Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use
The medicinal product should only be administered after a careful benefit-risk assessment in the presence of disorders of amino acid metabolism of other origin than stated under section       4.3.
Caution should be exercised when infusing larger volumes of fluid in patients with cardiac insufficiency.
Caution should be exercised in patients with increased serum osmolarity.
Disturbances of fluid and electrolyte balance (e.g. hypotonic dehydration, hyponatraemia, hypokalaemia) should be corrected prior to the administration of parenteral nutrition.
Serum electrolytes, blood glucose, fluid balance, acid-base balance and renal function should be monitored regularly.
Serum protein and hepatic function are to also be monitored.


Renal impairment
In patients with renal insufficiency, the dose must be carefully adjusted according to indi- vidual needs, the severity of organ insufficiency and the type of renal replacement therapy instituted (haemodialysis, haemofiltration etc.).


Hepatic impairment
In patients with hepatic insufficiency, the dose must be carefully adjusted according to indi- vidual needs and the severity of organ insufficiency.


Amino acid solutions are only one component of parenteral nutrition. For complete paren- teral nutrition, substrates for non-protein energy supply, essential fatty acids, electrolytes, vitamins, fluids and trace elements must be administered together with amino acids.

Effects on Driving

4.7   Effects on ability to drive and use machines
Not relevant.