Țară: Țările de Jos
Limbă: olandeză
Sursă: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
VORICONAZOL 200 mg/stuk
Pfizer B.V. Rivium Westlaan 142 2909 LD CAPELLE A/D IJSSEL
J02AC03
VORICONAZOL 200 mg/stuk
Filmomhulde tablet
CROSCARMELLOSE NATRIUM (E 468) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON (E 1201) ; TITAANDIOXIDE (E 171) ; ZETMEEL, GEPREGELATINEERD,
Oraal gebruik
Voriconazole
Hulpstoffen: CROSCARMELLOSE NATRIUM (E 468); GLYCEROLTRIACETAAT (E 1518); HYPROMELLOSE (E 464); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); POVIDON (E 1201); TITAANDIOXIDE (E 171); ZETMEEL, GEPREGELATINEERD;
1900-01-01
VORI PF 2627 EN PIL 50 200 FCT 025 EN track 05Oct2023 1/10 PACKAGE LEAFLET: INFORMATION FOR THE USER VORICONAZOL PFIZER 50 MG FILMOMHULDE TABLETTEN VORICONAZOL PFIZER 200 MG FILMOMHULDE TABLETTEN 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 Voriconazole Pfizer is and what it is used for 2. What you need to know before you take Voriconazole Pfizer 3. How to take Voriconazole Pfizer 4. Possible side effects 5. How to store Voriconazole Pfizer 6. Content of the pack and other information 1. WHAT VORICONAZOLE PFIZER IS AND WHAT IT IS USED FOR Voriconazole Pfizer contains the active substance voriconazole. Voriconazole Pfizer 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 Pfizer is intended for patients with worsening, possibly life-threatening, fungal infections. Prevention of fungal infections in high risk bone marrow transplant recipients. Citiți documentul complet
VORI PF 2627 EN SmPC 50 200 FCT 025 EN track 05Oct2023 1/31 1. NAME OF THE MEDICINAL PRODUCT Voriconazol Pfizer 50 mg filmomhulde tabletten Voriconazol Pfizer 200 mg filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 or 200 mg voriconazole. Excipient with known effect Voriconazole Pfizer 50 mg film-coated tablets Each tablet contains 63.42 mg lactose monohydrate. Voriconazole Pfizer 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 Voriconazole Pfizer 50 mg film coated tablets. White to off-white, round tablet, debossed “Pfizer” on one side and “VOR50” on the reverse (tablets). Voriconazole Pfizer 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 Voriconazole Pfizer, 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. Voriconazole Pfizer 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. VORI PF 2627 EN SmPC 50 200 FCT 025 EN track 05Oct2023 2/31 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). Voriconazole Pfizer is also available as 200 mg powder for solution for infusion and 40 mg/ml powder for oral suspensio Citiți documentul complet