Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Bica Vera 4.25% 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
System Organ Class                                    Preferred Term                                                          Frequency Metabolism and nutrition disorders                    Increased blood sugar levels                                            common Hyperlipidaemia                                                         common Increase in body weight due to the continuous uptake of glucose from common the peritoneal dialysis solution
Cardiac disorders                                     Tachycardia                                                             uncommon Vascular disorders                                    Hypotension                                                             uncommon Hypertension                                                            uncommon Respiratory, thoracic and mediastinal disorders       Dyspnoea                                                                uncommon Renal and urinary disorders                           Electrolyte disturbances, e.g. Hypokalaemia                             very common Electrolyte disturbances, e.g. Hypercalcaemia                           uncommon General disorders and administration site conditions Dizziness                                                                uncommon Oedema                                                                  uncommon Disturbances in hydration                                               uncommon 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 mediastinal disorders       Dyspnoea caused by the elevated diaphragm                                not known Gastrointestinal disorders                            Diarrhoea                                                                uncommon Constipation                                                             uncommon Hernia                                                                   very common Abdominal distension and sensation of fullness                           common Encapsulating peritoneal sclerosis                                       not known Injury, poisoning and procedural complications        In- and outflow disturbances of the dialysis solution                    common Shoulder pain                                                            common 
Peritonitis is 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 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