Pharmaceutical particulars : מידע רוקחי

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients
In the small compartment A:                   Water for injections
In the large compartment B:                   Water for injections, Carbon dioxide 

6.2 Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
It is the responsibility of the physician to judge the incompatibility of an additive medication with the HEMOSOL B0 solution by checking for eventual colour change and/or eventual precipitation, insoluble complexes or crystals. The Instructions for Use of the medication to be added must be consulted.
Before adding a drug, verify it is soluble and stable in water at the pH of HEMOSOL B0 (pH of reconstituted solution is 7.0 to 8.5).
The compatible medication must be added to the reconstituted solution and the solution must be administered immediately.


6.3 Shelf-life
The expiry date of the product is indicated on the packaging materials.
Chemical and physical in-use stability of the reconstituted solution has been demonstrated for 24 hours at 22° C. From a microbiological point of view, once opened (i.e. connected to the
line), and as hydrogen carbonate is present, the reconstituted solution should be used immediately. Other in-use storage times and conditions prior to use are the responsibility of the user and would not normally be longer than 24 hours, including the duration of the treatment.


6.4 Special precautions for storage
Store between +4°C and +30°C
For storage conditions after reconstitution of the medicinal product, see section 6.3.

6.5 Nature and contents of container
The container made of polyolefin is a two-compartment bag. The 5000 ml bag is comprised of a small compartment (250 ml) and a large compartment (4750 ml). The two compartments are separated by a peel seal.
The large compartment B is fitted with an injection connector (or spike connector) made of polycarbonate (PC), which is closed with a rubber disc covered by a cap as well as a luer connector (PC) with a valve made of silicone rubber for the connection of the bag with a suitable replacement solution line or dialysis line.
The bag is over wrapped with a transparent overwrap made of multilayer polymer film.

Each two-compartment bag contains 5000 ml.
Package size: 2 x 5000 ml in a box.

6.6 Special precautions for disposal and other handling
The electrolyte solution (small compartment A) is added to the buffer solution (large compartment B) after opening the peel seal immediately before use to obtain the reconstituted solution.
Aseptic technique should be used throughout the handling and administration to the patient.
Use only if the overwrap is not damaged, all seals are intact, peel seal is not broken, and the solution is clear. Press bag firmly to test for any leakage. If leakage is discovered, discard the solution immediately since sterility can no longer be assured.

The large compartment is fitted with an injection port for the possible addition of other necessary drugs after reconstitution of the solution.
Before adding a substance or medication, verify that it is soluble and stable in HEMOSOL B0, and that the pH range is appropriate (pH of reconstituted solution is 7.0 to 8.5).
Additives may be incompatible. The instructions for use of the medication to be added and other relevant literature must be consulted. After addition, if there is a colour change and/or the appearance of precipitates, insoluble complexes, or crystals, do not use.

Mix the solution thoroughly when additives have been introduced. The introduction and mixing of additives must always be performed prior to connecting the solution bag to the extracorporeal circuit.


The following instructions for use should be followed:
I       Immediately before use remove the overwrap from the bag and mix the solutions in the two different compartments. Hold the small compartment with both hands and squeeze it until an opening is created in the peel seal between the two compartments (see figure I below).
II      Push with both hands on the large compartment until the peel seal between the two compartments is entirely open. (see figure II below)
III     Secure complete mixing of the solution by shaking the bag gently. The solution is now ready for use, and can be hung on the equipment (see figure III below).
IV      The dialysis or replacement line may be connected to either of the two access ports.
IVa     If the luer access is used, remove the cap with a twist and pull motion, and connect the male luer lock on the dialysis or replacement line to the female luer receptor on the bag using a push and twist motion. Ensure that the connection is fully seated and tighten. The connector is now open. Verify that the fluid is flowing freely (see figure IV.a below).
When the dialysis or replacement line is disconnected from the luer connector, the connector will close and the flow of the solution will stop. The luer port is a needle-less and swabbable port.
IVb    If the injection port is used, first remove the snap-off cap. The injection port is a swabbable port. Then introduce the spike through the rubber septum. Verify that the fluid is flowing freely (see figure IV.b below).The solution should be used immediately after removal of the over wrap. If not used immediately, the reconstituted solution should be used within 24 hours, including the duration of the treatment, after addition of the electrolyte solution to the buffer solution.



The reconstituted solution is for single use only. Do not use if container is damaged or if solution is not clear. Discard any unused portion immediately after use.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. REGISTRATION NUMBER
129 26 30751 00