Topmax Prescribing Information
Package insert / product label
Generic name: ractopamine hydrochloride
Dosage form: FOR ANIMAL USE ONLY
ELANCO* AF0621
For Use in the Manufacture of Medicated Turkey Feed.
Topmax™ 9
Ractopamine
Hydrochloride
WARNING: The active ingredient in Topmax, 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 Topmax 9 formulation (Type A Medicated Article) poses a low dust potential under usual conditions of handling and mixing. When mixing and handling Topmax, 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.
Type A Medicated Article
| Do Not Feed Undiluted |
Active Drug Ingredient: ractopamine hydrochloride – 9 g per lb (20 g per kg)
Important: Must be thoroughly mixed into feeds before use. Follow label directions.
Indications: Toms: For increased rate of weight gain and improved feed efficiency in finishing tom turkeys when fed for the last 14 days prior to slaughter.
Hens: For increased rate of weight gain and improved feed efficiency in finishing hen turkeys when fed for the last 7 to 14 days prior to slaughter.
| Indications | Appropriate Concentration of |
| Ractopamine in Type C Medicated Feed | |
| 4.6 to 11.8 g/ton (5 ppm to 13 ppm) | |
| Toms: Increased Rate of Weight Gain | No increased benefit has been shown when |
| and Improved Feed Efficiency | ractopamine concentrations in the diet are |
| greater than 4.6 g/ton (5 ppm). | |
| Hens: Increased Rate of Weight Gain | |
| and Improved Feed Efficiency | 4.6 to 11.8 g/ton (5 ppm to 13 ppm) |
Inert Ingredients: Ground corn cobs.
Mixing Directions: Thoroughly mix Topmax 9 Type A Medicated Article into one 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:
| Pounds of Topmax 9 To Add Per Ton | Resulting Ractopamine Concentration in Type B Medicated Feed | |
| To Make a 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 Topmax 9 Type A Medicated Article into one ton of complete turkey 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 Topmax 9 to Add Per Ton
of Type C Medicated Feed | Resulting Ractopamine Concentration in
Type C Medicated Feed |
| 0.5 lb | 4.6 g/ton (5 ppm) |
| 0.9 lb | 8.2 g/ton (9 ppm) |
| 1.3 lb | 11.8 g/ton (13 ppm) |
Feeding Directions: Feed continuously as the sole ration, 4.6 to 11.8 g/ton to finishing tom turkeys for the last 14 days prior to slaughter. Feed continuously as the sole ration, 4.6 to 11.8 g/ton to finishing hen turkeys for the last 7 to 14 days prior to slaughter.
CAUTION: Feeding ractopamine to tom turkeys during periods of excessive heat can result in increased mortality.
Not for animals intended for breeding.
NOT FOR HUMAN USE.
Store at room temperature. Avoid moisture.
Expiration Date and Lot Number are printed on the bag. Not to be used after the expiry date.
To report adverse effects, access medical information, or obtain additional product information, call 1-800-428-4441.
Manufactured For: Elanco Animal Health
A Division of Eli Lilly and Company
Indianapolis, IN 46285, U.S.A.
Restricted Drug (California) – Use Only as Directed
NADA 141-290, Approved by FDA
*Elanco®, Topmax™, and the diagonal color bar are trademarks of Eli Lilly and Company.
YM9140DEAMM (V01-09-2008)
TAKE TIME TO
OBSERVE LABEL DIRECTIONS
Topmax™ 9
Net Weight 25 lb
(11.34 kg)
| TOPMAX
ractopamine hydrochloride granule |
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| Labeler - Elanco Animal Health Co (807447169) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Eli Lilly and Company Limited (Speke Operations) | 230761368 | MANUFACTURE, ANALYSIS | |
