11 years of age when added to intravenous infusion fluids.
INFUVITE Pediatric should not be given as a direct, undiluted intravenous injection as it may give rise to dizziness, faintness and possible tissue irritation.
A daily dose of INFUVITE Pediatric (4 mL of Vial 1 plus 1 mL of Vial 2) should be added directly to not less than 100 mL of intravenous dextrose, saline or similar infusion solutions.
For administration to infants weighing < 1 kg:
The daily dose is 30% of the contents of Vial 1 (1.2 mL) and of Vial 2 (0.3 mL). Do not exceed this daily dose. Supplemental vitamin A may be required for low-birth-weight infants.
For administration to infants weighing ≥1 kg and < 3 kg: The daily dose is 65% of the contents of Vial 1 (2.6 mL) and of Vial 2 (0.65 mL). Do not exceed this daily dose. Supplemental vitamin A may be required for low-birth-weight infants.
For administration to infants and children weighing ≥3 kg up to 11 years of age: The daily dose is the entire contents of Vial 1 (4 mL) and of Vial 2 (1 mL), unless there is clinical or laboratory evidence for increasing or decreasing the dosage.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
After INFUVITE Pediatric is diluted in an intravenous infusion, the resulting solution is ready for immediate use. Some of the vitamins in this product, particularly A, D, and riboflavin, are light sensitive, therefore, exposure to light should be minimized. DISCARD ANY UNUSED PORTION
HOW SUPPLIED
INFUVITE Pediatric – NDC 54643-5646-0, is available in boxes containing 2 vials – Vial 1 (4 mL) and Vial 2 (1 mL), both vials to be used for a single dose.
INFUVITE Pediatric – NDC 54643-5646-1, is available in boxes containing 10 vials – 5 each of Vial 1 (4 mL) and 5 each of Vial 2 (1 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
D1006224 Rev. September 2007
® INFUVITE is a registered trademark of Sandoz Canada Inc.
Infuvite Pediatric Carton
2A9008 NDC 54643-5646-1
Baxter
INFUVITE PEDiatric Multiple Vitamins for Infusion
For intravenous infusion after dilution only.
Sterile Rx only
Contains 5 each of Vial 1 (4 mL) and Vial 2 (1 mL).
One vial of each to be used for a single dose.
Store under refrigeration, 2-8°C (36-46°F).
INGREDIENTS AND APPEARANCE
PEDIATRIC 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
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54643-5646
Route of Administration INTRAVENOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 80 mg in 5 mL
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A 2300 [iU] in 5 mL
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) C |
