Presentation and Status in Health Basket
6 bags X 1,500 ml
4 bags X 2,000 ml
4 bags X 2,500 ml
4 bags X 3,000 ml
2 bags X 5,000 ml
CAPD/DPCA 17/18/19 is exclusively indicated 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): Unless otherwise prescribed, patients will receive 2,000 ml solution per exchange four times a day (corresponding to a daily dose of 8,000 ml). After a dwell time between 2 and 10 hours the solution will be drained. Adjustment of dosage will be necessary for individual patients. If pain due to abdominal distension occurs at the commencement of peritoneal dialysis treatment, the solution volume per exchange should be reduced. Children receive 500 and 1,500 ml (30 – 40 ml/kg body weight) of the solution per treatment, depending on weight. In large adults and/or patients who tolerate higher volumes, and if residual renal function is lost, the volume to be administered is increased to 2,500 – 3,000 ml.
Automated peritoneal dialysis (APD): If a machine (sleep.safe cycler) is used for intermittent or continuous cyclic peritoneal dialysis, larger volume bags (5,000 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. Peritoneal dialysis is a long term therapy involving repeated administration by the same method.
Method and duration of administration: Patients should be 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.
Continuous ambulatory peritoneal dialysis (CAPD): The ready-to-use solution is first warmed to body temperature. For bags with a volume up to 3,000 ml this should be done using an appropriate heater tray. The heating time for a 2,000 ml bag with a starting temperature of 22°C is approx. 120 min. The temperature control is done automatically and is set to 39°C ± 1°C. More detailed information can be obtained from the operating instructions of the bag warmer. Use of microwaves is not recommended due the risk of local overheating.
End-stage (decompensated) chronic renal failure of any origin which can be treated with peritoneal dialysis.
For this specific peritoneal dialysis solution: CAPD/DPCA 17 must not be used in patients with lactic acidosis, severe hypokalaemia, and severe hypocalcaemia.
CAPD/DPCA 18/19 must not be used in patients with lactic acidosis, severe hypokalaemia, severe hypocalcaemia, hypovolaemia and arterial hypotension.
Due to the content of fructose, this medicinal product is unsuitable for patients with fructose intolerance (hereditary fructose intolerance). A non-recognised hereditary fructose intolerance must be excluded prior to administration to babies and infants. For peritoneal dialysis treatment in general: A peritoneal dialysis treatment should not be commenced in the following circumstances: Recent abdominal surgery or injury, a history of abdominal operations with fibrous adhesions, severe abdominal burns, abdominal perforation, Extensive inflammation of the abdominal skin (dermatitis), Inflammatory bowel diseases (Crohn’s disease, ulcerative colitis, diverticulitis), Localised 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 an adequate protein supplementation is not guaranteed, Patients who are physically or mentally incapable of performing PD as instructed by the physician.
CAPD/DPCA 17/18/19 should only be administered after careful benefit-risk assessment in: Loss of electrolytes due to vomiting and/or diarrhoea (a temporary change to a peritoneal dialysis solution containing potassium might then become necessary). Hyperparathyroidism: The therapy should comprise the administration of calcium-containing phosphate binders and/or vitamin D to ensure adequate enteral calcium supply. Hypocalcaemia: A change to a peritoneal dialysis solution with a higher calcium concentration must be considered in case an adequate enteral supply with calcium by calcium-containing phosphate binders and/or vitamin D is not possible. Digitalis therapy: Regular monitoring of the serum potassium level is mandatory. Severe hypokalaemia may necessitate the use of a potassium-containing dialysis solution as well as dietary counselling. Peritoneal dialysis solutions with a high glucose concentration (2.3 % or 4.25 %) should be used cautiously to treat the peritoneal membrane with care, to prevent dehydration and to reduce the glucose load. A loss of proteins, amino acids, and vitamins (especially water-soluble vitamins) is unavoidable 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-hydration and dehydration. Serum sodium, potassium, calcium, magnesium, phosphate, acid base balance and blood proteins. Serum creatinine and urea. Blood sugar. Parathyroid hormone and other indicators of bone metabolism. Residual renal function in order to adapt the peritoneal dialysis treatment. It is mandatory to monitor for turbidity of the effluent, decreased effluent volume, and abdominal pain as they may be indicators of peritonitis.
Addition of medication to the peritoneal dialysis solution: The addition of medication to the peritoneal dialysis solution is generally not recommended because of the risk of contamination and of incompatibility between the peritoneal dialysis solution and the medication. It must be carried out under aseptic conditions. After thorough mixing and checking for the absence of any turbidity the peritoneal dialysis solution must be used immediately (no storage).
Handling: 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.
Possible side effects may result either from the technique of the peritoneal dialysis itself or may be induced by the dialysis solution. Potential adverse reactions of the peritoneal dialysis solution are: Hyperparathyroidism may develop or be aggravated, Electrolyte disturbances, e.g. hypokalaemia, hypocalcaemia, Disturbances in fluid balance. A rapid loss in body weight, drop in blood pressure and/or tachycardia might indicate dehydration; oedema, hypertension and possibly dyspnoea might indicate overhydration, Increased blood sugar levels, Hyperlipidaemia or deterioration of pre-existing hyperlipidaemia, Increase of body weight.
Potential side effects of the treatment mode are: Eritonitis, indicated by cloudy dialysate. Later, abdominal pain, fever and malaise (generally feeling unwell) may develop or, in very rare cases, generalised blood poisoning (sepsis), Skin exit site infection or tunnel infection of the catheter indicated by redness, swelling, pain, weeping or scabs. In case of any sign of infection the attending physician must be consulted immediately, In and outflow disturbances of the dialysis solution.
Diarrhoea or obstipation, Dyspnoea caused by the elevated diaphragm, Hernia, Abdominal distension and feeling of fullness (abdominal pain), Shoulder pain.
The use of this peritoneal dialysis solution can yield to a loss of efficacy of other medication if these are dialysable through the peritoneal membrane. A dose adjustment might become necessary. A distinct reduction of the serum potassium level can increase the frequency of digitalis-associated adverse reactions. Special attention and monitoring is required in the case of hyperparathyroidism. Therapy should include the administration of calcium-containing phosphate binders and/or vitamin D to ensure adequate enteral calcium supply. Use of diuretic agents may help maintain residual renal function, but may also result in water and electrolyte imbalances. In diabetics the daily dose of blood sugar reducing medication must be adjusted to the increased glucose intake.
Pregnancy and Lactation
No adequate or well-controlled studies with CAPD/DPCA 17/18/19 have been performed in pregnant or lactating women. No animal reproductive toxicity studies have been performed. Peritoneal dialysis with CAPD/DPCA 17/18/19 is not recommended during pregnancy or breast feeding, unless in the opinion of the Physician, its potential benefit outweighs the likely risk to the mother or the child.
Any excess of dialysis solution which has flowed into the peritoneal cavity can easily be drained into the drainage bag. In case of too frequent or too rapid exchanges, dehydration and/or electrolyte disturbances might result which necessitates immediate emergency treatment. If one or more of the daily exchanges have been forgotten or the administered volume of solution was too low, over-hydration and electrolyte disturbances may occur. If the treatment is interrupted or stopped completely life threatening oedema and uraemia may develop.