OPTAFLEXX 45- ractopamine hydrochloride powder
Optaflexx 45 by
Drug Labeling and Warnings
Optaflexx 45 by is a Animal medication manufactured, distributed, or labeled by Elanco US Inc., Evonik Corporation, TriRx Speke Limited. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
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INDICATIONS & USAGE
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 Feed aRactopamine (mg/hd/d) Increased Rate of Weight Gain,
and Improved Feed Efficiency8.2 to 24.6 g/ton
(9 ppm to 27 ppm)70-430 Increased Rate of Weight Gain,
Improved Feed Efficiency, and
Increased Carcass Leanness9.8 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 Ractopamine a 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 Feed aRactopamine
(mg/hd/d)Increased Rate of
Weight Gain and
Improved Feed
EfficiencyAppropriate 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.
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DOSAGE & ADMINISTRATION
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 45.4 g ractopamine hydrochloride per pound
b Based on 90% Dry Matter Basis
Pounds of Optaflexx 45 a
To Add Per Ton To Make a
Type B Medicated FeedResulting Ractopamine Concentration in
Type B Medicated Feed bgrams/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 45.4 g ractopamine hydrochloride per pound
b Based on 90% Dry Matter Basis
Pounds of Optaflexx 45 a Per Ton To Make
a Type C Medicated FeedResulting Ractopamine Concentration in
Type C Medicated Feed b0.18 8.2 grams/ton (9 ppm) 0.36 16.4 grams/ton (18 ppm) 0.54 24.6 grams/ton (27 ppm) -
DOSAGE & ADMINISTRATION
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 45.4 g ractopamine hydrochloride per pound
Pounds of Optaflexx 45 a To Add Per Ton To Make a
Liquid Type B Medicated FeedResulting Ractopamine Concentration in
Liquid Type B Medicated Feedgrams/ton grams/pound 36.1 1,640 0.82 44.1 2,000 1.00 50.7 2,300 1.15 -
DOSAGE & ADMINISTRATION
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 45.4 g ractopamine hydrochloride per pound
b Based on 90% Dry Matter Basis
Pounds of Optaflexx 45 a To Add Per Ton To
Make Type C Medicated Top Dress FeedResulting Ractopamine Concentration
in Type C Top Dress Medicated Feed bTop 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 - DOSAGE & ADMINISTRATION
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DOSAGE & ADMINISTRATION
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
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BOXED WARNING
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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.
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STORAGE AND HANDLING
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
TAKE TIME
OBSERVE LABEL DIRECTIONSOptaflexx™ 45
Manufactured for:
Elanco US, Inc
Greenfield, IN 46140, USATo report adverse effects, access medical information, or obtain additional product information, call 1-800-428-4441.
Optaflexx, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.
BG209769X
- Principal Display Panel – 25 lb Bag Label
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INGREDIENTS AND APPEARANCE
OPTAFLEXX 45
ractopamine hydrochloride powderProduct Information Product Type OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG Item Code (Source) NDC: 58198-0630 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ractopamine hydrochloride (UNII: 309G9J93TP) (ractopamine - UNII:57370OZ3P1) ractopamine hydrochloride 45.4 g in 0.45 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: 58198-0630-9 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 US Inc. (966985624)
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