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The following information has been produced for Veterinary Record by the Veterinary Medicines Directorate (VMD) to provide an update for veterinary surgeons on recent changes to marketing authorisations for veterinary medicines in the UK and other relevant issues.
THE points below highlight changes in marketing authorisations that may have a significant impact on veterinary surgeons' prescribing decisions.
New marketing authorisations
New marketing authorisations that were issued in November 2011 are listed in Table 1. Of the products authorised in this period, none contains an active ingredient not previously included in an authorised veterinary medicinal product in the UK.
These products may not yet be readily available in the UK. Veterinary surgeons should contact the marketing authorisation holder directly for details of supply.
Table 1 also indicates where a public assessment report should become available for a product on the VMD's website. Where available, links to these reports are accessible by clicking on the relevant product in the VMD's Product Information Database, www.vmd.defra.gov.uk/ProductInformationDatabase/
The European Medicines Agency (EMA) publishes European Public Assessment Reports (EPARs) for every veterinary medicine that is authorised through a centralised procedure. Links to these reports are accessible on www.ema.europa.eu
Marketing authorisation variations
The following clinically significant variations to marketing authorisations were approved and/or published during November 2011:
■ Bexepril 2.5 mg, 5 mg and 20 mg film-coated tablets for dogs.
Change of invented name to ‘Forzepril 2.5 mg, 5 mg and 20 mg film-coated tablets for dogs’.
■ Clavoral 500/125 mg tablets for dogs, 50/12.5 mg tablets for cats and dogs, 250/62.5 mg tablets for dogs.
Change of invented name of Clavoral tablets of all sizes to ‘Clavubactin’.
■ Combisyn suspension for injection.
The indications have been updated to include the treatment of urinary tract infections, skin and soft tissue infections (for example, abscesses, pyoderma, anal sacculitis and gingivitis) in dogs.
■ Duvaxyn EHV 1,4.
Change of invented name from Duvaxyn EHV 1,4 to ‘Equip EHV 1,4’.
■ FleaClear spot on solution 67 mg for small dogs, 134 mg for medium dogs, 268 mg for large dogs, 402 mg for extra large dogs. FleaClear spot on solution 50 mg for cats.
The legal distribution category becomes AVM-GSL.
There is an addition of a claim to the existing marketing authorisation to allow a third dose of the vaccine to be given 10 weeks or more after the second dose to entire male pigs intended for slaughter at heavy weights. The dosing instructions therefore are now as follows: ‘Entire male pigs from 8 weeks of age onwards should be vaccinated with 2 doses of 2 ml at least 4 weeks apart, with the second dose normally given 4 to 6 weeks prior to slaughter. If slaughter is intended to be later than 10 weeks after the second dose a third dose should be given 4 to 6 weeks before planned slaughter date. In case of suspected misdosing, the animal should be revaccinated immediately.’
■ Kloxerate DC.
The withdrawal period advice becomes: ‘Meat and offal: 28 days. Not intended for use within 35 days of calving. Milk for human consumption may only be taken from 108 hours after calving. Should a cow calve earlier than 35 days after the last treatment, milk for human consumption may only be taken from 35 days plus 108 hours after the last treatment. In cows suffering from hypocalcaemia it may be necessary to withhold milk for a longer period than that stated above. In such cases milk should be withheld until levels of antibiotics are below the maximum accepted residue levels, ie, 0.03 mg/ml for cloxacillin.’
Special precautions for use have been updated to include further warnings: ‘Anthelmintics are agents that destroy or result in the expulsion of susceptible parasitic worms. Parasite resistance to a particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class. To reduce this risk, dosing programmes should be discussed with a veterinary surgeon.
‘Tribex contains the anthelmintic triclabendazole. Fluke (Fasciola hepatica) resistance to triclabendazole has been identified and losses associated with resistant strains of fluke in sheep flocks treated with triclabendazole can be significant. If signs of fascioliasis continue after treatment with Tribex, DO NOT REPEAT THE DOSE and do not dose with other products containing triclabendazole. Seek veterinary advice. If resistance is suspected or confirmed, you should change active ingredient on veterinary advice.’
The withdrawal period for milk becomes six days (144 hours).
There may be delays in these changes being published on the products' labelling and packaging. For more information on any of these products, including the names of the marketing authorisation holders, visit the VMD's product database at www.vmd.defra.gov.uk/ProductInformationDatabase
In prescribing these veterinary medicines, veterinary surgeons should be aware that changes to the Summary of Product Characteristics, 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, the labelling instructions on the pack from which the product is dispensed should be followed. Detailed guidance on this issue is available at www.vmd.defra.gov.uk/vet/spc_label.aspx
Marketing authorisation suspensions
The marketing authorisation for Hiprabovis pneumos emulsion for injection for cattle was suspended in November 2011.
Further information on suspended products can be found at www.vmd.defra.gov.uk/vet/suspended.aspx
Product availability update
■ OrbeSeal: The VMD has been informed that Pfizer Animal Health is currently experiencing a disruption to the supply of both the 24 syringe and 120 syringe presentations of OrbeSeal. This disruption is due to a combination of an increase in the global demand for OrbeSeal and also short-term manufacturing constraints. Pfizer has been communicating with its customers to make them aware of this situation and it has advised that it is working with the manufacturing site in order to expedite supply. However, a period of eight to 10 weeks of intermittent supply is expected. Further information is available from Pfizer Account Managers or Pfizer Technical Services, telephone 0845 300 8034.
During this short-term out-of-stock situation, if veterinary surgeons identify and wish to use a suitable alternative product, they can submit an Import Certificate application to the VMD for these products to cover their immediate need.
■ Duvaxyn R: Further to recent supply issues regarding Duvaxyn R, the VMD has been made aware that it is estimated that stocks of this product will not return to the market until summer 2012 as opposed to December 2011 as first expected. Special Treatment Certificates (STCs) for an alternative product, Equine Rotavirus Vaccine, from the USA will continue to be granted until the UK-authorised product is fully back in stock. If veterinary surgeons are aware of any other alternative vaccines, they can submit STC applications for these vaccines. Each application will be assessed on its individual merits.
The VMD highlights significant supply problems on its website at www.vmd.defra.gov.uk/vet/supply.aspx. For each product where there is a significant supply problem, information is given on alternative products that may be imported under the prescribing cascade and there is information on how to make the necessary application for import certificates.
The presentations and transcript of a question and answer session held during the VMD's information meeting in November 2011 are now available on the VMD's website.
■ Details of all veterinary medicinal products currently authorised in the UK are available at www.vmd.defra.gov.uk/ProductInformationDatabase/
Further information about matters raised in this article is available from Matthew Isted, e-mail:
This summary forms part of a continuing series of monthly updates from the VMD. The last summary was published in VR, December 3, 2011, vol 169, pp 598–599.