FrancophonIA/ELRC3.0 huggingface dataset:
English: It is not recommended to co-administer OLYSIO with cobicistat-containing medicinal products.
Maltese: Mhux rakkomandat li OLYSIO jingħata flimkien ma' prodotti mediċinali li fihom cobicistat.
English: pruritus*, photosensitivity photosensitivity reaction*
Maltese: ħakk*, reazzjoni ta' sensittività għad-dawl*
English: OLYSIO is not recommended for patients with moderate or severe hepatic impairment (Child-Pugh B or C) (see sections 4.4 and 5.2).
Maltese: OLYSIO mhuwiex irrakkomandat għal pazjenti b'indeboliment tal-fwied moderat jew sever (Child-Pugh B jew Ċ) (ara sezzjonijiet 4.4 u 5.2).
English: In study HPC2002, photosensitivity reactions (grouped term) was reported in 7.1% of patients receiving 12 weeks of simeprevir and sofosbuvir without ribavirin versus 5.6% of patients receiving 12 weeks of simeprevir and sofosbuvir with ribavirin.
Maltese: Fl-istudju HPC2002, reazzjonijiet ta' fotosensittività (terminu kklassifikat flimkien) ġew irrappurtati f'7.1% tal-pazjenti li kienu qed jirċievu 12-il ġimgħa ta' simeprevir u sofosbuvir mingħajr ribavirin versus 5.6% tal-pazjenti li kienu qed jirċievu 12-il ġimgħa ta' simeprevir u sofosbuvir ma' ribavirin.
English: The dose of simeprevir in this interaction study was 50 mg when co-administered in combination with darunavir/ritonavir, compared to 150 mg in the simeprevir alone treatment group.
Maltese: Id-doża ta' simeprevir f'dan l-istudju ta' interazzjoni kienet ta' 50 mg meta ġiet mogħtija flimkien ma' darunavir/ritonavir, meta mqabbel ma' 150 mg fil-grupp ta' trattament ta' simeprevir waħdu.
English: Nifedipine
Maltese: Il-Belġju
English: Nagyenyed u. 8-14
Maltese: 48 ġimgħa
English: When ribavirin is added to the combination of OLYSIO and sofosbuvir, and ribavirin needs to be discontinued, treatment of OLYSIO with sofosbuvir without ribavirin can be continued (see section 5.1).
Maltese: Meta ribavirin jiżdied mal-kombinazzjoni ta' OLYSIO u sofosbuvir, u ribavirin ikun meħtieġ li jiġi mwaqqaf, ittrattament b'OLYSIO flimkien ma' sofosbuvir mingħajr ribavirin jista' jissokta (ara sezzjoni 5.1).
English: In study HPC3017, patients without cirrhosis were enrolled; in study HPC3018, patients with cirrhosis
Maltese: Fl-istudju HPC3017, ġew irreġistrati pazjenti mingħajr ċirrożi; fl-istudju HPC3018, ġew irreġistrati
English: In HCV genotype 1a infected patients with cirrhosis, testing for the presence of the Q80K polymorphism may be considered prior to initiation of therapy with OLYSIO in combination with sofosbuvir (see section 4.4).
Maltese: F'pazjenti infettati bil-ġenotip 1a ta' HCV b'ċirrożi, jista' jitqies ittestjar għall-preżenza ta' polimorfiżmu ta' Q80K qabel il-bidu tat-terapija b'OLYSIO flimkien ma' sofosbuvir (ara sezzjoni 4.4).
English: (mild intestinal CYP3A4 enzyme inhibition)
Maltese: (impediment tal-enzima ta' CYP3A4 intestinali
English: May include few patients with HCV non-genotype 1a/1b.
Maltese: Jista' jinkludi ftit pazjenti li mhumiex ġenotip 1a/1b ta' HCV.
English: Prior relapsers N = 22 % (n/N)
Maltese: N = 22 % (n/N)
English: The proportion of simeprevir-treated patients with HCV RNA < 25 IU/ml detectable at week 4 was 18% (47/259); 60% achieved SVR12.
Maltese: Il-proporzjon ta' pazjenti trattati b'simeprevir b'RNA ta' HCV < 25 IU/ml li setgħet titkejjel f'ġimgħa 4 kien ta' 18% (47/259); 60%
English: The overall SVR12 rate for patients without cirrhosis receiving 8 weeks of simeprevir + sofosbuvir was 75% (15/20); all patients not achieving SVR12 had viral relapse (25%; 5/20).
Maltese: Ir-rata totali ta' SVR12 għall-pazjenti mingħajr ċirrożi li kienu qed jirċievu 8 ġimgħat ta' simeprevir + sofosbuvir kienet 75% (15/20); il-pazjenti kollha li ma kisbux SVR12 kellhom rikaduta virali (25%; 5/20).
English: The planned total duration of HCV treatment was 24 weeks if the following on-treatment protocol-defined response-guided therapy criteria were met: HCV RNA < 25 IU/ml detectable or undetectable at week 4 AND undetectable HCV RNA at week 12.
Maltese: It-tul ta' żmien totali ta' trattament ippjanat għal HCV kien ta' 24 ġimgħa jekk kienu ssodisfati l-kriterji ta' terapija waqt it-trattament iddefiniti bi protokoll u gwidati mir-rispons li ġejjin:
English: Table 22: Treatment outcome in HCV genotype 1 infected patients with HIV-1 co-infection
Maltese: Tabella 13: Riżultat tat-trattament f'pazjenti infettati b'HCV tal-ġenotip 1 li kienu qed jirċievu
English: Simeprevir in combination with peginterferon alfa and ribavirin: During the first 12 weeks treatment with simeprevir, dyspnoea was reported in 11.8% of simeprevir-treated patients, compared to 7.6% in placebo-treated patients (all grades; pooled phase 3).
Maltese: Matul l-ewwel 12-il ġimgħa ta' trattament b'simeprevir, il-qtugħ ta' nifs kien osservat fi 11.8% ta' pazjenti trattati b'simeprevir meta mqabbla ma' 7.6% ta' pazjenti trattati bi plaċebo (il-gradi kollha: fażi 3 miġbura).
English: Metabolites identified in faeces were formed via oxidation at the macrocyclic moiety or aromatic moiety or both and by O-demethylation followed by oxidation.
Maltese: Il-metaboliti identifikati fl-ippurgar kienu fformati permezz tal-ossidazzjoni tal-moijetà makroċiklika jew moijetà aromatika jew it-tnejn u b'O-demetilazzjoni segwiti minn ossidazzjoni.
English: Table 5: Adverse reactions identified with simeprevir in combination with sofosbuvir or simeprevir in combination with peginterferon alfa and ribavirin
Maltese: Reazzjonijiet avversi identifikati b'simeprevir flimkien ma' sofosbuvir jew simeprevir flimkien ma' peginterferon alfa u ribavirin
English: Disopyramide
Maltese: Ġol-vina midazolam
English: Refer to the Summary of Product Characteristics of peginterferon alfa and ribavirin for pre-treatment, on-treatment and post-treatment laboratory testing requirements including haematology, biochemistry (including hepatic enzymes and bilirubin), and pregnancy testing requirements.
Maltese: Irreferi għas-Sommarju tal-Karatteristiċi tal-Prodott għal peginterferon alfa u ribavirin għar-rekwiżiti ta' testijiet tal-laboratorju qabel it-trattament, waqt it-trattament u wara t-trattament li jinkludu ematoloġija, bijokimika (li jinkludu enzimi tal-fwied u bilirubina) u rekwiżiti dwar testijiet tat-tqala.
English: Adverse reactions of simeprevir in combination with sofosbuvir or in combination with peginterferon alfa and ribavirin reported in adult patients with HCV genotype 1 infection are listed in table 5.
Maltese: Reazzjonijiet avversi ta' simeprevir flimkien ma' sofosbuvir jew flimkien ma' peginterferon alfa u ribavirin irrappurtati f'pazjenti adulti b'infezzjoni ta' HCV tal-ġenotip 1 huma mniżżla f'tabella 5.
English: Amino acid substitutions at NS3 positions 80, 122, 155, and/or 168, associated with in vitro low level resistance to simeprevir when occurring alone, reduced simeprevir activity by more than 50-fold when present in combination.
Maltese: Sostituzzjonijiet ta' aċidu amminiku fil pożizzjonijiet ta' NS3 80, 122, 155, u/jew 168, assoċjati ma' reżistenza ta' livell baxx għal simeprevir in vitro meta seħħew waħedhom, naqqsu l-attività ta' simeprevir b'aktar minn 50 darba meta kienu preżenti f'kombinazzjoni.
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: 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: Daclatasvir 60 mg once daily daclatasvir AUC 1.96 (1.84-2.10) ↑ daclatasvir Cmax 1.50 (1.39-1.62) ↑ daclatasvir Cmin 2.68 (2.42-2.98) ↑ simeprevir AUC 1.44 (1.32-1.56) ↑ simeprevir Cmax 1.39 (1.27-1.52) ↑ simeprevir Cmin 1.49 (1.33-1.67) ↑
Maltese: Tacrolimus 2 mg doża individwalizzata għal pazjent tacrolimus AUC 0.83 (0.59-1.16)  tacrolimus Cmax 0.76 (0.65-0.90)  tacrolimus Cmin ma ġiex studjat simeprevir AUC 1.90 (1.37-2.63) ↑ simeprevir Cmax 1.85 (1.40-2.46) ↑ simeprevir Cmin ma ġietx studjata
English: Simeprevir in combination with peginterferon alfa and ribavirin: During the 12 weeks treatment with simeprevir, ‘blood bilirubin increased' was reported in 7.4% of simeprevir-treated patients, compared to 2.8% in placebo-treated patients (all grades; pooled phase 3).
Maltese: Matul it-trattament ta' 12-il ġimgħa b'simeprevir, ġiet rapportata ‘żieda fil-bilirubin fid-demm' f'7.4% tal-pazjenti trattati b'simeprevir meta mqabbla ma' 2.8% f'pazjenti trattati bi plaċebo (il-gradi kollha: riżultati miġbura ta' fażi 3).
English: Table 22 shows the response rates in HCV genotype 1 infected patients with HIV-1 co-infection.
Maltese: Tabella 22 turi r-rati ta' rispons f'pazjenti infettati b'HCV tal-ġenotip 1 flimkien ma' infezzjoni ta' HIV-1.
English: Table 19: Treatment outcome in treatment-naïve HCV genotype 1 infected patients (pooled data studies C208 and C216)
Maltese: Ir-riżultati ta' trattament f'pazjenti infettati b'HCV tal-ġenotip 1 li qatt ma ħadu trattament qabel (tagħrif miġbur minn studji C208 u C216)
English: Simeprevir is primarily metabolised by the liver.
Maltese: Simeprevir huwa prinċipalment metabolizzat fil-fwied.
English: Elderly (above 65 years of age)
Maltese: Anzjani ('il fuq minn 65 sena)
English: No clinically relevant drug-drug interaction is expected.
Maltese: Mhux mistenni jkun hemm interazzjoni klinikament rilevanti bejn mediċina u oħra.
English: Prior null responders N = 40 % (n/N)
Maltese: N = 40 % (n/N)
English: 0.035 mg once daily/ 1 mg once daily ethinylestradiol AUC 1.12 (1.05-1.20) ↔ ethinylestradiol Cmax 1.18 (1.09-1.27) ↑ ethinylestradiol Cmin 1.00 (0.89-1.13) ↔ norethindrone AUC 1.15 (1.08-1.22) ↔ norethindrone Cmax 1.06 (0.99-1.14) ↔ norethindrone Cmin 1.24 (1.13-1.35) ↑
Maltese: AUC 1.18 (1.11-1.25)  darunavir Cmax 1.04 (0.99-1.10) ↔ darunavir Cmin 1.31 (1.13-1.52)  ritonavir AUC 1.32 (1.25-1.40)  ritonavir Cmax 1.23 (1.14-1.32)  ritonavir Cmin 1.44 (1.30-1.61)  simeprevir AUC 2.59 (2.15-3.11) * simeprevir Cmax 1.79 (1.55-2.06) *
English: Patient individualised dose at the discretion of the physician, according to local clinical practice.
Maltese: Doża individwalizzata tal-pazjent fid-diskrezzjoni tat-tabib, skont il-prattika klinika lokali.
English: (CYP3A4 enzyme induction)
Maltese: (sensibilizzazzjoni tal-enzima CYP3A4)
English: (intestinal CYP3A4 enzyme inhibition)
Maltese: (impediment tal-enzima intestinali ta' CYP3A4)
English: HCV geno/subtype and presence of baseline Q80K polymorphism in HCV genotype 1a
Maltese: Ġeno/sottotip ta' HCV u l-preżenza ta' polimorfiżmu ta' Q80K fil-linja bażi f'HCV tal-ġenotip 1a
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
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
English: Some of the treatment-emergent NS3 amino acid substitutions detected in simeprevir-treated patients who did not achieve SVR in clinical studies (e.g., R155K) have been shown to reduce anti-HCV activity of telaprevir, boceprevir, and other NS3/4A PIs.
Maltese: R155K) ġew osservati li jnaqqsu l-attività ta' anti-HCV ta' teleprevir, boceprevir, u PIs oħra ta' NS3/4A.
English: The median baseline CD4+ cell count in patients on highly active antiretroviral
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 10
English: Table 20 shows the response rates in treatment-experienced patients with HCV genotype 1 infection.
Maltese: Tabella 19 turi r-rati ta' rispons f'pazjenti infettati b'HCV tal-ġenotip 1 li ma kinux ħadu trattament
English: In patients aged > 45 years, dyspnoea was reported in 16.4% of simeprevir-treated patients compared to 9.1% in placebo-treated
Maltese: F'pazjenti ta' > 45 sena, il-qtugħ ta' nifs kien rapportat f'16.4% ta' pazjenti trattati b'simeprevir meta mqabbla ma' 9.1% ta' pazjenti trattati bi plaċebo (kull grad; riżultati miġbura ta' fażi 3).
English: Two patients had emerging single substitution I170T.
Maltese: Żewġ pazjenti kellhom sostituzzjoni waħda qed titfaċċa ta' I170T.
English: Increased simeprevir concentrations may occur due to mild inhibition of CYP3A4 by amlodipine and moderate inhibition of CYP3A4 by
Maltese: Żieda fil-konċentrazzjonijiet ta' simeprevir tista' sseħħ minħabba impediment ħafif ta' CYP3A4
English: Hepatic decompensation and hepatic failure, including fatal cases, have been reported post-marketing in patients treated with OLYSIO in combination with peginterferon alfa and ribavirin and in combination with sofosbuvir.
Maltese: Wara t-tqegħid fis-suq ġew irrappurtati dikumpens tal-fwied u insuffiċjenza tal-fwied, inkluż każijiet fatali, f'pazjenti ttrattati b'OLYSIO mogħti flimkien ma' peginterferon alfa u ribavirin u flimkien ma' sofosbuvir.
English: The most frequently reported adverse reactions (incidence ≥ 5% following 12 or 24 weeks of treatment) were rash, pruritus, constipation and photosensitivity reaction (see section 4.4).
Maltese: L-aktar reazzjonijiet avversi rrappurtati b'mod frekwenti (inċidenza ta' ≥ 5% wara 12 jew 24 ġimgħa ta' trattament) kienu raxx, ħakk, stitikezza, u reazzjoni ta' sensittività għad-dawl (ara sezzjoni 4.4).
English: Study HPC3007: includes 5 simeprevir-treated patients who experienced relapse
Maltese: L-istudju HPC3007: jinkludi 5 pazjenti ttrattati b'simeprevir li kellhom rikaduta wara
English: These characteristics have no clinically relevant effect on the pharmacokinetics of simeprevir based on a population pharmacokinetic analysis of HCV infected patients treated with simeprevir in combination with peginterferon alfa and ribavirin.
Maltese: Dawn il-karatteristiċi m'għandhomx effett klinikament rileventi fuq il-farmakokinetiċi ta' simeprevir abbażi tal-analiżi farmakokinetika tal-popolazzjoni ta' pazjenti infettati b'HCV trattati b'simeprevir flimkien ma' peginterferon alfa u ribavirin.
English: Βαρνάβας Χατζηπαναγής Λτδ, Λεωφόρος Γιάννου Κρανιδιώτη 226 Λατσιά
Maltese: OLYSIO għandu jintuża flimkien bħala parti minn kors ta' kura ma' mediċini oħra fit-trattament ta' infezzjoni kronika ta' epatite Ċ.
English: Treatment week 4: ≥ 25 IU/ml
Maltese: Orali: 0.075 mg/kg Ġol-vina 0.025 mg/kg
English: - being sensitive to sunlight (photosensitivity) - increased ‘bilirubin' levels in your blood (bilirubin is a pigment made by the liver).
Maltese: - tkun sensittiv għad-dawl tax-xemx (fotosensittività) - żieda fil-livelli tal-‘bilirubin' fid-demm tiegħek (bilirubin huwa pigment magħmul mill-fwied).
English: The safety profile of simeprevir in combination with sofosbuvir in patients with HCV genotype 1 infection with or without cirrhosis is based on pooled data from the phase 2 study HPC2002 and the phase 3 studies HPC3017 and HPC3018 which included 472 patients who received simeprevir with sofosbuvir without ribavirin (155, 286 and 31 patients received 8, 12 or 24 weeks of treatment, respectively) and 108 patients who received simeprevir with sofosbuvir and ribavirin (54 patients each received 12 or 24 weeks of treatment).
Maltese: Il-profil tas-sigurtà globali ta' simeprevir flimkien ma' sofosbuvir f'pazjenti b'infezzjoni ta' HCV talġenotip 1 b'ċirrożi jew mingħajrha huwa bbażat fuq ġabra ta' dejta mill-istudju HPC2002 tal-fażi 2 u l-istudji HPC3017 u HPC3018 tal-fażi 3 li kienu jinkludu 472 pazjent li rċivew simeprevir ma' sofosbuvir mingħajr ribavirin (155, 286 u 31 pazjent irċivew 8, 12 jew 24 ġimgħa ta' trattament, rispettivament) u 108 pazjenti li rċivew simeprevir ma' sofosbuvir u ribavirin (54 pazjent li kull wieħed irċieva 12 jew 24 ġimgħa ta' trattament).
English: Efficacy in treatment-experienced patients with HCV genotype 1 infection In study HPC3007 (PROMISE), patients who relapsed after prior IFN-based 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: FL-istudju HPC3007 (PROMISE), pazjenti li rkadew wara li kienu rċivew terapija preċedenti abbażi ta' IFN 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 t
English: Efficacy in patients with HCV genotype 4 infection In study HPC3011 (RESTORE), patients 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: Fl-istudju HPC3011 (RESTORE), pazjenti li qatt ma kienu ħadu trattament qabel jew li kienu 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 +
English: (studies HPC3007 and C206) Treatment Outcome
Maltese: u HPC3021) Riżultat tattrattament
English: Carcinogenicity studies with
Maltese: Calcium carbonate
English: Patients had compensated liver disease (including cirrhosis), HCV RNA of at least 10,000 IU/ml, and liver histopathology consistent with CHC (if available).
Maltese: IU/ml, u istopatoloġija tal-fwied konsistenti ma' CHC (jekk kienet disponibbli).
English: In HCV genotype 1a infected patients without cirrhosis, simeprevir efficacy in combination with sofosbuvir at the recommended 12-week treatment duration was not impacted by the presence of the NS3 Q80K polymorphism (see section 5.1).
Maltese: F'pazjenti infettati bil-ġenotip 1a ta' HCV mingħajr ċirrożi, l-effikaċja ta' simeprevir mogħti flimkien ma' sofosbuvir għat-tul ta' żmien ta' trattament rrakkomandat ta' 12-il ġimgħa ma ġietx affettwata mill-preżenza tal-polimorfiżmu NS3 Q80K (ara sezzjoni 5.1).
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
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
English: ≥ 1.1 to ≤ 1.5 x ULN 34 (11.9%)
Maltese: Dawk li qabel irkadew 3% (8/260) 27% (36/133)
English: Co-administration of OLYSIO with moderate or strong inhibitors of CYP3A4 may significantly increase the plasma exposure of simeprevir, while co-administration with moderate or strong inducers of CYP3A4 may significantly reduce the plasma exposure of simeprevir and lead to loss of efficacy (see table 4).
Maltese: L-għoti konġunt ta' OLYSIO ma' impedituri moderati jew qawwija ta' CYP3A4 jista' jżid b'mod sinifikanti l-esponiment ta' simeprevir fil-plażma, filwaqt li l-għoti konġunt ma' sensibilizzaturi moderati jew qawwija ta' CYP3A4 jista' jnaqqas b'mod sinifikanti l-esponiment ta' simeprevir fil-plażma u jwassal għal telf fl-effikaċja (ara tabella 4).
English: Hepatic impairment
Maltese: Rikaduta virali
English: Mild increases in concentrations of PDE-5 inhibitors may be expected.
Maltese: konċentrazzjonijiet ta' impedituri ta' PDE-5
English: Forty-five percent (13/29) of the simeprevir-treated HCV genotype 1a infected patients with Q80K polymorphism had undetectable HCV RNA at week 4; in these patients the SVR12 rate was 77%.
Maltese: Ħamsa u erbgħin fil-mija (13/29) talpazjenti ttrattati b'simeprevir infettati b'HCV tal-ġenotip 1a b'polimorfiżmu Q80K kellhom RNA ta' HCV li ma setax jitkejjel f'ġimgħa 4; f'dawn il-pazjenti ir-rata ta' SVR12 kienet 77%.
English: Testing for the presence of the Q80K polymorphism in patients with HCV genotype 1a is strongly recommended when considering therapy with OLYSIO in combination with peginterferon alfa and ribavirin.
Maltese: L-ittestjar għallpreżenza tal-polimorfiżmu Q80K f'pazjenti ta' epatite Ċ b'ġenotip 1a huwa rakkomandat bis-saħħa meta wieħed jikkonsidra terapija b'OLYSIO f'kombinazzjoni ma' peginterferon alfa u ribavirin.
English: CALCIUM CHANNEL BLOCKERS (oral administration) Amlodipine
Maltese: ANTIKONVULANTI Carbamazepine Oxcarbazepine Phenobarbital Phenytoin
English: Table 13: Treatment outcome in HCV genotype 1 infected patients receiving 12 weeks simeprevir + sofosbuvir (studies HPC3017 and HPC3018)
Maltese: 12-il ġimgħa ta' simeprevir + sofosbuvir (studji HPC3017 u HPC3018) Riżultat tat-trattament
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il
English: UAB "JOHNSON & JOHNSON" Eesti filiaal Lõõtsa 2
Maltese: UAB "JOHNSON &
English: Pooled phase 3 studies simeprevir + peginterferon alfa + ribavirin N = 152 n (%)
Maltese: Ġabra ta' studji ta'fażi 3 simeprevir + peginterferon alfa + ribavirin N = 781 n (%)
English: OLYSIO in combination with peginterferon alfa and ribavrin It is unlikely that patients with inadequate on-treatment virologic response will achieve a sustained virologic response (SVR), therefore discontinuation of treatment is recommended in these patients.
Maltese: OLYSIO flimkien ma' peginterferon alfa u ribavirin Huwa improbabbli li pazjenti b'rispons viroloġiku inadegwat waqt it-trattament ser jiksbu rispons viroloġiku sostnut (SVR - sustained virologic response), għalhekk il-waqfien ta' trattament hu rakkomandat f'dawn il-pazjenti.
English: Eighty-eight percent (459/521) of the simeprevir-treated patients were eligible for a total treatment duration of 24 weeks; in these patients the SVR12 rate was 88%.
Maltese: Tmienja u tmenin fil-mija (459/521) tal-pazjenti trattati b'simeprevir kienu eleġibbli għal tul ta' żmien totali ta' trattament ta' 24 ġimgħa; f'dawn il-pazjenti r-rata ta' SVR12 kienet 88%.
English: Simeprevir in combination with peginterferon alfa and ribavirin The efficacy of simeprevir in combination with peginterferon alfa and ribavirin was evaluated in patients with HCV genotype 1 or 4 infection, with or without HIV-1 co-infection, who were treatment-naïve or treatment-experienced (following prior interferon-based therapy) (tables 17 and
Maltese: Simeprevir flimkien ma' peginterferon alfa u ribavirin L-effikaċja ta' simeprevir flimkien ma' peginterferon alfa u ribavirin ġiet ivvalutata f'pazjenti b'infezzjoni ta' HCV tal-ġenotip 1 jew 4, b'infezzjoni ta' HIV-1 flimkien magħha jew mingħajrha, li qatt ma ħadu trattament qabel jew li kienu ħadu trattament qabel (wara trattament preċedenti abbażi ta'
English: Median baseline HCV RNA levels (log10 IU/ml) Presence of cirrhosis no cirrhosis with cirrhosis Prior treatment history treatment-naïve treatment-experienced IL28B genotype CC non-CC HCV geno/subtype and presence of baseline Q80K polymorphism in HCV genotype 1a
Maltese: F'pazjenti infettati bil-ġenotip 1a ta' HCV b'ċirrożi, jista' jitqies ittestjar għall-preżenza ta' polimorfiżmu Q80K qabel il-bidu tat-terapija b'OLYSIO flimkien ma' sofosbuvir (ara sezzjoni 5.1).
English: In patients receiving 24 weeks simeprevir with sofosbuvir, no grade 2 or 3 adverse reactions were reported; one patient (3.2%) experienced a grade 4 adverse reaction (‘blood bilirubin increased').
Maltese: F'pazjenti li kienu qed jirċievu 24 ġimgħa ta' simeprevir ma' sofosbuvir, ma ġew irrappurtati l-ebda reazzjonijiet avversi ta' grad 2 jew 3; pazjenti wieħed (3.2%) kellu reazzjoni avversa ta' grad 4 (‘żieda fil-bilirubin fid-demm').