KELAPROFEN 100 MG/ML, SOLUTION FOR INJECTION FOR CATTLE, HORSES AND PIGS

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

KETOPROFEN

Tilgjengelig fra:

Kela n.v.

ATC-kode:

QM01AE03

INN (International Name):

KETOPROFEN

Dosering :

100 Mg/Ml

Legemiddelform:

Solution for Injection

Resept typen:

POM

Terapeutisk gruppe:

Bovine, Equine - Food, Porcine

Terapeutisk område:

Ketoprofen

Indikasjoner:

N.S.A.I.D

Autorisasjon status:

Authorised

Autorisasjon dato:

2012-02-24

Preparatomtale

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
Per ml
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.
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.
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