FLUNIXIN INJECTION
Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Preparatomtale
(SPC)
10-06-2024
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Aktiv ingrediens:
FLUNIXIN MEGLUMINE
Tilgjengelig fra:
Norbrook Laboratories Limited
ATC-kode:
QM01AG90
INN (International Name):
FLUNIXIN MEGLUMINE
Dosering :
5 %w/v
Legemiddelform:
Solution for Injection
Resept typen:
POM
Terapeutisk gruppe:
Bovine, Equine - Food, Porcine
Terapeutisk område:
Flunixin
Indikasjoner:
N.S.A.I.D
Autorisasjon status:
Authorised
Autorisasjon dato:
1997-04-23
Preparatomtale
IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
VPA: 10999/069/001
Case No: 7006713
The Irish Medicines Board in exercise of the powers conferred on it by Animal Remedies (No. 2) Regulations (S.I. No. 786 of 2007) hereby
grants to:
NORBROOK LABORATORIES LIMITED
STATION WORKS, NEWRY, CO. DOWN BT35 6JP
an authorisation, subject to the provisions of the said Regulations and the general conditions of the attached authorisation, in respect of the
Veterinary Medicinal Product:
FLUNIXIN INJECTION
The particulars of which are set out in Part 1 and Part 2 of the said Schedule. The authorisation is also subject to any special conditions as may
be specified in the said Schedule.
The authorisation,unless revoked, shall continue in force from 29/09/2009.
Signed on behalf of the Irish Medicines Board
________________
A person authorised in that behalf by the said Board.
(NOTE: This authorisation replaces any previous authorisation in respect of this product which is now null and void.)
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 30/09/2009_
_CRN 7006713_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Flunixin Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
A sterile aqueous solution for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, horses and pigs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Flunixin Injection is indicated for use in cattle and horses in the alleviation of inflammation and pain.
In the horse, Flunixin Injection is indicated for the alleviation of inflammatory signs associated with musculo-skeletal
disorders and f
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