Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Velcade

VELCADE 1 mg powder for solution for injection · Abschnitt 4.8 · PDF-Seite 14

HOS-112778 · Präparat HOS-093755

Table 7: Adverse reactions in patients with Multiple Myeloma treated with VELCADE in clinical trials, and all post-marketing adverse reactions regardless of indication# System Organ Class Incidence Adverse reaction Infections and Common Herpes zoster (inc disseminated & ophthalmic), Pneumonia*, infestations Herpes simplex*, Fungal infection* Uncommon Infection*, Bacterial infections*, Viral infections*, Sepsis (inc septic shock)*, Bronchopneumonia, Herpes virus infection*, Meningoencephalitis herpetic#, Bacteraemia (inc staphylococcal), Hordeolum, Influenza, Cellulitis, Device related infection, Skin infection*, Ear infection*, Staphylococcal infection, Tooth infection* Rare Meningitis (inc bacterial), Epstein-Barr virus infection, Genital herpes, Tonsillitis, Mastoiditis, Post viral fatigue syndrome Neoplasms Rare Neoplasm malignant, Leukaemia plasmacytic, Renal cell benign, malignant carcinoma, Mass, Mycosis fungoides, Neoplasm benign* and unspecified (incl cysts and polyps) Blood and Very Common Thrombocytopenia*, Neutropenia*, Anaemia* lymphatic system Common Leukopenia*, Lymphopenia* disorders Uncommon Pancytopenia*, Febrile neutropenia, Coagulopathy*, Leukocytosis*, Lymphadenopathy, Haemolytic anaemia# Rare Disseminated intravascular coagulation, Thrombocytosis*, Hyperviscosity syndrome, Platelet disorder NOS, Thrombotic microangiopathy (inc thrombocytopenic purpura) #, Blood disorder NOS, Haemorrhagic diathesis, Lymphocytic infiltration Immune system Uncommon Angioedema#, Hypersensitivity*

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