INFUVITE Pediatric(Multiple Vitamins for Infusion)
SPL UNCLASSIFIED SECTION
For intravenous infusion after dilution only.
DESCRIPTION
INFUVITE Pediatric is a sterile product consisting of two vials: a 4 mL single-dose vial labeled Vial 1 and a 1 mL single-dose vial labeled Vial 2.
Each 4 mL of Vial 1 contains:
Ascorbic acid (Vitamin C) ......................................... 80 mg
Vitamin A1 (as palmitate)...................................... 2,300 IU
Vitamin D31 (cholecalciferol) ................................... 400 IU
Thiamine (Vitamin B1)
(as the hydrochloride)............................................ 1.2 mg
Riboflavin (Vitamin B2)
(as riboflavin 5-phosphate sodium) ....................... 1.4 mg
Pyridoxine HCl (Vitamin B6) ....................................... 1 mg
Niacinamide .............................................................. 17 mg
Dexpanthenol
(as d-pantothenyl alcohol) ........................................ 5 mg
Vitamin E1 (dl-α-tocopheryl acetate)........................... 7 IU
Vitamin K11.............................................................. 0.2 mg
Inactive ingredients: 50 mg polysorbate 80, sodium hydroxide and/or hydrochloric acid for pH adjustment and water for injection.
1Polysorbate 80 is used to water solubilize the oil-soluble vitamins A, D, E, and K.
Each 1 mL of Vial 2 contains:
Folic acid............................................................... 140 mcg
Biotin....................................................................... 20 mcg
Vitamin B12 (cyanocobalamin).................................. 1 mcg
Inactive ingredients: 75 mg mannitol, citric acid and/or sodium citrate for pH adjustment and water for injection.
Vitamin A 2,300 IU equals 0.7 mg
Vitamin D 400 IU equals 10 mcg
Vitamin E 7 IU equals 7 mg
Multiple vitamin preparation for intravenous infusion: INFUVITE Pediatric (Multiple Vitamins for Infusion) 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 30 mcg/L of aluminum (combined vials 1 and 2).
INDICATIONS AND USAGE
INFUVITE Pediatric is indicated as a daily multivitamin maintenance dosage for infants and children up to 11 years of age receiving parenteral nutrition.
INFUVITE Pediatric 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 Pediatric (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 |
