国家: 美国
语言: 英文
来源: 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 - UNII:X66NSO3N35), RIBOFLAVIN 5'-PHOSPHATE SODIUM (UNII: 20RD1DZH99) (RIBOFLAVIN - UNII:TLM2976OFR), PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z), NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4), D
Sandoz Canada Inc
ASCORBIC ACID
ASCORBIC ACID 200 mg in 10 mL
INTRAVENOUS
PRESCRIPTION DRUG
INFUVITE ADULT is indicated as a daily multivitamin maintenance supplement for adults and children aged 11 and older receiving parenteral nutrition. INFUVITE ADULT is also indicated in other situations where administration by the intravenous route is required. Such situations include surgery, extensive burns, fractures and other trauma, severe infectious diseases, and comatose states, which may provoke a “stress” situation with profound alterations in the body’s metabolic demands and consequent tissue depletion of nutrients. The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy. INFUVITE ADULT (administered in intravenous fluids under proper dilution) contributes intake of necessary vitamins toward maintaining the body’s normal resistance and repair processes. Patients with multiple vitamin deficiencies or with markedly increased requirements may be given multiples of the daily dosage for two or more days, as indicated by the clinical st
INFUVITE ADULT – NDC 54643-5649-1, is available in boxes containing 10 vials - 5 each of Vial 1 (5 mL) and Vial 2 (5 mL), one Vial 1 plus one Vial 2 to be used for a single dose. Store under refrigeration, 2-8°C (36-46°F). Rx only Manufactured by Sandoz Canada Inc. 145 Jules-Leger Street Boucherville, QC, Canada J4B 7K8 Distributed by Baxter Healthcare Corporation Clintec Nutrition Division Deerfield, IL 60015 USA Printed in Canada D 1006230 Rev. September 2007 ® INFUVITE is a registered trademark of Sandoz Canada Inc.
New Drug Application
ADULT INFUVITE MULTIPLE VITAMINS FOR INFUSION- ASORBIC 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 CANADA INC ---------- INFUVITE ADULT MULTIPLE VITAMINS FOR INFUSION FOR INTRAVENOUS INFUSION AFTER DILUTION ONLY. DES CRIPTION INFUVITE _ADULT_ is a sterile product consisting of two 5 mL single-dose vials labeled Vial 1 and Vial 2. EACH 5 ML OF VIAL 1 CONTAINS: Ascorbic acid (Vitamin C) ....................................... 200 mg Vitamin A* (as palmitate) ..................................... 3,300 IU Vitamin D * (cholecalciferol) .................................. 200 IU Thiamine (Vitamin B ) (as the hydrochloride) .............................................. 6 mg Riboflavin (Vitamin B ) (as riboflavin 5-phosphate sodium)........................ 3.6 mg Pyridoxine HCl (Vitamin B ) ....................................... 6 mg Niacinamide .............................................................. 40 mg Dexpanthenol (as d-pantothenyl alcohol)...................................... 15 mg Vitamin E* (_dl_-α-tocopheryl acetate)..........................10 IU Vitamin K * .......................................................... 150 mcg Inactive ingredients: 1.4% polysorbate 80, sodium hydroxide and/or hydrochloric acid for pH adjustment, and water for injection. *Polysorbate 80 is used to water solubilize the oil-soluble vitamins A, D, E, and K. EACH 5 ML OF VIAL 2 CONTAINS: Folic acid............................................................... 600 mcg Biotin....................................................................... 60 mcg Vitamin B (cyanocobalamin).................................. 5 mcg Inactive ingredients: 30% propylene glycol, citric acid and/or sodium citrate for pH adjustment, and water for injection. “AQUEOUS” MULTIPLE VITAMIN PREPARATION FOR INTRAVENOUS INFUSION: INFUVITE _ADULT_ 阅读完整的文件