COMPONENT TE-200 WITH TYLAN- trenbolone acetate, estradiol, tylosin tartrate implant
Elanco US Inc.
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Elanco™
Component™
TE-200 with Tylan
(trenbolone and estradiol and tylosin implant)
For Growing Beef Steers and Heifers Fed
in Confinement for Slaughter
Each implant consists of 200 mg trenbolone acetate,
20 mg estradiol USP and 29 mg tylosin tartrate
FOR GROWING BEEF STEERS AND HEIFERS FED IN CONFINEMENT FOR SLAUGHTER
20 dose Cartridge Belt
Use with a Component Implanter
DESCRIPTION:
Each cartridge belt holds 20 doses of Component TE-200 with Tylan (trenbolone and estradiol and tylosin implant) Implants. Each dose of 11 pellets consists of 10 pellets containing a total of 200 mg of trenbolone acetate and 20 mg estradiol plus 1 pellet containing 29 mg tylosin tartrate as a local antibacterial. Component TE-200 (trenbolone and estradiol implant) Implants are recommended for use in growing beef steers and heifers fed in confinement for slaughter for INCREASED RATE OF WEIGHT GAIN AND IMPROVED FEED EFFICIENCY.
INDICATIONS FOR USE:
This product contains trenbolone acetate and estradiol for increased rate of weight gain and improved feed efficiency in a slow-release delivery system. Do not use in veal calves. Effectiveness and animal safety in veal calves have not been established.
NOTE: Component TE-200 (trenbolone and estradiol implant) is not better for increased average daily gain or improved feed efficiency than Component TE-H (trenbolone and estradiol implant) (140 mg trenbolone acetate / 14 mg estradiol) in heifers fed in confinement for slaughter. Studies have demonstrated that administration of Component TE-200 can result in decreased marbling scores when compared to non-implanted steers and heifers.
GENERAL INSTRUCTIONS:
Study the instructions which should be followed carefully at all times, avoiding short cuts. Skin infection can be avoided by properly preparing implant site and implanter. During fly season use fly repellent on implant site. One designated team member should always do the implanting. Cleanliness of hands and instruments is important at all times.
WARNING:
Not to be used in animals intended for subsequent breeding, or in dairy animals. Implant one dose — 11 pellets (entire contents of one cartridge cell) — in the ear subcutaneously. Any other site of implantation is in violation of Federal Law. DO NOT attempt to salvage implantation site for animal feed or human food.
This product is intended for use in cattle at high risk of developing ear abscesses. Not recommended for use in cattle at low risk of developing ear abscesses (e.g., dry, clean cattle).
The benefit of using a cattle ear implant containing a tylosin tartrate pellet when animals receive a concomitant antimicrobial product has not been evaluated.
Withdrawal Periods and Residue Warnings
No withdrawal period is required when used according to labeling.
A withdrawal period has not been established for this product in pre-ruminating calves.
Do not use in calves to be processed for veal
RESTRICTED DRUG (CALIFORNIA) — USE ONLY AS DIRECTED — NOT FOR HUMAN USE —KEEP OUT OF REACH OF CHILDREN
IMPLANTING INSTRUCTIONS:
Loading the Implanter
Load the implanter following the instructions supplied with each implanter.
Restrain the Animal
Speed of implantation as well as safety of handlers is best achieved by restraining animal in a squeeze chute using head restraint. When implanting horned cattle, better control is obtained with additional use of nose tongs.
Prepare the Implant Site
Scrub the back side of the ear (implant site) with a piece of clean absorbent cotton which has been soaked with topical germicidal solution. Follow manufacturer's directions on germicide for correct strength and preparation of solution. Avoid getting disinfectant in animal's eyes.
Where to Implant
The full contents of one cartridge cell should be implanted beneath the skin on the back side of the middle one-third of the ear illustrated in the drawing. The implant must not be closer to the head than the edge of the auricular cartilage ring farthest from the head. The location for insertion of the needle is a point toward the tip of the ear at least a needle length away from the intended deposition site. Avoid injuring the large arteries, veins and cartilage of the ear.
Insert the Needle
With one hand firmly grasp the ear. With the other hand insert needle point through the skin and ease forward on a lateral plane until the entire length of the needle is under the skin.
Implant the Pellets
After inserting the needle fully in the correct implant position, squeeze the trigger fully as the needle is withdrawn from the ear. This properly deposits the implant in the needle track. This procedure should prevent breakage or crushing of pellets if otherwise forced into contact with tough fibrous-tissue underlying the skin. The length and total contact area of a single dose are designed to permit absorption of the hormones after implantation to stimulate good weight gain. Broken or crushed pellets may interfere with rates of gain.
Clean the Needle
Clean the implanter needle with alcohol or a properly diluted germicidal solution prior to implanting the next animal.
Storage Conditions
Store unopened product at or below 25°C (77°F). Avoid excessive heat and humidity.
Use before the expiration date printed on the foil pouch. Discard open foil pouches.
Approved by FDA under ANADA # 200-346
Manufactured by a non-sterilizing process.
Component TE-200 with Tylan (trenbolone and estradiol and tylosin implant) is covered by U.S. Patent No. 5,874,098
Component, Tylan, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.
© 2021 Elanco or its affiliates
Distributed by Elanco US Inc.,
Greenfield, IN 46140, USA
Tylosin: Product of the United Kingdom
To report suspected adverse events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Elanco US, Inc. at 1-888-545-5973.
For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.
PA102721X AH0513
| COMPONENT TE-200 WITH TYLAN
trenbolone acetate, estradiol, tylosin tartrate implant |
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| Labeler - Elanco US Inc. (966985624) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Ivy Animal Health, Inc | 088106096 | MANUFACTURE, PACK, LABEL | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Pharmacia and Upjohn Company LLC | 618054084 | API MANUFACTURE | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Richter Gedeon Nyrt. | 644781932 | API MANUFACTURE | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Bayer AG | 314398484 | API MANUFACTURE | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| TriRx Speke Limited | 228138655 | API MANUFACTURE | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Ivy Animal Health, Inc. | 080698078 | MANUFACTURE, PACK, LABEL | |