Equipalazone 1 g Oral Powder for Horses and Ponies

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Phenylbutazone

Available from:

Dechra Limited

ATC code:

QM01AA01

INN (International Name):

Phenylbutazone

Pharmaceutical form:

Oral powder

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Horses

Therapeutic area:

Anti Inflammatory NSAID

Authorization status:

Authorized

Authorization date:

2017-06-15

Summary of Product characteristics

Revised: October 2022
AN: 02070/2021 & 02071/2021
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Equipalazone 1 g Oral Powder for Horses and Ponies
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
per sachet
Phenylbutazone
1 g
EXCIPIENT(S)
For the 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 musculoskeletal 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
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 gastrointestinal 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.
Revised: October 2022
AN: 02070/2021 & 02071/2021
Page 2 of 6
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
Special precautions for use in animals
The therapeutic index of phenylbutazone is low. Do not exceed the
stated
dose or the duration of treatment.
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 man