Land: Storbritannien
Språk: engelska
Källa: VMD (Veterinary Medicines Directorate)
Phenylbutazone
Chanelle Pharmaceuticals Manufacturing Ltd
QM01AAO1
Phenylbutazone
Oral powder
POM-V - Prescription Only Medicine – Veterinarian
Horses
Anti Inflammatory NSAID
Authorized
2016-03-15
Revised: February 2021 AN: 00673/2020 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Chanazone 1 g, oral powder for horses. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet of 5 g contains: ACTIVE SUBSTANCE: Phenylbutazone 1 g. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral powder An off white to yellowish coloured granular powder 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses (non-food producing horses). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES The product is indicated for the treatment of musculoskeletal conditions in the horse where relief from pain and a reduction in the associated inflammation is required, e.g. in lameness associated with osteoarthritic conditions, bursitis, laminitis and soft tissue inflammation, particularly where continued mobility is considered desirable. It is also of value in limiting post surgical inflammation, myositis and other soft tissue inflammation. Phenylbutazone powder can be used as an anti-pyretic where this is considered advisable e.g. in viral respiratory infections. 4.3 CONTRAINDICATIONS Revised: February 2021 AN: 00673/2020 Page 2 of 7 Do not use in cases of known hypersensitivity to the active substance or to any of the excipients Do not use in animals suffering from cardiac, hepatic or renal disease, where there is the possibility of gastro-intestinal ulceration or bleeding or where there is evidence of a blood dyscrasia. Do not use in animals suffering from thyroid disease. Do not use in animals with severe hypertonia. Do not use in animals with lesions in the intestinal mucosa, caused by parasitic infestations. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The clinical effects of phenylbutazone can be evident for at least three days following cessation of therapy. This should be borne in mind when examining horses for soundness. The International Federation for Equestrian Sports (FEI) regards phenylbutazone as prohibited substance in the context of a participation of the Läs hela dokumentet