Country: United States
Language: English
Source: NLM (National Library of Medicine)
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R), VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) (VITAMIN A - UNII:81G40H8B0T), CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41), THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J), RIBOFLAVIN 5'-PHOSPHATE SODIUM (UNII: 20RD1DZH99) (FLAVIN MONONUCLEOTIDE - UNII:7N464URE7E), PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z), NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII
Sandoz Inc
ASCORBIC ACID
ASCORBIC ACID 80 mg in 4 mL
PRESCRIPTION DRUG
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 contraindicated in patients who have: 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). 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
How Supplied: INFUVITE PEDIATRIC (multiple vitamins injection) is supplied as follows: INFUVITE PEDIATRIC (multiple vitamins injection) Single Dose: INFUVITE PEDIATRIC (multiple vitamins injection) Pharmacy Bulk Package: 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).
New Drug Application
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, FOLIC ACID, BIOTIN, CYANOCOBALAMIN INJECTION, SOLUTION SANDOZ MANUFACTURING INC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE INFUVITE PEDIATRIC SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR INFUVITE PEDIATRIC. INFUVITE PEDIATRIC (MULTIPLE VITAMINS INJECTION), FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 2001 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 (1) DOSAGE AND ADMINISTRATION • • • • • • • • DOSAGE FORMS AND STRENGTHS • • 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 o o _WEIGHT LESS THAN 1 KG: _1.2 mL of Vial 1 and 0.3 mL of Vial 2 _WEIGHT 1 KG TO LESS THAN 3 KG: _2.6 mL of Vial 1 and 0.65 mL Vial 2 _WEIGHT 3 KG OR GREATER: _4 mL of Vial 1 and 1 mL of Vial 2 INFUVITE PEDIATRIC PHARMACY BULK PACKAGE: o o o _WEIGHT LESS THAN 1 KG: _1.5 mL of combined content of Vials 1 and 2 _WEIGHT 1 KG TO LESS THAN 3 KG: _3.25 mL of combined content of Vials 1 and 2 _WEIGHT 3 KG OR GRE Read the complete document