Parenteral nutrition preparations for infusion

NTPP No 1289: Parenteral nutrition emulsions for infusion

Following the first public inquiry (see Notification 2023/595/EN - NTPP 1277), the draft monograph has beenrevised. The revision covers the following points:

- the explanatory note has been completed: addition of the list of formulas, details of the non-exclusivity of theindications, of the two pocket volumes, the stability elements of the experimental study and the componentsused in that study, the method of calculating the quantities of the components and their units, the status of thepreparations (hospital preparations) and the obligation to report them remotely;
- a reference to the experimental stability study has been added;
- the amount of lipids has been changed in formula No 8 (15 g);
- 2 alternative components have been added for vitamins (ref. 11a + 11b for formulas Nos 8 and 9 and ref. 12a+ 12b for formula No 10);
- the ‘Precaution’ paragraph of the PRODUCTION section has been amended to clarify the recommendation ofthe order in which the components are added;
- indicative calculated mean pH and osmolarity values have been introduced in the corresponding tests;
- the storage section has been modified with the addition of information on physical stability.