ABUSE SECTION.

DRUG ABUSE AND DEPENDENCE. None known.

ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. None known.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

Carcinogenesis, Mutagenesis, and Impairment of Fertility. Long-term animal studies to evaluate the carcinogenic potential of Manganese 0.1 mg/mL (Manganese Chloride Injection, USP) have not been performed, nor have studies been done to assess mutagenesis or impairment of fertility.

CLINICAL PHARMACOLOGY SECTION.

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 specific transport protein, transmanganin, 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 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.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS. None known.

DESCRIPTION SECTION.

DESCRIPTION. Manganese 0.1 mg/mL (Manganese Chloride Injection, USP) is 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 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 4H2O), deliquescent, crystalline compound soluble in water.Sodium Chloride, USP is chemically designated NaCl, white, crystalline compound freely soluble in water.The semi-rigid vial is fabricated from specially formulated polyolefin. It is 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.

DOSAGE & ADMINISTRATION SECTION.

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 volume of fluid not less than 100 mL. For the adult receiving TPN, the suggested additive dosage for manganese is 0.15 to 0.8 mg/day (1.5 to mL/day). For pediatric patients, dosage of to 10 mcg manganese/kg/day (0.02 to 0.1 mL/kg/day) is recommended.Periodic monitoring of manganese plasma levels is suggested as guideline for subsequent administration.Parenteral products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (See PRECAUTIONS.).

GENERAL PRECAUTIONS SECTION.

General. Do not use unless solution is clear and seal is intact.Manganese 0.1 mg/mL (Manganese Chloride Injection, USP) should only be used in conjunction with pharmacy directed admixture program using aseptic technique in laminar flow environment; it should be used promptly and in single operation without any repeated penetrations. Solution contains no preservatives; discard unused portion immediately after admixture procedure is completed.

GERIATRIC USE SECTION.

Geriatric Use. An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

HOW SUPPLIED SECTION.

HOW SUPPLIED. Manganese 0.1 mg/mL (Manganese Chloride Injection, USP) is supplied in 10 mL Single-dose Plastic Vials. Unit of SaleConcentrationNDC 0409-4091-01Tray of 25 Single-dose plastic vials1 mg/10 mL(0.1 mg/mL)Store at 20 to 25C (68 to 77F) [See USP Controlled Room Temperature.]Distributed by Hospira, Inc., Lake Forest, IL 60045 USALAB-1068-3.0Revised: 4/2021. Logo.

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE. Manganese 0.1 mg/mL (Manganese Chloride Injection, USP) is indicated for use as 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.

LABORATORY TESTS SECTION.

Laboratory Tests. Serum manganese levels can be measured periodically at the discretion of the investigator. Because of the low serum concentration normally present, samples will usually be analyzed by reference laboratory.

NURSING MOTHERS SECTION.

Nursing Mothers. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Manganese 0.1 mg/mL (Manganese Chloride Injection, USP) additive is administered to nursing woman.

OVERDOSAGE SECTION.

OVERDOSAGE. Manganese toxicity in TPN patients has not been reported.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL 10 mL Vial Label. 10 mL VialNDC 0409-4091-11MANGANESE1 mg/10 mL (0.1 mg/mL)Manganese Chloride Inj., USPFOR INTRAVENOUS USE ONLY AFTER DILUTION. Rx onlyDistributed by Hospira, Inc., Lake Forest, IL 60045 USA. PRINCIPAL DISPLAY PANEL 10 mL Vial Label.

PEDIATRIC USE SECTION.

Pediatric Use. (See DOSAGE AND ADMINISTRATION section.) Safety and effectiveness in pediatric patients have not been established.

PRECAUTIONS SECTION.

PRECAUTIONS. General. Do not use unless solution is clear and seal is intact.Manganese 0.1 mg/mL (Manganese Chloride Injection, USP) should only be used in conjunction with pharmacy directed admixture program using aseptic technique in laminar flow environment; it should be used promptly and in single operation without any repeated penetrations. Solution contains no preservatives; discard unused portion immediately after admixture procedure is completed.. Laboratory Tests. Serum manganese levels can be measured periodically at the discretion of the investigator. Because of the low serum concentration normally present, samples will usually be analyzed by reference laboratory.. Carcinogenesis, Mutagenesis, and Impairment of Fertility. Long-term animal studies to evaluate the carcinogenic potential of Manganese 0.1 mg/mL (Manganese Chloride Injection, USP) have not been performed, nor have studies been done to assess mutagenesis or impairment of fertility.. Nursing Mothers. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Manganese 0.1 mg/mL (Manganese Chloride Injection, USP) additive is administered to nursing woman. Pediatric Use. (See DOSAGE AND ADMINISTRATION section.) Safety and effectiveness in pediatric patients have not been established.. Pregnancy. Animal reproduction studies have not been conducted with manganese chloride. It is also not known whether manganese chloride can cause fetal harm when administered to pregnant woman or can affect reproductive capacity. Manganese chloride should be given to pregnant woman only if clearly indicated.. Geriatric Use. An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

PREGNANCY SECTION.

Pregnancy. Animal reproduction studies have not been conducted with manganese chloride. It is also not known whether manganese chloride can cause fetal harm when administered to pregnant woman or can affect reproductive capacity. Manganese chloride should be given to pregnant woman only if clearly indicated.

SPL UNCLASSIFIED SECTION.

Manganese ChlorideInjection, USPFOR I.V. USE ONLY AFTER DILUTIONPlastic VialRx only.

WARNINGS SECTION.

WARNINGS. Direct intramuscular or intravenous injection of Manganese 0.1 mg/mL (Manganese Chloride Injection, USP) is contraindicated as the acidic pH of the solution (pH 2.0) may cause considerable tissue irritation.Liver and/or biliary tract dysfunction may require omission or reduction of copper and manganese doses because these elements are primarily eliminated in the bile.WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than to mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.