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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 (see Adverse Reactions).
In addition, an increase in bile acid levels (total and individual bile acids including glycocholic acid) 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 haemodialysis 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 (see Interactions).
Deficiency of one or more vitamins must be corrected by specific supplementation.
Vitamin K: Cernevit does not contain Vitamin K. Vitamin K must 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 haemoglobin values in some patients with vitamin B12 deficiency-associated megaloblastic anaemia. 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: Biotin: Biotin may interfere with laboratory tests that are based on a biotin/streptavidin interaction, leading to 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. When interpreting results of laboratory tests, possible biotin interference has to be taken into consideration, especially if a lack of coherence with the clinical presentation is observed (e.g. thyroid test results mimicking Graves' disease in asymptomatic patients taking biotin or false negative troponin test results in patients with myocardial infarction taking biotin). Alternative tests not susceptible to biotin interference should be used, if available, in cases where interference is suspected. The laboratory personnel should be consulted when ordering laboratory tests in patients taking biotin.
Ascorbic acid: 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.
Sodium Content: Cernevit contains 24 mg sodium (1 mmoL) per vial. This should be taken into consideration if patients are on a controlled sodium diet.
Effects on the 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 Children: Cernevit is indicated in paediatric patients over 11 years of age (see also Hypervitaminosis A under Warnings).
Use in the Elderly: In general, dosage adjustments for an elderly patient should be considered (reducing the dose and/or extending the dosing intervals) reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or drug therapy.
