Micafungine Pharmazac 50 mg poeder voor concentraat voor oplossing voor infusie

Land: Holland

Tungumál: hollenska

Heimild: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Virkt innihaldsefni:

MICAFUNGINE NATRIUM 50,9 mg/flacon SAMENSTELLING overeenkomend met ; MICAFUNGINE 50 mg/flacon

INN (Alþjóðlegt nafn):

MICAFUNGINE NATRIUM 50,9 mg/flacon SAMENSTELLING overeenkomend met ; MICAFUNGINE 50 mg/flacon

Lyfjaform:

Poeder voor concentraat voor oplossing voor infusie

Samsetning:

CITROENZUUR 0-WATER (E 330) ; LACTOSE 1-WATER ; NATRIUMHYDROXIDE (E 524) ; STIKSTOF (HEAD SPACE) (E 941)

Stjórnsýsluleið:

Intraveneus gebruik

Leyfisdagur:

1900-01-01

Upplýsingar fylgiseðill

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
MICAFUNGINE PHARMAZAC 50 MG POEDER VOOR CONCENTRAAT VOOR OPLOSSING
VOOR INFUSIE
MICAFUNGINE PHARMAZAC 100 MG POEDER VOOR CONCENTRAAT VOOR OPLOSSING
VOOR INFUSIE
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 Micafungine Pharmazac is and what it is used for
2.
What you need to know before you use Micafungine Pharmazac
3.
How to use Micafungine Pharmazac
4.
Possible side effects
5.
How to store Micafungine Pharmazac
6.
Contents of the pack and other information
1.
WHAT MICAFUNGINE PHARMAZAC IS AND WHAT IT IS USED FOR
Micafungine Pharmazac contains the active substance micafungin.
Micafungine Pharmazac is called
an antifungal medicine because it is used to treat infections caused
by fungal cells.
Micafungine Pharmazac is used to treat fungal infections caused by
fungal or yeast cells called Candida
_. _
Micafungine Pharmazac 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. Micafungine Pharmazac
causes defects in the fungal cell wall,
making the fungus unable to live and grow.
Your doctor has prescribed Micafungine Pharmazac 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
infe

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1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Micafungine Pharmazac 50 mg poeder voor concentraat voor oplossing
voor infusie
Micafungine Pharmazac 100 mg poeder voor concentraat voor oplossing
voor infusie
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Micafungine Pharmazac 50 mg
Each vial contains 50 mg micafungin (as sodium).
After reconstitution each ml contains 10 mg micafungin (as sodium).
Micafungine Pharmazac 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
Solid, white to off-white cake.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Micafungine Pharmazac 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 Micafungine Pharmazac should take into account a
potential risk for the
development of liver tumours (see section 4.4). Micafungine Pharmazac
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 Micafungine Pharmazac should be initiated by a
physician experienced in the
management of