Drug information for MYCAMINE

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
INJECTABLE; INJECTION 50MG Prescription   MICAFUNGIN SODIUM micafungin ASTELLAS 21506
2011-06-27 Label

2011-06-27 Label

2011-06-10 Letter

2011-06-10 Letter

2008-01-24 Letter

2008-01-24 Label

2007-08-07 Label

2007-08-07 Letter

2006-07-03 Letter

2006-06-28 Label

2005-08-24 Review

2005-03-18 Letter

2005-03-18 Label

2005-03-18 Other
INJECTABLE; INJECTION 50MG Prescription   MICAFUNGIN SODIUM micafungin FUJISAWA HLTHCARE 21754
2007-12-06 Review

2005-03-18 Letter

2005-03-18 Label

2005-03-18 Other
INJECTABLE; IV (INFUSION) 100MG/VIAL Prescription  (Reference Drug) MICAFUNGIN SODIUM micafungin ASTELLAS 21506
2011-06-27 Label

2011-06-27 Label

2011-06-10 Letter

2011-06-10 Letter

2008-01-24 Letter

2008-01-24 Label

2007-08-07 Label

2007-08-07 Letter

2006-07-03 Letter

2006-06-28 Label

2005-08-24 Review

2005-03-18 Letter

2005-03-18 Label

2005-03-18 Other
INJECTABLE; IV (INFUSION) 50MG/VIAL Prescription  (Reference Drug) MICAFUNGIN SODIUM micafungin ASTELLAS   "

Drug Adverse Effects information for MYCAMINE

Role code Indications Reaction # Reports
PS ACUTE MYELOID LEUKAEMIA GENERAL PHYSICAL HEALTH DETERIORATION 2
PS ACUTE MYELOID LEUKAEMIA NO ADVERSE EVENT 2
PS ACUTE RESPIRATORY DISTRESS SYNDROME BRONCHOPULMONARY ASPERGILLOSIS 1
PS ACUTE RESPIRATORY DISTRESS SYNDROME CAPILLARY LEAK SYNDROME 1
PS ACUTE RESPIRATORY DISTRESS SYNDROME ENTEROCOCCAL SEPSIS 1
PS ACUTE RESPIRATORY DISTRESS SYNDROME GRAFT VERSUS HOST DISEASE 1
PS ANTIFUNGAL PROPHYLAXIS DEATH 1
PS ANTIFUNGAL PROPHYLAXIS NO ADVERSE EVENT 1
PS B-CELL LYMPHOMA SYSTEMIC CANDIDA 1
PS CANDIDIASIS BONE MARROW TRANSPLANT 1
PS CANDIDIASIS THROMBOTIC THROMBOCYTOPENIC PURPURA 1
PS FUNGAL INFECTION BRONCHOPULMONARY ASPERGILLOSIS 1
PS FUNGAL INFECTION CAPILLARY LEAK SYNDROME 1
PS FUNGAL INFECTION ENTEROCOCCAL SEPSIS 1
PS FUNGAL INFECTION GRAFT VERSUS HOST DISEASE 1
PS FUNGAL INFECTION INCORRECT DOSE ADMINISTERED 1
PS FUNGAL INFECTION NEONATAL CHOLESTASIS 1
PS FUNGAL INFECTION OFF LABEL USE 1
PS FUNGAL INFECTION RASH 2
PS FUNGAL INFECTION SWELLING FACE 2
PS FUNGAL INFECTION SYSTEMIC CANDIDA 1
PS GRAFT VERSUS HOST DISEASE BRONCHOPULMONARY ASPERGILLOSIS 1
PS GRAFT VERSUS HOST DISEASE CAPILLARY LEAK SYNDROME 1
PS GRAFT VERSUS HOST DISEASE ENTEROCOCCAL SEPSIS 1
PS GRAFT VERSUS HOST DISEASE GRAFT VERSUS HOST DISEASE 1
PS IMMUNOSUPPRESSION BRONCHOPULMONARY ASPERGILLOSIS 1
PS IMMUNOSUPPRESSION CAPILLARY LEAK SYNDROME 1
PS IMMUNOSUPPRESSION ENTEROCOCCAL SEPSIS 1
PS IMMUNOSUPPRESSION GRAFT VERSUS HOST DISEASE 1
PS PNEUMONIA BRONCHOPULMONARY ASPERGILLOSIS 1
PS PNEUMONIA CAPILLARY LEAK SYNDROME 1
PS PNEUMONIA ENTEROCOCCAL SEPSIS 1
PS PNEUMONIA GRAFT VERSUS HOST DISEASE 1
PS PRODUCT USED FOR UNKNOWN INDICATION BLOOD CULTURE POSITIVE 2
PS PRODUCT USED FOR UNKNOWN INDICATION DEATH 10
PS PRODUCT USED FOR UNKNOWN INDICATION RESPIRATORY FAILURE 2
PS PRODUCT USED FOR UNKNOWN INDICATION SEPSIS 2
PS PROPHYLAXIS CANDIDIASIS 1
PS PROPHYLAXIS DRUG INEFFECTIVE 1
PS SEPTIC SHOCK BRONCHOPULMONARY ASPERGILLOSIS 2
PS SEPTIC SHOCK CAPILLARY LEAK SYNDROME 2
PS SEPTIC SHOCK ENTEROCOCCAL SEPSIS 2
PS SEPTIC SHOCK GRAFT VERSUS HOST DISEASE 2
SS B-CELL LYMPHOMA SYSTEMIC CANDIDA 1
SS FUNGAL INFECTION SYSTEMIC CANDIDA 1
SS PRODUCT USED FOR UNKNOWN INDICATION ABDOMINAL PAIN 3
SS PRODUCT USED FOR UNKNOWN INDICATION CHILLS 3
SS PRODUCT USED FOR UNKNOWN INDICATION DEATH 3
SS PRODUCT USED FOR UNKNOWN INDICATION INFUSION RELATED REACTION 3
SS SYSTEMIC CANDIDA ABDOMINAL PAIN 1
SS SYSTEMIC CANDIDA CHILLS 1
SS SYSTEMIC CANDIDA DEATH 1
SS SYSTEMIC CANDIDA INFUSION RELATED REACTION 1
C ANXIETY UPPER RESPIRATORY TRACT INFECTION 1
C CROHN'S DISEASE ABDOMINAL ABSCESS 3
C CROHN'S DISEASE ANAEMIA 3
C CROHN'S DISEASE DEVICE RELATED SEPSIS 3
C CROHN'S DISEASE FUNGAEMIA 3
C GLIOBLASTOMA UPPER RESPIRATORY TRACT INFECTION 2
C PAIN UPPER RESPIRATORY TRACT INFECTION 1
C PROPHYLAXIS UPPER RESPIRATORY TRACT INFECTION 2
I ANTIBIOTIC THERAPY COAGULATION FACTOR V LEVEL DECREASED 2
I ANTIBIOTIC THERAPY CYTOLYTIC HEPATITIS 2
I ANTIBIOTIC THERAPY DRUG INTERACTION 2
I ATRIAL FIBRILLATION COAGULATION FACTOR V LEVEL DECREASED 2
I ATRIAL FIBRILLATION CYTOLYTIC HEPATITIS 2
I ATRIAL FIBRILLATION DRUG INTERACTION 2
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