Equipalazone 1 g Oral Paste

Land: Verenigd Koninkrijk

Taal: Engels

Bron: VMD (Veterinary Medicines Directorate)

Werkstoffen:

Phenylbutazone

Beschikbaar vanaf:

Dechra Limited

ATC-code:

QM01AA01

INN (Algemene Internationale Benaming):

Phenylbutazone

farmaceutische vorm:

Oral paste

Prescription-type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutische categorie:

Horses

Therapeutisch gebied:

Anti Inflammatory NSAID

Autorisatie-status:

Authorized

Autorisatie datum:

1994-08-26

Productkenmerken

Revised: July 2022
AN: 00744/2022
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF 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 contraindicated in animals suffering from cardiac, hepatic or
renal
disease, where there is the possibility of gastrointestinal ulceration
or
Revised: July 2022
AN: 00744/2022
Page 2 of 7
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
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 hypotensive animal
as there is a risk of increased toxicity