FrancophonIA/ELRC3.0 huggingface dataset:
English: Ledipasvir activity (EC50, nM)
Maltese: Attività ta' ledipasvir (EC50, nM)
English: Adults-Genotype 2, 3, 4, 5 and 6
Maltese: Adulti-Ġenotip 2, 3, 4, 5 u 6
English: Metavir score F0-F3 95% (94/99) CPT Ac
Maltese: Punteġġ ta' metavir F0-F3 95% (94/99) CPT Aċ
English: Summary of the safety profile in adults
Maltese: Sommarju tal-profil tas-sigurtà fl-adulti
English: ANTIARRHYTHMICS Amiodarone
Maltese: ANTIARRITTMIĊI Amiodarone
English: 1200 mg/day
Maltese: 1200 mg/jum
English: Study 1468 (LEPTON)
Maltese: Studju 1468 (LEPTON) Studju 1119
English: h Bioequivalence/Equivalence boundary 80-125%.
Maltese: Bijoekwivalenza/Limitu tal-ekwivalenza 80-125%
English: Stable replicons
Maltese: Replikons stabbli
English: c CPT = Child-Pugh-Turcotte, FCH = Fibrosing cholestatic hepatitis.
Maltese: ċ. CPT = Child-Pugh-Turcotte, FCH = Epatite kolestatika b'fibrożi.
English: Adults-Genotype 1
Maltese: Adulti-Ġenotip 1
English: American
Maltese: Amerikana
English: Genotype 6e
Maltese: Ġenotip 6e
English: Sofosbuvir activity (EC50, nM)
Maltese: Attività ta' sofosbuvir (EC50, nM)
English: NARCOTIC ANALGESICS Methadone
Maltese: ANALĠESIĊI NARKOTIĊI Methadone
English: • antacids (such as aluminium/magnesium hydroxide or calcium carbonate).
Maltese: • antaċidi (bħal aluminium/magnesium hydroxide jew calcium carbonate).
English: In vitro, no detectable metabolism of ledipasvir was observed by human CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6 and CYP3A4.
Maltese: In vitro, ebda metaboliżmu li jista' jiġi osservat ta' ledipasvir ma ġie osservat minn CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6 u CYP3A4 umani.
English: Ribavirin was discontinued in 15% of the patients.
Maltese: Ribavirin twaqqaf fi 15% tal-pazjenti.
English: Genotype 1b 0.004 Genotype 2a
Maltese: Ġenotip 1b 0.004 Ġenotip 2a
English: Baseline HCV RNAa HCV RNA < 6 million IU/mL HCV RNA ≥ 6 million IU/mL
Maltese: HCV RNA < 6 miljun IU/mL HCV RNA ≥ 6 miljun IU/mL
English: • proton pump inhibitors (such as omeprazole, lansoprazole, rabeprazole, pantoprazole and esomeprazole).
Maltese: • inibituri tal-pompa tal-protoni (bħal omeprazole, lansoprazole, rabeprazole, pantoprazole u esomeprazole).
English: (Induction of P-gp)
Maltese: (Induzzjoni ta' P-gp)
English: In clinical studies - Adults-Genotype 2, 3, 4, 5 and 6
Maltese: Fi studji kliniċi - Adulti-Ġenotip 2, 3, 4, 5 u 6
English: CPT A = CPT score 5-6 (compensated), CPT B = CPT score 7-9 (decompensated), CPT C = CPT score 10-12 (decompensated).
Maltese: CPT A = punteġġ CPT 5-6 (kumpensat), CPT B = punteġġ CPT 7-9 (mhux kumpensat), CPT C = punteġġ CPT 10-12 (mhux kumpensat).
English: IL28CC genotype
Maltese: Ġenotip IL28CC
English: TOTAL (n = 865)
Maltese: (n = 865)
English: HMG-CoA REDUCTASE INHIBITORS Rosuvastating
Maltese: INIBITURI TA' HMG-CoA REDUCTASE Rosuvastating
English: Antacids e.g. Aluminium or magnesium hydroxide; calcium carbonate
Maltese: Aluminium jew magnesium hydroxide; calcium carbonate
English: Lopinavir boosted with ritonavir + emtricitabine/ tenofovir disoproxil fumarate
Maltese: Lopinavir imsaħħaħ b'ritonavir + emtricitabine/ tenofovir disoproxil fumarate
English: In clinical studies - Adults-Genotype 1
Maltese: Fi studji kliniċi - Adulti-Ġenotip 1
English: • H2-receptor antagonists (such as famotidine, cimetidine, nizatidine or ranitidine).
Maltese: • antagonisit tar-riċetturi H2 (bħal famotidine, cimetidine, nizatidine jew ranitidine).
English: HCV replicons with reduced susceptibility to sofosbuvir have been selected in cell culture for multiple genotypes including 1b, 2a, 2b, 3a, 4a, 5a and 6a.
Maltese: HCV replikons b'suxxettibilità mnaqqsa għal sofosbuvir intgħażlu fil-koltura taċ-ċelluli għal ġenotipi multipli li jinkludu 1b, 2a, 2b, 3a, 4a, 5a u 6a.
English: • tipranavir (used to treat HIV infection).
Maltese: • tipranavir (użat biex jittratta infezzjoni tal-HIV).
English: Ledipasvir is > 99.8% bound to human plasma proteins.
Maltese: Ledipasvir huwa > 99.8% marbut ma' proteini tal-plażma tal-bniedem.
English: Severe RI (eGFR <30 mL/min/1.73 m2)
Maltese: RI Sever (eGFR <30 mL/ min/ 1.73m2)
English: Overall
Maltese: Globalment
English: The most common variants were Q30R, Y93H and L31M.
Maltese: L-aktar varjanti komuni kienu Q30R, Y93H u L31M.
English: Child-Pugh-Turcotte (CPT) Class B cirrhosis pre-transplant
Maltese: Ċirrożi Child-Pugh-Turcotte (CPT) Klassi B qabel it-trapjant
English: The tablet is 19 mm long and 10 mm wide.
Maltese: Il-pillola hija twila 19 mm u wiesgħa 10 mm.
English: Each film-coated tablet contains 156.8 mg of lactose (as monohydrate) and 261 micrograms of sunset yellow FCF aluminium lake.
Maltese: Kull pillola miksija b'rita fiha 156.8 mg ta' lactose (bħala monohydrate) u 261 mikrogramma ta' sunset yellow FCF aluminium lake.
English: ↑ Rosuvastatin (Inhibition of drug transporters OATP and BCRP)
Maltese: ↑ Rosuvastatin (Inibizzjoni ta' trasportaturi tal-mediċina OATP u BCRP)
English: IL28 genotype
Maltese: Ġenotip IL28
English: TOTAL (n = 647)
Maltese: (n = 647)
English: Sofosbuvir and GS-331007 are not inhibitors of drug transporters P-gp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3, OCT1 and GS-331007 is not an inhibitor of OAT1, OCT2 and MATE1.
Maltese: Sofosbuvir u GS-331007 mhumiex inibituri tat-trasportaturi tal-mediċina P-gp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3, OCT1 u GS-331007 mhuwiex inibitur ta' OAT1, OCT2 u MATE1.
English: The metabolic activation pathway involves sequential hydrolysis of the carboxyl ester moiety catalysed by human cathepsin A or carboxylesterase 1 and phosphoramidate cleavage by histidine triad nucleotide-binding protein 1 followed by phosphorylation by the pyrimidine nucleotide biosynthesis pathway.
Maltese: Il-passaġġ ta' attivazzjoni metabolika jinvolvi idroliżi sekwenzjali tal-carboxyl ester moiety katalizzata minn cathepsin umana A jew carboxylesterase 1 u phosphoramidate cleavage minn histidine triad nucleotide-binding protein 1 segwita minn fosforilazzjoni mill-passaġġ tal-bijosintesi ta' pyrimidine nucleotide.
English: Sofosbuvir is extensively metabolised in the liver to form the pharmacologically active nucleoside analogue triphosphate GS-461203.
Maltese: Sofosbuvir jiġi metabolizzat b'mod estensiv fil-fwied biex jifforma n-nucleoside analog farmakoloġikament attiv triphosphate GS-461203.
English: Ribavirin dose*
Maltese: Doża ta' ribavirin*
English: Ribavirin Dose* 15 mg/kg/day 600 mg/day 800 mg/day 1000 mg/day
Maltese: 15-il mg/kg/jum 600 mg/jum 800 mg/jum 1000 mg/jum
English: GS-461203 (the active metabolite of sofosbuvir) is neither an inhibitor of human DNA and RNA polymerases nor an inhibitor of mitochondrial RNA polymerase.
Maltese: GS-461203 (il-metabolit attiv ta' sofosbuvir) la hu inibitur tad-DNA umana u RNA polymerases, u lanqas mhu inibitur ta' RNA polymerase mitokondrijali.
English: Medicinal products that are strong P-glycoprotein (P-gp) inducers in the intestine (carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin and St. John's wort).
Maltese: Prodotti mediċinali li huma indutturi qawwija ta' P-glikoproteina (P-gp) fl-imsaren (carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin u St.
English: Site-directed mutagenesis of the S282T substitution in replicons of 8 genotypes conferred 2- to 18-fold reduced susceptibility to sofosbuvir and reduced the viral replication capacity by 89% to 99% compared to the corresponding wild-type.
Maltese: Mutaġenesi diretta mis-sit tas-sostituzzjoni S282T f'replikons ta' 8 ġenotipi, irriżultat f'suxxettibilità mnaqqsa ta' minn 2 sa 18-il darba għal sofosbuvir u naqqset il-kapaċità tar-replikazzjoni virali b'89% sa 99% meta mqabbla mal-wild-type korrispondenti.
English: b Non-missing FibroTest results are mapped to Metavir scores according to: 0-0.31 = F0-F1; 0.32-0.58 = F2; 0.59-1.00 = F3-F4.
Maltese: Ir-riżultati tat-Test Fibro mhux neqsin ġew immappjati għal punteġġi ta' Metavir skont: 0-0.31 = F0-F1; 0.32-0.58 = F2; 0.59-1.00 = F3-F4.
English: Age (years): median (range)
Maltese: Età (snin): medjan (medda)
English: Sofosbuvir and GS-331007 are not inhibitors or inducers of CYP or uridine diphosphate glucuronosyltransferase (UGT) 1A1 enzymes.
Maltese: Sofosbuvir u GS-331007 mhumiex inibituri jew indutturi ta' enzimi CYP jew uridine diphosphate glucuronosyltransferase (UGT) 1A1.
English: (Increase in gastric pH)
Maltese: (Żieda fil-pH gastriku)
English: HCV/HBV (hepatitis B virus) co-infection
Maltese: Koinfezzjoni b'HCV/HBV (virus tal-epatite B)
English: TOTAL (n = 440)
Maltese: (n = 440)
English: HCV/HIV co-infected adults - ERADICATE
Maltese: Adulti ko-infettati b'HCV/HIV - ERADICATE
English: The most common variant was Y93H.
Maltese: L-aktar varjant komuni kien Y93H.
English: d Metavir score = 4 or Ishak score ≥ 5 by liver biopsy, or FibroTest score of > 0.75 and (APRI) of > 2.
Maltese: d. Punteġġ Metavir = 4 jew punteġġ Ishak > 5 skont il-bijopsija tal-fwied, jew punteġġ ta' FibroTest > 0.75 u (APRI) ta' > 2.
English: Tabulated list of adverse events
Maltese: Lista ta' avvenimenti avversi miġbura f'tabella
English: Genotype 4d 0.60 Genotype 5a
Maltese: Ġenotip 4d 0.60
English: Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) or very rare (< 1/10,000).
Maltese: Ilfrekwenzi huma definiti kif ġej: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000) jew rari ħafna (< 1/10,000).
English: The SVR rates for the 8, 12, and 24 week ledipasvir/sofosbuvir treatment groups were 93% (42/45), 100% (31/31), and 79% (15/19), respectively.
Maltese: Ir-rati ta' SVR għall-gruppi ta' trattament b'ledipasvir/sofosbuvir għal 8, 12, u 24 ġimgħa kienu ta' 93% (42/45), 100% (31/31), u 79% (15/19), rispettivament.
English: 84 (3 bottles of 28) film-coated tablets.
Maltese: 84 (3 fliexken ta' 28) pillola miksija b'rita.
English: Post-baseline NS5A and NS5B deep sequencing data (assay cut off of 1%) were available for 37/37 and 36/37 patients, respectively.
Maltese: Data ta' sekwenzjar profond NS5A u NS5B ta' wara l-linja bażi (cut off tal-assaġġ ta' 1%) kienet disponibbli għal 37/37 u 36/37 pazjent, rispettivament.
English: NS5A RAVs were seen at relapse in 5/5 patients (for genotype 1a: Q30R/H + L31M/V [n = 1] and Q30R [n = 1]; for genotype 1b: Y93H [n = 3]).
Maltese: NS5A RAVs ġew osservati firrikaduta f'5/5 tal-pazjenti (għal ġenotip 1a: Q30R/H + L31M/V [n = 1] u Q30R [n = 1]; għal ġenotip 1b: Y93H [n = 3]).
English: Neither ledipasvir nor sofosbuvir are substrates for hepatic uptake transporters, organic cation transporter (OCT) 1, organic anion-transporting polypeptide (OATP) 1B1 or OATP1B3.
Maltese: La ledipasvir u lanqas sofosbuvir ma huma sottostrati għal trasportaturi ta' teħid epatiku, trasportatur ta' cations organiku (OCT) 1, anion-transporting polypeptide organiku (OATP) 1B1 jew OATP1B3.
English: ANTICONVULSANTS Phenobarbital Phenytoin
Maltese: MEDIĊINI ANTIKONVULŻIVI Phenytoin
English: NS5B RAVs: The NS5B substitution S282T emerged in the HCV of 1/17 genotype 3-failures, and in the HCV of 1/3, 1/1 and 1/1 of genotype 4-, 5- and 6-failures, respectively.
Maltese: Is-sostituzzjoni NS5B S282T ħarġet f'HCV ta' 1/17 tal-fallimenti ta' ġenotip 3, u flHCV ta' 1/3, 1/1 u 1/1 tal-falliment ta' ġenotip 4, 5 u 6, rispettivament.
English: • rifapentine (antibiotic used to treat infections, including tuberculosis);
Maltese: • rifapentine (antibijotiku użat għat-trattament ta' infezzjonijiet, li jinkludu t-tuberkulożi);
English: SVR12 was achieved in 18/18 patients.
Maltese: L-SVR12 inkiseb fi 18/18-il pazjent.
English: Steady-state Cmax for ledipasvir, sofosbuvir and GS-331007 were 323, 618 and 707 ng/mL, respectively.
Maltese: Is-Cmax fl-istat fiss għal ledipasvir, sofosbuvir u GS-331007 kienet 323, 618 u 707 ng/mL, rispettivament.
English: The pharmacokinetics of ledipasvir, sofosbuvir, and GS-331007 have not been established in paediatric patients aged < 12 years (see section 4.2).
Maltese: Il-farmakokinetika ta' ledipasvir, sofosbuvir, u GS-331007 ma ġietx stabbilita f'pazjenti pedjatriċi b'età ta' < 12-il sena (ara sezzjoni 4.2).
English: The following pack sizes are available:
Maltese: Huma disponibbli d-daqsijiet tal-pakketti li ġejjin:
English: Date of first authorisation: 17 November 2014 Date of latest renewal: 01 August 2019
Maltese: Data tal-aħħar tiġdid: 01 ta' Awwissu 2019
English: HCV protease inhibitor + PEG-IFN+RBV
Maltese: Inibitur talprotease tal-HCV + PEG-IFN+RBV
English: EU/1/14/958/001 28 film-coated tablets EU/1/14/958/002 84 (3 bottles of 28) film-coated tablets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/14/958/001 28 pillola miksija b'rita EU/1/14/958/002 84 (3 fliexken ta' 28) pillola miksija b'rita
English: SEDATIVES/HYPNOTICS Midazolam (2.5 mg single dose)/ ledipasvir (90 mg single dose)
Maltese: SEDATTIVI/MEDIĊINI IPNOTIĊI Midazolam (2.5 mg doża waħda)/ ledipasvir (90 mg doża waħda)
English: For hepatitis C virus (HCV) genotype-specific activity see sections 4.4 and 5.1.
Maltese: Għall-attività speċifika tal-ġenotip tal-virus tal-epatite Ċ (HCV), ara sezzjonijiet 4.4 u 5.1.
English: NS: not studied.
Maltese: NS: ma ġietx studjata a.
English: Decreases in haemoglobin to < 10 g/dL and < 8.5 g/dL during treatment were experienced by 39% and 13% of patients treated with ledipasvir/sofosbuvir with ribavirin, respectively.
Maltese: Seħħ tnaqqis fl-emoglobina għal < 10 g/dL u < 8.5 g/dL matul il-kura minn 39% u 13% tal-pazjenti kkurati b'ledipasvir/sofosbuvir ma' ribavirin, rispettivament.
English: The active metabolite is not observed.
Maltese: Il-metabolit attiv mhuwiex osservat.
English: A total of 2 out of 100 patients (2%), both treatment- naïve, did not achieve SVR12 (due to loss to follow-up).
Maltese: Total ta' 2 minn 100 pazjent (2%), li t-tnejn qatt ma kienu ħadu trattament qabel, ma laħqux SVR12 (peress li ma baqgħux jiġu segwiti).
English: Based on the population pharmacokinetic analysis in HCV-infected patients, geometric mean steady-state AUC0-24 for ledipasvir (n = 2,113), sofosbuvir (n = 1,542), and GS-331007 (n = 2,113) were 7,290, 1,320 and 12,000 ng•h/mL, respectively.
Maltese: Ibbażat fuq analiżi farmakokinetika tal-popolazzjoni f'pazjenti infettati bl-HCV, il-medja ġeometrika tal-AUC0-24 fl-istat fiss għal ledipasvir (n = 2,113), sofosbuvir (n = 1,542), u GS-331007 (n = 2,113) kienet 7,290, 1,320 u 12,000 ng•h/mL, rispettivament.
English: HCV/HIV co-infected adults - ION-4
Maltese: Adulti koinfettati b'HCV/HIV - ION-4
English: Harvoni is indicated for the treatment of chronic hepatitis C (CHC) in adults and in adolescents aged 12 to < 18 years (see sections 4.2, 4.4 and 5.1).
Maltese: Harvoni huwa indikat għall-kura ta' epatite C kronika (CHC - chronic hepatitis C) fl-adulti u fladolexxenti ta' età minn 12 sa < 18-il sena (ara sezzjonijiet 4.2, 4.4 u 5.1).
English: Skin disorders Frequency Not known: Stevens-Johnson syndrome
Maltese: Is-sindrome ta' Stevens-Johnson
English: The pharmacokinetics of ledipasvir were studied with a single dose of 90 mg ledipasvir in HCV negative patients with severe renal impairment (eGFR < 30 mL/min by Cockcroft-Gault, median [range] CrCl 22 [17-29] mL/min).
Maltese: Il-farmakokinetika ta' ledipasvir ġew studjati b'doża waħda ta' 90 mg ledipasvir f'pazjenti negattivi għal HCV b'indeboliment tal-kliewi sever (eGFR < 30 mL/min minn Cockcroft-Gault, medjan [medda] CrCl 22 [17-29] mL/min).
English: Among patients with a baseline HCV RNA < 6 million IU/mL, the SVR was 97% (119/123) with 8-week treatment of ledipasvir/sofosbuvir and 96% (126/131) with 12-week treatment of ledipasvir/sofosbuvir.
Maltese: SVR kien 97% (119/123) b'kura ta' 8 ġimgħat ta' ledipasvir/sofosbuvir u 96% (126/131) b'kura ta'12-il ġimgħa ta' ledipasvir/sofosbuvir.
English: - Harvoni for 8 weeks may be considered in previously untreated genotype 1-infected patients (see section 5.1, ION-3 study).
Maltese: - Harvoni għal 8 ġimgħat jistgħu jiġu kkunsidrati f'pazjenti infettati ta' ġenotip 1 li ma rċivewx kura fil-passat (ara sezzjoni 5.1, studju ION-3).
English: At baseline, two patients had cirrhosis and the mean eGFR was 24.9 mL/min (range: 9.0-39.6).
Maltese: Fil-linja bażi, żewġ pazjenti kellhom ċirrożi u l-eGFR medja kienet ta' 24.9 mL/min (firxa: 9.0-39.6).
English: Relative to healthy subjects (n = 191), ledipasvir AUC0-24 and Cmax were 24% lower and 32% lower, respectively, in HCV-infected patients.
Maltese: Meta mqabbla ma' pazjenti b'saħħithom (n = 191), l-AUC0-24 u s-Cmax ta' ledipasvir kienu 24% aktar baxxi u 32% aktar baxxi, rispettivament, f'pazjenti infettati bl-HCV.
English: NS5A transient replicons Median (range)a
Maltese: Replikons NS5A temporanji Medjan (medda)a
English: The majority of patients (84%) had been infected through vertical transmission.
Maltese: Il-maġġoranza tal-pazjenti (84%) kienu ġew infettati permezz ta' trasmissjoni vertikali.
English: Harvoni + ribavirinA for 24 weeks (see sections 4.4 and 5.1).
Maltese: Harvoni + ribavirinA għal 24 ġimgħa (ara sezzjonijiet 4.4 u 5.1).
English: Orange, diamond-shaped, film-coated tablet of dimensions 19 mm x 10 mm, debossed with “GSI” on one side and “7985” on the other side.
Maltese: Pillola miksija b'rita, oranġjo, b'forma ta' djamant, b'daqs ta' 19 mm x 10 mm, imnaqqxa b'“GSI” fuq naħa waħda u “7985” fuq in-naħa l-oħra.
English: Norgestimate/ ethinyl estradiol (norgestimate 0.180 mg/ 0.215 mg/ 0.25 mg/ ethinyl estradiol 0.025 mg)/ sofosbuvir (400 mg once daily)d
Maltese: Norgestimate/ ethinyl estradiol (norgestimate 0.180 mg/ 0.215 mg/ 0.25 mg/ ethinyl estradiol 0.025 mg)/ sofosbuvir (400 mg darba kuljum) d
English: The efficacy of ledipasvir [LDV]/sofosbuvir [SOF] was evaluated in three open-label Phase 3 studies with data available for a total of 1,950 patients with genotype 1 CHC.
Maltese: L-effikaċja ta' ledipasvir [LDV]/sofosbuvir [SOF] ġiet evalwata fi tliet studji open-label ta' Fażi 3 b'data disponibbli għal total ta' 1,950 pazjent b'CHC ta' ġenotip 1.
English: A total of 80 patients (80%) were treatment-naïve, while 20 patients (20%) were treatment-experienced.
Maltese: Total ta' 80 pazjent (80%) qatt ma kienu ħadu trattament qabel, waqt li 20 pazjent (20%) kienu ħadu trattament qabel.
English: Following a single dose of 90 mg [14C]-ledipasvir, systemic exposure was almost exclusively due to the parent drug (> 98%).
Maltese: Wara doża waħda ta' 90 mg [14C]-ledipasvir, l-esponiment sistemiku kien kważi esklussivament dovut għall-mediċina ġenitur (> 98%).
English: The presence of 40% human serum had no effect on the anti-HCV activity of sofosbuvir but reduced the anti-HCV activity of ledipasvir by 12-fold against genotype 1a HCV replicons.
Maltese: Il-preżenza ta' 40% serum uman ma kellu l-ebda effett fuq l-attività kontra HCV ta' sofosbuvir iżda naqqset l-attività kontra HCV ta' ledipasvir bi 12-il darba kontra replikons tal-ġenotip 1a tal-HCV.
English: Severe bradycardia and heart block
Maltese: Bradikardija severa u mblokkar tal-qalb
English: A NS5B substitution E237G was detected in 3 patients (1 genotype 1b and 2 genotype 1a) in the Phase 3 studies (ION-3, ION-1 and ION-2) and 3 patients with genotype 1a infection in the SOLAR-1 and SOLAR-2 studies at the time of relapse.
Maltese: Sostituzzjoni E237G f'NS5B kienet osservata fi 3 pazjenti (1 b'ġenotip 1b u 2 b'ġenotip 1a) fl-istudji ta' Fażi 3 (ION-3, ION-1 u ION-2) u 3 pazjenti b'infezzjoni ta' ġenotip 1a fl-istudji SOLAR-1 u SOLAR-2 fil-ħin tar-rikaduta.
English: 1,000 mg per day for patients < 75 kg and 1,200 mg for those weighing ≥ 75 kg
Maltese: 1,000 mg kuljum għall-pazjenti ta' < 75 kg u 1,200 mg għal dawk li jiżnu ≥ 75 kg
English: How to take Harvoni
Maltese: Tiħux Harvoni
English: Cirrhosis was defined by biopsy, Fibroscan (> 12.5 kPa) or FibroTest > 0.75 and an AST:platelet ratio index (APRI) of > 2.
Maltese: Iċ-ċirrożi ġiet definita minn bijopsija, Fibroscan (> 12.5 kPa) jew FibroTest ta' > 0.75 u indiċi ta' proporzjon ta' AST:plejtlits (APRI) ta'
English: HERBAL SUPPLEMENTS St. John's wort
Maltese: John's wort
English: Harvoni 90 mg/400 mg film-coated tablets ledipasvir/sofosbuvir
Maltese: Harvoni 90 mg/400 mg pilloli miksija b'rita ledipasvir/sofosbuvir
English: Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analogue triphosphate (GS-461203), which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator.
Maltese: Sofosbuvir hu prodroga nucleotide li jgħaddi minn metaboliżmu intraċellulari biex jifforma l-uridine analog triphosphate (GS-461203) farmakoloġikament attiv (GS-461203), li jista' jiġi inkorporat ġo HCV RNA mill-NS5B polymerase u jaġixxi bħala terminatur tal-katina.
English: HCV-Infected Subjects
Maltese: Infettati bl-HCV
English: The 8-week treatment of ledipasvir/sofosbuvir without ribavirin was non-inferior to the 8-week treatment of ledipasvir/sofosbuvir with ribavirin (treatment difference 0.9%; 95% confidence interval: -3.9% to 5.7%) and the 12-week treatment of ledipasvir/sofosbuvir (treatment difference -2.3%; 97.5% confidence interval: -7.2% to 3.6%).
Maltese: Il-kura ta' 8 ġimgħat ta' ledipasvir/sofosbuvir mingħajr ribavirin kienet mhux inferjuri għall-kura ta' 8 ġimgħat ta' ledipasvir/sofosbuvir b'ribavirin (differenza fil-kura 0.9%; intervall ta' fiduċja ta' 95%: -3.9% sa 5.7%) u l-kura ta' 12-il ġimgħa ta' ledipasvir/sofosbuvir (differenza fil-kura -2.3%; 97.5% intervall ta' fiduċja: -7.2% sa 3.6%).
English: Clinically significant medicinal product interactions with ledipasvir/sofosbuvir mediated by CYP450s or UGT1A1 enzymes are not expected.
Maltese: Mhumiex mistennija interazzjonijiet talprodott mediċinali ma' ledipasvir/sofosbuvir li huma klinikament sinifikanti medjati minn enzimi CYP450 jew UGT1A1.
English: GS-331007 is not a substrate for renal transporters including organic anion transporter (OAT) 1 or OAT3, or OCT2.
Maltese: GS-331007 mhuwiex substrat għal trasportaturi renali li jinkludu trasportatur anion organiku (OAT) 1 jew OAT3 jew OCT2.
English: Relative to patients with normal hepatic function, the sofosbuvir AUC0-24 was 126% and 143% higher in moderate and severe hepatic impairment, while the GS-331007 AUC0-24 was 18% and 9% higher, respectively.
Maltese: Meta mqabbla ma' pazjenti b'funzjoni normali tal-fwied, l-AUC0-24 ta' sofosbuvir kienet 126% u 143% ogħla f'pazjenti b'indeboliment moderat u sever tal-fwied, filwaqt li l-AUC0-24 ta' GS-331007 kien 18% u 9% ogħla, rispettivament.
English: The pharmacokinetics of sofosbuvir were studied in HCV negative patients with mild (eGFR ≥ 50 and < 80 mL/min/1.73 m2), moderate (eGFR ≥ 30 and < 50 mL/min/1.73 m2), severe renal impairment (eGFR < 30 mL/min/1.73 m2) and patients with ESRD requiring haemodialysis following a single 400 mg dose of sofosbuvir,relative to patients with normal renal function (eGFR > 80 mL/min/1.73 m2).
Maltese: Il-farmakokinetika ta' sofosbuvir ġiet studjata f'pazjenti li kienu negattivi għal HCV, b'indeboliment tal-kliewi ħafif (eGFR ≥ 50 u < 80 mL/min/1.73m2), moderat (eGFR ≥ 30 u < 50 mL/min/1.73m2), u sever (eGFR < 30 mL/min/1.73 m2) u pazjenti b'ESRD li kienu jeħtieġu l-emodijaliżi wara doża waħda ta' 400 mg ta' sofosbuvir, meta mqabbla ma' pazjenti b'funzjoni normali tal-kliewi (eGFR > 80 mL/min/1.73 m2).
English: Reduce ribavirin dose to 600 mg/day if:
Maltese: Naqqas id-doża ta' ribavirin għal 600 mg/jum jekk:
English: Sofosbuvir is a pan-genotypic inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is essential for viral replication.
Maltese: Sofosbuvir hu inibitur panġenotipiku tal-HCV NS5B RNA-dependent RNA polymerase, li hu essenzjali għar-replikazzjoni virali.
English: At concentrations achieved in the clinic, ledipasvir is not an inhibitor of hepatic transporters including the OATP 1B1 or 1B3, BSEP, OCT1, OCT2, OAT1, OAT3, multidrug and toxic compound extrusion (MATE) 1 transporter, multidrug resistance protein (MRP) 2 or MRP4.
Maltese: F'konċentrazzjonijiet miksubin fil-klinika, ledipasvir mhuwiex inibitur ta' trasportaturi tal-fwied li jinkludu OATP 1B1 jew 1B3, BSEP, OCT1, OCT2, OAT1, OAT3, trasportatur ta' estrużjoni ta' mediċini differenti u ta' komposti tossiċi (MATE - multidrug and toxic compound extrusion) 1, ilproteina ta' reżistenza ta' mediċini differenti (MRP) 2 jew MRP4.
English: Expected:
Maltese: Mistennija: