Adverse reactions : תופעות לוואי

4.8 Undesirable effects
The following adverse reactions have been reported in post-marketing experience, listed by MedDRA System Organ Class (SOC), then where feasible, by Preferred Term in order of severity.

Frequencies cannot be estimated from the available data as all listed adverse reactions are based on spontaneous reporting, with the exception of "hyponatremia" in the pediatric population, for which there are references to literature on clinical trials.

The frequency of adverse reactions is based on the recommended frequency scale: 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), and not known (cannot be estimated from the available data).


Tabulated list of adverse reactions associated with these solutions

Adverse reactions
System Organ Class                                                       Frequency (Preferred Terms)
Hypervolemia                             Very
Hyponatremia                           common
Metabolism and nutrition disorders          Electrolyte imbalance                  Unknown Hospital-acquired                      Unknown hyponatremia**                        Not known
Nervous system disorders                     Hyponatremic encephalopathy**         Not known Cardiac disorders                            Heart failure                          Unknown Anaphylactic reaction*
Immune system disorders                                                             Unknown Hypersensitivity*
Renal and urinary disorders                  Polyuria                               Unknown Tabulated list of adverse reactions associated with the administration method (for example, intravenous administration)

Adverse reactions
System Organ Class                                                    Frequency (Preferred Terms)
Metabolism and nutrition disorders             Hypervolemia                     Unknown Vein damage
Vascular disorders                                                               Unknown Superficial thrombophlebitis
Pyrexia
Chills
Injection site infection
General disorders and administration site
Injection site pain              Unknown conditions
Injection site reaction
Injection site phlebitis
Extravasation
* Potential manifestation in patients with allergy to corn (see section 4.4) ** Hospital-acquired hyponatremia may cause irreversible brain damage and death due to development of acute hyponatremic encephalopathy (see sections 4.2 and 4.4).

For all patients, a gradual increase of flow rate should be considered when starting administration of glucose-containing products.

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.