Regarding amendments to the instructions for medical use of medicinal products for parenteral nutrition containing amino acids and/or lipids with or without the addition of vitamins and/or trace elements – adverse outcomes in newborns who were administered
19.08.2019
2773
The PRAC recommended updating the instructions for medical use of parenteral nutrition medicinal products containing amino acids and/or lipids, due to the risk of formation of toxic degradation products under the influence of light. The document defines mandatory changes to the sections of the instructions and labeling regarding protection of solutions from light when used in newborns and children under 2 years of age. compiled automatically
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