Land: Vereinigtes Königreich
Sprache: Englisch
Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)
Voriconazole
Pfizer Ltd
J02AC03
Voriconazole
200mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05020100; GTIN: 5013457010534
Page 1 of 9 PACKAGE LEAFLET: INFORMATION FOR THE USER VFEND® 50 MG FILM-COATED TABLETS VFEND® 200 MG FILM-COATED TABLETS Voriconazole READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor, pharmacist or nurse. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What VFEND is and what it is used for 2. What you need to know before you take VFEND 3. How to take VFEND 4. Possible side effects 5. How to store VFEND 6. Content of the pack and other information 1. WHAT VFEND IS AND WHAT IT IS USED FOR VFEND contains the active substance voriconazole. VFEND is an antifungal medicine. It works by killing or stopping the growth of the fungi that cause infections. It is used for the treatment of patients (adults and children over the age of 2) with: invasive aspergillosis (a type of fungal infection due to _Aspergillus sp_), candidaemia (another type of fungal infection due to _Candida sp_) in non-neutropenic patients (patients without abnormally low white blood cells count), serious invasive _Candida sp._ infections when the fungus is resistant to fluconazole (another antifungal medicine), serious fungal infections caused by _Scedosporium sp._ or _Fusarium sp_. (two different species of fungi). VFEND is intended for patients with worsening, possibly life-threatening, fungal infections. Prevention of fungal infections in high risk bone marrow transplant recipients. This product should only be taken under the supervision of a doctor. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VFEND DO NOT TAKE VFEND: If you are allergic to voriconazole or any of the ot Lesen Sie das vollständige Dokument
OBJECT 1 VFEND 40 MG/ML POWDER FOR ORAL SUSPENSION Summary of Product Characteristics Updated 01-May-2018 | Pfizer Limited 1. Name of the medicinal product VFEND 50 mg and 200 mg film-coated tablets. VFEND 200 mg powder for solution for infusion. VFEND 200 mg powder and solvent for solution for infusion. VFEND 40 mg/ml powder for oral suspension. 2. Qualitative and quantitative composition FILM-COATED TABLETS : Each tablet contains 50 mg or 200 mg voriconazole. Excipient with known effect Each tablet contains 63.42 mg or 253.675 mg lactose monohydrate. For the full list of excipients, see section 6.1. POWDER FOR SOLUTION FOR INFUSION: Each vial contains 200 mg of voriconazole. After reconstitution each ml contains 10 mg of voriconazole. Once reconstituted further dilution is required before administration. Excipient with known effect Each vial contains 217.6 mg sodium. For the full list of excipients, see section 6.1. SOLVENT FOR SOLUTION FOR INFUSION : Each 50 ml polypropylene bag contains sodium chloride 0.9% in Water for Injections. Excipient with known effect Each bag contains 177.02 mg sodium. For the full list of excipients, see section 6.1. POWDER FOR ORAL SUSPENSION: Each ml of oral suspension contains 40 mg of voriconazole when reconstituted with water. Each bottle contains 3 g of voriconazole. Excipient with known effect Each ml of suspension contains 0.54 g sucrose. For the full list of excipients, see section 6.1. 3. Pharmaceutical form FILM-COATED TABLETS: White to off-white, round tablet, debossed “Pfizer” on one side and “VOR50” on the reverse. White to off-white, capsule-shaped tablet, debossed “Pfizer” on one side and “VOR200” on the reverse. POWDER FOR SOLUTION FOR INFUSION: White lyophilised powder POWDER AND SOLVENT FOR SOLUTION FOR INFUSION: Powder for solution for infusion: White lyophilised powder Solvent for solution for infusion: Clear diluent solution POWDER FOR ORAL SUSPENSION: White to off-white powder 4. Clinical particulars 4.1 Therapeutic indications VFEND is a broad Lesen Sie das vollständige Dokument