DECTOMAX INJECTABLE ENDECTOCIDE

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

DORAMECTIN

Available from:

ZOETIS AUSTRALIA PTY LTD

INN (International Name):

doramectin(10mg/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

DORAMECTIN ANTHELMINTIC Active 10.0 mg/ml

Units in package:

200mL; 500mL

Class:

VM - Veterinary Medicine

Manufactured by:

ZOETIS AUSTRALIA

Therapeutic group:

CATTLE | PIGS | BEEF | BOAR | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK | CALF | COW | DAIRY COW | GILT | HEI

Therapeutic area:

PARASITICIDES

Therapeutic indications:

BARBER'S POLE WORM - HAEMONCHUS PLACEI | BLACK SCOUR WORM - TRICHOSTRONGYLUS SPP. | CATTLE BITING LOUSE | CATTLE TICK | CHORIOPTIC MANGE MITE | COOPERIA ONCOPHORA | COOPERIA PUNCTATA | HOOKWORM - BUNOSTOMUM PHLEBOTOMUM | HYOSTRONGYLUS RUBIDUS | INTESTINAL THREADWORM-STRONGYLOIDES SPP. | KIDNEY WORM | LARGE INTESTINAL ROUNDWORM - A. SUUM | LARGE ROUNDWORM - TOXOCARA VITULORUM | LONGNOSED CATTLE LOUSE | LUNGWORM - DICTYOCAULUS VIVIPARUS | LUNGWORM - METASTRONGYLUS SPP. | MANGE MITE - S. SCABIEI VAR. BOVIS | NODULE WORM - OESOPHAGOSTOMUM RADIATUM | NODULE WORM - OESOPHAGOSTOMUM SPP. | NODULE WORM - OESOPHAGOSTOMUN DENTATUM | SARCOPTIC MANGE SCABIES MITE | SHORTNOSED CATTLE LOUSE | SMALL BROWN STOMACH WORM - O. OSTERTAGI | SMALL INTESTINAL WORM - COOPERIA SPP. | STOMACH HAIR WORM | SUCKING LOUSE | TRICHOSTRONGYLUS LONGISPICULARIS | TUBERCLE-BEARING LOUSE | WHIPWORM - TRICHURIS SUIS | CATTLEBITING LOUSE | DAMALINIA BOVIS (OLD NAME) | HAEMA SPP. | INCLUDING INHIBITED STAGES | LARGE LUNGWORM | LARGE ROUNDWORM | LITT

Product summary:

Poison schedule: 5; Withholding period: WHP:Meat:Cattle 42 days: pigs 35 days Milk: Do not use during lactation or le ss than 60 days before calving when mil k or milk products are to be used for h uman consumption or processing.; Host/pest details: CATTLE: [BARBER'S POLE WORM - HAEMONCHUS PLACEI, BLACK SCOUR WORM - TRICHOSTRONGYLUS SPP., CATTLE BITING LOUSE, CATTLE TICK, CHORIOPTIC MANGE MITE, COOPERIA ONCOPHORA, COOPERIA PUNCTATA, HOOKWORM - BUNOSTOMUM PHLEBOTOMUM, LARGE ROUNDWORM - TOXOCARA VITULORUM, LONGNOSED CATTLE LOUSE, LUNGWORM - DICTYOCAULUS VIVIPARUS, MANGE MITE - S. SCABIEI VAR. BOVIS, NODULE WORM - OESOPHAGOSTOMUM RADIATUM, SHORTNOSED CATTLE LOUSE, SMALL BROWN STOMACH WORM - O. OSTERTAGI, SMALL INTESTINAL WORM , STOMACH HAIR WORM, SUCKING LOUSE, TRICHOSTRONGYLUS LONGISPICULARIS, TUBERCLE-BEARING LOUSE]; PIGS: [HYOSTRONGYLUS RUBIDUS, INTESTINAL THREADWORM-STRONGYLOIDES SPP., KIDNEY WORM, LARGE INTESTINAL ROUNDWORM - A. SUUM, LUNGWORM - METASTRONGYLUS SPP., NODULE WORM - OESOPHAGOSTOMUM SPP., NODULE WORM - OESOPHAGOSTOMUN DENTATUM, SARCOPTIC MANGE SCABIES MITE, SUCKING LOUSE, WHIPWORM - TRICHURIS SUIS]; For the treatment and control of doramectin sensitive internal and external parasites of cattle and pigs.Do not use during lactation or less than 60 days before calving when milk or milk products are to be used for human consumption or processing. Animals must not be repeat treated within 4 weeks of a previous treatment.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

PFIZER ANIMAL HEALTH
Product Name: DECTOMAX INJECTABLE ENDECTOCIDE
Date: 22 September
2011
Page
1
of
18
Product Size: 200 mL, 500 mL
Description: Composite label
File number: LAB0015- Dectomax Injectable Sept (2)
Version:
version 3
2011 in-use final.doc
Reason: Category
14-
Addition
of
In-use shelf life and ESI Statement
Text above this line and
in
italics between parallel lines
is
not included
in
the label copy.
IMMEDIATE CONTAINER (Bottle)
Front Panel
CAUTION
KEEP OUT OF REACH OF CHILDREN
READ ·SAFETY DIRECTIONS
FOR ANIMAL TREATMENT ONLY
DECTOMAX®
INJECTABLE ENDECTOCIDE
DORAMECTIN 10 MGLML
•
RLP
Approved
For
the treatment and control
of
doramectin sensitive internal
and
external parasites
of
cattle
and
pigs.
CODE
1M
MEDIATE CONTAINER (Bottle)
Left Panel
200
ml/500
ml
READ OUTER CONTAINER ZIP SEAL LABEL BEFORE USING THIS PRODUCT
DIRECTIONS FOR USE
. RESTRAINTS:
DO NOT USE
IN
CATTLE DURING LACTATION
OR
LESS THAN 60 DAYS BEFORE CALVING
WHEN MILK
OR
MILK PRODUCTS ARE TO
BE
USED FOR HUMAN CONSUMPTION
OR
PROCESSING.
.
DO NOT USE
IN
ANIMALS WITHIN 28 DAYS (4 WEEKS) OF A PREVIOUS TREATMENT.
DOSAGE AND ADMINISTRATION
USE CONTENTS WITHIN
28
DAYS OF FIRST BROACHING OF THE VIAL. STORE UPRIGHT.
DISCARD THE UNUSED PORTION.
CATTLE:
1
ml
per
50
kg
of bodyweight
SIC
s:\reg affairs\aust\inline\label\dectomax injectable\in-use\lab0015 -
dectomax injectable sept (2) 2011
in-use final.doc
Infopest
Verified
i
PFIZER ANIMAL HEALTH
Product Name: DECTOMAX INJECTABLE ENDECTOCIDE
Date: 22 September
2011
Page 2
of
18
Product Size: 200
mL,
500
mL
DESCRIPTION:
COMPOSITE
LABEL
File
number: LAB0015- Dectomax Injectable Sept
(2)
VERSION:
VERSION
3
2011
IN-USE
FINAL.
DOC
Reason: Cateoorv 14
ADDITION
OF
IN-USE
SHELF
LIFE
AND
ESI
STATEMENT
TEXT
ABOVE
THIS
LINE
AND
IN
ITALICS
BETWEEN
PARALLEL
LINES
IS
NOT
INCLUDED
IN
THE
LABEL
COPY.
PIGS:
1 mL per 33
kg
(0.3
ML
per 1
Okg)
of
bodyweight
1/M.
NOT TO BE USED FOR ANY PURPOSE OR
IN
ANY MANNER CONTRARY TO
THIS LABEL UNLESS AUTHORISED UNDER APPROPRIATE LEGISLATION.
WITHHOLDING PERIODS
MEAT-
CATTLE 42

Summary of Product characteristics

PRODUCT NAME: DECTOMAX® INJECTABLE ENDECTOCIDE
PAGE: 1 OF 7
THIS VERSION ISSUED: 19 NOVEMBER 2015
SAFETY DATA SHEET
Issued by: Zoetis Australia Pty Ltd
Phone: [phone]
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA
SECTION 1 - IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND SUPPLIER
ZOETIS AUSTRALIA PTY LTD
ABN 94 156 476 425
Level 6, 5 Rider Blvd
Rhodes NSW 2138 AUSTRALIA
Tel: [phone]
Fax: [phone]
Email: [e-mail]
PRODUCT IDENTIFIER:
DECTOMAX® INJECTABLE ENDECTOCIDE
APVMA APPROVAL NO:
46128
OTHER NAMES:
None.
CHEMICAL FAMILY:
Doramectin in an oily base.
RECOMMENDED USE:
Veterinary product used as Antiparasitic; endectocide.
RESTRICTIONS ON USE
For veterinary use only.
EMERGENCY PHONE:
1800 814 883 (ALL HOURS)
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
N, Dangerous to the environment. Not classified as hazardous according
to the
criteria of SWA.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
R63, R64, R50/53. Possible risk of harm to the unborn child. May cause
harm to breastfed babies.
Very toxic to aquatic organisms, may cause long-term adverse effects
to the aquatic environment.
SAFETY PHRASES:
S20, S36, S61. When using, do not eat or drink. Wear suitable
protective clothing. Avoid release
to the environment. Refer to special instructions/Safety Data Sheets.
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
GHS LABEL ELEMENTS:
GHS CLASSIFICATION: SIGNAL WORD: WARNING
HAZARD STATEMENT:
H361: Suspected of damaging fertility or the unborn child.
H362: May cause harm to breast-fed children.
H410: Very toxic to aquatic life with long lasting effects.
PREVENTION
P102: Keep out of reach of children.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and
understood.
P260: Do not breathe fumes, mists, vapours or spray.
P262: Do not get in eyes, on skin, or on clothing.
P263: Avoid conta