Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Hydrochloric acid            pH-correction
Sodium hydroxide             pH-correction
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
The expiry date of the product is indicated on the packaging materials Shelf life after first opening: The content must be used immediately.

6.4   Special precautions for storage
Store below 25 °C. Do not refrigerate or freeze.

6.5   Nature and contents of container stay•safe:
The stay•safe system is provided as a double bag system consisting of a non-PVC solution bag made of a multilayer polyolefine based foil with an injection port made of polyolefine/synthetic rubber, a tubing system also made of polyolefines, a system connector (DISC, polypropylene), a drainage bag that may have an injection port, and an overwrap, also made of polyolefine multi-layer film.
 sleep•safe:
The sleep•safe system is provided as a single bag system consisting of a non-PVC solution bag made of a multi-layer polyolefine based foil with an injection port made of polyolefine/synthetic rubber, a tubing system, a bag connector and an overwrap, also made of polyolefines.

Pack sizes stay•safe                             sleep•safe
4 bags of 2000 ml each               2 bags of 5000 ml each
4 bags of 2500 ml each
4 bags of 3000 ml each

Not all pack sizes may be marketed.
6.6   Special precautions for disposal and other handling
No special requirements for disposal.
 stay•safe system:
The solution is first warmed to body temperature. For bags with a volume up to 3000 ml this should be done using an appropriate bag warmer. The heating time depends on the bag volume and the used bag warmer (for a 2000 ml bag with a starting temperature of 22 °C usually 120 min). The temperature control is done automatically and is set to 39 °C ± 1 °C. More detailed information can be obtained from the operating instructions of the bag warmer. Use of microwaves is not recommended due the risk of local overheating.

1.    Check the solution bag (label, the expiry date, clearness of the solution, bag and overwrap not damaged) – open the overwrap and the packaging of the disinfection cap/closure cap.
2.    Wash your hands with an antimicrobial washing solution.
3.    Place the DISC into the organiser (suspend solution bag from the upper hole of the infusion pole – unroll the “solution bag-DISC” line – place the DISC into the organiser – afterwards place drainage bag into lower holder of the infusion pole).
4.    Place catheter extension into one of the two inserts of the organiser. Place the new disinfection cap/closure cap into the other free insert.
5.    Disinfect your hands and remove protection cap of the DISC.
6.    Connect catheter extension to the DISC:
7.    Open clamp on extension – position “ ” – outflow procedure starts.
8.    After completion of the outflow: Flush-position “ ” -flush fresh dialysate into the drainage bag (approx. 5 seconds).
9.    Inflow – position “      ” – connection between solution bag and catheter.
10.   Security step – position “       ” – automated closing of the catheter extension with the PIN.
11.   Disconnection - remove the protection cap from the new disinfection cap/closure cap and screw it onto the old one. Unscrew catheter extension from the DISC and screw it onto the new disinfection cap/closure cap.
12.   Close the DISC with the open end of the protection cap (which has remained in the other insert of the organiser).
13.   Check the drained dialysate for clarity and weight and, if the effluent is clear, discard it.


sleep•safe system (for the setup of the sleep•safe system please refer to its operating instructions): 1.   Preparation of the solution
• Check the solution bag (label, expiry date, clearness of the solution, bag and overwrap not damaged).
• Place the bag on a solid surface.
• Open the overwrap of the bag.
• Wash your hands with an antimicrobial washing lotion.
• Check whether the solution is clear and that the bag is not leaking.
2.   Unroll tubing of bag.
3.   Remove the protection cap.
4.   Insert connector in free tray port.
5.   The bag is now ready for use with the sleep•safe set.

See also section 4.2.

Handling
Plastic containers may occasionally be damaged during transport or storage. This can result in a contamination with growth of microorganisms in the dialysis solution. Thus, all containers should be carefully inspected for damage prior to connection of the bag and prior to use of the peritoneal dialysis solution. Any damage, even minor, to connectors, at the closure, container welds and corners, must be noted because of possible contamination.

Damaged bags or bags with cloudy content should never be used! In case of doubt, the attending physician should decide on the use of the solution.

Only use the peritoneal dialysis solution if container and seal are undamaged.

The overwrap should only be removed before administration.
Aseptic conditions must be maintained during dialysate exchange in order to reduce the risk of infection.

Addition of medication to the peritoneal dialysis solution:
The addition of medication to the peritoneal dialysis solution is generally not recommended because of the risk of contamination and of incompatibility between the peritoneal dialysis solution and the medication.
When adding medicinal products, use aseptic technique, mix thoroughly and after checking for the absence of any turbidity, which may occur due to incompatibilities, the peritoneal dialysis solution must be used immediately.