PEDIATRIC INFUVITE MULTIPLE VITAMINS FOR INFUSION (Page 4 of 4)

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity, and fertility studies have not been performed with INFUVITE PEDIATRIC.

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied:

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:

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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).

17 PATIENT COUNSELING INFORMATION

Instruct caregiver(s) and patients (if age appropriate):

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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.

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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.

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To report other adverse reactions that patients may experience such as rash, erythema, pruritus, headache, dizziness, agitation, anxiety, and diplopia.

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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.

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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.

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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.

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That vitamin C (ascorbic acid) contained in INFUVITE PEDIATRIC may cause false negative urine glucose results.

Manufactured by

Sandoz Canada Inc.

145 Jules-Léger Street

Boucherville, Qc, Canada, J4B 7K8

Distributed by

Baxter Healthcare Corporation

Clintec Nutrition Division

Deerfield, IL 60015 USA

Printed in Canada

® INFUVITE is a registered trademark of Sandoz Canada Inc.

D46143533

03-2016M

Carton

2A9008 NDC 54643-5646-1

Baxter

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

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54643-5646 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 80 mg in 5 mL VITAMIN A PALMITATE (VITAMIN A) VITAMIN A 2300 [iU] in 5 mL CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU] in 5 mL THIAMINE HYDROCHLORIDE (THIAMINE ION) THIAMINE 1.2 mg in 5 mL RIBOFLAVIN 5′-PHOSPHATE SODIUM (FLAVIN MONONUCLEOTIDE) FLAVIN MONONUCLEOTIDE 1.4 mg in 5 mL PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 1 mg in 5 mL NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 17 mg in 5 mL DEXPANTHENOL (DEXPANTHENOL) DEXPANTHENOL 5 mg in 5 mL .ALPHA.-TOCOPHEROL ACETATE (.ALPHA.-TOCOPHEROL) .ALPHA.-TOCOPHEROL ACETATE 7 [iU] in 5 mL PHYTONADIONE (PHYTONADIONE) PHYTONADIONE 0.2 mg in 5 mL FOLIC ACID (FOLIC ACID) FOLIC ACID 140 ug in 5 mL BIOTIN (BIOTIN) BIOTIN 20 ug in 5 mL CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 1 ug in 5 mL

Inactive Ingredients Ingredient Name Strength POLYSORBATE 80 ANHYDROUS CITRIC ACID SODIUM CITRATE, UNSPECIFIED FORM SODIUM HYDROXIDE HYDROCHLORIC ACID MANNITOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:54643-5646-0 2 VIAL in 1 CARTON contains a VIAL 1 5 mL in 1 VIAL This package is contained within the CARTON (54643-5646-0) 2 NDC:54643-5646-1 10 VIAL in 1 CARTON contains a VIAL 2 5 mL in 1 VIAL This package is contained within the CARTON (54643-5646-1)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021265 02/21/2001

Labeler — Sandoz Inc (005387188)

Revised: 03/2016 Sandoz Inc