ERAXIS 100MG FOR INJECTION

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

ANIDULAFUNGIN

Available from:

PFIZER (MALAYSIA) SDN. BHD.

INN (International Name):

ANIDULAFUNGIN

Units in package:

1 Vials

Manufactured by:

Pharmacia & Upjohn Company LLC

Patient Information leaflet

PFIZER CONFIDENTIAL
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
{(Invented) 100 mg Powder and Solvent for Solution for Infusion
Anidulafungin
Read all of this leaflet carefully before you start taking this
medicine.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1.
What Anidulafungin is and what it is used for
2.
What you should know before you are treated with Anidulafungin
3.
How to use Anidulafungin
4.
Possible side effects
5.
How Anidulafungin is stored
6.
Further information
1.
WHAT ANIDULAFUNGIN IS AND WHAT IT IS USED FOR
The active ingredient is anidulafungin.
Anidulafungin belongs to a group of medicines called echinocandins.
These medicines are used to
treat serious fungal infections.
Anidulafungin interferes with the production of a component
(1,3-β-D-glucan) of the fungal cell wall.
Fungal cells exposed to Anidulafungin have incomplete or defective
cell walls, making them fragile or
unable to grow.
Anidulafungin is prescribed to treat a type of fungal infection called
invasive candidiasis (including
candidaemia). The infection is caused by fungal cells (yeasts) called
Candida.
2.
WHAT YOU SHOULD KNOW BEFORE YOU ARE TREATED WITH
ANIDULAFUNGIN
You should not be treated with Anidulafungin
-
If you are allergic (hypersensitive) to anidulafungin, other
echinocandins, or any of the other
ingredients of Anidulafungin
Take special care with Anidulafungin
-
If you have any allergies.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines,
including medicines obtained without a prescription.
It is not expected that Anidulafungin will interact with other
medications or that any adj

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
ERAXIS 100 mg for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vials containing 100 mg anidulafungin powder for solution for infusion
(see Section 6.6).
The
reconstituted
solution
contains
3.33
mg/mL
anidulafungin
and
the
diluted
solution
contains
0.77 mg/mL anidulafungin.
For a full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Anidulafungin powder for solution for infusion.
White to off-white lyophilized solid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of invasive candidiasis, including candidemia, in adult and
in paediatric patients aged 1 month
to <18 years old see Sections 4.4 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Specimens for fungal culture and other relevant laboratory studies
(including histopathology) should be
obtained prior to therapy to isolate and identify causative
organism(s). Therapy may be instituted before
the results of the cultures and other laboratory studies are known.
However, once these results become
available, antifungal therapy should be adjusted accordingly.
ADULT PATIENTS
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.
PAEDIATRIC POPULATION (1 MONTH TO < 18 YEARS) (DOSING AND TREATMENT
DURATION)
A single loading dose of 3.0 mg/kg (not to exceed 200 mg) should be
administered on Day 1 followed by
a daily maintenance dose of 1.5 mg/kg (not to exceed 100 mg)
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.
The safety and efficacy of anidulafungin have not been established in
neonates (< 1 month old) (see Section
4.4).
1
WATER FOR INJECTION PRESENTATION
Anidulafungin should be reconstituted with water for injection to a
concentration of 3