M-V-I-12

M.V.I.-12 (Multivitamin Infusion)

Rhône-Poulenc Rorer

Multivitamins

Vitamin Supplement

Indications And Clinical Uses: This formulation is indicated as daily multivitamin maintenance dosage for adults and children aged 11 and above receiving parenteral nutrition.

It is also indicated in other situations where administration by the i.v. route is required.

Such situations include surgery, (including pre- and post-operative parenteral nutrition), 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.

The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy. The use of multivitamin product eliminates the need to speculate on the status of individual vitamin levels.

M.V.I.-12 (administered in i.v. fluids after proper dilution) contributes to the intake of these necessary vitamins toward maintaining the body’s normal resistance and repair processes.

Patients with multiple vitamin deficiencies or with markedly increased requirements may be given multiples of the daily dosage for 2 or more days as indicated by the clinical status.

M.V.I.-12 does not contain vitamin K, which may have to be administered separately.

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. No vitamin deficiencies were clinically evident, but blood levels of vitamins A, C, D and folic acid declined in a number of subjects who received this formulation as the only vitamin source for 4 to 6 months. Therefore, in patients for whom total parenteral nutrition will be continued for long periods of time, these vitamins should be monitored. If deficiencies appear to be developing, multiples of the formulation (1.5 to 3 times) may be needed for a period of time. When multiples of the formulation are used for more than a few weeks, vitamins A and D should be monitored occasionally to be certain that an excess accumulation of these vitamins is not occurring.

Contra-Indications: Known hypersensitivity to any of the vitamins contained in this product or pre-existing hypervitaminosis.

Precautions: Drug Interactions : M.V.I.-12 is not physically compatible with acetazolamide 500 mg, i.v. sodium chlorothiazide 500 mg, or moderately alkaline solutions. Tetracycline 500 mg may not be physically compatible with M.V.I.-12. It has been reported that folic acid is unstable in the presence of calcium salts such as calcium gluconate. Some of the vitamins in M.V.I.-12 may react with vitamin K bisulfite. Direct addition of M.V.I.-12 to i.v. fat emulsions is not recommended.

Adverse Reactions: There have been rare reports of anaphylactoid reactions following large i.v. doses of thiamine. The risk, however, is negligible if thiamine is co-administered with other vitamins in the B group. There have been no reports of fatal anaphylactoid reactions associated with M.V.I.-12.

There have been rare reports of the following types of reactions: Dermatologic: rash, erythema, pruritus.

CNS: headache, dizziness, agitation, anxiety.

Ophthalmic: diplopia.

Allergic: urticaria, periorbital and digital edema.

Dosage And Administration: M.V.I.-12 in the two-vial package is ready for immediate use in the adults and children aged 11 and above, when added to i.v. infusion fluids.

M.V.I.-12 should not be given as a direct, undiluted i.v. injection as it may give rise to dizziness, faintness, and possible tissue irritation.

For i.v. feeding, 1 daily dose of M.V.I.-12 (5 mL of vial 1 plus 5 mL of vial 2) should be added directly to not less than 500 mL, preferably 1 000 mL, of i.v. 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.

Storage: Keep the unopened vials in the refrigerator (2 to 8°C).

After M.V.I.-12 is diluted in an i.v. infusion, the resulting solution should be refrigerated unless it is to be administered immediately, and in any event should be stored in glass and administered within 48 hours. Some of the vitamins in this product, particularly vitamins A, D and riboflavin, are light-sensitive, and exposure to light should be minimized.

Availability And Storage: Each sterile, single dose package contains: one 5 mL vial (labelled Vial 1 ) and one 5 mL vial (labelled Vial 2 ) which after mixing, provide 1 dose of 10 mL. Boxes of 10.

Vial 1: Each mL provides ascorbic acid 20 mg, vitamin A 660 IU, vitamin D 40 IU, thiamine (as HCl) 0.6 mg, riboflavin (as phosphate) 0.72 mg, pyridoxine HCl 0.8 mg, niacinamide 8 mg, d-pantothenic acid (as d-panthenol) 3 mg and vitamin E 2.0 IU. Nonmedicinal ingredients: alkali oil, gentisic acid ethanolamide, polysorbate 80, propylene glycol and water for injection.

Vial 2: Each mL provides biotin 12 µg, folic acid 0.08 mg and vitamin B12 1 µg. Nonmedicinal ingredients: alkali oil, citric acid, propylene glycol, sodium citrate and water for injection.

M.V.I.-12 (Multivitamin Infusion) Rh´ne-Poulenc Rorer Multivitamins Vitamin Supplement

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