Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
PHENYLBUTAZONE
Dechra Limited
QM01AA01
PHENYLBUTAZONE
1.0 Grams
Oral Powder
POM
Equine Non Food
Phenylbutazone
N.S.A.I.D
Authorised
2001-10-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Equipalazone 1 g Oral Powder 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Substance per sachet Phenylbutazone 62.97 %w/w Excipients For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Oral powder. White/cream powder. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses and ponies. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of musculo-skeletal disorders in horses and ponies where the anti-inflammatory and analgesic properties of phenylbutazone can offer relief. Examples of conditions normally considered suitable for treatment with phenylbutazone include lameness associated with osteoarthritic conditions, acute and chronic laminitis, bursitis and carpitis, and in the reduction of post-surgical soft tissue reaction. 4.3 CONTRAINDICATIONS The therapeutic index of phenylbutazone is low. Do not exceed the stated dose or the duration of treatment. Do not administer with other non-steroidal anti-inflammatory agents concurrently or within 24 hours of each other. Do not use in animals suffering from cardiac, hepatic or renal disease; where there is the possibility of gastro-intestinal ulceration or bleeding; where there is evidence of a blood dyscrasia or of hypersensitivity to the product. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Discontinue treatment if no response is evident after four to five days treatment. The clinical effect of phenylbutazone can be evident for at least three days following cessation of administration. This should be borne in mind when examining horses for soundness. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Lue koko asiakirja