দেশ: যুক্তরাজ্য
ভাষা: ইংরেজি
সূত্র: VMD (Veterinary Medicines Directorate)
Phenylbutazone
Ecuphar NV
QM01AA01
Phenylbutazone
Oral powder
POM-V - Prescription Only Medicine – Veterinarian
Horses
Anti Inflammatory NSAID
Authorized
2019-04-16
Revised: August 2022 AN: 01024/2022 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Butazocare flavour 1g granules in sachet for horses and ponies 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: per sachet Phenylbutazone (microencapsulated) 1g For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM White to off-white granules in sachet for oral administration. 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 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 animals suffering from gastrointestinal diseases. Do not use in animals with haemorrhagic diathesis. Do not use in cases of known hypersensitivity to the active substance or to any of the excipients. 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. Revised: August 2022 AN: 01024/2022 Page 2 of 5 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 সম্পূর্ণ নথি পড়ুন