Equipalazone 200 mg/ml Solution for Injection

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:

200 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

phenylbutazone

Authorization status:

Authorised

Authorization date:

2005-10-01

Summary of Product characteristics

Health Products Regulatory Authority
07 January 2019
CRN008S6R
Page 1 of 6
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.
Health Products Regulatory Authority
07 January 2019
CRN008S6R
Page 2 of 6
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.
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 hypotensiv