Source: Marketing Authorisation Holder Revision Year: 2017 Publisher: Fresenius Medical Care Deutschland GmbH, Else-Kröner-Straße 1, 61352 Bad Homburg v.d.H., Germany
Pharmacotherapeutic group: Haemofiltrates
ATC code: B05ZB
Basic principles of haemodialysis, haemofiltration and haemodiafiltration:
During haemofiltration water and solutes such as uremic toxins, electrolytes, and bicarbonate are removed from the blood by ultrafiltration. The ultrafiltrate is replaced by a solution for haemofiltration, with a balanced electrolyte and buffer composition.
During haemodialysis, water and solutes such as uremic toxins, electrolytes, bicarbonate and other small molecules are exchanged between the patient’s blood and the solution for haemodialysis by diffusion. The direction and the magnitude of the diffusion process depend on the relevant concentration gradients between the blood and the solution for haemodialysis.
In haemodiafiltration, the underlying principles of haemofiltration and haemodialysis are combined.
This medicinal product is a bicarbonate-buffered solution for intravenous administration or for use as haemodialysis solution for the balancing of water and electrolyte removal during continuous renal replacement therapies which are applied, e.g. in the treatment of acute kidney injury.
The electrolytes Na, K, Mg2+, Ca2+, Cl-, and bicarbonate are essential for the maintenance and correction of fluids and electrolyte homeostasis (blood volume, osmotic equilibrium, acid-base balance).
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 4.4).
This medicinal product must only be administered intravenously or used as haemodialysis solution.
The distribution of electrolytes and bicarbonate is regulated in accordance with requirements and the metabolic status and residual renal function. The active substances of this medicinal product are not metabolised except for glucose. The elimination of water and electrolytes depends on cellular requirements, the metabolic status, the residual renal function, and on other routes of fluid losses (e.g., gut, lung, and skin).
There are no preclinical data of relevance to the prescriber.
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