Држава: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
Posaconazole
Merck Sharp & Dohme Australia Pty Ltd
Medicine Registered
NOXAFIL ® ORAL SUSPENSION _Posaconazole_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about NOXAFIL. 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 NOXAFIL against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING NOXAFIL, ASK YOUR DOCTOR OR PHARMACIST. READ THIS LEAFLET CAREFULLY BEFORE TAKING NOXAFIL. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT NOXAFIL IS USED FOR NOXAFIL contains the active ingredient, posaconazole. Posaconazole is a medicine that belongs to the triazole group of antifungal medicines. NOXAFIL works by killing or stopping the growth of the fungi causing these infections. NOXAFIL is used for: • The treatment of invasive aspergillosis, a fungal infection caused by a fungus called aspergillus • The treatment of other serious fungal infections called fusariosis, zygomycosis, chromoblastomycosis and mycetoma. • The treatment of superficial fungal infections of the mouth and throat called oropharyngeal candidiasis. These types of fungal infections usually occur in some patients who may have lowered resistance to infection due to poor immunity. Treatment of these serious fungal infections with NOXAFIL is usually reserved for patients who do not respond to or cannot tolerate other medicines used to treat these types of fungal infections. NOXAFIL is also used to treat coccidioidomycosis, a rare and serious fungal infection. NOXAFIL is also used to prevent fungal infections, such as yeasts and moulds, from occurring in patients who are at high-risk of developing these infections. Your doctor may have prescribed NOXAFIL for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY NOXAFIL HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. BEFORE YOU TAK Прочитајте комплетан документ
Ref:LRN#056592-POS-SUo-CCDS-7 Version 12 A20130731 Page 1 of 28 NOXAFIL ORAL SUSPENSION PRODUCT INFORMATION NAME OF THE MEDICINE Posaconazole. Posaconazole is a broad spectrum triazole antifungal compound with a molecular formula of C 37 H 42 F 2 N 8 O 4 yielding a molecular weight of 700.8. The chemical structure, which possesses four chiral centres, two R and two S, and chemical name are illustrated below: F F N N N O O N N N N ME O N ME OH _S_ _R_ _S_ SCH 56592 (POSACONAZOLE) _R_ CAS INDEX NAME: D-threo-Pentitol, 2,5-anhydro-1,3,4-trideoxy-2-C-(2,4- difluorophenyl)-4-[[4-[4-[4-[1-[(1S,2S)-1-ethyl-2-hydropropyl]-1,5-dihydro-5-oxo-4H- 1,2,4-triazol-4-yl]phenyl]-1-piperazinyl]phenoxy]methyl]-1-(1H-1,2,4-triazol-1-yl) CAS RN 171228-49-2. IUPAC NAME: 4-4-[4-(4-{(3R, 5R)-5-(2,4-difluorophenyl)-5-(1H-1,2,4-triazol-1- ylmethyl)tetrahydro-3-furanyl]methoxyphenyl)piperazino]phenyl-1-[(1S,2S)-1-ethyl-2- hydroxypropyl]-4,5-dihydro-1H-1,2,4-triazol-5-one. DESCRIPTION Posaconazole is a white to off-white crystalline powder. It has a melting range of 164 o C – 165 o C and is insoluble in water. NOXAFIL ORAL SUSPENSION is a white, cherry flavoured immediate-release oral suspension containing 40 mg of posaconazole per mL and the following inactive ingredients: polysorbate 80, simethicone, sodium benzoate, sodium citrate dihydrate, citric acid monohydrate, glycerol, xanthan gum, liquid glucose, titanium dioxide, artificial cherry flavouring, and purified water. PHARMACOLOGY _PHARMACODYNAMIC PROPERTIES _ Antiinfective for systemic use, triazole derivative, J02AC04 MECHANISM OF ACTION: Posaconazole is a triazole antifungal agent. It is an inhibitor of the enzyme lanosterol 14 -demethylase, which catalyses an essential step Прочитајте комплетан документ