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
Endocrine disorders
- Secondary hyperparathyroidism with potential disturbances of the bone metabolism (not known) 
Metabolism and nutrition disorders
- Increased blood sugar levels (common)
- Increase in body weight due to the continuous uptake of glucose form 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)
- Hypocalcaemia (uncommon)

General disorders and administration site conditions
- Dizziness (uncommon)
- Oedema (uncommon)
- Disturbances in fluid balance (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) indicated by redness, oedema, exudations, crusts and pain at the catheter exit site.
In case of skin exit site and 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
- In- and outflow disturbances of the dialysis solution (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