CASPOFUNGIN XELLIA 50 Milligram Pdr/Conc/Soln for Infus
البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
خصائص المنتج
(SPC)
12-11-2016
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ارسل طلب
ارسل طلب
العنصر النشط:
CASPOFUNGIN
متاح من:
Fresenius Kabi Limited
ATC رمز:
J02AX04
INN (الاسم الدولي):
CASPOFUNGIN
جرعة:
50 Milligram
الشكل الصيدلاني:
Pdr/Conc/Soln for Infus
نوع الوصفة الطبية :
Product subject to prescription which may not be renewed (A)
المجال العلاجي:
Other mycotics for systemic use
الوضع إذن:
Authorised
تاريخ الترخيص:
2016-10-28
خصائص المنتج
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Caspofungin Xellia 50 mg Powder for concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 50 mg caspofungin (as acetate). The concentration of the reconstituted vial is 5.2 mg/ml.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
The powder is a white to off-white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
•
Treatment of invasive candidiasis in adult or paediatric patients.
•
Treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of
amphotericin B, lipid formulations of amphotericin B and/or itraconazole. Refractoriness is defined as
progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective
antifungal therapy.
•
Empirical therapy for presumed fungal infections (such as Candida or Aspergillus) in febrile, neutropaenic
adult or paediatric patients.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Caspofungin should be initiated by a physician experienced in the management of invasive fungal infections.
Posology
_Adult patients_
A single 70 mg loading dose should be administered on Day-1, followed by 50 mg daily thereafter. In patients
weighing more than 80 kg, after the initial 70 mg loading dose, caspofungin 70 mg daily is recommended (see section
5.2). No dosage adjustment is necessary based on gender or race (see section 5.2).
_Paediatric patients (12 months to 17 years)_
In paediatric patients (12 months to 17 years of age), dosing should be based on the patient's body surface area (see
Instructions for Use in Paediatric Patients, Mosteller
1
Formula). For all indications, a
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