M.V.I. ADULT- retinol, ergocalciferol, .alpha.-tocopherol acetate, dl-, phytonadione, ascorbic acid, niacinamide, riboflavin 5-p

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

RETINOL (UNII: G2SH0XKK91) (RETINOL - UNII:G2SH0XKK91), ERGOCALCIFEROL (UNII: VS041H42XC) (ERGOCALCIFEROL - UNII:VS041H42XC), .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01), PHYTONADIONE (UNII: A034SE7857) (PHYTONADIONE - UNII:A034SE7857), ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R), NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4), RIBOFLAVIN 5'-PHOSPHATE SODIUM (UNII: 20RD1DZH99) (FLAVIN MONONUCLEOTIDE - UNII:7N464

Available from:

Hospira, Inc.

INN (International Name):

RETINOL

Composition:

RETINOL 1 mg in 5 mL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

M.V.I. Adult™ is a combination of vitamins indicated for the prevention of vitamin deficiency in adults and pediatric patients aged 11 years and above receiving parenteral nutrition. The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy. M.V.I. Adult is contraindicated in patients who have: Risk Summary Administration of the approved recommended dose of M.V.I. Adult in parenteral nutrition is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. Pregnant women should follow the U.S. Recommended Daily Allowances for pregnancy because their vitamin requirements may exceed those of nonpregnant women. Deficiency of essential vitamins may result in adverse pregnancy outcomes (see Clinical Considerations) . Animal reproduction studies have not been conducted with M.V.I. Adult administered by intravenous infusion. The estimated background risk of major birth defects and miscarriage for the indicated population

Product summary:

M.V.I. ADULT is an injection supplied in the following package configurations: M.V.I. ADULT Single-Dose Vial 1 is an amber vial containing a clear, amber to orange colored solution. Vial 2 is an amber vial containing a clear to light straw colored solution. Mix contents of Vial 1 and Vial 2 to provide a single 10 mL dose [see Dosage and Administration (2.3)]. M.V.I. ADULT Pharmacy Bulk Package Vial 1 is an amber vial containing a clear, amber to orange colored solution. Vial 2 is an amber vial containing a clear to light straw colored solution. Mix contents of Vial 1 and Vial 2 to provide ten 10 mL single doses [see Dosage and Administration (2.3)]. See Description section for vitamin strengths [see Description (11)]. Minimize the exposure of M.V.I. Adult to light, because vitamins A, D and riboflavin are light sensitive. Store at 2-8°C (36-46°F).

Authorization status:

New Drug Application

Summary of Product characteristics

M.V.I. ADULT- RETINOL, ERGOCALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE,
DL-,
PHYTONADIONE, ASCORBIC ACID, NIACINAMIDE, RIBOFLAVIN 5-PHOSPHATE
SODIUM,
THIAMINE HYDROCHLORIDE, PYRIDOXINE HYDROCHLORIDE, DEXPANTHENOL,
BIOTIN, FOLIC
ACID, AND CYANOCOBALAMIN
HOSPIRA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
M.V.I. ADULT™ SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR M.V.I. ADULT.
M.V.I. ADULT (MULTIPLE VITAMINS INJECTION), FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2004
INDICATIONS AND USAGE
M.V.I. Adult is a combination of vitamins indicated for prevention of
vitamin deficiency in adults and
pediatric patients aged 11 years and above receiving parenteral
nutrition. (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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M.V.I. Adult 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)
12
Recommended daily dosage is 10 mL. (2.2)
Administer by intravenous infusion after dilution. (2.1)
Supplied as a single-dose and a pharmacy bulk package:
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_M.V.I. Adult Single Dose:_ consists of two vials labeled Vial 1 and
Vial 2. Transfer contents of Vial 1
to Vial 2. The mixed solution (10 mL) will provide a single 10 mL
dose. Use within 4 hours of
puncture. (2.1, 2.3)
_M.V.I. Adult Pharmacy Bulk Package:_ consists of two vials labeled
Vial 1 and Vial 2. Transfer the
contents of Vial 1 to Vial 2. The mixed solution (100 mL) will provide
ten 10 mL single doses to
patients in a pharmacy admixture program. Use within 4 hours of
puncture. (2.1, 2.3)
Prior to intravenous administration, dilute the once daily dose of 10
mL by adding to at least 500 to
1,000 mL intravenous parenteral nutrition solution containing dextrose
or saline. (2.3)
After dilution in an intraveno