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

Component E-C With Tylan by

Drug Labeling and Warnings

Component E-C With Tylan by is a Animal medication manufactured, distributed, or labeled by Elanco US Inc., Ivy Animal Health, Inc., Pharmacia and Upjohn Company, Bayer AG, Elanco Speke Operations, Aspen API Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

Principal Display Panel - Component E-C With Tylan Cartridge Label

Elanco™

Component™

™

E-C with Tylan™

(progesterone and estradiol and tylosin implant)

STEERS

HEIFERS

Principal Display Panel - Component E-C With Tylan Pouch Label

Elanco™

Component™

™

E-C with Tylan™

(progesterone and estradiol and tylosin implant)

STEERS

HEIFERS

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

CALF IMPLANTS

20 dose Cartridge Belt

Principal Display Panel - Component E-C With Tylan Carton Label

Elanco™

Component™

™

E-C with Tylan™

(progesterone and estradiol and tylosin implant)

STEERS

HEIFERS

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 58198-0507
Route of Administration	SUBCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
progesterone (UNII: 4G7DS2Q64Y) (progesterone - UNII:4G7DS2Q64Y)	progesterone	100 mg
estradiol benzoate (UNII: 1S4CJB5ZGN) (estradiol - UNII:4TI98Z838E)	estradiol benzoate	10 mg
tylosin tartrate (UNII: 5P4625C51T) (tylosin - UNII:YEF4JXN031)	tylosin tartrate	29 mg

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHYL ALCOHOL (UNII: Y4S76JWI15)
WATER (UNII: 059QF0KO0R)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58198-0507-2	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
NADA	NADA110315	12/09/2013

Labeler - Elanco US Inc. (966985624)

Establishment
Name	Address	ID/FEI	Business Operations
Ivy Animal Health, Inc.		088106096	MANUFACTURE, PACK, LABEL

Establishment
Name	Address	ID/FEI	Business Operations
Pharmacia and Upjohn Company		618054084	API MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
Bayer AG		314398484	API MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
Elanco Speke Operations		230761368	API MANUFACTURE

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