FrancophonIA/ELRC3.0 huggingface dataset:
English: ↑ Ritonavir
Maltese: ↑ Lopinavir ↑ Ritonavir
English: and <50 mL/min/1.73 m2)
Maltese: (eGFR ≥30 u <50 mL/mi n/1.73m2)
English: Additionally a Q30E substitution developed in genotype 1a replicons.
Maltese: Barra minn hekk, żviluppat sostituzzjoni Q30E fir-replikons tal-ġenotip 1a.
English: Following a single 400 mg dose of sofosbuvir, a 4 hour haemodialysis removed 18% of administered sofosbuvir dose.
Maltese: Wara doża waħda ta' 400 mg ta' sofosbuvir, emodijaliżi ta' 4 sigħat neħħiet madwar 18% tad-doża mogħtija.
English: Gilead Sciences Ltd. Tel: + 44 (0) 8000 113700
Maltese: Tel: + 44 (0) 8000 113700
English: HBV/HCV co-infected patients are at risk of HBV reactivation, and should therefore be monitored and managed according to current clinical guidelines.
Maltese: Pazjenti infettati b'HBV/HCV f'daqqa għandhom riskju ta' attivazzjoni mill-ġdid ta' HBV, u għalhekk għandhom jiġu mmonitorjati u mmaniġjati skont il-linji gwida kliniċi attwali.
English: The highest documented doses of ledipasvir and sofosbuvir were 120 mg twice daily for 10 days and a single dose of 1,200 mg, respectively.
Maltese: L-ogħla dożi dokumentati ta' ledipasvir u sofosbuvir kienu 120 mg darbtejn kuljum għal 10 ijiem u doża waħda ta' 1,200 mg, rispettivament.
English: In a pooled analysis of patients who received ledipasvir/sofosbuvir in Phase 3 studies (ION-3, ION-1 and ION-2), 37 patients (29 with genotype 1a and 8 with genotype 1b) qualified for resistance analysis due to virologic failure or early study drug discontinuation and having HCV RNA > 1,000 IU/mL.
Maltese: F'analiżi miġbura ta' pazjenti li rċivew ledipasvir/sofosbuvir fi studji ta' Fażi 3 (ION-3, ION-1 u ION-2), 37 pazjent (29 b'ġenotip 1a u 8 b'ġenotip 1b) ikkwalifikaw għal analiżi ta' reżistenza minħabba falliment viroloġiku jew waqfien bikri tal-mediċina tal-istudju u kellhom HCV RNA ta' > 1,000 IU/mL.
English: Safety data are limited in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2) and ESRD requiring haemodialysis.
Maltese: Data dwar is-sigurtà hija limitata f'pazjenti b'indeboliment sever tal-kliewi (stima tar-rata ta' filtrazzjoni glomerulari [eGFR] < 30 mL/min/1.73 m2) u ESRD li kienu jeħtieġu emodijalisi.
English: A summary of the effect of varying degrees of renal impairment (RI) on the exposures of the components of Harvoni compared to subjects with normal renal function, as described in the text below, are provided in Table 20.
Maltese: Sommarju tal-effett ta' gradi differenti ta' indeboliment tal-kliewi (RI - renal impairment) fuq lesponimenti għall-komponenti ta' Harvoni meta mqabbla ma' individwi b'funzjoni normali tal-kliewi, kif deskritt fit-test hawn taħt, huwa pprovdut fit-Tabella 20.
English: The SVR12 rate was 98% overall (98% [78/80] in treatment-naïve patients and 100% [20/20] in treatment experienced patients).
Maltese: Ir-rata ta' SVR12 kienet ta' 98% b'mod globali (98% [78/80] f'pazjenti li qatt ma kienu ħadu trattament qabel u 100% [20/20] f'pazjenti li kellhom esperjenza ta' trattament).
English: Harvoni 90 mg/400 mg film-coated tablets
Maltese: Harvoni 90 mg/400 mg pilloli miksija b'rita
English: The proportion of patients who permanently discontinued treatment due to adverse events was 0%, < 1% and 1% for patients receiving ledipasvir/sofosbuvir for 8, 12 and 24 weeks, respectively; and < 1%, 0%, and 2% for patients receiving ledipasvir/sofosbuvir + ribavirin combination therapy for 8, 12 and 24 weeks, respectively.
Maltese: Il-proporzjon ta' pazjenti li waqqfu l-kura għal kollox minħabba avvenimenti avversi kien ta' 0%, < 1% u 1% għal pazjenti li kienu qed jirċievu ledipasvir/sofosbuvir għal 8, 12 u 24 ġimgħa, rispettivament; u < 1%, 0%, u 2% għal pazjenti li kienu qed jirċievu kura ta' kombinazzjoni ta' ledipasvir/sofosbuvir + ribavirin għal 8, 12 u 24 ġimgħa, rispettivament.
English: In study 1118, 44 patients with genotype 1 infection, including 12 cirrhotic patients, who had previously failed treatment with sofosbuvir + ribavirin + PEG-IFN or with sofosbuvir + ribavirin were treated with ledipasvir/sofosbuvir + ribavirin for 12 weeks; the SVR was 100% (44/44).
Maltese: Fi studju 1118, 44 pazjent b'infezzjoni ta' ġenotip 1, li jinkludu 12-pazjent ċirrotiku, li ma rnexxewx f'kura preċedenti fuq b'sofosbuvir + ribavirin + PEG-IFN jew b'sofosbuvir + ribavirin ġew ikkurati b'ledipasvir/sofosbuvir + ribavirin għal 12-il ġimgħa; l-SVR kienet 100% (44/44).
English: LDV/SOF+RBV 8 weeks (n = 216)
Maltese: LDV/SOF+RBV 8 ġimgħat (n = 216)
English: Population pharmacokinetic analysis in HCV-infected patients showed that within the age range (18 to 80 years) analysed, age did not have a clinically relevant effect on the exposure to ledipasvir, sofosbuvir or GS-331007.
Maltese: Analiżi farmakokinetika tal-popolazzjoni f'pazjenti infettati b'HCV uriet li fil-medda ta' età (18 sa 80 sena) analizzata, l-età ma kellhiex effett klinikament rilevanti fuq l-esponiment għal ledipasvir, sofosbuvir jew GS-331007.
English: LDV/SOF 24 weeks (n = 109)
Maltese: LDV/SOF 24 ġimgħa (n = 109)
English: Haemodialysis can efficiently remove the predominant circulating metabolite of sofosbuvir, GS-331007, with an extraction ratio of 53%.
Maltese: Emodijaliżi tista' tneħħi b'mod effiċjenti l-metabolit predominanti li jiċċirkola ta' sofosbuvir, GS-331007, bi proporzjon ta' estrazzjoni ta' 53%.
English: therapy without cirrhosis, 26% (13/50) of patients were HIV antiretroviral naïve and 74% (37/50) of patients were receiving concomitant HIV antiretroviral therapy.
Maltese: HCV fil-passat u kienu mhux ċirrotiċi, 26% (13/50) tal-pazjenti qatt ma kienu ħadu antiretrovirali għall-HIV u 74% (37/50) tal-pazjenti kienu qed jirċievu terapija antiretrovirali tal-HIV konkomittanti.
English: Of the 29 genotype 1a patients who qualified for resistance testing, 22/29 (76%) patients harboured one or more NS5A RAVs at positions K24, M28, Q30, L31, S38 and Y93 at failure, while the remaining 7/29 patients had no NS5A RAVs detected at failure.
Maltese: Mid-29 pazjent b'ġenotip 1a li kkwalifikaw għal provi tar-reżistenza, 22/29 (76%) pazjent laqgħu RAVs ta' NS5A wieħed jew aktar f'pożizzjonijiet K24, M28, Q30, L31, S38 u Y93 meta ma rnexxewx, filwaqt li fis-7/29 pazjent li baqa' ma rriżulta ebda RAV ta' NS5A meta ma rnexxewx.
English: Patients who are identified as being high risk of bradyarrhythmia should be continuously monitored for 48 hours in an appropriate clinical setting.
Maltese: Il-pazjenti li huma identifikati bħala li għandhom riskju għoli ta' bradiarritmija, għandhom jiġu ssorveljati b'mod kontinwu għal 48 siegħa f'ambjent kliniku xieraq.
English: Table 5 provides a listing of established or potentially clinically significant medicinal product interactions (where 90% confidence interval [CI] of the geometric least-squares mean [GLSM] ratio were within “↔”, extended above “↑”, or extended below “↓” the predetermined equivalence boundaries).
Maltese: It-Tabella 5 tipprovdi elenku ta' interazzjonijiet klinikament sinifikanti tal-prodott mediċinali li huma stabbiliti jew potenzjali (fejn 90% intervall ta' kunfidenza [CI - confidence interval] tal-proporzjon talgeometric least-squares mean [GLSM] kien fil-medda ta' “↔”, estiża 'l fuq “↑”, jew estiża 'l isfel “↓” tal-limiti determinati minn qabel tal-ekwivalenza).
English: The median age was 52 years (range: 26 to 72); 82% of the patients were male; 61% were white; 34% were black; 75% had genotype 1a HCV infection; 2% had genotype 4 infection; 76% had non-CC IL28B alleles (CT or TT); and 20% had compensated cirrhosis.
Maltese: L-età medjana kienet ta' 52 sena (medda: 26 sa 72); 82% tal-pazjenti kienu rġiel; 61% kienu bojod; 34% kienu suwed; 75% kellhom infezzjoni bl-HCV ta' ġenotip 1a; 2% kellhom infezzjoni ta' ġenotip 4; 76% kellhom alleli non-CC IL28B (CT jew TT); u 20% kellhom ċirrożi kkumpensata.
English: Available pharmacokinetic data in animals has shown excretion of ledipasvir and metabolites of sofosbuvir in milk (see section 5.3).
Maltese: Data farmakokinetika fl-annimali wriet li kien hemm l-eliminazzjoni ta' ledipasvir u l-metaboliti ta' sofosbuvir fil-ħalib (ara sezzjoni 5.3).
English: ↑ Dabigatran ↔ Ledipasvir
Maltese: Tiqafx tieħu Harvoni
English: Serum HCV RNA values were measured during the clinical studies using the COBAS TaqMan HCV test (version 2.0), for use with the High Pure System.
Maltese: Il-valuri tal-HCV RNA fis-serum tkejlu matul l-istudji kliniċi bl-użu tat-test COBAS TaqMan HCV (verżjoni 2.0), għall-użu mal-High Pure System.
English: CPT Cc
Maltese: Mhux CC
English: • rifampicin and rifabutin (antibiotics used to treat infections, including tuberculosis); • St. John's wort (herbal medicine used to treat depression);
Maltese: • rifampicin u rifabutin (antibijotiċi li jintużaw għall-kura ta' infezzjonijiet, li jinkludu ttuberkulożi);
English: Clinical studies of ledipasvir/sofosbuvir included 235 patients (8.6% of total number of patients) aged 65 years and over.
Maltese: L-istudji kliniċi ta' ledipasvir/sofosbuvir kienu jinkludu 235 pazjent (8.6% tan-numri totali ta' pazjenti) li kellhom 65 sena jew aktar.
English: Vitamin K antagonists
Maltese: Pazjenti kkurati b'antagonisti tal-vitamina K
English: The NS5A substitution Y93C emerged in the HCV of 1 patient (genotype 4), while NS5A RAVs present at baseline were observed at the time of failure in all patients.
Maltese: Is-sostituzzjoni NS5A Y93C ħarġet fl-HCV ta' pazjent wieħed (ġenotip 4), filwaqt li NS5A RAVs preżenti fil-linja bażi ġew osservati fil-ħin ta' falliment fil-pazjenti kollha.
English: Of the 670 treated patients, the median age was 59 years (range: 21 to 81 years); 77% of the patients were male; 91% were White; mean body mass index was 28 kg/m2 (range: 18 to 49 kg/m2); 94% and 6% had genotype 1 and 4 HCV infection, respectively; 78% of the patients failed a prior HCV therapy.
Maltese: Minn 670 pazjent ikkurati, l-età medjana kienet ta' 59 sena (firxa: 21 sa 81 sena); 77% tal-pazjenti kienu rġiel; 91% kienu Bojod; il-medja tal-indiċi tal-massa tal-ġisem kienet ta' 28 kg/m2 (firxa: 18 sa 49 kg/m2); 94% u 6% kellhom infezzjoni b'HCV ta' ġenotip 1 u 4 rispettivament; 78% tal-pazjenti ma kellhomx suċċess b'terapija preċedenti għal HCV.
English: Population pharmacokinetics analysis in HCV-infected patients indicated that cirrhosis (including decompensated cirrhosis) had no clinically relevant effect on the exposure to sofosbuvir and GS-331007.
Maltese: Analiżi farmakokinetika tal-popolazzjoni f'pazjenti infettati b'HCV, indikat li ċ-ċirrożi (inkluża ċirrożi dikumpensata) ma kellha l-ebda effett klinikament rilevanti fuq lesponiment għal sofosbuvir u GS-331007.
English: Harvoni contains lactose
Maltese: Harvoni fih lactose
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu/.
English: The pharmacokinetics of ledipasvir, sofosbuvir, and GS-331007 were studied in HCV-infected patients with ESRD requiring dialysis treated with ledipasvir/sofosbuvir (n=94) for 8, 12, or 24 weeks, and compared to patients without renal impairment in the ledipasvir/sofosbuvir Phase 2/3 trials.
Maltese: Il-farmakokinetika ta' ledipasvir, sofosbuvir, u GS-331007 ġiet studjata f'pazjenti infettati bl-HCV b'ESRD li kienu jeħtieġu dijalisi ttrattati b'ledipasvir/sofosbuvir (n=94) għal 8, 12, jew 24 ġimgħa, u mqabbla ma' pazjenti mingħajr indeboliment tal-kliewi fil-provi ta' Fażi 2/3 b'ledipasvir/sofosbuvir.
English: No dose adjustment of Harvoni is required for patients with mild, moderate or severe hepatic impairment (Child-Pugh-Turcotte [CPT] class A, B or C) (see section 5.2).
Maltese: L-ebda aġġustament fid-doża ta' Harvoni mhu meħtieġ għal pazjenti b'indeboliment ħafif, moderat jew sever tal-fwied (Child-Pugh-Turcotte [CPT] klassi A, B jew Ċ) (ara sezzjoni 5.2).
English: • carbamazepine, phenobarbital and phenytoin (medicines used to treat epilepsy and prevent seizures); • rosuvastatin (a medicine used to treat high cholesterol).
Maltese: • Carbamazepine, phenobarbital u phenytoin (mediċini li jintużaw għall-kura ta'
English: Famotidine dosed 12 hours prior to Harvonid
Maltese: Famotidine iddożat 12-il siegħa qabel Harvonid
English: Median peak plasma concentration of GS-331007 was observed at 4 hours post-dose.
Maltese: L-ogħla konċentrazzjoni medjana ta' GS-331007 fil-plażma ġiet osservata 4 sigħat wara d-doża.
English: Sofosbuvir ↑ Cmax 2.54 (1.87, 3.45)
Maltese: Sofosbuvir ↑ Cmax 2.54 (1.87, 3.45) ↑ AUC 4.53 (3.26, 6.30)
English: Ciclosporin (600 mg single dose)/ sofosbuvir (400 mg single dose)h
Maltese: Ciclosporin (600 mg doża waħda)/ sofosbuvir (400 mg doża waħda)h
English: When ribavirin is added to Harvoni, refer also to the Summary of Product Characteristics of ribavirin.
Maltese: Meta ribavirin jiżdied ma' Harvoni, irreferi wkoll għas-Sommarju tal-Karatteristiċi tal-Prodott ta' ribavirin.
English: Otherc
Maltese: Individwi
English: Use with moderate P-gp inducers
Maltese: L-użu ma' indutturi moderati ta' P-gp
English: Refer to the Summary of Product Characteristics for ribavirin for additional information.
Maltese: Irreferi għas-Sommarju tal-Karatteristiċi tal-Prodott għal ribavirin għal informazzjoni addizzjonali.
English: Starting dose of 600 mg, which can be titrated up to a maximum of 1,000/1,200 mg (1,000 mg for patients weighing < 75 kg and 1,200 mg for patients weighing ≥ 75 kg) if well tolerated.
Maltese: Doża tal-bidu ta' 600 mg, li tista' tiġi ttitrata sa massimu ta' 1,000/1,200 mg (1,000 mg għall-pazjenti li jiżnu < 75 kg u 1,200 mg għall-pazjenti li jiżnu ≥ 75 kg) jekk tkun ittollerata tajjeb.
English: Among post-transplant patients with compensated liver disease (SOLAR-1 and SOLAR-2 studies), no relapse occurred in patients with baseline NS5A RAVs (n = 23) following 12 weeks of treatment with ledipasvir/sofosbuvir + ribavirin.
Maltese: SOLAR-1 u SOLAR-2), ma seħħet l-ebda rikaduta f'pazjenti b'NS5A RAVs fil-linja bażi (n = 23) wara 12-il ġimgħa ta' kura b'ledipasvir/sofosbuvir + ribavirin.
English: The safety and efficacy of Harvoni in adolescents aged 12 to < 18 years is based on data from a Phase 2, open-label clinical study (Study 1116) that enrolled 100 patients with genotype 1 HCV infection who were treated with ledipasvir/sofosbuvir for 12 weeks.
Maltese: Is-sigurtà u l-effikaċja ta' Harvoni fl-adolexxenti ta' età minn 12 sa < 18-il sena huma bbażati fuq data minn studju kliniku open-label ta' Fażi 2 (Studju 1116) li fih kienu rreġistrati 100 pazjent b'infezzjoni tal-HCV ta' ġenotip 1 li kienu kkurati b'ledipasvir/sofosbuvir għal 12-il ġimgħa.
English: The pharmacokinetics of ledipasvir were studied with a single dose of 90 mg ledipasvir in HCV negative patients with severe hepatic impairment (CPT class C).
Maltese: Il-farmakokinetika ta' ledipasvir ġiet studjata wara doża waħda ta' 90 mg ledipasvir f'pazjenti negattivi għal HCV b'indeboliment sever tal-fwied (CPT klassi Ċ).
English: Protein binding of GS-331007 was minimal in human plasma.
Maltese: It-twaħħil ta' GS-331007 mal-proteina kien minimu fil-plażma tal-bniedem.
English: Previously treated adults with or without cirrhosis - ION-2 (study 0109) - Genotype 1 ION-2 was a randomised, open-label study that evaluated 12 and 24 weeks of treatment with ledipasvir/sofosbuvir with or without ribavirin (randomised 1:1:1:1) in genotype 1 HCV-infected patients with or without cirrhosis who failed prior therapy with an interferon-based regimen, including regimens containing an HCV protease inhibitor.
Maltese: Adulti li rċivew kura fil-passat bi jew mingħajr ċirrożi - ION-2 (studju 0109) - Ġenotip 1 ION-2 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 (b'mod każwali 1:1:1:1) f'pazjenti infettati b'HCV ta' ġenotip 1 bi jew mingħajr ċirrożi li esperjenzaw falliment f'kura preċedenti b'kors ibbażat fuq interferon inkluż korsijiet li fihom inibitur tal-protease tal-HCV.
English: Of the 8 genotype 1b patients who qualified for resistance testing, 7/8 (88%) harboured one or more NS5A RAVs at positions L31 and Y93 at failure, while 1/8 patients had no NS5A RAVs at failure.
Maltese: Mit-8 pazjenti ta' ġenotip 1b li kkwalifikaw għal prova ta' reżistenza, 7/8 (88%) laqgħu RAVs ta' NS5A wieħed jew aktar f'pożizzjonijiet L31 u Y93 meta ma rnexxewx, filwaqt li 1/8 pazjenti ma kellhom ebda RAV ta' NS5A meta ma rnexxewx.
English: Harvoni has been shown to increase tenofovir exposure, especially when used together with an HIV regimen containing tenofovir disoproxil fumarate and a pharmacokinetic enhancer (ritonavir or cobicistat).
Maltese: Harvoni ntwera li jżid l-esponiment għal tenofovir, speċjalment meta użat flimkien ma' kors tal-HIV li fih tenofovir disoproxil fumarate u enhancer farmakokinetiku (ritonavir jew cobicistat).
English: No clinically relevant pharmacokinetic differences due to race have been identified for ledipasvir, sofosbuvir or GS-331007.
Maltese: L-ebda differenza farmakokinetika klinikament rilevanti minħabba ir-razza ma ġiet identifikata għal ledipasvir, sofosbuvir jew GS-331007.
English: Harvoni + ribavirinA for 12 weeks or
Maltese: Harvoni + ribavirinA għal 12-il ġimgħa jew
English: Following a single 90 mg oral dose of [14C]-ledipasvir, mean total recovery of the [14C]-radioactivity in faeces and urine was 87%, with most of the radioactive dose recovered from faeces (86%).
Maltese: Wara doża orali waħda ta' 90 mg ta' [14C]-ledipasvir, il-medja tal-irkupru totali tas-[14C]-radjuattività fl-ippurgar u fl-awrina kienet ta' 87%, b'ħafna mid-doża radjuattiva rkuprata mill-ippurgar (ta' 86%).
English: Sofosbuvir is approximately 61-65% bound to human plasma proteins and the binding is independent of drug concentration over the range of 1 µg/mL to 20 µg/mL.
Maltese: Sofosbuvir jeħel b'rata ta' madwar 61-65% mal-proteini tal-plażma tal-bniedem u t-twaħħil hu indipendenti mill-konċentrazzjoni tal-mediċini fuq il-medda ta' 1 μg/mL sa 20 μg/mL.
English: Adult and adolescent patients 12 years of age or older with genotype 1, 4, 5 or 6 CHC Patients without cirrhosis
Maltese: Pazjenti adulti u adolexxenti b'età ta' 12-il sena jew aktar b'CHC ta' ġenotip 1, 4, 5 jew 6
English: Change in CPT score and class: Among those who achieved SVR12 with 12 weeks treatment with ledipasvir/sofosbuvir with ribavirin, 60% (74/123) and 34% (42/123) had an improvement or no change of CPT scores from baseline to post-treatment week 12, respectively; of the 32 patients who had CPT C cirrhosis at baseline, 53% (17/32) had CPT B cirrhosis at post-treatment Week 12; of the 88 patients who had CPT B cirrhosis at baseline, 25% (22/88) had CPT A cirrhosis at post-treatment Week 12.
Maltese: Tibdil fil-punteġġ u l-klassi ta' CPT: Fost dawk li kisbu SVR12 bi 12-il ġimgħa ta' kura b'ledipasvir/sofosbuvir flimkien ma' ribavirin, 60% (74/123) u 34% (42/123) kellhom titjib jew ma kellhomx bidla fil-punteġġi ta' CPT mil-linja bażi sa ġimgħa 12 wara l-kura, rispettivament; minn 32 pazjent li kellhom ċirrożi CPT C fil-linja bażi, 53% (17/32) kellhom ċirrożi CPT B f'Ġimgħa 12 wara l-kura; minn 88 pazjent li kellhom ċirrożi CPT B fil-linja bażi, 25% (22/88) kellhom ċirrożi CPT A f'Ġimgħa 12 wara l-kura.
English: d Lack of pharmacokinetics interaction bounds 70-143%.
Maltese: d. Medda ta' 70-143% li fiha ma jseħħu l-ebda interazzjonijiet farmakokinetiċi e.
English: LDV/SOF+RBV 8 weeks (n = 210)
Maltese: LDV/SOF+RBV 8 ġimgħat (n = 210)
English: 28 film-coated tablets.
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 28 pillola miksija b'rita.
English: The group of NS5A RAVs that conferred > 100-fold shift and was observed in patients were the following substitutions in genotype 1a (M28A, Q30H/R/E, L31M/V/I, H58D, Y93H/N/C) or in genotype 1b (Y93H).
Maltese: Il-grupp ta' NS5A RAVs li ta > 100 darba tibdil u kien osservat f'pazjenti kienu s-sostituzzjonijiet li ġejjin f'ġenotip 1a (M28A, Q30H/R/E, L31M/V/I, H58D, Y93H/N/C) jew fil-ġenotip 1b (Y93H).
English: Famotidine (40 mg single dose)/ ledipasvir (90 mg single dose)c/ sofosbuvir (400 mg single dose)c, d
Maltese: Famotidine (40 mg doża waħda)/ ledipasvir (90 mg doża waħda)ċ/ sofosbuvir (400 mg doża waħda)ċ, d
English: used to treat HIV infection;
Maltese: KONTRA L-HIV:
English: Ledipasvir AUC is dose proportional over the dose range of 3 to 100 mg. Sofosbuvir and GS-331007 AUCs are near dose proportional over the dose range of 200 mg to 400 mg.
Maltese: L-AUCs ta' sofosbuvir u ta' GS-331007 joqorbu biex ikunu proporzjonali għad-doża fuq il-medda tad-doża ta' 200 mg sa 400 mg.
English: Emtricitabine/ rilpivirine/ tenofovir disoproxil fumarate (200 mg/ 25 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c, d
Maltese: Emtricitabine/ rilpivirine/ tenofovir disoproxil fumarate (200 mg/ 25 mg/ 300 mg darba kuljum)/ ledipasvir (90 mg darba kuljum)ċ/ sofosbuvir (400 mg darba kuljum)ċ, d
English: Effects on medicinal product levels.
Maltese: Effetti fuq il-livelli talprodott mediċinali.
English: Pharmacotherapeutic group: Direct-acting antiviral, ATC code: J05AP51
Maltese: Antivirali li jaġixxu b'mod dirett, Kodiċi ATC:
English: LDV/SOF 24 weeks (n = 217)
Maltese: LDV/SOF 24 ġimgħa (n = 217)
English: The following pack sizes are available: outer cartons containing 1 bottle of 28 film-coated tablets and outer cartons containing 84 (3 bottles of 28) film-coated tablets.
Maltese: Huma disponibbli d-daqsijiet tal-pakketti li ġejjin: kartun ta' barra li fihom 1 flixkun ta' 28 pillola miksija b'rita u kartun ta' barra li jkun fihom 84 (3 fliexken ta' 28) pillola miksija b'rita.
English: AUC and Cmax of ledipasvir were 77% and 58% higher, respectively, in females than males; however, the relationship between gender and ledipasvir exposures was not considered clinically relevant.
Maltese: L-AUC u Cmax ta' ledipasvir kienu 77% u 58% ogħla, rispettivament, fin-nisa milli fl-irġiel; madankollu, ir-relazzjoni bejn is-sess u l-esponimenti ta' ledipasvir ma ġietx ikkunsidrata li hi klinikament rilevanti.
English: In genotype 3 infected patients experiencing virologic failure, development of NS5A RAVs (including enrichment of RAVs present at baseline) was typically not detected at the time of failure (n = 17).
Maltese: F'pazjenti infettati b'ġenotip 3 li esperjenzaw falliment viroloġiku, l-iżvilupp ta' NS5A RAVs (li jinkludi l-arrikkament ta' RAVs preżenti fil-linja bażi) tipikament ma ġewx osservati fiż-żmien ta' falliment (n = 17).
English: However, the NS5B S282T substitution in combination with NS5A substitutions L31M, Y93H and Q30L were detected in one patient at failure following 8 weeks of treatment with ledipasvir/sofosbuvir from a Phase 2 study (LONESTAR).
Maltese: Madankollu, is-sostituzzjoni NS5B S282T f'kombinazzjoni ma' sostituzzjonijiet ta' NS5A L31M, Y93H u Q30L ġew osservati f'pazjent wieħed mal-falliment wara 8 ġimgħat ta' kura b'ledipasvir/sofosbuvir minn studju ta' Fażi 2 (LONESTAR).
English: Presence of baseline NS5A resistance-associated substitutionsc No
Maltese: Replikons stabbli Replikons NS5B temporanji
English: However, it is not recommended that ribavirin be increased to the originally assigned dose (1,000 mg to 1,200 mg daily).
Maltese: Madankollu, mhuwiex rakkomandat li ribavirin jiżdied għad-doża oriġinali assenjata (1,000 mg sa 1,200 mg kuljum).
English: Prior HCV therapy
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: NS5A substitutions conferring resistance to ledipasvir may reduce the antiviral activity of other NS5A inhibitors.
Maltese: Sostituzzjonijiet ta' NS5A li jagħtu reżistenza għal ledipasvir jistgħu jnaqqsu l-attività antivirali ta' inibituri NS5A oħrajn.
English: b Patients with missing cirrhosis status were excluded from this subgroup analysis.
Maltese: b. Pazjenti bi status taċ-ċirrożi nieqes ġew esklużi minn din l-analiżi tas-subgrupp.
English: Harvoni is contraindicated with rifampicin (see section 4.3).
Maltese: Harvoni hu kontraindikat ma' rifampicin (ara sezzjoni 4.3).
English: Limited data indicate that such NS5A mutations do not revert on long-term follow-up.
Maltese: Data limitata tindika li dawn il-mutazzjonijiet NS5A ma jerġgħux lura għan-normal waqt segwitu fit-tul.