PEDIATRIC INFUVITE MULTIPLE VITAMINS FOR INFUSION

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, phytonadione, folic acid, biotin and cyanocobalamin injection, solution
Sandoz Manufacturing Inc

1 INDICATIONS AND USAGE

INFUVITE PEDIATRIC is a combination of vitamins indicated for the prevention of vitamin deficiency in pediatric patients up to 11 years of age receiving parenteral nutrition.

The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy.

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Instructions

INFUVITE PEDIATRIC is a combination product that contains the following vitamins: ascorbic acid, vitamin A, vitamin D, thiamine, riboflavin, pyridoxine, niacinamide, dexpanthenol, vitamin E, vitamin K1, folic acid, biotin, and vitamin B12.

INFUVITE PEDIATRIC is supplied as a single dose or as a pharmacy bulk package for intravenous use intended for administration by intravenous infusion after dilution:

INFUVITE PEDIATRIC Single Dose consists of two vials. A weightbased volume from each vial must be added directly to dextrose or saline solution prior to intravenous administration [see Dosage and Administration (2.2, 2.3)].
INFUVITE PEDIATRIC Pharmacy Bulk Package consists of two pharmacy bulk vials which must be mixed prior to use. The mixed solution will provide multiple daily doses which must be diluted prior to intravenous administration. Pharmacy bulk package of INFUVITE PEDIATRIC is intended for dispensing of single doses to multiple patients in a pharmacy admixture program and is restricted to the preparation of admixtures for infusion [see Dosage and Administration (2.2, 2.3)].

2.2 Dosage Information

The recommended daily dosage volume is based on the patient’s actual weight: less than 1 kg, 1 kg to less than 3 kg, and 3 kg or greater.

Patients with multiple vitamin deficiencies or with increased vitamin requirements may need multiple daily dosages as indicated or additional doses of individual vitamins. Supplemental vitamin A may be required for low-birth weight infants.

Additional daily dosages of Vitamin E in infants are not recommended [see Warnings and Precautions (5.8)].

INFUVITE PEDIATRIC Single Dose (see Table 1):

One daily dose of Vial 1 (1.2 mL, 2.6 mL or 4 mL) and one daily dose of Vial 2 (0.3 mL, 0.65 mL or 1 mL) based on the patient’s weight are added directly to a specified volume of an intravenous fluid [see Dosage and Administration (2.3)] (see Table 1).

Table 1: Recommended Weight-Based Dosage of INFUVITE PEDIATRIC Single Dose

Less than 1 kg

1 kg to less than 3 kg

3 kg or greater

Daily Dosage Volume –Vial 1

1.2 mL

2.6 mL

4 mL

Ascorbic acid (Vitamin C)

24 mg

52 mg

80 mg

Vitamin A (as palmitate)

690 IU (equals 0.2 mg)

1495 IU (equals 0.5 mg)

2,300 IU (equals 0.7 mg)

Vitamin D3 (cholecalciferol)

120 IU (equals 3 mcg)

260 IU (equals 7 mcg)

400 IU (equals 10 mcg)

Thiamine (Vitamin B1 ) (as the hydrochloride)

0.4 mg

0.8 mg

1.2 mg

Riboflavin (Vitamin B2 ) (as riboflavin 5-phosphate sodium)

0.4 mg

0.9 mg

1.4 mg

Pyridoxine HCl (Vitamin B6 )

0.3 mg

0.7 mg

1 mg

Niacinamide

5.1 mg

11.1 mg

17 mg

Dexpanthenol (as d -pantothenyl alcohol)

1.5 mg

3.3 mg

5 mg

Vitamin E (dl -α-tocopheryl acetate)

2.1 IU (equals 2 mg)

4.6 IU (equals 5 mg)

7 IU (equals 7 mg)

Vitamin K1

0.1 mg

0.1 mg

0.2 mg

Daily Dosage Volume – Vial 2

0.3 mL

0.65 mL

1 mL

Folic acid

42 mcg

91 mcg

140 mcg

Biotin

6 mcg

13 mcg

20 mcg

Vitamin B12 (cyanocobalamin)

0.3 mcg

0.7 mcg

1 mcg

INFUVITE PEDIATRIC Pharmacy Bulk Package (see Table 2):

The recommended daily dosage volume of combined content of vials 1 and 2 (1.5 mL, 3.25 mL or 5 mL) is based on the patient’s weight and then added directly to the specific volume of an intravenous fluid [see Dosage and Administration (2.3)].

Table 2: Recommended Weight-Based Dosage of INFUVITE PEDIATRIC Pharmacy Bulk Package

Less than 1 kg

1 kg to less than 3 kg

3 kg or greater

Daily Dosage Volume

(combined contents of Vial 1 and Vial 2)

1.5 mL

3.25 mL

5 mL

Ascorbic acid (Vitamin C)

24 mg

52 mg

80 mg

Vitamin A (as palmitate)

690 IU (equals 0.2 mg)

1495 IU (equals 0.5 mg)

2,300 IU (equals 0.7 mg)

Vitamin D3 (cholecalciferol)

120 IU (equals 3 mcg)

260 IU (equals 7 mcg)

400 IU (equals 10 mcg)

Thiamine (Vitamin B1 ) (as the

hydrochloride)

0.4 mg

0.8 mg

1.2 mg

Riboflavin (Vitamin B2 ) (as

riboflavin 5-phosphate sodium)

0.4 mg

0.9 mg

1.4 mg

Pyridoxine HCl (Vitamin B6 )

0.3 mg

0.7 mg

1 mg

Niacinamide

5.1 mg

11.1 mg

17 mg

Dexpanthenol (as d -pantothenyl

alcohol)

1.5 mg

3.3 mg

5 mg

Vitamin E (dl-α -tocopheryl

acetate)

2.1 IU (equals 2 mg)

4.6 IU (equals 5 mg)

7 IU (equals 7 mg)

Vitamin K1

0.1 mg

0.1 mg

0.2 mg

Folic acid

42 mcg

91 mcg

140 mcg

Biotin

6 mcg

13 mcg

20 mcg

Vitamin B12 (cyanocobalamin)

0.3 mcg

0.7 mcg

1 mcg

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