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Acetic acid, L-malic acid, Water for injections.
Supply of amino acids as part of a parenteral nutrition regimen for patients with renal failure, when oral or enteral feeding is impossible, insufficient, or contraindicated. The solution can be used for patients with acute or chronic renal failure, including patients receiving dialysis treatment. The solution can also be used for intradialytic supply of amino acids if an intradialytic parenteral nutrition therapy is indicated.
Posology: For administration as a continuous infusion.
Dosage must be adjusted for individual patient requirements.
Unless otherwise advised, in patients with acute and chronic renal failure:
Patients not receiving dialysis: 0.6 - 0.8 g AAs/kg bodyweight/day = 6 - 8 ml/kg bodyweight/day.
Patients receiving dialysis: 0.8 - 1.2 g AAs/kg bodyweight/day = 8 - 12 ml/kg bodyweight/day.
For intradialytic nutrition in patients receiving long term haemodialysis: 0.5 - 0.8 g AAs/kg bodyweight/dialysis = 5 - 8 ml/kg bodyweight/dialysis.
Maximum recommended daily dose: 0.8 - 1.2 g AAs/kg bodyweight = 8 - 12 ml/kg bodyweight, or 560 - 840 ml in a patient weighing 70 kg.
Maximum recommended infusion rates:
Parenteral nutrition: 0.1 g AAs/kg bodyweight/hour.
Intradialytic nutrition: 0.2 g AAs/kg bodyweight/hour.
Paediatric population: There is at present no clinical experience of the use of Nephrotect in children.
Method of administration: In general, amino acids should always be administered in combination with infusion solutions supplying the patient's energy requirements during parenteral nutrition.
Nephrotect can be used for total parenteral nutrition if administered in combination with energy carriers, electrolytes, vitamins, and trace elements.
For central venous infusion or in a peripheral vein if appropriately admixed with other nutrients.
Nephrotect can be administered using either separate infusion lines together with other nutritional substrates (multi-bottle/bag system), or can be mixed in one container with other solutions to give a total nutrient solution containing all components.
If Nephrotect is to be used for intradialytic nutrition, it can be injected directly into the venous drip chamber of the dialysis apparatus.
Amino acid solutions, including Nephrotect, are generally administered in combination with carbohydrates and lipids to ensure anabolic utilisation of the amino acids. An exception is the use of amino acid supplements in intradialytic nutrition, during which a dialysate containing glucose maybe used.
The duration of use depends on the clinical status of the patient.
If serum creatinine falls below 300 μmol/l, a conventional amino acid solution may be used.
The basic symptoms of overdosage or too rapid infusion of the solution may include nausea, fever, shivering, flushing, vomiting, hyperammonaemia, hyperaminoacidaemia, and acidosis. If any of these symptoms appears, the infusion should be discontinued immediately.
Hypersensitivity to the active substances or to any of the excipients listed in Description.
Inborn errors of amino acid metabolism.
Severe renal insufficiency without access to hemofiltration or dialysis.
General contraindications to infusion therapy: acute pulmonary edema, hyperhydration, decompensated cardiac insufficiency and hypotonic dehydration.
Severe liver insufficiency.
Caution should be observed in patients with hyponatraemia or elevated serum osmolarity.
It is necessary to monitor fluid balance, serum electrolyte levels, acid-base balance, serum urea and blood ammonia levels during therapy. Laboratory monitoring should also include blood glucose, serum protein, creatinine and liver function tests.
There is at present no clinical experience of the use of Nephrotect in children.
Effects on ability to drive and use machines: Not relevant.
No clinical data are available to assess the safety of Nephrotect in pregnancy and lactation. There are no studies available on reproductive and developmental toxicity in animals.
The prescriber should consider the benefit/risk relationship before administering Nephrotect to pregnant or breast feeding women.
None known if used as recommended.
Special precautions for disposal and other handling: Nephrotect should be used with sterile transfer equipment immediately after opening. Any unused solutions should be discarded.
Generally Nephrotect is given, according to therapeutical requirements, together with energy carriers, electrolytes, vitamins, and trace elements, if necessary, via a central vein (preferably continuously over 24 hours).
When used for intradialytic nutrition, Nephrotect can be infused into the venous part of the dialyzer, and so it is not necessary to place a venous line.
Chemical and physical stability data for a number of individual mixtures are available from the manufacturer upon request.
Additions should be made aseptically.
Use only clear solutions and undamaged containers. Do not draw multiple doses from one bottle.
Any unused product or waste material should be disposed of in accordance with local requirements.
Incompatibilities: Only medicinal products necessary for parenteral nutrition, such as energy carriers, electrolytes, trace elements and vitamins, for which compatibility has been documented, may be added to Nephrotect.
The combination must be well mixed. See Storage.
Keep container in the outer carton. Do not store above 25°C.
After addition of other nutritional elements: Nephrotect can be mixed with other nutrition solutions such as fat emulsions, carbohydrates, electrolyte solutions, trace elements and vitamins. Compatibility data are available upon request.
From a microbiological point of view, the product should be used immediately when additions have been made. If not used immediately, the user is responsible for storage conditions and duration of the mixture until use. Normally the mixture should be stored not longer than 24 hours at 2-8°C, unless it was made under controlled and validated aseptic conditions. If storage cannot be avoided and provided that the mixture is prepared under controlled and validated aseptic conditions the mixture may be stored for a longer period at 2-8°C before being used provided that compatibility has been proved. After removal from storage at 2-8°C, the admixture should be infused within 24 hours. Any unused mixture remaining after infusion should be discarded.
Shelf-life: 2 years.
B05BA01 - amino acids ; Belongs to the class of solutions for parenteral nutrition used in I.V. solutions.
Soln for infusion (bottle) (clear and colourless to slightly yellowish) 500 mL x 10's.