FrancophonIA/ELRC3.0 huggingface dataset:
English: Among genotype 1b/1 other-infected subjects, the median age was 55 years (range: 22 to 82); 61% were male; 60 % were White; 20% were Black or African American; 6% were Hispanic or Latino; 82% were treatment-naïve subjects; 18% were treatment-experienced subjects; mean body mass index was 26 kg/m2; 64 % had baseline HCV RNA levels greater than 800,000 IU/mL; 22 % had cirrhosis; 71% had non-C/C IL28B alleles (CT or TT); 18 % had HCV/HIV-1 co-infection.
Maltese: Fost l-individwi infettati bil-ġenotip 1b/1 ieħor, il-medjan tal-età kien 55 sena (firxa: 22 sa 82); 61% kienu rġiel; 60 % kienu Bojod; 20% kienu Suwed jew Amerikani Afrikani; 6% kienu Ispaniċi jew Latino; 82% kienu individwi li qatt ma kienu ħadu trattament qabel; 18% kienu individwi li diġà ħadu trattament qabel; il-medja tal-indiċi tal-massa tal-ġisem kienet 26 kg/m2; 64 % kellhom livelli ta' RNA ta' HCV fil-linja bażi ta' aktar minn 800,000
English: Among genotype 4-infected subjects, the median age was 51 years (range: 28 to 75); 66 % were male; 88 % were White; 8 % were Black or African American; 11% were Hispanic or Latino; 77% were treatment-naïve subjects; 23% were treatment-experienced subjects; mean body mass index was 25 kg/m2; 56 % had baseline HCV RNA levels greater than 800,000 IU/mL; 22 % had cirrhosis; 73% had non-C/C IL28B alleles (CT or TT); 40 % had HCV/HIV-1 co-infection.
Maltese: Fost l-individwi infettati bil-ġenotip 4, il-medjan tal-età kien 51 sena (firxa: 28 sa 75); 66 % kienu rġiel; 88 % kienu Bojod; 8 % kienu Suwed jew Amerikani Afrikani; 11% kienu Ispaniċi jew Latino; 77% kienu individwi li qatt ma kienu ħadu trattament qabel; 23% kienu individwi li diġà ħadu trattament qabel; il-medja tal-indiċi tal-massa tal-ġisem kienet 25 kg/m2; 56 % kellhom livelli ta' RNA ta' HCV fil-linja bażi ta' aktar minn 800,000
English: The efficacy of ZEPATIER in patients previously exposed to ZEPATIER, or to medicinal products of the same classes as those of ZEPATIER (NS5A inhibitors or NS3/4A inhibitors other than telaprevir, simeprevir, boceprevir), has not been demonstrated (see section 5.1).
Maltese: L-effikaċja ta' ZEPATIER f'pazjenti li qabel kienu diġà ġew esposti għal ZEPATIER, jew għal prodotti mediċinali tal-istess klassijiet bħal dawk ta' ZEPATIER (inibituri ta' NS5A jew inibituri ta' NS3/4A minbarra telaprevir, simeprevir, boceprevir), ma ntwerietx (ara sezzjoni 5.1).
English: In genotype 4 replicons, single NS3 substitutions D168A/V reduced grazoprevir antiviral activity by 110to 320-fold.
Maltese: Fir-replikoni bil-ġenotip 4, sostituzzjonijiet D168A/V singoli ta' NS3 naqqsu l-attività antivirali ta' grazoprevir b'110 sa 320 darba.
English: Outcome for subjects without SVR On-treatment virologic failure Relapse
Maltese: Riżultat għall-individwi mingħajr SVR Falliment viroloġiku waqt it-trattament*
English: It is very important that you complete the full course of treatment.
Maltese: Huwa importanti ħafna li inti ttemm il-kors sħiħ ta' trattament.
English: • ZEPATIER should be discontinued if ALT elevation is accompanied by signs or symptoms of liver inflammation or increasing conjugated bilirubin, alkaline phosphatase, or international normalised ratio (INR).
Maltese: • ZEPATIER għandu jitwaqqaf jekk mal-livelli għolja ta' ALT ikun hemm ukoll sinjali jew sintomi ta' infjammazzjoni fil-fwied jew żieda fil-bilirubina konjugata, fl-alkaline phosphatase, jew fil-proporzjon normalizzat internazzjonali (INR - international normalized ratio).
English: • Placebo for 12 weeks (N=113)
Maltese: • Plaċebo għal 12-il ġimgħa (N=113)
English: Sevelamer carbonate (2,400 mg single dose)/ elbasvir (50 mg single dose)/ grazoprevir (100 mg single dose)
Maltese: Sevelamer carbonate (doża waħda ta' 2,400 mg)/ elbasvir (doża waħda ta' 50 mg)/ grazoprevir (doża waħda ta'100 mg)
English: Elbasvir and grazoprevir are partially eliminated by oxidative metabolism, primarily by CYP3A.
Maltese: Elbasvir u grazoprevir huma eliminati b'mod parzjali permezz ta' metaboliżmu ossidattiv, l-aktar permezz ta' CYP3A.
English: Among genotype 1a-infected subjects, NS5A resistance-associated substitutions persisted at detectable levels at follow-up week 12 in 95% (35/37) of subjects and in 100% (9/9) of subjects with follow-up week 24 data.
Maltese: Fost individwi infettati bil-ġenotip 1a, sostituzzjonijiet assoċjati ma' reżistenza f'NS5A ippersistew f'livelli li setgħu jiġu osservati fil-ġimgħa 12 ta' segwitu f'95% (35/37) tal-individwi u f'100% (9/9) tal-individwi b'dejta mill-ġimgħa 24 ta' segwitu.
English: Grazoprevir is a substrate of OATP1B drug transporters.
Maltese: L-effett li prodotti mediċinali oħra jista' jkollhom fuq ZEPATIER Grazoprevir huwa sustrat tat-trasportaturi tal-mediċini OATP1B.
English: ZEPATIER is sometimes taken with another medicine, ribavirin.
Maltese: ZEPATIER xi drabi jittieħed ma' mediċina oħra, ribavirin.
English: The primary route of elimination of elbasvir and grazoprevir is through faeces with almost all (> 90 %) of the radiolabeled dose recovered in faeces compared to < 1 % in urine.
Maltese: Ir-rotta primarja ta' eliminazzjoni ta' elbasvir u grazoprevir hija permezz tal-ippurgar bi kważi d-doża radjutikkettata kollha (> 90 %) miġbura mill-ippurgar meta mqabbla ma' < 1 % fl-awrina.
English: ↔ Midazolam AUC 1.34 (1.29, 1.39) Cmax 1.15 (1.01, 1.31)
Maltese: AUC 1.34 (1.29, 1.39) Cmax 1.15 (1.01, 1.31)
English: ↔ Pitavastatin AUC 1.11 (0.91, 1.34) Cmax 1.27 (1.07, 1.52)
Maltese: AUC 1.11 (0.91, 1.34) Cmax 1.27 (1.07, 1.52)
English: Beige, oval tablet of dimensions 21 mm x 10 mm debossed with “770” on one side and plain on the other.
Maltese: Pillola ovali, ta' lewn kannella jagħti fl-isfar b'qies ta' 21 mm x 10 mm imnaqqxa b'“770” fuq naħa waħda u bla marki fuq in-naħa l-oħra.
English: (600 mg PO single dose)/ elbasvir (50 mg single dose)
Maltese: (doża waħda ta' 600 mg PO)/ elbasvir (doża waħda ta' 50 mg)
English: Subjects who had failed prior treatment with boceprevir, simeprevir, or telaprevir in combination with peg-IFN + RBV received EBR + GZR with RBV for 12 weeks.
Maltese: Individwi li ma ħadimx fuqhom trattament preċedenti b'boceprevir, simeprevir, jew telaprevir flimkien ma' peg-IFN + RBV irċivew EBR + GZR flimkien ma' RBV għal 12-il ġimgħa.
English: The safety of ZEPATIER was assessed based on 3 placebo-controlled studies and 7 uncontrolled Phase 2 and 3 clinical studies in approximately 2,000 subjects with chronic hepatitis C infection with compensated liver disease (with or without cirrhosis).
Maltese: Is-sigurtà ta' ZEPATIER ġiet ivvalutata abbażi ta' 3 studji kkontrollati bi plaċebo u 7 studji kliniċi mhux ikkontrollati ta' Fażi 2 u 3 f'madwar 2,000 individwu b'infezzjoni kronika tal-epatite Ċ b'mard ikkumpensat tal-fwied (b'ċirrożi jew mingħajrha).
English: In population pharmacokinetic analyses, elbasvir and grazoprevir AUCs are estimated to be 50 % and 30 % higher, respectively, in females compared to males.
Maltese: F'analiżi ta' farmakokinetika ta' popolazzjoni, l-AUCs ta' elbasvir u grazoprevir huma stmati li jkunu 50 % u 30 % ogħla, rispettivament, fin-nisa meta mqabbla mal-irġiel.
English: Sofosbuvir (400 mg single dose sofosbuvir)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily
Maltese: Sofosbuvir (doża waħda ta' 400 mg sofosbuvir)/ elbasvir (50 mg darba kuljum)/ grazoprevir (200 mg darba kuljum)
English: • muscle aches
Maltese: • ħalq xott
English: (intestinal BCRP inhibition)
Maltese: (inibizzjoni ta' BCRP tal-musrana)
English: In non-HCV-infected subjects with mild hepatic impairment (Child-Pugh A [CP-A], score of 5-6), elbasvir AUC0-inf was decreased by 40% and grazoprevir steady-state AUC0-24 was increased 70 % compared to matched healthy subjects.
Maltese: F'individwi mhux infettati b'HCV b'indeboliment ħafif tal-fwied (Child-Pugh A [CP-A], punteġġ ta' 5-6), l-AUC0-inf ta' elbasvir tnaqqset b'40% u l-AUC0-24 ta' grazoprevir fi stat fiss żdiedet b'70 % meta mqabbla ma' individwi f'saħħithom b'karatteristiċi jaqblu.
English: Elbasvir pharmacokinetics are similar in healthy subjects and HCV-infected subjects.
Maltese: Il-farmakokinetika ta' elbasvir hija simili f'individwi f'saħħithom u individwi infettati b'HCV.
English: • Placebo for 12 weeks (N=105)
Maltese: • Plaċebo għal 12-il ġimgħa (N=105)
English: • EBR/GZR for 12 weeks (N=218)
Maltese: 12-il ġimgħa (N=218)
English: (300 mg once daily)/elbasvir (50 mg once daily)/grazoprevir (100 mg once daily)
Maltese: (300 mg darba kuljum)/elbasvir (50 mg darba kuljum)/grazoprevir (100 mg darba kuljum)
English: Multiple-dose administration of elbasvir or grazoprevir is unlikely to induce the metabolism of medicinal products metabolised by CYP isoforms based on in vitro data.
Maltese: Abbażi ta' dejta in vitro l-għoti ta' ħafna dożi ta' elbasvir jew grazoprevir mhux probabbli li jikkaġuna l-metaboliżmu ta' prodotti mediċinali metabolizzati permezz ta' isoformi ta' CYP.
English: • This medicine has been prescribed for you only.
Maltese: • għandek xi kondizzjonijiet mediċi oħra.
English: Efavirenz (600 mg once daily)/ elbasvir (50 mg once daily)
Maltese: Efavirenz (600 mg darba kuljum)/ elbasvir (50 mg darba kuljum)
English: Digoxin (0.25 mg single dose)/ elbasvir (50 mg once daily)
Maltese: ANTIARRITMIĊI Digoxin (doża waħda ta' 0.25 mg)/ elbasvir (50 mg darba kuljum)
English: Grazoprevir pharmacokinetics increased in a greater than dose-proportional manner over the range of 10-800 mg once daily in HCV-infected subjects.
Maltese: Il-farmakokinetika ta' grazoprevir żdiedet b'mod aktar minn fi proporzjon maddoża fuq il-firxa ta' 10-800 mg darba kuljum f'individwi infettati b'HCV.
English: Midazolam (2 mg single dose)/ grazoprevir (200 mg once daily)
Maltese: Midazolam (doża waħda ta' 2 mg)/ grazoprevir (200 mg darba kuljum)
English: Among genotype 1b-infected subjects, NS3 resistance-associated substitutions persisted at detectable levels at follow-up week 24 in 50% (1/2) of subjects.
Maltese: Fost individwi infettati bil-ġenotip 1b, sostituzzjonijiet assoċjati ma' reżistenza f'NS3 ippersistew f'livelli li setgħu jiġu osservati fil-ġimgħa 24 ta' segwitu f'50% (1/2) tal-individwi.
English: Pitavastatin (1 mg single dose)/ grazoprevir (200 mg once daily)
Maltese: Pitavastatin (doża waħda ta' 1 mg)/ grazoprevir (200 mg darba kuljum)
English: FRI
Maltese: Assenti
English: Among genotype 1a-infected subjects, NS3 resistance-associated substitutions persisted at detectable levels at follow-up week 24 in 31% (4/13) of subjects.
Maltese: Fost individwi infettati bil-ġenotip 1a, sostituzzjonijiet assoċjati ma' reżistenza f'NS3 ippersistew f'livelli li setgħu jiġu osservati fil-ġimgħa 24 ta' segwitu f'31% (4/13) tal-individwi.
English: Other medicines and ZEPATIER
Maltese: Mediċini oħra u ZEPATIER
English: Atorvastatin (20 mg single dose)/ grazoprevir (200 mg once daily)
Maltese: Atorvastatin (doża waħda ta' 20 mg)/ grazoprevir (200 mg darba kuljum)
English: Less than 0.5 % of grazoprevir was recovered in dialysate over a 4-hour dialysis session.
Maltese: Anqas minn 0.5 % ta' grazoprevir ġie rkuprat missoluzzjoni tad-dijalisi wara sessjoni ta' 4 sigħat ta' dijalisi.
English: Tacrolimus (2 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Maltese: Tacrolimus (doża waħda ta' 2 mg)/ elbasvir (50 mg darba kuljum)/ grazoprevir (200 mg darba kuljum)
English: Patients should be informed that fatigue has been reported during treatment with ZEPATIER (see section 4.8).
Maltese: Il-pazjenti għandhom jiġu infurmati li ġiet irrappurtata għeja matul ittrattament b'ZEPATIER (ara sezzjoni 4.8).
English: In non-HCV-infected subjects with dialysis-dependent, severe renal impairment, elbasvir and grazoprevir AUC values were unchanged compared to subjects with normal renal function.
Maltese: F'individwi mhux infettati b'HCV b'indeboliment sever tal-kliewi, dipendenti fuq id-dijalisi, il-valuri tal-AUC ta' elbasvir u grazoprevir ma kinux mibdula meta mqabbla ma' individwi b'funzjoni normali tal-kliewi.
English: 16 Weeks
Maltese: Ħ Ġ S Ħ
English: • Placebo for 12 weeks (N=100)
Maltese: • Plaċebo għal 12-il ġimgħa (N=100)
English: Table 8: Studies conducted with ZEPATIER
Maltese: Tabella 8: Studji li saru b'ZEPATIER
English: Due to the limited number of genotype 4-infected subjects with treatment emergent NS5A and NS3 resistance associated substitutions, trends in persistence of treatment emergent substitutions in this genotype could not be established.
Maltese: Minħabba n-numru limitat ta' individwi infettati bil-ġenotip 4 b'sostituzzjonijiet assoċjati ma' reżistenza f'NS5A u NS3 li tfaċċaw minħabba t-trattament, ma setgħux jiġu determinati tendenzi filpersistenza ta' sostituzzjonijiet li jitfaċċaw minħabba t-trattament f'dan il-ġenotip.
English: (CYP3A inhibition)
Maltese: (inibizzjoni ta' CYP3A)
English: Raltegravir (400 mg single dose)/ elbasvir (50 mg single dose)
Maltese: Raltegravir (doża waħda ta' 400 mg)/ elbasvir (doża waħda ta' 50 mg)
English: • EBR/GZR for 12 weeks (N=201)
Maltese: 12-il ġimgħa (N=201)
English: The tablets are packaged into a carton containing two (2) cardboard cards, each cardboard card containing (2) 7-count aluminium blisters sealed in a cardboard card for a total of 28 tablets.
Maltese: Il-pilloli huma ppakkjati f'kartuna li fiha żewġ (2) kards tal-kartun, kull kard tal-kartun fiha (2) folji tal-aluminju b'għadd ta' 7 issiġillati fil-kard tal-kartun għal total ta' 28 pillola.
English: In population pharmacokinetic analyses, there was no effect of weight on elbasvir pharmacokinetics.
Maltese: F'analiżi ta' farmakokinetika ta' popolazzjoni, ma kien hemm l-ebda effett tal-piż fuq ilfarmakokinetika ta' elbasvir.
English: Includes four subjects infected with genotype 1 subtypes other than 1a or 1b.
Maltese: Ċirrotiċi †Jinkludi erba' individwi infettati b'sottotipi tal-ġenotip 1 li mhumiex 1a jew 1b.
English: In general, in HCV genotype 1a, 1b or 4replicons, combinations of grazoprevir resistance-associated substitutions further reduced grazoprevir antiviral activity.
Maltese: B'mod ġenerali, fir-replikoni ta' HCV bil-ġenotipi 1a, 1b, jew 4, kombinazzjonijiet ta' sostituzzjonijiet assoċjati ma' reżistenza għal grazoprevir komplew inaqqsu l-attività antivirali ta' grazoprevir.
English: (P-gp inhibition)
Maltese: (inibizzjoni ta' P-gp)
English: (combination of OATP1B and CYP3A inhibition)
Maltese: (kombinazzjoni ta' inibizzjoni ta' OATP1B u CYP3A)
English: Rosuvastatin (10 mg single dose)/ grazoprevir (200 mg once daily)
Maltese: Rosuvastatin (doża waħda ta' 10 mg)/ grazoprevir (200 mg darba kuljum)
English: (400 mg PO once daily)/ grazoprevir (100 mg single dose)
Maltese: (400 mg PO darba kuljum)/ grazoprevir (doża waħda ta' 100 mg)
English: Montelukast (10 mg single dose)/ grazoprevir (200 mg single dose)
Maltese: Montelukast (doża waħda ta'10 mg)/ grazoprevir (doża waħda ta' 200 mg)
English: Rilpivirine (25 mg once daily)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Maltese: Rilpivirine (25 mg darba kuljum) elbasvir (50 mg darba kuljum)/ grazoprevir (200 mg darba kuljum)
English: Co-administration of ZEPATIER with medicinal products that inhibit OATP1B transporters is contraindicated because it may result in a significant increase in the plasma concentration of grazoprevir (see sections 4.3 and 4.4).
Maltese: L-għoti ta' ZEPATIER flimkien ma' prodotti mediċinali li jinibixxu trasportaturi ta' OATP1B huwa kontraindikat minħabba li jista' jwassal għal żieda sinifikanti fil-konċentrazzjoni ta' grazoprevir fil-plażma (ara sezzjonijiet 4.3 u 4.4).
English: Both elbasvir and grazoprevir bind to human serum albumin and 1-acid glycoprotein.
Maltese: Kemm elbasvir kif ukoll grazoprevir jintrabtu mal-albumina tas-serum u malglikoproteina α1-acid tal-bniedem.
English: ↑ Grazoprevir AUC 12.86 (10.25, 16.13) Cmax 7.31 (5.65, 9.45) C24 21.70 (12.99, 36.25)
Maltese: 13) Cmax 7.31 (5.65, 9.45) C24 21.70 (12.99, 36.25)
English: Treatment outcomes in genotype 1b-infected subjects treated with elbasvir/grazoprevir for 12 weeks are presented in Table 9.
Maltese: Ir-riżultati tat-trattament f'individwi infettati bil-ġenotip 1b ittrattati b'elbasvir/grazoprevir għal 12-il ġimgħa huma ppreżentati f'Tabella 9.
English: Renal impairment and end stage renal disease (ESRD) No dose adjustment of ZEPATIER is required in patients with mild, moderate, or severe renal impairment (including patients receiving haemodialysis or peritoneal dialysis) (see section 5.2).
Maltese: Ma huwa meħtieġ l-ebda aġġustament fid-doża ta' ZEPATIER f'pazjenti b'indeboliment ħafif, moderat jew sever tal-kliewi (inkluż pazjenti li qed jirċievu l-emodijalisi jew dijalisi mill-peritonew) (ara sezzjoni 5.2).
English: C-SALVAGE (open-label)
Maltese: C-SALVAGE
English: It is important that both men and women read the information.
Maltese: Huwa importanti li kemm in-nisa kif ukoll l-irġiel jaqraw l-informazzjoni.
English: (300 mg once daily)/ ritonavir (100 mg once daily/ grazoprevir (200 mg once daily)
Maltese: (300 mg darba kuljum)/ ritonavir (100 mg darba kuljum/ grazoprevir (200 mg darba kuljum)
English: Ciclosporin (400 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Maltese: Ciclosporin (doża waħda ta' 400 mg)/ elbasvir (50 mg darba kuljum)/ grazoprevir (200 mg darba kuljum)
English: The persistence of elbasvir and grazoprevir treatment-emergent amino acid substitutions in NS5A, and NS3, respectively, was assessed in genotype 1-infected subjects in Phase 2 and 3 studies whose virus had treatment-emergent resistance-associated substitution in the drug target, and with available data through at least 24 weeks post-treatment using population (or Sanger) sequencing.
Maltese: Il-persistenza ta' sostituzzjonijiet f'aċidi amminiċi li jitfaċċaw minħabba trattament b'elbasvir u grazoprevir f'NS5A u NS3, rispettivament, ġiet ivvalutata f'individwi infettati bil-ġenotip 1 fi studji ta' Fażi 2 u Fażi 3 li l-virus tagħhom kellu sostituzzjoni assoċjata ma' reżistenza li tfaċċat minħabba ttrattament fil-mira tal-mediċina, u b'dejta disponibbli għal mill-anqas 24 ġimgħa wara t-trattament blużu ta' sekwenzar ta' popolazzjoni (jew Sanger).
English: Elbasvir is an inhibitor of HCV NS5A, which is essential for viral RNA replication and virion assembly.
Maltese: Elbasvir huwa inibitur ta' NS5A ta' HCV, li huwa essenzjali għar-replikazzjoni tal-RNA tal-virus u limmuntar tal-virion.
English: (10 mg single dose)/ elbasvir (50 mg once daily) / grazoprevir (200 mg once daily)
Maltese: (doża waħda ta' 10 mg)/ elbasvir (50 mg darba kuljum)/ grazoprevir (200 mg darba kuljum)
English: Elbasvir is not a CYP3A inhibitor in vitro and grazoprevir is a weak CYP3A inhibitor in humans.
Maltese: Elbasvir mhuwiex inibitur ta' CYP3A in vitro u grazoprevir huwa inibitur dgħajjef ta' CYP3A fil-bniedem.
English: • EBR/GZR for 12 or 16 weeks (N=105 and respectively)
Maltese: għal 12 jew 16-il ġimgħa (N=105 u 105, rispettivament)
English: Less than 1 % of subjects treated with ZEPATIER with or without ribavirin permanently discontinued treatment due to adverse reactions.
Maltese: Anqas minn 1 % tal-individwi ttrattati b'ZEPATIER b'ribavirin jew mingħajru waqqfu t-trattament b'mod permanenti minħabba reazzjonijiet avversi.
English: Some NS3 substitutions at A156 and at D168 confer reduced antiviral activity to grazoprevir as well as to other NS3/4A protease inhibitors.
Maltese: Xi wħud missostituzzjonijiet ta' NS3 f'A156 u f'D168 jagħtu attività antivirali mnaqqsa għal grazoprevir kif ukoll għal inibituri oħra ta' NS3/4A protease.
English: C-EDGE COSTAR (double-blind)
Maltese: C-EDGE COSTAR (la l-investigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża)
English: The safety and efficacy of elbasvir/grazoprevir (co-administered as a fixed-dose combination; EBR/GZR) or elbasvir + grazoprevir (co-administered as single agents; EBR + GZR) were evaluated in 8 clinical studies in approximately 2,000 subjects (see Table 8).
Maltese: Is-sigurtà u l-effikaċja ta' elbasvir/grazoprevir (mogħtija flimkien bħala mediċina waħda b'doża fissa; EBR/GZR) jew elbasvir + grazoprevir (mogħija flimkien bħala żewġ sustanzi separati;
English: Uncommon: may affect up to 1 in 100 people • abnormalities in laboratory tests of liver function
Maltese: Mhux komuni: jistgħu jaffettwaw sa persuna waħda minn kull 100 • anormalitajiet fit-testijiet tal-laboratorju għall-funzjoni tal-fwied
English: Expected: ↑ sunitinib
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: Sustained virologic response (SVR) was the primary endpoint in all studies and was defined as HCV RNA less than the lower limit of quantification (LLOQ: 15 HCV RNA IU/mL except in C-WORTHY and C-SCAPE [25 HCV RNA IU/mL]) at 12 weeks after the cessation of treatment (SVR12).
Maltese: Rispons viroloġiku miżmum (SVR - sustained virologic response) kien l-iskop finali primarju għallistudji kollha u kien iddefinit bħala RNA ta' HCV inqas mil-limitu l-aktar baxx ta' kwantifikazzjoni (LLOQ - lower limit of quantification: 15-il IU/mL ta' RNA ta' HCV ħlief f'C-WORTHY u CSCAPE [25
English: Expected: ↑ Fluvastatin (primarily due to intestinal BCRP inhibition)
Maltese: ↑ sunitinib (possibilment minħabba inibizzjoni ta' BCRP tal-musrana)
English: The highest dose of grazoprevir was 1,000 mg once daily for 10 days, and a single dose of 1,600 mg.
Maltese: L-ogħla doża ta' grazoprevir kienet 1,000 mg darba kuljum għal 10 ijiem, u doża waħda ta' 1,600 mg.
English: Grazoprevir is active in vitro against the following genotype 1a NS3 substitutions which confer resistance to other NS3/4A protease inhibitors: V36A/L/M, Q41R, F43L, T54A/S, V55A/I, Y56F, Q80K/R, V107I, S122A/G/R/T, I132V, R155K, A156S, D168N/S, I170T/V.
Maltese: V36A/L/M, Q41R, F43L, T54A/S, V55A/I, Y56F, Q80K/R, V107I, S122A/G/R/T, I132V, R155K, A156S, D168N/S, I170T/V.
English: Calcium acetate (2,668 mg single dose)/ elbasvir (50 mg single dose)/ grazoprevir (100 mg single dose)
Maltese: 2,668 mg)/ elbasvir (doża waħda ta' 50 mg)/ grazoprevir (doża waħda ta' 100 mg)
English: Relative to fasting conditions, the administration of a single dose of elbasvir/grazoprevir with a highfat (900 kcal, 500 kcal from fat) meal to healthy subjects resulted in decreases in elbasvir AUC0-inf and Cmax of approximately 11 % and 15 %, respectively, and increases in grazoprevir AUC0-inf and Cmax of approximately 1.5-fold and 2.8-fold, respectively.
Maltese: Meta mqabbel ma' kondizzjonijiet ta' sawm, l-għoti ta' doża waħda ta' elbasvir/grazoprevir ma' ikla b'ammont kbir ta' xaħam (900 kcal, 500 kcal ġejjin mix-xaħam) lil individwi f'saħħithom wasslet għal tnaqqis fl-AUC0-inf u s-Cmax ta' elbasvir ta' madwar 11 % u 15 %, rispettivament u żidiet fl-AUC0-inf u s-Cmax ta' grazoprevir ta' madwar 1.5 darbiet u 2.8 darbiet, rispettivament.
English: (400 mg twice daily)/ ritonavir (100 mg twice daily/ grazoprevir (200 mg once daily)
Maltese: (400 mg darbtejn kuljum)/ ritonavir (100 mg darbtejn kuljum/ grazoprevir (200 mg darba kuljum)
English: Dolutegravir (50 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Maltese: Dolutegravir (doża waħda ta' 50 mg)/ elbasvir (50 mg darba kuljum)/ grazoprevir (200 mg darba kuljum)
English: Among genotype 1binfected subjects, NS5A resistance-associated substitutions persisted at detectable levels in 100% (7/7) of subjects at follow-up week 12 and in 100% (3/3) of subjects with follow-up week 24 data.
Maltese: Fost individwi infettati bil-ġenotip 1b, sostituzzjonijiet assoċjati ma' reżistenza f'NS5A ippersistew f'livelli li setgħu jiġu osservati f'100% (7/7) tal-individwi fil-ġimgħa 12 ta' segwitu u f'100% (3/3) tal-individwi b'dejta mill-ġimgħa 24 ta' segwitu.
English: Contains lactose and sodium.
Maltese: TA' EĊĊIPJENTI Fih lactose u sodium.
English: The adverse reactions are listed below by body system organ class and frequency.
Maltese: Ir-reazzjonijiet avversi huma elenkati taħt skont il-klassi tas-sistemi u tal-organi talġisem u l-frekwenza.
English: ZEPATIER (administered alone or in combination with ribavirin) is not likely to have an effect on the ability to drive and use machines.
Maltese: ZEPATIER (mogħti waħdu jew flimkien ma' ribavirin) x'aktarx li ma jkollux effett fuq il-kapaċità ta' sewqan u tħaddim ta' magni.