Medicines News August 2020
Medicines news
Regulatory changes due to the COVID-19 pandemic
The VMD’s temporary relaxations of enforcement related to the supply of medicines will continue until 31 August:
Medicines supply may be made from a temporary premises when access to a RCVS-registered veterinary practice is no longer possible. Wholesale dealers will be allowed to supply veterinary medicines to such temporary premises.
Vets may delegate medicines supply to internet retailers or wholesalers for home delivery to end user.
SQPs may prescribe and authorise supply of veterinary medicines remotely.
SQPs may supply veterinary medicines from temporary premises. Wholesale dealers will be allowed to supply veterinary medicines to SQPs at such temporary premises.
Supply of veterinary specials may be made directly to the owner. In such cases, the requesting vet must supply the manufacturer with all information needed for labelling and informing the owner about warnings etc.
From 1 September:
the relaxations concerning the temporary change of veterinary practice and SQP retailer premises and the arrangements for SQP remote prescribing and authorisation of supply will apply only 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
All on-site VMD inspections have been postponed until further notice. Veterinary Medicines Regulations continue to apply. For full details click the link to go to the VMD website.
RCVS temporary guidance on remote prescribing of POM-V medicines:
is to remain until the end of September, but with a small change to step three of the coronavirus guidance flowchart (removing the words: ‘in the first instance’) to allow veterinary professionals more flexibility in deciding whether to consult remotely or face to face. Click here for details.
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. That is why we also highlight newly marketed medicines below.
Newly authorised medicines for small animals and horses
Doxyvet tablets (doxycycline) for cats and dogs. POM-V
Ketabel solution for injection (ketamine) for cats, cattle, dogs, goats, guinea pigs, hamsters, horses, mice, pigs, rabbits, rats, sheep. POM-V
Oxtra DD solution for injection (oxytetracycline) for cats, cattle, dogs, horses, pigs, sheep. POM-V
Newly authorised medicines for food production animals
Bovimox pour-on solution for cattle (moxidectin). POM-VPS
Ketabel solution for injection (ketamine) for cats, cattle, dogs, goats, guinea pigs, hamsters, horses, mice, pigs, rabbits, rats, sheep. POM-V, Schedule 2 CD.
Molecoxan oral suspension (diclazuril) for cattle and sheep. POM-VPS
Oxtra DD solution for injection (oxytetracycline) for cats, cattle, dogs, horses, pigs, sheep. POM-V
Ridamec pour-on solution (moxidectin) for cattle. POM-VPS
Stenorol Crypto oral solution (halofuginone) for calves. POM-V
Unomox pour-on solution (moxidectin) for cattle. POM-VPS
Newly marketed medicines
There is usually a delay between a product receiving a marketing authorisation from the VMD or EMA and being available for use. The following are products that have recently been launched onto the market.
Trymox LA suspension for injection (amoxicillin) for cattle, sheep, pigs, dogs, cats. First authorised April 2019. POM-V
Dilaterol syrup (clenbuterol) for horses. First authorised March 2013. A generic of Vetipulmin syrup. POM-V
Propomitor (propofol). (First authorised March 2020). There are now three brands of single-use propofol. POM-V
Thiamacare oral solution (thiamazole) for cats. First authorised March 2020. Higher strength (10mg/mL) compared with the existing brand Thyronorm (5mg/mL). POM-V
Tramvetol (tramadol) tablets for dogs. First authorised October 2019. A second brand of tramadol. POM-V, Schedule 3 CD.
Selfonta solution for injection (tigilanol tiglinate) for dogs for the treatment of non-resectable, non-metastatic subcutaneous mast cell tumours located at or distal to the elbow or the hock, and non-resectable, non-metastatic cutaneous mast cell tumours. POM-V.
Changes to product information
Small animals and horses
Alonate-P oral paste (pyrantel) for horses and ponies. Adverse effects section amended to read; ‘Impaction of the small intestine may occur very rarely, in foals infected with high numbers of Parascaris equorum. Symptoms (colic) may be seen as soon as 30 minutes after treatment.’
Amoxibactin tablets (amoxicillin) for dogs. Adverse effects section amended: ‘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 occasionally occur very rarely. In these cases, administration should be discontinued and a symptomatic treatment given.’
Cronyxin Injection (flunixin) for cattle and horses. Removal of the excipient Diethanolamine (DEA) from the finished product formulation and replacement with the alternative pH adjuster Sodium hydroxide 10%.
Emedog solution for injection (apomorphine) for dogs. Addition adverse effects: ataxia has been reported very rarely.
Endectrid Spot-on solutions (imidacloprid + moxidectin) for dogs. Addition user warnings: ‘In order to prevent children getting access to pipettes, keep the pipette in the original packaging until ready for use and dispose of used pipettes immediately.’ And: ‘After application do not stroke or groom animals until the application site is dry. This may be ensured by treating animals in the evening. Do not allow recently treated animals to sleep with owners, especially children, until the application site is dry.’ And: ‘If skin or eye symptoms persist or if the product is accidentally swallowed, seek medical advice immediately and show the package leaflet or label to the physician.’ Adverse effects updated to include: ‘Vomiting can occur on rare occasions. Transient local skin sensitivity reactions including increased itching, hair loss, greasy fur and redness at application site have been reported in very rare cases. On rare occasions greasy hair, erythema and vomiting can occur. These signs disappear without further treatment. The product may, in rare cases, cause local hypersensitivity reactions. If the animal licks the application site after treatment, neurological signs (most of which are transient) may be observed in very rare cases. Section on use in pregnancy updated to read: ‘The safety of the veterinary medicinal product has not been established during pregnancy and lactation in the target species. Moxidectin caused foetal malformations and reduced pup survival in rats. Therefore, the use of the product is not recommended in animals intended for breeding or during pregnancy and lactation.’
Endectrid Spot-on solutions (imidacloprid + moxidectin) for cats and ferrets . Addition of user warnings: ‘In order to prevent children getting access to pipettes, keep the pipette in the original packaging until ready for use and dispose of used pipettes immediately.’ And: ‘After application do not stroke or groom animals until the application site is dry. This may be ensured by treating animals in the evening. Do not allow recently treated animals to sleep with owners, especially children.’ Section on pregnancy: ‘The safety of the veterinary medicinal product has not been established during pregnancy and lactation in the target species. Therefore, the use of the product is not recommended in animals intended for breeding or during pregnancy and lactation.’
Fipralone Duo Spot-on (fipronil + pyriproxyfen) solution for dogs. Adverse effects section amended to read: ‘Transient cosmetic effects such as wet appearance or slight scaling may occur at the application site. According to the accumulated experience on these active ingredients within spot on pharmaceutical forms, transient cutaneous reactions at the application site (squamosis, local alopecia, pruritus, erythema, skin discolouration) and general pruritus or alopecia may be observed after use. Hypersalivation, reversible neurologic symptoms (hyperesthesia, depression, nervous symptoms), respiratory signs or vomiting might occur. These effects occur in very rare cases.’
X-Spectra flavoured tablets (febantel + pyrantel + praziquantel) for dogs Adverse effects added: ‘Gastro-intestinal signs (vomiting, diarrhoea), possibly associated with lethargy, have been observed very rarely in spontaneous reports.’
Food-production animals
Cevac Chlamydia (Chlamydophila abortus) for sheep. Adverse effects section amended: ‘A transient temperature rise may be observed after vaccination (average of 1.5°C for a maximum of 3 days). In very rare cases abortions may occur where the vaccine strain can be identified. Molecular investigations revealed the possible presence of the vaccine strain 1B in placentas collected in cases of enzootic abortion of ewes vaccinated with Cevac Chlamydophila. Although the causal relationship has not been firmly established (differential diagnosis incomplete), and the representative sampling should be specified in the domestic context, the possibility that the vaccine strain can be at the origin of abortions cannot however be excluded in the present state of knowledge. This should be considered in the benefit / risk analysis conducted by the vet before prescribing the vaccine, especially in farms where the infection pressure related to Chlamydophila abortus is low.’
Cronyxin Injection (flunixin) for cattle and horses. Removal of the excipient Diethanolamine (DEA) from the finished product formulation and replacement with the alternative pH adjuster Sodium hydroxide 10%.
Levafas Diamond oral suspension (levamisole + oxyclozanide) for cattle and sheep. Addition of warnings: ‘Animals should be dosed according to their individual weight, and not dosed as per the heaviest animal in the group, otherwise signs of overdose may occur.’ It is important that the container is shaken thoroughly before use to ensure that the two active substances are homogeneously resuspended and therefore the animals receive the correct dose.’ The warning ‘After treatment, animals should be moved to clean pasture in order to prevent re infection’ has been removed as it is not consistent with current principles of responsible use (i.e. it does not promote the maintenance of a parasite population in refugia). Adverse effects added: Rarely, animals may also display signs of ataxia, incoordination, recumbency and depression. Additionally, rarely, sheep may show an allergic reaction such as submandibular oedema, ear flap oedema and swelling of the head. If such a reaction occurs, appropriate treatment should be administered without delay. Such reactions may evolve to a more severe condition (anaphylaxis), which may be life-threatening. Addition of the following warnings on overdose: ‘Do not overdose. If recommended dosages are exceeded animals may exhibit signs of overdosage and toxicity. The effects of levamisole overdosage include impaired motor function, i.e. muscle tremors, head shaking, increased salivation, facial swelling, oedema, scouring and in most severe cases, death.’
The up-to-date SPCs for all the products can be viewed on the VMD product information database.
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