Adverse reactions : תופעות לוואי

4.8.         Undesirable effects
Undesirable effects which occurred in patients treated with Glucose 5% from the post-marketing experience are tabulated below.

The adverse drug reactions listed in this section are given following the recommended frequency convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); and not known (cannot be estimated from the available data).


Tabulated list of adverse reactions
System Organ Class                  Adverse reaction (MedDRA term)              Frequency 
Anaphylactic reaction*
Immune system disorders                                                     Not known Hypersensitivity*
Electrolyte imbalance
Hypokalaemia
Hypomagnesaemia
Metabolism and nutrition              Hypophosphatemia                      Not known disorders                             Hyperglycaemia
Dehydration
Hypervolaemia
Hospital acquired hyponatraemia**
Nervous system disorders              Hyponatraemic encephalopathy**        Not known 
Skin and subcutaneous
Rash                                  Not known tissue disorders

                                      Venous thrombosis
Vascular disorders                                                        Not known Phlebitis

Renal and urinary disorders           Polyuria                            Not known Chills*
Pyrexia*
Infusion site infection
General disorders and
Infusion site irritation for example Not known administration site erythema conditions
Extravasation
Local reaction
Pain localised
*Potential manifestation in patients with allergy to corn, see section 4.4 ** Hospital acquired hyponatraemia may cause irreversible brain injury and death due to development of acute hyponatraemic encephalopathy (see section 4.4).

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