FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on population pharmacokinetic analysis of data from Phase 3 clinical studies, Asian subjects had 18% to 21% higher ombitasvir exposures, and 37% to 39% higher paritaprevir exposures than non-Asian subjects.
Maltese: Ibbażat fuq analiżi farmakokinetika tal-popolazzjoni ta' dejta minn studji kliniċi Fażi 3, individwi Ażjatiċi kellhom minn 18% sa 21% espożizzjonijiet ogħla ta' ombitasvir, u 29 % sa 39% espożizzjonijiet ogħla ta' paritaprevir minn individwi mhux Asjatiċi.
English: NA Concomitant use of Viekirax with dasabuvir is contraindicated (see section 4.3).
Maltese: Viekirax ma' dasabuvir huwa kontraindikat (ara sezzjoni 4.3).
English: ANTIHISTAMINES
Maltese: ANTIVIRALI
English: Baseline platelet count, median (× 109/L)
Maltese: Linja bażi tal-għadd ta' plejtlits, medja (x109/L) 132.0
English: The High Pure system assay had a lower limit of quantification (LLOQ) of 25 IU per mL and the AmpliPrep assay had a LLOQ of 15 IU per mL.
Maltese: Is-sistema ta' analiżi High Pure kellha limitu aktar baxx ta' kwantifikazzjoni (LLOQ) ta' 25 IU għal kull mL u l-analiżi AmpliPrep kellha LLOQ ta' 15 IU għal kull mL.
English: Mechanism: CYP3A4 and/or P-gp inhibition by itraconazole, posaconazole and paritaprevir/ ritonavir/ombi tasvir
Maltese: Inibizzjoni ta' CYP3A4/ jew P-gp minn itraconazole, posaconazole u dasabuvir, paritaprevir/ ritonavir/ ombitasvir
English: Esomeprazole Lansoprazole Mechanism: CYP2C19 induction by ritonavir.
Maltese: induzzjoni ta' CYP2C19 minn ritonavir .
English: 20 mg single dose
Maltese: 20 mg doża waħda
English: Treated subjects (N = 63) had a median age of 51 years (range: 31 to 69); 24% were Black; 19% had compensated cirrhosis; 67% were treatment-naïve; 33% had failed prior treatment with pegIFN/RBV; 89% had HCV genotype 1a infection.
Maltese: Individwi trattati (N=63) kellhom medja ta' età ta' 51-il sena (medda 31 sa 69); 24% kienu Suwed; 19% tal-individwi kellhom ċirrożi kkumpensata; 67% tal-individwi kienu naïve għall-kura ta' HCV; 33% fallew qabel it-trattament bi pegIFN/RBV; 89% kellhom infezzjoni tal-ġenotip 1a HCV.
English: 600/300 mg once daily
Maltese: 600/300 mg darba kuljum
English: Based on population pharmacokinetic analysis of data from Phase 3 clinical studies, female subjects would have approximately 55% higher, 100% higher and 15% higher ombitasvir, paritaprevir and ritonavir exposures than male subjects.
Maltese: Ibbażat fuq analiżi farmakokinetika tal-popolazzjoni ta' dejta minn studji kliniċi Fażi 3, individwi nisa jkollhom jkollhom espożizzjonijiet ta' madwar 55% ogħla, 100% ogħla u 15% ogħla ta'ombitasvir, paritaprevir uta' ritonavir milli individwi rġiel.
English: INHALED BETA AGONISTS Salmeterol
Maltese: TAL-BETA LI JITTIEĦDU MAN-NIFS Salmeterol
English: • Check for side effects of Viekirax or other antiviral medicines your doctor has prescribed for you to use with Viekirax (such as “dasabuvir” and “ribavirin”).
Maltese: • Jiċċekkja għal effetti sekondarji ta' Viekirax jew mediċini anti-virali oħra li t-tabib tiegħek ordnalek biex tieħu ma' Viekirax (bħal "dasabuvir" u "ribavirin").
English: Expected in CYP2C19 Extensive Metabolisers:
Maltese: Mistenni fil-metabolizzaturi estensivi ta' CYP2C19:
English: In Phase 3 clinical trials, 91.5% of subjects did not require ribavirin dose adjustments during therapy.
Maltese: Fi provi kliniċi tal-Fażi 3, 91.5% tal-individwi ma kellhomx bżonn doża ta' aġġustamenti fid-doża ta' ribavirin matul it-terapija.
English: Expected ↑ alfuzosin
Maltese: ↑ alfuzosin
English: Dose normalized sirolimus ratios are shown for interaction with Viekirax + dasabuvir.
Maltese: Il- proporzjonijiet tad-doża normalizzata ta' sirolimus huma murija għal interazzjoni ma' Viekirax + dasabuvir.
English: Not studied: Similar effect is expected as observed with Viekirax + dasabuvir.
Maltese: Mistenni: Effett simili mistenni kif osservat b' Viekirax + dasabuvir.
English: Medicinal products renally excreted via transport proteins Ombitasvir, paritaprevir, and ritonavir do not inhibit organic anion transporter (OAT1) in vivo as shown by the lack of interaction with tenofovir (OAT1 substrate).
Maltese: Ombitasvir, paritaprevir, u ritonavir ma jimpedixxux trasportatur tal-anjonu organiku (OAT1) in vivo kif inhu muri min-nuqqas ta' interazzjoni ma' tenofovir (substrat ta' OAT1).
English: Arm B: Viekirax and dasabuvir + RBV (24 weeks)
Maltese: Fergħa B: Viekirax u dasabuvir + RBV (24
English: In the greater than 500 genotype 1a baseline samples in this analysis, the most frequently observed resistance-associated variants were M28V (7.4%) in NS5A and S556G (2.9%) in NS5B.
Maltese: Fil-kampjuni tal-linji bażi tal-ġenotip 1a akbar minn 500 f'din l-analiżi, il-varjanti assoċjati mar-reżistenza osservati l-aktar frekwentement kienu M28V (7.4%) f'NS5A u S556G (2.9%) f'NS5B.
English: In the greater than 200 genotype 1b baseline samples in this analysis, the most frequently observed resistance-associated variants observed were Y93H (7.5%) in NS5A, and C316N (17.0%) and S556G (15%) in NS5B.
Maltese: f'NS5A u C316N (17.0%) u S556G (15%) f'NS5B.
English: OPIOIDS Methadone
Maltese: OPJOJDI methadone:
English: Ombitasvir, paritaprevir and ritonavir are highly bound to plasma proteins.
Maltese: Distribuzzjoni Ombitasvir, paritaprevir u ritonavir huma marbuta ħafna mal-proteini fil-plażma.
English: Duloxetine 60 mg single dose
Maltese: 60 mg doża waħda
English: Viekirax with or without dasabuvir was also evaluated without ribavirin in 18 GT1a- and GT4-infected patients; no adverse events of anaemia were seen in these subjects.
Maltese: Viekirax bi jew mingħajr dasabuvir ġie wkoll evalwat mingħajr ribavirin f'18 -il pazjent infettati bil-GT1a u GT4; l-ebda avvenimenti avversi ta' anemija ma dehru f'dawn l-individwi.
English: The highest documented single dose administered to healthy volunteers was 400 mg for paritaprevir (with 100 mg ritonavir), 200 mg for ritonavir (with 100 mg paritaprevir) and 350 mg for ombitasvir.
Maltese: (b'100 mg ta' ritonavir), 200 mg għal ritonavir (b'100 mg paritaprevir) u 350 mg għal ombitasvir.
English: Two patients discontinued Viekirax and dasabuvir due to elevated ALT, including one on ethinyloestradiol.
Maltese: Żewġ pazjenti ma komplewx Viekirax u dasabuvir minħabba ALT elevat, inkluż wieħed fuq ethinyloestradiol.
English: • Each tablet contains 12.5 mg of ombitasvir, 75 mg of paritaprevir and 50 mg of ritonavir.
Maltese: • Kull pillola fiha 12.5 mg ta' ombitasvir, 75 mg ta' paritaprevir u 50 mg ta' ritonavir.
English: Viekirax and dasabuvir for 12 or 24 weeks with or without ribavirin ( investigator chosen dose ) for GT1 and GT4 infection
Maltese: Viekirax u dasabuvir għal 12 jew 24 ġimgħa b'ribavirin jew mingħajru (doża magħżula mill-investigatur) għall-infezzjoni GT1 u GT4
English: Mechanism: CYP3A4/Pgp inhibition by conivaptan and paritaprevir/ ritonavir/ombi tasvir
Maltese: Inibizzjoni ta' CYP3A4/Pgp minn conivaptan u paritaprevir/ ritonavir/omb itasvir
English: In a pooled analysis of clinical trials with Viekirax and dasabuvir with and without ribavirin, 1% of subjects experienced serum ALT levels greater than 5 times the upper limit of normal (ULN) after starting treatment.
Maltese: F'analiżi miġbura ta' provi kliniċi b'Viekirax u dasabuvir flimkien ma' jew mingħajr ribavirin, 1% tal individwi esperjenzaw livelli ta 'ALT fis-serum aktar minn 5 darbiet ogħla mil-limitu tan-normal ( ULN ) wara li beda t-trattament.
English: Arm A: Viekirax and dasabuvir + RBV (12 weeks)
Maltese: Fergħa A: Viekirax u dasabuvir + RBV (12-il ġimgħa)
English: Paritaprevir/ritonavir had no effects on embryo-foetal viability or on fertility when evaluated in rats at exposures 2- to 8-fold higher than the exposure in humans at the recommended clinical dose.
Maltese: Paritaprevir/ritonavir ma kellhomx effetti fuq il-vijabilità tal-embriju-fetu jew fuq il fertilità meta evalwati fil-firien b'esponimenti 2 sa 8 darbiet ogħla mill-espożizzjoni fil-bnedmin fid-doża klinika rrakkomandata.
English: TURQUOISE-III: treatment-naïve or pegIFN + RBV-experienced with compensated cirrhosis Design:
Maltese: TURQUOISE-III: naïve għall-kura jew bl-esperjenza ta' pegIFN+RBV, b'ċirrożi kkumpensata Disinn:
English: NS3 variants V36A/M and R155K and NS5B variants M414T and S556G remained detectable at posttreatment Week 48, whereas NS3 variant D168V and all other NS5B variants were not observed at posttreatment Week 48.
Maltese: Il-varjanti ta' NS3 V36A/M u R155K u l-varjanti ta' NS5B M414T u S556G baqgħu identifikabbli wara l kura fit-48 Ġimgħa, filwaqt li l-varjant ta' NS3 D168V u l-varjanti NS5B l-oħra kollha ma kinux osservati wara l-kura fit-48 Ġimgħa.
English: Treated subjects (N=68) had a median age of 58 years (range: 32-77 years); 83.8% were male; 58.8% were Black; 73.5% of subjects were infected with HCV GT1a; 75.0%% had Stage 5 CKD and 69.1% were on haemodialysis.
Maltese: 32-77 sena); 83.8% kienu rġiel; 58.8% kienu Suwed; 73.5%
English: See also Table 2 for specific advice on raltegravir and buprenorphine, which have been evaluated in drug interaction studies.
Maltese: Ara wkoll Tabella 2 għal parir speċifiku dwar raltegrevir u buprenorphine li ġew evalwati fi studji interazzjoni tal-mediċina .
English: Following a 25 mg single dose of 14C-ombitasvir given alone, unchanged parent drug accounted for 8.9% of total radioactivity in human plasma; a total of 13 metabolites were identified in human plasma.
Maltese: 8.9% tar-radjuattività totali fil-plażma; kienu identifikati total ta' 13-il metabolit fil-plażma tal-bniedem.
English: • colchicine in patients with renal or hepatic impairment
Maltese: • colchicine f'pazjenti b'indeboliment renali jew epatiku
English: With RBV n/N % n/N % n/N %
Maltese: n/N % n/N
English: The persistence of paritaprevir, ombitasvir, and dasabuvir resistance-associated amino acid substitutions in NS3, NS5A, and NS5B, respectively, was assessed in genotype 1a-infected subjects in Phase 2b trials.
Maltese: u dasabuvir f'NS3, NS5A, u NS5B, rispettivament, kienet ivvalutata fl-individwi infettati bil-ġenotip 1a fil-provi tal-Fażi 2b.
English: In HCV-infected subjects, in comparison to those without cirrhosis, paritaprevir AUC increased to 2.2- to 2.4-fold for those with compensated cirrhosis (Child-Pugh A) and 3- to 4-fold for those with Child-Pugh B cirrhosis.
Maltese: F'pazjenti infettati b'HCV, meta mqabbla ma' dawk mingħajr ċirrożi, l-AUC ta' paritaprevir żdied min 2.2sa 2.4-darbiet għal dawk b'ċirrożi kkumpensata (Child-Pugh A) u minn 3- sa 4 darbiet għal dawk li kellhom iċ-ċirrożi Child-Pugh B.
English: Ciclosporin 100 mg dosed alone, 10 mg administered with Viekirax and 30 mg administered with Viekirax + dasabuvir.
Maltese: 3. Ciclosporin 100 mg mogħti waħdu, 10mg mgħoti ma' Viekirax u 30 mg mogħtijama' Viekirax + dasabuvir.
English: Purpose of the medicine alprazolam, diazepam for anxiety, panic attacks and trouble sleeping ciclosporin, everolimus, sirolimus, tacrolimus to suppress the immune system cyclobenzaprine, carisoprodol for muscle spasms colchicine for patients whose kidney and liver function test are normal for treating gout attacks or familial Mediterranean fever digoxin, amlodipine, nifedipine, valsartan, diltiazem, verapamil, candesartan, losartan for heart problems or high blood pressure encorafenib for skin cancer furosemide for the build-up of too much fluid in the body hydrocodone for pain levothyroxine for thyroid problems rilpivirine, darunavir, atazanavir for HIV infection omeprazole, lansoprazole, esomeprazole for stomach ulcers and other stomach problems ibrutinib, imatinib for the treatment of some cancers of the blood fluvastatin, pitavastatin, pravastatin, rosuvastatin to lower blood cholesterol dabigatran to thin the blood fexofenadine for hay fever s-mephenytoin for epilepsy sulfasalazine for inflammatory bowel disease repaglinide for lowering blood sugar erythromycin for bacterial infections steroid or corticosteroid medicines (such as fluticasone)
Maltese: Omeprazole, lansoprazole, esomeprazole għal ulċeri fl-istonku u problemi fl istonku oħra ibrutinib, imatinib għat-trattament ta' xi kanċers taddemm fluvastatin, pitavastatin, pravastatin, rosuvastatin biex jitnaqqas il-kolesterol fid-demm dabigatran biex iraqqaq id-demm fexofenadine għall-hay fever s-mephenytoin għall-epilepsija sulfasalazine għall-marda infjammatorja tal-musrana repaglinide biex jitbaxxa iz-zokkor fid-demm erythromycin għall-infezzjonijiet batteriċi mediċini bi sterojdi jew kortiko-sterojdi (bħal fluticasone)
English: DIURETICS Furosemide
Maltese: Furosemide
English: Paritaprevir /ritonavir was not carcinogenic in a 6-month transgenic mouse study up to the highest dosage tested (300 mg/30 mg/kg/day), resulting in paritaprevir AUC exposures approximately 38-fold higher than those in humans at the recommended dose of 150 mg.
Maltese: Paritaprevir/ritonavir ma kienx karċinoġeniku f'studju tal-ġrieden transġeniċi ta' 6 xhur sal-ogħla dożaġġ ittestjat (300 mg/30 mg/kg/kuljum), li rriżulta f'espożizzjonijiet ta' AUC ta' paritaprevir madwar 38 darba ogħla minn dawk fil-bnedmin fid-doża rrakkomandata ta' 150 mg.
English: Pooled analyses of clinical trials
Maltese: Analiżi miġbura ta' provi kliniċi
English: Y56H alone could not be evaluated due to poor replication capacity, however, the combination of Y56H and D168A/V/Y reduced the activity of paritaprevir by 700- to 4118fold.
Maltese: replikazzjoni ħażina, madankollu, il-kombinazzjoni ta' Y56H u D168A/V/Y naqqsu l-attività ta' paritaprevir b'700 sa b'4118 darba.
English: Ritonavir did not exhibit a direct antiviral effect on the replication of HCV subgenomic replicons, and the presence of ritonavir did not affect the in vitro antiviral activity of paritaprevir.
Maltese: Ritonavir ma eżebixxix effetti antivirali dirett fuq ir-replikazzjoni tar-replicons subġenomiċi HCV, u lpreżenza ta' ritonavir ma affettwatx l-attività antivirali in vitro ta' paritaprevir..
English: In a phase 2, multicentre, open-label, single arm study, 38 treatment-naïve or pegIFN/RBV treatment experienced, non-cirrhotic subjects with genotype 1 infection who were on stable doses of methadone (N=19) or buprenorphine +/- naloxone (N=19) received 12 weeks of Viekirax and dasabuvir with ribavirin.
Maltese: Fil-fażi 2, multiċentriku, open-label,studju b'fergħha waħda, 38 li kienu naïve għall-kura jew blesperjenza fit-trattament ta' pegIFN/RBV, individwi mhux biċ-ċirrożi bl-infezzjoni tal-ġenotip 1 li kienu fuq doża stabbli ta' methadone (N=19) jew buprenorphine +/- naloxone (N=19) irċevew 12-il ġimgħa ta' Viekirax u dasabuvir ma' ribavirin.
English: 500 mg single dose
Maltese: 500 mg doża waħda
English: ↑ repaglinide
Maltese: Mistenni: ↑ repaglinide
English: ↑ disopyramide
Maltese: ↑ amiodarone ↑ disopyramide
English: Lopinavir/ritonavir 800/200 mg once daily (administered in the evening) was also administered with Viekirax with or without dasabuvir.
Maltese: Lopinavir/ritonavir 800/200 mg darba kuljum (amministrati fil-għaxija) kien ukoll amministrat ma' dasabuvir ma' ombitasvir/paritaprevir/ritonavir.
English: Concerning genotypespecific virological and clinical activity, see section 5.1.
Maltese: Rigward attività klinika u viroloġika speċifika għall-ġenotip, ara sezzjoni 5
English: Mechanism: CYP2C19 induction and CYP3A4 inhibition by ritonavir
Maltese: Induzzjoni ta' CYP2C19 minn ritonavir u inibizzjoni ta' CYP3A4 minn ritonavir
English: PEARL- I- genotype 4, treatment-naïve or pegIFN + RBV experienced without cirrhosis
Maltese: PEARL- I- naïve għall-kura, ġenotip 4 jew bl-esperjenza ta' pegIFN + RBV mingħajr ċirrożi Disinn:
English: Metabolism and nutrition disorders Uncommon
Maltese: Disturbi fill-metaboliżmu u n-nutrizzjoni
English: Patients who are taking ethinyloestradiol-containing medicinal products (i.e. most combined oral contraceptives or contraceptive vaginal rings) must switch to an alternative method of contraception (e.g., progestin only contraception or non-hormonal methods) prior to initiating Viekirax with or without dasabuvir therapy (see sections 4.3 and 4.5).
Maltese: Pazjenti li qed jieħdu prodotti mediċinali li fihom ethinyloestradiol (jiġifieri ħafna mill-kontraċettivi orali kkombinati jew ċrieki vaġinali kontraċettivi) għandhom jaqilbu għal metodu alternattiv ta' kontraċezzjoni (pereżempju, kontraċezzjoni li tinvolvi progestin biss jew metodi li m'humiex ormonali) qabel tinbeda terapija b'Viekirax bi jew mingħajr dasabuvir (ara sezzjonijiet 4.3 u 4.5).
English: Overall, 107 of 113 subjects without cirrhosis and 147 of 155 subjects with cirrhosis achieved SVR12 after 12-24 weeks of treatment.
Maltese: B'mod ġenerali, 107 minn 113 individwi mingħajr ċirrożi u 147 minn155 individwi b'ċirrożi kisbu SVR12 wara 12-24-il ġimgħa ta' trattament.
English: Ombitasvir, paritaprevir and ritonavir were absorbed after oral administration with mean Tmax of approximately 4 to 5 hours.
Maltese: Ombitasvir, paritaprevir u, ritonavir, kienu assorbiti wara għoti orali b'Tmax ta' madwar 4 sa 5 sigħat.
English: GT1b Arm A: Viekirax and dasabuvir + RBV Arm B: Viekirax and dasabuvir Treatment-naïve and peginterferon+ribavirin -experienced, with compensated cirrhosis
Maltese: GT1b Fergħa A: Viekirax u dasabuvir + RBV Fergħa B: Viekirax u dasabuvir Naïve għall-kura u bl-esperjenza ta' Peginterferon+ribavirin , b'ċirrożi kkumpensata
English: Bilirubin elevations were not associated with aminotransferase elevations.
Maltese: Ebda wieħed mill individwi bi iperbilirubinimja kellhom elevazzjonijiet konkomitanti ta' aminotransferases.
English: Clinical trials in subjects with genotype 4 chronic hepatitis C
Maltese: Provi kliniċi f'individwi b'epatite Ċ kronika tal-ġenotip 4
English: 10 mg single dose
Maltese: 10 mg doża waħda
English: The mean EC50 of paritaprevir against replicons containing NS3 from a panel of treatment-naïve genotype 1a and 1b isolates in the HCV replicon cell culture assay was 0.86 nM (range 0.43 to 1.87 nM; n=11) and 0.06 nM (range 0.03 to 0.09 nM; n=9), respectively.
Maltese: L-EC50 medja ta' paritaprevir meta mqabbel mar-replicons li fihom NS3 minn penil ta' iżolati tal-ġenotip 1a u 1b naïve għall-kura fl analiżi tal-kultura taċ-ċelloli ta' replicon ta' HCV kienet 0.86 nM (medda minn 0.43 sa 1.87 nM; n=11) u
English: Method of administration
Maltese: (amministrati
English: Tacrolimus 2 mg was dosed alone, 0.5 mg administered with Viekirax and 2 mg was administered with Viekirax + dasabuvir.
Maltese: Tacrolimus 2 mg ingħata waħdu , 0.5 mg ingħata ma' Viekirax u 2mg ġie mgħoti ma' Viekirax + dasabuvir.
English: In the genotype 1b replicon, the activity of paritaprevir was reduced 76- and 159-and 337- fold by D168A, D168H, D168V, and D168Y respectively.
Maltese: Firreplicon tal-ġenotip 1b, l-attività ta' paritaprevir tnaqqset b'76 ub'159 u b'337 darba minn D168A,
English: HIV protease inhibitors other than atazanavir and darunavir (e.g., indinavir, saquinavir, tipranavir, lopinavir/ritonavir) are contraindicated (see section 4.3).
Maltese: Inibituri tal-protease tal-HIV minbarra atazanavir u darunavir (e.ż. indinavir, saquinavir, tipranavir,
English: Sirolimus blood concentrations should be monitored every 4 to 7 days until 3 consecutive trough levels have shown stable concentrations of sirolimus.
Maltese: sirolimus fid-demm għandhom jiġu monitorjati kull 4 sa 7 ijiem sakemm 3 livelli ta' doża l-iktar minimi (troughs) konsekuttivi juru konċentrazzjonijiet stabbli ta' sirolimus.
English: ↔ tenofovir ombitasvir paritaprevir
Maltese: ↔ tenofovir ombitasvir paritaprevir mf darba kuljum
English: Mechanism: CYP3A4 inhibition by protease inhibitors.
Maltese: inibizzjoni ta' CYP3A4 minn inibituri tal-protease
English: The activity of ombitasvir was reduced by 661-, 77-, 284- and 142-fold against the genotype 1b substitutions L28T, Y93H, R30Q in combination with Y93H, and L31M in combination with Y93H, respectively.
Maltese: Fir-replicon tal-ġenotip 1b, l-attività ta' ombitasvir tnaqqset b'inqas minn 10 darbiet mill-varjanti fil-pożizzjonijiet talamino aċidi 30 u 31. L-attività ta' ombitasvir tnaqqset b'661, b'77, b'284 u b'142 darba meta mqabbel mas-sostituzzjonijiet tal-ġenotip 1b L28T, Y93H, R30Q flimkien ma' Y93H, u L31M flimkien ma' Y93H, rispettivament.
English: 10 of 34 subjects (29.4%) dose modified ribavirin due to decrease in haemoglobin and 2.9% (1/34) had an interruption of ribavirin.
Maltese: emoglobina ta'inqas minn 10 g / dL. 10 individwi minn 34 (29.4%) kellhom doża ta' ribavirin modifikata minħabba tnaqqqis fl-emoglobina u 2.9% (1/34) kellhom interruzzjoni ta' ribavirin.
English: Medicinal products transported by P-gp in the intestine While paritaprevir, ritonavir and dasabuvir are in vitro inhibitors of P-gp, no significant change was observed in the exposure of the P-gp substrate digoxin when administered with Viekirax and dasabuvir.
Maltese: Prodotti mediċinali trasportati minn P-gp fil-musrana Filwaqt li paritaprevir, ritonavir u dasabuvir huma inibituri in vitro ta' P-gp, ma ġiet osservata ebda bidla sinifikanti fl-espożizzjoni tas-substrat ta' P-gp digoxin meta jingħata ma' Viekirax u dasabuvir.
English: At least 5 minor metabolites of paritaprevir have been identified in circulation that accounted for approximately 10% of plasma radioactivity.
Maltese: Ġew identifikati tal-anqas 5 metaboliti minuri ta' paritaprevir fiċ-ċirkolazzjoni li ammontaw għal madwar 10% tar-radjuattività fil-plażma.
English: CYP3A4 inhibition by cobicistat
Maltese: inibizzjoni ta' CYP3A4 minn cobicistat
English: CYP3A4 inhibitors:
Maltese: Inibituri ta' CYP3A4:
English: Nausea, Diarrhoea
Maltese: Nawsja, Dijarea
English: Quinidine
Maltese: Quetiapine
English: Viekirax and dasabuvir without ribavirin or with weight-based ribavirin for 12 weeks Treated subjects (N=419) had a median age of 50 years (range: 19 to 70), 45.8% were male; 4.8% were Black; 9.3% had a history of depression or bipolar disorder; 73.3% had baseline HCV RNA of at least 800,000 IU/mL; 20.3% had portal fibrosis (F2) and 10.0% had bridging fibrosis (F3).
Maltese: Il-pazjenti kkurati (N=419) kellhom età medja ta' 50 sena (medda: 19 sa 70), 45.8% kienu rġiel; 4.8% kienu Suwed; 9.3% kellhom storja ta' dipressjoni jew disturb bipolari; 73.3% kellhom RNA tal-HCV fil linja bażi ta' mill-anqas 800,000
English: Prior pegIFN/RBV null responder Prior pegIFN/RBV partial responder Prior pegIFN/RBV relapser HCV genotype 1b
Maltese: Pazjenti li ma kellhom ebda rispons qabel pegIFN/RBV Pazjenti li kellhom rispons parzjali qabel pegIFN/RBV Pazjenti li rkadew qabel pegIFN/RBV Ġenotip 1b HCV
English: Target
Maltese: TIKKETTAR
English: Mechanism: CYP3A inhibition by ritonavir
Maltese: CYP3A minn ritonavir
English: Subjects had a median age of 56 years (range: 32 to 81); 50% were treatment-naïve, 28% were prior pegIFN/RBV null responders; 10% were prior pegIFN/RBV partial responders, 13% were prior pegIFN/RBV relapsers; 70% were male; 17% were Black; 73% had baseline HCV RNA levels of at least 800,000 IU per mL; 17% had platelet counts of less than 90 x 109 per L; and 4% had albumin less than 3.5 mg per dL.
Maltese: Individwi kellhom età medja ta' 56 sena (medda: 32-81); 50% kienu naïve għall-kura, 28% kienu qabel li ma rrispondewx għal pegIFN / RBV; 10% kienu qabel li irrispondew parzjalment għal pegIFN / RBV, 13% kienu qabel li kellhom rikaduta għal pegIFN / RBV; 70% kienu rġiel; 17% kienu Suwed; 73%
English: Paritaprevir -derived material was minimally transferred through the placenta in pregnant rats.
Maltese: Il-materjal derivat minn paritaprevir kien ittrasferit b'mod minimu mill-plaċenta f'firien tqal.
English: Mechanism: CYP2C19 induction by ritonavir.
Maltese: CYP2C19 minn ritonavir.
English: Mechanism: CYP3A4 induction by rifampicin.
Maltese: induzzjoni ta' CYP3A4/CY P2C8 minn rifampicin
English: D168Y V36Ac, V36Mc, F43Lc, D168H, E357Kc NS5A M28T M28Ve Q30Re Y93H H58D, H58P, Y93N NS5B A553T S556G C316Y, M414T, G554S, S556R, G558R, D559G, D559N, Y561H a. Observed in at least 2 subjects of the same subtype.
Maltese: C316Y, M414T, G554S, S556R, G558R, D559G, D559N, Y561H a.
English: The effect on Cmax and AUC of DAAs and lopinavir was similar to that observed when lopinavir/ritonavir 400/100 mg twice daily was administered with Viekirax with or without dasabuvir.
Maltese: L-effett fuq is-Cmass u l-AUC ta' DAAs u lopinavir kienet simili għal dik osservata meta lopinavir/ritonavir 400/100 mg kienu amministrati darbtejn kuljum ma' Viekirax bi jew mingħajr dasabuvir.