IVOMEC MAXIMIZER CONTROLLED RELEASE CAPSULES FOR ADULT SHEEP 40 TO 80KG

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:

IVERMECTIN

Available from:

Boehringer Ingelheim Animal Health Australia Pty. Ltd.

INN (International Name):

ivermectin(160mg/Cp)

Pharmaceutical form:

ORAL CAPSULE

Composition:

IVERMECTIN ANTHELMINTIC Active 160.0 mg/Cp

Units in package:

100 Caps; 20 Caps; 500 Caps

Class:

VM - Veterinary Medicine

Manufactured by:

MERIAL AUSTRALIA

Therapeutic group:

Therapeutic area:

PARASITICIDES

Therapeutic indications:

Product summary:

Poison schedule: 5; Withholding period: WHP: Sheep must not be slaughtered for human consumption within 126 days (18 weeks) of administration of the capsule . Do not administer to sheep producing milk for human consumption. TRADE ADVI CE: EXPORT SLAUGHTER INTERVAL (ESI): D O NOT USE less than 126 days before sla ughter for export.; Host/pest details: SHEEP: [BARBER'S POLE WORM-HAEMONCHUS CONTORTUS, BLACK SCOUR WORM - TRICHOSTRONGYLUS SPP., COOPERIA CURTICEI, DAGS - PREVENTION AID, FLY STRIKE, INTESTINAL HAIR WORM - T. COLUBRIFORMIS, INTESTINAL THREADWORM - S. PAPILLOSUS, LARGE BOWEL WORM - O. VENULOSUM, LARGE LUNGWORM - DICTYOCAULUS FILARIA, LARGE MOUTHED BOWEL WORM, NASAL BOT, NEMATODIRUS BATTUS, NEMATODIRUS FILICOLLIS, NODULE WORM - , OSTERTAGIA CIRCUMCINCTA, OSTERTAGIA TRIFURCATA, PROTOSTRONGYLUS RUFESCENS, SHEEP ITCH MITE, SHEEP KED, STOMACH HAIR WORM, THIN NECKED INTESTINAL WORM N. SPATHIGER, WHIPWORM - TRICHURIS SPP., WORM EGG]; Poison schedule: 5; Withholding period: ; Host/pest details: SHEEP: [BARBER'S POLE WORM-HAEMONCHUS CONTORTUS, BLACK SCOUR WORM - TRICHOSTRONGYLUS SPP., COOPERIA CURTICEI, DAGS - PREVENTION AID, FLY STRIKE, INTESTINAL HAIR WORM - T. COLUBRIFORMIS, INTESTINAL THREADWORM - S. PAPILLOSUS, LARGE BOWEL WORM - O. VENULOSUM, LARGE LUNGWORM - DICTYOCAULUS FILARIA, LARGE MOUTHED BOWEL WORM, NASAL BOT, NEMATODIRUS BATTUS, NEMATODIRUS FILICOLLIS, NODULE WORM - , OSTERTAGIA CIRCUMCINCTA, OSTERTAGIA TRIFURCATA, PROTOSTRONGYLUS RUFESCENS, SHEEP ITCH MITE, SHEEP KED, STOMACH HAIR WORM, THIN NECKED INTESTINAL WORM N. SPATHIGER, WHIPWORM - TRICHURIS SPP., WORM EGG]; For treatment and 100 day control of ivermectin-sensitive strains of internal and external parasites including BZ/levamisole/morantel/closante resistant worms, nasal bot and itchmite of sheep. Controls keds infestations. Aids in control of blowfly strike.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

PAGE:
1 of
16
DRAFT: 19
IVOMEC CRC (Adult
Sheep) - Australia
20/100
capsu le bag
Front
CAUTION
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
DATE : 20 Apri l
2010
IVOMEC MAXIMIZER®
Controlled
Release
Capsule
for
Adult
Sheep
40
to
80 KG
Active Constituent:
Each Capsule contains 160mg of
IVERMECTIN
For
treatment
and 100
day
control
of
ivermectin
-sensitive
strains
of
internal
and external
paras ites including benzim idazo le-, levamisole-,
morantel- , and closantel-res istant
worms , nasa l
bot and itchmite of sheep .
Controls ked infestations.
Aids in the prevent ion of dags and in the control
of
blowfly strike in the
breech area .
Reduces pasture contamination with worm eggs for at
least
100 days .
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
For product
information and techn ical
enqu iries vis it
\NVv'W
.merial.com .au or
call
Merial
Customer Solutions Australia : 1800-808-691 .
Contents :
20/100
Capsules
(Merial/ogo)
Merial Austral ia Pty Limited
Level
6, 79 George Street
Parramatta
NSW
2150
®
IVOMEC Maximizer and the sheep head logo are registered trademar ks of
Merlal
©
Merial
Limited , 2010.
All
rights reserved , RLP APPROVED
Info
PEST

Verified
PAGE : 2 of
16
DRAFT:
19
IVOMEC CRC (Adult
Sheep) - Australia
20/100 capsule bag
Back
DATE: 20 April
2010
IVOMEC Maximizer" Controlled Release Capsule for Adult
Sheep
DIRECTIONS FOR USE:
Restraints
DO NOT USE in sheep
producing
milk
for
human
consumption.
DOSAGE AND ADMINISTRATON:
Dose one capsule for animals between 40kg and 80kg liveweight.
For
animals over 80kg , dose with 2 capsules .
Sheep should be weighed if
liveweight
is uncertain .
WITHHOLDING PERIODS:
MEAT:
DO NOT USE less than 126 days (18 weeks) before
slaughter
for
human
consumption.
MILK:
DO NOT USE in sheep
producing
milk
for
human
consumption
.
TRADE ADVICE:
EXPORT SLAUGHTER INTERVAL (ESI):
DO NOT USE less than 126
days
before
slaughter
for
export
.
The ESI on
this
label
was
correct
at
the
time
of
label
approval.
Before
using
this
product,
confirm
the
current
ESI
from
the
registr

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Summary of Product characteristics

MATERIAL SAFETY DATA SHEET
SECTION 1
IDENTIFICATION OF THE MATERIAL AND SUPPLIER
Recommended use:
Oral capsule for adult sheep (40 kg to 80 kg) for 100-day control of
ivermectin-sensitive
strains of internal and external parasites.
Supplier name:
Merial Australia Pty Ltd
Address:
Building D, 12-24 Talavera
Road
Macquarie Park NSW 2113
Telephone number (toll-free):
1800 808 691 all-hours for technical help.
All hours emergency phone number - Poisons Information Centre 131126
anywhere in Australia
SECTION 2
HAZARDS IDENTIFICATION
Classified as hazardous according to the National Occupational Health
and Safety Commission’s Approved
Criteria for Classifying Hazardous Substances [NOHSC:1008(2004)].
A Dangerous Good according to the ADG Code 7 (Environmentally
hazardous).
Risk phrase(s) (Hazard):
HARMFUL IF SWALLOWED (R22)
HARMFUL BY INHALATION AND IN CONTACT
WITH SKIN (R20/21)
IRRITATING TO EYES AND SKIN (R36/38)
VERY TOXIC
TO AQUATIC ORGANISMS (R50)
Safety phrases:
KEEP OUT OF THE REACH OF CHILDREN (S2)
(Precautionary statements)
KEEP AWAY FROM FOOD, DRINK. (S13)
WHEN USING, DO NOT EAT OR DRINK (S20)
AFTER CONTACT
WITH SKIN, WASH IMMEDIATELY WITH PLENTY OF
WATER. (S28)
DO NOT EMPTY INTO DRAINS (S29)
IF SWALLOWED, SEEK MEDICAL ADVICE IMMEDIATELY AND SHOW
THE CONTAINER
OR LABEL. (S46)
NOHSC CLASSIFICATION:
HARMFUL Xn
SUSDP CLASSIFICATION
-
POISONS SCHEDULE: 5 (intraruminal implant)
ADG CODE CLASSIFICATION: Class 9 Environmentally Hazardous, but ADG
exemption AUD1 applies
(See Section 14).
UN No.
3082.
LOCAL EFFECTS:
TARGET ORGANS:
See note to physician in Section 4.
INHALATION:
Not a likely route of exposure. If capsules are broken, tablet dust
inhalation
may be harmful.
SKIN CONTACT:
Not a likely route of exposure. If capsules are broken, prolonged
contact
with tablets may be irritating.
EYE CONTACT:
If capsules are broken, tablet dust may irritate eyes.
INGESTION:
Not a likely route of exposure (tablets enclosed in a large
polypropylene
capsule). Active ingredient may cause dilated pupils (mydriasis), in-
coordinat

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