Adverse reactions : תופעות לוואי

4.8     Undesirable effects

Summary of the safety profile
The listed frequencies are based on internal clinical documentation comprising approximately 3000 patients.

The frequencies of the undesirable effects 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 determined with the data available).
Adverse drug reactions following administration of tetrofosmin (99mTc) are very rare (less than 1 in 10,000).

The following undesirable effects are recognised for Myoview:

Immune system disorders
Not known:, Hypersensitivity reactions, including anaphylactoid or anaphylactic reactions and anaphylactic or anaphylactoid shock.

Nervous system disorders
Uncommon: Taste metallic
Rare: Disturbances of smell
Not known: Headache, dizziness

Eye disorders
Rare: Abnormal vision
Cardiac disorders
Not known: Tachycardia, chest pain

Vascular disorders
Uncommon: Flushing
Not known: Hypotension

Respiratory, thoracic and mediastinal disorders
Not known: Dyspnoea, bronchospasm, throat tightness, cough
Gastrointestinal disorders
Uncommon: Vomiting,
Rare: Abdominal pain, nausea, burning mouth

Skin and subcutaneous tissue disorder
Rare: Rash
Not known: Urticaria, pruritus, erythema, angioedema

General disorders and administration site conditions
Uncommon: Feeling of warmth
Not known: Local swelling, face oedema, fever
Investigations
Not known: White blood cell count increased.

Some reactions were delayed by several hours following administration of tetrofosmin (99mTc). Isolated cases of serious reactions have been reported, including anaphylactic reaction (less than 1 in 100,000) and severe allergic reaction (single report).

Since the administered substance quantity is very low, the major risk is caused by the radiation. Exposure to ionising radiation is linked with cancer induction and a potential for developing hereditary defects.

As the effective dose is 8.5 mSv when the maximal recommended activity of 1200 MBq is administered these adverse reactions 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