Funzoren 50 mg powder for concentrate for solution for infusion

Maa: Malta

Kieli: englanti

Lähde: Malta Medicines Authority

Aktiivinen ainesosa:

MICAFUNGIN SODIUM

Saatavilla:

Vocate Pharmaceuticals S.A 150, Gounari str, 166 74 Glyfada, Athens, Greece

ATC-koodi:

J02AX05

INN (Kansainvälinen yleisnimi):

MICAFUNGIN SODIUM 10 mg/ml

Lääkemuoto:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Koostumus:

MICAFUNGIN SODIUM 10 mg/ml

Prescription tyyppi:

POM

Terapeuttinen alue:

ANTIMYCOTICS FOR SYSTEMIC USE

Tuoteyhteenveto:

Licence number in the source country: NOT APPLICAPABLE

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2020-10-20

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE USER
FUNZOREN 50 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
FUNZOREN 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
micafungin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Funzoren is and what it is used for
2.
What you need to know before you use Funzoren
3.
How to use Funzoren
4.
Possible side effects
5.
How to store Funzoren
6.
Contents of the pack and other information
1. WHAT FUNZOREN IS AND WHAT IT IS USED FOR
Funzoren contains the active substance micafungin. Funzoren is called
an antifungal medicine because
it is used to treat infections caused by fungal cells.
Funzoren is used to treat fungal infections caused by fungal or yeast
cells called Candida. Funzoren is
effective in treating systemic infections (those that have penetrated
within the body). It interferes with
the production of a part of the fungal cell wall. An intact cell wall
is necessary for the fungus to continue
living and growing. Funzoren causes defects in the fungal cell wall,
making the fungus unable to live
and grow.
Your doctor has prescribed Funzoren for you in the following
circumstances when there are no other
suitable antifungal treatments available (see section 2):
•
To treat adults, adolescents and children including neonates who have
a serious fungal infection
called invasive candidiasis (infection that has penetrated the body).
•
To treat adults and adolescents ≥ 16 years of age who have a fungal
infection in the gullet
(oesophagus) where treatment into a vein (intravenous) is appropriate.
•
To prevent infection with Candida in patients who are having a
bone-marrow transplant or who are
expected

Valmisteyhteenveto

1
1.
NAME OF THE MEDICINAL PRODUCT
Funzoren 50 mg powder for concentrate for solution for infusion
Funzoren 100 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Funzoren 50 mg
Each vial contains micafungin sodium equivalent to 50 mg micafungin.
After reconstitution each ml contains micafungin sodium equivalent to
10 mg micafungin.
Funzoren 100 mg
Each vial contains micafungin sodium equivalent to 100 mg micafungin.
After reconstitution each ml contains micafungin sodium equivalent to
20 mg micafungin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion
Lyophilized white to off-white powder
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Funzoren is indicated for:
Adults, adolescents ≥ 16 years of age and elderly:
-
Treatment of invasive candidiasis.
-
Treatment
of
oesophageal
candidiasis
in
patients
for
whom
intravenous
therapy
is
appropriate.
-
Prophylaxis of Candida infection in patients undergoing allogeneic
haematopoietic stem cell
transplantation or patients who are expected to have neutropenia
(absolute neutrophil count
< 500 cells / µl) for 10 or more days.
Children (including neonates) and adolescents < 16 years of age:
-
Treatment of invasive candidiasis.
-
Prophylaxis of Candida infection in patients undergoing allogeneic
haematopoietic stem cell
transplantation or patients who are expected to have neutropenia
(absolute neutrophil count
< 500 cells / µl) for 10 or more days.
The decision to use Funzoren should take into account a potential risk
for the development of
liver tumours (see section 4.4). Funzoren should therefore only be
used if other antifungals are
not appropriate.
Consideration should be given to official/national guidance on the
appropriate use of antifungal
agents.
2
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Funzoren should be initiated by a physician experienced
in the management of
fungal infections.
Posology
Specimens for fungal culture and other