FrancophonIA/ELRC3.0 huggingface dataset:
English: Disopyramide
Maltese: Paracetamol
English: Tacrolimus
Maltese: gemfibrozil
English: ↑ fluvastatin ↑ pitavastatin
Maltese: Mhux studjat . mistenni : ↑ fluvastatin ↑ pitavastatin
English: Double variants including combinations of V36LM, F43L, Y56H, Q80K or E357K with R155K or with a D168 substitution reduced the activity of paritaprevir by an additional 2 to 3-fold relative to the single R155K or D168 substitution.
Maltese: Y56H, Q80K jew E357K ma' R155K jew b'sostituzzjoni ta' D168 naqqsu l-attività ta' paritaprevir b'darbtejn sa 3 darbiet aktar relattivament għal sostituzzjoni unika ta' R155K jew D168.
English: A side-by-side tabulation is shown to simplify presentation; direct comparison across trials should not be made due to differing trial designs.
Maltese: Hija murija tabulazzjoni allinjata biex tiġi ssimplifikata l-preżentazzjoni; ma għandux isir tqabbil dirett fil-provi minħabba disinji ta' provi differenti.
English: Compared to the subjects with normal renal function, paritaprevir Cmax values were comparable, but AUC values were 19%, 33% and 45% higher in mild, moderate and severe renal impairment, respectively.
Maltese: Meta mqabbel mal-individwi b'funzjoni renali normali, il-valuri ta' Cmax ta' paritaprevir kienu komparabbli, iżda il-valuri ta' AUC kienu 19%,
English: NA ↔ ombitasvir/paritaprevir/dasabuvir (based on the crossstudy comparison)
Maltese: ↔ paritaprevirombitasvir/dasabuvir (bbażat fuq studju inkroċjat ta' tqabbil)
English: The activity of ombitasvir was attenuated 11- to 13-fold in the presence of 40% human plasma.
Maltese: L-attività ta' ombitasvir kienet imnaqqsa minn 11 sa 13-il darba fil-preżenza ta' 40% fil-plażma tal-bniedem.
English: • There may also be a risk for birth defects if ribavirin is taken by a male patient, whose female partner becomes pregnant.
Maltese: • Jista' jkun hemm ukoll riskju għal difetti tat-twelid jekk ribavirin huwa meħud minn pazjent, li l partner femminili tiegħu toħroġ tqila.
English: Effect of baseline HCV substitutions/polymorphisms on treatment outcome A pooled analysis of subjects with genotype 1 HCV infection, who were treated with ombitasvir, paritaprevir, and dasabuvir (a non-nucleotide NS5B inhibitor) with or without ribavirin in the Phase 2b and 3 clinical trials was conducted to explore the association between baseline NS3/4A, NS5A or NS5B substitutions/polymorphisms and treatment outcome in recommended regimens.
Maltese: Twettqet analiżi miġbura tal-individwi b'infezzjoni ta' HCV tal-ġenotip 1, li kienu trattati b' ombitasvir, paritaprevir, u dasabuvir (inibituri non-nukleotidi ta' NS5B ) bi jew mingħajr ribavirin fil-provi kliniċi tal-Fażi 2b u 3 ikkurati b'ABT-450, ombitasvir, u dasabuvir b'RBV jew mingħajru biex tiġi esplorata l assoċjazzjoni bejn is-sostituzzjonijiet/polimorfiżmi
English: Viekirax tablets are taken with other antiviral medicines such as dasabuvir and ribavirin.
Maltese: Il-pilloli ta' Viekirax jittieħdu ma' mediċini anti-virali oħra bħal dasabuvir u ribavirin .
English: Ranolazine
Maltese: Anzjani
English: Drug interactions need to be carefully taken into account in the setting of HIV co-infection (for details see section 4.5, Table 2).
Maltese: Interazzjonijiet tal-mediċina għandhom jitqiesu b'attenzjoni fil-każ ta' ko-infezzjoni bl-HIV (għad-dettalji ara sezzjoni 4.5, Tabella 2).
English: Viekirax administered with or without dasabuvir did not affect the exposures of the CYP2C9 substrate, warfarin.
Maltese: Viekirax amministrat bi jew mingħajr dasabuvir ma affettwatx l-espożizzjoni tas-substrat tal- CYP2C9, warfarin.
English: Mechanism: CYP3A4 induction by carbamazepine
Maltese: Induzzjoni ta' CYP3A4 minn carbamazepin e
English: In subjects with moderate hepatic impairment, ombitasvir and ritonavir mean Cmax and AUC values decreased by 29% to 30% and 30 to 33%, respectively, while paritaprevir mean Cmax and AUC values increased by 26% to 62% compared to subjects with normal hepatic function.
Maltese: F'individwi b'indeboliment moderat tal-fwied, il-valuri Cmax u AUC medji ta' ombitasvir u ritonavir naqqsu b'29% sa 30%, 30% sa 33% rispettivament, filwaqt il-valuri Cmax u AUC medji ta' paritaprevir żdiedu b'26% sa 62% meta mqabbel ma' individwi b'funzjoni normali tal-fwied (ara sezzjonijiet 4.2, 4.4
English: Ritonavir plasma concentrations increased when renal function was reduced: Cmax and AUC values were 26% to 42% higher, 48% to 80% higher and 66% to 114% higher in subjects with mild, moderate and severe renal impairment, respectively.
Maltese: 42% ogħla, 48% sa 80% ogħla u 66% sa 114% ogħla f'individwi f'indeboliment renali ħafif, moderat u sever, rispettivament.
English: 5 mg single dose
Maltese: 5 mg doża waħda
English: Treated subjects (N = 233) had a median age of 49 years (range: 26 to 69); 10% were Black; 12% had compensated cirrhosis; 66% were treatment-naïve; 32% had failed prior treatment with pegIFN/RBV; 2% had failed prior treatment with sofosbuvir.
Maltese: = 233) kellhom età medjana ta' 49 sena (firxa: 26-69); 10% kienu l-Iswed; 12% kellhom ċirrożi kkumpensata; 66% ma kellhomx kura; 32% kienu fallew trattament minn qabel b'pegIFN / RBV; 2% kienu fallew trattament minn qabel ma 'sofosbuvir.
English: Subjects with renal transplant and no cirrhosis were dosed for 12 weeks (with RBV for GT1a [n=9], without RBV for GT1b [n=3]).
Maltese: Is-suġġetti b'trasplan tal-kliewi u mingħajr ċirrożi ġew dożati għal 12-il ġimgħa (b'RBV għal GT1a [n = 9], mingħajr RBV għal GT1b [n = 3]).
English: Overall SVR12 HCV genotype 1a HCV genotype 1b Outcome for subjects without SVR12 On-treatment VFa Relapse Otherb a. Confirmed HCV ≥ 25 IU/mL after HCV RNA < 25 IU/mL during treatment, confirmed 1 log10 IU/mL increase in
Maltese: HCV ≥ 25 IU/mL ikkonfermat wara RNA tal-HCV < 25 IU/mL matul il-kura, żieda ta' 1 log10 IU/mL
English: ↑ Sulfamethoxazole,
Maltese: Viekirax mingħajr
English: Therefore, Viekirax with or without dasabuvir is not expected to affect medicinal products which are primarily excreted by the renal route via these transporters (see section 5.2).
Maltese: Għalhekk Viekirax bi jew mingħajr dasbuvir mhux mistenni li jaffettwa prodotti mediċinali li huma primarjament eliminati mill-kliewi permezz ta' dawn it-trasportaturi(ara sezzjoni 5.2).
English: Ombitasvir was not carcinogenic in a 6-month transgenic mouse study up to the highest dosage tested (150 mg/kg/day), resulting in ombitasvir AUC exposures approximately 26-fold higher than those in humans at the recommended clinical dose of 25 mg.
Maltese: Ombitasvir ma kienx karċinoġeniku f'studju tal-ġrieden transġeniċi ta' 6 xhur sal-ogħla dożaġġ ittestjat (150 mg/kg/kuljum), li rriżulta f'espożizzjonijiet ta' AUC ta' ombitasvir madwar 26 ogħla minn dawk fil bnedmin fid-doża klinika rrakkomandata ta' 25 mg.
English: Co-administration of Viekirax with or without dasabuvir with medicinal products primarily metabolized by CYP3A may result in increased plasma concentrations of these medicinal products.
Maltese: prodotti mediċinali primarjament metabolizzat minn CYP3A jista' jirriżulta f'żieda ta' konċentrazzjonijiet fil-plażma ta' dawn il-prodotti mediċinali.
English: Following a 200 mg 14C -paritaprevir dose with 100 mg ritonavir, approximately 88% of the radioactivity was recovered in faeces with limited radioactivity (8.8%) in urine.
Maltese: Wara doża ta' 200 mg, id-doża ta ‘ 14C - paritaprevir b'100 mg ta' ritonavir, madwar 88% tar-radjuattività ġiet irkuprata fl-ippurgar b'radjuattività limitita
English: Patients should be informed that fatigue has been reported during treatment with Viekirax in combination with dasabuvir and ribavirin (see section 4.8).
Maltese: Il-pazjenti għandhom jiġu infurmati li ġiet irrapportata għejja matul il-kura b'Viekirax flimkien ma' dasabuvir u ribavirin (ara sezzjoni 4.8).
English: Sirolimus 2 mg was dosed alone, 0.5 mg administered with Viekirax + dasabuvir.
Maltese: Sirolimus 2 mg kien mogħti waħdu, 0.5 mg mogħti ma' Viekirax + dasabuvir.
English: The activity of paritaprevir was attenuated 24 to 27 -fold in the presence of 40% human plasma.
Maltese: L-attività ta' paritaprevir kienet imnaqqsa b' 24 sa 27 darba fil-preżenza ta' 40% fil-plażma tal-bniedem.
English: AbbVie SA Tél/Tel: +32 10 477811
Maltese: AbbVie Polska Sp. z o.o. Tel.: +48 22 372 78 00
English: Medicines you must not take with Viekirax Medicine or active substance
Maltese: Mediċini li ma għandekx tieħu ma' Viekirax Mediċina jew sustanza attiva
English: Mechanism: P-gp inhibition by paritaprevir, ritonavir and dasabuvir.
Maltese: Inibizzjoni ta' BCRP u P-gp minn paritaprevir, ritonavir u dasabuvir
English: Clinical Comments ritonavir.
Maltese: inkluż ritonavir.
English: 300 mg single dose
Maltese: 300 mg doża waħda
English: GT1b Arm A: Viekirax and dasabuvir + RBV Arm B: Viekirax and dasabuvir
Maltese: GT1b Fergħa A: Viekirax u dasabuvir + RBV Fergħa B: Viekirax u dasabuvir
English: The absolute bioavailability of ombitasvir and paritaprevir was approximately 50% when administered with food as Viekirax.
Maltese: Il-bijodisponibilità assoluta ta' ombitasvir u paritaprevir kienet ta' madwar 50% meta jingħata mal-ikel bħala Viekirax.
English: 10 kg change in body weight from 76 kg (median weight in the Phase 3 studies) would results in <10% change in ombitasvir exposures, and no change in paritaprevir exposures.
Maltese: Bidla ta' 10 kg fil-piż tal-ġisem minn 76 kg (piż medjan fil-studji Fażi 3) se jiriżulta f' bidla ta' < 10% fl-espożizzjonijiet ta' ombitasvir, u l-ebda bidla fil-espożizzjonijiet ta' paritaprevir.
English: Concerning recommended regimens with different HCV genotypes, see section 4.2.
Maltese: Rigward korsijiet rrakkomandati b'ġenotipi differenti ta' HCV, ara sezzjoni 4.2.
English: INSULIN SECRETAGOGUES Repaglinide
Maltese: SUSTANZI LI JIKKAWŻAW SEKREZZJONI TAL-INSULINA Repaglinide
English: The interactions between pitavastatin and fluvastatin and Viekirax have not been investigated.
Maltese: Pitavastatin u fluvastatin L-interazzjonijiet ma' pitavastatin u fluvastatin u Viekirax ma ġewx investigati.
English: • mitotane
Maltese: • Rimettar
English: In subjects receiving Viekirax and dasabuvir with ribavirin, the most commonly reported adverse reactions (greater than 20% of subjects) were fatigue and nausea.
Maltese: F'individwi li jirċievu Viekirax u dasabuvir ma' ribavirin, l-iktarreazzjonijiet avversi komuni rrapportati (iktar minn 20% tal-individwi) kienu għejja u dardir.
English: Paritaprevir treatment-emergent variants V36A/M, R155K or D168V were observed in NS3 in 47 subjects.
Maltese: Kienu osservati l-varjanti emerġenti għall-kura ta' paritaprevir V36A/M, R155K jew D168V f'NS3 f'47 individwu.
English: MARKETING AUTHORISATION NUMBER(S)
Maltese: Individwi ttrattati (N
English: 200 mg once daily/300 mg once daily
Maltese: 200 mg darba kuljum/ 3
English: ↑ norgestrel ↑ nor elgestromine ombitasvir paritaprevir
Maltese: ↑ norgestrel ↑ nor elgestromine ombitasvir minħabba l inibizzjoni ta' UGT b' paritaprevir, ombitasvir u dasabuvir.
English: Treated subjects (N=380) had a median age of 58 years (range: 21 to 71); 42.1% were treatment-naïve, 36.1% were prior pegIFN/RBV null responders; 8.2% were prior pegIFN/RBV partial responders, 13.7% were prior pegIFN/RBV relapsers; 70.3% were male; 3.2% were Black; 14.7% had platelet counts of less than 90 x 109/L; 49.7% had albumin less than 40 g/L; 86.1% had baseline HCV RNA levels of at least 800,000 IU/mL; 24.7% had a history of depression or bipolar disorder; 68.7% had HCV genotype 1a infection, 31.3% had HCV genotype 1b infection.
Maltese: Il-pazjenti kkurati (N=380) kellhom età medja ta' 58 sena (medda: 21 sa 71); 42.1% kienu naïve għall kura; 36.1% kienu pazjenti li preċedentement ma rrispondewx għal pegIFN/RBV; 8.2% kienu pazjenti li rrispondew b'mod parzjali għal pegIFN/RBV, 13.7% kienu pazjenti li preċedentement irkadew għal pegIFN/RBV; 70.3% kienu rġiel; 3.2% kienu Suwed; 14.7% kellhom għadd ta' plejtlits ta' anqas minn 90
English: A majority (86.8%) had baseline HCV RNA levels of at least 800,000 IU/mL and a majority (84.2%) had genotype 1a infection; 15.8% had portal fibrosis (F2) and 5.3% had bridging fibrosis (F3); and 94.7% were naïve to prior HCV treatment.
Maltese: IU għal kull mL; 17.8% kellhom fibrożi portali (F2) u 14.5% kellhom fibrożi li tgħaqqad (F3); 58.4 % kellhom infezzjoni tal-ġenotip 1a HCV;
English: Coadministration with enzyme inducers may increase the risk of adverse reactions and ALT elevations (see Table 2).
Maltese: L-għoti flimkien ma' indutturi ta' enżimi jistgħu jżidu r-riskju ta' reazzjonijiet avversi u elevazzjonijiet ta'ALT (ara Tabella 2).
English: Inhibition of these transporters is not expected to show clinically relevant increases in exposures of ombitasvir and dasabuvir.
Maltese: Inibizzjoni ta' dawn it-trasportaturi mhux mistennija li juru żidiet klinikament rilevanti fil-espożizzjonijiet ta' ombitasvir u dasabuvir.
English: In another open-label phase 3b study evaluating 12 weeks of Viekirax with or without dasabuvir and without RBV in non-cirrhotic, treatment-naive GT1a and GT4 patients with CKD stage 4 or 5 (Ruby II), the SVR12 rate was 94.4% (17/18), with no subjects experiencing on-treatment virologic failure or relapse.
Maltese: Fi studju ieħor ta' open-label fażi 3b li evalwa 12-il ġimgħa ta' Viekirax bi jew mingħajr dasabuvir u mingħajr RBV f'pazjenti li ma kinux ċirrotiċi, li qadt ma ħadu kura GT1a u GT4 b'CKD stadju 4 jew 5, ir-rata ta' SVR12 kienet 94.4% ( 17/18), mingħajr l-ebda individwi ma kellhom nuqqas ta' falliment viroloġiku waqt it-trattament jew rikaduta.
English: Enzalutamide
Maltese: INIBITURI
English: Ombitasvir-derived material was minimally transferred through the placenta in pregnant rats.
Maltese: Il-materjal derivat minn Ombitasvir kien ittrasferit b'mod minimu mill plaċenta f'firien tqal.
English: Ritonavir does not inhibit OAT1 and is not expected to inhibit OCT2, OAT3, MATE1 and MATE2K at clinically relevant concentrations.
Maltese: OCT2, OAT3, MATE1 u MATE2K f'konċentrazzjonijiet klinikament rilevanti.
English: CYP3A4 inhibition by ritonavir
Maltese: Inibizzjoni ta' CYP3A4 minn ritonavir
English: Use of ethinyloestradiol-containing medicinal products such as those contained in most combined oral contraceptives or contraceptive vaginal rings (see sections 4.4 and 4.5).
Maltese: L-użu ta' prodotti mediċinali li fihom ethinylestradiol bħal dawk li jinsabu f'ħafna kontraċettivi orali kombinati jew ċrieki vaġinali kontraċettivi (ara sezzjonijiet 4.4 u 4.5).
English: Effects of food
Maltese: Prodotti
English: All other double substitutions of Y93H in combination with substitutions at positions 28, 31, or 58 reduced the activity of ombitasvir by more than 400-fold.
Maltese: Is-sostituzzjonijiet doppji l-oħrajn kollha ta' Y93H flimkien mas-sostituzzjonijiet filpożizzjonijiet 28, 31, jew 58 naqqsu l-attività ta' ombitasvir b'aktar minn 400 darba.
English: This is so that your doctor can:
Maltese: Indutturi ta'enżimi :
English: OATP1B1 inhibition by paritaprevir.
Maltese: OATP1B1/1B3 minn paritaprevir u emoliżi indotta minn ribavirin.
English: Fatigue *Data set includes all genotype 1-infected subjects in Phase 2 and 3 trials including subjects with cirrhosis.
Maltese: *Is-sett ta' dejta jinkludi l-individwi infettati bil-ġenotip 1 fil-provi tal-Fażi 2 u 3 inkluż individwi b'ċirrożi.
English: All treatment-emergent variants in NS5A remained detectable at post-treatment Week 48.
Maltese: Il-varjanti emerġenti għall-kura kollha fl-NS5A baqgħu identifikabbli wara lkura fit-48 Ġimgħa.
English: Gastrointestinal disorders Very common
Maltese: Disturbi gastrointestinali:
English: Paritaprevir/ritonavir has shown malformations (open eye lids) at a low incidence in mice at exposures 32/8-fold higher than the exposure in humans at the recommended clinical dose.
Maltese: Paritaprevir/ritonavir urew malformazzjonijiet (għotjien tal-għajnejn miftuħin) b'inċidenza baxxa fi ġrieden f'espożizzjonijiet ta' 32/8 darbiet ogħla mill-esponiment fil-bnedmin fid-doża klinika rrakkomandata.
English: Ritonavir was greater than 99% bound to human plasma proteins.
Maltese: Aktar minn 99% mir-Ritonavir kien marbut mal-proteini fil-plażma tal-bniedem.
English: The overall safety profile in HCV-infected transplant recipients who were administered Viekirax and dasabuvir and ribavirin (in addition to their immunosuppressant medications) was similar to subjects treated with Viekirax and dasabuvir and ribavirin in phase 3 clinical trials, although some adverse reactions were increased in frequency.
Maltese: Il-profil tas-sigurtà globali f'reċipjenti ta' trapjant infettati b'HCV li kienu amministrati Viekirax u dasabuvir u ribavirin (minbarra medikazzjonijiet immunosoppressanti tagħhom) kien simili għallindividwi ttrattati b' Viekirax u dasabuvir u ribavirin fi provi kliniċi fażi 3, għalkemm xi reazzjonijiet avversi kienu żdiedu fil-frekwenza.
English: HCV Genotype 1a Viekirax and dasabuvir with RBV
Maltese: GT1 Fergħa A: Viekirax u dasabuvir + RBV
English: In genotype 1b, substitutions L28T, L31F/V, as well as Y93H alone or in combination with L28M, R30Q, L31F/M/V or P58S in HCV NS5A reduced susceptibility to ombitasvir.
Maltese: Fil-ġenotip 1b, is-sostituzzjonijiet L28T, L31F/V, kif ukoll Y93H waħdu jew flimkien ma' L28M, R30Q, L31F/M/V jew P58S f'HCV NS5A naqqsu s-suxxettibbiltà għal ombitasvir.
English: Each film-coated tablet contains 12.5 mg of ombitasvir, 75 mg of paritaprevir and 50 mg of ritonavir.
Maltese: Kull pillola miksija b'rita fiha 12.5 mg ta' ombitasvir, 75 mg ta' paritaprevir u 50 mg ta' ritonavir.
English: salmeterol for asthma sildenafil when used to treat a heart and lung disorder called “pulmonary arterial hypertension”
Maltese: salmeterol għall-ażżma sildenafil meta jintuża biex jikkura disturb fil-qalb u lgrizmejn imsejjaħ "ipertensjoni arterjali pulmonari"
English: Ombitasvir Ombitasvir is an inhibitor of HCV NS5A which is essential for viral replication.
Maltese: Ombitasvir Ombitasvir huwa inibitur ta' HCV NS5A li huwa essenzjali għar-replikazzjoni virali.
English: NA Clinical monitoring of patients is recommended.
Maltese: Hija rrakkomandata sorveljanza klinika tal pazjenti.
English: For patients with cirrhosis:
Maltese: Mhux studjat:
English: In contrast, the rate of ALT elevations in subjects using other types of oestrogens as typically used in hormonal replacement therapy (i.e., oral and topical oestradiol and conjugated oestrogens) was similar to the rate observed in subjects who were not using oestrogen-containing products (approximately 1% in each group).
Maltese: ALT f'individwi li jużaw tipi oħra ta' estroġeni kif tipikament jiġu użati fit-terapija bl-ormoni, bħala sostitut (jiġifieri oestradiol orali u topiku u estroġeni konjugat ) kien simili għar-rata osservata f'pazjenti li ma kinux jużaw prodotti li fihom estroġenu (madwar 1% f'kull grupp) .
English: Mechanism: increase in dasabuvir possibly due to CYP2C8 inhibition by trimethoprim
Maltese: inibizzjoni ta' CYP2C8 minn trimethoprim
English: Paritaprevir was positive in an in vitro human chromosome aberration test. Paritaprevir was negative in a bacterial mutation assay, and in two in vivo genetic toxicology assays (rat bone marrow micronucleus and rat liver Comet tests).
Maltese: Paritaprevir kien negattiv f'analiżi ta' mutazzjoni tal-batterja, u f'żewġ analiżijiet tossikoloġiċi ġenetiċi in vivo (testijiet ta'
English: Extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients when Viekirax is taken in combination with ribavirin, see section 4.6 and refer to the Summary of Product Characteristics for ribavirin for additional information.
Maltese: Għandha tintuża kawtela estrema biex tiġi evitata tqala f'pazjenti femminili u fil-partner femminili ta' pazjenti maskili meta Viekirax jintuża flimkien ma' ribavirin, ara sezzjoni 4.6 u rreferi għas-Sommarju tal-Karrateristiċi tal-Prodott ta' ribavirin għal informazzjoni addizzjonali.
English: Co-administration of Viekirax with or without dasabuvir together with medicinal products that are substrates of BCRP may increase plasma concentrations of these transporter substrates, potentially requiring dose adjustment/clinical monitoring.
Maltese: L-għoti flimkien ta' Viekirax bi jew mingħajr dasabuvir flimkien ma' prodotti mediċinali li huma substrati ta' BCRP jista' jżid ilkonċentrazzjonijiet fil-plażma ta' dawn is-substrati ta' trasportaturi, potenzjalment jeħtieġu aġġustament fid-doża/ monitoraġġ kliniku.
English: In the presence of paritaprevir/ritonavir, dasabuvir exposures decreased by approximately 50% to 60% while ombitasvir exposures increased by 31-47%.
Maltese: filwaqt l-espożizzjonijiet ta' ombitasvir żdiedu bi 31-47%.
English: Mechanism: CYP3A4 induction apalutamide enzalutamide or mitotane.
Maltese: induzzjoni induzzjoni ta' CYP3A4 minn apalutamide, enzalutamide jew mitotane.
English: Following administration of a single 200 mg/100 mg oral dose of 14C paritaprevir /ritonavir to humans, the parent drug was the major circulating component, accounting for approximately 90% of the plasma radioactivity.
Maltese: Wara l-għoti ta' doża orali ta' 200 mg/100 mg ta'14C paritaprevir /ritonavir lil bnedmin, il-mediċina ewlenija kienet il komponent ewlieni li jiċċirkola, u jammonta għal madwar 90% tar-radjuattività fil-plażma.
English: TURQUOISE-I: treatment-naïve or pegIFN + RBV-experienced with HCV GT1 or GT4/HIV-1 coinfection, without cirrhosis or with compensated cirrhosis
Maltese: TURQUOISE-I: naïve għall-kura jew bl-esperjenza ta' pegIFN+RBV b'ko-infezzjoni b'HTV GT1 jew
English: for many different conditions including serious illnesses and allergies trazodone for anxiety and depression warfarin and other similar medicines called vitamin K antagonists*
Maltese: għal ħafna kundizzjonijiet differenti inkluż mard u allerġiji serji trazodone għall-ansjetà u d-dipressjoni warfarin u mediċini oħra simili li jissejħu antagonisti tal-vitamina
English: The impact of prior ombitasvir, paritaprevir or dasabuvir treatment experience on the efficacy of other NS5A inhibitors, NS3/4A protease inhibitors, or NS5B inhibitors has not been studied.
Maltese: L-impatt ta' esperjenza bil-kura ta' ombitasvir, paritaprevir jew dasabuvir fuq l-effikaċja ta' inibituri NS5A oħra, l-inibituri protease NS3/4A, jew inibituri NS5B ma ġiex studjat.
English: SVR12 for genotype 1-infected peginterferon+ribavirin-experienced subjects in SAPPHIRE-II
Maltese: SVR12 għal individwi li esperjenzaw kura, infettati bil-ġenotip 1 f'SAPPHIRE-II
English: Mitotane
Maltese: Rimettar
English: 0.5 mg single dose
Maltese: 0.5mg doża waħda
English: A temporary suspension of pitavastatin/fluvastatin is recommended for the duration of treatment with Viekirax.
Maltese: Sospensjoni temporanja ta' pitavastatin/fluvastatin hija rrakkomandat għat-tul tat-trattament b'Viekirax.
English: Table 2 provides the Least Squares Means Ratio (90% Confidence Interval) effect on concentration of Viekirax with or without dasabuvir and concomitant medicinal products.
Maltese: Kwadrati (90% ta' Intervall ta' Kunfidenza) fuq il-konċetrazzjoni ta' Viekirax ma' dasabuvir jew mingħajru u u prodotti mediċinali konkomitanti.
English: CORAL-I: treatment-naïve or pegIFN + RBV-experienced, at least 3 months post liver transplant or 12 months post renal transplant
Maltese: CORAL-I: naïve għall-kura jew bl-esperjenza ta' pegIFN+RBV, mill-inqas tlett xhur wara t-trapjant talfwied jew 12-il xahar wara it-trapjant tal-kliwi
English: No study related adverse reactions with paritaprevir, ritonavir, or ombitasvir were observed.
Maltese: L-ebda studju relatat ma' reazzjonijiet avversi ma' paritaprevir, ritonavir, jew ombitasvir kienu osservati.
English: Viekirax and dasabuvir without ribavirin or with weight-based ribavirin for 12 weeks Treated subjects (N=305) had a median age of 54 years (range: 19 to 70); 65.2% were male; 11.8% were Black; 20.7% had a history of depression or bipolar disorder; 86.6% had baseline HCV RNA levels of at least 800,000 IU/mL; 18.4% had portal fibrosis (F2) and 17.7% had bridging fibrosis (F3).
Maltese: Il-pazjenti kkurati (N=305) kellhom età medja ta' 54 sena (medda: 19 sa 70), 65.2% kienu rġiel; 11.8% kienu Suwed; 20.7% kellhom storja ta' dipressjoni jew disturb bipolari; 86.
English: CYP3A4/Pgp inhibition.
Maltese: inibizzjoni ta' CYP3A4/Pgp