Label: EXPERIOR 50- lubabegron granule
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- NDC Code(s): 58198-5567-1
- Packager: Elanco US Inc.
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
Drug Label Information
Updated November 30, 2020
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SPL UNCLASSIFIED SECTION
For Use in Feeds for Beef Steers and Heifers Fed in Confinement for Slaughter
Important: For further manufacturing only. Experior 50 must be thoroughly mixed into feeds before use. Follow label directions.
Active Drug Ingredient: Lubabegron (as lubabegron fumarate) - 50 g per kg (22.7 g per lb)
Inert Ingredients: Corn cob grits, mineral oil, citric acid.
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Indications for Use:
For reduction of ammonia gas emissions per pound of live weight and hot carcass weight in beef steers and heifers fed in confinement for slaughter during the last 14 to 91 days on feed.
Effectiveness has not been demonstrated when fed for less than 14 days.
Ammonia gas emissions were measured for individual animals or small groups of animals held in environmentally controlled facilities. Based on existing information, reliable predictions of the reduction of ammonia gas emissions cannot be made on a herd, farm, or larger scale.
Increased rate of weight gain, improved feed efficiency, and increased carcass leanness have not been demonstrated with this product.
Mixing Directions: Thoroughly mix Experior 50 Type A medicated article in a ton of appropriate feed ingredients according to the table below to obtain the proper concentration in the Type B medicated feed (maximum 720 g/ton). Type B medicated feeds should not be pelleted. The following table gives examples of how some Type B medicated feed concentrations can be prepared:
a Experior 50 contains 22.7 grams of lubabegron per pound
b Based on 90% Dry Matter Basis
Pounds of Experior 50 Type Aa
To Add Per Ton To Make a Type B Medicated FeedResulting lubabegron Concentration in Type B Medicated Feedb grams/ton grams/pound 2.0 45.4 0.02 15.4 350 0.17 31.7 720 0.36 Thoroughly mix Experior 50 Type A medicated article in a ton of complete cattle feed according to the table below to obtain the proper concentration in the Type C medicated feed. You must prepare an intermediate pre-blend by thoroughly mixing the required amount of Experior 50 Type A medicated article in a convenient quantity of feed ingredients, and then add the pre-blend to the remaining feed ingredients to make a complete feed.
a Experior 50 contains 22.7 grams of lubabegron per pound
b Based on 90% Dry Matter Basis
c Value is rounded. Rounded value from 0.0551.
Pounds of Experior 50 Type Aa
To Add Per Ton To Make a Type C
Medicated FeedResulting lubabegron Concentration (g/ton) in Type C Medicated Feedb 0.06c 1.25 0.11 2.50 0.20 4.54 Feeding Directions: Feed 1.25 to 4.54 g/ton (1.39 to 5 ppm) of complete feed (90% dry matter basis) to provide 13-90 mg lubabegron/head/day continuously to beef steers and heifers fed in confinement for slaughter as the sole ration during the last 14 to 91 days on feed.
Caution: Not approved for use in breeding animals because safety and effectiveness have not been evaluated in these animals. Do not allow horses or other equines access to feed containing Experior 50. A decrease in dry matter intake may be noticed in some animals.
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Warnings:
No withdrawal period is required when used according to labeling.
User Safety Warning: The active ingredient in Experior 50, lubabegron, is a beta-adrenergic agonist/antagonist. Individuals with cardiovascular disease should exercise special caution to avoid exposure. Not for human use. Keep out of reach of children. When mixing and handling Experior 50, 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 thoroughly with water; if wearing contact lenses, rinse eyes first, then remove contact lenses and continue to rinse for 5-20 minutes. If irritation persists, seek medical attention. The safety data sheet contains more detailed occupational safety information. To report adverse drug events, access medical information, or obtain additional product information, call Elanco US Inc. at 1-800-428-4441. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae
Lot No:
Expiry Date:
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Storage Information:
Store at or below 25°C (77°F). Excursions permitted to 30°C (86°F).
Not to be used after the date printed on the bag.
Restricted Drug (California) – Use Only as Directed
Approved by FDA under NADA #141-508
Manufactured For: Elanco US Inc. 2500 Innovation Way Greenfield, IN 46140, U.S.A. Experior, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.
Net Weight 10 kg
(22.04 lb)
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YL102500X
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INGREDIENTS AND APPEARANCE
EXPERIOR 50
lubabegron granuleProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:58198-5567 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Lubabegron (UNII: 8501207BZX) (Lubabegron - UNII:8501207BZX) Lubabegron 50 g in 1 kg Inactive Ingredients Ingredient Name Strength CORN GRAIN (UNII: C1Z9U7094Z) Mineral oil (UNII: T5L8T28FGP) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58198-5567-1 50 kg in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA141508 07/16/2020 Labeler - Elanco US Inc. (966985624) Establishment Name Address ID/FEI Business Operations Elanco Clinton Laboratories 039138631 API MANUFACTURE, MANUFACTURE, PACK, LABEL
