FrancophonIA/ELRC3.0 huggingface dataset:
English: Sustained virologic response (SVR) was the primary endpoint in all studies and was defined as HCV RNA less than the lower limit of quantification (LLOQ) detectable or undetectable 12 weeks (SVR12) or 24 weeks (SVR24) after the planned end of treatment (studies C206, C208, C212, C216, HPC2002, HPC3007 and HPC3011) or after the actual end of treatment (studies HPC2014, HPC3017, HPC3018 and HPC3021) (LLOQ of 25 IU/ml and limit of detection of 15 IU/ml, except in studies HPC2014 and HPC3021 where LLOQ and limit of detection were 15 IU/ml).
Maltese: Rispons viroloġiku miżmum (SVR -sustained virologic response) kien l-iskop finali primarju fl-istudji kollha u kien imfisser bħala RNA ta' HCV inqas mill-inqas limitu ta' kwantifikazzjoni (LLOQ - lower limit of quantification) li seta' jew li ma setax jitkejjel 12-il ġimgħa (SVR12) jew 24 ġimgħa (SVR24) wara t-tmiem ippjanat tat-trattament (studji C206, C208, C212, C216, HPC2002, HPC3007 u HPC3011) jew wara t-tmiem attwali tat-trattament (studji HPC2014, HPC3017, HPC3018 u HPC3021) (LLOQ ta' 25
English: placebo + peginterferon + ribavirin N = 264 % (n/N)
Maltese: plaċebo + peginterferon + ribavirin N = 264 % (n/N)
English: Table 11: Studies conducted with simeprevir + sofosbuvir: population and summary of study design
Maltese: Tabella 11: Studji li saru b'simeprevir + sofosbuvir: popolazzjoni u sommarju tal-pjan tal
English: The terminal elimination half-life of simeprevir was 10 to 13 hours in healthy subjects and 41 hours in HCV infected patients receiving 200 mg simeprevir.
Maltese: Il-half-life tal-eliminazzjoni terminali ta' simeprevir kienet ta' 10 sa 13-il siegħa f'individwi b'saħħithom u 41 siegħa f'pazjenti infettati b'HCV li rċevew 200 mg simeprevir.
English: Patients with cirrhosis N = 103 % (n/N)
Maltese: Pazjenti b'ċirrożi N = 103 % (n/N)
English: In study HPC3011 in HCV genotype 4 infected patients, 28 of 32 (88%) patients who did not achieve SVR had emerging amino acid substitutions at NS3 positions 80, 122, 155, 156 and/or 168 (mainly substitutions at position 168; 24 out of 32 [75%] patients), similar to the emerging amino acid substitutions observed in genotype 1 infected patients.
Maltese: Fl-istudju HPC3011 f'pazjenti infettati b'HCV bil-ġenotip 4, 28 minn 32 (88%) pazjent li ma kisbux SVR kellhom sostituzzjonijiet ta' aċidi amminiċi qed jitfaċċaw fil-pożizzjonijiet ta' NS3 80, 122, 155 u/jew 168 (prinċipalment sostituzzjonijiet fil-pożizzjoni 168; 24 minn 32 [75%] pazjent), simili għassostituzzjonijiet osservati tal-aċidi amminiċi li tfaċċaw f'pazjenti infettati b'ġenotip 1.
English: Compared to healthy subjects with normal hepatic function, the mean steady-state AUC of simeprevir was 2.4-fold higher in non-HCV infected subjects with moderate hepatic impairment (Child-Pugh B) and 5.2-fold higher in non-HCV infected subjects with severe hepatic impairment (Child-Pugh C).
Maltese: Meta mqabbel ma' individwi b'saħħithom b'funzjoni tal-fwied normali, l-AUC medju fl-istadju fiss ta' simeprevir kien 2.4 darbiet ogħla f'individwi infettati mhux b'HCV b'indeboliment moderat tal-fwied (Child-Pugh B) u 5.2 darbiet ogħla f'individwi infettati mhux b'HCV b'indeboliment sever
English: Table 6: Treatment-emergent laboratory abnormalities in amylase and lipase in patients receiving 12 or 24 weeks of simeprevir in combination with sofosbuvir (12 weeks: pooled studies HPC2002, HPC3017 and HPC3018; 24 weeks: study HPC2002)
Maltese: Tabella 6: Anormalitajiet tal-laboratorju fl-amylase u l-lipase li jfiġġu minħabba t-trattament f'pazjenti li jkunu qed jirċievu 12 jew 24 ġimgħa ta' simeprevir flimkien ma' sofosbuvir (12-il ġimgħa: ġabra tal-istudji HPC2002, HPC3017 u HPC3018; 24 ġimgħa: l-istudju HPC2002)
English: - Do not use this medicine after the expiry date which is stated on the carton and blister packaging after EXP.
Maltese: - Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u pakkett tal-folji wara EXP.
English: Cases of bradycardia have been observed when OLYSIO is used in combination with sofosbuvir and concomitant amiodarone (see sections 4.4 and 4.5).
Maltese: Ġew osservati każijiet ta' bradikardija meta OLYSIO jintuża flimkien ma' sofosbuvir mogħti flimkien ma' amiodarone (ara sezzjonijiet 4.4 u 4.5).
English: The Q80K polymorphism was not observed in patients with genotype 4 infection.
Maltese: Il-polimorfiżmu Q80K ma kienx osservat f'pazjenti b'infezzjoni bil-ġenotip 4.
English: In study C206 (ASPIRE), patients who failed prior peg-IFN/RBV therapy received 12, 24 or 48 weeks simeprevir (100 mg or 150 mg once daily) in combination with 48 weeks of peginterferon alfa-2a + ribavirin (see tables 17 and 18).
Maltese: Fl-istudju C206 (ASPIRE), pazjenti li fallew terapija preċedenti b'peg-IFN/RBV irċivew 12, 24 jew 48 ġimgħa ta' simeprevir (100 mg jew 150 mg darba kuljum) flimkien ma' 48 ġimgħa ta' peginterferon alfa-2a + ribavirin (ara t-tabelli 17 u 18).
English: Population pharmacokinetic estimates of exposure of simeprevir were comparable between Caucasian and Black/African American HCV infected patients treated with simeprevir in combination with peginterferon alfa and ribavirin.
Maltese: Stimi farmakokinetiċi dwar il-popolazzjoni dwar l-esponiment ta' simeprevir kienu komparabbli bejn pazjenti Kawkasi u Suwed/Afrikani Amerikani infettati b'HCV ittrattati b' simeprevir flimkien ma' peginterferon alfa u ribavirin.
English: 8 or 12 weeks SMV + sofosbuvir
Maltese: 8 jew 12-il ġimgħa SMV + sofosbuvir
English: OLYSIO is not recommended in patients with moderate or severe hepatic impairment (Child-Pugh B or C) (see sections 4.2, 4.8 and 5.2).
Maltese: OLYSIO mhuwiex irrakkomandat f'pazjenti b'indeboliment tal-fwied moderat jew sever (ChildPugh B jew Ċ) (ara sezzjonijiet 4.2, 4.8 u 5.2).
English: Baseline polymorphisms at NS3 positions 43, 80, 122, 155, 156, and/or 168, associated with reduced simeprevir activity in vitro were generally uncommon (1.3%) in patients with HCV genotype 1 infection (n = 2,007; pooled phase 2 and phase 3 studies with simeprevir in combination with peginterferon alfa and ribavirin), with exception of the substitution Q80K in HCV genotype 1a patients which was seen in 30% of patients with HCV genotype 1a and in 0.5% of patients with HCV genotype 1b.
Maltese: Polimorfiżmi fil-linja bażi ta' NS3 fil-pożizzjonijiet 43, 80, 122, 155, 156 u/jew 168, assoċjati ma' tnaqqis fl-attività ta' simeprevir in vitro kienu ġeneralment mhux komuni (1.3%) f'pazjenti b'infezzjoni ta' HCV ta' ġenotip 1 (n = 2,007; ġabra ta' studji ta' fażi 2 u fażi 3 b'simeprevir flimkien ma' peginterferon alfa u ribavirin), bl-eċċezzjoni tas-sostituzzjoni Q80K f'pazjenti b'HCV tal-ġenotip 1a li dehret fi 30% tal-pazjenti b'HCV ta' ġenotip 1a u f'0.5% tal-pazjenti b'HCV tal-ġenotip 1b. FlEwropa, il-prevalenza kienet inqas, 19% (73/377) f'pazjenti b'HCV tal-ġenotip 1a u 0.3% (3/877) ta'
English: Treatment-emergent laboratory abnormalities in amylase and lipase have been observed in patients treated with simeprevir in combination with sofosbuvir (table 6).
Maltese: Ġew osservati anormalitajiet tal-laboratorju fl-amylase u l-lipase li jfiġġu minħabba t-trattament f'pazjenti ttrattati b'simeprevir flimkien ma' sofosbuvir (tabella 6).
English: In vitro experiments show that simeprevir is a substrate for the drug transporters P-glycoprotein (P-gp), MRP2, OATP1B1/3 and OATP2B1.
Maltese: P-glycoprotein (P-gp), MRP2, OATP1B1/3 u OATP2B1 tal-mediċina.
English: (CYP3A4 enzyme induction [etravirine or nevirapine] or inhibition [delavirdine])
Maltese: (Sensibilizzazzjoni [etravirine jew nevirapine] jew impediment [delavirdine] tal-enzima ta'
English: To prior treatment with peginterferon alfa and ribavirin.
Maltese: Għal trattament preċedenti b'peginterferon alfa u ribavirin.
English: In healthy adult subjects receiving single doses up to 600 mg or once daily doses up to 400 mg for 5 days, and in HCV infected adult patients receiving 200 mg once daily for 4 weeks, adverse reactions were consistent with those observed in clinical studies at the recommended dose (see section 4.8).
Maltese: F'individwi adulti b'saħħithom li rċevew dożi waħdenin ta' 600 mg darba kuljum jew dożi sa 400 mg għal 5 ijiem, u f'pazjenti adulti infettati b'HCV li rċevew 200 mg darba kuljum għal 4 ġimgħat, reazzjonijiet avversi kienu konsistenti ma' dawk osservati fi studji kliniċi fid-doża rakkomandata (ara sezzjoni 4.8).
English: The presence of Q80K at baseline was associated with lower SVR rates in HCV genotype 1a patients treated with simeprevir in combination with peginterferon alfa and ribavirin (tables 19, 21, 22).
Maltese: Il-preżenza ta' Q80K fil-linja bażi kienet assoċjata ma' rati aktar baxxi ta' SVR għal ġenotip 1a ta' HCV ittrattati b'simeprevir flimkien ma' peginterferon alfa u ribavirin (tabelli 19, 21, 22).
English: In study HPC2002 (COSMOS), prior null responders with METAVIR fibrosis score F0-F2, or treatment-naïve and prior null responder patients with METAVIR fibrosis score F3-F4 and compensated liver disease received simeprevir + sofosbuvir, with or without ribavirin, for 12 or 24 weeks (see table 11).
Maltese: Fl-istudju HPC2002 (COSMOS), pazjenti li ma kellhomx ripons preċedenti għat-trattament b'punteġġ ta' fibrożi METAVIR ta' F0-F2, jew pazjenti li qatt ma ħadu trattament qabel u dawk li ma kellhomx ripons preċedenti għat-trattament b'punteġġ ta' fibrożi METAVIR ta' F3-F4 u mard kumpensat talfwied irċivew simeprevir + sofosbuvir, b'ribavirin jew mingħajru, għal 12 jew 24 ġimgħa (ara tabella 11).
English: Laboratory testing during treatment with OLYSIO, peginterferon alfa and ribavirin HCV RNA levels should be monitored at weeks 4 and 12 and as clinically indicated (see also guidelines for treatment duration and stopping rules; section 4.2).
Maltese: Il-livelli ta' HCV RNA għandhom jiġu monitorati fil-ġimgħat 4 u 12 u kif klinikament indikat (ara wkoll linji gwida għat-tul ta' trattament u regoli għal waqfien; sezzjoni 4.2).
English: The safety and efficacy of simeprevir have not been established in HCV infected patients with moderate or severe hepatic impairment (Child-Pugh B or C).
Maltese: Issigurtà u l-effikaċja ta' simeprevir ma ġewx determinati f'pazjenti infettati b'HCV b'indeboliment moderat jew sever tal-fwied (Child-Pugh B jew Ċ).
English: Treatment Outcome simeprevir + peginterferon + ribavirin N = 521 % (n/N)
Maltese: simeprevir + peginterferon + ribavirin N = 521 % (n/N)
English: In study HPC3021 (PLUTO), patients received simeprevir + sofosbuvir for 12 weeks (see table 11).
Maltese: Fl-istudju HPC3021 (PLUTO), il-pazjenti rċivew simeprevir + sofosbuvir għal 12-il ġimgħa (ara tabella 11).
English: Simeprevir in combination with peginterferon alfa and ribavirin: During the 12 weeks treatment with simeprevir, rash and pruritus were reported in 21.8% and 21.9% of simeprevir-treated patients, compared to 16.6% and 14.6% in placebo-treated patients, respectively (all grades; pooled phase 3).
Maltese: Matul it-trattament ta' 12-il ġimgħa b'simeprevir, ir-raxx u l-ħakk kienu rrappurtati f'21.8% u 21.9% ta' pazjenti trattati b'simeprevir meta mqabbla ma' 16.6% u 14.6% f'pazjenti trattati bi plaċebo, rispettivament (il-gradi kollha: riżultati miġbura ta' fażi 3).
English: Chimeric replicons carrying NS3 sequences derived from HCV PI treatment-naïve genotype 1a and genotype 1b patients displayed median fold change (FC) in simeprevir EC50 values of 1.4 (N = 78) and 0.4 (N = 59) compared to reference genotype 1b replicon, respectively.
Maltese: Replikons kimeriċi li jġorru sekwenzi ta' NS3 derivati minn pazjenti li ma kinux ittrattati qabel b'HCV PI ta' ġenotip 1a u ġenotip 1b urew valuri ta' fold change medjan (FC) għal simeprevir f'EC50 ta' 1.4 (N = 78) u 0.4
English: The safety profile of OLYSIO 150 mg in combination with peginterferon alfa and ribavirin in a phase 3 study conducted in Asian patients in China and South-Korea is comparable to non-Asian patients from a pooled phase 3 population from global studies, except for higher frequencies for ‘blood bilirubin increased' events (see table 8).
Maltese: Il-profil ta' sigurtà ta' OLYSIO 150 mg flimkien ma' peginterferon alfa u ribavirin fi studju ta' fażi 3 li sar f'pazjenti Asjatiċi fiċ-Ċina u fil-Korea t'Isfel huwa kumparabbli ma' pazjenti mhux Asjatiċi minn ġabra ta' popolazzjoni ta' fażi 3 minn studji globali, ħlief għal frekwenzi ogħla ta' każijiet ta' ‘żieda fil-bilirubina fid-demm' (ara tabella 8).
English: OATP1B1/3 and MRP2 are involved in the transport of bilirubin into and out of hepatocytes.
Maltese: OATP1B1/3 u MRP2 huma involuti fit-trasport ta' bilirubina fi u barra minn epatoċiti.
English: Following a single oral administration of 200 mg
Maltese: Wara għoti orali waħda ta' 200 mg
English: 600 mg once daily efavirenz AUC 0.90 (0.85-0.95) ↔ efavirenz Cmax 0.97 (0.89-1.06) ↔ efavirenz Cmin 0.87 (0.81-0.93) ↔ simeprevir AUC 0.29 (0.26-0.33) ↓ simeprevir Cmax 0.49 (0.44-0.54) ↓ simeprevir Cmin 0.09 (0.08-0.12) ↓
Maltese: 60 mg darba kuljum escitalopram AUC 1.00 (0.97-1.03) ↔ escitalopram Cmax 1.03 (0.99-1.07) ↔ escitalopram Cmin 1.00 (0.95-1.05) ↔ simeprevir AUC 0.75 (0.68-0.83)  simeprevir Cmax 0.80 (0.71-0.89)  simeprevir Cmin 0.68 (0.59-0.79) 
English: Re-evaluation of HCV RNA is recommended in case of HCV RNA ≥ 25 IU/ml after previous undetectable HCV RNA to confirm HCV RNA levels prior to discontinuing HCV treatment.
Maltese: Evalwazzjoni mill-ġdid ta' HCV RNA hu rakkomandat f'każ ta' HCV RNA ≥ 25 IU/ml wara HCV RNA mhux osservat sabiex jiġu kkonfermati l-livelli ta' HCV RNA qabel ma jitwaqqaf it-trattament għal HCV.
English: 12 weeks SMV + sofosbuvir
Maltese: 12-il ġimgħa SMV + sofosbuvir
English: In study HPC3007, 93% (241/260) of the simeprevir-treated patients were eligible for a total treatment duration of 24 weeks; in these patients the SVR12 rate was 83%.
Maltese: Fl-istudju HPC3007, 93% (241/260) tal-pazjenti ttrattati b'simeprevir kienu eliġibbli għat-tul ta' żmien totali ta' trattament ta' 24 ġimgħa; f'dawn il-pazjenti r-rata ta' SVR12 kienet 83%.
English: It acts against the virus that causes hepatitis C infection, called ‘hepatitis C virus' (HCV).
Maltese: Għall-attività speċifika marbuta mal-ġenotip tal-virus ta' epatite Ċ (HCV) (hepatitis C Virus, HCV),
English: In vitro combination of simeprevir with interferon, ribavirin, NS5A or NS5B inhibitors resulted in additive or synergistic
Maltese: Il-kombinazzjoni in vitro ta' simeprevir ma' interferon, ribavirin, inibituri ta' NS5A jew inibituri ta' NS5B għandhom effett addittiv jew sinerġistiku.
English: Hepatic uptake of simeprevir is mediated by OATP1B1/3.
Maltese: It-teħid mill-fwied ta' simeprevir isir permezz ta' OATP1B1/3.
English: Data from a phase 2 study in 9 HCV infected post-liver transplant patients.
Maltese: Dejta minn studju ta' fażi 2 f'9 pazjenti infettati b'HCV wara trapjant tal-fwied.
English: Eighty-eight percent (n = 93) of the patients were on HIV therapy, most commonly with 2 NRTIs + raltegravir.
Maltese: Tmienja u tmenin fil-mija (n = 93) tal-pazjenti kienu fuq terapija għall-HIV, l-iktar komuni b'2 NRTI's + raltegravir.
English: Compared to intake without food, administration of simeprevir with food to healthy subjects increased the AUC by 61% after a high-fat, high-caloric (928 kcal) and 69% after a normal caloric (533 kcal) breakfast, and delayed the absorption by 1 hour and 1.5 hours, respectively.
Maltese: Meta mqabbel mat-teħid mingħajr ikel, l-għoti ta' simeprevir ma' ikel f'individwi b'saħħithom żied l-AUC b'61% wara ikla b'kontenut għoli ta' xaħam, u kaloriji (928 kcal) u b'69% wara fatra kalorifika normali (533 kcal), u dewwem l-assorbiment b'siegħa u siegħa u nofs (1.5 sigħat),
English: Median simeprevir FC values against genotype 2 and genotype 3 baseline isolates tested were 25 (N = 4) and 1,014 (N = 2), respectively.
Maltese: FC ta' simeprevir kontra iżolati tal-ġenotip 2 u l-ġenotip 3 fil-linja bażi kienu 25 (N = 4) u 1,014
English: The efficacy of simeprevir (150 mg once daily) as part of an interferon-free regimen (sofosbuvir, 400 mg once daily) was evaluated in patients with HCV genotype 1 or 4 infection, who were treatment-naïve or treatment-experienced patients (following prior interferon-based therapy) (table 11).
Maltese: L-effikaċja ta' simeprevir (150 mg darba kuljum) bħala parti minn skeda ħielsa minn interferon (sofosbuvir, 400 mg darba kuljum) ġiet ivvalutata f'pazjenti b'infezzjoni ta' HCV tal-ġenotip 1 jew 4, li qatt ma ħadu trattament qabel jew li kienu ħadu trattament qabel (wara terapija preċedenti abbażi ta'
English: OLYSIO in combination with peginterferon alfa and ribavirin Simeprevir efficacy in combination with peginterferon alfa and ribavirin is substantially reduced in patients infected with hepatitis C genotype 1a with the NS3 Q80K polymorphism at baseline compared to patients with hepatitis C genotype 1a without the Q80K polymorphism (see section 5.1).
Maltese: OLYSIO flimkien ma' peginterferon alfa u ribavirin L-effikaċja ta' simeprevir flimkien ma' peginterferon alfa u ribavirin titnaqqas b'mod sostanzjali f'pazjenti infettati b'epatite Ċ ġenotip 1a bil-polimorfiżmu NS3 Q80K fil-linja bażi meta mqabbel ma' pazjenti b'epatite Ċ ġenotip 1a mingħajr il-polimorfiżmu ta' Q80K (ara sezzjoni 5.1).
English: peg-IFN-alfa = peginterferon alfa; RBV = ribavirin (body-weight based twice daily ribavirin dosing, according to the Summary of Product Characteristics of ribavirin); SMV = simeprevir.
Maltese: RBV = ribavirin (dożi ta' ribavirin mogħtija darbtejn kuljum ibbażati fuq il-piż talġisem, skont is-Sommarju tal-Karatteristiċi tal-Prodott ta' ribavirin);
English: Excipient of OLYSIO capsules
Maltese: Magnesium hydroxide
English: There are no clinical data on the use of OLYSIO in re-treating patients who have failed an HCV NS3-4A protease inhibitor-based therapy (see sections 5.1 and 5.3).
Maltese: M'hemmx tagħrif kliniku dwar l-użu ta' OLYSIO f'pazjenti trattati mill-ġdid li jkunu fallew terapija abbażi tal-impeditur ta' protease ta' HCV NS3-4A (ara sezzjonijiet 5.1 u 5.3).
English: Treatment-experienced to prior treatment with peginterferon and ribavirin.
Maltese: Kienu ħadu trattament preċedenti b'peginterferon u ribavirin.
English: Co-administration of OLYSIO with medicinal products that are substrates for OATP1B1/3, P-gp and BCRP transport may result in increased plasma concentrations of such medicinal products (see table 4).
Maltese: L-għoti konġunt ta' OLYSIO ma' prodotti mediċinali li huma sottostrati għat-trasport ta' OATP1B1/3, P-gp u BCRP jista' jirriżulta f'konċentrazzjonijiet ogħla fil-plażma ta' dawn il-prodotti mediċinali (ara tabella 3).
English: Resistance to simeprevir was characterised in HCV genotype 1a and 1b replicon-containing cells.
Maltese: Reżistenza għal simeprevir kienet ikkaraterizzata b'ċelluli li fihom replikon ta' HCV ta' ġenotip 1a u 1b.
English: Table 17: Studies conducted with simeprevir + peginterferon alfa + ribavirin: population and
Maltese: Tabella 17: Studji li saru b'simeprevir + peginterferon alfa + ribavirin: popolazzjoni u
English: Pre-treatment testing for NS3 Q80K polymorphism in patients infected with HCV genotype 1a
Maltese: Ittestjar qabel it-trattament għal polimorfiżmu Q80K ta' NS3 f'pazjenti infettati b'HCV tal-ġenotip 1a
English: The effect of simeprevir 150 mg once daily and 350 mg once daily for 7 days on the QT interval was evaluated in a randomised, double-blind, placebo- and positive-controlled (moxifloxacin 400 mg once daily), 4-way cross-over study in 60 healthy subjects.
Maltese: L-effett ta' simeprevir 150 mg darba kuljum u 350 mg darba kuljum għal 7 ijiem fuq l-intervall QT kien evalwat fi studju każwali, double-blind, bil-plaċebo bħala kontroll u b'kontroll pożittiv (moxifloxacin 400 mg darba kuljum), inkroċjat f'4 modi fuq 60 individwu b'saħħtu.
English: Janssen-Cilag Φαρμακευτική Α.Ε.Β.Ε.
Maltese: Mhux rakkomandat li OLYSIO jingħata flimkien ma' cisapride.
English: Felodipine
Maltese: Ranitidine
English: Antiretroviral - protease inhibitors (PIs)
Maltese: Antiretrovirali - impedituri ta' protease (PIs) Darunavir/ritonavir
English: Verapamil
Maltese: parzjali
English: BLISTER
Maltese: SVR12
English: Table 23: Treatment outcome in HCV genotype 4 infected patients (study HPC3011)
Maltese: Tabella 23: Ir-riżultat tat-trattament f'pazjenti infettati b'HCV tal-ġenotip 4 (studju
English: Data from a phase 2 study in 11 HCV infected post-liver transplant patients.
Maltese: Dejta minn studju ta' fażi 2 fi 11-il pazjent infettat b'HCV wara trapjant tal
English: Table 3: Treatment stopping rules in patients receiving OLYSIO in combination with peginterferon alfa and ribavirin with inadequate on-treatment virologic response
Maltese: Tabella 3: Regoli ta' waqfien ta' trattament f'pazjenti li jirċievu OLYSIO flimkien ma' peginterferon alfa u ribavirin b'rispons viroloġiku inadegwat waqt it-trattament
English: Plasma Cmax and the area under the plasma concentration time curve (AUC) increased more than dose proportional after multiple doses between 75 mg and 200 mg once daily, with accumulation occurring following repeated dosing.
Maltese: Cmax tal-plażma u ż-żona ta' taħt il-kurva tal-konċentrazzjoni fil-plażma mal-ħin (area under curve, AUC) żdiedu aktar mill-proporzjon tad-doża wara dożi multipli ta' bejn 75 mg u 200 mg darba kuljum, b'akkumulazzjoni sseħħ wara dożaġġ ripetut.
English: - The recommended dose of OLYSIO is one capsule (150 milligrams) once a day.
Maltese: - Id-doża rakkomandata ta' OLYSIO hi ta' kapsula waħda (150 milligrams) darba kuljum.
English: OLYSIO in combination with sofosbuvir: HCV/HIV-1 co-infected patients should be treated for the same duration as HCV mono-infected patients.
Maltese: OLYSIO flimkien ma' sofosbuvir: pazjenti koinfettati b'HCV/HIV-1 għandhom jiġu ttrattati għallistess tul ta' żmien bħal pazjenti infettati b'HCV biss.
English: Table 23 shows the response rates in HCV genotype 4 infected patients.
Maltese: Tabella 23 turi r-rati ta' rispons f'pazjenti infettati b'HCV tal-ġenotip 4.
English: HCV/Human immunodeficiency virus type 1 (HIV-1) co-infection No dose adjustment of OLYSIO is required in HCV/HIV-1 co-infected patients (see sections 4.8, 5.1
Maltese: Koinfezzjoni ta' HCV/Virus ta' immunodefiċjenza umana-1 (HIV-1) L-ebda aġġustament fid-doża ta' OLYSIO mhu meħtieġ f'pazjenti koinfettati b'HCV/HIV-1 (ara
English: The 40 enrolled patients had a median age of 51 years (range 29 to 69 years; with 5% above 65 years); 73% were male; 18% had a BMI ≥ 30 kg/m2; the median baseline HCV RNA level was 6.35 log10 IU/ml; 18% had cirrhosis; 25% had HCV genotype 4a, and 73% HCV genotype 4d; 85%
Maltese: L-40 pazjent irreġistrati fl-istudju kellhom medjan tal-età ta' 51 sena (firxa minn 29 sa 69 sena; b'5% li kellhom aktar minn 65 sena); 73% kienu rġiel; 18% kellhom BMI ≥ 30 kg/m2; illivell medjan ta' RNA ta 'HCV fil-linja bażi kien 6.35 log10
English: 12 weeks OLYSIO + sofosbuvir
Maltese: 12-il ġimgħa OLYSIO + sofosbuvir
English: The daily dose of ribavirin is weight based (< 75 kg = 1,000 mg and ≥ 75 kg = 1,200 mg) and administered orally in two divided doses with food; also refer to the Summary of Product Characteristics of ribavirin.
Maltese: Id-doża ta' kuljum ta' ribavirin hija bbażata fuq il-piż (< 75 kg = 1,000 mg u ≥ 75 kg = 1,200 mg) u tingħata mill-ħalq maqsuma fuq żewġ dożi mal-ikel; irreferi wkoll għas-Sommarju tal-Karatterisitiċi tal-Prodott ta' ribavirin.
English: The overall SVR12 rate for patients without cirrhosis receiving 8 weeks of simeprevir + sofosbuvir was 83% (128/155); all patients not achieving SVR12 had viral relapse (17%; 27/155).
Maltese: Ir-rata totali ta' SVR12 għal pazjenti mingħajr ċirrożi li kienu qed jirċievu 8 ġimgħat ta' simeprevir + sofosbuvir kien 83% (128/155); il-pazjenti kollha li ma kisbux SVR12 kellhom rikaduta virali (17%; 27/155).
English: Simeprevir in combination with peginterferon alfa and ribavirin There were no differences in haemoglobin, neutrophils or platelets between both treatment groups.
Maltese: Simeprevir flimkien ma' peginterferon alfa u ribavirin Ma kienx hemm differenza fil-emoglobina, newtrofili jew plejtlits bejn il-gruppi ta' trattament.