Anidulafungin 100 mg Powder for concentrate for solution for infusion

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Anidulafungin

Disponível em:

Rowex Ltd

Código ATC:

J02AX06

DCI (Denominação Comum Internacional):

Anidulafungin

Dosagem:

100 milligram(s)/dose

Forma farmacêutica:

Powder for concentrate for solution for infusion

Área terapêutica:

anidulafungin

Status de autorização:

Marketed

Data de autorização:

2019-02-15

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE USER
ANIDULAFUNGIN 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 Anidulafungin is and what it is used for
2. What you need to know before you or your child use Anidulafungin
3. How to use Anidulafungin
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
_ _
Anidulafungin 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 USE ANIDULAFUNGIN
_ _
DO NOT USE 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 or pharmacist or nurse before using Anidulafungin.
Your doctor may decide to monitor
- your liver function more closely if you develop liver problems
during your treatment.
- if you are given anaesthetics during your tr

Características técnicas

Health Products Regulatory Authority
21 November 2023
CRN00DWVP
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anidulafungin 100 mg Powder for concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 100 mg anidulafungin. The reconstituted concentrate
for solution for infusion contains 3.33 mg/mL
anidulafungin and the diluted solution for infusion contains 0.77
mg/mL anidulafungin.
Excipient with known effect
Each vial contains 100 mg of fructose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
White to off-white cake or 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 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. Anidulafungin can be given without
regard to the timing of haemodialysis (see section 5.2).
_Other spe