PEDIATRIC INFUVITE MULTIPLE VITAMINS FOR INFUSION- ascorbic acid, vitamin a palmitate, cholecalciferol, thiamine hydrochloride,

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R), VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) (VITAMIN A - UNII:81G40H8B0T), CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41), THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J), RIBOFLAVIN 5'-PHOSPHATE SODIUM (UNII: 20RD1DZH99) (FLAVIN MONONUCLEOTIDE - UNII:7N464URE7E), PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z), NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII

Available from:

Sandoz Inc

INN (International Name):

ASCORBIC ACID

Composition:

ASCORBIC ACID 80 mg in 5 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. INFUVITE PEDIATRIC is contraindicated in patients who have: INFUVITE PEDIATRIC has not been studied in pregnant women. Pregnant women should follow the U.S. recommended daily allowances for pregnancy because their vitamin requirements may exceed those of non-pregnant women. Animal reproduction studies have not been conducted with INFUVITE PEDIATRIC (multiple vitamins injection). INFUVITE PEDIATRIC has not been studied in nursing mothers. Lactating women may have vitamin requirements that exceed those of non-lactating women. Caution should be exercised when INFUVITE PEDIATRIC is administered to nursing mothers. INFUVITE PEDIATRIC is approved for the prevention of vitamin deficiency in pediatric patients up to 11 years

Product summary:

How Supplied: INFUVITE PEDIATRIC (multiple vitamins injection) is supplied as follows: INFUVITE PEDIATRIC (multiple vitamins injection) Single Dose : INFUVITE PEDIATRIC (multiple vitamins injection) Pharmacy Bulk Package : 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).

Authorization status:

New Drug Application

Summary of Product characteristics

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
SANDOZ MANUFACTURING INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
INFUVITE PEDIATRIC SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR INFUVITE PEDIATRIC.
INFUVITE PEDIATRIC (MULTIPLE VITAMINS INJECTION), FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2001
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 (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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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 (2.1)
INFUVITE PEDIATRIC is for administration by intravenous infusion after
dilution (2.1)
Recommended daily dosage is based on patient’s actual weight (2.2):
INFUVITE PEDIATRIC SINGLE DOSE:
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_WEIGHT LESS THAN 1 KG_: 1.2 mL of Vial 1 and 0.3 mL of Vial 2
_WEIGHT 1 KG TO LESS THAN 3 KG_: 2.6 mL of Vial 1 and 0.65 mL Vial 2
_WEIGHT 3 KG OR GREATER_: 4 mL of Vial 1 and 1 mL of Vial 2
INFUVITE PEDIATRIC PHARMACY BULK PACKAGE:
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_WEIGHT LESS THAN 1 KG_: 1.5 mL of combined content of Vials 1 and 2
_WEIGHT 1 KG TO LESS THAN 3 KG_: 3.25 mL of combined content of Vials
1 and 2
_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
(2.2)
INFUVITE PEDIATRIC is supplied as a single dose and as a pharmacy bulk
package:
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SINGLE DOSE consists