Equipalazone 1 g Oral Paste

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 paste

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

_[Version 8, 10/2012] _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Equipalazone 1 g oral paste
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Per unit dose
Phenylbutazone
1.00 g
EXCIPIENTS:
Sodium Methyl Parahydroxybenzoate
0.006 g
Sodium Propyl Parahydroxybenzoate
0.0015 g
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral paste.
Off white paste prefilled into 32 ml syringes.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses and ponies.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Indicated in the treatment of musculoskeletal disorders in horses and
ponies where the anti-
inflammatory and analgesic properties of phenylbutazone can offer
relief, for example, in
lameness associated with osteoarthritic 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 duration of
treatment.
Use is contra-indicated in animals suffering from cardiac, hepatic or
renal disease, where
there is the possibility of gastro-intestinal ulceration or bleeding,
and where there is evidence
of a blood dyscrasia or hypersensitivity to the product.
Do not administer other NSAIDs concurrently or within 24 hours of each
other.
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
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 hypotensive animal as
there is a risk of
increased toxicity.
It is preferable that NSAIDs which inhibit prostagla