Pharmaceutical particulars : מידע רוקחי

6            Pharmaceutical Particulars
Propofol Lipuro 2 spc Feb17-update_05-17 - clean14renewal   B. Braun Melsungen AG 6.1          List of excipients:

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

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

6.3          Shelf life

2 years.
After first opening: to 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

Glass vials are made of colourless glass (type II) according to Pharm. Eur. The vials are sealed with bromobutyl rubber closure and aluminium caps.

This product is supplied in glass vials of 50 ml, pack sizes: 1 and 10 vials.

Not all pack sizes may be marketed.
6.6          Special precautions for disposal and other handlings

Any unused product or waste material should be disposed of in accordance with local requirements.

Containers should be shaken before use.
For single use only. Any portion of contents remaining after use must be discarded, see section 4.2 and 4.4.

If two layers can be seen after shaking or if it is not milky-white the medicinal product should not be used.

Propofol-Lipuro 2% must not be mixed with other solutions for injection or infusion. However, co- administration of Propofol-Lipuro 2% together with glucose 50 mg/ml (5% w/v) solution or sodium chloride 9 mg/ml (0.9 % w/v) solution, or sodium chloride 1.8 mg/ml (0.18% w/v ) and glucose 40 mg/ml (4 % w/v)solution via a Y-connector close to the injection site is possible.