Micafungin 50 mg powder for concentrate for solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Micafungin

Available from:

Pinewood Laboratories Ltd,

ATC code:

J02AX05

INN (International Name):

Micafungin

Dosage:

50 milligram(s)

Pharmaceutical form:

Powder for concentrate for solution for infusion

Therapeutic area:

micafungin

Authorization date:

2021-03-19

Patient Information leaflet

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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 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 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

Summary of Product characteristics

Health Products Regulatory Authority
19 March 2021
CRN00923C
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Micafungin 50 mg powder for concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 50 mg micafungin (as sodium).
After reconstitution each ml concentrate for solution for infusion
contains 10 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 to off‑white cake or powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Micafungin is indicated for:
Adults, adolescent's ≥ 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/microL) 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/microL) 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.
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). Th