Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
meloxicam
Chanelle Pharmaceuticals Manufacturing Ltd
QM01AC06
meloxicam
Horses; Dogs; Cats; Cattle; Pigs
Anti-inflammatory and anti-rheumatic products, non-steroids
Dogs: alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.To reduce post-operative pain and inflammation following orthopaedic and soft tissue surgery.Cats: to reduce post-operative pain after ovariohysterectomy and minor soft tissue surgery.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 acute and chronic musculo-skeletal disorders in cats.Cattle: for use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs.For use in diarrhoea in combination with oral re‑hydration 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.For the relief of post-operative pain following dehorning in calves.Pigs: for 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.For the relief of post operative pain associated with minor soft tissue such as castration.Horses: alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders.For the relief of pain associated with equine colic.
Revision: 12
Authorised
2011-12-09
81 B. PACKAGE LEAFLET 82 PACKAGE LEAFLET: INFLACAM 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 and manufacturer responsible for batch release: Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, Co. Galway, Ireland. 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Inflacam 1.5 mg/ml oral suspension for dogs Meloxicam 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) One ml contains: 1.5 mg of meloxicam, 5 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 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, lethargy and renal failure have occasionally been reported. In very rare cases haemorrhagic diarrhoea, haematemesis, gastrointestinal ulceration and elevated liver enzymes have 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. 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 reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animal Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Inflacam 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 5 mg. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Oral suspension. A yellow coloured 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 case 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 renal toxicity. This product for dogs should not be used in cats as it is not suitable for use in this species. In cats, Inflacam 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, lethargy and renal failure have occasionally been reported. In very rare cases haemorrhagic diarrhoea, haematemesis, gastrointestinal ulceration and elevated liv Przeczytaj cały dokument