Infuvite Pediatric Pharmacy Bulk Package

DRUG DESCRIPTION

INFUVITE (multiple vitamins for infusion pharmacy bulk package) PEDIATRIC (PHARMACY BULK PACKAGE) is a sterile product consisting
of two vials: 1 each of Vial 1 (40 mL fill in 50 mL) and Vial 2 (10 mL), provided
as a pharmacy bulk package.

A pharmacy bulk package is a container of a sterile preparation for parenteral
use that contains many single doses. The contents are intended for use in a
pharmacy admixture program and are restricted to the preparation of admixtures
for intravenous infusion.

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.

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 (PHARMACY BULK PACKAGE) (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).