Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Phenylbutazone
Dechra Regulatory B.V.
QM01AA01
Phenylbutazone
1.0 gram(s)
Oral paste
POM: Prescription Only Medicine as defined in relevant national legislation
phenylbutazone
Authorised
2005-10-01
_[Version 8, 10/2012] _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Equipalazone 1 g oral paste 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Per unit dose Phenylbutazone 1.00 g EXCIPIENTS: Sodium Methyl Parahydroxybenzoate 0.006 g Sodium Propyl Parahydroxybenzoate 0.0015 g 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. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Use in any animal under six weeks of age or in aged animals may involve additional risks. If such use cannot be avoided, animals may require a reduced dosage and special clinical management. Avoid use in any dehydrated, hypovolaemic or hypotensive animal as there is a risk of increased toxicity. It is preferable that NSAIDs which inhibit prostagla Les hele dokumentet