CASPOFUNGIN FRESENIUS KABI 70 Milligram Pdr/Conc/Soln for Infus

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CASPOFUNGIN

Available from:

Fresenius Kabi Limited

ATC code:

J02AX04

INN (International Name):

CASPOFUNGIN

Dosage:

70 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:

Authorised

Authorization date:

2017-07-21

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CASPOFUNGIN FRESENIUS KABI 70 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
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Caspofungin Fresenius Kabi is and what it is used for
2. What you need to know before you are given Caspofungin Fresenius
Kabi
3. How to use Caspofungin Fresenius Kabi
4. Possible side effects
5. How to store Caspofungin Fresenius Kabi
6. Contents of the pack and other information
1. WHAT CASPOFUNGIN FRESENIUS KABI IS AND WHAT IT IS USED FOR
WHAT CASPOFUNGIN FRESENIUS KABI IS
Caspofungin Fresenius Kabi contains a medicine called caspofungin.
This belongs to a group
of medicines called antifungals.
WHAT CASPOFUNGIN FRESENIUS KABI IS USED FOR
Caspofungin Fresenius Kabi is used to treat the following infections
in children, adolescents
and adults:

serious fungal infections in your tissues or organs (called invasive
candidiasis’). This
infection 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.

suspected fungal infec

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Caspofungin Fresenius Kabi 70 mg powder for concentrate for solution
for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 70 mg vial contains 70 mg caspofungin (as acetate)
The concentration of the reconstituted vials is 7.2 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, neutropenic 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 to
exceed an actual dose of 70 mg daily). If the 50-mg/m2 daily dose is
w