Fluco capsules

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

fluconazole

Available from:

Tufenkji Group LLC

ATC code:

J02AC01

INN (International Name):

fluconazole

Dosage:

150mg

Pharmaceutical form:

capsules

Units in package:

(10/1x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2017-09-05

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
FLUCO
Fluconazole 150 mg Capsules
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 receiving
chemotherapy or
patients receiving Hematopoietic Stem Cell Transplantation (see
section 5.1)).
Fluco
is
indicated
in
term
newborn
infants,
infants,
toddlers,
children,
and
adolescents aged from 0 to 17 years old:
Fluco is us