Ketofen 10% Solution for Injection

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Ketoprofen

Available from:

Merial Animal Health Limited

ATC code:

QM01AE03

INN (International Name):

Ketoprofen

Pharmaceutical form:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle, Horses, Pigs

Therapeutic area:

Anti Inflammatory NSAID

Authorization status:

Authorized

Authorization date:

1992-02-12

Summary of Product characteristics

Revised: July 2014
AN: 01491/2013
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Ketofen 10% solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENT: Ketoprofen 100mg/ml
PRESERVATIVE: Benzyl alcohol 10mg/ml
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
4.
CLINICAL PARTICULARS
4.1. TARGET SPECIES
Horses, cattle, pigs.
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   conjunction   with   antimicrobial   therapy   as
appropriate;
-
improving   the   recovery   rate   in   acute   clinical   mastitis,   including   acute
endotoxin   mastitis,   caused   by   gram   negative   micro-organisms,   in
conjunction with antimicrobial therapy;
-
reducing oedema of the udder associated with calving;
-
reducing pain associated with lameness.
In pigs, Ketofen 10% is indicated for:
-
reducing the pyrexia and respiratory rate associated with bacterial or viral
respiratory disease when used in conjunction with antimicrobial therapy as
appropriate;
-
the supportive treatment of Mastitis Metritis Agalactia Syndrome in sows,
in conjunction with antimicrobial therapy as appropriate.
Page 1 of 5
Revised: July 2014
AN: 01491/2013
4.3. CONTRA-INDICATIONS
Do   not   administer   to   horses,   cattle   or   pigs   that �