Diflucan solution for i/v infusion

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

fluconazole

Доступна с:

Fareva Amboise

код АТС:

J02AC01

ИНН (Международная Имя):

fluconazole

дозировка:

2mg/ml

Фармацевтическая форма:

solution for i/v infusion

Штук в упаковке:

glass vial 50ml

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2018-12-24

Характеристики продукта

                                spcde-0v52df-i-0
1
30.09.2022
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
spcde-2v54df-i-0
2
30.09.2022
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
                                
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