Kelaprofen 100 mg/ml, solution for injection for cattle, horses and pigs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ketoprofen

Available from:

Kela n.v.

ATC code:

QM01AE03

INN (International Name):

Ketoprofen

Dosage:

100 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle, Horses, Pigs

Therapeutic area:

ketoprofen

Therapeutic indications:

N.S.A.I.D.

Authorization status:

Authorised

Authorization date:

2012-02-24

Summary of Product characteristics

Health Products Regulatory Authority
24 June 2021
CRN00C11H
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Kelaprofen 100 mg/ml, solution for injection for cattle, horses and
pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Ketoprofen 100 mg
EXCIPIENTS:
Benzyl alcohol (E1519) 10 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
Clear, colourless or yellowish solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses, cattle, pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Horse
-the alleviation of inflammation and pain associated with
musculoskeletal disorders;
-the alleviation of visceral pain associated with colic.
Cattle
-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
Pigs
-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.
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active
substances or to any of the excipients.
Do not administer other non-steroidal anti-inflammatory drugs (NSAIDs)
concurrently or within 24 hours of each other,
corticosteroids, diuretics and anticoagulants.
Health Products Regulatory Authority
24 June 2021
CRN00C11H
Page 2 of 5
Do not use in animals suffering from cardiac, hepatic or renal
disease, where there is the possibility of gastro-int