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

The neuromuscular blocking agents, atracurium and mivacurium should not be given through the same intravenous line as RIPOL 10MG/MLwithout prior flushing.

6.3    Shelf Life

The expiry date of the product is indicated on the packaging materials.
Shelf life after dilution
Prepare the mixture under asepsis immediately before administration and administer it within 7 hours after preparation.
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.

6.4     Special precautions for storage

Do not store above 25 °C.
Do not freeze.
Keep the ampules and the vials in the outer carton to protect from light.
6.5 Nature and Contents of Container
RIPOL 10MG/ML:
• Glass ampoules of 20 ml
Cardboard box containing carboard tray with 5 glass ampoules
• Glass vials of 20 ml with a bromobutyl rubber stopper Cardboard box containing carboard tray with 5 glass vials
• Glass vials of 50 ml /100ml with a bromobutyl rubber stopper Cardboard box containing 1 glass vial
Not all pack sizes may be marketed.

6.6    Special precautions for disposal

In-use precautions
The ampoules and vials must be shaken before use.
For single use only. Any portion of contents remaining after use must 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 10MG/ML should not be mixed prior to administration with injections or infusion fluids other than Sodium chloride 0.9%, Glucose 5% or preservative-free lidocaine injection 1% (see Section 4.2.4).

Co-administration of RIPOL 10MG/ML together with glucose solution 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.