Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Hydrochloric acid
Sodium hydroxide
Carbon dioxide
Water for injections
6.2 Incompatibilities

6.3 Shelf life

The expiry date of the product is indicated on the packaging materials.
Shelf life of the ready-to-use solution prepared as described in section 6.6 and without any additional drugs: 24 hours

6.4 Special precautions for storage

Do not store below 4°C.
6.5 Nature and contents of container

Double chamber bag:
One chamber contains the alkaline hydrogen carbonate solution; the other chamber contains the acidic glucose-based electrolyte solution. Mixing of both solutions (ratio 1:1) by opening the median seam between the two chambers results in the ready-to-use solution.

Stay safe:
The stay safe system is provided as a double bag system consisting of a double-chamber solution bag and a drainage bag, both with injection units, a transfer tubing system and a system connector.
All components are based on polypropylene. The bags and tubings also contain synthetic elastomers. The solution bag is laminated in addition by polyester. The stay safe system is wrapped up in an outer bag made of polyolefins.

Sleep safe:
The sleep safe system is provided as a single bag system consisting of a double-chamber solution bag with an injection unit, a transfer tubing system and a bag connector. All components are based on polypropylene. The bags and tubings also contain synthetic elastomers. Further materials of the solution bag are polyester and polyamide. The sleep safe system is wrapped up in an outer bag made of polyolefines.

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

Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
Disposal
No special requirements for disposal

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!

Only use the peritoneal dialysis solution if container and seal are undamaged. In case of doubt the attending physician should decide on the use of the solution.

The overwrap should only be removed before administration.

Do not use before the two solutions have been mixed.
Aseptic conditions must be maintained during dialysate exchange in order to reduce the risk of infection.

Instruction for use of the stay safe system:
The solution bag is first warmed to body temperature. This should be done by using an appropriate heater tray. The heating time for a 2000 ml bag with a starting temperature of 22°C is approximately 120 min. More detailed information can be obtained from the operating instructions of the bag warmer. The use of microwaves to warm the solution is not recommended due to the risk of local overheating. After warming the solution you can start with the exchange of the bags.

1. Preparation of the solution
• Place the bag on a solid ground
• Open the overwrap of the bag and seal of the disinfection cap.
• Control the solution bag (label, expiry date, clearness of the solution, integrity of the bag).
• Wash your hands with an antimicrobial washing lotion.
• Roll up the bag from one of the upper ends until the middle seam opens. The solutions in the two chambers are mixed automatically.
• Then roll up the bag from the upper edge, until the peel seam of the lower triangle is completely opened.
• The ready-to-use solution should be used immediately, but within a maximum of 24 hours after mixing!
2. Preparation of the bag exchange
• Hang the solution bag on the upper hook of the infusion pole, unroll the tubing line of the solution bag, and place the DISC into the organizer. After unrolling the tubing line to the drainage bag, hang the drainage bag on the lower hook of the infusion pole and place the disinfection cap into the organizer.
• Place catheter adapter into the organizer.
• Disinfect your hands and remove the protection cap of the DISC.
• Connect catheter adapter to the DISC.
3. Outflow
• Open the catheter clamp. The outflow starts.
Position ●
4. Flush
• Flush the drainage bag with fresh solution (approximately 5 seconds)
 Position ●●
5. Inflow
• Connect the solution bag with the catheter.
 Position ○◑●
6. Security step
• Close the catheter adapter by putting in the PIN
 Position ●●●●
7. Disconnection
• Remove the catheter adapter from the DISC and screw the new disinfection cap to the catheter adapter
8. Closure of the DISC
• Close the DISC with the open end of the protection cap of the used disinfection cap, which is placed in the right hole of the organizer.
9. Check the drained dialysate and dispose of it.

Instruction for use of sleep safe system:
With the sleep safe system for automated peritoneal dialysis (APD) the solution is warmed automatically in the machine.

1. Preparation of the solution
• Check the solution bag (label, expiry date, clearness of the solution, bag and overwrap are not damaged, peel seams are intact).
• Place the bag on a solid surface.
• Open the overwrap of the bag.
• Wash your hands with an antimicrobial washing lotion.
• Unfold middle seam and bag connector.
• Roll up the bag, which is lying on the overwrap, from the diagonal end towards the bag connector. The middle peel seam will open.
• Continue until the peel seam of the small chamber opens as well.
• Check that all peel seams are completely open.
• Check that the solution is clear and that the bag is not leaking.
2. Unroll tubing of bag.
3. Remove the protection cap and insert connector in one of the free tray ports of the sleep safe cycler.
4. The bag is now ready for use with the sleep safe set.

Medicinal products must be added under aseptic conditions only when medically prescribed.
Because of the risk of incompatibility between the dialysis solution and the added medicinal products only the following medicinal products may be added up to the mentioned concentration if indicated by the attending physician: heparin 1000 I.U./l, insulin 20 I.U./l, vancomycin 1000 mg/l, teicoplanin 400 mg/l, cefazolin 500 mg/l, ceftazidime 250 mg/l, gentamycin 8 mg/l. After thorough mixing and checking for the absence of any turbidity the peritoneal dialysis solution must be used immediately (no storage).

7. MANUFACTURER:
Fresenius Medical Care Deutschland GmbH
Else-Kroner-Strasse 1
D - 61352 Bad Homburg v.d.H
Germany