FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 13: Treatment outcome in HCV genotype 1 infected patients receiving 12 weeks simeprevir + sofosbuvir (studies HPC3017 and HPC3018) Treatment outcome
Maltese: Tabella 13: Riżultat tat-trattament f'pazjenti infettati b'HCV tal-ġenotip 1 li kienu qed jirċievu 12-il ġimgħa ta' simeprevir + sofosbuvir (studji HPC3017 u HPC3018)
English: (OATP1B1/3, BCRP transporter inhibition)
Maltese: (impediment tat-trasportatur OATP1B1/3, BCRP)
English: Discontinuation of simeprevir due to adverse reactions occurred in 0.9% of patients receiving simeprevir with peginterferon alfa and ribavirin.
Maltese: ll-waqfien ta' simeprevir minħabba reazzjonijiet avversi seħħew f'0.9% ta' pazjenti li ħadu simeprevir ma' peginterferon alfa u ribavirin.
English: Substitutions such as D168V or A, and R155K were usually associated with large reductions in susceptibility to simeprevir in vitro (FC in EC50 > 50), whereas other substitutions such as Q80K or R, S122R, and D168E displayed in vitro low level resistance (FC in EC50 between 2 and 50).
Maltese: f'EC50 > 50), filwaqt li sostituzzjonijiet oħra bħal Q80K jew R, S122R, u D168E wrew reżistenza ta' livell baxx (FC f'EC50bejn 2 u 50).
English: 1 p < 0.001 compared to historical control of peginterferon alfa and ribavirin.
Maltese: mingħajr Q80K Ġenotip 1b 1 p < 0.001 imqabbel ma' kontroll storiku ta' peginterferon alfa u ribavirin.
English: 3 Overall treatment duration with peg-IFN-alfa and RBV was response-guided.
Maltese: 3 It-tul ta' żmien totali ta' trattament b'peg-IFN-alfa u RBV kien iġġwidat mir-rispons.
English: 1 The one patient with on-treatment failure discontinued treatment early due to an adverse event.
Maltese: 1 Il-pazjenti wieħed li kellu falliment waqt it-trattament waqqaf it-trattament kmieni minħabba avveniment avvers.
English: Simeprevir is highly protein bound, therefore dialysis is unlikely to result in significant removal of simeprevir (see section 5.2).
Maltese: Simeprevir jintrabat b'mod qawwi mal-proteini, għalhekk huwa improbabbli li d-dijalisi tirriżulta fi tneħħija sinifikanti ta' simeprevir (ara sezzjoni 5.2).
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: HCV ittrattati b'simeprevir flimkien ma' peginterferon alfa u ribavirin (tabelli 19, 21, 22).
English: (intestinal CYP3A4 enzyme and P-gp transporter inhibition)
Maltese: (impediment tal-enzima ta' CYP3A4 intestinali u trasportatur ta' P-gp)
English: 2 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: 2 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: This effect was observed at higher systemic exposures (11-fold) than those in humans at the recommended dose of 150 mg once daily.
Maltese: Dan l-effett kien osservat f'esponimenti sistemiċi ogħla (11-il darba) minn dawk fil bniedem fid-doża rakkomandata ta' 150 mg darba kuljum.
English: Table 2: Recommended treatment duration for OLYSIO combination therapy with peginterferon alfa and ribavirin1 in HCV genotype 1 or 4
Maltese: Tabella 2: Tul ta' żmien rakkomandat għat-terapija b'OLYSIO flimkien ma' peginterferon alfa u ribavirin1 f'pazjenti bil-ġenotip 1 jew 4 ta' HCV
English: The primary enzyme involved in the biotransformation of simeprevir is CYP3A4 (see section 5.2) and clinically relevant effects of other medicinal products on simeprevir pharmacokinetics via CYP3A4 may occur.
Maltese: L-enzima prinċipali involuta fil-bijotrasformazzjoni ta' simeprevir hi CYP3A4 (ara sezzjoni 5.2) u jistgħu jseħħu effetti klinikament rilevanti minn prodotti mediċinali oħra fuq il-farmakokinetiċi ta'
English: 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 + RBV3; 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 + RBV3; 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: had non-CC IL28B alleles (CT or TT); 33% were treatment-naïve, and 68% were treatment-experienced.
Maltese: CC (CT jew TT); 33% ma kinux ħadu trattament qabel, u 68% kienu ħadu trattament qabel.
English: NAME OF THE MEDICINAL PRODUCT OLYSIO 150 mg hard capsules
Maltese: OLYSIO 150 mg kapsuli ibsin
English: (OATP1B1 transporter and/or CYP3A4 enzyme inhibition)
Maltese: (Trasportatur ta' OATP1B1 u/jew impediment tal-enzima ta' CYP3A4)
English: Sofosbuvir2 400 mg once daily sofosbuvir AUC 3.16 (2.25-4.44) ↑ sofosbuvir Cmax 1.91 (1.26-2.90) ↑ sofosbuvir Cmin not studied GS-331007 AUC 1.09 (0.87-1.37) ↔ GS-331007 Cmax 0.69 (0.52-0.93) ↓ GS-331007 Cmin not studied simeprevir AUC 0.94 (0.67-1.33) ↔ simeprevir Cmax 0.96 (0.71-1.30) ↔ simeprevir Cmin not studied
Maltese: Sofosbuvir2 400 mg darba kuljum sofosbuvir AUC 3.16 (2.25-4.44) ↑ sofosbuvir Cmax 1.91 (1.26-2.90) ↑ sofosbuvir Cmin ma ġiex studjat GS-331007 AUC 1.09 (0.87-1.37) ↔ GS-331007 Cmax 0.69 (0.52-0.93) ↓
English: Ritonavir1 100 mg twice daily simeprevir AUC 7.18 (5.63-9.15) ↑ simeprevir Cmax 4.70 (3.84-5.76) ↑ simeprevir Cmin 14.35 (10.29-20.01) ↑
Maltese: 100 mg darbtejn kuljum simeprevir AUC 7.18 (5.63-9.15) ↑ simeprevir Cmax 4.70 (3.84-5.76) ↑ simeprevir Cmin 14.
English: Simvastatin 40 mg simvastatin AUC 1.51 (1.32-1.73) ↑ simvastatin Cmax 1.46 (1.17-1.82) ↑ simvastatin Cmin not studied simvastatin acid AUC 1.88 (1.63-2.17) ↑ simvastatin acid Cmax 3.03 (2.49-3.69) ↑ simvastatin acid Cmin not studied
Maltese: simvastatin Cmin ma ġiex studjat simvastatin acid AUC 1.88 (1.63-2.17) ↑ simvastatin acid Cmax 3.03 (2.49-3.69) ↑
English: GASTROINTESTINAL PRODUCTS Antacid
Maltese: PRODOTTI GASTROINTESTINALI
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 HPC3007 ta' fażi 3).
English: SVR12 rates were statistically significantly higher for patients receiving simeprevir with peginterferon alfa-2a or peginterferon alfa-2b and ribavirin (88% and 78%, respectively) compared to patients receiving placebo with peginterferon alfa-2a or peginterferon alfa-2b and ribavirin (62% and 42%, respectively) (study C216).
Maltese: Ir-rati ta' SVR12 kienu statistikament b'mod sinifikanti ogħla għal pazjenti li kienu qed jirċievu simeprevir ma' peginterferon alfa-2a jew peginterferon alfa-2b u ribavirin (88% u 78%,
English: As simeprevir is highly bound to plasma proteins, it is unlikely that it will be significantly removed by dialysis.
Maltese: Peress li simeprevir jingħaqad b'mod qawwi ma' proteini fil-plażma, huwa improbabbli li ser jitneħħa f'ammonti sinifikanti bid-dijalisi.
English: (intestinal CYP3A4 enzyme inhibition)
Maltese: (impediment tal-enzima CYP3A4 intestinali)
English: Treatment-emergent laboratory abnormalities that were observed at a higher incidence in simeprevir-treated patients than in patients treated with placebo, peginterferon alfa and ribavirin are given in table 7.
Maltese: Abnormalitajiet tal-laboratorju li nkixfu waqt it-trattament li ġew osservati f'inċidenza ogħla f'pazjenti trattati b'simeprevir milli f'pazjenti trattati bi plaċebo, peginterferon alfa u ribavirin huma mogħtija f'tabella 7.
English: Simeprevir in combination with peginterferon alfa and ribavirin: During the 12 weeks treatment with simeprevir, photosensitivity reactions were reported in 4.7% of simeprevir-treated patients compared to 0.8% in placebo-treated patients (all grades; pooled phase 3).
Maltese: Simeprevir flimkien ma' peginterferon alfa u ribavirin: Matul it-trattament ta' 12-il ġimgħa b'simeprevir, ir-reazzjonijiet ta' fotosensittività kienu rapportati f'4.7% ta' pazjenti trattati b'simeprevir meta mqabbla ma' 0.8% f'pazjenti trattati bi plaċebo (il-gradi kollha: riżultati miġbura ta' fażi 3).
English: Table 4: Interactions and dose recommendation with other medicinal products Medicinal products by therapeutic areas
Maltese: Tabella 4: Interazzjonijiet u rakkomandazzjonijiet dwar id-doża ma' prodotti mediċinali oħra
English: DXM AUC 1.08 (0.87-1.35) ↑ DXM Cmax 1.21 (0.93-1.57) ↑ DXM Cmin not studied dextrorphan AUC 1.09 (1.03-1.15) ↔ dextrorphan Cmax 1.03 (0.93-1.15) ↔ dextrorphan Cmin not studied
Maltese: DXM Cmin ma ġiex studjat dextrorphan AUC 1.09 (1.03-1.15) ↔ dextrorphan Cmax 1.03 (0.93-1.15) ↔
English: (OATP1B1/3 transporter inhibition)
Maltese: (impediment tat-trasportatur OATP1B1/3)
English: Contraception
Maltese: ANTIARRITMIĊI
English: The median baseline CD4+ cell count in patients on highly active antiretroviral therapy (HAART) was 561 x 106 cells/ml (range: 275-1,407 x 106 cells/ml).
Maltese: Il-medjan tal-għadd ta ċelluli CD4+ fil-linja bażi f'pazjenti li kienu fuq terapija antiretrovirali attiva ħafna (HAART - highly active antiretroviral therapy) kien ta' 561 x 106
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 and sofosbuvir with ribavirin.
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: (CYP3A4 enzyme induction [etravirine or nevirapine] or inhibition [delavirdine])
Maltese: (Sensibilizzazzjoni [etravirine jew nevirapine] jew impediment [delavirdine] tal-enzima ta' CYP3A4).
English: tacrolimus AUC 0.83 (0.59-1.16) ↓ tacrolimus Cmax 0.76 (0.65-0.90) ↓ tacrolimus Cmin not studied simeprevir AUC 1.85 (1.18-2.91) ↑6 simeprevir Cmax 1.79 (1.22-2.62) ↑6 simeprevir Cmin not studied6
Maltese: tacrolimus Cmin ma ġiex studjat simeprevir AUC 1.85 (1.18-2.91) ↑6 simeprevir Cmax 1.79 (1.22-2.62) ↑6
English: It is not recommended to co-administer OLYSIO with cobicistat-containing medicinal products.
Maltese: OLYSIO jingħata flimkien ma' prodotti mediċinali li fihom cobicistat.
English: Table 17: Studies conducted with simeprevir + peginterferon alfa + ribavirin: population and summary of study design
Maltese: Tabella 18: Studji li saru b'simeprevir + peginterferon alfa + ribavirin: demografika u karatteristiċi fil-linja bażi
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: 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: Viral relapse2
Maltese: Rikaduta virali2
English: 2 Treatment-experienced to prior treatment with peginterferon and ribavirin.
Maltese: 2 Kienu ħadu trattament preċedenti b'peginterferon u ribavirin.
English: During administration of simeprevir with peginterferon alfa and ribavirin, the elevations in direct and indirect bilirubin were generally not associated with elevations in liver transaminases and normalised after end of treatment.
Maltese: Waqt l-għoti ta' simeprevir ma' peginterferon alfa u ribavirin, iż-żidiet fil-livelli ta' bilirubina diretta u indiretta ġeneralment ma kinux assoċjati ma' żidiet fil-livelli ta' transaminases tal-fwied u ġew normali wara t-tmiem tat-trattament.
English: or amiodarone to treat irregular heart beat - clarithromycin, erythromycin (when taken by mouth or given by injection) or telithromycin to treat bacterial infections - warfarin and other similar medicines called vitamin K antagonists used to thin the blood.
Maltese: - clarithromycin, erythromycin (meta jittieħdu mill-ħalq jew jingħataw b'injezzjoni) jew telithromycin biex jiġu ttrattati infezzjonijiet batteriċi - warfarin u mediċini oħra simili msejħa antagonisiti tal-vitamina K użati biex iraqqu d-demm.
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: 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 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: sofosbuvir kien 83% (128/155); il-pazjenti kollha li ma kisbux SVR12 kellhom rikaduta virali (17%;
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 għall istess tul ta' żmien bħal pazjenti infettati b'HCV biss.
English: How to store OLYSIO
Maltese: X'inhu OLYSIO
English: ciclosporin AUC 1.19 (1.13-1.26) ↑ ciclosporin Cmax 1.16 (1.07-1.26) ↑ ciclosporin Cmin not studied simeprevir AUC 5.81 (3.56-9.48) ↑5 simeprevir Cmax 4.74 (3.12-7.18) ↑5 simeprevir Cmin not studied5
Maltese: ciclosporin Cmin ma ġiex studjat simeprevir AUC 5.81 (3.56-9.48) ↑5 simeprevir Cmax 4.74 (3.12-7.18) ↑5
English: Effect on drug levels Least Squares Mean Ratio (90%CI)
Maltese: L-Inqas Proporzjon Medju Kwadru (90%CI)
English: 3 Substitutions only observed in combinations with other emerging substitutions at one or more of the NS3 positions 80,
Maltese: Sostituzzjonijiet ta' aċidi amminiċi fil-pożizzjonijiet ta' NS3 ta' 43, 80,
English: Amylase and lipase elevations were not associated with pancreatitis.
Maltese: Iż-żidiet fl-amylase u l-lipase ma kinux assoċjati ma' pankreatite.
English: HCV geno/subtype and presence of baseline Q80K polymorphism in HCV genotype 1a 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 Ġenotip 1a b'Q80K
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: 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: Excipient with known effect: each capsule contains 78.4 mg of lactose (as monohydrate).
Maltese: Kull kapsula iebsa fiha simeprevir sodium ekwivalenti għal 150 mg ta' simeprevir. Eċċipjent b'effett magħruf: kull pillola fiha 78.4 mg lactose (bħala monohydrate).
English: 1 Treatment-experienced to prior treatment with peginterferon and ribavirin.
Maltese: 1 Kienu ħadu trattament preċedenti b'peginterferon u ribavirin.
English: The 63 enrolled patients had a median age of 51 years (range 24 to 68 years; with 2% above 65 years); 54% were male; 43% had a BMI ≥ 30 kg/m2; the median baseline HCV RNA level was 6.01 log10 IU/ml; 37% had cirrhosis; 30% had HCV genotype 4a, and 56% HCV genotype 4c or 4d; 79% had non-CC IL28B alleles (CT or TT); 52% were treatment-naïve, and 48% were treatment-experienced.
Maltese: IU/ml; 37% kellhom ċirrożi; 30% kellhom HCV tal-ġenotip 4a, u 56% HCV tal-ġenotip 4c jew 4d; 79% kellhom alleli IL28B mhux CC (CT jew TT); 52% ma kinux ħadu trattament qabel, u 48% kienu ħadu trattament qabel.
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'
English: Pre-treatment testing for NS3 Q80K polymorphism in patients infected with HCV genotype 1a OLYSIO in combination with sofosbuvir
Maltese: Ittestjar qabel it-trattament għal polimorfiżmu Q80K ta' NS3 f'pazjenti infettati b'HCV tal-ġenotip 1a OLYSIO flimkien ma' sofosbuvir
English: The safety profile of simeprevir is comparable in patients with HCV genotype 4 infection and HCV genotype 1 infection, when given either in combination with sofosbuvir or in combination with peginterferon alfa and ribavirin.
Maltese: Il-profil ta' sigurtà ta' simeprevir huwa kumparabbli f'pazjenti b'infezzjoni ta' HCV tal-ġenotip 4 u infezzjoni ta' HCV tal-ġenotip 1, meta jew jingħata flimkien ma' sofosbuvir jew flimkien ma' peginterferon alfa u ribavirin.
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) Blood bilirubin increased
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: Inhibitors of OATP1B1/3 such as eltrombopag or gemfibrozil may result in increases in simeprevir plasma concentrations.
Maltese: Impedituri ta' OATP1B1/3 bħal eltrombopag jew gemfibrozil jistgħu jirriżultaw f'żidiet fil-konċentrazzjonijiet ta' simeprevir filplażma.
English: Common: may affect up to 1 in 10 people: - increased ‘bilirubin' levels in your blood (bilirubin is a pigment made by the liver)* - being sensitive to sunlight (photosensitivity) - constipation.
Maltese: Komuni: jistgħu jaffettwaw sa persuna 1 f'10 - żieda fil-livelli ta' ‘bilirubina' fid-demm tiegħek (il-bilirubina hija pigment magħmul mill fwied)* - tkun sensittiv għad-dawl tax-xemx (fotosensittività) - stitikezza.
English: without cirrhosis, who are co-infected with HIV
Maltese: b'ċirrożi jew mingħajrha, li mhumiex infettati b'HIV
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: 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: Table 5: Adverse reactions identified with simeprevir in combination with sofosbuvir or simeprevir in combination with peginterferon alfa and ribavirin1
Maltese: Reazzjonijiet avversi identifikati b'simeprevir flimkien ma' sofosbuvir jew simeprevir flimkien ma' peginterferon alfa u ribavirin1
English: Pharmacotherapeutic group: Antivirals for systemic use, direct acting antivirals, ATC code: J05AE14.
Maltese: Antivirali għal użu sistemiku, antivirali li jaġixxi direttament, Kodiċi
English: CT
Maltese: CBC
English: Interim data from a phase 2 study in 11 HCV infected post-liver transplant patients.
Maltese: Tagħrif interim minn studju ta' fażi 2 fi 11-il pazjent infettat b'HCV wara trapjant tal-fwied.
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) Laboratory parameter WHO toxicity range1 12 weeks simeprevir +
Maltese: sofosbuvir (12-il ġimgħa: ġabra tal-istudji HPC2002, HPC3017 u HPC3018; 24 ġimgħa: l-istudju HPC2002) Parametru tallaboratorju
English: OLYSIO is not recommended in patients with moderate or severe hepatic impairment (Child-Pugh class B or C) (see sections 4.2 and 4.4).
Maltese: OLYSIO mhuwiex irrakkomandat f'pazjenti b'indeboliment tal-fwied moderat jew sever (Klassi ta' Child-Pugh B jew Ċ) (ara sezzjonijiet 4.2 u 4.4).
English: Interactions with medicinal products
Maltese: Interazzjonijiet ma' prodotti mediċinali.
English: Missed dose
Maltese: NRTIs oħra
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 ribavirin.
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 12
English: Interim data from a phase 2 study in 9 HCV infected post-liver transplant patients.
Maltese: Tagħrif interim minn studju ta' fażi 2 f'9 pazjenti infettati b'HCV wara trapjant tal-fwied.
English: Most of these emerging substitutions have been shown to reduce simeprevir anti-HCV activity in cell culture replicon assays.
Maltese: Il-maġġoranza ta' dawn is-sostituzzjonijiet li tfaċċaw intwerew li jnaqqsu l anti-HCV ta' simeprevir f'assaġġi ta' replikon fil-kultura ċellulari.
English: Amino acid substitutions at NS3 positions 43, 80, 122, 155, 156, and 168 reduced in vitro simeprevir activity.
Maltese: 122, 155, 156 u 168 naqqsu l-attività ta' simeprevir in vitro.
English: The recommended co-administered medicinal product(s) and treatment duration for OLYSIO combination therapy are provided in tables 1 and 2.
Maltese: kombinazzjoni ta' OLYSIO huma provduti f'tabelli 1 u 2.