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

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 )

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.

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.