Medicines News September 2020
Medicines news
Regulatory changes due to the COVID-19 pandemic
VMD inspections have resumed
On-site VMD inspections, which had been suspended, resumed on 24 August.
Temporary relaxation of enforcement of regulations ended
On 31 August the VMD ended the temporary relaxation of enforcement of regulations related to the prescribing and supply of veterinary medicines. In view of the continuing and unique challenges posed by the COVID-19 pandemic, the relaxations concerning the temporary change of veterinary practice and SQP retailer premises and the arrangements for SQP remote prescribing and authorisation of supply may be re-applied in exceptional circumstances, where:
the veterinary practice premises/SQP retailer is located in an area where the Government has deployed local lockdown measures; and/or
a veterinary surgeon/SQP needs to self-isolate as they have tested positive for the virus or due to contact tracing.
New veterinary medicine authorisations
The following medicines have been authorised by the VMD in the past month. Newly authorised medicines usually do not appear on the market for many months.
Newly authorised medicines for small animals and horses
ephedrine tablets (Caniphedrin – Channelle) for dogs. POM-V
doxycycline tablets (Doxytab vet – CP Pharma) for dogs and cats. POM-V
flunixin solution for injection (Emdofluxin – DUGV UK Ltd) for horses, cattle and pigs. POM-V
Bordetella bronchiseptica vaccine (Nobivac Respira Bb – MSD) for dogs. POM-V
phenobarbital flavoured tablets (Phenotab – CP Pharma) for dogs. POM-V
omeprazole oral paste (Bimeprazol – Oy Medfiles Ltd) for horses. POM-V
omeprazole oral paste (Peptaleve – MiGroup) for horses. POM-V
Newly authorised medicines for food production animals
flunixin solution for injection (Emdofluxin – DUGV UK Ltd) for horses, cattle and pigs. POM-V
tulathromycin solution for injection (Macrosyn – Cross Vetpharm) for cattle, sheep and pigs. POM-V
tulathromyin solution for injection (Tulaxa – Krka) for pigs. POM-V
infectious bursal disease virus vaccine (Nextmune – Ceva) for chickens. POM-V
Marek’s disease virus vaccine (Prevexxion RN – Merial) for chickens. POM-V
Marek’s disease virus, Turkey disease virus vaccine (Prevexxion RN + HVD + IBD – Merial)
Changes to small animal-products information – adverse effects
Amoxibactin tablets for cats and dogs (amoxicillin): Adverse effects section of SPC updated: ‘Mild gastrointestinal symptoms (diarrhoea and vomiting) may occur very rarely (less than 1 animal in 10,000 animals treated, including isolated reports). Hypersensitivity reactions (allergic skin reactions, anaphylaxis) may occur very rarely. In these cases, administration should be discontinued, and a symptomatic treatment given.’
Carporal tablets for dogs (carprofen) Adverse effects section of SPC updated: ‘Typical undesirable effects associated with NSAIDs such as vomiting, soft faeces/diarrhoea, faecal occult blood, loss of appetite and lethargy have been reported very rarely. These adverse reactions occur generally 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.’
Simparica tablets for oral use in dogs (sarolaner). Adverse effects section of SPC updated to include: ‘Mild and transient gastrointestinal signs such as vomiting and diarrhoea and systemic disorders such as lethargy, anorexia/inappetence may occur in very rare cases based on post marketing experience. These signs typically resolve without treatment. Neurological disorders such as tremor, ataxia or convulsion may occur in vary rare cases based on post marketing experience. In most cases these signs are transient.’ For more on adverse effects of isoxazolines.
Zycortal 25 mg/ml prolonged-release suspension for injection for dogs (desoxycortone pivalate) Section 4.6 has been updated to include: ‘Injection site pain has been reported as an uncommon reaction.’
Changes to small-animal products information – other changes
Leucofeligen FeLV/RCP lyophilisate and solvent for suspension for injection for cats (Feline calicivirus; Feline leukemia virus; Feline panleukopenia virus; Feline viral rhinotracheitis virus). The onset of immunity for the calicivirus component of the vaccine has changed from 4 weeks after primary vaccination to 3 weeks after first vaccine injection of primary vaccination.
Panacur 18.75% oral paste (fenbendazole) for cats and dogs. NFA-VPS. The practical dosage recommendations have been updated to state that only puppies and kittens weighing more than 1 kg should be treated with this product. The following warning about use in pregnant dogs has been added: ‘Owing to the reduced dose rate for treatment of pregnant dogs (25 mg fenbendazole/kg bodyweight daily) which cannot accurately be attained when using the Panacur Paste 5 g syringe, it is recommended that alternative formulations of fenbendazole be used.’
Changes to product information – food-production animals
Aivlosin 625 mg/g granules for use in drinking water for pigs (tylvalosin). Addition of a new indication: ‘Treatment and metaphylaxis of swine enzootic pneumonia caused by susceptible strains of Mycoplasma hyopneumoniae. The presence of the disease in the group must be established before metaphylaxis’ and addition of related dosing information. Addition of the following warnings: ‘In severely diseased pigs, if water intake is reduced, pigs should be treated with a suitable injectable veterinary medicinal product prescribed by a veterinarian. At the recommended dose, lung lesions and clinical signs are reduced but infection with Mycoplasma hyopneumoniae is not eliminated.’; ‘An antibacterial with a lower risk of antimicrobial resistance selection, if available for the same indication, should be used for first line treatment where susceptibility testing suggests the likely efficacy of this approach.’
Denagard solution for injection for pigs (tiamulin). Increase in withdrawal period from 21 to 28 days.
Engemycin LA solution for injectionfor use in cattle, pigs, sheep (oxytetracycline). Change of withdrawal periods to: Cattle: Meat and offal – 41 days; Milk – 8 days; Sheep: Meat and offal – 24 days; Milk – 7 days; Pigs: Meat and offal – 20 days.
Imrestor for cattle (pegylated Bovine Granulocyte Colony Stimulating Factor). The adverse effects section has been updated to include: ‘Transient local swelling at the injection site as well as inflammatory reactions which resolve within 14 days post treatment may be induced through the subcutaneous administration of the veterinary medicinal product.’
Nobilis IB Ma5 for use in chickens (Infectious bronchitis virus). Addition of a new claim for associated non-mixed use of Nobilis IB Ma5 with Innovax-ND-IBD in the product information (PI) of Nobilis IB Ma5.
Permacyl powder and solvent for suspension for injection for cattle (penethamate hydriodide, micronized. Adverse effects section updated: ‘In very rare cases the symptoms of adverse reactions range from mild skin reactions such as urticaria and dermatitis to severe reactions such as anaphylactic shock with tremors, vomiting, salivation, gastrointestinal disorders and laryngeal oedema.’
Pharmasin premix for medicated feeding stuff for pigs, broilers and pullets (tylosin). In relation to the indication for the treatment of respiratory infections in broilers and pullets, deletion of the recommendation to repeat treatment at 3– 4 weeks of age.
Porcilis Lawsonia lyophilisate and solvent for emulsion for injection for pigs (Lawsonia intracellularis); Porcilis PVC M Hyo emulsion for injection for pigs (Mycoplasma hyopneumoniae, Porcine circovirus-2); Porcilis PRRS Lyophilisate and solvent for suspension for injection for pigs (Porcine respiratory and reproductive syndrome virus): the SPCs for these three products revised to include new associated use combinations to introduce the two- and three-way associated use combinations that are not yet registered for these vaccines (associated, non-mixed use of Porcilis Lawsonia either administered alone or reconstituted in Porcilis PCV M Hyo with Porcilis PRRS administered at the same time but at a different site).
Tyljet solution for injection for cattle and pigs (tylosin); Tylucyl solution for injection for cattle and pigs (tylosin). The following warning has been added: ‘In pigs do not administer more than 5 ml per injection site.’ There has also been a change of the withdrawal period for pigs (meat and offal) from 14 days to 16 days.
Winvil 3 Micro emulsion for injection for Atlantic salmon (Aeromonas salmonicida subsp. salmonicida, Infectious pancreatic necrosis virus, Moritella viscosa). The adverse events section 4.6 updated with frequency and severity of the adverse reactions during production cycle of the fish due to availability of the long-term safety data.
Zulvac BTV suspension for injection for sheep and cattle (Bluetongue virus). Addition of Serotype 4 strain of Bluetongue Virus (BTV) for use in cattle. Adverse event section updated: ‘Cattle administered a 4 ml dose: A transient increase in rectal temperature, not exceeding 2.7°C, was very commonly observed within 48 hours following vaccination in the laboratory and field safety studies conducted. The pyrexia observed had a maximum duration of 2 days. Local reactions at the injection site of up to 6 cm in diameter, which resolved in a maximum of 8 days, also very commonly appeared in the lab safety study conducted.’
The up-to-date SPCs for all the products can be viewed on the VMD product information database.
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