Component E-S With Tylan: Product Information

COMPONENT E-S WITH TYLAN- progesterone, estradiol benzoate and tylosin tartrate implant
Elanco US Inc.

Elanco™

Component™

E-S with Tylan

(progesterone and estradiol and tylosin implant)

STEERS

Each implant consists of 200 mg progesterone USP
and 20 mg estradiol benzoate and 29 mg tylosin tartrate

STEER IMPLANTS

20 dose Cartridge Belt

Use with a Component Implanter For Use In Animals Only

DESCRIPTION:

Each cartridge belt holds 20 doses of Component E-S with Tylan (progesterone and estradiol and tylosin implant) Implants. Each dose of 9 pellets consists of 8 pellets containing a total of 200 mg progesterone USP and 20 mg estradiol benzoate plus 1 pellet containing 29 mg tylosin tartrate as a local antibacterial. Component E-S (progesterone and estradiol implant) Implants are recommended for use in steers weighing 400 lbs or more for INCREASED RATE OF WEIGHT GAIN AND IMPROVED FEED EFFICIENCY.

Do not use in veal calves. Effectiveness and animal safety in veal calves have not been established.

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 — 9 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

CAUTION:

Bulling, rectal prolapse, ventral edema and elevated tail-heads have occasionally been reported in animals implanted with progesterone and estradiol benzoate.

IMPLANTING INSTRUCTIONS:

Loading the Implanter

Load the implanter following the instructions supplied with each implanter.

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

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 and at least a needle length away from the intended deposition site. Avoid injuring the large arteries, veins and cartilage of the ear.

Figure

Insert the Needle

With one hand firmly grasp the ear. With 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.

Figure

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 and may lead to undesirable side effects such as noted in the CAUTION.

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-S 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 the United Kingdom

To report suspected adverse drug 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

Revised: April 2020

PA101948X AH0328

Principal Display Panel — Component E-S With Tylan Cartridge Label

Elanco ™

Component ™

™

E-S with Tylan ™

(progesterone and estradiol and tylosin implant)

STEERS

Principal Display Panel — Component E-S With Tylan Pouch Label

Elanco ™

Component ™

™

E-S with Tylan ™

(progesterone and estradiol and tylosin implant)

STEERS

Each implant consists of 200 mg progesterone USP
and 20 mg estradiol benzoate and 29 mg tylosin tartrate

STEER IMPLANTS

20 dose Cartridge Belt

Principal Display Panel — Component E-S With Tylan Carton Label

Elanco ™

Component ™

™

E-S with Tylan ™

(progesterone and estradiol and tylosin implant)

STEERS

COMPONENT E-S WITH TYLAN progesterone, estradiol benzoate, tylosin tartrate implant

Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:58198-0328 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength progesterone (progesterone) progesterone 200 mg estradiol benzoate (estradiol) estradiol benzoate 20 mg tylosin tartrate (tylosin) tylosin tartrate 29 mg

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:58198-0328-2 5 POUCH in 1 CARTON contains a POUCH 1 1 CARTRIDGE in 1 POUCH This package is contained within the CARTON (58198-0328-2) and contains a CARTRIDGE 1 20 IMPLANT in 1 CARTRIDGE This package is contained within a POUCH and a CARTON (58198-0328-2)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA110315 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
Bayer AG		314398484	API MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
TriRx Speke Limited		228138655	API MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Aspen API Inc.		152349742	API MANUFACTURE

Revised: 06/2022 Elanco US Inc.