Pharmaceutical particulars : מידע רוקחי

6. Pharmaceutical particulars

6.1 List of excipients
Soybean oil, glycerol, egg lecithin, oleic acid, sodium hydroxide and water for injection.

6.2 Incompatibilities

Diprofol 2% should not be mixed prior to administration with injections or infusion fluids. However, Diprofol 2% may be administered via a Y-piece connector close to the injection site with the products mentioned in section 4.2.

The neuromuscular blocking agents, atracurium and mivacurium should not be given through the same intravenous line as Diprofol 2% without prior flushing.

6.3 Shelf life

The expiry date of the product is indicated on the packaging materials.


6.4 Special precautions for storage
Protect from light.
Store below 25°C. Do not freeze.
Vials that their contents have been frozen can no longer be used.

6.5 Nature and contents of container

Diprofol 2%: Glass vials of 50 ml or 100 ml.
Not all pack sizes may be marked.
6.6 Special precautions for disposal and other handling

In use precautions:

Vials must be shaken before use.
Any portion of the contents remaining after use should be discarded.
If two layers remain visible after shaking, the product should not be used.
Please inspect the product visually before using. If other visual appearances have changed or if the container is damaged the product should not be used 

Additional precautions:
Diprofol 2% contains no antimicrobial preservatives and supports growth of micro-organisms. Asepsis must be maintained for both
Diprofol 2% and infusion equipment throughout the infusion period.
Any drugs or fluids added to the Diprofol 2% infusion line must be administered close to the cannula site. Diprofol 2% must not be administered via a microbiological filter.

Diprofol 2% and any syringe containing Diprofol 2% are for single use in an individual patient. For use in long-term maintenance of anaesthesia or sedation in intensive care it is recommended that the infusion line and reservoir of Diprofol 2% be discarded and replaced at regular intervals.