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*, Disorientation*
Flashback*, Dysphoria*, Insomnia,
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 airways disorder*,
Apnoea*


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         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              Haemorrhagic cystitis*, ***, 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) * ADR identified during post-marketing use ** Extended period use (>3 days) or drug abuse
*** Long term use (1 month to several years), especially in the setting of ketamine 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/