Adverse reactions : תופעות לוואי

4.8   Undesirable effects

The frequencies of undesirable effects are defined as follows: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), very rare (<1/10,000) and not known (cannot be estimated from the available data).

Immune system disorders
Not known: Hypersensitivity including rash, erythema, urticaria, angioedema, pruritus. Re- injected Ceretec labelled leukocytes only:
Not known: Hypersensitivity including rash, erythema, urticaria, angioedema, pruritus, anaphylactoid reaction or anaphylactoid shock.

Nervous system disorders
Not known: Headache, dizziness, paraesthesia

Vascular disorders
Not known: Flushing
Gastrointestinal disorders
Not known: Nausea, vomiting

General disorders and administration site conditions
Not known: Asthenic conditions (e.g., malaise, fatigue)
Exposure to ionising radiation is linked with cancer induction and a potential for developing hereditary defects. As the effective dose is 5.2 mSv when the maximal recommended activity of 555 MBq is administered, these adverse events are expected to occur with a low probability.

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