FrancophonIA/ELRC3.0 huggingface dataset:
English: In a pooled analysis of treatment naïve patients without cirrhosis (including Phase 2 and 3 data) where SVR12 was assessed according to the presence of baseline A30K, a numerically lower SVR12 rate was achieved in patients with A30K treated for 8 weeks as compared to those treated for 12 weeks [78% (14/18) vs 93% (13/14)].
Maltese: F' analiżi miġbura ta' pazjenti mingħajr ċirrożi u li qatt ma ħadu kura (inkluż data ta' Fażi 2 u 3) fejn l-SVR12 ġie vvalutat skont il-preżenza tal-linja bażi A30K, inkisbet rata ta' SVR12 numerikament aktar baxxa f'pazjenti b'A30K ittrattati għal 8 ġimgħat meta mqabbla ma' dawk ittrattati għal 8 ġimgħat meta mqabbla ma' dawk ittrattati għal 12-il ġimgħa [78% (14/18) vs 93% (13/14].
English: Of the 100 subjects treated, the median age was 60 years (range: 39 to 78); 57% had HCV genotype 1, 13% had HCV genotype 2, 24% had HCV genotype 3, 4% had HCV genotype 4, 2% had HCV genotype 6; 75% were male; 8% were Black; 66% were HCV treatment-naïve; none had cirrhosis and 80% had a baseline fibrosis state of F0 or F1; 80% of subjects were post-liver transplant and 20% were post-kidney transplant.
Maltese: Mis-100 individwu kkurati, l-età medjana kienet ta' 60 sena (medda ta' bejn 39 u 78); 57% kellhom HCV ġenotip 1, 13% kellhom HCV ġenotip 2, 24% kellhom HCV ġenotip 3, 4% kellhom HCV ġenotip 4, 2% kellhom HCV ġenotip 6; 75% kienu rġiel; 8% kienu l-Iswed; 66% ma kellhomx trattament ta' HCV; ħadd ma kellu ċirrożi u 80% kellhom stat ta' fibrożi bażi ta' F0 jew F1; 80% tassuġġetti kienu trapjanti wara l-fwied u 20% kienu wara trapjant tal-kliewi.
English: Table 8: SVR12 in treatment-naïve and treatment-experienceda subjects to peginterferon, ribavirin and/or sofosbuvir with genotype 1, 2, 4, 5 and 6 infection who received the recommended duration (pooled data from ENDURANCE-1b, SURVEYOR-1, -2, and EXPEDITION-1, 2b, -4 and 8)
Maltese: Tabella 8: SVR12 f'individwi li qatt ma kienu ħadu kura qabel u f'individwi li kienu ħadu kura qabel a b'peginterferon, ribavirin u/jew sofosbuvir b'infezzjoni tal-ġenotip 1, 2, 4, 5 u 6 li rċevew it-tul rakkomandat (dejta miġbura flimkien minn ENDURANCE-1
English: SVR Outcome for subjects without SVR12 On-treatment VF Relapsea Otherb SVR by cirrhosis status No Cirrhosis
Maltese: Riżultat għal individwi mingħajr SVR12 VF waqt il-kura Rikadutac Oħrajnd
English: Contraceptive medicines that contain ethinylestradiol must not be used in combination with Maviret.
Maltese: Mediċini kontraċettivi li fihom l-ethinylestradiol ma jridux jintużaw f'kombinazzjoni ma' Maviret.
English: Estimation of the pharmacokinetic parameters using population pharmacokinetic models has inherent uncertainty due to dose non-linearity and cross interaction between glecaprevir and pibrentasvir.
Maltese: L-istima tal-parametri farmakokinetiċi li jużaw mudelli farmakokinetiċi tal-popolazzjoni għandha inċertezza inerenti minħabba nuqqas ta' linearità fid-doża u interazzjoni bejn glecaprevir u pibrentasvir.
English: No glecaprevir metabolites were observed in plasma.
Maltese: Ma kienu osservati l-ebda metaboliti ta' glecaprevir fil-plażma.
English: No dose adjustment of Maviret is required in patients with mild hepatic impairment (Child-Pugh A).
Maltese: M'hemmx bżonn ta' aġġustament fid-doża ta' Maviret f'pazjenti b'indeboliment ħafif tal-fwied (Child-Pugh A).
English: Among GT3b subjects without cirrhosis, a numerically lower SVR12 rate of 58.3% (7/12) [62.5% (5/8) for TN subjects and 50% (2/4) for TE-PRS subjects] was observed compared to GT3a subjects without cirrhosis (92.9% (13/14)).
Maltese: GT3b mingħajr ċirrożi, rata SVR12 numerikament aktar baxxa ta' 58.3% (7/12) [62.5% (5/8) għal individwi
English: (P-gp/BCRP inhibition)
Maltese: (Inibizzjoni tal-Pgp/BCRP)
English: Nervous system disorders Very common headache
Maltese: Disturbi fis-sistema nervuża Komuni ħafna uġigħ ta' ras
English: Maviret 100 mg/40 mg film-coated tablets
Maltese: Maviret 100 mg/40 mg pilloli miksijin b'rita
English: Valsartan 80 mg single dose
Maltese: 20 mg darba kuljum
English: For patients who failed prior therapy with an NS3/4A- and/or an NS5A-inhibitor, see section 4.4.
Maltese: Għall-pazjenti li fallew terapija preċedenti b'inibitur ta' NS3/4A u/jew ta' NS5A, ara sezzjoni 4.4.
English: ENDURANCE-5,6 Maviret for 12 weeks (n=9)
Maltese: Maviret għal 12-il ġimgħa (n=9)
English: In TN or TE-PRS subjects with compensated cirrhosis who received the recommended duration, 97.0% (288/297) achieved SVR12 (among which 98.0% [192/196] of TN subjects achieved SVR12), while 0.7% (2/297) experienced on-treatment virologic failure and 1.0% (3/289) experienced posttreatment relapse.
Maltese: TN jew TE-PRS b'ċirrożi kkumpensata li rċivew it-tul rakkomandat, 97.0% (288/297) kisbu SVR12 (fosthom 98.0% [192/196] ta' individwi
English: Co-administration of Maviret with ethinyloestradiolcontaining products is contraindicated due to the risk of ALT elevations (see section 4.3).
Maltese: L-għoti flimkien jista' jwassal għal effett terapewtiku mnaqqas ta' Maviret u huwa kontraindikat (ara sezzjoni 4.3).
English: Otherd
Maltese: Individwi
English: 92.1d
Maltese: 2b
English: The response rates observed for patients ≥ 65 years of age were similar to that of patients < 65 years of age, across treatment groups.
Maltese: Ir-rati ta' rispons osservati f'pazjenti li kellhom ≥ 65 sena kienu simili għal dawk ta' pazjenti li kellhom < 65 sena, fil-gruppi kollha ta' kura.
English: Drug-drug interactions
Maltese: GĦAMLA FARMAĊEWTIKA
English: Pravastatin 10 mg once daily
Maltese: Pravastatin 10 mg darba kuljum
English: ENDURANCE-2 Maviret (n=202) or Placebo (n=100) for 12 weeks SURVEYOR-2b
Maltese: ENDURANCE-2 Maviret (n=202) jew Plaċebo (n=100) għal 12-il ġimgħa SURVEYOR-2b Maviret għal 8 ġimgħat (n=199) jew għal 12-il ġimgħa (n=25)
English: The in vitro activity of glecaprevir was also studied in a biochemical assay, with similarly low IC50 values across genotypes.
Maltese: L-attività in vitro ta' glecaprevir kienet studjata wkoll f'analiżi bijokimika, b'valuri similarment baxxi tal-IC50 fil-ġenotipi kollha.
English: Studies in rats/mice with glecaprevir or pibrentasvir do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Maltese: Studji fuq il-firien/ġrieden bi glecaprevir jew pibrentasvir ma jurux effetti ħżiena diretti jew indiretti fuq is-sistema riproduttiva.
English: • feeling sick (nausea)
Maltese: • tħossok imdardar (nawżja)
English: Effect of baseline HCV amino acid polymorphisms on treatment response A pooled analysis of treatment-naïve and pegylated interferon, ribavirin and/or sofosbuvir treatmentexperienced subjects receiving Maviret in the Phase 2 and Phase 3 clinical studies was conducted to explore the association between baseline polymorphisms and treatment outcome and to describe substitutions seen upon virologic failure.
Maltese: Effett tal-polimorfiżmi tal-aċidu amminiku fil-linja bażi tal-HCV fuq ir-rispons tal-kura Twettqet analiżi miġbura ta' individwi li qatt ma kienu ħadu kura qabel u ta' individwi li kienu ħadu kura qabel b'pegylated interferon, ribavirin u/jew sofosbuvir, li ngħataw Maviret fl-istudji kliniċi ta' Fażi 2 u ta' Fażi 3, sabiex tiġi esplorata l-assoċjazzjoni bejn il-polimorfiżmi tal-linja bażi u r-riżultat tal-kura u sabiex jiġu deskritti s-sostituzzjonijiet li dehru wara falliment viroloġiku.
English: Co-administration with atorvastatin and simvastatin is contraindicated (see section 4.3).
Maltese: L-għoti flimkien huwa kontraindikat (ara sezzjoni 4.3).
English: Subjects with genotype 3b infection
Maltese: Individwi b'infezzjoni ta' ġenotip 3b
English: No subject experienced virologic failure.
Maltese: VF= falliment viroloġiku a.
English: Subjects were either treatment-naïve or treatment-experienced to combinations of (peg) interferon, ribavirin, and/or sofosbuvir and received Maviret for 8, 12, or 16 weeks per approved treatment durations.
Maltese: L-individwi kienu jew qatt ma ħadu t-trattament qabel jew li kellhom esperjenza bi trattament b' kombinazzjonijiet ta' (peg) interferon, ribavirin, u/jew sofosbuvir u rċivew Maviret għal 8, 12, jew 16il ġimgħa skont id-durati tat-trattament approvati.
English: The efficacy of Maviret in subjects who were treatment-naïve or treatment-experienced to combinations of peginterferon, ribavirin and/or sofosbuvir with genotype 3 chronic hepatitis C infection was demonstrated in the ENDURANCE-3 (treatment-naïve without cirrhosis) and SURVEYOR-2 Part 3 (subjects with and without cirrhosis and/or treatment-experienced) clinical studies.
Maltese: L-effikaċja ta' Maviret f'individwi b'infezzjoni kronika tal-ġenotip 3 tal-epatite Ċ, li qatt ma kienu ħadu kura qabel jew li kienu ħadu kura qabel b'kombinazzjonijiet ta' peginterferon, ribavirin u/jew sofosbuvir kienet murija fl-istudji kliniċi ENDURANCE-3 (qatt ma ħadu kura qabel, mingħajr ċirrożi) u SURVEYOR-2 Parti 3 (individwi bi u mingħajr ċirrożi u/jew li kienu ħadu kura qabel).
English: The safety of Maviret in HCV GT1-6 infected adolescents is based on data from a Phase 2/3 openlabel study in 47 subjects aged 12 years to <18 years treated with Maviret for 8 to 16 weeks (DORAPart 1).
Maltese: Is-sigurtà ta' Maviret f'adolexxenti infettati b'HCV GT1-6 hija bbażata fuq dejta minn studju openlabel ta' Fażi 2/3 f'47 individwu minn età ta' 12-il sena sa <18-il sena kkurati b'Maviret għal 8 sa 16
English: Substitutions at amino acid position 80 did not reduce susceptibility to glecaprevir except for Q80R in genotype 3a, which reduced susceptibility to glecaprevir by 21-fold.
Maltese: Issostituzzjonijiet fil-pożizzjoni 80 tal-aċidu amminiku ma naqqsux is-suxxettibilità għal glecaprevir ħlief għal Q80R fil-ġenotip 3a, li naqqset is-suxxettibilità għal glecaprevir b'21 darba.
English: One TN GT5-infected subject without cirrhosis experienced relapse, and one TN GT6-infected subject with compensated cirrhosis experienced ontreatment virologic failure.
Maltese: infettat b'GT5 mingħajr ċirrożi esperjenza rikaduta, u individwu wieħed TN infettat b'GT6 b'ċirrożi kkumpensata esperjenza falliment viroloġiku waqt it-trattament.
English: Medicinal products that are strong P-gp and CYP3A inducers (e.g., rifampicin, carbamazepine, St. John's wort (Hypericum perforatum), phenobarbital, phenytoin, and primidone) could significantly decrease glecaprevir or pibrentasvir plasma concentrations and may lead to reduced therapeutic effect of Maviret or loss of virologic response.
Maltese: John's wort (Hypericum perforatum), phenobarbital, phenytoin, u primidone) jistgħu jnaqqsu b'mod sinifikanti l-konċentrazzjonijiet ta' glecaprevir jew ta' pibrentasvir fil-plażma u jistgħu jwasslu għal effett terapewtiku mnaqqas ta' Maviret jew għat-telf tar-rispons viroloġiku.
English: Serum bilirubin elevations
Maltese: Żidiet fil-bilirubina fis-serum
English: Elderly No dose adjustment of Maviret is required in elderly patients (see sections 5.1 and 5.2).
Maltese: Anzjani M'hemmx bżonn ta' aġġustament fid-doża ta' Maviret f'pazjenti anzjani (ara sezzjonijiet 5.1 u 5.2).
English: The EC50 values of glecaprevir and pibrentasvir against full-length or chimeric replicons encoding NS3 or NS5A from laboratory strains are presented in Table 5.
Maltese: Il-valuri EC50 ta' glecaprevir u pibrentasvir kontra replikons ta' tul sħiħ jew kimeriċi li jikkodifikaw NS3 jew NS5A minn razez tal-laboratorju huma ppreżentati f'Tabella 5.
English: Each film-coated tablet contains 100 mg glecaprevir and 40 mg pibrentasvir.
Maltese: Kull pillola miksija b'rita fiha 100 mg glecaprevir u 40 mg pibrentasvir.
English: 10 mg once daily
Maltese: 10 mg darba kuljum
English: Film-coated tablet (tablet).
Maltese: Kisja tal-pillola
English: Potential for Maviret to affect other medicinal products
Maltese: Potenzjal li Maviret jaffettwa prodotti mediċinali oħra
English: Population pharmacokinetic analysis in HCV-infected subjects showed that within the age range (12 to 88 years) analysed, age did not have a clinically relevant effect on the exposure to glecaprevir or pibrentasvir.
Maltese: Analiżi farmakokinetika tal-popolazzjoni f'pazjenti infettati bl-HCV uriet li fil-medda ta' etajiet (12 sa 88 sena) analizzata, letà ma kellhiex effett klinikament rilevanti fuq l-esponiment għal glecaprevir jew pibrentasvir.
English: ANTICONVULSANTS Carbamazepine 200 mg twice daily
Maltese: ANTIMIKOBATTERIĊI Rifampicin doża waħda ta' 600 mg
English: There was one relapse and no on-treatment virologic failure.
Maltese: Kien hemm rikaduta waħda u ma kienx hemm falliment viroloġiku fit-trattament.
English: The effects of Maviret during pregnancy are not known.
Maltese: L-effetti ta' Maviret waqt it-tqala mhumiex magħrufa.
English: Maternal toxicity associated with embryo-foetal loss has been observed in the rabbit with glecaprevir which precluded evaluation of glecaprevir at clinical exposures in this species (see section 5.3).
Maltese: Kien osservat effett tossiku fl-omm assoċjat mat-telf tal-embriju/fetu filfniek bi glecaprevir li ma ppermettiex evalwazzjoni ta' glecaprevir f'esponimenti kliniċi f'din l-ispeċi (ara sezzjoni 5.3).
English: Potential for other medicinal products to affect Maviret
Maltese: Potenzjal li prodotti mediċinali oħra jaffettwaw Maviret
English: The adverse reactions are listed below by body system organ class and frequency.
Maltese: Ir-reazzjonijiet avversi huma elenkati hawn isfel skont is-sistema tal-klassifika tal-organi tal-ġisem u l-frekwenza.
English: Established and other potential medicinal product interactions
Maltese: Interazzjoni ma' prodotti mediċinali oħra
English: b. Mean systemic exposure with moderate to high fat meals.
Maltese: b. Esponiment sistemiku medju b'ikliet b'kontenut moderat sa għoli ta' xaħam.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu
English: The effect of efavirenz/emtricitabine/tenofovir disoproxil fumarate on glecaprevir and pibrentasvir was not directly quantified within this study, but glecaprevir and pibrentasvir exposures were significantly lower than historical controls.
Maltese: L-effett ta' efavirenz/emtricitabine/tenofovir disoproxil fumarate fuq glecaprevir u pibrentasvir ma ġiex kwantifikat direttament f'dan l-istudju, iżda l-esponimenti għal glecaprevir u pibrentasvir kienu konsiderevolment aktar baxxi millkontrolli storiċi
English: b. Effect of atazanavir and ritonavir on the first dose of glecaprevir and pibrentasvir is reported.
Maltese: b. Ġie rrappurtat effett ta' atazanavir u ritonavir fuq l-ewwel doża ta' glecaprevir u pibrentasvir.
English: There were no virologic failures.
Maltese: Ma kienx hemm fallimenti viruloġiċi.
English: Non-interventional post-authorisation safety study (PASS):
Maltese: Studju mhux intervenzjonali dwar is-sigurta wara l-awtorizzazzjoni (PASS):
English: Suomi/Finland
Maltese: Belgique/Belgien
English: Pregnancy
Maltese: IMBLOKKATURI
English: Clinical Study in Subjects with Genotype 5 or 6 Infection ENDURANCE-5,6 was an open-label study in 84 HCV GT5 (N=23) or 6-infected (N=61) TN or TEPRS subjects.
Maltese: ENDURANCE-5,6 kien studju open-label ta' 84 individwu TN jew TE-PRS infettati b'HCV GT5 (N=23) jew 6 (N=61). Individwi mingħajr ċirrożi rċivew Maviret għal 8 ġimgħat, u individwi b'ċirrożi kkumpensata rċivew Maviret għal 12-il ġimgħa.
English: IMMUNOSUPPRESSANTS Ciclosporin
Maltese: IMMUNOSOPPRESSANTI Ciclosporin doża waħda ta' 100 mg glecaprevirc
English: The recommended Maviret treatment durations for HCV genotype 1, 2, 3, 4, 5, or 6 infected patients with compensated liver disease (with or without cirrhosis) are provided in Table 1 and Table 2.
Maltese: It-tul rakkomandat tal-kura b'Maviret għal pazjenti infettati bil-ġenotip 1, 2, 3, 4, 5, jew 6 tal-HCV b'mard tal-fwied ikkumpensat (bi jew mingħajr ċirrożi) huwa pprovdut f'Tabella 1 u f'Tabella 2.
English: Available pharmacokinetic data in animals have shown excretion of glecaprevir and pibrentasvir in milk (for details see section 5.3).
Maltese: Dejta farmakokinetika disponibbli fl-annimali wriet li kien hemm eliminazzjoni ta' glecaprevir u pibrentasvir fil-ħalib tas-sider (għad-dettalji ara sezzjoni 5.3). Ir-riskju gћat-trabi mreddgħa mhux eskluż.
English: Diabetics may experience improved glucose control, potentially resulting in symptomatic hypoglycaemia, after initiating HCV direct acting antiviral treatment.
Maltese: Id-dijabetiċi jistgħu jesperjenzaw kontroll imtejjeb tal-glukożju, li potenzjalment jirriżulta f'ipoglemija sintomatika, wara li nidiet it-trattament ta' HCV b'mediċina antivirali li taġixxi direttament.
English: Expected: ↓ glecaprevir and ↓ pibrentasvir
Maltese: Mistenni: ↓ glecaprevir u ↓ pibrentasvir
English: Tabulated summary of adverse reactions
Maltese: Deskrizzjoni ta' reazzjonijiet avversi magħżula
English: Darunavir + ritonavir 800/100 mg once daily
Maltese: Darunavir + ritonavir
English: Maternal toxicity (anorexia, lower body weight, and lower body weight gain) with some embryofoetal toxicity (increase in post-implantation loss and number of resorptions and a decrease in mean foetal body weight), precluded the ability to evaluate glecaprevir in the rabbit at clinical exposures.
Maltese: It-tossiċità materna (anoressija, piż tal-ġisem aktar baxx, u żieda aktar baxxa fil-piż tal-ġisem) flimkien ma' xi effetti tossiċi fuq l-embriju/fetu (żieda fit-telf wara l-impjant u fin-numru ta' risorbimenti u tnaqqis fil-piż medju tal-ġisem tal-fetu), ma ppermettietx l-evalwazzjoni ta' glecaprevir fil-fniek f'esponimenti kliniċi.
English: Maviret tablets are pink, oblong, curved on both sides (biconvex), film-coated tablets with dimensions of 18.8 mm x 10.0 mm and debossed on one side with ‘NXT'.
Maltese: Il-pilloli Maviret huma pilloli miksijin b'rita, roża, oblongi, kurvati miż-żewġ naħat (bikonvessi), b'qisien ta' 18.8 mm x 10.
English: Pregnancy and contraception
Maltese: Tqala u kontraċezzjoni
English: Each tablet contains 100 mg of glecaprevir and 40 mg of pibrentasvir.
Maltese: Kull pillola fiha 100 mg ta' glecaprevir u 40 mg ta' pibrentasvir.
English: SURVEYOR-2 Part 3 was an open-label study randomizing non-cirrhotic treatment-experienced subjects to 12- or 16-weeks of treatment; in addition, the study evaluated the efficacy of Maviret in subjects with compensated cirrhosis and genotype 3 infection in two dedicated treatment arms using 12-week (treatment-naïve only) and 16-week (treatmentexperienced only) durations.
Maltese: SURVEYOR-2 Parti 3 kien studju open-label li għażel b'mod aleatorju individwi mingħajr ċirrożi li kienu ħadu kura qabel, għal 12 jew 16-il ġimgħa ta' kura; barra minn hekk, l-istudju evalwa l-effikaċja ta' Maviret f'individwi b'ċirrożi kkumpensata u infezzjoni bil-ġenotip 3 f'żewġ gruppi ta' kura ddedikati li użaw tulijiet ta' 12-il ġimgħa (individwi li qatt ma ħadu kura qabel biss) u ta' 16-il ġimgħa (individwi li kienu ħadu kura qabel biss).
English: The MAH shall complete, within the stated timeframe, the below measures:
Maltese: Kellem lit-tabib tiegħek jekk għandek dawn li ġejjin minħabba li t-tabib jista' jkun irid jiċċekkjak aktar mill-qrib:
English: There were no developmental effects with either compound in rodent peri/postnatal developmental studies in which maternal systemic exposures (AUC) to glecaprevir and pibrentasvir were approximately 47 and 74 times, respectively, the exposure in humans at the recommended dose.
Maltese: Ma kienx hemm effetti fuq l-iżvilupp blebda wieħed mill-komposti fi studji tal-iżvilupp waqt jew wara t-twelid ta' annimali gerriema li fihom l-esponimenti sistemiċi tal-omm (AUC) għal glecaprevir u pibrentasvir kienu madwar 47 u 74 darba, rispettivament, tal-esponiment fil-bniedem bid-doża rakkomandata.
English: 300/100 mg once dailyb
Maltese: 300/100 mg darba kuljumb
English: d. GT3 with cirrhosis from SURVEYOR-2 Part 2 - Maviret for 12 weeks (n=24) or 16 weeks (n=4); GT3 with cirrhosis from SURVEYOR-2 Part 3 - Maviret for 12 weeks (n=40) or 16 weeks (n=47).
Maltese: GT3 mingħajr ċirrożi minn SURVEYOR-2 Parti 1 u 2 - Maviret għal 8 ġimgħat (n=29) jew għal 12-il ġimgħa (n=54); GT3 mingħajr ċirrożi minn SURVEYOR-2 Parti 3 - Maviret għal 12-il ġimgħa (n=22) jew għal 16-il ġimgħa (n=22). d. GT3 b' ċirrożi minn SURVEYOR-2 Parti 2 - Maviret għal 12-il ġimgħa (n=24) jew għal 16-il ġimgħa (n=4); GT3 b' ċirrożi minn SURVEYOR-2 Parti 3 - Maviret għal 12-il ġimgħa (n=40) jew għal 16-il ġimgħa (n=47). e.
English: Maviret is an antiviral medicine used to treat adults and adolescents (12 to less than 18 years old) with long-term (‘chronic') hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus).
Maltese: Maviret huwa mediċina antivirali użata għall-kura ta' persuni adulti u adolexxenti (12-il sena sa inqas minn 18-il sena) b'epatite Ċ (marda li tittieħed li taffettwa l-fwied, ikkawżata mill-virus tal-epatite Ċ) fit-tul (kronika).
English: AbbVie s.r.o.
Maltese: Česká republika AbbVie s.r.o.
English: EXP
Maltese: AbbVie
English: United Kingdom
Maltese: Reżistenza
English: Use with strong P-gp/CYP3A inducers
Maltese: Użu ma' indutturi b'saħħithom tal-P-gp/CYP3A
English: Population pharmacokinetic analysis demonstrated that following administration of Maviret in HCVinfected subjects with compensated cirrhosis, exposure of glecaprevir was approximately 2-fold and pibrentasvir exposure was similar to non-cirrhotic HCV-infected subjects.
Maltese: Analiżi farmakokinetika tal-popolazzjoni wriet li wara l-għoti ta' Maviret f'individwi infettati bl-HCV b'ċirrożi kkumpensata, l-esponiment ta' glecaprevir kien madwar id-doppju u l-esponiment ta' pibrentasvir kien simili għal dak f'individwi infettati bl-HCV mingħajr ċirrożi.
English: Clinical Study in Renally Impaired Subjects
Maltese: Effett fuq il-livelli talprodott mediċinali
English: Caution and therapeutic concentration monitoring of digoxin is recommended.
Maltese: Huma rakkomandati kawtela u monitoraġġ talkonċentrazzjoni terapewtika ta' digoxin.
English: Ltd
Maltese: Tfal
English: Clinical Study in Liver or Kidney Transplant Recipients MAGELLAN-2 was a single-arm, open-label study in 100 post-liver or -kidney transplant HCV GT1-6 infected subjects without cirrhosis who received Maviret for 12 weeks.
Maltese: Studju Kliniku f'Riċevituri ta' Trapjant tal-Fwied jew tal-Kliewi MAGELLAN-2 kien studju open-label fost grupp wieħed ta' pazjenti fejn100 individwu infettati bilHCV GT1 6 mingħajr ċirrożi wara trapjant tal-fwied jew il-kliewi rċevew Maviret għal 12-il ġimgħa.
English: DAA=direct acting antiviral a. Effect of rifampicin on glecaprevir and pibrentasvir 24 hours after final rifampicin dose.
Maltese: DAA=antivirali li jaħdem b'mod dirett a.
English: PK-PD relationship
Maltese: Relazzjoni PK-PD
English: Pharmacotherapeutic group: other cardiac preparations, ATC code: C01 EB16
Maltese: Kategorija farmakoterapewtika: mediċini kardijaċi oħrajn, Kodiċi ATC: C01 EB16
English: - The active substance is ibuprofen.
Maltese: - Is-sustanza attiva hi ibuprofen.
English: Frequencies are defined as: very common (≥ 1/10), common (≥1/100, <1/10) and uncommon (≥1/1,000, <1/100).
Maltese: Il-frekwenzi huma mfissra bħala: komuni ħafna (≥1/10), komuni (≥1/100, <1/10) u mhux komuni (≥1/1,000, <1/100).
English: In vivo and in vitro studies indicate that the S(+) isomer is responsible for the clinical activity.
Maltese: Studji in vivo u in vitro jindikaw li l-iżomer S(+) huwa responsabbli għall-attività klinika.
English: Ibuprofen is a racemic mixture of S(+) and R(-) enantiomers.
Maltese: Ibuprofen hija taħlita raċemika ta' enantjomeri S(+) u R(-).
English: As a non-steroidal anti-inflammatory drug (NSAID), ibuprofen may mask the usual signs and symptoms of infection.
Maltese: Bħala mediċina anti-infjammatorja mhux sterojde (NSAID), ibuprofen jista' jgħatti s-sinjali u sintomi normali ta' infezzjoni.
English: The apparent volume of distribution is on average 200 ml/kg (62 to 350 according to various studies).
Maltese: Il-volum apparenti ta' distribuzzjoni huwa f'medja ta' 200 ml/kg (62 sa 350 skont l-istudji varji).