FrancophonIA/ELRC3.0 huggingface dataset:
English: ORAL CONTRACEPTIVES Norgestimate/ ethinyl estradiol (norgestimate 0.180 mg/ 0.215 mg/ 0.25 mg/ ethinyl estradiol 0.025 mg)/ ledipasvir (90 mg once daily)d
Maltese: Norgestimate/ ethinyl estradiol (norgestimate 0.180 mg/ 0.215 mg/ 0.25 mg/ ethinyl estradiol 0.025 mg)/ ledipasvir (90 mg darba kuljum) d
English: Safety and efficacy of ledipasvir/sofosbuvir have been established in patients with decompensated cirrhosis (see section 5.1).
Maltese: Is-sigurtà u leffikaċja ta' ledipasvir/sofosbuvir ġew determinati f'pazjenti b'ċirrożi dikumpensata (ara sezzjoni 5.1).
English: Reduced susceptibility to sofosbuvir was associated with the primary NS5B substitution S282T in all replicon genotypes examined.
Maltese: Suxxettibilità mnaqqsa għal sofosbuvir ġiet assoċjata mas-sostituzzjoni NS5B primarja S282T fil-ġenotipi replikon kollha eżaminati.
English: LDV/SOF+RBV 24 weeks (n = 307)a,b
Maltese: LDV/SOF+RBV 24-il ġimgħa (n = 307)a,b
English: The concomitant use of amiodarone was limited through the clinical development of sofosbuvir.
Maltese: L-użu konkomitanti ta' amiodarone kien limitat permezz tal-iżvilupp kliniku ta' sofosbuvir.
English: 24 weeks (n = 111)
Maltese: 24 ġimgħa (n = 111)
English: Table 17: Combined response rates (SVR12) in studies SOLAR-1 and SOLAR-2 LDV/SOF+RBV 12 weeks (n = 307)a,b
Maltese: SOLAR-1 u SOLAR-2 LDV/SOF+RBV 12-il ġimgħa (n = 307)a, b
English: Methadone (Methadone maintenance therapy [30 to 130 mg/daily])/ sofosbuvir (400 mg once daily)d
Maltese: Methadone (Terapija ta' manteniment b'methadone [30 sa 130 mg/kuljum])/ sofosbuvir (400 mg darba kuljum)d
English: Ledipasvir (90 mg once daily)
Maltese: Ledipasvir (90 mg darba kuljum)
English: f Staggered administration (12 hours apart) of atazanavir/ritonavir + emtricitabine/tenofovir disoproxil fumarate or darunavir/ritonavir + emtricitabine/tenofovir disoproxil fumarate and Harvoni provided similar results.
Maltese: f. Għoti mifrux (12-il siegħa l-bogħod minn xulxin) ta' atazanavir/ritonavir + emtricitabine/tenofovir disoproxil fumarate jew darunavir/ritonavir + emtricitabine/tenofovir disoproxil fumarate u Harvoni ta riżultati simili. g.
English: Subsequently, the marketing authorisation holder (MAH) shall submit PSUR for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: Sussegwentement, id-detentur tal-awtorizzazzjoni għattqegħid fis-suq (MAH) għandu jippreżenta PSUR għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tadDirettiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Prior HCV therapy PEG-IFN+RBV HCV protease inhibitor + PEG-IFN+RBV
Maltese: PEG-IFN+RBV Inibitur tal-protease talHCV + PEG-IFN+RBV
English: 8 weeks (n = 215)
Maltese: 8 ġimgħat (n = 215)
English: • oxcarbazepine (a medicine used to treat epilepsy and prevent seizures);
Maltese: • oxcarbazepine (mediċina użata għat-trattament tal-epilessija u għall-prevenzjoni ta'
English: The following adverse drug reactions have been identified with Harvoni (Table 6).
Maltese: Ir-reazzjonijiet avversi tal-mediċina li ġejjin ġew identifikati b'Harvoni (Tabella 6).
English: Within ledipasvir/sofosbuvir, GS-331007 accounts for approximately 85% of total systemic exposure.
Maltese: Fi ħdan ledipasvir/sofosbuvir, GS-331007 jammonta għal madwar 85% tal-esponiment sistemiku totali.
English: The majority of the sofosbuvir dose recovered in urine was GS-331007 (78%) while 3.5% was recovered as sofosbuvir.
Maltese: Il-maġġoranza tad-doża ta' sofosbuvir irkuprata flawrina kienet GS-331007 (78%) filwaqt li 3.5% ġiet irkuprata bħala sofosbuvir.
English: Harvoni is contraindicated with phenobarbital and phenytoin (see section 4.3).
Maltese: Harvoni hu kontraindikat ma' phenobarbital u phenytoin (ara sezzjoni 4.3).
English: Contains lactose and sunset yellow FCF aluminium lake (E110).
Maltese: TA' EĊĊIPJENTI Fih lactose u sunset yellow FCF aluminium lake (E110).
English: Each film-coated tablet contains 90 mg ledipasvir and 400 mg sofosbuvir.
Maltese: Kull pillola miksija b'rita fiha 90 mg ledipasvir u 400 mg sofosbuvir.
English: Table 20: Effect of Varying Degrees of Renal Impairment on Exposures (AUC) of Sofosbuvir, GS-331007, and Ledipasvir Compared to Subjects with Normal Renal Function
Maltese: Effett ta' Gradi Differenti ta' Indeboliment tal-Kliewi fuq Esponimenti (AUC) għal Sofosbuvir, GS-331007, u Ledipasvir Meta Mqabbla ma' Individwi b'Funzjoni Normali tal-Kliewi
English: Harvoni + ribavirinA for 12 weeks (see section 5.1).
Maltese: Harvoni + ribavirinA għal 12-il ġimgħa (ara sezzjoni 5.1).
English: CPT Bc
Maltese: CPT Bċ
English: The safety of tenofovir disoproxil fumarate in the setting of Harvoni and a pharmacokinetic enhancer (e.g. ritonavir or cobicistat) has not been established.
Maltese: Is-sigurtà ta' tenofovir disoproxil fumarate flambjent ta' Harvoni u enhancer farmakokinetiku (eż. ritonavir jew cobicistat) ma ġietx stabbilita.
English: Table 6: Adverse drug reactions identified with Harvoni Frequency
Maltese: Tabella 6: Reazzjonijiet avversi tal-mediċina identifikati b'Harvoni
English: ANTIMYCOBACTERIALS Rifampicin (600 mg once daily)/ ledipasvir (90 mg single dose)d
Maltese: ANTIMIKOBATTERJALI Rifampicin (600 mg darba kuljum)/ ledipasvir (90 mg doża waħda) d
English: The E237G substitution showed a 1.3-fold reduction in susceptibility to sofosbuvir in the genotype 1a replicon assay.
Maltese: Is-sostituzzjoni E237G uriet tnaqqis ta' 1.3 darbiet fis-suxxettibilità għal sofosbuvir fl-analiżi ta' replikon ta' ġenotip 1a.
English: Co-administration with rosuvastatin (see section 4.5).
Maltese: Għoti flimkien ma' rosuvastatin (ara sezzjoni 4.5).
English: Ledipasvir, sofosbuvir, and GS-331007 exposures in adolescents aged 12 to < 18 years were similar to those in adults from Phase 2/3 studies, following administration of ledipasvir/sofosbuvir (90 mg/400 mg).
Maltese: Esponimenti għal ledipasvir, sofosbuvir, u GS-331007 f'adolexxenti ta' età minn 12 sa < 18-il sena kienu simili għal dawk fl-adulti minn studji ta' Fażi 2/3, wara l-għoti ta' ledipasvir/sofosbuvir (90 mg/400 mg).
English: Table 8: Demographics and baseline characteristics in study ION-3 Patient disposition
Maltese: Tabella 8: Demografiċi u karatteristiċi tal-linja bażi fi studju ION-3 Dispożizzjoni tal-pazjent
English: Genotype 6a
Maltese: Ġenotip 6a
English: SVR was achieved in all 24 patients (n = 20 with L159F+C316N; n = 1 with L159F; and n = 3 with N142T) who had baseline variants associated with resistance to NS5B nucleoside inhibitors.
Maltese: SVR intlaħaq fl-24 pazjent kollha (n = 20 b'L159F+C316N; n = 1 b'L159F; u n = 3 b'N142T) li kellhom varjanti tal-linja bażi assoċjati mar-reżistenza għal inibituri nucleoside ta' NS5B.
English: The adverse reactions observed were consistent with those observed in clinical studies of ledipasvir/sofosbuvir in adults (see Table 6).
Maltese: Ir-reazzjonijiet avversi osservati kienu konsistenti ma' dawk osservati fi studji kliniċi ta' ledipasvir/sofosbuvir fladulti (ara Tabella 6).
English: Adult and adolescent patients 12 years of age or older with genotype 3 CHC
Maltese: Pazjenti adulti u adolexxenti b'età ta' 12-il sena jew aktar b'CHC ta' ġenotip 3
English: In genotype 4, 5 and 6 infection, only small numbers of patients have been evaluated (total of 5 patients with failure).
Maltese: F'infezzjoni ta' ġenotip 4, 5 u 6, numri żgħar biss ta' pazjenti ġew evalwati (total ta' 5 pazjenti li kellhom falliment).
English: AUC, Cmax, Cmina, b
Maltese: Proporzjon medju (90% intervall ta' kunfidenza) għal AUC, Cmax, Cmina,b
English: Genotype 4a
Maltese: Ġenotip 4a
English: • tenofovir disoproxil fumarate or any medicine containing tenofovir disoproxil fumarate,
Maltese: • tenofovir disoproxil fumarate jew kwalunkwe mediċina li fiha tenofovir disoproxil fumarate, użata biex tikkura infezzjoni tal-HIV;
English: The pharmacokinetics of sofosbuvir were studied following 7-day dosing of 400 mg sofosbuvir in HCV-infected patients with moderate and severe hepatic impairment (CPT class B and C).
Maltese: Il-farmakokinetika ta' sofosbuvir ġiet studjata wara dożaġġ ta' 7 ijiem ta' 400 mg ta' sofosbuvir f'pazjenti infettati b'HCV b'indeboliment moderat u sever tal-fwied (CPT klassi B u Ċ).
English: The clinical data to support the use of Harvoni in adults infected with HCV genotype 2 and 6 are limited (see section 5.1).
Maltese: Id-data klinika biex tappoġġa l-użu ta' Harvoni f'adulti infettati bil-ġenotip 2 u 6 tal-HCV hija limitata (ara sezzjoni 5.1).
English: The clinical significance of this substitution is currently unknown.
Maltese: Issinifikat kliniku ta' din is-sostituzzjoni bħalissa mhux magħruf.
English: Reduced susceptibility to ledipasvir was associated with the primary NS5A substitution Y93H in both genotype 1a and 1b.
Maltese: Suxxettibilità mnaqqsa għal ledipasvir ġiet assoċjata mas-sostituzzjoni NS5A primarja Y93H kemm fil-ġenotip 1a kif ukoll f'dak 1b.
English: HCV replicons with reduced susceptibility to ledipasvir have been selected in cell culture for genotype 1a and 1b.
Maltese: HCV replikons b'suxxettibilità mnaqqsa għal ledipasvir intgħażlu fil-koltura taċ-ċelluli għal ġenotipi 1a u 1b.
English: • statins used to treat high cholesterol;
Maltese: • statins jintużaw għall-kura ta' kolesterol għoli;
English: In the SOLAR-2 study, one patient with genotype 4d developed NS5B substitution E237G at the time of relapse.
Maltese: Fl-istudju SOLAR-2, pazjent wieħed b'ġenotip 4d żviluppa sostituzzjoni E237G f'NS5B fil-ħin tar-rikaduta.
English: 24 weeks (n = 217)
Maltese: 24 ġimgħa (n = 217)
English: A Adults: weight based ribavirin (< 75 kg = 1,000 mg and ≥ 75 kg = 1,200 mg), administered orally in two divided doses with food.
Maltese: A Adulti: ribavirin ibbażat fuq il-piż (< 75 kg = 1,000 mg u ≥ 75 kg = 1,200 mg), mogħti mill-ħalq f'żewġ dożi maqsumin mal-ikel.
English: Refer to tenofovir disoproxil fumarate, emtricitabine/tenofovir disoproxil fumarate, or elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate Summary of Product Characteristics for recommendations on renal monitoring.
Maltese: Irreferi għas-Sommarju tal-Karatteristiċi tal-Prodott ta' tenofovir disoproxil fumarate, emtricitabine/tenofovir disoproxil fumarate, jew elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate għal rakkomandazzjonijiet dwar il-monitoraġġ renali.
English: Genotype 1a
Maltese: Ġenotip 1a
English: Patients were on a stable HIV-1 antiretroviral therapy that included emtricitabine/tenofovir disoproxil fumarate, administered with efavirenz, rilpivirine or raltegravir.
Maltese: Il-pazjenti kienu fuq terapija antiretrovirali stabbli kontra l-HIV-1 li kienet tinkludi emtricitabine/tenofovir disoproxil fumarate, mogħtija ma' efavirenz, rilpivirine jew raltegravir.
English: In study ION-4, 13 HCV/HIV-1 co-infected patients with genotype 1, including 1 cirrhotic patient, who had failed a sofosbuvir + ribavirin regimen were enrolled; the SVR was 100% (13/13) after 12 weeks of treatment with ledipasvir/sofosbuvir.
Maltese: Fi studju ION-4, 13 HCV/HIV-1 pazjenti koinfettati b'ġenotip 1, li jinkludu 1 pazjent ċirrotiku, li ma rnexxewx fuq kors ta' sofosbuvir + ribavirin ġew irreġistrati; l-SVR kienet 100% (13/13) wara 12-il ġimgħa ta' kura b'ledipasvir/sofosbuvir.
English: The median terminal half-lives of sofosbuvir and GS-331007 following administration of ledipasvir/sofosbuvir were 0.5 and 27 hours, respectively.
Maltese: Il-medjan tal-half-lives terminali ta' sofosbuvir u ta' GS-331007 wara l-għoti ta' ledipasvir/sofosbuvir kien ta' 0.5 u 27 siegħa rispettivament.
English: Abacavir/ lamivudine (600 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c, d
Maltese: Abacavir/ lamivudine (600 mg/ 300 mg darba kuljum)/ ledipasvir (90 mg darba kuljum)ċ/ sofosbuvir (400 mg darba kuljum)ċ, d
English: In vitro potential for ledipasvir/sofosbuvir to affect other medicinal products
Maltese: Potenzjal in vitro għal ledipasvir/sofosbuvir li jaffettwa prodotti mediċinali oħrajn
English: • fainting
Maltese: • sturdament
English: Harvoni is sometimes taken with another medicine, ribavirin.
Maltese: Xi kultant, Harvoni jittieħed ma' mediċina oħra, ribavirin.
English: Genotype 3a
Maltese: Ġenotip 3a
English: EC50 (K24G/N/R, M28A/G/T, Q30E/G/H/L/K/R/T, L31I/F/M/V, P32L, S38F, H58D, A92K/T, and Y93C/F/H/N/S for genotype 1a and L31I/F/M/V, P32L, P58D, A92K, and Y93C/H/N/S for genotype 1b HCV infection).
Maltese: L-analiżi (permezz ta' sekwenzjar profond) inkludiet polimorfiżmi ta' NS5A assoċjati mar-reżistenza li taw bidla ta' > 2.5 darba f'EC50 (K24G/N/R, M28A/G/T, Q30E/G/H/L/K/R/T, L31I/F/M/V, P32L, S38F, H58D, A92K/T, u Y93C/F/H/N/S għal ġenotip 1a u L31I/F/M/V, P32L, P58D, A92K, u Y93C/H/N/S għal infezzjoni tal-HCV ta' ġenotip 1b).
English: The study (double-blind and placebo-controlled) evaluated 24 weeks of treatment ledipasvir/sofosbuvir (with ribavirin placebo) versus 12 weeks of treatment with ledipasvir/sofosbuvir with ribavirin.
Maltese: L-istudju (double-blind u kkontrollat bi plaċebo) evalwa 24 ġimgħa ta' kura b'ledipasvir/sofosbuvir (bi plaċebo ta' ribavirin) kontra 12-il ġimgħa ta' kura b'ledipasvir/sofosbuvir ma' ribavirin.
English: NS5A resistance-associated variants (RAVs) were observed in post-baseline isolates from 29/37 patients (22/29 genotype 1a and 7/8 genotype 1b) not achieving sustained virologic response (SVR).
Maltese: F'iżolati wara l-linja bażi ġew osservati varjanti assoċjati mar-reżistenza (RAVs - resistanceassociated variants) NS5A minn 29/37 pazjent (22/29 ġenotip 1a u 7/8 ġenotip 1b) li ma rċevewx rispons viroloġiku sostnut (SVR - sustained virologic response).
English: SIRIUS included patients with compensated cirrhosis who first failed therapy with pegylated interferon (PEG-IFN) + ribavirin, and then failed a regimen consisting of a pegylated interferon + ribavirin + an NS3/4A protease inhibitor.
Maltese: SIRIUS kien jinkludi pazjenti b'ċirrożi kumpensata li l-ewwel ma rnexxewx bit-terapija b'pegylated interferon (PEG-IFN) + ribavirin, u ma rnexxewx fuq kors li kien jikkonsisti minn pegylated interferon + ribavirin + u inibitur tal-protease NS3/4A.
English: Table 19: Response rates (SVR12) in patients with genotype 3 infection (ELECTRON-2) LDV/SOF+RBV 12 weeks
Maltese: Rati ta' rispons (SVR12) f'pazjenti b' infezzjoni ta' ġenotip 3 (ELECTRON-2) LDV/SOF+RBV 12-il ġimgħa
English: Both sofosbuvir and ledipasvir were fully active against substitutions associated with resistance to other classes of direct-acting antivirals with different mechanisms of actions, such as NS5B non-nucleoside inhibitors and NS3 protease inhibitors.
Maltese: Kemm sofosbuvir kif ukoll ledipasvir kienu attivi b'mod sħiħ kontra sostituzzjonijiet assoċjati ma' reżistenza għal klassijiet oħrajn ta' antivirali li jaġixxu b'mod dirett b'mekkaniżmi ta' azzjoni differenti, bħal inibituri non-nucleoside ta' NS5B u inibituri ta' protease ta' NS3.
English: No patient experienced virologic failure (see section 4.2 for information on paediatric use).
Maltese: L-ebda pazjent ma kellu falliment viroloġiku (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Table 7: Activity of ledipasvir and sofosbuvir against chimeric replicons Genotype replicons
Maltese: Attività ta' ledipasvir u sofosbuvir kontra replikons kimeriċi Ġenotip tarreplikons
English: b. The chimeric replicons carrying NS5A genes from genotype 2b, 5a, 6a and 6e were used for testing ledipasvir while the chimeric replicons carrying NS5B genes from genotype 2b, 5a or 6a were used for testing sofosbuvir.
Maltese: Ir-replikons kimeriċi li jġorru ġeni NS5A minn ġenotip 2b, 5a, 6a u 6e intużaw għall-ittestjar ta' ledipasvir filwaqt li rreplikons kimeriċi li jġorru ġeni NS5B minn ġenotip 2b, 5a jew 6a intużaw għall-ittestjar ta' sofosbuvir.
English: The clinical data to support the use of Harvoni in adults infected with HCV genotype 3 are limited (see section 5.1).
Maltese: Id-data klinika biex tappoġġa l-użu ta' Harvoni f'adulti infettati bil-ġenotip 3 tal-HCV hija limitata (ara sezzjoni 5.1).
English: Of the remaining 154 patients, a total of 149 achieved SVR12 across both treatment groups; 96% (74/77) of patients in the ledipasvir/sofosbuvir with ribavirin 12-week group and 97% (75/77) of patients in the ledipasvir/sofosbuvir 24-week group.
Maltese: Mill154 pazjent li kien fadal, total ta' 149 kisbu SVR12 fiż-żewġ gruppi ta' kura; 96% (74/77) tal-pazjenti fil-grupp ta' ledipasvir/sofosbuvir ma' ribavirin għal 12-il ġimgħa u 97% (75/77) tal-pazjenti fil-grupp ta' ledipasvir/sofosbuvir ta' 24 ġimgħa.
English: Elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate (150 mg/ 150 mg/ 200 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c
Maltese: Elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate (150 mg/ 150 mg/ 200 mg/ 300 mg darba kuljum)/ ledipasvir (90 mg darba kuljum)ċ/ sofosbuvir (400 mg darba kuljum)ċ
English: Site-directed mutagenesis of NS5A RAVs showed that substitutions conferring a fold-change > 100 and ≤ 1,000 in ledipasvir susceptibility are Q30H/R, L31I/M/V, P32L and Y93T in genotype 1a and P58D and Y93S in genotype 1b; and substitutions conferring a fold-change > 1,000 are M28A/G, Q30E/G/K, H58D, Y93C/H/N/S in genotype 1a and A92K and Y93H in genotype 1b.
Maltese: Mutaġenesi diretta mis-sit ta' NS5A RAVs uriet li sostituzzjonijiet li jagħtu drabi ta' tibdil ta' > 100 u ≤ 1,000 fis-suxxettibilità għal ledipasvir huma Q30H/R, L31I/M/V, P32L u Y93T f'ġenotip 1a u P58D u Y93S f'ġenotip 1b; u sostituzzjonijiet li jagħtu drabi ta' tibdil ta' > 1,000 huma M28A/G, Q30E/G/K, H58D, Y93C/H/N/S f'ġenotip 1a u A92K u Y93H f'ġenotip 1b.
English: Table 12: Response rates in study ION-1 LDV/SOF
Maltese: Tabella 12: Rati ta' rispons fl-istudju ION-1 LDV/SOF
English: For the combination of tenofovir/emtricitabine + atazanavir/ritonavir, please see below.
Maltese: Għall-kombinazzjoni ta' tenofovir/emtricitabine + atazanavir/ritonavir, jekk jogħġbok ara hawn taħt.
English: Dephosphorylation results in the formation of nucleoside metabolite GS-331007 that cannot be efficiently rephosphorylated and lacks anti-HCV activity in vitro.
Maltese: Id-defosforilazzjoni tirriżulta fil-formazzjoni tal-metabolit nucleoside GS-331007 li ma jistax jiġi fosforilizzat mill-ġdid b'mod effiċjenti u li hu nieqes minn attività kontra HCV in vitro.
English: Tacrolimus (5 mg single dose)/ sofosbuvir (400 mg single dose)h
Maltese: Tacrolimus (5 mg doża waħda)/ sofosbuvir (400 mg doża waħda) h
English: Diabetics may experience improved glucose control, potentially resulting in symptomatic hypoglycaemia, after initiating HCV direct-acting antiviral treatment.
Maltese: Pazjenti dijabetiċi jista' jkollhom kontroll aħjar tal-glucose, li potenzjalment iwassal għal ipogliċemija sintomatika, wara li jinbeda trattament għall-HCV bi trattament antivirali li jaġixxi b'mod dirett.
English: Warfarin and other similar medicines called vitamin K antagonists used to thin the blood.
Maltese: Warfarin u mediċini oħra simili msejħa antagonisiti tal-vitamina K użati biex iraqqu d-demm.
English: Table 18: Response rates (SVR12) with ledipasvir/sofosbuvir for 12 weeks in patients with genotype 2, 4, 5 and 6 HCV infection
Maltese: Tabella 18: Rati ta' rispons (SVR12) b'ledipasvir/sofosbuvir għal 12-il ġimgħa f'pazjenti b'infezzjoni ta' ġenotip 2, 4, 5 u 6
English: ANTICOAGULANTS Dabigatran etexilate
Maltese: Dabigatran etexilate
English: Site-directed mutagenesis of the Y93H substitution in both genotype 1a and 1b as well as the Q30R and L31M substitution in genotype 1a conferred high levels of reduced susceptibility to ledipasvir (fold-change in EC50 ranging from 544-fold to 1,677-fold).
Maltese: Mutaġenesi diretta mis-sit tas-sostituzzjoni Y93H kemm filġenotip 1a u f'dak 1b kif ukoll is-sostituzzjoni Q30R u L31M fil-ġenotip 1a irriżultat f'livelli għoljin ta' suxxettibilità mnaqqsa għal ledipasvir (drabi ta' tibdil f'EC50 li jvarjaw minn 544 darba sa 1,677 darba).
English: • outer cartons containing 3 bottles of 28 (84) film-coated tablets.
Maltese: • kartun ta' barra li fihom 3 fliexken ta' 28 (84) pillola miksija b'rita.
English: When Harvoni is used in combination with ribavirin refer also to the Summary of Product Characteristics for ribavirin for patients with creatinine clearance (CrCl) < 50 mL/min (see section 5.2).
Maltese: Meta Harvoni jintuża flimkien ma' ribavirin, irreferi wkoll għas-Sommarju tal-Karatteristiċi tal-Prodott għal ribavirin għal pazjenti b'eliminazzjoni tal-kreatinina(CrCl) < 50 mL/min (ara sezzjoni 5.2).
English: Randomisation was stratified by the presence or absence of cirrhosis, HCV genotype (1a versus 1b) and response to prior HCV therapy (relapse/breakthrough versus non-response).
Maltese: L-għażla b'mod każwali ġiet stratifikata bil-preżenza jew nuqqas ta' ċirrożi, ġenotip HCV (1a kontra 1b) u rispons għal kura HCV preċedenti (rikaduta/breakthrough kontra ebda-rispons).
English: Table 11: Demographics and baseline characteristics in study ION-1 Patient disposition
Maltese: Tabella 11: Demografiċi u karatteristiċi tal-linja bażi fl-istudju ION-1 Dispożizzjoni tal-pazjent
English: The sofosbuvir resistance-associated substitution S282T in NS5B was not detected in any virologic failure isolate from the Phase 3 studies.
Maltese: Is-sostituzzjoni S282T assoċjata mar-reżistenza ta' sofosbuvir f'NS5B ma ġiet osservata f'ebda iżolat ta' falliment viroloġiku mill-istudji ta' Fażi 3.
English: Tablet core:
Maltese: Tabella 9:
English: Sofosbuvir ↓ Cmax 0.23 (0.19, 0.29)
Maltese: Sofosbuvir ↓ Cmax 0.23 (0.19, 0.29) ↓ AUC 0.28 (0.24, 0.32)
English: The median age was 56 years (range: 23 to 77); 74% of patients were male; 97% were white; 63% had genotype 1a HCV infection; 94% had non-CC IL28B alleles (CT or TT).
Maltese: L-età medjana kienet ta' 56 sena (medda: 23 sa 77); 74% tal-pazjenti kienu rġiel; 97% kienu bojod; 63% kellhom infezzjoni bil-ġenotip 1a HCV; 94% kellhom alleli non-CC IL28B (CT jew TT).
English: 12 weeks (n = 109)
Maltese: 12-il ġimgħa (n = 109)
English: Harvoni is contraindicated with carbamazepine (see section 4.3).
Maltese: Harvoni hu kontraindikat ma' carbamazepine (ara sezzjoni 4.3).
English: Of the 100 treated patients, the median age was 15 years (range: 12 to 17); 63% of the patients were female; 90% were White, 7% were Black, and 2% were Asian; 13% were Hispanic/Latino; mean weight was 61.3 kg (range: 33.0 to 126.0 kg); 55% had baseline HCV RNA levels greater than or equal to 800,000 IU/mL; 81% had genotype 1a HCV infection; 76% had non-CC IL28B alleles (CT or TT) and 1% had known cirrhosis.
Maltese: Minn 100 pazjent ittrattat, l-età medjana kienet ta' 15-il sena (firxa: 12 sa 17); 63% tal-pazjenti kienu nisa; 90% kienu Bojod, 7% kienu Suwed, u 2% kienu Ażjatiċi; 13% kienu Ispaniċi/Latino; il-piż medju kien 61.3 kg (firxa: 33.0 sa 126.0 kg); 55% kellhom livelli ta' RNA ta' HCV fil-linja bażi akbar minn jew ugwali għal 800,000
English: These data suggest that biliary excretion of unchanged ledipasvir is a major route of elimination with renal excretion being a minor pathway (approximately 1%).
Maltese: Din id-data tissuġġerixxi li l-eliminazzjoni biljari ta' ledipasvir mhux mibdul hija r-rotta maġġuri ta' eliminazzjoni bl-eliminazzjoni renali tkun biss mogħdija minuri (madwar 1%).
English: Atazanavir concentrations are also increased, with a risk for an increase in bilirubin levels/icterus.
Maltese: Il-konċentrazzjonijiet ta' atazanavir jiżdiedu wkoll, b'riskju ta' żieda fil-livelli tal-bilirubina/icterus.
English: • The active substances are ledipasvir and sofosbuvir.
Maltese: • Is-sustanzi attivi huma ledipasvir u sofosbuvir.
English: Paediatric population aged < 12 years
Maltese: Popolazzjoni pedjatrika b'età ta' <12-il sena
English: Harvoni contains the azo colouring agent sunset yellow FCF aluminium lake (E110), which may cause allergic reactions.
Maltese: Harvoni fih is-sustanza koloranti azo sunset yellow FCF aluminium lake (E110), li tista' tikkawża reazzjonijiet allerġiċi.
English: SVR rates for selected subgroups Genotype
Maltese: Rati SVR għal subgruppi magħżula Ġenotip