Equipalazone 200 mg/ml Solution for Injection

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: VMD (Veterinary Medicines Directorate)

Δραστική ουσία:

Phenylbutazone

Διαθέσιμο από:

Dechra Limited

Φαρμακολογική κατηγορία (ATC):

QM01AA01

INN (Διεθνής Όνομα):

Phenylbutazone

Φαρμακοτεχνική μορφή:

Solution for injection

Τρόπος διάθεσης:

POM-V - Prescription Only Medicine – Veterinarian

Θεραπευτική ομάδα:

Horses

Θεραπευτική περιοχή:

Anti Inflammatory NSAID

Καθεστώς αδειοδότησης:

Authorized

Ημερομηνία της άδειας:

1994-08-26

Αρχείο Π.Χ.Π.

Amended pages: December 2022
AN: 01547/2022
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF VETERINARY MEDICINAL PRODUCT
Equipalazone 200 mg/ml Solution for Injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance
Phenylbutazone
200 mg/ml
Excipients
Benzyl Alcohol
0.015 ml
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless to pale yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses and ponies.
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
against inflammation, pain and lameness (for example, osteoarthritis,
acute
and chronic laminitis, bursitis and carpitis).
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 agents
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;
where there is
evidence of a blood dyscrasia or of hypersensitivity to the product.
Amended pages: December 2022
AN: 01547/2022
Page 2 of 5
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.