Drug information for TREANDA

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
INJECTABLE; INJECTION 100MG Prescription  (Reference Drug) BENDAMUSTINE HYDROCHLORIDE bendamustine CEPHALON 22303
2009-08-27 Review
2009-08-27 Summary Review
2008-11-07 Letter
2008-11-03 Label
POWDER; IV (INFUSION) 100MG/VIAL Prescription  (Reference Drug) BENDAMUSTINE HYDROCHLORIDE bendamustine CEPHALON 22249
2010-12-28 Letter
2010-12-26 Label
2010-03-04 Letter
2010-03-03 Label
2009-05-11 Label
2009-05-06 Letter
2009-04-28 Label
2009-04-27 Letter
2008-05-08 Review
2008-05-08 Summary Review
2008-03-21 Letter
2008-03-20 Label
POWDER; IV (INFUSION) 25MG/VIAL Prescription  (Reference Drug) BENDAMUSTINE HYDROCHLORIDE bendamustine CEPHALON   "

Drug Adverse Effects information for TREANDA

Role code Indications Reaction # Reports
PS ADULT T-CELL LYMPHOMA/LEUKAEMIA INFECTION 1
PS ADULT T-CELL LYMPHOMA/LEUKAEMIA PANCYTOPENIA 1
PS ANTIEMETIC SUPPORTIVE CARE NON-HODGKIN'S LYMPHOMA 1
PS ANTIEMETIC SUPPORTIVE CARE PNEUMONIA 1
PS ANTIEMETIC SUPPORTIVE CARE PULMONARY EMBOLISM 1
PS B-CELL LYMPHOMA ANAEMIA 2
PS B-CELL LYMPHOMA B-CELL LYMPHOMA 2
PS B-CELL LYMPHOMA EJECTION FRACTION DECREASED 1
PS B-CELL LYMPHOMA FEBRILE NEUTROPENIA 2
PS B-CELL LYMPHOMA HYPOTENSION 4
PS B-CELL LYMPHOMA HYPOXIA 4
PS B-CELL LYMPHOMA OEDEMA PERIPHERAL 4
PS B-CELL LYMPHOMA TOOTH ABSCESS 2
PS B-CELL SMALL LYMPHOCYTIC LYMPHOMA BONE MARROW FAILURE 1
PS B-CELL SMALL LYMPHOCYTIC LYMPHOMA PANCYTOPENIA 1
PS BLADDER CANCER DEATH 1
PS CHRONIC LYMPHOCYTIC LEUKAEMIA BLISTER 2
PS CHRONIC LYMPHOCYTIC LEUKAEMIA BLOOD PRESSURE DECREASED 2
PS CHRONIC LYMPHOCYTIC LEUKAEMIA BONE PAIN 1
PS CHRONIC LYMPHOCYTIC LEUKAEMIA CHILLS 2
PS CHRONIC LYMPHOCYTIC LEUKAEMIA CHRONIC LYMPHOCYTIC LEUKAEMIA 1
PS CHRONIC LYMPHOCYTIC LEUKAEMIA DEATH 2
PS CHRONIC LYMPHOCYTIC LEUKAEMIA DEHYDRATION 1
PS CHRONIC LYMPHOCYTIC LEUKAEMIA DERMATITIS BULLOUS 1
PS CHRONIC LYMPHOCYTIC LEUKAEMIA DRUG INEFFECTIVE 1
PS CHRONIC LYMPHOCYTIC LEUKAEMIA FACE OEDEMA 1
PS CHRONIC LYMPHOCYTIC LEUKAEMIA GRANULOCYTE COUNT DECREASED 1
PS CHRONIC LYMPHOCYTIC LEUKAEMIA HAEMOGLOBIN DECREASED 1
PS CHRONIC LYMPHOCYTIC LEUKAEMIA HAEMOLYTIC ANAEMIA 1
PS CHRONIC LYMPHOCYTIC LEUKAEMIA HYPERSENSITIVITY 2
PS CHRONIC LYMPHOCYTIC LEUKAEMIA HYPOTENSION 1
PS CHRONIC LYMPHOCYTIC LEUKAEMIA LIP SWELLING 1
PS CHRONIC LYMPHOCYTIC LEUKAEMIA PAIN 1
PS CHRONIC LYMPHOCYTIC LEUKAEMIA PANCYTOPENIA 4
PS CHRONIC LYMPHOCYTIC LEUKAEMIA PARAESTHESIA ORAL 1
PS CHRONIC LYMPHOCYTIC LEUKAEMIA PLATELET COUNT DECREASED 3
PS CHRONIC LYMPHOCYTIC LEUKAEMIA POLYURIA 1
PS CHRONIC LYMPHOCYTIC LEUKAEMIA PYREXIA 3
PS CHRONIC LYMPHOCYTIC LEUKAEMIA RASH 4
PS CHRONIC LYMPHOCYTIC LEUKAEMIA RED BLOOD CELL COUNT DECREASED 1
PS CHRONIC LYMPHOCYTIC LEUKAEMIA RENAL DISORDER 1
PS CHRONIC LYMPHOCYTIC LEUKAEMIA RENAL FAILURE 1
PS CHRONIC LYMPHOCYTIC LEUKAEMIA TACHYPNOEA 2
PS CHRONIC LYMPHOCYTIC LEUKAEMIA THROMBOCYTOPENIA 1
PS CHRONIC LYMPHOCYTIC LEUKAEMIA TUMOUR LYSIS SYNDROME 2
PS CHRONIC LYMPHOCYTIC LEUKAEMIA URTICARIA 1
PS CHRONIC LYMPHOCYTIC LEUKAEMIA WHEEZING 2
PS CHRONIC LYMPHOCYTIC LEUKAEMIA WHITE BLOOD CELL COUNT DECREASED 3
PS DIFFUSE LARGE B-CELL LYMPHOMA GASTRIC CANCER 2
PS DIFFUSE LARGE B-CELL LYMPHOMA REFRACTORY PNEUMONIA CYTOMEGALOVIRAL 2
PS DYSPEPSIA NON-HODGKIN'S LYMPHOMA 1
PS DYSPEPSIA PNEUMONIA 1
PS DYSPEPSIA PULMONARY EMBOLISM 1
PS HODGKIN'S DISEASE MENINGITIS ASEPTIC 3
PS LEUKAEMIA DEATH 1
PS LYMPHOMA BLOOD COUNT ABNORMAL 1
PS LYMPHOMA COLITIS 2
PS LYMPHOMA CYTOMEGALOVIRUS INFECTION 1
PS MANTLE CELL LYMPHOMA INTERSTITIAL LUNG DISEASE 2
PS MANTLE CELL LYMPHOMA RASH 1
PS MANTLE CELL LYMPHOMA URTICARIA 1
PS MULTIPLE MYELOMA ARRHYTHMIA SUPRAVENTRICULAR 2
PS MULTIPLE MYELOMA ATELECTASIS 3
PS MULTIPLE MYELOMA BACTERAEMIA 3
PS MULTIPLE MYELOMA FATIGUE 3
PS MULTIPLE MYELOMA GRANULOMA 3
PS MULTIPLE MYELOMA HAEMOGLOBIN DECREASED 3
PS MULTIPLE MYELOMA HYPERTENSION 1
PS MULTIPLE MYELOMA ILEUS 1
PS MULTIPLE MYELOMA INFECTION 3
PS MULTIPLE MYELOMA LUNG NEOPLASM 3
PS MULTIPLE MYELOMA LYMPHADENOPATHY 3
PS MULTIPLE MYELOMA NEUTROPENIA 3
PS MULTIPLE MYELOMA ORAL HERPES 3
PS MULTIPLE MYELOMA PLATELET COUNT DECREASED 3
PS MULTIPLE MYELOMA PNEUMONIA 6
PS MULTIPLE MYELOMA PYREXIA 3
PS MULTIPLE MYELOMA RASH PRURITIC 1
PS MULTIPLE MYELOMA STAPHYLOCOCCAL INFECTION 3
PS MULTIPLE MYELOMA SWOLLEN TONGUE 1
PS MULTIPLE MYELOMA WHITE BLOOD CELL COUNT DECREASED 3
PS NAUSEA NON-HODGKIN'S LYMPHOMA 1
PS NAUSEA PNEUMONIA 1
PS NAUSEA PULMONARY EMBOLISM 1
PS NON-HODGKIN'S LYMPHOMA ABDOMINAL PAIN 4
PS NON-HODGKIN'S LYMPHOMA CHRONIC MYELOMONOCYTIC LEUKAEMIA 1
PS NON-HODGKIN'S LYMPHOMA NEUTROPENIA 1
PS NON-HODGKIN'S LYMPHOMA NON-HODGKIN'S LYMPHOMA 2
PS NON-HODGKIN'S LYMPHOMA PANCYTOPENIA 2
PS NON-HODGKIN'S LYMPHOMA PNEUMONIA 2
PS NON-HODGKIN'S LYMPHOMA PULMONARY EMBOLISM 2
PS NON-HODGKIN'S LYMPHOMA RASH 6
PS NON-HODGKIN'S LYMPHOMA TACHYCARDIA 6
PS NON-HODGKIN'S LYMPHOMA TREMOR 6
PS PROPHYLACTIC CHEMOTHERAPY NON-HODGKIN'S LYMPHOMA 3
PS PROPHYLACTIC CHEMOTHERAPY PNEUMONIA 3
PS PROPHYLACTIC CHEMOTHERAPY PULMONARY EMBOLISM 3
SS B-CELL SMALL LYMPHOCYTIC LYMPHOMA PANCYTOPENIA 1
SS CHRONIC LYMPHOCYTIC LEUKAEMIA CONSTIPATION 2
SS CHRONIC LYMPHOCYTIC LEUKAEMIA IMPETIGO 1
SS CHRONIC LYMPHOCYTIC LEUKAEMIA OEDEMA 2
SS CHRONIC LYMPHOCYTIC LEUKAEMIA PANCYTOPENIA 1
SS CHRONIC LYMPHOCYTIC LEUKAEMIA PNEUMONIA 1
SS CHRONIC LYMPHOCYTIC LEUKAEMIA PYREXIA 1
SS CHRONIC LYMPHOCYTIC LEUKAEMIA RASH MACULO-PAPULAR 1
SS CHRONIC LYMPHOCYTIC LEUKAEMIA URINARY TRACT INFECTION 2
SS DIFFUSE LARGE B-CELL LYMPHOMA GASTRIC CANCER 2
SS MULTIPLE MYELOMA ATELECTASIS 3
SS MULTIPLE MYELOMA BACTERAEMIA 3
SS MULTIPLE MYELOMA FATIGUE 3
SS MULTIPLE MYELOMA GRANULOMA 3
SS MULTIPLE MYELOMA HAEMOGLOBIN DECREASED 3
SS MULTIPLE MYELOMA INFECTION 3
SS MULTIPLE MYELOMA LUNG NEOPLASM 3
SS MULTIPLE MYELOMA LYMPHADENOPATHY 3
SS MULTIPLE MYELOMA NEUTROPENIA 3
SS MULTIPLE MYELOMA ORAL HERPES 3
SS MULTIPLE MYELOMA PLATELET COUNT DECREASED 3
SS MULTIPLE MYELOMA PNEUMONIA 6
SS MULTIPLE MYELOMA PYREXIA 3
SS MULTIPLE MYELOMA STAPHYLOCOCCAL INFECTION 3
SS MULTIPLE MYELOMA WHITE BLOOD CELL COUNT DECREASED 3
SS NON-HODGKIN'S LYMPHOMA PANCYTOPENIA 4
SS NON-HODGKIN'S LYMPHOMA RASH 6
SS NON-HODGKIN'S LYMPHOMA TACHYCARDIA 6
SS NON-HODGKIN'S LYMPHOMA TREMOR 6
SS PRODUCT USED FOR UNKNOWN INDICATION CONSTIPATION 1
SS PRODUCT USED FOR UNKNOWN INDICATION OEDEMA 1
SS PRODUCT USED FOR UNKNOWN INDICATION URINARY TRACT INFECTION 1
SS TUMOUR LYSIS SYNDROME IMPETIGO 1
SS TUMOUR LYSIS SYNDROME PNEUMONIA 1
SS TUMOUR LYSIS SYNDROME PYREXIA 1
SS TUMOUR LYSIS SYNDROME RASH MACULO-PAPULAR 1
C HORDEOLUM LIVER DISORDER 1
C HORDEOLUM NEOPLASM RECURRENCE 1
C HORDEOLUM NON-HODGKIN'S LYMPHOMA 1
C MULTIPLE MYELOMA MULTIPLE MYELOMA 2
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