FrancophonIA/ELRC3.0 huggingface dataset:
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 (inter-quartile range 2027 to 6302 ng/ml), respectively.
Maltese: 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 interquartile 2027 sa 6302 ng/ml), rispettivament.
English: EU/1/13/835/001 2 film-coated tablets EU/1/13/835/002 10 film-coated tablets EU/1/13/835/003 14 film-coated tablets EU/1/13/835/004 20 film-coated tablets EU/1/13/835/005 28 film-coated tablets EU/1/13/835/006 30 film-coated tablets EU/1/13/835/007 50 film-coated tablets EU/1/13/835/008 56 film-coated tablets EU/1/13/835/009 100 film-coated tablets EU/1/13/835/019 10x1 film-coated tablets EU/1/13/835/020 14x1 film-coated tablets EU/1/13/835/021 28x1 film-coated tablets EU/1/13/835/022 30x1 film-coated tablets EU/1/13/835/023 56x1 film-coated tablets EU/1/13/835/024 100x1 film-coated tablets
Maltese: EU/1/13/835/001 2 pilloli miksija b'rita EU/1/13/835/002 10 pilloli miksija b'rita EU/1/13/835/003 14 pilloli miksija b'rita EU/1/13/835/004 20 pilloli miksija b'rita EU/1/13/835/005 28 pilloli miksija b'rita EU/1/13/835/006 30 pilloli miksija b'rita EU/1/13/835/007 50 pilloli miksija b'rita EU/1/13/835/008 56 pilloli miksija b'rita EU/1/13/835/009 100 pilloli miksija b'rita EU/1/13/835/019 10x1 pillola miksija b'rita EU/1/13/835/020 14x1 pillola miksija b'rita EU/1/13/835/021 28x1 pillola miksija b'rita EU/1/13/835/022 30x1 pillola miksija b'rita EU/1/13/835/023 56x1 pillola miksija b'rita EU/1/13/835/024 100x1 pillola miksija b'rita
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 (inkluż 1,603 pazjent adult f'testijiet terapewtiċi) u 270 adult addizzjonali fil-provi dwar il-profilassi.
English: There is limited data on the safety of voriconazole 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).
Maltese: Hemm dejta limitata dwar is-sigurtà ta' voriconazole 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: [CYP450 inducer; P-gp inducer]
Maltese: [induttur ta' CYP450 ; induttur ta' P-gp]
English: Other HIV Protease Inhibitors (e.g., saquinavir, amprenavir and nelfinavir)*
Maltese: Inibituri oħra tal-protease tal-HIV (e.ż., saquinavir, amprenavir u nelfinavir)*
English: Omeprazole Cmax 116% Omeprazole AUCτ  280% Voriconazole Cmax 15% Voriconazole AUCτ  41%
Maltese: Omeprazole Cmax 116% Omeprazole AUC 280% Voriconazole Cmax 15% Voriconazole AUC 41%
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.
Maltese: Ir-rata ta' rispons globali (ICC u EC kkombinati flimkien) kienet ta' 88.9% (8/9) għal dawk li għandhom bejn sentejn u<12-il sena u 62.5% (5/8) għal dawk li għandhom bejn 12 u <18-il sena.
English: Ciclosporin (in stable renal transplant recipients receiving chronic ciclosporin therapy)
Maltese: Ciclosporin (f'riċevituri stabbli ta' trapjant talkliewi li qed jirċievu terapija kronika b'ciclosporin)
English: Date of latest renewal: 8th February 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 16 ta' Mejju 2013 Data tal-aħħar tiġdid: Id-8 ta 'Frar 2018
English: Itraconazo le (N=143)
Maltese: Itraconazole (N=143)
English: Ethinylestradiol Cmax  36% Ethinylestradiol AUCτ  61% Norethisterone Cmax  15% Norethisterone AUCτ  53% Voriconazole Cmax  14%
Maltese: Ethinylestradiol Cmax 36% Ethinylestradiol AUC 61% Norethisterone Cmax 15% Norethisterone AUC 53% Voriconazole Cmax 14% Voriconazole AUC 46%
English: Voriconazole Cmax  57% Voriconazole AUCτ  79% Fluconazole Cmax ND Fluconazole AUCτ ND
Maltese: Voriconazole Cmax 57% Voriconazole AUC 79% Fluconazole Cmax ND Fluconazole AUC ND
English: Voriconazole Accord contains the active substance voriconazole.
Maltese: Voriconazole Accord fih is-sustanza attiva voriconazole.
English: • Statins (e.g., atorvastatin, simvastatin) (used for lowering cholesterol)
Maltese: • Statins (p.e., atorvastatin, simvastatin) (użati biex ibaxxu l-kolesterol)
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.
Maltese: Is-sigurtà ta' voriconazole kienet investigata f'288 pazjent pedjatriku li għandhom bejn sentejn u <12il sena (169) u bejn 12 u <18-il sena (119) li rċevew voriconazole għal profilassi (183) u użu terapewtiku (105) fi provi kliniċi.
English: The placebo- adjusted 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.
Maltese: 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: [P-gp substrate]
Maltese: [substrat ta' P-gp]
English: Phenytoin (CYP2C9 substrate and potent CYP450 inducer)
Maltese: Phenytoin (substrat ta' CYP2C9 u induttur qawwi ta' CYP450)
English: Ritonavir Cmax  25% Ritonavir AUCτ  13% Voriconazole Cmax  24% Voriconazole AUCτ  39%
Maltese: Ritonavir Cmax 25% Ritonavir AUC13% Voriconazole Cmax 24% Voriconazole AUC 39%
English: While being treated with Voriconazole Accord:
Maltese: Tiħux Voriconazole Accord:
English: • Patient Alert Card for Phototoxicity and SCC:
Maltese: • Kartuna ta' twissijja għal-Pazjent għal Fototossiċità u SCC:
English: Transcriptase Inhibitors (NNRTIs) (e.g., delavirdine, nevirapine)*
Maltese: Inibituri oħra tan-NonNucleoside Reverse Transcriptase Inhibitors (NNRTIs) (e.ż., delavirdine, nevirapine)*
English: The major metabolite of voriconazole is the N-oxide, which accounts for 72% of the circulating radiolabeled 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: 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 illimitu kliniku potenzjalment rilevanti ta' 500 msec (ara sezzjoni 5.1).
English: Ritonavir Cmax and AUCτ ↔ Voriconazole Cmax  66% Voriconazole AUCτ  82%
Maltese: Ritonavir Cmax u AUC ↔ Voriconazole Cmax 66% Voriconazole AUC 82%
English: Voriconazole Accord 50 mg film-coated tablets and 200mg film-coated tablets are available as packs of 2, 10, 14, 20, 28, 30, 50, 56 and 100 or unit dose blister packs (PVC / Aluminium) containing 10x1, 14x1, 28x1, 30x1, 56x1 or 100x1 film-coated tablets.
Maltese: Il-pilloli Voriconazole Accord 50 mg miksijin b'rita u l-pilloli Voriconazole Accord 200 mg miksijin b'rita huma disponibbli bħala pakketti ta' 2, 10, 14, 20, 28, 30, 50, 56 u 100 jew pakketti ta' folji ta' doża waħda (PVC / Aluminju) li fihom 10x1, 14x1, 28x1, 30x1, 56x1 jew 100x1 pilloli miksijin b'rita.
English: • Ergot alkaloids (e.g., ergotamine, dihydroergotamine; used for migraine)
Maltese: • Alkalojdi ta' l-ergotina (e.g., ergotamine, dihydroergotamine; użati għall-emigranja)
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 imċajpra, newrite ta' l-għajn u papilloedema (ara sezzjoni 4.8).
English: All other adolescents (12 to 14 years and ≥50 kg; 15 to 17 years regardless of body weight)
Maltese: Fl-adoloxxenti l-oħra kollha (12 sa 14-il sena u ≥50 kg; 15 sa 17-il sena irrispettivament mill-piż talġisem)
English: Stevens-Johnson syndrome, phototoxicity, purpura, urticaria, dermatitis allergic, rash papular, rash macular, eczema toxic epidermal necrolysis, angioedema, actinic keratosis*, pseudoporphyri a erythema multiforme, psoriasis, drug eruption, drug reaction with eosinophilia and systemic symptoms (DRESS)
Maltese: Sindrome ta' Stevens-Johnson, fototossiċità, purpura, urtikarja, dermatite allerġika, raxx papularu, raxx makulari, ekżema nekroliżi epidermika tossika, anġjoedima, keratosi aktinika*, pseudoporphyri a, eritema multiformi, psorijasi, eruzzjoni filġilda, reazzjoni għall-mediċina b'sintomi ta' esinofilja u sistemiċi (DRESS)
English: • Squamous cell carcinoma of the skin (SCC)
Maltese: • Karċinoma fiċ-ċelluli skwamużi tal-ġilda (SCC)
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 fil-passat, inklużi 31 b'asperġillosi , 5 b'candidiasis, u 4 b'IFI oħrajn.
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).
Maltese: 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: • Sulfonylureas (e.g., tolbutamide, glipizide, and glyburide) (used for diabetes)
Maltese: • Sulfonylureas (p.e., tolbutamide, glipizide, u glyburide) (użati għad-dijabete)
English: Other oral coumarins (e.g., phenprocoumon, acenocoumarol)
Maltese: Sustanzi orali oħra kontra l-koagulazzjoni tad-demm (e.ż., phenprocoumon, acenocoumarol)
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, it-twaqqif permanenti ta' voriconazole minħabba AEs ġie rrappurtat f'39.3% tal-individwi kontra 39.6% tal-individwi ttrattati b'itraconazole.
English: In fluconazole-resistant non albicans species, a successful outcome was seen in3/3 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: hepatic failure, hepatomegaly, cholecystitis, cholelithiasis
Maltese: insuffiċjenza talfwied, epatomegalija, koleċistite, kolelitijasi
English: Sirolimus Cmax  6.6-fold Sirolimus AUC0-∞ 11-fold
Maltese: Fi studju indipendenti ppubblikat, Sirolimus Cmax 6.6 darbiet Sirolimus AUC0- 11 il-darba
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 ilbażi tal-bijodisponibilità orali għolja (96 %; ara sezzjoni 5.2), il-qalba bejn amministrazzjoni fil-vini u orali hija f'waqtha meta klinikament indikata.
English: Methadone (CYP3A4 substrate)
Maltese: Methadone (substrat ta' CYP3A4)
English: Fentanyl (5 µg/kg single dose)
Maltese: Fentanyl (doża waħda ta' 5 g/kg)
English: (see sections 4.2 and 4.4).
Maltese: (Ara sezzjoni 4).
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,
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 T. infezzjonijiet beigelii.
English: Cardiac disorders arrhythmia supraventricular, tachycardia, bradycardia ventricular fibrillation, ventricular extrasystoles, ventricular tachycardia, electrocardiogram QT prolonged, supraventricular tachycardia torsades de pointes, atrioventricular block complete, bundle branch block, nodal rhythm
Maltese: Disturbi filqalb arritmija supraventrikulari, takikardija, bradikardija fibrillazzjoni ventrikulari, ekstrasistoli ventrikulari, takikardija ventrikulari, elettrokardjogram ma QT imtawwal, takikardija supraventrikulari torsades de pointes, imblokk atrijoventrikular i sħiħ, imblokk ta' bundle branch, ritmu tan-nodu
English: Pharmacotherapeutic group: Antimycotics for systemic use, triazole derivatives, ATC code: J02A C03 Mode of action
Maltese: Antimikosiċi għal użu sistemiku, derivattivi tat-triazole, Kodiċi ATC:
English: Fluconazole(CYP2C9, CYP2C19 and CYP3A4 inhibitor)
Maltese: Fluconazole(inibitur ta' CYP2C9, CYP2C19 u CYP3A4)
English: Scedosporium and Fusarium infections
Maltese: Infezzjonijiet bi Scedosporium u Fusarium
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-substrati 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: Dose reduction of methadone may be needed (see section 4.5).
Maltese: Jista' jkun meħtieġ tnaqqis fid-doża ta' methadone (ara sezzjoni 4.5).
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 < 20ml/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, il-farmakokinetika ta' voriconazole ma kinetx affettwata b'mod sinifikanti mill-indeboliment talkliewi.
English: Voriconazole was shown to be effective against the following rare fungal pathogens:
Maltese: Voriconazole ntwera li kien effettiv kontra l-patoġeni fungali rari li ġejjin:
English: [CYP3A4 substrate; CYP2C19 inhibitor]
Maltese: [substrat ta' CYP3A4 ; inibitur ta' CYP2C19]
English: Voriconazole Cmax and AUCτ
Maltese: Voriconazole Cmax u AUC ↔
English: Norethisterone/ethinylestradi
Maltese: Norethisterone/ethinylestradi ol (1 mg/0.
English: Dose reduction of alfentanil, fentanyl and other short-acting opiates similar in structure to alfentanil and metabolised by CYP3A4 (e.g., sufentanil) should be considered.
Maltese: Għandu jiġi kkunsidrat tnaqqis fid-doża ta' alfentanil, fentanyl u opiates oħra li jaħdmu fuq qasir żmien bi struttura simili għal alfentanil u metabolizzati minn CYP3A4 (e.ż., sufentanil).
English: [CYP3A4 substrate, P-gp substrate]
Maltese: [substrat ta' CYP3A4, substrat ta' P-gp]
English: • Vinca alkaloids (e.g., vincristine and vinblastine) (used in treating cancer)
Maltese: • Alkalojdi vinka (p.e., vincristine u vinblastine) (użati fil-kura tal-kanċer)
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 triacetin 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 triacetin li jiffurmaw il-kisja tar-rita.
English: In an oral multiple-dose study, AUCτ was similar in subjects with moderate hepatic cirrhosis (ChildPugh 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: Each tablet contains 251 mg lactose (as monohydrate).
Maltese: Eċċipjent bl-effett magħruf Kull pillola fiha 251 mg ta' lactose (bħala monoidrat).
English: • Benzodiazepines (e.g midazolam, triazolam) (used for severe insomnia and stress)
Maltese: • Benzodiazepines (p.e., midazolam, triazolam) (użati għal nuqqas ta' rqad sever u stress)
English: • Health Care Professional (HCP) Question and Answer Brochure for Phototoxicity, SCC and Hepatic toxicity;
Maltese: • Checklist tal-Professjonist fil-Qasam Mediku (HCP) għal Fototossiċità, SCC u Tossiċità talFwied
English: Coadministration with St John's Wort (see section 4.5).
Maltese: John's wort (fexfiex) (ara sezzjoni 4.5).
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).
Maltese: 7% (6/7) u għal pazjenti b'EC, ir-rata ta' rispons globali f'EOT kienet ta' 70% (7/10).
English: IFI to day 180
Maltese: Baqgħu ħajjin sa jum 180
English: Monitoring for voriconazole-associated adverse reactions is recommended if voriconazole is used sequentially after fluconazole (see section 4.5).
Maltese: Monitoraġġ ta' reazzjonijiet avversi assoċjati ma' voriconazole huwa rrakkomandat jekk voriconazole se jintuża wara fluconazole (ara sezzjoni 4.5).
English: Aspergillus infections - efficacy in aspergillosis patients with poor prognosis Voriconazole has in vitro fungicidal activity against Aspergillus spp.
Maltese: Voriconazole għandu attività fungiċida in vitro kontra l-Aspergillus spp.
English: Fentanyl AUC0-∞  1.34-fold
Maltese: Fi studju indipendenti ppubblikat, Fentanyl AUC0- 1.34 darbiet
English: Other medicines and Voriconazole Accord
Maltese: Mediċini oħra u Voriconazole Accord
English: Patients have developed severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) (uncommon), toxic epidermal necrolysis (TEN) (rare), drug reaction with eosinophilia and systemic symptoms (DRESS) (rare) and erythema multiforme (rare) during treatment with voriconazole (see section 4.4).
Maltese: Il-pazjenti żviluppaw reazzjonijiet avversi kutanji severi (SCARs), inkluż is-sindrome ta' Stevens-Johnson (SJS) (mhux komuni), nekroliżi epidermika tossika (TEN) (rari), reazzjoni għall-mediċina b'sintomi ta' eosinofilja u sistemiċi (DRESS) (rari) u eritema multiformi (rari) waqt kura b'voriconazole (ara sezzjoni 4.4).
English: achieves a voriconazole exposure similar to 3 mg/kg IV. A 300 mg (or 150 mg for patients less than 40 kg) oral maintenance dose achieves an exposure similar to 4 mg/kg IV.
Maltese: Id-doża orali ta' manteniment ta' 300 mg (jew 150 mg għall-pazjenti li l-piż tagħhom huwa anqas minn 40 kg) twassal għal espożizzjoni simili għal dik ta' 4 mg/kg IV.
English: Success at day 180*
Maltese: Suċċess f'jum 180*
English: [CYP3A4 substrates, inhibitors or CYP450 inducers]
Maltese: [substrati ta' CYP3A4, inibituri jew indutturi ta' CYP450]
English: Pharmacokinetic-Pharmacodynamic analyses of clinical trial data identified positive associations between plasma voriconazole concentrations and both liver function test abnormalities and visual disturbances.
Maltese: Analiżi farmakokinetiċi/farmakodinamiċi ta' dejta minn testijiet kliniċi identifikaw relazzjonijiet pożittivi bejn il-konċentrazzjonijiet ta' voriconazole fil-plasma u l-anormalitajiet fit-testijiet talfunzjoni tal-fwied u d-disturbi viżiv.
English: Rare: may affect up to 1 in 1000 people
Maltese: Rari: jistgħu jaffetwaw sa persuna 1 minn kull 1,000
English: Eye disorders visual impairment6 retinal haemorrhage optic nerve disorder7, papilloedema8, oculogyric crisis, diplopia, scleritis, blepharitis optic atrophy, corneal opacity
Maltese: emorraġija tarretina disturb fin-nerv ottiku7, papilloedima8, krizi okuloġirika, tara doppju, sklerite, blefarite atrofija ottika, opaċità talkornea
English: In vitro studies showed that voriconazole is metabolised by, the hepatic cytochrome P450 isoenzymes CYP2C19, CYP2C9 and CYP3A4.
Maltese: Studji in vitro wrew li voriconazole huwa metabolizzat mill-isoenzimi taċ-ċitokromu tal-fwied P450, CYP2C19, CYP2C9 U CYP3A4.
English: After an oral single-dose (200 mg), AUC was 233 % higher in subjects with mild to moderate hepatic cirrhosis (Child-Pugh A and B) compared with subjects with normal hepatic function.
Maltese: Wara doża waħda orali (200 mg), AUC kien 233 % ogħla f'suġġetti b'ċirrożi tal-fwied ħafifa għal moderata (Child-Pugh A u B) meta mqabbel ma' pazjenti b'funzjoni normali tal-fwied.
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 ta' 400 mg QD jew ogħla huwa kontraindikat (ara sezzjoni 4.3).
English: After IV voriconazole therapy, the median duration of oral voriconazole therapy was 76 days (range 2232days).
Maltese: Wara trattament b'voriconazole IV it-trattament b'voriconazole orali dam għal-medja ta' 76 jum (medda ta' 2-232 jum).
English: [CYP2C9 substrates]
Maltese: [substrati ta' CYP2C9]
English: In clinical trials, visual impairments (including blurred vision, photophobia, chloropsia, chromatopsia, colour blindness, cyanopsia, eye disorder, halo vision, night blindness, oscillopsia, photopsia, scintillating scotoma, visual acuity reduced, visual brightness, visual field defect, vitreous floaters, and xanthopsia) with voriconazole were very common.
Maltese: Fi studji kliniċi, indebolimenti viżiv (inkluż vista mċajpra, fotofobija, kloropsija, kromatopsija, problemi fir-rikonoxximent tal-kuluri, sijanopsja, disturb fl-għajn, vista halo, ma tibqax tara bil-lejl, oscillopsia, fotopsja, skotoma b'teptip, tnaqqis fl-akutezza tal-vista, luminożità viżiva, difett fil-kamp viżiv, floaters fil-vitriju, u xantopsija) b'voriconazole kienu komuni ħafna..