Micafungin 100 mg powder for concentrate for solution for infusion

Maa: Malta

Kieli: englanti

Lähde: Malta Medicines Authority

Aktiivinen ainesosa:

MICAFUNGIN SODIUM

Saatavilla:

Mylan Ireland Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

ATC-koodi:

J02AX05

INN (Kansainvälinen yleisnimi):

MICAFUNGIN SODIUM 20 mg/ml

Lääkemuoto:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Koostumus:

MICAFUNGIN SODIUM 20 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:

2020-08-14

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE USER
MICAFUNGIN 50 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
MICAFUNGIN 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 Micafungin is and what it is used for
2.
What you need to know before you use Micafungin
3.
How to use Micafungin
4.
Possible side effects
5.
How to store Micafungin
6.
Contents of the pack and other information
1. WHAT MICAFUNGIN IS AND WHAT IT IS USED FOR
Micafungin contains the active substance micafungin. Micafungin is
called an antifungal medicine
because it is used to treat infections caused by fungal cells.
Micafungin is used to treat fungal infections caused by fungal or
yeast cells called Candida. Micafungin
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. Micafungin causes defects in the fungal cell wall,
making the fungus unable to live
and grow.
Your doctor has prescribed Micafungin 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 trans

Valmisteyhteenveto

1
1.
NAME OF THE MEDICINAL PRODUCT
Micafungin 100 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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
Micafungin 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 Micafungin should take into account a potential
risk for the development
of liver tumours (see section 4.4). Micafungin 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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Micafungin should be initiated by a physician
experienced in the management
of fungal infections.
2
Posology
Specimens for fungal culture and other relevant laboratory studies
(including histopathology)
should be obtained prior to therapy to isolate and identify causative
organism(s). Therapy may
be instituted before the results of the cultures and other laboratory
studies are known. Ho