Ketofen 10% Solution for Injection

Pays: Royaume-Uni

Langue: anglais

Source: VMD (Veterinary Medicines Directorate)

Ingrédients actifs:

Ketoprofen

Disponible depuis:

Ceva Animal Health Ltd

Code ATC:

QM01AE03

DCI (Dénomination commune internationale):

Ketoprofen

forme pharmaceutique:

Solution for injection

Type d'ordonnance:

POM-V - Prescription Only Medicine – Veterinarian

Groupe thérapeutique:

Cattle, Horses, Pigs

Domaine thérapeutique:

Anti Inflammatory NSAID

Statut de autorisation:

Authorized

Date de l'autorisation:

1992-02-12

Résumé des caractéristiques du produit

Revised October 2022
AN: 01666/2022
Page 1 of 6
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 the 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;
Revised October 2022
AN: 01666/2022
Page 2 of 6
-
the supportive treatment of Mastitis Metritis Agalactia Syndrome in
sows, in conjunction with antimicrobial therapy as appropriate.
4.3.
CONTRA-INDICATIONS
Do not administer to horses, cattle or pigs 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