ACCUSOL 35 POTASSIUM Solution for haemofiltration, haemodialysis and haemodiafiltration Ref.[50646] Active ingredients: Calcium chloride Glucose Magnesium chloride Potassium chloride Sodium bicarbonate Sodium chloride

For haemofiltration, haemodialysis and haemodiafiltration.

Accusol 35 as substitution solution

The amount of substitution solution to be administered in adults is determined by the ultrafiltration rate and is set for each individual case to ensure an adequate electrolyte fluid balance.

Adults:

• Chronic renal failure: 7 to 35 ml/kg/hr,
• Acute renal failure: 20 to 35 ml/kg/hr,

Elderly: as for adults

These fluid volume recommendations may be adjusted by the prescribing physician according to the patient’s clinical status.

Accusol 35 can be administered into the extracorporeal blood circuit either in pre- and/or postdilution mode according to the physician’s prescription.

Accusol 35 as dialysis solution

The prescription and amount of dialysis solution depend upon the mode of therapy, frequency and duration of treatment and will be selected by the prescribing physician according to the patient’s clinical status.

Administration

Haemodialysis: via the dialysis compartment of the dialyser.

Haemofiltration: via the arterial or venous blood line

After removal of the overpouch, immediately open the long-seal (interchamber seal) to mix the two solutions and then open the short SafetyMoon seal (seal near access port) to allow administration of the mixed solution. For instructions for use and handling, please refer to section 5.5.

Overdose should not occur if the fluid and electrolyte balances are monitored regularly as recommended in section 4.4. Overdose may lead to hypervolaemia and electrolyte disturbances. These symptoms can be corrected by adjusting the ultrafiltration rate and the volume of solution administered.

Electrolyte imbalances should be managed according to the specific electrolyte disturbance.

Shelf life: 24 months when stored in the overpouch.

Shelf life after mixing: Accusol 35, once removed from the overpouch and mixed should be used within 24 hours.

Do not refrigerate or freeze.

Accusol 35 is stored in a non-PVC two-chamber bag made of a coextruded film of Polypropylene, Polyamide and a blend of Polypropylene, SEBS and Polyethylene (Clear-Flex). A long-seal (interchamber seal) separates the two chambers.

The large chamber ‘A’ is fitted with a medication port and the small chamber ‘B’ is fitted with an access port for connection to a suitable administration set. A short SafetyMoon seal (seal near access port) needs to be opened to allow administration of the mixed solution.

The two-chamber bag is presented in a protective transparent overpouch made of copolymers. The volume of the container after mixing is 5000 ml (3750 ml in the large chamber and 1250 ml in the small chamber).

Accusol 35 is available as 2 × 5000 ml per box.

• Check the integrity of the product. If one of the seals is opened prematurely, do not use the bag. In case of damage, discard the container.
• Do not administer unless the solution is clear.
• Aseptic technique should be observed throughout the whole procedure.
• Concomitant drugs may be added through the medication port in the larger chamber. Drug compatibility must be checked before admixture. Add the medication and activate the long-seal (interchamber seal) immediately. The product must be used immediately after any drug addition.
• After removal of the overpouch, immediately open the long-seal (interchamber seal) to mix the two solutions. Ensure the long-seal (interchamber seal) is completely activated and the two solutions are completely mixed. Then open the short Safety Moon seal (seal near access port) to allow administration of the mixed solution. Connect to the patient line and activate the access port. The solution must be used within 24 hours of mixing.
• Discard any unused remaining solution.
• For single use only.
• Use Accusol 35 only with adequate equipment able to monitor the therapy