Quốc gia: New Zealand
Ngôn ngữ: Tiếng Anh
Nguồn: Medsafe (Medicines Safety Authority)
Posaconazole 40 mg/mL ((Form-1))
Devatis Limited
40 mg/mL
Oral suspension
Active: Posaconazole 40 mg/mL ((Form-1)) Excipient: Cherry flavour 10787-33 Citric acid monohydrate Glucose liquid Glycerol Polysorbate 80 Simethicone emulsion USP Sodium benzoate Sodium citrate Titanium dioxide Xanthan gum
Prescription
POSACONAZOLE Oral Suspension is indicated for use in the treatment of the following invasive fungal infections in patients 18 years of age or older: - Invasive aspergillosis in patients with disease that is refractory to, or are intolerant of, amphotericin B, itraconazole or voriconazole.
Package - Contents - Shelf Life: Bottle, glass, Type III amber coloured with CR cap - 105 mL - 24 months from date of manufacture stored at or below 25°C. Do not freeze
2019-09-17
POSACONAZOLE 40 MG/ML ORAL SUSPENSION MODULE 1.3.2 CONSUMER MEDICINE INFORMATION (CMI) DEVATIS LIMITED Property-Strictly confidential Page 1 / 7 Version: NZ-V03/October 2023 POSACONAZOLE 40 MG/ML ORAL SUSPENSION _Posaconazole _ _ _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start using POSACONAZOLE Oral Suspension. This leaflet answers some common questions about POSACONAZOLE Oral Suspension. It does not contain all the available information. It does not take the place of talking to your doctor, nurse or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking POSACONAZOLE Oral Suspension against the benefits he/she expects it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING POSACONAZOLE ORAL SUSPENSION, ASK YOUR DOCTOR, NURSE OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT POSACONAZOLE ORAL SUSPENSION IS USED FOR POSACONAZOLE Oral Suspension are used for: The treatment of invasive aspergillosis, a fungal infection caused by a fungus called aspergillus The treatment of some other serious fungal infections called fusariosis, cryptococcosis, zygomycosis, chromoblastomycosis and mycetoma. POSACONAZOLE Oral Suspension is also used for: The treatment of fungal infections in the mouth and throat caused by Candida, such as oral thrush, and the more serious systemic infection called candidemia. Treatment of these serious fungal infections with POSACONAZOLE is usually reserved for patients who do not respond to or cannot tolerate other medicines used to treat these types of fungal infections. POSACONAZOLE is also used to treat coccidioidomycosis, a rare and serious fungal infection. These types of serious fungal infections usually occur in some patients who may have lowered resistance to infection due to poor immunity. POSACONAZOLE is also used to prevent fungal infections, such as yeasts and moulds, from occurring in patients who are at high-risk of developin Đọc toàn bộ tài liệu
POSACONAZOLE 40 mg/ml Oral Suspension MODULE 1.3.1 NEW ZEALAND DATA SHEET DEVATIS LIMITED Property-Strictly confidential Page 1 / 18 Version: NZ-V03/October 2023 NEW ZEALAND DATA SHEET 1. PRODUCT NAME POSACONAZOLE 40 mg/ml Oral Suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Each ml of oral suspension contains 40 mg of posaconazole. EXCIPIENT WITH KNOWN EFFECT: This medicinal product contains approximately 1.75 g of glucose per 5 ml of suspension. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral suspension White to off-white suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS POSACONAZOLE Oral Suspension is indicated for use in the treatment of the following invasive fungal infections in patients 18 years of age or older: Invasive aspergillosis in patients with disease that is refractory to, or are intolerant of, amphotericin B, itraconazole or voriconazole. Oesophageal candidiasis or candidemia in patients with disease that is refractory to, or who are intolerant of, amphotericin B, fluconazole or itraconazole. Fusariosis, zygomycosis, cryptococcosis, chromoblastomycosis, and mycetoma in patients with disease refractory to other therapy, or patients who are intolerant of other therapy. Coccidioidomycosis. POSACONAZOLE Oral Suspension is also indicated for use as: Prophylaxis of invasive fungal infections, including both yeasts and moulds, in patients 13 years of age and older who are at high risk of developing these infections, such as patients with prolonged neutropenia or hematopoietic stem cell transplant (HSCT) recipients. POSACONAZOLE Oral Suspension is also indicated for the use in the treatment of the following fungal infections in patients 18 years of age or older: Treatment of oropharyngeal candidiasis in immune-compromised adults, including patients with disease that is refractory to itraconazole and fluconazole. 4.2 DOSE AND METHOD OF ADMINISTRATION Co-administration of drugs that can decrease the plasma concentr Đọc toàn bộ tài liệu