Fluco capsules

País: Armènia

Idioma: anglès

Font: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

ingredients actius:

fluconazole

Disponible des:

A LAB PHARMACEUTICALS LLC

Codi ATC:

J02AC01

Designació comuna internacional (DCI):

fluconazole

Dosis:

150mg

formulario farmacéutico:

capsules

Unidades en paquete:

(10/1x10/) in blister

tipo de receta:

Prescription

Estat d'Autorització:

Registered

Data d'autorització:

2022-03-23

Fitxa tècnica

A - L A B P H A R M A C E U P T I C A L S , L L C
Address: Kochinyan 13/16 street Yerevan - Armenia
Tell: ( [phone] Web: www.alab.am E-Mail: [e-mail]
C O N F I D E N T I A L P a g e 1 o f 2 1
1.3 PRODUCT INFORMATION
1.3.1 SPC, LABELING & PACKAGE LEAFLET
SUMMARY OF PRODUCT CHARACTERISTICS
1.
Name of the medicinal product FLUCO
2.
Qualitative and quantitative composition Each capsule contains
Active substance:
fluconazole 150 mg
Excipient(s):
for the full list of excipients see Section 6.1.
3.
Pharmaceutical form Hard gelatin capsule
Maroon/White Opaque, hard gelatin capsule Size “2” filled with
white to off white
powder
4.
Clinical particulars
4.1
Therapeutic indications
Fluco is indicated in the following fungal infections (see section
5.1). Fluco is indicated in
adults for the treatment of:

Cryptococcal meningitis (see section 4.4).

Coccidioidomycosis (see section 4.4).

Invasive candidiasis.

Mucosal
candidiasis
including
oropharyngeal,
oesophageal
candidiasis, candiduria
and chronic mucocutaneous candidiasis.

Chronic
oral
atrophic
candidiasis
(denture
sore
mouth)
if
dental
hygiene
or
topical treatment are insufficient.

Vaginal candidiasis, acute or recurrent; when local therapy is not
appropriate.

Candidal balanitis when local therapy is not appropriate.

Dermatomycosis including tinea pedis, tinea corporis, tinea cruris,
tinea versicolor
and dermal candida infections when systemic therapy is indicated.

Tinea
unguinium
(onychomycosis)
when
other
agents
are
not
considered
appropriate.
Fluco is indicated in adults for the prophylaxis of:

Relapse of cryptococcal meningitis in patients with high risk of
recurrence.

Relapse of oropharyngeal or oesophageal candidiasis in patients
infected with HIV
who are at high risk of experiencing relapse.

To reduce the incidence of recurrent vaginal candidiasis (4 or more
episodes a year).

Prophylaxis of candidal infections in patients with prolonged
neutropenia (such as
patients
with
haematological
malignancies
rec