Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients
Glycerol
Egg lecithin all-rac--Tocopherol
Water for injections
Sodium hydroxide for pH adjustment
Sodium oleate

6.2   Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3   Shelf-life
2 years

Shelf life after first opening the container
Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C. From a microbiological point of view the emulsion should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C.

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


6.4   Special precautions for storage
Do not store above 25°C. Do not freeze.
Storage after mixing
If additions are made to Smoflipid, the admixtures should be used immediately from a microbiological point of view. If admixtures are not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless additions have taken place in controlled and validated aseptic conditions.


6.5   Nature and content of container
Glass bottles (type II, colourless) with stopper of butyl-rubber:


Package sizes:
Glass bottle
100 ml
10x100 ml

250 ml
10x250 ml

500 ml
10x500 ml
Not all pack sizes may be marketed.

6.6   Special precautions for disposal and other handling
Use only if the emulsion is homogeneous.

When used in neonates and children below 2 years, protect from light exposure, until administration is completed. Exposure of Smoflipid 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 section 4.2, 4.4 and 6.3).

Inspect the emulsion visually for phase separation prior to administration. Ensure that the final emulsion for infusion does not show any evidence of phase separation.
For single use only. Any unused emulsion should be discarded.

Additives
Smoflipid may be aseptically admixed with amino acid, glucose, and electrolyte solutions to produce "All-In-One" Total Parenteral Nutrition (TPN) admixtures.
Compatibility for different additives and the storage time of the different admixtures will be available upon request from the marketing authorisation holder.

Additions should be made aseptically.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.