EQUIPALAZONE 200 MG/ML SOLUTION FOR INJECTION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
20-08-2016
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Active ingredient:
PHENYLBUTAZONE
Available from:
Dechra Limited
ATC code:
QM01AA01
INN (International Name):
PHENYLBUTAZONE
Dosage:
200 Mg/Ml
Pharmaceutical form:
Solution for Injection
Prescription type:
POM
Therapeutic group:
Equine Non Food
Therapeutic area:
Phenylbutazone
Therapeutic indications:
N.S.A.I.D
Authorization status:
Authorised
Authorization date:
2005-10-01
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Equipalazone 200 mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substances
Phenylbutazone
200
mg/ml
Excipients
Benzyl Alcohol
0.015 ml/ml
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless to pale yellow solution.
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 against inflammation, pain and lameness (for example, osteoarthritis
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 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.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 05/08/2016_
_CRN 7023797_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
(I) SPECIAL PRECAUTION
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