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Animal NDC 58198-0758-1 Component Te-g

Trenbolone Acetate And Estradiol

Animal Product Information

Field Name Field Value
Animal NDC Code 58198-0758-1
Proprietary Name Component Te-g What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Trenbolone Acetate And Estradiol What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Elanco Us Inc.
Product Type Otc Animal Drug
Usage Information
    For increased rate of weight gain in growing beef steers and heifers on pasture (stocker, feeder, and slaughter).Not approved for repeated implantation (re-implantation) with this or any other cattle ear implant in growing beef steers and heifers on pasture (stocker, feeder, and slaughter). Safety and effectiveness following re-implantation have not been evaluated.Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because effectiveness and safety have not been established.Do not use in animals intended for subsequent breeding, or in dairy cows.
Active Ingredient(s)
  • Estradiol
  • Trenbolone Acetate
Marketing Category ANADA - ABBREVIATED NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number ANADA200221 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Component Te-g Images

Component Te-g Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



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ElancoTM

ComponentTM TE-G

(trenbolone acetate and estradiol implants)

FOR GROWING BEEF STEERS AND HEIFERS ON PASTURE
(Stocker, Feeder, and Slaughter)

20 dose Cartridge Belt

Use with a Component Implanter

Approved by FDA under ANADA # 200-221

Manufactured by a non-sterilizing process.

Component, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.
© 2023 Elanco or its affiliates

Distributed by Elanco US Inc,
Greenfield, IN 46140, USA

QUESTIONS/COMMENTS? For a copy of the Safety Data Sheet or to report side effects, 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.

June 2023

PA104036X            AH0758


Description:



Each cartridge belt holds 20 doses of Component TE-G (trenbolone acetate and estradiol implant) Implants. Each dose of 2 pellets consists of 2 pellets containing a total of 40 mg of trenbolone acetate and 8 mg estradiol.


Indications For Use:



For increased rate of weight gain in growing beef steers and heifers on pasture (stocker, feeder, and slaughter).

Not approved for repeated implantation (re-implantation) with this or any other cattle ear implant in growing beef steers and heifers on pasture (stocker, feeder, and slaughter). Safety and effectiveness following re-implantation have not been evaluated.

Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because effectiveness and safety have not been established.

Do not use in animals intended for subsequent breeding, or in dairy cows.


Withdrawal Periods And Residue Warnings



No withdrawal period is required when used according to labeling.

Do not use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves.

Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or calves born to these cows.

Implant pellets subcutaneously in ear only. Any other location is a violation of Federal law. Do not attempt salvage of implanted site for human or animal food.


User Safety Warnings:



Not for human use. Keep out of reach of children.

Restricted Drug (California) - use only as directed.


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 as 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 the 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.


Storage Conditions



Store unopened product at or below 25°C (77°F). Avoid excessive heat and humidity.

Use before the expiration date printed on foil pouch. Discard open foil pouches.


Package/Label Principal Display Panel – Cartridge Belt Label



ElancoTM

ComponentTM TE-G

(trenbolone acetate and estradiol implants)

For Growing Beef Steers and Heifers on
Pasture (Stocker, Feeder, and Slaughter)

TAKE TIME

OBSERVE LABEL
DIRECTIONS

One 20-Dose
Cartridge Belt

FL104036A


Package/Label Principal Display Panel – Carton Label



ElancoTM

ComponentTM TE-G

(trenbolone acetate and estradiol implants)

For Growing Beef Steers and Heifers on
Pasture (Stocker, Feeder, and Slaughter)

TAKE TIME

OBSERVE LABEL
DIRECTIONS


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.