Equipalazone Original 1 g Oral Powder

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: VMD (Veterinary Medicines Directorate)

Aktiivinen ainesosa:

Phenylbutazone

Saatavilla:

Dechra Limited

ATC-koodi:

QM01AA01

INN (Kansainvälinen yleisnimi):

Phenylbutazone

Lääkemuoto:

Oral powder

Prescription tyyppi:

POM-V - Prescription Only Medicine – Veterinarian

Terapeuttinen ryhmä:

Horses

Terapeuttinen alue:

Anti Inflammatory NSAID

Valtuutuksen tilan:

Authorized

Valtuutus päivämäärä:

1994-08-26

Valmisteyhteenveto

Revised: February 2020
AN: 01429/2019
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Equipalazone Original 1 g oral powder
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
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 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: February 2020
AN: 01429/2019
Page 2 of 5
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
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