FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients in these studies, 108, 111 and C216, had compensated liver disease, detectable HCV RNA, and liver histopathology consistent with chronic hepatitis C. Unless otherwise indicated, INCIVO was administered at a dosage of 750 mg every 8 hours (q8h); the peginterferon alfa-2a dose was 180 µg/week, and the ribavirin dose was 1,000 mg/day (patients weighing < 75 kg) or 1,200 mg/day (patients weighing ≥ 75 kg).
Maltese: Sakemm ma kienx indikat mod ieħor, INCIVO ngħata f'doża ta' 750 mg kull 8 sigħat (q8h); id-doża ta' peginterferon alfa-2a kienet ta' 180 µg/ġimgħa, u d-doża ta' ribavirin kienet ta' 1,000 mg/jum (pazjenti jiżnu < 75 kg) jew 1,200 mg/jum (pazjenti jiżnu ≥ 75 kg).
English: The 1,088 enrolled patients had a median age of 49 years (range: 18 to 69); 58% of the patients were male; 23% had a body mass index ≥ 30 kg/m2; 9% were Black; 11% were Hispanic or Latino; 77% had baseline HCV RNA levels ≥ 800,000 IU/ml; 15% had bridging fibrosis; 6% had cirrhosis; 59% had HCV genotype 1a; and 40% had HCV genotype 1b.
Maltese: L-1,088 pazjent imdaħħla fl-istudju kellhom età medjana ta' 49 sena(medda: 18 sa 69); 58% talpazjenti kienu rġiel; 23% kellhom indiċi tal-massa tal-ġisem ta' ≥ 30 kg/m2; 9% kienu Suwed; 11% kienu ta' dixxendenza Spanjola jew Latina; 77% kellhom livelli ta' RNA ta' HCV ta' ≥ 800,000 IU/ml fil-linja bażi; 15% kellhom fibrożi li tgħaqqad vini flimkien; 6% kellhom ċirrożi; 59% kellhom HCV tal-ġenotip 1a; u 40% kellhom HCV tal-ġenotip 1b.
English: INCIVO, 1,125 mg (three 375 mg film-coated tablets) should be taken orally twice daily (b.i.d.)
Maltese: INCIVO, 1,125 mg (tlett pilloli ta' 375 mg miksijin b'rita) għandhom jittieħdu mill-ħalq darbtejn kuljum (b.i.d.) mal-ikel.
English: Alternatively, telaprevir can be administered orally with food as 375 mg tablets, 750 mg every 8 hours (q8h) for 12 weeks, in combination with peginterferon alfa and ribavirin.
Maltese: Alternattivament, telaprevir jista' jingħata mal-ikel mill-ħalq bħala pilloli ta' 375 mgm 750 mg kull 8 sigħat (q8h) għal 12-il ġimgħa, flimkien ma' peginterferon alfa u ribavirin.
English: - Adequately controlled thyroid function (TSH) - Calculated creatinine clearance ≥ 50 ml/min
Maltese: - Funzjoni tat-tirojde kkontrollata b'mod xieraq (TSH) - Tneħħija tal-kreatinina kkalkulata ≥ 50 ml/min - Potassium ≥ 3.5 mmol/lAlbumin > 3.3 g/dl
English: 21.6% of patients receiving INCIVO combination treatment required ribavirin dose reduction for anaemia compared to 9.4% of patients receiving peginterferon alfa and ribavirin alone.
Maltese: 21.6% tal-pazjenti li kienu qed jirċievu kura bit-taħlita li tinkludi INCIVO kellhom bżonn ta' tnaqqis fid-doża ta' ribavirin meta mqabbla ma' 9.4% tal-pazjenti li kienu qed jirċievu peginterferon alfa u ribavirin biss.
English: EE-11415 Tallinn
Maltese: J05AE11
English: The incidence of adverse drug reactions (ADRs) of at least moderate intensity (≥ Grade 2) was higher in the INCIVO group than in the placebo group.
Maltese: L-inċidenza ta' reazzjonijiet avversi għall-mediċina (ADRs) ta' mill-anqas intensità moderata (≥ Grad 2) kienet ogħla fil-grupp ta' INCIVO milli fil-grupp ta' plaċebo.
English: Plasma concentrations with the telaprevir 1,875 mg every 8 hours dose used in this trial were comparable to those observed in studies in HCV-infected patients who received telaprevir 750 mg every 8 hours in combination with peginterferon alfa-2a and ribavirin.
Maltese: Il-konċentrazzjonijiet fil-plażma b'doża ta' 1,875 mg ta' telaprevir kull 8 sigħat li ntużat f'din il-prova kienu jixbhu lil dawk osservati fi studji ta' pazjenti infettati b'HCV li rċivew 750 mg ta' telaprevir kull 8 sigħat flimkien ma' peginterferon alfa-2a u ribavirin.
English: Study C216 was a randomised, double-blind, placebo-controlled, Phase 3 study conducted in patients who did not achieve SVR with prior treatment with peginterferon alfa-2a and ribavirin or peginterferon alfa-2b and ribavirin.
Maltese: L-istudju C216 kien studju randomised, double-blind, tal-Fażi 3, ikkontrollat bi plaċebo li sar f'pazjenti li ma kisbux SVR meta qabel kienet ingħatatilhom kura b'peginterferon alfa-2a u ribavirin jew peginterferon alfa-2b u ribavirin.
English: General disorders and administration site conditions common oedema peripheral, product taste abnormal the placebo-controlled Phase 2 and Phase 3 Studies (pooled data) included 1,346 HCV-infected patients incidence rates are based on adverse event reporting rates (additionally, see Laboratory abnormalities below)
Maltese: L-istudji ta' fażi 2 u fażi 3 ikkontrollati bil-plaċebo (dejta miġbura)inkludew 1,346 pazjent infettati bl-HCV rati ta' inċidenza huma bbażati fuq ir-rati ta' rrappurtar dwar każijiet avversi (addizzjonalment, ara Anormalitajiet tal
English: Toxic epidermal necrolysis (TEN) including fatal outcome has been observed in post-marketing experience (see section 4.8).
Maltese: Nekroliżi epidermali tossika (TEN) inkluż riżultat fatali ġiet osservata flesperjenza ta' wara t-tqegħid fis-suq (ara sezzjoni 4.8).
English: ↑ ketoconazole (200 mg) AUC 2.25 (1.93-2.61) Cmax 1.75 (1.51-2.03)
Maltese: ↑ amlodipine AUC 2.79 (2.58-3.01) Cmax 1.27 (1.21-1.33) impediment ta' CYP3A
English: Cmin 1.10 (0.97-1.24) induction of CYP3A by carbamazepine, and inhibition of CYP3A by telaprevir
Maltese: 73-0.98) Cmin 1.85 (1.40-2.44) impediment ta' CYP3A b'telaprevir
English: Co-administration of INCIVO and medicinal products that induce CYP3A and/or P-gp may markedly decrease telaprevir plasma concentrations.
Maltese: L-għoti ta' INCIVO flimkien ma' prodotti mediċinali li jinduċu CYP3A u/jew P-gp jista' jnaqqas b'mod sinifikanti l-konċentrazzjonijiet ta' telaprevir fil-plażma.
English: Table 15 shows the response rates for the T12/PR48 and the Pbo/PR48 arms.
Maltese: It-Tabella 15 turi r-rati ta' rispons għall-fergħat tal-kura T12/PR48 u Pbo/PR48.
English: Alternatively, 750 mg (two 375 mg tablets) can be taken orally every 8 hours (q8h) with food.
Maltese: Alternattivament, 750 mg (żewġ pilloli ta' 375 mg) jistgħu jittieħdu mill-ħalq kull 8 sigħat (q8h) mal-ikel.
English: )/PR group and the T12(q8h)/PR group.
Maltese: Tabella 5 turi r-rati ta' rispons għall-gruppi T12(b.i.d.)/PR u T12(q8h)/PR.
English: Rare side effects (affects less than 1 in 1,000 people): - a wide-spread severe rash with peeling skin which may be accompanied by fever, flu-like symptoms, blisters in the mouth, eyes, and/or genitals (Stevens-Johnson syndrome).
Maltese: Effetti sekondarji rari (jaffettwaw anqas minn persuna waħda minn kull 1,000) - raxx mifrux u qawwi bil-ġilda titqaxxar li jista' jseħħ flimkien ma' deni, sintomi bħal tal influwenza, nfafet fil-ħalq, fl-għajnejn u/jew fil-ġenitali (sindrome ta' Stevens-Johnson)
English: INCIVO acts against the virus that causes hepatitis C infection and is used to treat chronic hepatitis C infection in adult patients (aged 18-65 years) in combination with peginterferon alfa and ribavirin.
Maltese: INCIVO jaġixxi kontra l-virus li jikkawża l-infezzjoni tal-epatite Ċ u jintuża biex jikkura l-infezzjoni tal-epatite Ċ kronika f'pazjenti adulti (ta' età ta' bejn 18-il sena u 65 sena) flimkien ma' peginterferon alfa u ribavirin.
English: INCIVO, in combination with peginterferon alfa and ribavirin, is indicated for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease (including cirrhosis):
Maltese: INCIVO, flimkien ma' peginterferon alfa u ribavirin, huwa indikat għall-kura ta' epatite Ċ kronika talġenotip 1 f'pazjenti adulti b'mard tal-fwied ikkumpensat (inkluż ċirrożi):
English: Following administration of a single oral dose of 750 mg
Maltese: Wara għoti ta' doża singola ta' 750 mg telaprevir
English: amiodarone, bepridil, quinidine, other Class Ia or III antiarrhythmics to treat certain heart disorders such as irregular heart beat (antiarrhythmics)
Maltese: amiodarone, bepridil, quinidine, antiarritmiċi oħrajn tal-Klassi
English: At baseline, 3 (8%) patients had bridging fibrosis and 2 (5%) patients had cirrhosis in the T12/PR48 arm.
Maltese: Fil-linja bażi, 3 (8%) pazjenti kellhom fibrożi li tgħaqqad il-vini flimkien u 2 (5%) pazjenti kellhom ċirrożi fil-fergħa T12/PR48.
English: For all populations in the study (prior relapsers, prior partial responders, and prior null responders), SVR rates were higher for the T12/PR group than for the Pbo/PR48 group across subgroups by sex, age, race, ethnicity, body mass index, HCV genotype subtype, baseline HCV RNA level, and extent of liver fibrosis.
Maltese: Għall-popolazzjonijiet kollha tal-istudju (dawk li qabel kienu rkadew, dawk li qabel ma kinux irrispondew b'mod sħiħ u dawk li qabel ma kienu rrispondew xejn għall-kura), ir-rati ta' SVR kienu ogħla għall-grupp T12/PR milli għall-grupp ta' Pbo/PR48 fost is-sottogruppi skont is-sess, l-età, ir-razza, l-etniċità, l-indiċi tal-massa tal-ġisem, is-sottotip tal-ġenotip ta' HCV, il-livell tal-RNA ta' HCV fil-linja bażi u l-grad ta' fibrożi fil-fwied.
English: Patients were randomised to 12 weeks of INCIVO (750 mg every 8 hours if taken in combination with atazanavir/ritonavir, tenofovir disoproxil fumarate, and emtricitabine or lamivudine OR 1,125 mg every 8 hours if taken in combination with efavirenz, tenofovir disoproxil fumarate, and emtricitabine) or placebo.
Maltese: Il-pazjenti ntgħażlu b'mod każwali għal 12-il ġimgħa ta' INCIVO (750 mg kull 8 sigħat jekk ittieħed flimkien ma' atazanavir/ritonavir, tenofovir disoproxil fumarate, u emtricitabine jew lamivudine JEW 1,125 mg kull 8 sigħat jekk ittieħed flimkien ma' efavirenz, tenofovir disoproxil fumarate, u emtricitabine) jew plaċebo.
English: T12/P(2a)R48: INCIVO for 12 weeks in combination with peginterferon alfa-2a and ribavirin for 24 or 48 weeks T12/P(2b)R48: INCIVO for 12 weeks in combination with peginterferon alfa-2b and ribavirin for 24 or 48 weeks 95% confidence interval for the difference was (-10.8, 12.1) Denominator was the number of patients with undetectable HCV RNA (target not detected) at end of treatment
Maltese: T12/P(2a)R48: INCIVO għal 12-il ġimgħa flimkien ma' peginterferon alfa-2a u ribavirin għal 24 jew 48 ġimgħa T12/P(2b)R48: INCIVO għal 12-il ġimgħa flimkien ma' peginterferon alfa-2b u ribavirin għal 24 jew 48 ġimgħa 95% confidence interval għad-differenza kien ta' (-10.8, 12.1)
English: Co-administration with phenobarbital is contraindicated.
Maltese: L-għoti flimkien ma' phenobarbital huwa kontraindikat.
English: Rīga, LV-1004
Maltese: L-Istudju 106 u l-Istudju 107
English: There are no clinical data on the use of INCIVO in HCV patients with moderate or severe renal impairment (CrCl ≤ 50 ml/min) (see section 4.4).
Maltese: M'hemm l-ebda dejta klinika dwar l-użu ta' INCIVO f'pazjenti b'HCV b'indeboliment moderat jew qawwi tal-kliewi (CrCl ≤ 50 ml/min) (ara sezzjoni 4.4).
English: Of the 393 resistant variants detected in the 255 patients, 68% of NS3-36, 84% of NS3-54, 59% of NS3-155, 86% of NS3-156, and 52% of NS3-36M+NS3-155K variants were no longer detected.
Maltese: NS3-54, 59% tal-varjanti NS3-155, 86% tal-varjanti
English: The exposure to telaprevir was increased by 20% when taken following a high-fat caloric meal (56 g fat, 928 kcal) compared to an intake following a standard normal caloric meal (21 g fat, 533 kcal).
Maltese: L-esponiment għal telaprevir żdied b'20% meta ttieħed ma' ikla b'kontenut għoli ta' xaħam u kaloriji (56 g ta' xaħam, 928 kkal) meta tqabbel ma' meta ttieħed wara ikla normali b'ammont standard ta' kaloriji (21 g ta' xaħam, 533 kkal).
English: The 74 enrolled patients had a median age of 56 years (range: 43 to 68 years); 91.9% of the patients were male; 24.3% had a body mass index ≥ 30 kg/m2; 1.4% were Black; 95.9% had baseline HCV
Maltese: L-74 pazjent arwolat kellhom età medjana ta' 56 sena (firxa: 43 sa 68 sena); 91.9% tal-pazjenti kienu rġiel; 24.3% kellhom indiċi tat-toqol tal-ġisem ≥ 30 kg/m2; 1.4% kienu Suwed; 95.9% kellhom livelli ta' HCV RNA fil-linja bażi ta' ≥ 800,000
English: The overall safety profile of INCIVO is based on Phase 2 and 3 clinical trial data (both controlled and uncontrolled) containing 3,441 patients who received INCIVO combination treatment and on
Maltese: Il-profil totali ta' sigurtà ta' INCIVO huwa bbażat fuq dejta mill-provi kliniċi tal-fażijiet 2 u 3 (kemm ikkontrollati kif ukoll mhux ikkontrollati) li fihom kien hemm 3,441 pazjent li rċieva taħlita ta' kura li tinkludi INCIVO u fuq rapporti spontanji ta' wara t-tqegħid fis-suq.
English: Study C211 was a randomised, open-label, Phase 3 study conducted in treatment-naïve patients who were randomised to one of two treatment groups: INCIVO 750 mg every 8 hours [T12(q8h)/PR] or INCIVO 1,125 mg twice daily [T12(b.i.d.
Maltese: Fl-istudju kliniku ta' fażi 3 C211, ma kien hemm ebda differenza fit-tip ta' varjanti emerġenti bejn pazjenti li rċevew telaprevir 1,125 mg darbtejn kuljum (b.i.d.) u pazjenti li rċevew telaprevir 750 mg kull 8 sigħat (q8h).
English: an herbal product to relieve anxiety to lower cholesterol levels (HMG CoA reductase inhibitors)
Maltese: prodott magħmul mill-ħxejjex biex itaffi lansjetà biex inaqqas il-livelli tal-kolesterol (impedituri ta' HMG CoA reductase)
English: SVR rates for the T12(DS)/PR group were 88% (124/141) for prior relapsers, 56% (27/48) for prior partial responders, and 33% (25/75) for prior null responders.
Maltese: Rati ta' SVR għall-grupp T12(DS)/PR kienu ta' 88% (124/141) għal individwi li kienu rkadew qabel, 56% (27/48) għal individwi li qabel ma kinux rrispondew b'mod sħiħ, u 33% (25/75) għal individwi li qabel ma kienu rrispondew xejn għall-kura.
English: )/PR: INCIVO 1,125 mg twice daily for 12 weeks with peginterferon alfa-2a and ribavirin for 24 or 48 weeks; T12(q8h)/PR: INCIVO 750 mg every 8 hours for 12 weeks with peginterferon alfa-2a and ribavirin for 24 or 48 weeks
Maltese: T12(b.i.d.)/PR: INCIVO 1,125 mg darbtejn kuljum għal 12-il gimgħa bi peginterferon alfa-2a u ribavirin għal 24 jew 48 ġimgħa; T12(q8h)/PR: INCIVO 750 mg kull 8 sigħat għal 12-il ġimgħa bi peginterferon alfa-2a u ribavirin għal 24 jew
English: The 540 enrolled patients had a median age of 51 years (range: 19 to 70); 60% of the patients were male; 32% had a body mass index ≥ 30 kg/m2; 14% were Black; 10% were Hispanic or Latino; 82% had baseline HCV RNA levels > 800,000 IU/ml; 16% had bridging fibrosis; 11% had cirrhosis; 72% had HCV genotype 1a; and 27% had HCV genotype 1b.
Maltese: Il-540 pazjent imdaħħla fl-istudju kellhom età medja ta' 51 sena (medda: minn 19 sa 70); 60% talpazjenti kienu rġiel; 32% kellhom indiċi tal-massa tal-ġisem ta' ≥ 30 kg/m2; 14% kienu Suwed; 10% kienu ta' dixxendenza Spanjola jew Latina; 82% kellhom livelli ta' RNA ta' HCV ta' > 800,000 IU/ml fil-linja bażi; 16% kellhom fibrożi li tgħaqqad vini flimkien; 11% kellhom ċirrożi; 72% kellhom HCV tal-ġenotip 1a; u 27% kellhom HCV tal-ġenotip 1b.
English: AUC 1.30 (1.22-1.39) Cmax 1.30 (1.16-1.45) Cmin 1.41 (1.29-1.54) effect on P-gp transport in the gut
Maltese: AUC 1.85 (1.70-2.00) Cmax 1.50 (1.36-1.65) effett fuq it-trasport ta' P-gp filmusrana
English: ul.
Maltese: SVR
English: Study HPC3008 was an open-label, Phase 3b study conducted in patients with chronic genotype 1 HCV/HIV-1 co-infection who were treatment-naïve for hepatitis C or who did not achieve SVR with prior treatment with peginterferon alfa (2a or 2b) and ribavirin (including prior relapsers, prior partial responders and prior null responders).
Maltese: L-Istudju HPC3008 kien studju open-label, ta' Fażi 3b li sar f'pazjenti b'koinfezzjoni kronika b'HCV tal-ġenotip 1/HIV-1 li qatt ma kienu ħadu kura qabel għal epatite C jew li ma kisbux SVR b'kura qabel b'peginterferon alfa (2a jew 2b) u ribavirin (inkluż dawk li qabel kienu rkadew, dawk li qabel ma rrispondewx b'mod sħiħ u dawk li qabel ma rrispondew xejn għall-kura).
English: Peginterferon alfa and ribavirin may be continued.
Maltese: Peginterferon alfa u ribavirin jistgħu jitkomplew.
English: Haemoglobin should be monitored at regular intervals prior to and during INCIVO combination treatment (see section 4.4, Laboratory tests).
Maltese: L-emoglobina għandha tiġi mmonitorjata f'perijodi regolari qabel u waqt l-għoti tat-taħlita ta' kura li tinkludi INCIVO (ara sezzjoni 4.4, Testiijiet tal-laboratorju).
English: Co-administration of atorvastatin and telaprevir is contraindicated (see section 4.3).
Maltese: L-għoti ta' atorvastatin flimkien ma' telaprevir huwa kontraindikat (ara sezzjoni 4.3).
English: The 162 enrolled patients had a median age of 46 years (range: 20 to 67 years); 78.4% of the patients were male; 6.8% had a body mass index ≥ 30 kg/m2; 4.3% were Black; 1.9% were Asian; 87.0% had baseline HCV RNA levels ≥ 800,000 IU/ml; 17.3% had bridging fibrosis; 13.0% had cirrhosis; 65.6% had HCV genotype 1a; 33.8% had HCV genotype 1b; 39.5% (n = 64) were HCV treatment-naïve; 17.9% (n = 29) were prior relapsers; 11.1% (n = 18) were prior partial responders; 31.5% (n = 51) were prior null responders.
Maltese: Il-162 pazjent irreġistrati fl-istudju kellhom medjan ta' età ta' 46 sena (firxa: 20 sa 67 sena); 78.4% tal-pazjenti kienu rġiel; 6.8% kellhom indiċi tal-massa tal-ġisem ≥ 30 kg/m2; 4.3% kienu Suwed; 1.9% kienu Ażjatiċi; 87.0% kellhom livelli ta' RNA ta' HCV ≥ 800,000 IU/ml fil-linja bażi; 17.3% kellhom fibrożi li tgħaqqad il-vini; 13.0% kellhom ċirrożi; 65.6% kellhom HCV tal-ġenotip 1a; 33.8% kellhom
English: During the INCIVO/placebo treatment phase, the most frequently reported ADRs of at least Grade 3 in the INCIVO group (incidence ≥ 1.0%) were anaemia, rash, thrombocytopenia, lymphopenia,
Maltese: Waqt il-fażi ta' kura b'INCIVO/plaċebo, ADRs ta' mill-anqas Grad 3 irrappurtati b'mod l-aktar frekwenti fil-grupp ta' INCIVO (inċidenza ≥ 1.0%) kienu anemija, raxx, tromboċitopenija,
English: During the INCIVO/placebo treatment phase, the most frequently reported ADRs of at least Grade 2 in severity in the INCIVO group (incidence ≥ 5.0%) were anaemia, rash, pruritus, nausea, and
Maltese: Waqt il-fażi ta' kura b'INCIVO/plaċebo, ADRs ta' mill-anqas Grad 2 fil-qawwa tagħhom irrappurtati b'mod l-aktar frekwenti fil-grupp ta' INCIVO (inċidenza ≥ 5.0%) kienu anemija, raxx, ħakk, nawsja u
English: to treat epileptic seizures (anticonvulsants)
Maltese: SUSTANZI ANTIVIRALI
English: Λεωφόρος Ειρήνης 56
Maltese: M'għandekx tnaqqas id-doża tiegħek ta' INCIVO.
English: Refer also to the Summary of Product Characteristics for ribavirin for patients with CrCl < 50 ml/min.
Maltese: Irreferi wkoll għas-Sommarju tal-Karatteristiċi tal-Prodott ta' Ribavirin għal pazjenti b'CrCl ≤ 50 ml/min.
English: The resistance profile observed in Study HPC3006 in treatment-naïve and treatment-experienced HCV-1 infected liver transplant recipients who were on a stable regimen of the immunosuppressants tacrolimus or cyclosporine A was similar to the resistance profile in HCV-infected patients without a liver transplant.
Maltese: Il-profil ta' reżistenza osservat fi Studju HPC3006 f'reċipjenti ta' trapjant tal-fwied infettati b'HCV-1 li ma ngħatawx trattament qabel u b'esperjenza ta' trattament li kienu fuq programm stabbli ta' kura bl-immunosoppressanti tacrolimus jew cyclosporin A kien simili għall-profil ta' reżistenza f'pazjenti infettati b'HCV mingħajr trapjant tal-fwied.
English: In Phase 2 and 3 clinical trials of telaprevir, treatment-naïve and prior treatment-failure patients with predominant telaprevir-resistant variants at baseline (pre-treatment) were rare (V36M, T54A and R155K < 1% and T54S 2.7%).
Maltese: Fil-provi kliniċi tal-Fażi 2 u 3 b'telaprevir, pazjenti li qatt ma kienu ħadu kura qabel u dawk li qabel ma kinitx ħadmet il-kura fuqhom li kellhom varjanti li l-biċċa l-kbira tagħhom kienu reżistenti għal telaprevir fil-linja bażi (qabel il-kura) kienu rari (V36M, T54A u R155K < 1% u T54S 2.7%).
English: Eye disorders uncommon retinopathy
Maltese: Disturbi fis-sistema endokrinarja komuni
English: Mechanism of action Telaprevir is an inhibitor of the HCV NS3•4A serine protease, which is essential for viral replication.
Maltese: Mekkaniżmu ta' azzjoni Telaprevir huwa impeditur tal-protease serine ta' HCV NS3•4A, li huwa essenzjali għar-replikazzjoni
English: HCV/HBV (hepatitis B virus) co-infection There are no data on the use of INCIVO in patients with HCV/HBV co-infection.
Maltese: Koinfezzjoni b'HCV/HBV (virus tal-epatite B)
English: Table 3: Adverse drug reactions to INCIVO (taken in combination with peginterferon alfa and ribavirin) in HCV-infected patients in clinical trials a and post-marketing Adverse Drug Reactions INCIVO, peginterferon alfa, and ribavirin combination therapy oral candidiasis anaemia thrombocytopenia b, lymphopenia hypothyroidism hyperuricaemia b, hypokalaemia gout dysgeusia, syncope
Maltese: Tabella 3: Reazzjonijiet avversi għall-mediċina INCIVO (meta dan jittieħed flimkien ma' peginterferon alfa u ribavirin) f'pazjenti infettati b'HCV fi studji kliniċi a u wara t-tqegħid
English: In two double-blind, randomised, placebo- and active-controlled studies conducted to evaluate the effect on the QT interval, telaprevir monotherapy at a dose of 750 mg every 8 hours was not associated with a clinically relevant effect on QTcF interval.
Maltese: F'żewġ studji double-blind, randomised u kkontrollati bi plaċebo u b'mod attiv li saru biex jistmaw leffett fuq l-intervall QT, terapija b'telaprevir waħdu f'doża ta' 750 mg kull 8 sigħat ma kinitx assoċjata ma' effett klinikament rilevanti fuq l-intervall QTcF.
English: More than 90% of rashes were of mild or moderate severity.
Maltese: Aktar minn 90% tal-każijiet ta' raxx kienu ta' qawwa minn ħafifa sa moderata.
English: AUC 1.00 (0.94-1.07) Cmax 1.01 (0.96-1.05) Cmin 1.03 (0.93-1.14) ↑ tenofovir
Maltese: ↑ cyclosporine AUC 4.64 (3.90-5.51) Cmax 1.32 (1.08-1.60) ↑ sirolimus ↑ tacrolimus AUC 70.3 (52.9-93.4) Cmax 9.35 (6.73-13.0) ↑ sirolimus
English: When co-administration is required, high doses of itraconazole (> 200 mg/day) or ketoconazole (> 200 mg/day) are not recommended.
Maltese: Meta jkun meħtieġ l-għoti tagħhom flimkien, dożi kbar ta' itraconazole (> 200 mg/jum) jew ketoconazole (> 200 mg/jum) mhumiex irrakkomandati.
English: Use of peginterferon alfa 2a or 2b Two types of peginterferon alfa (2a and 2b) were studied in the Phase 2a open label, randomised
Maltese: Żewġ tipi ta' peginterferon alfa (2a u 2b) ġew studjati fl-istudju C208, open label, randomised talFażi 2a f'pazjenti li qatt ma kienu ħadu kura qabel.
English: All patients received 12 weeks of INCIVO in combination with the peginterferon alfa/ribavirin standard therapy.
Maltese: Il-pazjenti kollha rċivew 12 il-ġimgħa ta' INCIVO flimkien mat-terapija standard ta' peginterferon alfa/ribavirin.
English: The overall safety profile of INCIVO in treatment- naïve and treatment-experienced HCV-1 infected patients who were liver transplant recipients on a stable regimen of the immunosuppressants tacrolimus or cyclosporine A was generally similar to the safety profile of INCIVO in patients without a history of liver transplantation, although anaemia was reported more frequently (55.4% versus 32.1% in the Phase 2-3 safety pooling) during the INCIVO treatment phase.
Maltese: Il-profil tas-sigurtà totali ta' INCIVO f'pazjenti infettati b'HCV-1 li ma ngħatawx trattament qabel jew li ngħataw trattament fi programm ta' kura stabbli tal-immunosoppressanti tacrolimus jew cyclosporin A kien ġeneralment simili għall-profil tas-sigurtà ta' INCIVO f'pazjenti mingħajr storja ta' trapjant tal-fwied, għalkemm l-anemija ġiet rapportata b'mod aktar frekwenti (55.4% kontra
English: This will allow quick identification of new safety information.
Maltese: Ebda sejbiet ġodda ta' sigurtà ma ġew identifikati.
English: Since it is highly unlikely that patients with inadequate viral responses will achieve a sustained virologic response (SVR), it is recommended that patients with HCV RNA > 1,000 IU/ml at week 4 or week 12 discontinue therapy (refer to table 1).
Maltese: Minħbba li mhuwiex probabbli li pazjenti b'rispons mhux suffiċjenti għall-virus jiksbu rispons viroloġiku miżmum (SVR), huwa rrakkomandat li pazjenti b'RNA ta' HCV > 1,000 IU/ml filġimgħa 4 jew fil-ġimgħa 12 iwaqqfu t-terapija (irreferi għat-tabella 1).
English: Clinical monitoring is recommended.
Maltese: Effikaċja klinika u sigurtà