Source: Marketing Authorisation Holder Revision Year: 2022 Publisher: Fresenius Medical Care Deutschland GmbH, Else-Kröner-Straße 1, 61352 Bad Homburg, Germany
Pharmacotherapeutic group: Peritoneal dialytics, hypertonic solutions
ATC code: B05DB
The electrolyte profile of the solution is basically the same as that of physiological serum. It has been adapted for use in uraemic patients, to enable renal replacement therapy by means of intraperitoneal substance and fluid exchange. Substances which are normally eliminated with the urine, such as urea, creatinine, and water, are removed from the body into the dialysis solution. It should be borne in mind that therapeutic substances may also be eliminated during dialysis, and that a dose adjustment may be necessary.
Individual parameters (patient size and body weight, laboratory parameters, residual renal function, ultrafiltration, required dialysis dose) must be considered to determine the adequate dose and the combination of solutions with differing osmolarity (glucose concentration), and sodium, and calcium concentrations. The efficacy of therapy should be regularly monitored on the basis of these parameters.
The calcium concentration of this dialysis solution is 1.25 mmol/l, which has been shown to reduce the risk of hypercalcaemia during concomitant treatment with calcium containing phosphate binders and/or vitamin D.
BicaVera 1.5% Glucose, 1.25 mmol/l Calcium contains bicarbonate – the physiological buffer – instead of lactate or acetate.
No animal studies have been performed with the intraperitoneal application of bicarbonate-containing bicaVera solutions. Clinical studies in patients on bicaVera have shown that dialysate bicarbonate equilibrates with blood bicarbonate within a two-hour dwell time.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single dose toxicity and repeated dose toxicity.
The electrolytes and glucose included in bicaVera are physiological components in human plasma. According to the available data and the clinical experience with these substances no toxic effects are expected to occur as long as the indications, contraindications and dosage recommendations are adequately observed.
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