FrancophonIA/ELRC3.0 huggingface dataset:
English: Moderate or strong inhibitors of CYP3A4 significantly increase the plasma exposure of simeprevir, and moderate or strong inducers of CYP3A4 significantly reduce plasma exposure of simeprevir.
Maltese: Impedituri moderati jew qawwija ta' CYP3A4 jistgħu jżidu b'mod sinifikanti l-esponiment ta' simeprevir fil-plażma, filwaqt li sensibilizzaturi moderati jew qawwija ta' CYP3A4 jistgħu jnaqqsu b'mod sinifikanti l-esponiment ta' simeprevir.
English: Cobicistat-containing medicinal products
Maltese: TAL-PRODOTT MEDIĊINALI
English: Patients treated with vitamin K antagonists
Maltese: Pazjenti kkurati b'antagonisti tal-vitamina K
English: Clarithromycin
Maltese: ANALETTIĊI
English: Established and theoretical interactions between simeprevir and selected medicinal products are listed in table 4 (least square mean ratios with 90% confidence intervals (90% CI) are presented, increase is indicated as “↑”, decrease as “↓”, no change as “↔”).
Maltese: Interazzjonijiet stabbiliti u teoretiċi bejn simeprevir u prodotti mediċinali magħżula huma elenkati f'tabella 4 (l-inqas proporzjonijiet medji kwadri b'intervalli ta' kunfidenza ta' 90% (90% CI) huma preżentati, b'żieda hija indikata bħala “↑”, tnaqqis bħala “↓”, l-ebda bidla bħala “↔”).
English: Discontinuation of simeprevir due to rash or pruritus occurred in 0.8% and 0.1% of simeprevir-treated patients, compared to 0.3% and 0% of placebo-treated patients, respectively.
Maltese: Il-waqfien ta' simeprevir minħabba r-raxx jew il-ħakk seħħ f'0.8% u 0.1% ta' pazjenti trattati b'simeprevir, mqabbla ma' 0.3% u 0% tal-pazjenti ttrattati bi plaċebo, rispettivament.
English: Short term monotherapy data of simeprevir from studies C201 (genotype 1) and C202 (genotype 2, 3, 4, 5 and 6) in patients receiving 200 mg once daily simeprevir for 7 days is presented in table 9.
Maltese: Tagħrif ta' monoterapija għal terminu ta' żmien qasir b' simeprevir minn studji C201 (ġenotip 1) u C202 (ġenotip 2, 3, 4, 5 u 6) f'pazjenti li rċevew doża darba kuljum ta' 200 mg simeprevir għal 7 ijiem
English: In study HPC3007, 80% (24/30) of the simeprevir-treated HCV genotype 1a infected patients with Q80K polymorphism at baseline were eligible for a total treatment duration of 24 weeks; in these patients the SVR12 rate was 58%.
Maltese: Fl-istudju HPC3007, 80% (24/30) tal-pazjenti ttrattati b'simeprevir infettati b'HCV tal-ġenotip 1a b'polimorfiżmi Q80K fil-linja bażi kienu eliġibbli għat-tul ta' żmien totali ta' trattament ta' 24 ġimgħa; f'dawn il-pazjenti r-rata ta' SVR12 kienet 58%.
English: Patients who are identified as being at high risk of bradyarrhythmia should be continuously monitored for 48 hours in
Maltese: Il-pazjenti li huma identifikati li għandhom riskju kbir ta' bradiarritmija għandhom jiġu mmonitorjati kontinwament għal 48 siegħa f'ambjent kliniku xieraq.
English: Out of the 3 patients with on-treatment failure, 2 patients experienced viral breakthrough and one patient discontinued treatment early due to an adverse event.
Maltese: Mit-3 pazjenti b'falliment waqt it-trattament, 2 pazjenti kellhom progress virali u pazjent wieħed waqqaf it-trattament
English: Compared to healthy subjects with normal renal function (classified using the Modification of Diet in Renal Disease [MDRD] eGFR formula; eGFR ≥ 80 ml/min), the mean steady-state AUC of simeprevir was 1.62-fold higher (90% confidence interval: 0.73-3.6) in subjects with severe renal impairment (eGFR below 30 ml/min).
Maltese: Meta mqabbel mal-funzjoni tal-kliewi normali f'individwi b'saħħithom (klassifikazzjoni permezz tal-formula eGFR tal-Modifikazzjoni tad-Dieta fil-Mard tal-Kliewi [Modification of Diet in Renal Disease, MDRD]; eGFR ≥ 80 ml/min), l-istadju fiss medju tal-AUC ta' simeprevir kien ta' 1.62 drabi ogħla (intervall ta' kunfidenza ta' 90%: 0.
English: Vardenafil
Maltese: Amiodarone
English: The recommended co-administered medicinal product(s) and treatment duration for OLYSIO combination therapy are provided in tables 1 and 2.
Maltese: Il-prodott(i) mediċinali amministrati fl-istess waqt u t-tul tat-trattament għal trattament ta' kombinazzjoni ta' OLYSIO huma provduti f'tabelli 1 u 2.
English: In the pooled analysis of studies C208 and C216, 69% (58/84) of the simeprevir-treated HCV genotype 1a infected patients with Q80K polymorphism at baseline were eligible for a total treatment duration of 24 weeks; in these patients the SVR12 rate was 78%.
Maltese: Fil-ġabra ta' analiżi mill-istudji C208 u C216, 69% (58/84) tal-pazjenti ttrattati b'simeprevir infettati b'HCV tal-ġenotip 1a b'polimorfiżmu Q80K fil-linja bażi kienu eliġibbli għat-tul ta' żmien totali ta' trattament ta' 24 ġimgħa; f'dawn il-pazjenti ir-rata ta' SVR12 kienet 78%.
English: Simeprevir in combination with sofosbuvir
Maltese: Simeprevir flimkien ma' sofosbuvir:
English: The overall safety profile of simeprevir is based on data from 580 HCV genotype 1 infected patients who received simeprevir in combination with sofosbuvir with or without ribavirin (pooled data from the clinical phase 2 study HPC2002 and the clinical phase 3 studies HPC3017 and HPC3018) and 1,486 HCV genotype 1 infected patients who received simeprevir (or placebo) in combination with peginterferon alfa and ribavirin (pooled data from the clinical phase 2 studies C205 and C206 and the clinical phase 3 studies C208, C216 and HPC3007).
Maltese: Il-profil tas-sigurtà globali ta' simeprevir huwa bbażat fuq dejta minn 580 pazjent infettati b'HCV talġenotip 1 li rċivew simeprevir flimkien ma' sofosbuvir b'ribavirin jew mingħajru (ġabra ta' dejta millistudju kliniku HPC2002 ta' fażi 2 u l-istudji kliniċi HPC3017 u HPC3018 ta' fażi 3) u 1,486 pazjent infettati b'HCV tal-ġenotip 1 li rċivew simeprevir (jew plaċebo) flimkien ma' peginterferon alfa u ribavirin (ġabra ta' dejta mill-istudji kliniċi C205 u C206 ta' fażi 2 u l-istudji kliniċi C208, C216 u
English: Table 8: ‘Blood bilirubin increased' events observed in Asian patients from the phase 3 study HPC3005 versus the pooled phase 3 studies C208, C216 and HPC3007 receiving simeprevir or placebo in combination with peginterferon alfa and ribavirin (first 12 weeks of treatment)
Maltese: Tabella 8: Każijiet ta' ‘żieda fil-bilirubin fid-demm' osservati f'pazjenti Asjatiċi mill-istudju tal-fażi 3 HPC3005 versus il-ġabra ta' studji ta' fażi 3 C208, C216 u HPC3007 li kienu qed jirċievu simeprevir jew plaċebo flimkien ma' peginterferon alfa u ribavirin (l-ewwel 12-il ġimgħa ta' trattament)
English: Co-administration of OLYSIO with medicinal products that are primarily metabolised by CYP3A4 may result in increased plasma concentrations of such medicinal products (see table 4).
Maltese: L-għoti konġunt ta' OLYSIO ma' prodotti mediċinali li huma prinċipalment metabolizzati b'CYP3A4 jista' jirriżulta f'konċentrazzjonijiet ogħla fil-plażma ta' dawn il-prodotti mediċinali (ara tabella 4).
English: Medicinal products that are affected by the use of simeprevir Simeprevir mildly inhibits the CYP1A2 activity and intestinal CYP3A4 activity, while it does not affect hepatic CYP3A4 activity.
Maltese: Simeprevir jimpedixxi b'mod ħafif l-attività ta' CYP1A2 u l-attività ta' CYP3A4 fl-imsaren, filwaqt li ma jaffettwax l-attività ta' CYP3A4 fil-fwied.
English: EE-11415 Tallinn
Maltese: J05AE14.
English: No clinically relevant drug-drug
Maltese: Mhux mistenni jkun hemm interazzjoni klinikament rilevanti bejn mediċina
English: 2-OH-atorvastatin AUC 2.29 (2.08-2.52) ↑ 2-OH-atorvastatin Cmax 1.98 (1.70-2.31) ↑
Maltese: Atorvastatin 40 mg atorvastatin AUC 2.12 (1.72-2.62)  atorvastatin Cmax 1.70 (1.42-2.04)  atorvastatin Cmin not studied 2-OH-atorvastatin AUC 2.29 (2.08-2.52)  2-OH-atorvastatin Cmax 1.98 (1.70-2.31)  2-OH-atorvastatin Cmin ma ġiex studjat
English: 25-desacetyl-rifampicin AUC 1.24 (1.13-1.36) ↑ 25-desacetyl-rifampicin Cmax 1.08 (0.98-1.19) ↔
Maltese: 92 (0.80-1.07) ↔ rifampicin Cmin ma ġiex studjat 25-desacetyl-rifampicin AUC 1.24 (1.13-1.36)  25-desacetyl-rifampicin Cmax 1.08 (0.98-1.19) ↔ 25-desacetyl-rifampicin Cmin ma ġiex studjat simeprevir AUC 0.52 (0.
English: Patients with cirrhosis
Maltese: ANTIARRITMIĊI Digoxin
English: In 2% and 0.3% of the simeprevir-treated patients grade 3 or 4 ‘blood bilirubin increased' was reported, respectively (pooled phase 3 studies).
Maltese: Ġie rapportat li fi 2% u 0.3% tal-pazjenti trattati b'simeprevir, kien hemm ‘żieda fil-bilirubin fid-demm' ta' grad 3 jew grad 4, rispettivament (minn ġabra ta' studji ta' fażi 3).
English: OLYSIO in combination with peginterferon alfa-2b In the clinical studies, patients randomised to simeprevir in combination with peginterferon alfa-2b and ribavirin obtained numerically lower SVR12 rates and also experienced viral breakthrough and viral relapse more frequently than those treated with simeprevir in combination with peginterferon alfa-2a and ribavirin (see section 5.1).
Maltese: Fl-istudji kliniċi, pazjenti magħżula b'mod każwali għal simeprevir flimkien ma' peginterferon alfa-2b u ribavirin kellhom rati ta' SVR12 numerikament aktar baxxi u anke esperjenzaw sfondament virali u rkadar virali aktar frekwenti minn dawk trattati b'simeprevir flimkien ma' peginterferon alfa-2a u ribavirin (ara sezzjoni 5.1).
English: Table 7: Treatment-emergent laboratory abnormalities observed at a higher incidence in patients receiving simeprevir in combination with peginterferon alfa and ribavirin (pooled phase 3 studies C208, C216 and HPC3007; first 12 weeks of treatments)
Maltese: Anormalitajiet tal-laboratorju li jfiġġu minħabba t-trattament osservati b'inċidenza akbar f'pazjenti li jkunu qed jirċievu simeprevir flimkien ma' peginterferon alfa u ribavirin (ġabra tal-istudji C208, C216 u HPC3007 ta' fażi 3;
English: Simeprevir in combination with sofosbuvir: Rash and pruritus were reported in 8.0% and 8.4%, respectively, of patients receiving 12 weeks of treatment compared to 12.9% and 3.2%, respectively, of patients receiving 24 weeks of treatment (all grades).
Maltese: Raxx u ħakk kienu rrappurtati fi 8.0% u 8.4%, rispettivament, talpazjenti li kienu qed jirċievu 12-il ġimgħa ta' trattament imqabbla ma' 12.9% u 3.2%, rispettivament, ta' pazjenti li rċivew 24 ġimgħa ta' trattament (ta' kull grad).
English: In study HPC2002, rash (grouped term) was reported in 10.7% of patients receiving 12 weeks of simeprevir and sofosbuvir without ribavirin versus 20.4% of patients receiving 12 weeks of simeprevir
Maltese: Fl-istudju HPC2002, raxx (terminu kklassifikat flimkien) ġie rrappurtat f'10.7% tal-pazjenti li kienu qed jirċievu 12-il ġimgħa ta' simeprevir u sofosbuvir mingħajr ribavirin versus 20.
English: Simeprevir in combination with sofosbuvir: Photosensitivity reactions were reported in 3.1% of simeprevir-treated patients receiving 12 weeks of treatment compared to 6.5% in patients receiving 24 weeks of treatment (all grades).
Maltese: Simeprevir flimkien ma' sofosbuvir: Reazzjonijiet ta' fotosensittività kienu rrapppurtati fi 3.1% talpazjenti ttrattati b'simeprevir li kienu qed jirċievu trattament għal 12-il ġimgħa mqabbla ma' 6.5% f'pazjenti li kienu qed jirċievu trattament għal 24 ġimgħa (ta' kull grad).
English: Close monitoring is recommended if this medicinal product is administered with OLYSIO in combination with sofosbuvir (see section 4.4).
Maltese: Huwa rrakkomandat monitoraġġ kliniku millqrib jekk dan il-prodott mediċinali jingħata ma' OLYSIO flimkien ma' sofosbuvir (ara sezzjoni 4.4).
English: Table 14: Treatment outcome in HCV genotype 1 infected patients without cirrhosis receiving 12 weeks simeprevir + sofosbuvir, with or without ribavirin simeprevir + sofosbuvir + ribavirin N = 43 % (n/N)
Maltese: Riżultat tat-trattament f'pazjenti infettati b'HCV tal-ġenotip 1 b'ċirrożi li kienu qed jirċievu 12 jew 24 ġimgħa ta' simeprevir + sofosbuvir, b'ribavirin jew
English: Simeprevir in combination with peginterferon alfa and ribavirin The safety profile of simeprevir in combination with peginterferon alfa and ribavirin in patients with HCV genotype 1 infection is based on the pooled data from the phase 2 studies and phase 3 studies C205, C206, C208, C216 and HPC3007 which included 924 patients who received simeprevir 150 mg once daily for 12 weeks and 540 patients who received placebo with peginterferon alfa and
Maltese: Simeprevir flimkien ma' peginterferon alfa u ribavirin Il-profil tas-sigurtà ta' simeprevir flimkien ma' peginterferon alfa u ribavirin f'pazjenti b'infezzjoni ta' HCV ta' ġenotip 1 hu bbażat fuq tagħrif miġbur mill-istudji C205, C206, C208, C216 u HPC3007 talfażi 2 u tal-fażi 3 li kienu jinkludu 924 pazjent li rċivew simeprevir 150 mg darba kuljum għal 12il ġimgħa u 540 pazjent li rċevew plaċebo ma' peginterferon alfa u ribavirin.
English: Discontinue OLYSIO, peginterferon alfa and ribavirin
Maltese: OLYSIO flimkien ma' peginterferon alfa u ribavirin:
English: The majority of HCV genotype 1 infected patients treated with simeprevir in combination with sofosbuvir (with or without ribavirin) for 12 or 24 weeks who did not achieve SVR due to virologic reasons and with sequencing data available had emerging NS3 amino acid substitutions at position 168 and/or emerging R155K: 5 out of 6 patients in study HPC2002, 1 out of 3 patients in study HPC3017 and 11 out of 13 patients in study HPC3018.
Maltese: Fil-biċċa l-kbira tal-pazjenti infettati b'HCV bil-ġenotip 1 ittrattati b'simeprevir flimkien ma' sofosbuvir (b'ribavirin jew mingħajru) għal 12 jew 24 ġimgħa li ma kisbux SVR minħabba raġunijiet viroloġiċi u b'dejta disponibbli dwar sekwenzar kienu qed ifiġġu sostituzzjonijiet fl-aċidu amminiku ta' NS3 fil-pożizzjoni 168 u/jew kienet qed tfiġġ R155K: 5 minn 6 pazjenti fl-istudju HPC2002, pazjent wieħed minn 3 pazjenti fl-istudju HPC3017 u 11 minn 13-il pazjent fl-istudju HPC3018.
English: Additionally, resistance to simeprevir was evaluated in HCV genotype 1a and 1b replicon assays using site-directed mutants and chimeric replicons carrying NS3 sequences derived from clinical isolates.
Maltese: Barra minn hekk, reżistenza għal simeprevir kienet evalwata f'analiżi ta' replikons ta' HCV ta' ġenotip 1a u 1b, permezz ta' mutanti diretti lejn is-sit u replikons kimeriċi li jġorru sekwenzi ta' NS3 derivati minn iżolati kliniċi.
English: Prior null responders N = 28 % (n/N)
Maltese: N = 28 % (n/N)
English: simeprevir Cmin 0.86 (0.75-0.98) ↓
Maltese: 41-0.67)  simeprevir Cmax 1.31 (1.03-1.66)  simeprevir Cmin 0.08 (0.
English: Efficacy in treatment-naïve patients with HCV genotype 1 infection In studies C208 (QUEST-1) and C216 (QUEST-2), treatment-naïve patients received simeprevir (150 mg once daily) + peginterferon alfa + ribavirin for 12 weeks, followed by 12 or 36 additional weeks of peginterferon alfa + ribavirin (see tables 17 and 18).
Maltese: Effikaċja f'pazjenti b'infezzjoni ta' HCV tal-ġenotip 1 li qatt ma ħadu trattament qabel Fl-istudji C208 (QUEST-1) u C216 (QUEST-2), pazjenti li qatt ma ħadu trattament qabel rċivew simepravir (150 mg darba kuljum) + peginterferon alfa + ribavirin għal 12-il ġimgħa, segwiti minn 12 jew 36 ġimgħa addizzjonali ta' peginterferon alfa + ribavirin (ara tabelli 17 u 18).
English: Prior relapsers N = 15 % (n/N)
Maltese: Pazjenti mingħajr ċirrożi N = 155 % (n/N)
English: Patients with HCV genotype 1a predominantly had emerging R155K alone or in combination with amino acid substitutions at NS3 positions 80, 122 and/or 168, while patients with HCV genotype 1b had most often an emerging D168V substitution (table 10).
Maltese: Pazjenti bi predominanza ta' HCV ta' ġenotip 1a kellhom R155K li kien qed jitfaċċa waħdu jew f'kombinazzjoni ma' sostituzzjonijiet ta' aċidu amminiku fl-NS3 fil-pożizzjonijiet 80, 122 u/jew 168, waqt li pazjenti b'ġenotip 1b ta' HCV kellhom ta' spiss sostituzzjoni ta' D168V li kienet qed titfaċċa (tabella 10).
English: The safety profile of simeprevir in combination with peginterferon alfa and ribavirin is comparable between HCV genotype 1 infected patients with and without HIV-1 co-infection.
Maltese: Il-profil ta' sigurtà ta' simeprevir flimkien ma' peginterferon alfa u ribavirin huwa komparabbli bejn pazjenti infettati b' HCV ta' ġenotip 1 u bi u mingħajr koinfezzjoni ta' HIV-1.
English: Number of patients enrolled
Maltese: Numru ta' pazjenti rreġistrati
English: Table 4: Interactions and dose recommendation with other medicinal products Recommendation for co-administration
Maltese: Tabella 4: Interazzjonijiet u rakkomandazzjonijiet dwar id-doża ma' prodotti mediċinali terapewtiċi
English: Nicardipine
Maltese: Nizatidine
English: HORMONAL CONTRACEPTIVES Ethinylestradiol and norethindrone
Maltese: ANTISTAMINI Astemizole Terfenadine
English: The one patient with on-treatment failure discontinued treatment early due to an adverse event.
Maltese: Il-pazjenti wieħed li kellu falliment waqt it-trattament waqqaf it-trattament kmieni minħabba avveniment avvers.
English: Disposal: Read the package leaflet.
Maltese: Jista' jkun li mhux id-daqsijiet kollha tal-pakkett ikunu fis-suq.
English: OLYSIO is not recommended in patients with moderate or severe hepatic impairment (Child-Pugh B or C) (see sections 4.2 and 4.4).
Maltese: OLYSIO mhuwiex irrakkomandat f'pazjenti b'indeboliment tal-fwied moderat jew sever (Child-Pugh B jew Ċ) (ara sezzjonijiet 4.2 u 4.4).
English: HCV geno/subtype and presence of Q80K polymorphism in HCV genotype 1a with Q80K without Q80K Genotype 1b
Maltese: Ġeno/sottotip ta' HCV u l-preżenza ta' polimorfiżmu ta' Q80K f'HCV tal-ġenotip 1a mingħajr Q80K Ġenotip 1b p < 0.001.
English: The interaction between simeprevir and the medicinal product was evaluated in a pharmacokinetic substudy within a phase 2 study in 22 HCV infected patients.
Maltese: L-interazzjoni bejn simeprevir u l-prodott mediċinali kien evalwat f'sottostudju farmakokinetiku fi ħdan studju ta' fażi 2 bi 22 pazjent infettat b'HCV.
English: In study HPC2002, increased bilirubin was reported in 0% of patients receiving 12 weeks of simeprevir and sofosbuvir without ribavirin versus 9.3% of patients receiving 12 weeks of simeprevir and sofosbuvir with ribavirin.
Maltese: Fl-istudju HPC2002, żieda fil-bilirubin ġiet rrappurtata f'0% tal-pazjenti li kienu qed jirċievu 12-il ġimgħa ta' simeprevir u sofosbuvir mingħajr ribavirin versus 9.3% tal-pazjenti li kienu qed jirċievu 12-il ġimgħa ta' simeprevir u sofosbuvir ma' ribavirin.
English: 12 or 24 weeks SMV + sofosbuvir, with or without ribavirin patients without cirrhosis: 8 or 12 weeks SMV + sofosbuvir; patients with cirrhosis:
Maltese: 12 jew 24 ġimgħa SMV + sofosbuvir, b'ribavirin jew mingħajru pazjenti mingħajr ċirrożi: 8 jew 12-il ġimgħa SMV + sofosbuvir; pazjenti b'ċirrożi: 12-il ġimgħa SMV + sofosbuvir ċirrożi
English: Genotype 4, treatment-naïve or treatment-experienced patients, with compensated cirrhosis or without cirrhosis treatment-naïve patients or prior relapsers: 12 weeks SMV + peg-IFN-alfa + RBV, followed by 12 or 36 weeks peg-IFN-alfa + RBV prior non-responder patients (partial and null responders): 12 weeks SMV + peg-IFN-alfa + RBV, followed by 36 weeks peg-IFN-alfa + RBV
Maltese: Pazjenti li qatt ma ħadu trattament qabel jew dawk li rkadew qabel: 12-il ġimgħa ta' SMV + peg-IFN-alfa + RBV, segwiti minn 12 jew 36 ġimgħa ta' peg-IFN-alfa + RBV pazjenti li ma' kinux irrispondew qabel (dawk li rrispondew b'mod parzjali u dawk li ma rrispondewx): 12-il ġimgħa SMV + peg-IFN-alfa + RBV, segwiti minn 36 ġimgħa ta' peg-IFN-alfa + RBV
English: (OATP1B1/3, BCRP transporter inhibition)
Maltese: (impediment ta' OATP1B1 b'tacrolimus)
English: 12, 24 or 48 weeks SMV in combination with 48 weeks peg-IFN-alfa + RBV; control group: 48 weeks placebo + peg-IFN-alfa + RBV treatment-naïve patients or prior relapsers without cirrhosis: 12 weeks SMV + peg-IFN-alfa + RBV, followed by 12 or 36 weeks peg-IFN-alfa + RBV prior non-responder patients (partial and null responders) without cirrhosis and all treatment-naïve and treatment-experienced patients with cirrhosis: 12 weeks SMV + peg-IFN-alfa + RBV, followed by 36 weeks peg-IFN-alfa + RBV
Maltese: 12, 24 jew 48 ġimgħa ta' SMV flimkien ma' 48 ġimgħa peg-IFN-alfa + RBV; grupp ta' kontroll: 48 ġimgħa ta' plaċebo + peg-IFN-alfa + RBV pazjenti li qatt ma ħadu trattament qabel jew dawk li qabel kienu rkadew mingħajr ċirrożi:
English: It is not recommended to co-administer OLYSIO with systemic fluconazole or voriconazole.
Maltese: Mhux rakkomandat li OLYSIO jingħata flimkien ma' fluconazole sistemiku jew voriconazole.
English: OLYSIO must be used in combination with other medicinal products for the treatment of CHC (see section 5.1).
Maltese: OLYSIO għandu jintuża flimkien ma' prodotti mediċinali oħra għat-trattament ta' CHC (ara sezzjoni5.1).
English: Effect of baseline HCV polymorphisms on treatment response Analyses were conducted to explore the association between naturally-occurring baseline NS3/4A amino acid substitutions (polymorphisms) and treatment outcome.
Maltese: L-analiżi saru sabiex tiġi mistħarrġa r-rabta bejn is-sostituzzjonijiet ta' aċidu amminiku NS3/4A fil-linja bażi li jinsabu b'mod naturali (polimorfiżmi) u r-riżultati tal-analiżi.
English: Simeprevir-resistant variants studied remained susceptible to representative HCV nucleoside and non-nucleoside polymerase inhibitors, and NS5A inhibitors.
Maltese: Varjanti reżistenti għal simeprevir studjati baqgħu suxxetibbli għal impedituri ta' polymerase nukleosidi u mhux nukleosidi rappreżentattivi ta' HCV, u impedituri ta' NS5A.
English: Overall treatment duration with peg-IFN-alfa and RBV was response-guided.
Maltese: It-tul ta' żmien totali ta' trattament b'peg-IFN-alfa u RBV kien iġġwidat mir-rispons.
English: A higher incidence of anaemia in patients with advanced fibrosis receiving simeprevir in combination with peginterferon alfa and ribavirin has been reported.
Maltese: Ġiet irrappurtata inċidenza ogħla t'anemija f'pazjenti b'fibrosi avvanzata li kienu qed jirċievu simeprevir flimkien ma' peginterferon alfa u ribavirin.
English: Simeprevir was not genotoxic in a series of in vitro and in vivo tests.
Maltese: Simeprevir ma kienx ġenotossiku f'serje ta' tests in vitro u in vivo.
English: The pharmacokinetic properties of simeprevir have been evaluated in healthy adult subjects and in adult HCV infected patients.
Maltese: Il-karatteristiċi farmakokinetiċi ta' simeprevir ġew evalwati f'individwi adulti b'saħħithom f'pazjenti adulti infettati b'HCV.
English: The direction of the arrow (↑ = increase, ↓ = decrease, ↔ = no change) for each pharmacokinetic parameter is based on the 90% confidence interval of the geometric mean ratio being within (↔), below (↓) or above (↑) the 0.80 - 1.25 range.
Maltese: Id-direzzjoni tal-vleġġa (↑ = żieda, ↓ = tnaqqis, ↔ = ebda bidla) għal kull parametru farmakokinetiku hi bażata fuq intervall ta' kunfidenza ta' 90% tal-proporzjon ġeometriku medju li jkun fi (↔), taħt (↓) jew 'il fuq (↑) mill-medda ta' 0.80 1.25.
English: Rilpivirine 25 mg once daily rilpivirine AUC 1.12 (1.05-1.19) ↔ rilpivirine Cmax 1.04 (0.95-1.13) ↔
Maltese: Rifampicin 600 mg darba kuljum rifampicin AUC 1.00 (0.93-1.08) ↔ rifampicin Cmax 0.
English: In dogs, simeprevir was associated with a reversible multifocal hepatocellular necrosis with associated increases in ALT, AST, alkaline phosphatase and/or bilirubin.
Maltese: Fil-klieb, simeprevir kien assoċjat ma' nekrosi epatoċellulari multifokali riversibbli b'żidiet assoċjati fl-ALT, AST, alkaline phosphatase u/jew bilirubin.
English: Persistence of resistance-associated substitutions
Maltese: PRODOTTI GASTROINTESTINALI Antaċidu
English: Efficacy in patients with HCV genotype 1 and HIV-1 co-infection In study C212, patients with HIV-1 co-infection who were treatment-naïve or failed prior peg-IFN/RBV therapy received simeprevir (150 mg once daily) + peginterferon alfa-2a + ribavirin for 12 weeks, followed by 12 or 36 additional weeks of peginterferon alfa-2a + ribavirin (see tables 17 and 18).
Maltese: L-effikaċja f'pazjenti b'infezzjoni ta' HCV tal-ġenotip 1 flimkien ma' infezzjoni tal-HIV-1 Fl-istudju C212, pazjenti b'infezzjoni tal-HIV-1 flimkien ma' HCV li qatt ma kienu ħadu trattament qabel jew li fallew terapija preċedenti b'peg-IFN/RBV irċivew simeprevir (150 mg darba kuljum) + peginterferon alfa-2a + ribavirin għal 12-il ġimgħa, segwiti minn 12 jew 36 ġimgħa addizjonali ta' peginterferon alfa-2a + ribavirin (ara tabelli 17 u 18).