দেশ: অস্ট্রেলিয়া
ভাষা: ইংরেজি
সূত্র: Department of Health (Therapeutic Goods Administration)
Voriconazole
Pfizer Australia Pty Ltd
Medicine Registered
VFEND ® _TABLETS, IV INJECTION AND ORAL SUSPENSION_ _Voriconazole (vori-con-a-zole)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about VFEND. 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 VFEND against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. READ THIS LEAFLET CAREFULLY BEFORE TAKING VFEND AND KEEP THIS LEAFLET. You may need to read it again. WHAT VFEND IS USED FOR VFEND is used to treat fungal and yeast infections such as: • invasive aspergillosis (as-pur-ji- losis), 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-spore- rium) species and Fusarium (few- saa-rium) species. • other serious fungal infections in patients who do not respond to, or cannot tolerate, other antifungal medicines. Vfend is also used to prevent invasive fungal infections in patients who are at risk of developing such infections. This medicine belongs to a group of medicines called triazole antifungals. This medicine 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 prescrib সম্পূর্ণ নথি পড়ুন
Version: pfpvfend10913 Supersedes: pfpvfend10113 Page 1 of 38 PRODUCT INFORMATION VFEND® TABLETS, IV POWDER FOR INJECTION AND POWDER FOR ORAL SUSPENSION NAME OF THE MEDICINE Voriconazole The structural formula is: F F CH 3 N N F OH N N N CAS number 137234-62-9 Voriconazole is designated chemically as (2R, 3S)-2-(2,4-difluorophenyl)-3-(5-fluoro-4- pyrimidinyl)-1-(1_H _-1,2,4-triazol-1-yl)-2-butanol with an empirical formula of C 16 H 14 F 3 N 5 O and a molecular weight of 349.3. DESCRIPTION Voriconazole, a broad-spectrum, triazole antifungal agent, is available as film-coated tablets for oral administration, a powder for oral suspension and as a lyophilised powder for solution for intravenous infusion. Voriconazole drug substance is a white to off white powder. Its aqueous solubility is very low at 0.7 mg/mL at 25ºC. FILM-COATED TABLETS VFEND Tablets contain 50 mg or 200 mg of voriconazole and the following inactive ingredients: lactose, pregelatinised maize starch, croscarmellose sodium, povidone, magnesium stearate and a coating containing hypromellose, titanium dioxide, lactose and glycerol triacetate. Version: pfpvfend10913 Supersedes: pfpvfend10113 Page 2 of 38 POWDER FOR INJECTION VFEND IV is a white lyophilised powder containing nominally 200 mg voriconazole in a 30 mL Type I clear glass vial. VFEND IV is intended for administration by intravenous infusion. It is a single dose, unpreserved product. The lyophilised powder contents of the VFEND 200 mg vials are intended for reconstitution with 19 mL Water for Injections to produce a solution containing 10 mg/mL voriconazole and 160 mg/mL of sulfobutyl betadex sodium (SBECD). The r সম্পূর্ণ নথি পড়ুন