Thursday, September 15, 2016

Paylean 9





Dosage Form: FOR ANIMAL USE ONLY
Paylean® 9

Ractopamine

Hydrochloride

For Use in Finishing

Swine Feeds Only


Net Weight 25 lbs

(11.34 kg)


ELANCO* AF0602-25B



Type A Medicated Article



Do not feed undiluted.

Active Drug Ingredient: ractopamine hydrochloride - 9 g per lb (20 g per kg)



Important: Must be thoroughly mixed into feeds before use. Follow label directions.



Indication: For increased rate of weight gain, improved feed efficiency and increased carcass leanness in finishing swine, weighing not less than 150 lbs, fed a complete ration containing at least 16% crude protein for the last 45 to 90 lbs of gain prior to slaughter.







Appropriate Concentration of Ractopamine in Type C

Medicated Feed
4.5 to 9.0 g/ton*
(5 to 10 ppm)
* No increased benefit has been shown when ractopamine
concentrations in the diet are greater than 4.5 g/ton (5 ppm).

Inert Ingredients: Ground corncobs.
















































NC= No Change, = increased, = decreased,



a Improvement was observed only in pigs weighing less than 250 lbs.


VariableLast 45 lbs of body weight gainLast 90 lbs of body weight gain
4.5 g/ton ractopamine9.0 g/ton ractopamine4.5 g/ton ractopamine9.0 g/ton ractopamine 
Carcass Fat↓a↓a
10th Rib Backfat (3/4 location)NCNCNC
Last Rib Backfat (midline)NCNCNCNC
Loin Eye Area (10th Rib)↑a
Rate of Lean Gain
Efficiency of Lean Gain
Dressing PercentageNC

Mixing Directions: Thoroughly mix Paylean 9 Type A Medicated Article into one ton of appropriate feed ingredients according to the table below to obtain the proper concentration in the Type B Medicated Feed (maximum 4920 g/ton).


The following table gives examples of how some Type B Medicated Feed concentrations can be prepared:



















Pounds of Paylean 9 To Add Per Ton

To Make a Type B Medicated Feed
Resulting Ractopamine Concentration in Type B Medicated Feed
grams/tongrams/pound 
1009000.45
2001,8000.90
3002,7001.35
4003,6001.80

Thoroughly mix Paylean 9 Type A Medicated Article into one ton of complete swine feed according to the table below to obtain the proper concentration in the Type C Medicated Feed. Prepare an intermediate pre-blend of the premix prior to mixing in a complete feed. Thoroughly mix the required amount in a convenient quantity of feed ingredients, then add to the remaining feed ingredients to make a ton of complete feed.








Pounds of Paylean 9 To Add

Per Ton of Type C Medicated Feed
Resulting Ractopamine Concentration

in Type C Medicated Feed
0.54.5 grams/ton (5 ppm)
1.09 grams/ton (10 ppm)

Feeding Directions: Feed continuously as the sole ration to finishing swine weighing not less than 150 lbs for the last 45 to 90 lbs (group average) of weight gain prior to slaughter.



CAUTION: Ractopamine may increase the number of injured and/or fatigued pigs during marketing.


Not for use in breeding swine.


NOT FOR HUMAN USE




WARNING: The active ingredient in Paylean, ractopamine hydrochloride, is a beta-adrenergic agonist. Individuals with cardiovascular disease should exercise special caution to avoid exposure. Not for use in humans. Keep out of the reach of children. The Paylean 9 formulation (Type A Medicated Article) poses a low dust potential under usual conditions of handling and mixing. When mixing and handling Paylean, use protective clothing, impervious gloves, protective eye wear, and a NIOSH-approved dust mask. Operators should wash thoroughly with soap and water after handling. If accidental eye contact occurs, immediately rinse eyes thoroughly with water. If irritation persists, seek medical attention. The material safety data sheet contains more detailed occupational safety information. To report adverse effects, access medical information, or obtain additional product information, call 1-800-428-4441.




Store at room temperature. Avoid Moisture.


Expiration Date and Lot Number are printed on the bag. Not to be used after the expiry date.


Restricted Drug (California) - Use Only as Directed - NADA # 140-863, Approved by FDA


Manufactured for: Elanco Animal Health

                                 A Division of Eli Lilly and Company

                                 Indianapolis, IN 46285, USA


Paylean® 9



To report adverse effects, access medical information, or obtain additional product information, call 1-800-428-4441.


*Elanco®, Paylean® and the diagonal color bar are trademarks of Eli Lilly and Company.


BG5004DEAMB (V04-06-2007)


Principal Display Panel

Principal Display Panel - 25 lb Bag Label


ELANCO* AF0602-25B


Paylean® 9


Ractopamine


Hydrochloride


For Use in Finishing


Swine Feeds Only


Net Weight 25 lbs


(11.34 kg)










Paylean 9 
ractopamine hydrochloride  granule










Product Information
Product TypeOTC TYPE A MEDICATED ARTICLE ANIMAL DRUGNDC Product Code (Source)0986-0602
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RACTOPAMINE HYDROCHLORIDE (RACTOPAMINE)RACTOPAMINE HYDROCHLORIDE20 g  in 1 kg








Inactive Ingredients
Ingredient NameStrength
WATER 
SOYBEAN OIL 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
10986-0602-0911.34 kg In 1 BAGNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA14086305/24/2010


Labeler - Elanco Animal Health Co (807447169)









Establishment
NameAddressID/FEIOperations
Eli Lilly and Company Limited, Speke Operations230761368MANUFACTURE









Establishment
NameAddressID/FEIOperations
Eli Lilly S.A. - Irish Branch986500023API MANUFACTURE
Revised: 05/2010Elanco Animal Health Co



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