Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
PHENYLBUTAZONE
Dechra Limited
QM01AA01
PHENYLBUTAZONE
1.0 Grams
Oral Paste
POM
Equine Non Food
Phenylbutazone
N.S.A.I.D
Authorised
2005-10-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Equipalazone 1 g Oral Paste 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Oral paste. Off white paste prefilled into 32 ml syringes 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses and ponies 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Indicated in the treatment of musculoskeletal disorders in horses and ponies where the anti-inflammatory and analgesic properties of phenylbutazone can offer relief, for example, in lameness associated with osteoarthritic conditions, acute and chronic laminitis, bursitis and carpitis. 4.3 CONTRAINDICATIONS The therapeutic index of phenylbutazone is low. Do not exceed the stated dose or duration of treatment. Use is contra-indicated in animals suffering from cardiac, hepatic or renal disease, where there is the possibility of gastro-intestinal ulceration or bleeding, and where there is evidence of a blood dyscrasia or hypersensitivity to the product. Do not administer other NSAIDs concurrently or within 24 hours of each other. 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. ACTIVE SUBSTANCE: Per unit dose % w/w Phenylbutazone 1.00 g 16.66 EXCIPIENTS: Sodium Methyl Parahydroxybenzoate 0.006 g 0.10 Sodium Propyl Parahydroxybenzoate 0.0015 g 0.025 HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 05/08/2016_ _CRN 7023797_ _page number: 1_ 4.5 SPECIAL PRECAU Pročitajte cijeli dokument