattle, Dogs, Goats, Horses, Pigs, Rabbits, Sheep

Section 4.3: Do not use in cases of sodium and water retention (due to cardiac, hepatic or renal failure, or enteropathy).

Aqupharm 11 (Hartmann's) solution for infusion

Animalcare Ltd, Authorised in GB & NI, POM-V

For use in Cats, Cattle, Dogs, Goats, Horses, Pigs, Rabbits, Sheep

Section 4.5: This veterinary medicinal product should be used with caution in animals with cardiac or renal impairment as sodium overload may occur.  It should be noted that sodium excretion may be impaired post-surgery/trauma.

Closamectin 5 mg/ml + 200 mg/ml pour-on solution for cattle

Norbrook Laboratories Limited, Authorised in GB & NI, POM-VPS

Section 4.5: Due to the significant likelihood of cross-contamination of non-treated animals with this product due to grooming (licking), all animals in a group should be treated at the same time and treated animals should be kept separately from non-treated animals throughout the withdrawal period. Non-compliance with this recommendation may lead to residues violations or in very rare cases, it can lead to adverse events in non-treated animals.

Gallifen 200 mg/ml suspension for use in drinking water for chickens and pheasants

Huvepharma N.V., Authorised in GB & NI, POM-V

Section 4.2: Addition of an indication to treat chickens infected with Capillaria obsignata (adult stages).

Section 4.5: The safety of the product at overdose has not been evaluated in the target species (chickens and pheasants) of less than 3 weeks of age. 

Ketabel 100 mg/ml solution for injection

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

For use in Cats, Cattle, Dogs, Goats, Guinea Pigs, Hamsters, Horses, Mice, Pigs, Rabbits, Rats, Sheep

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).

Nobilis IB Primo QX

MSD Animal Health UK Limited, Authorised in GB & NI, POM-V

For use in Chickens

Section 4.7: To include the use of the product during the laying period in chickens.

Porcilis PCV ID emulsion for injection for pigs

MSD Animal Health UK Limited, Authorised in GB & NI, POM-V

Section 4.1, 4.2, 4.5, 4.6 and 4.7: To broaden the target species category for pigs.

Section 4.8 and 4.9: Added claim for associated mixed-use with Porcilis Lawsonia ID.

Rifen 100 mg/ml solution for injection for horses, cattle and swine

Richter Pharma AG, Authorised in GB & NI, POM-V

Section 4.11: Change to withdrawal periods for IV administration route in cattle and horses from 4 days to 1 day.  Not authorised for use in mares producing milk for human consumption.

VetOne Fluriso 1000 mg/g inhalation vapour liquid

Piramal Critical Care Limited, Authorised in the UK, POM-V

Cats, Chinchilla, Dogs, Ferrets, Gerbil, Guinea Pigs, Hamsters’ Horses, Mice, Ornamental Birds, Rats, Reptiles

Section 4.6: Cardiac and/or respiratory arrest has been very rarely reported.

Companion animals

Activyl Tick Plus 150 mg + 480 mg Spot-on solution for small dogs

MSD Animal Health UK Limited, Authorised in GB & NI, NFA-VPS

Section 4.6: If adverse reactions occur bathe the animal with mild soap and rinse with large amounts of water.

Ataxxa Spot-on solution for dogs (Range)

Krka d.d., Novo Mesto, Authorised in GB & NI, POM-V

Section 4.2: The product has persistent repellent efficacy (Ixodes ricinus) for three weeks.  One treatment provides repellent (anti-feeding) activity against the sand fly Phlebotomus perniciosus for three weeks and against the mosquito Aedes aegypti from 7 days up to 14 days after treatment.

Bravecto spot-on solution for cats (Range)

MSD Animal Health UK Limited, Authorised in GB & NI, POM-V

Section 4.6: Convulsions have been reported very rarely based on post marketing safety experience (pharmacovigilance).

Canigen L4, suspension for injection for dogs

MSD Animal Health UK Limited, Authorised in GB & NI, POM-V

Removal of all mixed-use claims from the product information.

Felisecto Plus Spot-on solution for cats (Range)

Zoetis UK Limited, Authorised in GB & NI, POM-

Section 4.6: Neurological signs (convulsions, ataxia) and gastrointestinal signs (emesis, diarrhoea) have been reported very rarely based on post-marketing safety experience. In most cases these signs are transient.

Fipronil Pyriproxyfen Virbac Spot-on solution (Range) for cats and dogs

Virbac, Authorised in GB & NI, NFA-VPS in GB, POM-V in NI

Change in distribution category from POM-V to NFA-VPS in Great Britain, with associated changes to other sections of the SPC. 

Milprazon Tablets for Dogs (Range) / Milprazon Chewable Film-coated Tablets for Cats (Range)

Krka d.d., Novo Mesto, Authorised in GB & NI, POM-V

Section 4.6: On very rare occasions hypersensitivity reactions have been observed following administration of the product.

Neptra

Bayer Animal Health GmbH, Authorised in GB & NI, POM-V

For use in dogs

Section 4.6: inclusion of eye disorders (such as eye irritation, blepharospasm, conjunctivitis, corneal ulcer, keratoconjunctivitis sicca) were reported very rarely in spontaneous (pharmacovigilance) reports.

Osurnia ear gel for dogs

Dechra Limited, Authorised in GB & NI, POM-V

Section 4.6: Application site reactions (i.e. erythema, pain, pruritus, oedema and ulcer) have been reported in very rare cases, in post authorisation experience.

Hypersensitivity reactions including facial oedema, urticaria and shock have been reported in very rare cases, in post authorisation experience.

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