NOROMECTIN ANTIPARASITIC INJECTION FOR CATTLE AND PIGS

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:

NORBROOK LABORATORIES AUSTRALIA PTY LIMITED

INN (International Name):

ivermectin(10mg/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

IVERMECTIN ANTHELMINTIC Active 10.0 mg/ml

Units in package:

100mL; 1L; 250mL; 500mL; 50mL

Class:

VP - Veterinary Pesticide

Therapeutic group:

Therapeutic area:

PARASITICIDES

Therapeutic indications:

Product summary:

Poison schedule: 5; Withholding period: WHP: MEAT: DO NOT USE LESS THAN 28 DAYS (PIGS) 42 DAYS (CATTLE) BEFORE SLAUGHT ER FOR HUMAN CONSUMPTION. MILK: DO NOT USE IN LACTATING COWS OR WITHIN 28 DAY S OF CALVING WHERE MILK OR MILK PRODUCT S MAY BE USED FOR HUMAN CONSUMPTION. E SI: DO NOT SLAUGHTER CATTLE FOR EXPORT LESS THEN 42 DAYS AFTER FINAL TREATMENT . ESI: DO NOT SLAUGHTER PIGS FOR EXPORT LESS THEN 35 DAYS AFTER FINAL TREATME NT.; Host/pest details: CATTLE: [BARBER'S POLE WORM - HAEMONCHUS PLACEI, CATTLE BITING LOUSE, CATTLE TICK, CHORIOPTIC MANGE MITE, EYEWORM - THELAZIA SPP., HOOKWORM - BUNOSTOMUM PHLEBOTOMUM, INTESTINAL HAIR WORM - T. COLUBRIFORMIS, INTESTINAL THREADWORM - S. PAPILLOSUS, LARGE ROUNDWORM - TOXOCARA VITULORUM, LUNGWORM - DICTYOCAULUS VIVIPARUS, MANGE MITE - S. SCABIEI VAR. BOVIS, NEMATODIRUS HELVETIANUS, NODULE WORM - OESOPHAGOSTOMUM RADIATUM, OSTERTAGIA SPP. - ADULT, OSTERTAGIA SPP. - LARVAE, SCREW WORM FLY - CHRYSOMYA BEZZIANA, SHORTNOSED CATTLE LOUSE, SMALL INTESTINAL WORM , STOMACH HAIR WORM, SUCKING LICE - LINOGNATHUS VITULI, THIN NECKED INTESTINAL WORM N. SPATHIGER, TUBERCLE-BEARING LOUSE, WHIPWORM - TRICHURIS OVIS (ADULTS ONLY)]; PIGS: [HYOSTRONGYLUS RUBIDUS, KIDNEY WORM, LARGE INTESTINAL ROUNDWORM - A. SUUM, LUNGWORM - METASTRONGYLUS SPP., NODULE WORM - OESOPHAGOSTOMUM SPP., PIG LOUSE, SARCOPTES SCABEI VAR. BOVIS, STRONGYLOIDES RANSOMI, WHIPWORM - TRICHURIS SUIS]; Poison schedule: 5; Withholding period: ; Host/pest details: CATTLE: [BARBER'S POLE WORM - HAEMONCHUS PLACEI, CATTLE BITING LOUSE, CATTLE TICK, CHORIOPTIC MANGE MITE, EYEWORM - THELAZIA SPP., HOOKWORM - BUNOSTOMUM PHLEBOTOMUM, INTESTINAL HAIR WORM - T. COLUBRIFORMIS, INTESTINAL THREADWORM - S. PAPILLOSUS, LARGE ROUNDWORM - TOXOCARA VITULORUM, LUNGWORM - DICTYOCAULUS VIVIPARUS, MANGE MITE - S. SCABIEI VAR. BOVIS, NEMATODIRUS HELVETIANUS, NODULE WORM - OESOPHAGOSTOMUM RADIATUM, OSTERTAGIA SPP. - ADULT, OSTERTAGIA SPP. - LARVAE, SCREW WORM FLY - CHRYSOMYA BEZZIANA, SHORTNOSED CATTLE LOUSE, SMALL INTESTINAL WORM , STOMACH HAIR WORM, SUCKING LICE - LINOGNATHUS VITULI, THIN NECKED INTESTINAL WORM N. SPATHIGER, TUBERCLE-BEARING LOUSE, WHIPWORM - TRICHURIS OVIS (ADULTS ONLY)]; PIGS: [HYOSTRONGYLUS RUBIDUS, KIDNEY WORM, LARGE INTESTINAL ROUNDWORM - A. SUUM, LUNGWORM - METASTRONGYLUS SPP., NODULE WORM - OESOPHAGOSTOMUM SPP., PIG LOUSE, SARCOPTES SCABEI VAR. BOVIS, STRONGYLOIDES RANSOMI, WHIPWORM - TRICHURIS SUIS]; For the treatment and control of ivermectin sensitive internal and external parasites of cattle and pigs.

Authorization status:

Stopped

Authorization date:

2021-07-01

Patient Information leaflet

LIVEWEIGHT
DOSE VOLUME
NUMBER OF PIGS TREATED/PACK
(KG)
(ML)
50 ML
100 ML
250 ML
500 ML
1L
16
0.5
100
200
500
1000
2000
33
1.0
50
100
250
500
1000
66
2.0
25
50
125
250
500
100
3.0
16
33
83
166
333
133
4.0
12
25
62
125
250
166
5.0
10
20
50
100
200
200
6.0
8
16
41
83
166
Heavier animals (for example mature boars) should receive an
additional 1 mL for each 33 kg over 200 kg.
NOT TO BE USED FOR ANY PURPOSE OR IN ANY MANNER
CONTRARY TO THIS LABEL UNLESS AUTHORISED UNDER
APPROPRIATE LEGISLATION
WITHHOLDING PERIODS
MEAT: DO NOT USE LESS THAN 28 DAYS (PIGS) 42 DAYS (CATTLE) BEFORE
SLAUGHTER FOR HUMAN CONSUMPTION.
MILK: DO NOT USE IN LACTATING COWS OR WITHIN 28 DAYS OF CALVING
WHERE MILK OR MILK PRODUCTS MAY BE USED FOR HUMAN CONSUMPTION.
EXPORT SLAUGHTER INTERVAL (CATTLE): DO NOT SLAUGHTER CATTLE
FOR EXPORT LESS THAN 42 DAYS AFTER FINAL TREATMENT.
EXPORT SLAUGHTER INTERVAL (PIGS): DO NOT SLAUGHTER PIGS FOR
EXPORT LESS THAN 35 DAYS AFTER FINAL TREATMENT.
SAFETY DIRECTIONS:
Poisonous if swallowed. Avoid contact with eyes, skin and clothing.
FIRST AID:
If poisoning occurs contact a doctor or Poisons Information Centre
(Phone Australia 13 11 26).
PROTECTION OF WILDLIFE, FISH, CRUSTACEANS AND THE
ENVIRONMENT:
Ivermectin is extremely toxic to aquatic species. Do not
contaminate dams, rivers, streams or other waterways with the
chemical or used container.
NORBROOK LABORATORIES AUSTRALIA PTY LIMITED
A.C.N. 080 972 596
Unit 7/1 Trade Park Drive
Tullamarine, VIC 3043
Free call: 1800 665 866
DISPOSAL:
Dispose of empty container by wrapping with paper and putting in
garbage. Discarded needles/sharps should immediately be placed
in a designated and appropriately labelled ‘sharps’ container.
STORAGE:
Store below 30°C (Room temperature) away from light. Once
broached, the product must be used within 6 months.
APVMA Approval Number: 56769/50ML/0906
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
INDICATIONS
For the treatment and control of ivermectin-sensitive internal and
external parasites of cattle and pigs. When used at the

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Summary of Product characteristics

PRODUCT NAME: NOROMECTIN ANTIPARASITIC INJECTION FOR CATTLE AND PIGS
PAGE: 1 OF 5
THIS REVISION ISSUED: SEPTEMBER, 2009
MATERIAL SAFETY DATA SHEET
Issued by: Norbrook Laboratories Australia Pty Ltd
Freecall: 1800 665 866
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
NORBROOK LABORATORIES AUSTRALIA PTY LTD
FREECALL: 1800 665 866
UNIT 7/1 TRADE PARK DRIVE
TULLAMARINE, VIC 3043 AUSTRALIA
SUBSTANCE:
Ivermectin is a fermentation product.
TRADE NAME:
NOROMECTIN ANTIPARASITIC INJECTION FOR CATTLE AND PIGS
APVMA CODE:
56769
PRODUCT USE:
For the treatment and control of Ivermectin-sensitive internal and
external parasites of
cattle and pigs.
CREATION DATE:
SEPTEMBER, 2009
THIS VERSION ISSUED:
SEPTEMBER, 2009
and is valid for 5 years from this date.
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
T, Toxic. N, Dangerous to the environment. Hazardous according to the
criteria of
SWA.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
R25, R50, R61, R64. Toxic if swallowed. Very toxic to aquatic
organisms. May cause harm to the
unborn child. May cause harm to breastfed babies.
SAFETY PHRASES:
S20, S36, S61, S24/25. When using, do not eat or drink. Wear suitable
protective clothing. Avoid
release to the environment. Refer to special instructions/Safety Data
Sheets. Avoid contact with skin and eyes.
SUSDP CLASSIFICATION:
S5
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 odour.
MAJOR HEALTH HAZARDS:
may cause harm to unborn children, may cause harm to breastfed babies.
POTENTIAL HEALTH EFFECTS
INHALATION:
SHORT TERM EXPOSURE:
Available data indicates that this product is not harmful. In addition
product is unlikely to
cause any discomfort or irritation.
LONG TERM EXPOSURE:
No data f

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