M.V.I. Adult (Page 3 of 3)

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity and fertility studies were not performed.

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

M.V.I.-ADULT™ is supplied in the following package configurations:

M.V.I.-ADULT™ SINGLE DOSE

NDC 61703-434-82. Bundle of 10 boxes. Each box contains two vials – Vial 1 (5 mL) and Vial 2 (5 mL), both vials to be used for a single 10 mL dose [see Dosage and Administration (2.3) ].

Unit of Sale

Each Box

Each

Vial 1

Each

Vial 2

NDC 61703-434-82

Bundle of 10 Boxes of 2 vials (Vial 1 and Vial 2)

NDC 61703-434-01

Box of 2 vials (Vial 1 and Vial 2)

NDC 61703-426-02

10 Vitamin Blend, 5 mL

NDC 61703-430-02

3 Vitamin Blend, 5 mL

M.V.I.-ADULT™ PHARMACY BULK PACKAGE

NDC 61703-422-83. 2 Boxes of 10 vials (5 Vial 1 and 5 Vial 2), 50 mL each. Mix contents of Vial 1 and Vial 2 to provide ten single 10 mL doses [see Dosage and Administration (2.3) ].

Unit of Sale

Intermediate

Multi-Pack

Each

Vial 1

Each

Vial 2

NDC 61703-422-83

Case of 2 Boxes of 10 vials (5 Vial 1 and 5 Vial 2)

NDC 61703-422-78

Box of 10 vials (5 Vial 1 and 5 Vial 2)

NDC 61703-426-01

10 Vitamin Blend, 50 mL

NDC 61703-430-01

3 Vitamin Blend, 50 mL

Storage and Handling

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 signs of allergic reactions (i.e. urticaria, periorbital and digital edema) to thiamine in M.V.I-Adult. Hypersensitivity reactions may occur to any of the vitamins or excipients contained in M.V.I.-Adult.
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 that patients may experience such as rash, erythema, pruritus, headache, dizziness, agitation, anxiety, and diplopia.
That the 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 and the need to monitor renal function, calcium, phosphorus, aluminum, and vitamin A levels in patients with renal impairment.

EN-3848

Manufactured by Hospira logoHospira, Inc., Lake Forest, IL 60045 USA

CA-3918 (Front)

Carton NDC 61703-422-78 (Front)
(click image for full-size original)

CA-3918 (Back)

Carton NDC 61703-422-78 (Back)
(click image for full-size original)
Carton NDC 61703-422-78 (Front)Carton NDC 61703-422-78 (Back)

CA-3917

Carton NDC 61703-434-01
(click image for full-size original)
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 kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61703-422
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61703-422-83 2 BOX in 1 CASE contains a BOX (61703-422-78)
1 NDC:61703-422-78 5 KIT in 1 BOX This package is contained within the CASE (61703-422-83) and contains a KIT
1 1 KIT in 1 KIT This package is contained within a BOX (61703-422-78) and a CASE (61703-422-83)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL, MULTI-DOSE 50 mL
Part 2 1 VIAL, MULTI-DOSE 50 mL
Part 1 of 2
RETINOL, ERGOCALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PHYTONADIONE, ASCORBIC ACID, NIACINAMIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM, THIAMINE HYDROCHLORIDE, PYRIDOXINE HYDROCHLORIDE, AND DEXPANTHENOL retinol, ergocalciferol, .alpha.-tocopherol acetate, dl-, phytonadione, ascorbic acid, niacinamide, riboflavin 5-phosphate sodium, thiamine hydrochloride, pyridoxine hydrochloride, and dexpanthenol injection, solution, concentrate
Product Information
Item Code (Source) NDC:61703-426
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RETINOL (RETINOL) RETINOL 1 mg in 5 mL
ERGOCALCIFEROL (ERGOCALCIFEROL) ERGOCALCIFEROL 5 ug in 5 mL
.ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 10 mg in 5 mL
PHYTONADIONE (PHYTONADIONE) PHYTONADIONE 150 ug in 5 mL
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 200 mg in 5 mL
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 40 mg in 5 mL
RIBOFLAVIN 5′-PHOSPHATE SODIUM (RIBOFLAVIN) RIBOFLAVIN 3.6 mg in 5 mL
THIAMINE HYDROCHLORIDE (THIAMINE ION) THIAMINE 6 mg in 5 mL
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 6 mg in 5 mL
DEXPANTHENOL (DEXPANTHENOL) DEXPANTHENOL 15 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL
GENTISIC ACID ETHANOLAMIDE
SODIUM HYDROXIDE
POLYSORBATE 80
POLYSORBATE 20
BUTYLATED HYDROXYTOLUENE
BUTYLATED HYDROXYANISOLE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61703-426-01 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021643 02/18/2004
Part 2 of 2
BIOTIN, FOLIC ACID, AND CYANOCOBALAMIN biotin, folic acid, and cyanocobalamin injection, solution, concentrate
Product Information
Item Code (Source) NDC:61703-430
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BIOTIN (BIOTIN) BIOTIN 60 ug in 5 mL
FOLIC ACID (FOLIC ACID) FOLIC ACID 600 ug in 5 mL
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 5 ug in 5 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL
CITRIC ACID MONOHYDRATE
SODIUM CITRATE
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61703-430-01 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021643 02/18/2004
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021643 02/18/2004
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 kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61703-434
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61703-434-82 10 KIT in 1 PACKAGE contains a KIT (61703-434-01)
1 NDC:61703-434-01 1 KIT in 1 KIT This package is contained within the PACKAGE (61703-434-82)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL, SINGLE-DOSE 5 mL
Part 2 1 VIAL, SINGLE-DOSE 5 mL
Part 1 of 2
RETINOL, ERGOCALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PHYTONADIONE, ASCORBIC ACID, NIACINAMIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM, THIAMINE HYDROCHLORIDE, PYRIDOXINE HYDROCHLORIDE, AND DEXPANTHENOL retinol, ergocalciferol, .alpha.-tocopherol acetate, dl-, phytonadione, ascorbic acid, niacinamide, riboflavin 5-phosphate sodium, thiamine hydrochloride, pyridoxine hydrochloride, and dexpanthenol injection, solution, concentrate
Product Information
Item Code (Source) NDC:61703-426
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RETINOL (RETINOL) RETINOL 1 mg in 5 mL
ERGOCALCIFEROL (ERGOCALCIFEROL) ERGOCALCIFEROL 5 ug in 5 mL
.ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 10 mg in 5 mL
PHYTONADIONE (PHYTONADIONE) PHYTONADIONE 150 ug in 5 mL
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 200 mg in 5 mL
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 40 mg in 5 mL
RIBOFLAVIN 5′-PHOSPHATE SODIUM (RIBOFLAVIN) RIBOFLAVIN 3.6 mg in 5 mL
THIAMINE HYDROCHLORIDE (THIAMINE ION) THIAMINE 6 mg in 5 mL
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 6 mg in 5 mL
DEXPANTHENOL (DEXPANTHENOL) DEXPANTHENOL 15 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL
GENTISIC ACID ETHANOLAMIDE
SODIUM HYDROXIDE
POLYSORBATE 80
POLYSORBATE 20
BUTYLATED HYDROXYTOLUENE
BUTYLATED HYDROXYANISOLE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61703-426-02 5 mL in 1 VIAL, SINGLE-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021625 01/30/2004
Part 2 of 2
BIOTIN, FOLIC ACID, AND CYANOCOBALAMIN biotin, folic acid, and cyanocobalamin injection, solution, concentrate
Product Information
Item Code (Source) NDC:61703-430
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BIOTIN (BIOTIN) BIOTIN 60 ug in 5 mL
FOLIC ACID (FOLIC ACID) FOLIC ACID 600 ug in 5 mL
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 5 ug in 5 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL
CITRIC ACID MONOHYDRATE
SODIUM CITRATE
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61703-430-02 5 mL in 1 VIAL, SINGLE-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021625 01/30/2004
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021625 01/30/2004
Labeler — Hospira Worldwide, Inc. (141588017)

Revised: 04/2015 Hospira Worldwide, Inc.

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