FrancophonIA/ELRC3.0 huggingface dataset:
English: Once ribavirin has been withheld due to either a laboratory abnormality or clinical manifestation, an attempt may be made to restart ribavirin at 600 mg daily and further increase the dose to 800 mg daily.
Maltese: Ġaladarba ribavirin ikun twaqqaf minħabba jew anormalità fir-riżultati tal-laboratorju jew manifestazzjoni klinika, jista' jsir tentattiv biex ribavirin jerġa' jinbeda f'doża ta' 600 mg kuljum u żżid id-doża b'mod addizzjonali għal 800 mg kuljum.
English: c Other includes patients who did not achieve SVR and did not meet virologic failure criteria (e.g. lost to follow-up).
Maltese: Oħrajn jinkludu pazjenti li ma kisbux SVR u ma ssodisfawx il-kriterji ta' falliment viroloġiku (eż., ma ġewx segwiti (lost to follow up)).
English: Harvoni is contraindicated with St. John's wort (see section 4.3).
Maltese: John's wort (ara sezzjoni 4.3).
English: • dabigatran used to thin the blood;
Maltese: • dabigatran użata biex traqqaq id-demm;
English: GS-331007 ↓ Cmax 0.60 (0.53, 0.69)
Maltese: GS-331007 ↓ Cmax 0.60 (0.53, 0.69) ↔ AUC 1.04 (0.90, 1.20)
English: HIV ANTIVIRAL AGENTS: INTEGRASE INHIBITORS Raltegravir (400 mg twice daily)/ ledipasvir (90 mg once daily)d
Maltese: INIBITURI TA' INTEGRASE Raltegravir (400 mg darbtejn kuljum)/ ledipasvir (90 mg darba kuljum)d
English: Mild RI (eGFR
Maltese: TAGĦRIF
English: Darunavir boosted with ritonavir (800 mg/ 100 mg once daily) + emtricitabine/ tenofovir disoproxil fumarate (200 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c, d
Maltese: Darunavir imsaħħaħ b' ritonavir (800 mg/ 100 mg darba kuljum) + emtricitabine/ tenofovir disoproxil fumarate (200 mg/ 300 mg darba kuljum)/ ledipasvir (90 mg darba kuljum)c/ sofosbuvir (400 mg darba kuljum)c, d
English: ERADICATE was an open-label study to evaluate 12 weeks of treatment with ledipasvir/sofosbuvir in 50 patients with genotype 1 CHC co-infected with HIV.
Maltese: ERADICATE kien studju open-label sabiex jevalwa 12-il ġimgħa ta' kura b'ledipasvir/sofosbuvir f'50 pazjent b'CHC tal-ġenotip 1 ko-infettati bl-HIV.
English: Cmin (NA)
Maltese: NUMRU(I)
English: Darunavir boosted with ritonavir (800 mg/ 100 mg once daily)/ ledipasvir (90 mg once daily)d
Maltese: Darunavir imsaħħaħ b'ritonavir (800 mg/ 100 mg darba kuljum)/ ledipasvir (90 mg darba kuljum)d
English: ↑ Cmin 1.47 (1.38, 1.57) Ledipasvir ↑ Cmax 1.68 (1.54, 1.84)
Maltese: Ledipasvir ↑ Cmax 1.63 (1.51, 1.75) ↑ AUC 1.78 (1.64, 1.94) ↑ Cmin 1.91 (1.76, 2.08)
English: Relapseb
Maltese: Tqala
English: Gilead Sciences Ireland UC Tel: + 353 (0) 214 825 999
Maltese: Tel: + 353 (0) 214 825 999
English: Film-coating
Maltese: Koltura fiċ-ċelluli
English: GS 331007 ↔ Cmax 1.15 (1.03, 1.27)
Maltese: GS 331007 ↔ Cmax 1.15 (1.03, 1.27) ↔ AUC 1.03 (0.95, 1.12) Cmin (NA)
English: Among the patients who had decompensated cirrhosis (pre- or post-transplant), 64% and 36% were CPT class B and C at screening, respectively, 24% had a baseline Model for End Stage Liver Disease (MELD) score greater than 15.
Maltese: Fost il-pazjenti li kellhom ċirrożi dikumpensata (qabel jew wara ttrapjant), 64% u 36% kienu CPT klassi B u Ċ meta ġew eżaminati, rispettivament, 24% kellhom punteġġ ta' Mudell għall-Marda tal-Fwied tal-Aħħar Stadju (MELD - Model for End Stage Liver Disease) fil-linja bażi akbar minn 15.
English: GS-331007 ↓ Cmax 0.73 (0.65, 0.83)
Maltese: GS-331007 ↓ Cmax 0.73 (0.65, 0.83) ↔ AUC 1.04 (0.89, 1.22)
English: Ledipasvir ↓ Cmax 0.65 (0.56, 0.76)
Maltese: Ledipasvir ↓ Cmax 0.65 (0.56, 0.76) ↓ AUC 0.41 (0.36, 0.48)
English: Ledipasvir plasma exposure (AUCinf) was similar in patients with severe hepatic impairment and control patients with normal hepatic function.
Maltese: L-esponiment ta' ledipasvir filplażma AUCinf) kien simili f'pazjenti b'indeboliment sever tal-fwied u f'pazjenti ta' kontroll b'funzjoni normali tal-fwied.
English: In rabbit studies exposure to sofosbuvir was 6 times the expected clinical exposure.
Maltese: Fi studji fil-fniek, l-esponiment għal sofosbuvir kien ta' 6 darbiet tal-esponiment kliniku mistenni.
English: Treatment-experienced patients had failed prior treatment with PEG-IFN + ribavirin ± an HCV protease inhibitor or sofosbuvir + ribavirin ± PEG-IFN.
Maltese: L-istudji kliniċi rreġistraw pazjenti bi jew mingħajr ċirrożi, li qatt ma rċivew kura fil-passat jew li kellhom falliment tal-kura wara t-terapija b'PEG-IFN + ribavirin +/-inibitur tal-protease tal-HCV.
English: Randomisation was stratified by the presence or absence of cirrhosis and HCV genotype (1a versus 1b).
Maltese: L-għażla b'mod każwali ġiet stratifikata bil-preżenza jew bin-nuqqas ta' ċirrożi u ġenotip tal-HCV (1a kontra 1b).
English: Sofosbuvir ↔ Cmax 1.12 (0.88, 1.42)
Maltese: Sofosbuvir ↔ Cmax 1.12 (0.88, 1.42) ↔ AUC 1.00 (0.80, 1.25)
English: HIV ANTIVIRAL AGENTS: REVERSE TRANSCRIPTASE INHIBITORS Efavirenz/ emtricitabine/ tenofovir disoproxil fumarate (600 mg/ 200 mg/ 300 mg/ once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c, d
Maltese: INIBITURI TA' REVERSE TRANSCRIPTASE Efavirenz/ emtricitabine/ tenofovir disoproxil fumarate (600 mg/ 200 mg/ 300 mg/ darba kuljum)/ ledipasvir (90 mg darba kuljum)ċ/ sofosbuvir (400 mg darba kuljum)ċ, d
English: GS 331007 ↔ Cmax 1.04 (0.97, 1.11)
Maltese: GS 331007 ↔ Cmax 1.04 (0.97, 1.11) ↔ AUC 0.99 (0.94, 1.04) Cmin (NA)
English: ↑ Cmin 1.91 (1.76, 2.08) Sofosbuvir ↑ Cmax 1.33 (1.14, 1.56)
Maltese: Sofosbuvir ↑ Cmax 1.33 (1.14, 1.56) ↑ AUC 1.36 (1.21, 1.52)
English: Study 0154 was an open-label clinical study that evaluated the safety and efficacy of 12 weeks of treatment with ledipasvir/sofosbuvir in 18 genotype 1 HCV-infected patients with severe renal impairment not requiring dialysis.
Maltese: L-Istudju 0154 kien studju kliniku open label li evalwa s-sigurtà u l-effikaċja ta' 12-il ġimgħa ta' trattament b'ledipasvir/sofosbuvir fi 18-il pazjent infettati b'HCV tal-ġenotip 1 b'indeboliment sever tal-kliewi li ma kinux jeħtieġu dijaliżi.
English: Ledipasvir ↓ Cmax 0.83 (0.69, 1.00)
Maltese: Ledipasvir ↓ Cmax 0.83 (0.69, 1.00) ↔ AUC 0.98 (0.80, 1.20)
English: Norelgestromin ↔ Cmax 1.07 (0.94, 1.22)
Maltese: Norelgestromin ↔ Cmax 1.07 (0.94, 1.22) ↔ AUC 1.06 (0.92, 1.21) ↔ Cmin 1.07 (0.89, 1.28)
English: Cirrhosisd
Maltese: Ċirrożidd
English: HIV ANTIVIRAL AGENTS: HIV PROTEASE INHIBITORS Atazanavir boosted with ritonavir (300 mg/ 100 mg once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c, d
Maltese: TAL-PROTEASE TAL-HIV Atazanavir imsaħħaħ b'ritonavir (300 mg/ 100 mg darba kuljum)/ ledipasvir (90 mg darba kuljum)ċ/ sofosbuvir (400 mg darba kuljum)ċ, d
English: Omeprazole dosed simultaneously with Harvoni
Maltese: Omeprazole iddożat flistess ħin ma' Harvoni
English: Ledipasvir ↓ Cmax 0.80 (0.69, 0.93)
Maltese: Ledipasvir ↓ Cmax 0.80 (0.69, 0.93) ↔ AUC 0.89 (0.76, 1.06)
English: No dose adjustment of Harvoni or abacavir/ lamivudine is required.
Maltese: Mhux meħtieġ aġġustament fid-doża ta' Harvoni jew abacavir/ lamivudine.
English: Co-administration of Harvoni with rosuvastatin is contraindicated (see section 4.3).
Maltese: L-għoti flimkien ta' Harvoni ma' rosuvastatin hu kontraindikat (ara sezzjoni 4.3).
English: a One patient in the LDV/SOF 24-week treatment arms and one patient in the LDV/SOF+RBV 24-week treatment arm were prior treatment failures of a non-pegylated interferon-based regimen.
Maltese: Pazjent wieħed fil-fergħat ta' kura ta' 24 ġimgħa ta' LDV/SOF u pazjent wieħed fil-fergħa ta' kura ta' 24 ġimgħa ta' LDV/SOF + RBV kienu diġà fallew minn kura preċedenti ta' kors ibbażat fuq interferon mhux pegylated.
English: Sofosbuvir ↓ Cmax 0.64 (0.53, 0.77)
Maltese: Sofosbuvir ↓ Cmax 0.63 (0.52, 0.75) ↓ AUC 0.73 (0.65, 0.82)
English: LDV/SOF 12 weeks
Maltese: LDV/SOF 12-il ġimgħa
English: LDV/SOF 12 weeks (n = 211)
Maltese: LDV/SOF 12-il ġimgħa (n = 211)
English: Sofosbuvir ↔ Cmax 1.00 (0.76, 1.32)
Maltese: Sofosbuvir ↔ Cmax 1.00 (0.76, 1.32) ↔ AUC 0.95 (0.82, 1.10)
English: Norelgestromin ↔ Cmax 1.02 (0.89, 1.16)
Maltese: Norelgestromin ↔ Cmax 1.02 (0.89, 1.16) ↔ AUC 1.03 (0.90, 1.18) ↔ Cmin 1.09 (0.91, 1.31)
English: Following 12 weeks of treatment with ledipasvir/sofosbuvir with ribavirin in treatment-experienced patients with compensated cirrhosis (SIRIUS, n = 77), 8/8 patients with baseline NS5A RAVs conferring > 100-fold reduced susceptibility to ledipasvir achieved SVR12.
Maltese: Wara 12-il ġimgħa ta' kura b'ledipasvir/sofosbuvir b'ribavirin f'pazjenti b'ċirrożi kumpensata li ħadu l-kura qabel (SIRIUS, n = 77), 8/8 tal-pazjenti b'linja bażi ta' NS5A RAVs li rriżultat f'suxxettibiltà mnaqqsa ta' > 100 darba għal ledipasvir, kisbu SVR12.
English: GS-331007 ↔ Cmax 1.06 (0.97, 1.14)
Maltese: GS-331007 ↔ Cmax 1.06 (0.97, 1.14) ↔ AUC 1.06 (1.02, 1.11)
English: Table 13: Demographics and baseline characteristics in study ION-2 Patient disposition LDV/SOF 12 weeks (n = 109)
Maltese: Tabella 13: Demografiċi u karatteristiċi tal-linja bażi fl-istudju ION-2 Dispożizzjoni tal pazjent
English: Among patients with decompensated liver disease (pre- and posttransplant), 4/16 (25%) patients with NS5A RAVs conferring > 100-fold resistance relapsed after 12 weeks treatment with ledipasvir/sofosbuvir + ribavirin compared to 7/120 (6%) in those without any baseline NS5A RAVs or RAVs conferring a fold-change of ≤ 100.
Maltese: Fost pazjenti b'mard dikumpensat tal-fwied (qabel u wara t-trapjant), 4/16 (25%) pazjenti b'NS5A RAVs li jagħtu reżistenza ta' > 100 darba kellhom rikaduta wara 12-il ġimgħa ta' kura b'ledipasvir/sofosbuvir + ribavirin meta mqabbel ma' 7/120 (6%) f'dawk mingħajr l-ebda NS5A RAVs jew RAVs li jagħtu bidla ta' ≤ 100 darba fil-linja bażi.
English: Atazanavir boosted with ritonavir (300 mg/ 100 mg once daily) + emtricitabine/ tenofovir disoproxil fumarate (200 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c, d
Maltese: Atazanavir imsaħħaħ b'ritonavir (300 mg/ 100 mg darba kuljum) + emtricitabine/ tenofovir disoproxil fumarate (200 mg/ 300 mg darba kuljum)/ ledipasvir (90 mg darba kuljum)c/ sofosbuvir (400 mg darba kuljum)c, d
English: Following 12 weeks of treatment with ledipasvir/sofosbuvir (without ribavirin) in treatmentexperienced patients (arm 1 of ION-2 study) 4/4 patients with baseline NS5A RAVs conferring a ledipasvir fold-change of ≤ 100 achieved SVR.
Maltese: Wara 12-il ġimgħa ta' kura b'ledipasvir/sofosbuvir (mingħajr ribavirin) f'pazjenti li ħadu l-kura qabel (fergħa 1 ta' studju ION-2) 4/4 pazjenti b'NS5A RAVs fil-linja bażi li jagħtu drabi ta' tibdil ta' ledipasvir ta' ≤ 100 kisbu SVR.
English: Patients were randomised in a 1:1:1 ratio to one of the three treatment groups and stratified by HCV genotype (1a versus 1b).
Maltese: Il-pazjenti ntgħażlu b'mod każwali fi proporzjon ta' 1:1:1 għal wieħed mit-tliet gruppi ta' kura u ġew stratifikati skont il-ġenotip HCV (1a kontra 1b).
English: White
Maltese: Iva
English: Ledipasvir ↑ Cmax 1.98 (1.78, 2.20)
Maltese: Ledipasvir ↑ Cmax 1.98 (1.78, 2.20) ↑ AUC 2.13 (1.89, 2.40) ↑ Cmin 2.36 (2.08, 2.67)
English: Proton pump inhibitors Omeprazole (20 mg once daily)/ ledipasvir (90 mg single dose)c/ sofosbuvir (400 mg single dose)c
Maltese: Omeprazole (20 mg darba kuljum)/ ledipasvir (90 mg doża waħda)ċ/ sofosbuvir (400 mg doża waħda)ċ
English: NS5B transient replicons Median (range)a
Maltese: NS5B RAVs:
English: Contents of the pack and other information What Harvoni contains
Maltese: INFORMAZZJONI BIL-BRAILLE Harvoni [Ippakkjar ta' barra biss]
English: GS-331007 ↔ Cmax 0.97 (0.90, 1.05)
Maltese: GS-331007 ↔ Cmax 0.97 (0.90, 1.05) ↔ AUC 1.24 (1.18, 1.30)
English: LDV/SOF 12 weeks (n = 214)
Maltese: LDV/SOF 12-il ġimgħa (n = 214)
English: Medicinal products that are moderate P-gp inducers in the intestine (e.g. oxcarbazepine) may decrease ledipasvir and sofosbuvir plasma concentrations leading to reduced therapeutic effect of Harvoni.
Maltese: Prodotti mediċinali li huma indutturi moderati ta' P-gp fl-imsaren (eż. oxcarbazepine) jistgħu jnaqqsu l-konċentrazzjonijiet ta' ledipasvir u sofosbuvir fil-plażma u jwasslu għal effett terapewtiku mnaqqas ta' Harvoni.
English: At the no observed effect level, AUC exposure to ledipasvir was approximately 7- and 3-fold, in males and females, respectively, the human exposure at the recommended clinical dose.
Maltese: Fil-livell ta' ebda effett osseervat, lesponiment AUC għal ledipasvir kien madwar 7 u 3 darbiet, fl-irġiel u fin-nisa, rispettivament, lesponiment tal-bniedem fid-doża klinika rakkomandata.
English: Animal studies do not indicate harmful effects of ledipasvir or sofosbuvir on fertility.
Maltese: Studji f'annimali ma urewx effetti tossiċi ta' ledipasvir jew sofosbuvir fuq il-fertilità.
English: No target organs of toxicity were identified in rat and dog studies with ledipasvir at AUC exposures approximately 7 times the human exposure at the recommended clinical dose.
Maltese: Ebda organu fil-mira tat-tossiċità ma ġie identifikat fi studji fuq il-firien u l-klieb b'ledipasvir f'esponimenti AUC ta' madwar 7 darbiet l-esponiment uman fid-doża klinika rakkomandata.
English: The safety of tenofovir disoproxil fumarate in the setting of Harvoni and a pharmacokinetic enhancer has not been established.
Maltese: Is-sigurtà ta' tenofovir disoproxil fumarate fl-ambjent ta' Harvoni u enhancer farmakokinetiku ma ġietx stabbilita.
English: Medicinal products that increase gastric pH are expected to decrease concentration of ledipasvir.
Maltese: Prodotti mediċinali li jżidu l-pH gastriku huma mistennija li jnaqqsu l-konċentrazzjoni ta' ledipasvir.
English: In phenotypic analyses, post-baseline isolates from patients who harboured NS5A RAVs at failure showed 20- to at least a 243-fold (the highest dose tested) reduced susceptibility to ledipasvir.
Maltese: F'analiżi fenotipika, iżolati ta' wara l-linja bażi minn pazjenti li laqgħu RAVs ta' NS5A meta ma rnexxewx urew 20- sa mill-inqas 243 darba (l-ogħla doża ttestjata) suxxettibilità mnaqqsa għal ledipasvir.
English: The relative efficacy of a 12-week regimen consisting of ledipasvir/sofosbuvir + ribavirin, compared to a 24-week regimen of sofosbuvir + ribavirin has not been investigated.
Maltese: L-effikaċja relattiva ta' kors ta' 12-il ġimgħa li jikkonsisti minn ledipasvir/sofosbuvir + ribavirin, imqabbel ma' kors ta' 24 ġimgħa ta' sofosbuvir + ribavirin ma ġietx investigata.
English: Female
Maltese: Mara
English: ↑ Cmin 1.63 (1.45, 1.84) Ritonavir ↔ Cmax 0.86 (0.79, 0.93)
Maltese: Ethinyl estradiol ↑ Cmax 1.40 (1.18, 1.66) ↔ AUC 1.20 (1.04, 1.39) ↔ Cmin 0.98 (0.79, 1.22)
English: The safety of Harvoni has been evaluated in a 12-week non-controlled study including 95 patients with ESRD requiring dialysis (Study 4063).
Maltese: Is-sigurtà ta' Harvoni ġiet evalwata fi studju mhux ikkontrollat ta' 12-il ġimgħa li kien jinkludi 95 pazjent b'ESRD li kienu jeħtieġu dijalisi (Studju 4063).
English: The sofosbuvir resistance-associated substitution S282T was not detected in the baseline NS5B sequence of any patient in Phase 3 studies by population or deep sequencing.
Maltese: Is-sostituzzjoni S282T assoċjata mar-reżistenza ta' sofosbuvir f'NS5B ma ġietx osservata fissekwenza tal-linja bażi NS5B ta' ebda pazjent fl-istudji ta' Fażi 3 skont is-sekwenzjar tal-popolazzjoni jew sekwenzjar profond.
English: ↑ Cmin 1.36 (1.23, 1.49) Cobicistat ↔ Cmax 1.25 (1.18, 1.32)
Maltese: Cobicistat ↔ Cmax 1.25 (1.18, 1.32) ↑ AUC 1.59 (1.49, 1.70) ↑ Cmin 4.25 (3.47, 5.22)
English: GS-331007 ↔ Cmax 1.13 (1.07, 1.20)
Maltese: GS-331007 ↔ Cmax 1.13 (1.07, 1.20) ↔ AUC 1.06 (1.01, 1.12)
English: Haemodialysis is unlikely to result in significant removal of ledipasvir as ledipasvir is highly bound to plasma protein.
Maltese: Mhuwiex probabbli li emodijaliżi tirriżulta fi tneħħija sinifikanti ta' ledipasvir minħabba li ledipasvir jintrabat ħafna mal-proteina tal-plażma.
English: ↔ Cmin 0.97 (0.86, 1.10) Ledipasvir ↑ Cmax 1.45 (1.34, 1.56)
Maltese: Sofosbuvir ↑ Cmax 1.45 (1.10, 1.92) ↑ AUC 1.34 (1.12, 1.59)
English: Ledipasvir was not genotoxic in a battery of in vitro or in vivo assays, including bacterial mutagenicity, chromosome aberration using human peripheral blood lymphocytes and in vivo rat micronucleus assays.
Maltese: Ledipasvir ma kellux effett tossiku fuq il-ġeni f'sensiela ta' assaġġi in vitro jew in vivo, li kienu jinkludu mutaġeniċità batterjali, aberrazzjoni fil-kromożomi bl-użu ta' limfoċiti tad-demm periferali uman u assaġġi tal-mikronuklei tal-ġrieden in vivo.
English: Ledipasvir is a HCV inhibitor targeting the HCV NS5A protein, which is essential for both RNA replication and the assembly of HCV virions.
Maltese: Ledipasvir huwa inibitur tal-HCV li jimmira l-proteina NS5A tal-HCV, li hija essenzjali kemm għal replikazzjoni tal-RNA kif ukoll għall-assemblaġġ tal-virjoni tal-HCV.
English: Treatment-naïve adults with or without cirrhosis - ION-1 (study 0102) - Genotype 1 ION-1 was a randomised, open-label study that evaluated 12 and 24 weeks of treatment with ledipasvir/sofosbuvir with or without ribavirin in 865 treatment-naïve patients with genotype 1 CHC including those with cirrhosis (randomised 1:1:1:1).
Maltese: Adulti li qatt ma rċivew kura fil-passat bi jew mingħajr ċirrożi - ION-1 (studju 0102) - Ġenotip 1 ION-1 kien studju li fih il-parteċipanti ntgħażlu b'mod każwali, open-label, li evalwa 12 u 24 ġimgħa ta' kura b'ledipasvir/sofosbuvir bi jew mingħajr ribavirin fi 865 pazjent li qatt ma rċieva kura filpassat b'CHC ta' ġenotip 1 inkluż dawk b'ċirrożi ((b'mod każwali 1:1:1:1).
English: Relapsea
Maltese: Rikadutaa
English: ↔ Cmin 1.09 (0.91, 1.31) Norgestrel ↔ Cmax 1.03 (0.87, 1.23)
Maltese: Norgestrel ↔ Cmax 1.03 (0.87, 1.23) ↔ AUC 0.99 (0.82, 1.20) ↔ Cmin 1.00 (0.81, 1.23)
English: Ledipasvir was fully active against the sofosbuvir resistance-associated substitution S282T in NS5B while all ledipasvir resistance-associated substitutions in NS5A were fully susceptible to sofosbuvir.
Maltese: Ledipasvir kien attiv għal kollox kontra s-sostituzzjoni S282T assoċjata ma' reżistenza għal sofosbuvir f'S282T f'NS5B filwaqt li s-sostituzzjonijiet kollha assoċjati mar-reżistenza ta' ledipasvir f'NS5A kienu suxxettibbli għal kollox għal sofosbuvir.
English: ↔ Cmin 1.04 (0.98, 1.11) Tenofovir ↑ Cmax 1.79 (1.56, 2.04)
Maltese: Tenofovir ↑ Cmax 1.79 (1.56, 2.04) ↑ AUC 1.98 (1.77, 2.23) ↑ Cmin 2.63 (2.32, 2.97)
English: 12 weeks (n = 214)
Maltese: 12-il ġimgħa (n = 214)
English: ↔ Cmin 1.12 (1.05, 1.20) Ledipasvir ↔ Cmax 1.10 (1.01, 1.19)
Maltese: Ledipasvir ↔ Cmax 1.10 (1.01, 1.19) ↔ AUC 1.18 (1.10, 1.28) ↔ Cmin 1.26 (1.17, 1.36)
English: Pre-transplant
Maltese: TAL-PRODOTT MEDIĊINALI
English: • if you are awaiting a liver transplant; • if you have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely;
Maltese: • jekk bħalissa għandek infezzjoni jew kellek infezzjoni preċedenti bil-virus tal-epatite B, minħabba li t-tabib tiegħek jista' jkun irid jimmonitorjak aktar mill-qrib;
English: ↑ Digoxin ↔ Ledipasvir
Maltese: Mogħtija Doża Siegħa
English: Patients awaiting liver transplantation and post-liver transplant - SOLAR-1 and SOLAR-2 SOLAR-1 and SOLAR-2 were two open-label clinical studies that evaluated 12 and 24 weeks of treatment with ledipasvir/sofosbuvir in combination with ribavirin in genotype 1 and 4 HCV-infected patients who have undergone liver transplantation and/or who have decompensated liver disease.
Maltese: Pazjenti li jkunu qed jistennew trapjant tal-fwied u wara trapjant tal-fwied - SOLAR-1 u SOLAR-2 SOLAR-1 u SOLAR-2 kienu żewġ studji kliniċi open-label li evalwaw 12 u 24 ġimgħa ta' kura b'ledipasvir/sofosbuvir flimkien ma' ribavirin f'pazjenti infettati b'HCV ta' ġenotip 1 u 4 li kienu għaddew minn trapjant tal-fwied u/jew li għandhom mard dikumpensat tal-fwied.
English: Genotype 1b
Maltese: Ġenotip 1a Ġenotip 1b
English: Among the 8 patients who had no NS5A RAVs at failure, 7 patients received 8 weeks of treatment (n = 3 with ledipasvir/sofosbuvir; n = 4 with ledipasvir/sofosbuvir + ribavirin) and 1 patient received ledipasvir/sofosbuvir for 12 weeks.
Maltese: (n = 3 b'ledipasvir/sofosbuvir; n = 4 b'ledipasvir/sofosbuvir +ribavirin) u 1 pazjent rċieva ledipasvir/sofosbuvir għal 12-il ġimgħa.
English: Do not use this medicine after the expiry date which is stated on the bottle and carton after “EXP”.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-flixkun u il-kartuna wara “EXP”.
English: • Tell your doctor if you are allergic to sunset yellow FCF aluminium lake, also called “E110” before taking this medicine.
Maltese: • Għid lit-tabib tiegħek jekk inti allerġiku/a għal sunset yellow FCF aluminium lake, imsejjaħ ukoll “E110” qabel tieħu din il-mediċina.
English: ↔ Cmin 1.08 (0.98, 1.20) Ritonavir ↔ Cmax 1.17 (1.01, 1.35)
Maltese: Ledipasvir ↔ Cmax 1.01 (0.95, 1.07) ↔ AUC 1.08 (1.02, 1.15) ↔ Cmin 1.16 (1.08, 1.25)
English: (Inhibition of CYP3A) Midazolam ↔ Cmax 0.95 (0.87, 1.04)
Maltese: Midazolam ↔ Cmax 0.95 (0.87, 1.04) ↔ AUC 0.89 (0.84, 0.95) (Induzzjoni ta' CYP3A)
English: The medicinal product interactions described are based on studies conducted with either ledipasvir/sofosbuvir or ledipasvir and sofosbuvir as individual agents, or are predicted medicinal product interactions that may occur with ledipasvir/sofosbuvir.
Maltese: L-interazzjonijiet tal-prodott mediċinali deskritti huma bbażati fuq studji mwettqa b'ledipasvir/sofosbuvir jew ledipasvir u sofosbuvir bħala sustanzi individwali, jew huma interazzjonijiet imbassra tal-prodott mediċinali li jistgħu jseħħu b'ledipasvir/sofosbuvir.
English: Body weight did not have a significant effect on sofosbuvir exposure according to a population pharmacokinetic analysis.
Maltese: Il-piż tal-ġisem ma kellux effett sinifikanti fuq l-esponiment għal sofosbuvir skont analiżi farmakokinetika tal-popolazzjoni.
English: ↑ Cmin 1.59 (1.49, 1.70) Ledipasvir ↔ Cmax 1.11 (0.99, 1.24)
Maltese: Ledipasvir ↔ Cmax 1.11 (0.99, 1.24) ↔ AUC 1.12 (1.00, 1.25) ↔ Cmin 1.17 (1.04, 1.31)
English: ↔ Cmin 1.16 (1.08, 1.25) Sofosbuvir ↔ Cmax 1.05 (0.93, 1.20)
Maltese: Sofosbuvir ↔ Cmax 1.08 (0.85, 1.35) ↔ AUC 1.21 (1.09, 1.35)
English: Following oral administration of ledipasvir/sofosbuvir to HCV-infected patients, ledipasvir median peak plasma concentration was observed at 4.0 hours post-dose.
Maltese: Wara l-għoti orali ta' ledipasvir/sofosbuvir lil pazjenti infettati bl-HCV, l-ogħla konċentrazzjoni medjana fil-plażma ta' ledipasvir ġiet osservata 4.0 sigħat wara d-doża.
English: ↔ Cmin 0.91 (0.83, 0.99) Emtricitabine ↔ Cmax 1.08 (0.97, 1.21)
Maltese: Emtricitabine ↔ Cmax 1.02 (0.96, 1.08) ↔ AUC 1.04 (1.00, 1.08) ↔ Cmin 1.03 (0.97, 1.10)
English: ↔ Cmin 1.12 (1.03, 1.21) Tenofovir ↔ Cmax 1.32 (1.25, 1.39)
Maltese: Tenofovir ↔ Cmax 1.32 (1.25, 1.39) ↑ AUC 1.40 (1.31, 1.50) ↑ Cmin 1.91 (1.74, 2.10)
English: Cases of hepatitis B virus (HBV) reactivation, some of them fatal, have been reported during or after treatment with direct-acting antiviral agents.
Maltese: Każijiet ta' attivazzjoni mill-ġdid tal-virus tal-epatite B (HBV - hepatitis B virus), xi wħud minnhom fatali, ġew irrappurtati matul jew wara trattament b'sustanzi antivirali li jaġixxu b'mod dirett.
English: ↔ Cmin 1.06 (0.97, 1.15) Rilpivirine ↔ Cmax 0.97 (0.88, 1.07)
Maltese: Ethinyl estradiol ↔ Cmax 1.15 (0.97, 1.36) ↔ AUC 1.09 (0.94, 1.26) ↔ Cmin 0.99 (0.80, 1.23)
English: Although adverse events, including serious adverse events, occurred more frequently in this study compared to studies that excluded decompensated patients and/or patients who were postliver transplantation, the adverse events observed were those expected as clinical sequelae of advanced liver disease and/or transplantation or were consistent with the known safety profile of ribavirin (see section 5.1 for details of this study).
Maltese: Għalkemm avvenimenti avversi, li jinkludu avvenimenti avversi serji, seħħew aktar ta' spiss f'dan l-istudju meta mqabbla ma' studji li eskludew pazjenti dikumpensati u/jew pazjenti wara trapjant tal-fwied, l-avvenimenti avversi osservati kienu dawk mistennija bħala konsegwenzi kliniċi ta' mard avvanzat tal-fwied u/jew trapjant, jew kienu konsistenti mal-profil tas-sigurtà magħruf ta' ribavirin (ara sezzjoni 5.1 għad-dettalji ta' dan l-istudju).
English: ↔ Cmin 0.95 (0.81, 1.12) Sofosbuvir ↔ Cmax 0.87 (0.71, 1.08)
Maltese: Sofosbuvir ↔ Cmax 0.96 (0.88, 1.05) ↔ AUC 1.08 (1.02, 1.15)