COMPUDOSE- estradiol implant
Elanco US Inc.
----------
Elanco™
AH0948
Compudose™
(estradiol extended-release implants)
Each extended-release implant consists of 25.7 mg estradiol
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.
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.
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 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. |
Increased sexual activity (bulling, riding and excitability) has been reported in animals implanted with Compudose. Implanted animals should be observed for such signs particularly during the first few days after implanting and animals being excessively ridden (bullers) should be removed to prevent physical injury.
Vaginal and rectal prolapse have been reported in heifers implanted with Compudose.
Udder development, swollen or enlarged vulva and high tailheads may be observed in implanted heifers.
A Compudose (estradiol extended-release implant) or Encore (estradiol extended-release implant) Implanter must be used to implant cattle.
Insert one implant under the skin of the ear.
Figure 1
Proper Position
To maximize implant retention:
The needle has been scientifically designed to maximize retention. When it becomes dull, use a new needle. If the needle is resharpened, sharpen only the point.
Failure to follow antiseptic implanting procedures, particularly when the ears are contaminated with fecal material, may result in infection and excessive implant loss. Implanting cattle during wet weather may increase infection and implant loss.
Carefully check the ears for implant loss approximately 4 weeks after implantation. If loss occurs, reimplant using recommended procedures.
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
COMPUDOSE
estradiol implant |
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
Labeler - Elanco US Inc. (966985624) |