Adverse reactions : תופעות לוואי

4.8     Undesirable effects

Provided the product is used in accordance with the directions given, undesirable effects are not to be expected.

The following side effects, which are not directly related to the product but to the conditions of administration, underlying disorders or accompanying treatment, may occur: 
Metabolism and nutrition disorders
Not known: Hospital Acquired Hyponatraemia

– Hypokalemia may be related to insulin therapy. In addition, hypokalaemia, hypomagnesaemia and hypophosphataemia may be caused by refeeding with glucose especially in malnourished patients.
– Abrupt discontinuation and/or insulin application may cause rebound hypoglycemia, especially in patients with glucose tolerance disorders.

Neurological disorders :
Not known: Hyponatraemic encephalopathy

Hospital acquired hyponatraemia may cause irreversible brain injury and death due to development of acute hyponatraemic encephalopathy (see sections 4.2 and 4.4) 
Vascular disorders
Thrombophlebitis may be caused by osmolarities above 800 mmol/l. The osmolarity of the added medication should be kept in mind.

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)