Cernevit Special Precautions

Hepatic Effects: Monitoring of liver function parameters is recommended in patients receiving Cernevit. Particularly close monitoring is recommended in patients with hepatic jaundice or other evidence of cholestasis.
In patients receiving Cernevit, instances of liver enzyme increases have been reported, including isolated alanine aminotransferase (ALT) increases in patients with inflammatory bowel disease.
In addition, an increase in bile acid levels have been reported in patients receiving Cernevit.
Hepatobiliary disorders including cholestasis, hepatic steatosis, fibrosis and cirrhosis, possibly leading to hepatic failure, as well as cholecystitis and cholelithiasis are known to develop in some patients on parenteral nutrition (including vitamin supplemented parenteral nutrition). The etiology of these disorders is thought to be multifactorial and may differ between patients. Patients developing abnormal laboratory parameters or other signs of hepatobiliary disorders should be assessed early by a clinician knowledgeable in liver diseases in order to identify possible causative and contributory factors, and possible therapeutic and prophylactic interventions.
Use in Patients with Impaired Hepatic Function: Patients with hepatic impairment may need individualized vitamin supplementation. Particular attention should be placed on preventing vitamin A toxicity, because the presence of liver disease is associated with increased susceptibility to vitamin A toxicity, in particular in combination with chronic excessive alcohol consumption (See also Hypervitaminosis A under Warnings and Hepatic Effects as previously mentioned).
Use in Patients with Impaired Renal Function: Patients with renal impairment may need individualized vitamin supplementation, depending on the degree of renal impairment and the presence of concomitant medical conditions. In patients with severe renal impairment, particular attention should be placed on maintaining adequate vitamin D status and preventing vitamin A toxicity, which may develop in such patients with low-dose vitamin A supplementation or even without supplementation.
Pyridoxine (vitamin B6) hypervitaminosis and toxicity (peripheral neuropathy, involuntary movements) have been reported in patients on chronic hemodialysis receiving intravenous multivitamins containing 4 mg pyridoxine administered three times a week.
General Monitoring: Clinical status and vitamin levels should be monitored in patients receiving parenteral multivitamins as the only source of vitamins for extended periods of time. It is particularly important to monitor for adequate supplementation of, for example: Vitamin A in patients with pressure ulcers, wounds, burns, short bowel syndrome or cystic fibrosis;
Vitamin B1 in dialysis patients;
Vitamin B2 in cancer patients;
Vitamin B6 in patients with renal impairment;
Individual vitamins whose requirements may be increased due to interactions with other medicines.
Deficiency of one or more vitamins must be corrected by specific supplementation.
Vitamin K: Cernevit does not contain vitamin K, which should be administered separately if necessary.
Use in Patients with Vitamin B12 Deficiency: Evaluation of vitamin B12 status is recommended before starting supplementation with Cernevit in patients at risk for vitamin B12 deficiency and/or when supplementation with Cernevit over several weeks is planned.
After several days of administration, both the individual amounts of cyanocobalamin (vitamin B12) and folic acid in Cernevit may be sufficient to result in an increase in red blood cell count, reticulocyte count, and hemoglobin values in some patients with vitamin B12 deficiency-associated megaloblastic anemia. This may be masking an existing vitamin B12 deficiency. Effective treatment of vitamin B12 deficiency requires higher doses of cyanocobalamin than provided in Cernevit.
Folic acid supplementation in patients with vitamin B12 deficiency, who do not also receive vitamin B12, does not prevent the development or progression of neurologic manifestations associated with the vitamin B12 deficiency. It has been suggested that neurologic deterioration may even be accelerated.
When interpreting levels of vitamin B12, it should be taken into account that recent intake of vitamin B12 may result in normal levels despite a tissue deficiency.
Laboratory Test Interferences: Depending on the reagents used, the presence of ascorbic acid in blood and urine may cause false high or low glucose readings in some urine and blood glucose testing systems, including test strips and handheld glucose meters. The technical information for any laboratory test should be consulted to determine the potential interference from vitamins.
Biotin may interfere with laboratory tests that are based on a biotin/streptavidin interaction including tests used in emergency situations. The interference may result in either falsely decreased or falsely increased test results, depending on the assay. The risk of interference is higher in children and patients with renal impairment and increases with higher doses. Cases of interference with laboratory tests based on a biotin/streptavidin interaction have been reported in adults receiving high daily biotin oral doses of 5 to 300 mg. The recommended daily dose of Cernevit contains a dose of 69 μg biotin and thus, there is minimal risk for laboratory interference when Cernevit is administered as part of a parenteral nutrition infusion over 12-24 hours. However, biotin plasma concentrations that interfere with certain assays may be reached in some patients e.g. when the daily dose is administered as a bolus injection over 10 minutes (see Dosage & Administration), in patients of low weight, and when Cernevit is administered over 12 to 24 hours to children or to patients with renal impairment.
When interpreting results of laboratory tests, possible biotin interference must be taken into consideration, especially if lack of coherence with the clinical presentation is observed (e.g. inaccurate thyroid test results mimicking Grave's disease in asymptomatic patients or falsely low troponin T test results in patients with myocardial infarction). Consult laboratory personnel for alternative tests in cases where biotin interference is suspected.
Effects on Ability to Drive and Use Machines: There is no information on the effects of CERNEVIT on the ability to operate an automobile or other heavy machinery.
Use in Pregnancy & Lactation: The use of Cernevit has not been studied in human pregnancy. Experimental animal studies are insufficient to assess the safety with respect to the development of the embryo or foetus, the course of gestation, and peri and post-natal development. It is recommended, therefore, that this product should not be used in pregnancy. Since vitamins are known to be excreted in breast milk, this product should also not be used in women who are breast feeding.