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Zubrin
tepoxalin

Medicinal product no longer authorised


Medicinal product no longer authorised

PACKAGE LEAFLET


Zubrin oral lyophilisates for dogs


  1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT


    Marketing Authorisation Holder:


    Intervet International B. V. Wim de Körverstraat 35 5831 AN Boxmeer

    The Netherlands


    Manufacturer for the Batch Release:


    S-P Veterinary Ltd Breakspear Road South Harefield

    Uxbridge UB9 6LS United Kingdom


  2. NAME OF THE VETERINARY MEDICINAL PRODUCT


    Zubrin 50 mg oral lyophilisates for dogs Zubrin 100 mg oral lyophilisates for dogs Zubrin 200 mg oral lyophilisates for dogs


  3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS Active substance

    Tepoxalin 50 mg / oral lyophilisate

    Tepoxalin 100 mg / oral lyophilisate

    Tepoxalin 200 mg / oral lyophilisate


  4. INDICATIONS


    Reduction of inflammation and relief of pain caused by acute and chronic musculoskeletal disorders.


  5. CONTRAINDICATIONS


    Do not use if your dog

    • is pregnant or lactating or in bitches intended for breeding

    • has cardiac or hepatic disease

    • has had gastrointestinal ulceration or bleeding

    • is hypersensitive to the product

    • is dehydrated, hypovolaemic or hypotensive, as there is an increased risk of renal toxicity.

      Medicinal product no longer authorised

  6. ADVERSE REACTIONS


    Vomiting or diarrhoea may occur due to treatment. Alopecia and erythema may also occur occasionally.

    Typical undesirable side-effects associated with NSAIDs are vomiting, soft faeces/diarrhoea, blood in faeces, reduced appetite, lethargy and renal disorders. If there are such undesirable effects, treatment should be discontinued immediately. In rare cases, particularly in older or in sensitive dogs, these undesirable effects may be serious or fatal.

    During clinical trial testing of the product, the incidence of gastrointestinal reactions (diarrhoea/vomiting) occurred in 1 out of 10 animals.

    If you notice any other side effects, please inform your veterinary surgeon.


  7. TARGET SPECIES


    Dogs


  8. DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION 10 mg/kg once daily.

    The weight of the animal should be accurately determined before start of treatment.

    Peel back foil to reveal a single oral lyophilisate in the form of a round tablet. Push the bottom of the blister and the tablet will pop out. Place the tablet in the dog’s mouth. The tablet will disintegrate upon contact with moisture. Keep the mouth of the dog closed for a few seconds to ensure complete tablet wetting. Administer to dogs within 1-2 hours after feeding. When this is not possible, or when dogs resist having the product placed directly into the mouth, put the tablet immediately before administration into a small amount of moistened food, or in a moist treat. Ensure the food or treat containing the medication is completely consumed.


  9. ADVICE ON CORRECT ADMINISTRATION


    The duration of treatment is dependent on clinical response. After a treatment period of 7-10 days, the condition of the dog should be re-evaluated in order to establish the need for continuation of treatment. Long term treatment should be under regular veterinary supervision.

    Ensure hands are dry to prevent the oral lyophilisate from sticking to fingers. Tepoxalin is not water- soluble and becomes very sticky upon wetting. If the oral lyophilisate disintegrates prematurely, wash hands thoroughly.


  10. WITHDRAWAL PERIOD


    Not applicable


  11. SPECIAL STORAGE PRECAUTIONS


    Keep out of the reach and sight of children.

    This veterinary medicinal product does not require any special storage conditions. Do not use after the expiry date, which is stated on the blister.

    Medicinal product no longer authorised

  12. SPECIAL WARNINGS


    The recommended dose should not be exceeded.

    Use in animals less than 6 months of age, with a weight below 5 kg, or in aged animals, may involve additional risk. If such use cannot be avoided, close veterinary supervision to monitor for gastrointestinal blood loss is necessary.

    Special care should be taken when treating dogs with marked renal insufficiency


    Tepoxalin must not be administered in conjunction with other NSAIDs or glucocorticosteroids, diuretics or anticoagulants.

    If side effects occur, treatment should be discontinued and the advice of a veterinary surgeon should be sought.

    In case of ingestion of a number of oral lyophilisates by a person, the advice of a doctor should be sought immediately.


  13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY


    Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.


  14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED


    Detailed information on this product is available on the website of the European Medicines Agency


  15. OTHER INFORMATION


Not all pack sizes may be marketed.