Țară: Uniunea Europeană
Limbă: engleză
Sursă: EMA (European Medicines Agency)
voriconazole
Pfizer Europe MA EEIG
J02AC03
voriconazole
Antimycotics for systemic use
Candidiasis; Mycoses; Aspergillosis
Voriconazole, is a broad spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows:treatment of invasive aspergillosis;treatment of in candidaemianon-neutropenic patients;treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei);Treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp.Vfend should be administered primarily to patients with progressive, possibly life-threatening infections.Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT) recipients.
Revision: 55
Authorised
2002-03-19
116 B. PACKAGE LEAFLET 117 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 Citiți documentul complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT VFEND 50 mg film-coated tablets VFEND 200 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 or 200 mg voriconazole. Excipient with known effect VFEND 50 mg film-coated tablets Each tablet contains 63.42 mg lactose monohydrate. VFEND 200 mg film-coated tablets Each tablet contains 253.675 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM VFEND 50 mg film-coated tablets White to off-white, round tablet, debossed “Pfizer” on one side and “VOR50” on the reverse (tablets). VFEND 200 mg film-coated tablets White to off-white, capsule-shaped tablet, debossed “Pfizer” on one side and “VOR200” on the reverse (tablets). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS VFEND, is a broad-spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows: Treatment of invasive aspergillosis. Treatment of candidaemia in non-neutropenic patients. Treatment of fluconazole-resistant serious invasive _Candida_ infections (including _C. krusei_ ). Treatment of serious fungal infections caused by _Scedosporium_ spp. and _Fusarium_ spp. VFEND should be administered primarily to patients with progressive, possibly life-threatening infections. Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT) recipients. 3 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Electrolyte disturbances such as hypokalaemia, hypomagnesaemia and hypocalcaemia should be monitored and corrected, if necessary, prior to initiation and during voriconazole therapy (see section 4.4). VFEND is also available as 200 mg powder for solution for infusion and 40 mg/ml powder for oral suspension. Treatment _Adults _ Therapy must be initiated with the specified loading dose regimen of either intravenous or oral VFEND to achieve plasma concentrations on Day 1 that are close to steady state. O Citiți documentul complet