Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Frequency             Common              Uncommon              Rare                 Very rare Organ System          (>1/100,            (>1/1,000,            (<1/1,000            (<1/10,000, incl.
<1/10)              <1/100)               >1/10,000)           isolated reports Blood and                                                                            Leukopenia; lymphatic                                                                            Thrombocytopenia system
Gastrointestinal      Upper abdominal     Nausea /              Dry mouth disorders             pain,               vomiting
Diarrhoea,
Constipation,
Flatulence
General disorders                                                                    Injection site and                                                                                  thrombophlebitis; administration site                                                                  peripheral edema conditions
Hepatobiliary                                                                        Severe disorders                                                                              hepatocellular damage leading to jaundice with or without hepatic failure
Immune system                                                                          Anaphylactic disorders                                                                              reactions including anaphylactic shock
Investigations                                                                         Increased liver enzymes
(transaminases,
γ-GT);
Elevated triglycerides;
Increased body temperature
Musculoskeletal,                                                 Arthralgia            Myalgia connective tissue disorders
Nervous system       Headache              Dizziness;
disorders                                  Disturbances in vision (blurred vision)
Psychiatric                                                                            Mental depression disorders
Renal and urinary                                                                      Interstitial disorders                                                                              nephritis 
Skin and                                   Allergic reactions                          Urticaria; subcutaneous                               such as pruritus                            Angioedema; tissue disorders                           and skin rash                               Severe skin reactions such as Stevens-
Johnson
Syndrome,
Erythema multiforme, Lyell-
Syndrome;
Photosensitivity