Anidulafungin 100 mg powder for concentrate for solution for infusion

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Anidulafungin

Fáanlegur frá:

Accord Healthcare Ireland Ltd.

ATC númer:

J02AX06

INN (Alþjóðlegt nafn):

Anidulafungin

Skammtar:

100 milligram(s)

Lyfjaform:

Powder for concentrate for solution for infusion

Gerð lyfseðils:

Product subject to prescription which may not be renewed (A)

Lækningarsvæði:

anidulafungin

Leyfisstaða:

Not marketed

Leyfisdagur:

2019-01-18

Upplýsingar fylgiseðill

1/7
NL/H/4543/001/IB/010/G, ver 01, Nov 2023
PACKAGE LEAFLET: INFORMATION FOR THE USER
ANIDULAFUNGIN 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
anidulafungin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD 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 or
nurse.
-
If you or your child get any side effects, talk to your doctor, or
pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET:
1.
What Anidulafungin Powder is and what it is used for
2.
What you need to know before you or your child use Anidulafungin
Powder
3.
How to use Anidulafungin Powder
4.
Possible side effects
5.
How to store Anidulafungin Powder
6.
Contents of the pack and other information
1.
WHAT ANIDULAFUNGIN POWDER
IS AND WHAT IT IS USED FOR
Anidulafungin Powder contains the active substance anidulafungin and
is prescribed in adults and in
paediatric patients aged 1 month to less than 18 years to treat a type
of fungal infection of the blood or
other internal organs called invasive candidiasis. The infection is
caused by fungal cells (yeasts) called
_Candida_
.
Anidulafungin Powder belongs to a group of medicines called
echinocandins. These medicines are
used to treat serious fungal infections.
Anidulafungin Powder prevents normal development of fungal cell walls.
In the presence of
Anidulafungin Powder, fungal cells have incomplete or defective cell
walls, making them fragile or
unable to grow.
2.
WHAT YOU NEED TO KNOW BEFORE YOU OR YOUR CHILD USE ANIDULAFUNGIN
POWDER
DO NOT USE ANIDULAFUNGIN POWDER
-
if you are allergic to anidulafungin, other echinocandins (e.g.
CANCIDAS), or any of the other
ingredients of this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist or nurse before using Anidulafungin
Powder.
Your doctor may decide to monitor you
-
for liver functio

Vara einkenni

Health Products Regulatory Authority
25 August 2023
CRN00DDXK
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anidulafungin 100 mg powder for concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 100 mg anidulafungin. The reconstituted solution
contains 3.33 mg/mL anidulafungin and the diluted
solution contains 0.77 mg/mL anidulafungin.
Excipient with known effect
Andiulafungin 100 mg Powder for Concentrate for Solution for Infusion
contains 102.5 mg fructose in each vial
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.
The reconstituted solution has a pH of 3.5 to 5.5.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of invasive candidiasis in adult and paediatric patients
aged 1 month to < 18 years (see sections 4.4 and 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Anidulafungin should be initiated by a physician
experienced in the management of invasive fungal infections.
Posology
Specimens for fungal culture should be obtained prior to therapy.
Therapy may be initiated before culture results are known
and can be adjusted accordingly once they are available.
_Adult population (dosing and treatment duration)_A single 200 mg
loading dose should be administered on Day 1, followed by
100 mg daily thereafter. Duration of treatment should be based on the
patient's clinical response. In general, antifungal
therapy should continue for at least 14 days after the last positive
culture.
There are insufficient data to support the 100 mg dose for longer than
35 days of treatment.
_Patients with renal and hepatic impairment_
No dosing adjustments are required for patients with mild, moderate,
or severe hepatic impairment. No dosing adjustments
are required for patients with any degree of renal insufficiency,
including those on dialysis. Anidulafungin can be given without
regard to the timing of haemodialysis (see