COMPONENT TE-IH WITH TYLAN- trenbolone acetate, estradiol, tylosin tartrate implant
Component TE-IH With Tylan by
Drug Labeling and Warnings
Component TE-IH With Tylan by is a Animal medication manufactured, distributed, or labeled by Elanco US Inc., Ivy Animal Health, Inc., Pharmacia and Upjohn Company LLC, Richter Gedeon Nyrt., Bayer AG, TriRx Speke Limited. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
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DESCRIPTION:
Each cartridge belt holds 20 doses of Component TE-IH with Tylan (trenbolone and estradiol and tylosin implant) Implants. Each dose of 5 pellets consists of 4 pellets containing a total of 80 mg of trenbolone acetate and 8 mg estradiol plus 1 pellet containing 29 mg tylosin tartrate as a local antibacterial. Component TE-IH (trenbolone and estradiol implant) Implants are recommended for use in heifers fed in confinement for slaughter for INCREASED RATE OF WEIGHT GAIN.
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INDICATIONS FOR USE:
This product contains trenbolone acetate and estradiol for increased rate of weight gain in a slow-release delivery system. Do not use in veal calves. Effectiveness and animal safety in veal calves have not been established.
NOTE: Studies have demonstrated that administration of Component TE-IH can result in decreased marbling scores when compared to non-implanted heifers.
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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.
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WARNING:
Not to be used in animals intended for subsequent breeding, or in dairy animals. Implant one dose — 5 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.
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 — FOR USE IN ANIMALS ONLY — NOT FOR HUMAN USE — KEEP OUT OF REACH OF CHILDREN
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IMPLANTING INSTRUCTIONS:
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 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.
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Storage Conditions
Store in a refrigerator 2° to 8°C (36° to 46°F) and protect from sunlight. Use before the expiration date printed on the foil pouch. Discard open foil pouches.
ANADA 200-346, Approved by FDA
Manufactured by a non-sterilizing process.
Component TE-IH 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
Distributed by Elanco US Inc., Greenfield, IN 46140, USA
Tylosin: Product of the United Kingdom
To report adverse events, access medical information, or to obtain additional product information, call 1-800-428-4441
PA100974X
AH0511
- Principal Display Panel – Carton Label
- Principal Display Panel – Pouch Label
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INGREDIENTS AND APPEARANCE
COMPONENT TE-IH WITH TYLAN
trenbolone acetate, estradiol, tylosin tartrate implantProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC: 58198-0511 Route of Administration SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength trenbolone acetate (UNII: RUD5Y4SV0S) (trenbolone - UNII:P53R4420TR) trenbolone acetate 80 mg estradiol (UNII: 4TI98Z838E) (estradiol - UNII:4TI98Z838E) estradiol 8 mg tylosin tartrate (UNII: 5P4625C51T) (tylosin - UNII:YEF4JXN031) tylosin tartrate 29 mg Inactive Ingredients Ingredient Name Strength CHOLESTEROL (UNII: 97C5T2UQ7J) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE K30 (UNII: U725QWY32X) ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B) ISOPROPYL ALCOHOL (UNII: ND2M416302) POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 58198-0511-1 5 in 1 CARTON 1 1 in 1 POUCH 1 20 in 1 CARTRIDGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200346 12/09/2013 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 Gedeon Richter Plc. 644781932 API MANUFACTURE Establishment Name Address ID/FEI Business Operations Bayer AG 314398484 API MANUFACTURE Establishment Name Address ID/FEI Business Operations Elanco Speke Operations 230761368 API MANUFACTURE Establishment Name Address ID/FEI Business Operations Ivy Animal Health, Inc. 080698078 MANUFACTURE
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