PARAMUS, N.J., Jan. 15, 2019 /PRNewswire/ — WG Critical Care (WGCC), A Pharmasphere company, has launched the first and only FDA approved Calcium Gluconate in Sodium Chloride Injection in a Ready-To-Use Bag.
“In addition to addressing a chronic drug shortage of this product, I’m excited to add another unique product to our expanding portfolio,” says Joe Pizza, President of Pharmasphere, Inc. “It’s consistent with WGCC’s vision of introducing Smart Solutions that increase efficiency and safety for clinicians and patients in the hospital setting.”
Calcium Gluconate in Sodium Chloride Injection is FDA approved in 1,000mg per 50mL (20 mg per mL) and 2,000mg per 100mL (20 mg per mL) Ready-To-Use Bags with a 24-month shelf life, when stored at controlled room temperature, which:
- Provides a significant convenience advantage over doses admixed using vials that must be administered within 4 hours, or premixed bags outsourced from 503B compounding facilities.
- Promotes hospital compliance with the next revision of USP 797 Sterile Compounding-Pharmaceutical Preparations and USP 800 Hazardous Drugs-Handling in the Healthcare Setting, anticipated to become official on December 1, 2019.
“WGCC Ready-To-Use Calcium Gluconate in Sodium Chloride Injection saves the hospital pharmacy time and decreases waste while reducing product handling and the risk of contamination. Additionally, hospitals purchasing compounded Calcium Gluconate will appreciate the extended shelf life and the quality assurance of an FDA approved product,” explains Ron Mannino, RPh, New Jersey Pharmacists Association Past President and CEO of Pharmasphere, Inc.
The WGCC Calcium Gluconate in Sodium Chloride Injection bags and ports are free of natural rubber latex, DEHP and PVC and are bar coded in order to enhance supply chain integrity. This product meets the Drug Supply Chain Security Act enhanced serialization requirements effective November 27, 2018.
About Calcium Gluconate in Sodium Chloride Injection
Calcium Gluconate in Sodium Chloride Injection is a sterile, preservative-free, nonpyrogenic, solution of calcium gluconate, a form of calcium, for intravenous use. Intravenous administration of calcium gluconate increases serum ionized calcium level. Calcium gluconate dissociates into ionized calcium in plasma. Ionized calcium and gluconate are constituents of body fluids. Calcium Gluconate in Sodium Chloride Injection is a form of calcium indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. The safety of Calcium Gluconate in Sodium Chloride Injection for long term use has not been established.
About WG Critical Care, A Pharmasphere Company
WG Critical Care, LLC is wholly owned by Pharmasphere, Inc. Pharmasphere and its affiliates, market an extensive line of FDA approved anti-infectives and other critical care products. Its focus is to supply conventional injectable products and convenient drug formulations that help increase efficiency and safety in the hospital setting. WGCC and its affiliates bring over thirty-five years of experience in finished dose and API development and manufacturing. WGCC is headquartered in Paramus, New Jersey. Please visit www.wgccrx.com for more information on the WGCC full line of essential injectable products.
WGCC – Smart Solutions to increase efficiency for clinicians, safety for patients.
SOURCE WG Critical Care, LLC