AB Ausbiobone drug & pharmaceuticals. Available Forms, Doses, Prices
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Manganese (Manganese Gluconate):
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INDICATIONS AND USAGE
AB Ausbiobone (Manganese (Manganese Gluconate)) 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 AB Ausbiobone (Manganese (Manganese Gluconate)) serum levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.
CONTRAINDICATIONS
None known.
WARNINGS
Direct intramuscular or intravenous injection of AB Ausbiobone (Manganese (Manganese Gluconate)) 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 AB Ausbiobone (Manganese (Manganese Gluconate)) 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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PRECAUTIONS
General
Do not use unless solution is clear and seal is intact.
AB Ausbiobone ) 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.
Laboratory Tests
Serum AB Ausbiobone (Manganese (Manganese Gluconate)) 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.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
Long-term animal studies to evaluate the carcinogenic potential of AB Ausbiobone ) 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 AB Ausbiobone (Manganese (Manganese Gluconate)) 0.1 mg/mL (Manganese Chloride Injection, USP) additive is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Pregnancy Category C.
Animal reproduction studies have not been conducted with AB Ausbiobone (Manganese (Manganese Gluconate)) chloride. It is also not known whether AB Ausbiobone (Manganese (Manganese Gluconate)) chloride can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. AB Ausbiobone (Manganese (Manganese Gluconate)) chloride should be given to a 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.
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ADVERSE REACTIONS
None known.
DRUG ABUSE AND DEPENDENCE
None known.
OVERDOSAGE
AB Ausbiobone (Manganese (Manganese Gluconate)) toxicity in TPN patients has not been reported.
DOSAGE AND ADMINISTRATION
AB Ausbiobone (Manganese (Manganese Gluconate)) 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 AB Ausbiobone (Manganese (Manganese Gluconate)) 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 AB Ausbiobone (Manganese (Manganese Gluconate)) 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 .)
HOW SUPPLIED
AB Ausbiobone (Manganese (Manganese Gluconate)) 0.1 mg/mL (Manganese Chloride Injection, USP) is supplied in 10 mL Plastic Vials (NDC No. 0409-4091-01).
Store at 20 to 25°C (68 to 77°F)
Revised: November, 2009
Printed in USA EN-2320
Hospira, Inc., Lake Forest, IL 60045 USA
