Ország: Európai Unió
Nyelv: angol
Forrás: EMA (European Medicines Agency)
meloxicam
Dechra Regulatory B.V.
QM01AC06
meloxicam
Dogs; Cats
Musculo-skeletal system, Anti-inflammatory and anti-rheumatic products, non-steroids
CatsAlleviation of inflammation and pain in chronic musculoskeletal disorders.DogsAlleviation of inflammation and pain in both acute and chronic musculoskeletal disorders.
Revision: 9
Authorised
2010-11-19
24 B. PACKAGE LEAFLET 25 PACKAGE LEAFLET: MELOXORAL 1.5 MG/ML ORAL SUSPENSION 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: Dechra Regulatory B.V. Handelsweg 25 5531 AE Bladel THE NETHERLANDS Manufacturer for the batch release: Produlab Pharma B.V. Forellenweg 16 4941 SJ Raamsdonksveer THE NETHERLANDS 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Meloxoral 1.5 mg/ml oral suspension for dogs Meloxicam 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS One ml contains: Meloxicam 1.5 mg. Yellow/ green suspension. 4. INDICATION(S) Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs. 5. CONTRAINDICATIONS Do not use in dogs suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders. Do not use in case of hypersensitivity to the active substance or to any of the excipients. Do not use in dogs less than 6 weeks of age. 6. ADVERSE REACTIONS Typical adverse reactions of non-steroidal anti-inflammatory drugs (NSAIDs) such as loss of appetite, vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been reported. In very rare cases haemorrhagic diarrhoea, haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported. These adverse reactions 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. If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought. 26 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 Olvassa el a teljes dokumentumot
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Meloxoral 1.5 mg/ml oral suspension for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains: ACTIVE SUBSTANCE: Meloxicam 1.5 mg. EXCIPIENT: Sodium benzoate 1.75 mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral suspension. Yellow/ green 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 in dogs. 4.3 CONTRAINDICATIONS Do not use in dogs suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders. Do not use in case of hypersensitivity to the active substance or to any of the excipients. Do not use in dogs less than 6 weeks of age. See section 4.7. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity. This product for dogs should not be used in cats as it is not suitable for use in this species. In cats, Meloxoral 0.5 mg/ml oral suspension for cats should be used. 3 Special precautions to be taken by the person administering the veterinary medicinal product to animals People with known hypersensitivity to non-steroidal anti-inflammatory drugs (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 reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been reported. In very rare cases haemorrhagic diarrhoea, haematemesis, gastrointestinal ulceration and elevated liver enzymes have Olvassa el a teljes dokumentumot