Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use
The solution for peritoneal dialysis must not be used for intravenous infusion.

CAPD 2/3/4 should only be administered after careful benefit-risk assessment in: -  loss of electrolytes due to vomiting and/or diarrhoea (a temporary switch to peritoneal dialysis solution containing potassium may then become necessary).
-  hypercalcaemia, e.g. resulting from high doses of calcium-containing phosphate binders and/or vitamin D, a temporary or permanent switch to a solution with a lower calcium content may be necessary.
-  patients receiving digitalis therapy: regular monitoring of the serum potassium level is mandatory.
Severe hypokalaemia may require the use of a potassium-containing dialysis solution together with dietary counselling.

Peritoneal dialysis solutions with a high glucose concentration (2.3 % or 4.25 %) should be used cautiously to protect the peritoneal membrane, to prevent dehydration and to reduce the high glucose intake. CAPD solution is not biocompatible.

A loss of proteins, amino acids and water-soluble vitamins occurs during peritoneal dialysis. To avoid deficiencies, an adequate diet or dietary supplementats should be ensured.

The peritoneal membrane transport characteristics 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 hyper- and dehydration,
- serum sodium, potassium, calcium, magnesium, phosphate levels, acid-base balance and blood proteins,
-   serum creatinine and urea,
-   blood sugar,
-   parathormone and other indicators of bone metabolism,
-   residual renal function in order to adjust the peritoneal dialysis treatment.

CAPD 2 contains 15 g glucose in 1000 ml solution. Depending on the dosage instructions and on the used pack size, up to 38 g glucose (CAPD: 2500 ml stay•safe) or up to 90 g glucose (APD: 6000 ml sleep•safe or safe•lock) are supplied to the body with each bag. This should be taken into account in patients with diabetes mellitus.
CAPD 3 contains 42.5 g glucose in 1000 ml solution. Depending on the dosage instructions and on the used pack size, up to 106 g glucose (CAPD: 2500 ml stay•safe) or up to 255 g glucose (APD: 6000 ml sleep•safe or safe•lock) are supplied to the body with each bag. This should be taken into account in patients with diabetes mellitus.
CAPD 4 contains 22.73 g glucose in 1000 ml solution. Depending on the dosage instructions and on the used pack size, up to 57 g glucose (CAPD: 2500 ml stay stay•safe ) or up to 136 g glucose (APD: 6000 ml sleep•safe or safe•lock ) are supplied to the body with each bag. This should be taken into account in patients with diabetes mellitus.

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 sometimes have a fatal outcome.

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

Effects on Driving

4.7 Effects on ability to drive and use machines
CAPD 2/3/4 has no or negligible influence on the ability to drive and use machines.