FrancophonIA/ELRC3.0 huggingface dataset:
English: There is limited data on the safety of VFEND in patients with abnormal liver function tests (aspartate transaminase [AST], alanine transaminase [ALT], alkaline phosphatase [ALP], or total bilirubin >5 times the upper limit of normal).
Hungarian: Hemm dejta limitata dwar is-sigurtà ta' VFEND f'pazjenti b'testijiet tal-funzjoni tal-fwied mhux normali (aspartate transaminase [AST], alanine transaminase [ALT], alkaline phosphatase [ALP], jew bilirubin totali >5 darbiet il-limitu ta' fuq tan-normal).
English: Fusarium spp.
Hungarian: prolificans u Fusarium spp.
English: • Fluconazole (used for fungal infections)
Hungarian: • Fluconazole (użat għal infezzjonijiet fungali)
English: Film-coating Hypromellose Titanium dioxide (E171) Lactose monohydrate Glycerol triacetate
Hungarian: Kisja tar-rita Hypromellose Titanium dioxide (E171) Lactose monohydrate Glycerol triacetate
English: Step 5
Hungarian: Punt 5
English: Voriconazole Cmax and AUC ↔
Hungarian: Voriconazole Cmax u AUC ↔
English: Methadone (32-100 mg QD) [CYP3A4 substrate]
Hungarian: Methadone (32-100 mg QD) [sustratt ta' CYP3A4]
English: Erythromycin (1 g BID) [CYP3A4 inhibitor]
Hungarian: Erythromycin (1 g BID) [inibitur ta' CYP3A4]
English: Contraindicated (see section
Hungarian: Kontraindikat (ara sezzjoni
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Hungarian: GĦAMLA KWALITATTIVA U KWANTITATTIVA
English: Prophylaxis
Hungarian: Profilassi
English: Multiple intravenous doses of 3, 4, 6, 7 and 8 mg/kg twice daily and multiple oral doses (using the powder for oral suspension) of 4 mg/kg, 6 mg/kg, and 200 mg twice daily were evaluated in 3 paediatric pharmacokinetic studies.
Hungarian: .Dożi multipli filvina ta' 3, 4, 6, 7 u 8 mg/kg darbtejn kuljum u dożi multipli orali (bl-użu tat-trab għas-suspensjoni orali) ta' 4 mg/kg, 6 mg/kg, u 200 mg darbtejn kuljum kienu evalwati fi 3 studji farmakokinetiċi f'pazjenti tfal.
English: A single adverse reaction of photophobia of 10 minutes duration was reported.
Hungarian: Kienet irrapportata reazzjoni avversa waħda ta' fotofobija li damet 10 minuti.
English: Sulfonylureas (e.g., tolbutamide, glipizide, glyburide) [CYP2C9 substrates]
Hungarian: Sulfonylureas (e.ż., tolbutamide, glipizide, glyburide) [sustratti ta' CYP2C9]
English: Hypersensitivity
Hungarian: Sensittività eċċessiva
English: Statins (e.g., lovastatin) [CYP3A4 substrates]
Hungarian: Statins (e.ż., lovastatin) [sustratti ta' CYP3A4]
English: 4.9 Overdose
Hungarian: 4.9 Doża eċċessiva
English: The survival rate at Day 180 was 80.0% (32/40) and at 1 year was 70.0% (28/40).
Hungarian: Ir-rata ta' sopravivenza f'Jum 180 kienet ta' 80.0% (32/40) u massena kienet ta' 70.0% (28/40).
English: St. John's Wort [CYP450 inducer; Pgp inducer] 300 mg TID (coadministered with voriconazole 400 mg single dose)
Hungarian: St John's Wort (fexfiex) [induttur ta' CYP450; induttur ta' P-gp] 300 mg TID (mogħti flimkien ma' doża waħda ta' 400 mg voriconazole)
English: The overall rate of response (ICC and EC combined) was 88.9% (8/9) for 2 to <12 years old and 62.5% (5/8) for 12 to <18 years old.
Hungarian: Ir-rata ta' rispons globali (ICC u EC flimkien) kienet 88.9% (8/9) għal pazjenti li kellhom minn sentejn sa <12-il sena u 62.5% (5/8) għal pazjenti li kellhom minn 12 sa <18-il sena.
English: Mycophenolic acid Cmax ↔ Mycophenolic acid AUCt ↔
Hungarian: Aċidu mikofenoliku Cmax ↔ Aċidu mikofenoliku AUCt ↔
English: • Statins (e.g., atorvastatin, simvastatin) (used for lowering cholesterol)
Hungarian: • Statins (e.ż., atorvastatin, simvastatin) (użati biex ibaxxu l-kolesterol)
English: LIST OF EXCIPIENTS
Hungarian: LISTA TA' EĊĊIPJENTI
English: Oxycodone (10 mg single dose)
Hungarian: Oxycodone (doża waħda ta' 10 mg)
English: The placeboadjusted mean maximum increases in QTc from baseline after 800, 1200 and 1600 mg of voriconazole were 5.1, 4.8, and 8.2 msec, respectively and 7.0 msec for ketoconazole 800 mg. No subject in any group had an increase in QTc of ≥ 60 msec from baseline.
Hungarian: Iż-żidiet massimi medji aġġustati bil-plaċebo fil-QTc mil-linja bażika wara 800, 1200 u 1600 mg ta' voriconazole kienu 5.1, 4.8, u 8.2 msec, rispettivament u 7.0 msec għal ketoconazole 800 mg.
English: • Astemizole (used for allergy)
Hungarian: • Astemizole (użat għal allerġija)
English: VFEND must not be infused into the same line or cannula concomitantly with other drug infusions, including parenteral nutrition (e.g., Aminofusin 10% Plus).
Hungarian: VFEND ma għandux jiġi infuż fl-istess linja jew kannula fl-istess ħin ma' infużjonjiet ta' prodotti mediċinali oħra, inkluż nutriment parenterali (eż Aminofusin 10% Plus).
English: • Ergot alkaloids (e.g., ergotamine, dihydroergotamine; used for migraine)
Hungarian: • Alkalojdi ta' l-ergotina (e.ż., ergotamine, dihydroergotamine; użati għall-emigranja)
English: including A. flavus, A. fumigatus, A. terreus, A. niger, A. nidulans; Candida spp., including C. albicans, C. glabrata, C. krusei, C. parapsilosis and C. tropicalis; and limited numbers of C. dubliniensis, C. inconspicua, and C. guilliermondii, Scedosporium spp., including S. apiospermum, S. prolificans; and Fusarium spp.
Hungarian: fumigatus, A. terreus, A. niger, A. nidulans, Candida spp; fosthom C. albicans, C. glabrata, C. krusei, C. parapsilosis u C. Tropicalis; u ammonti limitati ta' C. dubliniensis, C. inconspicua, u C. guilliermondii, Scedosporium spp., fosthom S. apiospermum, S. prolificans u Fusarium spp.
English: Frequency categories are expressed as: Very common (1/10); Common (1/100 to 1/10); Uncommon (1/1,000 to 1/100); Rare (1/10,000 to 1/1,000); Very rare (1/10,000); Not known (cannot be estimated from the available data).
Hungarian: Il-kategoriji tal-frekwenzi huma ppreżentati bħala: Komuni ħafna (≥1/10; Komuni (≥1/100 u <1/10); Mhux komuni (≥1/1,000 u <1/100); Rari (≥1/10,000 u <1/1,000); Rari ħafna (<1/10,000); Mhux magħruf (ma setgħetx tittieħed stima mid-dejta disponnibli).
English: Mycophenolic acid (1 g single dose) [UDP-glucuronyl transferase substrate]
Hungarian: Aċidu mikofenoliku (doża waħda ta' 1 g) [sustratt ta' UDP-glucuronyl transferas]
English: Pharmacokinetic/pharmacodynamic Relationship
Hungarian: Relazzjonijiet farmakokinetiċi/farmakodinamiċi
English: Powder for oral suspension
Hungarian: Suspensjoni orali
English: In an independent published study, Voriconazole AUC0-  59%
Hungarian: Fi studju indipendenti ppublikat, Voriconazole AUC0-  59%
English: Content of the pack and other information
Hungarian: Kontenut tal-pakkett u informazzjoni oħra
English: The asterisk (*) indicates a twoway interaction.
Hungarian: L-asterisk (*) jindika interazzjoni miż-żewġ naħat.
English: Fentanyl (5 g/kg single dose)
Hungarian: Fentanyl (doża waħda ta' 5 g/kg)
English: Reporting of side effects
Hungarian: Rappurtar tal-effetti sekondarji
English: Oral
Hungarian: Orali
English: In an independent published study, Sirolimus Cmax  6.6-fold Sirolimus AUC0-  11-fold
Hungarian: Fi studju indipendenti ppublikat, Sirolimus Cmax  6.6 darbiet Sirolimus AUC0-  11 il-darba
English: Other Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) (e.g., delavirdine, nevirapine) [CYP3A4 substrates, inhibitors or CYP450 inducers]
Hungarian: Inibituri oħra tan-NonNucleoside Reverse Transcriptase Inhibitors (NNRTIs) (e.ż., delavirdine, nevirapine) [sustratti ta' CYP3A4, inibituri jew indutturi ta' CYP450]
English: Efavirenz (a non-nucleoside reverse transcriptase inhibitor) [CYP450 inducer; CYP3A4 inhibitor and substrate]
Hungarian: Efavirenz (inibittur tan-nonnucleoside reverse transcriptase) [induttur ta' CYP450; inibitur u sustratt ta' CYP3A4]
English: • Rifabutin (used for treating tuberculosis).
Hungarian: • Rifabutin (użat għall-kura tat-tuberkulosi).
English: Overall, the safety profile of voriconazole in paediatric population was similar to that in adults.
Hungarian: Globalment, il-profil tas-sigurtà ta' voriconazole fil-popolazzjoni pedjatrika kien simili għal dak fl-adulti.
English: • Non-nucleoside reverse transcriptase inhibitors (e.g., efavirenz, delavirdine, nevirapine) (used for treating HIV) (some doses of efavirenz can NOT be taken at the same time as VFEND)
Hungarian: • Non-nucleoside reverse transcriptase inhibitors (e.ż., efavirenz, delavirdine, nevirapine) (użati għall-kura ta' l-HIV) (ċerti dożi ta' efavirenz MHUX suppost jittieħdu fl-istess ħin ma voriconazole)
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Hungarian: Studji fl-annimali wrew tossiċità riproduttiva (ara sezzjoni 5.3).
English: MIC breakpoint (mg/L) ≤S (Susceptible) >R (Resistant)
Hungarian: MIC breakpoint (mg/L)
English: - The other ingredients are sucrose; silica colloidal; titanium dioxide; xanthan gum; sodium citrate; sodium benzoate; citric acid; natural orange flavour.
Hungarian: • Is-sustanzi l-oħra huma sucrose; silica, colloidal ; titanium dioxide; xanthan gum; sodium citrate; sodium benzoate; aċidu ċitriku; togħma naturali tal-larinġ.
English: 6 weeks after EOT
Hungarian: 6 ġimgħat wara EOT
English: High dose (400 mg BID)
Hungarian: Doża għolja (400 mg BID)
English: squamous cell carcinoma*
Hungarian: karċinoma fiċ-ċelluli skwamużi*
English: Low dose (100 mg BID)
Hungarian: Doża baxxa (100 mg BID)
English: • serious fungal infections caused by Scedosporium sp. or Fusarium sp. (two different species of fungi).
Hungarian: • infezzjonijiet fungali serji kkawżati minn Scedosporium spp. u Fusarium spp. (żewġ speċi differenti ta' fungus).
English: The potential risk for humans is unknown.
Hungarian: Ir-riskju potenzjali għan-nies mhux magħruf.
English: • serious invasive Candida sp. infections when the fungus is resistant to fluconazole (another antifungal medicine),
Hungarian: • infezzjonijiet invażivi serji ta' Candida sp. fejn il-fungus huwa reżistenti għal fluconazole (mediċina antifungali oħra),
English: • Terfenadine (used for allergy)
Hungarian: • Terfenadine (użat għal allerġija)
English: In 10 therapeutic studies, the median for the average and maximum plasma concentrations in individual subjects across the studies was 2425 ng/ml (inter-quartile range 1193 to 4380 ng/ml) and 3742 ng/ml (interquartile range 2027 to 6302 ng/ml), respectively.
Hungarian: F'10 studji terapewtiċi, il-punt medjan għal konċentrazzjonijiet medji u massimi fil-plasma f'suġġetti individwali madwar l-istudji kien 2425 ng/ml (medda inter-quartile 1193 sa 4380 ng/ml) u 3742 ng/ml (medda inter-quartile 2027 sa 6302 ng/ml), rispettivament.
English: Alfentanil (20 μg/kg single dose, with concomitant naloxone)
Hungarian: Alfentanil (doża waħda ta' 20 μg/kg, flimkien ma' naloxone)
English: Note: Based on a population pharmacokinetic analysis in 112 immunocompromised paediatric patients aged 2 to <12 years and 26 immunocompromised adolescents aged 12 to <17 years.
Hungarian: Nota: Fuq bażi tal-analiżi farmakokinetika tal-popolazzjoni fi 112 pazjenti immunokompromessi tfal ta' bejn 2 u <12-il sena u 26 adoloxxenti immunokompromessi ta' bejn 12 u <17-il sena.
English: • Sulfonylureas (e.g., tolbutamide, glipizide, and glyburide) (used for diabetes)
Hungarian: • Sulfonylureas (e.ż., tolbutamide, glipizide, u glyburide) (użati għad-dijabete)
English: Store in a refrigerator (2°C - 8°C).
Hungarian: Aħżen fi friġġ (2°C - 8°C ) qabel rikostituzzjoni.
English: Step 4
Hungarian: Punt 4
English: Immunosuppressants [CYP3A4 substrates]
Hungarian: Immunosoppressanti [sustratti ta' CYP3A4]
English: Treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei).
Hungarian: Kura ta' infezzjonijiet invażivi serji Candida reżistenti għal fluconazole (fosthom C. krusei).
English: Total parenteral nutrition: Total parenteral nutrition (TPN) need not be discontinued when prescribed with VFEND, but does need to be infused through a separate line.
Hungarian: Nutrizzjoni parenterali totali: In-nutrizzjoni parenterali totali (TPN) m'hemmx għalfejn tiġi mwaqqfa meta ordnata ma' VFEND, iżda trid tiġi infuża minn linja separata.
English: VFEND 50 mg film-coated tablets Each tablet contains 63.42 mg lactose monohydrate.
Hungarian: VFEND 50 mg pilloli miksijin b'rita Kull pillolla fiha 63.42 mg lactose monohydrate
English: Ergot alkaloids (e.g., ergotamine and dihydroergotamine) [CYP3A4 substrates]
Hungarian: Alkalojdi tal-ergotina (e.ż., ergotamine u dihydroergotamine) [sustratti ta' CYP3A4]
English: Vinca Alkaloids (e.g., vincristine and vinblastine) [CYP3A4 substrates]
Hungarian: Alkalojdi Vinca (e.ż., vincristine u vinblastine) [sustratti ta' CYP3A4]
English: The safety of voriconazole was investigated in 288 paediatric patients aged 2 to <12 years (169) and 12 to <18 years (119) who received voriconazole for prophylaxis (183) and therapeutic use (105) in clinical trials.
Hungarian: Is-sigurtà ta' voricoanzole ġiet studjata f'288 pazjenti tfal fl-etajiet ta' 2 sa <12-il sena (169) u 12 sa <18-il sena (119) li rċevew voriconazole għal profilassi (183) u għal użu terapewtiku (105) fil-provi kliniċi.
English: In an independent published study, Alfentanil AUC0-  6-fold
Hungarian: Fi studju indipendenti ppublikat, Alfentanil AUC0-  6 darbiet
English: Tacrolimus (0.1 mg/kg single dose)
Hungarian: Tacrolimus (doża waħda ta' 0.1 mg/kg)
English: In an independent published study, Fentanyl AUC0-  1.34-fold
Hungarian: Fi studju indipendenti ppublikat, Fentanyl AUC0-  1.34 darbiet
English: Ciclosporin (in stable renal transplant recipients receiving chronic ciclosporin therapy)
Hungarian: Ciclosporin (f'riċevituri stabbli ta' trapjant tal-kliewi li qed jirċievu terapija kronika b'ciclosporin)
English: Other medicines and VFEND
Hungarian: Mediċini oħra u VFEND
English: Phenytoin (CYP2C9 substrate and potent CYP450 inducer) Careful monitoring of phenytoin levels is recommended when phenytoin is coadministered with voriconazole.
Hungarian: Phenytoin (sustratt ta' CYP2C9 u induttur qawwi ta' CYP450) Huwa rakkomandat monitoraġġ attent tal-livelli ta' phenytoin meta phenytoin jiġi amministrat flimkien ma' voriconazole.
English: Step 2
Hungarian: Punt 2
English: Serious dermatological adverse reactions
Hungarian: Reazzjonijiet avversi dermatoloġiċi serji
English: R-Pharm Germany GmbH Heinrich-Mack-Str. 35, 89257 Illertissen Germany
Hungarian: 35, 89257 Illertissen Il-Ġermanja
English: Voriconazole is haemodialysed with a clearance of 121 ml/min.
Hungarian: Voriconazole jiġi ħemodijalizzat bi tneħħija ta' 121 ml/min.
English: Step 7
Hungarian: Punt 7
English: Phenytoin [CYP2C9 substrate and potent CYP450 inducer]
Hungarian: Phenytoin [sustratt ta' CYP2C9 u induttur qawwi ta' CYP450]
English: 1 sterile, single use syringe.
Hungarian: 1 siringa sterili, li tintuża darba biss.
English: 3 years
Hungarian: 3 snin
English: For patients with ICC the global response rate at EOT was 85.7% (6/7) and for patients with EC the global response rate at EOT was 70% (7/10).
Hungarian: Għal pazjenti b'ICC ir-rata ta' rispons globali f'EOT kienet 85.7% (6/7) u għal pazjenti b'EC, ir-rata ta' rispons globali f'EOT kienet 70% (7/10).
English: Voriconazole has not been studied in patients with severe chronic hepatic cirrhosis (Child-Pugh C).
Hungarian: Voriconazole ma ġiex studjat f'pazjenti b'ċirrożi tal-fwied kronika severa (Child-Pugh C).
English: (See section 3 ‘How to take VFEND').
Hungarian: (Ara sezzjoni 3 ‘Kif għandek tieħu VFEND').
English: For the full list of excipients, see section 6.1.
Hungarian: Għal-lista kompleta ta' sustanzi mhux attivi, ara sezzjoni 6.1.
English: Voriconazole (N=248)
Hungarian: Punt taż-żmien Voriconazole (N=248)
English: Ritonavir Cmax and AUC ↔ Voriconazole Cmax  66% Voriconazole AUC  82%
Hungarian: Ritonavir Cmax u AUC ↔ Voriconazole Cmax  66% Voriconazole AUC  82%
English: 6.5 Nature and contents of container
Hungarian: 6.5 In-natura tal-kontenitur u x'hemm fih
English: In vitro activity against clinical isolates has been observed for Acremonium spp., Alternaria spp., Bipolaris spp., Cladophialophora spp., and Histoplasma capsulatum, with most strains being inhibited by concentrations of voriconazole in the range 0.05 to 2 µg/ml.
Hungarian: Attività in vitro kontra iżolati kliniċi kienet osservata għal Acremonium spp., Alternaria spp., Bipolaris spp., Cladophialophora spp., u Histoplasma capsulatum, bil-maġġoranza tal-forom jiġu mwaqqfa b'konċentrazzjonijiet ta' voriconazole fil-medda ta' 0.05 sa 2 g/ml.
English: Ibuprofen (400 mg single dose)
Hungarian: Ibuprofen (doża waħda ta' 400 mg)
English: VFEND contains sucrose
Hungarian: VFEND fih is-sucrose
English: Excipient: sulfobutylether beta cyclodextrin sodium.
Hungarian: Eċċipjent: sulfobutylether beta cyclodextrin sodium.
English: • Vinca alkaloids (e.g., vincristine and vinblastine) (used in treating cancer)
Hungarian: • Alkalojdi vinka (e.ż., vincristine u vinblastine) (użati fil-kura tal-kanċer)
English: Monitoring of pancreatic function
Hungarian: Monitoraġġ tal-funzjoni pankreas
English: Endocrine disorders adrenal insufficiency, hypothyroidism hyperthyroidism
Hungarian: Disturbi fissistema endokrinarja insuffiċjenza adrenali, ipotirojdiżmu ipertirojdiżmu
English: Prophylaxis with study drug was started immediately after HSCT: 224 received voriconazole and 241 received itraconazole.
Hungarian: Profilassi bil-mediċina tal-istudju nbdiet immedjatament wara HSCT: 224 irċivew voriconazole u 241 irċivew itraconazole.
English: Not for bolus injection.
Hungarian: Mhux għal injezzjoni bolus.
English: Warfarin (30 mg single dose, co- administered with 300 mg BID voriconazole) [CYP2C9 substrate]
Hungarian: Warfarin (doża waħda ta' 30 mg, amministrata flimkien ma' voriconazole 300 mg BID) [sustratt ta' CYP2C9]
English: In the 22 patients less than 2 years old who received voriconazole in a compassionate use programme, the following adverse reactions (for which a relationship to voriconazole could not be excluded) were reported: photosensitivity reaction (1), arrhythmia (1), pancreatitis (1), blood bilirubin increased (1), hepatic enzymes increased (1), rash (1) and papilloedema (1).
Hungarian: Fit-22 pazjent ta' anqas minn sentejn li rċevew voriconazole fi programm ta' użu ħanin, kienu rrapportati r-reazzjonijiet avversi li ġejjin (li għalihom ma setgħetx tiġi eskluża relazzjoni ma' voriconazole): reazzjoni ta' fotosensittività (1), arritmija (1), pankreatite (1), bilirubin fid-demm aktar (1), enzimi epatiċi aktar (1), raxx (1) u papilloedima (1).
English: 9 mg/kg twice daily (a maximum dose of 350 mg twice daily)
Hungarian: 9 mg/kg darbtejn kuljum (doża massima ta' 350 mg darbtejn kuljum)
English: VFEND 40 mg/ml powder for oral suspension
Hungarian: VFEND 40 mg/ml trab għal suspensjoni orali
English: VFEND 50 mg film-coated tablets EU/1/02/212/001-012
Hungarian: VFEND 50 mg pilloli miksijin b'rita EU/1/02/212/001-012
English: Tablets Patients 40 kg and above Patients less than 40 kg
Hungarian: Pilloli Pazjenti li jiżnu 40 kg u aktar
English: In vivo studies indicated that CYP2C19 is significantly involved in the metabolism of voriconazole.
Hungarian: Studji in vivo indikaw li CYP2C19 huwa involut b'mod sinifikanti fil-metaboliżmu ta' voriconazole.
English: • Phenytoin (used to treat epilepsy).
Hungarian: • Phenytoin (użat għall-kura ta' l-epilessija).
English: Step 6
Hungarian: Punt 6
English: Coadministration with CYP3A4 substrates, terfenadine, astemizole, cisapride, pimozide or quinidine since increased plasma concentrations of these medicinal products can lead to QTc prolongation and rare occurrences of torsades de pointes (see section 4.5).
Hungarian: L-amministrazzjoni flimkien mas-sustratti ta' CYP3A4, terfenadine, astemizole, cisapride, pimozide jew quinidine billi konċentrazzjonijiet akbar ta' dawn il-prodotti mediċinali fil-plasma jistgħu jwasslu għal titwil tal-QTc u okkorrenzi rari ta' torsades de pointes (ara sezzjoni 4.5).
English: Dermatological reactions
Hungarian: Reazzjonijiet dermatoloġiċi
English: In vitro, voriconazole displays broad-spectrum antifungal activity with antifungal potency against Candida species (including fluconazole-resistant C. krusei and resistant strains of C. glabrata and C. albicans) and fungicidal activity against all Aspergillus species tested.
Hungarian: In vitro, voriconazole juri attività antifungali ta' spettru wiesgħa b'qawwa antifungali kontra speċi Candida (fosthom C. krusei reżistenti għal fluconazole u forom reżistenti ta' C. glabrata u C. albicans) u attività funġiċida kontra l-ispeċi Aspergillus kollha ttestjati.
English: In fluconazole-resistant non-albicans species, a successful outcome was seen in 3/3 C. krusei (complete responses) and 6/8 C. glabrata (5 complete, 1 partial response) infections.
Hungarian: Fi speċi mhux albicans reżistenti għal fluconazole, eżitu ta' suċċess kien muri fi 3/3 infezzjonijiet bil- C. krusei (risponsi sħaħ) u 6/8 infezzjonijiet bil- C. glabrata (5 risponsi sħaħ, rispons 1 parzjali).
English: Everolimus (CYP3A4 substrate, P-gp substrate)
Hungarian: Everolimus (sustratt CYP3A4, sustratt P-gp)
English: Everolimus [CYP3A4 substrate, P-gp substrate]
Hungarian: Everolimus [sustratt ta' CYP3A4, sustratt ta' P-gp]
English: ANNEX III
Hungarian: ANNESS III
English: • Rifampicin (used for treating tuberculosis)
Hungarian: • Rifampicin (użat għall-kura tat-tuberkulosi)
English: Includes immune thrombocytopenic purpura.
Hungarian: Tinkludi purpura tromboċitopenika immuni.
English: In an open-label, comparative, multicenter study comparing voriconazole and itraconazole as primary prophylaxis in adult and adolescent allogeneic HSCT recipients without prior proven or probable IFI, permanent discontinuation of voriconazole due to AEs was reported in 39.3% of subjects versus 39.6% of subjects in the itraconazole arm. Treatment-emergent hepatic AEs resulted in permanent discontinuation of study medication for 50 subjects (21.4%) treated with voriconazole and for 18 subjects (7.1%) treated with itraconazole.
Hungarian: Fi studju open-label, komparattiv, multiċentriku li qabbel voriconazole u itraconazole bħala profilassi primarja f'riċevituri adulti u adolexxenti alloġeniċi ta' HSCT mingħajr IFIs li ġew ikkonfermati jew li setgħu seħħew fil-passat, t-twaqqif permanenti ta' voriconazole minħabba AEs ġie rrappurtat f'39.3% tal-individwi kontra 39.6% tal-individwi trattati b'itraconazole.
English: There was evidence of attenuation with repeated doses of voriconazole.
Hungarian: Kien hemm evidenza ta' attenwazzjoni b'dożi ripetuti ta' voriconazole.
English: • Serious dermatological adverse reactions (including SCC) The frequency of phototoxicity reactions is higher in the paediatric population.
Hungarian: • Reazzjonijiet avversi dermatoloġiċi serji (inkluż SCC) Il-frekwenza ta' reazzjonijiet ta' fototossiċità hi ogħla fil-popolazzjoni fit-tfal.
English: • Ciclosporin (used in transplant patients)
Hungarian: • Ciclosporin (użat f'pazjenti tat-trapjanti)
English: No subject experienced an interval exceeding the potentially clinically-relevant threshold of 500 msec (see section 5.1).
Hungarian: Ebda suġġett ma esperjenza intervall li jaqbeż il-limitu kliniku potenzjalment rilevanti ta' 500 msec (ara sezzjoni 5.1).
English: Efavirenz (CYP450 inducer; CYP3A4 inhibitor and substrate) When voriconazole is coadministered with efavirenz the dose of voriconazole should be increased to 400 mg every 12 hours and the dose of efavirenz should be decreased to 300 mg every 24 hours (see sections 4.2, 4.3 and 4.5).
Hungarian: Efavirenz (induttur ta' CYP450; inibitur u sustratt ta' CYP3A4) Meta voriconazole jiġi amministrat ma' efavirenz, id-doża ta' voriconazole għandha tiżdied għal 400 mg kull 12-il siegħa u d-doża ta' efavirenz għandha tiġi mnaqqsa għal 300 mg kull 24 siegħa (ara sezzjonijiet 4.2, 4.3 u 4.5).
English: Fluconazole (200 mg QD) [CYP2C9, CYP2C19 and CYP3A4 inhibitor]
Hungarian: Fluconazole (200 mg QD) [inibitur ta' CYP2C9, CYP2C19 u CYP3A4]
English: The absolute bioavailability of voriconazole after oral administration is estimated to be 96%.
Hungarian: Ilbijodisponibilità assoluta ta' voriconazole wara amministrazzjoni orali hija stmata għal 96%.
English: The plasma protein binding of voriconazole was similar in subjects with different degrees of renal impairment (see sections 4.2 and 4.4).
Hungarian: It-tqabbid ta' voriconazole mal-proteini tal-plasma kien simili f'suġġetti bi gradi differenti ta' indeboliment tal-kliewi (ara sezzjonijiet 4.2 u 4.4).
English: Diclofenac (50 mg single dose)
Hungarian: Diclofenac (doża waħda ta' 50 mg)