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
Hospira Worldwide, Inc.
1 INDICATIONS AND USAGE
M.V.I.-Adult™ is a combination of vitamins indicated for the prevention of vitamin deficiency in adults and children aged 11 and older receiving parenteral nutrition.
The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy.
2 DOSAGE AND ADMINISTRATION
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.
M.V.I.-Adult™ (Multi-Vitamin 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:
M.V.I.-Adult™ supplied as single dose
(a) Vial 1 (5 mL)
(b) Vial 2 (5 mL).
The mixed solution will provide a single 10 mL dose.
M.V.I.-Adult™ supplied as pharmacy bulk package
(a) Vial 1 (50 mL) (b) Vial 2 (50 mL).
The mixed solution will provide ten single doses of 10 mL each.
Each 5 mL of Vial 1 contains 10 vitamins and each 5 mL of Vial 2 contains 3 vitamins (see Table 1).