BICAVERA

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.

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) A machine is used for intermittent or continuous cyclic peritoneal dialysis. The use of larger volume bags (3000 or 5000 ml) is recommended providing more than one solution exchange.

The cycler performs the solution exchanges according to the medical prescription stored in the 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.

e. with higher osmolarity). 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.

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.

Method 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.

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 22º 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 tray ports and then automatically connected to the 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 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 cycler).

25 mmol/l Calcium is an electrolyte solution which composition is similar to blood. In addition, the physiological buffer bicarbonate is used. Possible adverse reactions may result from the peritoneal dialysis itself or may be induced by the peritoneal dialysis solution.

g. g. Hypocalcaemia uncommon Dizziness uncommon Oedema uncommon General disorders and administration site conditions Disturbances in hydration uncommon Potential adverse reactions of the treatment mode: System Organ Class Preferred Term Frequency Peritonitis very commonInfections and infestations Skin exit site and tunnel infections very common Respiratory, thoracic and mediastinal disorders Dyspnoea caused by the elevated diaphragm not known Diarrhoea uncommon Constipation uncommon Hernia very common Abdominal distension and sensation of fullness common Gastrointestinal disorders Encapsulating peritoneal sclerosis not known In- and outflow disturbances of the dialysis solution commonInjury, poisoning and procedural complications Shoulder pain common Peritonitis is indicated by a cloudy effluent.

Later abdominal pain, fever, and general malaise may develop or, in very rare cases, sepsis. The patient should seek medical advice immediately. The bag with the cloudy effluent should be closed with a sterile cap and assessed for microbiological contamination and white blood cell count.

Skin exit site and tunnel infections are indicated by redness, oedema, exudations, crusts and pain at the catheter exit site. In case of skin exit site and tunnel infections the attending physician should be consulted as soon as possible.

Disturbances in hydration is indicated by a rapid decrease (dehydration) or increase (overhydration) in body weight. Severe dehydration might occur when using solutions of higher glucose concentration. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

25 mmol/l Calcium may only be administered after careful benefit-risk assessment in: - patients with loss of electrolytes due to vomiting and/or diarrhoea. - patients with hypocalcaemia: It may be necessary to use a peritoneal dialysis solution with a higher calcium concentration either temporarily or permanently, in case an adequate enteral supply of calcium, by calcium-containing phosphate binders and/or vitamin D, is not possible.

- patients with hyperparathyroidism: The administration of calcium-containing phosphate binders and/or vitamin D may be considered to ensure adequate enteral calcium supply. - 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. - patients with large polycystic kidneys. The natural metabolic acidosis due to renal failure might not be totally compensated by the 34 mmol/l bicarbonate level of the final solution.

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.

25 mmol/l Calcium must not be used in patients with severe hypokalaemia and severe hypocalcaemia. This peritoneal dialysis solution must not be used for intravenous infusion. For peritoneal dialysis in general Peritoneal dialysis should not be commenced in case of - recent abdominal surgery or injury, a history of abdominal operations with fibrous adhesions, severe abdominal burns, bowel perforation, - extensive inflammatory conditions of the abdominal skin (dermatitis), - inflammatory bowel diseases (Crohn's disease, ulcerative colitis, diverticulitis), - localized peritonitis, - internal or external abdominal fistula, - umbilical, inguinal or other abdominal hernia, - intra-abdominal tumours, - ileus, - pulmonary disease (especially pneumonia), - sepsis, - extreme hyperlipidaemia, - in rare cases of uraemia, which cannot be managed by peritoneal dialysis, - cachexia and severe weight loss, particularly in cases in which the ingestion of adequate protein is not guaranteed, - patients who are physically or mentally incapable of performing peritoneal dialysis as instructed by the physician.

If any of the above mentioned disorders develops during the peritoneal dialysis treatment, the attending physician has to decide on how to proceed.