NDC 61703-422 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

NDC Product Code 61703-422

NDC CODE: 61703-422

Proprietary Name: M.v.i. Adult What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Retinol, Ergocalciferol, .alpha.-tocopherol Acetate, Dl-, Phytonadione, Ascorbic Acid, Niacinamide, Riboflavin 5-phosphate Sodium, Thiamine Hydrochloride, Pyridoxine Hydrochloride, Dexpanthenol, Biotin, Folic Acid, And Cyanocobalamin What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 61703 - Hospira, Inc.

NDC 61703-422-83

Package Description: 2 BOX in 1 CASE > 5 KIT in 1 BOX (61703-422-78) > 1 KIT in 1 KIT * 50 mL in 1 VIAL, MULTI-DOSE (61703-426-01) * 50 mL in 1 VIAL, MULTI-DOSE (61703-430-01)

NDC Product Information

M.v.i. Adult with NDC 61703-422 is a a human prescription drug product labeled by Hospira, Inc.. The generic name of M.v.i. Adult is retinol, ergocalciferol, .alpha.-tocopherol acetate, dl-, phytonadione, ascorbic acid, niacinamide, riboflavin 5-phosphate sodium, thiamine hydrochloride, pyridoxine hydrochloride, dexpanthenol, biotin, folic acid, and cyanocobalamin. The product's dosage form is kit and is administered via form.

Dosage Form: Kit - A packaged collection of related material.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • GENTISIC ACID ETHANOLAMIDE (UNII: H4E039OIGX)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Hospira, Inc.
Labeler Code: 61703
FDA Application Number: NDA021625 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 01-27-2015 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

M.v.i. Adult Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

1 Indications And Usage

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.

2.1 Important Dosage And Administration Instructions

  • 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: •M.V.I. Adult Single Dose: consists of two vials which must be mixed prior to use. The mixed solution will provide a single 10 mL dose which must be diluted prior to intravenous administration [see Dosage and Administration (2.3)]. •M.V.I. Adult 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. Adult 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. Adult as a direct, undiluted intravenous injection as it may cause dizziness, faintness, and tissue irritation.

2.2 Dosage Information

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.

2.3 Preparation And Administration Instructions

  • M.V.I. Adult supplied as a single dose: •M.V.I Adult is to be used only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area). •Transfer the contents of Vial 1 (5 mL of solution) into the contents of Vial 2 (5 mL of solution). The mixed solution (10 mL) will provide a single 10 mL dose. •Once the closure system has been penetrated, complete withdrawal of vial contents within 4 hours. Mixed solution may be stored for up to 4 hours refrigerated. •Visually inspect for particulate matter and discoloration prior to intravenous administration. •Utilizing a suitable sterile automated compounding device or dispensing pin for accuracy, aseptically transfer the 10 mL dose into a plastic or glass bottle containing at least 500 to 1,000 mL intravenous parenteral nutrition solution containing dextrose or saline. •After M.V.I. Adult is diluted in an intravenous infusion, refrigerate the resulting solution unless it is to be used immediately, and use the solution within 24 hours after dilution. •Minimize exposure to light because some of the vitamins in M.V.I. Adult, particularly A, D and riboflavin, are light sensitive. M.V.I. Adult supplied as a pharmacy bulk package: •M.V.I. Adult is to be used only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area). •Transfer the contents of Vial 1 (50 mL) into Vial 2 (50 mL). The mixed solution (100 mL) will provide ten 10 mL single doses to patients in a pharmacy admixture program. •Each bulk vial closure shall be penetrated only one time with a suitable sterile transfer device or dispensing set that allows measured dispensing of the contents. •Once the closure system has been penetrated, complete dispensing from the pharmacy bulk vial within 4 hours. Mixed solution may be stored for up to 4 hours refrigerated. •Discard unused portion. •Visually inspect for particulate matter and discoloration prior to administration. •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 to 1,000 mL intravenous parenteral nutrition solution containing dextrose or saline. •After M.V.I. Adult is diluted in an intravenous infusion, refrigerate the resulting solution unless it is to be used immediately, and use the solution within 24 hours after dilution. •Minimize exposure to light because some of the vitamins in M.V.I. Adult, particularly A, D and riboflavin, are light sensitive.

2.4 Monitoring Vitamin Blood Levels

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.

2.5 Drug Incompatibilities

  • •M.V.I. Adult 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.Adult may react with bisulfite solutions such as sodium bisulfite or vitamin K bisulfite. Do not add M.V.I. Adult directly to intravenous fat emulsions. •Consult appropriate references for listings of physical and chemical compatibility of solutions and drugs with M.V.I. Adult. In such circumstances, admixture or Y-site administration with M.V.I. Adult should be avoided.

3 Dosage Forms And Strengths

  • M.V.I. Adult is an injection available as a: •Single dose: 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 (10 mL) will provide a single 10 mL dose [see Dosage and Administration (2.3) and Description (11)]. •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)].See Description section for vitamin strengths [see Description (11)].

4 Contraindications

  • M.V.I. Adult is contraindicated in patients who have: •A history of known hypersensitivity to any of the vitamins or excipients in M.V.I. Adult [see Warnings and Precautions (5.4), Adverse Reactions (6)] •An existing hypervitaminosis

5.1 Decreased Anticoagulant Effect Of Warfarin

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.

5.2 Aluminum Toxicity

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.

5.3 Risk Of Low Vitamin A Levels

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.

5.4 Allergic Reactions To Thiamine

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.

5.5 Hypervitaminosis A

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.

5.6 Interference With Diagnosis Of Megaloblastic Anemia

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.

5.7 Potential To Develop Vitamin Deficiencies Or Excesses

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)].

5.8 Interference With Urine Glucose Testing

M.V.I. Adult contains Vitamin C which is also known as ascorbic acid. Ascorbic acid in the urine may cause false negative urine glucose determinations.

6 Adverse Reactions

  • The following adverse reactions are discussed in greater detail in other section of the labeling. •Allergic Reactions to Thiamine [see Warnings and Precautions (5.4)]. •Hypervitaminosis A [see Warnings and Precautions (5.5)].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, pruritusCNS: headache, dizziness, agitation, anxietyOphthalmic: diplopia

7.1 Effect Of M.V.I. Adult On Other Drugs

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.

7.2 Effect Of Other Drugs On M.V.I. Adult

Hydralazine or Isoniazid: Concomitant administration of hydralazine or isoniazid may increase pyridoxine requirements. Phenytoin:Phenytoin may decrease serum folic acid concentrations.

Other

Risk SummaryAdministration 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.

Clinical Considerations

Disease-Associated Maternal and/or Embryo/Fetal RiskDeficiency 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.

Risk SummaryMultiple 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.

8.4 Pediatric Use

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.

8.5 Geriatric Use

Reported clinical experience has not identified differences in responses between the elderly and younger patients.

8.6 Renal Impairment

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)].

8.7 Hepatic Impairment

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)].

10 Overdosage

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.

11 Description

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:Table 1: M.V.I. ADULT FORMULATION (INTENDED FOR AGES 11 AND OLDER)Vial 1*Fat Soluble Vitamins**IngredientAmount per Unit DoseVitamin A (retinol)1 mgaVitamin D (ergocalciferol)5 mcgbVitamin E (dl-alpha-tocopheryl acetate)10 mgcVitamin K (phytonadione)150 mcgWater Soluble VitaminsVitamin C (ascorbic acid)200 mgNiacinamide40 mgVitamin B2 (as riboflavin 5-phosphate sodium)3.6 mgVitamin B1 (thiamine)6 mgVitamin B6 (pyridoxine HCl)6 mgDexpanthenol (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, E and K are water solubilized with polysorbate 80.(a) 1 mg vitamin A equals 3,300 USP units.(b) 5 mcg ergocalciferol equals 200 USP units.(c) 10 mg vitamin E equals 10 USP units.Vial 2*Biotin60 mcgFolic acid600 mcgB12 (cyanocobalamin)5 mcg*      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.

13.1 Carcinogenesis, Mutagenesis, Impairment Of Fertility

Carcinogenicity, mutagenicity and fertility studies were not performed.

16 How Supplied/Storage And Handling

M.V.I. ADULT is an injection supplied in the following package configurations:M.V.I. ADULT Single-DoseUnit of SaleEach BoxEach Vial 1Each Vial 2NDC 61703-434-82NDC 61703-434-01NDC 61703-426-02NDC 61703-430-02Bundle of 10 Boxes of 2 vials (Vial 1 and Vial 2)Box of 2 vials (Vial 1 and Vial 2)10 Vitamin Blend, 5 mL3 Vitamin Blend, 5 mLVial 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 PackageUnit of SaleIntermediate Multi-PackEach Vial 1Each Vial 2NDC 61703-422-83NDC 61703-422-78NDC 61703-426-01NDC 61703-430-01Case 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 mL3 Vitamin Blend, 50 mLVial 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).

17 Patient Counseling Information

  • Instruct patients (if age appropriate) and caregivers: •To watch for and immediately report signs of allergic reactions (i.e. urticaria, periorbital and digital edema). •To watch for and immediately report signs of hypervitaminosis A, manifested by nausea, vomiting, headache, dizziness, blurred vision, if patients have renal impairment. •To report other adverse reactions such as rash, erythema, pruritus, headache, dizziness, agitation, anxiety, and diplopia. •That patients on warfarin anticoagulant therapy will be monitored periodically for blood prothrombin/ INR levels to determine if the dose of warfarin needs to be adjusted. •About the significance of periodic monitoring of blood vitamin concentrations to determine if vitamin deficiencies or excesses are developing. •About the need to monitor renal function, calcium, phosphorus, aluminum, and vitamin A levels in patients with renal impairment.Distributed by Hospira, Inc., Lake Forest, IL 60045 USALAB-0989-3.0

* Please review the disclaimer below.