Label: MANGANESE SULFATE injection, solution
- NDC Code(s): 0517-6410-25
- Packager: American Regent, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Updated December 6, 2019
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- SPL UNCLASSIFIED SECTION
Manganese Sulfate Injection, USP is a sterile, nonpyrogenic solution intended for use as an additive to solutions for Total Parenteral Nutrition (TPN). Each mL contains 0.308 mg of Manganese Sulfate Monohydrate, USP, Water for Injection q.s. pH adjusted with Sulfuric Acid. It delivers elemental manganese 0.1 mg/mL. It is a single dose preservative free vial. Discard any unused portion.
Manganese is an activator for enzymes such as polysaccharide polymerase, liver arginase, cholinesterase and pyruvate carboxylase. Providing manganese during TPN prevents development of the following deficiency symptoms: nausea and vomiting, weight loss, dermatitis and changes in growth and color of hair.
- INDICATIONS AND USAGE
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 4 to 5 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.
Manganese is eliminated via the bile. The possibility of manganese retention should be considered in patients with biliary tract obstruction. Decreasing or omitting manganese supplements entirely may be necessary for such patients. However, ancillary routes of manganese excretion include pancreatic juice, or reabsorption into the lumen of the duodenum, jejunum or ileum.
- ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION
Manganese Sulfate Injection, USP provides 0.1 mg manganese/mL. For the metabolically stable adult receiving TPN, the suggested additive dosage level for manganese is 0.15 to 0.8 mg/day. For pediatric patients, a dosage level of 2 to 10 mcg manganese/kg/day is recommended.
Aseptic addition of Manganese Sulfate Injection, USP to the TPN solution under a laminar flow hood is recommended. Manganese is physically compatible with the electrolytes and vitamins usually present in the amino acid/dextrose solution used for TPN. Periodic monitoring of manganese plasma levels is suggested as a guideline for subsequent administration.
Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit.
- HOW SUPPLIED
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Container Label
PACKAGE LABEL PRINCIPAL DISPLAY PANEL - Carton Labeling
25 x 10 mL
SINGLE DOSE VIALS
MANGANESE SULFATE INJECTION, USP
Manganese 1 mg/10 mL
10 mL SINGLE DOSE VIAL
Trace Element Additive
FOR IV USE AFTER DILUTION. PRESERVATIVE FREE
Each mL contains: Manganese Sulfate (Monohydrate) 0.308 mg, Water for Injection q.s.
pH adjusted with Sulfuric Acid. Sterile, nonpyrogenic.
WARNING: DISCARD UNUSED PORTION. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature). Directions for Use: See Package Insert.
AMERICAN REGENT, INC.
SHIRLEY, NY 11967
- Serialization Label
INGREDIENTS AND APPEARANCE
manganese sulfate injection, solution
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0517-6410 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MANGANESE SULFATE (UNII: W00LYS4T26) (MANGANESE CATION (2+) - UNII:H6EP7W5457) MANGANESE CATION (2+) 0.1 mg in 1 mL Inactive Ingredients Ingredient Name Strength SULFURIC ACID (UNII: O40UQP6WCF) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0517-6410-25 25 in 1 TRAY 09/30/1990 1 10 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 09/30/1990 Labeler - American Regent, Inc. (002033710) Establishment Name Address ID/FEI Business Operations American Regent, Inc. 002033710 ANALYSIS(0517-6410) , MANUFACTURE(0517-6410)