Adverse reactions : תופעות לוואי

8 ADVERSE REACTIONS
8.1 Adverse Drug Reaction Overview
Most common adverse reactions reported post-market in patients receiving Technetium Tc 99m Pentetate injection include; allergic reactions, rash, itching.

See Sensitivity reactions under section 7 WARNINGS AND PRECAUTIONS.

8.5 Post-Market Adverse Reactions
The following adverse reactions have been identified post-approval, from Canadian and international exposure. Because these reactions are voluntarily reported from a population of uncertain size, it is not always possible to reliably estimate their exact frequency or establish a causal relationship to Technetium Tc 99m Pentetate exposure.

Adverse reactions are presented per alphabetical system organ class and in decreasing order of frequency:

•   Cardiac disorders: cyanosis, tachycardia;
•   Gastrointestinal disorders: nausea, vomiting;
•   General disorders and administration site conditions: chills;
•   Immune system disorders: allergic reaction, anaphylactic reaction, angioedema; •   Nervous system disorders: headache, fainting, dizziness;
•   Respiratory, thoracic and mediastinal disorders: throat irritation, wheezing, dyspnoea; •   Skin and subcutaneous tissue disorders: rash, itching, hives, erythema; •   Vascular disorders: hypotension, hypertension, flushing.


Reporting of suspected adverse reactions
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).