Pediatric Infuvite Multiple Vitamins

(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)

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Pediatric Infuvite Multiple Vitamins Prescribing Information

•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 for administration by intravenous infusion after dilution
•Recommended daily dosage is based on patient’s actual weight :
- •INFUVITE PEDIATRIC
  Single Dose:
  - o
    Weight less than 1 kg:
    1.2 mL
    of Vial 1 and
    0.3 mL
    of Vial 2
  - o
    Weight 1 kg to less than 3 kg:
    2.6 mL
    of Vial 1 and
    0.65 mL
    Vial 2
  - o
    Weight 3 kg or greater:
    4 mL
    of Vial 1 and
    1 mL
    of Vial 2
- •INFUVITE PEDIATRIC
  Pharmacy Bulk Package
  :
  - o
    Weight less than 1 kg:
    1.5 mL
    of combined content of Vials 1 and 2
  - o
    Weight 1 kg to less than 3 kg:
    3.25 mL
    of combined content of Vials 1 and 2
  - o
    Weight 3 kg or greater:
    5 mL
    of combined content of Vials 1 and 2.
•Supplemental vitamin A may be required for low-birth weight infants
•INFUVITE PEDIATRIC is supplied as a single dose and as a pharmacy bulk package:
- •
  Single Dose
  consists of two vials labeled Vial 1 and Vial 2. Add one daily dose of Vial 1 and one daily dose of Vial 2 directly to at least 100 mL of intravenous dextrose or saline solution prior to intravenous use
- •
  Pharmacy Bulk Package
  consists of two vials labeled Vial 1 and Vial 2. Transfer contents of Vial 2 to contents of Vial 1. Then, take 1.5 mL, 3.25 mL, or 5 mL from mixture and add to at least 100 mL of intravenous dextrose or saline solution prior to intravenous use
•After dilution in an intravenous infusion, refrigerate resulting solution unless used immediately. Use solution within 24 hours after dilution
•Monitor blood vitamin concentrations
•See Full Prescribing Information for drug incompatibilities .

INFUVITE PEDIATRIC

Single Dose

is an injection consisting of two single-dose vials labeled Vial 1 (4 mL) and Vial 2 (1 mL). For the vitamin strengths [

see Dosage and Administration (

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 ].

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

] (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 mc g)	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

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 mc g)	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

) and Description (

11 DESCRIPTION

INFUVITE PEDIATRIC (multiple vitamins injection) is a sterile product consisting of two vials provided as a single dose or as a pharmacy bulk package for intravenous use intended for administration by intravenous infusion after dilution:

INFUVITE PEDIATRIC (multiple vitamins injection) supplied as single dose consists of:

(a)Vial 1 (4 mL); and
(b)Vial 2 (1 mL).

Vial 1 will provide one daily dose of 1.2 mL, 2.6 mL or 4 mL and Vial 2 will provide one daily dose of 0.3 mL, 0.65 mL or 1 mL [

see Dosage and Administration

]

INFUVITE PEDIATRIC (multiple vitamins injection) supplied as pharmacy bulk package consists of:

(a)Vial 1 (40 mL Fill in 50 mL Vial); and
(b)Vial 2 (10 mL).

The mixed solution will provide many single doses [

see Dosage and Administration

Each 4 mL of Vial 1 contains 10 vitamins and each 1 mL of Vial 2 contains 3 vitamins (see Table 3).

Table 3: INGREDIENTS IN INFUVITE PEDIATRIC FORMULATION
Vial 1
Active Ingredient	Quantity per 4 mL
Ascorbic acid (Vitamin C)	80 mg
Vitamin A* (as palmitate)	2,300 IU (equals 0.7 mg)
Vitamin D₃* (cholecalciferol)	400 IU (equals 10 mcg)
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 E* ( dl -α-tocopheryl acetate)	7 IU (equals 7 mg)
Vitamin K₁*	0.2 mg
*Polysorbate 80 is used to water solubilize the oil-soluble vitamins A, D, E, and K. Inactive ingredients in 4 mL of Vial 1: 50 mg polysorbate 80, sodium hydroxide and/or hydrochloric acid for pH adjustment, and water for injection.
Vial 2
Active Ingredient	Quantity per 1 mL
Folic acid	140 mcg
Biotin	20 mcg
Vitamin B₁₂(cyanocobalamin)	1 mcg
Inactive ingredients in 1 mL of Vial 2: 75 mg mannitol, citric acid and/or sodium citrate for pH adjustment and water for injection.

INFUVITE PEDIATRIC (multiple vitamins injection) makes available a combination of 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.

INFUVITE PEDIATRIC contains no more than 30 mcg/L of aluminum (combined Vials 1 and 2).

)

INFUVITE PEDIATRIC

Pharmacy Bulk Package

is an injection consisting of two vials labeled Vial 1 (40 mL Fill in 50 mL Vial) and Vial 2 (10 mL). The mixed solution (50 mL) will provide thirty-three 1.5 mL single doses, fifteen 3.25 mL single doses or ten 5 mL single doses. For the vitamin strengths [

see Dosage and Administration (

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.

Additional daily dosages of Vitamin E in infants are not recommended

[see Warnings and Precautions ].

INFUVITE PEDIATRIC

Single Dose

(see Table 1):

see Dosage and Administration

] (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 mc g)	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):

see Dosage and Administration

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 mc g)	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

) and Description (

11 DESCRIPTION

INFUVITE PEDIATRIC (multiple vitamins injection) supplied as single dose consists of:

(a)Vial 1 (4 mL); and
(b)Vial 2 (1 mL).

Vial 1 will provide one daily dose of 1.2 mL, 2.6 mL or 4 mL and Vial 2 will provide one daily dose of 0.3 mL, 0.65 mL or 1 mL [

see Dosage and Administration

]

INFUVITE PEDIATRIC (multiple vitamins injection) supplied as pharmacy bulk package consists of:

(a)Vial 1 (40 mL Fill in 50 mL Vial); and
(b)Vial 2 (10 mL).

The mixed solution will provide many single doses [

see Dosage and Administration

Each 4 mL of Vial 1 contains 10 vitamins and each 1 mL of Vial 2 contains 3 vitamins (see Table 3).

Table 3: INGREDIENTS IN INFUVITE PEDIATRIC FORMULATION
Vial 1
Active Ingredient	Quantity per 4 mL
Ascorbic acid (Vitamin C)	80 mg
Vitamin A* (as palmitate)	2,300 IU (equals 0.7 mg)
Vitamin D₃* (cholecalciferol)	400 IU (equals 10 mcg)
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 E* ( dl -α-tocopheryl acetate)	7 IU (equals 7 mg)
Vitamin K₁*	0.2 mg
*Polysorbate 80 is used to water solubilize the oil-soluble vitamins A, D, E, and K. Inactive ingredients in 4 mL of Vial 1: 50 mg polysorbate 80, sodium hydroxide and/or hydrochloric acid for pH adjustment, and water for injection.
Vial 2
Active Ingredient	Quantity per 1 mL
Folic acid	140 mcg
Biotin	20 mcg
Vitamin B₁₂(cyanocobalamin)	1 mcg
Inactive ingredients in 1 mL of Vial 2: 75 mg mannitol, citric acid and/or sodium citrate for pH adjustment and water for injection.

INFUVITE PEDIATRIC contains no more than 30 mcg/L of aluminum (combined Vials 1 and 2).

)

•
Risk of Aluminum Toxicity:
For at risk patients (renal failure or those with prolonged therapy), consider periodic monitoring of aluminum levels
•
Allergic Reactions:
To thiamine may occur
•
Hypervitaminosis A
: Patients with renal failure or liver disease may be at higher risk
•
Decreased Anticoagulant Effect of Warfarin:
Monitor INR
•
Interferes with Megaloblastic Anemia Diagnosis:
Avoid during testing for this disorder
•
Risk of Vitamin Deficiencies or Excesses:
Monitor blood vitamin concentrations
•
False Negative Urine Glucose Tests:
Due to vitamin C
•
Risk of Vitamin E Toxicity:
Additional oral and parenteral vitamin E may result in elevated vitamin E blood concentrations in infants
•
Low Vitamin A Levels:
Monitor vitamin A levels
•
Risk of E-Ferol Syndrome:
Due to polysorbates

Report Adverse Event

Pediatric Infuvite Multiple Vitamins

Pediatric Infuvite Multiple Vitamins Prescribing Information

Pediatric Infuvite Multiple Vitamins PubMed™ News