Country: Ռումինիա
language: անգլերեն
source: HMA (Heads of Medicines Agencies)
phenylbutazone 200 mg/ml
Dopharma Research B. V.
QM01AA01
Oral powder
phenylbutazone
Horses
2012-11-21
Issued: February 2013 AN: 01533/2011 Page 1 of 5 _ _ SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Butagran Equi, 200 mg/g, oral powder for horses. Butagran Equi, 200 mg/g (DK) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per g: _ACTIVE SUBSTANCE: _ Phenylbutazone 200 mg _Excipients: _ For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral powder. White powder. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES The product is indicated for the treatment of musculo-skeletal conditions 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. The product can be used as an anti-pyretic where this is considered advisable e.g. in viral respiratory infections. 4.3 CONTRAINDICATIONS Do not use in animals with known hypersensitivity to the active ingredient. Use is contraindicated in animals suffering from cardiac, hepatic or renal disease, where there is the possibility of gastrointestinal ulceration or bleeding or where there is evidence of a blood dyscrasia. 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. Issued: February 2013 AN: 01533/2011 Page 2 of 5 _ _ FEI regards phenylbutazone as read_full_document