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) anaphylactic reaction*,
Immune system disorders                                             Not known hypersensitivity* hyponatraemia,
Metabolism and nutrition hyperglycaemia,                     Not known disorders hospital acquired hyponatraemia**
Nervous system disorders        hyponatraemic encephalopathy**      Not known Vascular disorders              phlebitis                           Not known Skin and subcutaneous           rash
Not known tissue disorders                pruritus



injection site reactions including:
General disorders and administration site               pyrexia conditions                                                      Not known chills infusion site pain infusion site vesicles
*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.

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