STABILANOL

País: Israel

Idioma: anglès

Font: Ministry of Health

ingredients actius:

FLUCONAZOLE

Disponible des:

TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD

Codi ATC:

J02AC01

formulario farmacéutico:

SOLUTION FOR INFUSION

Composición:

FLUCONAZOLE 2 MG/ML

Vía de administración:

I.V

tipo de receta:

Required

Fabricat per:

PHARMATHEN S.A., GREECE

Grupo terapéutico:

FLUCONAZOLE

Área terapéutica:

FLUCONAZOLE

indicaciones terapéuticas:

Stabilanol is indicated in the following fungal infections .Stabilanol is indicated in adults for the treatment of: • Cryptococcal meningitis .• Coccidioidomycosis. 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.Stabilanol is indicated in adults for the prophylaxis of: • Relapse of crytopcoccal 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 Hematopoietic Stem Cell Transplantation ).Stabilanol is indicated in term newborn infants, infants, toddlers, children and adolescents aged from 0 to 17 years old: Sta

Data d'autorització:

2011-06-30

Informació per a l'usuari

טסוגוא
2019
,ה/דבכנ ה/אפור
,ה/דבכנ ת/חקור
:ןודנה
ןוכדע
ולע
ן
אפורל
ש
ל
ה
רישכת
SOLUTION FOR INFUSION
ILANOL
STAB
ליעפ ביכרמ
:
Fluconazole 2 mg/ml
:היוותה
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 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.
וננוצרב
עידוהל
ולעב ןוכדע לחש
ן
אפורל
ןודנבש רי�

Fitxa tècnica

Page 1 of 27
STABILANOL
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
STABILANOL
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution for infusion contains 2 mg of fluconazole.
50 ml solution for infusion contains 100 mg fluconazole.
200 ml solution for infusion contains 400 mg 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.
A clear and colourless solution.
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.
Page 2 of 27
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 rel