Pharmaceutical particulars : מידע רוקחי

6      PHARMACEUTICAL PARTICULARS

6.1    List of excipients
Glycerol: 25.0 g/l
Egg Phospholipids for Injection: 8.0 g/l
-Tocopherol: 0.10 g/l
Sodium oleate (for pH-adjustment): 0.30 g/l
Water for injection: 860 g/l


6.2    Incompatibilities
Lipofundin MCT/LCT 10 % must not be used as carrier solutions for electrolyte concentrates or other pharmaceuticals nor must the emulsion be mixed with other infusion solutions, since adequate stability of the emulsion would no longer be guaranteed.

Combined regimens are only to be used for parenteral nutrition after their pharmaceutical compatibility has been controlled and guaranteed.

The combination of Lipofundin MCT/LCT 10 % with alcohol-containing infusion or injection solutions must be avoided.
6.3       Shelf life

Unopened
The expiry date of the product is indicated on the packaging materials.
After first opening the container
After first opening the medicinal product should be used immediately.
When used in infants aged to 2 years old, the emulsion (including administration sets) should be protected from light exposure after preparation for infusion until administration is completed (see sections 4.2, 4.4 and 6.6).

After reconstitution or dilution
Not applicable, see section 6.2.

6.4       Special precautions for storage

Store below 25 °C.
Do not freeze.
Store in original package, in order to protect from light.

6.5       Nature and contents of container

●    Glass bottles (type II glass) sealed with rubber stoppers:
Contents: 100 ml, available in packs of 10 x 100 ml
250 ml, available in packs of 10 x 250 ml
500 ml, available in packs of 10 x 500 ml

Not all pack sizes may be marketed.

6.6       Special precautions for disposal

No special requirements for disposal.

If filters are used, these must be permeable to lipids.

Before infusing a lipid emulsion together with other solutions via a Y connector or bypass set, the compatibility of these fluids should be checked, especially when co-administering carrier solutions to which drugs have been added. Particular caution should be exercised when co- infusing solutions that contain divalent electrolytes (such as calcium or magnesium).

Shake gently prior to use.

The emulsion has to be brought to room temperature unaided prior to infusion, i.e., the product should not be put in a heating device (such as oven or microwave).

For single use only. Any unused emulsion should be discarded.
Products that have been frozen should be discarded.

Only use containers that are undamaged and in which the emulsion is homogenous and milky white. Inspect the emulsion visually for phase separation prior to administration.

When used in infants aged to 2 years old, parenteral nutrition mixtures containing Lipofundin MCT/LCT 10% should be protected from light exposure, after preparation for infusion until administration is completed. Exposure of such mixtures to light, especially after admixture with trace elements and/ or vitamins, generates peroxides and other degradation products that can be reduced by protection from light exposure (see sections 4.2, 4.4 and 6.3).