FrancophonIA/ELRC3.0 huggingface dataset:
English: Taking into account the protein binding and in vitro activity of M1 against HCV genotype 1, its contribution to efficacy is expected to be similar to that of dasabuvir.
Maltese: Meta tara l-irbit mal-proteini u l-attività in vitro ta M1 kontra HCV ta' ġenotip 1, il-kontribuzzjoni għall-effikaċja huwa mistenni li jkun simili għal dak ta' dasabuvir.
English: GARNET - Genotype 1b, Treatment-Naïve without cirrhosis.
Maltese: GARNET - Ġenotip 1b, Trattament naïve mingħajr ċirrożi
English: PEARL-II - genotype 1b, pegIFN+RBV-experienced, without cirrhosis Design:
Maltese: PEARL-II - ġenotip 1b, li esperjenzaw pegIFN+RBV , bla ċirrożi Disinn:
English: Adverse events of anaemia were not seen in the 18 GT1b-infected subjects who did not receive ribavirin.
Maltese: Avvenimenti avversi ta' anemija ma dehrux fit-18-il individwu infettati bil-GT1b li ma rċevewx ribavirin.
English: Dasabuvir is an inhibitor of BCRP in vivo.
Maltese: Dasabuvir huwa inibitur ta' BCRP in vivo.
English: CYP2C8 inhibitor:
Maltese: Inibitur ta' CYP2C8 :
English: ↑ GS
Maltese: UŻU
English: Sixty four of 68 (94.1%) subjects achieved SVR12.
Maltese: Erbgħa u sittin mis-68 (94.1%) individwi kisbu SVR12.
English: Mechanism: CYP3A4 induction by phenytoin.
Maltese: Induzzjoni ta' CYP3A4 minn phenytoin.
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 minn 29/32 (90.
English: Medicinal products renally excreted via transport proteins Dasabuvir does not inhibit organic anion transporter (OAT1) in vivo as shown by the lack of interaction with tenofovir (OAT1 substrate).
Maltese: Prodotti mediċinali eliminati mill-kliewi permezz ta' proteini tat-trasport Dasabuvir ma jimpedixxix trasportatur anion organiku (OAT1) in vivo kif muri min-nuqqas ta' interazzjoni ma' tenofovir (substrat OAT1).
English: Beige, ovaloid, film-coated tablets with dimensions of 14.0 mm x 8.0 mm and debossed on one side with ‘AV2'.
Maltese: Beige, ovali, pilloli miksijin b'rita, b'daqs ta'14.0 mm x 8.0 mm u imnaqqxa fuq naħa waħda bi ‘AV2'
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 dabigatran to thin the blood deferasirox to help reduce iron levels in the blood digoxin, amlodipine for heart problems or high blood pressure furosemide for the build-up of too much fluid in the body hydrocodone for pain imatinib for the treatment of some cancers of the blood levothyroxine for thyroid problems darunavir/ritonavir, atazanavir/ritonavir, rilpivirine for HIV infection omeprazole, lansoprazole, esomeprazole for stomach ulcers and other stomach problems rosuvastatin, pravastatin, fluvastatin, pitavastatin to lower blood cholesterol s-mephenytoin for epilepsy teriflunomide for multiple sclerosis sulfasalazine to treat and manage inflammatory bowel disease or to treat rheumatoid arthritis warfarin and other similar medicines called vitamin K antagonists*
Maltese: Levothyroxine għall-problemi tat-tirojde darunavir/ritonavir, atazanavir/ritonavir, rilpivirine għal infezzjoni tal-HIV omeprazole, lansoprazole, esomeprazole għal ulċeri fl-istonku u problemi fl istonku oħra rosuvastatin, pravastatin, fluvastatin,pitavastatin biex jitnaqqas il-kolesterol fid-demm s-mephenytoin għall-epilessija
English: Paritaprevir treatment-emergent variants V36A/M, R155K or D168V were observed in NS3 in 47 subjects.
Maltese: Il-varjanti emerġenti b'paritaprevir V36A/M, R155K jew D168V f'NS3 kienu osservati f'47 individwu.
English: The activity of dasabuvir was reduced by 5- and 11-fold by C316N and S556G, respectively; 46-fold by M414T or Y448H; and 1569-fold by the C316Y substitutions in the genotype 1b replicon.
Maltese: L-attività ta' dasabuvir tnaqqset b'5 u 11-il darba minn C316N u S556G, rispettivament; b'46 darba minn M414T jew Y448H; u b'1569 darba minn sostituzzjonijiet C316Y fir-replikon tal-ġenotip 1b.
English: You will take Exviera for 8, 12 or 24 weeks.
Maltese: Ser tieħu Exviera għal 8, 12 jew 24 ġimgħa.
English: The replicon activity of dasabuvir was attenuated 12- to 13fold in the presence of 40% human plasma.
Maltese: L-attività replikon ta' dasabuvir kienet mnaqqsa minn 12- sa 13-il darba fil-preżenza ta' 40% tal-plażma umana.
English: SVR12 window.
Maltese: RNA fit-tieqa SVR12.
English: ↔ digoxin 1.15
Maltese: ↑ dasabuvir 1.15
English: In subjects with all three favourable baseline laboratory values (AFP < 20 ng/mL, platelets ≥ 90 x 109/L, and albumin ≥ 35 g/L), relapse rates were similar in subjects treated for 12 or 24 weeks.
Maltese: F'suġġetti bi tliet valuri tal-linja bażi tal-laboratorju kollha favorevoli (AFP < 20 ng/mL, plejtlets ≥ 90 x 109 /L, u albumina ≥ 35 g/L), rati ta' rikaduta kienu simili f'suġġetti kkurati għal 12 jew 24 ġimgħa.
English: This is not an exclusive list.
Maltese: Din mhix lista esklussiva.
English: Blood tests
Maltese: TAT-TEST
English: Genotype 1b N=7 % (n)
Maltese: N=7 % (n)
English: Design:
Maltese: Disinn:
English: Coadministration with ethinyloestradiol may lead to increased risk of ALT elevations (see sections 4.3 and 4.4).
Maltese: Koamministrazzjoni ma' ethinyloestradiol jista' jwassal għal riskju akbar ta' żiediet fl-ALT (ara sezzjonijiet 4.3 u 4.4).
English: randomised, global multicentre, open-label
Maltese: ‘randomised', ‘multicentre' globali, ‘open-label'
English: Following a 400 mg 14C-dasabuvir dose, approximately 94% of the radioactivity was recovered in faeces with limited radioactivity (approximately 2%) in urine.
Maltese: Wara doża ta' 400 mg 14C-dasabuvir, madwar 94% tar-radjuattività kienet irrkuprata fl-ippurgar b'radjuattività limitata (madwar 2%) fl-awrina.
English: SVR12 for genotype 1-infected peginterferon+ribavirin-experienced subjects in SAPPHIRE-II
Maltese: SVR12 għal individwi li esperjenzaw peginterferon+ribavirin, infettati bil-ġenotip 1 f'SAPPHIRE-II
English: Treated subjects had a median age of 51 years (range: 26 to 64); 65.8% were male and 5.3% were Black.
Maltese: Individwi kkurati kellhom età medja ta' 51 sena (medda: 26 sa 64); 65.8% kienu kienu rġiel u 5.3% kienu Suwed.
English: Pravastatin 10 mg once daily
Maltese: Pravastatin 10mg darba kuljum
English: EXPIRY DATE
Maltese: DATA TA' REVIŻJONI
English: For dosing recommendations with HIV antiviral medicinal products, refer to sections 4.4 and 4.5.
Maltese: dożaġġ ma prodotti mediċinali antivirali għal HIV, irreferi għal sezzjonijiet 4.4 u 4.5.
English: PEARL-IV - genotype 1a, treatment-naïve, without cirrhosis
Maltese: PEARL-IV- ġenotip 1a, naïve għall-kura, mingħajr ċirrożi
English: TURQUOISE-II: relapse rates by baseline laboratory values after 12 and 24 weeks of treatment in subjects with genotype 1a infection and compensated cirrhosis dasabuvir and ombitasvir/paritaprevir/ritonavir with RBV 12-week arm dasabuvir and ombitasvir/paritaprevir/ritonavir with RBV 24-week arm
Maltese: TURQUOISE-II: rati ta' rikaduta minn valuri bażiċi tal-laboratorju wara 12 u 24 ġimgħa ta' kuraf'individwi b'infezzjoni ta' ġenotip 1a u ċirrożi kkumpensata dasabuvir u ombitasvir/paritaprevir/ritonavir ma' RBV
English: Pharmacodynamic interactions
Maltese: Interazzjonijiet farmakodinamiċi
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: (N = 68) kellhom età medjana ta' 58 sena (firxa: 32-77 sena); 83.8% kienu rġiel; 58.8% kienu Suwed; 73.5% tas-suġġetti kienu infettati b'HCV GT1a; 75.0% kellhom l-Istadju 5
English: HIV/HCV co-infected patients
Maltese: Pazjenti ko-infettati b'HIV/HCV
English: dasabuvir + ombitasvir/paritaprevir/ritonavir was administered as multiple doses in all the drug interaction studies except the drug interaction studies with carbamazepine, gemfibrozil, ketoconazole, and sulfamethoxazole/trimethoprim.
Maltese: ombitasvir/paritaprevir/ritonavir ingħataw bħala dożi multipli fl-istudji kollha ta' interazzjoni tal-mediċina ħlief l istudji ta' interazzjoni tal-mediċina ma' carbamazepine, gemfibrozil, ketoconazole, u sulfamethoxazole/trimethoprim..
English: Diazepam2 mg single dose
Maltese: Diazepam2 mg doża waħda Mekkaniżmu:
English: Subjects were on a stable HIV-1 antiretroviral therapy (ART) regimen that included ritonavir-boosted atazanavir or 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: individwi kienu fuq kors ta' terapija antiretrovirali (ART) HIV-1 li tinkludi ritonavir imsaħħaħ b'atazanavir jew raltegravir, dolutegravir (Parti 2 biss), jew darunavir (Parti 1b u Parti 2 GTr biss), amministrati fl-istess ħin b'sinsla ta' tenofovir + emtricitabine jew lamivudine.
English: For immunosuppressive medication, most subjects were taking tacrolimus (81%), with the remainder taking cyclosporine.
Maltese: Għal medikazzjoni immunosoppressiva, ħafna mill-individwi kienu qed jieħdu tacrolimus (81%), filwaqt li l-bqija jieħdu cyclosporine.
English: No increase in incidence of ALT elevations was observed with other types of systemic oestrogens commonly used for hormone replacement therapy (e.g., oestradiol and conjugated oestrogens).
Maltese: Ebda żieda fl-inċidenza ta' elevazzjoni fl-ALT ma kienet osservata ma' tipi oħra ta' estroġeni sistemiċi komunament użati għal terapija ta' sostituzzjoni bl-ormoni (e.ż, estradiol u estroġeni konjugat).
English: 250 mg single dose
Maltese: 250 mg doża waħda
English: PC:
Maltese: PC SN NN:
English: Mechanism: CYP3A4 induction by carbamazepi ne.
Maltese: Induzzjoni ta' CYP3A4 minn carbamazepine.
English: Lopinavir/ritonavir 800/200 mg once daily (administered in the evening) was also administered with dasabuvir with ombitasvir/paritaprevir/ritonavir.
Maltese: Lopinavir/ritonavir 800/200 mg darba kuljum (amministrati fil-għaxija) kien ukoll amministrat ma' dasabuvir ma' ombitasvir/paritaprevir/ritonavir.
English: Among all GT1 subjects who were post liver transplant, 111/114 (97.4%) achieved SVR12; with 2 relapsing post treatment and 1 breakthrough on treatment.
Maltese: Fost is-suġġetti GT1 kollha li b'trapjant tal-fwied wara, 111/114 (97.4%) kisbu SVR12; b'2 trattament ta 'wara l-irkadar u 1 avvanz fit-trattament.
English: NA ombitasvir/paritaprevir/ ritonavir).
Maltese: ombitasvir/paritaprevir/ritonavir.
English: c. Substitutions were observed in combination with other emergent substitutions at NS3 position R155 or D168.
Maltese: Kienu osservati sostituzzjonijiet flimkien ma' sostituzzjonijiet emerġenti oħra f'pożizzjoni NS3 R155
English: NA Decrease in amlodipine dose by 50% and monitor patients for clinical effects.
Maltese: Huwa rrakomandat tnaqqis fid-doża ta' amlodipine b'50% u seqgwi l-pazjenti għal effetti kliniċi.
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
English: The lack of detection of virus containing a resistance-associated substitution does not indicate that the resistant virus is no longer present at clinically significant levels.
Maltese: In-nuqqas ta' detezzjoni ta' virus li fih sostituzzjoni assoċjata mar-reżistenza ma jindikax li l-virus reżistenti m'għadux preżenti f'livelli klinikament sinifikanti.
English: Treatment outcome dasabuvir and ombitasvir/paritaprevir/ritonavir with RBV for 12 weeks n/N % 95% CI
Maltese: Riżultat ta' kura dasabuvir u ombitasvir/paritaprevir/ritonavir ma' RBV għal 12-il ġimgħa n/N % 95% CI
English: OATP/BCRP /P-gp inhibition by ciclosporin.
Maltese: tkun minħabba inibizzjoni ta' OATP/BCRP/P-gp b' ciclosporin.
English: Co-administration of dasabuvir with ombitasvir/paritaprevir/ritonavir can decrease exposures of medicinal products that are metabolized by CYP2C19 (e.g. lansoprazole, esomeprazole, smephenytoin), which may require dose adjustment/clinical monitoring.
Maltese: Prodotti mediċinali metabolizzati minn CYP2C19 L-għoti ta' dasabuvirma ombitasvir/paritaprevir/ritonavir jista' jnaqqas l-espożizzjonijiet ta' prodotti mediċinali li huma metabolizzati minn CYP2C19 (e.ż. lansoprazole, esomeprazole, s-mephenytoin) li jistgħu jeħtieġu aġġustament tad-doża/monitoraġġ kliniku .
English: dasabuvir and ombitasvir/paritaprevir/ritonavir for 8 weeks Treated subjects (N=166) had a median age of 53 years (range: 22 to 82); 56.6% were female; 3.0% were Asian; 0.6% were Black; 7.2% had baseline HCV RNA levels of at least 6,000,000 IU per mL;
Maltese: dasabuvir u ombitasvir/paritaprevir/ritonavir għal 8 ġimgħat Il-pazjenti kkurati (N = 166) kellhom età medjana ta' 53 sena (medda: 22-82); 56.6% kienu nisa; 3.0%
English: Immune system disorders Frequency unknown
Maltese: Disturbi tas-sistema immunitarja Frekwenza mhux magħrufa
English: Exviera tablets are packed into foil blisters containing 2 tablets.
Maltese: Il-pilloli ta' Exviera huma ppakjati f'pakketti ta' folji ta' kuljum li fihom 2 pilloli.
English: AbbVie (as logo)
Maltese: AbbVie (bħala logow)
English: Patients treated with vitamin K antagonists
Maltese: Pazjenti ttrattati b'antagonisti tal-vitamina K
English: Extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients when dasabuvir is used with ribavirin.
Maltese: Għandha tingħata kawtela estrema biex tiġi evitata tqala f'pazjenti nisa u fil-partners femminili ta' pazjenti rġiel meta dasabuvir jintuża ma' ribavirin.
English: All clinical trials with dasabuvir have been conducted following administration with food.
Maltese: Stat fiss ta' farmakokinetika għall-dasabuvir meta jiġi amministrat ma'
English: Medicinal products transported by the OATP family Refer to the ombitasvir/paritaprevir/ritonavir Summary of Product Characteristics for details on OATP1B1, OATP1B3 and OATP2B1 substrates (see also Table 2).
Maltese: Irreferi għas-Sommarju tal-Karatteristiċi tal-Prodott ta' ombitasvir/paritaprevir/ritonavir għal dettalji dwar substrati OTAP1B1, OATP1B3 u OATP2B1 (ara wkoll Tabella 2).
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 pegIFN + RBV-esperjenzat b'HCV GT1 jew GT4/HIV-1
English: Atazanavir/ ritonavir 300/100 mg once daily
Maltese: Lopinavir/ritonavir 400/100mg darbtejn kuljum1
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton of multipack containing 56 (4 packs of 14) film-coated tablets - including blue box
Maltese: Kartuna ta' Barra ta' pakkett multiplu li fih 56 (4 pakketti ta 14-il) pillola miksijin b'rita inkluż kaxxa blu
English: It is important not to miss a dose of this medicine.
Maltese: Huwa importanti li ma taqbiżx doża ta' din il-mediċina.
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 kkurati (N=63) kellhom medja ta' età ta' 51-il sena (medda 31 sa 69); 24% kienu Suwed 19% kellhom ċirrożi kkumpensata; 67% kienu naive għall-kura; 33% fallew qabel ilkura bi pegIFN/RBV; 89% kellhom infezzjoni tal-ġenotip 1a HCV.
English: AbbVie Biofarmacevtska družba d.o.o.
Maltese: AbbVie Biopharmaceuticals GmbH Eesti filiaal Tel.
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 e.ż. ibuprofen), antidijabetiċi (e.ż.
English: randomised, global multicentre, double-blind, regimen-controlled
Maltese: ‘randomised', ‘multicentre' globali, double-blind, kkontrollat minn reġim
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: Fil-kampjuni tal-linji bażi tal ġenotip 1b akbar minn 200 f'din l-analiżi, il-varjanti assoċjati mar-reżistenza osservati l-aktar frekwentement kienu Y93H (7.5%) f'NS5A u C316N (17.0%) u S556G (15%) f'NS5B.
English: HCV genotype (GT)
Maltese: Ġenotip HCV
English: 0.5 mg single dose5
Maltese: 0.5 mg
English: Changes in exposures of the metabolite were generally consistent with that observed with dasabuvir except for studies with CYP2C8 inhibitor, gemfibrozil, where the metabolite exposures decreased by up to 95% and CYP3A inducer, carbamazepine, where the metabolite exposures decreased by only up to 39%.
Maltese: Bidliet fl espożizzjonijiet tal-metabolit kienu ġeneralment konsistenti ma' dawk osservati b'dasabuvir ħlief għall-istudji bl-inibitur CYP2C8, gemfibrozil, fejn l-espożizzjoni tal-metabolit tnaqsu sa 95% u linduttur CYP3A, carbamazepine, fejn l-espożizzjoni tal-metabolit tnaqqsu biss sa 39% .
English: CORAL-I: treatment-naïve or pegIFN + RBV-experienced, GT 1 or GT4 infected, at least 3 months post liver transplant or 12 months post renal transplant
Maltese: CORAL-I: trattament-naïve jew esperjenzat b' pegIFN +RBV, infettat b'GT 1 jew GT4, mill-inqas 3 xhur wara t-trapjant tal-fwied jew 12-il xahar wara t-trapjant renali
English: Dasabuvir retained full activity against replicons containing substitutions S282T in the nucleoside binding site, M423T in the lower thumb site, and P495A/S, P496S or V499A in the upper thumb site.
Maltese: Dasabuvir żamm l-attività sħiħa kontra r-replikonijiet li fihom is-sostituzzjonijiet S282T fis-sit tat-twaħħil tal-nucleoside, M423T fis-sit laktar baxx tas-saba' l-kbir, u P495A/S, P496S jew V499A fis-sit ta' fuq tas-saba' l-kbir.
English: Tacrolimus 2 mg single dose7
Maltese: 2 mg doża waħda 7 Mekkaniżmu:
English: Transient elevations in serum bilirubin (predominantly indirect) were observed in subjects receiving dasabuvir and ombitasvir/paritaprevir/ritonavir with ribavirin, related to the inhibition of the bilirubin transporters OATP1B1/1B3 by paritaprevir and ribavirin-induced haemolysis.
Maltese: Elevazzjonijiet temporanji tal-bilirubin fis-serum (il-biċċa l-kbira indiretti) ġew osservati f'individwi li kienu qed jirċievu dasabuvir u ombitasvir/paritaprevir/ritonavir b'ribavirin, relatati mal-inibizzjoni ta' trasportaturi ta' bilirubin OATP1B1/1B3 minn paritapreviru u emoliżi indotta minn ribavirin.
English: България АбВи ЕООД
Maltese: АбВи ЕООД Тел.:
English: 30 mg once daily single dose3
Maltese: 30mg doża waħda darba kuljum3
English: 3 years
Maltese: 3 snin.
English: Dasabuvir is predominantly metabolised by CYP2C8 and to a lesser extent by CYP3A.
Maltese: Dasabuvir huwa prinċipalment metabolizzat minn CYP2C8 u sa punt iżgħar minn CYP3A.
English: In clinical studies
Maltese: Fi studji kliniċi
English: Dasabuvir does not inhibit organic anion transporter (OAT1) in vivo and is not expected to inhibit organic cation transporters (OCT2), organic anion transporters (OAT3), or multidrug and toxin extrusion proteins (MATE1 and MATE2K) at clinically relevant concentrations; therefore, dasabuvir does not affect medicinal product transport by these proteins.
Maltese: Dasabuvir ma jimpedixxix trasportatur anion organiku (OAT1) in vivo u mhuwiex mistenni li jinibixxi t-trasportaturi organiċi katjoni (OCT2), it-trasportaturi anjoni organiċi (OAT3), jew proteini tal estrużjoni ta' ħafna mediċini u tossini MATE1 u MATE2K) f'konċentrazzjonijiet klinikamentrilevanti; għalhekk , dasabuvir ma taffettwax it-trasport tal-prodott mediċinali minn dawn il-proteini .
English: Pharmacokinetics of the combination of ombitasvir 25 mg, paritaprevir 150 mg, and ritonavir 100 mg, with dasabuvir 400 mg were evaluated in subjects with mild (CrCl: 60 to 89 ml/min), moderate (CrCl: 30 to 59 ml/min) and severe (CrCl: 15 to 29 ml/min) renal impairment, relative to subjects with normal renal function.
Maltese: 60 sa 89 ml/min), moderat (CrCl: 30 sa 59 ml/min), u sever (CrCl: 15 sa 29 ml/min), meta mqabbla ma' individwi b'funzjoni renali normali.
English: increase in HCV RNA from nadir, or HCV RNA persistently ≥ 25 IU/mL with at least 6 weeks of treatment.
Maltese: ikkonfermata fl-RNA tal-HCV minn nadir, jew RNA tal-HCV persistentament ≥ 25 IU/mL b'ta' mill-inqas 6
English: Ombitasvir treatment-emergent variants M28T, M28V or Q30R in NS5A were observed in 32 subjects.
Maltese: Il-varjanti emerġenti għall-kura b'ombitasvir M28T, M28V jew Q30R f'NS5A kienu osservati f'32 individwu.
English: randomised, global multicentre, open-label, regimen-controlled
Maltese: ‘randomised', ‘multicentre' globali, ‘open-label', ikkontrollat minn reġimen
English: Inhibition of P-gp and BCRP is not expected to show clinically relevant increases in exposures of dasabuvir (Table 2).
Maltese: Inibizzjoni ta' P-gp u BCRP mhijiex mistennija li turi żidiet klinikament relevanti fil espożizzjonijiet ta' dasabuvir (Tabella 2).
English: d. Observed in combination in genotype 1b-infected subjects.
Maltese: d. Osservati flimkien mal-individwi infettati bil-ġenotip 1b. e.
English: Arm A: dasabuvir and ombitasvir/paritaprevir/ritonavir + RBV Arm B: dasabuvir and ombitasvir/paritaprevir/ritonavir
Maltese: Fergħa A: dasabuvir u ombitasvir/paritaprevir/ritonavir + RBV Fergħa B: dasabuvir u ombitasvir/paritaprevir/ritonavir
English: Date of first authorisation: 15 January 2015 Date of latest renewal:
Maltese: Data tal-ewwel awtorizzazzjoni: 15 Jannar 2015
English: Dasabuvir treatment-emergent variants M414T, G554S, S556G, G558R or D559G/N in NS5B were observed in 34 subjects.
Maltese: Il-varjanti emerġenti għall-kura b'dasabuvir M414T, G554S, S556G, G558R jew D559G/N f'NS5B kienu osservati f'34 individwu .
English: The pharmacokinetics of dasabuvir with ombitasvir/paritaprevir/ritonavir in paediatric patients has not been investigated (see section 4.2).
Maltese: Il-farmakokinetiċi ta' dasabuvir ma' ombitasvir/paritaprevir/ritonavir f'pazjenti pedjatriċi ma ġewx investigati(ara sezzjoni 4.2).
English: In the post-liver transplant study, ribavirin dosing was individualized and most subjects received 600 to 800 mg per day (see section 5.1).
Maltese: Fl-istudju li sar wara t-trapjant tal-fwied, id-dożi ta' ribavirin kienu individwalizzati u ħafna mill-individwi rċevew 600-800 mg kuljum (ara sezzjoni 5.2).
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għall-galattożju, defiċjenza totali tal-lactase jew assorbiment ħażin ta' glukożju u galattożju m'għandhomx jieħdu din il-mediċina.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis sezzjoni 6.1.
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 post-treatment 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: 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 (għaddettalji ara sezzjoni 4.5, Tabella 2).
English: Geometric mean Cmax, AUC of multiple doses of dasabuvir 250 mg twice daily and ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily with food in healthy volunteers
Maltese: Cmass, AUC medji ġeometriċi ta' dożi multipli ta' dasabuvir 250 mg darbtejn kuljum u ombitasvir/paritaprevir/ritonavir25 mg/150 mg/100 mg darba kuljum bl-ikel f'voluntiera b'saħħitom.