Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Flunixin
Bimeda Animal Health Limited
QM01AG90
Flunixin
50 milligram(s)/gram
Oral paste
POM: Prescription Only Medicine as defined in relevant national legislation
flunixin
Authorised
2018-11-16
1 _[Version 9,03/2022] corr. 11/2022_ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Cronyxin 50 mg/g Oral paste for horses (DE, AT, BE, EE, ES, FR, IE, IT, NL, PL, UK(NI)) Cronyxin vet 50 mg/g Oral paste for horses (SE) Cronyxin vet (DK) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g of paste contains: ACTIVE SUBSTANCE: Flunixin 50 mg (as Flunixin meglumine 83 mg) EXCIPIENTS: QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS Silica, colloidal anhydrous Propylene glycol Titanium dioxide (E171) Xanthan gum Aluminium magnesium silicate Sorbitol, liquid (crystallising) Apple flavour FL02791 Purified water White to off-white paste 3. CLINICAL INFORMATION 3.1 TARGET SPECIES Horses 3.2 INDICATIONS FOR USE FOR EACH TARGET SPECIES Treatment of acute inflammatory musculoskeletal disorders in horses. 3.3 CONTRAINDICATIONS Do not exceed the stated dose or duration of treatment. Do not administer other NSAIDs or glucocorticosteroids concurrently or within 24 hours of each other. Do not use in animals suffering from cardiac, hepatic or renal disease. Do not use in animals suspected of having gastrointestinal ulceration or bleeding. Do not use in case of hypersensitivity to the active substance or to any of the excipients. Do not use in dehydrated or hypovolaemic animals, except in the case of endotoxaemia or septic shock, as there is a potential risk of increased renal toxicity. Do not use in animals suffering from chronic musculoskeletal disorders. See also section 3.7. 3 3.4 SPECIAL WARNINGS Use of the veterinary medicinal product may lead to temporary relief due to its ameliorating effects on inflammatory signs. This may appear as effective treatment of the underlying disease. The cause of the underlying inflammatory condition should be determined and treated with appropriate concomitant therapy. 3.5 SPECIAL PRECAUTIONS FOR USE Special precautions for safe use in the target species Animals should be rested and a sufficient supply of drinking water has to be ensured duri Læs hele dokumentet