Equipalazone 200 mg/ml Solution for Injection

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Phenylbutazone

Διαθέσιμο από:

Dechra Ltd

Φαρμακολογική κατηγορία (ATC):

QM01AA01

INN (Διεθνής Όνομα):

Phenylbutazone

Δοσολογία:

200 milligram(s)/millilitre

Φαρμακοτεχνική μορφή:

Solution for injection

Τρόπος διάθεσης:

POM: Prescription Only Medicine as defined in relevant national legislation

Θεραπευτική ομάδα:

Horses, Non food-producing horses

Θεραπευτική περιοχή:

phenylbutazone

Θεραπευτικές ενδείξεις:

N.S.A.I.D.

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2005-10-01

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Equipalazone 200 mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substances
Phenylbutazone
200
mg/ml
Excipients
Benzyl Alcohol
0.015
ml/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 musculo-skeletal 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
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 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 gastro-intestinal
ulceration or bleeding; where there is evidence of a blood dyscrasia
or of hypersensitivity to the product.
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.
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