This information is not for clinical use. These highlights do not include all the information needed to use M.v.i. Pediatric safely and effectively. Before taking M.v.i. Pediatric please consult with your doctor. See full prescribing information for M.v.i. Pediatric.

Indications And Usage

This formulation is indicated as daily multivitamin maintenance dosage for infants and children up to 11 years of age receiving parenteral nutrition. It is also indicated in other situations where administration by the intravenous route is required. Such situations include surgery, extensive burns, fractures and other trauma, severe infectious diseases, and comatose states, which may provoke a "stress" situation with profound alterations in the body's metabolic demands and consequent tissue depletion of nutrients. The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy. M.V.I. Pediatric® (reconstituted and administered in intravenous fluids under proper dilution) contributes intake of these necessary vitamins toward maintaining the body's normal resistance and repair processes. Patients with multiple vitamin deficiencies or with markedly increased requirements may be given multiples of the daily dosage for two or more days as indicated by the clinical status. Blood vitamin concentrations should be monitored to ensure maintenance of adequate levels, particularly in patients receiving parenteral multivitamins as their sole source of vitamins for long periods of time.

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Contraindications

Known hypersensitivity to any of the vitamins or excipients in this product or a pre-existing hypervitaminosis. Allergic reaction has been known to occur following intravenous administration of thiamine and vitamin K. The formulation is contraindicated prior to blood sampling for detection of megaloblastic anemia, as the folic acid and cyanocobalamin in the vitamin solution can mask serum deficits.

Adverse Reactions

There have been rare reports of anaphylactic reactions following parenteral multivitamin administration. Rare reports of anaphylactoid reactions have also been reported after large intravenous doses of thiamine. The risk, however, is negligible if thiamine is coadministered with other vitamins in the B group. There have been no reports of fatal anaphylactoid reactions associated with M.V.I. Pediatric®. There have been rare reports of the following types of reactions: Dermatologic - rash, erythema, pruritus CNS - headache, dizziness, agitation, anxiety Ophthalmic -diplopia Allergic - urticaria, shortness of breath, wheezing, and angioedema

Drug Interactions

Drug-Drug Interactions Physical Incompatibilities: M.V.I. Pediatric® is not physically compatible with alkaline solutions or moderately alkaline drugs such as Diamox (Acetazolamide), Diuril Intravenous Sodium (Chlorothiazide sodium), Aminophylline or sodium bicarbonate. M.V.I. Pediatric® is not physically compatible with ampicillin and it may not be physically compatible with ACHROMYCIN (tetracycline HCl). It has also been reported that folic acid is unstable in the presence of calcium salts such as calcium gluconate. Direct addition of M.V.I. Pediatric® to intravenous fat emulsions is not recommended. Consult appropriate references for listings of physical compatibility of solutions and drugs with the vitamin infusion. In such circumstances, admixture or Y-site administration with vitamin solutions should be avoided. Several vitamins have been reported to decrease the activity of certain antibiotics. Thiamine, riboflavin, pyridoxine, niacinamide, and ascorbic acid have been reported to decrease the antibiotic activity of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin. Bleomycin is inactivated in vitro by ascorbic acid and riboflavin. Some of the vitamins in M.V.I. Pediatric® may react with vitamin K bisulfite or sodium bisulfite; if bisulfite solutions are necessary, patients should be monitored for vitamin A and thiamine deficiencies.