ANIDACCORD 100 POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100 MG

Pajjiż: Singapor

Lingwa: Ingliż

Sors: HSA (Health Sciences Authority)

Ingredjent attiv:

Anidulafungin

Disponibbli minn:

ACCORD HEALTHCARE PRIVATE LIMITED

Kodiċi ATC:

J02AX06

Għamla farmaċewtika:

INJECTION, POWDER, FOR SOLUTION

Kompożizzjoni:

Anidulafungin 100 mg

Rotta amministrattiva:

INTRAVENOUS

Tip ta 'preskrizzjoni:

Prescription Only

Manifatturat minn:

SIA PHARMIDEA

L-istatus ta 'awtorizzazzjoni:

ACTIVE

Data ta 'l-awtorizzazzjoni:

2021-02-19

Karatteristiċi tal-prodott

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PACKAGE INSERT
1.
NAME OF THE MEDICINAL PRODUCT
ANIDACCORD (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 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 adult patients (see sections 4.4
and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with ANIDACCORD 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.
Posology
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.
_Duration of treatment _
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. ANIDACCORD can be given without regard to the timing of
haemodialysis (see section 5.2).
_Other special populations _
No dosing adjustments are required for adult patients based on gender,
weight, ethnicity, HIV
positivity, or elderly (see section 5.2).
_Paediatric population _
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The experience i