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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