Product Information
| NDC Package Code | 54643-5649-1 |
| Proprietary Name | Infuvite Adult Multiple Vitamins |
| Non-Proprietary Name | 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 |
| Package | 10 VIAL in 1 CARTON (54643-5649-1) > 5 mL in 1 VIAL |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 10; 200; 60; 200; 5; 15; 600; 40; 150; 6; 3.6; 6; 3300 |
| Active Ingredient Units | [iU]/10mL; mg/10mL; ug/10mL; [iU]/10mL; ug/10mL; mg/10mL; ug/10mL; mg/10mL; ug/10mL; mg/10mL; mg/10mL; mg/10mL; [iU]/10mL |
| Substance Name | .ALPHA.-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE |
Description
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 (multiple vitamins injection) is a sterile product consisting of two vials provided as a single dose or as a pharmacy bulk package, both intended for intravenous use for administration by intravenous infusion after dilution. INFUVITE ADULT Single Dose- two 5 mL single-dose vials labeled Vial 1 and Vial 2. INFUVITE ADULT Pharmacy Bulk Package- two vials – 1 each of Vial 1 (50 mL) and Vial 2 (50 mL Fill in 100 mL Vial). The mixed solution (100 mL) will provide ten 10 mL single doses. Each 5 mL of Vial 1 contains. Ascorbic acid (Vitamin C) . . . . . . . . . . . . . . . . . . . . . . . . . . .200 mg. Vitamin A* (as palmitate) . . . . . . . . . . . . . . . . . . . . . . . . . .3,300 IU. Vitamin D3* (cholecalciferol) . . . . . . . . . . . . . . . . . . . . . . . . .200 IU. Thiamine (Vitamin B1) (as the hydrochloride) . . . . . . . . . . . . . 6 mg. Riboflavin (Vitamin B2). (as riboflavin 5-phosphate sodium) . . . . . . . . . . . . . . . . . . . . .3.6 mg. Pyridoxine HCl (Vitamin B6) . . . . . . . . . . . . . . . . . . . . . . . . . . 6 mg. Niacinamide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40 mg. Dexpanthenol. (as d-pantothenyl alcohol) . . . . . . . . . . . . . . . . . . . . . . . . . . . .15 mg. Vitamin E* (dl-a-tocopheryl acetate) . . . . . . . . . . . . . . . . . . . 10 IU. Vitamin K1* . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .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 B12 (cyanocobalamin) . . . . . . . . . . . . . . . . . . . . . . 5 mcg. Inactive ingredients: 30% propylene glycol, citric acid and/or sodium citrate for pH adjustment, and water for injection. INFUVITE ADULT makes available a combination of important oil-soluble and water-soluble vitamins in an aqueous solution, formulated for incorporation into intravenous solutions. The liposoluble vitamins A, D, E, and K have been solubilized in an aqueous medium with polysorbate 80, permitting intravenous administration of these vitamins. Contains no more than 70 mcg/L of aluminum (combined Vials 1 and 2).
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