Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
meloxicam
Norbrook Laboratories (Ireland) Limited
QM01AC06
meloxicam
Dogs; Cats; Cattle; Pigs
Anti-inflammatory and anti-rheumatic products, non-steroids
DogsAlleviation of inflammation and pain in both acute and chronic musculoskeletal disorders. To reduce postoperative pain and inflammation following orthopaedic and soft-tissue surgery.CatsAlleviation of inflammation and pain in chronic musculoskeletal disorders in cats. To reduce postoperative 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 noninfectious 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: 17
Authorised
2009-02-10
80 B. PACKAGE LEAFLET 81 PACKAGE LEAFLET: LOXICOM 0.5 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 Norbrook Laboratories (Ireland) Limited Rossmore Industrial Estate Monaghan Ireland Manufacturer responsible for batch release Norbrook Manufacturing Limited Rossmore Industrial Estate Monaghan Town Co. Monaghan H18 W620 Ireland Norbrook Laboratories Limited 105 Armagh Road Newry Co. Down, BT35 6PU United Kingdom 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Loxicom 0.5 mg/ml oral suspension for dogs meloxicam 3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS Each ml contains: Meloxicam 0.5 mg Sodium benzoate 1.5 mg 4. INDICATION(S) Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders. 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. 82 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 (less than 1 animal in 10,000 animals treated, including isolated reports), 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. If you notice any side e Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Loxicom 0.5 mg/ml oral suspension for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Meloxicam 0.5 mg EXCIPIENTS: Sodium benzoate 1.5 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral suspension. 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 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 If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought. Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity. 3 This product for dogs should not be used in cats due to the different dosing devices. In cats, Loxicom 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 Прочетете целия документ