Source: Marketing Authorisation Holder Revision Year: 2022 Publisher: Fresenius Medical Care Deutschland GmbH, Else-Kröner-Straße 1, 61352 Bad Homburg, Germany
End-stage (decompensated) chronic renal failure of any origin treated with peritoneal dialysis.
BicaVera 1.5% Glucose, 1.25 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.
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.
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.
If a machine (sleep safe cycler) is used for intermittent or continuous 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.
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.
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, bicaVera 1.5% Glucose, 1.25 mmol/l Calcium can be used sequentially with other peritoneal dialysis solutions with higher glucose content (i.e. with 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.
BicaVera 1.5% Glucose, 1.25 mmol/l Calcium contains 15 g glucose in 1000 ml solution. According to the dosage instruction up to 30 g glucose are supplied to the body with each bag.
Peritoneal dialysis is a long-term therapy involving repeated administrations of single solutions.
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 section 6.6.
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°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.
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).
Any excess of dialysis solution infused in the peritoneal cavity can easily be drained in the drainage bag. In case of too frequent exchanges dehydration and/or electrolyte disturbances might result which necessitate immediate medical attention.
If one or more of the daily exchanges are missed or a too small solution volume has been administered, overhydration and electrolyte disturbances may develop.
Interruption or discontinuation of treatment may result in life-threatening overhydration and uraemia.
Shelf life within the container: 2 years.
Shelf life of the ready-to-use solution prepared as described in section 6.6 and without any additional drugs: 24 hours.
BicaVera stay safe/sleep safe: Do not store below 4°C.
BicaVera sleep safe combo: Store at 5°C-30°C.
One chamber contains the alkaline hydrogen carbonate solution; the other chamber contains the acidic glucose-based electrolyte solution. Mixing of both solutions (ratio 1:1) by opening the median seam between the two chambers results in the ready-touse solution.
The stay safe system is provided as a double bag system consisting of a doublechamber solution bag and a drainage bag, both with injection units, a transfer tubing system and a system connector. All components are based on polypropylene. The bags and tubings also contain synthetic elastomers. The solution bag is laminated in addition by polyester. The stay safe system is wrapped up in an outer bag made of polyolefins.
The sleep safe system is provided as a single bag system consisting of a doublechamber solution bag with an injection unit, a transfer tubing system and a bag connector. All components are based on polypropylene. The bags and tubings also contain synthetic elastomers. Further materials of the solution bag are polyester and polyamide. The sleep safe system is wrapped up in an outer bag made of polyolefines.
The sleep safe combo system is bicaVera sleep safe additionally provided with a disinfection cap and a sleep safe Set Plus for the application to the patient.
Pack sizes:
| Stay safe | sleep safe |
| 4 bags of 2000 ml | 4 bags of 3000 ml |
| 4 bags of 2500 ml | 2 bags of 5000 ml |
Sleep safe combo:
2 bags of 5000 ml + disinfection cap + sleep safe Set Plus
Not all pack sizes may be marketed.
No special requirements for disposal.
Plastic containers may occasionally be damaged during transport or storage. This can result in a contamination with growth of microorganisms in the dialysis solution. Thus all containers should be carefully inspected for damage prior to connection of the bag and prior to use of the peritoneal dialysis solution. Any damage, even minor, to connectors, at the closure, container welds and corners must be noted because of possible contamination.
Damaged bags or bags with cloudy content should never be used!
Only use the peritoneal dialysis solution if container and seal are undamaged. In case of doubt the attending physician should decide on the use of the solution.
The overwrap should only be removed before administration.
Do not use before the two solutions have been mixed.
Aseptic conditions must be maintained during dialysate exchange in order to reduce the risk of infection.
The solution bag is first warmed to body temperature. This should be done by using an appropriate bag warmer. The heating time for a 2000 ml bag with a starting temperature of 22°C is approximately 120 min. More detailed information can be obtained from the operating instructions of the bag warmer. A microwave oven must not be used to warm the solution due to the risk of local overheating. After warming the solution you can start with the exchange of the bags.
During automated peritoneal dialysis (APD) the solution is warmed automatically by the cycler.
Medicinal products must be added under aseptic conditions only when medically prescribed.
Because of the risk of incompatibility between the dialysis solution and the added medicinal products only the following medicinal products may be added up to the mentioned concentration if indicated by the attending physician: heparin 1000 I.U./l, insulin 20 I.U./l, vancomycin 1000 mg/l, teicoplanin 400 mg/l, cefazolin 500 mg/l, ceftazidime 250 mg/l, gentamycin 8 mg/l. After thorough mixing and checking for the absence of any turbidity the peritoneal dialysis solution must be used immediately (no s
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