Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients

-   Hydrochloric acid (for pH adjustment)
-   Water for Injections
6.2. Incompatibilities

-   NUTRYELT must not be used as a vehicle for other drugs.
-   NUTRYELT, as with other trace element solutions, cannot be added directly to inorganic phosphate (additive) solutions.
- Degradation of ascorbic acid in parenteral nutrition mix is accelerated by trace elements This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3. Shelf life

The expiry date of the product is indicated on the packaging materials.
After dilution, chemical and physical in-use stability has been demonstrated for 48 h at 25°C protected from light.
From a microbiological point of view, the product should be used immediately after dilution. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

6.4. Special precautions for storage

Store below 25oC
Do not freeze
Keep the container in the outer carton in order to protect from light.
6.5. Nature and contents of container

10 ml solution in polypropylene ampoule in pack sizes of 10, 25 and 50.
Not all pack sizes may be marketed

6.6. Special precautions
Before use, check that the concentrate for solution for infusion is homogeneous and that the bottle is not damaged and is free of particles.
NUTRYELT is not intended to be administered in its current presentation. NUTRYELT must be diluted or mixed with gentle agitation during preparation under strict aseptic conditions, before infusion.
NUTRYELT must be diluted with respect to the final appropriate osmolarity. For example: - 10 to 20 ml of NUTRYELT can be diluted in at least 250 ml of Sodium Chloride 0.9 % solution for infusion,
- 10 to 20 ml of NUTRYELT can be diluted in at least 250 ml of Glucose 5% solution for infusion -
The pH after reconstitution of 20 ml of NUTRYELT with 250 ml Sodium chloride 0.9% will be 3.3, or 3.3-3.4 with Glucose 5%.
The reconstituted solution for infusion has to be visually inspected prior to use. Only clear solution without particles should be used.
Do not store partly used containers and discard all equipment after use.
The compatibility with solutions administered simultaneously via a common inlet cannula must be ensured.