M.V.I. ADULT- retinol, ergocalciferol, .alpha.-tocopherol acetate, dl-, phytonadione, 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. ADULT™ safely and effectively. See full prescribing information for M.V.I. ADULT.
M.V.I. ADULT (multiple vitamins injection), for intravenous use
Initial U.S. Approval: 2004
INDICATIONS AND USAGE
M.V.I. Adult is a combination of vitamins indicated for prevention of vitamin deficiency in adults and pediatric patients aged 11 years and above receiving parenteral nutrition. (1)
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
WARNINGS AND PRECAUTIONS
Effect of M.V.I. Adult on other drugs:
Effects of other drugs on M.V.I. Adult:
USE IN SPECIFIC POPULATIONS
See 17 for PATIENT COUNSELING INFORMATION.
FULL PRESCRIBING INFORMATION: CONTENTS*
M.V.I. Adult™ is a combination of vitamins indicated for the prevention of vitamin deficiency in adults and pediatric patients aged 11 years and above receiving parenteral nutrition.
The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy.
M.V.I. Adult is a combination product that contains the following vitamins: ascorbic acid, vitamin A, vitamin D, thiamine, riboflavin, pyridoxine, niacinamide, dexpanthenol, vitamin E, vitamin K, folic acid, biotin, and vitamin B12.
M.V.I. Adult is supplied as a single dose or as a pharmacy bulk package for intravenous use intended for administration by intravenous infusion after dilution:
Do not administer M.V.I. Adult 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.
M.V.I. Adult supplied as a single dose:
M.V.I. Adult supplied as a pharmacy bulk package:
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. Adult is an injection available as a:
See Description section for vitamin strengths [see Description (11)].
M.V.I. Adult is contraindicated in patients who have:
M.V.I. Adult contains Vitamin K which may decrease the anticoagulant effect of warfarin. In patients who are on warfarin anticoagulant therapy receiving M.V.I. Adult, prothrombin time/INR should be periodically monitored to determine if the dose of warfarin needs to be adjusted.
M.V.I. Adult 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. Adult.
Vitamin A may adhere to plastic, resulting in lower vitamin A concentrations after administration of M.V.I. Adult. 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. Adult. There have been rare reports of anaphylaxis following intravenous doses of thiamine. No fatal anaphylaxis reactions associated with M.V.I. Adult 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. Adult, should be undertaken with caution [see Use in Specific Populations (8.6, 8.7)]. Blood levels of Vitamin A should be monitored periodically.
M.V.I. Adult contains folic acid and cyanocobalamin which can mask serum deficits of folic acid and cyanocobalamin in patients with megaloblastic anemia. Avoid the use of M.V.I. Adult in patients with suspected or diagnosed megaloblastic anemia prior to blood sampling for the detection of the folic acid and cyanocobalamin deficiencies.
In patients receiving parenteral multivitamins, such as with M.V.I. Adult, blood vitamin concentrations should be periodically monitored to determine if vitamin deficiencies or excesses are developing. M.V.I. Adult 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 have been identified during post approval use of M.V.I. Adult. Because these reactions are 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.
Methotrexate: Folic acid may decrease a patient's response to methotrexate therapy.
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.
Bleomycin: Ascorbic acid and riboflavin inactivate bleomycin in vitro, thus the activity of bleomycin may be reduced.
Administration of the approved recommended dose of M.V.I. Adult in parenteral nutrition is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. Pregnant women should follow the U.S. Recommended Daily Allowances for pregnancy because their vitamin requirements may exceed those of nonpregnant women. Deficiency of essential vitamins may result in adverse pregnancy outcomes (see Clinical Considerations). Animal reproduction studies have not been conducted with M.V.I. Adult administered by intravenous infusion.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Disease-Associated Maternal and/or Embryo/Fetal Risk
Deficiency of essential vitamins has been associated with adverse pregnancy and fetal outcomes, such as maternal folic acid deficiency and an increased risk of neural tube defects. Therefore, parental nutrition with multiple vitamins injection should be considered if a pregnant woman's nutritional requirements cannot be fulfilled by oral or enteral intake.
Multiple vitamins present in M.V.I. Adult are also present in human milk. Administration of the approved recommended dose of M.V.I. Adult in parenteral nutrition is not expected to cause harm to a breastfed infant. There is no information on the effects of M.V.I. Adult on milk production. Lactating women should follow the U.S. Recommended Daily Allowances for their condition, because their vitamin requirements may exceed those of nonlactating women. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for M.V.I. Adult and any potential adverse effects on the breastfed child from M.V.I. Adult or from the underlying maternal condition.
M.V.I. Adult is indicated for the prevention of vitamin deficiency in pediatric patients aged 11 years and older receiving parenteral nutrition. M.V.I. Adult is not indicated for use in pediatric patients below the age of 11 years.
Reported clinical experience has not identified differences in responses between the elderly and younger patients.
M.V.I. Adult 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 (5.2, 5.5)].
M.V.I. Adult has not been studied in patients with hepatic impairment. Monitor vitamin A level in patients with liver disease or high alcohol consumption [see Warnings and Precautions (5.5)].
Signs and symptoms of acute or chronic overdosage may be those of individual M.V.I. Adult component toxicity. There is no clinical experience with M.V.I. Adult overdosage.
M.V.I. Adult (multiple vitamins injection) is a sterile product consisting of two vials provided as a single dose or as a pharmacy bulk package for intravenous use intended for administration by intravenous infusion after dilution.
Table 1 provides the strengths of the vitamins provided in vial 1 and vial 2:
Fat Soluble Vitamins**
Amount per Unit Dose
Vitamin A (retinol)
Vitamin D (ergocalciferol)
Vitamin E (dl-alpha-tocopheryl acetate)
Vitamin K (phytonadione)
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.
* With 30% propylene glycol; and citric acid, sodium citrate, and sodium hydroxide for pH adjustment.
Multiple vitamin preparation for intravenous infusion:
M.V.I. Adult (multiple vitamins 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, E, and K have been solubilized in an aqueous medium with polysorbate 80, permitting intravenous administration of these vitamins.
M.V.I. ADULT is an injection supplied in the following package configurations:
M.V.I. ADULT Single-Dose
|Unit of Sale||Each Box||Each Vial 1||Each Vial 2|
|NDC 61703-434-82||NDC 61703-434-01||NDC 61703-426-02||NDC 61703-430-02|
|Bundle of 10 Boxes of 2 vials (Vial 1 and Vial 2)||Box of 2 vials (Vial 1 and Vial 2)||10 Vitamin Blend, 5 mL||3 Vitamin Blend, 5 mL|
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 a single 10 mL dose [see Dosage and Administration (2.3)].
M.V.I. ADULT Pharmacy Bulk Package
|Unit of Sale||Intermediate Multi-Pack||Each Vial 1||Each Vial 2|
|NDC 61703-422-83||NDC 61703-422-78||NDC 61703-426-01||NDC 61703-430-01|
|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)||10 Vitamin Blend, 50 mL||3 Vitamin Blend, 50 mL|
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)].
See Description section for vitamin strengths [see Description (11)].
Minimize the exposure of M.V.I. Adult to light, because vitamins A, D and riboflavin are light sensitive.
Store at 2-8°C (36-46°F).
Instruct patients (if age appropriate) and caregivers:
Distributed by Hospira, Inc., Lake Forest, IL 60045 USA