Adverse reactions : תופעות לוואי

4.8 Undesirable effects
The following CIOMS frequency rating is used, when applicable: 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 (frequency cannot be estimated from the available data).
Infections and infestations:
Not known: antibiotic-associated colitis (including pseudomembranous colitis), superinfection (caused by gentamicin-resistant bacteria)
Blood and lymphatic system disorders:
Not known: anaemia, blood dyscrasias
Immune system disorders:
Not known: hypersensitivity (see section 4.4), anaphylaxis/anaphylactic reaction (including anaphylactic shock)
Metabolism and nutrition disorders:
Not known: hypomagnesaemia on prolonged therapy
Psychiatric disorders:
Not known: depression, hallucinations, confusion
Nervous system disorders:
Not known: central neuropathy (including convulsions, lethargy, encephalopathy), peripheral neuropathy
Ear and labyrinth disorders:
Not known: vestibular damage, transitory hearing loss, irreversible hearing loss, deafness, particularly after exposure to ototoxic drugs or in the presence of renal dysfunction (see section 4.4).
Gastrointestinal disorders:
Very common: vomiting
Not known: stomatitis, nausea
Hepatobiliary disorders:
Not known: abnormal liver function, transaminases increased
Skin and subcutaneous tissue disorders:
Not known: Stevens-Johnson syndrome, toxic epidermal necrosis, rash, purpura, urticaria, pruritus
Renal and urinary disorders:
Very rare: acute renal failure, Fanconi-like syndrome in patients treated with a prolonged course of high dose
Not known: nephrotoxicity (usually reversible) has been reported 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