FrancophonIA/ELRC3.0 huggingface dataset:
English: When elbasvir/grazoprevir was studied with ribavirin, the most frequent adverse reactions to elbasvir/grazoprevir + ribavirin combination therapy were consistent with the known safety profile of ribavirin.
Maltese: Meta elbasvir/grazoprevir ġie studjat ma' ribavirin, l-aktar reazzjonijiet avversi frekwenti tat-terapija b'elbasvir/grazoprevir + ribavirin flimkien kienu konsistenti mal-profil ta' sigurtà magħruf ta' ribavirin.
English: HBV AND HIV ANTIVIRAL AGENTS: NUCLEOS(T)IDE REVERSE TRANSCRIPTASE INHIBITORS
Maltese: INIBITURI NUCLEOS(T)IDE TA' REVERSE TRANSCRIPTASE
English: • feeling nervous (anxiety)
Maltese: • tħossok nervuż/a (ansjetà)
English: The pharmacokinetics of elbasvir/grazoprevir in paediatric patients less than 18 years of age have not been established (see section 4.2).
Maltese: Il-farmakokinetika ta' elbasvir/grazoprevir f'pazjenti pedjatriċi li għandhom inqas minn 18-il sena ma ġietx determinata (ara sezzjoni 4.2).
English: ZEPATIER 50 mg/100 mg film-coated tablets elbasvir/grazoprevir
Maltese: ZEPATIER 50 mg/100 mg pilloli miksija b'rita elbasvir/grazoprevir
English: • trouble sleeping (insomnia)
Maltese: • problemi bl-irqad (insomnja)
English: Treatment-emergent substitutions were detected in both HCV drug targets in 23/37 (62 %) genotype 1a, 1/8 (13 %) genotype 1b and 2/5 (40 %) genotype 4 subjects.
Maltese: Sostituzzjonijiet li tfaċċaw minħabba ttrattament nstabu fiż-żewġ miri tal-mediċini ta' HCV fi 23/37 (62 %) individwu bil-ġenotip 1a, 1/8 (13 %) individwi bil-ġenotip 1b, u 2/5 (40 %) individwi bil-ġenotip 4.
English: In a biochemical assay, grazoprevir inhibited the proteolytic activity of the recombinant NS3/4A protease enzymes from HCV genotypes 1a, 1b, 3 and 4a with IC50 values ranging from 4 to 690 pM.
Maltese: F'assaġġ bijokimiku, grazoprevir inibixxa l-attività proteolitika tal-enzimi rikombinanti ta' NS3/4A protease mill-ġenotipi 1a, 1b, 3 u 4a ta' HCV, b'valuri IC50 li jvarjaw minn 4 sa 690 pM.
English: Expected: ↓ Elbasvir ↓ Grazoprevir
Maltese: Mistenni: ↓ Elbasvir ↓ Grazoprevir
English: Expected: ↔ Elbasvir ↔ Grazoprevir
Maltese: Mistenni: ↔ Elbasvir ↔ Grazoprevir
English: (CYP3A or P-gp induction)
Maltese: (induzzjoni ta' CYP3A jew P-gp)
English: TE = Treatment-Experienced (failed prior treatment with interferon [IFN] or peginterferon alfa [peg-IFN] with or without ribavirin (RBV) or were intolerant to prior therapy) *EBR = elbasvir 50 mg; GZR = grazoprevir 100 mg; EBR/GZR = co-administered as a fixed-dose combination; EBR + GZR = co-administered as separate single agents
Maltese: TE = Diġà Kienu Ħadu Trattament Qabel (Treatment-Experienced) (ma ħadimx fuqhom trattament preċedenti b'interferon [IFN] jew peginterferon alfa [peg-IFN] b'ribavirin (RBV) jew mingħajru jew ma ttollerawx it-terapija ta' qabel) * EBR = elbasvir 50 mg; GZR = grazoprevir 100 mg; EBR/GZR = mogħtija flimkien bħala mediċina waħda b'doża fissa;
English: In the clinical studies, the dose of ribavirin was weight-based (< 66 kg = 800 mg/day, 66 to 80 kg = 1,000 mg/day, 81 to 105 kg = 1,200 mg/day, > 105 kg = 1,400 mg/day) administered in two divided doses with food.
Maltese: A Fl-istudji kliniċi, id-doża ta' ribavirin kienet ibbażata fuq il-piż (< 66 kg = 800 mg/jum, 66 sa 80 kg = 1,000 mg/jum, 81 sa 105 kg = 1,200 mg/jum, > 105 kg = 1,400 mg/jum) mogħtija maqsuma fuq żewġ dożi mal-ikel.
English: Do not take ZEPATIER if:
Maltese: Tiħux ZEPATIER jekk:
English: • EBR* + GZR* + RBV
Maltese: • EBR* + GZR* + RBV† għal
English: Methadone (20-120 mg once daily)/ elbasvir (50 mg once daily)
Maltese: Methadone (20-120 mg darba kuljum)/ elbasvir (50 mg darba kuljum)
English: Table 1: Recommended ZEPATIER therapy for treatment of chronic hepatitis C infection in patients with or without compensated cirrhosis (Child-Pugh A only) HCV genotype
Maltese: Tabella 1: Terapija ta' ZEPATIER rakkomandata għat-trattament ta' infezzjoni kronika talepatite Ċ f'pazjenti b'ċirrożi kkumpensata jew mingħajrha (Child-Pugh A biss) Ġenotip ta' HCV
English: The potential for grazoprevir to be a breast cancer resistance protein (BCRP) substrate cannot be excluded.
Maltese: Ma tistax tiġi eskluża l-possibbiltà li grazoprevir jkun sustrat tal-proteina ta' reżistenza tal-kanċer tas sider (BCRP - breast cancer resistance protein).
English: • check for side effects
Maltese: • jiċċekkja għal effetti sekondarji
English: GT1a NS5A polymorphisms: M28T/A, Q30E/H/R/G/K/D, L31M/V/F, H58D, and Y93C/H/N.
Maltese: §Polimorfiżmi ta' NS5A tal-GT1a: M28T/A, Q30E/H/R/G/K/D, L31M/V/F, H58D, u Y93C/H/N.
English: Table 5: Activities of elbasvir and grazoprevir in GT1a, GT1b and GT4 reference sequences and clinical isolates in replicon cells
Maltese: Attivitajiet ta' elbasvir u grazoprevir f'sekwenzi ta' referenza u iżolati kliniċi ta' GT1a, GT1b u GT4 f'ċelluli ta' replikoni
English: (0.03 mg EE/ 0.15 mg LNG single-dose)/ grazoprevir (200 mg once daily)
Maltese: (doża waħda ta' 0.03 mg EE/ 0.15 mg LNG)/ grazoprevir (200 mg darba kuljum)
English: Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) or very rare (< 1/10,000).
Maltese: Il-frekwenzi huma ddefiniti kif ġej: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000) jew rari ħafna
English: ZEPATIER is contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh B or C) (see sections 4.3 and 5.2).
Maltese: ZEPATIER huwa kontraindikat f'pazjenti b'indeboliment moderat jew sever tal-fwied (Child-Pugh B jew C) (ara sezzjonijiet 4.3 u 5.2).
English: Interactions between ZEPATIER and other medicinal products
Maltese: Interazzjonijiet bejn ZEPATIER u prodotti mediċinali oħra
English: Tenofovir disoproxil fumarate (300 mg once daily)/ elbasvir (50 mg once daily)
Maltese: Tenofovir disoproxil fumarate (300 mg darba kuljum)/ elbasvir (50 mg darba kuljum)
English: In genotype 1b replicons, single NS3 substitutions F43S, A156S/T/V, and D168A/G/V reduced grazoprevir antiviral activity by 3- to 375-fold.
Maltese: Fir-replikoni bil-ġenotip 1b, sostituzzjonijiet F43S, A156S/T/V, u D168A/G/V singoli ta' NS3 naqqsu l-attività antivirali ta' grazoprevir bi 3 darbiet sa 375 darba.
English: ZEPATIER 50 mg/100 mg film-coated tablets
Maltese: ZEPATIER 50 mg/100 mg pilloli miksija b'rita
English: What ZEPATIER is ZEPATIER is an antiviral medicine that contains the active substances elbasvir and grazoprevir.
Maltese: ZEPATIER huwa mediċina antivirali li fih is-sustanzi attivi elbasvir u grazoprevir.
English: In population pharmacokinetic analysis in HCV-infected patients, elbasvir and grazoprevir AUCs were 25 % and 10 % higher, respectively, in dialysis-dependent patients and 46 % and 40 % higher, respectively, in non-dialysis-dependent patients with severe renal impairment compared to elbasvir and grazoprevir AUC in patients without severe renal impairment.
Maltese: F'analiżi ta' farmakokinetika ta' popolazzjoni f'pazjenti infettati b'HCV, l-AUCs ta' elbasvir u grazoprevir kienu 25 % u 10 % ogħla, rispettivament, f'pazjenti dipendenti fuq id-dijalisi u 46 % u 40 % ogħla, rispettivament, f'pazjenti li mhumiex dipendenti fuq id-dijalisi b'indeboliment sever talkliewi meta mqabbla mal-AUC ta' elbasvir u grazoprevir f'pazjenti mingħajr indeboliment sever talkliewi.
English: • rosuvastatin, atorvastatin, fluvastatin, simvastatin, or lovastatin, for lowering blood cholesterol
Maltese: • rosuvastatin, atorvastatin, fluvastatin, simvastatin, jew lovastatin, biex ibaxxu l-livell ta'
English: • have ever taken any medicine for hepatitis C
Maltese: • qatt ħadt mediċini għall-epatite Ċ
English: Patients with moderate or severe hepatic impairment (Child-Pugh B or C) (see sections 4.2 and 5.2).
Maltese: Pazjenti b'indeboliment moderat jew sever tal-fwied (Child-Pugh B jew C) (ara sezzjonijiet 4.2 u 5.2).
English: Population PK analyses of HCV-infected patients in Phase 2 and 3 studies demonstrated that grazoprevir steady-state AUC0-24 increased by approximately 65 % in HCV-infected patients with compensated cirrhosis (all with CP-A) compared to HCV-infected non-cirrhotic patients, while elbasvir steady-state AUC was similar (see section 4.2).
Maltese: Analiżi PK ta' popolazzjoni ta' pazjenti infettati b'HCV fi studji ta' Fażi 2 u 3 uriet li l-AUC0-24 ta' grazoprevir fi stat fiss żdiedet b'madwar 65% f'pazjenti infettati b'HCV b'ċirrożi kkumpensata (kollha b'CP-A) meta mqabbla ma' pazjenti infettati b'HCV mingħajr ċirrożi, filwaqt li l-AUC ta' elbasvir fi stat fiss kienet simili (ara sezzjoni 4.2).
English: In non-HCV-infected subjects with severe renal impairment (eGFR < 30 mL/min/1.73 m2) who were not on dialysis, elbasvir and grazoprevir AUC values were increased by 86 % and 65 %, respectively, compared to non-HCV-infected subjects with normal renal function (eGFR > 80 mL/min/1.73 m2).
Maltese: F'individwi mhux infettati b'HCV b'indeboliment sever tal-kliewi (eGFR < 30 mL/min/1.73 m2) li ma kinux fuq id-dijalisi, il-valuri tal-AUC għal elbasvir u grazoprevir żdiedu b'86 % u 65 %, rispettivament, meta mqabbla ma' individwi mhux infettati b'HCV b'funzjoni normali tal-kliewi (eGFR > 80 mL/min/1.73 m2).
English: HCV replicons with reduced susceptibility to elbasvir and grazoprevir have been selected in cell culture for genotypes 1a, 1b and 4.
Maltese: Replikoni ta' HCV b'suxxettibilità mnaqqsa għal elbasvir u grazoprevir intgħażlu f'koltura ta' ċelluli għall-ġenotipi 1a, 1b, u 4.
English: St. John's wort (Hypericum perforatum)
Maltese: (Hypericum perforatum)
English: The geometric mean apparent terminal half-life (% geometric mean coefficient of variation) is approximately 24 (24 %) hours at 50 mg elbasvir and approximately 31 (34 %) hours at 100 mg grazoprevir in HCV-infected subjects.
Maltese: Il-medja ġeometrika tal-half-life terminali apparenti (medja ġeometrika tal-koeffiċjent ta' varjazzjoni %) hija madwar 24 (24 %) siegħa b'50 mg elbasvir u madwar 31 (34 %) siegħa b'100 mg grazoprevir f'individwi infettati b'HCV.
English: For hepatitis C virus (HCV) genotype-specific activity see sections 4.4 and 5.1.
Maltese: Għal attività speċifika għall-ġenotip tal-virus tal-epatite Ċ (HCV - hepatitis C virus) ara sezzjonijiet 4.4 u 5
English: In clinical studies
Maltese: Iżolati kliniċi
English: (8-24 mg/2-6 mg once daily)/ grazoprevir (200 mg once daily)
Maltese: (8-24 mg/2-6 mg darba kuljum)/ grazoprevir (200 mg darba kuljum)
English: For elbasvir, in HCV genotype 1a replicons, single NS5A substitutions Q30D/E/H/R, L31M/V and Y93C/H/N reduced elbasvir antiviral activity by 6- to 2,000-fold.
Maltese: Għal elbasvir, fir-replikoni ta' HCV bil-ġenotip 1a, sostituzzjonijiet Q30D/E/H/R, L31M/V u Y93C/H/N singoli ta' NS5A naqqsu l-attività antivirali ta' elbasvir b'6 darbiet sa 2,000 darba.
English: Buprenorphine/naloxone (8 mg/2 mg single dose)/ elbasvir (50 mg single dose)
Maltese: Buprenorphine/naloxone (doża waħda ta' 8 mg/2 mg)/ elbasvir (doża waħda ta' 50 mg)
English: Grazoprevir AUC is estimated to be 15 % higher in a 53 kg subject compared to a 77 kg subject.
Maltese: L-AUC ta' grazoprevir hija stmata li tkun 15 % ogħla f'individwu li jiżen 53 kg meta mqabbel ma' individwu ta' 77 kg.
English: Subjects with baseline NS3 polymorphisms, % (n/N)
Maltese: Individwi b'polimorfiżmi ta' NS3 fil-linja bażi,¶ % (n/N)
English: Each film-coated tablet contains 50 mg elbasvir and 100 mg grazoprevir.
Maltese: Kull pillola miksija b'rita fiha 50 mg elbasvir u 100 mg grazoprevir.
English: 12 weeks (N=79)
Maltese: 12-il ġimgħa (N=79)
English: ‡Reference sequences for NS5A at amino acid 58 are H (genotype 1a) and P (genotype 1b and genotype 4a and 4d).
Maltese: ‡Sekwenzi ta' referenza għal NS5A fl-aċidu amminiku 58 huma H (ġenotip 1a) u P (ġenotip 1b u ġenotip 4a u 4d).
English: Table 11: SVR in genotype 4-infected subjects Baseline Characteristics
Maltese: Tabella 11: SVR f'individwi¶ infettati bil-ġenotip 4 Karatteristiċi fil-Linja Bażi
English: Based on the population pharmacokinetic modeling in non-cirrhotic, HCV-infected subjects, the geometric mean steady-state elbasvir AUC0-24 and Cmax at 50 mg were 2,180 nM•hr and 137 nM, respectively, and the geometric mean steady-state grazoprevir AUC0-24 and Cmax at 100 mg were 1,860 nM•hr and 220 nM, respectively.
Maltese: Abbażi tal-mudellar farmakokinetiku ta' popolazzjoni f'individwi mhux ċirrotiċi, infettati b'HCV, il-medja ġeometrika tal-AUC0-24 u s-Cmax ta' elbasvir fi stat fiss b'50 mg kienu 2,180 nM•siegħa u 137 nM rispettivament, u l-medja ġeometrika tal-AUC0-24 u s-Cmax ta' grazoprevir fi stat fiss b'100 mg kienu 1,860 nM•siegħa u 220 nM, rispettivament.
English: Grazoprevir is an inhibitor of the HCV NS3/4A protease which is necessary for the proteolytic cleavage of the HCV encoded polyprotein (into mature forms of the NS3, NS4A, NS4B, NS5A, and NS5B proteins) and is essential for viral replication.
Maltese: Grazoprevir huwa inibitur ta' NS3/4A protease ta' HCV li huwa meħtieġ għall-qsim proteolitiku talpoliproteina b'kowd ikkonvertit minn HCV (għall-forom maturi tal-proteini NS3, NS4A, NS4B, NS5A, u NS5B) u huwa essenzjali għar-replikazzjoni tal-virus.
English: ↔ Pravastatin AUC 1.33 (1.09, 1.64) Cmax 1.28 (1.05, 1.55)
Maltese: AUC 1.33 (1.09, 1.64) Cmax 1.28 (1.05, 1.55)
English: Serum Late ALT elevations
Maltese: Żieda fil-livelli ta' ALT
English: Date of first authorisation: 22 July 2016
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 22 ta' Lulju 2016
English: (OATP1B inhibition)
Maltese: (inibizzjoni ta' OATP1B)
English: ↑ Grazoprevir AUC 10.21 (8.68, 12.00) Cmax 10.94 (8.92, 13.43) C24 1.77 (1.40, 2.24)
Maltese: 21 (8.68, 12.00) Cmax 10.94 (8.92, 13.43) C24 1.77 (1.40, 2.24)
English: Persistence of resistance-associated substitutions
Maltese: Persistenza ta' sostituzzjonijiet marbuta mar-reżistenza
English: For grazoprevir, the absolute bioavailability after a 200 mg single dose ranged from 15 - 27% and after multiple 200 mg doses ranged from 20 - 40%.
Maltese: Għal elbasvir, il-bijodisponibiltà assoluta hija stmata li tkun 32%. Għal grazoprevir, ilbijodisponibiltà assoluta wara doża waħda ta' 200 mg varjat minn 15 - 27% u wara ħafna dożi ta' 200 mg varjat minn 20 - 40%.
English: (20-150 mg once daily)/ grazoprevir (200 mg once daily)
Maltese: (20-150 mg darba kuljum)/ grazoprevir (200 mg darba kuljum)
English: In population pharmacokinetic analyses, elbasvir and grazoprevir AUCs are estimated to be 16 % and 45 % higher, respectively, in subjects ≥ 65 years of age compared to subjects less than 65 years of age.
Maltese: F'analiżi ta' farmakokinetika ta' popolazzjoni, l-AUCs ta' elbasvir u grazoprevir huma stmati li jkunu 16 % u 45 % ogħla, rispettivament, f'individwi b'età ta' ≥ 65 sena meta mqabbla ma individwi li għandhom inqas minn 65 sena.
English: C-SURFER (double-blind)
Maltese: C-SURFER (la l-investigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed titnuża)
English: TN = Treatment-Naïve
Maltese: TN = Qatt ma Kienu Ħadu Trattament Qabel (Treatment-Naïve)
English: In population pharmacokinetic analyses, elbasvir and grazoprevir AUCs are estimated to be 15 % and 50 % higher, respectively, for Asians compared to Whites.
Maltese: F'analiżi ta' farmakokinetika ta' popolazzjoni, l-AUCs ta' elbasvir u grazoprevir huma stmati li jkunu 15 % u 50 % ogħla, rispettivament, għal Asjatiċi meta mqabbla ma' Bojod.
English: • EBR* + GZR* + RBV† for 12 weeks (N=14)
Maltese: • EBR* + GZR* + RBV† għal 12-il ġimgħa (N=14)
English: Pharmacotherapeutic group: Antivirals for systemic use, Direct acting antivirals, Antivirals for treatment of HCV infections, ATC code: J05AP54.
Maltese: Antivirali għal użu sistemiku, Antivirali li jaħdmu b'mod dirett, Antivirali għat-trattament tal-infezzjonijiet tal-HCV Kodiċi, ATC:
English: Clinical study in subjects with advanced chronic kidney disease with genotype 1 CHC infection In the C-SURFER study, overall SVR was achieved in 94 % (115/122) of subjects receiving EBR + GZR for 12 weeks.
Maltese: Fl-istudju C-SURFER, SVR totali inkiseb f'94 % (115/122) tal-individwi li kienu qed jirċievu EBR + GZR għal 12-il ġimgħa.
English: Emtricitabine (200 mg once daily)
Maltese: Emtricitabine (200 darba kuljum)
English: Darunavir/ritonavir (600 mg twice daily)/ ritonavir (100 mg twice daily/ elbasvir (50 mg once daily)
Maltese: Darunavir/ritonavir (600 mg darbtejn kuljum)/ ritonavir (100 mg darbtejn kuljum/ elbasvir (50 mg darba kuljum)
English: Placebo-controlled study in subjects with CKD Stage 4 (eGFR 15-29 mL/min/1.73 m2) or Stage 5 (eGFR < 15 mL/min/1.73 m2), including subjects on hemodialysis, Subjects were randomised in a 1:1 ratio to one of the following treatment groups: EBR + GZR for 12 weeks (ITG) or placebo for 12 weeks followed by open-label treatment with EBR/GZR for 12 weeks (DTG).
Maltese: Studju kkontrollat bi plaċebo f'individwi b'CKD ta' Stadju 4 (eGFR 15-29 mL/min/1.73 m2) jew Stadju 5 (eGFR < 15 mL/min/1.73 m2), inkluż individwi fuq l-emodijalisi, L-individwi ntagħżlu b'mod każwali fi proporzjon ta' 1:1 għal wieħed mill-gruppi ta' trattament li ġejjin:
English: Merck Sharp & Dohme B.V. Tel: 0800 99 99 000 (+31 23 5153153) medicalinfo.nl@merck.com
Maltese: Tel: 0800 99 99 000 (+31 23 5153153) medicalinfo.nl@merck.com
English: (combination of mechanisms including CYP3A inhibition)
Maltese: (kombinazzjoni ta' mekkaniżmi inkluż inibizzjoni ta' CYP3A)
English: SVR EBR with GZR for 12 weeks (N = 312)
Maltese: SVR EBR ma' GZR għal 12-il ġimgħa (N=312)
English: Ketoconazole (400 mg PO once daily)/ elbasvir (50 mg single dose)
Maltese: Ketoconazole (400 mg PO darba kuljum)/ elbasvir (doża waħda ta' 50 mg)
English: NS5A Any of the following NS5A substitutions: M/L28A/G/T/S* Q30H/K/R/Y, L/M31F/M/I/V, H/P58D, Y93H/N/S
Maltese: M/L28A/G/T/S* Q30H/K/R/Y, L/M31F/M/I/V, H/P58D, Y93H/N/S
English: Mycophenolate mofetil (1,000 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Maltese: Mycophenolate mofetil (doża waħda ta' 1,000 mg)/ elbasvir (50 mg darba kuljum)/ grazoprevir (200 mg darba kuljum)
English: Elbasvir has minimal intestinal P-gp inhibition in humans, and does not result in clinically relevant increases in concentrations of digoxin (a P-gp substrate), with an 11% increase in plasma AUC.
Maltese: Elbasvir jikkawża inibizzjoni minima ta' P-gp tal-intestini fil-bnedmin, u ma jwassalx għal żidiet rilevanti b'mod kliniku fil-konċentrazzjonijiet ta' digoxin (sustrat ta' P-gp), b'żieda ta' 11 % fl-AUC tal-plażma.
English: Subjects were randomised in a 1:1:1:1 ratio to the study arms.
Maltese: L-individwi ntgħażlu b'mod każwali fi proporzjon ta' 1:1:1:1 għall-fergħat talistudju.
English: ↔ Elvitegravir AUC 1.10 (1.00, 1.21) Cmax 1.02 (0.93, 1.11) C24 1.31 (1.11, 1.55)
Maltese: AUC 1.10 (1.00, 1.21) Cmax 1.02 (0.93, 1.11) C24 1.31 (1.11, 1.55)
English: • The active substances are: elbasvir and grazoprevir.
Maltese: • Is-sustanzi attivi huma: elbasvir u grazoprevir.
English: *Reference sequences for NS5A at amino acid 28 are M (genotype 1a) and L (genotype 1b and genotype 4a and 4d).
Maltese: *Sekwenzi ta' referenza għal NS5A fl-aċidu amminiku 28 huma M (ġenotip 1a) u L (ġenotip 1b u ġenotip 4a u 4d).
English: ZEPATIER is not for use in children and adolescents under 18 years of age.
Maltese: ZEPATIER mhuwiex qiegħed biex jintuża fi tfal u adolexxenti taħt l-età ta' 18-il sena.
English: During clinical studies with ZEPATIER with or without ribavirin, < 1 % of subjects experienced elevations of ALT from normal levels to greater than 5 times the upper limit of normal (ULN), (see section 4.8).
Maltese: Waqt studji kliniċi b'ZEPATIER ma' ribavirin jew mingħajru, < 1 % talindividwi kellhom żieda fil-livelli ta' ALT minn dawk normali sa aktar minn 5 darbiet aktar mill-ogħla livell tan-normal (ULN - upper limit of normal), (ara sezzjoni 4.8).
English: SEDATIVES
Maltese: SEDATTIVI
English: In genotype 1b replicons, single NS5A substitutions L31F and Y93H reduced elbasvir antiviral activity by 17-fold.
Maltese: Firreplikoni bil-ġenotip 1b, sostituzzjonijiet L31F u Y93H singoli ta' NS5A naqqsu l-attività antivirali ta' elbasvir bi 17-il darba.
English: (300 mg once daily)/ ritonavir (100 mg once daily/ elbasvir (50 mg once daily)
Maltese: (300 mg darba kuljum)/ ritonavir (100 mg darba kuljum/ elbasvir (50 mg darba kuljum)
English: Elbasvir is active in vitro against genotype 1a NS5A substitutions, M28V and Q30L, genotype 1b substitutions, L28M/V, R30Q, L31V, Y93C, and genotype 4 substitution, M31V, which confer resistance to other NS5A inhibitors.
Maltese: In vitro elbasvir huwa attiv kontra s-sostituzzjonijiet M28V u Q30L ta' NS5A tal-ġenotip 1a, issostituzzjonijiet L28M/V, R30Q, L31V, Y93C, tal-ġenotip 1b, u s-sostituzzjoni M31V tal-ġenotip 4, li jagħtu reżistenza għal inibituri oħra ta' NS5A.
English: For grazoprevir, in HCV genotype 1a replicons, single NS3 substitutions D168A/E/G/S/V reduced grazoprevir antiviral activity by 2- to 81-fold.
Maltese: Għal grazoprevir, fir-replikoni ta' HCV bil-ġenotip 1a, sostituzzjonijiet D168A/E/G/S/V singoli ta' NS3 naqqsu l-attività antivirali ta' grazoprevir b'darbtejn sa 81 darba.
English: • sunitinib to treat certain cancers
Maltese: • sunitinib biex jittratta ċerti kanċers
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Il-pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, defiċjenza ta' Lapp lactase, jew assorbiment ħażin ta' glucose-galactose m'għandhomx jieħdu dan il-prodott mediċinali.
English: In genotype 4 replicons, single NS5A substitutions L30S, M31V, and Y93H reduced elbasvir antiviral activity by 3to 23-fold.
Maltese: Fir-replikoni bil-ġenotip 4, sostituzzjonijiet L30S, M31V, u Y93H singoli ta' NS5A naqqsu l-attività antivirali ta' elbasvir bi 3 darbiet sa 23 darba.
English: GT4 (treatmentexperienced)
Maltese: GT4 (li jkunu ħadu trattament qabel)♯
English: In a pooled analysis of subjects treated with regimens containing elbasvir/grazoprevir or elbasvir + grazoprevir with or without ribavirin in Phase 2 and 3 clinical studies, resistance analyses were conducted for 50 subjects who experienced virologic failure and had sequence data available (6 with on-treatment virologic failure, 44 with post-treatment relapse).
Maltese: F'ġabra ta' analiżi ta' individwi ttrattati bi skedi li kien fihom elbasvir/grazoprevir jew elbasvir + grazoprevir b'ribavirin jew mingħajru fi studji kliniċi ta' Fażi 2 u 3, saru analiżi ta' reżistenza għal 50 individwu li kellhom falliment viroloġiku u kellhom dejta ta' sekwenzar disponibbli (6 b'falliment viroloġiku waqt it-trattament, 44 b'irkadar wara t-trattament).
English: Among genotype 1a-infected subjects, the median age was 54 years (range: 19 to 76); 71 % were male; 71 % were White; 22 % were Black or African American; 9% were Hispanic or Latino; 74% were treatment-naïve subjects; 26% were treatment-experienced subjects; mean body mass index was 27 kg/m2; 75 % had baseline HCV RNA levels greater than 800,000 IU/mL; 23 % had cirrhosis; 72% had non-C/C IL28B alleles (CT or TT); 30 % had HCV/HIV-1 co-infection.
Maltese: Fost l-individwi infettati bil-ġenotip 1a, il-medjan tal-età kien 54 sena (firxa: 19 sa 76); 71% kienu rġiel; 71 % kienu Bojod; 22% kienu Suwed jew Amerikani Afrikani; 9% kienu Ispaniċi jew Latino; 74% kienu individwi li qatt ma kienu ħadu trattament qabel; 26% kienu individwi li diġà ħadu trattament qabel; il-medja tal-indiċi tal-massa tal-ġisem kienet 27 kg/m2; 75 % kellhom livelli ta' RNA ta' HCV fil-linja bażi ta' aktar minn 800,000
English: †Reference sequences for NS5A at amino acid 31 are L (genotype 1a and genotype 1b) and M (genotype 4a and 4d).
Maltese: †Sekwenzi ta' referenza għal NS5A fl-aċidu amminiku 31 huma L (ġenotip 1a u ġenotip 1b) u M (ġenotip 4a u 4d).
English: Lopinavir/ritonavir (400 mg twice daily)/ ritonavir (100 mg twice daily/ elbasvir (50 mg once daily)
Maltese: Lopinavir/ritonavir (400 mg darbtejn kuljum)/ ritonavir (100 mg darbtejn kuljum/ elbasvir (50 mg darba kuljum)