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Fresenius Kabi Expands Ready-to-Administer Portfolio with Glycopyrrolate Injection, USP Simplist® Prefilled Syringe

Reducing preparation steps to help support patient safety

LAKE ZURICH, Ill.–(BUSINESS WIRE)–#FreseniusKabi–Fresenius Kabi announced today the immediate availability in the U.S. of Glycopyrrolate Injection, USP in 0.6 mg per 3 mL Simplist® ready-to-administer prefilled syringes.


Fresenius Kabi Simplist Glycopyrrolate Injection, USP is the most recent manufacturer-prepared product available in the company’s proprietary, ready-to-administer portfolio of Simplist prefilled syringes, which reduce the amount of time nurses spend preparing doses and documenting waste.1

“Fresenius Kabi is focused on helping reduce clinician burden by expanding our ready-to-administer offerings,” said John Ducker, president and CEO of Fresenius Kabi USA. “We’re pleased that our Simplist prefilled syringe portfolio now includes Glycopyrrolate Injection, USP, which will minimize preparation complexity to streamline workflows and help support patient safety in the U.S.”

Fresenius Kabi Glycopyrrolate Injection, USP 0.6 mg per 3 mL Simplist prefilled syringe may be administered prior to or concomitantly with Simplist Neostigmine Methylsulfate Injection, USP 3 mg per 3 mL prefilled syringe for reversal of neuromuscular blockade. See package inserts for complete dosage and administration information at www.simplist-us.com. Fresenius Kabi also offers Glycopyrrolate Injection, USP in vials.

Fresenius Kabi continues to invest in expanding its suite of ready-to-administer (RTA) offerings to assure pharmacists and nurses have a wide range of prefilled, standard strengths, single-patient delivery systems options — from bags to syringes — that streamline medication management from the pharmacy to the bedside, eliminating steps where errors can occur.

Fresenius Kabi Simplist Glycopyrrolate Injection, USP is formulated, filled and packaged in the U.S., and is the newest example of the company’s commitment to investing “More in America.” This effort is focused on providing more supply, more science, more support and more care to its customers and the patients they serve in the U.S. Fresenius Kabi has invested nearly $1 billion to modernize and expand advanced U.S. pharmaceutical production and distribution facilities.

To learn more about the Simplist portfolio with pharmacy clinical education support, please visit www.simplist-us.com.

INDICATIONS AND USAGE

Glycopyrrolate Injection, for intramuscular or intravenous use, is an anticholinergic indicated:

in anesthesia (adult and pediatric patients)

in peptic ulcer (adults)

IMPORTANT SAFETY INFORMATION

Do not use Glycopyrrolate Injection 0.6 mg per 3 mL single-dose prefilled syringe to administer a dose of less than 0.1 mg (0.5 mL).

Contraindications:

Warnings and Precautions:

Adverse Events: Most common adverse reactions are related to anticholinergic pharmacology and may include xerostomia (dry mouth); urinary hesitancy and retention; blurred vision and photophobia due to mydriasis (dilation of the pupil); cycloplegia; increased ocular tension; tachycardia; bradycardia; palpitation; and decreased sweating.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions:

Pediatric Use: Infants, patients with Down’s Syndrome, and pediatric patients with spastic paralysis or brain damage may experience an increased response to anticholinergics, thus increasing the potential for side effects. Large doses may cause hyperexcitability.

This Important Safety Information does not include all the information needed to use Simplist Glycopyrrolate Injection, USP safely and effectively. Please see accompanying full prescribing information for Glycopyrrolate Injection, USP. Full prescribing information is also available at www.fresenius-kabi.com/us.

References

1. Fanikos J, Burger M, Canada T. An assessment of currently available i.v. push medication delivery systems. Am J Health Syst Pharm. 2017;74(9): e230-e235.

About Fresenius Kabi

Fresenius Kabi (www.fresenius-kabi.com/us) is a global health care company that specializes in medicines and technologies for infusion, transfusion, and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany. To learn about U.S. career opportunities at Fresenius Kabi, visit us at www.fresenius-kabi.com/us/join-us and follow us on LinkedIn.

Contacts

Joanie Clougherty (614) 717-5741

joan.clougherty@fresenius-kabi.com

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