Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1703
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| rdf:type | |
| rdfs:label |
MANGANESE (Injection, Solution)
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| dailymed-instance:dosage |
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.
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| dailymed-instance:descripti... |
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���4HO), 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.
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| dailymed-instance:clinicalP... |
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 suchas 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.
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| dailymed-instance:activeIng... | |
| dailymed-instance:contraind... |
None known.
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| dailymed-instance:supply |
Manganese 0.1 mg/mL (Manganese Chloride Injection, USP) is
supplied in 10 mL Plastic Vials (List No. 4091). Store
at controlled room temperature 15��to 30��C (59��to 86��F)
[See USP.] HOSPIRA, INC., LAKE FOREST,
IL 60045 USA
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| dailymed-instance:inactiveI... | |
| dailymed-instance:precautio... |
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.<br/>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 a reference laboratory.<br/>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.<br/>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 a nursing woman.<br/>Pediatric Use: See DOSAGE AND ADMINISTRATION section. Safety and effectiveness
in pediatric patients have not been established.<br/>Pregnancy Category C.: 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.<br/>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.
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| dailymed-instance:overdosag... |
Manganese toxicity in TPN patients has not been reported.
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| dailymed-instance:genericMe... |
Manganese Chloride
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| dailymed-instance:fullName |
MANGANESE (Injection, Solution)
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| dailymed-instance:adverseRe... |
None known.
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| dailymed-instance:warning |
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 at even lower rates of administration.
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| dailymed-instance:indicatio... |
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.
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| dailymed-instance:represent... | |
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| dailymed-instance:name |
MANGANESE
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