Country: Bretland
Tungumál: enska
Heimild: VMD (Veterinary Medicines Directorate)
Phenylbutazone
Dechra Limited
QM01AA01
Phenylbutazone
Oral powder
POM-V - Prescription Only Medicine – Veterinarian
Horses
Anti Inflammatory NSAID
Authorized
2017-06-15
Revised: October 2022 AN: 02070/2021 & 02071/2021 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Equipalazone 1 g Oral Powder for Horses and Ponies 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: per sachet Phenylbutazone 1 g EXCIPIENT(S) For the 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 (non-food producing). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of musculoskeletal 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 Do not administer with other non-steroidal anti-inflammatory drugs (NSAIDs) 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 gastrointestinal ulceration or bleeding or where there is evidence of a blood dyscrasia. Do not use in cases of known hypersensitivity to the active substance or to any of the excipients. Revised: October 2022 AN: 02070/2021 & 02071/2021 Page 2 of 6 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES 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 The therapeutic index of phenylbutazone is low. Do not exceed the stated dose or the duration of treatment. 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 man Lestu allt skjalið