Anidulafungin Teva 100 mg Powder for Concentrate for Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Anidulafungin

Available from:

Teva B.V.

ATC code:

J02AX; J02AX06

INN (International Name):

Anidulafungin

Dosage:

100 milligram(s)

Pharmaceutical form:

Powder for concentrate for solution for infusion

Prescription type:

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

Therapeutic area:

Other antimycotics for systemic use; anidulafungin

Authorization status:

Marketed

Authorization date:

2018-02-16

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ANIDULAFUNGIN TEVA 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, pharmacist or
nurse.
-
If you or your child 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 Anidulafungin Teva is and what it is used for
2.
What you need to know before you or your child use Anidulafungin Teva
3.
How to use Anidulafungin Teva
4.
Possible side effects
5.
How to store Anidulafungin Teva
6.
Contents of the pack and other information
1.
WHAT ANIDULAFUNGIN TEVA IS AND WHAT IT IS USED FOR
Anidulafungin Teva 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 Teva belongs to a group of medicines called
echinocandins. These medicines are used
to treat serious fungal infections.
Anidulafungin Teva prevents normal development of fungal cell walls.
In the presence of
Anidulafungin Teva, 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 TEVA
DO NOT USE ANIDULAFUNGIN TEVA
-
if you are allergic to anidulafungin, other echinocandins (e.g.
caspofungin, micafungin), 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 Anidulafungin
Teva.
Your doctor may decide to monitor you
-
for liver function more closely if you develop liver problems during
you

Summary of Product characteristics

Health Products Regulatory Authority
27 June 2022
CRN00CWLR
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anidulafungin Teva 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.
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 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 Teva 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 renalandhepaticimpairment_
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 Teva can be given
without regard to the timing of haemodialysis (see section 5.2).
_Other special populations_
No dosing adjustments are required for adult