Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use
Bica Vera may only be administered after careful benefit-risk assessment in: -   patients with loss of electrolytes due to vomiting and/or diarrhoea (a temporary change to a peritoneal dialysis solution containing potassium might then become necessary.) -   patients with hypercalcaemia, e.g. due to the administration of calcium-containing phosphate binders: A transient or permanent change to a peritoneal dialysis solution with a lower calcium concentration should be considered.
-   patients receiving digitalis therapy: Regular monitoring of the serum potassium level is mandatory. Severe hypokalaemia may necessitate the use of a potassium-containing dialysis solution besides dietary counselling.

The natural metabolic acidosis due to renal failure might not be totally compensated by the 34 mmol/l bicarbonate level of the final solution. Acidosis might be associated with undesirable effects e.g. malnutrition.

A loss of proteins, amino acids, and water-soluble vitamins occurs during peritoneal dialysis. To avoid deficiencies an adequate diet or supplementation should be ensured.

The transport characteristics of the peritoneal membrane may change during long-term peritoneal dialysis primarily indicated by a loss of ultrafiltration. In severe cases peritoneal dialysis must be stopped and haemodialysis commenced.
The monitoring of the following parameters is recommended:
- body weight for the early recognition of over- and dehydration,
- serum sodium, potassium, calcium, magnesium, phosphate, acid base status and blood proteins,
- serum creatinine and urea,
- parathormone and other indicators of bone metabolism,
- blood sugar,
- residual renal function in order to adapt the peritoneal dialysis.

Encapsulating peritoneal sclerosis is considered to be a known, rare complication of peritoneal dialysis therapy which can infrequently lead to fatal outcome.

Elderly patients
The increased incidence of hernia should be considered in elderly patients prior to the start of peritoneal dialysis.

Effects on Driving

4.7 Effects on ability to drive and use machines

Bica Vera has no or negligible influence on the ability to drive and to use machines.