FrancophonIA/ELRC3.0 huggingface dataset:
English: DAA-naïve patients, GT 1, 2, 4, 5, or 6, with or without cirrhosis GT 3 without cirrhosis
Maltese: Pazjenti li qatt ma rċivew DAA filpassat, GT1, 2, 4, 5, 6, bi jew mingħajr ċirrożi
English: For both velpatasvir and voxilaprevir, combinations of RAVs often showed greater reductions in susceptibility than individual RAVs alone.
Maltese: Interazzjonijiet ma' inibituri oħrajn ta' HMG-CoA reductase ma jistgħux jiġu esklużi.
English: SOF/VEL 12 weeks (n = 109)
Maltese: SOF/VEL għal 12-il ġimgħa (n = 109)
English: Co-administration of Vosevi with edoxaban is not recommended.
Maltese: Uża biss jekk ma tkun disponibbli ebda alternattiva oħra.
English: Voxilaprevir is primarily a substrate of CYP3A4 with slow turnover.
Maltese: Voxilaprevir huwa primarjament sottostrat ta' CYP3A4 b'ċiklu bil-mod.
English: Animal studies have shown a possible link to reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali wrew rabta possibbli ma' tossiċità fuq is-sistema riproduttiva (ara sezzjoni 5.3).
English: No NS3, NS5A, or NS5B nucleoside inhibitor (NI) RAVs emerged in the other 5 patients who relapsed.
Maltese: Ma ħarġu l-ebda RAVs għal inibituri tan-nukleoside (NI - nucleoside inhibitor) f'NS3, NS5A, jew NS5B fil-5 pazjenti l-oħra li rkadew.
English: Sofosbuvir and GS-331007 AUCs are near dose-proportional over the dose range of 200 mg to 1200 mg. Velpatasvir AUC increases in a greater than proportional manner from 5 to 50 mg and in a less than proportional manner from 50 to 450 mg, indicating velpatasvir absorption is solubility limited.
Maltese: L-AUC ta' velpatasvir tiżdied b'mod iktar minn proporzjonali minn 5 sa 50 mg u b'mod inqas minn proporzjonali minn 50 sa 450 mg, li jindika li l-assorbiment ta' velpatasvir huwa limitat mis-solubilità.
English: The pharmacokinetics of voxilaprevir were studied with a single dose of 100 mg voxilaprevir in HCV negative patients with moderate and severe hepatic impairment (CPT Class B and C).
Maltese: Il-farmakokinetika ta' voxilaprevir kienet studjata b'doża waħda ta' 100 mg ta' voxilaprevir f'pazjenti negattivi għal HCV b'indeboliment moderat u sever tal-fwied (Klassi B u Ċ ta' CPT).
English: Table 10 presents the SVR12 by HCV genotype for the POLARIS-1 trial.
Maltese: It-Tabella 10 tippreżenta l-SVR12 skont il-ġenotip tal-HCV għall-prova POLARIS-1.
English: The film-coated tablets are beige, capsule-shaped tablets debossed with “GSI” on one side and “3” on the other side.
Maltese: Il-pilloli miksija b'rita huma beige , b'forma ta' kapsula, imnaqqxa b'“GSI” fuq naħa waħda u “3” fuq in-naħa l-oħra.
English: Rosuvastatin (10 mg single dose) + sofosbuvir/ velpatasvir/voxilaprevir (400/100/100 mg once daily) + voxilaprevir (100 mg once daily)f
Maltese: Rosuvastatin (10 mg doża waħda) + sofosbuvir/velpatasvir/ voxilaprevir (400/100/100 mg darba kuljum) + voxilaprevir (100 mg darba kuljum)f
English: Omeprazole (20 mg once daily) + sofosbuvir/velpatasvir/ voxilaprevir (400/100/ 100 mg single dose)c
Maltese: Omeprazole (20 mg darba kuljum) + sofosbuvir/velpatasvir/ voxilaprevir (400/100/100 mg doża waħda)ċ
English: HIV ANTIVIRAL AGENTS: HIV PROTEASE INHIBITORS Atazanavir boosted with ritonavir (300 + 100 mg single dose) + sofosbuvir/ velpatasvir/voxilaprevir (400/100/100 mg single dose)f
Maltese: TAL-PROTEASE TAL-HIV Atazanavir imsaħħaħ b'ritonavir (300 + 100 mg doża waħda) + sofosbuvir/velpatasvir/ voxilaprevir (400/100/100 mg doża waħda)f
English: Interaction only studied with sofosbuvir/ velpatasvir.
Maltese: L-interazzjoni ġiet studjata biss b'sofosbuvir/ velpatasvir.
English: SOF/VEL 12 weeks (n = 151)
Maltese: SOF/VEL għal 12-il ġimgħa (n = 151)
English: 1a 1b 2a 2b 3a 4a
Maltese: 1a 1b
English: ORAL CONTRACEPTIVES Norgestimate/ethinyl estradiol (norgestimate 0.180 mg/0.215 mg/0.25 m g/ethinyl estradiol 0.025 mg) + sofosbuvir/velpatasvir/ voxilaprevir (400/100/ 100 mg once daily) + voxilaprevir (100 mg once daily)f
Maltese: 215 mg/0.25 mg/ ethinyl estradiol 0.025 mg) + sofosbuvir/velpatasvir/ voxilaprevir (400/100/100 mg darba kuljum) + voxilaprevir (100 mg darba kuljum)f
English: Sofosbuvir was not genotoxic in a battery of in vitro or in vivo assays, including bacterial mutagenicity, chromosome aberration using human peripheral blood lymphocytes and in vivo mouse micronucleus assays.
Maltese: Sofosbuvir ma kienx ġenotossiku f'sensiela ta' assays in vitro jew in vivo, li kienu jinkludu mutaġeniċità batterjali, aberrazzjoni fil-kromożomi bl-użu ta' limfoċiti tad-demm periferali uman u assays tal-mikronukleju tal-ġurdien in vivo.
English: No NS3 or NS5A RAVs Any NS3 or NS5A RAV NS3 only NS5A only NS3 and NS5A RAVs not determined for both NS3 and NS5Aa a. Patients with NS3 and/or NS5A gene sequencing failure.
Maltese: L-ebda RAVs f'NS3 jew NS5A Kwalunkwe RAV f'NS3 jew NS5A 97% (199/205) NS3 Biss NS5A Biss NS3 u NS5A RAVs mhux iddeterminati kemm għal NS3 kif ukoll għal NS5Aa a.
English: RAVs not determined for both NS3 and NS5Aa a. Patients with NS3 and/or NS5A gene sequencing failure.
Maltese: Pazjenti b'falliment fis-sekwenzar tal-ġeni NS3 u/jew NS5A.
English: Kidney problems
Maltese: Problemi fil-kliewi
English: • amiodarone, used to treat irregular heartbeats;
Maltese: • amiodarone, użat biex jikkura rata ta' taħbit irregolari tal-qalb;
English: POLARIS-2 (open label)
Maltese: POLARIS-2
English: POLARIS-3 (open label)
Maltese: POLARIS-3
English: Additionally, the pharmacokinetics of voxilaprevir were studied with a single dose of 100 mg voxilaprevir in HCV negative patients with severe renal impairment (eGFR < 30 mL/min by Cockcroft-Gault).
Maltese: Barra minn hekk, il-farmakokinetika ta' voxilaprevir ġiet studjata b'doża waħda ta' 100 mg ta' voxilaprevir f'pazjenti negattivi għal HCV b'indeboliment sever tal-kliewi (eGFR < 30 mL/min skont Cockcroft-Gault).
English: No teratogenic effects were observed in the mouse and rat developmental toxicity studies with velpatasvir at AUC exposures approximately 23- and 4-fold higher, respectively, than the human exposure at the recommended clinical dose.
Maltese: Ma ġewx osservati effetti teratoġeniċi fl-istudji dwar it-tossiċità fl-iżvilupp li saru fuq il-ġurdien u l-far b'velpatasvir b'esponimenti tal-AUC bejn wieħed u ieħor 23 u 4 darbiet ogħla, rispettivament, mill-esponiment tal-bniedem fid-doża klinika rakkomandata.
English: Pravastatin (40 mg single dose) + sofosbuvir/ velpatasvir/voxilaprevir (400/100/100 mg once daily) + voxilaprevir (100 mg once daily)f
Maltese: Pravastatin (40 mg doża waħda) + sofosbuvir/velpatasvir/ voxilaprevir (400/100/100 mg darba kuljum) + voxilaprevir (100 mg darba kuljum)f
English: Patients treated with ethinylestradiol-containing medicinal products
Maltese: Pazjenti kkurati bi prodotti mediċinali li fihom ethinylestradiol
English: Musculoskeletal and connective tissue disorders: Common myalgia
Maltese: Disturbi muskoluskeletriċi u tat-tessuti konnettivi:
English: b. Stable chimeric 1b replicons carrying NS5B genes from genotype 2b, 5a or 6a were used for testing.
Maltese: Ir-replicons 1b kimeriċi stabbli li jġorru ġeni NS5B minn ġenotip 2b, 5a jew 6a ntużaw għall-ittestjar.
English: EU/1/17/1223/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/17/1223/001
English: These are shown in Table 7.
Maltese: Tabella 7:
English: The potential risks and benefits associated with co-administration of Vosevi with the fixed-dose combination tablet containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or tenofovir disoproxil fumarate given in conjunction with a boosted HIV protease inhibitor (e.g. darunavir) should be considered, particularly in patients at increased risk of renal dysfunction.
Maltese: Ir-riskji u l-benefiċċji potenzjali assoċjati mal-għoti ta' Vosevi flimkien mal-pillola kombinata ta' doża fissa, li fiha elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate jew tenofovir disoproxil fumarate mogħtija fl-istess ħin ma' inibitur tal-protease tal-HIV imsaħħaħ (boosted) (eż. darunavir), għandhom jiġu kkunsidrati, b'mod partikulari f'pazjenti li għandhom riskju akbar ta' disfunzjoni renali.
English: Rifapentine (Induction of P-gp and CYPs)
Maltese: Modafinil (Induzzjoni ta' P-gp u CYPs)
English: ANTIMYCOBACTERIALS Rifampicin (single dose)
Maltese: Rifampicin (doża waħda)
English: Sofosbuvir and GS-331007 AUC0-24 and Cmax were similar in healthy adult subjects and patients with HCV infection.
Maltese: L-AUC0-24 u s-Cmax ta' sofosbuvir u GS-331007 kienu simili f'individwi adulti f'saħħithom u f'pazjenti b'infezzjoni bl-HCV.
English: Rifampicin (600 mg single dose) + velpatasvir (100 mg single dose)f
Maltese: Rifampicin (600 mg doża waħda) + velpatasvir (100 mg doża waħda)f
English: These data indicate that biliary excretion of parent drug was a major route of elimination for velpatasvir.
Maltese: Din id-data tindika li t-tneħħija biljari tal-mediċina oriġinali kienet rotta maġġuri ta' eliminazzjoni għal velpatasvir.
English: In healthy volunteer studies with sofosbuvir and velpatasvir, there were no untoward effects observed at these dose levels, and adverse events were similar in frequency and severity to those reported in the placebo groups.
Maltese: Fi studji fuq voluntiera f'saħħithom b'sofosbuvir u velpatasvir, ma kien hemm l-ebda effetti mhux mixtieqa osservati f'dawn il-livelli ta' doża, u l-avvenimenti avversi kienu simili fil-frekwenza u fis-severità għal dawk irrappurtati fil-gruppi tal-plaċebo.
English: NS5A inhibitorexperienced patients, GT1-6, with or without cirrhosis
Maltese: Pazjenti li rċivew inibitur ta' NS5A fil-passat, GT1-6, bi jew mingħajr ċirrożi
English: Rifampicin (600 mg single dose) + voxilaprevir (100 mg single dose)f
Maltese: Rifampicin (600 mg doża waħda) + voxilaprevir (100 mg doża waħda)f
English: Table 6: SVR12 in DAA-experienced patients with or without baseline NS3 or NS5A RAVs by study sofosbuvir/velpatasvir/voxilaprevir 12 weeks POLARIS-1 (n = 260)
Maltese: Tabella 6: SVR12 f'pazjenti li rċivew DAA fil-passat bi jew mingħajr RAVs f'NS3 jew NS5A fillinja bażi skont l-istudju sofosbuvir/velpatasvir/voxilaprevir għal 12-il ġimgħa
English: Age (years) median (range) Male Gender Race Black/African American 14% (60) White Hispanic/Latino Genotype Genotype 1a Genotype 1b Genotype 2 Genotype 3 Genotype 4 Genotype 5 Genotype 6 IL28B CC HCV RNA ≥ 800,000 IU/mL 74% (306) Compensated cirrhosis Site US Non-US
Maltese: L-RAV S282T għal NI f'NS5B ma ġiet osservata fl-ebda pazjent fl-istudji POLARIS-2 u POLARIS-3. Fost l-individwi bil-ġenotip 1a f'POLARIS-2, SVR12 kien ta' 87% (53/61) għal dawk b'RAVs Q80K/L/R u 94% (99/105) għal dawk mingħajr RAVs Q80K/L/R.
English: However, a possible teratogenic effect was indicated in rabbits where an increase in total visceral malformations was seen in exposed animals at AUC exposures up to 0.5 fold the human exposure at recommended clinical dose.
Maltese: Madankollu, effett teratoġeniku possibbli ġie indikat fil-fniek, fejn żieda fil-malformazzjonijiet vixxerali totali ġiet osservata f'annimali esposti b'esponimenti tal-AUC li kienu sa 0.5 darbiet tal-esponiment tal-bniedem bid-doża klinika rakkomandata.
English: The median terminal half-life of velpatasvir following administration of Vosevi was approximately 17 hours.
Maltese: Il-medjan tal-half-life terminali ta' velpatasvir wara l-għoti ta' Vosevi kien ta' madwar 17-il siegħa.
English: • If you are allergic to sofosbuvir, velpatasvir, voxilaprevir or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
Maltese: • Jekk inti allerġiku għal sofosbuvir, velpatasvir, voxilaprevir jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis-sezzjoni 6 ta' dan il-fuljett).
English: Following a single 400 mg oral dose of [14C]-sofosbuvir, mean total recovery of the [14C]-radioactivity was greater than 92%, consisting of approximately 80%, 14%, and 2.5% recovered in urine, faeces, and expired air, respectively.
Maltese: Wara doża orali waħda ta' 400 mg ta' [14C]-sofosbuvir, il-medja tal-irkupru totali tar-radjuattività ta' [14C] kienet iktar minn 92%, u kienet tikkonsisti minn madwar 80%, 14%, u 2.5% irkuprata mill-awrina, mill-ippurgar u mill-arja li tintrema 'l barra man-nifs, rispettivament.
English: Medicinal products that are sensitive substrates of these transporters and for which elevated plasma levels are associated with serious events are contraindicated (see Table 2).
Maltese: Il-prodotti mediċinali li huma sottostrati sensittivi ta' dawn it-trasportaturi u li għalihom livelli miżjuda tal-plażma huma assoċjati ma' avvenimenti serji huma kontraindikati (ara Tabella 2).
English: HIV ANTIVIRAL AGENTS: INTEGRASE INHIBITORS Raltegravir (400 mg twice daily)k + emtricitabine/ tenofovir disoproxil fumarate (200/300 mg once daily)j + sofosbuvir/ velpatasvir (400/100 mg once daily)f, h
Maltese: Efavirenz/emtricitabine/ tenofovir disoproxil fumarate (600/200/300 mg/darba kuljum)g + sofosbuvir/velpatasvir (400/100 mg darba kuljum)f, h
English: Gilead Sciences Ireland UC Tel: + 353 (0) 214 825 999
Maltese: Tel: +353 (0) 214 825 999
English: Rifampicin (600 mg once daily) + voxilaprevir (100 mg single dose)f
Maltese: Rifampicin (600 mg darba kuljum) + voxilaprevir (100 mg doża waħda)f
English: Animal studies do not indicate harmful effects of sofosbuvir, velpatasvir or voxilaprevir on fertility.
Maltese: Studji f'annimali ma wrewx effetti tossiċi ta' sofosbuvir, velpatasvir jew voxilaprevir fuq il-fertilità.
English: d. These are medicinal products within class where similar interactions could be predicted.
Maltese: d. Dawn huma prodotti mediċinali fi klassi fejn interazzjonijiet simili jistgħu jiġu mbassra.
English: Dosed 1
Maltese: Tabella 10:
English: How to take Vosevi
Maltese: X'fih Vosevi
English: No teratogenic effects were observed in the rat and rabbit developmental toxicity studies with voxilaprevir at AUC exposures approximately 141- and 4-times higher, respectively, than the human exposure at the recommended clinical dose.
Maltese: Ma ġewx osservati effetti teratoġeniċi fl-istudji dwar it-tossiċità fl-iżvilupp li saru fuq il-faru l-fenek b'voxilaprevir b'esponimenti tal-AUC bejn wieħed u ieħor 141 u 4 darbiet ogħla, rispettivament, mill-esponiment tal-bniedem bid-doża klinika rakkomandata.
English: * 23% of patients enrolled into POLARIS-2 had received prior treatment with an interferon-based regimen.
Maltese: * 23% tal-pazjenti rreġistrati f'POLARIS-2 kienu rċivew kura qabel b'kors ibbażat fuq interferon.
English: Vosevi has been shown to increase tenofovir exposure when used together with an HIV regimen containing tenofovir disoproxil fumarate and a pharmacokinetic enhancer (ritonavir or cobicistat).
Maltese: Vosevi ntwera li jżid l-esponiment għal tenofovir meta jintuża flimkien ma' kors tal-HIV li jkun fih tenofovir disoproxil fumarate u sustanza li ttejjeb il-farmakokinetika (pharmacokinetic enhancer) tiegħu (ritonavir jew cobicistat).
English: The pharmacokinetics of voxilaprevir have not been studied in subjects with ESRD requiring dialysis (see section 4.2).
Maltese: Il-farmakokinetika ta' voxilaprevir ma ġietx studjata f'individwi b'ESRD li kienu jeħtieġu dijalisi (ara sezzjoni 4.2).
English: Rifampicin (600 mg once daily) + velpatasvir (100 mg single dose)f
Maltese: Rifampicin (600 mg darba kuljum) + velpatasvir (100 mg doża waħda)f
English: Following a single 100 mg oral dose of [14C]-voxilaprevir, mean total recovery of the [14C]-radioactivity was 94%, with all radioactivity measured in the faeces and none in the urine.
Maltese: Wara doża orali waħda ta' 100 mg ta' [14C]-voxilaprevir, il-medja tal-irkupru totali tar-radjuattività ta' [14C] kienet ta' 94%, bir-radjuattività kollha mkejla fl-ippurgar u l-ebda radjuattività fl-awrina.
English: • rosuvastatin (a medicine used to treat high blood cholesterol or decrease the risk of certain cardiovascular events);
Maltese: • rosuvastatin (mediċina li tintuża biex tikkura l-kolesterol għoli fid-demm jew tnaqqas ir-riskju ta' ċerti avvenimenti kardjovaskulari);
English: The hydrolysed and dehydrogenated voxilaprevir were the major metabolites identified in human plasma.
Maltese: Il-hydrolysed u dehydrogenated voxilaprevir kienu l-metaboliti maġġuri identifikati fil-plażma tal-bniedem.
English: g. Administered as efavirenz, emtricitabine and tenofovir DF fixed-dose combination.
Maltese: ġ. Mogħti bħala kombinazzjoni ta' doża fissa ta' efavirenz, emtricitabine u tenofovir DF. h.
English: Liver transplant patients
Maltese: PROPRJETAJIET FARMAKOLOĠIĊI
English: The pharmacokinetics of sofosbuvir, GS-331007, and velpatasvir were studied in HCV-infected patients with ESRD requiring dialysis treated with once daily sofosbuvir/velpatasvir 400/100 mg for
Maltese: Il-farmakokinetika ta' sofosbuvir, GS-331007, u velpatasvir ġiet studjata f'pazjenti infettati bl-HCV b'ESRD li kienu jeħtieġu dijalisi ttrattati b'sofosbuvir/velpatasvir 400/100 mg darba kuljum għal 12-il ġimgħa, u mqabbla ma' pazjenti mingħajr indeboliment tal-kliewi fil-provi ta' Fażi 2/3 b'sofosbuvir/velpatasvir.
English: Table 13 presents the SVR12 by HCV genotype by cirrhosis status for the POLARIS-2 trial.
Maltese: It-Tabella 12 tippreżenta l-SVR12 skont il-ġenotip tal-HCV u r-riżultat viroloġiku għall-prova POLARIS-2.
English: Voxilaprevir was not genotoxic in a battery of in vitro or in vivo assays, including bacterial mutagenicity, chromosome aberration using human peripheral blood lymphocytes and in vivo rat micronucleus assays.
Maltese: Voxilaprevir ma kienx ġenotossiku f'sensiela ta' assays in vitro jew in vivo, li kienu jinkludu mutaġeniċità batterjali, aberrazzjoni fil-kromożomi bl-użu ta' limfoċiti tad-demm periferali uman u assays tal-mikronukleju tal-far in vivo.
English: Proton pump inhibitors may be administered with Vosevi at a dose that does not exceed doses comparable with omeprazole 20 mg.
Maltese: Inibituri tal-pompa talprotoni jistgħu jingħataw ma' Vosevi f'doża li ma taqbiżx dożi komparabbli ma' omeprazole 20 mg.
English: Sofosbuvir was not carcinogenic in the 2-year mouse and rat carcinogenicity studies at GS-331007 exposures up to 17 and 10-times higher, respectively than human exposure.
Maltese: Sofosbuvir ma kienx karċinoġeniku fl-istudji li damu sentejn dwar il-karċinoġeniċità fuq il-ġrieden u l-firien f'esponimenti ta' GS-331007 sa 17-il darba u 10 darbiet ogħla, rispettivament mill-esponiment tal-bniedem.
English: The pharmacokinetics of velpatasvir were studied with a single dose of 100 mg velpatasvir in HCV negative patients with moderate and severe hepatic impairment (CPT Class B and C).
Maltese: Il-farmakokinetika ta' velpatasvir kienet studjata b'doża waħda ta' 100 mg ta' velpatasvir f'pazjenti negattivi għal HCV b'indeboliment moderat u sever tal-fwied (Klassi B u Ċ ta' CPT).
English: Total bilirubin levels decreased after completing Vosevi treatment.
Maltese: Il-livelli ta' bilirubina totali naqsu wara t-tlestija tal-kura b'Vosevi.
English: After a single 100 mg dose of [14C]-voxilaprevir in healthy subjects, the blood to plasma ratio of [14C]-radioactivity ranged between 0.5 and 0.8.
Maltese: Wara doża waħda ta' 100 mg ta' [14C]-voxilaprevir f'individwi f'saħħithom, il-proporzjon ta' radjuattività ta' [14C] tad-demm meta mqabbel mal-plażma kien ivarja bejn 0.5 u 0.8.
English: • dabigatran (a medicine used to prevent blood clots);
Maltese: • dabigatran (mediċina li tintuża biex tipprevjeni tagħqid tad-demm);
English: Body weight did not have a clinically significant effect on sofosbuvir, velpatasvir or voxilaprevir exposure according to a population pharmacokinetic analysis.
Maltese: Il-piż tal-ġisem ma kellux effett klinikament sinifikanti fuq l-esponiment għal sofosbuvir, velpatasvir jew voxilaprevir skont analiżi farmakokinetika tal-popolazzjoni.
English: h. Administered as sofosbuvir, velpatasvir fixed-dose combination.
Maltese: Mogħti bħala kombinazzjoni ta' doża fissa ta' sofosbuvir, velpatasvir.
English: Both of these patients had virus with emergent NS5A RAV Y93H at failure.
Maltese: Dawn iż-żewġ pazjenti kellhom virus li fih fiġġu RAVs Y93H f'NS5A fil-falliment.
English: Of the 182 DAA-experienced patients treated with sofosbuvir/velpatasvir/voxilaprevir for 12 weeks in POLARIS-4 (see Table 11), 1 of 182 (1%) patients relapsed and qualified for resistance analysis.
Maltese: Mill-182 pazjent li rċivew DAA fil-passat ikkurati b'sofosbuvir/velpatasvir/voxilaprevir għal 12-il ġimgħa f'POLARIS-4 (ara Tabella 11), 1 minn 182 (1%) pazjent irkada u kkwalifika għal analiżi ta' reżistenza.
English: No dose adjustment of Vosevi, raltegravir or emtricitabine/tenofovir disoproxil fumarate is required.
Maltese: Mhux meħtieġ aġġustament fid-doża ta' Vosevi, raltegravir jew emtricitabine/tenofovir disoproxil fumarate.
English: Vosevi may be co-administered with P-gp, BCRP and CYP inhibitors.
Maltese: Vosevi jista' jintgħata flimkien ma' inibituri ta' P-gp, BCRP u CYP.
English: INSTRUCTIONS ON USE
Maltese: Mhux disponibbli
English: Film-coating:
Maltese: Frekwenza mhux magħrufa:
English: Co-administration of Vosevi with ciclosporin is not recommended (see section 4.4).
Maltese: L-għoti flimkien ta' Vosevi ma' ciclosporin mhuwiex rakkomandat (ara sezzjoni 4.4).
English: Population pharmacokinetic analysis in HCV-infected patients indicated that patients with cirrhosis (CPT Class A) had 73% higher exposure of voxilaprevir than those without cirrhosis (see section 4.2).
Maltese: Analiżi farmakokinetika tal-popolazzjoni f'pazjenti infettati bl-HCV indikat li pazjenti b'ċirrożi (Klassi A ta' CPT) kellhom esponiment għal voxilaprevir ta' 73% ogħla minn dawk mingħajr ċirrożi (ara sezzjoni 4.2).
English: The median terminal half-life of voxilaprevir following administration of Vosevi was approximately 33 hours.
Maltese: Il-medjan tal-half-life terminali ta' voxilaprevir wara l-għoti ta' Vosevi kien ta' madwar 33 siegħa.
English: Haemodialysis is unlikely to result in significant removal of velpatasvir or voxilaprevir since velpatasvir and voxilaprevir are highly bound to plasma proteins.
Maltese: Mhuwiex probabbli li emodijaliżi tirriżulta fi tneħħija sinifikanti ta' velpatasvir jew voxilaprevir minħabba li velpatasvir u voxilaprevir jintrabtu ħafna mal-proteini tal-plażma.
English: There are no data on the use of Vosevi in patients with HCV/hepatitis B virus (HBV) co-infection.
Maltese: M'hemm l-ebda data dwar l-użu ta' Vosevi f'pazjenti b'infezzjoni fl-istess ħin b'HCV/virus talepatite B (HBV).
English: Voxilaprevir is active in vitro against most of the NS3 RAVs that confer resistance to first generation NS3/4A protease inhibitors.
Maltese: Voxilaprevir huwa attiv in vitro kontra l-maġġoranza ta' RAVs f'NS3 li jikkonferixxu reżistenza għall-inibituri tal-protease NS3/4A tal-ewwel ġenerazzjoni.
English: Caution is warranted and therapeutic concentration monitoring of digoxin is recommended.
Maltese: Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: • outer cartons containing 1 bottle of 28 film-coated tablets
Maltese: • kartun ta' barra li fihom flixkun ta' 28 pillola miksija b'rita
English: f. Lack of pharmacokinetics interaction bounds 70-143%.
Maltese: Medda ta' 70-143% li fiha ma jseħħu l-ebda interazzjonijiet farmakokinetiċi.
English: (eGFR ≥30
Maltese: <30 mL/
English: Velpatasvir was not genotoxic in a battery of in vitro or in vivo assays, including bacterial mutagenicity, chromosome aberration using human peripheral blood lymphocytes and in vivo rat micronucleus assays.
Maltese: Velpatasvir ma kienx ġenotossiku f'sensiela ta' assays in vitro jew in vivo, li kienu jinkludu mutaġeniċità batterjali, aberrazzjoni fil-kromożomi bl-użu ta' limfoċiti tad-demm periferali uman u assays tal-mikronukleju tal-far in vivo.
English: The concomitant use of amiodarone was limited through the clinical development of sofosbuvir.
Maltese: L-użu fl-istess waqt ta' amiodarone kien limitat għal waqt l-iżvilupp kliniku ta' sofosbuvir.
English: Famotidine (40 mg single dose) + sofosbuvir/velpatasvir/ voxilaprevir (400/100/ 100 mg single dose)c
Maltese: (40 mg doża waħda) + sofosbuvir/velpatasvir/ voxilaprevir (400/100/100 mg doża waħda)ċ
English: a. Mean ratio (90% CI) of co-administered drug pharmacokinetics of study medicinal products alone or in combination.
Maltese: Proporzjon medju (90% CI) tal-farmakokinetika tal-mediċini mogħtija flimkien tal-prodotti mediċinali tal-istudju waħedhom jew flimkien.