FrancophonIA/ELRC3.0 huggingface dataset:
English: Phenytoin (CYP2C9 substrate and potent CYP450 inducer) Careful monitoring of phenytoin levels is recommended when phenytoin is coadministered with voriconazole.
Maltese: 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
Maltese: Punt 2
English: Aspergillus infections - efficacy in aspergillosis patients with poor prognosis Voriconazole has in vitro fungicidal activity against Aspergillus spp.
Maltese: Infezzjonijiet bl-aspergillus - effikaċja f'pazjenti b'aspergillosi bi pronjosi fqira Voriconazole għandu attività fungiċida in vitro kontra l-Aspergillus spp.
English: Step 7
Maltese: Punt 7
English: Non-Steroidal AntiInflammatory Drugs (NSAIDs) [CYP2C9 substrates]
Maltese: Mediċini anti-infjammatorji non-sterojdali (NSAIDs)
English: 1 sterile, single use syringe.
Maltese: 1 siringa sterili, li tintuża darba biss.
English: Voriconazole (N=248)
Maltese: Punt taż-żmien Voriconazole (N=248)
English: Ritonavir Cmax and AUC ↔ Voriconazole Cmax  66% Voriconazole AUC  82%
Maltese: Ritonavir Cmax u AUC ↔ Voriconazole Cmax  66% Voriconazole AUC  82%
English: Ibuprofen (400 mg single dose)
Maltese: Ibuprofen (doża waħda ta' 400 mg)
English: VFEND contains sucrose
Maltese: VFEND fih is-sucrose
English: Excipient: sulfobutylether beta cyclodextrin sodium.
Maltese: Eċċipjent: sulfobutylether beta cyclodextrin sodium.
English: • Vinca alkaloids (e.g., vincristine and vinblastine) (used in treating cancer)
Maltese: • Alkalojdi vinka (e.ż., vincristine u vinblastine) (użati fil-kura tal-kanċer)
English: Monitoring of pancreatic function
Maltese: Monitoraġġ tal-funzjoni pankreas
English: Prophylaxis with study drug was started immediately after HSCT: 224 received voriconazole and 241 received itraconazole.
Maltese: Profilassi bil-mediċina tal-istudju nbdiet immedjatament wara HSCT: 224 irċivew voriconazole u 241 irċivew itraconazole.
English: Warfarin (30 mg single dose, co- administered with 300 mg BID voriconazole) [CYP2C9 substrate]
Maltese: Warfarin (doża waħda ta' 30 mg, amministrata flimkien ma' voriconazole 300 mg BID) [sustratt ta' CYP2C9]
English: 9 mg/kg twice daily (a maximum dose of 350 mg twice daily)
Maltese: 9 mg/kg darbtejn kuljum (doża massima ta' 350 mg darbtejn kuljum)
English: VFEND 40 mg/ml powder for oral suspension
Maltese: VFEND 40 mg/ml trab għal suspensjoni orali
English: VFEND 50 mg film-coated tablets EU/1/02/212/001-012
Maltese: 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
Maltese: Pilloli Pazjenti li jiżnu 40 kg u aktar
English: EU/1/02/212/001 2 film-coated tablets EU/1/02/212/002 10 film-coated tablets EU/1/02/212/003 14 film-coated tablets EU/1/02/212/004 20 film-coated tablets EU/1/02/212/005 28 film-coated tablets EU/1/02/212/006 30 film-coated tablets EU/1/02/212/007 50 film-coated tablets EU/1/02/212/008 56 film-coated tablets EU/1/02/212/009 100 film-coated tablets EU/1/02/212/028 2 film-coated tablets EU/1/02/212/029 10 film-coated tablets EU/1/02/212/030 14 film-coated tablets EU/1/02/212/031 20 film-coated tablets EU/1/02/212/032 28 film-coated tablets EU/1/02/212/033 30 film-coated tablets EU/1/02/212/034 50 film-coated tablets EU/1/02/212/035 56 film-coated tablets EU/1/02/212/036 100 film-coated tablets
Maltese: EU/1/02/212/001 2 pilloli miksijin b'rita EU/1/02/212/002 10 pilloli miksija b'rita EU/1/02/212/003 14-il pillola miksija b'rita EU/1/02/212/004 20 pillola miksija b'rita EU/1/02/212/005 28 pillola miksija b'rita EU/1/02/212/006 30 pillola miksija b'rita EU/1/02/212/007 50 pillola miksija b'rita EU/1/02/212/008 56 pillola miksija b'rita EU/1/02/212/009 100 pillola miksija b'rita
English: Step 6
Maltese: 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).
Maltese: 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: 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.
Maltese: 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: Other medicines and VFEND
Maltese: Mediċini oħra u VFEND
English: Everolimus (CYP3A4 substrate, P-gp substrate)
Maltese: Everolimus (sustratt CYP3A4, sustratt P-gp)
English: Everolimus [CYP3A4 substrate, P-gp substrate]
Maltese: Everolimus [sustratt ta' CYP3A4, sustratt ta' P-gp]
English: Includes immune thrombocytopenic purpura.
Maltese: 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.
Maltese: 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: • St. John's Wort (herbal supplement)
Maltese: John's Wort (fexfiex) (suppliment erbali)
English: No subject experienced an interval exceeding the potentially clinically-relevant threshold of 500 msec (see section 5.1).
Maltese: Ebda suġġett ma esperjenza intervall li jaqbeż il-limitu kliniku potenzjalment rilevanti ta' 500 msec (ara sezzjoni 5.1).
English: The absolute bioavailability of voriconazole after oral administration is estimated to be 96%.
Maltese: Ilbijodisponibilità assoluta ta' voriconazole wara amministrazzjoni orali hija stmata għal 96%.
English: VFEND contains lactose
Maltese: Borża tal-infużjoni
English: When multiple doses of voriconazole oral suspension are administered with high fat meals, Cmax and AUCτ are reduced by 58% and 37% respectively.
Maltese: Meta dożi multipli tas-suspensjoni orali ta' voriconazole jingħataw ma' ikliet b'kontenut għoli ta' xaħam, Cmax u AUC jitnaqqsu bi 58 % u 37% rispettivament.
English: Indinavir (800 mg TID) [CYP3A4 inhibitor and substrate]
Maltese: Indinavir (800 mg TID) [inibitur u sustratt ta' CYP3A4]
English: Other treated fungal infections (often with either partial or complete response) included isolated cases of Alternaria spp., Blastomyces dermatitidis, Blastoschizomyces capitatus, Cladosporium spp., Coccidioides immitis, Conidiobolus coronatus, Cryptococcus neoformans, Exserohilum rostratum, Exophiala spinifera, Fonsecaea pedrosoi, Madurella mycetomatis, Paecilomyces lilacinus, Penicillium spp.
Maltese: Infezzjonijiet fungali oħra kkurati (ħafna drabi jew b'rispons parzjali jew sħiħ) kienu jinkludu każi iżolati ta' Alternaria spp., Blastomyces dermatitidis, Blastoschizomyces capitatus, Cladosporium spp., Coccidioides immitis, Conidiobolus coronatus, Cryptococcus neoformans, Exserohilum rostratum, Exophiala spinifera, Fonsecaea pedrosoi, Madurella mycetomatis, Paecilomyces lilacinus, Penicillium spp. fosthom P. marneffei, Phialophora richardsiae, Scopulariopsis brevicaulis u Trichosporon spp. fosthom infezzjonijiet T. beigelii.
English: Required Volumes of 10 mg/ml VFEND Concentrate
Maltese: Volumi Meħtieġa ta' 10 mg/ml ta' Konċentrat VFEND
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.
Maltese: 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: EU/1/02/212/013 2 film-coated tablets EU/1/02/212/014 10 film-coated tablets EU/1/02/212/015 14 film-coated tablets EU/1/02/212/016 20 film-coated tablets EU/1/02/212/017 28 film-coated tablets EU/1/02/212/018 30 film-coated tablets EU/1/02/212/019 50 film-coated tablets EU/1/02/212/020 56 film-coated tablets EU/1/02/212/021 100 film-coated tablets EU/1/02/212/037 2 film-coated tablets EU/1/02/212/038 10 film-coated tablets EU/1/02/212/039 14 film-coated tablets EU/1/02/212/040 20 film-coated tablets EU/1/02/212/041 28 film-coated tablets EU/1/02/212/042 30 film-coated tablets EU/1/02/212/043 50 film-coated tablets EU/1/02/212/044 56 film-coated tablets EU/1/02/212/045 100 film-coated tablets
Maltese: EU/1/02/212/028 2 pilloli miksija b'rita EU/1/02/212/029 10 pilloli miksija b'rita EU/1/02/212/030 14-il pillola miksija b'rita EU/1/02/212/031 20 pillola miksija b'rita EU/1/02/212/032 28 pillola miksija b'rita EU/1/02/212/033 30 pillola miksija b'rita EU/1/02/212/034 50 pillola miksija b'rita EU/1/02/212/035 56 pillola miksija b'rita EU/1/02/212/036 100 pillola miksija b'rita
English: Pharmacotherapeutic group: Antimycotics for systemic use, triazole derivatives, ATC code: J02A C03
Maltese: Antimikosiċi għal użu sistemiku, derivattivi tat-triazole, Kodiċi ATC:
English: • The other ingredients are lactose monohydrate, pregelatinised starch, croscarmellose sodium, povidone and magnesium stearate which make up the tablet core and hypromellose, titanium dioxide (E171), lactose monohydrate and glycerol triacetate which make up the film-coat.
Maltese: • Is-sustanzi l-oħra huma lactose monohydrate, pregelatinised starch, croscarmellose sodium, povidone u magnesium stearate li jiffurmaw il-qalba tal-pillola u hypromellose, titanium dioxide (E171), lactose monohydrate u glycerol triacetate li jiffurmaw il-kisja tar-rita.
English: A measuring cup (graduated to indicate 23 ml), 5 ml oral syringe and a press-in bottle adaptor
Maltese: Kikkra tal-kejl (gradata biex tindika 23 ml), siringa orali ta' 5 ml u adapter press-in għall-flixkun
English: Repeat step 3 again.
Maltese: Irrepeti pass 3 mill-ġdid.
English: The plasma protein binding of voriconazole was similar in subjects with different degrees of renal impairment (see sections 4.2 and 4.4).
Maltese: 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: Each bottle contains 3 g of voriconazole.
Maltese: Kull flixkun fih 3 g voriconazole.
English: PVC / Aluminium/PVC/PVDC blister in cartons of 2, 10, 14, 20, 28, 30, 50, 56 or 100 film-coated tablets.
Maltese: Blister tal-PVC / Aluminium/PVC/PVDC f'pakketti ta' 2, 10, 14, 20, 28, 30, 50, 56 jew 100 pillola miksija b'rita.
English: • Benzodiazepines (e.g midazolam, triazolam) (used for severe insomnia and stress)
Maltese: • Benzodiazepines (e.ż., midazolam, triazolam) (użati għal nuqqas ta' rqad sever u stress)
English: 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.
Maltese: Il-profil tas-sigurtà ta' voriconazole fl-adulti huwa bbażat fuq database integrata tas-sigurtà ta' aktar minn 2,000 suġġett (li jinkludu 1,603 pazjent adult f'testijiet terapewtiċi) u 270 adult addizzjonali filprovi dwar il-profilassi.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Maltese: >R (Reżistenti)
English: (See section 3 ‘How to take VFEND').
Maltese: (Ara sezzjoni 3 ‘Kif għandek tieħu VFEND').
English: The major metabolite of voriconazole is the N-oxide, which accounts for 72% of the circulating radiolabelled metabolites in plasma.
Maltese: Il-metabolit prinċipali ta' voriconazole huwa l-ossidu N, li jammonta għal 72 % tal-metaboliti radjutikkettati li jiċċirkolaw fil-plasma.
English: For example, 15-20% of Asian populations may be expected to be poor metabolisers.
Maltese: Ngħidu aħna, 15-20% tal-popolazzjonijiet Asjatiċi aktarx li jkunu metabolizzaturi ħżiena.
English: Solvent for solution for infusion:
Maltese: Soluzzjonijiet Kompatibbli għal Infużjoni:
English: During oral administration of 200 mg or 300 mg twice daily for 14 days in patients at risk of aspergillosis (mainly patients with malignant neoplasms of lymphatic or haematopoietic tissue), the observed pharmacokinetic characteristics of rapid and consistent absorption, accumulation and non-linear pharmacokinetics were in agreement with those observed in healthy subjects.
Maltese: Waqt amministrazzjoni orali ta' 200 mg jew 300 mg darbtejn kuljum għal 14-il jum f'pazjenti fil-periklu ta' asperġillosi (l-aktar pazjenti b'neoplażmi malinnji ta' tessut limfatiku jew haematopoietic), il-karatteristiċi farmakokinetiċi osservati ta' assorbiment rapidu u konsistenti, akkumulazzjoni u farmakokinetika mhux lineari kienu jaqblu ma' dawk osservati f'suġġetti b'saħħithom.
English: VFEND contains the active substance voriconazole.
Maltese: VFEND fih is-sustanza attiva voriconazole.
English: Lactose monohydrate Pregelatinised starch Croscarmellose sodium Povidone
Maltese: Qalba tal-pillola Lactose monohydrate Pregelatinised starch
English: VFEND 200 mg powder and solvent for solution for infusion Each 50 ml polypropylene bag contains sodium chloride 0.9% in Water for Injections.
Maltese: VFEND 200 mg trab u solvent għal soluzzjoni għall-infużjoni Kull borża tal-polypropylene ta' 50 ml fiha sodium chloride 0.9% f'Ilma għall-Injezzjonijiet.
English: In an oral multiple-dose study, AUCτ was similar in subjects with moderate hepatic cirrhosis (Child-Pugh B) given a maintenance dose of 100 mg twice daily and subjects with normal hepatic function given 200 mg twice daily.
Maltese: Fi studju ta' doża multipla orali, AUC kien simili f'suġġetti b'ċirrożi tal-fwied moderata (Child-Pugh B) mogħtija doża ta' manteniment ta' 100 mg darbtejn kuljum u suġġetti b'funzjoni normali tal-fwied mogħtija 200 mg darbtejn kuljum.
English: Rifabutin (Potent CYP450 inducer)
Maltese: Rifabutin (Induttur qawwi ta' CYP450)
English: Each vial of VFEND contains 217.6 mg of sodium.
Maltese: Kull kunjett ta' VFEND fih 217.6 mg ta' sodju.
English: VFEND 200 mg film-coated tablets EU/1/02/212/013-024
Maltese: VFEND 200 mg pilloli miksijin b'rita EU/1/02/212/013-024
English: Methadone (CYP3A4 substrate)
Maltese: Methadone (sustratt CYP3A4)
English: Oral Contraceptives [CYP3A4 substrate; CYP2C19 inhibitor]
Maltese: Kontraċettivi orali [sustratt ta' CYP3A4 ; inibitur ta' CYP2C19]
English: Medicinal product [Mechanism of interaction]
Maltese: Prodott Mediċinali [Mekkaniżmu ta' interazzjoni]
English: Respiratory, thoracic and mediastinal disorders respiratory distress acute respiratory distress syndrome, pulmonary oedema
Maltese: Disturbi respiratorji, toraċiċi u medjastinali disturb respiratorju9
English: Step 3
Maltese: Punt 3
English: The second study enrolled 22 patients with invasive candidiasis including candidaemia (ICC), and esophageal candidiasis (EC) requiring either primary or salvage therapy, of whom 17 were included in the MITT efficacy analyses.
Maltese: It-tieni studju kellu rreġistrati fi ħdanu 22 pazjent b'kandidijażi invażiva inkluż kandidemija (ICC- invasive candidiasis including candidaemia), u kandidijażi esofageali (ECesophageal candidiasis) li kellhom bżonn ta' terapija primarja jew ta' salvataġġ, li minnhom, 17 ġew inklużi fl-analiżi tal-effikaċja tal-MITT.
English: Powder for oral suspension: store at 2°C - 8°C (in a refrigerator) before constitution.
Maltese: Trab għal suspensjoni orali: aħżen f'temperatura ta' 2°C - 8°C (fi friġġ) qabel rikostituzzjoni.
English: While being treated with VFEND:
Maltese: Waqt li tkun qed tingħata kura b'VFEND:
English: 50 ml infusion bag containing 0.9% of sodium chloride.
Maltese: Borża tal-infużjoni ta' 50 ml li fiha 0.9% ta' sodium chloride
English: 300 mg QD (coadministered with voriconazole 350 mg BID)
Maltese: 300 mg QD (amministrat flimkien ma' voriconazole 350 mg BID)
English: Oral Suspension Patients 40 kg and above*
Maltese: Suspensjoni Orali Pazjenti li jiżnu 40 kg u aktar*
English: For the constituted suspension:
Maltese: Suspensjoni kostitwita:
English: • Congenital or acquired QTc-prolongation.
Maltese: • Titwil konġenitu jew akkwiżit tal-QTc.
English: Voriconazole (N=125)
Maltese: Punti aħħarin tal-istudju Voriconazole (N=125)
English: The median duration of study drug prophylaxis was 96 days for voriconazole and 68 days for itraconazole in the MITT group.
Maltese: Il-medjan tat-tul ta' żmien tal-profilassi bilmediċina tal-istudju kien ta' 96 jum għal voriconazole u 68 jum għal itraconazole fil-grupp MITT.
English: Prednisolone (60 mg single dose) [CYP3A4 substrate]
Maltese: Prednisolone (doża waħda ta' 60 mg) [sustratt ta' CYP3A4]
English: Sirolimus (2 mg single dose)
Maltese: Sirolimus (doża waħda ta' 2 mg)
English: Ritonavir (protease inhibitor) [potent CYP450 inducer; CYP3A4 inhibitor and substrate]
Maltese: Ritonavir (inibitur tal-protease ) [induttur qawwi ta' CYP450; inibitur u sustratt ta' CYP3A4]
English: 4 mg/kg twice daily 200 mg (5 ml) twice daily
Maltese: 4 mg/kg darbtejn kuljum200 mg (5 ml) darbtejn kuljum
English: On the basis of the high oral bioavailability (96%; see section 5.2), switching between intravenous and oral administration is appropriate when clinically indicated.
Maltese: Fuq il-bażi tal-bijodisponibilità orali għolja (96%; ara sezzjoni 5.2), il-qalba bejn amministrazzjoni fil-vini u orali hija f'waqtha meta klinikament indikata.
English: The MITT group included 40 patients with prior IFI, including 31 with aspergillosis, 5 with candidiasis, and 4 with other IFI.
Maltese: Il-grupp MITT kien jinkludi 40 pazjent b'IFIs filpassat, inklużi 31 b'asperġillosi , 5 b'candidiasis, u 4 b'IFI oħrajn.
English: Powder for oral suspension White to off-white powder
Maltese: Trab għal suspensjoni orali Trab abjad għal offwajt
English: Omeprazole (40 mg QD) [CYP2C19 inhibitor; CYP2C19 and CYP3A4 substrate]
Maltese: Omeprazole (40 mg QD) [inibitur ta' CYP2C19; sustratt ta' CYP2C19 u CYP3A4]
English: The species most frequently involved in causing human infections include C. albicans, C. parapsilosis, C. tropicalis, C. glabrata and C. krusei, all of which usually exhibit minimal inhibitory concentration (MICs) of less than 1 mg/L for voriconazole.
Maltese: L-aktar speċi li spiss jikkawżaw infezzjonijiet tal-bniedem jinkludu C. albicans, C. parapsilosis, C. tropicalis, C. glabrata u C. krusei, li kollha normalment juru konċentrazzjoni inibitorja minima (MICs) ta' inqas minn 1 mg/L għal voriconazole.
English: In clinical studies, response to voriconazole in patients with C. glabrata infections was 21% lower compared to C. albicans, C. parapsilosis and C. tropicalis.
Maltese: Fi studji kliniċi, ir-rispons għal voriconazole f'pazjenti b'infezzjonijiet ta' C. glabrata kien 21% inqas meta mqabbel ma' C. albicans, C. parapsilosis u C. tropicalis.
English: Voriconazole may be coadministered with efavirenz if the voriconazole maintenance dose is increased to 400 mg BID and the efavirenz dose is decreased to 300 mg QD.
Maltese: Voriconazole jista' jkun amministrat flimkien ma' efavirenz jekk id-doża ta' manteniment ta' voriconazole tiżdied għal 400 mg BID u iddoża ta' efavirenz titnaqqas għal 300 mg QD.
English: VFEND 200 mg powder for solution for infusion EU/1/02/212/025
Maltese: VFEND 200 mg trab għal soluzzjoni għall-infużjoni EU/1/02/212/025
English: Use of standard doses of voriconazole with efavirenz doses of 400 mg QD or higher is contraindicated (see section 4.3).
Maltese: Użu ta' dożi standard ta' voriconazole ma' dożi ta' efavirenz 400mg QD jew aktar) huma kontraindikati (ara sezzjoni 4.3).
English: VFEND 40 mg/ml powder for oral suspension voriconazole
Maltese: VFEND 40 mg/ml trab għal suspensjoni orali voriconazole
English: VFEND 40 mg/ml powder for oral suspension Voriconazole
Maltese: VFEND 40 mg/ml trab għal suspensjoni orali Voriconazole
English: Other HIV Protease Inhibitors (e.g., saquinavir, amprenavir and nelfinavir) [CYP3A4 substrates and inhibitors]
Maltese: Inibituri oħra tal-protease talHIV (e.ż., saquinavir, amprenavir u nelfinavir) [sustratti u inibituri ta' CYP3A4]
English: There have been reports of prolonged visual adverse reactions, including blurred vision, optic neuritis and papilloedema (see section 4.8).
Maltese: Kien hemm rapporti ta' episodji twal ta'reazzjonijiet avversi tal-vista, inklużi vista mċajpra, newrite ta' l-għajn u papilloedema (ara sezzjoni 4.8).
English: Coadministration with rifampicin, carbamazepine and phenobarbital since these medicinal products are likely to decrease plasma voriconazole concentrations significantly (see section 4.5).
Maltese: L-amministrazzjoni flimkien ma' rifampicin, carbamazepine u phenobarbital billi dawn il-prodotti mediċinali huma probabbli li jnaqqsu l-konċentrazzjonijiet ta' voriconazole fil-plasma b'mod sinifikanti (ara sezzjoni 4.5).
English: 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.
Maltese: Voriconazole ġie mqabbel ma' itraconazole bħala profilassi primarja fi studju open-label, komparattiv, multiċentriku, ta' riċevituri adulti u adolexxenti alloġeniċi ta' HSCT mingħajr IFIs li ġew ikkonfermati jew li setgħu seħħew fil-passat.
English: Powder for solution for infusion: Sulfobutylether beta cyclodextrin sodium (SBECD)
Maltese: Trab għal soluzzjoni għall-infużjoni: Sulfobutylether beta cyclodextrin sodium (SBECD).
English: Other oral coumarins (e.g., phenprocoumon, acenocoumarol) [CYP2C9 and CYP3A4 substrates]
Maltese: Sustanzi orali oħra kontra lkoagulazzjoni tad-demm (e.ż., phenprocoumon, acenocoumarol) [sustratti ta' CYP2C9 u CYP3A4]
English: The safety of voriconazole was also investigated in 158 additional paediatric patients aged 2 to <12 years in compassionate use programs.
Maltese: Is-sigurtà ta' voriconazole ġiet investigata wkoll f'158 pazjent pedjatriku addizzjonali fl-etajiet ta' 2 sa <12-il sena fi programmi ta' użu ta' kompassjoni.
English: Excipient with known effect Each ml of suspension contains 0.54 g sucrose.
Maltese: Eċċipjent bl-effett magħruf Kull ml ta' suspensjoni fih 0.54 g ta' sucrose.
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)
Maltese: • Non-nucleoside reverse transcriptase inhibitors (e.ż., efavirenz, delavirdine, nevirapine)
English: In an oral single-dose (200 mg) study in subjects with normal renal function and mild (creatinine clearance 41-60 ml/min) to severe (creatinine clearance <20 ml/min) renal impairment, the pharmacokinetics of voriconazole were not significantly affected by renal impairment.
Maltese: Fi studju ta' doża waħda orali (200 mg) f'suġġetti b'funzjoni normali tal-kliewi u indeboliment ħafif (tneħħija ta' krejatinina 41-60 ml/min) għal sever (tneħħija ta' krejatinina <20 ml/min) tal-kliewi, ilfarmakokinetika ta' voriconazole ma kinetx affettwata b'mod sinifikanti mill-indeboliment tal-kliewi.