Adverse reactions : תופעות לוואי

4.8   Undesirable effects

The following adverse events have been reported:
MedDRA
Frequency Undesirable Effects
System Organ Class         †
Immune system              Rare      Anaphylactic reaction* disorders
Metabolism and             Uncommon Anorexia nutrition disorders
Psychiatric disorders      Common       Hallucination, Abnormal dreams, Nightmare, Confusion, Agitation,
Abnormal behavior
Uncommon Anxiety
Rare         Delirium*, Flashback*,
Dysphoria*, Insomnia,
Disorientation*
Nervous system             Common       Nystagmus, Hypertonia, Tonic- disorders                               clonic movements
Eye disorders              Common       Diplopia
Not known    Intraocular pressure increased
Cardiac disorders          Common       Blood pressure increased, Heart rate increased
Uncommon Bradycardia, Arrhythmia
Vascular disorders         Uncommon Hypotension
Respiratory, thoracic      Common       Respiratory rate increased and mediastinal
Uncommon Respiratory depression,
disorders                           Laryngospasm
Rare     Obstructive airway disorder*, Apnea*
Gastrointestinal           Common       Nausea, Vomiting disorders
Rare         Salivary hypersecretion*
Hepatobiliary disorders    Not known    Liver function test abnormal, Drug- induced liver injury**
Skin and                   Common       Erythema, Rash morbilliform subcutaneous tissue disorders
Renal and                  Rare         Cystitis*, Hemorrhagic cystitis* urinary disorders
General disorders          Uncommon Injection site pain, Injection site rash and administration site conditions

† Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Not known (frequency cannot be estimated from the available data) * AE frequency estimated from post-marketing safety database
** Extended period use (>3 days) or drug abuse
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization 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/