Adverse reactions : תופעות לוואי

4.8 Undesirable effects

The table below lists the adverse reactions identified through clinical trial experience and post- marketing surveillance by system organ class and frequency. The frequency grouping is defined 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); and Not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.


System Organ          Common                Uncommon             Rare       Very Rare    Not Known Class                 ≥ 1/100 to < 1/10     ≥ 1/1 000 to         ≥ 1/10 000 < 1/10 000   (cannot be estimated <1/100               to <1/1 000             from available data)

Infections and        pseudomembranous                                                   vaginal infection* Infestations          colitis*#

Blood and Lymphatic                                                                      agranulocytosis*, System Disorders                                                                         neutropenia*, thrombocytopenia*,
leukopenia*, eosinophilia

Immune System                                                                            anaphylactic shock*, Disorders                                                                                anaphylactoid reaction*, anaphylactic reaction*,
hypersensitivity*

Nervous System                              dysgeusia
Disorders

Cardiac Disorders                           cardio-respiratory arrest †§
Vascular Disorders    thrombophlebitis†     hypotension†§



Gastrointestinal                                 diarrhea, nausea                            abdominal pain, vomiting, Disorders                                                                                    oesophageal ulcers, oesophagitis

Hepatobiliary                                                                                jaundice* Disorders

Skin and                rash maculopapular       urticaria,                                  toxic epidermal necrolysis Subcutaneous                                     erythema                                    (TEN)*, Stevens-Johnson Tissue Disorders                                 multiforme,                                 syndrome (SJS)*, drug pruritus                                    reaction with eosinophilia and systemic symptom
(DRESS)*, acute generalised exanthematous pustulosis
(AGEP)*, dermatitis exfoliative*, dermatitis bullous*, rash morbilliform*

Renal and urinary                                                                            Acute kidney injury# disorders


General Disorders                                pain†, injection                            injection site irritation†* and Administrative                               site abscess†
Conditions

Investigations          liver function test abnormal

* ADR identified post-marketing.
† ADRs apply only to injectable formulations.
# See section 4.4.
§ Rare instances have been reported following too rapid intravenous administration (see section 4.2).
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/