TRODAX INJECTABLE ANTHELMINTIC

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

19-06-2017

Summary of Product characteristics (SPC)

19-06-2017

Active ingredient:

NITROXYNIL AS EGLUMINE

Available from:

Boehringer Ingelheim Animal Health Australia Pty. Ltd.

INN (International Name):

nitroxynil as eglumine(340g/L)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

NITROXYNIL AS EGLUMINE PHENOL Active 340.0 mg/ml

Units in package:

500mL

Class:

VM - Veterinary Medicine

Manufactured by:

MERIAL AUSTRALIA

Therapeutic group:

Therapeutic area:

PARASITICIDES

Therapeutic indications:

Product summary:

Poison schedule: 6; Withholding period: WHP:Meat: Do not use less than 28 days before slaughter for human consumption. Milk: Do not use on lactating cows or ewes or within 30 days of calving or l ambing where milk or milk products may be used for human consumption.; Host/pest details: CATTLE: [BARBER'S POLE WORM - HAEMONCHUS PLACEI, HOOKWORM - BUNOSTOMUM PHLEBOTOMUM, LIVER FLUKE, LIVER FLUKE - MATURE AND IMMATURE, NODULE WORM - OESOPHAGOSTOMUM RADIATUM]; SHEEP: [BARBER'S POLE WORM-HAEMONCHUS CONTORTUS, LIVER FLUKE - MATURE AND IMMATURE]; Poison schedule: 6; Withholding period: ; Host/pest details: CATTLE: [BARBER'S POLE WORM - HAEMONCHUS PLACEI, HOOKWORM - BUNOSTOMUM PHLEBOTOMUM, LIVER FLUKE, LIVER FLUKE - MATURE AND IMMATURE, NODULE WORM - OESOPHAGOSTOMUM RADIATUM]; SHEEP: [BARBER'S POLE WORM-HAEMONCHUS CONTORTUS, LIVER FLUKE - MATURE AND IMMATURE]; Controls nitroxynil sensitive strains of the following internal parasites: cattle: liver fluke, barber's pole worm, hookworm and nodule worm; sheep: liver fluke and barber's pole worm.

Authorization status:

Stopped

Authorization date:

2023-07-01

Patient Information leaflet

PAGE:
1 019
DRAFT:
3
TRODAX
INJECTABLE
ANTHELMINTIC
500ML CARTON
DATE:
17 SEPTEMBER 2002
PANEL:
FRONT
POISON
KEEP
OUT
OF REACH OF CHILDREN
FOR
ANIMAL
TREATMENT
ONLY
TRODAX'"
INJECTABLE
ANTHELMINTIC
340mglmL NITROXYNIL (as eglumlne salt)
CONTROLS NITROXYNIL SENSITIVE STRAINS OF THE FOLLOWING
INTERNAL
PARASITES
CATTLE
LIVER
FLUKE
(Fasciola hepatica)
-MATURE
&
IMMATURE
(6
weeks)
HOOKWORM
(Bunostomum phlebolomum)
MATURE
&
IMMATURE
SHEEP
LIVER
FLUKE
(Fasciola hepatica)
MATURE
&
IMMATURE
(6
weeks)
BARBER'S
POLE WORM
(Haemonchus placei)
MATURE
&
IMMATU.RE
•
NODULE
WORM
(Oesophagostomum radiaturn)
MATURE
&
IMMATURE
BARBER'S
POLE
WORM
(Haemonchus contorlus)
MATURE
(including
benzimidazole
resistant strains)
TRODAX
contains nitroxynil
a member
01
the substituted phenol
lamily
01
drenches.
Resistance may develop to any drench.
[Fort Dodge logo]
5DDmL
READ
DIRECTIONS
FOR
USE BEFORE USING THIS PRODUCT
TRDOAX
is a
registered
trademark
usedunder
licence:
TheFortDodgelogo is a
registered
trademark
in
USA.
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PAGE:
2019
DRAFT: 3
TRODAX
INJECTABLE
ANTHELMINTIC
500ML CARTON
DATE:
17 SEPTEMBER 2002
PANEL:
LHS
TRODAX@
INJECTABLE
ANTHELMINITIC
(Insert diagram
of
Liver
Fluke life cycle)
Lile Cycle 01 Liver Fluke
(Insert map
of
S.E. Australia)
SHADING
INDICATES
LIVER
FLUKE
AREAS
•
THIS
MAP
INDICATES
CONFIRMED
AREAS
OF
LIVER
FLUKE
IN
SOUTH
EASTERN
AUSTRALIA.
CATTLE
GRAZED
IN
THE
AREAS
SHOWN
ARE
LIKELY
TO
BE
INFECTED
WITH
LIVER
FLUKE.
STOCK
TRANSPORTED
FROM
INFECTED
AREAS
TO SAFE
AREAS
DUE
TO
SALE
OR
agistment should be treated with
TRODAX.
G:\merial\regulatory
_ftfTairs\labels\trodax\lrodax
_
500ml_
draft_3
_170902.doc
PAGE:
30f9
DRAFT:
3
TRODAX INJECTABLE ANTHELMINTIC
500ML CARTON
DATE:
17 SEPTEMBER 2002
PANEL:
BACK
TRODAX@
INJECTABLE ANTHELMINITIC
DIRECTIONS FOR USE:
Administer by subcutaneous injection only.
•
A representative sample of animals should
be
weighed (or a
weighb

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Summary of Product characteristics

PRODUCT NAME: TRODAX® INJECTABLE ANTHELMINTIC
PAGE: 1 OF 5
THIS REVISION ISSUED: AUGUST, 2007
MATERIAL SAFETY DATA SHEET
Issued by: Fort Dodge Australia Pty Limited
Phone: (02)9899 0444
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
_FORT DODGE AUSTRALIA PTY LIMITED_
_ _
_MATERIAL _
_ABN 64 000 074 902 _
_SAFETY _
_1 MAITLAND PLACE _
_DATA SHEET _
_BAULKHAM HILLS NSW 2153 _
_ _
_TELEPHONE: (02) 9899 0444 _
_ _
_FACSIMILE: _
_(02) 9899 2151 _
_ _
_EMERGENCY: 1800 033 111 _
_ _
SUBSTANCE:
Water solution of ingredients (see below). Active ingredient is
nitroxynil.
TRADE NAME:
TRODAX
® INJECTABLE ANTHELMINTIC
OTHER NAMES:
None
APVMA CODE:
38044
PRODUCT USE:
Control of fascioliasis and some round worms in ruminants
.
CREATION DATE:
AUGUST, 2002
REVISION DATE:
AUGUST, 2007
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Not classified as hazardous according to the criteria of ASCC.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
R20/21/22. Harmful by inhalation, in contact with skin, and if
swallowed.
SAFETY PHRASES:
S20, S24, S38, S36/37. When using, do not eat or drink. Avoid contact
with skin. In case of
insufficient ventilation, wear suitable respiratory equipment. Wear
suitable protective clothing and gloves.
SUSDP CLASSIFICATION:
S6
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
EMERGENCY OVERVIEW
PHYSICAL DESCRIPTION & COLOUR
: Bright orange red aqueous liquid.
ODOUR:
No data.
MAJOR HEALTH HAZARDS:
Harmful by inhalation, in contact with skin, and if swallowed.
POTENTIAL HEALTH EFFECTS
NOTE: DIFFERENT HAZARD ASSESSMENT CRITERIA OF ASCC AND TGA MAY RESULT
IN SEEMING INCONSISTENCIES BETWEEN
MSDS AND LABEL. EFFECTS DESCRIBED IN THIS MSDS RELATE TO SHORT TERM
EMERGENCY SITUATIONS, SUCH AS ACCIDENTS
AND SPILLS WITH THE POTENTIAL FOR GROSS OVEREXPOSURE, AND TO LONG TER

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