Country: European Union
Language: English
Source: EMA (European Medicines Agency)
meloxicam
Bimeda Animal Health Limited
QM01AC06
meloxicam
Horses; Pigs; Cattle
Oxicams
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: 5
Authorised
2011-09-13
17 B. PACKAGE LEAFLET 18 PACKAGE LEAFLET RECOCAM 20 MG/ML SOLUTION FOR INJECTION FOR CATTLE, PIGS AND HORSES 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: Bimeda Animal Health Limited, 2, 3 & 4 Airton Close, Tallaght, Dublin 24, Ireland. 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Recocam 20 mg/ml solution for injection for cattle, pigs and horses Meloxicam 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) One ml contains: ACTIVE SUBSTANCE: Meloxicam 20 mg EXCIPIENT: Ethanol 99.9% 150 mg Clear, yellow solution 4. INDICATION(S) Cattle For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle. 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. 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. Horses For use in the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders. For the relief of pain associated with equine colic. 5. CONTRAINDICATIONS Do not use in horses less than 6 weeks of age. Do not use in pregnant or lactating mares. Do not use in horses producing milk for human consumption. 19 Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastrointestinal lesions. Do not use in case of hypersensitivity to the active substance or to any of the excipients. For the treatment of diarrhoea in cattle, do not use in animals of l Read the complete document
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Recocam 20 mg/ml solution for injection for cattle, pigs and horses 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains: ACTIVE SUBSTANCE: Meloxicam 20 mg EXCIPIENT: Ethanol 150 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear yellow solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, pigs and horses. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Cattle For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle. 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. 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. Horses For use in the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders. For the relief of pain associated with equine colic. 4.3 CONTRAINDICATIONS See also section 4.7. 3 Do not use in horses less than 6 weeks of age. Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastrointestinal lesions. Do not use in cases of hypersensitivity to the active substance or to any of the excipient(s). For the treatment of diarrhoea in cattle, do not use in animals of less than one week 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 very severe Read the complete document