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CERNEVIT is a brand name for D-Biotin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Supply of vitamins corresponding to the daily needs of adults and children over 11 years requiring multi-vitamin supplementation by the parenteral route when oral nutrition is contraindicated, impossible or insufficient (e.g. due to malnutrition, gastrointestinal malabsorption, parenteral nutrition, etc).
Verbatim from this product's MHRA label. Tap a section to expand.
Dosage Adults and children aged over 11 years : 1 vial/day. 6, Instruction for use and handling. 9% sodium chloride solution for infusion. Cernevit may be included in the composition of nutritive mixtures combining carbohydrates, lipids, amino acids and electrolytes provided that compatibility and stability have been confirmed for each nutritive mixture, to meet nutrient needs and prevent deficiencies and complications from developing.
5) should be considered. The patient’s clinical status and vitamin levels should be monitored to ensure maintenance of adequate levels. , direct or indirect sun light). In addition, loss of vitamins A, B1, C, and E may increase with higher levels of oxygen in the solution.
These factors should be considered if adequate vitamin levels are not achieved.
Adverse drug reactions (ADRs) that occurred after administration of Cernevit are presented with their relative frequencies; these include ADRs documented in clinical trials and those from post-marketing reports. Cernevit was administered during 3 clinical trials to 267 adult patients requiring a parenteral vitamin supplement.
Frequencies of ARs are reported, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10000 to <1/1000); very rare (<1/10000); and unknown (cannot be estimated from the available data).
, burning sensation, rash Common Unknown Unknown Unknown 1 The frequency either cannot be determined or the overall number of patients in the individual studies is too small to permit a valid estimation of frequency. 2 No symptoms of hypervitaminosis A were reported 3 Elevated plasma vitamin A levels have been reported in 8 of 20 patients receiving Cernevit in parenteral nutrition at day 45 of administration.
6 μmol/L). In addition, an average increase in retinol binding protein (RBP) was also identified. A maximum observed RBP value of 60 mg/L at day 90 (normal values: 30 to 50 mg/L), was reported. 4 Isolated alanine aminotransferase increases was reported in the presence of inflammatory bowel disease.
Cernevit was administered by intravenous injection in the absence of parenteral nutrition. 5 An increase in total and individual bile acids including glycocholic acid has been reported to develop early in the course of parenteral nutrition administration in patients receiving Cernevit.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme.
WARNINGS
Hypersensitivity Reactions • Severe systemic hypersensitivity reactions have been reported with Cernevit, other multivitamin preparations, and individual vitamins (including B1, B2, B12 and folic acid). 8). • 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. 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. , 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.
1, including soy protein/products (lecithin in mixed micelle is soy-derived) or peanut protein/products, - hypervitaminosis from any vitamin contained in this formulation
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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. 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.
8). 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 and Hepatic Effects above).
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 […]