Source: Marketing Authorisation Holder Revision Year: 2017 Publisher: Fresenius Medical Care Deutschland GmbH, Else-Kröner-Straße 1, 61352 Bad Homburg v.d.H., Germany
multiBic potassium-free/2/3 mmol/l potassium:
multiBic 4 mmol/l potassium:
Use only after mixing of the two solutions.
multiBic potassium-free/2/3/4 mmol/l potassium should be warmed prior to use with appropriate equipment to approximately body temperature and must not be used under any circumstances below room temperature.
The warming of the ready-to-use solution to approximately body temperature must be carefully controlled verifying that the ready-to-use solution is clear and without particles. During application of the ready-to-use solution, white calcium carbonate precipitation has been observed in the tubing lines in rare cases, particularly close to the pump unit and the heating unit warming the ready-to-use solution.
Precipitations particularly can occur if the temperature of the ready-to-use solution at the inlet of the pump unit is already higher than 30°C.
Therefore, the ready-to-use solution in the tubing lines must be closely visually inspected every 30 min during continuous renal replacement therapy in order to ensure, that the solution in the tubing system is clear and free from precipitate. Precipitations may occur also with substantial delay after start of treatment.
If precipitate is observed, the ready-to-use solution and the tubing lines used for continuous renal replacement therapy must be replaced immediately and the patient carefully monitored.
The serum potassium concentration must be checked regularly before and during continuous renal replacement therapy. The potassium status of the patient and its trend during the treatment must be considered:
In case of hypokalaemia supplementation of potassium and/or changing to a solution for haemodialysis/haemofiltration with higher potassium concentration may be required. In case of hyperkalaemia an increase in the applied dose and / or change to a solution for haemodialysis/haemofiltration with a lower potassium concentration may be indicated as well as usual measures of intensive care medicine.
The serum sodium concentration must be checked regularly before and during use of this solution for haemodialysis/haemofiltration to control risks related to hypo/hypernatraemia. The solution for haemodialysis/haemofiltration may be diluted with an adequate amount of water for injections or concentrated sodium chloride solution may be added if required. The speed of desired normalisation must then be carefully planned to avoid adverse reactions due to rapid changes in serum sodium concentration.
In addition, the following parameters must be monitored before and during continuous renal replacement therapy: Serum calcium, serum magnesium, serum phosphate, serum glucose, acidbase status, levels of urea and creatinine, body weight and fluid balance (for the early recognition of hyper- and dehydration).
Clinically important substances may be removed with the haemodialysis, haemofiltration and haemodiafiltration treatment and are not supplemented with this medicinal product. This removal of important nutrients must be compensated by adequate nutrition, nutritional supplements, or an adapted parenteral nutrition.
There is no clinical experience on the use of this product in children. This medicinal product is not recommended for use in children until further data become available (see sections 4.2 and 5.1).
No interaction studies have been performed.
The correct dose of multiBic potassium-free/2/3/4 mmol/l potassium and strict monitoring of clinical chemistry parameters and vital signs will avoid risks related to interactions with other medicinal products.
The following interactions are conceivable:
There are no or limited amount of data from the use of multiBic potassium-free/2/3/4 mmol/l potassium in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
multiBic potassium-free/2/3/4 mmol/l potassium should not be used during pregnancy unless the clinical condition of the woman requires continuous renal replacement therapy.
There is insufficient information on the excretion of multiBic potassium-free/2/3/4 mmol/l potassium active substances/metabolites in human milk. Breastfeeding is not recommended during treatment with multiBic potassium-free/2/3/4 mmol/l potassium.
No data available.
Not relevant.
Adverse reactions may result from the treatment mode itself or may be induced by this medicinal product:
Gastrointestinal disorders - nausea, vomiting
Vascular disorders - hypertension, hypotension
Musculoskeletal and connective tissue disorders - muscle cramps
The following adverse reaction can be anticipated for the treatment mode: Metabolism and nutrition disorders – hyper- or hypohydration, electrolyte disturbances (e.g., hypokalaemia), hypophosphataemia, hyperglycaemia, and metabolic alkalosis.
The exact frequency of such events is not known (cannot be estimated from the available data).
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: [the national reporting system listed in Appendix V].
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
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