Adverse reactions : תופעות לוואי

4.8     Undesirable effects

The following adverse reactions have been reported in the post-marketing experience, with various electrolyte solutions similar to Plasma-lyte, listed by MedDRA System Organ Class (SOC), then by Preferred Term in order of severity, where feasible.
Frequency is defined as very common (≥1/10); common (≥1/100 to < 1/10); uncommon (≥1/1000 to < 1/100): rare (≥1/10,000 to < 1/1000); very rare (< 1/10,000); and not known (cannot be estimated from the available data)

System Organ Class (SOC)      MedDRA Preferred Term                                Frequency Immune system disorders      Hypersensitivity/infusion reaction                    Not known (including Anaphylactoid reaction, and the following manifestations:
Tachycardia,
Palpitations,
Chest pain,
Chest discomfort, Dyspnea,
Respiratory rate increased,
Flushing,
Hyperaemia,
Asthenia,
Feeling abnormal, Piloerection,
Oedema peripheral, Pyrexia
Urticaria
*Hypotension, Wheezing, Cold sweat,
Chills, Hyperkalaemia)
Metabolism and nutrition     Hypervolaemia                                         Not known disorders                    Hospital acquired hyponatraemia**
Nervous system disorders     Seizures                                              Not known Acute hyponatraemic encephalopathy**
Vascular disorders           Thrombophlebitis                                      Not known Venous thrombosis                                     Not known
Skin and subcutaneous        Urticaria                                             Not known tissue disorders
General disorders and        Infusion site reactions                               Not known administration site                  (e.g., Burning sensation conditions                           Fever
Injection site pain
Injection site reaction
Injection site phlebitis
Injection site irritation
Injection site infection
Extravasation)
Investigations               False positive laboratory results (Bio-Rad            Not known Laboratories’ Platelia Aspergillus EIA test)
(see Section 4.4)

* The adverse reactions highlighted in italic are reported for other similar products **Hospital acquired hyponatraemia may cause irreversible brain injury and death, due to development of acute hyponatraemic encephalopathy, frequency unknown (see sections 4.2. 4.4, 4.5).


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/