Nazione: Austria
Lingua: inglese
Fonte: HMA (Heads of Medicines Agencies)
flunixin meglumine 5 % w/v
Laboratorios Calier
QM01AG90
Solution for injection
flunixin
Cattle Food, Horses Food, Pigs Food
2012-09-02
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT : NIGLUMINE 50mg/ml solution for injection for cattle, horses and pigs Flunixin meglumine 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains Active substance Flunixin (meglumine)................................................................50.0 mg (Equivalent to 82.9 mg flunixin meglumine) Excipients Phenol. ..........................................................................................5 mg Other excipients ....................................................................... q.s. 1ml For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM: Solution for injection Colourless to slightly yellowish clear solution 4. CLINICAL PARTICULARS 4.1. TARGET SPECIES: Cattle, horses and pigs. 4.2. INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES CATTLE: For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs. HORSES: For the alleviation of inflammation and pain associated with musculoskeletal disorders, especially in acute to sub-acute stages and to relieve visceral pain associated with colic. PIGS: For alleviation of Mastitis-Metritis-Agalactia Syndrome (MMA) with appropriate antibiotic treatment to reduce clinical signs. 4.3. CONTRAINDICATIONS: Do not use in animals suffering from chronic musculoskeletal disorders. Do not use in animals suffering from hepatic, renal, or cardiac disease. Do not use in animals with lesions of the gastrointestinal tract (for example gastro- intestinal ulceration or bleeding). Do not use when there is evidence of blood dyscrasia. Do not use in anima Leggi il documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT : NIGLUMINE 50mg/ml solution for injection for cattle, horses and pigs Flunixin meglumine 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains Active substance Flunixin (meglumine)................................................................50.0 mg (Equivalent to 82.9 mg flunixin meglumine) Excipients Phenol. ..........................................................................................5 mg Other excipients ....................................................................... q.s. 1ml For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM: Solution for injection Colourless to slightly yellowish clear solution 4. CLINICAL PARTICULARS 4.1. TARGET SPECIES: Cattle, horses and pigs. 4.2. INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES CATTLE: For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs. HORSES: For the alleviation of inflammation and pain associated with musculoskeletal disorders, especially in acute to sub-acute stages and to relieve visceral pain associated with colic. PIGS: For alleviation of Mastitis-Metritis-Agalactia Syndrome (MMA) with appropriate antibiotic treatment to reduce clinical signs. 4.3. CONTRAINDICATIONS: Do not use in animals suffering from chronic musculoskeletal disorders. Do not use in animals suffering from hepatic, renal, or cardiac disease. Do not use in animals with lesions of the gastrointestinal tract (for example gastro- intestinal ulceration or bleeding). Do not use when there is evidence of blood dyscrasia. Do not use in anima Leggi il documento completo