CASPOFUNGIN XELLIA 50 Milligram Pdr/Conc/Soln for Infus

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

CASPOFUNGIN

Dostupné s:

Xellia Pharmaceuticals ApS

ATC kód:

J02AX04

INN (Mezinárodní Name):

CASPOFUNGIN

Dávkování:

50 Milligram

Léková forma:

Pdr/Conc/Soln for Infus

Druh předpisu:

Product subject to prescription which may not be renewed (A)

Terapeutické oblasti:

Other mycotics for systemic use

Stav Autorizace:

Authorised

Datum autorizace:

2017-02-03

Charakteristika produktu

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 single 70-mg/m
2
loading dose
(not to exceed an actual dose of 70 mg) should be administered on Day
1, followed by 50 mg/m
2
daily thereafter (not to
exceed an actual dose of 70 mg daily). If the 50-mg/m
2
daily dose is well tolerated but doe