FLUNIX ANTIINFLAMMATORY INJECTION

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

01-07-2013

Summary of Product characteristics (SPC)

01-07-2013

Active ingredient:

FLUNIXIN AS FLUNIXIN MEGLUMINE

Available from:

ELANCO AUSTRALASIA PTY LTD

INN (International Name):

flunixin as meglumine(50mg/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

FLUNIXIN AS FLUNIXIN MEGLUMINE BENZENE Active 50.0 mg/ml

Units in package:

100mL; 50mL

Class:

VM - Veterinary Medicine

Manufactured by:

BAYER AUSTRALIA

Therapeutic group:

Therapeutic area:

ANALGESIC+MUSCULOSKELETAL

Therapeutic indications:

Product summary:

Poison schedule: 4; Withholding period: WHP: CATTLE: MEAT: DO NOT USE less tha n 28 days before slaughter for human c onsumption. MILK: Milk collected from c ows within 36 hours following treatment MUST NOT BE USED for human consumption or processing This milk should not be fed to bobby calves. PIGS: DO NOT USE less than 28 days befor slaughter for h uman consumption. HORSES: MEAT WITHHOLD ING PERIOD 28 DAYS.; Host/pest details: CATTLE: [ANALGESIC, ANTI-INFLAMMATORY AGENT]; DOG: [ANALGESIC, ANTI-INFLAMMATORY AGENT]; HORSE: [ANALGESIC, ANTI-INFLAMMATORY AGENT]; PIGS: [ANALGESIC, ANTI-INFLAMMATORY AGENT]; Poison schedule: 4; Withholding period: ; Host/pest details: CATTLE: [ANALGESIC, ANTI-INFLAMMATORY AGENT]; DOG: [ANALGESIC, ANTI-INFLAMMATORY AGENT]; HORSE: [ANALGESIC, ANTI-INFLAMMATORY AGENT]; PIGS: [ANALGESIC, ANTI-INFLAMMATORY AGENT]; Non-steroidal anti-inflammatory, analgesic and antipyretic for use in horses, cattle, pigs and dogs.Do not use in cats. Use with caution in animals with pre-existing gastrointestinal ulceration, renal, hepatic or haematologic disorders. Safety of the use of flunixin during pregnancy has not been established.

Authorization status:

Stopped

Authorization date:

2023-07-01

Patient Information leaflet

Product Name:
PARNELL Laboratories
FLUNIX
50mL
Carton
Date:
20/02/2008
Dimensions:
44.5mm x 44.5mm x 80mm
Colours:
PMS 431 Grey
PMS 032 Red
READ THE ENCLOSED LEAFLET
BEFORE USING THIS PRODUCT
DIRECTIONS FOR USE:
CONTRAINDICATED FOR USE IN CATS.
_HORSES:_ 1.1mg/kg (1mL/45kg) bodyweight daily
for up to 5 days, by intravenous or intramuscular
injection.
_CATTLE:_ 1.1 - 2.2mg/kg (1 - 2mL/45kg)
bodyweight daily for 3 - 5 days, by intravenous or
intramuscular injection.
_PIGS:_ 1.1- 2.2mg/kg (1 - 2mL/45kg) bodyweight
daily for up to 3 days, by deep intramuscular
injection.
_DOGS:_ 1mg/kg (0.2mL/10 kg) bodyweight daily
for up to 3 days, by intravenous or intramuscular
injection.
WITHHOLDING PERIODS:
MEAT: 28 DAYS; MILK: 36 HOURS
HORSES: MEAT WITHHOLDING PERIOD
28 DAYS.
TRADE ADVICE:
EXPORT SLAUGHTER INTERVAL (ESI): This product
does not have an ESI established. For advice on the
ESI, contact manufacturer on 1800 665 882 before
using this product.
Dispose of empty container by wrapping with paper
and putting in garbage.
Store below 30
O
C (Room Temperature).
APVMA Approval No. 47802/50mL/1107
PARNELL LABORATORIES (AUST) PTY. LTD.
6/476 Gardeners Road, Alexandria, NSW 2015
50020-01
FLUNIX
NON-STEROIDAL ANTIINFLAMMATORY,
ANALGESIC AND ANTIPYRETIC FOR USE IN
HORSES, CATTLE, PIGS AND DOGS.
50ML
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
ANTIINFLAMMATORY INJECTION
ACTIVE CONSTITUENT:
FLUNIXIN (as meglumine) 50mg/mL
FLUNIX
ANTIINFLAMMATORY INJECTION
FLUNIX
NON-STEROIDAL ANTIINFLAMMATORY,
ANALGESIC AND ANTIPYRETIC FOR USE IN
HORSES, CATTLE, PIGS AND DOGS.
50ML
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
ANTIINFLAMMATORY INJECTION
ACTIVE CONSTITUENT:
FLUNIXIN (as meglumine) 50mg/mL

APPROVED
LABEL

Info

PEST

Verified

FLUNIX
READ THE ENCLOSED LEAFLET BEFORE
USING THIS PRODUCT
DIRECTIONS FOR USE:
CONTRAINDICATED FOR USE IN CATS.
_HORS

Read the complete document

Summary of Product characteristics

DATE OF ISSUE: DECEMBER 2008

M
M
A
A
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A
A
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S
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D
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S
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:

_F_
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1

STATEMENT OF HAZARDOUS NATURE:
Hazardous substance according to criteria of Worksafe Australia.

MANUFACTURER COMPANY DETAILS:
Bomac Pty Ltd

ADDRESS

15/36 Leighton Place
Hornsby NSW 2077
Australia

TELEPHONE NUMBER

61 (0)2 9987 4922

EMERGENCY TELEPHONE NUMBER

61 (0)2 9987 4922 (Business Hours)

FACSIMILE NUMBER

61 (0)2 9987 4188

IDENTIFICATION

PRODUCT NAME
_Flunix Antiinflammatory Injection _(Australia)
_Flunix Injection_ (New Zealand)

OTHER NAMES
Flunix, Flunixin, Finadyne

U.N. NUMBER
No UN number allocated

DANGEROUS GOODS CLASS AND SUBSIDIARY RISK
No class and subsidiary risk allocated

HAZCHEM CODE
No Hazchem code allocated

POISONS SCHEDULE
Schedule 4 (Australia)
Prescription Animal Remedy (P.A.R) Class I (New Zealand)

PACKAGING
50mL  glass  vial  with  grey  butyl  plug  and  aluminium  cap,  labelled,  with  product  leaflet  in  carton  (carton:
Australia only)

USE
FOR ANIMAL TREATMENT ONLY.
Non-steroidal antiinflammatory, analgesic and antipyretic for use in horses, cattle, pigs and dogs.

DATE OF ISSUE: DECEMBER 2008

M
M
A
A
T
T
E
E
R
R
I
I
A
A
L
L

S
S
A
A
F
F
E
E
T
T
Y
Y

D
D
A
A
T
T
A
A

S
S
H
H
E
E
E
E
T
T
:
:

_F_
_F_
_L_
_L_
_U_
_U_
_N_
_N_
_I_
_I_
_X_
_X_
_ _
_ _
_A_

Read the complete document