FLUCONAZOLE B.BRAUN 2 MGML

Quốc gia: Israel

Ngôn ngữ: Tiếng Anh

Nguồn: Ministry of Health

Thành phần hoạt chất:

FLUCONAZOLE

Sẵn có từ:

LAPIDOT MEDICAL IMPORT AND MARKETING LTD

Mã ATC:

J02AC01

Dạng dược phẩm:

SOLUTION FOR INFUSION

Thành phần:

FLUCONAZOLE 2 MG / 1 ML

Tuyến hành chính:

I.V

Loại thuốc theo toa:

Required

Sản xuất bởi:

B.BRAUN MEDICAL S.A., SPAIN

Khu trị liệu:

FLUCONAZOLE

Chỉ dẫn điều trị:

Fluconazole is indicated in the following fungal infections.Fluconazole is indicated in adults for the treatment of:• Cryptococcal meningitis.• Coccidioidomycosis, Invasive candidiasis.• Mucosal candidiasis (including oropharyngeal candidiasis, oesophageal candidiasis, candiduria and chronic mucocutaneous candidiasis).• Chronic oral atrophic candidiasis (denture sore mouth) if dental hygiene topical treatment are insufficient.Fluconazole 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.• Prophylaxis of candidal infections in patients with prolonged neutropenia (such as patients with haematological malignancies receiving chemotherapy or patients receiving Haematopoetic Stem Cell Transplantation).Fluconazole is indicated in term newborn infants, infants, toddlers, children and adolescents aged from 0 to 17 years old:Fluconazole is used for the treatment of mucosal candidiasis (oropharyngeal, oesophageal), invasive candidiasis, cryptococcal meningitis and the prophylaxis of candidal infections in immunocompromised patients. Fluconazole can be used as maintenance therapy to prevent relapse of cryptococcal meningitis in children with high risk of reoccurrence.Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.

Ngày ủy quyền:

2022-11-30

Đặc tính sản phẩm

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Fluconazole B.Braun 2 mg/ml solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 2 mg of fluconazole.
Excipient with known effect:
Each ml also contains 0.15 mmol (3.5 mg) sodium.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for infusion
Clear, colourless aqueous solution
pH:
4.0
–
8.0
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fluconazole is indicated in the following fungal infections (see
section 5.1).
Fluconazole 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 candidiasis, oesophageal
candidiasis,
candiduria and chronic mucocutaneous candidiasis).
•
Chronic oral atrophic candidiasis (denture sore mouth) if dental
hygiene topical
treatment are insufficient.
Fluconazole 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.
•
Prophylaxis of candidal infections in patients with prolonged
neutropenia (such as
patients with haematological malignancies receiving chemotherapy or
patients
receiving Haematopoetic Stem Cell Transplantation (see section 5.1)).
Fluconazole is indicated in term newborn infants, infants, toddlers,
children and
adolescents aged from 0 to 17 years old:
Fluconazole is used for the treatment of mucosal candidiasis
(oropharyngeal,
oesophageal), invasive candidiasis, cryptococcal meningitis and the
prophylaxis of
candidal infections in immunocompromised patients. Fluconazole can be
used as
maintenance therapy to prevent relapse of cryptococcal meningitis in
children with high
risk of reoccurrence (see section 4.4).
Therapy may be instituted before the results of the cultures and other
laborator