Adverse reactions : תופעות לוואי

4.8. UNDESIRABLE EFFECTS
the following undesirable effects have been reported to have occurred during or following infusion of Sodium Chloride 0.45% Solution for Infusion.


System Organ Class                  Symptoms (LLT terms MedDRA)
Metabolism and nutrition disorders   Overhydration* (associated or not with polyuria) in patients with cardiac disorder or pulmonary oedema
Asymptomatic electrolyte disturbance
Hyponatraemia
Hospital acquired hyponatraemia**
Nervous system disorders             Acute hyponatraemic encephalopathy** Cardiac disorders                    Heart failure in patients with cardiac disorder or pulmonary oedema
Vascular disorders                   Thrombophlebitis*
Venous thrombosis*
General disorders and administration Fever*
site conditions                      Injection site pain*
Injection site reaction*
Injection site phlebitis*
Injection site irritation*
Injection site infection*
Extravasation*

The frequency of the adverse drug reactions listed in this section cannot be estimated from the available data

* Adverse reactions associated with the technique of administration
**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).


The following adverse reactions have not been reported with this product but may occur: • Hyperchloraemic metabolic acidosis
• Infusion reactions, including hypotension, tremor, chills, urticaria, rash, and pruritus.

Adverse reactions may be associated to the medicinal products added to the solution; the nature of the additive will determine the likelihood of any other undesirable effects.

If an adverse event occurs the patient should be evaluated and appropriate countermeasures started, if needed the infusion should be stopped.

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/