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Component E-C with Tylan

Elanco Animal Health Co

Component

FULL PRESCRIBING INFORMATION: CONTENTS*

CALF IMPLANTS
COMPONENT E-C WITH TYLAN DESCRIPTION:
DOSAGE:
GENERAL INSTRUCTIONS:
WARNING:
CAUTION:
IMPLANTING INSTRUCTIONS:
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FULL PRESCRIBING INFORMATION

Steers

Heifers

E-C with Tylan ^®

(progesterone and estradiol and tylosin implant)

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

CALF 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-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. Component E-C (progesterone and estradiol implant) Implants are indicated for increased rate of weight gain in suckling beef calves up to approximately 400 lbs of body weight.

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 and follow them carefully at all times, avoiding shortcuts. Skin infection can be avoided by properly preparing implant site and implanter. One designated team member should always do the implanting. Cleanliness of hands and instruments is important at all times.

DO NOT USE IN BULL CALVES INTENDED FOR REPRODUCTION OR IN CALVES LESS THAN 45 DAYS OLD.

WARNING:

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.

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 and vaginal prolapse, udder development, ventral edema and elevated tailheads may be reported in calves administered progesterone and estradiol benzoate.

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 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) Avoid excessive heat and humidity. Discard open foil pouches.

NADA 110-315, Approved by FDA

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

Elanco, Component, Tylan and the diagonal bar are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries or affiliates.

Distributed by Elanco Animal Health, a Division of Eli Lilly and Company, Indianapolis, IN 46285, USA

To report adverse events, access medical information, or to obtain additional product information, call 1-800-428-4441

PA086878AMX
AH0507

Principal Display Panel - Pouch Label

Elanco ^TM

Component ^®

Steers

Heifers

E-C with Tylan ^®

(progesterone and estradiol and tylosin implant)

One 20-Dose Cartridge Belt

Principal Display Panel - Carton Label

Elanco ^TM

Component ^®

Steers

Heifers

E-C with Tylan ^®

(progesterone and estradiol and tylosin implant)

100 IMPLANTS