Land: Vereinigte Staaten
Sprache: Englisch
Quelle: 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 200 mg in 10 mL
INTRAVENOUS
PRESCRIPTION DRUG
INFUVITE ADULT is a combination of vitamins indicated for the prevention of vitamin deficiency in adults and children aged 11 and older receiving parenteral nutrition. The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy. INFUVITE ADULT is contraindicated in patients who have INFUVITE ADULT has not been studied in pregnant women. Pregnant women should follow the U.S. Recommended Daily Allowances for their condition, because their vitamin requirements may exceed those of nonpregnant women. Animal reproduction studies have not been conducted with INFUVITE ADULT. INFUVITE ADULT has not been studied in lactating women.Lactating women should follow the U.S. Recommended Daily Allowances for their condition, because their vitamin requirement may exceed those of nonlactating women. Caution should be exercised when INFUVITE ADULT is administered to a nursing mother. Safety and effectiveness in children below the age of 11 years have not been establish
How Supplied: INFUVITE ADULT (multiple vitamins injection) is supplied as follows: INFUVITE ADULT Single Dose : INFUVITE ADULT Pharmacy Bulk Package: Storage and Handling: Minimize exposure of INFUVITE ADULT to light because vitamins A, D and riboflavin are light sensitive. Store under refrigeration, 2-8°C (36-46°F).
New Drug Application
INFUVITE ADULT 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 REFERENCE LABEL SET ID: 59754E70-D6D1-4738-8BA7-B8E2BC959DCF ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE INFUVITE ADULT SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR INFUVITE ADULT INFUVITE ADULT (MULTIPLE VITAMINS INJECTION), FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 2003 INDICATIONS AND USAGE INFUVITE ADULT is a combination of vitamins indicated for prevention of vitamin deficiency in adults and children aged 11 and older receiving parenteral nutrition (1) DOSAGE AND ADMINISTRATION • • • • • • • DOSAGE FORMS AND STRENGTHS • • CONTRAINDICATIONS • • WARNINGS AND PRECAUTIONS • • • • • • • ADVERSE REACTIONS INFUVITE ADULT 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 ADULT is for administration by intravenous infusion after dilution (2.1) Recommended daily dosage is 10 mL (2.1) INFUVITE ADULT is supplied as a single dose and as a pharmacy bulk package. SINGLE DOSE: Add one daily dose of 10 mL (5 mL from Vial 1 and 5 mL from Vial 2) to not less than 500 mL, and preferably 1000 mL, of intravenous dextrose, saline or similar infusion solutions. (2.2) PHARMACY BULK PACKAGE: Add the contents of Vial 1 to the contents of Vial 2. This provides ten 10 mL daily doses. Take 10 mL from Vial 2 and add to not less than 500 mL, and preferably 1000 mL, of intravenous dextrose, saline or similar infusion solutions. (2.2) After dilution in an intravenous infusion, refrigerate resulting solution unless used immediately. Lesen Sie das vollständige Dokument