Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
firocoxib
Boehringer Ingelheim Vetmedica GmbH
QM01AH90
firocoxib
Dogs
Anti-inflammatory and anti-rheumatic products, non-steroids
TabletsFor the relief of pain and inflammation associated with osteoarthritis in dogs.For the relief of postoperative pain and inflammation associated with soft-tissue, orthopaedic and dental surgery in dogs.Oral pasteAlleviation of pain and inflammation associated with osteoarthritis and reduction of associated lameness in horses.
Revision: 23
Authorised
2004-09-13
18 3B B. PACKAGE LEAFLET 19 PACKAGE LEAFLET PREVICOX 57 MG CHEWABLE TABLETS FOR DOGS PREVICOX 227 MG CHEWABLE TABLETS 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: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY Manufacturer responsible for batch release: Boehringer Ingelheim Animal Health France SCS, 4 Chemin du Calquet, 31000 Toulouse, France 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Previcox 57 mg chewable tablets for dogs Previcox 227 mg chewable tablets for dogs firocoxib 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each chewable tablet contains: ACTIVE SUBSTANCE: firocoxib 57 mg or firocoxib 227 mg EXCIPIENTS: Iron oxides (E172) Caramel (E150d) Tan-brown, round, convex, tablets with a cross-shaped break line on one side. The tablets can be divided into 2 or 4 equal parts. 4. INDICATION(S) For the relief of pain and inflammation associated with osteoarthritis in dogs. For the relief of post-operative pain and inflammation associated with soft-tissue, orthopaedic and dental surgery in dogs. 5. CONTRAINDICATIONS Do not use in pregnant or lactating bitches. Do not use in animals less than 10 weeks of age or less than 3 kg bodyweight. Do not use in animals suffering from gastrointestinal bleeding, blood dyscrasia or haemorrhagic disorders. 20 Do not use concomitantly with corticosteroids or other non-steroidal anti-inflammatory drugs (NSAIDs). 6. ADVERSE REACTIONS Emesis and diarrhoea have occasionally been reported. These reactions are generally of a transitory nature and are reversible when the treatment is stopped. Renal and/or hepatic disorders have been reported in very rare cases in dogs administered the recommended treatment dose _. _ Rarely, nervous system disorders have been reported in treated dogs. _ _ If adverse reactions like vomiting, repeated diarrhoea, faecal occult blood, sudden weight loss, anorexia, lethargy, degra Pročitajte cijeli dokument
1 ANNEX I 0B SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Previcox 57 mg chewable tablets for dogs Previcox 227 mg chewable tablets for dogs firocoxib 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains: ACTIVE SUBSTANCE: firocoxib 57 mg or firocoxib 227 mg EXCIPIENTS: Iron oxides (E172) Caramel (E150d) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Chewable tablets. Tan-brown, round, convex, tablets with a cross-shaped break line on one side. The tablets can be divided into 2 or 4 equal parts. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the relief of pain and inflammation associated with osteoarthritis in dogs. For the relief of post-operative pain and inflammation associated with soft-tissue, orthopaedic and dental surgery in dogs. 4.3 CONTRAINDICATIONS Do not use in pregnant or lactating bitches. Do not use in animals less than 10 weeks of age or less than 3 kg body weight. Do not use in animals suffering from gastrointestinal bleeding, blood dyscrasia or haemorrhagic disorders. Do not use concomitantly with corticosteroids or other non-steroidal anti-inflammatory drugs (NSAIDs). 4.4 SPECIAL WARNINGS None. 3 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals The recommended dose, see section 4.9, should not be exceeded. Use in very young animals, or animals with suspected or confirmed impairment of renal, cardiac or hepatic function may involve additional risk. If such use cannot be avoided, those dogs require careful veterinary monitoring. Avoid use in dehydrated, hypovolaemic or hypotensive animals, as there is a potential risk of increased renal toxicity. Concurrent administration of potentially nephrotoxic drugs should be avoided. Use this product under strict veterinary monitoring where there is a risk of gastrointestinal bleeding, or if the animal previously displayed intolerance to NSAIDs. Renal and/or hepatic disorders have been reported Pročitajte cijeli dokument