Adverse reactions : תופעות לוואי

4.8 Undesirable effects
The following adverse reactions are classified by system organ class and ranked under heading of frequency using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 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.


System organ class                Frequency                   Adverse Reaction 
Infections and infestations       Not known                   Fever
Immune system disorders           Not known                   Hypersensitivity Nervous system disorders          Not known                   Cerebral haemorrhage; Cerebral subdural haematoma
Vascular disorders                Not known                   Haemorrhage Respiratory, thoracic and         Not known
Haemothorax, epistaxis
mediastinal disorders
Gastrointestinal disorders        Not known                   Gastroinestinal haemorrhage, rectal haemorrhage,
haematemesis; pancreatitis;
diarrhoea; nausea; vomiting;
melaena
Hepatobiliary disorders           Not known                   Jaundice; hepatic dysfunction Skin and subcutaneous             Not known                   Rash; alopecia; purpura; 'purple disorders                                                     toes' syndrome; erythematous swollen skin patches leading to

ecchymosis, infarction and skin
necrosis; calciphylaxis
Renal and Urinary disorders        Not known                    Haematuria Investigations                     Not known                    Unexplained drop in haematocrit; haemoglobin
decreased

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization 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