Ketofen 10 % Solution for Injection

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Ketoprofen

Disponible depuis:

Ceva Santé Animale

Code ATC:

QM01AE03

DCI (Dénomination commune internationale):

Ketoprofen

Dosage:

10 percent weight/volume

forme pharmaceutique:

Solution for injection

Type d'ordonnance:

POM: Prescription Only Medicine as defined in relevant national legislation

Groupe thérapeutique:

Cattle, Horses

Domaine thérapeutique:

ketoprofen

indications thérapeutiques:

N.S.A.I.D.

Statut de autorisation:

Authorised

Date de l'autorisation:

1996-03-15

Résumé des caractéristiques du produit

Health Products Regulatory Authority
28 May 2019
CRN008Q4Q
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Ketofen 10 % Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient:
Ketoprofen 100 mg/ml
Preservative:
Benzyl alcohol 10 mg/ml
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.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Use in any animals less than 6 weeks of age or in aged animals may
involve additional risk.If such use cannot be avoided
animals may require a reduced dosage and careful management.
Avoid use in any dehydrated, hypovolaemic or hypotensive animals as
there is a potential risk o