ADVERSE REACTIONS SECTION.


6 ADVERSE REACTIONS. The following adverse reactions are discussed in greater detail in other sections of the label.Allergic Reactions to Thiamine [see Warnings and Precautions (5.2) ].Hypervitaminosis [see Warnings and Precautions (5.3) ].The following adverse reactions have been identified during post approval use of M.V.I. Pediatric. Because these reactions are reported voluntarily from population of uncertain size, it is not always possible to reliably estimate their frequency or establish causal relationship to drug exposure.Allergic: anaphylaxis, urticaria, shortness of breath, wheezing, angioedemaCNS: headache, dizziness, agitation, anxietyDermatologic: rash, erythema, pruritusOphthalmic: diplopia. Allergic Reactions to Thiamine [see Warnings and Precautions (5.2) ].. Hypervitaminosis [see Warnings and Precautions (5.3) ].. Adverse reactions have included anaphylaxis, rash, erythema, pruritus, headache, dizziness, agitation, anxiety, diplopia, urticaria, shortness of breath, wheezing and angioedema (6)To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.


13.1Carcinogenesis, Mutagenesis, Impairment of Fertility. Carcinogenicity, mutagenicity, and fertility studies have not been performed with M.V.I. Pediatric.

CONTRAINDICATIONS SECTION.


4 CONTRAINDICATIONS. M.V.I. Pediatric is contraindicated in patients who have:A history of known hypersensitivity to any of the vitamins or excipients in M.V.I. Pediatric [see Warnings and Precautions (5.2), Adverse Reactions (6)] An existing hypervitaminosis. history of known hypersensitivity to any of the vitamins or excipients in M.V.I. Pediatric [see Warnings and Precautions (5.2), Adverse Reactions (6)] An existing hypervitaminosis. Hypersensitivity to any of the vitamins or excipients (4)Existing hypervitaminosis (4). Hypersensitivity to any of the vitamins or excipients (4). Existing hypervitaminosis (4).

DESCRIPTION SECTION.


11DESCRIPTION. M.V.I. Pediatric (multiple vitamins for injection) is yellow to amber colored lyophilized, sterile powder for reconstitution intended for administration by intravenous infusion after dilution [see Dosage and Administration (2.3)].Table provides the strengths of the vitamins provided in each mL of reconstituted product:Table 2: M.V.I. PEDIATRIC FORMULATIONIngredientAmount per Unit DoseWith Butylated Hydroxyanisole 14 mcg; Butylated Hydroxytoluene 58 mcg; Mannitol 375 mg; Polysorbate 20 0.8 mg; Polysorbate 80 50 mg; Sodium hydroxide for pH adjustment.Fat Soluble VitaminsFat-soluble vitamins A, D, and K1 are water-solubilized with polysorbate 80.Vitamin A0.7 mg vitamin equals 2,300 USP units 2,300 IU. (retinol)2,300 IUIU international units. (equals 0.7 mg)Vitamin D10 mcg ergocalciferol equals 400 USP units 400 IU. (ergocalciferol)400 IU (equals 10 mcg)Vitamin E7 mg vitamin equals USP units 7 IU. (dl-alpha-tocopheryl acetate)7 IU (equals mg)Vitamin K1 (phytonadione)200 mcgWater Soluble VitaminsVitamin B2 (as riboflavin 5-phosphate sodium)1.4 mgVitamin (ascorbic acid)80 mgVitamin B6 (pyridoxine hydrochloride)1 mgNiacinamide17 mgDexpanthenol (as d-pantothenyl alcohol)5 mgVitamin B1 (thiamine hydrochloride)1.2 mgBiotin20 mcgFolic acid140 mcgVitamin B12 (cyanocobalamin)1 mcgM.V.I. Pediatric (multiple vitamins for injection) provides combination of oil-soluble and water-soluble vitamins, formulated for incorporation into intravenous infusions after reconstitution. The liposoluble vitamins A, D, and K1 have been solubilized in an aqueous medium with polysorbate 80, permitting intravenous administration of these vitamins.

DOSAGE & ADMINISTRATION SECTION.


2 DOSAGE AND ADMINISTRATION. M.V.I. Pediatric is 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 (2.1)Supplied as single-dose vial of lyophilized powder for reconstitution intended for administration by intravenous infusion after dilution. (2.1)Recommended daily dosage is based on patients actual weight (2.2)Less than kg: The daily dose is 1.5 mL1 kg to kg: The daily dose is 3.25 mL3 kg or more: The daily dose is mL One daily dose of the reconstituted solution (1.5 mL, 3.25 mL or mL) is then added directly to the intravenous fluid (2.2,2.3)See Full Prescribing Information for reconstitution instructions (2.3)Monitor blood vitamin concentrations (2.4)See Full Prescribing Information for drug incompatibilities (2.5). M.V.I. Pediatric is 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 (2.1). Supplied as single-dose vial of lyophilized powder for reconstitution intended for administration by intravenous infusion after dilution. (2.1). Recommended daily dosage is based on patients actual weight (2.2)Less than kg: The daily dose is 1.5 mL1 kg to kg: The daily dose is 3.25 mL3 kg or more: The daily dose is mL Less than kg: The daily dose is 1.5 mL. kg to kg: The daily dose is 3.25 mL. kg or more: The daily dose is mL. One daily dose of the reconstituted solution (1.5 mL, 3.25 mL or mL) is then added directly to the intravenous fluid (2.2,2.3). See Full Prescribing Information for reconstitution instructions (2.3). Monitor blood vitamin concentrations (2.4). See Full Prescribing Information for drug incompatibilities (2.5). 2.1Important Dosage and Administration Instructions. M.V.I. Pediatric is 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 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 direct, undiluted intravenous injection as it may cause dizziness, faintness and tissue irritation.. 2.2Dosage Information The recommended daily dosage volume of 1.5 mL, 3.25 mL, or mL of the reconstituted solution is based on the patients actual weight of less than kg, kg to less than kg, and more than or equal to kg, respectively (see Table 1).Table - Recommended Weight-Based Dosage of M.V.I. PediatricLess than kg1 kg to less than kgMore than or equal to kgDaily Dosage Volume1.5 mL3.25 mL5 mLVitamin A0.1 mg vitamin equals 333.3 USP units 333.3 IU. (retinol)690 IUIU international units. (equals approx. 0.207 mg)1,495 IU (equals approx. 0.449 mg)2,300 IU (equals approx. 0.690 mg)Vitamin D1 mcg ergocalciferol equals 40 USP units 40 IU. (ergocalciferol)120 IU (equals mcg)280 IU (equals mcg)400 IU (equals 10 mcg)Vitamin E1 mg vitamin equals USP units 1 IU. (dl-alpha-tocopheryl acetate)2.1 IU (equals mg)4.6 IU (equals mg)7 IU (equals mg)Vitamin K1 (phytonadione)0.1 mg0.1 mg0.2 mgVitamin B2 (as riboflavin 5-phosphate sodium)0.4 mg0.9 mg1.4 mgVitamin (ascorbic acid)24 mg52 mg80 mgVitamin B6 (pyridoxine hydrochloride)0.3 mg0.7 mg1 mgNiacinamide5.1 mg11.1 mg17 mgDexpanthenol (as d-pantothenyl alcohol)1.5 mg3.3 mg5 mgVitamin B1 (thiamine hydrochloride)0.4 mg0.8 mg1.2 mgBiotin6 mcg13 mcg20 mcgFolic acid42 mcg91 mcg140 mcgVitamin B12 (cyanocobalamin)0.3 mcg0.7 mcg1 mcgOne daily dose of the reconstituted solution (1.5 mL, 3.25 mL or 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 may be required for low-birth weight infants.. The recommended daily dosage volume of 1.5 mL, 3.25 mL, or mL of the reconstituted solution is based on the patients actual weight of less than kg, kg to less than kg, and more than or equal to kg, respectively (see Table 1).. One daily dose of the reconstituted solution (1.5 mL, 3.25 mL or 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 may be required for low-birth weight infants.. 2.3Preparation and Administration Instructions. M.V.I Pediatric is to be reconstituted and diluted only in suitable work area such as laminar flow hood (or an equivalent clean air compounding area).Reconstitue the single-dose vial of M.V.I. Pediatric by adding 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 hours. The reconstituted solution may be refrigerated and stored for up to 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, and riboflavin, are light sensitive.. M.V.I Pediatric is to be reconstituted and diluted only in suitable work area such as laminar flow hood (or an equivalent clean air compounding area).. Reconstitue the single-dose vial of M.V.I. Pediatric by adding 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 hours. The reconstituted solution may be refrigerated and stored for up to 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, and riboflavin, are light sensitive.. 2.4Monitoring 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.. 2.5Drug Incompatibilities. M.V.I. Pediatric is not physically compatible with alkaline solutions such as 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 and thiamine in M.V.I. Pediatric may react with bisulfite solutions such as sodium bisulfite or vitamin 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.. M.V.I. Pediatric is not physically compatible with alkaline solutions such as 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 and thiamine in M.V.I. Pediatric may react with bisulfite solutions such as sodium bisulfite or vitamin 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.

DOSAGE FORMS & STRENGTHS SECTION.


3 DOSAGE FORMS AND STRENGTHS. M.V.I. Pediatric for injection is available as single-dose vial of yellow to amber colored lyophilized powder for reconstitution.See Description section for vitamin strengths [see Description (11)].. M.V.I. Pediatric for injection is available as single-dose vial for reconstitution (3) See Full Prescribing Information for vitamin content (11).

DRUG INTERACTIONS SECTION.


7 DRUG INTERACTIONS. Drug Interactions Affecting Co-administered Drugs:Antibiotics: Thiamine, riboflavin, pyridoxine, niacinamide and ascorbic acid decrease activities of erythromycin, kanamycin, streptomycin, doxycycline and lincomycin (7.1)Bleomycin: Ascorbic acid and riboflavin may reduce the activity of bleomycin (7.1)Levodopa: Pyridoxine may decrease blood levels of levodopa and levodopa efficacy may decrease (7.1)Phenytoin: Folic acid may decrease phenytoin blood levels and increase risk of seizure (7.1)Methotrexate: Folic acid may decrease response to methotrexate (7.1)Drug Interactions Affecting Vitamin Levels:Hydralazine, Isoniazid: Concomitant administration of hydralazine or isoniazid may increase pyridoxine requirements (7.2)Phenytoin: May decrease folic acid conentrations (7.2). Antibiotics: Thiamine, riboflavin, pyridoxine, niacinamide and ascorbic acid decrease activities of erythromycin, kanamycin, streptomycin, doxycycline and lincomycin (7.1). Bleomycin: Ascorbic acid and riboflavin may reduce the activity of bleomycin (7.1). Levodopa: Pyridoxine may decrease blood levels of levodopa and levodopa efficacy may decrease (7.1). Phenytoin: Folic acid may decrease phenytoin blood levels and increase risk of seizure (7.1). Methotrexate: Folic acid may decrease response to methotrexate (7.1). Hydralazine, Isoniazid: Concomitant administration of hydralazine or isoniazid may increase pyridoxine requirements (7.2). Phenytoin: May decrease folic acid conentrations (7.2). 7.1Effect of M.V.I. Pediatric on Other Drugs. Warfarin: Vitamin K, component of M.V.I. Pediatric, antagonizes the anticoagulant action of warfarin. In patients who are co-administered warfarin and M.V.I. Pediatric, monitor blood levels of prothrombin/INR periodically to determine if the dose of warfarin needs to be adjusted.. Phenytoin: Folic acid may increase phenytoin metabolism and lower the serum concentration of phenytoin, resulting in increased seizure frequency.. Methotrexate: Folic acid may decrease patients response to methotrexate therapy. Levodopa: Pyridoxine may increase the metabolism of levodopa (decrease blood level of levodopa) and decrease its efficacy.. Antibiotics: Thiamine, riboflavin, pyridoxine, niacinamide, and ascorbic acid decrease antibiotic activities of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin.. Bleomycin: Ascorbic acid and riboflavin inactivate bleomycin in vitro, thus the activity of bleomycin may be reduced.. 7.2Effect of Other Drugs on M.V.I. Pediatric. Hydralazine or Isoniazid: Concomitant administration of hydralazine or isoniazid may increase pyridoxine requirements.. Chloramphenicol: In patients with pernicious anemia, the hematologic response to vitamin B12 therapy may be inhibited by concomitant administration of chloramphenicol.. Phenytoin: Phenytoin may decrease serum folic acid concentrations.

HEPATIC IMPAIRMENT SUBSECTION.


8.7Hepatic Impairment. M.V.I. Pediatric has not been studied in patients with hepatic impairment. Monitor vitamin level in patients with liver disease [see Warnings and Precautions (5.3)].

HOW SUPPLIED SECTION.


16HOW SUPPLIED/STORAGE AND HANDLING. M.V.I. Pediatric for injection is supplied as single-dose vial of lyophilized powder for reconstitution available as:Box of 10 single-dose glass fliptop vials (NDC 61703-421-53)See Description section for vitamin strengths [see Description (11)]. Box of 10 single-dose glass fliptop vials (NDC 61703-421-53). Minimize the exposure of M.V.I. Pediatric to light, because vitamins A, and riboflavin are light sensitive. Store under refrigeration, to 8C (36 to 46F).

INDICATIONS & USAGE SECTION.


1 INDICATIONS AND USAGE. M.V.I. Pediatric is combination of vitamins indicated for the prevention of vitamin deficiency in pediatric patients up to 11 years of age receiving parenteral nutrition.The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy.. M.V.I. Pediatric is combination of vitamins indicated for the prevention of vitamin deficiency in pediatric patients up to 11 years of age receiving parenteral nutrition (1).

INFORMATION FOR PATIENTS SECTION.


17PATIENT COUNSELING INFORMATION. Instruct patients (if age appropriate) and caregivers:To watch for and immediately report signs of allergic reactions (i.e., urticaria, shortness of breath, wheezing, and angioedema).To watch for and immediately report signs of hypervitaminosis A, manifested by nausea, vomiting, headache, dizziness, and blurred vision, if patients have renal impairment.To report other adverse reactions such as rash, erythema, pruritus, headache, dizziness, agitation, anxiety, and diplopia.That patients on warfarin anticoagulant therapy will be monitored periodically for blood prothrombin levels to determine the appropriate dose of warfarin.About the significance of periodic monitoring of blood vitamin concentrations to determine if vitamin deficiencies or excesses are developing.About the need to monitor renal function, calcium, phosphorus, aluminum, and vitamin levels in patients with renal impairment.. To watch for and immediately report signs of allergic reactions (i.e., urticaria, shortness of breath, wheezing, and angioedema).. To watch for and immediately report signs of hypervitaminosis A, manifested by nausea, vomiting, headache, dizziness, and blurred vision, if patients have renal impairment.. To report other adverse reactions such as rash, erythema, pruritus, headache, dizziness, agitation, anxiety, and diplopia.. That patients on warfarin anticoagulant therapy will be monitored periodically for blood prothrombin levels to determine the appropriate dose of warfarin.. About the significance of periodic monitoring of blood vitamin concentrations to determine if vitamin deficiencies or excesses are developing.. About the need to monitor renal function, calcium, phosphorus, aluminum, and vitamin levels in patients with renal impairment.

NONCLINICAL TOXICOLOGY SECTION.


13NONCLINICAL TOXICOLOGY. 13.1Carcinogenesis, Mutagenesis, Impairment of Fertility. Carcinogenicity, mutagenicity, and fertility studies have not been performed with M.V.I. Pediatric.

OVERDOSAGE SECTION.


10OVERDOSAGE. Signs and symptoms of acute or chronic overdosage may be those of individual M.V.I. Pediatric component toxicity.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


PRINCIPAL DISPLAY PANEL 5 mL Vial Label. NDC 61703-421-63M.V.I. Pediatric(R) (multiple vitamins for injection)For Intravenous Infusion Only.Single-Dose Vial Discard Unused Portion, SterileRx onlyDistributed by:Hospira, Inc.Lake Forest, IL 60045 USAHospira. PRINCIPAL DISPLAY PANEL 5 mL Vial Label.

PEDIATRIC USE SECTION.


8.4Pediatric 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 supplementation of infants receiving M.V.I. Pediatric may result in elevated blood concentrations of vitamin and potential vitamin 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)].

RECENT MAJOR CHANGES SECTION.


Dosage And Administration, Dosage Information (2.2)2/2019.

RENULLL IMPAIRMENT SUBSECTION.


8.6Renal Impairment. M.V.I. Pediatric has not been studied in patients with renal impairment. Monitor renal function, calcium, phosphorus and vitamin levels in patients with renal impairment [see Warnings and Precautions (5.1, 5.3)].

SPL UNCLASSIFIED SECTION.


2.1Important Dosage and Administration Instructions. M.V.I. Pediatric is 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 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 direct, undiluted intravenous injection as it may cause dizziness, faintness and tissue irritation.

STORAGE AND HANDLING SECTION.


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

USE IN SPECIFIC POPULATIONS SECTION.


8 USE IN SPECIFIC POPULATIONS. Renal Impairment: Monitor renal function, calcium, phosphorus and vitamin levels (8.6)Hepatic Impairment: Monitor vitamin levels (8.7). Renal Impairment: Monitor renal function, calcium, phosphorus and vitamin levels (8.6). Hepatic Impairment: Monitor vitamin levels (8.7). 8.4Pediatric 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 supplementation of infants receiving M.V.I. Pediatric may result in elevated blood concentrations of vitamin and potential vitamin 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)]. 8.6Renal Impairment. M.V.I. Pediatric has not been studied in patients with renal impairment. Monitor renal function, calcium, phosphorus and vitamin levels in patients with renal impairment [see Warnings and Precautions (5.1, 5.3)]. 8.7Hepatic Impairment. M.V.I. Pediatric has not been studied in patients with hepatic impairment. Monitor vitamin level in patients with liver disease [see Warnings and Precautions (5.3)].

WARNINGS AND PRECAUTIONS SECTION.


5 WARNINGS AND PRECAUTIONS. Risk of Aluminum Toxicity: Aluminum may reach toxic levels with prolonged administration. Monitor aluminum levels in at risk patients (5.1)Allergic Reactions: to thiamine may occur (5.2)Hypervitaminosis A: Patients with renal failure or liver disease may be at higher risk (5.3)Decreased Anticoagulant Effect of Warfarin: Periodically monitor prothrombin time (5.4)Interferes with Megaloblastic Anemia Diagnosis: Avoid use during testing for this disorder (5.5)Risk of Vitamin Deficiencies or Excesses: Monitor blood vitamin concentrations (5.6)False Negative Urine Glucose Tests: May occur due to vitamin (5.7)Risk of Vitamin Toxicity: Additional oral and parenteral vitamin may result in elevated vitamin blood concentrations in infants (5.8)Low Vitamin Levels: Monitor vitamin levels (5.9)Risk of E- Ferol Syndrome: due to polysorbates (5.10). Risk of Aluminum Toxicity: Aluminum may reach toxic levels with prolonged administration. Monitor aluminum levels in at risk patients (5.1). Allergic Reactions: to thiamine may occur (5.2). Hypervitaminosis A: Patients with renal failure or liver disease may be at higher risk (5.3). Decreased Anticoagulant Effect of Warfarin: Periodically monitor prothrombin time (5.4). Interferes with Megaloblastic Anemia Diagnosis: Avoid use during testing for this disorder (5.5). Risk of Vitamin Deficiencies or Excesses: Monitor blood vitamin concentrations (5.6). False Negative Urine Glucose Tests: May occur due to vitamin (5.7). Risk of Vitamin Toxicity: Additional oral and parenteral vitamin may result in elevated vitamin blood concentrations in infants (5.8). Low Vitamin Levels: Monitor vitamin levels (5.9). Risk of E- Ferol Syndrome: due to polysorbates (5.10). 5.1Aluminum 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 to 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.. 5.2Allergic 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.. 5.3Hypervitaminosis 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 should be monitored periodically.. 5.4Decreased 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.. 5.5Interference 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.. 5.6Potential 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) ].. 5.7Interference 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.. 5.8Vitamin Overdose in Infants Receiving Additional Vitamin E. Additional vitamin supplementation of patients receiving M.V.I Pediatric may result in elevated blood concentrations of vitamin and potential vitamin toxicity in infants. Avoid additional oral or parenteral doses of vitamin in infants. daily dose of M.V.I. Pediatric contains adequate concentrations of vitamin required to achieve normal blood levels of vitamin E.. 5.9Risk of Low Vitamin Levels. Vitamin may adhere to plastic, resulting in lower vitamin concentrations after administration of M.V.I. Pediatric. Therefore, blood vitamin concentrations should be periodically monitored and the administration of additional therapeutic doses of Vitamin may be required, especially in low birth weight infants.. 5.10Risk 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.