SPORANOX ORAL SOLUTION 10 mgml

国家: 新加坡

语言: 英文

来源: HSA (Health Sciences Authority)

有效成分:

ITRACONAZOLE

可用日期:

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

ATC代码:

J02A C02

剂量:

10 mg/ml

药物剂型:

SOLUTION

组成:

ITRACONAZOLE 10 mg/ml

给药途径:

ORAL

处方类型:

Prescription Only

厂商:

JANSSEN PHARMACEUTICA NV

授权状态:

ACTIVE

授权日期:

1998-06-12

资料单张

 
1 
PRODUCT NAME

TRADE NAME 
SPORANOX
® 
ORAL SOLUTION 

GENERIC NAME/INTERNATIONAL NON-PROPRIETARY NAME 
Itraconazole 

DOSAGE FORMS AND STRENGTHS 
SPORANOX
®
 oral solution is clear.                             

1 ml SPORANOX
®
 oral solution contains 10 mg itraconazole. 

For excipients, see _List of Excipients._ 

CLINICAL INFORMATION 

INDICATIONS 
SPORANOX
®
 oral solution is indicated: 

  For  the  treatment  of  oral  and/or  esophageal  candidosis  in  HIV-positive  or  other 
immunocompromised patients. 

  As  prophylaxis  of  deep  fungal  infections,  in  patients  with  hematological  malignancy  or 
undergoing bone marrow transplant, and who are expected to become neutropenic (i.e. < 500 
cells/µl). 

  For  empiric  therapy  of  febrile  neutropenic  patients  with  suspected  systemic  mycoses  as 
follow-up therapy to SPORANOX
®
 IV._ _

DOSAGE AND ADMINISTRATION 
For optimal  absorption, SPORANOX
®
 oral  solution should be taken without food (patients  are 
advised to refrain from eating for at least 1 hour
after intake). 

For  the  treatment  of  oral  and/or  esophageal  candidosis,_  _the  oral  solution  should  be  swished 
around  the  oral  cavity  (approx.  20  seconds)  and  swallowed.  There  should  be  no  rinsing  after 
swallowing.  

TREATMENT OF ORAL AND/OR ESOPHAGEAL CANDIDOSIS  
200 mg (2 measuring cups) per day in two intakes, or alternatively in one intake, for 1 week. If 
there is no response after 1 week, treatment
should be continued for another week. 

TREATMENT OF FLUCONAZOLE RESISTANT ORAL AND/OR ESOPHAGEAL CANDIDOSIS  
100 to 200 mg (1-2 measuring cups) twice�

产品特点

1
PRODUCT NAME
SPORANOX
®
ORAL SOLUTION
GENERIC NAME/INTERNATIONAL NON-PROPRIETARY NAME
Itraconazole
DOSAGE FORMS AND STRENGTHS
SPORANOX
®
oral solution is clear.
1 mL SPORANOX
®
oral solution contains 10 mg itraconazole.
For excipients, see
_List of Excipients._
CLINICAL INFORMATION
INDICATIONS
SPORANOX
®
oral solution is indicated:
•
For
the
treatment
of
oral
and/or
esophageal
candidosis
in
HIV-positive
or
other
immunocompromised patients.
•
As prophylaxis of deep fungal infections, in patients with
hematological malignancy or
undergoing bone marrow transplant, and who are expected to become
neutropenic (i.e. < 500
cells/µL).
•
For empiric therapy of febrile neutropenic patients with suspected
systemic mycoses as follow-
up therapy to SPORANOX
®
IV.
_ _
DOSAGE AND ADMINISTRATION
For optimal absorption, SPORANOX
®
oral solution should be taken without food (patients are
advised to refrain from eating for at least 1 hour after intake).
For the treatment of oral and/or esophageal candidosis,
_ _
the oral solution should be swished around
the oral cavity (approx. 20 seconds) and swallowed. There should be no
rinsing after swallowing.
TREATMENT OF ORAL CANDIDOSIS
200 mg (2 measuring cups, i.e. 20 mL) per day in two intakes, or
alternatively in one intake, for 1
week. If there is no response after 1 week, treatment should be
continued for another week.
TREATMENT OF ESOPHAGEAL CANDIDOSIS
100 mg (1 measuring cup, i.e. 10 mL) daily for a minimum treatment of
three weeks. Treatment
should continue for 2 weeks following resolution of symptoms. Doses up
to 200 mg (2 measuring
cups, i.e. 20 mL) per day may be used based on the clinical response
of the patient.
TREATMENT OF FLUCONAZOLE RESISTANT ORAL AND/OR ESOPHAGEAL CANDIDOSIS
100 to 200 mg (1-2 measuring cups) twice daily for 2 weeks. If there
is no response after 2 weeks,
treatment should be continued for another 2 weeks. The 400 mg daily
dose should not be used for
longer than 14 days if there are no signs of improvement.
2
PROPHYLAXIS OF FUNGAL INFECTIONS