Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients
Glycerol
Egg phospholipids for injection
Sodium oleate
Ascorbyl palmitate
α-Tocopherol
Sodium hydroxide (for pH adjustment)
Water for injections

6.2   Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

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 neonates and children below 2 years, the solution (in bottles and administration sets) should be protected from light exposure until administration is completed (see sections 4.2, 4.4 and 6.6).

After admixture of compatible additives
From a microbiological point of view, the product should be used immediately after admixture of additives. If not used immediately after admixture of additives, in-use storage times and conditions prior to use are the responsibility of the user.

6.4    Special precautions for storage
Do not store above 25 °C.
Do not freeze. If accidentally frozen, discard the container.
Store in the original package in order to protect from light.

6.5   Nature and contents of container
Glass bottle (type II glass) with a halogen butyl rubber stopper.
Pack sizes:
100 ml, available in packs of 10 x 100 ml
250 ml, available in packs of 1 x 250 ml and 10 x 250 ml
500 ml, available in packs of 1 x 500 ml and 10 x 500 ml
Not all pack sizes may be marketed.

6.6   Special precautions for disposal and other handling

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 cations (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. Container and unused residues must be discarded after use.
Do not reconnect partially used containers.

Only use containers that are undamaged and in which the emulsion is homogeneous and milky-white. Inspect the emulsion visually for phase separation and discoloration prior to administration (oil drops, oil layer).
When used in neonates and children below 2 years, protect from light exposure, until administration is completed. Exposure of Lipidem 200mg/ml to ambient 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).