FrancophonIA/ELRC3.0 huggingface dataset:
English: Relative to healthy subjects (n = 284), the sofosbuvir and GS-331007 AUC0-24 was 57% higher and 39% lower, respectively in HCV infected subjects.
Maltese: Meta mqabbla ma' individwi b'saħħithom (n = 284), l-AUC0-24 ta' sofosbuvir u GS-331007 kienet 57% ogħla u 39% iktar baxxi,
English: Emtricitabine ↔ Cmax 0.97 (0.88, ↔ AUC 0.99 (0.94, ↔ Cmin 1.04 (0.98, 1.11) Sofosbuvir ↓ Cmax 0.81 (0.60, 1.10) ↔ AUC 0.94 (0.76, Cmin (NA)
Maltese: ↔ Cmin 1.04 (0.98, 1.11) Sofosbuvir ↓ Cmax 0.81 (0.60, 1.10) ↔ AUC 0.94 (0.76, Cmin (NA)
English: The safety profile of sofosbuvir and ribavirin in HCV/HIV co-infected subjects was similar to that observed in mono-infected HCV subjects treated with sofosbuvir and ribavirin in Phase 3 clinical studies (see section 5.1).
Maltese: Il-profil tas-sigurtà ta' sofosbuvir u ribavirin f'individwi koinfettati b'HCV/HIV kien simili għal dak osservat f'individwi infettati b'HCV biss, ikkurati b'sofosbuvir u ribavirin fi studji kliniċi ta' Fażi 3 (ara sezzjoni 5.1).
English: The virologic response rates of the 41 subjects transplanted with HCV RNA <LLOQ is described in Table 17.
Maltese: Ir-rati ta' rispons viroloġiku tal41 individwu ttrapjantati b'HCV RNA < LLOQ huma deskritti f'Tabella 17.
English: NARCOTIC ANALGESICS Methadonef (Methadone maintenance therapy [30 to
Maltese: Methadonef (Terapija ta' manteniment b'methadone [30 sa 130 mg/jum])
English: Table 10 presents the subgroup analysis by genotype for cirrhosis and interferon classification.
Maltese: Tabella 10 tippreżenta l-analiżi tas-sottogrupp skont il-ġenotip taċ-ċirrożi u l-interferon.
English: The safety of Sovaldi has not been assessed in subjects with severe renal impairment (eGFR <30 mL/min/1.73 m2) or ESRD requiring haemodialysis.
Maltese: Is-sigurtà ta' Sovaldi ma ġietx evalwata f'individwi b'indeboliment sever tal-kliewi (eGFR ta' < 30 mL/min/1.73 m2) jew ESRD li jkunu jeħtieġu l-emodijaliżi.
English: Treatment of patients with genotype 5 or 6 HCV infection The clinical data to support the use of Sovaldi in patients with genotype 5 and 6 HCV infection is very limited (see section 5.1).
Maltese: Id-dejta klinika li tappoġġja l-użu ta' Sovaldi f'pazjenti b'infezzjoni bl-HCV ta' ġenotip 5 u 6 hi limitata ħafna (ara sezzjoni 5.1).
English: No cirrhosis
Maltese: U L-UŻU
English: The safety and efficacy of Sovaldi in children and adolescents aged <18 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Sovaldi fit-tfal u adolexxenti li għandhom < 18-il sena ma ġewx determinati s'issa.
English: In a pooled analysis of 991 subjects who received sofosbuvir in Phase 3 studies, 226 subjects 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' 991 individwu li rċivew sofosbuvir fi studji ta' Fażi 3, 226 individwu kkwalifikaw għal analiżi ta' reżistenza minħabba falliment viroloġiku jew waqfien bikri tal-mediċina tal-istudju u kellhom HCV RNA ta' > 1,000 IU/mL.
English: Exposure to GS-331007 in these studies was up to 30 times (mouse) and 15 times (rat) higher than the clinical exposure at 400 mg sofosbuvir.
Maltese: GS-331007 f'dawn l-istudji kien sa 30 darba (fil-ġrieden) u 15-il darba (fil-firien) ogħla mill esponiment kliniku f'doża ta' 400 mg ta' sofosbuvir.
English: Liver transplant recipients - Study 0126
Maltese: Pazjenti li jirċievu trapjant tal-fwied - studju 0126
English: This subject harboured <1% HCV S282T at baseline and developed S282T (>99%) at 4 weeks post-treatment which resulted in a 13.5-fold change in sofosbuvir EC50 and reduced viral replication capacity.
Maltese: Dan l-individwu kellu < 1% HCV S282T fil-linja bażi u żviluppa S282T (> 99%) 4 ġimgħat wara l-kura, li rriżultat f'bidla ta' 13.5 drabi fl-EC50 ta' sofosbuvir u naqqset il-kapaċità tar-replikazzjoni virali.
English: HCV/HIV co-infected 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 subjects with genotype 1, 2 or 3 chronic hepatitis C co-infected with HIV-1.
Maltese: 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'individwi b'ġenotip 1, 2 jew 3 ta' epatite Ċ kronika koinfettati bl-HIV-1.
English: Population pharmacokinetics analysis in HCV infected subjects indicated that cirrhosis had no clinically relevant effect on the exposure to sofosbuvir and GS-331007.
Maltese: Analiżi farmakokinetika tal-popolazzjoni f'individwi infettati b'HCV, indikat li ċ-ċirrożi ma kellha l-ebda effett klinikament rilevanti fuq l-esponiment għal sofosbuvir u GS-331007.
English: Pharmacotherapeutic group: Direct-acting antiviral; ATC code: J05AX15
Maltese: Antivirali li jaġixxu b'mod dirett, Kodiċi ATC:
English: Subjects were randomised in a 1:1 ratio and stratified by cirrhosis (presence versus absence) and HCV genotype (2 versus 3).
Maltese: L-individwi ntgħażlu b'mod każwali fi proporzjon ta' 1:1 u ġew stratifikati skont iċ-ċirrożi (preżenza kontra assenza) u ġenotip HCV (2 kontra 3).
English: All subjects who achieved SVR12 achieved SVR24 and SVR48.
Maltese: L-individwi kollha li kisbu SVR12, kisbu SVR24 u SVR48.
English: Co-administration with other direct-acting antivirals against HCV Sovaldi should only be co-administered with other direct-acting antiviral medicinal products if the benefit is considered to outweigh the risks based upon available data.
Maltese: Għoti flimkien ma' antivirali oħrajn li jaġixxu b'mod dirett kontra HCV Sovaldi għandu jingħata flimkien ma' prodotti mediċinali antivirali oħrajn li jaġixxu b'mod dirett biss jekk il-benefiċċju jiġi kkunsidrat li jiżboq ir-riskji bbażati fuq id-dejta disponibbli.
English: Sovaldi is contraindicated with rifabutin, a potent intestinal P-gp inducer (see section 4.3).
Maltese: Sovaldi hu kontraindikat ma' rifabutin, induttur potenti ta' P-gp fl-imsaren (ara sezzjoni 4.3).
English: Interferon intolerant, ineligible or unwilling (POSITRON)
Maltese: Adulti intolleranti, ineliġibbli jew li ma ridux interferon - POSITRON (studju 107)
English: In 5 subjects (12.5%), study drugs were discontinued, modified or interrupted due to adverse events.
Maltese: F'5 individwi (12.5%), il-mediċini tal-istudju twaqqfu, ġew modifikati jew interrotti minħabba avvenimenti avversi.
English: SOF+RBV 12 weeks (n = 73)
Maltese: SOF+RBV 12-il ġimgħa (n = 73)
English: An interim analysis was conducted on 61 subjects who received sofosbuvir and ribavirin; the majority of subjects had HCV genotype 1, 44 subjects were CPT class A and 17 subjects were CPT class B. Of these 61 subjects, 44 subjects underwent liver transplantation following up to 48 weeks of treatment with sofosbuvir and ribavirin; 41 had HCV RNA <LLOQ at the time of transplantation.
Maltese: Minn dawn il-61 individwu, 44 individwu kellhom trapjant tal-fwied wara sa 48 ġimgħa ta' kura b'sofosbuvir u ribavirin; 41 kellhom HCV RNA < LLOQ fil-ħin tat-trapjant.
English: Genotype 1bc No cirrhosisc Cirrhosisc n = number of subjects with SVR12 response; N = total number of subjects per group.
Maltese: L-ebda ċirrożi Ċirrożi n = numru ta' individwi b'rispons għal SVR12; N = numru total ta' individwi f'kull grupp.
English: In subjects with ESRD, relative to subjects with normal renal function, sofosbuvir AUC0-inf was 28% higher when sofosbuvir was dosed 1 hour before haemodialysis compared with 60% higher when sofosbuvir was dosed 1 hour after haemodialysis.
Maltese: F'individwi b'ESRD, meta mqabbla ma' individwi b'funzjoni normali tal-kliewi, l-AUC0-inf ta' sofosbuvir kienet ta' 28% ogħla meta d-doża ta' sofosbuvir ingħatat siegħa qabel l-emodijaliżi, meta mqabbla ma' 60% ogħla meta d-doża ta' sofosbuvir ingħatat siegħa wara l-emodijaliżi.
English: Sovaldi is contraindicated with rifampicin, a potent intestinal P-gp inducer (see section 4.3).
Maltese: Sovaldi hu kontraindikat ma' rifampicin, induttur potenti ta' P-gp fl-imsaren (ara sezzjoni 4.3).
English: The safety of Sovaldi has not been assessed in patients with severe renal impairment or ESRD (see section 4.4).
Maltese: Is-sigurtà ta' Sovaldi ma ġietx evalwata f'pazjenti b'indeboliment sever tal-kliewi jew ESRD (ara sezzjoni 4.4).
English: The S282T substitution in NS5B was detected in a single subject receiving Sovaldi monotherapy in a Phase 2 study.
Maltese: Is-sostituzzjoni S282T f'NS5B ġiet osservata f'individwu wieħed li kien qed jirċievi Sovaldi waħdu fi studju ta' Fażi 2.
English: GS-331007 ↓ Cmax 0.60 (0.53, 0.69) ↔ AUC 1.04 (0.90,
Maltese: GS-331007 ↓ Cmax 0.60 (0.53, 0.69)
English: Sofosbuvir was studied in HCV infected subjects prior to undergoing liver transplantation in an open-label clinical study evaluating the safety and efficacy of sofosbuvir and ribavirin administered pre-transplant to prevent post-transplant HCV reinfection.
Maltese: Sofosbuvir ġie studjat f'individwi infettati b'HCV qabel ma sarilhom trapjant tal-fwied, fi studju kliniku open-label li evalwa s-sigurtà u l-effikaċja ta' sofosbuvir u ribavirin mogħtija qabel it-trapjant biex jipprevjeni infezzjoni mill-ġdid b'HCV wara t-trapjant.
English: Table 4: Adverse drug reactions identified with sofosbuvir in combination with ribavirin or peginterferon alfa and ribavirin
Maltese: Tabella 4: Reazzjonijiet avversi tal-mediċina identifikati b'sofosbuvir flimkien ma' ribavirin jew peginterferon alfa u ribavirin Frekwenza SOFa + RBVb
English: Sovaldi contains the active substance sofosbuvir which is given to treat hepatitis C virus infection in adults of 18 years and older.
Maltese: Sovaldi fih is-sustanza attiva sofosbuvir li jingħata biex jikkura infezzjoni bil-virus tal-epatite Ċ f'adulti li jkollhom 18-il sena u aktar.
English: Subjects 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: 3) u livell ta' HCV RNA fil-linja bażi(< 6 log10 IU/mL kontra ≥ 6 log10
English: When you take Sovaldi in combination with another medicine to treat hepatitis C virus infection (including daclatasvir, simeprevir and ledipasvir) and amiodarone (a medicine used for heart problems), you may get one or more of the side effects below:
Maltese: Meta qed tieħu Sovaldi flimkien ma' mediċina oħra biex tittratta infezzjoni mill-mikrobu tal-epatite Ċ (inkluż daclatasvir, simeprevir u ledipasvir) u amiodarone (mediċina użata minħabba problemi talqalb), jista' jkollok wieħed jew aktar mill-effetti sekondarji li ġejjin:
English: Common pyrexia, asthenia chest pain, asthenia a. SOF = sofosbuvir; b. RBV = ribavirin; c. PEG = peginterferon alfa.
Maltese: Għandha tingħata konsiderazzjoni għallkura ta' dawn il-pazjenti, u li t-tul tat-terapija b'sofosbuvir, peginterferon alfa u ribavirin jista'
English: Patients with genotype 1, 4, 5 or 6 CHC
Maltese: Studji kliniċi f'individwi b'epatite Ċ kronika ta' ġenotip 1, 4, 5 u 6
English: Cases of severe bradycardia and heart block have been observed when sofosbuvir is used in combination with another direct-acting antiviral (DAAs, including daclatasvir, simeprevir and ledipasvir) and concomitant amiodarone with or without other drugs that lower heart rate.
Maltese: Każijiet ta' bradikardija severa u mblokkar tal-qalb ġew osservati meta sofosbuvir jintuża flimkien ma' prodott antivirali ieħor li jaġixxi direttament (DAAs, inkluż daclatasvir, simeprevir u ledipasvir) u amiodarone konkomitanti ma' mediċini oħrajn li jbaxxu r-rata ta' taħbit tal-qalb jew mingħajrhom.
English: Clinical studies in subjects with genotype 2 and 3 chronic hepatitis C Treatment-naïve adults - FISSION (study 1231)
Maltese: Pazjenti koinfettati b'HCV/HIV - PHOTON-1 (studju 123)
English: In the ELECTRON study (N = 11), the duration of peginterferon alfa ranged from 4-12 weeks in combination with sofosbuvir + ribavirin.
Maltese: Fl istudju ELECTRON (N = 11), it-tul tal-kura b'peginterferon alfa varja minn 4-12-il ġimgħa flimkien ma' sofosbuvir + ribavirin.
English: SOF+RBV 12 weeks
Maltese: SOF+RBV 12
English: Subjects received 400 mg sofosbuvir and weight-based ribavirin (1,000 mg for subjects weighing <75 kg or 1,200 mg for subjects weighing ≥75 kg).
Maltese: Jekk id-doża tal-bidu ta' ribavirin tkun ittollerata tajjeb, id-doża tista' tiġi titrata għal massimu ta' 1,000-1,200 mg kuljum (1,000 mg għal pazjenti li jiżnu < 75 kg u 1,200 mg għal pazjenti li jiżnu ≥ 75 kg).
English: The safety and appropriate dose of Sovaldi have not been established in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m2) or end stage renal disease (ESRD) requiring haemodialysis (see section 5.2).
Maltese: Is-sigurtà u doża xierqa ta' Sovaldi ma ġewx stabbiliti f'pazjenti b'indeboliment sever tal kliewi (stima tar-rata tal-filtrazzjoni glomerulari [eGFR - estimated glomerular filtration rate] ta' < 30 mL/min/1.73 m2) jew b'mard tal-kliewi li jinsab fl-aħħar stadju (ESRD - end stage renal disease)
English: Treated subjects (n = 278) had a median age of 54 years (range: 21 to 75); 54% of the subjects were male; 91% were White; 5% were Black; 11% were Hispanic or Latino; mean body mass index was 28 kg/m2 (range: 18 to 53 kg/m2); 70% had baseline HCV RNA levels greater than 6 log10 IU/mL;
Maltese: L-individwi kkurati (n = 278) kellhom età medjana ta' 54 sena (medda: 21 sa 75); 54% tal-individwi kienu rġiel; 91% kienu Bojod; 5% kienu Suwed; 11% kienu Ispaniċi jew mill-Amerika Latina; il medja tal-indiċi tal-piż tal-ġisem (BMI) kienet ta' 28 kg/m2 (medda: 18 sa 53 kg/m2); 70% kellhom livelli ta' HCV RNA fil-linja bażi ta' iktar minn 6 log10
English: Available pharmacokinetic data in animals has shown excretion of metabolites in milk (for details see section 5.3).
Maltese: Dejta farmakokinetika fl-annimali wriet li kien hemm l-eliminazzjoni tal-metaboliti fil-ħalib (għaddettalji ara sezzjoni 5.3).
English: No effect = 1.00 b. All interaction studies conducted in healthy volunteers c. Comparison based on historical control d. Administered as Atripla e. Bioequivalence boundary 80%-125% f. Equivalence boundary 70%-143%
Maltese: Limiti ta' bijoekwivalenza 80%-125% f. Limiti ta' ekwivalenza 70%-143%
English: Medicinal products that are potent P-gp inducers in the intestine (rifampicin, rifabutin, St. John's wort, carbamazepine, phenobarbital and phenytoin) may significantly decrease sofosbuvir plasma concentration leading to reduced therapeutic effect of Sovaldi and thus are contraindicated with Sovaldi (see section 4.3).
Maltese: carbamazepine, phenobarbital u phenytoin) jistgħu jnaqqsu b'mod sinifikanti l-konċentrazzjoni ta' sofosbuvir fil-plażma u jwasslu għal effett terapewtiku mnaqqas ta' Sovaldi u għalhekk huma kontraindikati ma' Sovaldi (ara sezzjoni 4.3).
English: SOF+PEG+RBV 12 weeks
Maltese: SOF+PEG+RBV 12
English: Treated subjects (n = 499) had a median age of 50 years (range: 19 to 77); 66% of the subjects were male; 87% were White; 3% were Black; 14% were Hispanic or Latino; mean body mass index was 28 kg/m2 (range: 17 to 52 kg/m2); 57% had baseline HCV RNA levels greater than 6 log10 IU/mL;
Maltese: L-individwi kkurati (n = 499) kellhom età medjana ta' 50 sena (medda: 19 sa 77); 66% tal-individwi kienu rġiel; 87% kienu Bojod; 3% kienu Suwed; 14% kienu Ispaniċi jew mill-Amerika Latina; il medja tal-indiċi tal-piż tal-ġisem (BMI) kienet ta' 28 kg/m2 (medda: 17 sa 52 kg/m2); 57% kellhom livelli ta' HCV RNA fil-linja bażi ta' iktar minn 6 log10
English: Table 17: Virologic response post-transplant in subjects with HCV RNA <LLOQ at the time of liver transplantation
Maltese: Tabella 17: Rispons viroloġiku wara t-trapjant f'individwi b'HCV RNA < LLOQ fil-ħin tattrapjant tal-fwied
English: Medicinal products that are moderate P-gp inducers in the intestine (e.g. oxcarbazepine and modafinil) may decrease sofosbuvir plasma concentration leading to reduced therapeutic effect of Sovaldi.
Maltese: Prodotti mediċinali li huma indutturi moderati ta' P-gp fl-imsaren (eż. oxcarbazepine u modafinil) jistgħu jnaqqsu l-konċentrazzjoni ta' sofosbuvir fil-plażma u jwasslu għal effett terapewtiku mnaqqas ta' Sovaldi.
English: Interferon classification Ineligible Intolerant Unwilling
Maltese: Intolleranti għal interferon, ineliġibbli jew ma ridux
English: Darunavir ↔ Cmax 0.97 (0.94, ↔ AUC 0.97 (0.94, ↔ Cmin 0.86 (0.78, 0.96) Sofosbuvir ↑ Cmax 1.45 (1.10, 1.92) ↑ AUC 1.34 (1.12, 1.59) Cmin (NA)
Maltese: ↔ Cmin 0.86 (0.78, 0.96) Sofosbuvir ↑ Cmax 1.45 (1.10, 1.92)
English: Treated subjects (n = 201) had a median age of 56 years (range: 24 to 70); 70% of the subjects were male; 87% were White; 3% were Black; 9% were Hispanic or Latino; mean body mass index was 29 kg/m2 (range: 19 to 44 kg/m2); 73% had baseline HCV RNA levels greater than 6 log10 IU/mL;
Maltese: L-individwi kkurati (n = 201) kellhom età medjana ta' 56 sena (medda: 24 sa 70); 70% tal-individwi kienu rġiel; 87% kienu Bojod; 3% kienu Suwed; 9% kienu Ispaniċi jew mill-Amerika Latina; il-medja tal-indiċi tal-piż tal-ġisem (BMI) kienet ta' 29 kg/m2 (medda: 19 sa 44 kg/m2); 73% kellhom livelli ta'
English: During treatment with sofosbuvir in combination with ribavirin or with peginterferon alfa and ribavirin, the most frequently reported adverse drug reactions were consistent with the expected safety profile of ribavirin and peginterferon alfa treatment, without increasing the frequency or severity of the expected adverse drug reactions.
Maltese: Waqt il-kura b'sofosbuvir flimkien ma' ribavirin jew ma' peginterferon alfa u ribavirin, l-iktar reazzjonijiet avversi tal-mediċina li ġew irrappurtati b'mod frekwenti kienu konsistenti mal-profil tas sigurtà mistenni tal-kura b'ribavirin u peginterferon alfa, mingħajr ma żdiedet il-frekwenza jew isseverità tar-reazzjonijiet avversi mistennija tal-mediċina.
English: Sofosbuvir ↓ Cmax 0.97 (0.65, 1.43) ↑ AUC 1.13 (0.81, 1.57) Cmin (NA)
Maltese: Sofosbuvir ↓ Cmax 0.97 (0.65, 1.43)
English: Cirrhotic
Maltese: Ċirrożi
English: Treatment-naïve co-infected with HIV (PHOTON-1)
Maltese: Qatt ma rċivew kura fil passat u 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. Farmakokinetika f'popolazzjonijiet speċjali
English: Two NS5B substitutions, L159F and V321A, were detected in post-treatment relapse samples from multiple genotype 3 HCV infected subjects in the Phase 3 clinical studies.
Maltese: Żewġ sostituzzjonijiet ta' NS5B, L159F u V321A, ġew osservati f'kampjuni minn rikaduta wara lkura minn individwi multipli infettati b'HCV ta' ġenotip 3 fi studji kliniċi ta' Fażi 3. Ma ġie osservat l-ebda ċaqliq fis-suxxettibilità fenotipika għal sofosbuvir jew ribavirin ta' iżolati ta' individwi b'dawn is-sostituzzjonijiet.
English: ↔ Cmin 0.99 (0.91, 1.07)
Maltese: ↓ AUC 0.73 (0.59, 0.91)
English: Tacrolimus ↓ Cmax 0.73 (0.59, 0.90) ↔ AUC 1.09 (0.84, Cmin (NA)
Maltese: Tacrolimus ↓ Cmax 0.73 (0.59, 0.90)
English: Overalla No cirrhosis a
Maltese: 12-il ġimgħa
English: Treated subjects (n = 327) had a median age of 54 years (range: 19 to 70); 64% of the subjects were male; 79% were White; 17% were Black; 14% were Hispanic or Latino; mean body mass index was 29 kg/m2 (range: 18 to 56 kg/m2); 78% had baseline HCV RNA greater than 6 log10 IU/mL; 17% had cirrhosis; 89% had HCV genotype 1 and 11% had HCV genotype 4, 5 or 6.
Maltese: L-individwi kkurati (n = 327) kellhom età medjana ta' 54 sena (medda: 19 sa 70); 64% tal-individwi kienu rġiel; 79% kienu Bojod; 17% kienu Suwed; 14% kienu Ispaniċi jew mill-Amerika Latina; il medja tal-indiċi tal-piż tal-ġisem (BMI) kienet ta' 29 kg/m2 (medda: 18 sa 56 kg/m2); 78% kellhom livelli ta' HCV RNA fil-linja bażi ta' iktar minn 6 log10
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
English: No dose adjustment of sofosbuvir or tenofovir disoproxil fumarate is required when sofosbuvir and tenofovir disoproxil fumarate are used concomitantly.
Maltese: L-ebda aġġustament fid-doża ta' sofosbuvir jew tenofovir disoproxil fumarate mhu meħtieġ meta sofosbuvir u tenofovir disoproxil fumarate jintużaw fl-istess ħin.
English: Clinical studies of sofosbuvir included 65 subjects aged 65 and over.
Maltese: L-istudji kliniċi ta' sofosbuvir kienu jinkludu 65 individwu li kellhom 65 sena jew aktar.
English: Treatment-experienced co-infected with HIV (PHOTON-1)
Maltese: HIV (PHOTON-1)
English: Otherc a. The efficacy analysis includes 3 subjects with recombinant genotype 2/1 HCV infection.
Maltese: L-analiżi tal-effikaċja tinkludi 3 individwi b'infezzjoni ta' ġenotip HCV 2/1 rikombinanti.
English: Drug interaction information for Sovaldi with potential concomitant medicinal products is summarised in Table 3 below (where 90% confidence interval (CI) of the geometric least-squares mean (GLSM)
Maltese: Informazzjoni dwar interazzjonijiet ta' Sovaldi ma' prodotti mediċinali potenzjali li jingħataw fl-istess ħin qed jintwerew fil-qosor f'Tabella 3 hawn taħt (fejn 90% intervall ta' kunfidenza (CI - confidence interval) tal-proporzjon tal-geometric least-squares mean (GLSM) kien fil-medda ta' “↔”, estiża 'l fuq “↑”, jew estiża 'l isfel “↓” tal-limiti determinati minn qabel tal-ekwivalenza).
English: PROTONb)
Maltese: (VALENCE)
English: The extent of absorption of sofosbuvir was increased approximately 1.8-fold, with little effect on peak concentration.
Maltese: assorbiment ta' sofosbuvir żdied b'madwar 1.8 drabi, bi ftit effett fuq l-ogħla konċentrazzjoni.
English: Otherc a. The efficacy analysis includes 6 subjects with recombinant genotype 2/1 HCV infection.
Maltese: L-analiżi tal-effikaċja tinkludi 6 individwi b'infezzjoni ta' ġenotip HCV 2/1 rikombonanti.
English: level was 6.4 log10 IU/mL; 21% had cirrhosis; 78% had HCV genotype 3; 65% were prior relapsers.
Maltese: IU/mL; 21% kellhom ċirrożi; 78%
English: 34% had cirrhosis; 63% had HCV genotype 3; 75% were prior relapsers.
Maltese: HCV 3; 75% kellhom rikaduta fil-passat.
English: Table 12: SVR12 rates for selected subgroups by genotype in study FUSION Genotype 2
Maltese: Tabella 12: Rati ta' SVR12 għal sottogruppi magħżula skont il-ġenotip fl-istudju FUSION Ġenotip 2
English: Consideration should be given to treating these patients, and potentially extending the duration of therapy with sofosbuvir, peginterferon alfa and ribavirin beyond 12 weeks and up to 24 weeks; especially for those subgroups who have one or more factors historically associated with lower response rates to interferon-based therapies (prior null response to peginterferon alfa and ribavirin therapy, advanced fibrosis/cirrhosis, high baseline viral concentrations, black race, IL28B non CC genotype).
Maltese: potenzjalment jiġi estiż għal aktar minn 12-il ġimgħa u sa u mhux aktar minn 24 ġimgħa; speċjalment għal dawk is-sottogruppi li jkollhom fattur wieħed jew aktar storikament assoċjat ma' rati iktar baxxi ta' rispons għal terapiji bbażati fuq interferon (l-ebda rispons fil-passat għal terapija b'peginterferon alfa u ribavirin, fibrożi/ċirrożi avvanzata, konċentrazzjonijiet virali għoljin fil-linja bażi, razza sewda, ġenotip IL28B mhux CC). b.
English: Infections and infestations: Common nasopharyngitis Blood and lymphatic system disorders:
Maltese: Komuni anemija Disturbi fil-metaboliżmu u n-nutrizzjoni:
English: Table 1: Recommended co-administered medicinal product(s) and treatment duration for Sovaldi combination therapy
Maltese: Tabella 1: Prodott(i) mediċinali mogħti(ja) flimkien rakkomandat(i) u t-tul ta' żmien tat terapija kkombinata b'Sovaldi Popolazzjoni ta' pazjenti*
English: Mean ratio (90% confidence interval) for AUC, Cmax, Cmin a,b
Maltese: Cmax, Cmin a,b