Label: COMPONENT TE-G- trenbolone acetate and estradiol implant
- NDC Code(s): 58198-0758-1
- Packager: Elanco US Inc.
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Animal Drug Application
Drug Label Information
Updated December 6, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- DESCRIPTION:
-
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:
-
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
-
SPL UNCLASSIFIED SECTION
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 affiliatesDistributed by Elanco US Inc,
Greenfield, IN 46140, USAQUESTIONS/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
- Package/Label Principal Display Panel – Cartridge Belt Label
- Package/Label Principal Display Panel – Carton Label
-
INGREDIENTS AND APPEARANCE
COMPONENT TE-G
trenbolone acetate and estradiol implantProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:58198-0758 Route of Administration SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRENBOLONE ACETATE (UNII: RUD5Y4SV0S) (TRENBOLONE - UNII:P53R4420TR) TRENBOLONE ACETATE 40 mg ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E) ESTRADIOL 8 mg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58198-0758-1 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 ANADA200221 01/02/2024 Labeler - Elanco US Inc. (966985624)