FLUCONAZOLE MBI 2 MG ML

Quốc gia: Israel

Ngôn ngữ: Tiếng Anh

Nguồn: Ministry of Health

Thành phần hoạt chất:

FLUCONAZOLE

Sẵn có từ:

MBI PHARMA LTD., ISRAEL

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:

ALTAN PHARMACEUTICALS, S.A., SPAIN

Khu trị liệu:

FLUCONAZOLE

Chỉ dẫn điều trị:

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 or 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 laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.Consideration should be given to official guidance on the appropriate use of antifungals.

Ngày ủy quyền:

2019-03-18

Đặc tính sản phẩm

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Fluconazole MBI 2 mg/ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 2 mg of fluconazole.
Each 100 ml solution for infusion contains 200 mg of fluconazole.
Each 200 ml solution for infusion contains 400 mg of fluconazole.
Excipient(s) 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, I.V
.
Clear solution and practically free from particles.
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 or
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