Ecalta

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

anidulafungin

Saadav alates:

Pfizer Europe MA EEIG

ATC kood:

J02AX06

INN (Rahvusvaheline Nimetus):

anidulafungin

Terapeutiline rühm:

Antimycotics for systemic use

Terapeutiline ala:

Candidiasis

Näidustused:

Treatment of invasive candidiasis in adults and paediatric patients aged 1 month to < 18 years.

Toote kokkuvõte:

Revision: 26

Volitamisolek:

Authorised

Loa andmise kuupäev:

2007-09-20

Infovoldik

25
B. PACKAGE LEAFLET
26
PACKAGE LEAFLET: INFORMATION FOR THE USER
ECALTA 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 ECALTA is and what it is used for
2.
What you need to know before you or your child use ECALTA
3.
How to use ECALTA
4.
Possible side effects
5.
How to store ECALTA
6.
Contents of the pack and other information
1.
WHAT ECALTA IS AND WHAT IT IS USED FOR
ECALTA 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_.
ECALTA belongs to a group of medicines called echinocandins. These
medicines are used to treat
serious fungal infections.
ECALTA prevents normal development of fungal cell walls. In the
presence of ECALTA, 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 ECALTA
DO NOT USE ECALTA
-
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 or pharmacist or nurse before using ECALTA.
Your doctor may decide to monitor you
-
for liver function more closely if you develop liver problems during
your treatment
-
if you are given anaesthetics during your treatment with ECALTA
-
for signs of an allergic reaction such as itching,

Toote omadused

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ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
ECALTA 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: ECALTA contains 119 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 solid.
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 ECALTA 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. ECALTA can be given without regard to the timing of
haemodialysis (see section 5.2).
_Other special populations _
No dosing adjustments are required for adult pa