Adverse reactions : תופעות לוואי

4.8   Undesirable effects
The following undesirable effects are recognised for DaTSCAN:
Tabulated summary of adverse reactions
The frequencies of adverse reactions are defined as follows:
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). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Immune system disorders
Not known: Hypersensitivity
Metabolism and nutrition disorders
Uncommon: Appetite increased
Nervous system disorders
Common: Headache
Uncommon: Dizziness, formication (paraesthesia), dysgeusia
Ear and labyrinth disorders
Uncommon: Vertigo
Skin and subcutaneous tissue disorders
Not known: Erythema, pruritus, rash, urticaria, hyperhidrosis
Respiratory, thoracic and mediastinal disorders
Not known: Dyspnea
Gastrointestinal disorders
Uncommon: Nausea, dry mouth
Not known: Vomiting

Vascular disorders
Not known: Blood pressure decreased

General disorders and administration site conditions
Uncommon: Injection site pain (intense pain or burning sensation following administration into small veins)
Not known: Feeling hot
Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. As the effective dose is 4.63 mSv when the maximal recommended activity of 185 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