Sign Out
Hypersensitivity Reactions: Severe systemic hypersensitivity reactions have been reported with Cernevit, other multivitamin preparations, and individual vitamins (including B1, B2, B12 and folic acid). Reactions with fatal outcome have been reported with Cernevit and other parenteral vitamin products (see Adverse Reactions).
Cross-allergic reactions between soybean and peanut proteins have been observed.
In some cases, the manifestations of a hypersensitivity reaction during intravenous administration of multivitamins may be rate related. If infused intravenously, Cernevit should be administered slowly. If injected intravenously, the injection must be administered slowly (over at least 10 minutes).
The infusion or injection must be stopped immediately if signs or symptoms of a hypersensitivity reaction develop.
Mild allergic reactions such as sneezing or mild asthma are warning signs that a further injection may give rise to anaphylactic shock.
Vitamin Toxicity: The patient's clinical status and blood vitamin concentrations should be monitored to avoid overdose and toxic effects, especially with vitamins A, D and E, and in particular in patients who receive additional vitamins from other sources or use other agents that increase the risk of vitamin toxicity.
Monitoring is particularly important in patients receiving long-term supplementation.
Hypervitaminosis A: The risk for hypervitaminosis A and vitamin A toxicity (e.g., skin and bone abnormalities, diplopia, cirrhosis) is increased in, for example: patients with protein malnutrition, patients with renal impairment (even in the absence of vitamin A supplementation), patients with hepatic impairment, patients with small body size (e.g., paediatric patients), and patients on chronic therapy.
Acute hepatic disease in patients with saturated hepatic vitamin A stores can lead to the manifestation of vitamin A toxicity.
Refeeding Syndrome in Patients Receiving Parenteral Nutrition: Refeeding severely undernourished patients may result in refeeding syndrome that is characterized by the shift of potassium, phosphorus, and magnesium intracellularly as the patient becomes anabolic. Thiamine deficiency and fluid retention may also develop. Careful monitoring and slowly increasing nutrient intakes while avoiding overfeeding can prevent these complications. Should nutrient deficiencies occur, appropriate supplementation may be warranted.
Precipitates in Patients Receiving Parenteral Nutrition: Pulmonary vascular precipitates have been reported in patients receiving parenteral nutrition. In some cases, fatal outcomes have occurred. Excessive addition of calcium and phosphate increases the risk of the formation of calcium phosphate precipitates. Precipitates have been reported even in the absence of phosphate salt in the solution. Precipitation distal to the in-line filter and suspected precipitate formation in the blood stream have also been reported.
In addition to inspection of the solution, the infusion set and catheter should also periodically be checked for precipitates.
If signs of pulmonary distress occur, the infusion should be stopped and medical evaluation initiated.
