American Regent announces the launch of Selenious Acid Injection, USP in a 12 mcg/2 mL single-dose vial.
Selenious Acid, in this new concentration and vial size has been specifically designed for pediatric and neonatal patients weighing less than 7 kg
MELVILLE, N.Y., March 31, 2022 /PRNewswire/ -- American Regent, Inc. is pleased to announce the launch of Selenious Acid Injection, USP in a new concentration and vial size. The Selenious Acid family now includes a 12 mcg/2 mL (6 mcg/mL of selenium) single-dose vial designed for pediatric and neonatal patients less than 7 kg. Selenious Acid Injection is a trace element indicated in adult and pediatric patients as a source of selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.¹
"We are pleased to add the 12 mcg/2 mL (6 mcg/mL) single-dose vial of Selenious Acid to our family of FDA-approved products. Both Selenious Acid products available from American Regent have been developed to align with the American Society for Parenteral and Enteral Nutrition (ASPEN) Dosing Recommendations for trace elements supplementation.² This launch demonstrates our continued commitment to the needs of special patient populations through the expansion of the Selenious Acid product line," stated Joann Gioia, Vice President and Chief Commercial Officer at American Regent, Inc.
This product is available for immediate shipment. Customers can order Selenious Acid Injection, USP through their wholesaler/distributor, or by contacting our Customer Support Group at 1-800-645-1706.
Selenious Acid Injection, USP is supplied as follows:
See the following Important Safety Information, in addition to the product's Full Prescribing Information.
For intravenous use
INDICATIONS AND USAGE
Important Administration Information
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
USE IN SPECIFIC POPULATIONS
Lactation: Risk Summary: Selenium is present in human milk. There is no information on the effects of selenious acid on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Selenious Acid Injection and any potential adverse effects on the breastfed infant from Selenious Acid Injection or from the underlying maternal condition.
Pediatric Use: Safety and dosing recommendations in pediatric patients are based on clinical experience.
Geriatric Use: Dose selection should be individualized based on the patient's clinical condition, nutritional requirements, and additional nutritional intake provided orally or enterally to the patient.
For additional safety information, please see Full Prescribing Information.
You are encouraged to report adverse drug events (ADEs) to American Regent:
ADEs may also be reported to the FDA:
For medical information outside of normal business hours
About American Regent
American Regent is committed to US-based manufacturing. To that end, over the last several years, we have made significant investments in expanding and modernizing our manufacturing facilities in Ohio and New York. This expansion will nearly double our capacity and allow us to better serve our customers now and in the future.
Speed counts. Flexibility matters. Reliability and quality are paramount. Because patients should never have to wait for the medications they need.
For more information, please visit www.americanregent.com.
About Daiichi Sankyo Group
For more information, please visit: www.daiichisankyo.com.
Daiichi Sankyo, Inc., headquartered in Basking Ridge, New Jersey, is a member of the Daiichi Sankyo Group.
For more information on Daiichi Sankyo, Inc., please visit www.dsi.com.
View original content to download multimedia:https://www.prnewswire.com/news-releases/american-regent-announces-the-launch-of-selenious-acid-injection-usp-in-a-12-mcg2-ml-single-dose-vial-301515255.html
SOURCE American Regent, Inc.