Χώρα: Ισραήλ
Γλώσσα: Αγγλικά
Πηγή: Ministry of Health
FLUCONAZOLE
TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD
J02AC01
SOLUTION FOR INFUSION
FLUCONAZOLE 2 MG/ML
I.V
Required
PHARMATHEN S.A., GREECE
FLUCONAZOLE
FLUCONAZOLE
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
2011-06-30
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 Διαβάστε το πλήρες έγγραφο
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 Διαβάστε το πλήρες έγγραφο