Country: European Union
Language: English
Source: EMA (European Medicines Agency)
meloxicam
CP-Pharma Handelsgesellschaft mbH
QM01AC06
meloxicam
Dogs; Cats; Guinea pigs
Musculo-skeletal system
Dogs:Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.Cats:Alleviation of mild to moderate post-operative pain and inflammation following surgical procedures in cats, e.g. orthopaedic and soft tissue surgery.Alleviation of pain and inflammation in chronic musculo-skeletal disorders in cats.Guinea pigs:Alleviation of mild to moderate post-operative pain associated with soft tissue surgery such as male castration.
Revision: 7
Authorised
2011-02-21
25 B. PACKAGE LEAFLET 26 PACKAGE LEAFLET: MELOSUS 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: CP-Pharma Handelsgesellschaft mbH Ostlandring 13 D-31303 Burgdorf Germany Manufacturer responsible for batch release: Produlab Pharma B.V. Forellenweg 16 4941 SJ Raamsdonksveer The Netherlands 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Melosus 1.5 mg/ml oral suspension for dogs Meloxicam 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS ACTIVE SUBSTANCE: Meloxicam 1.5 mg/ml EXCIPIENTS: Sodium benzoate 1.75 mg/ml 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 dogs suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders. Do not use in cases 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 27 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. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less th Read the complete document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Melosus 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 pregnant or lactating animals. 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 cases of hypersensitivity to the active substance or to any of the excipients. 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 Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity. 3 This veterinary medicinal product for dogs should not be used in cats as it is not suitable for use in this species. In cats, Melosus 0.5 mg/ml oral suspension for cats should be used. 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 Read the complete document