Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Bica Vera 2.3% Glucose, 1.75 mmol/l Calcium is an electrolyte solution which composition is similar to blood.
In addition the physiological buffer bicarbonate is used.

Possible adverse reactions may result from the peritoneal dialysis itself or may be induced by the peritoneal 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:

System Organ Class                  Preferred Term                                  Frequency Metabolism and nutrition            Increased blood sugar levels                    common disorders                           Hyperlipidaemia                                 common Increase in body weight due to the              common continuous uptake of glucose from the peritoneal dialysis solution
Cardiac and vascular                Hypotension                                     uncommon disorders                           Tachycardia                                     uncommon Hypertension                                    uncommon
Respiratory, thoracic and           Dyspnoea                                        uncommon mediastinal disorders
Renal and urinary disorders         Electrolyte disturbances, e.g                   very common Hypokalaemia
Electrolyte disturbances, e.g                   uncommon
Hypercalcaemia
General disorders and               Dizziness                                       uncommon administration site                 Oedema                                          uncommon conditions                          Disturbances in hydration                       uncommon 
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Potential adverse reactions of the treatment mode
System Organ Class                  Preferred Term                                  Frequency Infections and infestations         Peritonitis                                     very common Skin exit site and tunnel infections            very common
Respiratory, thoracic and          Dyspnoea caused by the elevated                 not known mediastinal disorders              diaphragm
Gastrointestinal disorders         Diarrhoea                                       uncommon Constipation                                    uncommon
Hernia                                          very common
Abdominal distension and sensation of           common fullness
Encapsulating peritoneal sclerosis              not known
Injury, poisoning and              In- and outflow disturbances of the             common procedural complications           dialysis solution
Shoulder pain                                   common

Peritonitis is indicated by 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 are 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.

Disturbances in hydration is indicated by a rapid decrease (dehydration) or increase (overhydration) in body weight.
Severe dehydration might occur when using solutions of higher glucose concentration.

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