Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Hydrochloric acid
Sodium hydroxide
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. Do not freeze.

6.5 Nature and contents of container safe•lock:
The safe•lock system is provided as a non-PVC bag made of a multi-layered polyolefin-based foil, with tubes inside the bag seams also made of polyolefins, with an injection port made of polyolefin and synthetic rubber and a bag connector made of polycarbonate and silicone components.
 stay•safe:
The stay•safe system is provided as a double bag system consisting of a non-PVC made of a multi-layered polyolefin-based foil, a tubing system also made of polyolefin, a connector system (DISC, polypropylene), a drainage bag and an overwrap, also made of multi-layered polyolefin film.
 sleep•safe:
The sleep•safe system is provided as a single bag system consisting of a non-PVC bag made of a multi- layered polyolefin-based foil, a tubing system, a connector, both also made of polyolefin, and an injection port made of polyolefin/synthetic rubber.

Pack sizes: stay•safe:                       sleep•safe:               safe•lock: 4 bags of 2000 ml each           2 bags of 5000 ml each    2 bags of 5000 ml each
4 bags of 2500 ml each           2 bags of 6000 ml each    2 bags of 6000 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 for continuous ambulatory peritoneal dialysis (CAPD): 
The solution is first warmed up to body temperature. For bags with a volume of up to 3000 ml, an appropriate bag warmer should be used. The heating time for a 2000 ml bag with a starting temperature of 22°C is approx. 120 min. 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 microwave ovens is not recommended due to the risk of local overheating.
1. Check the solution bag (label, expiry date           8. After completion of the outflow: Flush - and ensure that the solution is clear) – open           position “ ”–flush with fresh solution that the bag overwrap and the packaging of the               will be drained into the drainage bag disinfection cap.                                       (approx. 5 seconds).
2. Clean your hands with an antimicrobial               9. Inflow – position “      ” – connect the washing solution.                                       solution bag to the catheter.
3. Place the DISC into the organiser                    10. Safety measure – position “          ”– (suspend the solution bag from the upper                automated closing of the catheter extension holder of the infusion stand – unroll the               by inserting the PIN.
“solution bag-DISC” line – place the DISC               11. Disconnection - remove the protective into the organiser – afterwards place the               cap from the new disinfection cap and screw drainage bag into lower holder of the                   it onto the old one. Unscrew the catheter infusion stand).                                        extension from the DISC and screw the             4. Place the catheter extension into one of             catheter extension onto the new disinfection the two inserts of the organiser. Place the             cap.
new disinfection cap into the other free                12. Close the DISC with the open end of the insert.                                                 protective cap (which has remained in the 5. Disinfect your hands and remove the                  right insert of the organiser).
protective cap of the DISC.                             13. Check the drained dialysate for clarity 6. Connect the catheter extension to the                and quantity and, if the effluent is clear, DISC.                                                   discard it.
7. Open the clamp of the extension – position “ ” – outflow procedure starts.

 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, clearity of the solution, bag and overwrap not damaged).
• Place the bag on a solid surface.
• Open the overwrap of the solution bag.
• Wash your hands with an antimicrobial washing lotion.
• Check whether the solutive is clear and that the bag is not leaking.
2. Unroll the tubing of the solution bag.
3. Remove the protection cap.
4. Insert the connector into the free sleep•safe tray port.
5. The bag is now ready for use with the sleep•safe set.
 safe•lock system for automated peritoneal dialysis (APD)
(for the setup of the safe•lock system, please refer to its operating instructions): 
1. Preparation of the solution
• Check the solution bag (label, expiry date, clarity 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 leak proof.
• Place the bag on the heater plate or hang it on a hook of the infusion stand of the cycler.
2. Remove the protective cap of the connector from the connecting line of the tubing set.
3. Remove the protective cap from the bag connector and connect the line of the tubing set.
4. Break the inner lock by bending the line and the PIN by more than 90° to both sides.
5. The bag is now ready for use.

A separate injection can be performed through the injection port.

See also section 4.2.
Handling
Plastic containers may occasionally be damaged during transport or storage. This can result in a contamination, leading to proliferation 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 a 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 drugs, use an 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.