M.V.I.-12™ (Multi-Vitamin Infusion without Vitamin K)  12种复方维生素注射液 MULTI VITAMIN INFUSION (retinol, ergocalciferol, ascorbic acid, niacinamide, thiamine, biotin, folic acid, cyanocobalamin, .alpha.-tocopherol acetate, dl-, riboflavin 5-phosphate sodium, pyridoxine hydrochloride, and dexpanthenol) injection, solution, concentrate
[Hospira Worldwide, Inc.]
M.V.I.-12™ (Multi-Vitamin Infusion without Vitamin K)
Currently available in 2 x 50 mL. Learn more about the available product in the table below.
Now discontinued in 10 mL Single Dose Unit Glass Vial (Two-Chambered) (NDC number 61703-423-81). View information and possible alternate sources for discontinued products here.
Availability
Out of Stock: 61703-423-83 Additional Information:  See below for more information regarding specific products. View additional information and potential alternatives. ClassVitaminGeneric NameMulti-Vitamin Infusion without Vitamin KBrand Name EquivalentM.V.I.-12
Mayne Pharma公司推出一种新型的多种维生素冲剂(multivitamin infusion，M.V.I.-12，不包含维生素K)，用于预防那些接受全静脉营养(TPN)输注治疗伴warfarin类抗凝药治疗的患者的维生素缺乏及血栓性栓塞并发症。维生素K可对抗warfarin的作用。
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
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 FLUID. (2.3)
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
This product contains aluminum that may be toxic. (5.1)
Studies have shown that vitamin A may adhere to plastic, resulting in inadequate vitamin A administration in the doses recommended with M.V.I.-12™. (5.2)
M.V.I.-12™ may not correct long standing specific vitamin deficiencies. The administration of additional doses may be required. (5.3)
Allergic reactions such as urticaria, periorbital and digital edema, have been reported following intravenous administration of thiamine. (5.4)
Hypervitaminosis A has been reported in patients with renal failure receiving 1.5 mg/day retinol and in patients with liver disease. (5.5)
Do not administer M.V.I.-12™ to patients with suspected or diagnosed megaloblastic anemia prior to the blood sampling for the detection of the folic acid and cyanocobalamin deficiencies. (5.6)
Blood vitamin concentration should be periodically monitored to determine if vitamin deficiencies or excesses are developing. (5.7)
Ascorbic acid in the urine may cause negative urine glucose determination. (5.8)
ADVERSE REACTIONS
There have been rare reports of the following types of reactions:
Allergic — anaphylactoid reactions following large intravenous doses of thiamine, urticaria, periorbital and digital edema (6)
Dermatologic — rash, erythema, pruritus (6)
CNS — headache, dizziness, agitation, anxiety (6)
Ophthalmic — diplopia (6)
To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or electronically at ProductComplaintsPP@hospira.com, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
A number of interactions between vitamins and drugs have been reported. The following are examples of these interactions:
Physical Incompatibilities:
Acetazolamide (2.4)
Intravenous chlorothiazide sodium (2.4)
Aminophylline (2.4)
Ampicillin (2.4)
Moderately alkaline solutions (2.4)
Tetracycline HCl (2.4)
Calcium salts such as calcium gluconate (2.4)
Vitamin K bisulfite or sodium bisulfite (2.4)
Thiamine, riboflavin, pyridoxine, niacinamide, and ascorbic acid have been reported to decrease the antibiotic activity of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin (7.1)
Bleomycin (7.1)
Clinical Interactions:
Phenytoin (7.1)
Levodopa (7.1)
Chloramphenicol (7.2)
USE IN SPECIFIC POPULATIONS
Pregnant and Nursing Mothers: Pregnant women should follow the U.S. Recommended Daily Allowances for their condition, because their vitamin requirements may exceed those of nonpregnant women. (8.1, 8.3)
Pediatric Use: Safety and effectiveness in children below the age of 11 years have not been established. (8.4)
Monitor calcium and phosphorus levels in patients with renal impairment. (8.6)
Monitor vitamin A level in patients with liver disease, high alcohol consumption. (8.7)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 6/2010

FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
M.V.I.-12™ Pharmacy Bulk Package (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.
2 DOSAGE AND ADMINISTRATION
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.
2.1 Starting Dose, Dose Range and Route of Administration
The starting dose is one 10 mL daily dose added directly to an intravenous fluid. Patients with multiple vitamin deficiencies or with increased vitamin 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.
2.2 Monitoring
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.
2.3 Instructions for Intravenous Administration
The solution must be prepared prior to intravenous administration.
•    Aseptically transfer the contents of the 50 mL Vial 1 into 50 mL Vial 2. The mixed solution will provide ten 10 mL single doses. Once closure system has been compromised, withdrawal of container contents should be completed within 4 hours. Mixed solution may be stored for up to 4 hours refrigerated. Discard unused portion.
•    Do not administer M.V.I.-12™ as a direct, undiluted intravenous injection as it may cause dizziness, faintness, and tissue irritation.
•    Utilizing a suitable sterile automated compounding device or dispensing pin for accuracy, aseptically transfer each 10 mL dose into a plastic or glass bottle containing at least 500 – 1000 mL intravenous total parenteral nutrition solution containing dextrose or saline. Discard unused portions. This infusion solution may be stored up to 24 hours refrigerated.
•    Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
•    Handling of M.V.I.-12™ solution, including preparation of the Pharmacy Bulk Pack, should be restricted to a suitable work area, such as a laminar flow hood.
2.4 Drug Incompatibilities
•    M.V.I.-12™ (Multi-Vitamin Infusion without vitamin K) is not physically compatible with moderately alkaline solutions such as a sodium bicarbonate solution and other alkaline drugs such as acetazolamide sodium, aminophylline, ampicillin sodium, and chlorothiazide sodium.
•    Folic acid is unstable in the presence of calcium salts such as calcium gluconate.
•    Vitamin A and thiamine in M.V.I.-12™ may react with bisulfite solutions such as sodium bisulfite or vitamin K bisulfate. Patients should be monitored for vitamin A and thiamine deficiencies.
•    Consult appropriate references for listings of physical and chemical compatibility of solutions and drugs with the vitamin infusion. In such circumstances, admixture or Y-site administration with vitamin solutions should be avoided.
3 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 [see Description (11)].
4 CONTRAINDICATIONS
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.
5 WARNINGS AND PRECAUTIONS
5.1 Aluminum Toxicity
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 microgram per kg per day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
5.2 Adherence of Vitamin A to Plastic

17 PATIENT COUNSELING INFORMATION