Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: Baxter Holding B.V., Kobaltweg 49, 3542CE Utrecht, Netherlands
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
The substitution solution Hemosol B0 is potassium-free. The serum potassium concentration must be monitored before and during hemofiltration and/or hemodialysis.
The electrolyte solution must be mixed with the buffer solution before use to obtain the final solution suitable for haemofiltration/haemodiafiltration/continuous haemodialysis.
Use only with appropriate extracorporeal renal replacement equipment.
Because the solution contains no glucose, administration may lead to hypoglycemia. Blood glucose levels should be monitored regularly.
Hemosol B0 contains hydrogen carbonate (bicarbonate), and lactate (a hydrogen carbonate precursor) which can influence the patient’s acid–base balance. If metabolic alkalosis develops or worsens during therapy with the solution, the administration rate may need to be decreased, or the administration stopped.
The use of contaminated haemofiltration solution may cause sepsis, shock and fatal conditions.
Hemosol B0 may be warmed to 37°C to enhance patient comfort. Warming of the solution prior to use should be done before reconstitution with dry heat only. Solutions should not be heated in water or in a microwave oven. The solution should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer unless the solution is clear and the seal is intact.
Before and during treatment, electrolyte and acid-base balance should be closely monitored throughout the procedure. Phosphate up to 1.2 mmol/L may be added to the solution. If potassium phosphate is added, the total potassium concentration should not exceed 4 mEq/L (4 mmol/L). Potassium supplement might be necessary.
The patient’s hemodynamic status and fluid balance should be monitored throughout the procedure and corrected as needed.
There are no specific warnings and precautions when using this medicine for children.
The blood concentration of filterable/dialysable drugs may be reduced during treatment. Corresponding corrective therapy should be instituted if necessary to establish the desired blood concentrations for drugs removed during treatment. Interactions with other medications due to electrolyte and/or acid-base imbalances can be avoided by correct dosage of the solution for haemodialysis/haemofiltration and precise monitoring.
No effects during pregnancy or on the breast-fed newborn/infant are anticipated. There is no report on Hemosol B0 during pregnancy or lactation but literature on renal replacement therapy during acute kidney injury does not suggest risks associated with solutions. The prescriber should consider the benefit/risk relationship before administering Hemosol B0 to pregnant or breast feeding women.
There are no clinical data on fertility. However no effects on fertility are anticipated.
Not relevant.
The following undesirable effects are reported from post-marketing experience. The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level). Frequencies: Not known (cannot be estimated from the available data).
| System Organ Class | Preferred Term | Frequency |
|---|---|---|
| Metabolism and nutrition disorders | Electrolyte imbalances, e.g.:hypophosphataemia, hypokalaemia | Not known |
| Acid-base balance disorders | Not known | |
| Fluid imbalance | Not known | |
| Vascular disorders | Hypotension | Not known |
| Gastrointestinal disorders | Nausea | Not known |
| Vomiting | Not known | |
| Musculoskeletal and connective tissue disorders | Muscle spasms | Not known |
Special attention must be taken for patients with hypokalaemia as this solution is potassium-free (see section 4.4).
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 Earlsfort Terrace IRL – Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: medsafety@hpra.ie
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
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