Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
meloxicam
Ceva Santé Animale
QM01AC06
meloxicam
Dogs; Cats; Cattle; Pigs; Horses
Oxicams
DogsAlleviation of inflammation and pain in both acute and chronic musculoskeletal disorders.Reduction of post-operative pain and inflammation following orthopaedic and soft-tissue surgery.CatsReduction of post-operative pain after ovariohysterectomy and minor soft-tissue surgery.CattleFor use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.For use in diarrhoea in combination with oral rehydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle.For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.PigsFor use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation.For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome) with appropriate antibiotic therapy.HorsesFor use in the alleviation of inflammation and relief of pain in both acute and chronic musculoskeletal disorders.For the relief of pain associated with equine colic.
Revision: 14
Authorised
2007-01-15
42 B. PACKAGE LEAFLET 43 PACKAGE LEAFLET: MELOXIDYL 1.5 MG/ML ORAL SUSPENSION FOR DOGS 10, 32 & 100 ML 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: Ceva Santé Animale 10 avenue de la Ballastière 33500 Libourne France Manufacturers responsible for batch release: Ceva Santé Animale Z.I. Très le Bois 22600 Loudéac France Vetem SpA Lungomare Pirandello, 8 92014 Porto Empedocle (AG) Italy 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Meloxidyl 1.5 mg/ml oral suspension for dogs. Meloxicam 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS Each ml contains: - 1.5 mg of meloxicam - 2 mg of sodium benzoate 4. INDICATION(S) Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs. 5. CONTRAINDICATIONS Do not use in pregnant or lactating animals. Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of individual hypersensitivity to the product. Do not use in dogs less than 6 weeks of age. 44 6. ADVERSE REACTIONS Typical adverse drug reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood and apathy have occasionally been reported. These side effects occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal. 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 treated, includin Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Meloxidyl 1.5 mg/ml oral suspension for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Composition for 1 ml _ _ ACTIVE SUBSTANCE (S)_ _ Meloxicam 1.5 mg EXCIPIENTS Sodium benzoate 2 mg For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Pale yellow suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders. 4.3 CONTRAINDICATIONS Do not use in pregnant or lactating animals. Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of individual hypersensitivity to the product. Do not use in dogs less than 6 weeks of age. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals 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, if there is a potential risk of increased renal toxicity. 3 Special precautions to be taken by the person administering the veterinary medicinal product to animals People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Typical adverse drug reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood and apathy have occasionally been reported. These side effects occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal. The frequency of adverse reacti Прочетете целия документ