warnings and cautions
5 WARNINGS AND PRECAUTIONS • This product contains aluminum that may be toxic. ( 5.1 ) • Studies have shown that vitamin A may adhere to plastic, resulting in inadequate vitamin A administration in the doses recommended with M.V.I.–12™. ( 5.2 ) • Do not add M.V.I.–12™ directly to intravenous fat emulsions. ( 5.3 ) • Allergic reactions such as urticaria, periorbital and digital edema, have been reported following intravenous administration of thiamine. ( 5.4 ) • Hypervitaminosis A has been reported in patients with renal failure receiving 1.5 mg/day retinol and in patients with liver disease. ( 5.5 ) • Do not administer M.V.I.–12™ to patients with suspected or diagnosed megaloblastic anemia prior to the blood sampling for the detection of the folic acid and cyanocobalamin deficiencies. ( 5.6 ) • Blood vitamin concentration should be periodically monitored to determine if vitamin deficiencies or excesses are developing. ( 5.7 ) • Ascorbic acid in the urine may cause negative urine glucose determination. ( 5.8 ) 5.1 Aluminum Toxicity M.V.I.-12™ 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. 5.2 Adherence of Vitamin A to Plastic Studies have shown that vitamin A, which is found in M.V.I.-12™, may adhere to polyvinyl chloride (PVC) plastic, resulting in lower vitamin A concentrations in the administered M.V.I.-12™ doses. Therefore, blood vitamin concentrations should be periodically monitored and the administration of additional therapeutic doses of Vitamin A may be required [ see Warnings and Precautions (5.7) ]. 5.3 Intravenous Fat Emulsions Do not add M.V.I.–12™ directly to intravenous fat emulsions. 5.4 Allergic Reactions to Thiamine Allergic reactions such as urticaria, periorbital and digital edema, have been reported following intravenous administration of thiamine, which is found in M.V.I.-12™. There have been rare reports of anaphylactoid reactions following large intravenous doses of thiamine. No fatal anaphylactoid reactions associated with M.V.I.–12™ have been reported. 5.5 Hypervitaminosis A Hypervitaminosis A, manifested by nausea, vomiting, headache, dizziness, blurred vision, has been reported in patients with renal failure receiving 1.5 mg/day retinol and in patients with liver disease. Therefore, supplementation of renal failure patients and patients with liver diseases with vitamin A, an ingredient found in M.V.I.-12™, should be undertaken with caution [ see Use in Specific Populations ( 8.6 , 8.7 ) ]. 5.6 Blood Sampling of Megaloblastic Anemia Patients Do not administer M.V.I.–12 ™ to patients with suspected or diagnosed megaloblastic anemia prior to blood sampling for the detection of the folic acid and cyanocobalamin deficiencies. The folic acid and the cyanocobalamin in the M.V.I.–12™ solution can mask serum deficits of folic acid and cyanocobalamin in these patients. 5.7 Monitor Blood Vitamin Concentrations In patients receiving parenteral multivitamins, such as with M.V.I.-12™, blood vitamin concentrations should be periodically monitored to determine if vitamin deficiencies or excesses are developing. M.V.I.–12™ may not correct long-standing specific vitamin deficiencies. The administration of additional therapeutic doses of specific vitamins may be required [ see Dosage and Administration (2.2) ]. 5.8 Interference with Urine Glucose Testing M.V.I-12™ contains Vitamin C, which is also known as ascorbic acid. Ascorbic acid in the urine may cause false negative urine glucose determinations.