FrancophonIA/ELRC3.0 huggingface dataset:
English: * - If a more normalized dose of ribavirin (by weight and renal function) cannot be reached for reasons of tolerability, 24 weeks of Harvoni + ribavirin should be considered in order to minimize the risk for relapse.
Maltese: * - Jekk doża aktar normalizzata ta' ribavirin (skont il-piż u l-funzjoni renali) ma tkunx tista' tintlaħaq minħabba raġunijiet ta' tollerabilità, għandhom jiġu kkunsidrati 24 ġimgħa ta' Harvoni + ribavirin sabiex jiġi minimizzat ir-riskju ta' rikaduta.
English: In HCV-infected patients with severe renal impairment treated with ledipasvir/sofosbuvir for 12 weeks (n = 18), the pharmacokinetics of ledipasvir, sofosbuvir, and GS-331007 were consistent with that observed in HCV negative patients with severe renal impairment.
Maltese: F'pazjenti infettati b'HCV b'indeboliment sever tal-kliewi ttrattati b'ledipasvir/sofosbuvir għal 12-il ġimgħa (n=18), il-farmakokinetika ta' ledipasvir, sofosbuvir, u GS-331007 kienet konsistenti ma' dik osservata f'pazjenti negattivi għal HCV b'indeboliment sever tal-kliewi.
English: It is given to treat chronic (long-term) hepatitis C virus infection in adults and adolescents 12 to less than 18 years of age.
Maltese: Jingħata biex jikkura infezzjoni kronika (għal żmien twil) bil-virus tal-epatite Ċ f'adulti u adolexxenti ta' età minn 12 sa inqas minn 18-il sena.
English: FibroTest-Determined Metavir scoreb F0-F1
Maltese: Punteġġ Metavir Stabbilit b'Test Fibrob
English: The assay had a lower limit of quantification (LLOQ) of 25 IU/mL.
Maltese: Lassaġġ kellu limitu iktar baxx ta' kwantifikazzjoni (LLOQ - lower limit of quantification) ta' 25
English: • amiodarone used to treat irregular heartbeats;
Maltese: • amiodarone, użat biex jikkura rata ta' taħbit tal-qalb irregolari;
English: Age (years): median (range) Male gender
Maltese: Età (snin): medjan (medda) Sess maskili
English: Body weight kg
Maltese: Piż tal-ġisem kg
English: Common side effects
Maltese: Rappurtar tal-effetti sekondarji
English: LDV/SOF 12 weeks (n = 335)
Maltese: LDV/SOF 12-il ġimgħa (n = 335)
English: Film-coating:
Maltese: Disturbi ġenerali:
English: In the SIRIUS study (see “Clinical efficacy and safety”, below) 5 patients with genotype 1 infection relapsed after treatment with ledipasvir/sofosbuvir with or without ribavirin.
Maltese: Fl-istudju SIRIUS (ara “Effikaċja klinika u sigurtà”, hawn taħt) 5 pazjenti b'infezzjoni ta' ġenotip 1, irkadew wara kura b'ledipasvir/sofosbuvir bi jew mingħajr ribavirin.
English: No dose adjustment of oral contraceptives is required.
Maltese: Mhux meħtieġ aġġustament fid-doża ta' kontraċettivi orali.
English: The EC50 values of ledipasvir and sofosbuvir against full-length or chimeric replicons encoding NS5A and NS5B sequences from clinical isolates are detailed in Table 7.
Maltese: Il-valuri ta' EC50 ta' ledipasvir u sofosbuvir kontra sekwenzi ta' replikons ta' tul sħiħ jew kimeriċi li jikkodifikaw NS5A u NS5B minn iżolati kliniċi huma murija fid-dettall f'Tabella 7.
English: Darunavir boosted with ritonavir (800 mg/ 100 mg once daily)/ sofosbuvir (400 mg once daily)
Maltese: Darunavir imsaħħaħ b'ritonavir (800 mg/ 100 mg darba kuljum)/ sofosbuvir (400 mg darba kuljum)
English: Rifampicin (600 mg once daily)/ sofosbuvir (400 mg single dose)d
Maltese: Rifampicin (600 mg darba kuljum)/ sofosbuvir (400 mg doża waħda)d
English: Clinical efficacy and safety in genotype 2, 3, 4, 5 and 6 (see also section 4.4) Ledipasvir/sofosbuvir has been evaluated for the treatment of non-genotype 1 infection in small Phase 2 studies, as summarised below.
Maltese: Effikaċja klinika u sigurtà fil-ġenotip 2, 3, 4, 5 u 6 (ara wkoll sezzjoni 4.4) Ledipasvir/sofosbuvir ġie evalwat għall-kura ta' infezzjoni mhux ta' ġenotip 1 fi studji żgħar ta' Fażi 2, kif qed jintwera fil-qosor hawn taħt.
English: Exposure to GS-331007 in these studies was up to 17 times (mouse) and 9 times (rat) higher than the clinical exposure at 400 mg sofosbuvir.
Maltese: L-esponiment għal GS-331007 f'dawn l-istudji kien sa 17-il darba (fil-ġrieden) u 9 darbiet (fil-firien) ogħla mill-esponiment kliniku f'doża ta' 400 mg ta' sofosbuvir.
English: No clinically relevant pharmacokinetic differences due to gender have been identified for sofosbuvir or GS-331007.
Maltese: L-ebda differenza farmakokinetika klinikament rilevanti minħabba s-sess ma ġiet identifikata għal sofosbuvir jew GS-331007.
English: Forty patients with genotype 4 CHC were enrolled in SOLAR-1 and SOLAR-2 studies, SVR12 were 92% (11/12) and 100% (10/10) in post-transplant patients without decompensated cirrhosis and 60% (6/10) and 75% (6/8) in patients with decompensated cirrhosis (pre- and post-liver transplantation) treated for 12 or 24 weeks, respectively.
Maltese: Erbgħin pazjent b'CHC ta' ġenotip 4 kienu rreġistrati fl-istudji SOLAR-1 u SOLARI-2, SVR 12 kienu 92% (11/12) u 100% (10/10) f'pazjenti wara t-trapjant mingħajr ċirrożi dikumpensata u 60% (6/10) u 75% (6/8) f'pazjenti b'ċirrożi dikumpensata (qabel u wara trapjant tal-fwied) irċevew kura għal 12 jew 24 ġimgħa, rispettivament.
English: The safety profile of ledipasvir/sofosbuvir with ribavirin for 12 or 24 weeks in adults with decompensated liver disease and/or those post-liver transplant was assessed in two open-label studies (SOLAR-1 and SOLAR-2).
Maltese: Il-profil tas-sigurtà ta' ledipasvir/sofosbuvir ma' ribavirin għal 12 jew 24 ġimgħa f'adulti b'mard dikumpensat tal-fwied u/jew dawk ta' wara t-trapjant tal-fwied, ġew evalwati f'żewġ studji open-label (SOLAR-1 u SOLAR-2).
English: Potential for other medicinal products to affect Harvoni Ledipasvir and sofosbuvir are substrates of drug transporter P-gp and BCRP while GS-331007 is not.
Maltese: Ledipasvir u sofosbuvir huma sottostrati ta' trasportatur tal-mediċina P-gp u BCRP filwaqt li GS-331007 mhuwiex.
English: After a single 90 mg dose of [14C]-ledipasvir in healthy subjects, the blood to plasma ratio of [14C]-radioactivity ranged between 0.51 and 0.66.
Maltese: Wara doża waħda ta' 90 mg ta' [14C]-ledipasvir f'individwi b'saħħithom, il-proporzjon tad-demm għall-plażma ta' [14C]-radjuattività jvarja bejn 0.51 u 0.66.
English: Harvoni is contraindicated with rifabutin (see section 4.3).
Maltese: Harvoni hu kontraindikat ma' rifabutin (ara sezzjoni 4.3).
English: Previously treated adults with cirrhosis - SIRIUS - Genotype 1
Maltese: Adulti li rċivew kura fil-passat b'ċirrożi - SIRIUS - Ġenotip 1
English: HCV-Negative Subjects
Maltese: Negattivi għal HCV
English: virus.
Maltese: KLINIKU
English: Ciclosporin ↔ Cmax 1.06 (0.94, 1.18)
Maltese: Ciclosporin ↔ Cmax 1.06 (0.94, 1.18) ↔ AUC 0.98 (0.85, 1.14)
English: Proton pump inhibitor doses comparable to omeprazole 20 mg can be administered simultaneously with Harvoni.
Maltese: Dożi ta' inibituri tal-pompa tal-protoni komparabbli ma' omeprazole 20 mg jistgħu jingħataw fl-istess ħin ma' Harvoni.
English: 12 weeks (n = 111)
Maltese: 12-il ġimgħa (n = 111)
English: Ledipasvir/sofosbuvir was administered for 12 weeks to 18 patients with genotype 1 CHC and severe renal impairment in an open-label study (Study 0154).
Maltese: Ledipasvir/sofosbuvir ingħata għal 12-il ġimgħa lil 18-il pazjent b'CHC ta' ġenotip 1 u indeboliment sever tal-kliewi fi studju open-label (Studju 0154).
English: As Harvoni contains ledipasvir and sofosbuvir, any interactions that have been identified with these active substances individually may occur with Harvoni.
Maltese: Minħabba li Harvoni fih ledipasvir u sofosbuvir, kwalunkwe interazzjoni li ġiet identifikata ma' dawn is-sustanzi attivi individwalment tista' sseħħ bi Harvoni.
English: Impact of DAA therapy on drugs metabolized by the liver
Maltese: L-impatt ta' terapija b'DAA fuq mediċini metabolizzati mill-fwied
English: Harvoni can be used in these patients with no dose adjustment when no other relevant treatment options are available (see section 4.4, 4.8, 5.1 and 5.2).
Maltese: Harvoni jista' jintuża f'dawn il-pazjenti mingħajr aġġustament fid-doża meta ma jkunx hemm disponibbli għażliet oħra ta' trattament rilevanti (ara sezzjoni 4.4, 4.8, 5.1 u 5.2).
English: Ledipasvir solubility decreases as pH increases.
Maltese: Is-solubilità ta' ledipasvir tonqos hekk kif il-pH jiżdied.
English: Baseline NS5A RAVs were overrepresented in patients who experienced relapse in the Phase 3 studies (see “Clinical efficacy and safety”).
Maltese: NS5A RAVs tal-linja bażi ġew irrappreżentanti żżejjed f'pazjenti li esperjenzaw rikaduta flistudji ta' Fażi 3 (ara “Effikaċja klinika u sigurtà”).
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 dialysis.
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 d-dijaliżi.
English: Carcinogenicity studies in mice and rats do not indicate any carcinogenicity potential of sofosbuvir administered at doses up to 600 mg/kg/day in mouse and 750 mg/kg/day in rat.
Maltese: Studji dwar ir-riskju ta' kanċer fil-ġrieden u l-firien ma jindikaw l-ebda riskju ta' kanċer ta' sofosbuvir mogħti f'dożi sa 600 mg/kg/jum fil-ġrieden u 750 mg/kg/jum fil-firien.
English: For genotype 2, 4, 5 and 6 infection, therapy consisted of ledipasvir/sofosbuvir without ribavirin, given for 12 weeks (Table 18).
Maltese: Għal infezzjoni ta' ġenotip 2, 4, 5 u 6, it-terapija kienet tikkonsisti f'ledipasvir/sofosbuvir mingħajr ribavirin, mogħti għal 12-il ġimgħa (Tabella 18).
English: Patients were stratified by HCV genotype (1a versus 1b) and prior treatment response (whether HCV RNA < LLOQ had been achieved).
Maltese: Il-pazjenti ġew stratifikati skont il-ġenotip ta' HCV (1a kontra 1b) u r-rispons għall-kura ta' qabel (jekk inkisibx HCV RNA <LLOQ).
English: Sofosbuvir ↑ Cmax 1.15 (0.88, 1.50)
Maltese: Sofosbuvir ↑ Cmax 1.15 (0.88, 1.50) ↔ AUC 1.11 (1.00, 1.24)
English: Study 4063 was an open-label three-arm clinical study that evaluated 8, 12, and 24 weeks of treatment with ledipasvir/sofosbuvir in a total of 95 patients with genotype 1 (72%), 2 (22%), 4 (2%), 5 (1%), or 6 (2%) CHC and ESRD requiring dialysis: 45 treatment-naïve genotype 1 HCV-infected patients without cirrhosis received ledipasvir/sofosbuvir for 8 weeks; 31 treatment-experienced genotype 1
Maltese: Studju 4063 kien studju kliniku open-label bi tliet gruppi li evalwa 8, 12, u 24 ġimgħa ta' trattament b'ledipasvir/sofosbuvir f'total ta' 95 pazjent b'CHC ta' ġenotip 1 (72%), 2 (22%), 4 (2%), 5 (1%), jew
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas totali ta' lactase jew għandhom problemi biex jassorbu l-glucose-galactose m'għandhomx jieħdu dan il-prodott mediċinali.
English: Patients with a CPT score > 12 were excluded.
Maltese: Pazjenti b'punteġġ CPT ta' >12 kienu esklużi.
English: Co-administration of Harvoni and HMG-CoA reductase inhibitors (statins) can significantly increase the concentration of the statin, which increases the risk of myopathy and rhabdomyolysis (see section 4.5).
Maltese: L-għoti flimkien ta' Harvoni u inibituri ta' HMG-CoA reductase (statins) jista' jżid b'mod sinifikanti l-konċentrazzjoni tal-istatin, li żżid ir-riskju ta' mijopatija u rabdomijolożi (ara sezzjoni 4.5).
English: Age (years): median (range) Male gender Race: Black/ African American White Genotype 1aa IL28CC genotype FibroTest-Determined Metavir scoreb F0-F1 F2 F3-F4 Not interpretable a Two patients in the LDV/SOF 12-week treatment arm, one patient in the LDV/SOF+RBV 12-week treatment arm, two patients in the LDV/SOF 24-week treatment arm, and two patients in the LDV/SOF+RBV 24-week treatment arm did not have a confirmed genotype 1 subtype.
Maltese: Żewġ pazjenti fil-fergħa ta' kura ta' 12-il ġimgħa ta' LDV/SOF, pazjent wieħed fil-fergħa ta' kura ta' 12-il ġimgħa ta' LDV/SOF+RBV, żewġ pazjenti fil-fergħa ta' kura ta' 24 ġimgħa ta' LDV/SOF, u żewġ pazjenti fil-fergħa ta' kura ta' 24 ġimgħa ta' LDV/SOF+RBV ma kellhomx subtip tal-ġenotip 1 konfermat.
English: Sofosbuvir ↓ Cmax 0.52 (0.43, 0.62)
Maltese: Sofosbuvir ↓ Cmax 0.52 (0.43, 0.62) ↓ AUC 0.52 (0.46, 0.59) Cmin (NA)
English: Sofosbuvir and GS-331007 AUC0-24 and Cmax were similar in healthy adult subjects and patients with HCV infection.
Maltese: L-AUC0-24 u s-Cmax ta' sofosbuvir u GS-331007 kienu simili f'individwi adulti b'saħħithom u f'pazjenti b'infezzjoni tal-HCV.
English: Animal studies do not indicate direct harmful effects with respect to reproductive toxicity.
Maltese: Studji f'annimali ma urewx effetti diretti tossiċi fuq is-sistema riproduttiva.
English: Change in MELD score: Among those who achieved SVR12 with 12 weeks treatment with ledipasvir/sofosbuvir + ribavirin, 57% (70/123) and 19% (23/123) had an improvement or no change in MELD score from baseline to post-treatment week 12, respectively; of the 32 patients whose MELD score was ≥ 15 at baseline, 59% (19/32) had a MELD score < 15 at post-treatment Week 12.
Maltese: Fost dawk li kisbu SVR12 bi 12-il ġimgħa ta' kura b'ledipasvir/sofosbuvir + ribavirin, 57% (70/123) u 19% (23/123) kellhom titjib jew l-ebda bidla fil-punteġġ MELD mil-linja bażi sa ġimgħa 12 wara l-kura, rispettivament; minn 32 pazjent li l-punteġġ MELD tagħhom kien ≥ 15 fil-linja bażi, 59% (19/32) kellhom punteġġ MELD < 15 f'Ġimgħa 12 wara l-kura.
English: Ledipasvir ↓ Cmax 0.89 (0.61, 1.30)
Maltese: Ledipasvir ↓ Cmax 0.89 (0.61, 1.30) ↓ AUC 0.96 (0.66, 1.39)
English: Population pharmacokinetics analysis in HCV-infected patients indicated that cirrhosis (including decompensated cirrhosis) had no clinically relevant effect on the exposure to ledipasvir.
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 ledipasvir.
English: Unchanged ledipasvir excreted in faeces accounted for a mean of 70% of the administered dose and the oxidative metabolite M19 accounted for 2.2% of the dose.
Maltese: Ledipasvir mhux mibdul eliminat mal-ippurgar ammonta għal medja ta' 70% tad-doża mogħtija u lmetabolit ossidattiv M19 ammonta għal 2.2% tad-doża.
English: Missed dose
Maltese: Doża rakkomandata
English: d Patients with missing cirrhosis status were excluded from this subgroup analysis.
Maltese: d. Pazjenti bi status taċ-ċirrożi nieqes ġew esklużi minn din l-analiżi tas-subgrupp.
English: For the combination of tenofovir/emtricitabine + darunavir/ritonavir, please see below.
Maltese: Għall-kombinazzjoni ta' tenofovir/emtricitabine + darunavir/ritonavir, jekk jogħġbok ara hawn taħt.
English: The pharmacokinetics of drugs that are metabolized by the liver (e.g. immunosuppressive agents such as calcineurin inhibitors) may be impacted by changes in liver function during DAA therapy, related to clearance of HCV virus.
Maltese: Il-farmakokinetika ta' mediċini li huma metabolizzati mill-fwied (eż. sustanzi immunosoppressivi bħal inibituri ta' calcineurin) tista' tiġi affettwata minn bidliet fil-funzjoni tal-fwied waqt terapija b'DAA, relatati mat-tneħħija tal-virus tal-HCV.
English: Sofosbuvir ↓ Cmax 0.97 (0.65, 1.43)
Maltese: Sofosbuvir ↓ Cmax 0.97 (0.65, 1.43) ↑ AUC 1.13 (0.81, 1.57)
English: GS-331007 ↑ Cmax 1.33 (1.22, 1.44)
Maltese: GS-331007 ↑ Cmax 1.33 (1.22, 1.44) ↑ AUC 1.44 (1.41, 1.48) ↑ Cmin 1.53 (1.47, 1.59)
English: LDV/SOF 8 weeks (n = 215)
Maltese: LDV/SOF 8 ġimgħat (n = 215)
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 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: Cases of severe bradycardia and heart block have been observed when Harvoni is used with amiodarone and/or other drugs that lower heart rate (see sections 4.4 and 4.5).
Maltese: Każijiet ta' bradikardija severa u mblokkar tal-qalb ġew osservati meta Harvoni jintuża ma' amiodarone u/jew mediċini oħrajn li jbaxxu r-rata ta' taħbit tal-qalb (ara s-sezzjonijiet 4.4 u 4.5).
English: ↔ Dolutegravir ↔ Ledipasvir ↔ Sofosbuvir
Maltese: ↔ Dolutegravir ↔ Ledipasvir ↔ Sofosbuvir ↔ GS-331007
English: Adolescents: for ribavirin dosing recommendations see table 3 below.
Maltese: Adolexxenti: għal rakkomandazzjonijiet dwar id-dożaġġ ta' ribavirin ara t-tabella 3 hawn taħt.
English: The potential risks and benefits associated with co-administration of Harvoni with the fixed-dose combination tablet containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or tenofovir disoproxil fumarate given in conjunction with a boosted HIV protease inhibitor (e.g. atazanavir or darunavir) should be considered, particularly in patients at increased risk of renal dysfunction.
Maltese: Ir-riskji u l-benefiċċji potenzjali assoċjati mal-għoti flimkien ta' Harvoni mal-pillola kombinata ta' doża fissa li fiha elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate jew tenofovir disoproxil fumarate mogħtija fl-istess ħin ma' inibitur tal-protease tal-HIV imsaħħaħ (eż. atazanavir jew darunavir) għandhom jiġu kkunsidrati, b'mod partikolari f'pazjenti b'riskju miżjud ta' disfunzjoni renali.
English: • swelling of the face, lips, tongue or throat (angioedema).
Maltese: • nefħa tal-wiċċ, xufftejn, ilsien jew gerżuma (anġjoedema).
English: GS-331007 ↔ Cmax 1.09 (0.99, 1.19)
Maltese: GS-331007 ↔ Cmax 1.09 (0.99, 1.19) ↔ AUC 1.02 (0.97, 1.08)
English: The exposures to GS-331007 and ledipasvir were not altered in the presence of either meal type.
Maltese: L-esponimenti għal GS-331007 u ledipasvir ma bidilx fil-preżenza ta' ikla ta' tip jew ieħor.
English: Other effects that may be seen during treatment with sofosbuvir:
Maltese: Effetti oħra li jistgħu jiġu osservati waqt it-trattament b'sofosbuvir:
English: When ledipasvir/sofosbuvir was studied with ribavirin, the most frequent adverse drug reactions to ledipasvir/sofosbuvir + ribavirin combination therapy were consistent with the known safety profile of ribavirin, without increasing the frequency or severity of the expected adverse drug reactions.
Maltese: Meta ledipasvir/sofosbuvir ġie studjat b'ribavirin, l-aktar reazzjonijiet avversi għall-mediċina frekwenti għall-kura ta' kombinazzjoni ta' ledipasvir/sofosbuvir + ribavirin kienu konsistenti mal-profil tas-sigurtà magħruf ta' ribavirin, mingħajr ma żdiedet il-frekwenza jew isseverità tar-reazzjonijiet avversi għall-mediċina mistennija.
English: • outer cartons containing 1 bottle of 28 film-coated tablets
Maltese: • kartun ta' barra li fihom 1 flixkun ta' 28 pillola miksija b'rita
English: Tacrolimus ↓ Cmax 0.73 (0.59, 0.90)
Maltese: Tacrolimus ↓ Cmax 0.73 (0.59, 0.90) ↑ AUC 1.09 (0.84, 1.40)
English: ↔ GS-331007
Maltese: ↔ Sofosbuvir ↔ GS-331007
English: Exposure to sofosbuvir in rodent studies could not be detected likely due to high esterase activity; however, exposure to the major metabolite GS-331007 at doses which cause adverse effects was 16 times (rat) and 71 times (dog) higher than the clinical exposure at 400 mg sofosbuvir.
Maltese: GS-331007 f'dożi li jikkawżaw effetti avversi kien 16-il darba (fil-firien) u 71 darba (filklieb) ogħla mill-esponiment kliniku f'doża ta' 400 mg ta' sofosbuvir.
English: Harvoni (without ribavirin) for 24 weeks.
Maltese: Harvoni (mingħajr ribavirin) għal 24 ġimgħa.
English: The proportion of such baseline NS5A RAVs seen with deep sequencing varied from very low (cut off for assay = 1%) to high (main part of the plasma population).
Maltese: Ilproporzjon ta' NS5A RAVs tal-linja bażi bħal dawn muri b'sekwenzjar profond varja minn baxx ħafna (cut off tal-assaġġ = 1%) għal għoli (parti ewlenija tal-popolazzjoni tal-plasma).
English: The film-coated tablets are orange, diamond-shaped tablets debossed with “GSI” on one side and “7985” on the other side.
Maltese: Il-pilloli miksija b'rita huma oranġjo, b'forma ta' djamant, imnaqqxa b'“GSI” fuq naħa waħda u “7985” fuq in-naħa l-oħra.
English: Of the 155 patients enrolled, 1 patient discontinued treatment whilst on placebo.
Maltese: Mill-155 pazjent irreġistrati, pazjent wieħed ma kompliex il-kura waqt li kien fuq plaċebo.
English: Table 14: Response rates in study ION-2 LDV/SOF
Maltese: Rati ta' rispons fl-istudju ION-2 LDV/SOF
English: Harvoni contains sunset yellow FCF aluminium lake (E110) which can cause allergic reactions
Maltese: Harvoni fih sunset yellow FCF aluminium lake (E110) li jista' jikkawża reazzjonijiet allerġiċi
English: Genotype-specific activity
Maltese: Attività speċifika tal-ġenotip
English: Following a single 400 mg oral dose of [14C]-sofosbuvir, mean total recovery of the dose was greater than 92%, consisting of approximately 80%, 14%, and 2.5% recovered in urine, faeces, and expired air, respectively.
Maltese: Wara doża orali waħda ta' 400 mg ta' [14C]-sofosbuvir, il-medja tal-irkupru totali tad-doża kienet iktar minn 92%, u kienet tikkonsisti minn madwar 80%, 14%, u 2.5% irkuprata fl-awrina, fl-ippurgar u flarja li tintrema 'l barra man-nifs, rispettivament.
English: Famotidine dosed simultaneously with Harvonid
Maltese: Famotidine iddożat flistess ħin ma' Harvonid
English: The median terminal half-life of ledipasvir in healthy volunteers following administration of ledipasvir/sofosbuvir in the fasted state was 47 hours.
Maltese: Il-medjan tal-half-life terminali ta' ledipasvir f'voluntiera b'saħħithom wara l-għoti ta' ledipasvir/sofosbuvir fl-istat sajjem kien ta' 47 siegħa.
English: Close monitoring is recommended if this medicinal product is administered with Harvoni (see sections 4.4 and 4.8).
Maltese: Huwa rrakkomandat monitoraġġ mill-qrib jekk dan il-prodott mediċinali jingħata ma' Harvoni (ara s-sezzjonijiet 4.4 u 4.8).
English: Use with certain HIV antiretroviral regimens
Maltese: L-użu ma' ċerti korsijiet antiretrovirali tal-HIV
English: ↑ Cmin 1.39 (1.29, 1.51)
Maltese: Ledipasvir ↑ Cmax 1.45 (1.34, 1.56) ↑ AUC 1.39 (1.28, 1.49) ↑ Cmin 1.39 (1.29, 1.51)
English: ↔ Cmin 0.94 (0.77, 1.14) S-methadone ↔ Cmax 0.95 (0.79, 1.13)
Maltese: S-methadone ↔ Cmax 0.95 (0.79, 1.13) ↔ AUC 0.95 (0.77, 1.17) ↔ Cmin 0.95 (0.74, 1.22)
English: Yesd
Maltese: St.
English: The physician in charge of the diabetic care of the patient should be informed when direct-acting antiviral therapy is initiated.
Maltese: It-tabib responsabbli għall-kura dijabetika tal-pazjent għandu jiġi infurmat meta tinbeda terapija antivirali li taġixxi b'mod dirett.
English: LDV/SOF 12 weeks (n = 216)
Maltese: LDV/SOF 12-il ġimgħa (n = 216)
English: Raltegravir (400 mg twice daily)/ sofosbuvir (400 mg once daily)d
Maltese: Raltegravir (400 mg darbtejn kuljum)/ sofosbuvir (400 mg darba kuljum)d
English: Table 9: Response rates in study ION-3 LDV/SOF
Maltese: Rati ta' rispons fl-istudju ION-3 LDV/SOF
English: 1.6-fold↑ 2.1-fold↑ 2.7-fold↑ 1.3-fold↑ 1.6-fold↑ ~2-fold↑ 1.9-fold↑ GS-331007 1.6-fold↑ 1.9-fold↑ 5.5-fold↑ ≥10-fold↑ ≥20-fold↑ ~6-fold↑ 23-fold↑ Ledipasvir
Maltese: GS-331007 1.6 darbiet↑ 1.9 darbiet↑ 5.5 darbiet↑ ≥10 darbiet↑
English: Concerning recommended regimens with different HCV genotypes, see section 4.2.
Maltese: Dwar korsijiet rakkomandati b'ġenotipi tal-HCV differenti, ara sezzjoni 4.2.
English: Concerning genotype-specific virological and clinical activity, see section 5.1.
Maltese: Dwar attività viroloġika u klinika speċifika għall-ġenotip, ara sezzjoni 5
English: Similarly, there are presently no data to support the effectiveness of NS3/4A protease inhibitors in patients who previously failed prior therapy that included an NS3/4A protease inhibitor.
Maltese: Bl-istess mod, bħalissa m'hemmx data li tappoġġja l-effettività ta' inibituri tal-protease NS3/4A f'pazjenti li fil-passat ma rnexxewx b'terapija li kienet tinkludi inibitur tal-protease NS3/4A.
English: GS-331007 ↔ Cmax 0.97 (0.83, 1.14)
Maltese: GS-331007 ↔ Cmax 0.97 (0.83, 1.14) ↔ AUC 1.00 (0.87, 1.13)