M.V.I.-12 retinol ergocalciferol .alpha.-tocopherol acetate dl- ascorbic acid niacinamide riboflavin 5-phosphate sodium thiamine

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

RETINOL (UNII: G2SH0XKK91) (RETINOL - UNII:G2SH0XKK91)

Available from:

Hospira Worldwide, Inc.

INN (International Name):

RETINOL

Composition:

RETINOL 1 mg in 5 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

M.V.I.-12- RETINOL, ERGOCALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-,
ASCORBIC ACID, NIACINAMIDE,
RIBOFLAVIN 5-PHOSPHATE SODIUM, THIAMINE HYDROCHLORIDE, PYRIDOXINE
HYDROCHLORIDE, DEXPANTHENOL,
BIOTIN, FOLIC ACID, AND CYANOCOBALAMIN
HOSPIRA WORLDWIDE, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
M.V.I.-12™ PHARMACY BULK PACKAGE (MULTI-
VITAMIN INFUSION WITHOUT VITAMIN K) SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR M.V.I.-12™
PHARMACY BULK PACKAGE (MULTI-VITAMIN INFUSION WITHOUT VITAMIN K).
M.V.I.-12™ PHARMACY BULK PACKAGE (MULTI-VITAMIN INFUSION WITHOUT
VITAMIN K) DILUTION FOR INTRAVENOUS
INFUSION ONLY.
INITIAL U.S. APPROVAL: 1953
RECENT MAJOR CHANGES
Dosage and Administration (2.1) (2.3) (2.4) 06/2012
Warnings and Precautions (5.1) (5.2) (5.3) (5.4) (5.5) (5.6) (5.7)
(5.8) 06/2012
INDICATIONS AND USAGE
M.V.I.-12™ Pharmacy Bulk Package is indicated for prevention of
vitamin deficiency in adults and children aged 11 years
and above who are on warfarin anticoagulant therapy receiving home
parenteral nutrition. (1)
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
M.V.I.-12™ Pharmacy Bulk Package is a sterile product consisting of
two vials labeled Vial 1 (50 mL) and Vial 2 (50 mL).
The mixed solution (100 mL) will provide ten 10 mL single doses. (3)
CONTRAINDICATIONS
Hypersensitivity to any of the vitamins in this product or an existing
hypervitaminosis. (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
•
ADVERSE REACTIONS
There have been rare reports of the following types of reactions:
•
•
•
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT HOSPIRA, INC. AT
1-800-441-4100 OR ELECTRONICALLY AT
[e-mail], OR FDA AT 1-800-FDA-1088 OR
_WWW.FDA.GOV/MEDWATCH_.
DRUG INTERACTIONS
M.V.I.-12™ is ready for immediate use in adults and children aged 11
years and above when added to intravenous
infusion fluids. (2)
M.V.I.-12™ SHOULD BE ASEPTICALLY TRANSFERRED TO THE INFUSION F