Clinical Information
Gen. Code and Des.1696 manganese chloride INTRAVEN VIAL 0.1 MG/ML
GCN and Des.5230 manganese chloride INTRAVEN VIAL 0.1 MG/ML
Strength0.1MG/ML
Dose FormVIAL (ML)
Product CategoryRX Pharmaceuticals
Fine Line Class850085008510 All Rx Products
DEA ClassNCOMP Family
AHFS Class40120000 REPLACEMENT PREPARATIONS
Active Ingredients857 manganese chloride 7773015
MANGANESE- manganese chloride injection, solution
Hospira, Inc.
Manganese Chloride
Injection, USP
FOR I.V. USE ONLY AFTER DILUTION
Plastic Vial
Rx only
DESCRIPTION
Manganese 0.1 mg/mL (Manganese 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 0.36 mg manganese chloride, tetrahydrate 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 sodium hydroxide for pH adjustment. The osmolarity is 0.313 mOsmol/mL (calc.).
Manganese Chloride, USP is chemically designated manganese chloride, tetrahydrate (MnCl2 � 4H2 O), a deliquescent, 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
Manganese is an essential nutrient which serves as an activator for enzymes such as polysaccharide polymerase, liver arginase, cholinesterase and pyruvate carboxylase. Providing manganese during TPN helps prevent development of deficiency symptoms such as nausea and vomiting, weight loss, dermatitis and changes in growth and color of hair.
Under conditions of minimal intake, 20 mcg manganese/day is retained. Manganese is bound to a specific transport protein, transmanganin, a beta-l-globulin. Manganese is widely distributed but concentrates in the mitochondria rich tissues such as brain, kidney, pancreas, and liver. Assays for manganese in whole blood result in concentrations ranging from 6 to 12 mcg/manganese/liter.
Excretion of manganese occurs mainly through the bile, but in the event of obstruction, ancillary excretion routes include pancreatic juice, or return into the lumen of the duodenum, jejunum, or ileum. Urinary excretion of manganese is negligible.
INDICATIONS AND USAGE
Manganese 0.1 mg/mL (Manganese Chloride Injection, USP) is indicated for use as a supplement to intravenous solutions given for total parenteral nutrition (TPN).
Administration helps to maintain manganese serum levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.
