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     Not Known Class                ≥ 1/100              ≥ 1/1 000         ≥ 1/10   Rare     (cannot be to < 1/10            to <1/100         000 to   < 1/10   estimated from <1/1    000      available data)
000
Infections and       pseudomembran                                            vaginal infection* Infestations         ous colitis*#
Blood and                                                                     agranulocytosis*, Lymphatic                                                                     neutropenia*, System                                                                        thrombocytopenia*, Disorders                                                                     leukopenia*, eosinophilia
Immune System                                                                 anaphylactic shock*, Disorders                                                                     anaphylactoid reaction*,
anaphylactic reaction*,
hypersensitivity*
Nervous System                            dysgeusia
Disorders
Cardiac                                   cardio-
Disorders                                 respiratory arrest †§,

Vascular             thrombophlebitis     hypotension†
†                    §
Disorders
Gastrointestinal                          diarrhoea,                          abdominal pain, Disorders                                 nausea,                             vomiting, oesophageal ulcers,
oesophagitis
Hepatobiliary                                                                 jaundice* Disorders
Skin and             rash                 urticaria                           toxic epidermal Subcutaneous         maculopapular        erythema                            necrolysis (TEN)*, Tissue Disorders                          multiforme,                         Stevens-Johnson pruritus                            syndrome (SJS)*,
drug reaction with eosinophilia and systemic symptom
(DRESS)*, acute generalised exanthematous pustulosis (AGEP)*,
dermatitis exfoliative*,
dermatitis bullous*,
rash morbilliform*,
Renal and                                                                     Acute kidney injury# urinary disorders
General                                   pain†,                              injection site Disorders and                             injection site                      irritation†* System Organ         Common               Uncommon         Rare     Very        Not Known Class                ≥ 1/100              ≥ 1/1 000        ≥ 1/10   Rare        (cannot be to < 1/10            to <1/100        000 to   < 1/10      estimated from <1/1    000         available data)
000
Administrative                            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/