Drug information for NOXAFIL
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
SUSPENSION; ORAL
40MG/ML
Prescription
(Reference Drug)
POSACONAZOLE
posaconazole
SCHERING
22003
2010-09-13 Letter
2010-09-10 Label
2009-02-23 Letter
2009-02-20 Label
2008-05-21 Letter
2008-05-21 Letter
2006-11-09 Review
2006-09-20 Letter
2006-09-18 Label
SUSPENSION; ORAL
40MG/ML
Prescription
POSACONAZOLE
posaconazole
SCHERING
22027
2010-09-13 Letter
2010-09-10 Label
2008-09-05 Review
2006-10-23 Label
2006-10-23 Letter
Drug Adverse Effects information for NOXAFIL
Role code
Indications
Reaction
# Reports
PS
ANTIFUNGAL TREATMENT
PANCYTOPENIA
1
PS
ASPERGILLOSIS
CHOLESTASIS
1
PS
ASPERGILLOSIS
NEUROPATHY PERIPHERAL
1
PS
FUNGAL INFECTION
CENTRAL NERVOUS SYSTEM INFECTION
1
PS
HEPATOSPLENIC CANDIDIASIS
ARRHYTHMIA
1
PS
HEPATOSPLENIC CANDIDIASIS
ARRHYTHMIA SUPRAVENTRICULAR
1
PS
HEPATOSPLENIC CANDIDIASIS
ATRIOVENTRICULAR BLOCK SECOND DEGREE
1
PS
HEPATOSPLENIC CANDIDIASIS
BRADYCARDIA
1
PS
HEPATOSPLENIC CANDIDIASIS
CARDIAC ARREST
1
PS
HEPATOSPLENIC CANDIDIASIS
DRUG INTERACTION
1
PS
HEPATOSPLENIC CANDIDIASIS
NODAL ARRHYTHMIA
1
PS
HEPATOSPLENIC CANDIDIASIS
SINOATRIAL BLOCK
1
PS
HEPATOSPLENIC CANDIDIASIS
SINUS TACHYCARDIA
1
PS
LUNG INFECTION
DRUG INEFFECTIVE
2
PS
PNEUMONIA
DRUG INEFFECTIVE
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
ARRHYTHMIA
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
ARRHYTHMIA SUPRAVENTRICULAR
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
ATRIOVENTRICULAR BLOCK SECOND DEGREE
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
BRADYCARDIA
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
CARDIAC ARREST
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
DRUG INTERACTION
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
NODAL ARRHYTHMIA
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
SINOATRIAL BLOCK
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
SINUS TACHYCARDIA
1
PS
SINUSITIS
PANCYTOPENIA
1
PS
VISCERAL LEISHMANIASIS
CYSTITIS RADIATION
1
PS
VISCERAL LEISHMANIASIS
HAEMATURIA
1
PS
ZYGOMYCOSIS
PANCYTOPENIA
1
SS
ACUTE LEUKAEMIA IN REMISSION
SINOATRIAL BLOCK
2
SS
CANDIDIASIS
SINOATRIAL BLOCK
1
SS
HEPATOSPLENIC CANDIDIASIS
ARRHYTHMIA
2
SS
HEPATOSPLENIC CANDIDIASIS
ATRIOVENTRICULAR BLOCK SECOND DEGREE
4
SS
HEPATOSPLENIC CANDIDIASIS
BRADYARRHYTHMIA
2
SS
HEPATOSPLENIC CANDIDIASIS
BRADYCARDIA
2
SS
HEPATOSPLENIC CANDIDIASIS
DRUG INTERACTION
5
SS
HEPATOSPLENIC CANDIDIASIS
HEPATOSPLENIC CANDIDIASIS
1
SS
HEPATOSPLENIC CANDIDIASIS
NODAL ARRHYTHMIA
3
SS
HEPATOSPLENIC CANDIDIASIS
SINOATRIAL BLOCK
5
SS
HEPATOSPLENIC CANDIDIASIS
SINUS BRADYCARDIA
3
SS
HEPATOSPLENIC CANDIDIASIS
SINUS TACHYCARDIA
4
SS
PRODUCT USED FOR UNKNOWN INDICATION
ARRHYTHMIA
18
SS
PRODUCT USED FOR UNKNOWN INDICATION
ATRIOVENTRICULAR BLOCK SECOND DEGREE
41
SS
PRODUCT USED FOR UNKNOWN INDICATION
BRADYARRHYTHMIA
18
SS
PRODUCT USED FOR UNKNOWN INDICATION
BRADYCARDIA
18
SS
PRODUCT USED FOR UNKNOWN INDICATION
DRUG INTERACTION
49
SS
PRODUCT USED FOR UNKNOWN INDICATION
HEPATOSPLENIC CANDIDIASIS
8
SS
PRODUCT USED FOR UNKNOWN INDICATION
NODAL ARRHYTHMIA
35
SS
PRODUCT USED FOR UNKNOWN INDICATION
SINOATRIAL BLOCK
40
SS
PRODUCT USED FOR UNKNOWN INDICATION
SINUS BRADYCARDIA
35
SS
PRODUCT USED FOR UNKNOWN INDICATION
SINUS TACHYCARDIA
34
SS
PROPHYLAXIS OF NAUSEA AND VOMITING
SINOATRIAL BLOCK
1
C
ABDOMINAL PAIN
ADENOVIRAL HEPATITIS
1
C
ABDOMINAL PAIN
ANAEMIA
1
C
ABDOMINAL PAIN
CARDIOVASCULAR DISORDER
1
C
ABDOMINAL PAIN
COAGULATION FACTOR V LEVEL DECREASED
1
C
ABDOMINAL PAIN
CYSTITIS HAEMORRHAGIC
1
C
ABDOMINAL PAIN
ENCEPHALITIS
1
C
ABDOMINAL PAIN
GENERAL PHYSICAL HEALTH DETERIORATION
1
C
ABDOMINAL PAIN
HEPATIC FAILURE
1
C
ABDOMINAL PAIN
MULTI-ORGAN FAILURE
1
C
ABDOMINAL PAIN
RESPIRATORY DISORDER
1
C
ACUTE GRAFT VERSUS HOST DISEASE
ADENOVIRAL HEPATITIS
1
C
ACUTE GRAFT VERSUS HOST DISEASE
ANAEMIA
1
C
ACUTE GRAFT VERSUS HOST DISEASE
CARDIOVASCULAR DISORDER
1
C
ACUTE GRAFT VERSUS HOST DISEASE
COAGULATION FACTOR V LEVEL DECREASED
1
C
ACUTE GRAFT VERSUS HOST DISEASE
CYSTITIS HAEMORRHAGIC
1
C
ACUTE GRAFT VERSUS HOST DISEASE
ENCEPHALITIS
1
C
ACUTE GRAFT VERSUS HOST DISEASE
GENERAL PHYSICAL HEALTH DETERIORATION
1
C
ACUTE GRAFT VERSUS HOST DISEASE
HEPATIC FAILURE
1
C
ACUTE GRAFT VERSUS HOST DISEASE
MULTI-ORGAN FAILURE
1
C
ACUTE GRAFT VERSUS HOST DISEASE
RESPIRATORY DISORDER
1
C
ACUTE MYELOID LEUKAEMIA
ATRIAL FIBRILLATION
3
C
ACUTE MYELOID LEUKAEMIA
BRADYCARDIA
3
C
ACUTE MYELOID LEUKAEMIA
CARDIAC ARREST
9
C
ACUTE MYELOID LEUKAEMIA
FUSARIUM INFECTION
9
C
ACUTE MYELOID LEUKAEMIA
GANGRENE
3
C
ACUTE MYELOID LEUKAEMIA
HAEMODIALYSIS
3
C
ACUTE MYELOID LEUKAEMIA
METABOLIC ACIDOSIS
3
C
ACUTE MYELOID LEUKAEMIA
NEUTROPENIC COLITIS
9
C
ACUTE MYELOID LEUKAEMIA
RENAL IMPAIRMENT
3
C
ACUTE MYELOID LEUKAEMIA
SINUS ARREST
3
C
ACUTE MYELOID LEUKAEMIA
ZYGOMYCOSIS
9
C
ANTIFUNGAL PROPHYLAXIS
ATRIAL FIBRILLATION
1
C
ANTIFUNGAL PROPHYLAXIS
BRADYCARDIA
1
C
ANTIFUNGAL PROPHYLAXIS
CARDIAC ARREST
3
C
ANTIFUNGAL PROPHYLAXIS
FUSARIUM INFECTION
3
C
ANTIFUNGAL PROPHYLAXIS
GANGRENE
1
C
ANTIFUNGAL PROPHYLAXIS
HAEMODIALYSIS
1
C
ANTIFUNGAL PROPHYLAXIS
METABOLIC ACIDOSIS
1
C
ANTIFUNGAL PROPHYLAXIS
NEUTROPENIC COLITIS
3
C
ANTIFUNGAL PROPHYLAXIS
RENAL IMPAIRMENT
1
C
ANTIFUNGAL PROPHYLAXIS
SINUS ARREST
1
C
ANTIFUNGAL PROPHYLAXIS
ZYGOMYCOSIS
3
C
BREAST CANCER
ACUTE MYELOID LEUKAEMIA
1
C
BREAST CANCER
DEATH
1
C
BREAST CANCER
NEOPLASM MALIGNANT
1
C
BRONCHIECTASIS
BRONCHOSPASM
1
C
BRONCHIECTASIS
CANDIDIASIS
1
C
BRONCHIECTASIS
CHEST DISCOMFORT
1
C
BRONCHIECTASIS
DEVICE MALFUNCTION
1
C
BRONCHIECTASIS
EMPHYSEMA
1
C
BRONCHIECTASIS
OXYGEN SATURATION DECREASED
1
C
BRONCHIECTASIS
PULMONARY CONGESTION
1
C
BRONCHIECTASIS
TOOTH DISORDER
1
C
DIALYSIS
ACUTE GRAFT VERSUS HOST DISEASE IN SKIN
1
C
DIALYSIS
BACTERIAL INFECTION
1
C
DIALYSIS
BRONCHOPULMONARY ASPERGILLOSIS
1
C
DIALYSIS
GENERAL PHYSICAL HEALTH DETERIORATION
1
C
DIALYSIS
INFECTION
1
C
INFECTION
ATRIAL FIBRILLATION
1
C
INFECTION
BRADYCARDIA
1
C
INFECTION
CARDIAC ARREST
3
C
INFECTION
FUSARIUM INFECTION
3
C
INFECTION
GANGRENE
1
C
INFECTION
HAEMODIALYSIS
1
C
INFECTION
METABOLIC ACIDOSIS
1
C
INFECTION
NEUTROPENIC COLITIS
3
C
INFECTION
RENAL IMPAIRMENT
1
C
INFECTION
SINUS ARREST
1
C
INFECTION
ZYGOMYCOSIS
3
C
INFECTION PROPHYLAXIS
DYSPNOEA
4
C
INFECTION PROPHYLAXIS
HYPERCALCAEMIA
2
C
INFECTION PROPHYLAXIS
PNEUMONIA
2
C
INFECTION PROPHYLAXIS
TUMOUR LYSIS SYNDROME
2
C
INSOMNIA
ADENOVIRAL HEPATITIS
1
C
INSOMNIA
ANAEMIA
1
C
INSOMNIA
CARDIOVASCULAR DISORDER
1
C
INSOMNIA
COAGULATION FACTOR V LEVEL DECREASED
1
C
INSOMNIA
CYSTITIS HAEMORRHAGIC
1
C
INSOMNIA
ENCEPHALITIS
1
C
INSOMNIA
GENERAL PHYSICAL HEALTH DETERIORATION
1
C
INSOMNIA
HEPATIC FAILURE
1
C
INSOMNIA
MULTI-ORGAN FAILURE
1
C
INSOMNIA
RESPIRATORY DISORDER
1
C
MULTIPLE MYELOMA
ACUTE GRAFT VERSUS HOST DISEASE IN SKIN
1
C
MULTIPLE MYELOMA
BACTERIAL INFECTION
1
C
MULTIPLE MYELOMA
BRONCHOPULMONARY ASPERGILLOSIS
1
C
MULTIPLE MYELOMA
GENERAL PHYSICAL HEALTH DETERIORATION
1
C
MULTIPLE MYELOMA
INFECTION
1
C
NAUSEA
ADENOVIRAL HEPATITIS
1
C
NAUSEA
ANAEMIA
1
C
NAUSEA
CARDIOVASCULAR DISORDER
1
C
NAUSEA
COAGULATION FACTOR V LEVEL DECREASED
1
C
NAUSEA
CYSTITIS HAEMORRHAGIC
1
C
NAUSEA
ENCEPHALITIS
1
C
NAUSEA
GENERAL PHYSICAL HEALTH DETERIORATION
1
C
NAUSEA
HEPATIC FAILURE
1
C
NAUSEA
MULTI-ORGAN FAILURE
1
C
NAUSEA
RESPIRATORY DISORDER
1
C
PAIN
ACUTE GRAFT VERSUS HOST DISEASE IN SKIN
1
C
PAIN
ADENOVIRAL HEPATITIS
1
C
PAIN
ANAEMIA
1
C
PAIN
BACTERIAL INFECTION
1
C
PAIN
BRONCHOPULMONARY ASPERGILLOSIS
1
C
PAIN
CARDIOVASCULAR DISORDER
1
C
PAIN
COAGULATION FACTOR V LEVEL DECREASED
1
C
PAIN
CYSTITIS HAEMORRHAGIC
1
C
PAIN
DYSPNOEA
2
C
PAIN
ENCEPHALITIS
1
C
PAIN
GENERAL PHYSICAL HEALTH DETERIORATION
2
C
PAIN
HEPATIC FAILURE
1
C
PAIN
HYPERCALCAEMIA
1
C
PAIN
INFECTION
1
C
PAIN
MULTI-ORGAN FAILURE
1
C
PAIN
PNEUMONIA
1
C
PAIN
RESPIRATORY DISORDER
1
C
PAIN
TUMOUR LYSIS SYNDROME
1
C
PNEUMONIA
DYSPNOEA
2
C
PNEUMONIA
HYPERCALCAEMIA
1
C
PNEUMONIA
PNEUMONIA
1
C
PNEUMONIA
TUMOUR LYSIS SYNDROME
1
C
PRODUCT USED FOR UNKNOWN INDICATION
ADENOVIRAL HEPATITIS
27
C
PRODUCT USED FOR UNKNOWN INDICATION
ANAEMIA
27
C
PRODUCT USED FOR UNKNOWN INDICATION
CARDIOVASCULAR DISORDER
27
C
PRODUCT USED FOR UNKNOWN INDICATION
COAGULATION FACTOR V LEVEL DECREASED
27
C
PRODUCT USED FOR UNKNOWN INDICATION
CYSTITIS HAEMORRHAGIC
27
C
PRODUCT USED FOR UNKNOWN INDICATION
ENCEPHALITIS
27
C
PRODUCT USED FOR UNKNOWN INDICATION
GENERAL PHYSICAL HEALTH DETERIORATION
27
C
PRODUCT USED FOR UNKNOWN INDICATION
HEPATIC FAILURE
27
C
PRODUCT USED FOR UNKNOWN INDICATION
MULTI-ORGAN FAILURE
27
C
PRODUCT USED FOR UNKNOWN INDICATION
RESPIRATORY DISORDER
27
C
PROPHYLAXIS
CARDIAC ARREST
1
C
PROPHYLAXIS
DYSPNOEA
4
C
PROPHYLAXIS
FUSARIUM INFECTION
1
C
PROPHYLAXIS
HYPERCALCAEMIA
2
C
PROPHYLAXIS
NEUTROPENIC COLITIS
1
C
PROPHYLAXIS
PNEUMONIA
2
C
PROPHYLAXIS
TUMOUR LYSIS SYNDROME
2
C
PROPHYLAXIS
ZYGOMYCOSIS
1
C
PYREXIA
ADENOVIRAL HEPATITIS
1
C
PYREXIA
ANAEMIA
1
C
PYREXIA
CARDIOVASCULAR DISORDER
1
C
PYREXIA
COAGULATION FACTOR V LEVEL DECREASED
1
C
PYREXIA
CYSTITIS HAEMORRHAGIC
1
C
PYREXIA
ENCEPHALITIS
1
C
PYREXIA
GENERAL PHYSICAL HEALTH DETERIORATION
1
C
PYREXIA
HEPATIC FAILURE
1
C
PYREXIA
MULTI-ORGAN FAILURE
1
C
PYREXIA
RESPIRATORY DISORDER
1
C
THROMBOSIS PROPHYLAXIS
DYSPNOEA
2
C
THROMBOSIS PROPHYLAXIS
HYPERCALCAEMIA
1
C
THROMBOSIS PROPHYLAXIS
PNEUMONIA
1
C
THROMBOSIS PROPHYLAXIS
TUMOUR LYSIS SYNDROME
1
I
ACUTE LEUKAEMIA IN REMISSION
ARRHYTHMIA
2
I
ACUTE LEUKAEMIA IN REMISSION
ATRIOVENTRICULAR BLOCK SECOND DEGREE
2
I
ACUTE LEUKAEMIA IN REMISSION
BRADYCARDIA
2
I
ACUTE LEUKAEMIA IN REMISSION
DRUG INTERACTION
2
I
ACUTE LEUKAEMIA IN REMISSION
SINOATRIAL BLOCK
2
I
ACUTE LEUKAEMIA IN REMISSION
SINUS TACHYCARDIA
2
I
HEPATOSPLENIC CANDIDIASIS
ARRHYTHMIA
3
I
HEPATOSPLENIC CANDIDIASIS
ATRIOVENTRICULAR BLOCK SECOND DEGREE
12
I
HEPATOSPLENIC CANDIDIASIS
BRADYARRHYTHMIA
4
I
HEPATOSPLENIC CANDIDIASIS
BRADYCARDIA
6
I
HEPATOSPLENIC CANDIDIASIS
DRUG INTERACTION
12
I
HEPATOSPLENIC CANDIDIASIS
HEPATOSPLENIC CANDIDIASIS
1
I
HEPATOSPLENIC CANDIDIASIS
NODAL ARRHYTHMIA
4
I
HEPATOSPLENIC CANDIDIASIS
SINOATRIAL BLOCK
12
I
HEPATOSPLENIC CANDIDIASIS
SINUS BRADYCARDIA
4
I
HEPATOSPLENIC CANDIDIASIS
SINUS TACHYCARDIA
6
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