Label: PAYLEAN 9- ractopamine hydrochloride granule
- NDC Code(s): 58198-0602-9
- Packager: Elanco US Inc.
- Category: VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
Updated November 1, 2018
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INDICATIONS & USAGE
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
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.
Last 45 lbs of body weight gain Last 90 lbs of body weight gain Variable 4.5 g/ton ractopamine 9.0 g/ton ractopamine 4.5 g/ton ractopamine 9.0 g/ton ractopamine Carcass Fat ↓a ↓a ↓ ↓ 10th Rib Backfat (3/4 location) NC NC NC ↓ Last Rib Backfat (midline) NC NC NC NC Loin Eye Area (10th Rib) ↑a ↑ ↑ ↑ Rate of Lean Gain ↑ ↑ ↑ ↑ Efficiency of Lean Gain ↑ ↑ ↑ ↑ Dressing Percentage NC ↑ ↑ ↑
DOSAGE & ADMINISTRATION
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/ton grams/pound 100 900 0.45 200 1,800 0.90 300 2,700 1.35 400 3,600 1.80
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
0.5 4.5 grams/ton (5 ppm) 1.0 9 grams/ton (10 ppm)
DOSAGE & ADMINISTRATION
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
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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.
STORAGE AND HANDLING
Storage information: Store at less than or equal to 25°C (77°F).
Excursions to 40°C (104°F) are acceptable. Avoid excessive 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 US, Inc
Greenfield, IN 46140, USA
To report adverse effects, access medical information, or obtain additional product information, call 1-800-428-4441.
Paylean, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.
- Principal Display Panel – 25 lbs Bag Label
INGREDIENTS AND APPEARANCE
ractopamine hydrochloride granule
Product Information Product Type VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG Item Code (Source) NDC:58198-0602 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ractopamine hydrochloride (UNII: 309G9J93TP) (ractopamine - UNII:57370OZ3P1) ractopamine hydrochloride 20 g in 1 kg Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) soybean oil (UNII: 241ATL177A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58198-0602-9 11.34 kg in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA140863 05/24/2010 Labeler - Elanco US Inc. (966985624)