EQUIPALAZONE 1 G ORAL POWDER

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PHENYLBUTAZONE

Available from:

Dechra Limited

ATC code:

QM01AA01

INN (International Name):

PHENYLBUTAZONE

Dosage:

1.0 Grams

Pharmaceutical form:

Oral Powder

Prescription type:

POM

Therapeutic group:

Equine Non Food

Therapeutic area:

Phenylbutazone

Therapeutic indications:

N.S.A.I.D

Authorization status:

Authorised

Authorization date:

2001-10-01

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Equipalazone 1 g Oral Powder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substance
per sachet
Phenylbutazone
62.97 %w/w
Excipients
For a 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.
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.
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
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.
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