M.V.I. Adult

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.

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 1000 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 1000 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 the vitamin infusion. In such circumstances, admixture or Y-site administration with vitamin solutions should be avoided.

3 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)].

4 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.

5 WARNINGS AND PRECAUTIONS

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.

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