Pharmaceutical particulars : מידע רוקחי

6. Pharmaceutical Particulars

6.1 List of excipients:
Soybean oil, glycerol, egg phospholipids, sodium hydroxide and water for injection.
6.2 Incompatibilities

RIPOL 20MG/ML should not be mixed prior to administration with injections or infusion fluid However, RIPOL 20 MG/ML may be co-administered via a Y-piece connector close to the injection site into infusions of the following:
• Dextrose 5% Intravenous Infusion
• Sodium Chloride 0.9% Intravenous Infusion
• Dextrose 4% with Sodium Chloride 0.18% Intravenous Infusion B.P.
The neuromuscular blocking agents, atracurium and mivacurium should not be given through the same intravenous line as RIPOL 20MG/ML without prior flushing.

6.3 Shelf life
The expiry date of the product is indicated on the packaging materials.
Shelf life after first opening
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Shelf life after dilution
RIPOL 20MG/ML should not be diluted.


6.4 Special precautions for storage
Store below 25 °C.
Do not freeze.
Keep the vial in the outer carton to protect from light.
6.5 Nature and contents of container

Glass vials of 50 ml with a bromobutyl rubber stopper.
Cardboard box containing 1 glass vial.

6.6 Special precautions for disposal
In-use precautions:
The vials must be shaken before use.

For single use only. Any portion of the contents remaining after use should be discarded.
If two layers can be seen after shaking or if it is not milky-white the medicinal product should not be used.
RIPOL 20MG/ML must not be mixed with other solutions for injection or infusion. However, co- administration of RIPOL 20 MG/ML 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.