ACCUSOL

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 post- dilution 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.

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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).

Clinical Trials System Organ Class Adverse Drug Reaction Frequency Procedure related Solution related Metabolic and Nutritional Hypoglycaemia NOS Rare Yes Yes 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

• 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 and/or changing to a substitution solution with higher potassium concentration may be required. 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.

Solution dependent contraindications - Hypokalaemia, if no simultaneous adapted potassium supplementation. - Metabolic alkalosis. Haemofiltration / haemodialysis/ haemodiafiltration dependent contraindication due to the technical procedure itself: - Renal failure with increased hypercatabolism in cases where uraemic symptoms can no longer be relieved by haemofiltration.

- Inadequate blood flow from vascular access. - If there is a high risk of haemorrhage on account of systemic anticoagulation