Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Bortezomib Accord

Bortezomib Accord 2.5 mg/mL solution for injection · Abschnitt 4.8 · PDF-Seite 17–18

HOS-133285 · Präparat HOS-097412

17 System Organ Class Incidence Adverse reaction Reproductive Uncommon Vaginal haemorrhage, Genital pain*, Erectile dysfunction, system and breast Rare Testicular disorder*, Prostatitis, Breast disorder female, disorders Epididymal tenderness, Epididymitis, Pelvic pain, Vulval ulceration Congenital, Rare Aplasia, Gastrointestinal malformation, Ichthyosis familial and genetic disorders General disorders Very Common Pyrexia*, Fatigue, Asthenia and administration Common Oedema (inc peripheral), Chills, Pain*, Malaise* site conditions Uncommon General physical health deterioration*, Face oedema*, Injection site reaction*, Mucosal disorder*, Chest pain, Gait disturbance, Feeling cold, Extravasation*, Catheter related complication*, Change in thirst*, Chest discomfort, Feeling of body temperature change*, Injection site pain* Rare Death (inc sudden), Multi-organ failure, Injection site haemorrhage*, Hernia(inc hiatus)*, Impaired healing*, Inflammation, Injection site phlebitis*, Tenderness, Ulcer, Irritability, Non-cardiac chest pain, Catheter site pain, Sensation of foreign body Investigations Common Weight decreased Uncommon Hyperbilirubinaemia*, Protein analyses abnormal*, Weight increased, Blood test abnormal*,C-reactive protein increased Rare Blood gases abnormal*, Electrocardiogram abnormalities (inc QT prolongation)*, International normalised ratio abnormal*, Gastric pH decreased, Platelet aggregation increased, Troponin I increased, Virus identification and serology*, Urine analysis abnormal* Injury, poisoning Uncommon Fall, Contusion and procedural Rare Transfusion reaction, Fractures*, Rigors*, Face injury, Joint complications injury*, Burns, Laceration, Procedural pain, Radiation injuries* Surgical and Rare Macrophage activation medical procedures NOS=not otherwise specified * Grouping of more than one MedDRA preferred term. # Post-marketing adverse reaction regardless of indication

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