Diflucan capsules

Nazione: Armenia

Lingua: inglese

Fonte: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Principio attivo:

fluconazole

Commercializzato da:

Fareva Amboise

Codice ATC:

J02AC01

INN (Nome Internazionale):

fluconazole

Dosaggio:

150mg

Forma farmaceutica:

capsules

Confezione:

(1/1x1/) in blister

Tipo di ricetta:

Prescription

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2023-11-07

Scheda tecnica

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PFIZER ((logo))
Diflucan
®
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Diflucan
®
50 mg hard capsules
Diflucan
®
150 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains fluconazole 50 mg
Excipient with known effect: each hard capsule also contains 49.707 mg
lactose monohydrate
Each hard capsule contains fluconazole 150 mg
Excipient with known effect: each hard capsule also contains 149,120
mg lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
50 mg capsules: hard gelatine capsules No. 4 with a turquoise cap and
white body, marked with the
“Pfizer” logo and “FLU-50” in black.
150 mg capsules: hard gelatine capsules No. 1 with a turquoise cap and
body, marked with the
“Pfizer” logo and “FLU-150” in black.
Capsule content: white to pale yellow powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Diflucan is indicated in the following fungal infections (see section
5.1).
Diflucan 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.
Diflucan is indicated in adults for the prophylaxis of:

Relapse of cryptococcal meningitis in patients with high risk of
recurrence.
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
Relapse of orop