Optaflexx 45

Generic Name: ractopamine hydrochloride granule
Dosage Form: FOR ANIMAL USE ONLY

Optaflexx® 45
Ractopamine
Hydrochloride

For use in Feeds For Cattle
Fed In Confinement For Slaughter Only

Net Weight 25 lb (11.34 kg)

Elanco® AF0630-25B

Type A Medicated Article

Do Not Feed Undiluted

Active Drug Ingredient: Ractopamine Hydrochloride - 45.4 g per lb (100 g per kg)

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

Indication: Complete Feed: For increased rate of weight gain, improved feed efficiency and increased carcass leanness in cattle fed in confinement for slaughter during the last 28 to 42 days on feed.

Top Dress Feed: For increased rate of weight gain and improved feed efficiency in cattle fed in confinement for slaughter during the last 28 to 42 days on feed.

Note: Carcass leanness effects are not an approved indication for use when feeding ractopamine by Top Dress Feeding methods.

Complete Feed

a Based on 90% Dry Matter Basis

Indications Appropriate Concentration of Ractopamine in Type C Medicated Feeda Ractopamine (mg/hd/d)
Increased Rate of Weight Gain, and Improved Feed Efficiency 8.2 to 24.6 g/ton (9 ppm to 27 ppm) 70-430
Increased Rate of Weight Gain, Improved Feed Efficiency, and Increased Carcass Leanness 9.8 to 24.6 g/ton (11 ppm to 27 ppm) 90-430

a The effect of ractopamine on parameters listed in this table is supported by data generated at the doses tested in the clinical field efficacy trials.

   NC = No Change, ↑= Increased, ↓ = Decreased

b Steers Only

c Reduction indicates an improvement in USDA Yield Grade.

Carcass Measurements Effect of Ractopaminea
8.2 grams/ton (9 ppm) 16.4 grams/ton (18 ppm) 24.6 grams/ton (27 ppm)
Hot Carcass Weight, lbs
Dressing Percentage, % NC b b
Carcass Percent Fat, % NC
12th Rib Fat Thickness, in. NC NC NC
Average Rib Eye Area, sq. in.
USDA Yield Grade NC NC c
Marbling Score NC NC NC
Rate of Carcass Lean Gain per Day NC
Efficiency of Carcass Lean Gain per Day NC

Top Dress Feed

a Based on 90% Dry Matter Basis

Indications Appropriate Concentration of Ractopamine in Type C Medicated Feeda Ractopamine (mg/hd/d)
Increased Rate of Weight Gain and Improved Feed Efficiency Appropriate Concentration of Ractopamine in a minimum of 1.0 lb Top Dressed Type C Medicated Feeda (maximum of 800 g/ton) 70-400

Inert Ingredients: Ground corn cobs.

Mixing Directions (Complete Feed): Thoroughly mix Optaflexx 45 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 (maximum 4,920 g/ton). The following table gives examples of how some Type B Medicated Feed concentrations can be prepared:

a Optaflexx 45 contains 45.4g ractopamine hydrochloride per pound

b Based on 90% Dry Matter Basis

Pounds of Optaflexx 45a
To Add Per Ton To Make a Type B Medicated Feed
Resulting Ractopamine Concentration in Type B Medicated Feedb
grams/ton grams/pound
36.1 1,640 0.82
72.2 3,280 1.64
108.3 4,920 2.46

Thoroughly mix Optaflexx 45 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. 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 one ton of complete feed.

a Optaflexx 45 contains 45.4g ractopamine hydrochloride per pound

b Based on 90% Dry Matter Basis

Pounds of Optaflexx 45a
Per Ton To Make a Type C Medicated Feed
Resulting Ractopamine Concentration in
Type C Medicated Feedb
0.18 8.2 grams/ton (9 ppm)
0.36 16.4 grams/ton (18 ppm)
0.54 24.6 grams/ton (27 ppm)

Mixing Directions (Liquid Type B Feeds): Thoroughly mix Optaflexx 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 (maximum 2300 g/ton).

Maintain supplement pH at 4.5 to 7.5. For stored liquid Type B medicated feeds containing ractopamine, recirculate immediately prior to use for not less than 10 minutes, moving not less than 1% of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not in use.

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

a Optaflexx 45 contains 45.4g ractopamine hydrochloride per pound

Pounds of Optaflexx 45a
To Add Per Ton To Make a Liquid Type B Medicated Feed
Resulting Ractopamine Concentration in Liquid Type B Medicated Feed
grams/ton grams/pound
36.1 1,640 0.82
44.1 2,000 1.00
50.7 2,300 1.15

Mixing Directions for Preparing Type C Medicated Top Dress Feed: Thoroughly mix Optaflexx 45 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 C Medicated Feed (maximum 800 g/ton). The following table gives examples of how some Type C Medicated Top Dress Feed concentrations can be prepared:

a Optaflexx 45 contains 45.4g ractopamine hydrochloride per pound

b Based on 90% Dry Matter Basis

Pounds of Optaflexx 45a To Add Per Ton To Make Type C
Medicated Top Dress Feed
Resulting Ractopamine Concentration in
Type C Top Dress Medicated Feedb
Top Dress grams/ton grams/pound mg/pound
2.20 100 0.05 50
4.41 200 0.10 100
6.61 300 0.15 150
8.81 400 0.20 200
17.62 800 0.40 400

Directions for Use (Complete Feed): Feed continuously to cattle fed in confinement for slaughter as the sole ration for the last 28 to 42 days on feed.

Directions for Use (Type C Medicated Top Dress Feed): Feed continuously to cattle fed in confinement for slaughter a Type C Medicated Feed containing up to a maximum of 800 g/ton ractopamine (see mixing direction table) to provide 70 to 400 mg/head/day for the last 28 to 42 days on feed. Type C Medicated Top Dress feed must be fed in a minimum of 1.0 lb per head per day to provide 70 to 400 mg/head/day.

CAUTION: Not for animals intended for breeding.

NOT FOR HUMAN USE

WARNING: The active ingredient in Optaflexx, 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 Optaflexx 45 formulation (Type A Medicated Article) poses a low dust potential under usual conditions of handling and mixing. When mixing and handling Optaflexx, 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 # 141-221, Approved by FDA

Optaflexx® 45

Elanco Animal Health
A Division of Eli Lilly and Company
Indianapolis, IN 46285, U.S.A.

To report adverse effects, access medical information, or obtain additional product information, call 1-800-428-4441.
Elanco®, Optaflexx®, and the diagonal bar are trademarks of Eli Lilly and Company.

BG5850DEAMB (V03-01-2010)

Principal Display Panel

Principal Display Panel – 25lb Bag Label

Elanco® AF0630-25B

For use in Feeds For Cattle Fed In Confinement For Slaughter Only

Optaflexx® 45

Ractopamine Hydrochloride

Net Weight 25lb

(11.34 kg)

Optaflexx 45 
ractopamine hydrochloride granule
Product Information
Product Type OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG Item Code (Source) NDC:0986-0630
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RACTOPAMINE HYDROCHLORIDE (RACTOPAMINE) RACTOPAMINE HYDROCHLORIDE 9 g  in 0.45 kg
Inactive Ingredients
Ingredient Name Strength
WATER  
SOYBEAN OIL  
Packaging
# Item Code Package Description
1 NDC:0986-0630-09 11.34 kg in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141221 06/03/2010
Labeler - Elanco Animal Health Co (807447169)
Establishment
Name Address ID/FEI Operations
Eli Lilly and Company Limited, Speke Operations 230761368 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Eli Lilly S.A. - Irish Branch 986500023 API MANUFACTURE
Revised: 06/2010
 
Elanco Animal Health Co



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