EXPERIOR 50- lubabegron granule

Experior 50 by

Drug Labeling and Warnings

Experior 50 by is a Animal medication manufactured, distributed, or labeled by Elanco US Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Experior™50TM

(lubabegron Type A medicated article)

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.

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 (Dry Type B Medicated Feeds):

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). If mixing less than 5 pounds of Type A medicated article per ton to make a dry Type B 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 into the remaining feed ingredients to make a dry Type B medicated feed. 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 Feed	Resulting lubabegron Concentration in; Type B Medicated Feedb
	grams/ton
2.0	45.4
15.4	350
31.7	720

Mixing Directions (Liquid Type B Medicated Feeds):

Thoroughly mix Experior 50 Type A medicated article in a ton of appropriate feed ingredients or diluents according to the table below to obtain the proper concentration in the Type B Medicated Feed (15.5 to 185 g/ton). If mixing less than 5 pounds of Type A medicated article per ton to make a Type B liquid 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 or diluents, and then mix the pre-blend into the remaining feed ingredients or diluents to make a Type B liquid medicated feed.

Formulate medicated feed to a pH of 4 to 9 and dry matter content of 60% to 75%. Liquid Type B Medicated Feeds containing Experior stored in recirculation tank systems: Recirculate immediately prior to use for not less than 10 minutes, moving no less than 1% of the tank contents per minute from the bottom to the top of the tank. Recirculate daily as described even when not used. For liquid feeds stored in mechanical, air, or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used.

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

a Experior 50 contains 22.7 g lubabegron per pound
Pounds of Experior 50 Type Aa; To Add Per Ton to Make a; Liquid Type B Medicated Feed	Resulting lubabegron Concentration in; Liquid Type B Medicated Feed
	grams/ton
0.7	15.5
4.4	100
8.1	184

Mixing Directions (Dry Type C Medicated Complete Feeds):

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 Feed	Resulting 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.

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:

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.

Experior, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.

© 2021 Elanco or its affiliates

Net Weight 10 kg
(22.04 lb)

TAKE TIME

OBSERVE LABEL
DIRECTIONS

YL103064X

Principal Display Panel - 10 kg Bag Label

Elanco™

Experior™ 50 ™

(lubabegron Type A
medicated article)

INGREDIENTS AND APPEARANCE

EXPERIOR 50 
lubabegron granule

Product 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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58198-5567-1	10 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)