FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP retained his concerns regarding: efficacy (therapeutic indication and the optimal daily dose), safety (drug interactions), kinetic properties, and extent of use of tolperisone.
Maltese: Is-CHMP żamm it-tħassib tiegħu fir-rigward ta': l-effikaċja (indikazzjoni terapewtika u doża ottimali ta' kuljum), is-sigurtà (interazzjonijiet tal-mediċina), karatteristiċi kinetiċi, u l-firxa tal-użu ta' tolperisone.
English: The article has scientific merit and seems to support the efficacy of tolperisone in decreasing of spasticity of the skeletal muscles due to post-cerebral stroke.
Maltese: L-artikolu kellu merti xjentifiċi u jidher li jappoġġja l-effikaċja ta' tolperisone fit-tnaqqis tal-ispastiċità tal-muskoli skeletali dovut għal puplesija post-ċerebrali.
English: Considering the number of tolperisone formulations on the market, the CHMP asked the MAH to elaborate on the difference in the bioavailability of tolperisone between the various manufacturing procedures.
Maltese: Meta wieħed jikkunsidra n-numru ta' formulazzjonijiet ta' tolperisone fis-suq, is-CHMP talab lill-MAH biex jelabora fuq id-differenza fil-bijodisponibbiltà ta' tolperisone bejn il-proċeduri varji tal-manifattura.
English: The MAH proposed a 3-fold higher dose than in the approved German PI for the innovator.
Maltese: Il-MAH ippropona doża tliet darbiet ogħla minn dik tal-PI Ġermaniża approvata għall-innovatur.
English: In the response document to CHMP list of questions, the MAH did not pursuit of presenting full text of scientific articles to be evaluated.
Maltese: Fid-dokument ta' tweġiba għal-lista ta' mistoqsijiet tas-CHMP, il-MAH ma fittixx li jippreżenta test sħiħ tal-artikli xjentifiċi li jeħtieġu jiġu evalwati.
English: The Marketing Application of Myderison had been submitted under the WEU (well established use) legal basis.
Maltese: L-Applikazzjoni għat-Tqegħid fis-Suq ta' Myderison ġiet ippreżentata skont il-bażi legali tal-WEU (użu stabbilit sew).
English: Oral use blister (PVC/PCTFE/PVC/Al)
Maltese: Użu orali folja (blister) (PVC/PCTFE/PVC/Al)
English: 123 mg Capsule, hard
Maltese: 123 mg Kapsula, iebsa
English: MA (EU) number Invented name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size EU/1/15/1082/001 Galafold
Maltese: UE/1/15/1082/001 Galafold
English: EU/1/13/894/001 EU/1/13/894/002
Maltese: EU/1/13/894/002
English: a. These data are preliminary.
Maltese: Din id-dejta hi preliminari.
English: Intolerant
Maltese: Intolleranti
English: In clinical studies - Adults
Maltese: Fi studji kliniċi - Adulti
English: SVR12 rate % (n/N)
Maltese: Rata ta' % ta' SVR12 (n/N)
English: Film-coating: Polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, yellow iron oxide.
Maltese: Polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, yellow iron oxide.
English: • The active substance is sofosbuvir.
Maltese: • Is-sustanza attiva hi sofosbuvir.
English: ORAL CONTRACEPTIVES Norgestimate/ethinyl estradiol
Maltese: Norgestimate/ethinyl estradiol
English: Overall SVR12
Maltese: SVR12 globali
English: Tenofovir disoproxilf (245 mg once daily)d
Maltese: Tenofovir disoproxilf (245 mg darba kuljum)d
English: The predominant (>90%) metabolite, GS-331007, is inactive.
Maltese: Il-metabolit predominanti (> 90%), GS-331007, hu inattiv.
English: Common anaemia
Maltese: Komuni anemija
English: Expected: ↓ Sofosbuvir ↔ GS-331007
Maltese: ↓ Sofosbuvir ↔ GS-331007
English: Preliminary SVR12 data are available for 210 patients.
Maltese: Dejta preliminari dwar SVR12 hi disponibbli għal 210 pazjenti.
English: • Rifapentine (a medicine used to treat infections, including tuberculosis);
Maltese: • Rifapentine (mediċina użata biex tittratta infezzjonijiet, inkluża t-tuberkulożi).
English: SVR12 was achieved in 100 % (18/18) of patients treated with ledipasvir/sofosbuvir.
Maltese: SVR12 inkiseb f'100% (18/18) tal-pazjenti ttrattati b'ledipasvir/sofosbuvir.
English: Genotype 4, 5 or 6 Cirrhosis
Maltese: Ġenotip 4, 5 jew 6 Ċirrożi
English: Tacrolimuse (5 mg single dose)
Maltese: Tacrolimuse (Doża ważda ta' 5 mg)
English: SVR12 to SVR24 concordance
Maltese: Konkordanza SVR12 sa SVR24
English: Treatment-experienced (LONESTAR-2b)
Maltese: Irċivew kura (LONESTAR-2b)
English: Genotype 2 (n = 109)
Maltese: Ġenotip 2 (n = 109)
English: SVR12 rates were similarly high in patients with baseline IL28B C/C allele [94/95 (99%)] and non-C/C (C/T or T/T) allele [202/232 (87%)].
Maltese: Ir-rati ta' SVR12 kienu għoljin b'mod simili f'pazjenti b'IL28B C/C allele [94/95 (99%)] fil-linja bażi u non-C/C (C/T jew T/T) allele [202/232 (87%)].
English: Rilpivirinef (25 mg once daily)
Maltese: Rilpivirinef (25 mg darba kuljum)
English: - Keep this leaflet.
Maltese: Popolazzjoni ta' pazjenti*
English: Date of first authorisation: 16 January 2014 Date of latest renewal: 17 September 2018
Maltese: Data tal-aħħar tiġdid: 17 Settembru 2018
English: Sofosbuvir is a nucleotide prodrug.
Maltese: Sofosbuvir hu prodroga nucleotide.
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 replicons b'suxxettibilità mnaqqsa għal sofosbuvir intgħażlu fil-koltura taċ-ċelluli għal ġenotipi multipli li jinkludu 1b, 2a, 2b, 3a, 4a, 5a u 6a.
English: 27/28 patients with genotype 4 HCV achieved SVR12.
Maltese: 27/28 pazjent b'ġenotip 4 HCV kisbu SVR12.
English: The metabolic activation pathway involves sequential hydrolysis of the carboxyl ester moiety catalysed by human cathepsin A (CatA) or carboxylesterase 1 (CES1) and phosphoramidate cleavage by histidine triad nucleotide-binding protein 1 (HINT1) 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 (CatA) jew carboxylesterase 1 (CES1) u phosphoramidate cleavage minn histidine triad nucleotide-binding protein 1 (HINT1) segwita minn fosforilazzjoni mill-passaġġ tal-bijosintesi ta' pyrimidine nucleotide.
English: Sofosbuvir ↑ Cmax 2.54 (1.87, 3.45) ↑ AUC 4.53 (3.26, 6.30) Cmin (NA)
Maltese: ↑ Cmax 2.54 (1.87, 3.45) ↑ AUC 4.53 (3.26, 6.30) Cmin (NA)
English: Sofosbuvir is not a substrate for hepatic uptake transporters, organic anion-transporting polypeptide (OATP) 1B1 or 1B3, and organic cation transporter (OCT) 1.
Maltese: Sofosbuvir mhuwiex substrat għal trasportaturi tal-assorbiment tal-fwied, organic anion-transporting polypeptide (OATP) 1B1 jew 1B3, u organic cation transporter (OCT) 1.
English: Protein binding of GS-331007 was minimal in human plasma.
Maltese: Ittwaħħil ta' GS-331007 mal-proteina kien minimu fil-plażma umana.
English: Emtricitabinef (200 mg once daily)d
Maltese: Emtricitabinef (200 mg darba kuljum)d
English: HIV ANTIVIRAL AGENTS: REVERSE TRANSCRIPTASE INHIBITORS Efavirenzf (600 mg once daily)d
Maltese: INIBITURI TA' REVERSE TRANSCRIPTASE Efavirenzf (600 mg darba kuljum)d
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 replication viral capacity by 89% to 99% compared to the corresponding wild-type.
Maltese: Mutaġenesi diretta mis-sit tas-sostituzzjoni S282T f'replicons 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: EU/1/13/894/001 28 film-coated tablets EU/1/13/894/002 84 (3 bottles of 28) film-coated tablets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/13/894/001 28 pillola miksija b'rita EU/1/13/894/002 84 (3 fliexken ta' 28) pillola miksija b'rita
English: NARCOTIC ANALGESICS Methadonef (Methadone maintenance therapy [30 to
Maltese: ANALĠESIĊI NARKOTIĊI Methadonef (Terapija ta' manteniment b'methadone [30 sa 130 mg/jum])
English: The mean ± SD EC50 of sofosbuvir against chimeric replicons encoding NS5B sequences from clinical isolates was 0.068 ± 0.024 μM for genotype 1a (n = 67), 0.11 ± 0.029 μM for genotype 1b (n = 29), 0.035 ± 0.018 μM for genotype 2 (n = 15) and 0.085 ± 0.034 μM for genotype 3a (n = 106).
Maltese: Il-medja ta' ± SD EC50 ta' sofosbuvir kontra sekwenzi ta' replicons kimeriċi li jikkodifikaw NS5B minn iżolati kliniċi kienet ta' 0.068 ± 0.024 μM għal ġenotip 1a (n = 67), 0.11 ± 0.029 μM għal ġenotip 1b (n = 29), 0.035 ± 0.018 μM għal ġenotip 2 (n = 15) u 0.085 ± 0.034 μM għal ġenotip 3a (n = 106).
English: Sofosbuvir and GS-331007 are not substrates or inhibitors of UGT1A1 or CYP3A4, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and CYP2D6 enzymes.
Maltese: Sofosbuvir u GS-331007 mhumiex substrati jew inibituri ta' UGT1A1 jew enzimi ta' CYP3A4, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, u CYP2D6.
English: HCV genotype 3
Maltese: HCV ġenotip 3
English: HCV ANITIVIRAL AGENTS: HCV PROTEASE INHIBITORS Boceprevir (BOC)
Maltese: TAL-PROTEASE TAL-HCV Boceprevir (BOC)
English: GS-461203 (the active metabolite of sofosbuvir) is not an inhibitor of human DNA and RNA polymerases nor an inhibitor of mitochondrial RNA polymerase.
Maltese: GS-461203 (il-metabolit attiv ta' sofosbuvir) mhuwiex inibitur tad-DNA umana u RNA polymerases, u lanqas mhu inibitur ta' RNA polymerase mitokondrijali.
English: Mannitol, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate.
Maltese: • Is-sustanzi mhux attivi l-oħra huma Qalba tal-pillola: Mannitol, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate.
English: HCV genotype 2
Maltese: HCV ġenotip 2
English: • Peginterferon alfa and ribavirin
Maltese: • Ribavirin, jew • Peginterferon alfa u ribavirin
English: Adult liver transplant recipients - Study 0126
Maltese: Pazjenti adulti li jirċievu trapjant tal-fwied - Studju 0126
English: Medicinal products that are strong P-glycoprotein (P-gp) inducers in the intestine (carbamazepine, phenobarbital, phenytoin, rifampicin and St. John's wort).
Maltese: Prodotti mediċinali li huma indutturi qawwija ta' P-glikoproteina (P-gp) fl-imsaren (carbamazepine, phenobarbital, phenytoin, rifampicin u St.
English: Intracellular hydrolytic prodrug cleavage catalysed by enzymes including carboxylesterase 1 and sequential phosphorylation steps catalysed by nucleotide kinases result in formation of the pharmacologically active uridine nucleoside analogue triphosphate.
Maltese: Cleavage idrolitiku intraċellulari tal-prodroga kkatalizzat minn enzimi li jinkludu carboxylesterase 1 u passi sekwenzjali ta' fosforilazzjoni kkatalizzata minn nucleotide kinases, jirriżultaw fil-formazzjoni ta' uridine nucleoside analogue triphosphate farmakoloġikament attiv.
English: In HCV replicon assays, the effective concentration (EC50) values of sofosbuvir against full-length replicons from genotype 1a, 1b, 2a, 3a and 4a were 0.04, 0.11, 0.05, 0.05 and 0.04 μM, respectively, and EC50 values of sofosbuvir against chimeric 1b replicons encoding NS5B from genotype 2b, 5a or 6a were 0.014 to 0.015 μM.
Maltese: F'assaġġi HCV replicon, il-valuri tal-konċentrazzjoni effettiva (EC50) ta' sofosbuvir kontra replicons b'tul sħiħ minn ġenotip 1a, 1b, 2a, 3a u 4a kienu 0.04, 0.11, 0.05, 0.05 u 0.04 μM, rispettivament, u l-valuri EC50 ta' sofosbuvir kontra replicons 1b kimeriċi encoding NS5B minn ġenotip 2b, 5a jew 6a kienu 0.014 sa 0.015 μM.
English: The SVR12 rate in the sofosbuvir + ribavirin treatment group was statistically significant when compared to placebo (p <0.001).
Maltese: Ir-rata ta' SVR12 fil-grupp ta' kura ta' sofosbuvir + ribavirin kienet statistikament sinifikanti meta mqabbla mal-plaċebo (p < 0.001).
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 (medda: 9.0-39.6).
English: Previously treated adults - FUSION (study 108)
Maltese: Adulti li rċivew kura fil-passat - FUSION (studju 108)
English: How to take Sovaldi
Maltese: Tiħux Sovaldi
English: Among these, one patient was found to have a NS5B RAV substitution (F289L).
Maltese: Fost dawn, pazjent wieħed instab li kellu sostituzzjoni NS5B RAV (F289L).
English: Sofosbuvir ↑ Cmax 1.45 (1.10, 1.92) ↑ AUC 1.34 (1.12, 1.59) Cmin (NA)
Maltese: ↑ Cmax 1.45 (1.10, 1.92) ↑ AUC 1.34 (1.12, 1.59) Cmin (NA)
English: Sofosbuvir retained activity against the NS5B substitutions L159F and L320F associated with resistance to other nucleoside inhibitors.
Maltese: Sofosbuvir żamm l-attività kontra s-sostituzzjonijiet ta' NS5B, L159F u L320F, assoċjati ma' reżistenza għal inibituri oħrajn ta' nucleoside.
English: The majority of patients (69%) had been infected through vertical transmission.
Maltese: Il-maġġoranza tal-pazjenti (69%) kienu ġew infettati permezz ta' trasmissjoni vertikali.
English: The median terminal half-lives of sofosbuvir and GS-331007 were 0.4 and 27 hours respectively.
Maltese: Il-medjan tal-half-lives terminali ta' sofosbuvir u ta' GS-331007 kien ta' 0.4 u 27 siegħa rispettivament.
English: * Includes patients co infected with human immunodeficiency virus (HIV).
Maltese: * Tinkludi pazjenti koinfettati bil-virus tal-immunodefiċjenza umana (HIV).
English: The presence of 40% human serum had no effect on the anti-HCV activity of sofosbuvir.
Maltese: Il-preżenza ta' 40% tas-serum uman ma kellu l-ebda effett fuq l-attività kontra HCV ta' sofosbuvir.
English: Monotherapy of Sovaldi is not recommended (see section 5.1).
Maltese: Monoterapija ta' Sovaldi mhijiex rakkomandata (ara sezzjoni 5.1).
English: Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analog 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 farmakoloġikament attiv (GS-461203), li jista' jiġi inkorporat ġo HCV RNA mill-NS5B polymerase u jaġixxi bħala terminatur tal-katina.
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: 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
Maltese: Il-frekwenzi 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: Sofosbuvir and GS-331007 are not inhibitors of drug transporters P-gp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3 and OCT1.
Maltese: Sofosbuvir u GS-331007 mhumiex inibituri tat-trasportaturi tal-mediċina ta' P-gp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3 u OCT1.
English: Sofosbuvir was fully active against substitutions associated with resistance to other direct-acting antivirals with different mechanisms of actions, such as NS5B non-nucleoside inhibitors, NS3 protease inhibitors and NS5A inhibitors.
Maltese: Sofosbuvir kien attiv b'mod sħiħ kontra sostituzzjonijiet assoċjati ma' reżistenza għal antivirali oħrajn li jaġixxu b'mod dirett b'mekkaniżmi ta' azzjoni differenti, bħal inibituri nonnucleoside ta' NS5B, inibituri ta' protease NS3 u inibituri ta' NS5A.
English: Following treatment with sofosbuvir 200 mg or 400 mg in combination with ribavirin the SVR12 rate in patients with ESRD was 40% and 60%, respectively.
Maltese: Wara trattament b'sofosbuvir 200 mg jew 400 mg f'kombinazzjoni ma' ribavirin, ir-rata SVR12 f'pazjenti b'ESRD kienet ta' 40% u 60%, rispettivament.
English: The assay had a lower limit of quantification (LLOQ) of 25 IU/mL.
Maltese: L-assaġġ kellu limitu iktar baxx ta' kwantifikazzjoni (LLOQ - lower limit of quantification) ta' 25 IU/mL.
English: Yellow, capsule-shaped, film-coated tablet of dimensions 20 mm x 9 mm, debossed on one side with “GSI” and “7977” on the other side.
Maltese: Pillola miksija b'rita, safra, b'forma ta' kapsula, b'daqs ta' 20 mm x 9 mm, imnaqqxa b'“GSI” fuq naħa waħda u “7977” fuq in-naħa l-oħra.
English: The median ribavirin dose was 600 mg-800 mg daily at weeks 4-24.
Maltese: Ilmedjan tad-doża ta' ribavirin kien ta' 600 mg-800 mg kuljum f'ġimgħat 4-24.
English: The ribavirin doses used in the sofosbuvir + ribavirin and peginterferon alfa 2a + ribavirin arms were weight-based 1,000-1,200 mg/day and 800 mg/day regardless of weight, respectively.
Maltese: Id-dożi ta' ribavirin użati fil-parti tal-istudju dwar sofosbuvir + ribavirin u peginterferon alfa 2a + ribavirin, kienu bbażati fuq il-piż, u kienu ta' 1,000-1,200 mg/jum u 800 mg/jum irrispettivament mill-piż, rispettivament.
English: HIV ANTIVIRAL AGENTS: INTEGRASE INHIBITORS Raltegravirf (400 mg twice daily)
Maltese: INIBITURI TA' INTEGRASE Raltegravirf (400 mg darbtejn kuljum)
English: • Carbamazepine, phenobarbital and phenytoin (medicines used to treat epilepsy and prevent seizures).
Maltese: • Carbamazepine, phenobarbital u phenytoin (mediċini li jintużaw għall-kura ta'
English: In 5 patients (12.5%), study drugs were discontinued, modified or interrupted due to adverse events.
Maltese: F'5 pazjenti (12.5%), il-mediċini tal-istudju twaqqfu, ġew modifikati jew interrotti minħabba avvenimenti avversi.
English: Sovaldi is contraindicated with phenobarbital and phenytoin (see section 4.3).
Maltese: Sovaldi hu kontraindikat ma' phenobarbital u phenytoin (ara sezzjoni 4.3).
English: HIV ANTIVIRAL AGENTS: HIV PROTEASE INHIBITORS Darunavir boosted with ritonavirf (800/100 mg once daily)
Maltese: TAL-PROTEASE TAL-HIV Darunavir imsaħħaħ b'ritonavirf (800/100 mg darba kuljum)
English: ↔ GS-331007 (Induction of P-gp)
Maltese: ↓ Sofosbuvir ↔ GS-331007 (Induzzjoni ta' P-gp)
English: The concomitant use of amiodarone was limited through the clinical development of sofosbuvir .
Maltese: L-użu konkomitanti ta' amiodarone kien limitat permezz tal-iżvilupp kliniku ta' sofosbuvir.
English: The difference in the overall SVR12 rates between sofosbuvir + ribavirin and peginterferon alfa + ribavirin treatment groups was 0.3% (95% confidence interval: -7.5% to 8.0%) and the study met the predefined non-inferiority criterion.
Maltese: Id-differenza fir-rati globali ta' SVR12 bejn il-gruppi tal-kura b'sofosbuvir + ribavirin u peginterferon alfa + ribavirin kienet ta' 0.3% (95% intervall ta' kunfidenza: -7.5% sa 8.0%) u l-istudju ssodisfa l-kriterju ta' nuqqas ta' inferjorità definit minn qabel.
English: Sovaldi is indicated in combination with other medicinal products 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: Sovaldi huwa indikat flimkien ma' prodotti mediċinali oħra għall-kura ta' epatite C kronika (CHCchronic hepatitis C) f'adulti u fl-adolexxenti minn età ta' 12 sa <18-il sena (ara sezzjonijiet 4.2, 4.4 u 5.1).
English: The parent sofosbuvir accounts for approximately 4% of drug-related material systemic exposure (see section 5.2).
Maltese: Sofosbuvir ġenitur jammonta għal madwar 4% tal-esponiment sistemiku tal-materjal relatat malmediċina (ara sezzjoni 5.2).
English: 28 out of 40 (70%) patients achieved SVR12: 22/33 (73%) with HCV genotype 1 infection, 6/6 (100%) with HCV genotype 3 infection, and 0/1 (0%) with HCV genotype 4 infection.
Maltese: 22/33 (73%) b'infezzjoni bl-HCV ta' ġenotip 1, 6/6 (100%) b'infezzjoni bl-HCV ta' ġenotip 3, u 0/1 (0%) b'infezzjoni bl-HCV ta' ġenotip 4.
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: In study 0126, decreases in haemoglobin during treatment were very common with 32.5% (13/40 patients) experiencing a decline in haemoglobin to <10 g/dL, 1 of whom also had a decline to <8.5 g/dL.
Maltese: Fi studju 0126, tnaqqis fl-emoglobina waqt il-kura kien komuni ħafna, bi 32.5% (13/40 pazjent) li kellhom tnaqqis fl-emoglobina għal < 10 g/dL, li 1 minnhom kellu wkoll tnaqqis għal <8.5 g/dL.
English: Post-baseline NS5B sequences were available for 225 of the 226 patients, with deep sequencing data (assay cutoff of 1%) from 221 of these patients.
Maltese: Sekwenzi NS5B wara l-linja bażi kienu disponibbli għal 225 mill-226 pazjent, b'dejta b'sekwenzar profond (cutoff tal-assaġġ ta' 1%) ta' 221 minn dawn ilpazjenti.
English: Sovaldi is contraindicated with carbamazepine (see section 4.3).
Maltese: Sovaldi hu kontraindikat ma' carbamazepine (ara sezzjoni 4.3).
English: mL/min/1.
Maltese: IU/mL).
English: Reduced susceptibility to sofosbuvir was associated with the primary NS5B substitution S282T in all replicon genotypes examined.
Maltese: Suxxettibilità mnaqqsa għal sofosbuvir ġiet assoċjata mas-sostituzzjoni NS5B primarja S282T fil-ġenotipi replicon kollha eżaminati.
English: RBV daily dose* 15 mg/kg/day 600 mg/day 800 mg/day 1000 mg/day 1200 mg/day
Maltese: Doża ta' kuljum ta' RBV* 15-il mg/kg/jum 600 mg/jum
English: ANTICONVULSANTS Phenobarbital Phenytoin
Maltese: MEDIĊINI ANTIKONVULŻIVI Phenobarbital
English: In a biochemical assay, GS-461203 inhibited the polymerase activity of the recombinant NS5B from HCV genotype 1b, 2a, 3a and 4a with a 50% inhibitory concentration (IC50) value ranging from 0.7 to 2.6 μM.
Maltese: F'assaġġ bijokimiku, GS-461203 inibixxa l-attività ta' polymerase tal-NS5B rikombinanti minn ġenotip tal-HCV 1b, 2a, 3a u 4a b'50% konċentrazzjoni inibitorja (IC50) ta' valur li jvarja minn 0.7 sa 2.6 μM.
English: ANTICOAGULANTS Vitamin K antagonists
Maltese: Pazjenti kkurati b'antagonisti tal-vitamina K
English: In clinical pharmacology studies, both sofosbuvir and GS-331007 were monitored for purposes of pharmacokinetic analyses.
Maltese: Fi studji farmakoloġiċi kliniċi, kemm sofosbuvir kif ukoll GS-331007 ġew immonitorjati għal skopijiet ta' analiżi tal-farmakokinetika.
English: Relative to healthy subjects (n = 284), the sofosbuvir and GS-331007 AUC0-24 was 57% higher and 39% lower, respectively in HCV infected patients.
Maltese: Meta mqabbla ma' individwi b'saħħithom (n = 284), l-AUC0-24 ta' sofosbuvir u GS-331007 kienet 57% ogħla u 39% iktar baxxi, rispettivament f'pazjenti infettati bl-HCV.
English: b. pTVR: post-transplant virologic response (HCV RNA <LLOQ at 12 weeks post-procedure).
Maltese: b. pTVR (post transplant virologic response): rispons viroloġiku wara t-trapjant (HCV RNA < LLOQ 12-il ġimgħa wara l-proċedura).
English: Common abdominal discomfort, constipation, dyspepsia constipation, dry mouth, gastroesophageal reflux
Maltese: Komuni skonfort addominali, stitikezza, dispepsija stitikezza, ħalq xott, rifluss gastroesofagali
English: Sofosbuvir is approximately 85% bound to human plasma proteins (ex vivo data) and the binding is independent of drug concentration over the range of 1 μg/mL to 20 μg/mL.
Maltese: Sofosbuvir jeħel b'rata ta' madwar 85% mal-proteini tal-plażma tal-bniedem (dejta ex vivo) u ttwaħħil hu indipendenti mill-konċentrazzjoni tal-mediċini fuq il-medda ta' 1 μg/mL sa 20 μg/mL.
English: PEG+RBV 24 weeks (n = 176)
Maltese: PEG+RBV 24 ġimgħa (n = 176)
English: Interferon-free therapy for genotype 1, 4, 5 and 6 HCV infection
Maltese: Terapija mingħajr interferon għal infezzjoni bl-HCV ta' ġenotip 1, 4, 5 jew 6
English: Monotherapy of Sovaldi is not recommended.
Maltese: Monoterapija ta' Sovaldi mhijiex rakkomandata.