Supply Problems

Equip Rotavirus (Duvaxyn R) Vaccine for Horses

Equip Rotavirus (previously Duvaxyn R) is indicated for the vaccination of pregnant mares to provide passive transfer of antibodies to foals to reduce the risk of diarrhoea caused by Equine Rotavirus H2 serotype.

The VMD has become aware of a supply problem for Equip Rotavirus with stocks expected to be available again in August 2012. Due to the clinical need for this vaccine in the UK, an alternative product called Equine Rotavirus Vaccine by Pfizer Animal Health and authorised in the USA has been identified and approved for import.

To address the supply problem under the prescribing cascade it is possible for a veterinary surgeon to use this product once the necessary import certificate has been obtained. Given that the UK authorised product is forecast to be available again in August, the VMD will only be granting Special Treatment Certificates (STCs) for a sufficient quantity to cover the immediate need. 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.

In advance of applying for STCs for any product it is recommended that the supplier is contacted to ensure that sufficient stock is available to meet your needs.

Vibravenos

The VMD has been made aware that Pfizer are again able to supply quantities of Vibravenos for avian psittacosis from France. Veterinary surgeons wishing to import this product should submit a Special Treatment Certificate (STC) application to the VMD.

Orbeseal Dry Cow Intramammary Suspension

The VMD has been made aware that the supply of OrbeSeal is being restored with product being allocated to veterinary surgeons to cover their immediate need. Please contact your Pfizer Account Manager or Pfizer Technical Services (0845 300 8034) for further information.

Therefore, no further import certificates will be issued for alternative products with immediate effect. Existing certificates will remain valid but are limited by time and the quantity specified on the certificate. Should there be a supply problem with OrbeSeal in the future; the VMD will reinstate the ability to apply for import certificates.

Ketamine Solution for Injection

The VMD has been made aware that the supplies of veterinary medicinal products containing Ketamine Hydrochloride which are indicated for use as an anaesthetic agent have been restored.

Therefore, no further import certificates will be issued for Ketamine Virbac 1000 with immediate effect. Existing certificates will remain valid but are limited by time and the quantity specified on the certificate. Should there be a supply problem with veterinary medicinal products containing Ketamine Hydrochloride in the future; the VMD will reinstate the ability to apply for import certificates.

Scabivax Forte for Sheep

The VMD has been made aware that the supply of Scabivax Forte has been restored and product will be available for order the week commencing 12th September.

Therefore, no further import certificates will be issued for alternatives to Scabivax Forte with immediate effect. Existing certificates will remain valid but are limited by time and the quantity specified on the certificate.

Toxovax

The VMD has become aware of a short term supply problem with Toxovax which is a vaccine indicated for the active immunisation of susceptible breeding female sheep to reduce the effects of infection by Toxoplasma gondii, namely early embryonic death, barrenness and abortion. This supply is expected to gradually return to normal from mid-September 2011.

Unfortunately, no available alternative has been identified to satisfy the shortfall in supply to the UK market.

If veterinary surgeons are aware of any alternative products indicated for the immunisation against Toxoplasma gondii that are authorised outside the UK, applications for import certificates may be submitted. Each application will be assessed on its individual merits.

Torbutrol Tablets

The VMD has become aware of an intermittent supply problem with Torbutrol Tablets 10 mg and 5 mg which are indicated as an antitussive. This supply problem is likely to last until sometime in 2012.

To address the supply problem, under the prescribing cascade it is possible for a veterinary surgeon to use a veterinary medicine authorised in the UK for use with another animal species or for another condition in the same species. If this option is not available to the veterinarian then a human product authorised in the UK without any prior notification to the VMD may also be used. If there is no suitable UK authorised human product, veterinary surgeons may apply to import an EU authorised veterinary medicine or failing this, a veterinary medicine authorised outside the EU, once the necessary import certificate has been obtained. The veterinary surgeon may also decide to prescribe a medicine prepared extemporaneously (a "Special"). It should be noted that these options should only be explored after attempts to obtain and use UK authorised products have been unsuccessful.

So far, the VMD is not aware of an alternative veterinary products authorised in the EU; however, Torbutrol Tablets are also authorised in the United States and Canada. Applications to import these Tablets should be made via Special Treatment Certificate (STC) and applications should be made in hard copy. Please note, the VMD has no information on the availability of these tablets.

In advance of applying for SICs or STCs for any product it is recommended that the supplier is contacted to ensure that sufficient stock is available to meet your needs.

If veterinary surgeons are aware of any other alternative products, you may submit import certificate applications for these. Each application will be assessed on its individual merits.

Applications for Online Special Import Certificates for Amprolium Products

In 2010, the VMD took the decision to remove the ability to obtain Special Import Certificates (SICs) online via our website for products containing amprolium. This decision was taken to closely monitor the justifications for importation and to review the quantity being imported due to the rapidly increasing use of these products.

After monitoring the use of amprolium products for several months, the VMD is satisfied of the need for these products in the quantity that is being imported and has therefore decided to reinstate the ability to obtain SICs online. However, the VMD will continue to monitor use on a retrospective basis and veterinary surgeons may be contacted if they are found to be requesting certificates for an unusually high quantity of product.

Veterinary surgeons are reminded that the import certificate schemes are designed to allow treatment for the immediate need in the animal(s) concerned where there is no suitable authorised product in the UK to treat a particular condition and when the health situation so requires. The special import certificate scheme should not be used to obtain and hold product in anticipation of a requirement for it. Instead, wholesale dealers may apply for a Wholsale Dealers Import Certificate (WDIC) which allows them to hold product and supply it to veterinary surgeons in possession of a valid SIC. This enables product to be rapidly obtained without having to await importation into the UK.

Singvac Botulinum Vaccine for Cattle

Singvac is a vaccine used to prevent botulism caused by Clostridium botulinum types C and D. The VMD has been permitting the importation of Singvac from Australia for use by veterinary surgeons under our Special Treatment Certificate (STC) Scheme as there is currently no authorised vaccine against botulism in the UK and, as far as we are aware, there is no suitable authorised vaccine in the EU.

The VMD has become aware of a supply problem for Singvac and Pfizer Animal Health, the manufacturer, has contacted all recent purchasers of the product to notify them of this. Due to the clinical need for a botulism vaccine in the UK, in consultation with manufacturers, the VMD has approved the following products for import:

Product: Ultravac Botulinum
Country of Origin: Australia
Contact Details: Pfizer Animal Health
Tel: 0845 300 8034 (Technical Helpline)

Product: Botulism Vaccine
Country of Origin: South Africa
Contact Details: Nolwazi Bam (International Sales Manager)
Onderstepoort Biological Products Ltd
Private Bag X07
Onderstepoort 0110
South Africa
Email: nolwazi@obpvaccines.co.za
Tel: +27 (0)12 522 1631
Fax: +27 (0)12 565 5260

To address the supply problem under the prescribing cascade it is possible for a vet to use these products once the necessary import certificate has been obtained. 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.

In advance of applying for STCs for any product it is recommended that the supplier is contacted to ensure that sufficient stock is available to meet your needs.

ACP Injectable Products

ACP Injection 2mg/ml Solution for Injection Vm 12501/4124

ACP Injection 10mg/ml Solution for Injection Vm 12501/4125

The VMD has been informed that these two ACP injectable products manufactured by Novartis Animal Health UK Ltd will be unavailable in the UK from January 2011. Novartis have notified all recent purchasers of ACP injectable products.

The VMD and Novartis recognise the importance of these products to UK veterinary surgeons and alternative products have been identified for import into the UK. Novartis have been working with Vetoquinol and have obtained the appropriate Wholesale Dealers Import Certificate (WDIC) for the Vetoquinol French product Calmivet Solution for Injection.

Calmivet is an acepromazine injection licensed for use in dogs, cats and (non-food) horses in France. Please be aware that Calmivet is only available as a 5mg/ml injection so dose volumes will differ from your practice protocol, check your dose before administering. The recommended dose rates (mg per kg bodyweight) in France differ to those licensed for ACP products in the UK. Veterinary surgeons may prefer for clinical reasons to use these products in accordance with the UK dose rates for ACP injectable products, adjusting the dose volumes appropriately.

Calmivet is available via Special Import Certificate (SIC) from the VMD online Special Import site. The online SIC is free of charge.

The VMD have acknowledged that Calmivet is authorised for use in multiple species, and it may be desired by Veterinary Surgeons for this product to be held in stock for use in multiple species on a case by case basis. To accommodate this, the VMD have changed the online Import Scheme to allow 'mixed' to be selected as the chosen species for Calmivet applications. Any paper applications for 'mixed' species should also state which species it is expected the product will be used in.

Please note the decision to add 'mixed' as a species type for other products will be made on a case by case basis following assessment.

If veterinary surgeons are aware of any other alternative EU authorised acepromazine products you may submit SIC applications for these. Each application will be assessed on its individual merits.

For more information please contact Anna Burrows on 01932 338496 or a.burrows@vmd.defra.gsi.gov.uk.

Insulin

The VMD has been informed that, for the foreseeable future, there will be no further supplies of the following Pfizer Insuvet products:

• Insuvet Lente
• Insuvet Neutral
• Insuvet Protamine Zinc

Pfizer have very recently contacted all wholesale purchasers of the Insuvet range to make them aware of this lack of stock and provided contact details in case they have any specific questions regarding the management of any diabetic cases.

The only other UK authorised veterinary medicinal product containing insulin is Caninsulin (Intervet/Schering Plough). Veterinary surgeons should contact Intervet/Schering-Plough's Veterinary Support Group directly on 01908 685685 for specific advice for how to switch a case from Insuvet to Caninsulin.

In patients for whom Caninsulin is not suitable, use of a medicinal product for human use or use of a veterinary medicinal product authorised in another member state may be considered under the provisions of the prescribing cascade.

Vitamin K1 Tablets

The VMD has become aware of a supply problem for the human medicinal product Vitamin K1 tablets (Konakion) which are commonly used following an initial injection of Vitamin K1 in the management of poisoned animals caused by ingesting anticoagulant rodenticides.

The VMD has identified an alternative product which is in tablet form and approved for use in dogs, Vitamine K1 Comprime TVM, authorised in France and manufactured by Laboratoire TVM. Special Import Certificates (SICs) for this product are now available for online application through the VMD's website.

The VMD has also approached wholesale dealers encouraging them to apply for Wholesaler Dealers Import Certificates (WDICs) for this product to enable it to be rapidly supplied to Veterinary Practices for emergency situations.

For more information please see VMGN 7 (Import Certificate Schemes) and VMGN 10 (Wholesale Dealer's Authorisation for Veterinary Medicines).

At this stage there is no evidence that there is a supply problem for human Vitamin K1 Injection.

For more information, please contact Sam Ward on 01932 338496 or via email s.ward@vmd.defra.gsi.gov.uk.

Viper Venom Antiserum (adder bite antivenom) for veterinary use

The Veterinary Medicines Regulations allow veterinary surgeons to prescribe and administer a human product to animals under the cascade if there are no suitable authorised products for animals. At present there is no viper venom antiserum authorised in the UK for the treatment of adder bites in dogs.

The VMD can now approve Special Treatment Certificates and Wholesale Dealers Import Certificates for European Viper Antiserum, sourced from Poland (Biomed) or from Croatia (Institute of Immunology, Zagreb).

The applications for these STCs no-longer need to be made on a named animal basis, and applications based upon submission of retrospective records of use are acceptable.

In urgent cases the antivenom may be supplied, purchased and used prior to the STC being obtained from the VMD. This is a special dispensation made for this clinical condition only. For further information please contact Sam Ward on 01932 338496.

The contact details of the approved manufacturers are:

BIOMED Warsaw
Wytwornia Surowic i szczepionek BIOMED Ltd
Ul. Chelmska 30/34
00-725 Warsaw
Phone. 022 841 4071
Biomed Website

Institute of Immunology
Rockefellerova 2
10000 Zagreb, Croatia
Phone +385 1 46 84 500
Institute of Immunology website

We recommend that before submitting an application you contact the relevant manufacturer to ensure they are able to supply the quantity of product you wish to import.