CASPOFUNGIN XELLIA 50 Milligram Pdr/Conc/Soln for Infus

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CASPOFUNGIN

Available from:

Xellia Pharmaceuticals ApS

ATC code:

J02AX04

INN (International Name):

CASPOFUNGIN

Dosage:

50 Milligram

Pharmaceutical form:

Pdr/Conc/Soln for Infus

Prescription type:

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

Therapeutic area:

Other mycotics for systemic use

Authorization status:

Transfer Pending

Authorization date:

2016-09-16

Patient Information leaflet

60400026
Xellia 
PACKAGE LEAFLET: INFORMATION FOR THE USER
CASPOFUNGIN XELLIA 50 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
Caspofungin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD ARE GIVEN
THIS MEDICINE BECAUSE 
IT CONTAINS IMPORTANT INFORMATION FOR YOU.
•  Keep this leaflet. You may need to read it again.
•  If you have further questions, please ask your doctor, nurse or
pharmacist.
•  If you get any side effects, talk to your doctor, nurse or
pharmacist. This includes any possi-
ble side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Caspofungin Xellia is and what it is used for
2. What you need to know before you are given Caspofungin Xellia 
3. How to use Caspofungin Xellia 
4. Possible side effects
5. How to store Caspofungin Xellia 
6. Contents of the pack and other information
1. WHAT CASPOFUNGIN XELLIA IS AND WHAT IT IS USED FOR
WHAT CASPOFUNGIN XELLIA IS 
Caspofungin Xellia contains a medicine called caspofungin. This belongs to a group of medicines 
called antifungals.
WHAT CASPOFUNGIN XELLIA IS USED FOR
Caspofungin Xellia is used to treat the following infections in
children, adolescents and adults:
•  Serious fungal infections in your tissues or organs (called
‘invasive candidiasis’). This infec-
tion is caused by fungal (yeast) cells called Candida.
•  People who might get this type of infection include those who
have just had an operation or 
those whose immune systems are weak. Fever and chills that do not
respond to an antibiotic 
are the most common signs of this type of infection.
•  Fungal infections in your nose, nasal sinuses or lungs (called
‘invasive aspergillosis’) if other 
anti-fungal treatments have not worked or have caused side
effects. This infection is caused 
by a mould called Aspergillus.
•  People who might get this type of infection include those
having chemotherapy, those who 
have had a transplant and those whose immune systems are weak.
•  Sus

Summary of Product characteristics

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