FrancophonIA/ELRC3.0 huggingface dataset:
English: Four subjects experienced a haemoglobin level < 8 g/dL.
Maltese: Erba' individwi kellhom livell ta' emoglobina <8 g/dL.
English: In the 67 genotype 1a infected subjects, NS3 variants were observed in 50 subjects, NS5A variants were observed in 46 subjects, NS5B variants were observed in 37 subjects, and treatmentemergent variants were seen in all 3 drug targets in 30 subjects.
Maltese: Fis-67 individwu infettat bil ġenotip 1a, kienu osservati varjanti NS3 f'50 individwu, kienu osservati varjanti NS5A f'46 individwu, kienu osservati varjanti NS5B f'37 individwu, u kienu osservati varjanti emerġenti f'kuri fit-3 miri ta' mediċini fi 30 individwu.
English: Concomitant use with fluvastatin and pitavastatin is not recommended (see section 4.4).
Maltese: fluvastatin u pitavastatin mhuwiex rrakkomandat (ara sezzjoni 4.4).
English: Unchanged dasabuvir accounted for 26.2% and M1 for 31.5% of the total dose in faeces.
Maltese: 2% u M1 għal 31.5% tad-doża totali fl-ippurgar.
English: Dasabuvir was not carcinogenic in a 6-month transgenic mouse study up to the highest dosage tested (2 g/kg/day), resulting in dasabuvir AUC exposures approximately 19-fold higher than those in humans at the recommended dose of 500 mg (250 mg twice daily).
Maltese: Dasabuvir ma kienx karċinoġeniku fi studju transġeniku ta' 6 xhur fuq il-ġrieden sa l-ogħla doża ttestjata (2 g/kg/ġurnata), li rriżultat f'espożizzjoni tal-AUC ta' dasabuvir bejn wieħed u ieħor 19-il darba oħla minn dawk fi bnedmin fid-doża rrakkomandata ta' 500 mg (250 mg darbtejn kuljum).
English: ↑ norgestrel ↑ nor elgestromin e
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u Manifattur
English: 5 mg single dose
Maltese: 5 mg darba kuljum
English: Based on population pharmacokinetic analysis of data from Phase 3 clinical studies, Asian subjects had 29% to 39% higher dasabuvir exposures than non-Asian subjects.
Maltese: Ibbażata fuq analiżi farmakokinetika tal-popolazzjoni ta' dejta minn studji kliniċi ta' Fażi 3, suġġetti Ażjatiċi kellhom minn 29 % sa 39% espożizzjonijiet ogħla għal dasabuvir minn suġġetti mhux Asjatiċi.
English: In subjects with mild, moderate and severe renal impairment, dasabuvir mean AUC values were 21% higher, 37% higher and 50% higher, respectively.
Maltese: F'individwi b'indeboliment renali ħafif, moderat u sever, valuri medja tal-AUC kienu 21% ogħla, 37% ogħla u 50% ogħla, rispettivament.
English: In a pooled analysis of clinical trials with dasabuvir and ombitasvir/paritaprevir/ritonavir 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'dasabuvir u ombitasvir/paritaprevir/ritonavir flimkien ma' jew mingħajr ribavirin, 1% tas-suġġetti esperjenzaw livelli ta 'ALT fis-serum aktar minn 5 darbiet ogħla mil-limitu tan-normal ( ULN ) wara li beda l-kura.
English: Tel: +385 (0)1 5625 501
Maltese: AbbVie d.o.o. Tel: +385 (0)1 5625 501
English: Serum ALT elevations
Maltese: Elevazzjonijet fl-ALT tas-serum
English: Co-administration of dasabuvir with ombitasvir/paritaprevir/ritonavir 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 ta' dasabuvir ma' ombitasvir/paritaprevir/ritonavir flimkien ma' prodotti mediċinali li huma substrati ta' BCRP jista' jżid il-konċentrazzjonijiet fil-plażma ta' dawn s-substrati trasportaturi, li potenzjalment jeħtieġu aġġustament fid-doża/monitoraġġ kliniku.
English: OPIOIDS Methadone
Maltese: OPJOJDI Methadone:
English: Duloxetine 60 mg single dose dasabu vir + ombitas vir/parit aprevir/ ritonavi r duloxetine
Maltese: 60 mg doża waħda dasabuvir ombitasvir/ paritaprevi r/ritonavir duloxetine
English: 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: Dose normalized sirolimus ratios are shown for interaction with ombitasvir/paritaprevir/ritonavir + dasabuvir.
Maltese: Ilproporzjonijiet tad-doża normalizzata ta' sirolimus huma murija għal interazzjoni ma' ombitasvir/paritaprevir/ritonavir + dasabuvir.
English: Expected:
Maltese: Mistenni:
English: The efficacy and safety of dasabuvir in combination with ombitasvir/paritaprevir/ritonavir with and without ribavirin was evaluated in eight Phase 3 clinical trials, including two trials exclusively in subjects with compensated cirrhosis (Child-Pugh A), in over 2,360 subjects with genotype 1 chronic hepatitis C infection as summarised in Table 6.
Maltese: L-effikaċja u sigurtà ta' Exviera f'kombinazzjoni ma' ombitasvir/paritaprevir/ritonavir bi jew mingħajr ribavirin ġew evalwati fi tmien provi kliniċi ta' Fażi 3, inklużi żewġ provi esklussivament f'individwi b'ċirrożi ikkumpensata (Child-Pugh A), f'iktar minn 2,360 individwu b'infezzjoni tal epatite Ċ kronika ta' ġenotip 1 kif imqassra f'Tabella 6.
English: Coadministration with enzyme inducers may lead to an increased risk of adverse reactions and ALT elevations (see Table 2).
Maltese: Koamministrazzjoni ma' indutturi ta' l-enżimi tista twassal għal riskju akbar ta' reazzjonijiet avversi u elevazzjonijiet ta' ALT (ara Tabella 2).
English: Of the 2,510 HCV genotype 1 infected subjects who were treated with regimens containing dasabuvir, ombitasvir and paritaprevir 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 individwi infettati b'HCV ta' ġenotip 1 li kienu kkurati b'reġimi li fihom ombitasvir, paritaprevir, u dasabuvir bi jew mingħajr ribavirin (għal 8, 12, jew 25 ġimgħa) fil-provi kliniċi ta' Fażi 2b u 3 ikkurati b'korsijiet li fihom ABT-450, ombitasvir, u dasabuvir, bi jew mingħajr ribavirin (għal 8, 12, jew 24 ġimgħa), total ta' 74 individwu (3%) esperjenzaw falliment viroloġiku (primarjament rikaduta wara l-kura).
English: Dasabuvir is highly bound to plasma proteins.
Maltese: Dasabuvir huwa marbut ħafna mal-proteini tal-plażma.
English: Contraindicated enzyme inducers are provided in section 4.3.
Maltese: Indutturi ta' enżimi kontraindikati huma pprovduti fit-Taqsima 4.3.
English: Esomeprazol e
Maltese: TA' EĊĊIPJENTI
English: 40 mg once daily
Maltese: 40 mg darba kuljum
English: Cirrhosis was not a risk factor for elevated ALT (see section 4.4).
Maltese: Ċirrożi ma kienx fattur ta' riskju għall-ALT elevat (ara sezzjoni 4.4).
English: Overall SVR12 HCV genotype 1a Treatment naïve Prior pegIFN/RBV null responders Prior pegIFN/RBV partial responders Prior pegIFN/RBV Prior relapsers HCV genotype 1b Treatment naïve Prior pegIFN/RBV null responders Prior pegIFN/RBV partial responders Prior pegIFN/RBV Prior relapsers Outcome for subjects without SVR12 On-treatment VF Relapse Other a. 97.5% confidence intervals are used for the primary efficacy endpoints (overall SVR12 rate); 95% confidence intervals are used for additional efficacy endpoints (SVR12 rates in HCV genotype 1a and 1b-infected subjects).
Maltese: 97.5% intervall ta' kunfidenza jintuża għall-punti ta' tmiem tal-effikaċja primarja (rata SVR12 globali); jintużaw 95% intervalli ta' kunfidenza għal punti ta' tmiem addizzjonali tal-effikaċja (rati SVR12 fl individwi infettati bil-ġenotip 1a u 1b HCV).
English: Resistance to dasabuvir conferred by variants in NS5B selected in cell culture or identified in Phase 2b and 3 clinical trials were phenotypically characterised in the appropriate genotype 1a or 1b replicons.
Maltese: Reżistenza mogħtija minn varjanti NS5B, magħżula f'kulturi ta' ċelloli jew identifikati fi provi kliniċi ta' Fażi 2b u 3 kienet ikkaratterizzata fenotipikament fir-replikons ta' ġenotip 1a jew 1b xierqa.
English: The type of food is not important.
Maltese: It-tip ta' ikel mhux importanti.
English: 400 mg once daily
Maltese: 400 mg darba kuljum
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 with or without naloxone (N=19) received 12 weeks of dasabuvir in combination with ombitasvir/paritaprevir/ritonavir and ribavirin.
Maltese: F'fażi 2, multiċentriku, open-label, studju b'fergħha waħda, 38 li kienu naïve għal-kura jew esperjenzati bil-kura 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' dasabuvir flimkien ma' ombitasvir/paritaprevir/ritonavir u ribavirin.
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: NN:
Maltese: *Nota:
English: trimethopri m
Maltese: trimethoprim
English: The safety and efficacy of dasabuvir in children less than 18 years of age have not been established.
Maltese: Is-sigurtà u effikaċja ta' dasabuvir fi tfal ta' età inqas minn 18 ma ġewx determinati s'issa.
English: Dasabuvir is recommended in combination with paritaprevir/ombitasvir/ritonavir, and ritonavir may select for PI resistance in HIV co-infected patients without ongoing antiretroviral therapy.
Maltese: Dasabuvir huwa rrakkomandat flimkien ma' paritaprevir/ombitasvir/ritonavir,u ritonavir jista' jagħżel reżistenza għall-PI f'pazjenti ko-infettati b'HIV mingħajr terapija antiretrovirali kontinwa.
English: GT1b dasabuvir and ombitasvir/paritaprevir/ritonavir (8 weeks)
Maltese: GT1b dasabuvir u ombitasvir/paritaprevir/ritonavir (8
English: Medicinal Product/ Possible Mechanism of Interaction
Maltese: Mediċinali /Mekkaniżmu possibbli ta' Interazzjoni
English: Darunavir, dosed 800 mg once daily, if administered at the same time as ombitasvir/paritaprevir/ritonavir, can be used in the absence of extensive PI resistance (darunavir exposure lowered).
Maltese: Darunavir, mogħti 800 mg darba kuljum, jekk jingħata fl-istess ħin ma ombitasvir/paritaprevir/ritonavir, jista' jintuża fin-nuqqas ta' reżistenza estensiva ta' PI (esponiment ta' darunavir titbaxxa).
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 dasabuvir with ombitasvir/paritaprevir/ritonavir 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'dasabuvir ma' ombitasvir/paritaprevir /ritonavir (ara sezzjonijiet 4.3 u 4.5).
English: Refer to the Summary of Product Characteristics for ribavirin for additional information.
Maltese: Sommarju tal-Karrateristiċi tal-Prodott ta' ribavirin għal informazzjoni addizzjonali.
English: Strong CYP2C8 inhibitors are contraindicated with dasabuvir (see section 4.3 and Table 2).
Maltese: huma kontraindikati ma' dasabuvir (ara sezzjoni 4.3 u Tabella 2).
English: 5 mg single dose and other vitamin K antagonists dasabu vir +
Maltese: 5 mg u antagonisti oħra tal-vitamina K
English: dasabuvir and ombitasvir/paritaprevir /ritonavir + ribavirin
Maltese: dasabuvir u ombitasvir/paritaprevir /ritonavir + ribavirin
English: The combination carries an increased risk for hyperbilirubinemia (including ocular icterus), in particular when ribavirin is part of the hepatitis C regimen.
Maltese: Il-kombinazzjoni ġġorr riskju akbar għall iperbilirubinimja (inkluż ikterus okulari), b'mod partikolari meta ribavirin huwa parti mill-kors ta' epatite Ċ.
English: TURQUOISE II (open-label)
Maltese: TURQUOISE II
English: Atazanavir
Maltese: Paracetamol
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
Maltese: HCV ≥ 25 IU/mL ikkonfermata wara HCV RNA < 25 IU/mL waqt il-kura, żieda ta' 1 log10 IU/mL
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: • Rapporti perjodiċi aġġornati dwar is-sigurtà Ir-rekwiżiti biex jiġu ppreżentati PSURs għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: Side effects when taking Exviera and ombitasvir/paritaprevir/ritonavir with ribavirin:
Maltese: Effetti sekondarji meta tieħu Exviera u ombitasvir/paritaprevir/ritonavirma' ribavirin:
English: (administere d in the evening)
Maltese: (tikketta miftuħa)
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
Maltese: Varjanti NS3 A156T fil-ġenotip 1a, u R155Q u D168H fil-ġenotip 1b; varjanti NS5A Y93C/H fil-ġenotip 1a, u
English: *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: TURQUOISE III (open-label)
Maltese: TURQUOISE III
English: In another open-label phase 3b study evaluating 12 weeks of ombitasvir/paritaprevir/ritonavir 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 ontreatment virologic failure or relapse.
Maltese: Fi studju ieħor ta' open-label fażi 3b li evalwa 12-il ġimgħa ta' ombitasvir/paritaprevir/ritonavir bi jew mingħajr dasabuvir u mingħajr RBV f'pazjenti li ma kinux ċirrotiċi, li qadt ma ħadukura GT1a u GT4 b'CKD stadju 4 jew 5 (Ruby II), 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: Belgique/Belgien Tél/Tel: +32 10 477811
Maltese: AbbVie Polska Sp. z o.o. Tel.: +48 22 372 7800
English: SVR12 for Genotype 1b-infected treatment-naïve subjects without cirrhosis dasabuvir and ombitasvir/paritaprevir/ritonavir for 8 weeks n/N (%)
Maltese: SVR12 għal individwi naïve għall-kura infettati b'Ġenotip 1b mingħajr ċirrożi dasabuvir u ombitasvir/paritaprevir/ritonavir għal 8 ġimgħat n/N (%)
English: NS5A M28T M28Ve
Maltese: NS5B A553T
English: Treated subjects (N=179) had a median age of 57 years (range: 26 to 70); 35.2% were prior pegIFN/RBV null responders; 28.5% were prior pegIFN/RBV partial responders; and 36.3% were prior pegIFN/RBV relapsers; 54.2% were male; 3.9% were Black; ; 12.8% had a history of depression or bipolar disorder; 87.7% had baseline HCV RNA levels of at least 800,000 IU/mL; 17.9% had portal fibrosis (F2) and 14.0% had bridging fibrosis (F3).
Maltese: Il-pazjenti kkurati (N=179) kellhom età medja ta' 57 sena (medda: 26 sa 70); 35.2% kienu persuni li ma tawx risposta għal pegIFN/RBV qabel; 28.5% kienu taw risposta parzjali għal pegIFN/RBV, 36.3% kienu rikadew wara pegIFN/RBV; 54.2% kienu rġiel; 3.9% kienu Suwed; 12.8% kellhom storja ta' dipressjoni jew disturb bipolari; 87.7% kellhom linja bażi ta' livelli ta' RNA tal-HCV ta' mill-inqas 800,000
English: TURQUOISE-III: treatment-naïve or pegIFN + RBV-experienced with compensated cirrhosis
Maltese: TURQUOISE-III: naïve għall-kura jew pegIFN + RBV esperjenzat- b'ċirrożi kkumpensata Disinn:
English: Phase 3 global multicentre trials conducted with dasabuvir and ombitasvir/paritaprevir/ritonavir with or without ribavirin (RBV).
Maltese: Provi ta' Fażi 3 globali multiċentrali mwettqa b'disabuvir u ombitasvir/paritaprevir/ritonavirbi jew mingħajr ribavirin (RBV).
English: Medicines you must not take with Exviera Medicine or active substance
Maltese: Mediċina jew sustanza attiva
English: Alprazolam 0.5 mg single dose
Maltese: Sirolimus 0.5 mg doża waħda5
English: AbbVie B.V. Tel: +31 (0)88 322 2843
Maltese: Tel: +31 (0)88 322 2843
English: Paediatric population Drug interaction studies have only been performed in adults.
Maltese: Studji ta' interazzjoni ta' mediċina twettqu biss f'adulti.
English: Seven metabolites were identified in plasma.
Maltese: Kienu identifikati seba' metaboliti fil-plażma.
English: Hydrocodone (as given in a fixed-dose hydrocodone /paracetamol
Maltese: (mogħti bħala doża fissa ta' hydrocodone/parac etamol)
English: These measures will help to protect the environment.
Maltese: INIBITURI TA' PROTEASE
English: • Monitoring should be performed for clinical signs and symptoms of hepatic decompensation (such as ascites, hepatic encephalopathy, variceal haemorrhage).
Maltese: • Għandha ssir sorveljanza għal sinjali kliniċi u sintomi ta' dikompensazzjoni epatika (bħal axxite, enċefalopatija epatika, emorraġija variceal).
English: The overall safety profile in HCV-infected transplant recipients who were administered dasabuvir and ombitasvir/paritaprevir/ritonavir and ribavirin (in addition to their immunosuppressant medicinal products) was similar to subjects treated with dasabuvir and ombitasvir/paritaprevir/ritonavir and ribavirin in phase 3 clinical trials, although some adverse reactions were increased in frequency.
Maltese: Il-profil tas-sigurtà globali, f'pazjenti sottoposti għal trapjant tal-fwied li huma infettati b'HCV u li kienu amministrati dasabuvir u ombitasvir/paritaprevir/ritonavir u ribavirin (minbarra l-mediċinali immunosoppressanti tagħhom ) kien simili għal suġġetti kkurati b'dasabuvir u ombitasvir/paritaprevir/ritonavir u ribavirin fil-fażi provi kliniċi 3, għalkemm xi reazzjonijiet avversi kienu żdiedu fil-frekwenza.
English: Dasabuvir should be used in combination with other medicinal products for the treatment of HCV (see section 5.1).
Maltese: prodotti mediċinali oħra għall-kura ta' HCV(ara sezzjoni 5.1).
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'trasplant tal-kliewi u mingħajr ċirrożi ġew dożati għal 12-il ġimgħa (b'RBV għal GT1a [n=9], mingħajr RBV għal GT1b [n=3]).
English: Wort.
Maltese: ISEM
English: ombitas vir/parit aprevir/r itonavir omeprazole
Maltese: dasabuvir ombitasvir/ paritaprevi r/ritonavir omeprazole
English: Contraceptive medicines that contains ethinyloestradiol cannot be used in combination with Exviera.
Maltese: Metodi ta' kontraċezzjoni li fihom ethinyloestradiol ma' jistgħux jintużaw f'kombinazzjoni ma' Exviera.
English: Mechanism: CYP3A4 induction by phenobarbita l.
Maltese: Induzzjoni ta' CYP3A4 minn phenobarbital.
English: The mean baseline haemoglobin level was 12.1 g/dL and the mean decline in haemoglobin at the end of treatment for subjects taking RBV was 1.2 g/dL.
Maltese: Il-livell medju ta' emoglobina fil-linja bażi kien ta' 12.1 g / dL u t-tnaqqis medju fl-emoglobina fl-aħħar tat-trattament għal individwi li kienu qed jieħdu RBV kien ta' 1.2 g/dL.
English: Smephenytoin Mechanism: CYP2C19 induction by ritonavir.
Maltese: induzzjoni ta' CYP2C19 minn ritonavir.
English: Mechanism: CYP3A4 inhibition by ritonavir.
Maltese: Inibizzjoni ta' CYP3A4 b' ritonavir.
English: Impact of ribavirin dose adjustment on probability of SVR In Phase 3 clinical trials, 91.5% of subjects did not require ribavirin dose adjustments during therapy.
Maltese: Impatt ta' ribavirin f'aġġustament tad-doża fuq probabbiltà ta' SVR Fi provi kliniċi tal-Fażi 3, 91.5% tal-individwi ma kellhomx bżonn doża ta' aġġustamenti fid-doża ta' ribavirin matul it-terapija.
English: Mechanism: CYP3A4/Pgp inhibition by ketoconazole and paritaprevir/ ritonavir/ ombitasvir aprevir/ ritonavi r ombitasvir
Maltese: Inibizzjoni ta' CYP3A4/P-gp minn ketoconazole u paritaprevir /ritonavir/ ombitasvir dasabuvir ombitasvir/ paritaprevi r/ritonavir
English: The highest dasabuvir dose tested produced exposures equal to 16 to 24-fold (rat) or 6-fold (rabbit) the exposures in humans at the maximum recommended clinical dose.
Maltese: L-ogħla doża ta' dasabuvir ittestjata pproduċiet espożizzjonijiet ugwali għal 16 sa 24 darba (far) jew 6 darbiet (fenek) iktar mill-espożizzjoni fid-doża klinika massima rrakkomandata.
English: How to store Exviera
Maltese: Tiħux Exviera :
English: If statin treatment is required during the treatment period, a switch to a reduced dose of pravastatin/rosuvastatin is possible (see section 4.5, Table 2).
Maltese: Jekk il-kura bi statin huwa meħtieġ waqt il-perijodu ta' kura, tnaqqis fid-doża ta' pravastatin/rosuvastatin huwa possibbli (ara sezzjoni 4.5, Tabella 2).
English: Bilirubin elevations were not associated with aminotransferase elevations.
Maltese: Ebda wieħed mill-individwi b'iperbilirubinimja ma kellu elevazzjonijiet konkomitanti ta' aminotransferases.
English: Peginteferon+ribavirin-experienced, without cirrhosis SAPPHIRE II
Maltese: B'esperjenza ta' peginterferon+ribavirin5, mingħajr ċirrożi SAPPHIRE II
English: The most abundant plasma metabolite was M1, which represented 21% of drug-related radioactivity (AUC) in circulation following single dose; it's formed via oxidative metabolism predominantly by CYP2C8.
Maltese: Il-metabolit fil-plażma l-aktar preżenti kien M1, li rrappreżenta 21% tar-radjuattività relatata mal mediċina (AUC) li bdiet tiċċirkola wara doża waħda; huwa ffurmat permezz tal-metaboliżmu ossidattiv prinċipalment minn CYP2C8.
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: Individwi ttrattati (N = 233) kellhom età medjana ta' 49 sena (firxa: 26-69); 10% kienu l-Iswed; 12% kellhom ċirrożi kkumpensata; 66% ma kellhomx kura;
English: 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 linja bażi ta'
English: A 10 kg change in body weight from 76 kg (median weight in the Phase 3 studies) would result in <10% change in dasabuvir exposures.
Maltese: 10 kg fil-piż tal-ġisem minn 76 kg (piż medjan fl-istudji ta' fażi 3) ser tirriżulta f' bidla <10 % flespożizzjonijiet għal dasabuvir.
English: ↑ darunavir ↓ dasabuvir ombitasvir paritaprevir lopinavir / ritonavir 400/100 mg dasabu vir + ombitas vir/parit lopinavir
Maltese: L-effett fuq l-espożizzjonijiet ta' rilpivirine kienet simili għal dik osservata meta rilpivirine ingħata fil-għodu mal-ikel ma' dasabuvir + ombitasvir / paritaprevir / ritonavir 3. Ciclosporin 100 mg mogħti waħdu u 30 mg mogħtija ma' dasabuvir + 4. ombitasvir/paritaprevir/ritonavir.
English: PEARL-III - genotype 1b, treatment-naïve, without cirrhosis Design:
Maltese: PEARL-III - ġenotip 1b, naïve għall-kura, mingħajr ċirrożi