Adverse reactions : תופעות לוואי

4.8.   Undesirable effects
Information on adverse reactions is available from spontaneous reporting. The reported reaction types are anaphylactoid reactions, neurovegetative reactions, and different kinds of injection site reactions. Sodium perchtechnetate (99mTc) from the Tekcis generator is used for radioactive labelling of a variety of compounds. These pharmaceuticals generally have a higher potential for side effects than 99mTc, and therefore the reported side effects are related more to the labelled compounds than to 99mTc. The possible types of side effects following intravenous administration of a 99mTc-labelled pharmaceutical preparation are dependent on the specific compound being used. Such information can be found in the SmPC of the Kit used for radiopharmaceutical preparation.

Anaphylactoid reactions:
Anaphylactoid reactions have been reported following intravenous injection of perchtechnetate (99mTc) and include various skin or respiratory symptoms like skin irritations, oedema, or dyspnoea².
neuroVegetative reactions (nervous system and gastrointestinal disorders): Single cases of severe neurovegetative reactions have been reported, however, most of the reported effects include gastrointestinal reactions like nausea or vomiting². Other reports include vasovagal reactions like headache² or dizziness². neuroVegetative effects are generally considered to be related to the examination setting rather than to technetium (99mTc), especially in anxious patients.
General disorders and administration site conditions
Other reports describe local injection site reactions. Such reactions are related to extravasation of the radioactive material during the injection, and the reported reactions range from local swelling² up to cellulitis². Depending on the administered radioactivity and the labelled compound, extensive extravasation may necessitate surgical treatment.


The following table subsumes the observed reaction types and symptoms. Due to the fact that only spontaneous reports could be analysed, no frequency indications could be provided.

Adverse Reactions sorted by System Organ Class
Immune system disorders
Frequency unknown*: Anaphylactoid reactions (e.g. dyspnoea², coma, urticaria, erythema, rash, pruritus, oedema at various location e.g. face oedema)
Nervous system disorders
Frequency unknown*: Vasovagal reactions (e.g. syncope, tachycardia, bradycardia, vertigo², headache², vision blurred, flushing)
Gastrointestinal disorders
Frequency unknown*: Vomiting², nausea, diarrhoea²
General disorders and administration site conditions
Frequency unknown*: Injection site reactions (e.g. cellulitis², pain², erythema², swelling²) * Adverse reactions derived from spontaneous reporting
² These adverse reactions have been reported with similar products and are therefore likely to occur with Tekcis.

Exposure to ionising radiation is linked with cancer induction and a potential congenital defects. As the effective dose is 5.2 mSv when the maximal recommended activity of 400 MBq is administered, the probability of such adverse is low.

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