Flunixin Injection
Country: Austria
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
29-09-2012
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Active ingredient:
Flunixin meglumine 5 % w/v = 50 mg/
Available from:
Norbrook Laboratories Limited
ATC code:
QM01AX
Pharmaceutical form:
Solution for injection
Therapeutic group:
steroids
Therapeutic area:
Horses
Authorization date:
2009-11-18
Summary of Product characteristics
Revised: 16 July 2009
AN: 00229/2009
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Flunixin 50mg/ml Solution for Injection for Cattle, Horses and Pigs
Flunixin N-Vet for Cattle, Horses and Pigs (Sweden)
Paraflunixin RPS 50 mg/ml, Solution for Injection for Cattle, Horses and
Pigs (Germany)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ACTIVE SUBSTANCE _
Flunixin (as flunixin meglumine)
50 mg/ml
_EXCIPIENTS _
Phenol
5.0 mg/ml
Sodium Formaldehyde Sulphoxylate Dihydrate
2.5 mg/ml
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection.
A clear colourless solution
4.
CLINICAL PARTICULARS
4.1
_TARGET SPECIES_:
Cattle, Horses and Pigs
4.2
_INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES:_
In horses, indicated for the alleviation of inflammation and pain
associated with musculo-skeletal disorders and for the alleviation of
visceral pain associated with colic, also indicated for the treatment of
endotoxaemia or septic shock associated with gastric torsion and for
other conditions in which the circulation of the blood to the
gastrointestinal tract is compromised.
In cattle, indicated for the control of acute inflammation associated with
respiratory disease. It may also be used as adjunctive therapy in the
treatment of acute mastitis.
In pigs, the product is indicated for use as an adjunctive therapy in the
treatment of swine respiratory diseases.
Revised: 16 July 2009
AN: 00229/2009
4.
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