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AstraZeneca

Equioxx
firocoxib


PACKAGE LEAFLET

EQUIOXX 8.2 mg/g oral paste for horses


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


    Marketing authorisation holder: Audevard

    37-39 rue de Neuilly 92110, Clichy France


    Manufacturer responsible for batch release: Boehringer Ingelheim Animal Health France 4 chemin du Calquet

    31000 Toulouse France


    Ceva Santé Animale 10, av. de La Ballastière 33500 Libourne

    France


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  2. NAME OF THE VETERINARY MEDICINAL PRODUCT


    EQUIOXX 8.2 mg/g oral paste for horses.


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  3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS


    Firocoxib 8.2 mg/g


  4. INDICATION(S)


    Alleviation of pain and inflammation associated with osteoarthritis and reduction of associated lameness in horses.


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  5. CONTRAINDICATIONS


    Do not use in animals suffering from gastrointestinal disorders and haemorrhage, impaired hepatic, cardiac or renal function and bleeding disorders.

    Do not use in breeding, pregnant or lactating animals.

    Do not use concomitantly with corticosteroids or other NSAIDs.

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  6. ADVERSE REACTIONS


    Lesions (erosion/ulceration) of the oral mucosa and of the skin around the mouth were very commonly observed in treated animals during tolerance studies. These lesions were mild and resolved without treatment. Salivation and labial and tongue oedema have been uncommonly associated with the oral lesions in a field study.


    The frequency of adverse reactions is defined using the following convention:

    • very common (more than 1 in 10 animals treated displaying adverse reaction(s))

    • common (more than 1 but less than 10 animals in 100 animals treated)

    • uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

    • rare (more than 1 but less than 10 animals in 10,000 animals treated)

    • very rare (less than 1 animal in 10,000 animals, including isolated reports treated)


      If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.


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  7. TARGET SPECIES


    Horses.


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  8. DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION


    0.1 mg firocoxib per kg bodyweight, once daily for up to 14 days. Oral use.


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  9. ADVICE ON CORRECT ADMINISTRATION


    To administer EQUIOXX at the dose of 0.1 mg firocoxib/kg, set the syringe plunger to the appropriate dose division for the horse’s weight. Each full dose division on the syringe plunger delivers sufficient firocoxib to treat 100 kg body weight. The contents of one syringe will treat horses weighing up to 600 kg. To ensure correct dosage, bodyweight should be determined as accurately as possible to avoid overdosing.


    To deliver firocoxib at the appropriate dosage, unlock the knurled ring on the syringe plunger by rotating it ¼ turn and slide it along the plunger shaft to the appropriate dose division for the horse’s weight. Rotate the plunger ring ¼ turn to lock it in place and ensure it is locked.


    Make sure the horse’s mouth contains no feed. Remove the cover from the tip of the syringe. Insert the syringe tip into the horse’s mouth at the interdental space and deposit the paste on the base of the tongue.


  10. WITHDRAWAL PERIOD(S)


    Withdrawal period(s): Meat and offal: 26 days.

    Not authorized for use in animals producing milk for human consumption.

  11. SPECIAL STORAGE PRECAUTIONS


    Keep out of the sight and reach of children.

    This veterinary medicinal product does not require any special storage conditions. Replace cap after use.

    Do not use after the expiry date stated on the label. Shelf-life after first opening the syringe: 3 months.


  12. SPECIAL WARNING(S)


    Special warnings for each target species:

    If side effects occur, treatment should be discontinued and the advice of a veterinarian should be sought. Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there may be potential risk of increased renal toxicity. Concurrent administration of potentially nephrotoxic drugs should be avoided.


    Do not use in animals less than 10 weeks.

    The recommended treatment dose and duration should not be exceeded.


    Special precautions to be taken by the person administering the veterinary medicinal product to animals:

    In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

    Avoid contact with eyes and skin. If it occurs, rinse affected area immediately with water. Wash hands after use of the product.

    Like other medicinal products that inhibit COX-2, pregnant women or women attempting to conceive should avoid contact with, or wear disposable gloves, when administering the product.


    Pregnancy and lactation:

    No data on use during pregnancy is available in horses. Therefore, do not use in breeding, pregnant or lactating animals.


    Interaction with other medicinal products and other forms of interaction:

    Other NSAIDs, diuretic and substances with high protein binding may compete for binding and lead to toxic effects. Do not use concomitantly with corticosteroids or other NSAIDs.

    Pre-treatment with other anti-inflammatory substances may result in additional or increased adverse effects and a treatment-free period with such products should therefore be observed. The treatmentfree period should take into account the pharmacological properties of the products used previously.


    Concomitant treatment with molecules displaying action on renal flow (e.g. diuretics) should be subject to clinical monitoring. Concurrent administration of potentially nephrotoxic drugs should be avoided as there might be an increased risk of renal toxicity.


  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


    .


  15. OTHER INFORMATION


Firocoxib is a non-steroidal anti-inflammatory drug (NSAID) belonging to the Coxib group, which acts by selective inhibition of cyclooxygenase-2 (COX-2)-mediated prostaglandin synthesis.

The oral paste is available in the following pack sizes:


If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.


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  1. TARGET SPECIES


    Horses (450–600 kg).


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  2. DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION


    Oral use.

    Administer one tablet once daily for horses weighing 450–600 kg bodyweight.


    Duration of treatment will be dependent on the response observed, but should not exceed 14 days.


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  3. ADVICE ON CORRECT ADMINISTRATION


    One tablet should be administered with a small amount of food in a bucket or direct by hand, presenting the tablet combined with a small amount of food or with a treat in the palm of the hand. After administration, it is recommended to examine the buccal cavity to ensure that the tablet has been adequately swallowed.

    Do not exceed the recommended dosage.

    For safe and effective use, this product should only be administered to horses in the weight range 450- 600 kg. For horses weighing under 450 kg or over 600 kg, and where firocoxib is the treatment of choice, use of other firocoxib-containing formulations that allow for accurate dosing is advised.


  4. WITHDRAWAL PERIOD(S)


    Withdrawal period(s): Meat and offal: 26 days.

    Not authorized for use in animals producing milk for human consumption.

  5. SPECIAL STORAGE PRECAUTIONS


    Keep out of the sight and reach of children. Do not store above 30 °C.

    Store in the original package.

    Do not use this veterinary medicinal product after the expiry date stated on the label after EXP.


  6. SPECIAL WARNING(S)


    Special warnings for each target species:

    If side effects occur, treatment should be discontinued and the advice of a veterinarian should be sought. Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there may be potential risk of increased renal toxicity. Concurrent administration of potentially nephrotoxic drugs should be avoided.

    The recommended treatment dose and duration should not be exceeded.


    Special precautions to be taken by the person administering the veterinary medicinal product to animals.

    In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

    Wash hands after use of the veterinary medicinal product.

    Like other medicinal products that inhibit COX-2, pregnant women or women attempting to conceive should avoid contact with, or wear disposable gloves, when administering the product.


    Pregnancy and lactation:

    No data on use during pregnancy is available in horses. Therefore, do not use in breeding, pregnant or lactating animals.


    Interaction with other medicinal products and other forms of interaction:

    Other NSAIDs, diuretic and substances with high protein binding may compete for binding and lead to toxic effects. Do not use concomitantly with corticosteroids or other NSAIDs.

    Pre-treatment with other anti-inflammatory substances may result in additional or increased adverse effects and a treatment-free period with such products should therefore be observed. The treatmentfree period should take into account the pharmacological properties of the products used previously.


    Concomitant treatment with molecules displaying action on renal flow (e.g. diuretics) should be subject to clinical monitoring. Concurrent administration of potentially nephrotoxic drugs should be avoided as there might be an increased risk of renal toxicity.


  7. 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.


  8. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED


    .

  9. OTHER INFORMATION


    Mode of action:

    Firocoxib is a non-steroidal anti-inflammatory drug (NSAID) that acts by selective inhibition of cyclooxygenase-2 (COX-2) mediated prostaglandin synthesis. COX-2 is the isoform of the enzyme that has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. In in-vitro equine whole blood assays, firocoxib exhibited 222 to 643 fold selectivity for COX-2 over COX-1.


    The 57 mg chewable tablets are available in the following pack sizes:


    • 1 cardboard box containing 10 tablets in blisters

    • 1 cardboard box containing 30 tablets in blisters

    • 1 cardboard box containing 180 tablets in blisters

    • 1 cardboard box containing 60 tablets in a 30 ml bottle Not all pack sizes may be marketed.