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

• Accusol 35 solution must only be used by or under the direction of a physician experienced in haemofiltration, haemodialysis or haemodiafiltration techniques,
• Rarely, precipitation of the solution may occur several hours after the start of therapy and if precipitate is formed, the Accusol 35 solution and CRRT tubing lines must be replaced immediately and the patient carefully monitored.
• Fluid balance must be carefully monitored,
• Acid-base balance must be carefully monitored,
• Similarly, electrolyte balance (chloraemia, phosphataemia, calcaemia, magnesaemia and natraemia) should be monitored regularly to detect any potential imbalance,
• Kalaemia must be monitored regularly before and during treatment. If hypokalaemia is present or starts to develop, supplementation of potassium may be required. If hyperkalaemia starts to develop, an increase in the filtration rate and/or changing to a substitution solution with a lower potassium concentration may be indicated as well as usual measures of intensive care medicine,
• Blood glucose levels must be monitored closely, especially in diabetic patients,
• In case the long-seal (interchamber seal) is not opened (i.e. only short SafetyMoon seal near access port opens) and the solution of the small chamber “B” is given, alkalosis may arise. Most common clinical signs/symptoms of alkalosis are nausea, lethargy, headache, arrhythmia, respiratory depression.

When prescribing Accusol 35 Potassium 4 mmol/L, consideration should be given to the potential interactions between this treatment and other concomitant therapies related to other pre-existing conditions.

• Blood concentration of other medicinal products may be altered during haemodialysis, haemofiltration and haemodiafiltration.
• Plasma levels of potassium in patients using cardiac glycosides must be carefully monitored due to an increased risk of hypokalaemia associated arrhythmias.
• Vitamin D and medicinal products containing calcium can increase the risk of hypercalcaemia (eg calcium carbonate acting as a chelator of potassium).
• The additional substitution of sodium bicarbonate can increase the risk of metabolic alkalosis.

There are no preclinical or clinical data on the use of Accusol 35 during pregnancy and lactation.

Accusol 35 should only be administered to pregnant and lactating women if clearly needed.

Not relevant.

The undesirable effects reported are based on adverse event reports from clinical trials (see (1) below), which were assessed by the investigator to be related to Accusol, as well as from a literature review (see (2) below).

The frequency has been evaluated by using the following criteria: very common (>1/10), common (>1/100, <1/10), uncommon (>1/1,000, <1/100), rare (>1/10,000, <1/1,000) and very rare (<1/10,000).

1) Clinical Trials

2) Literature review

The undesirable effects below listed reflect the type of undesirable effects that may be reported with haemofiltration or haemodialysis solutions.

• Potential adverse reactions related to the treatment may include nausea, vomiting, muscle cramps, hypotension, bleeding, clotting, infection and air embolism. Potential adverse reactions related to the product may include metabolic alkalosis, electrolyte disturbances and/or fluid imbalances: hypophosphataemia, hypoglycaemia, hypo- and hypervolaemia, hypo- and hypertension.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance Website: www.hpra.ie.

This medicinal product must not be mixed with other medicinal products except those mentioned in section 5.5.