Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Possible adverse reactions may result from the peritoneal dialysis treatment itself or may be induced by the dialysis solution.

The adverse drug reactions are ranked under the headings of reporting frequency, using the following convention: very common            1/10 common                 1/100 to <1/10 uncommon               1/1,000 to <1/100 rare                   1/10,000 to <1/1,000 very rare             <1/10,000 not known             cannot be estimated from the available data

Potential adverse reactions of the peritoneal dialysis solution

Metabolism and nutrition disorders
-   Increased blood sugar levels (common)
-   Increase in body weight due to the continuous uptake of glucose from the peritoneal dialysis solution (common)
-   Hyperlipidaemia or deterioration of pre-existing hyperlipidaemia (common) 
Cardiac and vascular disorders
-   Hypotension (uncommon)
-   Tachycardia (uncommon)
-   Hypertension (uncommon)

Respiratory, thoracic and mediastinal disorders
-    Dyspnoea (uncommon)
Renal and urinary disorders
-   Electrolyte disturbances, e.g. hypokalaemia (very common)
-   Hypercalcaemia can occur (common) if calcium intake is increased, e.g. through concomitant use of calcium-containing phosphate binders.

General disorders and administration site conditions
-   Dizziness (uncommon)
-   Oedema (uncommon)
-   Disturbances in fluid balance (uncommon) indicated either by a rapid decrease (dehydration) or increase (hyperhydration) in body weight. Severe dehydration might occur when using solutions with higher glucose concentrations.

Potential adverse reactions of the treatment mode
Infections and infestations
-   Peritonitis (very common) indicated by a cloudy effluent. Subsequent abdominal pain, fever, and general malaise or, in very rare cases, sepsis may develop. 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 for the white blood cell count.
-   Skin infections at the exit site and tunnel infections (very common) indicated by redness, oedema, exudations, crusts and pain at the catheter exit site.
In case of skin infections at the exit site and of tunnel infections, the attending physician should be consulted as soon as possible.

Respiratory, thoracic and mediastinal disorders
-    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)
Injury, poisoning and procedural complications
-    Dialysis solution inflow and outflow disturbances (common)
-    Shoulder pain (common)

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.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form: https://sideeffects.health.gov.il