FrancophonIA/ELRC3.0 huggingface dataset:
English: Paritaprevir is an inhibitor of the hepatic uptake transporters OATP1B1 and OATP1B3, and paritaprevir and ritonavir are inhibitors of OATP2B1.
Maltese: Paritaprevir huwa inibitur ta' trasportaturi tat-teħid epatiku ta' OATP1B1 u OATP1B3 u paritaprevir u ritonavir huma inibituri ta' OATP2B1.
English: Diazepam2 mg single dose
Maltese: Diazepam2 mg doża waħda
English: 4-24 mg/16 mg once daily8
Maltese: 4-24 mg/ 1-6 mg darba kuljum5
English: 400/100 mg twice daily1
Maltese: 400/100 mg darbtejn kuljum 1
English: You will take Viekirax for 8, 12 or 24 weeks.
Maltese: Sejjer tieħu Viekirax għal 8, 12 jew 24 ġimgħa.
English: Immune system disorders Frequency unknown
Maltese: Disturbi tas-sistema immunitarja Frekwenza mhux magħrufa Reazzjonijiet anafilaktici
English: The doses of ombitasvir, paritaprevir, ritonavir were 25 mg 150 mg, 100 mg once daily in PEARL-I, while the dose of paritaprevir was 100 mg or 150 mg in study M12-536.
Maltese: Id-dożi ta' ombitasvir, paritaprevir, ritonavir kienu 25 mg, 150 mg, 100 mg darba kuljum f'PEARL-I, filwaqt li d-doża ta' paritaprevir kienet ta' 100 mg jew 150 mg fl-istudju M12-536.
English: Mechanism: CYP3A4/Pgp inhibition by clarithromyci n and ritonavir.
Maltese: inibizzjoni ta' CYP3A4/Pgp minn clarithromyci n u ritonavir
English: Retreatment
Maltese: Trattament
English: Viekirax 12.5 mg / 75 mg / 50 mg tablets ombitasvir / paritaprevir / ritonavir
Maltese: Viekirax 12.5 mg/75 mg/50 mg pilloli miksijin b'rita ombitasvir / paritaprevir / ritonavir
English: Results from the pharmacokinetic evaluation of the combination of ombitasvir 25 mg, paritaprevir 200 mg, and ritonavir 100 mg, with dasabuvir 400 mg can be extrapolated to the combination of ombitasvir 25 mg, paritaprevir 200 mg, and ritonavir 100 mg.
Maltese: mg, paritaprevir 200 mg, u ritonavir 100 mg, ma' dasubuvir 400 mg tista' tiġi estrapolata għallkombinazzjoni ta' ombitsavir 25 mg, paritaprevir 200 mg, u ritonavir 100 mg.
English: The proportion of subjects who permanently discontinued treatment due to adverse reactions was 0.2% (5/2,044) and 4.8% (99/2,044) of subjects had ribavirin dose reductions due to adverse reactions.
Maltese: Il-proporzjon ta' individwi li waqqfu l-kura b'mod permanenti minħabba reazzjonijiet avversi kien 0.2% (5/2,044). 0.2% (5/2,044) u 4.8% (99/2,044) talindividwi kellhom tnaqqis fid-doża ta' ribavirin minħabba reazzjonijiet avversi.
English: In the presence of ombitasvir, paritaprevir exposures were minimally affected (5% to 27% change) while dasabuvir exposures increase by approximately 30%.
Maltese: Fil- preżenza ta' ombitasvir, paritaprevir l-espożizzjonijiet kienu affettwati minimament (5% sa 27% bidla) filwaqt l-espożizzjonijiet ta' dasabuvir żdiedu b'madwar 30%.
English: Ritonavir is predominantly metabolised by CYP3A and to a lesser extent, by CYP2D6.
Maltese: Ritonavir huwa prinċipalment metabolizzat minn CYP3A u ftit anqas minn CYP2D6.
English: Viekirax safety and efficacy have been established in combination with dasabuvir and/or ribavirin.
Maltese: Is-sigurtà u l-effikaċja ta' Viekirax ma ġiex stabbilità f'kombinazzjoni ma' dasabuvir u/jew ribavirin.
English: Viekirax contains the active substances ombitasvir, paritaprevir and ritonavir.
Maltese: Viekirax fiha is-sustanzi attivi ombitasvir, paritaprevir u ritonavir.
English: Darunavir, dosed 800 mg once daily, if administered at the same time as Viekirax and dasabuvir, can be used in the absence of extensive PI resistance (darunavir exposure lowered).
Maltese: Darunavir, mogħti 800 mg darba kuljum, jekk amministrat fl-istess ħin ta' Viekirax u dasabuvir, jista' jintuża fin-nuqqas ta' reżistenza estensiva ta' PI (l-esponiment ta' darunavir titbaxxa).
English: Mechanism: CYP3A4/Pgp inhibition by erythromycin, paritaprevir, ritonavir and dasabuvir.
Maltese: inibizzjoni ta' CYP3A4/Pgp minn erythromycin, paritaprevir, ritonavir u dasabuvir.
English: Emergent amino acid substitutionsa
Maltese: Sostituzzjonijiet tal-amino aċidi emerġentia
English: CONTRACEPTIVES
Maltese: KONTRAĊETTIVI
English: Among the GT1 subjects who were post renal transplant, 9/12 (75%) achieved SVR12; however, there were no virologic failures.
Maltese: Fost is-suġġetti GT1 b'trapjant tal-kliewi wara, 9/12 (75%) kisbu SVR12; madankollu, ma kienx hemm fallimenti viroloġiċi.
English: C12:= concentration at 12 hours following single dose of everolimus.
Maltese: C12:= konċentrazzjoni wara 12-il siegħa minn doża waħda ta' everolimus.
English: PEARL-IV - genotype 1a, treatment-naïve, without cirrhosis
Maltese: PEARL-IV - ġenotip 1a, naïve għall-kura, mingħajr ċirrożi
English: Viekirax is contraindicated in patients with moderate to severe hepatic impairment (Child-Pugh B or C) (see sections 4.3 and 5.2).
Maltese: Viekirax huwa kontraindikat f'pazjenti b'indeboliment epatiku moderat għal sever (Child-Pugh B jew C) (ara sezzjoni 4.3 u 5.2).
English: Primary SVR12 Assessment for Part 2 Subjects with HCV GT1/HIV-1 co-infection in TURQUOISE-I
Maltese: Tabella 17.Valutazzjoni Primarja SVR12 għall-Parti 2 Suġġetti b'HCV GT1 / HIV-1 infezzjoni fl
English: For dosing recommendations with calcineurin inhibitors see section 4.5.
Maltese: Għal rakkomandazzjonijiet ta' dożaġġ ma' inibituri ta' calcineurin ara sezzjoni 4.5.
English: Clinical monitoring and dose adjustment may be needed for other CYP1A2 substrates (e.g. ciprofloxacin, cyclobenzaprine, theophylline and caffeine).
Maltese: Monitoraġġ kliniku u l-aġġustament fid-doża jista' jkun meħtieġ għall-substrati oħra ta' CYP1A2 (eż ciprofloxacin, cyclobenzaprine, theophylline u kaffeina).
English: For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1.
Maltese: Għall-attività speċifika marbuta mal-ġenotip tal-virus ta' epatite C (HCV), ara sezzjonijiet 4.4 u 5
English: Part 2 was a Phase 3 cohort consisting of 233 subjects.
Maltese: Il-Parti 2 kienet ko-orti ta' Fażi 3 li tikkonsisti minn 233 suġġett.
English: Liver transplant subjects with cirrhosis were dosed with Viekirax and dasabuvir with RBV (GT1a for 24 weeks [n=4], GT1b for 12 weeks [n=2]).
Maltese: Suġġetti b' trapjanti tal-fwied b'ċirrożi ġew dożati b'Viekirax u dasabuvir ma' RBV (GT1a għal 24 ġimgħa [n = 4], GT1b għal 12-il ġimgħa [n = 2]).
English: No increase in incidence of ALT elevations was observed with other types of estrogens commonly used for hormone replacement therapy (e.g. oestradiol and conjugated estrogens).
Maltese: Ebda żieda fl-inċidenza ta' elevazzjoni fl-ALT ma kienet osservata ma' tipi oħra ta ' estroġeni sistemiċi komunament użati għal terapija ta' sostituzzjoni bl-ormoni (e.ż, oestradiol u estroġeni konjugat).
English: The combination of atazanavir and Viekirax + dasabuvir increase bilirubin levels, in particular when ribavirin is part of the hepatitis C regimen (see sections 4.4 and 4.8).
Maltese: dasabuvir jżid il-livelli tal bilirubin, b'mod partikolari meta ribavirin huwa parti mir-reġimen tal-epatite C (ara sezzjonijiet 4.4 u 4.8).
English: Of the 2,510 HCV genotype 1 infected subjects who were treated with regimens containing ombitasvir, paritaprevir, and dasabuvir with or without ribavirin (for 8, 12, or 24 weeks) in Phase 2b and 3 clinical trials, a total of 74 subjects (3%) experienced virologic failure (primarily post-treatment relapse).
Maltese: Mill-2,510 individwu infettati tal-ġenotipi 1 HCV li kienu trattati b'reġimi li fihom ombitasvir, paritaprevir, u dasabuvir bi jew mingħajr ribavirin (għal 8, 12, jew 24 ġimgħa) fil-provi kliniċi tal-Fażi 2b u 3, total ta' 74 individwu (3%) esperjenzaw indeboliment viroloġiku (prinċipalment rikaduta wara lkura).
English: 5 mg single dose and other vitamin K antagonists
Maltese: Doża waħda ta' 5 mg u antagonisti oħra tal vitamina K
English: Viekirax 12.5 mg/75 mg/50 mg film-coated tablets
Maltese: Viekirax 12.5 mg/75 mg/50 mg pilloli miksijin b'rita
English: 0.75 mg single dose
Maltese: 0.75 mg doża waħda
English: CYP3A4 induction by phenobarbital.
Maltese: Induzzjoni ta' CYP3A4 minn phenobarbital
English: Ombitasvir + paritaprevir + ritonavir* for 12 weeks Treatment-naïve
Maltese: Ombitasvir + paritaprevir + ritonavir* għal 12-il ġimgħa
English: Ombitasvir has EC50 values of 12, 4.3, 19, 1.7, 3.2, and 366 pM against replicon cell lines constructed with NS5A from single isolates representing genotypes 2a, 2b, 3a, 4a, 5a, and 6a, respectively.
Maltese: 3.2 u 366 pM meta mqabbel mal-linji fiċ-ċelloli ta' replicon mibnija b'NS5a minn iżolati uniċi li jirrappreżentaw il-ġenotipi 2a, 2b, 3a, 4a, 5a, u 6a, rispettivament.
English: 800/100 mg once daily
Maltese: 800/100 mg darba kuljum
English: In the post-liver transplant study, ribavirin dosing was individualized and most subjects received 600 to 800 mg per day (see section 5.1).
Maltese: Fl-studju li sar wara t-trapjant tal-fwied, id-dożaġġ ta' ribavirin kien individwalizzat u ħafna mill-individwi rċevew 600 sa 800mg kuljum (ara sezzjoni 5.1).
English: In subjects with mild hepatic impairment, paritaprevir, ritonavir and ombitasvir mean Cmax and AUC values decreased by 29% to 48%, 34% to 38% and up to 8%, respectively, compared to subjects with normal hepatic function.
Maltese: F'individwi b'indeboliment ħafif tal-fwied, paritaprevir, ritonavir u ombitasvir il-valuri Cmax u AUC medji naqqsu b'29% sa 48%, 34% sa 40% u sa 8%, rispettivament, meta mqabbel ma' individwi b'funzjoni normali tal-fwied.
English: Viekirax tablets are pink, oblong film-coated tablets of dimmensions 18.8 mm x 10.0 mm, marked with ‘AV1'.
Maltese: Pilloli roża, tawwalin, bikonvessi, miksijin b'rita b'daqs ta' 18.8mm x 10.
English: Examples of other CYP3A4 substrates which may require dose adjustment and/or clinical monitoring include calcium channel blockers (e.g. nifedipine), and trazodone.
Maltese: Eżempji ta' substrati ta' CYP3A4 oħra li jistgħu jeħtieġu aġġustament fid-doża u / jew monitoraġġ kliniku jinkludu imblokkaturi tal-kanali tal-kalċju (Eż nifedipine), u trazodone.
English: Paritaprevir had an EC50 value of 5.3 nM against the 2a-JFH-1 replicon cell line, and EC50 values of 19, 0.09, and 0.68 nM against replicon cell lines containing NS3 from a single isolate each of genotype 3a, 4a, and 6a, respectively
Maltese: Paritaprevir kellu valur EC50 ta' 5.3 nM meta mqabbel mal-linja taċ-ċelloli replicon 2a-JFH-1, u l-valuri EC50 ta' 19, 0.09, u 0.68 nM meta mqabbel mal-linji taċ-ċelloli ta' replicon li fihom NS3 minn iżolat kull wieħed tal-ġenotip 3a, 4a, u 6a,
English: In the genotype 1a replicon, the activity of ombitasvir was reduced by 896-, 58- and 243-fold against the M28T/V and H58D substitutions, respectively, and 1326-, 800-, 155-foldand 1675- to 66740- fold by the Q30E/R, L31V and Y93C/H/N substitutions, respectively.
Maltese: Fir-replicon tal-ġenotip 1a, l-attività ta' ombitasvir tnaqqset b' 896, b'58 ub'243 darba meta mqabbel mas-sotituzzjonijiet M28T/V u H58D, rispettivament, u b'1326, b'800, b'155 u b'1675 sa b'66740 darba mis-sotituzzjonijiet Q30ER, L31V u Y93C/H/N, rispettivament.
English: ↔ dasabuvir sirolimus is used together with Viekirax + dasabuvir, administer sirolimus 0.2 mg twice a week (every 3 or 4 days on the same two days each week).
Maltese: Jekk sirolimus jintuża flimkien ma' Viekirax + dasabuvir, amministra sirolimus 0.2 mg darbtejn fil-ġimgħa (kull 3 jew 4 ijiem fuq l istess jumejn kull ġimgħa).
English: ↑ sulfasalazine
Maltese: Mistenni: ↑ sulfasalazine
English: ↔ dasabuvir
Maltese: ↔ dasabuvi
English: Dasabuvir treatment-emergent variants M414T, G554S, S556G, G558R or D559G/N in NS5B were observed in 34 subjects.
Maltese: F'34 individwu kienu osservati l-varjanti emerġenti għall-kura b'dasabuvir M414T, G554S, S556G, G558R jew D559G/N f'NS5B.
English: Digoxin 0.5 mg single
Maltese: Doża waħda ta' 0.5 mg
English: Co-administration of Viekirax with or without dasabuvir with medicinal products that are substrates of OATP1B1, OATP1B3, OATP2B1 or OCT1 may increase plasma concentrations of these transporter substrates, potentially requiring dose adjustment/clinical monitoring.
Maltese: L-għoti ta' Viekirax bi jew mingħajr dasabuvir flimkien ma' prodotti mediċinali li huma substrati ta' OATP1B1, OATP1B3, OATP2B1 jew OCT1 jista' jżid il-konċentrazzjonijiet tal-plażma ta' dawn it-trasportaturi substrati, potenzjalment jeħtieġu aġġustament fid-doża / monitoraġġ kliniku.
English: Subjects (N=135) had a median age of 51 years (range: 19 to 70); 63,7% were treatment-naïve, 17.0% were prior pegIFN/RBV null responders, 6.7% were prior pegIFN/RBV partial responders, 12.6% were prior pegIFN/RBV relapsers; 65.2%were male; 8.9% were Black, 69.6% had baseline HCV RNA levels at least 800,000 IU/mL; 6.7% had bridging fibrosis (F3).
Maltese: Pazjenti (N=135) kellhom età medja ta' 51 sena (medda: 19 sa 70); 63.7% kienu naïve għall-kura, 17.0% kienu ma rrispondewx qabel b'punteġġ ta' pegIFN/RBV, 6.7% kellhom rispons parzjali qabel pegIFN/RBV, 12.6% irkadew qabel pegIFN/RBV, 65.2% kienu rġiel; 8.9% kienu Suwed, 69.6% kellhom livelli ta' RNA ta' HCV ta' mill-anqas 800,000
English: PEARL-II - genotype 1b, pegIFN+RBV-experienced, without cirrhosis
Maltese: PEARL-II - ġenotip 1b, bl-esperjenza ta' pegIFN+RBV, mingħajr ċirrożi Disinn:
English: Theoretically, Viekirax with and without dasabuvir is expected to increase the exposure to pitavastatin and fluvastatin.
Maltese: Teoretikament, Viekirax bi jew mingħajr dasabuvir huwa mistenni li jżid l-espożizzjoni għall-pitavastatin u fluvastatin.
English: In subjects with severe hepatic impairment, paritaprevir mean Cmax and AUC values increased by 3.2-to 9.5-fold; ritonavir mean Cmax values were 35% lower and AUC values were 13% higher and ombitasvir mean Cmax and AUC values decreased by 68% and 54%, respectively, compared to subjects with normal hepatic function, therefore, Viekirax must not be used in patients with severe hepatic impairment (see sections 4.2 and 4.4).
Maltese: F'individwi b'indeboliment sever tal-fwied, il-valuri Cmaxu AUC medji ta' paritaprevir u żdiedu b'3.2 sa 9.5 darbiet; il-valuri Cmax medji ta' ritonavir kienu 35% aktar baxxi u l-valuri AUC kienu 13% ogħla u lvaluri Cmax u AUC medji ta' ombitasvir naqqsu b'68% u 54%, rispettivament, meta mqabbel ma' funzjoni normali tal-fwied, għalhekk, Viekirax u dasabuvir ma għandhomx jintużaw f'pazjenti b'indeboliment sever tal-fwied (ara sezzjonijiet 4.2 u 4.4).
English: GARNET - Genotype 1b, Treatment-Naïve without cirrhosis.
Maltese: Oħrajn GARNET - Ġenotip 1b, Trattament naïve mingħajr ċirrożi
English: Purpose of the medicine alfuzosin for an enlarged prostate amiodarone, disopyramide, dronedarone used to correct irregular heartbeats astemizole, terfenadine for allergy symptoms.
Maltese: Għan tal-mediċina alfuzosin għal prostata mkabbra amiodarone, disopyramide, dronedarone użat biex jikkoreġi taħbit tal-qalb irregolari astemizole, terfenadine għal sintomi tal-allerġija.
English: Co-administration of Viekirax with or without dasabuvir can decrease exposures of medicinal products that are metabolized by CYP2C19 (e.g. lansoprazole, esomeprazole, s-mephenytoin), which may require dose adjustment/clinical monitoring.
Maltese: L-għoti flimkien ta' Viekirax bi jew mingħajr dasabuvir jistgħu jnaqqsu espożizzjonijiet ta' prodotti mediċinali li huma metabolizzati minn CYP2C19 (e.ż. lansoprazole, esomeprazole, s-mephenytoin) li jistgħu jeħtieġu aġġustament fid-doża /monitoraġġ kliniku.
English: In clinical studies
Maltese: Kummenti Kliniċi/
English: Phase 3 global multicentre studies conducted with Viekirax and dasabuvir with or without ribavirin (RBV).
Maltese: Tabella 6 Studji multiċentriċi globali, ta' Fażi 3, imwettqa b'Viekirax u dasabuvir b'ribavirin jew mingħajru (RBV).
English: The EC50 of paritaprevir against genotype 1a-H77 and 1b-Con1 strains in the HCV replicon cell culture assay was 1.0 and 0.21 nM, respectively.
Maltese: Paritaprevir L-EC50 ta' paritaprevir meta mqabbel mar-razez tal-ġenotip 1a-H77 u 1b-Con1 fl-analiżi tal-kultura taċ ċelloli ta' replicon ta' HCV kienet 1.0 u 0.21 pM, rispettivament.
English: Contraindicated enzyme inducers are provided in section 4.3 and Table
Maltese: Indutturi ta' enżimi kontraindikati huma pprovduti f'sezzjoni 4.3 u tabella 4.2.
English: Plasma HCV RNA values were measured during the clinical trials using the COBAS TaqMan HCV test (version 2.0), for use with the High Pure System (except GARNET which used COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0).
Maltese: GARNET fejn intuża COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0).
English: Uncommon: may affect up to 1 in 100 people
Maltese: Mhux komuni: jista' jaffetwa sa 1 minn kull 100 persuna
English: PEARL I was conducted in the US and Europe, M12536 in Japan.
Maltese: PEARL I kien sar fl-Istati Uniti u l-Ewropa, M12
English: Compared to the subjects with normal renal function, ombitasvir exposures were comparable in subjects with mild, moderate and severe renal impairment.
Maltese: Meta mqabbel mal-individwi b'funzjoni renali normali, l-esponimenti ta' ombitasvir kienu komparabbli f'individwi b'indeboliment ħafif, moderat u sever tal-kliewi.
English: Note: The following variants were selected in cell culture but were not treatment-emergent: NS3 variants A156T in genotype 1a, and R155Q and D168H in genotype 1b; NS5A variants Y93C/H in genotype 1a, and L31F/V or Y93H in combination with L28M, L31F/V or P58S in genotype 1b; and NS5B variants Y448H in genotype 1a, and M414T and Y448H in genotype 1b.
Maltese: Varjanti NS3 A156T fil-ġenotip 1a, u R155Q u D168H fil-ġenotip 1b; varjanti NS5A Y93C/H fil ġenotip 1a, u L31F/V jew Y93H flimkien ma' L28M, L31F/V jew P58S fil-ġenotip 1b; u l-varjanti f'NS5B Y448H fil-ġenotip 1a, u M414T u Y448H fil-ġenotip 1b.
English: Severe renal impairment or ESRD includes CKD Stage 4 defined as eGFR <30-15 mL/min/1.73 m2 or CKD Stage 5 defined as <15 mL/min/1.73 m2 or requiring haemodialysis.
Maltese: Viekirax u dasabuvir bi jew mingħajr RBV għal 12 jew 24 ġimgħat Indeboliment renali sever jew ESRD jinkludi CKD Stadju 4 definit bħala eGFR <30-15 mL/min/1.73 m2 jew CKD Stadju 5 definit bħala <15 mL/min/1.73 m2 jew li jeħtieġu emodijaliżi.
English: Substitution L28V in HCV NS5A reduced the susceptibility to ombitasvir by 21-fold.
Maltese: Is-sostituzzjoni L28V f'NS5A tal-HCV naqset is-suxxettibbiltà għal ombitasvir b'21 darba.
English: These medicines may be available without a prescription atorvastatin, lovastatin, simvastatin, lomitapide to lower blood cholesterol carbamazepine, phenytoin, phenobarbital for epilepsy cisapride for relieving certain stomach problems clarithromycin, fusidic acid, rifampicin, telithromycin for bacterial infections colchicine in patients who have severe problems with their liver or kidneys for treating gout attacks conivaptan for making the sodium levels in the blood normal efavirenz, etravirine, lopinavir/ritonavir, saquinavir, tipranavir, nevirapine, indinavir, cobicistat for HIV infection apalutamide,enzalutamide for prostate cancer ergotamine, dihydroergotamine for migraine headaches ergonovine, methylergometrine used in childbirth ethinyloestradiol-containing medicines such as those contained in most contraceptive pills and vaginal rings used for contraception for contraception itraconozole, ketoconozole, posaconazole, voriconazole for fungal infections midazolam, triazolam (when taken by mouth) for anxiety or trouble sleeping mitotane for symptoms of malignant tumours of the adrenal glands pimozide, lurasidone for schizophrenia quetiapine for schizophrenia, bipolar disorder and major depressive disorder quinidine for abnormal heart rhythms or malaria ranolazine for chronic angina (chest pain)
Maltese: Dawn il-mediċini jistgħu jkunu disponibbli mingħajr riċetta atorvastatin, lovastatin, simvastatin, lomitapide biex jitnaqqas il-kolesterol fid-demm carbamazepine, phenytoin, phenobarbital għal epilessija cisapride biex itaffi ċerti problemi fl-istonku clarithromycin, fusidic acid, rifampicin, telithromycin għall-infezzjonijiet batteriċi colchicine in patients who have severe problems with their liver or kidneys għat-trattament tal-attakki tal-gotta conivaptan
English: Mechanism: possible CYP3A4 induction by efavirenz.
Maltese: Induzzjoni ta 'CYP3A4 possibbli minn efavirenz .
English: Cases of hepatitis B virus (HBV) reactivation, some of them fatal, have been reported during or after treatment with direct-acting antiviral medicinal products.
Maltese: Każijiet ta' attivazzjoni mill-ġdid tal-virus tal-epatite B (HBV, hepatitis B virus), xi wħud minnhom fatali, ġew irrappurtati matul jew wara trattament bi prodotti mediċinali antivirali li jaħdmu b'mod dirett.
English: Geometric mean Cmax, AUC of multiple doses of Viekirax 150 mg/100 mg/25 mg once daily with dasabuvir 250 mg twice daily with food in healthy volunteers
Maltese: Cmax medju ġeometriku, AUC ta' dożi multipli ta' Viekirax 150 mg/100 mg/25 mg darba kuljum ma' dasabuvir 250 mg darbtejn kuljum mal-ikel f'voluntiera b'saħħithom
English: Among these subjects, the positive predictive value of SVR12 on SVR24 was 99.8%.
Maltese: Fost dawn l-individwi, il-valur imbassar pożittiv ta' SVR12 fuq SVR24 kien 99.8%.
English: Following a single 25 mg dose of 14C- ombitasvir approximately 90% of the radioactivity was recovered in faeces and 2% in urine.
Maltese: Wara doża waħda ta' 25mg ta' 14C- ombitasvir madwar 90% tar-radjuattività ġiet irkuprata fl-ippurgar u 2% fl- awrina.
English: 20-120 mg once daily8
Maltese: 20-120mgdarba kuljum5
English: Medicinal products metabolised by glucuronidation (UGT1A1) Paritaprevir, ombitasvir and dasabuvir are inhibitors of UGT1A1.
Maltese: Prodotti mediċinali metabolizzati minn glukuronidazzjoni (UGT1A1)
English: In vitro data indicate that paritaprevir is a substrate for the human hepatic uptake transporters, OATP1B1 and OATP1B3.
Maltese: Dejta in vitro tindika li paritaprevir huwa substrat għat-trasportaturi tat-teħid epatiku tal-bniedem, OATP1B1 u OATP1B3.
English: Overall, 660 subjects in Phase 2 and 3 clinical trials had HCV RNA results for both the SVR12 and SVR24 time points.
Maltese: Globalment, 660 individwu fil-provi kliniċi tal-Fażi 2 u 3 kellhom riżultati HCV RNA kemm għall-punti ta' tmien SVR12 kif ukoll SVR24.
English: Prior pegIFN/RBV relapser
Maltese: Fallimenti oħra b pegIFN/RBV TOTAL
English: The mean EC50 of ombitasvir against replicons containing NS5A from a panel of treatment-naïve genotype 1a and 1b isolates in the HCV replicon cell culture assay was 0.66 pM (range 0.35 to 0.88 pM; n=11) and 1.0 pM (range 0.74 to 1.5 pM; n=11), respectively.
Maltese: L-EC50 medja ta' ombitasvir meta mqabbel mar-replicons li fihom NS5A minn penil ta' iżolati ta'ġenotip 1a u 1b naïve għall-kura fl-analiżi tal-kultura taċ-ċelloli ta' replicon ta' HCV kienet 0.66 pM (medda minn 0.35 sa 0.88 pM; n=11) u 1.0 pM
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton of multipack containing 56 (4 packs of 14) film-coated tablets - including blue box
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kartuna ta' barra ta' pakkett multiplu li fih 56 (4 pakketti ta 14-il) pillola miksijin b'rita - inkluż kaxxa blu
English: Ritonavir is an in vitro inhibitor of OCT1, but the clinical relevance is unknown.
Maltese: Ritonavir huwa inibitur in vitro ta' OCT1, iżda r-rilevanza klinika mhix magħrufa.
English: Co-administration may result in increased risk for adverse events.
Maltese: Ko-amministrazzjoni tista' tirriżulta f'riskju aktar għoli għal reazzjonijiet avversi.
English: A temporary suspension of fluvastatin and pitavastatin is recommended for the duration of treatment with Viekirax.
Maltese: Sospensjoni temporanja ta' fluvastatin u pitavastatin huwa rrakkomandat għat tul tat-trattament bi Viekirax.
English: 600/100 mg twice daily
Maltese: 600/100 mg darbtejn kuljum
English: Paritaprevir is metabolised predominantly by CYP3A4 and to a lesser extent CYP3A5.
Maltese: Paritaprevir huwa prinċipalment metabolizzat minn CYP3A4 u ftit anqas minn CYP3A5.
English: The EC50 of ombitasvir against genotype 1a-H77 and 1b-Con1 strains in HCV replicon cell culture assays was 14.1 and 5 pM, respectively.
Maltese: Ombitasvir L-EC50 ta' ombitasvir meta mqabbel mar-razez tal-ġenotip 1a-H77 u 1b-Con1 fl-analiżijiet tal-kultura taċ ċelloli ta' replicon ta' HCV kienet 14.1 u 5 pM, rispettivament.