Mycamine
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
08-01-2024
Fachinformation
(SPC)
08-01-2024
Öffentlichen Beurteilungsberichts
(PAR)
14-09-2011
Wirkstoff:
micafungin
Verfügbar ab:
Astellas Pharma Europe B.V.
ATC-Code:
J02AX05
INN (Internationale Bezeichnung):
micafungin
Therapiegruppe:
Antimycotics for systemic use
Therapiebereich:
Candidiasis
Anwendungsgebiete:
Mycamine is indicated for:Adults, adolescents ≥ 16 years of age and elderlytreatment 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 agetreatment 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 Mycamine should take into account a potential risk for the development of liver tumours. Mycamine should therefore only be used if other antifungals are not appropriate.
Produktbesonderheiten:
Revision: 18
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2008-04-25
Gebrauchsinformation
26
B. PACKAGE LEAFLET
27
PACKAGE LEAFLET: INFORMATION FOR THE USER
MYCAMINE 50 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
MYCAMINE 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 or 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 Mycamine is and what it is used for
2.
What you need to know before you use Mycamine
3.
How to use Mycamine
4.
Possible side effects
5.
How to store Mycamine
6.
Contents of the pack and other information
1.
WHAT MYCAMINE IS AND WHAT IT IS USED FOR
Mycamine contains the active substance micafungin. Mycamine is called
an antifungal medicine
because it is used to treat infections caused by fungal cells.
Mycamine is used to treat fungal infections caused by fungal or yeast
cells called Candida_._ Mycamine
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. Mycamine causes defects in the fungal
cell wall, making the fungus
unable to live and grow.
Your doctor has prescribed Mycamine 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 tr
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Mycamine 50 mg powder for concentrate for solution for infusion
Mycamine 100 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Mycamine 50 mg
Each vial contains 50 mg micafungin (as sodium).
After reconstitution each ml contains 10 mg micafungin (as sodium).
Mycamine 100 mg
Each vial contains 100 mg micafungin (as sodium).
After reconstitution each ml contains 20 mg micafungin (as sodium).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion
White compact powder
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mycamine 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 Mycamine should take into account a potential risk
for the development of liver
tumours (see section 4.4). Mycamine 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 Mycamine should be initiated by a physician experienced
in the management of fungal
infections.
3
Posology
Specimens for fungal culture and other relevant laboratory studies
(including histopat
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