";s:4:"text";s:4253:"Predchádzanie hubovým infekciám u vysoko rizikových pacientov, ktorí sú príjemcami transplantátu kostnej drene.Tablety sa užívajú v pravidelných časových odstupoch, vždy vcelku a zapíjajú sa dostatočným množstvom tekutiny. Warfarin (30 mg single dose, co- administered with 300 mg BID voriconazole) Coadministration of voriconazole with everolimus is not recommended because voriconazole is expected to significantly increase everolimus concentrations (see section 4.4).The reduced dose and/or frequency of voriconazole and fluconazole that would eliminate this effect have not been established. No subject experienced an interval exceeding the potentially clinically-relevant threshold of 500 msec. Oral bioavailability may, however, be limited in paediatric patients with malabsorption and very low body weight for their age.
The median treatment duration was 15 days in both treatment arms. If phototoxic reactions occur, multidisciplinary advice should be sought, VFEND discontinuation and use of alternative antifungal agents should be considered and the patient should be referred to a dermatologist. The Investigator's assessment of successful outcome at each of these time points is shown in the following table.The study comprised 55 patients with serious refractory systemic Voriconazole was shown to be effective against the following rare fungal pathogens:The majority of patients receiving voriconazole treatment of the above mentioned rare infections were intolerant of, or refractory to, prior antifungal therapy.Voriconazole was compared to itraconazole as primary prophylaxis in an open-label, comparative, multicenter study of adult and adolescent allogeneic HSCT recipients without prior proven or probable IFI.
VFEND 200 mg kalvopäällysteiset tabletit ovat valkoisia tai luonnonvalkoisia, kapselinmuotoisia, kalvopäällysteisiä tabletteja, joiden toisella puolella on merkintä "Pfizer" ja toisella puolella merkintä "VOR200".
The median duration of study drug prophylaxis was 96 days for voriconazole and 68 days for itraconazole in the MITT group.Success rates and other secondary endpoints are presented in the table below:Completed at least 100 days of study drug prophylaxis Developed proven or probable IFI while on study drug** Difference in proportions, 95% CI and p-values obtained after adjustment for randomizationThe breakthrough IFI rate to Day 180 and the primary endpoint of the study, which is Success at Day 180, for patients with AML and myeloablative conditioning regimens respectively, is presented in the table below:** Using a margin of 5%, non inferiority is demonstrated ***Difference in proportions, 95% CI obtained after adjustment for randomization** Using a margin of 5%, non inferiority is demonstrated *** Difference in proportions, 95% CI obtained after adjustment for randomization Voriconazole was investigated as secondary prophylaxis in an open-label, non-comparative, multicentre study of adult allogeneic HSCT recipients with prior proven or probable IFI. Patients must avoid potentially hazardous tasks, such as driving or operating machinery while experiencing these symptoms.The safety profile of voriconazole in adults is based on an integrated safety database of more than 2,000 subjects (including 1,603 adult patients in therapeutic trials) and an additional 270 adults in prophylaxis trials.
It is likely that these subjects may metabolize voriconazole more similarly to children than to adults. This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
These visual impairments were transient and fully reversible, with the majority spontaneously resolving within 60 minutes and no clinically significant long-term visual effects were observed. A higher frequency of liver enzyme elevations was observed in the paediatric population (see section 4.8). Protein binding of voriconazole was not affected by impaired hepatic function.