Adverse reactions : תופעות לוואי

4.8   Undesirable effects

The following adverse events have been reported:
MedDRA
Frequency† Undesirable Effects
System Organ Class

Immune system disorders         Rare           Anaphylactic reaction* 
Metabolism and nutrition        Uncommon       Anorexia disorders
Psychiatric disorders           Common         Hallucination, Abnormal dreams, Nightmare, Confusion, Agitation,
Abnormal behaviour
Uncommon       Anxiety

Rare           Delirium*, Flashback*, Dysphoria*,
Insomnia, Disorientation*
Nervous system disorders        Common         Nystagmus, Hypertonia, Tonic-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 and       Common         Respiratory rate increased mediastinal disorders
Uncommon       Respiratory depression, Laryngospasm
Rare           Obstructive airway disorder*,
Apnoea*
Gastrointestinal disorders      Common         Nausea, Vomiting
Rare           Salivary hypersecretion*

Hepatobiliary disorders         Not known      Liver function test abnormal, Drug- induced liver injury**
Skin and subcutaneous           Common         Erythema, Rash morbilliform tissue disorders
Renal and urinary               Rare           Cystitis*, Haemorrhagic cystitis* disorders
General disorders and           Uncommon       Injection site pain, Injection site rash 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 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