Kelaprofen 100 mg/ml Solution for Injection for Cattle, Horses and Pigs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Ketoprofen

Available from:

Kela – Kempisch Laboratorium – Kela Laboratoria NV

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:

2012-02-27

Summary of Product characteristics

Revised: October 2022
AN: 01658/2022
Page 1 of 6
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.
Revised: October 2022
AN: 01658/2022
Page 2 of 6
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.
Do not use in animals suffering from cardiac, hepatic or renal
disease, where there is
the possibility of gastro-intestinal ulceration or bleeding, or