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

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 Single Dose: o Weight less than 1 kg: 1. 3 mL o Weight 1 kg to less than 3 kg: 2. 65 mL o Weight 3 kg or greater: 4 mL 1 mL Pharmacy Bulk Package : o Weight less than 1 kg: 1. 5 mL o Weight 1 kg to less than 3 kg: 3. 25 mL o Weight 3 kg or greater: 5 mL 2. 2 Single Dose 2. 3 Pharmacy Bulk Package 2. 5 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: Single Dose see Dosage and Administration ( 2. 3 Pharmacy Bulk Package see Dosage and Administration ( 2. 3 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 One daily dose of Vial 1 (1. 6 mL or 4 mL) and one daily dose of Vial 2 (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 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 en dash Vial 1 1. 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 3 120 IU (equals 3 mcg) 260 IU (equals 7 mc g) 400 IU (equals 10 mcg) Thiamine (Vitamin B 1 0. 2 mg Riboflavin (Vitamin B 2 0. 4 mg Pyridoxine HCl (Vitamin B 6 0. 7 mg 1 mg Niacinamide 5. 1 mg 17 mg Dexpanthenol (as d 1. 3 mg 5 mg Vitamin E ( dl 2. 1 IU (equals 2 mg) 4. 6 IU (equals 5 mg) 7 IU (equals 7 mg) Vitamin K 1 0. 2 mg Daily Dosage Volume en dash Vial 2 0. 65 mL 1 mL Folic acid 42 mcg 91 mcg 140 mcg Biotin 6 mcg 13 mcg 20 mcg Vitamin B12 (cyanocobalamin) 0. 7 mcg 1 mcg INFUVITE PEDIATRIC Pharmacy Bulk Package The recommended daily dosage volume of combined content of vials 1 and 2 (1. 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. 25 mL 5 mL Ascorbic acid (Vitamin C) 24 mg 52 mg 80 mg Vitamin A (as palmitate) 690 IU (equals 0. 2 mg Folic acid 42 mcg 91 mcg 140 mcg Biotin 6 mcg 13 mcg 20 mcg Vitamin B12 (cyanocobalamin) 0. 7 mcg 1 mcg 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: INFUVITE PEDIATRIC Pharmacy Bulk Package 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. .

The following adverse reactions are discussed in greater detail in other sections of the labeling. see Warnings and Precautions ( 5. 2 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: CNS: Ophthalmic: 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. gov/medwatch.

INFUVITE PEDIATRIC is contraindicated in patients who have: 4 4.

USE IN SPECIFIC POPULATIONS
Renal Impairment: 8. 6 Hepatic Impairment: 8. 7 INFUVITE PEDIATRIC has not been studied in pregnant women. Pregnant women should follow the U. 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). 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. 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 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. 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.
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).

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: 7. 1 Bleomycin: 7. 1 Levodopa: 7. 1 Phenytoin: 7. 1 Methotrexate: 7. 1 Effects of other drugs on INFUVITE PEDIATRIC: Hydralazine, Isoniazid: 7. 2 Phenytoin: 7. 2 Warfarin see Warnings and Precautions ( 5. 4 Antibiotics Bleomycin in vitro Levodopa Phenytoin Methotrexate Hydralazine, Isoniazid Phenytoin.

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.
NONCLINICAL TOXICOLOGY
Carcinogenicity, mutagenicity, and fertility studies have not been performed with INFUVITE PEDIATRIC.

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_injection, solution

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 Product manual source documgent