Ország: Hollandia
Nyelv: holland
Forrás: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
VORICONAZOL 200 mg/flacon
Betapharm Arzneimittel GmbH Kobelweg 95 D-86156 AUGSBURG (DUITSLAND)
J02AC03
VORICONAZOL 200 mg/flacon
Poeder voor oplossing voor infusie
HYDROXYPROPYLBETADEX ; LACTOSE 1-WATER,
Intraveneus gebruik
Voriconazole
Hulpstoffen: HYDROXYPROPYLBETADEX; LACTOSE 1-WATER;
2014-12-16
131 PACKAGE LEAFLET: INFORMATION FOR THE USER VORICONAZOL BETAPHARM 200 MG, POEDER VOOR OPLOSSING VOOR INFUSIE voriconazole READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 [PRODUCT NAME] is and what it is used for 2. What you need to know before you use [PRODUCT NAME] 3. How to use [PRODUCT NAME] 4. Possible side effects 5. How to store [PRODUCT NAME] 6. Content of the pack and other information 1. WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR [PRODUCT NAME] contains the active substance voriconazole. [PRODUCT NAME] 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). [PRODUCT NAME] 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 used under the supervision of a doctor. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE [PRODUCT NAME] DO NOT USE Olvassa el a teljes dokumentumot
131 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Voriconazol betapharm 200 mg, poeder voor oplossing voor infusie 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 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 2,600 mg hydroxypropylbetadex. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for infusion White to off-white lyophilized powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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 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. [PRODUCT NAME] 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. 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). It is recommended that [PRODUCT NAME] is administered at a maximum rate of 3 mg/kg per hour over 1 to 3 hours. 131 [PRODUCT NAME] is also available as 50 mg and 200 mg film-coated tablets. Additionally, other brands have voriconazole available as a 40 mg/ml powder for oral suspension. Not all strengths may be marketed. Treatment _Adults_ Therapy must be initiated with the specified loading dose regimen of either intravenous or oral voriconazole to achieve plasma concentrations on Day 1 that are close to s Olvassa el a teljes dokumentumot