Adverse reactions : תופעות לוואי

4.8   Undesirable effects
The adverse reactions reported from clinical studies and post-marketing experience are listed below according to system organ class.

Tabulated list of adverse reactions
Adverse reactions reported are presented in the table below. Adverse reactions are listed according to MedDRA primary system organ class. Within each system organ class, adverse reactions are ranked by frequency. Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. Frequencies were defined as follows: Common (>1/100 to <1/10); uncommon (>1/1,000 to <1/100), not known (can not be estimated from the available data).

MedDRA                   Frequency               Undesirable Effects
System Organ Class

Immune system disorders                Not known
- Hypersensitivity reactions including anaphylaxis
Nervous system disorders               Not known - Dizziness, Convulsions particularly in case of misuse (refer to sections 4.3 and 4.4)

Eye disorders                          Not known - Visual disturbances including impaired colour vision 
Vascular disorders                     Not known
- Malaise with hypotension, with or without loss of consciousness (generally following a too fast intravenous injection, exceptionally after oral administration)
- Arterial or venous thrombosis at any sites

Gastrointestinal disorders             Common      - Diarrhoea
- Vomiting
- Nausea


Skin and subcutaneous
Uncommon - Dermatitis allergic tissues disorders


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.