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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