General Information

Cernevit-12 (multivitamins for infusion) is a lyophilized, sterile powder containing both water soluble and fat soluble vitamins (except Vitamin K) combined with mixed micelles (glycocholic acid and lecithin) in a single-dose amber glass vial intended for intravenous infusion following reconstitution and further dilution.

This formulation is indicated as a 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.

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

This product (administered in intravenous fluids under proper dilution) contributes intake of these necessary vitamins, except Vitamin K, 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 two or more days as indicated by the clinical status.

Clinical Results

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.. Although there was no clinical evidence of vitamin deficiency or toxicity, blood levels of Vitamin E and 1,25-OH Vitamin D were low and Vitamin A levels were high in a number of subjects who received this formulation as the only source of vitamins for 3 months. In addition, blood levels of Vitamin C, thiamine and folic acid declined or were low normal in some subjects who received a similar 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, serum levels of 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.

Side Effects

Anaphylactic reactions have been reported following large intravenous doses of thiamine. There have been very rare reports of anaphylactic reactions following IV injection of Cernevit-12 (multivitamins for infusion) over 1-4 minutes. Urticaria and rash have also been associated with Cernevit-12 (multivitamins for infusion).

Mechanism of Action

Dosage and Administration

The single-dose vial of Cernevit-12 (multivitamins for infusion) is reconstituted by adding 5 mL of Sterile Water for Injection into the vial and gently mixing to dissolve the lyophilized powder. The resultant solution should be administered by intravenous infusion. After reconstitution, Cernevit-12 (multivitamins for infusion) should be used immediately or stored under refrigeration for no more than 24 hours. To minimize vitamin losses in parenteral nutrition admixtures, add the vitamins immediately prior to administration and complete administration within 24 hours. Discard any unused portion. Many parenteral vitamins are light sensitive and exposure to light should be minimized. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Use of a final filter is recommended during administration of all parenteral solutions where possible.

Literature References

• Shils ME, Baker H, Frank O. Blood vitamin levels of long-term adult home total parenteral nutrition patients: the efficacy of the AMA-FDA parenteral multivitamin formulation. J Paren Enteral Nutr. 1985;9(2):179-88.
• Guentert TW, Oie S, Paalzow L, et al. Interaction of mixed micelles formed from glycocholic acid and lecithin with the protein binding of various drugs. Br. J Clin Pharmac. 1987;23:569-77.
• Wood M. Plasma drug binding: implications for anesthesiologists. Anesth. Analg. 1986;65:786-804.
• Kremer JM, Wilting J, Janssen LH. Drug binding to human alpha-1-acid glycoprotein in health and disease. Pharmacol Rev. 1988;40(1):1-47.
• Smith JL, Canham JE, Wells PA. Effect of phototherapy light, sodium bisulfite, and pH on vitamin stability in total parenteral nutrition admixtures. J Paren Enteral Nutr. 1988;12(4):394-402.
• Multivitamin preparations for parenteral use a statement by the Nutrition Advisory Group. J Paren Enteral Nutr. 1979;3(4):258-62.