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.
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese 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 CHANGESINDICATIONS AND USAGEM.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 ADMINISTRATIONM.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 STRENGTHSM.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) CONTRAINDICATIONSHypersensitivity to any of the vitamins in this product or an existing hypervitaminosis. (4) WARNINGS AND PRECAUTIONS
ADVERSE REACTIONSThere 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. DRUG INTERACTIONSA number of interactions between vitamins and drugs have been reported. The following are examples of these interactions: Physical Incompatibilities (7.1):
Clinical Interactions: USE IN SPECIFIC POPULATIONS
See 17 for PATIENT COUNSELING INFORMATION. Revised: 3/2013 |
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.
The starting dose is one 10 mL daily dose added directly to an intravenous fluid. Patients with multiple vitamin deficiencies or with markedly increased requirements may need multiple daily dosages as indicated. Some patients do not maintain adequate levels of certain vitamins when this formulation in recommended amounts is the only source of vitamins.
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.
The solution must be prepared prior to intravenous administration.
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.
M.V.I.-12™ contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Studies have shown that vitamin A, which is found in M.V.I.-12™, may adhere to polyvinyl chloride (PVC) plastic, resulting in lower vitamin A concentrations in the administered M.V.I.-12™ doses. Therefore, blood vitamin concentrations should be periodically monitored and the administration of additional therapeutic doses of Vitamin A may be required [see Warnings and Precautions (5.7)].
Allergic reactions such as urticaria, periorbital and digital edema, have been reported following intravenous administration of thiamine, which is found in M.V.I.-12™. There have been rare reports of anaphylactoid reactions following large intravenous doses of thiamine. No fatal anaphylactoid reactions associated with M.V.I.–12™ have been reported.
Hypervitaminosis A, manifested by nausea, vomiting, headache, dizziness, blurred vision, has been reported in patients with renal failure receiving 1.5 mg/day retinol and in patients with liver disease. Therefore, supplementation of renal failure patients and patients with liver diseases with vitamin A, an ingredient found in M.V.I.-12™, should be undertaken with caution [see Use in Specific Populations (8.6, 8.7)].
Do not administer M.V.I.–12™ to patients with suspected or diagnosed megaloblastic anemia prior to blood sampling for the detection of the folic acid and cyanocobalamin deficiencies. The folic acid and the cyanocobalamin in the M.V.I.–12™ solution can mask serum deficits of folic acid and cyanocobalamin in these patients.
In patients receiving parenteral multivitamins, such as with M.V.I.-12™, blood vitamin concentrations should be periodically monitored to determine if vitamin deficiencies or excesses are developing. M.V.I.–12™ may not correct long-standing specific vitamin deficiencies. The administration of additional therapeutic doses of specific vitamins may be required [see Dosage and Administration (2.2)].
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
Ophthalmic: diplopia
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:
Folic acid
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.
Pyridoxine
The metabolism of levodopa may be increased and its efficacy may be decreased by pyridoxine.
Antibiotics
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.
Hydralazine, Isoniazid
Pyridoxine requirements may be increased by concomitant administration of hydralazine or isoniazid.
Chloramphenicol
In patients with pernicious anemia, the hematologic response to vitamin B12 therapy may be inhibited by concomitant administration of chloramphenicol.
Phenytoin
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.
Ingredient | 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) | 200 mg |
Niacinamide | 40 mg |
Vitamin B2 (as riboflavin 5-phosphate sodium) | 3.6 mg |
Vitamin B1 (thiamine) | 6 mg |
Vitamin B6 (pyridoxine HCl) | 6 mg |
Dexpanthenol (d-pantothenyl alcohol) | 15 mg |
* 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. |
Biotin | 60 mcg |
Folic acid | 600 mcg |
Vitamin B12 (cyanocobalamin) | 5 mcg |
* 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).
EN-3244