COMPONENT E-C- progesterone and estradiol benzoate implant
Component E-C by
Drug Labeling and Warnings
Component E-C by is a Animal medication manufactured, distributed, or labeled by Elanco US Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- SPL UNCLASSIFIED SECTION
- DESCRIPTION:
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INDICATIONS FOR USE:
For increased rate of weight gain in beef calves 45 days of age and older and weighing up to 400 lbs.
This implant is not approved for repeated implantation (reimplantation) with this or any other cattle ear implant as safety and effectiveness has not been evaluated.
Do not use in calves less than 45 days of age or veal calves because effectiveness and safety have not been evaluated.
Do not use in animals intended for subsequent breeding, or in dairy cows.
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DIRECTIONS:
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. Do not use in bull calves intended for reproduction. 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:
- ANIMAL SAFETY WARNINGS:
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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 ANIMAL SAFETY WARNINGS.
- STORAGE CONDITIONS:
- SPL UNCLASSIFIED SECTION
- Package/Label Principal Display Panel – Cartridge Belt Label
- Package/Label Principal Display Panel – Carton Label
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INGREDIENTS AND APPEARANCE
COMPONENT E-C
progesterone and estradiol benzoate implantProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC: 58198-0792 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 58198-0792-1 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 NADA NADA110315 01/02/2024 Labeler - Elanco US Inc. (966985624)
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