Adverse reactions : תופעות לוואי

4.8 Undesirable effects

The most common undesirable effects are cardiovascular and nervous system disorders, which occur in up to 10% of patients.
It should be borne in mind that the occurrence and severity of these effects depend on the route of administration, with the subcutaneous and intramuscular routes having a lower incidence than the intravenous and intracardiac routes.

•   Common (≥ 1/100 to < 1/10)

Nervous system disorders: fear, anxiety, throbbing headache, dyspnoea, sweating and nausea, vomiting, trembling and dizziness.

Cardiovascular disorders: tachycardia, palpitations, pallor, a (modest) increase in blood pressure. These manifestations are not serious and disappear with rest, calm and reassurance of the patient.

•   Uncommon (≥ 1/1,000 to < 1/100)

Cardiovascular disorders: hypertension, which could lead to cerebral haemorrhage or acute cardiac insufficiency with pulmonary oedema, angina pectoris (even with doses common in patients with coronary insufficiency), ventricular arrhythmias, tachycardia and ventricular fibrillation, which can be fatal.

Difficulty urinating, necrosis at the injection site, metabolic acidosis and renal failure have also been reported in some cases.

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