M.V.I. PEDIATRIC- ascorbic acid, retinol, ergocalciferol, thiamine hydrochloride, riboflavin 5-phosphate sodium, pyridoxine hydr

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R), RETINOL (UNII: G2SH0XKK91) (RETINOL - UNII:G2SH0XKK91), ERGOCALCIFEROL (UNII: VS041H42XC) (ERGOCALCIFEROL - UNII:VS041H42XC), 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:25X51I8RD4), DE

Disponible desde:

Hospira, Inc.

Designación común internacional (DCI):

ASCORBIC ACID

Composición:

ASCORBIC ACID 80 mg in 5 mL

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

M.V.I. 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. M.V.I. Pediatric is contraindicated in patients who have: - A history of known hypersensitivity to any of the vitamins or excipients in M.V.I. Pediatric [see Warnings and Precautions (5.2), Adverse Reactions (6)] - An existing hypervitaminosis The safety and effectiveness of M.V.I. Pediatric for the prevention of vitamin deficiency have been established in pediatric patients up to 11 years of age receiving parenteral nutrition. The safety and effectiveness of M.V.I. Pediatric have not been established in pediatric patients older than 11 years of age. M.V.I. Pediatric contains aluminum that may be toxic for premature neonates. Aluminum levels should be monitored periodically during administration of M.V.I. Pediatric to p

Resumen del producto:

M.V.I. Pediatric for injection is supplied as a single-dose vial of lyophilized powder for reconstitution available as: See Description section for vitamin strengths [see Description (11)]. Minimize the exposure of M.V.I. Pediatric to light, because vitamins A, D and riboflavin are light sensitive. Store under refrigeration, 2 to 8°C (36 to 46°F).

Estado de Autorización:

New Drug Application

Ficha técnica

M.V.I. PEDIATRIC- ASCORBIC ACID, RETINOL, ERGOCALCIFEROL, THIAMINE
HYDROCHLORIDE, RIBOFLAVIN 5-
PHOSPHATE SODIUM, PYRIDOXINE HYDROCHLORIDE, NIACINAMIDE, DEXPANTHENOL,
.ALPHA.-TOCOPHEROL
ACETATE, DL-, BIOTIN, FOLIC ACID, CYANOCOBALAMIN, AND PHYTONADIONE
INJECTION, POWDER, LYOPHILIZED,
FOR SOLUTION
HOSPIRA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
M.V.I. PEDIATRIC SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR M.V.I. PEDIATRIC.
M.V.I. PEDIATRIC (MULTIPLE VITAMINS FOR INJECTION), FOR INTRAVENOUS
USE
INITIAL U.S. APPROVAL: 1983
RECENT MAJOR CHANGES
Dosage And Administration, Dosage Information (2.2)
2/2019
INDICATIONS AND USAGE
M.V.I. 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
M.V.I. Pediatric is a combination product that contains the following
vitamins: ascorbic acid, vitamin A, vitamin D,
thiamine, riboflavin, pyridoxine, niacinamide, dexpanthenol, vitamin
E, vitamin K, folic acid, biotin, and vitamin B (2.1)
Supplied as a single-dose vial of lyophilized powder for
reconstitution intended for administration by intravenous
infusion after dilution. (2.1)
Recommended daily dosage is based on patient's actual weight (2.2)
Less than 1 kg: The daily dose is 1.5 mL
1 kg to 3 kg: The daily dose is 3.25 mL
3 kg or more: The daily dose is 5 mL
One daily dose of the reconstituted solution (1.5 mL, 3.25 mL or 5 mL)
is then added directly to the intravenous fluid
(2.2,2.3)
See Full Prescribing Information for reconstitution instructions (2.3)
Monitor blood vitamin concentrations (2.4)
See Full Prescribing Information for drug incompatibilities (2.5)
DOSAGE FORMS AND STRENGTHS
M.V.I. Pediatric for injection is available as a single-dose vial for
reconstitution . (3) See Full Prescribing Information for
vitamin content (11)
CONTRAINDICATIONS
Hypersensitivity to any of the vitamins or exci