ELANCO AF0602 PAYLEAN 20 RACTOPAMINE HYDROCHLORIDE PREMIX

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

RACTOPAMINE HYDROCHLORIDE

Available from:

ELANCO AUSTRALASIA PTY LTD

INN (International Name):

ractopamine as HCl(17.8g/kg)

Pharmaceutical form:

ORAL POWDER, PRE-MIX

Composition:

RACTOPAMINE HYDROCHLORIDE UNGROUPED Active 20.0 g/kg

Units in package:

10kg

Class:

VM - Veterinary Medicine

Manufactured by:

ELANCO ANIMAL HEALTH

Therapeutic group:

PIG GROWER | GROWER FINISHER PIG | PIG GROWER/FINISHER

Therapeutic area:

NUTRITION & METABOLISM

Therapeutic indications:

IMPROVE FEED EFFICIENCY | INCREASED CARCASS LEANNESS | INCREASED DRESSING PERCENTAGE | PRODUCTIVITY IMPROVEMENTS | IMPROVING FEED EFFICIENCY | INCREASING RATE OF WEIGHT GAIN

Product summary:

Poison schedule: 5; Withholding period: WHP: Meat-Do not use less than 12 hours before slaughter for human consumption .; Host/pest details: PIG GROWER: [IMPROVE FEED EFFICIENCY, INCREASED CARCASS LEANNESS, INCREASED DRESSING PERCENTAGE, PRODUCTIVITY IMPROVEMENTS]; PIGS: [FOR REDUCED LACTATION WEIGHT LOSS IN BREEDING SOWS, IMPROVE FEED EFFICIENCY, INCREASED CARCASS LEANNESS, INCREASED DRESSING PERCENTAGE, PRODUCTIVITY IMPROVEMENTS]; TURKEYS: [IMPROVE FEED EFFICIENCY, INCREASE WEIGHT GAIN RATE]; Poison schedule: 5; Withholding period: WHP: Meat-Do not use less than 12 hours before slaughter for human consumption .; Host/pest details: FINISHER TURKEY: [IMPROVE FEED EFFICIENCY]; PIG GROWER: [IMPROVE FEED EFFICIENCY, INCREASED CARCASS LEANNESS, INCREASED DRESSING PERCENTAGE, PRODUCTIVITY IMPROVEMENTS]; PIGS: [FOR REDUCED LACTATION WEIGHT LOSS IN BREEDING SOWS, IMPROVE FEED EFFICIENCY, INCREASED CARCASS LEANNESS, INCREASED DRESSING PERCENTAGE]; TURKEYS: [IMPROVE FEED EFFICIENCY, INCREASE WEIGHT GAIN RATE]; For increased rate of weight gain, improved feed efficiency, increased carcass leanness and increased dressing percentage in finisher pigs.For increased rate of weight gain & improved feed efficiency in finisher turkeys.DO NOT USE IN SPECIES OTHER THAN PIGS. NOT FOR USE IN BREEDING PIGS (FOR USE IN FINISHER PIG FEEDS ONLY).

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

ELANCO AF0602 PAYLEAN 20 RACTOPAMINE HYDROCHLORIDE PREMIX
54172/109774
Product Name:
APVMA Approval No:
Label Name:
ELANCO AF0602 PAYLEAN 20 RACTOPAMINE HYDROCHLORIDE PREMIX
Signal Headings:
CAUTION
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
READ SAFETY DIRECTIONS BEFORE OPENING OR USING
Constituent
Statements:
20 g/kg ractopamine hydrochloride (equivalent to 17.8 g/kg
ractopamine)
Claims:
Pigs:
Finisher pigs: For increased rate of weight gain, improved feed
efficiency, increased
carcass leanness and increased dressing percentage.
Sows: For reduced lactation weight loss in breeding sows.
Turkeys:
For increased rate of weight gain and improved feed efficiency in
finisher turkeys.
Net Contents:
10kg
Directions for Use:
Restraints:
DO NOT ADMINISTER PAYLEAN TO SPECIES OTHER THAN PIGS AND TURKEYS.
DO NOT USE in turkeys which are producing or may in the future produce
eggs for human
consumption.
DO NOT USE IN BREEDING TURKEYS.
FOR USE IN PIG AND FINISHER TURKEY FEEDS ONLY.
Note to feed formulators:
Unintended inclusion of medication into animal feeds may result in
residues that adversely
impact trade access or the rules of professional competition. Use
cleaning or flushing,
or avoid sequencing feed for other species (in particular ruminant and
horse feeds)
immediately after manufacture of pig or turkey finisher feeds
containing Paylean.
A copy of directions for use relevant to final feed are required to be
provided to the
producers with each consignment of Paylean treated feed. Contact
Elanco Animal Health
for further information. RLP APPROVED
Contraindications:
Precautions:
Feeding ractopamine to tom turkeys during periods of excessive heat
can result in
increased mortality.
Pigs fed Paylean are at an increased risk for exhibiting the downer
pig syndrome (could
also be referred to as leg weakness syndrome). Pig handling methods to
reduce the
incidence of downer pigs should be thoroughly evaluated prior to
initiating use of Paylean.
Side Effects:
Dosage and
Administration:
Pigs
Recommended dosages of ract

Summary of Product characteristics

Issue date: 28-September-2015
Version number: 01
SAFETY DATA SHEET
1. Identification
Elanco AF0602 Paylean 20 Ractopamine Hydrochloride Premix
Product identifier
Other means of identification
Paylean 2.25 * Paylean 45
Synonyms
AF0602, AF0601, AF0605, AF0632, QD389A, QD357S, QA425U, QI0336, AF0610
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 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 1
Sensitization, respiratory
Health hazards
Category 1
Sensitization, skin
Not classified.
Environmental hazards
Label elements, including precautionary statements
Hazard symbol(s)
Health hazard
Signal word
Danger
Hazard Statement(s)
May cause an allergic skin reaction. May cause allergy or asthma
symptoms or breathing difficulties
if inhaled.
Precautionary Statement(s)
Prevention
Avoid breathing dust. Contaminated work clothing should not be allowed
out of the workplace.
Wear protective gloves/protective clothing. In case of inadequate
ventilation wear respiratory
protection.
Response
IF ON SKIN: Wash with plenty of soap and water. If skin irritation or
rash occurs: Get medical
advice/attention. If inhaled: If breathing is difficult, remove person
to fresh air and keep
comfortable for breathing. If experiencing respiratory symptoms: Call
a POISON CENTRE or
doctor/physician. Wash contaminated clothing before reuse.

Safety Data Sheet

Lot
DOM
EXP
10KG NET
AF0602
CAUTION
KEEP OUT OF REACH OF CHILDREN
READ SAFETY DIRECTIONS BEFORE OPENING OR USING
FOR ANIMAL TREATMENT ONLY
_Ractopamine Hydrochloride _
_Premix_
YL209745X
Restraint:
DO NOT ADMINISTER PAYLEAN TO SPECIES OTHER THAN
PIGS AND TURKEYS.
DO NOT USE in turkeys which are producing or may in the
future produce eggs for human consumption.
DO NOT USE IN BREEDING TURKEYS.
FOR USE IN PIG AND FINIHSER TURKEY FEEDS ONLY.
Note to feed formulators:
Unintended inclusion of medication into animal feeds may
result in residues that adversely impact trade access or the
rules of professional competition. Use cleaning or flushing, or
avoid sequencing feed for other species (in particular ruminant
and horse feeds) immediately after manufacture of pig or
turkey finisher feeds containing Paylean.
A copy of directions for use relevant to final feed are required
to be provided to the producers with each consignment of
Paylean treated feed. Contact Elanco Animal Health for
further information.
Precautions:
Pigs fed Paylean are at an increased risk for exhibiting the downer
pig syndrome (could also be referred to as leg weakness syndrome).
Pig handling methods to reduce the incidence of downer pigs
should be thoroughly evaluated prior to initiating use of Paylean.
Feeding ractopamine to tom turkeys during periods of excessive
heat can result in increased mortality.
Dosage and Administration:
Pigs
Recommended dosages of ractopamine hydrochloride:
•
5-20 ppm in final feed for increased rate of weight gain and
improved feed efficiency.
•
10-20 ppm in final feed for increased carcass leanness and
increased carcass dressing percent.
•
20 ppm in lactating sows to reduce weight loss.
Pigs Mixing Directions:
PAYLEAN 20 PREMIX MUST BE THOROUGHLY MIXED INTO
FEEDS BEFORE USE.
All calculations are based on 90% dry matter.
Ractopamine Concentration
in Final Feed g/tonne (ppm)
Grams of Paylean 20 Premix
to Add per Tonne of Final Feed
5
250
10
500
15
750
20
1000 (1 kg)
IMPORTANT – To ensure adequate mixing, it is recom