Butagran Equi 200 mg/g Oral Powder for Horses

Land: Storbritannia

Språk: engelsk

Kilde: VMD (Veterinary Medicines Directorate)

Aktiv ingrediens:

Phenylbutazone

Tilgjengelig fra:

Dopharma Research B.V.

ATC-kode:

QM01AA01

INN (International Name):

Phenylbutazone

Legemiddelform:

Oral powder

Resept typen:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutisk gruppe:

Horses

Terapeutisk område:

Anti Inflammatory NSAID

Autorisasjon status:

Authorized

Autorisasjon dato:

2013-02-08

Preparatomtale

Revised: January 2018
AN: 00340/2017
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Butagran Equi, 200 mg/g, oral powder for horses.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per g:
ACTIVE SUBSTANCE:
Phenylbutazone
200 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral powder.
White powder.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The product is indicated for the treatment of musculo-skeletal
conditions
where relief from pain and a reduction in the associated inflammation
is
required e.g. in lameness associated with osteoarthritic conditions,
bursitis,
laminitis and soft tissue inflammation, particularly where continued
mobility
is considered desirable.
It is also of value in limiting post-surgical inflammation, myositis
and other
soft tissue inflammation.
The product can be used as an anti-pyretic where this is considered
advisable e.g. in viral respiratory infections.
4.3
CONTRAINDICATIONS
Do not use in known cases of hypersensitivity to the active substance,
or to
any of the excipients.
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.
Revised: January 2018
AN: 00340/2017
Page 2 of 6
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The clinical effects of phenylbutazone can be evident for at least
three days
following cessation of therapy. This should be borne in mind when
examining horses for soundness.
4.5
SPECIAL PRECAUTIONS FOR USE
I. SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Do not exceed the stated dose as the therapeutic index of
phenylbutazone
is low.
Use in any animal less than 6 weeks of age or in aged animals may
involve
additional risk. If such use cannot be avoided, animals may require
careful
clinical management.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal as
there
is a potential risk of increased renal