Negara: Israel
Bahasa: Inggris
Sumber: Ministry of Health
FLUCONAZOLE
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
J02AC01
CAPSULES
FLUCONAZOLE 200 MG
PER OS
Required
FAREVA AMBOISE, FRANCE
FLUCONAZOLE
FLUCONAZOLE
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, oesophageal candidiasis, candiduria and chronic mucocutaneous candidiasis.• Chronic oral atrophic candidiasis (denture sore mouth) if dental hygiene or topical treatment are insufficient.• Vaginal candidiasis, acute or recurrent; when local therapy is not appropriate.• Candidal balanitis when local therapy is not appropriate.• Dermatomycosis including tinea pedis, tinea corporis, tinea cruris, tinea versicolor and dermal candida infections when systemic therapy is indicated.• Tinea unguinium (onychomycosis) when other agents are not considered appropriate.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.• To reduce the incidence of recurrent vaginal candidiasis (4 or more episodes a year).• Prophylaxis of candidal infections in patients with prolonged neutropenia (such as patients with haematological malignancies receiving chemotherapy or patients receiving Hematopoietic 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.Consideration should be given to official guidance on the appropriate use of antifungals.
2020-04-30
Trican 200 mg Capsules PIL CC 041222 Pfleet 2021-0072854 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor’s prescription only TRICAN ® 200 MG CAPSULES Capsules Each capsule contains fluconazole 200 mg Inactive ingredients and allergens: See section 2 under ‘Important information about some of this medicine’s ingredients’ and section 6 “Further information”. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed to treat you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. 1. WHAT IS THE MEDICINE INTENDED FOR? ADULTS Trican 200 mg capsules are intended for treating the following types of fungal infections: - Cryptococcal meningitis – a fungal infection in the brain - Coccidioidomycosis – a disease of the bronchopulmonary system - Infections caused by _Candida_ and originating in the blood stream, body organs (e.g., heart, lungs) or urinary tract - Oral thrush – infection affecting the lining of the oral cavity, throat and dentures - Genital thrush – infection of the vagina or penis - Skin fungus, including athlete’s foot, fungus in the groin area, pityriasis versicolor, nail fungus and skin inflammations caused by _Candida_. THE MEDICINE IS ALSO INTENDED FOR: - Preventing cryptococcal meningitis from coming back - Preventing oral thrush from coming back - Reducing the recurrence of vaginal thrush - Stopping you from getting an infection caused by _Candida_ (if your immune system is weak and not working properly). CHILDREN AND ADOLESCENTS (0 TO 17 YEARS OLD) Trican 200 mg capsules are intended for treating the following types of fungal infections: - Oral thrush – infection affecting the lining of the oral cavity and throat - Infections caused by _Candida_ and Baca dokumen lengkapnya
Triflucan IV LPD CC 041222 Pfleet 2021-0072854 Page 1 of 23 TRIFLUCAN ® I.V. SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT TRIFLUCAN ® I.V. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 2 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 Clear, colourless solution with no visible 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 : Triflucan IV LPD CC 041222 Pfleet 2021-0072854 Page 2 of 23 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 cry Baca dokumen lengkapnya