Pharmaceutical particulars : מידע רוקחי

6. Pharmaceutical particulars
6.1 List of excipients
Small compartment A:         Water for injections
Hydrochloric acid (for pH adjustment)
Large compartment B:         Water for injections
Carbon dioxide (for pH adjustment)

6.2 Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3 Shelf-life
The expiry date of the product is indicated on the packaging materials.
After reconstitution:
Chemical and physical in-use stability of the reconstituted solution has been demonstrated for 24 hours at 22oC. If not used immediately, 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 below 30ºC. Do not refrigerate or freeze.
For the storage condition of the reconstituted solution, see section 6.3.

6.5 Nature and contents of container
The container made in 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 a 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 solution in the small compartment A is added to the solution in the large compartment B after breaking the peel seal immediately before use. The reconstituted solution shall be clear and colourless.

Aseptic technique shall be used throughout the handling and administration to the patient.
Use only if the overwrap is undamaged, 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 B is fitted with an injection port for the possible addition of other necessary drugs after reconstitution of the solution. It is the responsibility of the user to judge the compatibility of an additive medication with Phoxilium by checking for eventual colour change and/or eventual precipitation, insoluble complexes or crystals. Before adding a medication, verify if it is soluble and stable in this medicine and that the pH range of Phoxilium is appropriate (pH of reconstituted solution is 7.0–8.5). Additives may be incompatible. The Instructions for Use of the medication to be added must be consulted.

Remove any fluid from the injection port, hold the bag upside down, insert the drug through the injection port and mix thoroughly. The introduction and mixing of additives must always be performed prior to connecting the solution bag to the extracorporeal circuit. The solution must be administered immediately.
I    Remove the over wrap from the bag immediately before use and discard any other packaging materials. Open the seal by holding the small compartment with both hands and squeezing 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.
IV.a 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.
IV.b 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 reconstituted solution shall be used immediately. If not used immediately, the reconstituted solution should be used within 24 hours including the duration of the treatment after addition of the solution A to solution B.

The reconstituted solution is for single use only.
Discard any unused solution immediately after use.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Registration Number
153 30 34067 00