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/