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*



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/