2.1 Important Dosage and Administration Instructions

M.V.I. Pediatric is a combination product that contains the following vitamins: ascorbic acid, vitamin A, vitamin D, thiamine, riboflavin, pyridoxine, niacinamide, dexpanthenol, vitamin E, vitamin K, folic acid, biotin, and vitamin B12 [see Dosage and Administration (2.2)].

M.V.I. Pediatric is supplied as a single-dose vial of lyophilized powder for reconstitution and intended for administration by intravenous infusion after dilution.

Do not administer M.V.I. Pediatric as a direct, undiluted intravenous injection as it may cause dizziness, faintness and tissue irritation.

2.2 Dosage Information

• The recommended daily dosage volume of 1.5 mL, 3.25 mL, or 5 mL of the reconstituted solution is based on the patient's actual weight of less than 1 kg, 1 kg to less than 3 kg, and more than or equal to 3 kg, respectively (see Table 1).

• One daily dose of the reconstituted solution (1.5 mL, 3.25 mL or 5 mL) is then added directly to the intravenous fluid [see Dosage and Administration (2.3)].
• Patients with multiple vitamin deficiencies or with increased vitamin requirements may need multiple daily dosages as indicated or additional doses of individual vitamins. However, additional daily dosages in infants are not recommended [see Warnings and Precautions (5.8)]. Supplemental vitamin A may be required for low-birth weight infants.

2.3 Preparation and Administration Instructions

• M.V.I Pediatric is to be reconstituted and diluted only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area).
• Reconstitue the single-dose vial of M.V.I. Pediatric by adding 5 mL of Sterile Water for Injection USP, or Dextrose Injection USP 5%, or Sodium Chloride Injection USP to the 10 mL vial.
• Swirl the vial gently after the addition of the diluent to hasten reconstitution. The reconstituted solution is ready within three minutes for use.
• Visually inspect for particulate matter and discoloration prior to administration.
• Once reconstituted, immediately withdraw the dose to be added to the appropriate intravenous fluids [see Dosage Information (2.2)] and discard any unused portion. After reconstitution, complete withdrawal of vial contents within 4 hours. The reconstituted solution may be refrigerated and stored for up to 4 hours.
• After M.V.I. Pediatric is diluted in an intravenous infusion, refrigerate the resulting solution unless it is to be used immediately, and use the solution within 24 hours after dilution.
• Minimize exposure to light because some of the vitamins in M.V.I.Pediatric, particularly A, D and riboflavin, are light sensitive.

2.4 Monitoring Vitamin Blood Levels

Monitor blood vitamin concentrations to ensure maintenance of adequate levels, particularly in patients receiving parenteral multivitamins as the only source of vitamins for long periods of time.

2.5 Drug Incompatibilities

• M.V.I. Pediatric is not physically compatible with alkaline solutions such as a sodium bicarbonate solution and other alkaline drugs such as acetazolamide sodium, aminophylline, ampicillin sodium, tetracycline HCl and chlorothiazide sodium.
• Folic acid is unstable in the presence of calcium salts such as calcium gluconate.
• Vitamin A and thiamine in M.V.I. Pediatric may react with bisulfite solutions such as sodium bisulfite or vitamin K bisulfite.
• Do not add M.V.I. Pediatric directly to intravenous fat emulsions.
• Consult appropriate references for listings of physical and chemical compatibility of solutions and drugs with M.V.I. Pediatric. In such circumstances, admixture or Y-site administration with M.V.I. Pediatrc should be avoided.

5.1 Aluminum Toxicity

M.V.I. Pediatric contains aluminum, up to 42 mcg/L that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration in patients with renal impairment. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 micrograms per kg per day, accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration. To prevent aluminum toxicity, periodically monitor aluminum levels with prolonged parenteral administration of M.V.I. Pediatric.

5.2 Allergic Reactions to Thiamine

Allergic reactions such as urticaria, shortness of breath, wheezing and angioedema have been reported following intravenous administration of thiamine, an ingredient in M.V.I. Pediatric. There have been rare reports of anaphylaxis following intravenous doses of thiamine. No fatal anaphylaxis reactions associated with M.V.I. Pediatric have been reported.

5.3 Hypervitaminosis A

Hypervitaminosis A, manifested by nausea, vomiting, headache, dizziness, and blurred vision, has been reported in patients with renal failure receiving 1.5 mg per day retinol and in patients with liver disease. Therefore, supplementation of patients with renal failure and patients with liver diseases with vitamin A, an ingredient found in M.V.I. Pediatric, should be undertaken with caution [see Use in Specific Populations (8.6, 8.7)]. Blood levels of Vitamin A should be monitored periodically.

5.4 Decreased Anticoagulant Effect of Warfarin

M.V.I. Pediatric contains Vitamin K, which may decrease the anticoagulant effect of warfarin. In patients who are on warfarin anticoagulant therapy receiving M.V.I. Pediatric, prothrombin time/INR should be periodically monitored to determine if the dose of warfarin needs to be adjusted.

5.5 Interference with Diagnosis of Megaloblastic Anemia

M.V.I. Pediatric contains folic acid and cyanocobalamin, which can mask serum deficits of folic acid and cyanocobalamin in patients with megaloblastic anemia. Avoid the use of M.V.I. Pediatric in patients with suspected or diagnosed megaloblastic anemia prior to blood sampling for the detection of the folic acid and cyanocobalamin deficiencies.

5.6 Potential to Develop Vitamin Deficiencies or Excesses

In patients receiving parenteral multivitamins, such as with M.V.I. Pediatric, blood vitamin concentrations should be periodically monitored to determine if vitamin deficiencies or excesses are developing. M.V.I. Pediatric may not correct long-standing specific vitamin deficiencies. The administration of additional doses of specific vitamins may be required [see Dosage and Administration (2.2)].

5.7 Interference with Urine Glucose Testing

M.V.I. Pediatric contains Vitamin C, which is also known as ascorbic acid. Ascorbic acid in the urine may cause false negative urine glucose determinations.

5.8 Vitamin E Overdose in Infants Receiving Additional Vitamin E

Additional vitamin E supplementation of patients receiving M.V.I Pediatric may result in elevated blood concentrations of vitamin E and potential vitamin E toxicity in infants. Avoid additional oral or parenteral doses of vitamin E in infants. A daily dose of M.V.I. Pediatric contains adequate concentrations of vitamin E required to achieve normal blood levels of vitamin E.

5.9 Risk of Low Vitamin A Levels

Vitamin A may adhere to plastic, resulting in lower vitamin A concentrations after administration of M.V.I. Pediatric. Therefore, blood vitamin A concentrations should be periodically monitored and the administration of additional therapeutic doses of Vitamin A may be required, especially in low birth weight infants.

5.10 Risk of E-Ferol syndrome

E-Ferol syndrome, manifested by thrombocytopenia, renal dysfunction, hepatomegaly, cholestasis, ascites, hypotension and metabolic acidosis, has been reported in low-birth weight infants following administration of polysorbates, which are found in M.V.I. Pediatric. No E-Ferol syndrome associated with M.V.I. Pediatric has been reported.

7.1 Effect of M.V.I. Pediatric on Other Drugs

7.2 Effect of Other Drugs on M.V.I. Pediatric

8.4 Pediatric Use

The safety and effectiveness of M.V.I. Pediatric for the prevention of vitamin deficiency have been established in pediatric patients up to 11 years of age receiving parenteral nutrition. The safety and effectiveness of M.V.I. Pediatric have not been established in pediatric patients older than 11 years of age.

M.V.I. Pediatric contains aluminum that may be toxic for premature neonates. Aluminum levels should be monitored periodically during administration of M.V.I. Pediatric to premature neonates [see Warnings and Precautions (5.1)].

Additional vitamin E supplementation of infants receiving M.V.I. Pediatric may result in elevated blood concentrations of vitamin E and potential vitamin E toxicity [see Warnings and Precautions (5.8)].

E-Ferol syndrome has been reported in low-birth weight infants following administration of polysorbates, which are found in M.V.I. Pediatric [see Warnings and Precautions (5.10)].

8.6 Renal Impairment

M.V.I. Pediatric has not been studied in patients with renal impairment. Monitor renal function, calcium, phosphorus and vitamin A levels in patients with renal impairment [see Warnings and Precautions (5.1, 5.3)].

8.7 Hepatic Impairment

M.V.I. Pediatric has not been studied in patients with hepatic impairment. Monitor vitamin A level in patients with liver disease [see Warnings and Precautions (5.3)].

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity, and fertility studies have not been performed with M.V.I. Pediatric.

Minimize the exposure of M.V.I. Pediatric to light, because vitamins A, D and riboflavin are light sensitive. Store under refrigeration, 2 to 8°C (36 to 46°F).