Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Soya bean oil
Medium Chain Triglycerides (MCT)
Glycerol anhydrous
Purified egg phospholipids
Oleic acid
Sodium Hydroxide
Water For Injection
6.2 Incompatibilities

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

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

6.3 Shelf life

The expiry date of the product is indicated on the packaging materials.
Shelf life after dilution
The mixture should be prepared aseptically immediately prior to administration and must be administered within 6 hours after preparation.

6.4 Special precautions for storage

Store below 25°C. Do not freeze.
6.5 Nature and contents of container

Glass ampoules: 5 x 20 ml
Glass vials: 1 x 20 ml, 5 x 20 ml, 10 x 20 ml
Glass bottles (Vial): 1 x 50 ml, 10 x 50, 15 x 50 ml, 1 x 100 ml, 10 x 100 ml, 15 x 100 ml.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling In-use precautions 
Containers must be shaken before use.
For single use. Any unused emultion must be discarded. After opening the product must be used immediately.
The mixture may be mixed with 5% w/v glucose solution or 0.9% w/v sodium chloride solution or 1% preservative free lidocaine injection solution.