Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS

6.1    List of excipients
Water For Injections
Soya-bean oil
Glycerol
Egg lecithin
Oleic acid
Sodium Hydroxide

6.2    Incompatibilities

The neuromuscular blocking agent, atracurium should not be given through the same intravenous line as Propofol 1% Fresenius without prior flushing.

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

6.3    Shelf life

The expiry date of the product is indicated on the packaging materials.
Administration systems with undiluted Propofol Fresenius should be replaced after 12 hours.

Dilutions with 5% w/v glucose solution or 0.9% w/v sodium chloride solution or an admixture with 1% preservative free lidocaine injection solution (at least 2 mg propofol per ml) should be prepared aseptically (controlled and validated conditions preserved) immediately before administration and administration should be completed within 6 hours after dilution.

After opening the product must be used immediately.

6.4    Special precautions for storage
Do not store above 25 °C. Do not freeze.

6.5    Nature and contents of container

Colourless glass ampoule(s) (type I) of 20 ml
Colourless glass vial(s) (type II) of 50 ml with a bromobutyl rubber closure Colourless glass vial(s) (type II) of 100 ml with a bromobutyl rubber closure 

Not all pack sizes may be marketed.
6.6    Special precautions for disposal and other handling
Propofol 1% (10 mg/1 ml) Fresenius should not be mixed prior to administration with injection or infusion solutions other than 5% w/v glucose solution or 0.9% w/v sodium chloride solution or 1% preservative free lidocaine injection solution (see also section 4.2 Posology and method of administration). Final propofol concentration must not be below 2 mg/ml.

For single use. Any unused emulsion must be discarded.

Containers should be shaken before use.
If two layers can be seen after shaking the emulsion should not be used.
Use only homogeneous preparations and undamaged containers.
Prior to use, the ampoule neck or rubber membrane should be cleaned using an alcohol spray or a swab dipped in alcohol. After use, tapped containers must be discarded.