Caspofungin Fresenius Kabi 50 mg powder for concentrate for solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Caspofungin

Available from:

Fresenius Kabi Deutschland GmbH

ATC code:

J02AX; J02AX04

INN (International Name):

Caspofungin

Dosage:

50 milligram(s)

Pharmaceutical form:

Powder for concentrate for solution for infusion

Prescription type:

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

Therapeutic area:

Other antimycotics for systemic use; caspofungin

Authorization status:

Not marketed

Authorization date:

2016-12-02

Summary of Product characteristics

Health Products Regulatory Authority
07 May 2021
CRN009XVH
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Caspofungin Fresenius Kabi 50 mg powder for concentrate for solution
for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 50 mg vial contains 50 mg caspofungin (as acetate).
The concentration of the reconstituted vials 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.
White to off-white-compact 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 Fresenius Kabi 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