The following information is obtained from various newswires,
published medical journal articles, and medical conference presentations.
Company: Baxter Healthcare
Approval Status: Approved April 1999.
Treatment for: Diet/Nutrition
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.
