Adverse reactions : תופעות לוואי

4.8 Undesirable effects
General disorders and administration site conditions can be provoked.
Inadequate or excessive administration of physiologic saline solution can produce hyperhydration, hypernatremia, hyperchloremia and related signs such as metabolic acidosis because of decrease of bicarbonate concentration and oedema formation.
An excess of sodium chloride can produce nausea, vomiting and headache.
When Sodium chloride 9 mg/ml, solvent for parenteral use is used as a diluent of injectable preparations, the nature of the product added determine the probability of appearance of undesirable effects.
In case adverse reactions due to the associated medicine are shown, infusion should be immediately discontinued, the patient should be evaluated, suitable corrective measures should be established and the solution should be kept for a later analysis in case it was necessary.
Adverse reactions may be associated to the technique of administration including febrile response, infection at the site of injection, local pain or reaction, vein irritation, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.
Rare case of central pontine myelinolysis (a potentially severe of lethal demyelinating disorder to the central nervous system) have been reported.

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