Anidulafungin 100 mg powder for concentrate for solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Anidulafungin

Available from:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC code:

J02AX06

INN (International Name):

Anidulafungin

Dosage:

100 milligram(s)

Pharmaceutical form:

Powder for concentrate for solution for infusion

Therapeutic area:

anidulafungin

Authorization status:

Not marketed

Authorization date:

2020-02-14

Patient Information leaflet

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 nurse.
-
If you or your child get any side effects, talk to your doctor 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 or your child you 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. Anidulafungin belongs to
a group of
medicines called echinocandins, which are used to treat serious fungal
infections.
This medicine is used in adults and children 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 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, pharmacist or nurse before using anidulafungin.
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 anidulafungin
for signs of an allergic
rea

Summary of Product characteristics

Health Products Regulatory Authority
28 June 2021
CRN00CFGP
Page 1 of 12
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 solution contains 3.33 mg/mL anidulafungin and the
diluted solution contains 0.77 mg/mL anidulafungin.
Excipient with known effect:
Fructose 102.5 mg per 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 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 impairment,
including those on
dialysis. Anidulafungin can be given without regard to the timing of
haemodialysis (see section 5.2).
_Special populations_
No dosing adjustments are required for adult patient