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          Adverse reactions (Preferred Term)          Frequency (SOC)
Nervous system disorders     Tremor                                        Not known Acute hyponatraemic encephalopathy*
Metabolism and nutrition     Hospital acquired hyponatraemia*              Not known disorders
Vascular disorders           Hypotension                                   Not known 
Skin and subcutaneous        Urticaria
Not known tissue disorders             Rash
Pruritus
General disorders and        Infusion site reactions, such as administration site           • Infusion site erythema conditions:                   • Vein irritation, injection site
Not known streaking, burning sensation
• 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 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