Carcinogenicity, mutagenicity, and fertility studies have not been performed with INFUVITE PEDIATRIC.
INFUVITE PEDIATRIC (multiple vitamins injection) is supplied as follows:
INFUVITE PEDIATRIC (multiple vitamins injection) Single Dose:
- NDC 54643-5646-1 — Boxes containing ten single dose vials – five each of Vial 1 (4 mL) and five each of Vial 2 (1 mL), one Vial 1 plus one Vial 2 to be used for a single dose [see Dosage and Administration (2.2, 2.3)].
INFUVITE PEDIATRIC (multiple vitamins injection) Pharmacy Bulk Package:
- NDC 54643-5647-0 — Boxes containing two vials – Vial 1 (40 mL Fill in 50 mL Vial) and Vial 2 (10 mL). Mixed contents of Vial 2 with Vial 1 provide thirty-three 1.5 mL single doses, fifteen 3.25 mL single doses or 10 single 5 mL doses [see Dosage and Administration (2.2, 2.3)].
Storage and Handling:
Minimize exposure of INFUVITE PEDIATRIC to light because vitamins A, D and riboflavin are light sensitive.
Store under refrigeration 2-8°C (36-46°F).
Instruct caregiver(s) and patients (if age appropriate):
- To watch for signs of allergic reactions such as urticaria, shortness of breath, wheezing and angioedema since hypersensitivity reactions may occur to any of the vitamins or excipients contained in INFUVITE PEDIATRIC.
- To watch for and immediately report nausea, vomiting, headache, dizziness, blurred vision, especially if patients have renal impairment, as these may be signs of hypervitaminosis A.
- To report other adverse reactions that patients may experience such as rash, erythema, pruritus, headache, dizziness, agitation, anxiety, and diplopia.
- Patients on warfarin anticoagulant therapy will be monitored periodically with blood prothrombin/ INR levels to determine if the dose of warfarin needs to be adjusted.
- About the significance of periodic monitoring of blood vitamin concentrations to determine if vitamin deficiencies or excesses are developing and the need to monitor renal function, calcium, phosphorus, aluminum and vitamin A levels in patients with renal impairment.
- That INFUVITE PEDIATRIC should be avoided in patients with suspected or diagnosed megaloblastic anemia prior to blood sampling for the detection of the folic acid and cyanocobalamin deficiencies.
- That vitamin C (ascorbic acid) contained in INFUVITE PEDIATRIC may cause false negative urine glucose results.
Sandoz Canada Inc.
145 Jules-Léger Street
Boucherville, Qc, Canada, J4B 7K8
Baxter Healthcare Corporation
Clintec Nutrition Division
Deerfield, IL 60015 USA
Printed in Canada
® INFUVITE is a registered trademark of Sandoz Canada Inc.
2A9008 NDC 54643-5646-1
INFUVITE® PEDiatric Multiple Vitamins Injection
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).
| PEDIATRIC INFUVITE MULTIPLE VITAMINS FOR INFUSION |
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
|Labeler — Sandoz Inc (005387188)|
Revised: 03/2016 Sandoz Inc
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