Anidulafungine Sigillata 100 mg, poeder voor concentraat voor oplossing voor intraveneuze infusie

Ülke: Hollanda

Dil: Hollandaca

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

Aktif bileşen:

ANIDULAFUNGINE 0-WATER, FRUCTOSE VRIJ

Mevcut itibaren:

Sigillata Limited

ATC kodu:

J02AX06

INN (International Adı):

ANIDULAFUNGINE 0-WATER, FRUCTOSE FREE

Farmasötik formu:

Poeder voor concentraat voor oplossing voor infusie

Kompozisyon:

NATRIUMHYDROXIDE (E 524) ; POLYSORBAAT 80 (E 433) ; SACCHAROSE ; WIJNSTEENZUUR, (L (+) Vorm) (E 334) ; ZOUTZUUR (E 507),

Uygulama yolu:

Intraveneus gebruik

Terapötik alanı:

Anidulafungin

Ürün özeti:

Hulpstoffen: NATRIUMHYDROXIDE (E 524); POLYSORBAAT 80 (E 433); SACCHAROSE; WIJNSTEENZUUR, (L (+) Vorm) (E 334); ZOUTZUUR (E 507);

Yetkilendirme tarihi:

2018-05-30

Bilgilendirme broşürü

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ANIDULAFUNGINE SIGILLATA 100 MG, POEDER VOOR CONCENTRAAT VOOR
OPLOSSING VOOR INTRAVENEUZE
INFUSIE
Anidulafungine
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 or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Anidulafungine Sigillata is and what it is used for
2.
What you need to know before you use Anidulafungine Sigillata
3.
How to use Anidulafungine Sigillata
4.
Possible side effects
5.
How to store Anidulafungine Sigillata
6.
Contents of the pack and other information
1.
WHAT ANIDULAFUNGINE SIGILLATA IS AND WHAT IT IS USED FOR
Anidulafungine Sigillata contains the active substance anidulafungin
and is prescribed in adults 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_.
Anidulafungine Sigillata belongs to a group of medicines called
echinocandins. These medicines are
used to treat serious fungal infections.
Anidulafungine Sigillata prevents normal development of fungal cell
walls. In the presence of
Anidulafungine Sigillata, fungal cells have incomplete or defective
cell walls, making them fragile or
unable to grow.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ANIDULAFUNGINE SIGILLATA
DO NOT USE ANIDULAFUNGINE SIGILLATA:
-
if you are allergic to anidulafungin, other echinocandins (e.g.
caspofungin), or any of the other
ingredients of this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using Anidulafungine
Sigillata.
Your doctor may decide to monitor you
-
for liver function more closely if you develop liver problems during
your treatment.
-
if you are given an

Ürün özellikleri

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Anidulafungine Sigillata 100 mg, poeder voor concentraat voor
oplossing voor intraveneuze infusie
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.
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, free of visible evidence of contamination
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 patients (see sections 4.4
and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Anidulafungine Sigillata 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.
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.
_Duration of treatment _
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. Anidulafungine Sigillata 100 mg can be given without
regard to the timing of
haemodialysis (see section 5.2).
_Other special populations_
No dosing adjustments are required for adult patients based on gender,
weight, ethnicity, HIV
positivity, or elderly (see section 5.2)._ _