Pediatric Infuvite Multiple Vitamins

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling. • Allergic reactions to thiamine [ see Warnings and Precautions ( 5.2 ) ]. • Hypervitaminosis A [ see Warnings and Precautions ( 5.3 ) ] The following adverse reactions have been identified during postapproval use of INFUVITE PEDIATRIC. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Dermatologic: rash, erythema, pruritis CNS: headache, dizziness, agitation, anxiety Ophthalmic: diplopia Adverse reactions have included anaphylaxis, rash, erythema, pruritis, headache, dizziness, agitation, anxiety, diplopia ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

4 CONTRAINDICATIONS INFUVITE PEDIATRIC is contraindicated in patients who have: • An existing hypervitaminosis, or • A history of hypersensitivity to any vitamins or excipients contained in this formulation. • Hypersensitivity to any of vitamins or excipients ( 4 ) • Existing hypervitaminosis ( 4 )

11 DESCRIPTION INFUVITE PEDIATRIC (multiple vitamins injection) is a sterile product consisting of two vials provided as a single dose or as a pharmacy bulk package for intravenous use intended for administration by intravenous infusion after dilution: INFUVITE PEDIATRIC (multiple vitamins injection) supplied as single dose consists of: (a) Vial 1 (4 mL); and (b) Vial 2 (1 mL). Vial 1 will provide one daily dose of 1.2 mL, 2.6 mL or 4 mL and Vial 2 will provide one daily dose of 0.3 mL, 0.65 mL or 1 mL [ see Dosage and Administration ( 2.2 ) ] . INFUVITE PEDIATRIC (multiple vitamins injection) supplied as pharmacy bulk package consists of: (a) Vial 1 (40 mL Fill in 50 mL Vial); and (b) Vial 2 (10 mL). The mixed solution will provide many single doses [ see Dosage and Administration ( 2.2 ) ]. Each 4 mL of Vial 1 contains 10 vitamins and each 1 mL of Vial 2 contains 3 vitamins (see Table 3). Table 3: INGREDIENTS IN INFUVITE PEDIATRIC FORMULATION Vial 1 Active Ingredient Quantity per 4 mL Ascorbic acid (Vitamin C) 80 mg Vitamin A* (as palmitate) 2,300 IU (equals 0.7 mg) Vitamin D 3 * (cholecalciferol) 400 IU (equals 10 mcg) Thiamine (Vitamin B 1 ) (as the hydrochloride) 1.2 mg Riboflavin (Vitamin B 2 ) (as riboflavin 5-phosphate sodium) 1.4 mg Pyridoxine HCl (Vitamin B 6 ) 1 mg Niacinamide 17 mg Dexpanthenol (as d -pantothenyl alcohol) 5 mg Vitamin E* ( dl -α-tocopheryl acetate) 7 IU (equals 7 mg) Vitamin K 1 * 0.2 mg *Polysorbate 80 is used to water solubilize the oil-soluble vitamins A, D, E, and K. Inactive ingredients in 4 mL of Vial 1: 50 mg polysorbate 80, sodium hydroxide and/or hydrochloric acid for pH adjustment, and water for injection. Vial 2 Active Ingredient Quantity per 1 mL Folic acid 140 mcg Biotin 20 mcg Vitamin B 12 (cyanocobalamin) 1 mcg Inactive ingredients in 1 mL of Vial 2: 75 mg mannitol, citric acid and/or sodium citrate for pH adjustment and water for injection. INFUVITE PEDIATRIC (multiple vitamins injection) makes available a combination of oil-soluble and water-soluble vitamins in an aqueous solution, formulated for incorporation into intravenous solutions. The liposoluble vitamins A, D, E, and K have been solubilized in an aqueous medium with polysorbate 80, permitting intravenous administration of these vitamins. INFUVITE PEDIATRIC contains no more than 30 mcg/L of aluminum (combined Vials 1 and 2).

2 DOSAGE AND ADMINISTRATION • INFUVITE PEDIATRIC is a combination product that contains the following vitamins: ascorbic acid, vitamin A, vitamin D, thiamine, riboflavin, pyridoxine, niacinamide, dexpanthenol, vitamin E, vitamin K1, folic acid, biotin, and vitamin B12 ( 2.1 ) • INFUVITE PEDIATRIC is for administration by intravenous infusion after dilution ( 2.1 ) • Recommended daily dosage is based on patient’s actual weight ( 2.2 ): • INFUVITE PEDIATRIC Single Dose: o Weight less than 1 kg: 1.2 mL of Vial 1 and 0.3 mL of Vial 2 o Weight 1 kg to less than 3 kg: 2.6 mL of Vial 1 and 0.65 mL Vial 2 o Weight 3 kg or greater: 4 mL of Vial 1 and 1 mL of Vial 2 • INFUVITE PEDIATRIC Pharmacy Bulk Package : o Weight less than 1 kg: 1.5 mL of combined content of Vials 1 and 2 o Weight 1 kg to less than 3 kg: 3.25 mL of combined content of Vials 1 and 2 o Weight 3 kg or greater: 5 mL of combined content of Vials 1 and 2. • Supplemental vitamin A may be required for low-birth weight infants ( 2.2 ) • INFUVITE PEDIATRIC is supplied as a single dose and as a pharmacy bulk package: • Single Dose consists of two vials labeled Vial 1 and Vial 2. Add one daily dose of Vial 1 and one daily dose of Vial 2 directly to at least 100 mL of intravenous dextrose or saline solution prior to intravenous use ( 2.3 ) • Pharmacy Bulk Package consists of two vials labeled Vial 1 and Vial 2. Transfer contents of Vial 2 to contents of Vial 1. Then, take 1.5 mL, 3.25 mL, or 5 mL from mixture and add to at least 100 mL of intravenous dextrose or saline solution prior to intravenous use ( 2.3 ) • After dilution in an intravenous infusion, refrigerate resulting solution unless used immediately. Use solution within 24 hours after dilution ( 2.3 ) • Monitor blood vitamin concentrations ( 2.4 ) • See Full Prescribing Information for drug incompatibilities ( 2.5 ). 2.1 Important Dosage Instructions INFUVITE PEDIATRIC is a combination product that contains the following vitamins: ascorbic acid, vitamin A, vitamin D, thiamine, riboflavin, pyridoxine, niacinamide, dexpanthenol, vitamin E, vitamin K1, folic acid, biotin, and vitamin B12 . INFUVITE PEDIATRIC is supplied as a single dose or as a pharmacy bulk package, for intravenous use intended for administration by intravenous infusion after dilution: • INFUVITE PEDIATRIC Single Dose consists of two vials. A weight-based volume from each vial must be added directly to dextrose or saline solution prior to intravenous administration [ see Dosage and Administration ( 2.2 , 2.3 ) ]. • INFUVITE PEDIATRIC Pharmacy Bulk Package consists of two pharmacy bulk vials which must be mixed prior to use. The mixed solution will provide multiple daily doses which must be diluted prior to intravenous administration. Pharmacy bulk package of INFUVITE PEDIATRIC is intended for dispensing of single doses to multiple patients in a pharmacy admixture program and is restricted to the preparation of admixtures for infusion. [ see Dosage and Administration ( 2.2 , 2.3 ) ]. 2.2 Dosage Information The recommended daily dosage volume is based on the patient's actual weight less than 1 kg, 1 kg to less than 3 kg, and 3 kg or greater. Patients with multiple vitamin deficiencies or with increased vitamin requirements may need multiple daily dosages as indicated or additional doses of individual vitamins. Supplemental vitamin A may be required for low-birth weight infants. Additional daily dosages of Vitamin E in infants are not recommended [see Warnings and Precautions ( 5.8 )]. INFUVITE PEDIATRIC Single Dose (see Table 1): One daily dose of Vial 1 (1.2 mL, 2.6 mL or 4 mL) and one daily dose of Vial 2 (0.3 mL, 0.65 mL or 1 mL) based on the patient’s weight are added directly to a specified volume of an intravenous fluid [ see Dosage and Administration ( 2.3 ) ] (see Table 1). Table 1: Recommended Weight-Based Dosage of INFUVITE PEDIATRIC Single Dose Less than 1 kg 1 kg to less than 3 kg 3 kg or greater Daily Dosage Volume – Vial 1 1.2 mL 2.6 mL 4 mL Ascorbic acid (Vitamin C) 24 mg 52 mg 80 mg Vitamin A (as palmitate) 690 IU (equals 0.2 mg) 1495 IU (equals 0.5 mg) 2,300 IU (equals 0.7 mg) Vitamin D 3 (cholecalciferol) 120 IU (equals 3 mcg) 260 IU (equals 7 mc g) 400 IU (equals 10 mcg) Thiamine (Vitamin B 1 ) (as the hydrochloride) 0.4 mg 0.8 mg 1.2 mg Riboflavin (Vitamin B 2 ) (as riboflavin 5-phosphate sodium) 0.4 mg 0.9 mg 1.4 mg Pyridoxine HCl (Vitamin B 6 ) 0.3 mg 0.7 mg 1 mg Niacinamide 5.1 mg 11.1 mg 17 mg Dexpanthenol (as d -pantothenyl alcohol) 1.5 mg 3.3 mg 5 mg Vitamin E ( dl -α-tocopheryl acetate) 2.1 IU (equals 2 mg) 4.6 IU (equals 5 mg) 7 IU (equals 7 mg) Vitamin K 1 0.1 mg 0.1 mg 0.2 mg Daily Dosage Volume – Vial 2 0.3 mL 0.65 mL 1 mL Folic acid 42 mcg 91 mcg 140 mcg Biotin 6 mcg 13 mcg 20 mcg Vitamin B12 (cyanocobalamin) 0.3 mcg 0.7 mcg 1 mcg INFUVITE PEDIATRIC Pharmacy Bulk Package (see Table 2): The recommended daily dosage volume of combined content of vials 1 and 2 (1.5 mL, 3.25 mL or 5 mL) is based on the patient’s weight and then added directly to the specific volume of an intravenous fluid [ see Dosage and Administration ( 2.3 ) ]. Table 2: Recommended Weight-Based Dosage of INFUVITE PEDIATRIC Pharmacy Bulk Package Less than 1 kg 1 kg to less than 3 kg 3 kg or greater Daily Dosage Volume(combined contents of Vial 1 and Vial 2) 1.5 mL 3.25 mL 5 mL Ascorbic acid (Vitamin C) 24 mg 52 mg 80 mg Vitamin A (as palmitate) 690 IU (equals 0.2 mg) 1495 IU (equals 0.5 mg) 2,300 IU (equals 0.7 mg) Vitamin D 3 (cholecalciferol) 120 IU (equals 3 mcg) 260 IU (equals 7 mc g) 400 IU (equals 10 mcg) Thiamine (Vitamin B 1 ) (as the hydrochloride) 0.4 mg 0.8 mg 1.2 mg Riboflavin (Vitamin B 2 ) (as riboflavin 5-phosphate sodium) 0.4 mg 0.9 mg 1.4 mg Pyridoxine HCl (Vitamin B 6 ) 0.3 mg 0.7 mg 1 mg Niacinamide 5.1 mg 11.1 mg 17 mg Dexpanthenol (as d -pantothenyl alcohol) 1.5 mg 3.3 mg 5 mg Vitamin E ( dl -α-tocopheryl acetate) 2.1 IU (equals 2 mg) 4.6 IU (equals 5 mg) 7 IU (equals 7 mg) Vitamin K 1 0.1 mg 0.1 mg 0.2 mg Folic acid 42 mcg 91 mcg 140 mcg Biotin 6 mcg 13 mcg 20 mcg Vitamin B12 (cyanocobalamin) 0.3 mcg 0.7 mcg 1 mcg 2.3 Preparation and Administration Instructions Do not administer INFUVITE PEDIATRIC as a direct, undiluted intravenous injection as it may cause dizziness, faintness, and possible tissue irritation. INFUVITE PEDIATRIC Single Dose: • Use only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area). Add one weight-based dose of Vial 1 (1.2 mL, 2.6 mL or 4 mL) and one weight-based dose of Vial 2 (0.3 mL, 0.65 mL or 1 mL) directly to at least 100 mL of intravenous dextrose or saline solution. • Discard unused portion. • Visually inspect for particulate matter and discoloration prior to administration. • After INFUVITE 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 INFUVITE PEDIATRIC, particularly A, D and riboflavin, are light sensitive. INFUVITE PEDIATRIC Pharmacy Bulk Package : • Use only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area). • Transfer the contents of Vial 2 (10 mL of solution) into the contents of Vial 1 (40 mL of solution). The mixed solution (50 mL) will provide thirty-three 1.5 mL single doses, fifteen 3.25 mL single doses or ten 5 mL single doses. • Each bulk vial closure shall be penetrated only one time with a suitable sterile transfer device or dispensing set that allows measured dispensing of the contents. • Once the closure system has been penetrated, complete dispensing from the pharmacy bulk vial should be completed within 4 hours. The mixed solution may be refrigerated and stored for up to 4 hours. • Discard unused portion. • Visually inspect for particulate matter and discoloration prior to administration. • Add one dose directly to at least 100 mL of intravenous dextrose or saline solution for each patient. • After INFUVITE 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 INFUVITE PEDIATRIC, particularly A, D and riboflavin, are light sensitive. 2.4 Monitoring Vitamin Blood Levels Blood vitamin concentrations should be monitored 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 • INFUVITE PEDIATRIC is not physically compatible with moderately 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 INFUVITE PEDIATRIC may react with bisulfite solutions such as sodium bisulfite or vitamin K bisulfite. • Do not add INFUVITE PEDIATRIC directly to intravenous fat emulsions. • Consult appropriate references for additional listings of physical and chemical compatibility of solutions and drugs with the vitamin infusion when needed. If incompatibilities are identified, avoid admixture or Y-site administration with vitamin solutions.

1 INDICATIONS AND USAGE INFUVITE PEDIATRIC is a 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. INFUVITE PEDIATRIC is a combination of vitamins indicated for the prevention of vitamin deficiency in pediatric patients up to 11 years of age receiving parenteral nutrition ( 1 )

10 OVERDOSAGE Signs and symptoms of acute or chronic overdosage may be those of individual INFUVITE PEDIATRIC component toxicity. There is no clinical experience with INFUVITE PEDIATRIC overdosage.

7 DRUG INTERACTIONS A number of interactions between vitamins and drugs have been reported. The following are examples of these types of interactions. Effect of INFUVITE PEDIATRIC on other 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 activity ( 7.1 ) • Methotrexate: Folic acid may decrease response to methotrexate ( 7.1 ) Effects of other drugs on INFUVITE PEDIATRIC: • Hydralazine, Isoniazid: Concomitant administration of hydralazine or isoniazid may increase pyridoxine requirements ( 7.2 ). • Phenytoin: May decrease folic acid concentrations ( 7.2 ) 7.1 Drug Interactions Affecting Co-administered Drugs Warfarin : Vitamin K, a component of INFUVITE PEDIATRIC, antagonizes the anticoagulant action of warfarin. In patients who are co-administered warfarin and INFUVITE PEDIATRIC, blood levels of prothrombin/INR should be monitored to determine if dose of warfarin needs to be adjusted [ see Warnings and Precautions ( 5.4 ) ]. 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. Levodopa : Pyridoxine may increase the metabolism of levodopa (decrease blood levels of levodopa) and decrease its efficacy. Phenytoin : Folic acid may increase phenytoin metabolism and lower the serum concentration of phenytoin resulting in increased seizure activity. Methotrexate : Folic acid may decrease a patient’s response to methotrexate therapy. 7.2 Drug Interactions Affecting Vitamin Levels Hydralazine, Isoniazid : Concomitant administration of hydralazine or isoniazid may increase pyridoxine requirements. Phenytoin : Phenytoin may decrease serum folic acid concentrations.

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3 DOSAGE FORMS AND STRENGTHS INFUVITE PEDIATRIC Single Dose is an injection consisting of two single-dose vials labeled Vial 1 (4 mL) and Vial 2 (1 mL). For the vitamin strengths [ see Dosage and Administration ( 2.2 ) and Description ( 11 ) ]. INFUVITE PEDIATRIC Pharmacy Bulk Package is an injection consisting of two vials labeled Vial 1 (40 mL Fill in 50 mL Vial) and Vial 2 (10 mL). The mixed solution (50 mL) will provide thirty-three 1.5 mL single doses, fifteen 3.25 mL single doses or ten 5 mL single doses. For the vitamin strengths [ see Dosage and Administration ( 2.2 ) and Description ( 11 ) ]. • INFUVITE PEDIATRIC single dose is an injection consisting of two vials labeled Vial 1 (4 mL) and Vial 2 (1 mL) ( 3 ) • INFUVITE PEDIATRIC pharmacy bulk package is an injection consisting of two vials labeled Vial 1 (50 mL) and Vial 2 (10 mL) ( 3 ) • See Full Prescribing Information for vitamin strengths ( 11 )

Pediatric Infuvite Multiple Vitamins Ascorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin Pediatric Infuvite Multiple Vitamins Ascorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin 5-phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1 ASCORBIC ACID ASCORBIC ACID VITAMIN A PALMITATE VITAMIN A CHOLECALCIFEROL CHOLECALCIFEROL THIAMINE HYDROCHLORIDE THIAMINE ION THIAMINE RIBOFLAVIN 5'-PHOSPHATE SODIUM FLAVIN MONONUCLEOTIDE PYRIDOXINE HYDROCHLORIDE PYRIDOXINE NIACINAMIDE NIACINAMIDE DEXPANTHENOL DEXPANTHENOL .ALPHA.-TOCOPHEROL ACETATE .ALPHA.-TOCOPHEROL PHYTONADIONE PHYTONADIONE POLYSORBATE 80 SODIUM HYDROXIDE HYDROCHLORIC ACID WATER Pediatric Infuvite Multiple Vitamins Folic Acid, Biotin, Cyanocobalamin FOLIC ACID FOLIC ACID BIOTIN BIOTIN CYANOCOBALAMIN CYANOCOBALAMIN MANNITOL ANHYDROUS CITRIC ACID SODIUM CITRATE, UNSPECIFIED FORM WATER Pediatric Infuvite Multiple Vitamins Ascorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin ASCORBIC ACID ASCORBIC ACID VITAMIN A PALMITATE VITAMIN A CHOLECALCIFEROL CHOLECALCIFEROL THIAMINE HYDROCHLORIDE THIAMINE ION THIAMINE RIBOFLAVIN 5'-PHOSPHATE SODIUM FLAVIN MONONUCLEOTIDE PYRIDOXINE HYDROCHLORIDE PYRIDOXINE NIACINAMIDE NIACINAMIDE DEXPANTHENOL DEXPANTHENOL .ALPHA.-TOCOPHEROL ACETATE .ALPHA.-TOCOPHEROL PHYTONADIONE PHYTONADIONE FOLIC ACID FOLIC ACID BIOTIN BIOTIN CYANOCOBALAMIN CYANOCOBALAMIN POLYSORBATE 80 ANHYDROUS CITRIC ACID SODIUM CITRATE, UNSPECIFIED FORM SODIUM HYDROXIDE HYDROCHLORIC ACID WATER MANNITOL

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity, mutagenicity, and fertility studies have not been performed with INFUVITE PEDIATRIC.

13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity, mutagenicity, and fertility studies have not been performed with INFUVITE PEDIATRIC.

NDA021265

Pediatric Infuvite Multiple Vitamins

Ascorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin

54643-9023

HUMAN PRESCRIPTION DRUG

INTRAVENOUS

Vials Carton NDC 54643-9023-1 2A9008NP INFUVITE ® PEDiatric Multiple Vitamins Injection Rx only For intravenous infusion after dilution only. STERILE Contains 5 each of Vial 1 (4 mL) and Vial 2 (1 mL). One vial of each to be used for a single dose. Vial 1 (4 mL) Vial 2 (1 mL) Store under refrigeration 2° to 8° C (36° to 46° F). NOVAPLUS ® Infuvite Pediatric Single Dose

17 PATIENT COUNSELING INFORMATION Instruct caregiver(s) and patients (if age appropriate): • To watch for signs of allergic reactions such as urticaria, shortness of breath, wheezing and angioedema since hypersensitivity reactions may occur to any of the vitamins or excipients contained in INFUVITE PEDIATRIC. • To watch for and immediately report nausea, vomiting, headache, dizziness, blurred vision, especially if patients have renal impairment, as these may be signs of hypervitaminosis A. • To report other adverse reactions that patients may experience such as rash, erythema, pruritus, headache, dizziness, agitation, anxiety, and diplopia. • Patients on warfarin anticoagulant therapy will be monitored periodically with blood prothrombin/ INR levels to determine if the dose of warfarin needs to be adjusted. • About the significance of periodic monitoring of blood vitamin concentrations to determine if vitamin deficiencies or excesses are developing and the need to monitor renal function, calcium, phosphorus, aluminum and vitamin A levels in patients with renal impairment. • That INFUVITE PEDIATRIC should be avoided in patients with suspected or diagnosed megaloblastic anemia prior to blood sampling for the detection of the folic acid and cyanocobalamin deficiencies. • That vitamin C (ascorbic acid) contained in INFUVITE PEDIATRIC may cause false negative urine glucose results. Manufactured by Sandoz Canada Inc. 145 Jules-Léger Street Boucherville, Qc, Canada, J4B 7K8 Distributed by Baxter Healthcare Corporation for NOVAPLUS ® Clintec Nutrition Division Deerfield, IL 60015 USA Printed in Canada NOVAPLUS is a registered trademark of Vizient, Inc. ® INFUVITE is a registered trademark of Sandoz Canada Inc. 46194735 10-2016

8.3 Nursing Mothers INFUVITE PEDIATRIC has not been studied in nursing mothers. Lactating women may have vitamin requirements that exceed those of non-lactating women. Caution should be exercised when INFUVITE PEDIATRIC is administered to nursing mothers.

8.4 Pediatric Use INFUVITE PEDIATRIC is approved for the prevention of vitamin deficiency in pediatric patients up to 11 years old receiving parenteral nutrition. INFUVITE PEDIATRIC has not been studied in pediatric patients older than 11 years. INFUVITE PEDIATRIC contains aluminum that may be toxic for premature neonates. Aluminum levels should be monitored periodically during administration of INFUVITE PEDIATRIC to premature neonates [ see Warnings and Precautions ( 5.1 ) ]. Additional vitamin E supplementations of infants receiving INFUVITE 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 INFUVITE PEDIATRIC. No E-Ferol syndrome associated with INFUVITE PEDIATRIC has been reported [ see Warnings and Precautions ( 5.10 ) ].

8.1 Pregnancy Pregnancy Category C. INFUVITE PEDIATRIC has not been studied in pregnant women. Pregnant women should follow the U.S. recommended daily allowances for pregnancy because their vitamin requirements may exceed those of non-pregnant women. Animal reproduction studies have not been conducted with INFUVITE PEDIATRIC (multiple vitamins injection).

8 USE IN SPECIFIC POPULATIONS • Renal Impairment: Monitor renal function, calcium, phosphorus and vitamin A levels ( 8.6 ) • Hepatic Impairment: Monitor vitamin A levels ( 8.7 ) 8.1 Pregnancy Pregnancy Category C. INFUVITE PEDIATRIC has not been studied in pregnant women. Pregnant women should follow the U.S. recommended daily allowances for pregnancy because their vitamin requirements may exceed those of non-pregnant women. Animal reproduction studies have not been conducted with INFUVITE PEDIATRIC (multiple vitamins injection). 8.3 Nursing Mothers INFUVITE PEDIATRIC has not been studied in nursing mothers. Lactating women may have vitamin requirements that exceed those of non-lactating women. Caution should be exercised when INFUVITE PEDIATRIC is administered to nursing mothers. 8.4 Pediatric Use INFUVITE PEDIATRIC is approved for the prevention of vitamin deficiency in pediatric patients up to 11 years old receiving parenteral nutrition. INFUVITE PEDIATRIC has not been studied in pediatric patients older than 11 years. INFUVITE PEDIATRIC contains aluminum that may be toxic for premature neonates. Aluminum levels should be monitored periodically during administration of INFUVITE PEDIATRIC to premature neonates [ see Warnings and Precautions ( 5.1 ) ]. Additional vitamin E supplementations of infants receiving INFUVITE 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 INFUVITE PEDIATRIC. No E-Ferol syndrome associated with INFUVITE PEDIATRIC has been reported [ see Warnings and Precautions ( 5.10 ) ]. 8.6 Renal Impairment INFUVITE 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 INFUVITE PEDIATRIC has not been studied in patients with liver impairment. Monitor vitamin A levels in patients with liver disease [ see Warnings and Precautions ( 5.3 ) ] .

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied: INFUVITE PEDIATRIC (multiple vitamins injection) is supplied as follows: INFUVITE PEDIATRIC (multiple vitamins injection) Single Dose: • NDC 54643-9023-1 - Boxes containing ten single dose vials – five each of Vial 1 (4 mL) and five each of Vial 2 (1 mL), one Vial 1 plus one Vial 2 to be used for a single dose [ see Dosage and Administration ( 2.2 , 2.3 ) ] . INFUVITE PEDIATRIC (multiple vitamins injection) Pharmacy Bulk Package: • NDC 54643-9031-0 - Boxes containing two vials – Vial 1 (40 mL Fill in 50 mL Vial) and Vial 2 (10 mL). Mixed contents of Vial 2 with Vial 1 provide thirty-three 1.5 mL single doses, fifteen 3.25 mL single doses or 10 single 5 mL doses [see Dosage and Administration ( 2.2 , 2.3 )]. Storage and Handling: Minimize exposure of INFUVITE PEDIATRIC to light because vitamins A, D and riboflavin are light sensitive. Store under refrigeration 2° to 8°C (36° to 46°F).