Posology : מינונים

4.2   Posology and method of administration

Posology
Bica Vera 2.3% Glucose, 1.75 mmol/l Calcium is exclusively indicated for the intraperitoneal use.
The mode of therapy, frequency of administration, and dwell time required will be specified by the attending physician.

Continuous ambulatory peritoneal dialysis (CAPD)
Adults:
Unless otherwise advised, patients will receive an infusion of 2000 ml solution per exchange four times a day. After a dwell time between 2 and 10 hours the solution will be drained.

Adjustment of dosage, volume and number of exchanges will be necessary for individual patients.

If dilation pain occurs at the commencement of peritoneal dialysis treatment, the solution volume per exchange should be temporarily reduced to 500 - 1500 ml.

In large patients, and if residual renal function is lost, an increased volume of dialysis solution will be necessary. In these patients, or patients who tolerate larger volumes, a dose of 2500 ml solution per exchange may be given.

Children:
In children the solution volume per exchange should be prescribed according to age and body surface area (BSA).
For initial prescription, the volume per exchange should be 600-800 ml/m2 BSA with 4 (sometimes 3 or 5) exchanges per day. It can be increased up to 1000-1200 ml/m2 BSA depending on tolerance, age and residual renal function.

Automated peritoneal dialysis (APD)
If a machine (sleep safe cycler) is used for intermittent or continous cyclic peritoneal dialysis larger volume bags (3000 or 5000 ml) providing more than one solution exchange are used.
The cycler performs the solution exchanges according to the medical prescription stored in the sleep safe cycler.
Adults:
Typically patients spend 8-10 hours a night cycling. Dwell volumes range from 1500 to 3000 ml and the number of cycles usually varies from 3 to 10 per night. The amount of fluid used is typically between 10 and 18 l but can range from 6 to 30 l. The cycler therapy at night is usually combined with 1 or 2 exchanges during the daytime.

Children:
The volume per exchange should be 800-1000 ml/m2 BSA with 5-10 exchanges overnight. It can be increased up to 1400 ml/m2 BSA depending on tolerance, age and residual renal function.

There are no special dosage recommendations for elderly patients.

Depending on the required osmotic pressure, Bica Vera 2.3% Glucose, 1.75 mmol/l Calcium can be used sequentially with other peritoneal dialysis solutions with lower or higher glucose content (i.e. with lower or higher osmolarity).

Peritoneal dialysis solutions with a high glucose concentration (2.3% or 4.25%) are used when the body weight is above the desired dry weight. The withdrawal of fluid from the body increases in relation to the glucose concentration of the peritoneal dialysis solution.
These solutions should be used cautiously to protect the peritoneal membrane and to prevent dehydration and in order to keep the glucose burden as low as possible.

Bica Vera 2.3% Glucose, 1.75 mmol/l Calcium contains 22.73 g glucose in 1000 ml solution.
According to the dosage instruction up to 45.5 g glucose are supplied to the body with each bag.

Peritoneal dialysis is a long-term therapy involving repeated administrations of single solutions.

Method and duration of administration
Patients should proficient at performing peritoneal dialysis before performing it at home. The training should be performed by qualified personnel. The attending physician must ensure that the patient masters the handling techniques sufficiently before the patient performs peritoneal dialysis at home. In case of any problems or uncertainty the attending physician should be contacted.

Dialysis using the prescribed doses should be performed daily.
Peritoneal dialysis should be continued for as long as renal function substitution therapy is required.

For the step-by-step instruction for use please be referred to paragraph 6.6.

Continuous ambulatory peritoneal dialysis (CAPD)
The solution bag is first warmed up to body temperature.
The heating will be performed with a heating plate. The time for heating is about 120 minutes for a 2000 ml bag at a temperature of 22 º C. Details can be read in the instruction manual of the heating plate. A microwave oven must not be used due to the risk of local overheating.

Depending on physician's instructions, the dose should dwell in the peritoneal cavity for 2 to 10 hours (equilibrium time), and then be drained.

Automated peritoneal dialysis (APD)
The connectors of the prescribed sleep safe solution bags are inserted in the free sleep safe tray ports and then automatically connected to the sleep safe tubing set by the cycler. The cycler checks the bar codes of the solution bags and gives an alarm when the bags do not comply with the prescription stored in the cycler. After this check the tubing set can be connected to the patient’s catheter extension and the treatment be started. The sleep safe solution is automatically warmed up to body temperature by the sleep safe cycler during the inflow into the abdominal cavity. Dwell times and selection of glucose concentrations are carried out according to the medical prescription stored in the cycler (for more details please refer to the operating instructions of the sleep safe cycler).