ELANCO AF0250 TYLAN 250 TYLOSIN PHOSPHATE PREMIX

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

TYLOSIN AS THE PHOSPHATE

Available from:

ELANCO AUSTRALASIA PTY LTD

INN (International Name):

tylosin as phosphate(250g/kg)

Pharmaceutical form:

ORAL POWDER, PRE-MIX

Composition:

TYLOSIN AS THE PHOSPHATE ANTIBIOTIC Active 250.0 g/kg

Units in package:

25kg

Class:

VM - Veterinary Medicine

Manufactured by:

ELANCO ANIMAL HEALTH

Therapeutic group:

CATTLE | PIGS | POULTRY BROILERS (MEAT FOR HUMAN CONSUM) | PULLET - REPLACEMENT | BEEF | BOAR | BOS INDICUS | BOS TAURUS | BOVIN

Therapeutic area:

ANTIBIOTIC & RELATED

Therapeutic indications:

ILEITIS | IMPROVE FEED EFFICIENCY | LIVER ABSCESS | NECROTIC ENTERITIS | PROMOTE ANIMAL GROWTH | SWINE DYSENTERY | FEED CONVERSION | FINISHING | GROWTH PROMOTION | GROWTH RATE | LIVEWEIGHT GAIN

Product summary:

Poison schedule: 4; Withholding period: WHP: Meat (pigs cattle poultry): NIL (at 100g or less tylosin per tonne of per tonne of final feed). Milk: Nil Eg gs: Nil; Host/pest details: CATTLE: [LIVER ABSCESS]; PIGS: [ILEITIS, SWINE DYSENTERY]; POULTRY BROILERS (MEAT FOR HUMAN CONSUM): [NECROTIC ENTERITIS]; PULLET - REPLACEMENT: [NECROTIC ENTERITIS]; As an aid in controlling enteric diseases caused by organisms 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 the control of necrotic enteritis in .

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

Product Name:
APVMA Approval No:
ELANCO AF0250 TYLAN 250 TYLOSIN PHOSPHATE PREMIX
36806/115806
Label Name:
ELANCO AF0250 TYLAN 250 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:
250
g/kg
TYLOSIN
as
the
phosphate
Claims:
For use as an aid in controlling enteric diseases caused by organisms
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.
NOTE: This product is not for resale in this form and directions for
use are
given as guidelines only. This pack is intended for use by feed
formulators for
incorporation in medicated premixes and, when utilised as recommended
by
the formulator, will supply registered levels of tylosin in the feed.
Net Contents:
25kg NET
Directions for Use:
Refer to Page 4.
Restraints:
‘
Prior to prescribing Tylan 250 Premix investigate the use of
non-antibiotic
options. If Tylan 250 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.
’ RLP APPROVED
Contraindications:
Precautions:
Side
Effects:
Dosage and
Administration:
Refer to Page 4.
General
Directions:
Withholding
Periods:
MEAT [pigs, cattle, poultry]: NIL (at 100g or less tylosin per tonne
of final feed).
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-le

Summary of Product characteristics

Issue date: 29-September-2015
Supersedes date: 29-September-2015
Revision date: 31-March-2016
Version number: 02
SAFETY DATA SHEET
1. Identification
Elanco AF0250 Tylan 250 Tylosin Phosphate Premix
Product identifier
Other means of identification
Tylosin Phosphate Concentrate
Synonyms
AF0093, AF0188, AF0248, AF0250, AF0275, AF0276, AF0292, AF0333,
QA188G, QA243P, QA344P,
QA345N, QA358C
Item Code
Recommended use of the chemical and restrictions on use
Veterinary Pharmaceutical
Recommended use
Not available.
Restrictions on use
Details of manufacturer or importer
Manufacturer
Company name
Elanco Australasia Pty Ltd.
ACN: 076 745 198
Address
112 Wharf Road
West Ryde, NSW 2114
Australia
Telephone
1800 226 324 (toll free)
e-mail
[e-mail]
Emergency phone
number
Elanco Australasia 1800 226 324 (toll free)
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
2.1. Classification of the substance or mixture
Classification according to Regulation (EC) No 1272/2008 as amended
Causes serious eye irritation.
Category 2A
Serious eye damage/eye irritation
Health hazards
May cause allergy or asthma
symptoms or breathing difficulties if
inhaled.
Category 1
Sensitization, respiratory
May cause an allergic skin reaction.
Category 1
Sensitization, skin
Very toxic to aquatic life.
Category 1
Hazardous to the aquatic environment, acute
hazard
Environmental hazards
Very toxic to aquatic life with long
lasting effects.
Category 1
Hazardous to the aquatic environment,
long-term hazard
2.2. Label elements
Label according to Regulation (EC) No. 1272/2008 as amended
Contains:
Excipient: Grain Dust, Tylosin Phosphate
Hazard pictograms
1 / 10
Material name: Elanco AF0250 Tylan 250 Tylosin Phosphate Premix
4771
SDS AUSTRALIA
Signal word
Danger
Hazard statements
Causes damage to organs. May cause an allergic skin reaction. Causes
serious eye irritation. May
cause allergy or asthma symptoms or bre