Micafungin Sandoz 100 mg powder for concentrate for solution for infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MICAFUNGIN SODIUM

Available from:

Sandoz Pharmaceuticals d.d. Verovškova Ulica 57, SI-1000 Ljubljana, Slovenia

ATC code:

J02AX05

INN (International Name):

MICAFUNGIN SODIUM 100 mg

Pharmaceutical form:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

MICAFUNGIN SODIUM 100 mg

Prescription type:

POM

Therapeutic area:

ANTIMYCOTICS FOR SYSTEMIC USE

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2020-08-13

Patient Information leaflet

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

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Micafungin Sandoz 50 mg powder for concentrate for solution for
infusion
Micafungin Sandoz 100 mg powder for concentrate for solution for
infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Micafungin Sandoz 50 mg
Each vial contains micafungin sodium equivalent to 50 mg micafungin.
After reconstitution each ml contains micafungin sodium equivalent to
10 mg micafungin.
Micafungin Sandoz 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
Micafungin Sandoz 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 Sandoz should take into account a
potential risk for the
development of liver tumours (see section 4.4). Micafungin Sandoz
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 Micafungin Sandoz should be initiated by a physician
experienced in the
manageme