Phenylarthrite solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Phenylbutazone

Available from:

Vetoquinol Ireland Limited

ATC code:

QM01AA01

INN (International Name):

Phenylbutazone

Dosage:

20 percent weight/volume

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Dogs, Horses, Non food-producing horses

Therapeutic area:

phenylbutazone

Therapeutic indications:

N.S.A.I.D.

Authorization status:

Authorised

Authorization date:

1989-10-01

Summary of Product characteristics

Health Products Regulatory Authority
28 August 2019
CRN00987J
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Phenylarthrite solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE
Phenylbutazone
20 % w/v
EXCIPIENT
Benzyl Alcohol
1 % w/v
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
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
there is a potential risk of increased renal toxicity.
Response to long term therapy should be monitored at regular intervals
by a veterinary surgeon.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
None.
Health Products Regulatory Authority
28 August 2019
CRN00987J
Page 2 of 3
4.6 ADVERSE