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
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use M.V.I.-12™ safely and effectively. See full prescribing information for M.V.I.-12.
M.V.I.-12 (multiple vitamins without vitamin K injection), for intravenous use
Initial U.S. Approval: 1953
INDICATIONS AND USAGE
M.V.I.-12 is indicated for prevention of vitamin deficiency in adults and pediatric patients aged 11 years and above who are on warfarin anticoagulant therapy receiving home parenteral nutrition. (1)
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
WARNINGS AND PRECAUTIONS
Adverse reactions have included anaphylactoid reactions, rash, erythema, pruritus, headache, dizziness, agitation, anxiety, diplopia (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.
Effect of M.V.I.-12 on other drugs:
Effects of other drugs on M.V.I.-12:
USE IN SPECIFIC POPULATIONS
See 17 for PATIENT COUNSELING INFORMATION.
FULL PRESCRIBING INFORMATION: CONTENTS*
M.V.I.-12™ is indicated for the prevention of vitamin deficiency in adults and pediatric patients 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 a combination product that contains the following vitamins: ascorbic acid, vitamin A, vitamin D, thiamine, riboflavin, pyridoxine, niacinamide, dexpanthenol, vitamin E, folic acid, biotin, and vitamin B12.
M.V.I.-12 is supplied as a pharmacy bulk package for intravenous use intended for administration by intravenous infusion after dilution:
M.V.I.-12 Pharmacy Bulk Package: consists of two pharmacy bulk vials which must be mixed prior to use. The mixed solution will provide ten 10 mL single doses which must be diluted prior to intravenous administration. Pharmacy bulk package of M.V.I.-12 is intended for dispensing of single doses to multiple patients in a pharmacy admixture program and is restricted to the preparation of admixtures for infusion [see Dosage and Administration (2.3)].
Do not administer M.V.I.-12 as a direct, undiluted intravenous injection as it may cause dizziness, faintness, and tissue irritation.
The recommended daily dosage volume is 10 mL. One daily dose (10 mL) is diluted by adding directly to a specified volume of an intravenous fluid [see Dosage and Administration (2.3)].
Patients with multiple vitamin deficiencies or with increased vitamin requirements may need multiple daily dosages as indicated or additional doses of individual 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.
M.V.I.-12 is an injection available as:
Pharmacy bulk package consisting of two vials labeled Vial 1 and Vial 2. 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. Both vials must be mixed prior to use. The mixed solution (100 mL) will provide ten 10 mL single doses [see Dosage and Administration (2.3)].
M.V.I.-12 is contraindicated in patients who have:
M.V.I.-12 contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration in patients with renal impairment. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
Patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 micrograms 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. To prevent aluminum toxicity monitor periodically aluminum levels with prolonged parenteral administration of M.V.I.-12.
Vitamin A may adhere to plastic, resulting in lower vitamin A concentrations after administration of M.V.I.-12. Therefore, blood vitamin concentrations should be periodically monitored and the administration of additional therapeutic doses of Vitamin A may be required.
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 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 and 8.7)]. Blood levels of Vitamin A should be monitored periodically.
Avoid the use of M.V.I.-12 in patients with suspected or diagnosed megaloblastic anemia prior to blood sampling for the detection of the folic acid and cyanocobalamin deficiencies. M.V.I.-12 contains folic acid and cyanocobalamin which can mask serum deficits of folic acid and cyanocobalamin in patients with megaloblastic anemia.
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 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.
The following adverse reactions associated with the use of M.V.I.-12 were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Dermatologic: rash, erythema, pruritus
CNS: headache, dizziness, agitation, anxiety
Phenytoin: Folic acid may increase phenytoin metabolism and lower the serum concentration of phenytoin resulting in increased seizure activity.
Levodopa: Pyridoxine may increase the metabolism of levodopa (decrease blood level of levodopa) and decrease its efficacy.
Antibiotics: Thiamine, riboflavin, pyridoxine, niacinamide, and ascorbic acid decrease antibiotic activities of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin.
Hydralazine or Isoniazid: Concomitant administration of hydralazine or isoniazid may increase pyridoxine requirements.
Chloramphenicol: In patients with pernicious anemia, the hematologic response to vitamin B12 therapy may be inhibited by concomitant administration of chloramphenicol.
M.V.I.-12 has not been studied in pregnant women. Pregnant women should follow the U.S. Recommended Daily Allowances for pregnancy, because their vitamin requirements may exceed 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 exceed those of nonlactating women. Caution should be exercised when M.V.I.-12 is administered to a nursing woman.
M.V.I.-12 is indicated for the prevention of vitamin deficiency in pediatric patients age 11 years and above on warfarin anticoagulant therapy receiving parenteral nutrition. Safety and effectiveness of M.V.I.-12 in pediatric patients below the age of 11 years have not been established.
Reported clinical experience has not identified differences in responses between the elderly and younger patients.
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 Warning and Precautions (5.1, 5.4)].
M.V.I.-12 has not been studied in patients with hepatic impairment. Monitor vitamin A level in patients with liver disease or high alcohol consumption [see Warning and Precautions (5.4)].
Signs and symptoms of acute or chronic overdosage may be those of individual M.V.I.-12 component toxicity. There is no clinical experience with M.V.I.-12 overdosage.
M.V.I.-12 Pharmacy Bulk Package: A sterile product consisting of two Type 1, amber glass vials labeled Vial 1 (50 mL) and Vial 2 (50 mL). The mixed solution will provide ten single doses of 10 mL each.
Table 1 provides the strengths of the vitamins provided in vial 1 and vial 2:
|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|
|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|
|Ingredient||Amount per Unit Dose|
|Folic acid||600 mcg|
|Vitamin B12 (cyanocobalamin)||5 mcg|
"Aqueous" multivitamin formula for intravenous infusion: M.V.I.-12 (multiple vitamins without vitamin K injection) makes available a combination of fat-soluble and water-soluble vitamins in an aqueous solution, formulated for incorporation into intravenous infusions. 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 is an injection available as:
M.V.I.-12 Pharmacy Bulk Package
|Unit of Sale||Intermediate Multi-Pack||Each|
(Vial 1 and Vial 2)
|NDC 61703-423-83||NDC 61703-423-78||Vial 1: NDC 61703-423-73|
Vial 2: NDC 61703-423-93
|Case of 2 Boxes of 10 vials|
(5 vial 1 and 5 vial 2)
|Box of 10 vials|
(5 Vial 1 and 5 Vial 2)
|50 mL (Vial 1 and Vial 2) multiple dose vial|
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)].
Instruct patients (if age appropriate) and caregivers: