Pharmaceutical particulars : מידע רוקחי

 6.     PHARMACEUTICAL PARTICULARS
6.1    List of excipients
Small compartment:
Water for injections
Hydrochloric acid 25%

Large compartment:
Water for injections
Carbon dioxide
Sodium dihydrogen phosphate dihydrate

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.
Storage conditions after mixing of the two compartments (ready-to-use solution): Chemical and physical in-use stability of the ready-to-use solution has been demonstrated for 48 hours at 30°C. It is not recommended to store the ready-to-use solution longer than 48 h including duration treatment or at a temperature higher than 30°C prior to the inlet of the pump unit.
From a microbiological point of view, once connected to the haemodialysis, haemofiltration or haemodiafiltration circuit, and as hydrogen carbonate is present, the product shall be used immediately.

6.4    Special precautions for storage

Do not store below +4°C.
Do not refrigerate or freeze

6.5     Nature and contents of container
Double chamber bag with 4750 ml (alkaline hydrogen carbonate solution) + 250 ml (acidic electrolyte, glucose solution) = 5000 ml (ready-to-use solution).

The foil used for the bag is made of polyethylene-terephthalate, SiOx, polyamide, and polyolefine.

Each bag is equipped with a HF-connector, a Luer-lock-connector and an injection port, and is covered by a protective foil.

Pack size:
2 bags of 5000 ml

6.6     Special precautions for disposal and other handling
Do not use unless the ready-to-use solution is clear and colourless and the bag and connectors are undamaged.
For single use only. Any unused solution must be discarded.
Must be used by means of metering pumps.

The solution for haemodialysis/haemofiltration should be administered in three steps: 1. Removal of the protective foil and careful inspection of the bag 
The protective foil should only be removed immediately before administration.
Plastic containers may occasionally be damaged during transport from the manufacturer to the clinic or within the clinic itself. This can lead to contamination and microbiological or fungal growth in the solutions. Therefore, careful visual inspection of the bag and the solutions before mixing is necessary. Particular attention should be paid to even the slightest damage to the closure, the welded seam and the corners of the bag in view of a possible contamination.
2. Mixing of the two compartments
The two-compartment-bag - the bicarbonate and the electrolytes including glucose compartments - are mixed immediately before use to obtain a ready-for-use solution.

A)                                 B)                             C) 


Unfold the small                                                    …until the peel seam compartment.                  Roll up the solution bag                between both starting from the corner              compartments has opposite the small               opened along its entire compartment ...               length and the solutions from both compartments are mixed.


After mixing both compartments, it must be checked, that the peel seam is completely open, that the mixed solution is clear and colourless and that the bag is not leaking.

3. Application of the ready-to-use solution

The ready-to-use solution must be used immediately, but within a maximum of 48 hours after mixing.
Any admixture to the ready-to-use solution must only be done after the ready-to-use solution has been thoroughly mixed. After such an admixture, the ready-to-use solution should again be thoroughly mixed prior to use.

Admixtures of sodium chloride solution (concentration between 3% and 30% sodium chloride; up to 250 mmol sodium chloride per 5 litre MULTIBIC solution) and water for injection (up to 1250 ml per 5 litre MULTIBIC solution) are compatible with this medicinal product.
If not otherwise prescribed, the ready-to-use solution should be warmed immediately before use to 36.5 °C – 38.0 °C. The exact temperature must be selected depending on clinical requirements and the technical equipment used.

No special requirements for disposal.