Caspofungin 70 mg powder for concentrate for solution for infusion

Krajina: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktívna zložka:

CASPOFUNGIN ACETATE

Dostupné z:

Centrient Pharmaceuticals Netherlands B.V (DSM Sinochem) Alexander Fleminglaan 1, 2613 AX Delft, Netherlands

ATC kód:

J02AX04

INN (Medzinárodný Name):

CASPOFUNGIN ACETATE 70 mg

Forma lieku:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Zloženie:

CASPOFUNGIN ACETATE 70 mg

Typ predpisu:

POM

Terapeutické oblasti:

ANTIMYCOTICS FOR SYSTEMIC USE

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2017-01-13

Príbalový leták

Page
1
of
9
PACKAGE LEAFLET: INFORMATION FOR THE USER
CASPOFUNGIN 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 is and what it is used for
2.
What you need to know before you are given Caspofungin
3.
How to use Caspofungin
4.
Possible side effects
5.
How to store Caspofungin
6.
Contents of the pack and other information
1.
WHAT CASPOFUNGIN IS AND WHAT IT IS USED FOR
WHAT CASPOFUNGIN IS
Caspofungin
<
name
>
contains a medicine called caspofungin. This belongs to a group of
medicines called antifungals.
WHAT CASPOFUNGIN IS USED FOR
Caspofungin 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 if you have a fever and a low white cell
count that have not
improved on treatment with an antibiotic. People who are at

Súhrn charakteristických

Page
1
of
22
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
CASPOFUNGIN 50 mg powder for concentrate for solution for infusion
CASPOFUNGIN 70 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
CASPOFUNGIN 50 mg powder for concentrate for solution for
infusion 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 of Caspofungin.
CASPOFUNGIN 70 mg powder for concentrate for solution for
infusion Each vial contains 70 mg caspofungin (as acetate).
After reconstitution in 10.5 ml of water for injection, 1 ml of
concentrate contains
7.2. mg of Caspofungin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
Before reconstitution, the powder 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,
Page
2
of
22
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 mon