Adverse reactions : תופעות לוואי

8 ADVERSE REACTIONS

8.1 Adverse Drug Reaction Overview
The most common adverse reactions reported in patients receiving Technetium Tc 99m Medronate injection are nausea, rash, and other skin irritations such as dermatitis, urticaria and pruritus.

At least one death secondary to cardiac arrest following the administration of Technetium Tc 99m Medronate has been reported, with insufficient information to determine a causal relationship.

8.5 Post-Market Adverse Reactions
The following adverse reactions have been identified from post-marketing surveillance. 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 the causal relationship to Technetium Tc 99m Medronate exposure against the patient’s pre-existing medical condition.

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

•   Cardiac disorders: arrhythmia, cardiac arrest.
•   Gastrointestinal disorders: nausea, vomiting.
•   General disorders and administration site conditions: chills, asthenia, pyrexia, malaise, peripheral swelling, chest discomfort, swelling.
•   Hepatobiliary disorders: jaundice.
•   Immune system disorders: hypersensitivity.
•   Musculoskeletal and connective tissue disorders: myalgia, arthralgia.
•   Nervous system disorders: dizziness, headache, syncope.
•   Respiratory, thoracic and mediastinal disorders: dyspnoea, cough.
•   Skin and subcutaneous tissue disorders: pruritus, rash, urticaria, erythema, dermatitis.
•   Vascular disorders: hypotension, 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).