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Multi Vitamin Concentrate

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MVI

INDICATIONS

Adults and Children Aged 11 and Above: This formulation is indicated as daily multivitamin maintenance dosage for adults and children aged 11 years and above receiving parenteral nutrition. It is also indicated in other situations where administration by the intravenous route is required. Such situations include surgery, extensive burns, fractures and other trauma, severe infectious diseases, and comatose states, which may provoke a “stress” situation with profound alterations in the body's metabolic demands and consequent tissue depletion of nutrients. M.V.I. Adult (administered in intravenous fluids under proper dilution) contributes toward the intake of these vitamins that are necessary toward maintaining the body's normal resistance and repair processes.

The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy.

Patients with multiple vitamin deficiencies or with markedly increased requirements may be given multiples of the daily dosage for two or more days as indicated by the clinical status. Clinical testing indicates that some patients do not maintain adequate levels of certain vitamins when this formulation in recommended amounts is the sole source of vitamins.

DOSAGE AND ADMINISTRATION

M.V.I. Adult is ready for immediate use in adults and children aged 11 years and above when added to intravenous infusion fluids.

Directions for Dual Vial: Dilute the contents of Vial 1 (5mL) and the contents of Vial 2 (5mL) in not less than 500 mL infusion fluid, both vials to be used for a single dose. The Vial 1 and Vial 2 container closures may be penetrated only one time, utilizing a suitable sterile transfer device or dispensing set, which allows measured distribution of the contents.

The withdrawal of container contents should be accomplished without delay. The solution should be administered within 4 hours after dilution.

Use of this product is restric ted to a suitable work area, such as a laminar flow hood.

M.V.I. Adult should not be given as a direct, undiluted intravenous injection as it may give rise to dizziness, faintness, and possible tissue irritation.

Directions for Unit-Vial: Remove the protective plastic cap, turn the plunger-stopper 90 ° and press down firmly to force liquid in the upper chamber and the center seal into the lower compartment. Gently agitate to mix solution. Sterilize the rubber stopper in the usual manner and insert needle squarely through the center of the plunger-stopper until tip is just visible. Vial should be mixed just prior to use. Invert vial and withdraw a 10mL dose in the usual manner. The mixed solution is ready for dilution in not less than 500mL of infusion fluid. M.V.I. Adult should not be given as a direct, undiluted intravenous injection as it may give rise to dizziness, faintness, and possible tissue irritation.

Dual Vial

For intravenous feeding, one daily dose of M.V.I. Adult (5 mL of Vial 1 plus 5 mL of Vial 2) added directly to not less than 500 mL, preferably 1,000 mL, of intravenous dextrose, saline or similar infusion solutions.

Unit-Vial

For intravenous feeding, one daily dose of M.V.I. Adult (10 mL) added directly to not less than 500 mL, pre ferably 1,000 mL, of intravenous dextrose, saline or similar infusion solutions.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

After M.V.I. Adult is diluted in an intravenous infusion, the resulting solution is ready for immediate use. Some of the vitamins in this product, particularly A and D and riboflavin, are light sensitive, and exposure to light should be minimized.

Store at 2–8°C (36-46°F).

HOW SUPPLIED

M.V.I. Adult — NDC 66591-84-32 Boxes of 10 and cartons of 100. Each box contains two vials — Vial 1 (5 mL) and Vial 2 (5 mL), both vials to be used for a single dose.

M.V.I. Adult UNIT VIAL — NDC 66591-184-42 Boxes of 10 two-chambered 10mL vials.

M.V.I. Adult UNIT VIAL, Sterilized and Filled by: Enzon Pharmaceuticals, Inc. Indianapolis, IN 46268. Manufactured for: aaiPharma Wilmington, NC 28405. By: AstraZeneca LP. Westborough, MA. FDA revision date: 1/30/2004

Last reviewed on RxList: 12/9/2008
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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