Component TE-IH With Tylan: Product Information

COMPONENT TE-IH WITH TYLAN- trenbolone acetate, estradiol and tylosin tartrate implant
Elanco US Inc.

Elanco

Component

TE-IH with Tylan

(trenbolone and estradiol and tylosin implant)

For Growing Beef Heifers
Fed in Confinement
for Slaughter

Each implant consists of 80 mg trenbolone acetate,
8 mg estradiol USP and 29 mg tylosin tartrate

FOR GROWING BEEF 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-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.

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.

DOSAGE:

Administer 1 implant per animal according to the following instructions.

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 — 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.

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.

Figure Figure

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.

Figure Figure

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.

Figure Figure

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.

Fiigure Fiigure

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.

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-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.

© 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

PA102722X AH0511

Principal Display Panel — Carton Label

Elanco

Component

TE-IH with Tylan

(trenbolone and estradiol and tylosin implant)

For Growing Beef Heifers
Fed in Confinement
for Slaughter

100 IMPLANTS

Principal Display Panel -- Carton Label
(click image for full-size original)

Principal Display Panel — Cartridge Label

Elanco

Component

TE-IH with Tylan

(trenbolone and estradiol and tylosin implant)

For Growing Beef Heifers
Fed in Confinement
for Slaughter

One 20-Dose
Cartridge Belt

Principal Display Panel -- Cartridge Label
(click image for full-size original)
COMPONENT TE-IH WITH TYLAN
trenbolone acetate, estradiol, tylosin tartrate implant
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:58198-0511
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
trenbolone acetate (trenbolone) trenbolone acetate 80 mg
estradiol (estradiol) estradiol 8 mg
tylosin tartrate (tylosin) tylosin tartrate 29 mg
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58198-0511-1 5 POUCH in 1 CARTON contains a POUCH
1 1 CARTRIDGE in 1 POUCH This package is contained within the CARTON (58198-0511-1) and contains a CARTRIDGE
1 20 IMPLANT in 1 CARTRIDGE This package is contained within a POUCH and a CARTON (58198-0511-1)
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 Operations
Ivy Animal Health, Inc. 088106096 MANUFACTURE, PACK, LABEL
Establishment
Name Address ID/FEI Operations
Pharmacia and Upjohn Company LLC 618054084 API MANUFACTURE
Establishment
Name Address ID/FEI Operations
Richter Gedeon Nyrt. 644781932 API MANUFACTURE
Establishment
Name Address ID/FEI Operations
Bayer AG 314398484 API MANUFACTURE
Establishment
Name Address ID/FEI Operations
TriRx Speke Limited 228138655 API MANUFACTURE
Establishment
Name Address ID/FEI Operations
Ivy Animal Health, Inc. 080698078 MANUFACTURE, PACK, LABEL

Revised: 06/2022 Elanco US Inc.

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