Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
fluconazole, Quantity: 2 mg/mL
Sandoz Pty Ltd
Fluconazole
Injection, solution
Excipient Ingredients: hydrochloric acid; water for injections; sodium chloride
Intravenous
1
(S4) Prescription Only Medicine
Fluconazole Sandoz Injection is indicated in adults and children for the following conditions only if fluconazole can not be administered 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 and intravenous therapy has a less favourable ratio of benefits to risks. (See Adverse Effects.)
Visual Identification: Clear, colourless solution, free from visible particles; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2005-07-27
FLUCONAZOLE SANDOZ ® 1 FLUCONAZOLE SANDOZ ® _Fluconazole injection _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Fluconazole Sandoz injection. 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 having this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT HAVING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT FLUCONAZOLE SANDOZ IS USED FOR This medicine is used to treat _ _ certain fungal and 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 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 ARE GIVEN FLUCONAZOLE SANDOZ _WHEN YOU MUST NOT BE GIVEN _ THIS MEDICINE SHOULD NOT BE GIVEN 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 medicines related to fluconazole 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. YOU MUST NOT BE GIVEN FLUCONAZOLE SANDOZ INJECTION IF YOU ARE TAKING ANY OF THE FOLLOWING MEDICINES: • terfenadine or astemizole (a medicine used to treat allergies) • cisapride (a medicine used to treat stomach problems • erythromycin (a medicines used to t Læs hele dokumentet
211202-Fluconazole Sandoz-pi Page 1 of 25 AUSTRALIAN PRODUCT INFORMATION FLUCONAZOLE SANDOZ ® (FLUCONAZOLE) INJECTION 1 NAME OF THE MEDICINE Fluconazole 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Fluconazole Sandoz vials contains 2 mg/mL fluconazole. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Fluconazole Sandoz injection 2 mg/mL is a clear colourless solution, free from visible particles. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Fluconazole Sandoz injection is indicated in adults and children for the following conditions only if fluconazole cannot be administered orally: 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 Section 4.8 Adverse effects (Undesirable effects)) 4.2 D OSE AND METHOD OF ADMINISTRATION DOSAGE Th Læs hele dokumentet