Šalis: Europos Sąjunga
kalba: portugalų
Šaltinis: EMA (European Medicines Agency)
enflicoxib
Ecuphar NV
QM01AH95
enflicoxib
Cães
Produtos antiinflamatórios e anti-reumáticos
For the treatment of pain and inflammation associated with osteoarthritis (or degenerative joint disease) in dogs.
Autorizado
2021-04-20
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Daxocox 15 mg tablets for dogs Daxocox 30 mg tablets for dogs Daxocox 45 mg tablets for dogs Daxocox 70 mg tablets for dogs Daxocox 100 mg tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: Enflicoxib 15 mg Enflicoxib 30 mg Enflicoxib 45 mg Enflicoxib 70 mg Enflicoxib 100 mg EXCIPIENTS: Iron oxide black (E172) 0.26% Iron oxide yellow (E172) 0.45% Iron oxide red (E172) 0.50% For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets Brown, round and convex tablets. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of pain and inflammation associated with osteoarthritis (or degenerative joint disease) in dogs. 4.3 CONTRAINDICATIONS Do not use in animals suffering from gastrointestinal disorders, protein or blood losing enteropathy or haemorrhagic disorders. Do not use in cases of impaired renal or hepatic function. Do not use in cases of cardiac insufficiency. Do not use in pregnant or lactating dogs. Do not use in animals intended for breeding purposes. Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Do not use in cases of known hypersensitivity to sulphonamides. 3 Do not use in any dehydrated, hypovolemic or hypotensive animal, as there is a potential risk of increased renal toxicity. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Do not administer other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or glucocorticoids concurrently or within 2 weeks of the last administration of this veterinary medicinal product. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Since the safety of the medicinal product has not been fully demonstrated in very young animals, careful monitoring is advised during the treatment of young dogs aged less than 6 months. The active metabolite of enflicoxib exhibits an extended plasma half-life du Perskaitykite visą dokumentą
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Daxocox 15 mg tablets for dogs Daxocox 30 mg tablets for dogs Daxocox 45 mg tablets for dogs Daxocox 70 mg tablets for dogs Daxocox 100 mg tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: Enflicoxib 15 mg Enflicoxib 30 mg Enflicoxib 45 mg Enflicoxib 70 mg Enflicoxib 100 mg EXCIPIENTS: Iron oxide black (E172) 0.26% Iron oxide yellow (E172) 0.45% Iron oxide red (E172) 0.50% For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets Brown, round and convex tablets. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of pain and inflammation associated with osteoarthritis (or degenerative joint disease) in dogs. 4.3 CONTRAINDICATIONS Do not use in animals suffering from gastrointestinal disorders, protein or blood losing enteropathy or haemorrhagic disorders. Do not use in cases of impaired renal or hepatic function. Do not use in cases of cardiac insufficiency. Do not use in pregnant or lactating dogs. Do not use in animals intended for breeding purposes. Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Do not use in cases of known hypersensitivity to sulphonamides. 3 Do not use in any dehydrated, hypovolemic or hypotensive animal, as there is a potential risk of increased renal toxicity. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Do not administer other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or glucocorticoids concurrently or within 2 weeks of the last administration of this veterinary medicinal product. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Since the safety of the medicinal product has not been fully demonstrated in very young animals, careful monitoring is advised during the treatment of young dogs aged less than 6 months. The active metabolite of enflicoxib exhibits an extended plasma half-life du Perskaitykite visą dokumentą