Drug Catalog - Product Detail
MANGANESE IV SOL 1MG/10ML 10ML X 25
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00409-4091-01 | HOSPIRA | 10 | 0.1MG/ML | SOLUTION |
PACKAGE FILES
Generic Name
MANGANESE CHLORIDE
Substance Name
MANGANESE CHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
INTRAVENOUS
Application Number
NDA018962
Description
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 (MnCl 2 • 4H 2 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.
How Supplied
HOW SUPPLIED Manganese 0.1 mg/mL (Manganese Chloride Injection, USP) is supplied in 10 mL Single-dose Plastic Vials. Unit of Sale Concentration NDC 0409-4091-01 Tray of 25 Single-dose plastic vials 1 mg/10 mL (0.1 mg/mL) Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1068-4.0 Revised: 12/2023 Logo
Indications & Usage
INDICATIONS AND USAGE Manganese 0.1 mg/mL (Manganese Chloride Injection, USP) is indicated for use in adult patients as a supplement to intravenous solutions given for TPN. Administration helps to maintain manganese serum levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.
Dosage and Administration
DOSAGE AND ADMINISTRATION Manganese 0.1 mg/mL (Manganese Chloride Injection, USP) contains 0.1 mg manganese/mL and is administered intravenously only after dilution. The additive should be administered in a volume of fluid at least 100 mL. For the adult receiving TPN, the suggested additive dosage for manganese is 55 mcg/day (0.55 mL/day). Periodic monitoring of manganese plasma levels is suggested as a guideline for subsequent administration. (See WARNINGS .) Parenteral products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (See PRECAUTIONS .)