ILIUM TOLFEJEC ANTI-INFLAMMATORY INJECTION FOR CATTLE AND PIGS

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Buy It Now

Patient Information leaflet (PIL)

06-09-2022

Summary of Product characteristics (SPC)

20-06-2017

Active ingredient:

TOLFENAMIC ACID

Available from:

TROY LABORATORIES PTY LTD

INN (International Name):

tolfenamic acid(40mg/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

TOLFENAMIC ACID ANTI-INFLAMMATORY-NON-STEROID Active 40.0 mg/ml

Units in package:

100mL

Class:

VM - Veterinary Medicine

Manufactured by:

TROY LABORATORIES

Therapeutic group:

Therapeutic area:

MUSCULOSKELETAL SYSTEM

Therapeutic indications:

Product summary:

Poison schedule: 4; Withholding period: MEAT: Cattle - DO NOT USE less than 10 days (intramuscular administration) and 4 days (intravenous administration) bef ore slaughter for human consumption. Pi gs - DO NOT USE less than 6 days before slaughter for human consumption. MILK: Cattle - Milk collected from cows withi n 12 hours (1 milking) MUST NOT BE USED or processed for human consumption, or f ed to bobby calves. Repeat treatments o r higher doses could result in residues above the MRL unless the label withholdi ng period is extended. The prescribing v eterinarian would need to advise on an e xtended withholding period. EXPORT SLAU GHTER INTERVAL (ESI): Cattle: DO NOT US E less than 28 days before slaughter for export. Pigs: DO NOT USE less than 21 days for pigs before slaughter for expor t. Before using this product, confirm t he current ESI from Troy Laboratories on 02 8808 3600 or the APVMA website (www. apvma.gov.au/residues).; Host/pest details: CATTLE: [ANTI-INFLAMMATORY AGENT, MASTITIS, PNEUMONIA]; PIGS: [AGALACTIA, ANTI-INFLAMMATORY AGENT, MASTITIS, METRITIS]; Poison schedule: 4; Withholding period: MEAT: Cattle - DO NOT USE less than 10 days (intramuscular administration) and 4 days (intravenous administration) bef ore slaughter for human consumption. Pi gs - DO NOT USE less than 6 days before slaughter for human consumption. MILK: Cattle - Milk collected from cows withi n 12 hours (1 milking) MUST NOT BE USED or processed for human consumption, or fed to bobby calves. Repeat treatment s or higher doses could result in residu es above the MRL unless the label withh olding period is extended. The prescribi ng veterinarian would need to advise on an extended withholding period. EXPORT SLAUGHTER INTERVAL (ESI): Cattle: DO NOT USE less than 28 days before slaugh ter for export. Pigs: DO NOT USE less t han 21 days for pigs before slaughter fo r export. Before using this product, confirm the current ESI from Troy Labora tories on 02 8808 3600 or the APVMA webs ite (www.apvma.gov.au/residues).; Host/pest details: CATTLE: [ANTI-INFLAMMATORY AGENT, MASTITIS, PNEUMONIA]; PIGS: [AGALACTIA, ANTI-INFLAMMATORY AGENT, MASTITIS, METRITIS]; Poison schedule: 4; Withholding period: WHP: MEAT: Cattle by intramuscular ad ministration: DO NOT USE less than 10 d ays before slaughter for human comsumpt ion. Cattle by intravenous administrati on: DO NOT USE less than 4 days before slaughter for human consumption. Pigs by intramuscular administration: DO NOT USE less than 6 days before slaughter for human consumption. MILK: Cattle by intramuscular or inravenous administra tion: Milk collected from cows within 1 2 hours (1 milking) MUST NOT BE USED fo r human consumption or processing. This milk should not be fed to bobby calves .; Host/pest details: CATTLE: [ANTI-INFLAMMATORY AGENT, MASTITIS, PNEUMONIA]; PIGS: [AGALACTIA, ANTI-INFLAMMATORY AGENT, MASTITIS, METRITIS]; Poison schedule: 4; Withholding period: ; Host/pest details: CATTLE: [ANTI-INFLAMMATORY AGENT, MASTITIS, PNEUMONIA]; PIGS: [AGALACTIA, ANTI-INFLAMMATORY AGENT, MASTITIS, METRITIS]; Non steroidal anti-inflammatory analgesic - antipyretic for use in cattle and pigs.PRECAUTIONS, etc: SEE LABEL. Safe use of this product during pregnancy has NOT been established.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

OZ ART ADVERTISING
SBB400
TROY LABORATORIES
Side Shown:
Product Code:
Carton Area:
0.0357sq. m
Cut
Crease
12
55
52
55
51.25
33.75
100
33.75
107
235
Project :
Description:
Dimensional Size:
Material Type:
Operator:
Customer:
Date:
printed
TRO9330
Ilium Pentobarbitone 100ml carton.
Justin Keane
01/12/06
Style:
55.00mm
52.00mm
x
x
100.00mm
Overall Dimensions:
x
235
225.25
107
jec
File Name: 61712_41426_100MLG_CARTON_MPL_V1
Dimensions: 100 x 55 x 52mm
Scale: A4 = 70% to scale
Date: 21st Sep 2007
9313754373506
barcode
Batch: Expiry:
READ THE ENCLOSED LEAFLET BEFORE
USING THIS PRODUCT
INDICATIONS
For use by or under the direction of registered veterinarian as an
aid in the treatment of pneumonia and acute mastitis in cattle
and metritis-mastitis-agalactia in pigs.
DIRECTIONS FOR USE
Restraints: DO NOT inject cattle other than into muscle tissue
high on the side of the neck (see leaflet for diagram). Injection
of product into muscles other than as described is likely to result
in residues in meat above the MRL.
PRECAUTIONS
Repeat treatments or higher doses could result in residues above
the MRL unless the label withholding period is extended. The
prescribing Veterinarian would need to advise on an extended
withholding period. Safe use of ILIUM Tolfejec Injection during
pregnancy has not been established.
DOSAGE AND ADMINISTRATION
Use the contents of this vial within six months
of initial broaching. Discard the unused portion.
100mL
100mL
CATTLE
_Pneumonia:_ 2 mg/kg (1mL per 20kg bw)
by intramuscular injection high in the neck
(see leaflet for diagram). Treatment may
be repeated once only after 48 hours.
_Mastitis:_ 4mg/kg (1mL per 10kg bw) as
a single intravenous injection.
PIGS
_Metritis-mastitis-agalactia_: 2mg/kg
(1mL per 20kg bw) as a single
intramuscular injection.
Anti-inflammatory Injection
for Cattle and Pigs
WITHHOLDING PERIODS
_MEAT:_ Cattle by intramuscular administration: DO NOT USE less than
10 days before slaughter for human consumption.
Cattle by intravenous administration: DO NOT USE less than 4
days bef

Read the complete document

Summary of Product characteristics

MATERIAL SAFETY DATA SHEET
PRODUCT NAME: TOLFEJEC ANTI-INFLAMMATORY INJECTION FOR CATTLE AND PIGS
PAGE: 1 OF 4
THIS REVISION ISSUED: JULY, 2010
MATERIAL SAFETY DATA SHEET
Issued by: Troy Laboratories Australia Pty Ltd
Phone: 02 9677 9000
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER
TROY LABORATORIES AUSTRALIA PTY. LTD ABN: 21 000 283 769
TEL:
(02)9677 9000
31-35 GLENDENNING ROAD
FAX:
(02) 9677 9300
GLENDENNING NSW 2761
CHEMICAL NATURE:
Tolfenamic acid is 2-[(3-chloro-2-methylphenyl)amino]benzoic acid) -
one of the class
of non steroidal anti-inflammatory drugs (NSAIDs).
TRADE NAME:
TOLFEJEC ANTI-INFLAMMATORY INJECTION FOR CATTLE AND PIGS
PRODUCT USE:
Non steroidal anti-inflammatory agent for animal use.
CREATION DATE:
NOVEMBER, 2007
THIS VERSION ISSUED:
JULY, 2010
and is valid for 5 years from this date.
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Not classified as hazardous according to the criteria of SWA.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
S25. Avoid contact with eyes.
SUSDP CLASSIFICATION:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
EMERGENCY OVERVIEW
PHYSICAL DESCRIPTION & COLOUR
: Clear, colourless to pale yellow liquid.
ODOUR:
No data.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product.
POTENTIAL HEALTH EFFECTS
Exposure to this product from normal use will not usually result in
any health related problems. However, we note that
exposure to Tolfenamic acid as a medication has resulted in reports of
Headache, Allergy (hypersensitivity), Shaking,
usually of the hands (tremor), Fatigue, Disturbances of the gut such
as diarrhoea, constipation, nausea, vomiting or
abdominal pain, Ulceration of the stomach or intestine, Balance
problems involving the inner ear (

Read the complete document