KETOFEN 10% SOLUTION FOR INJECTION

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

KETOPROFEN

Available from:

Merial Animal Health Limited

ATC code:

QM01AE03

INN (International Name):

KETOPROFEN

Dosage:

10 %w/v

Pharmaceutical form:

Solution for Injection

Prescription type:

POM

Therapeutic group:

Bovine, Equine

Therapeutic area:

Ketoprofen

Therapeutic indications:

N.S.A.I.D

Authorization status:

Authorised

Authorization date:

1996-03-15

Summary of Product characteristics

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Ketofen 10 % Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses, cattle
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In the horse, Ketofen 10% is indicated for:
- the alleviation of inflammation and pain associated with
musculoskeletal disorders.
- the alleviation of visceral pain associated with colic.
In cattle, Ketofen 10% is indicated for:
- the supportive treatment of parturient paresis associated with
calving;
- reducing the pyrexia and distress associated with bacterial
respiratory disease when used in connection with anti
microbial therapy as appropriate;
- reducing the clinical signs of mastitis associated with acute
endotoxin mastitis;
- improving the recovery rate in acute clinical mastitis,
caused by gram negative micro-organisms,
in conjunction with
antimicrobial therapy;
- reducing oedema of the udder associated with calving.
4.3 CONTRAINDICATIONS
Do not administer to horses or cattle that have previously shown a
hypersensitivity to ketoprofen.
Do not administer other non-steroidal anti-inflammatory drugs (NSAIDs)
concurrently or within 24 hours of each
other.
Use is contraindicated 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 hypersensitivity to the product.
Active ingredient:
Ketoprofen
100 mg/ml
Preservative:
Benzyl alcohol
10
mg/ml
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