VMD Medicines Update
Posted: 29 May 2020 at 2:49 pm
New MAs and changes made and published to end of April 2020
The points below highlight changes in marketing authorisations (MAs) that may have a significant impact on veterinary surgeons’ prescribing decisions.
New marketing authorisations
New marketing authorisations relevant to veterinary surgeons in the UK that were issued or published in April are listed in Table 1.
Aservo EquiHaler 30 mg/ml inhalation solution for horses
The first product containing ciclesonide, authorised in horses. Indicated for the alleviation of clinical signs of severe equine asthma (formerly known as Recurrent Airway Obstruction– (RAO), Summer Pasture Associated Recurrent Airway Obstruction – (SPA-RAO)).
Hemosilate 125 mg/ml solution for injection
The first product containing etamsylate, authorised in cattle, sheep, goats, pigs, horses, dogs and cats. Indicated for the prevention and treatment of surgical, post traumatic, obstetric and gynecological haemorrhages.
Enrocat Flavour 25 mg/ml oral suspension for cats
An oral formulation containing the active substance enrofloxacin, authorised in cats for the treatment of single or mixed bacterial infections of the respiratory, digestive and urinary tract, otitis externa, skin and wound infections caused by the following enrofloxacin-sensitive Gram-positive and Gram-negative bacteria: Staphylococcus spp., Escherichia coli, Haemophilus spp. and Pasteurella spp.
Table 1 also indicates where a public assessment report should become available for a product. Where available, links to these reports are accessible by clicking on the relevant product on the VMD’s Product Information Database https://www.gov.uk/check-animal-medicine-licensed
The European Medicines Agency (EMA) publishes European Public Assessment Reports (EPARs) for every veterinary medicine which is authorised through a centralised procedure. Links to these reports are accessible on http://www.ema.europa.eu
|Marketing Authorisations issued/published in April 2020|
|Product name||Active substance||Authorisation Holder||Public Assessment Report to be made available from VMD?|
|Aservo EquiHaler 30 mg/ml inhalation solution for horses||Ciclesonide||Boehringer Ingelheim Vetmedica Gmbh||No – EPAR|
|Avishield IB GI-13, lyophilisate for oculonasal suspension/use in drinking water for chickens||Infectious bronchitis virus||Genera Inc.||No – RMS Netherlands|
|Enrocat Flavour 25 mg/ml oral suspension for cats||Enrofloxacin||Livisto Int’l S.L.||No – RMS Spain|
|Hemosilate 125 mg/ml solution for injection||Etamsylate||Ecuphar Veterinaria S.L.U.||No – RMS Spain|
|Prolusyn 50 micrograms/ml solution for injection for cattle||Gonadorelin||Cyton AH Biosciences GmbH||No – RMS Ireland|
|Tulieve 100 mg/ml solution for injection for cattle, pigs and sheep||Tulathromycin||Norbrook Laboratories Limited||No – RMS Germany|
|Versican Plus BbPi IN nasal drops, lyophilisate and solvent for suspension for dogs||Bordetella bronchiseptica; Canine parainfluenza virus||Zoetis UK Limited||No – RMS Germany|
Please note that there may be a delay between the issuing of a marketing authorisation to a company and the product being placed on the market.
Prid Delta 1.55 g vaginal delivery system for cattle
(Progesterone) (Ceva Animal Health Ltd)
Section 4.6 of the SPC has been updated: “During the course of the seven day treatment, the device may induce a mild local reaction (i.e. inflammation of the vaginal wall). A clinical study carried out with 319 cows and heifers has demonstrated that 25% of animals presented ropy or cloudy vulvar secretions at the device removal.
This local reaction disappears rapidly without any treatment between removal and insemination and does not affect fertility at inseminations nor pregnancy rates.”
Vectra 3D spot-on solution for dogs range
(Dinotefuran; Permethrin (Cis:Trans 40:60); Pyriproxyfen) (Ceva Sante Animale)
Change in legal distribution category from POM-V to NFA-VPS.
MiPet Easecto 10 mg chewable tablets for dogs >2.5–5 kg
(Sarolaner) (Zoetis Belgium)
The following adverse reactions have been added to section 4.6 of the SPC; ‘systemic disorders such as lethargy, anorexia/inappetence may occur in very rare cases’.
Previcox 57, 227 mg chewable tablets for dogs
(Firocoxib) (Boehringer Ingelheim Vetmedica Gmbh)
Section 4.6 of the SPC has been updated: “Emesis and diarrhoea have occasionally been reported. These reactions are generally of a transitory nature and are reversible when the treatment is stopped. Renal and/or hepatic disorders have been reported in very rare cases in dogs administered the recommended treatment dose. Rarely, nervous system disorders have been reported in treated dogs.
If adverse reactions like vomiting, repeated diarrhoea, faecal occult blood, sudden weight loss, anorexia, lethargy, degradation of renal or hepatic biochemistry parameters occur, use of the product should be stopped and the advice of a veterinarian should be sought. As with other NSAIDs, serious adverse effects can occur and, in very rare cases, may be fatal.”
Rimadyl Palatable for dogs 20 mg, 50 mg, 100 mg
(Carprofen) (Zoetis UK Limited)
Section 4.6 of the SPC has been updated as follows:
“Typical undesirable effects associated with NSAIDs, such as vomiting, soft faeces/diarrhoea, faecal occult blood, loss of appetite and lethargy have been reported. These adverse reactions generally occur within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal. If adverse reactions occur, use of the product should be stopped and the advice of a veterinarian should be sought. As with other NSAIDs there is a risk of rare renal or idiosyncratic hepatic adverse events.”
Scalibor Protectorband 4% w/w 48 cm collar for small and medium sized dogs, 65 cm for large sized dogs
(Deltamethrin) (Intervet UK Ltd)
Section 4.6 of the SPC has been updated: “Local skin reactions (e.g. pruritus/scratching, erythema/rash, hair loss) involving the neck or the skin in general have been observed which might indicate a local or general hypersensitivity reaction in rare cases.
Altered behaviour (e.g. lethargy or hyperactivity) often associated with skin irritation has been reported in very rare cases Gastrointestinal symptoms such as vomiting, diarrhoea and hypersalivation have been observed in very rare cases.
Neurological problems such as ataxia and muscle tremor have been observed in very rare cases. The symptoms usually subside within 48 hours after removal of the collar.
If any of these symptoms occur, the collar should be removed. Treatment should be
symptomatic as no specific antidote is known.”
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; firstname.lastname@example.org