Anidulafungin Fresenius Kabi 100 mg powder for concentrate for solution for infusion

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Anidulafungin

から入手可能:

Fresenius Kabi Deutschland GmbH

ATCコード:

J02AX; J02AX06

INN（国際名）:

Anidulafungin

投薬量:

100 milligram(s)

医薬品形態:

Powder for concentrate for solution for infusion

治療領域:

Other antimycotics for systemic use; anidulafungin

認証ステータス:

Not marketed

承認日:

2020-07-24

情報リーフレット

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 is and what it is used for
2. What you need to know before you or your child
are given Anidulafungin
3. How Anidulafungin is given
4. Possible side effects
5. How to store Anidulafungin
6. Contents of the pack and other information
1. WHAT ANIDULAFUNGIN IS AND WHAT IT IS
USED FOR
This medicine 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 belongs to a group of medicines called
echinocandins. These medicines are used to treat
serious fungal infections.
Anidulafungin prevents normal development of
fungal cell walls. In the presence of Anidulafungin ,
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 ARE GIVEN ANIDULAFUNGIN
YOU MUST NOT BE GIVEN ANIDULAFUNGIN
-
if you are allergic to anidulafungin, other
echinocandins (e.g.caspofungin acetate), or any
of the other ingredients of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before being
given Anidulafungin .
Your doctor may decide to monitor you:
-
for liver function more closely if you develop liver
problems during your treatment;
-
for signs of an allergic reaction such as itching,
wheezing, blotchy skin,
-
if you are given anaesthetics during your
treatment with Anidulafungi

製品の特徴

Health⋅Products⋅Regulatory⋅Authority
04⋅August⋅2021
CRN00C58J
Page⋅1⋅of⋅12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anidulafungin⋅Fresenius⋅Kabi⋅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:⋅Fructose⋅100⋅mg⋅per⋅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⋅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⋅adults⋅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⋅Fresenius⋅Kabi⋅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.
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_Pati