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

Land: Storbritannien

Sprog: engelsk

Kilde: VMD (Veterinary Medicines Directorate)

Aktiv bestanddel:

Ketoprofen

Tilgængelig fra:

Kela – Kempisch Laboratorium – Kela Laboratoria NV

ATC-kode:

QM01AE03

INN (International Name):

Ketoprofen

Lægemiddelform:

Solution for injection

Recept type:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutisk gruppe:

Cattle, Horses, Pigs

Terapeutisk område:

Anti Inflammatory NSAID

Autorisation status:

Authorized

Autorisation dato:

2012-02-27

Produktets egenskaber

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