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 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: It may be necessary to use a peritoneal dialysis solutions with a higher calcium concentration either temporarily or permanently, in case an adequate enteral supply with calcium by calcium-containing phosphate binders and/or vitamin D is not possible.
- 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 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 glucose load.
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 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 balance and blood proteins, -   serum creatinine and urea,
-   blood sugar,
-   parathormone and other indicators of bone metabolism,
-   residual renal function in order to adapt the peritoneal dialysis treatment.

CAPD 17 contains 15 g glucose CAPD 19 contains 22.73 g              CAPD 18 contains 42.5 g in 1000 ml solution. Depending glucose in 1000 ml solution.         glucose in 1000 ml solution.
on the dosage instructions and Depending on the dosage              Depending on the dosage the pack size used up to 45 g    instructions and the pack size     instructions and the pack size glucose (CAPD 3000 ml            used up to 68.19 g glucose         used up to 127.5 g glucose stay•safe) or 75 g glucose       (CAPD 3000 ml stay•safe) or        (CAPD 3000 ml stay•safe) or (APD, 5000 ml sleep•safe) are 113.65 g glucose (APD, 5000           212.5 g glucose (APD, 5000 ml supplied to the body with each ml sleep•safe) are supplied to       sleep•safe) are supplied to the bag.                             the body with each bag.            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 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.



Effects on Driving

4.7   Effects on ability to drive and use machines
CAPD 17/18/19 has no or negligible influence on the ability to drive and use machines.