AUSMECTIN CATTLE POUR-ON

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

20-06-2017

Summary of Product characteristics (SPC)

20-06-2017

Active ingredient:

IVERMECTIN

Available from:

INTERNATIONAL ANIMAL HEALTH PRODUCTS PTY LTD

INN (International Name):

ivermectin(5mg/mL)

Pharmaceutical form:

TOPICAL SOLUTION/SUSPENSION

Composition:

IVERMECTIN ANTHELMINTIC Active 5.0 mg/ml

Units in package:

1 L; 10 L; 2.5 L; 20 L; 21 L; 250 mL; 5 L

Class:

VM - Veterinary Medicine

Manufactured by:

IAHP

Therapeutic group:

Therapeutic area:

PARASITICIDES

Therapeutic indications:

Product summary:

Poison schedule: 5; Withholding period: WITHHOLDING PERIODS: MEAT:DO NOT USE L ESS THAN 42 DAYS BEFORE SLAUGHTER FOR H UMAN CONSUMPTION MILK:NIL; Host/pest details: CATTLE: [BARBER'S POLE WORM - HAEMONCHUS PLACEI, BUFFALO FLY, CATTLE BITING LOUSE, CATTLE TICK, COOPERIA ONCOPHORA, COOPERIA PUNCTATA, EYEWORM - THELAZIA SPP., INTESTINAL HAIR WORM - T. COLUBRIFORMIS, INTESTINAL THREADWORM - S. PAPILLOSUS, LARGE BOWEL WORM - O. VENULOSUM, LUNGWORM - DICTYOCAULUS VIVIPARUS, MITE - CHORIOPTES BOVIS, NODULE WORM - OESOPHAGOSTOMUM RADIATUM, SARCOPTES SCABEI VAR. BOVIS, SHORTNOSED CATTLE LOUSE, SMALL BROWN STOMACH WORM - O. OSTERTAGI, SMALL INTESTINAL WORM , STOMACH HAIR WORM, SUCKING LICE - LINOGNATHUS VITULI, THIN NECKED INTESTINAL WORM, TUBERCLE-BEARING LOUSE, WHIPWORM - TRICHURIS OVIS (ADULTS ONLY)]; Poison schedule: 5; Withholding period: ; Host/pest details: CATTLE: [BARBER'S POLE WORM - HAEMONCHUS PLACEI, BUFFALO FLY, CATTLE BITING LOUSE, CATTLE TICK, COOPERIA ONCOPHORA, COOPERIA PUNCTATA, EYEWORM - THELAZIA SPP., INTESTINAL HAIR WORM - T. COLUBRIFORMIS, INTESTINAL THREADWORM - S. PAPILLOSUS, LARGE BOWEL WORM - O. VENULOSUM, LUNGWORM - DICTYOCAULUS VIVIPARUS, MITE - CHORIOPTES BOVIS, NODULE WORM - OESOPHAGOSTOMUM RADIATUM, SARCOPTES SCABEI VAR. BOVIS, SHORTNOSED CATTLE LOUSE, SMALL BROWN STOMACH WORM - O. OSTERTAGI, SMALL INTESTINAL WORM , STOMACH HAIR WORM, SUCKING LICE - LINOGNATHUS VITULI, THIN NECKED INTESTINAL WORM, TUBERCLE-BEARING LOUSE, WHIPWORM - TRICHURIS OVIS (ADULTS ONLY)]; For the treatment and control of ivermectin sensitive internal and external parasites of cattle. For external use only.For application to the skin surface only - do not give orally or parenterally. Treatment should not be repeated in less than 42 days. See PRECAUTIONS on label also.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

For Official Use Only
E-LABEL APPLICATION (DRAFT)
COMPANY NAME:
INTERNATIONAL ANIMAL HEALTH PRODUCTS PTY LTD
PRODUCT NAME:
AUSMECTIN CATTLE POUR-ON
ELABEL APPLICATION NO:
DC12-96596956E43
APVMA APPROVAL NO:
59900/103329
PRODUCT NO:
59900
VERSION NO:
8.0
APPLICATION STARTED:
2015-Jun-19 12:20:02
VERSION CREATED:
2015-Sep-22 12:04:22
STARTED BY:
Anne Tavares
PRINTED:
2015-Sep-22 12:09:47
LABEL NAME:
AUSMECTIN CATTLE POUR-ON
SIGNAL HEADINGS:
CAUTION
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
READ SAFETY DIRECTIONS BEFORE OPENING OR USING
CONSTITUENT
STATEMENTS:
5 mg/mL IVERMECTIN
CLAIMS:
For the treatment and control of ivermectin sensitive
internal and external parasites of cattle.
INDICATIONS
For the treatment and control of ivermectin-sensitive gastrointestinal
nematodes (including
inhibited immature Ostertagia ostertagi), lungworms (Dictyocaulus
viviparus), eyeworms
(Thelazia spp.), sucking and biting lice, chorioptic and sarcoptic
mange mites, buffalo flies
(Haematobia irritans exigua) and cattle ticks [Rhipicephalus
(Boophilus) microplus].
AUSMECTIN® Cattle Pour-On is a ready-to-use solution of ivermectin,
which is a member
of the avermectin family. The avermectins are potent broad-spectrum
antiparasitic agents,
which are isolated from fermentation of the naturally occurring soil
organism, Streptomyces
avermitilis.
Ivermectin is a member of the macrocyclic lactone class of
endectocides, which have
a unique mode of action. Compounds of the class bind selectively and
with high affinity
to glutamate-gated chloride ion channels, which occur in invertebrate
nerve and muscle
cells. This leads to an increase in the permeability of the cell
membrane to chloride ions
with hyperpolarisation of the nerve or muscle cell, resulting in
paralysis and death of
the parasite. Compounds of this class may also interact with other
ligand-gated chloride
channels, such as those gated by the neurotransmitter,
gamma-aminobutyric acid (GABA).
The margin of safety for compounds of this class is attributable to
the fact tha

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Summary of Product characteristics

INTERNATIONAL ANIMAL HEALTH PRODUCTS PTY LTD
Chemwatch Hazard Alert Code: 3
AUSMECTIN CATTLE POUR-ON
Chemwatch: 4866-26
Version No: 4.1.1.1
Safety Data Sheet according to WHS and ADG requirements
Issue Date: 10/12/2013
Print Date: 17/09/2015
Initial Date: NOT AVAILABLE
S.GHS.AUS.EN
SECTION 1 IDENTIFICATION OF THE SUBSTANCE / MIXTURE AND OF THE COMPANY
/ UNDERTAKING
PRODUCT IDENTIFIER
PRODUCT NAME
Ausmectin Cattle Pour-on
PROPER SHIPPING NAME
ALCOHOLS, N.O.S. (contains isopropanol)
OTHER MEANS OF
IDENTIFICATION
Not Available
RELEVANT IDENTIFIED USES OF THE SUBSTANCE OR MIXTURE AND USES ADVISED
AGAINST
RELEVANT IDENTIFIED
USES
For the treatment and control of ivermectin sensitive internal and
external parasites of cattle. For external application to
cattle only. DO NOT USE less than 42 days before slaughter for human
consumption.
DETAILS OF THE SUPPLIER OF THE SAFETY DATA SHEET
REGISTERED COMPANY
NAME
International Animal Health Products Pty Ltd
ADDRESS
18 Healey Circuit Huntingwood 2148 NSW Australia
TELEPHONE
+61 2 9672 7944
FAX
+61 2 9672 7988
WEBSITE
www.iahp.com.au
EMAIL
info@iahp.com.au
EMERGENCY TELEPHONE NUMBER
ASSOCIATION /
ORGANISATION
Not Available
EMERGENCY TELEPHONE
NUMBERS
+61 2 9672 7944
OTHER EMERGENCY
TELEPHONE NUMBERS
131 126 (Poisons Info. Centre Australia)
SECTION 2 HAZARDS IDENTIFICATION
CLASSIFICATION OF THE SUBSTANCE OR MIXTURE
HAZARDOUS CHEMICAL. DANGEROUS GOODS. ACCORDING TO THE MODEL WHS
REGULATIONS AND THE ADG CODE.
POISONS SCHEDULE
S5
GHS CLASSIFICATION
[1]
Flammable Liquid Category 2, Acute Toxicity (Oral) Category 4, Eye
Irritation Category 2A, Reproductive Toxicity Category
1B, STOT - SE (Narcosis) Category 3
LEGEND:
1. Classified by Chemwatch; 2. Classification drawn from HSIS ; 3.
Classification drawn from EC Directive 1272/2008 - Annex
VI
LABEL ELEMENTS
CONTINUED...
GHS LABEL ELEMENTS
SIGNAL WORD
DANGER
HAZARD STATEMENT(S)
H225
Highly flammable liquid and vapour
H302
Harmful if swallowed
H319
Causes serious eye irritation
H360
May damage fertility or the unborn child
H336
May cause

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