NUTRATAIN

Posology Adults, adolescents and children aged 11 years and older: 1 vial per day Elderly The adult dose does not necessarily have to be adjusted because of age per se. 4).

Patients with hepatic and renal impairment:

Plasma levels of the vitamins should be monitored during administration and the dosage should be adjusted accordingly.

Paediatric population-Children aged under 11 years of age:

Nutratain is contraindicated in newborns, infants and children under 11 years of age.

Note:

When administering Nutratain together with other vitamin containing products, the total amount of these vitamins have to be taken into account to avoid overdose. Method of administration Intravenous use. Nutratain should be administered slowly.

6). Precaution to be taken before manipulating or administering the product Nutratain must only be used as additive to infusion solutions. 6). Only use if the reconstituted solution is clear and yellow-orange in colour.

8. The infusion or injection must be stopped immediately if signs or symptoms of a hypersensitivity reaction develop. One vial per day is intended to cover the normal daily vitamin requirements and maintenance of vitamin homeostasis.

If there are specific deficiencies of individual vitamins, individual supplementation of these vitamins is required. Additional vitamins from other sourcesneed to be taken into account to avoid overdose and toxic effects. g. patients with protein malnutrition, with renal impairment (even in the absence of vitamin A supplementation), with hepatic impairment, paediatric patients and patients on long-term treatment.

Acute hepatic disease in patients with saturated hepatic vitamin A stores can lead to the manifestation of vitamin A toxicity. Alcohol promotes hepatic vitamin A depletion and enhances vitamin A toxicity. Therefore special care needs to be taken on patients with chronic alcohol abuse.

Excessive quantities of vitamin D can cause hypercalcaemia and hypercalciuria. The risk of vitamin D toxicity is greater in patients with diseases and/or disorders that can cause hypercalcaemia and/or hypercalciuria and patients on chronic vitamin therapy.

Although extremely rare, excessive quantities of vitamin E can impair wound healing because of platelet dysfunction and disorders of blood coagulation. The risk of vitamin E toxicity is greater in patients with impaired hepatic function, patients with coagulation disorders or on oral anticoagulation therapy and patients on chronic vitamin therapy.

Folic acid and vitamin K may lead to gastrointestinal disorders, when large doses are applied. g. 5), should be noted. Clinical status and vitamin plasma levels (especially vitamins A, D and E) should be monitored regularly, especially in patients with hepatic dysfunction, renal insufficiency and patients which require long-term administration.

Patients receiving parenteral multivitamins as the only vitamin source over long periods of time should be monitored to ensure adequate supplementation. Rapid refeeding of malnourished or depleted patients may cause refeeding syndrome characterised by severe electrolyte and fluid shifts associated with metabolic complications.

Refeeding requires minerals such as phosphate and magnesium and cofactors such as thiamine. Therefore vitamin supplementation should also be started with refeeding. An adequate supply of thiamine should be provided. Due to the content of Vitamin K, the coagulation factors of the patient should be monitored regularly.

An increase in bile acid levels (total and individual bile acids including glycocholic acid) has been reported in patients receiving multivitamin supplementation. Because of the content of glycocholic acid in Nutratain, close monitoring of liver function is recommended.

g. direct or indirect sunlight). In addition, loss of, particularely vitamin A, B1, C and D can result from higher oxygen levels in the solution. These factors should be considered if sufficient vitamin levels are not achieved. General monitoring of parenteral nutrition 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).

Therefore, monitoring of liver function parameters is recommended in patient on parenteral nutrition receiving Nutratain. 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.

Patients with hepatic impairment Patients with impaired liver function may need individualised vitamin supplementation. Special attention needs to be payed to the vitamin A levels, because the presence of liver disease is associated with increased susceptibility to vitamin A toxicity, especially in patients with chronic alcohol abuse.

Because of the content of glycocholic acid, careful monitoring of the liver function is mandatory in the case of repeated or long-term administration of Nutratain. Patients with renal impairment Patients with renal impairment have a potential risk of overdose/toxicity in the pre-dialysis phase due to the decreased ability of renal excretion of excess water-soluble vitamins.

While on dialysis, the loss of vitamins, especially water-soluble vitamins, may lead to increased vitamin requirements Individualized vitamin supplementation may be needed, depending on the degree of renal impairment and the presence of comorbidities.

Special attention needs to be payed to patients with severe renal insufficiency to maintain vitamin D status and to prevent vitamin A toxicity. g. patients with short bowel syndrom, inflammatory bowel disease, use of metformin > four months, use of proton pump inhibitors or histamine H2 blockers > 12 months, vegans or strict vegetarians, and adults older than 75 years, and/or when treatment over several weeks is planned, evaluation of vitamin B12 status is recommended before starting treatment with Nutratain.

After several days of administration, the individual amounts of both cyanocobalamin (vitamin B12) and folic acid in Nutratain may be sufficient to result in an increase in red blood cell count, reticulocyte count and haemoglobin values in some […]

4. 1. 3. PHARMACEUTICAL FORM Powder for solution for infusion Yellow-orange cake or powder 4. 1 Therapeutic indications Parenteral vitamin substitution, when oral or enteral nutrition is impossible, insufficient or contraindicated. Nutratain is indicated in adults and children aged 11 years and older.

2 Posology and method of administration Posology Adults, adolescents and children aged 11 years and older: 1 vial per day Elderly The adult dose does not necessarily have to be adjusted because of age per se. 4).

Patients with hepatic and renal impairment:

Plasma levels of the vitamins should be monitored during administration and the dosage should be adjusted accordingly.

Paediatric population-Children aged under 11 years of age:

Nutratain is contraindicated in newborns, infants and children under 11 years of age.

Note:

When administering Nutratain together with other vitamin containing products, the total amount of these vitamins have to be taken into account to avoid overdose. Method of administration Intravenous use. Nutratain should be administered slowly.

6). Precaution to be taken before manipulating or administering the product Nutratain must only be used as additive to infusion solutions. 6). Only use if the reconstituted solution is clear and yellow-orange in colour. 1, including soy protein/soy products or peanut protein/peanut products.

g. ). 5). 8. The infusion or injection must be stopped immediately if signs or symptoms of a hypersensitivity reaction develop. One vial per day is intended to cover the normal daily vitamin requirements and maintenance of vitamin homeostasis.

If there are specific deficiencies of individual vitamins, individual supplementation of these vitamins is required. Additional vitamins from other sourcesneed to be taken into account to avoid overdose and toxic effects. g. patients with protein malnutrition, with renal impairment (even in the absence of vitamin A supplementation), with hepatic impairment, paediatric patients and patients on long-term treatment.

Acute hepatic disease in patients with saturated hepatic vitamin A stores can lead to the manifestation of vitamin A toxicity. Alcohol promotes hepatic vitamin A depletion and enhances vitamin A toxicity. Therefore special care needs to be taken on patients with chronic alcohol abuse.

Excessive quantities of vitamin D can cause hypercalcaemia and hypercalciuria. The risk of vitamin D toxicity is greater in patients with diseases and/or disorders that can cause hypercalcaemia and/or hypercalciuria and patients on chronic vitamin therapy.

Although extremely rare, excessive quantities of vitamin E can impair wound healing because of platelet dysfunction and disorders of blood coagulation. The risk of vitamin E toxicity is greater in patients with impaired hepatic function, patients with coagulation disorders or on oral anticoagulation therapy and patients on chronic vitamin therapy.

Folic acid and vitamin K may lead to gastrointestinal disorders, when large doses are applied. g. 5), should be noted. Clinical status and vitamin plasma levels (especially vitamins A, D and E) should be monitored regularly, especially in patients with hepatic dysfunction, renal insufficiency and patients which require long-term administration.

Patients receiving parenteral multivitamins as the only vitamin source over long periods of time should be monitored to ensure adequate supplementation. Rapid refeeding of malnourished or depleted patients may cause refeeding syndrome characterised by severe electrolyte and fluid shifts associated with metabolic complications.

Refeeding requires minerals such as phosphate and magnesium and cofactors such as thiamine. Therefore vitamin supplementation should also be started with refeeding. An adequate supply of thiamine should be provided. Due to the content of Vitamin K, the coagulation factors of the patient should be monitored regularly.

An increase in bile acid levels (total and individual bile acids including glycocholic acid) has been reported in patients receiving multivitamin supplementation. Because of the content of glycocholic acid in Nutratain, close monitoring of liver function is recommended.

g. direct or indirect sunlight). In addition, loss of, particularely vitamin A, B1, C and D can result from higher oxygen levels in the solution. These factors should be considered […]

1, including soy protein/soy products or peanut protein/peanut products. g. ). 5).