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 injection, solution, concentrate
Hospira Worldwide, Inc.
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use M.V.I.-12™ Unit Vial (Multi-Vitamin Infusion without vitamin K) safely and effectively. See full prescribing information for M.V.I.-12™ Unit Vial (Multi-Vitamin Infusion without vitamin K).
M.V.I.-12™ Unit Vial (Multi-Vitamin Infusion without vitamin K) for dilution in intravenous infusions only.
Initial U.S. Approval: 1953
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
M.V.I.-12™ Unit Vial is indicated for the 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
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)
A number of the physical incompatibilities between M.V.I.-12™ infusion and drugs have been reported. The following are examples of these interactions (2.4):
DOSAGE FORMS AND STRENGTHS
M.V.I.–12™ Unit Vial is a sterile product in a two-chambered single-dose 10 mL vial which must be mixed just prior to use. (3)
Hypersensitivity to any of the vitamins in this product or an existing hypervitaminosis. (4)
WARNINGS AND PRECAUTIONS
There have been rare reports of the following types of reactions (6):
To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
A number of interactions between vitamins and drugs have been reported. The following are examples of these interactions:
Physical Incompatibilities (7.1):
USE IN SPECIFIC POPULATIONS
See 17 for PATIENT COUNSELING INFORMATION.
FULL PRESCRIBING INFORMATION: CONTENTS*
M.V.I.-12™ Unit Vial (Multi-Vitamin Infusion without vitamin K) is indicated for the prevention of vitamin deficiency in adults and children aged 11 years and above on warfarin anticoagulant therapy receiving parenteral nutrition.
The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy.
M.V.I.–12™ is ready for immediate intravenous use in adults and children aged 11 years and above when added to intravenous infusion fluids. Do not administer M.V.I.-12™ as a direct, undiluted intravenous injection as it may cause dizziness, faintness, and tissue irritation.
Blood vitamin concentrations should be monitored to ensure maintenance of adequate levels, particularly in patients receiving parenteral multivitamins as the only source of vitamins for long periods of time.
M.V.I.–12™ Unit Vial is a sterile product in a two-chambered single-dose 10 mL vial which must be mixed just prior to use [see Description (11)].
M.V.I.–12™ is contraindicated in patients who have a history of hypersensitivity to any of the vitamins in this product or existing hypervitaminosis due to any vitamins contained in this formulation.
The following adverse reactions are discussed in greater detail in other section of the labeling.
Other adverse reactions:
Dermatologic: rash, erythema, pruritus
CNS: headache: dizziness, agitation, anxiety
A number of drug interactions between vitamins and other drugs have been reported. Consult appropriate references for additional specific vitamin-drug interactions. The following are examples of these types of interactions:
Phenytoin metabolism may be increased by folic acid. Low serum concentration of phenytoin may result in increased seizure frequency.
Patient's response to methotrexate therapy may be decreased by folic acid.
The metabolism of levodopa may be increased and its efficacy may be decreased by pyridoxine.
Antibiotic activity of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin is decreased by thiamine, riboflavin, pyridoxine, niacinamide, and ascorbic acid. Bleomycin is inactivated in vitro by ascorbic acid and riboflavin.
Pyridoxine requirements may be increased by concomitant administration of hydralazine or isoniazid.
In patients with pernicious anemia, the hematologic response to vitamin B12 therapy may be inhibited by concomitant administration of chloramphenicol.
Serum folic acid concentrations may be decreased by phenytoin and, therefore it should be avoided in pregnancy.
M.V.I.-12™ has not been studied in pregnant women. Pregnant women should follow the U.S. Recommended Daily Allowances for their condition, because their vitamin requirements may be different than those of nonpregnant women.
M.V.I.-12™ has not been studied in lactating women. Lactating women should follow the U.S. Recommended Daily Allowances for their condition, because their vitamin requirements may be different than a nonlactating women. Caution should be exercised when M.V.I.-12™ Unit Vial is administered to a nursing woman.
Safety and effectiveness of M.V.I.-12™ in children below the age of 11 years have not been established.
M.V.I.-12™ has not been studied in patients with renal impairment. Monitor renal function, calcium, phosphorus and vitamin A levels in patients with renal impairment [see Warnings and Precautions (5.1, 5.5)].
M.V.I.-12™ has not been studied in patients with liver impairment. Monitor vitamin A level in patients with liver disease, high alcohol consumption [see Warnings and Precautions (5.5)].
There is no clinical experience with M.V.I.-12™ overdosage. Signs and symptoms of acute or chronic overdosage may be those of individual M.V.I.-12™ component toxicity.
M.V.I.–12™ Unit Vial: A sterile product in a two-chambered single-dose Type I amber glass, vial, 10 mL, which must be mixed just prior to use.
Amount per Unit Dose
Fat Soluble Vitamins**
Vitamin A (retinol)
1 mg (3,300 USP units)
Vitamin D (ergocalciferol)
5 mcg (200 USP units)
Vitamin E (dl-alpha-tocopheryl acetate)
10 mg (10 USP units)
Water Soluble Vitamins
Vitamin C (ascorbic acid)
Vitamin B2 (as riboflavin 5-phosphate sodium)
Vitamin B1 (thiamine)
Vitamin B6 (pyridoxine HCl)
Dexpanthenol (d-pantothenyl alcohol)
* With 30% propylene glycol and 2% gentisic acid ethanolamide as stabilizers and preservatives; sodium hydroxide for pH adjustment; 1.6% polysorbate 80; 0.028% polysorbate 20; 0.002% butylated hydroxytoluene; 0.0005% butylated hydroxyanisole.
** Fat-soluble vitamins A, D, and E are water solubilized with polysorbate 80.
Vitamin B12 (cyanocobalamin)
* With 30% propylene glycol and citric acid, sodium citrate, and sodium hydroxide for pH adjustment.
“Aqueous” multivitamin formula for intravenous infusion: M.V.I.–12™ (Multi-Vitamin Infusion without vitamin K) makes available a combination of important fat-soluble and water-soluble vitamins in an aqueous solution, formulated specially for incorporation into intravenous infusions. Through special processing techniques, the liposoluble vitamins A, D, and E have been solubilized in an aqueous medium with polysorbate 80, permitting intravenous administration of these vitamins.
M.V.I. – 12™ UNIT VIAL NDC 61703-423-11 Boxes of 25 two-chambered 10 mL vials.
Minimize the exposure of M.V.I.–12™ to the light, because vitamins A, D and riboflavin are light sensitive.
Store at 2-8°C (36-46°F).