Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Most of the reported adverse reactions were transient and mild or moderate in intensity.
The most frequently reported adverse reactions from clinical studies were bladder spasm, reported by 2.0% of the patients, dysuria by 1.6%, bladder pain by 1.4% and haematuria by 1.5%, of the patients. The adverse reactions that were observed were expected, based on previous experience with standard cystoscopy and transurethral resection of the bladder (TURB) procedures.
The table below includes adverse reactions from clinical trials and spontaneous reporting.
The adverse reactions are classified by System Organ Class and frequency, using the following convention: Very common (>1/10), Common (>1/100 to < 1/10), Uncommon (> 1/1,000 to < 1/100), Rare (> 1/10,000 to < 1/1,000), Very rare (< 1/10,000), Not known (cannot be estimated from the available data).

System Organ Class                   Frequency      Adverse reaction
(MedDRA)
Infections and infestations          Uncommon       Cystitis, sepsis, urinary tract infection Blood and lymphatic system           Uncommon       White blood cell count increased, disorders                                           anaemia
Immune system disorders             Not known     Anaphylactoid shock Metabolism and nutrition            Uncommon      Gout disorders
Psychiatric disorders               Uncommon      Insomnia
Nervous system disorders            Uncommon      Headache
Gastrointestinal disorders          Common        Nausea, vomiting, constipation, diarrhoea
Hepatobiliary disorders             Uncommon      Increased serum bilirubin, hepatic enzyme increased
Skin and subcutaneous tissue        Uncommon      Rash, pruritus disorders
Musculoskeletal and connective      Uncommon      Back pain tissue disorders
Renal and urinary bladder           Common        Bladder spasm, bladder pain, dysuria, disorders                                         urinary retention, haematuria Uncommon      Urethral pain, pollakuria, micturition urgency, urinary tract disorder
Reproductive system and breast      Uncommon      Balanitis disorders
General disorders and               Common        Pyrexia administration site conditions
Injury, poisoning and procedural    Common        Post procedural pain complications                       Uncommon      Post-operative fever 
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