Pharmaceutical particulars : מידע רוקחי

6      PHARMACEUTICAL PARTICULARS
6.1    List of excipients

Soya-bean oil, refined,
Medium-chain triglycerides,
Glycerol,
Egg lecithin,
Sodium oleate,
Water for injections

6.2    Incompatibilities

Etomidate-Lipuro 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.

6.4    Special precautions for storage

Store below 25°C.
Keep ampoules in the outer carton in order to protect from light.

For storage conditions after first opening of the medicinal product, see section 6.3.

6.5    Nature and contents of container

The product is supplied in colourless glass ampoules (type I glass, Ph. Eur.) containing 10 ml
Pack sizes:     packs of 10 ampoules


6.6    Special precautions for disposal and other handling
Any unused product or waste material should be disposed of in accordance with local requirements.

Ampoules should be shaken prior to use to ensure homogenous distribution. Only to be used if the emulsion is homogenous and milky-white after shaking. If two layers can be seen after shaking the ampoule should not be used.
Not to be used if ampoule shows signs of damage.

Etomidate-Lipuro does not contain antimicrobial preservatives. Immediately after opening of the ampoule, the emulsion has to be drawn up in a syringe under aseptic conditions and injected, because fat emulsions promote microbial growth.
Unused portions must be discarded.

Drugs to be given concurrently with Etomidate-Lipuro, e.g. an analgesic, should be administered consecutively through the same line or through separate venous cannulae.

Etomidate-Lipuro may be injected into the tubing of an infusion of isotonic sodium chloride having temporarily been stopped.