Diflucan solution for i/v infusion

מדינה: ארמניה

שפה: אנגלית

מקור: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

מרכיב פעיל:

fluconazole

זמין מ:

Fareva Amboise

קוד ATC:

J02AC01

INN (שם בינלאומי):

fluconazole

כמות:

2mg/ml

טופס פרצבטיות:

solution for i/v infusion

יחידות באריזה:

glass vial 50ml

סוג מרשם:

Prescription

מצב אישור:

Registered

תאריך אישור:

2018-12-24

מאפייני מוצר

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PFIZER ((logo))
Diflucan
®
IV 2 mg/ml
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Diflucan
®
IV 2 mg/ml solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 2 mg of fluconazole.
1 vial with 50 ml solution for infusion contains 100 mg fluconazole.
1 vial with 100 ml solution for infusion contains 200 mg fluconazole.
1 vial with 200 ml solution for infusion contains 400 mg fluconazole.
Excipient with known effect:
Each ml contains 9 mg sodium chloride (equivalent to 0.154 mmol
sodium) (see section 4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion
Clear, colourless solution with no visible particles.
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.
Diflucan 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.

Candidal infections in patients with prolonged neutropenia (such as
patients receiving chemotherapy with haematological malignancies or
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patients receiving Hematopoietic Stem Cell Transplantation [see
section 5.1]).
Diflucan is indicated in term newborn infants, infants, toddlers,
children, and adolescents
aged from 0 to 17 years old:
Diflucan is used for the treatment of mucosal candidiasis
(oropharyngeal, oesophageal),
invasive candidiasis, cryptococcal meningi