Parenteral nutrition preparations for infusion

NTPP 1288: Parenteral nutrition solutions for infusion

Following the first public inquiry (see Notification 2023/594/FR - NTPP 1276), 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;
- 1 alternative component has been added for vitamins (ref. 10a for formulas Nos 1, 3 and 7, and ref. 11a forformulas Nos 2, 4, 5, 6);
- the maximum concentration of the element chlorine in formula No 2 has been modified (15 mmol/L)
- the ‘Precaution’ paragraph of the PRODUCTION section has been amended to clarify the recommendation ofthe order in which the components are added;
- indicative measured 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.