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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 bodys 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 bodys 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.
This product 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. 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.1 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.
DOSAGE AND ADMINISTRATION
The single-dose vial of CernevitTM (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, CernevitTM (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.5 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.
Adults and Children aged 11 years and above
Adults and children aged 11 years and above should receive the contents of one vial (5 mL) per day.
CernevitTM (multivitamins for infusion) is supplied in a single-dose amber glass vial as follows:
100 vials/case 2A6736 NDC 64371-869-60
Storage Store between 4° C (39° F) 25° C (77° F). Protect from light and heat. Do not freeze.
- 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.
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
Additional Cernevit Information
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