Caspofungin Galenicum Health Pdr/Conc/Soln for Infus 70mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CASPOFUNGIN ACETATE

Available from:

Galenicum Health, S.L. Avenida Diagonal 123, 11ª Planta, 08005, Barcelona, Spain

ATC code:

J02AX04

INN (International Name):

CASPOFUNGIN ACETATE

Pharmaceutical form:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

CASPOFUNGIN ACETATE 70 milligram(s)

Prescription type:

POM

Therapeutic area:

ANTIMYCOTICS FOR SYSTEMIC USE

Authorization status:

Authorised

Authorization date:

2017-11-24

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
CASPOFUNGIN GALENICUM HEALTH 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 Galenicum Health is and what it is used for
2.
What you need to know before you are given Caspofungin Galenicum
Health
3.
How to use Caspofungin Galenicum Health
4.
Possible side effects
5.
How to store Caspofungin Galenicum Health
6.
Contents of the pack and other information
1.
WHAT CASPOFUNGIN GALENICUM HEALTH IS AND WHAT IT IS USED FOR
WHAT CASPOFUNGIN GALENICUM HEALTH IS
Caspofungin Galenicum Health belongs to a group of medicines called
antifungals.
WHAT CASPOFUNGIN GALENICUM HEALTH IS USED FOR
Caspofungin Galenicum Health 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 infections

Summary of Product characteristics

SUMMARY OF PRODUCT CHARATERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
CASPOFUNGIN Galenicum Health 50 mg powder for concentrate for solution
for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 50 mg caspofungin (as acetate).
After reconstitution in 10.5 ml of water for injection, 1 ml of
concentrate contains 5.2 mg
caspofungin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
Before reconstitution, the product is a 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 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 thereaf