Eraxis 100mg For Injection

Riik: Singapur

keel: inglise

Allikas: HSA (Health Sciences Authority)

Toimeaine:

84% anhydrous Anidulafungin 122mg eqv. Anidulafungin

Saadav alates:

PFIZER PRIVATE LIMITED

ATC kood:

JO2AX06

Annus:

100mg/vial

Ravimvorm:

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Koostis:

84% anhydrous Anidulafungin 122mg eqv. Anidulafungin 100mg/vial

Manustamisviis:

INTRAVENOUS

Retsepti tüüp:

Prescription Only

Valmistatud:

Pharmacia and Upjohn Company LLC

Volitamisolek:

ACTIVE

Loa andmise kuupäev:

2008-12-17

Infovoldik

ERAXIS
TABLE OF CONTENT
_Please click on either of the following links to access the required
information: _
PRESCRIBING INFORMATION
PATIENT INFORMATION LEAFLET
Page
1
of
16
ERAXIS
™
100 MG FOR INJECTION
1.
NAME OF THE MEDICINAL PRODUCT
ERAXIS™ 100 MG FOR INJECTION.
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: Fructose 102.5 mg per vial.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for infusion.
Powder: White to off-white lyophilised 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 in paediatric patients
one month and older (see sections
4.4 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with ERAXIS should be initiated by a physician experienced
in the management of
invasive fungal infections. 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 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 patients (one month and older)
The recommended dose is 3.0 mg/kg (not to exceed 200 mg) loading dose
of anidulafungin on Day 1,
followed by 1.5 mg/kg (not to exceed 100 mg) daily dose thereafter. In
general, antifungal therapy
should continue for at least 14 days after the last negative culture
(defined as the second of two
consecutive negative cultures, separated by at least 24 hours,
following the last positive culture) and
improvement of clinical signs and symptoms of invasive candidiasis
including candidaemi

Toote omadused

ERAXIS
™
100 MG FOR INJECTION
1.
NAME OF THE MEDICINAL PRODUCT
ERAXIS™ 100 MG FOR INJECTION.
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: Fructose 102.5 mg per vial.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for infusion.
Powder: White to off-white lyophilised 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 in paediatric patients
one month and older (see sections
4.4 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with ERAXIS should be initiated by a physician experienced
in the management of
invasive fungal infections. 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 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 patients (one month and older)
The recommended dose is 3.0 mg/kg (not to exceed 200 mg) loading dose
of anidulafungin on Day 1,
followed by 1.5 mg/kg (not to exceed 100 mg) daily dose thereafter. In
general, antifungal therapy
should continue for at least 14 days after the last negative culture
(defined as the second of two
consecutive negative cultures, separated by at least 24 hours,
following the last positive culture) and
improvement of clinical signs and symptoms of invasive candidiasis
including candidaemia (ICC).
Switch to an oral antifungal may occur after a minimum of 10 days on
anidulafungin intravenous
therapy.
The efficacy and safety of anidulafungin has not been establi