Manganese
Manganese Chloride
Hospira, Inc.
Human Prescription Drug
NDC 0409-4091Manganese also known as Manganese Chloride is a human prescription drug labeled by 'Hospira, Inc.'. National Drug Code (NDC) number for Manganese is 0409-4091. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Manganese drug includes Manganese Chloride - .1 mg/mL . The currest status of Manganese drug is Active.
Drug Information:
| Drug NDC: | 0409-4091 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Manganese |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Manganese Chloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Hospira, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection, Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | MANGANESE CHLORIDE - .1 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAVENOUS
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | NDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 31 Jan, 2005 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 18 Jan, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | NDA018962 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Hospira, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 237521
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | QQE170PANO
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Magnetic Resonance Contrast Activity [MoA]
Paramagnetic Contrast Agent [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0409-4091-01 | 25 VIAL, PLASTIC in 1 TRAY (0409-4091-01) / 10 mL in 1 VIAL, PLASTIC (0409-4091-11) | 31 Jan, 2005 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Manganese manganese chloride manganese chloride manganese cation (2+) sodium chloride hydrochloric acid sodium hydroxide water
Indications and Usage:
Indications and usage manganese 0.1 mg/ml (manganese chloride injection, usp) is indicated for use 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.
Warnings:
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 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. tissue loading may occur a
Read more...t even lower rates of administration.
General 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 a pharmacy directed admixture program using aseptic technique in a laminar flow environment; it should be used promptly and in a single operation without any repeated penetrations. solution contains no preservatives; discard unused portion immediately after admixture procedure is completed.
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 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 8 ml/day). for pediatric patients, a dosage of 2 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 a 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 .)
Contraindications:
Contraindications none known.
Adverse Reactions:
Adverse reactions none known.
Use in Pregnancy:
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 a pregnant woman or can affect reproductive capacity. manganese chloride should be given to a pregnant woman only if clearly indicated.
Pediatric Use:
Pediatric use (see dosage and administration section.) safety and effectiveness in pediatric patients have not been established.
Geriatric Use:
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.
Overdosage:
Overdosage manganese toxicity in tpn patients has not been reported.
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.
Clinical Pharmacology:
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.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
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.
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-1068-3.0 revised: 4/2021 logo
Package Label Principal Display Panel:
Principal display panel - 10 ml vial label 10 ml vial ndc 0409-4091-11 manganese 1 mg/10 ml (0.1 mg/ml) manganese chloride inj., usp for intravenous use only after dilution. rx only distributed by hospira, inc., lake forest, il 60045 usa principal display panel - 10 ml vial label
Principal display panel - 10 ml vial tray 10 ml single-dose ndc 0409-4091-01 contains 25 of ndc 0409-4091-11 rx only manganese 1 mg/10 ml (0.1 mg/ml) manganese chloride injection, usp caution: for intravenous use only after dilution. hospira principal display panel - 10 ml vial tray