Component E-C with Tylan

This treatment applies to the following species:

Beef Cattle

Company: Elanco US

(progesterone and estradiol and tylosin implant)

Each implant consists of 100 mg progesterone USP and 10 mg estradiol benzoate and 29 mg tylosin tartrate

IMPLANTS FOR BEEF CALVES AT LEAST 45 DAYS OLD & UP TO 400 LBS

BEEF CALVES AT LEAST 45 DAYS OLD & UP TO 400 LBS

20 dose Cartridge Belt

Use with a Component Implanter

Description

Each cartridge belt holds 20 doses of Component E-C with Tylan (progesterone and estradiol and tylosin implant) Implants. Each dose of 5 pellets consists of 4 pellets containing a total of 100 mg progesterone USP and 10 mg estradiol benzoate plus 1 pellet containing 29 mg tylosin tartrate as a local antibacterial.

INDICATIONS FOR USE: For increased rate of weight gain in beef calves at least 45 days old and up to 400 lbs of body weight.

Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant prior to weaning. Safety and effectiveness following reimplantation have not been established.

Do not use in beef calves less than 45 days 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.

Directions For Use

Administer 1 implant - the entire contents of one cartridge cell (5 pellets) - subcutaneously in the back of the middle third of the ear. Study and carefully follow at all times the “IMPLANTING INSTRUCTIONS” presented below, 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.

Withdrawal Periods and Residue Warnings

No withdrawal period is required when used according to labeling.

Do not use in beef calves less than 45 days 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 in 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 use in humans. Keep out of reach of children.

RESTRICTED DRUG (CALIFORNIA) - USE ONLY AS DIRECTED

Warnings

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.

Bulling, rectal and vaginal prolapse, udder development, ventral edema and elevated tailheads have occasionally been reported in beef calves implanted with Component E-C with Tylan implants.

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.

Prepare The Implant Site

Scrub the back side of the ear (implant site) with a piece of clean absorbent cotton or brush 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 and 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 lead to undesirable side effects such as bulling, rectal and vaginal prolapse, etc., as noted in the WARNINGS.

Clean The Needle

Clean the implanter needle with alcohol or a properly diluted germicidal solution prior to implanting the next animal.

STORAGE CONDITIONS: Store at controlled room temperature 15° to 30°C (59° to 86°F) DO NOT refrigerate - avoid excessive heat and humidity. Discard open foil pouches.

Approved by FDA under NADA # 110-315

Manufactured by a non-sterilizing process.

Component E-C with Tylan (progesterone 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 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-VET or http://www.fda.gov/reportanimalae.

Revised: October 2021

AH0507

PA103444X

W1b

CPN: 1131051.1

ELANCO US, INC.
2500 INNOVATION WAY, GREENFIELD, IN, 46140

Customer Service:		317-276-1262
Technical Service:		800-428-4441
Website:		www.elanco.us
Email:		elanco@elanco.com

THIS SERVICE AND DATA ARE PROVIDED "AS IS". DVMetrics assumes no liability, and each user assumes full risk, responsibility, and liability, related to its use of the DVMetrics service and data. See the Terms of Use for further details.