EQUIPALAZONE 1 G ORAL PASTE
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:
1.0 Grams
Pharmaceutical form:
Oral Paste
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 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
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_Date Printed 05/08/2016_
_CRN 7023797_
_page number: 1_
4.5 SPECIAL PRECAU
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