国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
CHROMIC CHLORIDE (UNII: KB1PCR9DMW) (CHROMIC CATION - UNII:X1N4508KF1)
HF Acquisition Co LLC, DBA HealthFirst
INTRAVENOUS
PRESCRIPTION DRUG
Chromium 4 mcg/mL (Chromic Chloride Injection, USP) is indicated for use as a supplement to intravenous solutions given for TPN. Administration helps to maintain chromium serum levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms. None known. None known.
CHROMIUM CHROMIC CHLORIDE INJECTION, USPis supplied in the following dosage forms. NDC 51662-1415-1 CHROMIUM CHROMIC CHLORIDE INJECTION, USP 40 mcg/10 mL (4 mcg/mL) 10 mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Chromium (Chromic Chloride Injection, USP) is supplied as follows: Store at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1065-2.0 Revised: 5/2018
New Drug Application
CHROMIUM CHROMIC CHLORIDE- CHROMIUM CHROMIC CHLORIDE INJECTION, SOLUTION HF ACQUISITION CO LLC, DBA HEALTHFIRST ---------- CHROMIUM CHROMIC CHLORIDE INJECTION, USP 40 MCG/10 ML (4 MCG/ML) 10 ML VIAL SPL UNCLASSIFIED FOR I.V. USE ONLY AFTER DILUTION Plastic Vial Rx Only DESCRIPTION Chromium 4 mcg/mL (Chromic Chloride Injection, USP) is a sterile, nonpyrogenic solution intended for use as an additive to intravenous solutions for total parenteral nutrition (TPN). Each mL of solution contains 20.5 mcg chromic chloride, hexahydrate and 9 mg sodium chloride. The solution contains no bacteriostat, antimicrobial agent, or added buffer. The pH is 2.0 (1.5 to 2.5); product may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. The osmolarity is 0.308 mOsm/mL (calc.). Chromic Chloride, USP is chemically designated chromic chloride, hexahydrate CrCl3• 6H2O, a crystalline compound soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white, crystalline compound freely soluble in water. The semi-rigid vial is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The small amount of water vapor that can pass through the plastic container wall will not significantly alter the drug concentration. CLINICAL PHARMACOLOGY Trivalent chromium is part of glucose tolerance factor, an essential activator of insulin-mediated reactions. Chromium helps to maintain normal glucose metabolism and peripheral nerve function. Providing chromium during TPN helps prevent deficiency symptoms including impaired glucose tolerance, ataxia, peripheral neuropathy and a confusional state similar to mild/moderate hepatic encephalopathy. Serum chromium is bound to transferrin (siderophilin) in the beta globulin fraction. Typical blood levels for chromium range from 1 to 5 mcg/liter, but blood levels are not considered a meaningful index of tissue stores. 阅读完整的文件