Pharmaceutical particulars : מידע רוקחי

6         PHARMACEUTICAL PARTICULARS
6.1       List of excipients
Sodium oleate, sodium hydroxide, water for injections

6.2       Incompatibilities
Incompatibilities may occur through the addition of polyvalent cations, e.g. calcium, especially when combined with heparin.

6.3       Shelf life
Shelf life of the medicinal product as packaged for sale:

The expiry date of the product is indicated on the packaging materials.
Shelf life after dilution or reconstitution according to directions:

Chemical and physical in-use stability of mixtures containing Omegaven has been demonstrated for 24 hours at 25 oC and data is available from the manufacturer. From a microbiological point of view, mixtures with fat emulsions or fat emulsions containing fat-soluble vitamins should be used immediately. If not used immediately, in-use storage time and conditions prior to use are the responsibility of the user. Only if compounding has taken place in controlled and validated aseptic conditions can storage conditions be based on the manufacturers stability data. From a microbiological point of view, mixtures compounded in uncontrolled and unvalidated conditions should normally be used within 24 hours, including the infusion time (see 6.6 for further information).
Shelf life after first opening the container:

Omegaven should be used with sterile transfer equipment immediately after opening.
To be used immediately after breaking the vial seal.

6.4        Special precautions for storage
Do not store above 25 °C. Do not freeze.
6.5        Nature and contents of container
Packs containing 10 glass vials with 50 or 100 ml emulsion.
Glass bottles (type II, colourless). Halobutyl rubber stoppers.

Not all pack sizes may be marketed.

6.6        Special precautions for disposal and other handling
•   Containers should be shaken before use.
•   Use only if the emulsion is homogeneous and the container is undamaged.
•   Non-phthalate containing equipment should be used for administration wherever possible.
•   Any portions of contents as well as mixtures remaining after use should be discarded.
Omegaven may be aseptically mixed with fat emulsions as well as fat-soluble vitamins. When simultaneously administered with other fat emulsions admixed or diluted before administration (see 6.2 and 6.3.for further information), the fish oil portion from Omegaven should constitute 10-20% of the total daily lipid intake.