Ecafunzor 100mg powder for concentrate for solution for infusion

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Vocate Pharmaceuticals S.A 150, Gounari str, 166 74 Glyfada, Athens, Greece

ATC code:

J02AX06

INN (International Name):

ANIDULAFUNGIN 100 mg

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

ANIDULAFUNGIN 100 mg

Prescription type:

POM

Therapeutic area:

ANTIMYCOTICS FOR SYSTEMIC USE

Authorization status:

Authorised

Authorization date:

2022-10-12

Patient Information leaflet

1
PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE USER
ECAFUNZOR 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
Anidulafungin
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 or pharmacist or
nurse.
-
If you 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 Ecafunzor is and what it is used for
2.
What you need to know before you use Ecafunzor
3.
How to use Ecafunzor
4.
Possible side effects
5.
How to store Ecafunzor
6.
Contents of the pack and other information
1.
WHAT ECAFUNZOR IS AND WHAT IT IS USED FOR
Ecafunzor 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_
.
Ecafunzor belongs to a group of medicines called echinocandins. These
medicines are used to
treat serious fungal infections.
Ecafunzor prevents normal development of fungal cell walls. In the
presence of Ecafunzor, fungal
cells have incomplete or defective cell walls, making them fragile or
unable to grow.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ECAFUNZOR DO NOT USE ECAFUNZOR
-
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 Ecafunzor.
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 Ecafunzor
-
for signs of an allergic reaction such as itching, wheezing, blotchy

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ecafunzor 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:
Ecafunzor contains fructose 102.5 mg 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 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 Ecafunzor 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. Ecafunzor 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
positivi