Kraj: Holandia
Język: niderlandzki
Źródło: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
VORICONAZOL
Apotex Europe B.V.
J02AC03
VORICONAZOLE
Filmomhulde tablet
CROSCARMELLOSE NATRIUM (E 468) ; LACTOSE 1-WATER ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; POLYVINYLALCOHOL (E1203) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Voriconazole
Hulpstoffen: CROSCARMELLOSE NATRIUM (E 468); LACTOSE 1-WATER; MACROGOL 8000; MAGNESIUMSTEARAAT (E 470b); POLYVINYLALCOHOL (E1203); TALK (E 553 B); TITAANDIOXIDE (E 171);
2016-05-17
VORICONAZOLE APOTEX 50 MG, 200 MG FILM-COATED TABLETS MODULE 1.3 Product Information Version: 2019-02 MODULE 1.3.1 Package Leaflet Replaces: 2017-06 1 PACKAGE LEAFLET: INFORMATION FOR THE USER VORICONAZOL APOTEX 50 MG FILMOMHULDE TABLETTEN VORICONAZOL APOTEX 200 MG FILMOMHULDE TABLETTEN Voriconazol 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 Voriconazole Apotex is and what it is used for 2. What you need to know before you take Voriconazole Apotex 3. How to take Voriconazole Apotex 4. Possible side effects 5. How to store Voriconazole Apotex 6. Content of the pack and other information 1. WHAT VORICONAZOLE APOTEX IS AND WHAT IT IS USED FOR Voriconazole Apotex contains the active substance voriconazole. Voriconazole Apotex 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). Voriconazole Apotex is intended for patients with worsening, possibly life-threatening, fungal inf Przeczytaj cały dokument
VORICONAZOLE APOTEX 50 MG, 200 MG FILM-COATED TABLETS MODULE 1.3 Product Information Version: 2019-02 MODULE 1.3.1 Summary of Product Characteristics Replaces: 2017-12 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Voriconazol Apotex 50 mg, filmomhulde tabletten Voriconazol Apotex 200 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 or 200 mg voriconazole Excipient(s) with known effect: Voriconazole Apotex 50 mg film-coated tablets: Each tablet contains 91.00 mg lactose monohydrate. Voriconazole Apotex 200 mg film-coated tablets: Each tablet contains 364.00 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets Voriconazole Apotex 50 mg film-coated tablets: White coloured, round-shaped, film-coated tablet (size: 7.0 mm) engraved “APO” on one side and “VOR” over “50” on the other side. Voriconazole Apotex 200 mg film-coated tablets: White coloured, modified oval-shaped, bi- convex film-coated tablet (size: 15.50 x 7.90 mm), engraved “APO” on one side and “VOR 200” on the other side. 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 candidemia in non-neutropenic patients. VORICONAZOLE APOTEX 50 MG, 200 MG FILM-COATED TABLETS MODULE 1.3 Product Information Version: 2019-02 MODULE 1.3.1 Summary of Product Characteristics Replaces: 2017-12 2 Treatment of fluconazole-resistant serious invasive _Candida_ infections (including _C. krusei_). Treatment of serious fungal infections caused by _Scedosporium_ spp. and _Fusarium_ spp. Voriconazole Apotex 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 O Przeczytaj cały dokument