Multi Vitamin Infusion M.V.I. Adult
Name: Multi Vitamin Infusion M.V.I. Adult
Dosage Forms and Strengths
M.V.I.-Adult™ single dose is an injection consisting of two vials labeled Vial 1 and Vial 2. 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)].
M.V.I.-Adult™ pharmacy bulk package is an injection consisting of two vials labeled Vial 1 and Vial 2. 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) and Description (11)].
Contraindications
M.V.I.-Adult™ is contraindicated in patients who have:
• A history of hypersensitivity to any of the vitamins or excipients contained in this formulation, or • An existing hypervitaminosis.Use in specific populations
Pregnancy
Pregnancy Category C
M.V.I.-Adult™ 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. Animal reproduction studies have not been conducted with M.V.I-Adult (Multi-Vitamin Injection) administered by intravenous infusion.
Nursing Mothers
M.V.I.-Adult™ has not been studied in lactating women. Lactating women may have vitamin requirements that exceed those of nonlactating woman. Caution should be exercised when M.V.I.-Adult™ is administered to a nursing woman.
Pediatric Use
M.V.I.-Adult™ has not been studied in children below the age of 11 years.
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)].
Hepatic Impairment
M.V.I.-Adult™ has not been studied in patients with hepatic impairment. Monitor vitamin A level in patients with liver disease, high alcohol consumption [see Warnings and Precautions (5.5)].
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.
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 | NDC 61703-434-01 Box of 2 vials | NDC 61703-426-02 10 Vitamin Blend, | NDC 61703-430-02 3 Vitamin Blend, |
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 | NDC 61703-422-78 Box of 10 vials | NDC 61703-426-01 10 Vitamin Blend, | NDC 61703-430-01 3 Vitamin Blend, |
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).
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, Inc., Lake Forest, IL 60045 USA