Država: Australija
Jezik: engleski
Izvor: Department of Health (Therapeutic Goods Administration)
voriconazole
Apotex Pty Ltd
Voriconazole
Registered
VORICONAZOLE APOTEX TABLETS _Contains the active ingredient voriconazole_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE. This leaflet answers some common questions about voriconazole. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available. ASK YOUR DOCTOR OR PHARMACIST: • if there is anything you do not understand in this leaflet, • if you are worried about taking your medicine, or • to obtain the most up-to-date information. You can also download the most up to date leaflet from www.apotex.com.au. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. Pharmaceutical companies cannot give you medical advice or an individual diagnosis. Keep this leaflet with your medicine. You may want to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is Voriconazole APOTEX tablets. It contains the active ingredient voriconazole. It is used to treat fungal and yeast infections such as: • invasive aspergillosis (as-pur- jilosis), a fungal infection caused by a fungus called Aspergillus (as-pur-jilus), which usually begins in the respiratory tract (in the nose, sinuses or lungs). Aspergillus is harmless in most healthy people; however, in people with poor immune systems (such as people who have had organ transplants and people with cancer or HIV/AIDS) invasive aspergillosis can be serious and spread to other tissues and organs. • serious Candida (can-did-da) infections, including Candida infections of the oesophagus (food pipe or gullet) and those that have spread into the blood stream or to other parts of the body. • serious fungal infections caused by Scedosporium (ski-doe-s Pročitajte cijeli dokument
Product Information – Australia Voriconazole APOTEX Tablets Page 1 VORICONAZOLE APOTEX TABLETS NAME OF THE MEDICINE Voriconazole Chemical Name: (2_R_, 3_S_)-2-(2,4-difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1_H_ -1,2,4-triazol- 1-yl)butan-2-ol Structural Formula: Molecular Formula: C 16 H 14 F 3 N 5 O Molecular Weight: 349.3 CAS Registry Number: 137234-62-9 DESCRIPTION Voriconazole, a broad-spectrum, triazole antifungal agent intended for oral administration. Voriconazole is a white or almost white powder. It is very slightly soluble in water, freely soluble in acetone and in methylene chloride. Voriconazole Tablets contain 50 mg or 200 mg of voriconazole as the active ingredient. In addition, each tablet contains the following inactive ingredients: lactose, croscarmellose sodium, magnesium stearate and a coating containing polyvinyl alcohol, macrogol 8000, purified talc and titanium dioxide. PHARMACOLOGY PHARMACOLOGICAL ACTIONS Mechanism of Action Voriconazole is a triazole antifungal agent. Voriconazole’s primary mode of action is the inhibition of fungal cytochrome P450-mediated 14α-sterol demethylation, an essential step in ergosterol biosynthesis. Voriconazole is more selective than some other azole drugs for fungal as opposed to various mammalian cytochrome P450 enzyme systems. The subsequent loss of normal sterols correlates with the accumulation of 14α-methyl sterols in fungi and may be responsible for its fungistatic/fungicidal activity. _In vitro_, voriconazole displays broad-spectrum antifungal activity with high antifungal potency against _Candida_ species (including fluconazole resistant _C. krusei_ and resistant strains of _C. glabrata_ and _C. _ _albicans_) and fungicidal activity against all _Aspergillus_ species tested. In addition, voriconazole shows _in vitro_ activity against emerging fungal pathogens, such as _Scedosporium_ or _Fusarium_, some isolates of which have limited susceptibility to existing antifungal agents. In addition, voriconazole exhibits _in _ _vitro_ fungicidal activ Pročitajte cijeli dokument