FrancophonIA/ELRC3.0 huggingface dataset:
English: ≥ 1.1 to ≤ 1.5 x ULN
Maltese: ≥ 1.1 sa ≤ 1.5 x ULN
English: 7 The interaction between simeprevir and the medicinal product was evaluated in a pharmacokinetic study in opioid-dependent adults on stable methadone maintenance therapy.
Maltese: 7 L-interazzjoni bejn simeprevir u l-prodott mediċinali ġiet evalwata fi studju farmakokinetiku f'adulti dipendenti fuq l opijoidi fuq terapija ta' manteniment b'methadone stabbli.
English: F3-4
Maltese: F0-2 F3-4
English: > 3.0 to ≤ 5.0 x ULN 1 (0.3%)
Maltese: > 3.0 sa ≤ 5.0 x ULN 1 (0.3%)
English: ≥ 1.1 to ≤ 1.5 x ULN 34 (11.9%)
Maltese: ≥ 1.1 sa ≤ 1.5 x ULN 34 (11.9%)
English: - carbamazepine, oxcarbazepine, phenobarbital or phenytoin to prevent seizures - astemizole or terfenadine to treat allergies - itraconazole, fluconazole, ketoconazole, posaconazole or voriconazole (when taken by mouth or given by injection) to treat fungal infections - rifabutin, rifampicin or rifapentine to treat infections like tuberculosis - amlodipine, bepridil, diltiazem, felodipine, nicardipine, nifedipine, nisoldipine or verapamil
Maltese: - itraconazole, fluconazole, ketoconazole, posaconazole jew voriconazole (meta jittieħdu mill ħalq jew jingħataw b'injezzjoni) biex jiġu ttrattati infezzjonijiet bil-fungi - rifabutin, rifampicin jew rifapentine biex jiġu ttrattati infezzjonijiet bħat-tuberkulożi - amlodipine, bepridil, diltiazem, felodipine, nicardipine, nifedipine, nisoldipine jew verapamil
English: 1 p < 0.001.
Maltese: mingħajr Q80K Ġenotip 1b 1 p < 0.001.
English: In these patients the SVR12 rates were 96%, 94%, 100% and 68%, respectively.
Maltese: F'dawn il-pazjenti r-rati ta' SVR kienu 96%. 94%, 100% u 68% rispettivament.
English: LIST OF EXCIPIENTS Contains lactose monohydrate
Maltese: Fih lactose monohydrate
English: HCV/Human immunodeficiency virus type 1 (HIV-1) co-infection No dose adjustment of OLYSIO is required in HCV/HIV-1 co-infected patients (see sections 4.8, 5.1 and 5.2).
Maltese: Koinfezzjoni ta' HCV/Virus ta' immunodefiċjenza umana-1 (HIV-1) L-ebda aġġustament fid-doża ta' OLYSIO mhu meħtieġ f'pazjenti koinfettati b'HCV/HIV-1 (ara sezzjonijiet 4.8. 5.1 u 5.2).
English: 1 HCV/HIV-1 co-infected patients.
Maltese: 1 pażjenti infettati b'HCV/HIV-1 fl-istess waqt.
English: Patients co-infected with HIV-1
Maltese: Pazjenti koinfettati b'HIV-1
English: Hepatitis B virus (HBV) co-infection
Maltese: Koinfezzjoni b'virus ta' Epatite B (HBV)
English: 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 not studied
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) ↑
English: The clinical relevance of this difference in viral breakthrough rates is unknown.
Maltese: Ir-rilevanza klinika ta' din id-differenza fir-rati ta' progress virali mhix magħrufa.
English: PHOSPHODIESTERASE TYPE 5 INHIBITORS Sildenafil
Maltese: TA' PHOSPHODIESTERASE TIP 5
English: 12 weeks N = 286
Maltese: N = 286
English: 2 SVR: SVR12 for study HPC3007 and SVR24 for study C206.
Maltese: 2 SVR: SVR12 għall-istudju HPC3007 u SVR24 għall-istudju C206. p < 0.001.
English: TT
Maltese: U
English: ≥ 1.25 to ≤ 2.50 x ULN
Maltese: ≥ 1.25 sa ≤ 2.50 x ULN
English: Table 23: Treatment outcome in HCV genotype 4 infected patients (study HPC3011) Treatment outcome
Maltese: Tabella 23: Ir-riżultat tat-trattament f'pazjenti infettati b'HCV tal-ġenotip 4 (studju HPC3011)
English: > 1.5 to ≤ 2.0 x ULN 15 (5.2%)
Maltese: > 1.5 sa ≤ 2.0 x ULN 15 (5.2%)
English: ANALEPTIC Caffeine 150 mg caffeine AUC 1.26 (1.21-1.32) ↑ caffeine Cmax 1.12 (1.06-1.19) ↔ caffeine Cmin not studied
Maltese: Kafeina 150 mg kafeina AUC 1.26 (1,21-1.32) ↑ kafeina Cmax 1.12 (1,06-1.10) ↔
English: What OLYSIO is - OLYSIO contains the active substance ‘simeprevir'.
Maltese: - OLYSIO fih is-sustanza attiva ‘simeprevir'.
English: STIMULANTS Methylphenidate
Maltese: STIMULANTI Methylphenidate Ma ġiex studjat.
English: peg-IFN-alfa = peginterferon alfa; RBV = ribavirin (body-weight based twice daily ribavirin dosing, according to the Summary of Product Characteristics of ribavirin); SMV = simeprevir.
Maltese: RBV = ribavirin (dożi ta' ribavirin mogħtija darbtejn kuljum ibbażati fuq il-piż tal ġisem, skont is-Sommarju tal-Karatteristiċi tal-Prodott ta' ribavirin); SMV = simeprevir.
English: ≥ 1.1 to ≤ 1.5 x ULN 13 (4.5%)
Maltese: ≥ 1.1 sa ≤ 1.5 x ULN 13 (4.5%)
English: OLYSIO 150 mg hard capsules simeprevir
Maltese: OLYSIO 150 mg kapsuli ibsin simeprevir
English: > 2.50 to ≤ 5.00 x ULN
Maltese: > 2.50 sa ≤ 5.00 x ULN
English: 12 weeks SMV + peg-IFN-alfa + RBV, followed by 12 or 36 weeks peg-IFN-alfa + RBV3; control group: 48 weeks placebo + peg-IFN-alfa + RBV
Maltese: 12-il ġimgħa ta' SMV + peg-IFN-alfa + RBV, segwiti minn 12 jew 36 ġimgħa peg-IFN-alfa + RBV3; grupp ta' kontroll: 48 ġimgħa ta' plaċebo + peg-IFN-alfa + RBV
English: Clinical study examining QT interval
Maltese: Studju Kliniku li jeżamina l-intervall QT
English: 0.25 mg digoxin AUC 1.39 (1.16-1.67) ↑ digoxin Cmax 1.31 (1.14-1.51) ↑ digoxin Cmin not studied
Maltese: Digoxin 0.25 mg digoxin AUC 1.39 (1.16-1.67) ↑ digoxin Cmax 1.31 (1.14-1.51) ↑
English: X represents multiple amino acids.
Maltese: jirrapreżenta aċidi amminiċi multipli.
English: White gelatin capsule of approximately 22 mm in length, marked with “TMC435 150” in black ink.
Maltese: Kapsula iebsa (kapsula) Kapsula bajda tal-ġelatina twila madwar 22 mm, immarkata b' "TMC435 150" b'linka sewda.
English: SVR12 rates for selected subgroups METAVIR fibrosis score F0-2
Maltese: Rati ta' SVR12 għal sottogruppi magħżula Punteġġ ta' fibrożi METAVIR
English: Each capsule contains simeprevir sodium equivalent to 150 milligrams of simeprevir.
Maltese: Kull kapsula iebsa fiha simeprevir sodium ekwivalenti għal 150 mg ta' simeprevir.
English: Patients who are identified as being at high risk of bradyarrhythmia should be continuously monitored for 48 hours in an appropriate clinical setting.
Maltese: Il-pazjenti li huma identifikati li għandhom riskju kbir ta' bradiarritmija għandhom jiġu mmonitorjati kontinwament għal 48 siegħa f'ambjent kliniku xieraq.
English: Baseline polymorphisms at NS3 positions 43, 80, 122, 155, 156, and/or 168, associated with reduced simeprevir activity in vitro were generally uncommon (1.3%) in patients with HCV genotype 1 infection (n = 2,007; pooled phase 2 and phase 3 studies with simeprevir in combination with peginterferon alfa and ribavirin), with exception of the substitution Q80K in HCV genotype 1a patients which was seen 30% in patients with HCV genotype 1a and 0.5% in patients with HCV genotype 1b.
Maltese: Polimorfiżmi fil-linja bażi ta' NS3 fil-pożizzjonijiet 43, 80, 122, 155, 156 u/jew 168, assoċjati ma' tnaqqis fl-attività ta' simeprevir in vitro kienu ġeneralment mhux komuni (1.3%) f'pazjenti b'infezzjoni ta' HCV ta' ġenotip 1 (n = 2,007; ġabra ta' studji ta' fażi 2 u fażi 3 b'simeprevir flimkien ma' peginterferon alfa u ribavirin), bl-eċċezzjoni tas-sostituzzjoni Q80K f'pazjenti b'HCV tal-ġenotip 1a li dehret 30% f'pazjenti b'HCV ta' ġenotip 1a u 0.5% f'pazjenti b'HCV tal-ġenotip 1b.
English: There were no adverse effects of simeprevir on vital functions (cardiac, respiratory and central nervous system) in animal studies.
Maltese: Ma kienx hemm effetti avversi ta' simeprevir fuq funzjonijiet vitali (sistema kardijaka, respiratorja u sistema nervuża ċentrali) fi studji fuq l-annimali.
English: Severe bradycardia and heart block
Maltese: Bradikardija severa u imblokk tal-qalb
English: > 2.5 to ≤ 5.0 x ULN
Maltese: > 2.5 sa ≤ 5.0 x ULN
English: Age (18-73 years) had no clinically meaningful effect on the pharmacokinetics of simeprevir based on a population pharmacokinetic analysis (n = 21, age above 65 years) of HCV infected patients treated with simeprevir.
Maltese: L-età (18-il sena73 sena) ma kellha l-ebda effett klinikament validu fuq il-farmakokinetiċi ta' simeprevir abbażi tal-analiżi farmakokinetika tal-popolazzjoni (n = 21, eta taħt 65 sena) ta' pazjenti infettati b'HCV
English: Phase 3)
Maltese: Fażi 3)
English: Mean (SE) change in HCV RNA at day 7/8 (log10 IU/mL)
Maltese: Bidla medja (SE) f'HCV RNA f'jum 7/8 (log10
English: Co-administration of OLYSIO with medicinal products that are substrates for OATP1B1/3, P-gp and BCRP transport may result in increased plasma concentrations of such medicinal products (see table 4).
Maltese: prodotti mediċinali li huma sottostrati għat-trasport ta' OATP1B1/3, P-gp u BCRP jista' jirriżulta f'konċentrazzjonijiet ogħla fil-plażma ta' dawn il-prodotti mediċinali (ara tabella 3).
English: It is not recommended to co-administer OLYSIO with systemic itraconazole, ketoconazole or posaconazole.
Maltese: Itraconazole Ketoconazole Posaconazole
English: Overall SVR12
Maltese: SVR12 totali
English: Intravenous: midazolam AUC 1.10 (0.95-1.26) ↑ midazolam Cmax 0.78 (0.52-1.17) ↓ midazolam Cmin not studied
Maltese: AUC 1.10 (0.95-1.26) ↑ midazolam Cmax 0.78 (0.52-1.17) ↓
English: Genotype 1a and 1b isolates with a baseline Q80K polymorphism resulted in median FC in simeprevir EC50 of 11 (N = 33) and 8.4 (N = 2), respectively.
Maltese: Iżolati ta' ġenotip 1a u 1b b'linja bażi ta' polimorfiżmu ta' Q80K irriżulta f'FC medjan għal EC50 ta' simeprevir ta' 11 (N = 33) u 8.4 (N = 2)
English: ANTICOAGULANTS Warfarin and other vitamin K antagonists warfarin 10 mg:
Maltese: warfarin 10 mg:
English: In Europe, the prevalence was lower, 19% (73/377) in patients with HCV genotype 1a and 0.3% (3/877) in genotype 1b.
Maltese: Fl-Ewropa, il-prevalenza kienet inqas, 19% (73/377) f'pazjenti b'HCV tal-ġenotip 1a u 0.3% (3/877) ta'
English: F0-2
Maltese: SI-1000
English: common rash*, pruritus*, photosensitivity reaction*
Maltese: komuni raxx*, ħakk*, reazzjoni ta' sensittività għad-dawl*
English: The safety and efficacy of simeprevir have not been established in HCV infected patients with moderate or severe hepatic impairment (Child-Pugh class B or C).
Maltese: Is sigurtà u l-effikaċja ta' simeprevir ma ġewx determinati f'pazjenti infettati b'HCV b'indeboliment moderat jew sever tal-fwied (Kategorija ta' Child-Pugh B jew Ċ).
English: 122, 155 and/or 168.
Maltese: 122, 155, 156 jew 1682 D168E
English: nelfinavir, nevirapine, ritonavir, saquinavir or tipranavir to treat HIV infection - atorvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin or simvastatin to lower cholesterol levels - ciclosporin, sirolimus or tacrolimus to lower immune response or prevent organ transplant failures - sildenafil or tadalafil to treat ‘pulmonary arterial hypertension' - midazolam or triazolam (when taken by mouth) to help you sleep or for anxiety
Maltese: - atazanavir, darunavir, delavirdine, efavirenz, etravirine, fosamprenavir, indinavir, lopinavir, nelfinavir, nevirapine, ritonavir, saquinavir jew tipranavir biex tiġi ttrattata infezzjoni ta' HIV - atorvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin jew simvastatin biex inaqqas illivelli tal-kolesterol - ciclosporin, sirolimus jew tacrolimus sabiex jonqos ir-rispons immuni jew jiġu evitati fallimenti ta' trapjant - sildenafil jew tadalafil biex tiġi ttrattata ‘pressjoni għolja fl-arterja tal-pulmuni'
English: The 167 enrolled patients had a median age of 57 years (range 27 to 70 years; with 5% above 65 years); 64% were male; 81% were White, 19% Black or African American, and 21% Hispanic; 37% had a BMI ≥ 30 kg/m2; the median baseline HCV RNA level was 6.7 log10 IU/ml;
Maltese: Il-167 pazjent irreġistrati kellhom medjan ta' età ta' 57 sena (firxa minn 27 sa 70 sena; b'5% aktar minn 65 sena); 64% kienu rġiel; 81% kienu Bojod, 19% kienu Suwed jew Amerikani Afrikani, u 21% kienu Ħispaniċi; 37% kellhom BMI ≥ 30 kg/m2; il-livell medjan ta' RNA ta' HCV fil linja bażi kien 6.7 log10
English: 3 To prior treatment with peginterferon alfa and ribavirin.
Maltese: 3 Għal trattament preċedenti b'peginterferon alfa u ribavirin.
English: 12 weeks SMV + sofosbuvir
Maltese: SMV + sofosbuvir
English: 1 Simeprevir in combination with sofosbuvir: pooled studies HPC2002, HPC3017 and HPC3018 (12 weeks) or study HPC2002 (24 weeks); simeprevir in combination with peginterferon alfa and ribavirin: pooled phase 3 studies C208, C216 and HPC3007 (first 12 weeks of treatments).
Maltese: 1 Simeprevir flimkien ma' sofosbuvir: ġabra ta' studji HPC2002, HPC3017 u HPC3018 (12-il ġimgħa) jew l-istudju HPC2002 (24 ġimgħa); simeprevir flimkien ma' peginterferon alfa u ribavirin: ġabra ta' studji C208, C216 u HPC3007
English: (OATP1B1/3 transporter and/or CYP3A4 enzyme inhibition)
Maltese: (impediment tat-trasportatur OATP1B1/3 u/jew tal-enzima CYP3A4)
English: - digoxin, disopyramide, flecainide, mexiletine, propafenone or quinidine (when taken by mouth)
Maltese: - digoxin, disopyramide, flecainide, mexiletine, propafenone jew quinidine (meta jittieħdu mill ħalq) jew amiodarone biex jiġi ttrattat taħbit irregolari tal-qalb
English: Table 11: Studies conducted with simeprevir + sofosbuvir: population and summary of study design
Maltese: Tabella 11: Studji li saru b'simeprevir + sofosbuvir: popolazzjoni u sommarju tal-pjan talistudju
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: Antivirali Daclatasvir 60 mg darba kuljum 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) ↑
English: > 1.5 to ≤ 2.5 x ULN
Maltese: > 1.5 sa ≤ 2.5 x ULN
English: Compared to healthy subjects with normal hepatic function, the mean steady-state AUC of simeprevir was 2.4-fold higher in non-HCV infected subjects with moderate hepatic impairment (Child-Pugh class B) and 5.2-fold higher in non-HCV infected subjects with severe hepatic impairment (Child-Pugh class C).
Maltese: Meta mqabbel ma' individwi b'saħħithom b'funzjoni tal-fwied normali, l-AUC medju fl-istadju fiss ta' simeprevir kien 2.4 darbiet ogħla f'individwi infettati mhux b'HCV b'indeboliment moderat tal-fwied (Child-Pugh kategorija B) u 5.2 darbiet ogħla f'individwi infettati mhux b'HCV
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: 1 mg darba kuljum 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) ↑
English: 1 Re-evaluation of HCV RNA is recommended in case of HCV RNA ≥ 25 IU/ml after previous undetectable HCV RNA to confirm HCV RNA levels prior to discontinuing HCV treatment.
Maltese: 1 Evalwazzjoni mill-ġdid ta' HCV RNA hu rakkomandat f'każ ta' HCV RNA ≥ 25 IU/ml wara HCV RNA mhux osservat sabiex jiġu kkonfermati l-livelli ta' HCV RNA qabel ma jitwaqqaf it-trattament għal HCV.
English: What OLYSIO contains - The active substance is simeprevir.
Maltese: X'fih OLYSIO - Is-sustanza attiva hi simeprevir.
English: In a biochemical assay, simeprevir inhibited the proteolytic activity of recombinant genotype 1a and 1b HCV NS3/4A proteases, with median Ki values of 0.5 nM and 1.4 nM, respectively.
Maltese: 1b ta' HCV NS3/4A proteases rikombinanti, b'valuri Ki medjani ta' 0.5 nM u 1.4 nM rispettivament.
English: 300 mg once daily tenofovir AUC 1.18 (1.13-1.24) ↔ tenofovir Cmax 1.19 (1.10-1.30) ↑ tenofovir Cmin 1.24 (1.15-1.33) ↑ simeprevir AUC 0.86 (0.76-0.98) ↓ simeprevir Cmax 0.85 (0.73-0.99) ↓ simeprevir Cmin 0.93 (0.78-1.11) ↓
Maltese: 300 mg darba kuljum tenofovir AUC 1.18 (1.13-1.24) ↔ tenofovir Cmax 1.19 (1.10-1.30) ↑ tenofovir Cmin 1.24 (1.15-1.33) ↑ simeprevir AUC 0.86 (0.76-0.98) ↓ simeprevir Cmax 0.85 (0.73-0.99) ↓ simeprevir Cmin 0.93 (0.78-1.11) ↓
English: It is not recommended to co-administer OLYSIO with delavirdine, etravirine or nevirapine.
Maltese: OLYSIO jingħata flimkien ma' delavirdine, etravirine jew nevirapine.
English: 2 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: 2 Mit-3 pazjenti b'falliment waqt it-trattament, 2 pazjenti kellhom progress virali u pazjent wieħed waqqaf it-trattament kmieni minħabba avveniment avvers.
English: 800/100 mg once daily darunavir 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) ↑* simeprevir Cmin 4.58 (3.54-5.92) ↑*
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) ↑* simeprevir Cmin 4.58 (3.54-5.92) ↑*
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 qed jiġi preżentat f'tabella 9.
English: Erythromycin 500 mg three times a day erythromycin AUC 1.90 (1.53-2.36) ↑ erythromycin Cmax 1.59 (1.23-2.05) ↑ erythromycin Cmin 3.08 (2.54-3.73) ↑ simeprevir AUC 7.47 (6.41-8.70) ↑ simeprevir Cmax 4.53 (3.91-5.25) ↑ simeprevir Cmin 12.74 (10.19-15.93) ↑
Maltese: Erythromycin 500 mg tliet darbiet kuljum erythromycin AUC 1.90 (1.53-2.36) ↑ erythromycin Cmax 1.59 (1.23-2.05) ↑ erythromycin Cmin 3.08 (2.54-3.73) ↑ simeprevir AUC 7.47 (6.41-8.70) ↑ simeprevir Cmax 4.53 (3.91-5.25) ↑ simeprevir Cmin 12.74 (10.19-15.93) ↑
English: Increased simeprevir concentrations may occur due to mild inhibition of CYP3A4 by amlodipine and moderate inhibition of CYP3A4 by diltiazem and verapamil.
Maltese: b'amlodipine u impediment moderat ta' CYP3A4 b'diltiazem u verapamil.
English: Antimycobacterials Bedaquiline
Maltese: Antimikobatteriċi
English: 400 mg twice a day raltegravir AUC 1.08 (0.85-1.38) ↑ raltegravir Cmax 1.03 (0.78-1.36) ↔ raltegravir Cmin 1.14 (0.97-1.36) ↑ simeprevir AUC 0.89 (0.81-0.98) ↔ simeprevir Cmax 0.93 (0.85-1.02) ↔ simeprevir Cmin 0.86 (0.75-0.98) ↓
Maltese: 400 mg darbtejn kuljum raltegravir AUC 1.08 (0.85-1.38) ↑ raltegravir Cmax 1.03 (0.78-1.36) ↔ raltegravir Cmin 1.14 (0.97-1.36) ↑ simeprevir AUC 0.89 (0.81-0.98) ↔ simeprevir Cmax 0.93 (0.85-1.02) ↔ simeprevir Cmin 0.86 (0.75-0.98) ↓
English: Rilpivirine 25 mg once daily rilpivirine AUC 1.12 (1.05-1.19) ↔ rilpivirine Cmax 1.04 (0.95-1.13) ↔ rilpivirine Cmin 1.25 (1.16-1.35) ↑ simeprevir AUC 1.06 (0.94-1.19) ↔ simeprevir Cmax 1.10 (0.97-1.26) ↑ simeprevir Cmin 0.96 (0.83-1.11) ↔
Maltese: Rilpivirine 25 mg darba kuljum rilpivirine AUC 1.12 (1.05-1.19) ↔ rilpivirine Cmax 1.04 (0.95-1.13) ↔ rilpivirine Cmin 1.25 (1.16-1.35) ↑ simeprevir AUC 0.94 (0.67-1.33) ↔ simeprevir Cmax 1.10 (0.97-1.26) ↑ simeprevir Cmin 0.96 (0.83-1.11) ↔
English: CC
Maltese: C.
English: Following a single oral administration of 200 mg 14C-simeprevir to healthy subjects, on average 91% of the total radioactivity was recovered in faeces.
Maltese: Wara għoti orali waħda ta' 200 mg 14C-simeprevir lil individwi b'saħħithom, medja ta' 91% tar-radjuattività totali kienet irkuprata fl-ippurgar.
English: Please refer to sections 4.4 and 4.5 for relevant interactions with antiretroviral agents.
Maltese: Jekk jogħġbok irreferi għal sezzjonijiet 4.4 u 4.5 għall-interazzjonijiet rilevanti ma' sustanzi antiretrovirali.
English: Discontinue OLYSIO, peginterferon alfa and ribavirin
Maltese: OLYSIO flimkien ma' peginterferon alfa u ribavirin
English: OLYSIO is not recommended in patients with moderate or severe hepatic impairment (Child-Pugh class B or C) (see sections 4.2, 4.8 and 5.2).
Maltese: OLYSIO mhuwiex irrakkomandat f'pazjenti b'indeboliment tal-fwied moderat jew sever (Klassi ta' Child-Pugh B jew Ċ) (ara sezzjonijiet 4.2, 4.8 u 5.2).
English: In vitro combination of simeprevir with interferon, ribavirin, NS5A or NS5B inhibitors resulted in additive or synergistic effects.
Maltese: Il-kombinazzjoni in vitro ta' simeprevir ma' interferon, ribavirin, inibituri ta' NS5A jew inibituri ta' NS5B għandhom effett addittiv jew sinerġistiku.
English: In study HPC3017, patients without cirrhosis were enrolled; in study HPC3018, patients with cirrhosis were enrolled (table 12).
Maltese: Fl-istudju HPC3017, ġew irreġistrati pazjenti mingħajr ċirrożi; fl-istudju HPC3018, ġew irreġistrati pazjenti b'ċirrożi (tabella 12).
English: OLYSIO contains lactose
Maltese: OLYSIO fih lactose.
English: In study HPC2002 (COSMOS), prior null responders with METAVIR fibrosis score F0-F2, or treatment-naïve and prior null responder patients with METAVIR fibrosis score F3-F4 and compensated liver disease received simeprevir + sofosbuvir, with or without ribavirin, for 12 or 24 weeks (see table 11).
Maltese: COSMOS Fl-istudju HPC2002 (COSMOS), pazjenti li ma kellhomx ripons preċedenti għat-trattament b'punteġġ ta' fibrożi METAVIR ta' F0-F2, jew pazjenti li qatt ma ħadu trattament qabel u dawk li ma kellhomx ripons preċedenti għat-trattament b'punteġġ ta' fibrożi METAVIR ta' F3-F4 u mard kumpensat talfwied irċivew simeprevir + sofosbuvir, b'ribavirin jew mingħajru, għal 12 jew 24 ġimgħa (ara tabella 11).
English: placebo + peginterferon alfa + ribavirin N = 152 n (%)
Maltese: plaċebo + peginterferon alfa + ribavirin N = 152 n (%)
English: 4 Patient individualised dose at the discretion of the physician, according to local clinical practice.
Maltese: 4 Doża individwalizzata tal-pazjent fid-diskrezzjoni tat-tabib, skont il-prattika klinika lokali.
English: 75% had no cirrhosis (METAVIR fibrosis score F0-3) and 25% had cirrhosis (METAVIR fibrosis score F4); 78% had HCV genotype 1a of which 45% carried Q80K at baseline, and 22% had HCV genotype 1b; 86% had non-CC IL28B alleles (CT or TT); 76% were prior null responders to peginterferon alfa and ribavirin, and 24% were treatment-naïve.
Maltese: IU/ml; 75% ma kellhom l-ebda ċirrożi (punteġġ ta' fibrożi METAVIR F0-3) u 25% kellhom ċirrożi (punteġġ ta' fibrożi METAVIR F4); 78% kellhom HCV tal-ġenotip 1a li minnhom 45% kellhom Q80K fil-linja bażi, u 22% kellhom HCV tal-ġenotip 1b; 86% kellhom alleli
English: ANTIDEPRESSANTS Escitalopram 10 mg once daily escitalopram AUC 1.00 (0.97-1.03) ↔ escitalopram Cmax 1.03 (0.99-1.07) ↔ escitalopram Cmin 1.00 (0.95-1.05) ↔ simeprevir AUC 0.75 (0.68-0.83) ↓ simeprevir Cmax 0.80 (0.71-0.89) ↓ simeprevir Cmin 0.68 (0.59-0.79) ↓
Maltese: AUC 1.00 (0.97-1.03) ↔ escitalopram Cmax 1.03 (0.99-1.07) ↔ escitalopram Cmin 1.00 (0.95-1.05) ↔ simeprevir AUC 0.75 (0.68-0.83) ↓ simeprevir Cmax 0.80 (0.71-0.89) ↓ simeprevir Cmin 0.68 (0.59-0.79) ↓
English: In study HPC3011 in HCV genotype 4 infected patients, 28 of 32 (88%) patients who did not achieve SVR had emerging amino acid substitutions at NS3 positions 80, 122, 155, 156 and/or 168 (mainly substitutions at position 168; 24 out of 32 [75%] patients), similar to the emerging amino acid substitutions observed in genotype 1 infected patients.
Maltese: SVR kellhom sostituzzjonijiet ta' aċidi amminiċi qed jitfaċċaw fil-pożizzjonijiet ta' NS3 80, 122, 155 u/jew 168 (prinċipalment sostituzzjonijiet fil-pożizzjoni 168; 24 minn 32 [75%] pazjent), simili għassostituzzjonijiet osservati tal-aċidi amminiċi li tfaċċaw f'pazjenti infettati b'ġenotip 1.