Equipalazone 1 g Oral Powder

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Phenylbutazone

MAH:

Dechra Ltd

ATC_code:

QM01AA01

INN:

Phenylbutazone

dosage:

1.0 gram(s)

pharmaceutical_form:

Oral powder

prescription_type:

POM: Prescription Only Medicine as defined in relevant national legislation

therapeutic_group:

Non food-producing horses

therapeutic_area:

phenylbutazone

therapeutic_indication:

N.S.A.I.D.

authorization_status:

Authorised

authorization_date:

2001-10-01

SPC

Health Products Regulatory Authority
29 September 2017
CRN000VSY
Page 1 of 6
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.
Health Products Regulatory Authority
29 September 2017
CRN000VSY
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
(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.
A