BALANCE

Posology This solution is indicated exclusively for 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 prescribed, 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, 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 volume of 2500-3000 ml solution per exchange may be given.

Paediatric population:

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 (cycler) is used for intermittent or continuous cyclic peritoneal dialysis. The use of larger bags 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.

Paediatric population:

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 the elderly.

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 handle the peritoneal membrane with care, to prevent dehydration and in order to keep the glucose burden as low as possible.

Peritoneal dialysis is a long-term therapy involving repeated administrations of single solutions. 75 mmol/l calcium contains 15 g glucose in 1000 ml solution. Method of administration Before performing peritoneal dialysis at home, the patient must be trained appropriately, must practice the technique and be shown to be proficient.

The training should be performed by qualified personnel. The attending physician must ensure that the patient masters the handling techniques sufficiently before being discharged to carry out 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 and should be continued for as long as renal function substitution therapy is required. Continuous ambulatory peritoneal dialysis (CAPD): stay•safe bag The solution bag is first warmed up to body temperature.

6. The appropriate dose is infused in the peritoneal cavity using a peritoneal catheter over 5 - 20 minutes. 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): sleep•safe bag 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).

Automated peritoneal dialysis (APD):

Safe•Lock bag The connectors of the prescribed Safe•Lock solution bags are connected manually to the tubing set of the cycler. The Safe•Lock solution is placed on the heater plate of the cycler for warming of the solution that will be transferred to the abdominal cavity of the patient during the treatment.

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). , with higher osmolarity).

75 mmol/l calcium is an electrolyte solution the composition of which is similar to blood. In addition, the solution has a neutral pH which is similar to the physiological pH value. Possible adverse reactions may result from the peritoneal dialysis itself or may be induced by the peritoneal dialysis solution.

g. g. by the administration of calcium-containing phosphate binders (common) General disorders - Dizziness (uncommon) - Oedema (uncommon) - Disturbances in hydration (uncommon) indicated either by a rapid decrease (dehydration) or increase (overhydration) in body weight.

Severe dehydration might occur when using solutions of higher glucose concentration. Potential adverse reactions of the treatment mode Infections and infestations - Peritonitis (very common) 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 (very common).

In case of skin exit site and tunnel infections the attending physician should be consulted as soon as possible. - Sepsis (very rare) Respiratory, thoracic and mediastinal disorders - Shoulder pain (common) - Dyspnoea caused by the elevated diaphragm (not known) Gastrointestinal disorders - Hernia (very common) - Abdominal distension and sensation of fullness (common) - Diarrhoea (uncommon) - Constipation (uncommon) - Encapsulating peritoneal sclerosis (not known) General disorders and administration/catheter site conditions - Redness, oedema, exudations, crusts and pain at the catheter exit site (very common) - In- and outflow disturbances of the dialysis solution (common) - General malaise (not known) 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.

The solution for peritoneal dialysis must not be used for intravenous infusion. g. due to the administration of calcium-containing phosphate binders and/or vitamin D (a temporary or permanent change to a peritoneal dialysis solution with a lower calcium concentration should be considered).

• loss of electrolytes due to vomiting and/or diarrhoea (a temporary change to a peritoneal dialysis solution containing potassium might then become necessary). 5). Severe hypokalaemia may necessitate the use of a potassium-containing dialysis solution together with dietary counselling.

• patients with large polycystic kidneys. 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. Regular 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, blood gases 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.

The effluent should be checked for clarity and volume. Turbidity and/or abdominal pain are indicators of peritonitis. Encapsulating peritoneal sclerosis is considered to be a known, rare complication of peritoneal dialysis therapy which can infrequently lead to fatal outcome.

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

25 mmol/l calcium must not be used in patients with lactic acidosis, severe hypokalaemia and severe hypocalcaemia. 25 mmol/l calcium must not be used in patients with lactic acidosis, severe hypokalaemia, severe hypocalcaemia, hypovolaemia and arterial hypotension.

75 mmol/l calcium must not be used in patients with lactic acidosis, severe hypokalaemia and severe hypercalcaemia. 75 mmol/l calcium must not be used in patients with lactic acidosis, severe hypokalaemia, severe hypercalcaemia, hypovolaemia and arterial hypotension.

For peritoneal dialysis in general Peritoneal dialysis should not be commenced if any of the following are present: - 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), - 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 where 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, the attending physician will have to decide on how to proceed.