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.

Adverse reactions
System Organ Class                                                Frequency (Preferred terms)
Hypervolaemia                    Not known
Metabolism and nutrition         Electrolyte imbalance            Not known disorders                        Hospital acquired
Not known hyponatraemia*
Hyponatraemia*                    Not known
Hyponatraemic
Nervous system disorders                                            Not known encephalopathy**
Cardiac disorders                 Cardiac failure                   Not known Renal and urinary disorders       Polyuria                          Not known Hypersensitivity                  Not known
Immune system disorders
Anaphylactic reaction             Not known
*Potential manifestation in patients with allergy to corn, see section 4.4 ** Hospital acquired hyponatraemia may cause irreversible brain injury and death due to development of acute hyponatraemic encephalopathy (see sections 4.2 and 4.4).

Adverse reactions may be associated to the medicinal product(s) added to the solution; the nature of the additive will determine the likelihood of any other adverse reactions.

Adverse reactions
System Organ Class                                                 Frequency (Preferred terms)
Metabolism and nutrition
Hypervolaemia                     Not known disorders
Vein injury                       Not known
Vascular disorders
Thrombophlebitis superficial      Not known
Chills                            Not known
Pyrexia                           Not known
Application site infection        Not known
General disorders and
Application site pain             Not known administration site conditions
Application site reaction         Not known
Injection site phlebitis          Not known
Injection site extravasation      Not known

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 and emailed to the Registration Holder’s Patient Safety Unit at: drugsafety@neopharmgroup.com