البلد: أستراليا
اللغة: الإنجليزية
المصدر: Department of Health (Therapeutic Goods Administration)
fluconazole, Quantity: 50 mg
Sandoz Pty Ltd
Fluconazole
Capsule, hard
Excipient Ingredients: lactose monohydrate; maize starch; magnesium stearate; colloidal anhydrous silica; sodium lauryl sulfate; titanium dioxide; Gelatin; indigo carmine; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; strong ammonia solution; ethanol absolute; iron oxide black; ethanol; Shellac; sulfuric acid; potassium hydroxide; industrial methylated spirit; ammonia
Oral
28
(S4) Prescription Only Medicine
Orally for treatment of cryptococcal meningitis in patients who are unable to tolerate amphotericin B. Note. Data suggest that the clinical efficacy of fluconazole is lower than that of amphotericin B in the treatment of the acute phase of cryptococcal meningitis. Maintenance therapy to prevent relapse of cryptococcal meningitis in patients with acquired immune deficiency syndrome (AIDS). Treatment of oropharyngeal and oesophageal candidiasis in AIDS and other immunosuppressed patients. Secondary prophylaxis of oropharyngeal candidiasis in patients with human immunodeficiency virus (HIV) infection. Serious and life threatening Candida infections in patients who are unable to tolerate amphotericin B. Note. It remains to be shown that fluconazole is as effective as amphotericin B in the treatment of serious and life threatening Candida infections. Until such data are available, amphotericin B remains the drug of choice. Vaginal candidiasis, when topical therapy has failed. Treatment of extensive tinea corporis, extensive tinea cruris and extensive tinea pedis infections in immunocompetent patients in whom topical therapy is not a practical treatment option. Usually, topical therapy should be attempted first because oral therapy has a less favourable ratio of benefits to risks. (See Adverse Reactions.)
Visual Identification: Hard gelatin capsules, snap-fit closure, turquoise cap white body with the imprint FC50, containing a white odourless powder.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2005-07-27
FLUCONAZOLE SANDOZ ® 1 FLUCONAZOLE SANDOZ ® _fluconazole capsules _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Fluconazole Sandoz. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may want to read it again. WHAT FLUCONAZOLE SANDOZ IS USED FOR This medicine is used to treat certain types of fungal or yeast infections. It contains the active ingredient fluconazole. Fluconazole belongs to a group of medicines called azole antibiotics. It works by preventing the growth of the fungal and yeast organisms causing your infection. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE FLUCONAZOLE SANDOZ _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • fluconazole, the active ingredient, or to any of the other ingredients listed at the end of this leaflet under Product Description • any other similar antifungal medicines such as miconazole, ketoconazole or clotrimazole. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. DO NOT TAKE THIS MEDICINE IF YOU ARE TAKING: • cisapride, a medicine used to treat stomach problems • terfenadine or astemizole, a medicine used to treat allergies • erythromycin, a medicine used to treat infections • pimozide, a medicine used to treat mental illness • quinidi اقرأ الوثيقة كاملة
211202-Fluconazole Sandoz-pi Page 1 of 24 AUSTRALIAN PRODUCT INFORMATION FLUCONAZOLE SANDOZ (FLUCONAZOLE) CAPSULES 1. NAME OF THE MEDICINE Fluconazole 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Fluconazole Sandoz 50 mg capsules contains 50 mg fluconazole. Each Fluconazole Sandoz 100 mg capsules contains 100 mg fluconazole. Each Fluconazole Sandoz 150 mg capsules contains 150 mg fluconazole. Each Fluconazole Sandoz 200 mg capsules contains 200 mg fluconazole. _Excipients with known effect:_ Lactose monohydrate For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Fluconazole Sandoz 50 mg capsules - Hard gelatin capsules, turquoise cap, white body with the imprint FC50 Fluconazole Sandoz 100 mg capsules - Hard gelatin capsules, blue cap white body with the imprint FC100. Fluconazole Sandoz 150 mg capsules* - Hard gelatin capsules, white cap white body with the imprint FC150. Fluconazole Sandoz 200 mg capsules - Hard gelatin capsules, purple cap white body with the imprint FC200. 4. CLINICAL PARTICULARS 4.1. T HERAPEUTIC INDICATIONS Orally for treatment of cryptococcal meningitis in patients who are unable to tolerate amphotericin B. _Note._ Data suggest that the clinical efficacy of fluconazole is lower than that of amphotericin B in the treatment of the acute phase of cryptococcal meningitis. Maintenance therapy to prevent relapse of cryptococcal meningitis in patients with acquired immune deficiency syndrome (AIDS). Treatment of oropharyngeal and oesophageal candidiasis in AIDS and other immunosuppressed patients. Secondary prophylaxis of oropharyngeal candidiasis in patients with human immunodeficiency virus (HIV) infection. Serious and life-threatening Candida infections in patients who are unable to tolerate amphotericin B. _Note._ It remains to be shown that fluconazole is as effective as amphotericin B in the treatment of serious and life-threatening Candida infections. Until such data are available, amphotericin B remains the drug of choice. 211202-Fluconazole San اقرأ الوثيقة كاملة