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Information contained on a label

Just like human medicines, veterinary medicines have the potential to cause serious harm if they are not used as instructed.

The product literature of all veterinary medicinal products authorised in the UK has been approved by the Veterinary Medicines Directorate (VMD) and reflects the scientific data presented in support of the authorisation. It is essential that you take the time to read the product literature that accompanies the veterinary medicinal product and follow the instructions before you use it. It contains important information to help you use the medicine safely and to get the best results from it. The term "product literature" refers to the immediate label attached to the container, the outer box (carton) and the package leaflet.

Sometimes all the information cannot be placed on the immediate label due to the small size of the container - for example, in the case of single vaccine vials. In this instance some information is placed on the outer box, so the container must always be kept in its outer box. Where all of the instructions cannot fit onto the label or carton, a package leaflet is included in the packaging. It is important that you keep the package leaflet with the medicine. The product literature contains all the information that you need to use the product safely, correctly and legally.

Some of the terms frequently used in the product literature are explained below:

  • Active ingredients (Active Substances): The substances in the product that have a medicinal effect. The amount of each active ingredient is always stated on the label.
  • Excipients: These are inactive substances such as colourings, flavourings, binders and stabilisers that are present in the product.
  • Dosage form: A description of the type of product, e.g., tablet, solution for injection.
  • Presentation: The physical form of the product, e.g., a yellow syrup, a live, freeze-dried vaccine.
  • Use (or Indications): This refers to the condition which the product will treat (therapeutic indication) or prevent (prophylactic indication).
  • Dosage and administration (Posology): This indicates the amount of product to be given to the animal, how often and for how long, and the route of administration, e.g., by mouth, injection.
  • Warnings or Special precautions for use: The general precautions to be taken when using the product, in relation to animal safety. It includes information on possible interactions between two products used at the same time and on possible side effects in the treated animal. Advice on whether it is safe to use the product in pregnant or nursing animals may be given in this section or under Contraindications.
  • Contraindications: Information on situations where it is not safe to use the product. Some products contain a pictogram to draw attention to particular risks that the they present to a certain species. You should never ignore contraindications.
  • Operator warnings: Information on the precautions to be taken by the person administering the product to the animal, to avoid hurting themselves.
  • Withdrawal period: The period of time in which the meat, milk or eggs from the treated animal cannot enter the human food chain due to possible presence of residues.
  • Storage and precautions: This section contains information on product storage. The inuse shelf life indicates for how long a product can be used following opening of the bottle or preparation. If a product is used outside the recommended shelf life or has been incorrectly stored it may not work or may cause adverse effects in your animal.
  • Expiry date: The date after which the product should not be used. It can be expressed as:
    Expiry date: DD/MM/YY
    EXP: DD/MM/YY
    EXP: end MM/YY
    Use by end MM/YY
  • Disposal advice: Information on how to dispose of the product and containers to ensure that the environmental is not harmed.
  • Legal category: This indicates the distribution category of the product in the UK. The current legal categories are indicated as POM-V (Prescription Only Medicine-Veterinarian), POM-VPS (Prescription Only Medicine-Veterinarian, Pharmacist, Suitably Qualified Person), NFA-VPS (Non-Food Animal Medicine - Veterinarian, Pharmacist, Suitably Qualified Person) and AVM-GSL (Authorised Veterinary Medicine-General Sales List). Details of the animal medicines classification can be found here.
  • Batch number: This is the lot number, e.g., AB123. It is always present on the product label.
  • MA number: This is the Marketing Authorisation number, the number under which the product is licensed. It is unique to the product, and starts with the prefix Vm or EU, e.g., Vm 123/04, EU/1/23/123/001- 002.

It is very important that users take time to read the product literature, even if they have used the veterinary medicine before, as the instructions may change. If there is anything that you do not understand, contact your veterinary surgeon, pharmacist or the MAH (Marketing Authorisation Holder) for advice. The product literature contains the contact address for the MAH. Pay particular attention to any pictograms on the product literature and keep all veterinary medicinal products out of reach of children.

There may be occasions when a veterinary surgeon advises you to use a product in a way not shown on the product literature. When this happens the veterinary surgeon should also inform you of any extra precautions you should take. If you are unclear on how to use the veterinary medicine you should speak to your veterinary surgeon again. Only when you have received professional veterinary advice is it acceptable for you to depart from the advice given on the product literature.

If you use a veterinary medicine and you believe it has resulted in your animal, yourself, a member of your family becoming unwell or if you believe that using the product has caused harm to the environment, you should report this suspected adverse reaction to the MAH or to the VMD, via the Suspected Adverse Reaction Surveillance Scheme (SARSS). Details on how to report a suspected adverse reaction to the VMD can be found here.

Last Updated: 21 January 2011

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