Equipalazone 1 g Oral Powder

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Phenylbutazone

Available from:

Dechra Regulatory B.V.

ATC code:

QM01AA01

INN (International Name):

Phenylbutazone

Dosage:

1.0 gram(s)

Pharmaceutical form:

Oral powder

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

phenylbutazone

Authorization status:

Authorised

Authorization date:

2001-10-01

Summary of Product characteristics

Health Products Regulatory Authority
06 March 2020
CRN009GKN
Page 1 of 4
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
​
1 g
​
EXCIPIENT(S)
​
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 (non-food producing).
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 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 gastro-intestinal
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.
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
(I) 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 hy