Adverse reactions : תופעות לוואי

4.8. Undesirable effects
The following adverse reactions have been reported in post-marketing experience. The frequency of the adverse drug reactions listed in this section cannot be estimated from the available data.

System Organ Class (SOC)            Adverse reactions (Preferred Term)                      Frequency Nervous system disorders             Tremor                                                    Not known Acute hyponatraemic encephalopathy*

Metabolism and nutrition disorders Hospital acquired hyponatraemia*                            Not known Vascular disorders                   Hypotension                                               Not known 
Skin and subcutaneous tissue         Urticaria Rash                                            Not known disorders                            Pruritus
General disorders and                Infusion site reactions, such as: administration site conditions:       • Infusion site erythema,
• Vein irritation, Injection site streaking,
burning sensation,                                   Not known
• Local pain or reaction , Infusion site
urticaria
• Infection at the site of injection,
Venous thrombosis or phlebitis
extending from the site of injection,
extravasation and hypervolemia
• Pyrexia
• Chills

* Hospital acquired hyponatraemia may cause irreversible brain injury and death, due to development of acute hyponatraemic encephalopathy, frequency unknown (see sections 4.4, 4.5).

The following adverse reactions have not been reported with this product but may occur:
• Hypernatraemia (e.g., when administered to patients with nephrogenic diabetes insipidus or high nasogastric output).
• Hyperchloraemic metabolic acidosis
• Hyponatraemia, which may be symptomatic. Hyponatraemia may occur when normal free water excretion is impaired (e.g., SIADH or postoperative)

General adverse effects of sodium excess are described in section 4.9 Overdose.

Additives
When Sodium Chloride 0.9% is used as a diluent for injectable preparations of other drugs, the nature of additives will determine the likelihood of any other undesirable effect.

If an adverse event occurs the patient should be evaluated and appropriate counter measures be started, if needed the infusion should be stopped. The remaining part of the solution should be kept for investigation if deemed necessary.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization 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