FrancophonIA/ELRC3.0 huggingface dataset:
English: The monohydroxylated and desmethylated velpatasvir were the metabolites identified in human plasma.
Maltese: Il-monohydroxylated u d-desmethylated velpatasvir kienu l-metaboliti identifikati fil-plażma tal-bniedem.
English: Clinical studies of Vosevi included 189 patients aged 65 and over (17% of total number of patients in the Phase 2 and 3 clinical studies).
Maltese: L-istudji kliniċi ta' Vosevi kienu jinkludu 189 pazjent li kellhom 65 sena jew aktar (17% tan-numru totali ta' pazjenti fl-istudji kliniċi tal-Fażi 2 u 3).
English: (Inhibition of OATP1B, P-gp and CYP3A)
Maltese: (Inibizzjoni ta' OATP1B, P-gp u CYP3A)
English: In the POLARIS-3 sofosbuvir/velpatasvir/voxilaprevir 8-week treatment group (see Table 14), 2 of 110 (2%) patients (genotype 3) qualified for resistance analysis due to relapse.
Maltese: Fil-grupp ta' kura ta' 8 ġimgħat b'sofosbuvir/velpatasvir/voxilaprevir f'POLARIS-3 (ara Tabella 14), 2 minn 110 (2%) pazjenti (ġenotip 3) ikkwalifikaw għal analiżi ta' reżistenza minħabba rkaduta.
English: Population pharmacokinetics analysis in HCV-infected patients indicated that cirrhosis (CPT Class A) had no clinically relevant effect on the exposure to sofosbuvir and GS-331007.
Maltese: Analiżi farmakokinetika tal-popolazzjoni f'pazjenti infettati bl-HCV, indikat li ċ-ċirrożi (Klassi A ta' CPT) ma kellha l-ebda effett klinikament rilevanti fuq l-esponiment għal sofosbuvir u GS-331007.
English: Dolutegravir (50 mg once daily) + sofosbuvir/ velpatasvir (400/100 mg once daily)h
Maltese: Dolutegravir (50 mg darba kuljum) + sofosbuvir/velpatasvir (400/100 mg darba kuljum)h
English: Pack size: outer carton containing 1 bottle of 28 film-coated tablets.
Maltese: Daqs tal-pakkett: kartuna ta' barra li fiha flixkun ta' 28 pillola miksija b'rita.
English: The pharmacokinetics of velpatasvir were studied with a single dose of 100 mg velpatasvir in HCV negative patients with severe renal impairment (eGFR < 30 mL/min by Cockcroft-Gault).
Maltese: Il-farmakokinetika ta' velpatasvir ġiet studjata b'doża waħda ta' 100 mg ta' velpatasvir f'pazjenti negattivi għal HCV b'indeboliment sever tal-kliewi (eGFR < 30 mL/min skont Cockcroft-Gault).
English: • rifapentine (an antibiotic used to treat infections, including tuberculosis);
Maltese: • rifapentine (antibijotiku li jintuża għall-kura ta' infezzjonijiet, li jinkludu t-tuberkulożi);
English: Dephosphorylation results in the formation of nucleoside metabolite GS-331007 that cannot be efficiently rephosphorylated and lacks anti-HCV activity in vitro.
Maltese: Id-defosforilazzjoni tirriżulta fil-formazzjoni tal-metabolit nucleoside GS-331007 li ma jistax jiġi fosforilizzat mill-ġdid b'mod effiċjenti u li m'għandux attività kontra HCV in vitro.
English: The pharmacokinetics of sofosbuvir was studied following 7-day dosing of 400 mg sofosbuvir in HCV-infected patients with moderate and severe hepatic impairment (CPT Class B and C).
Maltese: Il-farmakokinetika ta' sofosbuvir kienet studjata wara dożaġġ ta' 7 ijiem ta' 400 mg ta' sofosbuvir f'pazjenti infettati bl-HCV b'indeboliment moderat u sever tal-fwied (Klassi B u Ċ ta' CPT).
English: No NS3, NS5A, or NS5B NI RAVs emerged in this patient infected with genotype 1a HCV.
Maltese: Ma ħarġu l-ebda RAVs għal NI f'NS3, NS5A, jew NS5B f'dan il-pazjent infettat bil-ġenotip 1a tal-HCV.
English: The metabolic activation pathway involves sequential hydrolysis of the carboxyl ester moiety catalysed by human cathepsin A (CatA) or carboxylesterase 1 (CES1) and phosphoramidate cleavage by histidine triad nucleotide-binding protein 1 (HINT1) followed by phosphorylation by the pyrimidine nucleotide biosynthesis pathway.
Maltese: Sofosbuvir jiġi metabolizzat b'mod estensiv fil-fwied biex jifforma n-nucleoside analogue triphosphate farmakoloġikament attiv GS-461203Il-passaġġ ta' attivazzjoni metabolika jinvolvi idrolisi sekwenzjali tal-parti carboxyl ester ikkatalizzata minn cathepsin tal-bniedem A (CatA) jew carboxylesterase 1 (CES1) u qsim ta' phosphoramidate mill-proteina histidine triad li tintrabat man-nucleotide 1 (HINT1 - histidine triad nucleotide-binding protein 1) segwita minn fosforilazzjoni permezz tas-sensiela ta' reazzjonijiet ta' bijosintesi ta' pyrimidine nucleotide.
English: No clinically relevant pharmacokinetic differences due to race or gender have been identified for sofosbuvir, GS-331007, velpatasvir or voxilaprevir.
Maltese: L-ebda differenza farmakokinetika klinikament rilevanti minħabba r-razza jew is-sess tal-persuna ma ġiet identifikata għal sofosbuvir, GS-331007, velpatasvir jew voxilaprevir.
English: Safety data are limited in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2) and ESRD requiring haemodialysis.
Maltese: Data dwar is-sigurtà hija limitata f'pazjenti b'indeboliment sever tal-kliewi (stima tar-rata ta' filtrazzjoni glomerulari [eGFR - estimated glomerular filtration rate] < 30 mL/min/1.73 m2) u b'ESRD li jkunu jeħtieġu l-emodijalisi.
English: STIMULANTS Modafinil
Maltese: STIMULANTI
English: Pharmacotherapeutic group: Direct-acting antiviral, ATC code: J05AP56
Maltese: Antivirali li jaġixxi direttament, Kodiċi ATC:
English: GS-331007 AUC0-inf did not change and Cmax was 19% to 35% lower when Vosevi or its components together were administered with food.
Maltese: L-AUC0-inf ta' GS-331007 ma nbidlitx u s-Cmax kien 19% sa 35% aktar baxx meta Vosevi jew il-komponenti tiegħu flimkien ingħataw mal-ikel.
English: Genotype 2
Maltese: ANNESS II
English: Voxilaprevir is an inhibitor of drug transporters P-gp, BCRP, OATP1B1 and OATP1B3, and its involvement in drug interactions with these transporters is primarily limited to the process of absorption.
Maltese: Voxilaprevir huwa inibitur tat-trasportaturi tal-mediċina P-gp, BCRP, OATP1B1 u OATP1B3, u l-involviment tiegħu fl-interazzjonijiet tal-mediċini ma' dawn it-trasportaturi huwa limitat primarjament għall-proċess ta' assorbiment.
English: Haemodialysis can efficiently remove the predominant circulating metabolite of sofosbuvir, GS-331007, with an extraction ratio of 53%.
Maltese: L-emodijaliżi tista' tneħħi b'mod effiċjenti l-metabolit predominanti ta' sofosbuvir li jiċċirkola fid-demm, GS-331007, bi proporzjon ta' estrazzjoni (extraction ratio) ta' 53%.
English: For velpatasvir in genotype 1-6 replicons, resistance-associated substitutions selected in 2 or more genotypes were L31I/V and Y93H.
Maltese: Għal velpatasvir fir-replicons tal-ġenotip 1-6, sostituzzjonijiet assoċjati mar-reżistenza magħżulin f'2 ġenotipi jew iktar kienu L31I/V u Y93H.
English: j. Administered as emtricitabine, tenofovir disoproxil fumarate fixed-dose combination.
Maltese: Mogħti bħala kombinazzjoni ta' doża fissa ta' emtricitabine, tenofovir disoproxil fumarate.
English: Medicinal products that inhibit OATP1B, CYP2B6, CYP2C8, or CYP3A4 may increase plasma concentrations of velpatasvir or voxilaprevir.
Maltese: Prodotti mediċinali li jinibixxu OATP1B, CYP2B6, CYP2C8, jew CYP3A4 jistgħu jżidu l-konċentrazzjonijiet ta' velpatasvir jew voxilaprevir fil-plażma.
English: l. Administered as elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide fixed-dose combination.
Maltese: l. Mogħti bħala kombinazzjoni ta' doża fissa ta' elvitegravir, cobicistat, emtricitabine u tenofovir alafenamide.
English: Vosevi is not recommended in patients with moderate or severe hepatic impairment (CPT Class B or C) (see section 5.2).
Maltese: Vosevi mhuwiex rakkomandat f'pazjenti b'indeboliment moderat jew sever tal-fwied (Klassi B jew Ċ ta' CPT) (ara sezzjoni 5.2).
English: No dose adjustment of Vosevi, darunavir (ritonavir boosted) or emtricitabine/tenofovir disoproxil fumarate is required.
Maltese: Mhux meħtieġ aġġustament fid-doża ta' Vosevi darunavir (imsaħħaħ b'ritonavir) jew emtricitabine/tenofovir disoproxil fumarate.
English: Date of first authorisation: 26 July 2017
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 26 ta' Lulju 2017
English: 8 weeks may be considered in genotype 3 infected patients (see section 5.1)
Maltese: 8 ġimgħat jistgħu jitqiesu f'pazjenti infettati bil-ġenotip 3 (ara sezzjoni 5.1)
English: Medicinal products that are moderate P-gp inducers and/or moderate CYP inducers (e.g. efavirenz, modafinil, oxcarbazepine or rifapentine) may decrease sofosbuvir, velpatasvir and/or voxilaprevir plasma concentrations leading to reduced therapeutic effect of Vosevi.
Maltese: Prodotti mediċinali li huma indutturi moderati ta' P-gp u/jew indutturi moderati ta' CYP (eż. efavirenz, modafinil, oxcarbazepine jew rifapentine), jistgħu jnaqqsu l-konċentrazzjonijiet ta' sofosbuvir, velpatasvir u/jew voxilaprevir fil-plażma u jwasslu għal effett terapewtiku mnaqqas ta' Vosevi.
English: • SOF/VEL/VOX 8 weeks (N=501)
Maltese: • SOF/VEL/VOX għal 8 ġimgħat (N=501)
English: No individual RAV tested in genotypes 2a, 4a or 5a conferred a > 100-fold reduction in velpatasvir susceptibility.
Maltese: L-ebda RAV individwali ttestjat f'ġenotipi 2a, 4a jew 5a ma ta tnaqqis ta' > 100 darba fis-suxxettibilità għal velpatasvir.
English: • The active substances are sofosbuvir, velpatasvir and voxilaprevir.
Maltese: • Is-sustanzi attivi huma sofosbuvir, velpatasvir u voxilaprevir.
English: Consequently, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Konsegwentement, pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas ta' Lapp lactase, jew li għandhom problemi biex jassorbu l-glucose-galactose m'għandhomx jieħdu dan il-prodott mediċinali.
English: Vosevi is contraindicated with rifampicin (see section 4.3).
Maltese: Vosevi hu kontraindikat ma' rifampicin (ara sezzjoni 4.3).
English: Vosevi has been shown to increase tenofovir exposure (P-gp inhibition).
Maltese: Intwera li Vosevi jżid l-esponiment għal tenofovir (inibizzjoni ta' P-gp).
English: Atorvastatin (40 mg single dose) + sofosbuvir/ velpatasvir (400/100 mg once daily)f
Maltese: Atorvastatin (40 mg doża waħda) + sofosbuvir/ velpatasvir (400/100 mg darba kuljum)f
English: One patient with genotype 4d who relapsed developed the NS5A RAV Y93H.
Maltese: Pazjent wieħed bil-ġenotip 4d li rkada żviluppa l-RAV Y93H f'NS5A.
English: Following a single 100 mg oral dose of [14C]-velpatasvir, mean total recovery of the [14C]-radioactivity was 95%, consisting of approximately 94% and 0.4% recovered from the faeces and urine, respectively.
Maltese: Wara doża orali waħda ta' 100 mg ta' [14C]-velpatasvir, il-medja tal-irkupru totali tar-radjuattività ta' [14C] kienet ta' 95%, u kienet tikkonsisti f'madwar 94% u 0.4% irkuprata mill-ippurgar u mill-awrina, rispettivament.
English: i. Administered as emtricitabine, rilpivirine, and tenofovir alafenamide fixed-dose combination.
Maltese: i. Mogħti bħala kombinazzjoni ta' doża fissa ta' emtricitabine, rilpivirine, u tenofovir alafenamide.
English: Following a single 400 mg dose of sofosbuvir, a 4-hour haemodialysis removed 18% of administered dose.
Maltese: Wara doża waħda ta' 400 mg ta' sofosbuvir, emodijaliżi ta' 4 sigħat neħħiet madwar 18% tad-doża mogħtija.
English: In the Phase 3 trials increases in total bilirubin less than or equal to 1.5 x the upper limit of normal were observed in 4% of patients without cirrhosis and 10% of patients with compensated cirrhosis, due to inhibition of OATP1B1 and OATP1B3 by voxilaprevir.
Maltese: Fil-provi tal-Fażi 3 ġew osservati żidiet fil-bilirubina totali ta' inqas minn jew daqs 1.5 x l-ogħla limitu tan-normal f'4% tal pazjenti mingħajr ċirrożi u f'10% tal-pazjenti b'ċirrożi kumpensata, minħabba inibizzjoni ta' OATP1B1 u OATP1B3 permezz ta' voxilaprevir.
English: Following a single dose of 100 mg [14C]-voxilaprevir, the majority (approximately 91%) of radioactivity in plasma was parent drug.
Maltese: Wara doża waħda ta' 100 mg [14C]-voxilaprevir, il-maġġoranza (madwar 91%) tar-radjuattività fil-plażma kienet il-mediċina oriġinali.
English: Voxilaprevir ↔ ↔ ↔
Maltese: Norelgestromin ↔ ↔ ↔
English: Voxilaprevir, and to a lesser extent velpatasvir, are also substrates of OATP1B1 and OATP1B3.
Maltese: Voxilaprevir, u sa ċertu punt velpatasvir, huma wkoll sottostrati ta' OATP1B1 u OATP1B3.
English: SOF/VEL/VOX 12 weeks (n = 263)
Maltese: SOF/VEL/VOX għal 12-il ġimgħa (n = 263)
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of sofosbuvir, velpatasvir, voxilaprevir or Vosevi in pregnant women.
Maltese: M'hemmx data jew hemm data limitata (inqas min 300 riżultat ta' tqala) dwar l-użu ta' sofosbuvir, velpatasvir, voxilaprevir jew Vosevi fin-nisa tqal.
English: Concomitant use with ethinylestradiol-containing medicinal products such as combined oral contraceptives or contraceptive vaginal rings (see section 4.5).
Maltese: L-użu fl-istess waqt ma' prodotti mediċinali li fihom ethinylestradiol bħal kontraċettivi orali kkombinati jew ċrieki vaġinali kontraċettivi (ara sezzjoni 4.5).
English: Vosevi is contraindicated with St. John's wort (see section 4.3).
Maltese: John's wort (ara sezzjoni 4.3).
English: The EC50 values of sofosbuvir, velpatasvir and voxilaprevir against clinical isolates are presented in Table 5.
Maltese: Il-valuri ta' EC50 ta' sofosbuvir, velpatasvir u voxilaprevir meta mqabbla ma' iżolati kliniċi huma ppreżentati fit-Tabella 5.
English: Sustained virologic response (SVR12), defined as HCV RNA less than LLOQ at 12 weeks after the cessation of treatment, was the primary endpoint to determine the HCV cure rate.
Maltese: Rispons viroloġiku sostnut (SVR12), li ġie definit bħala RNA ta' HCV ta' inqas minn LLOQ wara 12-il ġimgħa wara l-waqfien tal-kura, kien il-punt aħħari primarju għad-determinazzjoni tar-rata ta' kura tal-HCV.
English: Safety data are limited in patients with severe renal impairment (estimated Glomerular Filtration Rate [eGFR] < 30 mL/min/1.73 m2) and end stage renal disease (ESRD) requiring haemodialysis.
Maltese: Data dwar is-sigurtà hija limitata f'pazjenti b'indeboliment sever tal-kliewi (stima tar-Rata ta' Filtrazzjoni Glomerulari [eGFR - estimated Glomerular Filtration Rate] < 30 mL/min/1.73 m2) u b'mard tal-kliewi li jinsab fl-aħħar stadju (ESRD - end stage renal disease) li jkunu jeħtieġu l-emodijalisi.
English: Ciclosporin (600 mg single dose)e + velpatasvir (100 mg single dose)f
Maltese: Ciclosporin (600 mg doża waħda)e + velpatasvir (100 mg doża waħda)f
English: Medicinal products that may decrease plasma exposure of Vosevi Medicinal products that are strong inducers of P-gp and/or strong inducers of CYP2B6, CYP2C8, or CYP3A4 (e.g. carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin and St. John's wort) may decrease plasma concentrations of sofosbuvir, velpatasvir and/or voxilaprevir leading to reduced therapeutic effect of Vosevi.
Maltese: Prodotti mediċinali li jistgħu jnaqqsu l-esponiment għal Vosevi fil-plażma Prodotti mediċinali li huma indutturi qawwija ta' P-gp u/jew indutturi qawwija ta' CYP2B6, CYP2C8, jew CYP3A4 (eż. carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin u St.
English: • SOF/VEL/VOX 12 weeks (N=263)
Maltese: • SOF/VEL/VOX għal 12-il ġimgħa (N=263)
English: Ketoconazole (200 mg twice daily) + velpatasvir (100 mg single dose)f
Maltese: Ketoconazole (200 mg darbtejn kuljum) + velpatasvir (100 mg doża waħda)f
English: No dose adjustment of Vosevi or elvitegravir/cobicistat/ emtricitabine/tenofovir alafenamide fumarate is required.
Maltese: Mhux meħtieġ aġġustament fid-doża ta' Vosevi jew elvitegravir/cobicistat/ emtricitabine/tenofovir alafenamide fumarate.
English: Voriconazole (200 mg twice daily) + voxilaprevir (100 mg single dose)f
Maltese: Voriconazole (200 mg darbtejn kuljum) + voxilaprevir (100 mg doża waħda)f
English: • SOF/VEL/VOX 12 weeks (N=182)
Maltese: • SOF/VEL/VOX għal 12-il ġimgħa (N=182)
English: Based on the population pharmacokinetic analysis in HCV-infected patients mean steady-state AUC0-24 and Cmax for velpatasvir (n = 1595) were 4041 ng•hr/mL and 311 ng/mL, respectively.
Maltese: Ibbażat fuq analiżi farmakokinetika tal-popolazzjoni f'pazjenti infettati bl-HCV, il-medji tal-AUC0-24 u s-Cmax fl-istat fiss għal velpatasvir (n = 1595) kienu 4041 ng•siegħa/mL u 311 ng/mL, rispettivament.
English: Rifampicin (600 mg once daily) + sofosbuvir (400 mg single dose)f
Maltese: Rifampicin (600 mg darba kuljum) + sofosbuvir (400 mg doża waħda)f
English: The medicinal product interactions described are based on studies conducted with either sofosbuvir/velpatasvir/voxilaprevir, its components (sofosbuvir, velpatasvir, and/or voxilaprevir), or are predicted medicinal product interactions that may occur with Vosevi.
Maltese: L-interazzjonijiet tal-prodott mediċinali deskritti huma bbażati fuq studji mwettqa b'sofosbuvir/velpatasvir/voxilaprevir, il-komponenti tiegħu (sofosbuvir, velpatasvir, u/jew voxilaprevir), jew huma interazzjonijiet imbassra tal-prodott mediċinali li jistgħu jseħħu b'Vosevi.
English: The safety assessment of Vosevi was based on data from Phase 2 and 3 clinical trials in which 1383 patients received sofosbuvir/velpatasvir/voxilaprevir or sofosbuvir/velpatasvir + voxilaprevir for 8 or 12 weeks.
Maltese: L-evalwazzjoni tas-sigurtà ta' Vosevi kienet ibbażata fuq data minn provi kliniċi tal-Fażi 2 u 3 li fihom 1383 pazjent ingħataw sofosbuvir/velpatasvir/voxilaprevir jew sofosbuvir/velpatasvir + voxilaprevir għal 8 jew 12-il ġimgħa.
English: Patients with GT4-6 infection were enrolled into the SOF/VEL/VOX 12 week group only.
Maltese: Pazjenti b'infezzjoni GT4-6 ġew irreġistrati fil-grupp ta' 12-il ġimgħa ta' SOF/VEL/VOX biss.
English: Vosevi is contraindicated with rifabutin (see section 4.3).
Maltese: Vosevi hu kontraindikat ma' rifabutin (ara sezzjoni 4.3).
English: * 29% of patients enrolled into POLARIS-3 had received prior treatment with an interferon-based regimen.
Maltese: * 29% tal-pazjenti rreġistrati f'POLARIS-3 kienu rċivew kura minn qabel b'kors ibbażat fuq interferon.
English: POLARIS-4 (open label)
Maltese: POLARIS-4
English: k. Lack of pharmacokinetics interaction bounds 50-200%.
Maltese: k. Medda ta' 50-200% li fiha ma jseħħu l-ebda interazzjonijiet farmakokinetiċi.
English: R-methadon e
Maltese: Oħrajne a.
English: Ciclosporin (600 mg single dose)e + voxilaprevir (100 mg single dose)f
Maltese: Ciclosporin (600 mg doża waħda)e + voxilaprevir (100 mg doża waħda)f
English: Population pharmacokinetic analysis in HCV-infected patients indicated that cirrhosis (CPT Class A) had no clinically relevant effect on the exposure of velpatasvir.
Maltese: Analiżi farmakokinetika tal-popolazzjoni f'pazjenti infettati bl-HCV, indikat li ċ-ċirrożi (Klassi A ta' CPT) ma kellha l-ebda effett klinikament rilevanti fuq l-esponiment għal velpatasvir.
English: The use of strong inhibitors of OATP1B (e.g. ciclosporin) with Vosevi is not recommended (see section 4.4 and Table 2).
Maltese: L-użu ta' inibituri qawwija ta' OATP1B (eż. ciclosporin) ma' Vosevi mhuwiex rakkomandat (ara sezzjoni 4.4 u Tabella 2).
English: SOF/VEL/VOX 8 weeks (n = 110)
Maltese: SOF/VEL/VOX għal 8 ġimgħat (n = 110)
English: Relapsed
Maltese: Rikadutaa
English: Velpatasvir plasma exposure (AUCinf) was similar in patients with moderate hepatic impairment, severe hepatic impairment, and control subjects with normal hepatic function.
Maltese: L-esponiment għal velpatasvir fil-plażma (AUCinf) kien simili f'pazjenti b'indeboliment moderat tal-fwied, b'indeboliment sever tal-fwied u f'individwi bħala kontroll b'funzjoni normali tal-fwied.
English: • SOF/VEL 12 weeks (N=440)
Maltese: • SOF/VEL għal 12-il ġimgħa (N=440)
English: Table 11: SVR12 by HCV genotype and virologic outcome in study POLARIS-4
Maltese: Tabella 11: SVR12 skont il-ġenotip tal-HCV u r-riżultat viroloġiku fl-istudju POLARIS-4
English: • muscle pain (myalgia)
Maltese: • spażmi fil-muskoli
English: Based on the population pharmacokinetic analysis in HCV-infected patients mean steady-state AUC0-24 and Cmax for voxilaprevir (n = 1591) were 2577 ng•hr/mL and 192 ng/mL, respectively.
Maltese: Ibbażat fuq analiżi farmakokinetika tal-popolazzjoni f'pazjenti infettati bl-HCV, il-medji tal-AUC0-24 u s-Cmax fl-istat fiss għal voxilaprevir (n = 1591) kienu 2577 ng•siegħa/mL u 192 ng/mL, rispettivament.
English: Vitamin K antagonists (Liver function changes during treatment with Vosevi).
Maltese: Antagonisti tal-vitamina K (Il-funzjoni tal-fwied tinbidel waqt il-kura b'Vosevi).
English: ANTICOAGULANTS Dabigatran etexilate (75 mg single dose) + sofosbuvir/velpatasvir/ voxilaprevir (400/100/ 100 mg single dose) + voxilaprevir (100 mg single dose)f
Maltese: Dabigatran etexilate (75 mg doża waħda) + sofosbuvir/velpatasvir/ voxilaprevir (400/100/100 mg doża waħda) + voxilaprevir (100 mg doża waħda)f
English: Available pharmacokinetic data in animals have shown excretion of velpatasvir and metabolites of sofosbuvir in milk.
Maltese: Data farmakokinetika fl-annimali wriet li kien hemm l-eliminazzjoni ta' velpatasvir u l-metaboliti ta' sofosbuvir fil-ħalib.
English: Table 7: SVR12 in DAA-naïve patients with or without baseline NS3 or NS5A RAVs by study sofosbuvir/velpatasvir/voxilaprevir 8 weeks POLARIS-2 (n = 498)
Maltese: Tabella 12: SVR12 skont il-ġenotip tal-HCV u r-riżultat viroloġiku fl-istudju POLARIS-2* SOF/VEL/VOX għal 8 ġimgħat (n = 501)
English: At clinically relevant concentrations, voxilaprevir is not an inhibitor of hepatic transporters OCT1, renal transporters OCT2, OAT1, OAT3 or MATE1, or CYP or UGT1A1 enzymes.
Maltese: F'konċentrazzjonijiet klinikament rilevanti, voxilaprevir mhuwiex inibitur tat-trasportaturi epatiċi OCT1, tat-trasportaturi renali OCT2, OAT1, OAT3 jew MATE1, jew tal-enzimi CYP jew UGT1A1.
English: The SVR12 was 98% among those with two or fewer factors and 81% among those with three or four factors.
Maltese: L-SVR12 kien ta' 98% fost dawk b'żewġ fatturi jew inqas u 81%
English: Patients with GT2-6 infection were enrolled into the SOF/VEL/VOX 12 week group only.
Maltese: Pazjenti b'infezzjoni GT2-6 ġew irreġistrati fil-grupp ta' 12-il ġimgħa ta' SOF/VEL/VOX biss.
English: Other statins (Inhibition of OATP1B)
Maltese: Statins oħrajn (Inibizzjoni ta' OATP1B)
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali ma wrewx effetti diretti jew indiretti li kienu tossiċi fuq is-sistema riproduttiva (ara sezzjoni 5.3).
English: Voxilaprevir is approximately > 99% bound to human plasma proteins.
Maltese: Voxilaprevir jintrabat b'rata ta' madwar > 99% mal-proteini tal-plażma tal-bniedem.
English: Vosevi can be used in these patients with no dose adjustment when no other relevant treatment options are available (see section 4.4, 4.8, 5.1 and 5.2).
Maltese: Vosevi jista' jintuża f'dawn il-pazjenti mingħajr aġġustament fid-doża meta ma jkunx hemm disponibbli għażliet oħra ta' trattament rilevanti (ara sezzjoni 4.4, 4.8, 5.1 u 5.2).
English: • SOF/VEL/VOX 8 weeks (N=110)
Maltese: • SOF/VEL/VOX għal 8 ġimgħat (N=110)
English: Darunavir boosted with ritonavir (800 + 100 mg once daily) + emtricitabine/ tenofovir disoproxil fumarate (200/300 mg once daily)j + sofosbuvir/ velpatasvir/voxilaprevir (400/100/100 mg once daily) + voxilaprevir (100 mg once daily)f
Maltese: Darunavir imsaħħaħ b'ritonavir (800 + 100 mg darba kuljum) + emtricitabine/tenofovir disoproxil fumarate (200/300 mg darba kuljum)j + sofosbuvir/ velpatasvir/voxilaprevir (400/100/100 mg darba kuljum) + voxilaprevir (100 mg darba kuljum)f
English: • SOF/VEL 12 weeks (N=151)
Maltese: • SOF/VEL għal 12-il ġimgħa (N=151)
English: • SOF/VEL 12 weeks (N=109)
Maltese: • SOF/VEL għal 12-il ġimgħa (N=109)
English: The use of such medicinal products with Vosevi is contraindicated (see section 4.3 and Table 2).
Maltese: L-użu ta' prodotti mediċinali bħal dawn ma' Vosevi hu kontraindikat (ara sezzjoni 4.3 u Tabella 2).
English: In the sofosbuvir/velpatasvir 12-week treatment group, a total of 3 of 440 (1%) patients (2 with genotype 1, 1 with genotype 4) qualified for resistance analysis due to relapse.
Maltese: Fil-grupp ta' kura ta' 12-il ġimgħa b'sofosbuvir/velpatasvir, total ta' 3 minn 440 (1%) pazjent (2 bil-ġenotip 1, 1 bil-ġenotip 4) ikkwalifikaw għal analiżi ta' reżistenza minħabba rkaduta.