ELANCO AH0328 COMPONENT S WITH TYLAN GROWTH AND FINISHING IMPLANTS FOR STEERS

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

TYLOSIN TARTRATE; OESTRADIOL BENZOATE; PROGESTERONE

Available from:

ELANCO AUSTRALASIA PTY LTD

INN (International Name):

progesterone(200mg)+oestradiol benzoate(20mg)+tylosin tartrate(29mg)

Pharmaceutical form:

PARENTERAL IMPLANT, DEVICE

Composition:

TYLOSIN TARTRATE ANTIBIOTIC Active 29.0 mg; OESTRADIOL BENZOATE STEROID-ESTROGEN Active 20.0 mg; PROGESTERONE STEROID-PROGESTIN Active 200.0 mg

Units in package:

#5x20; #Implants

Class:

VM - Veterinary Medicine

Manufactured by:

ELANCO ANIMAL HEALTH

Therapeutic group:

STEER (CASTRATED MALE CATTLE) | BEEF | BOVINE | BULLOCK (YOUNG) | MALE CATTLE - CASTRATED

Therapeutic area:

NUTRITION & METABOLISM

Therapeutic indications:

PROMOTE ANIMAL GROWTH | FEED CONVERSION | FINISHING | GROWTH PROMOTION | GROWTH RATE | LIVEWEIGHT GAIN

Product summary:

Poison schedule: 4; Withholding period: WHP: MEAT: NIL TRADE ADVICE: EXPORT SLAUGHTER INTERVAL (ESI): This product does not have an ESI established For ad vice on the ESI contact Elanco Animal Health (Australia) on 1800 226 324 befo re using this product.; Host/pest details: STEER (CASTRATED MALE CATTLE): [PROMOTE ANIMAL GROWTH]; For improved weight gain in steers. Tylan is included as a local antibacterial to reduce the incidence of abscess formation caused by tylosin sensitive organisms at the implant stage.FOR USE ONLY in steers producing beef for human consumption. For other restraints and precautions, refer to product label.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

DIRECTIONS FOR USE
USE ONLY IN ACCORDANCE WITH THE INSTRUCTIONS ON THIS LABEL
UNLESS AUTHORISED UNDER APPROPRIATE LEGISLATION.
RESTRAINTS
FOR USE ONLY IN STEERS PRODUCING BEEF FOR HUMAN CONSUMPTION.
DO NOT USE THIS PRODUCT IN ANY OTHER SPECIES OF ANIMAL.
INSERT ONLY ONE IMPLANT PER STEER.
IMPLANT ONLY BENEATH THE SKIN IN THE MIDDLE THIRD OF THE EAR.
DO NOT IMPLANT THIS PRODUCT IN ANY OTHER SITE.
INSERT ONLY ONE IMPLANT EVERY 70 DAYS.
IT IS A BREACH OF AQIS ACCREDITATION CONDITIONS TO USE THIS PRODUCT
ON HGP FREE ACCREDITED CATTLE OR TO POSSESS THIS PRODUCT ON ANY
HGP FREE ACCREDITED PROPERTY (EXCEPT FOR FEEDLOTS WITH FLEXIBLE
ACCREDITATION). CATTLE IMPLANTED WITH THIS PRODUCT MUST BE
INDIVIDUALLY IDENTIFIED WITH AN APPROVED EAR PUNCH MARK.
PRECAUTIONS
Implanting cattle under 6 weeks of age is NOT recommended.
Implanting cattle intended for breeding is NOT recommended as
they may experience decreased fertility.
Growth responses may vary widely for nutritional or other reasons.
Improved performance may be noted only when conditions are
favourable for good growth.
Rectal and preputial prolapse, increased bulling activity, high
tailheads, sunken loins, ventral oedema and udder development may
occur as side effects of treatment.
To help avoid abscess formation at the site of implant, the surface
of the ear should be thoroughly cleaned and disinfected before
implantation.
ADMINISTRATION
READ THE ENCLOSED LEAFLET BEFORE USING THIS
PRODUCT
Approved implantation technique is fully described in the enclosed
leaflet.
Implant complete contents of a single implant (9 pellets plus marker)
per animal. Implant site is beneath the skin on the back side of the
middle one-third of the ear.
WITHHOLDING PERIODS
MEAT: NIL
TRADE ADVICE:
EXPORT SLAUGHTER INTERVAL (ESI): THIS PRODUCT DOES NOT
HAVE AN ESI ESTABLISHED. FOR ADVICE ON THE ESI, CONTACT ELANCO
ANIMAL HEALTH (AUSTRALIA) ON 1800 226 324 BEFORE USING THIS
PRODUCT.
ACTIONS: COMPONENT-S WITH TYLAN contains a combination of two growth
promoting agents.
Progesterone and oestradiol ar

Summary of Product characteristics

Issue date: 11-September-2015
Version number: 01
SAFETY DATA SHEET
1. Identification
Product identifier
Elanco AH0328 Component S with Tylan Growth and Finishing Implants for
Steers
Other means of identification
Synonyms
Component E-S Implant with Tylan * Component S Implant with Tylan *
Component E-C Implant
with Tylan
Item Code
AH0328, AH0507
Recommended use of the chemical and restrictions on use
Recommended use
Veterinary Pharmaceutical
Restrictions on use
Not available.
Details of manufacturer or importer
Manufacturer
Company name
Elanco Animal Health
A Division of Eli Lilly Australia Pty Ltd
Address
A.B.N. 39 000 233 992
112 Wharf Road, West Ryde, N.S.W. 2114, Australia
Telephone
[phone]
Fax
[phone]
e-mail
[e-mail]
Emergency phone
number
Elanco Animal Health: 1800 226 324 (Toll free)
OR Poisons Information Centre: 131126 (Australia-wide)
24 hr emergency contact
number
CHEMWATCH 1800 039 008 (spills and accidents)
24 hr emergency contact
number (Local)
CHEMWATCH [phone] (spills and accidents)
2. Hazard(s) identification
Classification of the hazardous chemical
Not classified.
Physical hazards
Category 2A
Serious eye damage/eye irritation
Health hazards
Category 1
Sensitization, respiratory
Category 1
Sensitization, skin
Category 1A
Carcinogenicity
Category 1A
Reproductive toxicity
Effects on or via lactation
Reproductive toxicity
Category 2
Hazardous to the aquatic environment, acute
hazard
Environmental hazards
Category 2
Hazardous to the aquatic environment,
long-term hazard
Label elements, including precautionary statements
Hazard symbol(s)
Health hazard Environment
Signal word
Danger
Hazard Statement(s)
May cause an allergic skin reaction. Causes serious eye irritation.
May cause cancer. May cause
allergy or asthma symptoms or breathing difficulties if inhaled. May
damage fertility or the unborn
child. May cause harm to breast-fed children. Toxic to aquatic life
with long lasting effects.
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Material name: Elanco AH0328 Component S with Tylan Growth and
Finishing Imp