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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

progesterone (UNII: 4G7DS2Q64Y) (progesterone - UNII:4G7DS2Q64Y), estradiol benzoate (UNII: 1S4CJB5ZGN) (estradiol - UNII:4TI98Z838E), tylosin tartrate (UNII: 5P4625C51T) (tylosin - UNII:YEF4JXN031)

Available from:

Elanco US Inc.

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION

Therapeutic indications:

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. Not for use in humans. Keep out of reach of children. Restricted Drug (California) – Use Only as Directed

Authorization status:

New Animal Drug Application

Summary of Product characteristics

COMPONENT E-C WITH TYLAN- PROGESTERONE, ESTRADIOL BENZOATE, TYLOSIN
TARTRATE IMPLANT
ELANCO US INC.
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_ELANCO_™
_COMPONENT_™
_E-C WITH TYLAN_™
(PROGESTERONE AND ESTRADIOL BENZOATE AND TYLOSIN TARTRATE IMPLANT)
_BEEF CALVES 45 DAYS OF AGE AND OLDER_
_AND WEIGHING UP TO 400 LBS_
Each implant consists of 100 mg progesterone USP and 10 mg estradiol
benzoate and
29 mg tylosin tartrate
Caution: Federal law restricts this drug to use by or on the order of
a licensed
veterinarian.
IMPLANTS FOR BEEF CALVES 45 DAYS OF AGE AND OLDER AND WEIGHING UP
TO 400 LBS
USE WITH A COMPONENT IMPLANTER
DESCRIPTION:
Each cartridge belt holds 20 doses of Component E-C with Tylan
(progesterone and
estradiol benzoate and tylosin tartrate 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 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.
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 labelin