ELANCO AF 0091 TYLAN 100 TYLOSIN PHOSPHATE PREMIX

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

03-04-2018

Summary of Product characteristics (SPC)

03-04-2018

Active ingredient:

TYLOSIN AS THE PHOSPHATE

Available from:

ELANCO AUSTRALASIA PTY LTD

INN (International Name):

tylosin as phosphate(100g/kg)

Pharmaceutical form:

ORAL POWDER, PRE-MIX

Composition:

TYLOSIN AS THE PHOSPHATE ANTIBIOTIC Active 100.0 g/kg

Units in package:

20kg

Class:

VM - Veterinary Medicine

Manufactured by:

ELANCO ANIMAL HEALTH

Therapeutic group:

Therapeutic area:

ANTIBIOTIC & RELATED

Therapeutic indications:

Product summary:

Poison schedule: 4; Withholding period: WHP: Nil; Host/pest details: CATTLE: [LIVER ABSCESS]; PIGS: [ANTIBIOTIC - ANTI-INFECTIVE, BACTERIAL INFECTION, ILEITIS]; POULTRY: [NECROTIC ENTERITIS]; POULTRY BROILERS (MEAT FOR HUMAN CONSUM): [NECROTIC ENTERITIS]; As an aid controlling enteric diseases susceptible to tylosin in pigs. For the treatment and prevention of ileitis in pigs. For reduction in the incidence of liver abscess in cattle. As an aid in the control of necrotic enteritis in broiler and replacemenFor use in pig feed only

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

PRODUCT NAME: ELANCO AF0091 Tylan 100 Tylosin phosphate premix Page 1
of 4
Company Name:
ELANCO ANIMAL HEALTH A DIV OF ELI LILLY AUST PTY LTD
Product Name:
ELANCO AF 0091 TYLAN 100 TYLOSIN PHOSPHATE PREMIX
APVMA Approval No:
36790/RV0318A
Label Name:
ELANCO
AF
0091
TYLAN
100
TYLOSIN
PHOSPHATE
PREMIX
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
READ SAFETY DIRECTIONS BEFORE OPENING OR USING
Constituent
Statements:
100
g/kg
TYLOSIN
AS
THE
PHOSPHATE
Claims:
For use as an aid in controlling enteric diseases susceptible to
tylosin in pigs.
For the treatment and prevention of ileitis in pigs.
For reduction in the incidence of liver abscess in cattle.
As an aid in the control of necrotic enteritis caused by Clostridium
perfringens
in broiler and replacement chickens.
Net Contents:
20kg
Directions for Use:
Refer to Page 3.
Restraints:
‘
Prior to prescribing ELANCO
AF
0091
TYLAN
100
TYLOSIN
PHOSPHATE
PREMIX investigate the use of non-antibiotic options. If ELANCO
AF
0091
TYLAN
100
TYLOSIN
PHOSPHATE
PREMIX is indicated and selected for
use, prudent prescribing practices (appropriate dose, duration and
frequency
to minimise treatment failure while minimising the emergence of
antimicrobial
resistance) must be adhered to.
NOT TO BE USED FOR ANY PURPOSE, OR IN ANY MANNER,
CONTRARY TO THIS LABEL.
’
Contraindications:
Precautions: RLP APPROVED
PRODUCT NAME: ELANCO AF0091 Tylan 100 Tylosin phosphate premix Page 2
of 4
Side
Effects:
Dosage and
Administration:
Refer to Page 3.
General
Directions:
Withholding
Periods:
MEAT [pigs, cattle, poultry]: NIL
MILK: NIL
EGGS: NIL
Trade
Advice:
Safety
Directions:
Harmful if swallowed. Will irritate the eyes and skin. Avoid contact
with eyes and
skin. Repeated exposure may cause allergic disorders. Do not inhale
dust.
When opening the container and mixing into premixes wear cotton
overalls
buttoned to the neck and wrist and a washable hat, elbow-length PVC
gloves
and disposable dust face mask covering mouth and nose. After use and
befo

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Summary of Product characteristics

MATERIAL SAFETY DATA SHEET
ELANCO AF0091 TYLAN 100 TYLOSIN PHOSPHATE PREMIX
AF0091
Revision No: 4.0 8 November 2010
COMPANY NAME AND ADDRESS:
Elanco Animal Health
A Division of Eli Lilly Australia Pty Ltd
A.B.N. 39 000 233 992
112 Wharf Road, West Ryde, N.S.W. 2114, Australia
CONTACT NUMBERS:
Tel:
(02) 9878 7777
Fax:
(02) 9878 7720
EMERGENCY TELEPHONE NUMBERS:
Elanco Animal Health:
1800 226 324 (Toll free)
_OR_
Poisons Information Centre:
131126 (Australia-wide)
CHEMWATCH:
1800 039 008: 24 hour emergency contact number (spills and accidents)
SECTION 1 - IDENTIFICATION
PRODUCT NAME:
Elanco AF0091 Tylan 100 Tylosin Phosphate Premix
OTHER NAMES:
Tylosin Phosphate (salt), Tylosin Phosphate Premix, Tylosin
Premix, 033840 Formulation
MANUFACTURER’S PRODUCT
CODE:
AF0091
UN NUMBER:
None allocated
DANGEROUS GOODS
CLASS/SUBSIDIARY RISK:
None allocated
HAZCHEM CODE:
2X
POISONS SCHEDULE:
4
PACK SIZE AND
CONTAINER TYPE:
20 kg bag
USE:
Major Recommended Uses: For use as aid in controlling enteric
diseases susceptible to tylosin and as an aid in stimulating
growth and improving feed efficiency in pigs. For the treatment
and prevention of ileitis in pigs. For reduction in the incidence of
liver abscess in cattle. As an aid in the control of necrotic
enteritis caused by _Clostridium perfringens_ in broiler and
replacement chickens.
Major Recommended Method of Application: Mixed with feed.
SECTION 2 – HAZARDS IDENTIFICATION
HAZARDOUS ACCORDING TO CRITERIA OF WORKSAFE AUSTRALIA
NOT CLASSIFIED AS DANGEROUS GOODS FOR TRANSPORT BY ROAD AND RAIL
ACCORDING TO THE
CRITERIA OF ADG 7
MATERIAL SAFETY DATA SHEET, ELANCO AF0091 TYLAN 100 TYLOSIN PHOSPHATE
PREMIX
Revision No: 4.0 8 November 2010
Page 2 of 5
Irritating to eyes. Can cause allergic reactions
RISK PHRASES:
R36
Irritating to eyes
R42/43 May cause sensitisation by inhalation and skin contact
SAFETY PHRASES:
S2 Keep out of the reach of children
S26
In case of contact with eyes, rinse immediately with plenty
of water and seek medical advice
S36/37/39 Wear suitable protective cloth

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