FrancophonIA/ELRC3.0 huggingface dataset:
English: Medicinal products transported by the OATP family and OCT1
Maltese: Prodotti mediċinali trasportati mill-familja tal-OATP u OCT1
English: Laboratory Parameters
Maltese: Parametri talLaboratorju
English: AFP* < 20 ng/mL, platelets ≥ 90 x 109/L, AND albumin ≥ 35 g/L prior to treatment
Maltese: AFP* < 20 ng/mL, plejtlits ≥ 90 x 109/L, U albumina ≥ 35 g/L qabel it-trattament
English: − Confusion
Maltese: − Konfużjoni
English: − Tablet film-coating: poly(vinyl alcohol) (E 1203), macrogol (3350), talc (E 553b), titanium dioxide (E 171) and red iron oxide (E 172).
Maltese: − Kisja tar-rita tal-pillola: poly(vinyl alcohol) (E 1203) , macrogol (3350), talc, (E 553b), titanium dioxide (E 171) u red iron oxide (E 172).
English: HIV-1 Co-infection
Maltese: HIV-1 koinfezzjioni
English: Overall, 37 (97.4%) of 38 subjects achieved SVR12.
Maltese: Globalment, 37 (97.4%) minn 38 individwi kisbu SVR12.
English: Oral midazolam Triazolam
Maltese: Midazolam Triazolam Orali
English: ↑ losartan ↑ candesartan
Maltese: ↑ valsartan ↑ losartan ↑ candesartan
English: HIV ANTIVIRALS: NUCLEOSIDE INHIBITORS Abacavir/ lamivudine
Maltese: INIBITURI NUCLEOSIDE Abacavir/ lamivudine
English: See sections 4.8 and 5.1 for additional information.
Maltese: Ara s-sezzjonijiet 4.8 u 5.1 għal aktar informazzjoni.
English: Cyclobenzapr ine 5 mg single dose
Maltese: Cyclobenzapr ine 5 mg doża waħda
English: PEARL II, III, and IV TURQUOISE II (subjects with cirrhosis)
Maltese: PEARL II, III, u IV TURQUOISE II
English: − Tablet core: copovidone, tocofersolan, propylene glycol monolaurate, sorbitan monolaurate, colloidal anhydrous silica (E 551), sodium stearyl fumarate.
Maltese: − Qalba tal-pillola: copovidone, tocofersolan, propylene glycol monolaurate, sorbitan monolaurate, colloidal anhydrous silica (E 551), sodium stearyl fumarate.
English: Expected: ↑ sildenafil
Maltese: Mistenni: ↑ sildenafil
English: Race or ethnicity
Maltese: Razza jew etniċità
English: ANTICONVULSANTS Carbamazepine
Maltese: ANTITKONVULSANTI Carbamazepine
English: Lurasidone Pimozide Quetiapine
Maltese: ANTIPSIKOTIĊI Lurasidone Pimozide
English: Efavirenz/ emtricitabine/ tenofovir disoproxil fumarate mg once daily
Maltese: Efavirenz/ emtricitabine/ disoproxil fumarate mg darba kuljum
English: ERGOT ALKALOIDS Ergotamine
Maltese: ALKALOJDI TAL-ERGOT Ergotamine
English: ANTI-DIURETIC HORMONE Conivaptan
Maltese: ORMON ANTI-DIJURETIKU Conivaptan
English: Medicinal products transported by BCRP
Maltese: Prodotti mediċinali li huma trasportati minn BCRP
English: Dose normalised parameters reported for methadone, buprenorphine and naloxone.
Maltese: Parametri normalizzati tad- doża rrapportati għal methadone, buprenorphine u naloxone.
English: CALCIUM CHANNEL BLOCKERS Amlodipine
Maltese: TAL-KANAL TAL-KALĊJU Amlodipine
English: In vitro interaction data
Maltese: Interazzjoni tad-dejta in vitro
English: Genotype 4
Maltese: Ġenotip 4
English: Paritaprevir, ritonavir and dasabuvir are inhibitors of BCRP in vivo.
Maltese: Paritaprevir, ritonavir u dasabuvir huma inibitturi ta' BCRP in vivo.
English: PEARL II (open-label)
Maltese: PEARL II (tikketta mikxufa)
English: In Part 2, SVR12 was achieved by 27/28 (96.4%) subjects with HCV GT4/HIV-1 coinfection (95% CI: 82.3%, 99.4%) with no virologic failures.
Maltese: Fil-Parti 2, SVR12 inkiseb minn 27/28 (96.4%) suġġetti b' ko-infezzjoni HCV GT4 / HIV-1 (95% CI: 82.3%, 99.4%) mingħajr fallimenti viroloġiċi.
English: 30 mg once daily single dose3
Maltese: 30mg darba kuljum single dose3
English: 250 mg single dose
Maltese: 250 mg doża
English: randomised, global multicentre, double-blind, placebo-controlled
Maltese: każwali, multiċentriku globali, double-blind, ikkontrollat bil-korsijiet
English: Table 20.
Maltese: Tabella 20.
English: Y93H, Y93N or M28V in combination with Q30R reduced the activity of ombitasvir by more than 42,802-fold.
Maltese: Y93H, Y93N jew M28V flimkien ma' Q30R naqqsu l-attività ta' ombitasvir b'aktar minn 42,802 darba.
English: Hydrocodone (as given in a fixed-dose hydrocodone/ paracetamol)
Maltese: hydrocodone/ paracetamol)
English: NNRTIs other than rilpivirine (efavirenz, etravirine and nevirapine) are contraindicated (see section 4.3).
Maltese: NNRTIs minbarra rilpivirine (efavirenz, etravirine u nevirapine) huma kontraindikati (ara sezzjoni 4.3).
English: Patients treated with vitamin K antagonists
Maltese: Pazjenti trattati b'antagonisti tal-vitamina K
English: St. John's Wort (hypericum perforatum)
Maltese: John's Wort (Fexfiex)(hypericum perforatum)
English: EFFECT Cmax
Maltese: B'EFFETT Cmax
English: Cross-resistance is expected among NS5A inhibitors, NS3/4A protease inhibitors, and non-nucleoside NS5B inhibitors by class.
Maltese: Hija mistennija reżistenza inkroċjata fost l-inibituri NS5A, l-inibituri protease NS3/4A, u l-inibituri NS5B non-nucleoside skont il-klassi.
English: 300/100 mg once daily (administered 12 hours apart)
Maltese: 300/100 mg darba kuljum (amministrati
English: randomised, global multicentre, double-blind, regimen-controlled
Maltese: każwali, multiċentriku globali, double-blind, ikkontrollat bi plaċebo
English: Simvastatin, lovastatin and atorvastatin are contraindicated (see sections 4.3 and 4.5).
Maltese: Simvastatin, lovastatin u atorvastatin huma kontraindikati (ara sezzjonijiet 4.3 u 4.5).
English: Mechanism: OATP1B/BC RP inhibition by paritaprevir
Maltese: Inibizzjoni ta' OATP1B/BC RP b' paritaprevir
English: Caution is advised if co-administering Viekirax with medicinal products that are both moderate inhibitors of CYP3A4 and inhibitors of multiple transporters (P-gp, BCRP and/or OATP1B1/ OATP1B3).
Maltese: Kawtela hija rrakkomandata jekk il-ko-amministrazzjoni ta' Viekirax ma' prodotti mediċinali li huma inibituri moderati ta' CYP3A4 u inibituri ta' trasportaturi multipli (P-gp, BCRP u / jew OATP1B1 / OATP1B3).
English: CYP2C19 substrates evaluated in drug interaction studies include omeprazole and escitalopram (see Table 2).
Maltese: Substrati ta' CYP2C19 evalwati fi studji ta' interazzjoni ta' mediċina jinkludu omeprazole u escitalopram (ara Tabella 2).
English: In the genotype 1a replicon, the activity of paritaprevir was reduced 20-, 37-, and 17-fold by the F43L, R155K and A156T substitutions, respectively.
Maltese: Fir-replicon tal-ġenotip 1a, l-attività ta' paritaprevir tnaqqset b'20, 37 u 17-il darba mis-sostituzzjonijiet F43L, R155K u A156T, rispettivament.
English: With RBV
Maltese: B'RBV
English: SEDATIVES / HYPNOTICS Zolpidem
Maltese: SEDATIVI / IPNOTIĊI
English: Food increased the exposure (AUC) of ombitasvir, paritaprevir and ritonavir by up to 82%, 211% and 49%, respectively relative to the fasting state.
Maltese: L-ikel żied l-espożizzjoni (AUC) ta' ombitasvir, paritaprevir, u ritonavir sa 82%, 211% u 49%,
English: Carisoprodol
Maltese: Carisoprodo
English: Paritaprevir is an inhibitor of HCV NS3/4A protease which is necessary for the proteolytic cleavage of the HCV encoded polyprotein (into mature forms of the NS3, NS4A, NS4B, NS5A, and NS5B proteins) and is essential for viral replication.
Maltese: Paritaprevir huwa inibitur ta' protease HCV NS3/4A li huwa meħtieġ għall-qsim proteolitiku talpoliproteina dekodifikat b'HCV (f'forom maturi tal-proteini NS3, NS4A, NS4B, NS5A, u NS5B) u huwa essenzjali għal replikazzjoni virali.
English: Viekirax and dasabuvir without ribavirin for 12 weeks 60 patients were randomized and treated, and 60/60 (100%) achieved SVR12.
Maltese: Viekirax u dasabuvir mingħajr b'ribavirin għal 12-il ġimgħa 60 pazjent kienu randomizzati u trattati, u 60/60 (100%) kisbu SVR12.
English: Q80K, although a highly prevalent polymorphism in NS3 (41.2% of samples), confers minimal resistance to paritaprevir.
Maltese: Q80K, għalkemm polimorfiżmu ferm prevalenti f'NS3 (41.2% tal-kampjuni), jikkonferixxi reżistenza minima għal ABT450.
English: Overall, 72 of 79 treatment-naive subjects (45 of 52 GT1a and 27 of 27 GT1b) and 40 of 45 treatment-experienced subjects (21 of 26 GT1a and 19 of 19 GT1b) achieved SVR12 after 12 weeks of treatment.
Maltese: B'mod ġenerali, 72 minn 79 individwi li kienu naïve għat-trattament (45 minn 52 GT1a u 27 minn 27 GT1b) u 40 minn 45 individwi li esperjenzaw trattament (21 minn 26 GT1a u 19 minn 19 GT1b) kisbu SVR12 wara 12-il ġimgħa ta' trattament.
English: ↑ S
Maltese: ↑ GS
English: Ethinyloestradiol is contraindicated in combination with Viekirax (see sections 4.3 and 4.4).
Maltese: Ethinyloestradiol huwa kontraindikat f'kombinazzjoni ma' Viekirax (ara sezzjoni 4.3 u 4.4).
English: Other CYP2C9 substrates (NSAIDs (e.g. ibuprofen), antidiabetics (e.g. glimepiride, glipizide) are not expected to require dose adjustments.
Maltese: Substrati oħra ta' CYP2C9 (NSAIDs (eż ibuprofen), antidijabetiċi (eż glimepiride, glipizide) mhumiex mistennija li jeħtieġu aġġustamenti fid-doża.
English: Such medicinal products include some statins (see Table 2), fexofenadine, repaglinide and angiotensin II receptor antagonists (e.g., valsartan).
Maltese: Prodotti mediċinali bħal dawn jinkludu xi statins (ara Tabella 2), fexofenadine, repaglinide u antagonisti tarriċettur tal-angiotensin II (eż. valsartan).
English: Such medicinal products include sulfasalazine, imatinib and some of the statins (see Table 2).
Maltese: Prodotti mediċinali bħal dawn jinkludu sulfasalazine, imatinib u wħud mill statins ( ara Tabella 2).
English: < 90, n (%)
Maltese: < 90, n (%) > 90, n (%)
English: The recommended tacrolimus dosing is 0.5 mg every 7 days.
Maltese: tacrolimus hija 0.5 mg kull 7 ijiem.
English: Viekirax may increase the plasma exposure to medicinal products that are sensitive for changed intestinal P-gp activity (such as dabigatran etexilate).
Maltese: Viekirax jista' jżid l-espożizzjoni tal-plażma ta' prodotti mediċinali li huma sensittivi għall-bidla fl-attività intestinali ta' P-gp (bħal dabigatran etexilate).
English: Total bilirubin >3-10 × ULN (grade 3) >10 × ULN (grade 4) *ULN: Upper limit of normal according to testing laboratory.
Maltese: Bilirubin totali >3-10 × ULN (grad 3) >10 × ULN (grad 4) *ULN:
English: CYP3A substrates evaluated in drug interaction studies which may require dose adjustment and/or clinical monitoring include (see Table 2) ciclosporin, sirolimus, tacrolimus, amlodipine, rilpivirine and alprazolam.
Maltese: Substrati ta' CYP3A evalwati fi studji ta' interazzjoni ta' mediċina li jistgħu jeħtieġu aġġustament fiddoża u/ jew monitoraġġ kliniku jinkludu (ara Tabella 2) ciclosporin, sirolimus, tacrolimus, amlodipine, rilpivirine u alprazolam .
English: In Part 1a, SVR12 was achieved by 29/31 (93.5%) subjects on the 12-week arm (95% CI: 79.3%, 98.2%) and by 29/32 (90.6%) subjects on the 24-week arm (95% CI: 75.8% - 96.8%).
Maltese: Fil-Parti 1a, SVR12 inkiseb b'29/31 (93.5%) suġġetti fuq il-fergħa ta '12-il ġimgħa (95% CI: 79.3%, 98.2%) u b'29/32 (90.6%) suġġetti fuq il-ġimgħa 24 95% CI: 75.8% - 96.8%).
English: Medicinal products metabolised by CYP2C19
Maltese: Prodotti mediċinali metabolizzati minn CYP2C19
English: paritaprevir recommended.
Maltese: Dejta mhux disponibbli.
English: SVR12 % (n/N) Outcome for subjects without SVR12
Maltese: SVR12 % (n/N)
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: 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: Ombitasvir was approximately 99.9% bound to human plasma proteins.
Maltese: Madwar 99.9% mill-Ombitasvir kien marbut mal-proteini fil-plażma talbniedem..
English: In this combination, the maximum daily dose of rosuvastatin should be 10 mg (see section 4.5, Table 2).
Maltese: F'din il-kombinazzjoni, id-doża massima ta' kuljum ta' rosuvastatin għandha tkun ta' 10 mg (ara sezzjoni 4.5, Tabella 2).
English: The activity of paritaprevir in genotype 1a was not significantly affected (less than or equal to 3-fold) by single substitutions V36A/M, V55I, Y56H, Q80K or E357K.
Maltese: Lattività ta' paritaprevir fil-ġenotip 1a ma kinitx affettwata sinifikatament (3 darbiet jew anqas) minn sostituzzjonijiet uniċi V36A/M, V55I, Y56H, Q80K jew E357K.
English: Unchanged parent drug accounted for 88% of total radioactivity recovered in faeces, indicating that biliary excretion is a major elimination pathway for ombitasvir.
Maltese: Mediċina oriġinali mhux mibdula ammontat għal 88% ta' radjuattività totali li ġiet irkuprata mill-ippurgar, li tindika li l-eskrezzjoni biljari hija passaġġ ta' eliminazzjoni ewlenija għall-ombitasvir.
English: UNIQUE IDENTIFIER - 2D BARCODE UNIQUE IDENTIFIER - HUMAN READABLE DATA
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D IDENTIFIKATUR UNIKU - DATA LI TINQARA MILL-BNIEDEM
English: Ombitasvir is metabolised via amide hydrolysis followed by oxidative metabolism.
Maltese: Ombitasvir huwa metabolizzat permezz tal-idrolisi amide segwit minn metaboliżmu ossidattiv.
English: Pack-size of 56 tablets (multipack carton containing 4 inner cartons of 14 tablets each).
Maltese: Daqs ta' pakkett ta' 56 pilloli (kartuna multiplika fiha 4 kartun intern ta' 14 pilloli kull waħda).
English: HIV/HCV co-infected patients
Maltese: Pazjenti ko-infettati bl-HIV / HCV
English: Co-administration with other direct-acting antivirals against HCV
Maltese: Għoti flimkien ma' antivirali b'azzjoni diretta oħra kontra HCV
English: S-warfarin paritaprevir
Maltese: S-warfarin paritaprevir ombitasvir
English: HCV genotype (GT)
Maltese: Il-ġenotip ta' HCV (GT)
English: Following a 600 mg dose of 14C -ritonavir oral solution, 86.4% of the radioactivity was recovered in the faeces and 11.3% of the dose was excreted in the urine.
Maltese: Wara doża ta' 600 mg ta' soluzzjoni orali ta' 14C -ritonavir, 86.4% tar-radjuattività ġiet irkuprat fl ippurgar u 11.3% tad-doża tneħħiet fl-awrina.
English: PHOSPHODIESTERASE-(PDE-5) INHIBITORS Sildenafil (when used for treatment of pulmonary hypertension)
Maltese: INIBITURI TA' PHOSPHODIESTERASE-(PDE-5) Sildenafil
English: GLUCOCORTICOIDS (INHALED) Fluticasone
Maltese: GLUKOKORTIKOJDI (LI JITTIEĦDU MAN-NIFS) Fluticasone
English: ≥ 35, n (%)
Maltese: <35, n (%) >35, n (%)
English: OATP1B1/3 substrates evaluated in drug interaction studies include pravastatin and rosuvastatin (see Table 2).
Maltese: Substrati ta' OATP1B1/3 evalwati fi studji ta' interazzjonijiet li jinkludu pravastatin, rosuvastatin u cyclosporine (ara Tabella 2).
English: Substitutions R155C, A156T/V, and D168H/V in HCV NS3 reduced susceptibility to paritaprevir by 40- to 323-fold.
Maltese: R155C, A156T/V, u D168H/V fl-NS3 tal-HCV naqqsu s-suxxettibbiltà għal paritaprevir b'40 sa b'323 darba.
English: (see sections 4.2, 4.4, and
Maltese: (ara sezzjonijiet 4.2, 4.3, 4.8 u 5.2).
English: The activity of paritaprevir was reduced 96-fold by D168V, and 50- to 219-fold by each of the other D168 substitutions.
Maltese: L-attività ta' paritaprevir tnaqqset b'96 darba minn D168V, u b'50 sa 219 darba minn kull waħda mis-sostituzzjonijiet D168 l-oħra.
English: Viekirax is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults (see sections 4.2, 4.4, and 5.1).
Maltese: Viekirax huwa indikat f'kombinazzjoni ma' prodotti mediċinali oħrajn għall-kura tal-epatit Ċ kronika (CHC) f'adulti (ara sezzjonijiet 4.2, 4.4, u 5.1).
English: Medicinal products that inhibit transport proteins
Maltese: Prodotti mediċinali li jinibixxu proteini tat-trasport
English: The maximum daily dose of rosuvastatin should be 10 mg (see section 4.4).
Maltese: kuljum ta' rosuvastatin għandha tkun ta' 10mg (ara sezzjoni 4.4).
English: Resistance-associated variants at amino acid positions R155 and D168 in NS3 were rarely observed (less than 1%) at baseline.
Maltese: Varjanti assoċjati mar-reżistenza fil-pożizzjonijiet tal-amino aċidi R155 u D168 fl-NS3 kienu rarament rarament(anqas minn 1%) fil-linja bażi.
English: Each carton contains 56 tablets (multipack carton containing 4 inner cartons of 14 tablets each).
Maltese: Kull kartuna fiha 56 pilloli (kartuna multiplika fiha 4 kartun intern ta' 14 pilloli kull waħda)
English: Use with colchicine
Maltese: ANTI-GOTTA Colchicine
English: Side effects when taking Viekirax with dasabuvir and ribavirin:
Maltese: Effetti sekondarji meta tieħu Viekirax ma' dasabuvir u ribavirin:
English: HIV ANTIVIRALS: PHARMACOKINETIC ENHANCER Cobicistatcontaining regimens
Maltese: HIV: PROMOTUR FARMAKOKINETIKU Korsijiet li jikkontenu
English: Viekirax administered with or without dasabuvir did not affect the exposures of the CYP2D6/CYP1A2 substrate, duloxetine.
Maltese: Viekirax amministrat bi jew mingħajr dasabuvir ma affettwatx l-espożizzjoni tas-substrat tal- CYP2D6 / CYP1A2, duloxetine.
English: Refer to the Summary of Product Characteristics for ribavirin for additional information.
Maltese: Irreferi għas-Sommarju talKarrateristiċi tal-Prodott ta' ribavirin għal informazzjoni addizzjonali.
English: HCV RNA from nadir, or HCV RNA persistently ≥ 25 IU/mL with at least 6 weeks of treatment.
Maltese: ikkonferma f'RNA tal-RNA tal-HCV minn nadir, jew RNA tal-HCV persistentement ≥ 25 IU/mL b'talanqas kura ta' 6 ġimgħat.
English: Viekirax and dasabuvir for 8 weeks n/N (%)
Maltese: Viekirax u dasabuvir għal 8 ġimgħat n/N (%)
English: 2 mg single dose7
Maltese: 2 mg doża waħda 7
English: ANTIANGINA/ANTIARRYTHMICS Amiodarone
Maltese: ANTIANĠINA/ANTIARRITMIĊI
English: In genotype 1a, substitutions F43L, R155K, A156T, and D168A/F/H/V/Y in HCV NS3 reduced susceptibility to paritaprevir.
Maltese: Fil-ġenotip 1a, is-sostituzzjonijiet F43L, R155K, A156T, u D168A/F/H/V/Y f'HCV NS3 naqqsu ssuxxettibbiltà għal paritaprevir.
English: Ethinyloestra diol/ norgestimate
Maltese: Ethinyl oestradiol/ norgestimate mg darba kuljum
English: In genotype 1a, substitutions M28T/V, Q30E/R, L31V, H58D, Y93C/H/N, and M28V + Q30R in HCV NS5A reduced susceptibility to ombitasvir.
Maltese: Fil-ġenotip 1a, is-sostituzzjonijiet M28T/V, Q30E/R, L31V, H58D, Y93C/H/N, u M28V + Q30R f'HCV NS5A naqqsu s-suxxettibbiltà għal ombitasvir.
English: The overall safety profile in HCV/HIV-1 co-infected subjects was similar to that observed in HCV monoinfected subjects.
Maltese: Il-profil tas-sigurtà globali f'individwiko-infettati b'HCV / HIV-1 kien simili għal dak osservat f'individwi infettati b'HCV biss.
English: PVC/PE/PCTFE aluminium foil blister packs.
Maltese: Pakketti ta' folji tal-aluminju PVC/PE/PCTFE
English: CYP3A4 substrates:
Maltese: Substrati ta' CYP3A4:
English: • sildenafil (when used for the treatment of pulmonary arterial hypertension)
Maltese: • sildenafil (meta jintuża għall-kura ta' ipertensjoni arterjali tal-pulmuni)
English: 800/160 mg twice daily
Maltese: 800/160 mg darbtejn kuljum
English: 24 weeks (see section 5.1.)
Maltese: 24-il ġimgħa (ara sezzjoni 5.1)
English: All 3 (100%) subjects with GT4 infection who were post liver transplant achieved SVR12.
Maltese: Tt-3 suġġetti kollha (100%) b'infezzjoni ta' GT4 b'trapjanti wara l-fwied kisbu SVR12.
English: Concomitant use of fluticasone can increase systemic exposures of fluticasone.
Maltese: Użu konkomitanti ta' fluticasone jista' jżid esponimenti sistemiċi ta'
English: Viekirax dasabuvir
Maltese: Viekirax u dasabuvir
English: HCV GT1- or 4-infected subjects with HIV-1 coinfection were on a stable HIV-1 antiretroviral therapy (ART) regimen that included ritonavir-boosted atazanavir, raltegravir, dolutegravir (Part 2 only), or darunavir (Part 1b and Part 2 GT4 only)-, co-administered with a backbone of tenofovir plus emtricitabine or lamivudine.
Maltese: Suġġetti HCV GT1- jew 4-infettati b'infezzjoni tal-HIV-1 li kienu fuq kors ta' terapija antiretrovirali (ART) HIV-1 li kienu inklużi ritonavir imsaħħaħ b'atazanavir, raltegravir, dolutegravir (it-tieni Parti biss), jew darunavir (Parti 1b u t-tieni Parti GT4 biss)- amministrati fl-istess ħin b'sinsla ta' tenofovir + emtricitabine jew lamivudine.
English: GT1b Viekirax and dasabuvir (8 weeks) Peginterferon+ribavirin experienced -, without cirrhosis SAPPHIRE II
Maltese: GT1b Viekirax u dasabuvir (8 ġimgħat) -esperjenza ta'Peginterferon+ribavirin, mingħajr ċirrożi SAPPHIRE II
English: Note: For laboratory abnormalities, refer to Table 4
Maltese: Nota: Għal abnormalitajiet tal-laboratorju irreferi għat-Tabella 4 .
English: Ombitasvir and paritaprevir do not inhibit organic anion transporter (OAT1) in vivo and are not expected to inhibit organic cation transporters (OCT1 and OCT2), organic anion transporters (OAT3), or multidrug and toxin extrusion proteins (MATE1 and MATE2K) at clinically relevant concentrations.
Maltese: Ombitasvir u paritaprevir,ma jinibixxux it-trasportatur tal-anjonu organiku (OAT1) in vivo u mhumiex mistennija li jinibixxu t-trasportaturi tal-ketajin organika (OCT1 u OCT2), it-trasportaturi tal-enajin organiku (OAT3), jew proteini tal-estrużjoni ta' ħafna mediċini u tossini (MATE1 u MATE2K)
English: BCRP substrates evaluated in drug interaction studies include rosuvastatin (see Table 2).
Maltese: Substrati ta' BCRP evalwati fi studji ta' interazzjoni tal-mediċina jinkludu rosuvastatin (ara Tabella 2).
English: Note: Doses used for Viekirax and dasabuvir were: ombitasvir 25 mg, paritaprevir 150 mg, ritonavir 100 mg, once daily and dasabuvir 400 mg twice daily or 250 mg twice daily.
Maltese: Nota: Id-dożi użati għal Viekirax u dasabuvir kienu: ombitasvir 25 mg, paritaprevir 150 mg, ritonavir 100 mg, darba kuljum u dasabuvir 400 mg darbtejn kuljum jew 250 mg darbtejn kuljum.
English: In vitro studies show that ombitasvir, paritaprevir, and ritonavir are not inhibitors of organic cation transporters (OCT2), organic anion transporters (OAT3), or multidrug and toxin extrusion proteins (MATE1 and MATE2K) at clinically relevant concentrations.
Maltese: Studji in vitro juru ombitasvir, paritaprevir, u ritonavir m'humiex inibituri tat-trasportaturi tal-ketaljin organika (OCT2), trasportaturi talanjonu organiku (OAT3), jew għal diversi medicini u proteini li jestrudutossini (MATE1 u MATE2K)
English: Drug interactions were evaluated for the Viekirax and dasabuvir regimen, but not for the Viekirax without dasabuvir, with carbamazepine, furosemide, zolpidem, darunavir twice daily, darunavir (evening administration), atazanavir (evening administration), rilpivirine, abacavir/lamivudine, dolutegravir, metformin, sulfamethoxazole/trimethoprim, cyclobenzaprine, carisoprodol, hydrocodone/
Maltese: furosemide, zolpidem, darunavir darbtejn kuljum, darunavir (għoti filgħaxija), atazanavir (għoti filgħaxija), rilpivirine, abacavir/lamivudine, dolutegravir, metformin, sulfamethoxazole/trimethoprim, cyclobenzaprine, carisoprodol, hydrocodone/ paracetamol or diazepam.
English: Pharmacotherapeutic group: Antivirals for systemic use; direct-acting antivirals, ATC code: J05AP53
Maltese: Antivirali għal użu sistemiku; antivirali b'azzjoni diretta, Kodiċi ATC:
English: Pharmacokinetics of the combination of ombitasvir 25 mg, paritaprevir 200 mg, and ritonavir 100 mg were not evaluated in subjects with mild (Child-Pugh A), moderate (Child-Pugh B) and severe (ChildPugh C) hepatic impairment.
Maltese: Il-farmokokinetika tal-kombinazzjoni ta' ombitasvir 25 mg, paritaprevir 200 mg, u ritonavir 100 mg, ma ġietx evalwata f'individwi b'indeboliment ħafif (Child-Pugh A), moderat (Child-Pugh B) u sever (Child
English: Ribavirin was dosed based on weight (1000 mg - 1200 mg per day).
Maltese: Ribavirin kellu doża ibbażata fuq il-piż (1000 mg - 1200 mg kuljum).
English: On-treatment VF
Maltese: F'kura VF Rikaduta
English: Ombitasvir and its major inactive human metabolites (M29, M36) were not genotoxic in a battery of in vitro or in vivo assays, including bacterial mutagenicity, chromosome aberration using human peripheral blood lymphocytes and in vivo mouse micronucleus assays.
Maltese: Ombitasvir u l-metaboliti tal-bniedem inattivi ewlenin tiegħu (M29, M36) ma kinux ġenotossiċi f'batteriji ta' analiżijiet in vitro jew in vivo, inkluż mutaġeniċità batterika, aberrazzjoni tal-kromożomi permezz ta'