FrancophonIA/ELRC3.0 huggingface dataset:
English: After a single 400 mg oral dose of [14C]-sofosbuvir, sofosbuvir and GS-331007 accounted for approximately 4% and >90% of drug-related material (sum of molecular weight-adjusted AUC of sofosbuvir and its metabolites) systemic exposure, respectively.
Maltese: Wara doża waħda orali ta' 400 mg ta' [14C]-sofosbuvir, sofosbuvir u GS-331007 kienu jammontaw għal madwar 4% u > 90% tal-esponiment sistemiku tal-materjal relatat mal-mediċina (it-total tal-AUC molekulari aġġustat għall-piż ta' sofosbuvir u l-metaboliti tiegħu), rispettivament.
English: Sofosbuvir is a nucleotide prodrug that is extensively metabolised.
Maltese: Sofosbuvir hu prodroga nucleotide li jiġi metabolizzat b'mod estensiv.
English: Patient population (Study number/name)
Maltese: Popolazzjoni ta' pazjenti (Numru/isem tal-istudju)
English: Interferon intolerant, ineligible or unwilling (POSITRON)
Maltese: Intolleranti għal interferon, ineliġibbli jew ma ridux (POSITRON)
English: Sovaldi 400 mg film-coated tablets sofosbuvir
Maltese: Sovaldi 400 mg pilloli miksija b'rita sofosbuvir
English: Sofosbuvir is a substrate of drug transporter P-gp and breast cancer resistance protein (BCRP) while GS-331007 is not.
Maltese: Sofosbuvir hu substrat tat-trasportatur P-gp tal-mediċina u tal-proteina tar-reżistenza tal-kanċer tassider (BCRP - breast cancer resistance protein) filwaqt li GS-331007 mhuwiex.
English: In these assays, the in vitro antiviral activity of sofosbuvir against the less common genotypes 4, 5 and 6 was similar to that observed for genotypes 1, 2 and 3.
Maltese: F'dawn l-assaġġi, l-attività antivirali in vitro ta' sofosbuvir kontra l-ġenotipi inqas komuni 4, 5 u 6 kienet simili għal dik osservata għal ġenotipi 1, 2 u 3.
English: Overall Genotype 1a Genotype 1b No cirrhosis Cirrhosis
Maltese: Ġenotip 1a Ġenotip 1b L-ebda ċirrożi Ċirrożi
English: Sovaldi is contraindicated with rifampicin (see section 4.3).
Maltese: Sovaldi hu kontraindikat ma' rifampicin (ara sezzjoni 4.3).
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: Patients were randomised in a 1:1 ratio and stratified by cirrhosis (presence versus absence), HCV genotype (2 versus 3) and baseline HCV RNA level (<6 log10 IU/mL versus ≥6 log10 IU/mL).
Maltese: Il-pazjenti ntgħażlu b'mod każwali fi proporzjon ta' 1:1 u ġew stratifikati skont iċ-ċirrożi (preżenza kontra assenza), ġenotip HCV (2 kontra 3) u livell ta' HCV RNA fil-linja bażi(< 6 log10
English: ↑ Sofosbuvir (TPV) ↔ Sofosbuvir (BOC)
Maltese: ↑ Sofosbuvir (TPV) ↔ Sofosbuvir (BOC) ↔ GS-331007 (TPV jew BOC)
English: In biochemical assays, recombinant NS5B polymerase from genotypes 1b, 2a, 3a and 4a expressing the S282T substitution showed reduced susceptibility to GS-461203 compared to respective wild-types.
Maltese: F'assaġġi bijokimiċi, NS5B polymerase rikombinanti minn ġenotipi 1b, 2a, 3a u 4a li jesprimu s-sostituzzjoni S282T, urew suxxettibilità mnaqqsa għal GS-461203 meta mqabbla ma' wild-types rispettivi.
English: Table 11 presents the response rates for the treatment groups of sofosbuvir + ribavirin and placebo.
Maltese: Tabella 11 tippreżenta r-rati ta' rispons għall-gruppi ta' kura b'sofosbuvir + ribavirin u plaċebo.
English: The safety of sofosbuvir in a fixed dose combination with either ledipasvir or velpatasvir has been studied in 154 patients with ESRD requiring dialysis (Study 4062 and Study 4063).
Maltese: Is-sigurtà ta' sofosbuvir f'kombinazzjoni ta' doża fissa ma' ledipasvir jew velpatasvir ġiet studjata f'154 pazjent b'ESRD li kienu jeħtieġu emodijalisi (Studju 4062 u Studju 4063).
English: Sofosbuvir ↓ Cmax 0.52 (0.43, 0.62) ↓ AUC 0.52 (0.46, 0.59) Cmin (NA)
Maltese: ↓ Cmax 0.52 (0.43, 0.62) ↓ AUC 0.52 (0.46, 0.59) Cmin (NA)
English: Haemodialysis can efficiently remove (53% extraction ratio) the predominant circulating metabolite GS-331007.
Maltese: L-emodijaliżi tista' tneħħi b'mod effiċjenti (53% proporzjon ta' estrazzjoni) il-metabolit predominanti li jiċċirkola GS-331007.
English: Refer to the peginterferon alfa Summary of Product Characteristics for additional information about how to reduce and/or discontinue the peginterferon alfa dose.
Maltese: Irreferi għas-Sommarju tal-Karatteristiċi tal-Prodott ta' peginterferon alfa għal informazzjoni addizzjonali dwar kif tnaqqas u/jew twaqqaf id-doża ta' peginterferon alfa.
English: Based on population pharmacokinetic analysis in patients with genotypes 1 to 6 HCV infection (n = 986), steady-state AUC0-24 for sofosbuvir and GS-331007 was 1,010 ng•h/mL and 7,200 ng•h/mL, respectively.
Maltese: Ibbażat fuq analiżi farmakokinetika tal-popolazzjoni f'pazjenti b'infezzjoni bl-HCV ta' ġenotipi 1 sa 6 (n = 986), l-AUC0-24 fl-istat fiss għal sofosbuvir u GS-331007 kien ta' 1,010 ng•h/mL u 7,200 ng•h/mL, rispettivament.
English: General disorders and administration site conditions: Very common fatigue, irritability chills, fatigue, influenza-like illness, irritability, pain, pyrexia
Maltese: Komuni ħafna għeja, irritabilità tertir ta' bard, għeja, mard qisu influwenza, irritabilità, uġigħ, deni
English: Pharmacotherapeutic group: Antivirals for systemic use, direct-acting antiviral; ATC code: J05AP08
Maltese: Antivirali għal użu sistemiku, antivirali li jaġixxi b'mod dirett, Kodiċi ATC:
English: IMMUNOSUPPRESSANTS Ciclosporine (600 mg single dose)
Maltese: Ciclosporine (Doża ważda ta' 600 mg)
English: Table 12: SVR12 rates for selected subgroups by genotype in POSITRON
Maltese: Tabella 12: Rati ta' SVR12 għal sottogruppi magħżula skont il-ġenotip f'POSITRON
English: While subject to active tubular secretion, GS-331007 is not a substrate for renal transporters including organic anion transporter (OAT) 1 or 3, OCT2, MRP2, P-gp, BCRP or MATE1.
Maltese: Filwaqt li jkun soġġett għal tnixxija tubulari attiva, GS-331007 mhuwiex substrat għal trasportaturi tal-kliewi li jinkludu organic anion transporter (OAT) 1 jew 3, OCT2, MRP2, P-gp, BCRP jew MATE1.
English: ANTIMYCOBACTERIALS Rifampicinf (600 mg single dose)
Maltese: Rifampicinf (600 mg doża waħda)
English: 12 weeksa,b
Maltese: 12-il ġimgħaa, b
English: Co-administration with other direct-acting antivirals against HCV
Maltese: Rispons għal kura kontra HCV filpassat
English: Efavirenz ↔ Cmax 0.95 (0.85, 1.06) ↔ AUC 0.96 (0.91, 1.03) ↔ Cmin 0.96 (0.93, 0.98)
Maltese: ↔ Cmax 0.95 (0.85, 1.06) ↔ AUC 0.96 (0.91, 1.03) ↔ Cmin 0.96 (0.93, 0.98)
English: Plasma 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 fil-plażma tkejlu matul l-istudji kliniċi bl-użu tat-test COBAS TaqMan HCV (verżjoni 2.0), għall-użu mal-High Pure System.
English: Table 24: Effect of varying degrees of renal impairment on exposures (AUC) of sofosbuvir and GS-331007 compared to subjects with normal renal function
Maltese: Effett ta' gradi differenti ta' indeboliment tal-kliewi fuq esponimenti (AUC) għal sofosbuvir u GS-331007 meta mqabbla ma' individwi b'funzjoni normali tal-kliewi
English: Sofosbuvir ↓ Cmax 0.97 (0.65, 1.43) ↑ AUC 1.13 (0.81, 1.57) Cmin (NA)
Maltese: ↓ Cmax 0.97 (0.65, 1.43) ↑ AUC 1.13 (0.81, 1.57) Cmin (NA)
English: Table 6: Adverse drug reactions identified with sofosbuvir in combination with ribavirin or peginterferon alfa and ribavirin
Maltese: Tabella 6: Reazzjonijiet avversi tal-mediċina identifikati b'sofosbuvir flimkien ma' ribavirin jew peginterferon alfa u ribavirin
English: Sovaldi contains the active substance sofosbuvir which is given to treat hepatitis C virus infection in adults and adolescents from the age of 12 years up to the age of 18 years.
Maltese: Sovaldi fih is-sustanza attiva sofosbuvir li jingħata biex jikkura infezzjoni bil-virus tal-epatite Ċ f'adulti u adolexxenti mill-età ta' 12-il sena sal-età ta' 18-il sena.
English: The concordance between SVR12 and SVR24 (SVR 24 weeks after the end of the treatment) following treatment with sofosbuvir in combination with ribavirin or ribavirin and pegylated interferon demonstrates a positive predictive value of 99% and a negative predictive value of 99%.
Maltese: Il-konkordanza bejn SVR12 u SVR24 (SVR 24 ġimgħa wara t-tmiem tal-kura) wara l-kura b'sofosbuvir flimkien ma' ribavirin jew ribavirin u pegylated interferon turi valur ta' tbassir pożittiv ta' 99% u valur ta' tbassir negattiv ta' 99%.
English: Each film-coated tablet contains 400 mg of sofosbuvir.
Maltese: Kull pillola miksija b'rita fiha 400 mg ta' sofosbuvir.
English: Interferon intolerant, ineligible or unwilling adults - POSITRON (study 107) POSITRON was a randomised, double-blinded, placebo-controlled study that evaluated 12 weeks of treatment with sofosbuvir and ribavirin (n = 207) compared to placebo (n = 71) in patients who are interferon intolerant, ineligible or unwilling.
Maltese: Adulti intolleranti, ineliġibbli jew li ma ridux interferon - POSITRON (studju 107) POSITRON kien studju li fih il-parteċipanti ntgħażlu b'mod każwali, double-blind, ikkontrollat bi placebo, li evalwa 12-il ġimgħa ta' kura b'sofosbuvir u ribavirin (n = 207) meta mqabbla ma' plaċebo (n = 71) f'pazjenti li kienu intolleranti, ineliġibbli jew li ma ridux interferon.
English: Interferon classification Ineligible
Maltese: Klassifikazzjoni ta' interferon Ineliġibbli
English: Darunavir ↔ Cmax 0.97 (0.94, 1.01) ↔ AUC 0.97 (0.94, 1.00) ↔ Cmin 0.86 (0.78, 0.96)
Maltese: ↔ Cmax 0.97 (0.94, 1.01) ↔ AUC 0.97 (0.94, 1.00) ↔ Cmin 0.86 (0.78, 0.96)
English: Sofosbuvir ↓ Cmax 0.95c (0.68, 1.33) ↑ AUC 1.30c (1.00, 1.69) Cmin (NA)
Maltese: ↓ Cmax 0.95ċ (0.68, 1.33) ↑ AUC 1.30ċ (1.00, 1.69) Cmin (NA)
English: The adverse reactions observed were consistent with those observed in clinical studies of Sovaldi plus ribavirin in adults (see Table 6).
Maltese: Ir-reazzjonijiet avversi osservati kienu konsistenti ma' dawk osservati fl-istudji kliniċi ta' Sovaldi flimkien ma' ribavirin fl adulti (ara Tabella 6).
English: Common disturbance in attention migraine, memory impairment, disturbance in attention
Maltese: Komuni disturbi fl-attenzjoni emigranja, disturbi fil-memorja, disturb flattenzjoni
English: AUC, Cmax, Cmina,b
Maltese: Proporzjon medju (90% intervall ta' kunfidenza) għal AUC, Cmax, Cmina,b
English: The following adverse drug reactions have been identified with sofosbuvir in combination with ribavirin or in combination with peginterferon alfa and ribavirin (Table 6).
Maltese: Ir-reazzjonijiet avversi tal-mediċina li ġejjin ġew identifikati b'sofosbuvir flimkien ma' ribavirin jew flimkien ma' peginterferon alfa u ribavirin (Tabella 6).
English: SOF+RBV 16 weeks (n = 98)a
Maltese: SOF+RBV 16-il ġimgħa (n = 98)a
English: SOF+RBV 24 weeks (n = 250)
Maltese: SOF+RBV 24 ġimgħa (n = 250)
English: However, it is not recommended that ribavirin be increased to the original 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: Sofosbuvir 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 mouse micronucleus assays.
Maltese: Sofosbuvir ma kienx ġenotossiku 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: Sofosbuvir ↓ Cmax 0.23 (0.19, 0.29) ↓ AUC 0.28 (0.24, 0.32) Cmin (NA)
Maltese: ↓ Cmax 0.23 (0.19, 0.29) ↓ AUC 0.28 (0.24, 0.32) Cmin (NA)
English: Table 7 presents the response rates for the treatment group of sofosbuvir + peginterferon alfa + ribavirin.
Maltese: Tabella 7 tippreżenta r-rati ta' rispons għall-grupp ta' kura b'sofosbuvir + peginterferon alfa + ribavirin.
English: Study 4062 was an open-label study that evaluated a fixed dose combination of sofosbuvir and velpatasvir in 59 HCV-infected patients with ESRD requiring dialysis.
Maltese: Studju 4062 kien studju open-label li evalwa kombinazzjoni ta' doża fissa ta' sofosbuvir u velpatasvir f'59 pazjent infettat bl-HCV u b'ESRD li kienu jeħtieġu dijalisi.
English: Sovaldi + ribavirina for 12 weeks b
Maltese: Sovaldi + ribavirina għal 12-il ġimgħa b
English: The predominant inactive circulating metabolite GS-331007 that accounts for greater than 90% of drug-related material systemic exposure is formed through pathways sequential and parallel to formation of active metabolite.
Maltese: Il-metabolit predominanti inattiv li jiċċirkola GS-331007 li jammonta għal iktar minn 90% tal-esponiment sistemiku tal-materjal relatat mal-mediċina jiġi ffurmat permezz ta' passaġġi sekwenzjali u paralleli għall-formazzjoni tal-metabolit attiv.
English: Tenofovir ↑ Cmax 1.25 (1.08, 1.45) ↔ AUC 0.98 (0.91, 1.05) ↔ Cmin 0.99 (0.91, 1.07)
Maltese: ↑ Cmax 1.25 (1.08, 1.45) ↔ AUC 0.98 (0.91, 1.05) ↔ Cmin 0.99 (0.91, 1.07)
English: Sovaldi + ribavirin a for 24 weeks
Maltese: Sovaldi + ribavirina għal 24 ġimgħa
English: Treatment-naïve co-infected with HIV (PHOTON-1)
Maltese: Irċivew kura koinfettati bl-HIV (PHOTON-1)
English: 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: No clinically relevant pharmacokinetic differences due to gender or race have been identified for sofosbuvir and GS-331007.
Maltese: L-ebda differenza farmakokinetika klinikament rilevanti minħabba s-sess jew ir-razza ma ġiet identifikata għal sofosbuvir u GS-331007.
English: Tablet core:
Maltese: Tabella 15:
English: Table 18: SVR12 rates for selected subgroups by genotype in study PHOTON-1
Maltese: Tabella 18: Rati ta' SVR12 għal sottogruppi magħżula skont il-ġenotip fl-istudju PHOTON-1
English: Adolescents (12 to 18 years of age) The recommended dose of Sovaldi is one tablet once daily with food (see section 5.2).
Maltese: Adolexxenti (12 sa 18-il sena) Id-doża rakkomandata ta' Sovaldi hi ta' pillola waħda darba kuljum mal-ikel (ara sezzjoni 5.2).
English: Treatment-naïve (VALENCE)
Maltese: Irċivew kura (VALENCE)
English: 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 sofosbuvir (400 mg).
Maltese: L-esponimenti ta' sofosbuvir u GS-331007 f'adolexxenti li kellhom minn 12 sa < 18-il sena kienu simili għal dawk fl-adulti mill-istudji ta' Fażi 2/3 wara l-għoti ta' sofosbuvir (400 mg).
English: 24 weeks (n = 28)
Maltese: (n = 28)
English: The efficacy of sofosbuvir in HCV-infected patients aged 12 to <18 years was evaluated in a Phase 2, open label clinical trial that enrolled 50 patients with genotype 2 (n = 13) or genotype 3 (n = 37) chronic HCV infection.
Maltese: L-effikaċja ta' sofosbuvir f'pazjenti infettati bl-HCV li kellhom minn 12 sa <18-il sena ġiet evalwata fi prova klinika open-label ta' Fażi 2, li rreġistrat 50 pazjent b'infezzjoni kronika bl-HCV ta' ġenotip 2 (n = 13) jew ġenotip 3 (n = 37).
English: When Sovaldi is used in combination with ribavirin or peginterferon alfa/ribavirin, refer also to the Summary of Product Characteristics for ribavirin for patients with creatinine clearance (CrCl) <50 mL/min (see also section 5.2).
Maltese: Meta Sovaldi jintuża flimkien ma' ribavirin jew peginterferon alfa/ribavirin, irreferi wkoll għas-Sommarju tal-Karatteristiċi tal-Prodott għal ribavirin għal pazjenti bi tneħħija tal-krejatinina (CrCl) ta' < 50 mL/min (ara wkoll sezzjoni 5.2).
English: Table 4: Recommended dosing for ribavirin in combination therapy with Sovaldi in adolescents aged 12 to < 18 years
Maltese: Tabella 4: Dożaġġ rakkomandat għal ribavarin f'terapija kombinata ma' Sovaldi f'adolexxenti li jkollhom minn 12 sa < 18 il-sena
English: Rilpivirine ↔ Cmax 1.05 (0.97, 1.15) ↔ AUC 1.06 (1.02, 1.09) ↔ Cmin 0.99 (0.94, 1.04)
Maltese: ↔ Cmax 1.05 (0.97, 1.15) ↔ AUC 1.06 (1.02, 1.09) ↔ Cmin 0.99 (0.94, 1.04)
English: Raltegravir ↓ Cmax 0.57 (0.44, 0.75) ↓ AUC 0.73 (0.59, 0.91) ↔ Cmin 0.95 (0.81, 1.12)
Maltese: ↓ Cmax 0.57 (0.44, 0.75) ↓ AUC 0.73 (0.59, 0.91) ↔ Cmin 0.95 (0.81, 1.12)
English: Treatment-naïve (QUANTUMb and 11-1-0258b) SOF+RBV 24 weeks
Maltese: Qatt ma rċivew kura fil-passat (QUANTUMb u 11-1-0258b)
English: S-methadone ↔ Cmax 0.95 (0.79, 1.13) ↔ AUC 0.95 (0.77, 1.17) ↔ Cmin 0.95 (0.74, 1.22)
Maltese: ↔ Cmax 0.95 (0.79, 1.13) ↔ AUC 0.95 (0.77, 1.17) ↔ Cmin 0.95 (0.74, 1.22)
English: Table 12 presents the subgroup analysis by genotype for cirrhosis and interferon classification.
Maltese: Tabella 12 tippreżenta l-analiżi tas-sottogrupp skont il-ġenotip taċ-ċirrożi u l-klassifikazzjoni ta' interferon.
English: Population pharmacokinetic analysis in HCV infected patients showed that within the age range (19 to 75 years) analysed, age did not have a clinically relevant effect on the exposure to sofosbuvir and GS-331007.
Maltese: Analiżi farmakokinetika tal-popolazzjoni f'pazjenti infettati b'HCV uriet li fil-medda ta' età (19 sa 75 sena) analizzata, l-età ma kellhiex effett klinikament rilevanti fuq l-esponiment għal sofosbuvir u GS-331007.
English: Common alopecia, dry skin, pruritus alopecia, dry skin
Maltese: Komuni alopeċja, ġilda xotta, ħakk alopeċja, ġilda xotta
English: a. For previously treated patients with HCV genotype 1 infection, no data exists with the combination of Sovaldi, ribavirin and peginterferon alfa (see section 4.4).
Maltese: Għal pazjenti li rċivew kura fil-passat b'infezzjoni ta' HCV ġenotip 1, ma teżisti l-ebda dejta bil-kombinazzjoni ta' Sovaldi, ribavirin u peginterferon alfa (ara sezzjoni 4.4).
English: Patients with genotype 1, 4, 5 or 6 CHC
Maltese: Pazjenti b'CHC ta' ġenotip 1, 4, 5 jew 6
English: Clinical studies in patients with genotype 1, 4, 5 and 6 chronic hepatitis C Treatment-naïve adult patients - NEUTRINO (study 110) NEUTRINO was an open-label, single-arm study that evaluated 12 weeks of treatment with sofosbuvir in combination with peginterferon alfa 2a and ribavirin in treatment-naïve patients with genotype 1, 4, 5 or 6 HCV infection.
Maltese: Pazjenti adulti li qatt ma rċivew kura fil-passat - NEUTRINO (studju 110) NEUTRINO kien studju open-label, li kellu parti waħda biss, li evalwa 12-il ġimgħa ta' kura b'sofosbuvir flimkien ma' peginterferon alfa 2a u ribavirin f'pazjenti li qatt ma rċivew kura fil-passat b'infezzjoni bl-HCV ta' ġenotip 1, 4, 5 jew 6.
English: A summary of the effect of varying degrees of renal impairment (RI) on the exposures of sofosbuvir and GS-331007 compared to subjects with normal renal function, as described in the text below, are provided in Table 24.
Maltese: Sommarju tal-effett ta' gradi differenti ta' indeboliment tal-kliewi (RI - renal impairment) fuq l-esponimenti għal sofosbuvir u GS-331007 meta mqabbla ma' individwi b'funzjoni normali talkliewi, kif deskritt fit-test hawn taħt, huwa pprovdut fit-Tabella 24.
English: Ciclosporin ↔ Cmax 1.06 (0.94, 1.18) ↔ AUC 0.98 (0.85, 1.14) Cmin (NA)
Maltese: ↔ Cmax 1.06 (0.94, 1.18) ↔ AUC 0.98 (0.85, 1.14) Cmin (NA)
English: Safety data are limited in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m2) and end stage renal disease (ESRD) requiring haemodialysis.
Maltese: Data dwar is-sigurtà hija limitata f'pazjenti b'indeboliment sever tal-kliewi (stima tar-rata talfiltrazzjoni glomerulari [eGFR - estimated glomerular filtration rate] ta' < 30 mL/min/1.73 m2) u b'mard tal-kliewi li jinsab fl-aħħar stadju (ESRD - end stage renal disease) li jkunu jeħtieġu l-emodijaliżi.
English: The virologic response rates of the 41 patients transplanted with HCV RNA <LLOQ is described in Table 19.
Maltese: Ir-rati ta' rispons viroloġiku tal-41 pazjent ttrapjantati b'HCV RNA < LLOQ huma deskritti f'Tabella 19.
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, emodijalisi ta' 4 sigħat neħħiet 18% tad-doża ta' sofosbuvir mogħtija.
English: HCV/HIV co-infected adult patients - PHOTON-1 (study 123) Sofosbuvir was studied in an open-label clinical study evaluating the safety and efficacy of 12 or 24 weeks of treatment with sofosbuvir and ribavirin in patients with genotype 1, 2 or 3 chronic hepatitis C co-infected with HIV-1.
Maltese: Effikaċja klinika u sigurtà f'popolazzjonijiet speċjali Pazjenti adulti koinfettati b'HCV/HIV - PHOTON-1 (studju 123) Sofosbuvir ġie studjat fi studju kliniku open-label li evalwa s-sigurtà u l-effikaċja ta' 12 jew 24 ġimgħa ta' kura b'sofosbuvir u ribavirin f'pazjenti b'ġenotip 1, 2 jew 3 ta' epatite Ċ kronika koinfettati bl-HIV-1.
English: Sofosbuvir ↑ Cmax 1.21 (0.90, 1.62) ↔ AUC 1.09 (0.94, 1.27) Cmin (NA)
Maltese: ↑ Cmax 1.21 (0.90, 1.62) ↔ AUC 1.09 (0.94, 1.27) Cmin (NA)
English: Paediatric population
Maltese: Popolazzjonoi pedjatrika
English: The pharmacokinetics of 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 or sofosbuvir/velpatasvir (n = 59) for 12 weeks, and compared to patients without renal impairment in the ledipasvir/sofosbuvir and sofosbuvir/velpatasvir Phase 2/3 trials (see section 4.4).
Maltese: Il-farmakokinetika ta' sofosbuvir, u GS-331007 ġiet studjata f'pazjenti infettati bl-HCV b'ESRD li kienu jeħtieġu emodijalisi ttrattati b'ledipasvir/sofosbuvir (n = 94) għal 8, 12, jew 24 ġimgħa jew b'sofosbuvir/velpatasvir
English: Close monitoring is recommended if this medicinal product is administered with Sovaldi (see sections 4.4 and 4.8).
Maltese: Huwa rrakkomandat monitoraġġ mill-qrib jekk dan il-prodott mediċinali jingħata ma' Sovaldi (ara s-sezzjonijiet 4.4 u 4.8).
English: Common arthralgia, back pain, muscle spasms, myalgia back pain, muscle spasms
Maltese: Komuni artralġja, uġigħ fid-dahar, spażmi filmuskoli, majalġja uġigħ fid-dahar, spażmi fil-muskoli
English: The recommended treatment regimen and durations for Sovaldi combination therapy are provided in Table 3 and Table 4.
Maltese: Il-kors ta' kura rakkomandat u kemm iddum it-terapija kombinata għal Sovaldi qed jingħataw f'Tabella 3 u Tabella 4.
English: Treatment-experienced (FUSION)
Maltese: Irċivew kura (FUSION)
English: Table 1: Recommended co-administered medicinal product(s) and treatment duration for adults treated with Sovaldi combination therapy
Maltese: Tabella 1: Prodott(i) mediċinali mogħti(ja) flimkien rakkomandat(i) u t-tul ta' żmien tal-kura għal adulti kkurati bit-terapija kkombinata b'Sovaldi Popolazzjoni ta'
English: The intracellular metabolic activation pathway of sofosbuvir is mediated by generally low affinity and high capacity hydrolase and nucleotide phosphorylation pathways that are unlikely to be affected by concomitant medicinal products (see section 5.2).
Maltese: Il-passaġġ tal-attivazzjoni metabolika intraċellulari ta' sofosbuvir hu medjat minn passaġġi ta' hydrolase ta' kapaċità għolja u ta' affinità ġeneralment baxxa u fosforilazzjoni nucleotide li x'aktarx li mhux se jiġu affettwati minn prodotti mediċinali li jingħataw fl-istess ħin (ara sezzjoni 5.2).
English: R-methadone ↔ Cmax 0.99 (0.85, 1.16) ↔ AUC 1.01 (0.85, 1.21) ↔ Cmin 0.94 (0.77, 1.14)
Maltese: ↔ Cmax 0.99 (0.85, 1.16) ↔ AUC 1.01 (0.85, 1.21) ↔ Cmin 0.94 (0.77, 1.14)
English: Sovaldi + ribavirin Only for use in patients ineligible or intolerant to peginterferon alfa (see section 4.4)
Maltese: Għall-użu biss f'pazjenti ineliġibbli jew intolleranti għal peginterferon alfa (ara sezzjoni 4.4)
English: Outcome for patients without SVR12 On-treatment virologic failure Relapseb
Maltese: Riżultat għal pazjenti mingħajr SVR12 Falliment viroloġiku waqt il-kura Rikadutaa