Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
firocoxib
Audevard
QM01AH90
firocoxib
Horses
Anti-inflammatory and anti-rheumatic products, non-steroids
Alleviation of pain and inflammation associated with osteoarthritis and reduction of associated lameness in horses.
Revision: 12
Authorised
2008-06-25
33 B. PACKAGE LEAFLET 34 PACKAGE LEAFLET EQUIOXX 8.2 MG/G ORAL PASTE FOR HORSES 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 2. NAME OF THE VETERINARY MEDICINAL PRODUCT EQUIOXX 8.2 mg/g oral paste for horses. 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 _. _ _ _ _ _ 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. 35 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 yo Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT EQUIOXX 8.2 mg/g oral paste for horses. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each syringe contains 7.32 g of paste and delivers: Firocoxib 8.2 mg/g For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral paste. White to off-white paste. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Alleviation of pain and inflammation associated with osteoarthritis and reduction of associated lameness in horses _. _ _ _ 4.3 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 (see section 4.7). Do not use concomitantly with corticosteroids or other non-steroidal anti-inflammatory drugs (NSAIDs) (see section 4.8). Do not use in case of hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Do not use in animals less than 10 weeks. 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 veterinary medicinal products should be avoided. The recommended treatment dose and duration should not be exceeded. 3 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 veterinary medicinal product. Like other medicinal products that inhibit COX-2, pregnan Aqra d-dokument sħiħ