COMPUDOSE- estradiol implant

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

estradiol (UNII: 4TI98Z838E) (estradiol - UNII:4TI98Z838E)

Available from:

Elanco US Inc.

Administration route:

SUBCUTANEOUS

Prescription type:

OTC

Therapeutic indications:

Safety and effectiveness following reimplantation have not been evaluated. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because effectiveness and safety have not been established. Do not use in animals intended for subsequent breeding or in dairy cows. Not for use in humans. Keep out of reach of children.

Product summary:

Compudose Implants are supplied in cartridges of 20 implants each. Storage Conditions Store at 15 to 25°C (59-77°F). Do not refrigerate or freeze. Approved by FDA under NADA # 118-123 Manufactured by a non-sterilizing process. RESTRICTED DRUG (CALIFORNIA) – USE ONLY AS DIRECTED Compudose, Encore, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. © 2023 Elanco or its affiliates Distributed by Elanco US, Inc. Greenfield, IN 46140, USA Product of Germany To report side effects, 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 reporting side effects for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae. May 2023                       PA104038X

Authorization status:

New Animal Drug Application

Summary of Product characteristics

COMPUDOSE- ESTRADIOL IMPLANT
ELANCO US INC.
----------
ELANCO™
AH0948
COMPUDOSE™
(ESTRADIOL EXTENDED-RELEASE IMPLANTS)
EACH EXTENDED-RELEASE IMPLANT CONSISTS OF 25.7 MG ESTRADIOL
DESCRIPTION:
Each Compudose (estradiol extended-release implant) silicone rubber
implant contains
25.7 mg estradiol and is coated with sodium bicarbonate.
For subcutaneous ear implantation only.
INDICATIONS FOR USE:
•
•
•
•
Safety and effectiveness following reimplantation have not been
evaluated.
Do not use in beef calves less than 2 months of age, dairy calves, and
veal calves
because effectiveness and safety have not been established.
Do not use in animals intended for subsequent breeding or in dairy
cows.
DIRECTIONS:
Insert one implant under the skin of the ear as directed in the
detailed "DIRECTIONS FOR
IMPLANTATION" below.
WITHDRAWAL PERIODS AND RESIDUE WARNINGS
NO WITHDRAWAL PERIOD IS REQUIRED WHEN USED ACCORDING TO LABELING. DO
NOT
USE IN BEEF CALVES LESS THAN 2 MONTHS OF AGE, DAIRY CALVES, AND VEAL
CALVES. A
For increased rate of weight gain for up to 200 days in beef steer
calves 2 months
of age and older.
For increased rate of weight gain for up to 200 days in growing beef
steers on
pasture (stocker, feeder, and slaughter).
For increased rate of weight gain and improved feed efficiency for up
to 200 days
in growing beef steers and heifers fed in confinement for slaughter.
This implant is not approved for repeated implantation
(reimplantation) with this or
any other cattle ear implant within each separate production phase:
•
•
•
Beef steer calves 2 months of age and older
Growing beef steers on pasture (stocker, feeder, and slaughter)
Growing beef steers and heifers fed in confinement for slaughter
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