PHENYLARTHRITE SOLUTION FOR INJECTION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
28-10-2015
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Active ingredient:
PHENYLBUTAZONE
Available from:
Vetoquinol Ireland Limited
ATC code:
QM01AA01
INN (International Name):
PHENYLBUTAZONE
Dosage:
20 %w/v
Pharmaceutical form:
Solution for Injection
Prescription type:
POM
Therapeutic group:
Canine, Equine Non Food
Therapeutic area:
Phenylbutazone
Therapeutic indications:
N.S.A.I.D
Authorization status:
Authorised
Authorization date:
1989-10-01
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Phenylarthrite solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Solution for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs
Horses declared as not being intended for slaughter for human consumption.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of arthritis, tendinitis, muscular and articular rheumatisms, congestive processes, hyperthermia,
heatstroke, inflammatory complications of various traumatic or bacterial infections. (With approved antibiotic if
necessary).
4.3 CONTRAINDICATIONS
Do not use in treatment of animals suffering from cardiac, hepatic and renal deficiencies.
Do not use in cats.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not administer other non-steroidal anti-inflammatory drugs concurrently or within 24 hours of each other.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The intravenous injections should be done slowly. In case of intravenous injection, avoid mixing blood and product in
the syringe.
Intramuscular injections should be done deeply in the muscular tissues.
In all cases the injections should be performed under rigorous asepsis
Active substance
Phenylbutazone 20 % w/v
Excipient
Benzyl Alcohol
1 % w/v
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 13/10/2015_
_CRN 7022044_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Use in very young or old animals may involve additional risk. If such use cannot be avoided, animals require careful
clinical management.
Avoid use in any dehydrated, hypovolaemic or hypotensive animals as the
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