FrancophonIA/ELRC3.0 huggingface dataset:
English: For subjects who received ribavirin, the ribavirin dose was 1000 mg per day for subjects weighing less than 75 kg or 1200 mg per day for subjects weighing greater than or equal to 75 kg.
Maltese: Għal individwi li rċevew ribavirin, id-doża ta' ribavirin kienet 1000 mg kuljum għal individwi li jiżnu anqas minn 75 kg jew 1200 mg kuljum għal individwi li jiżnu 75 kg jew aktar.
English: Peg-IFN + RBV, n (%) Baseline albumin, median g/L < 35, n (%)
Maltese: Eta, snin medja (firxa) Sess maskil, n (%) Qabel it-trattament ta' HCV: naïve, n (%) Peg-IFN + RBV, n (%) Linja bażi ta' albumina, medja g/L <35, n (%) >35, n (%) Linja bażi tal-għadd ta' plejtlits, medja (x109/L) 132.0 < 90, n (%) > 90, n (%)
English: The High Pure system assay had a lower limit of quantification (LLOQ) of 25 IU per mL and the AmpliPrep assay had a LLOQ of 15 IU per mL.
Maltese: analiżi High Pure kellha limitu aktar baxx ta' kwantifikazzjoni (LLOQ) ta' 25 IU għal kull mL u l analiżi AmpliPrep kellha LLOQ ta' 15 IU għal kull mL.
English: Each film-coated tablet contains 250 mg of dasabuvir (as sodium monohydrate).
Maltese: Kull pillola miksija b'rita fiha 250 mg ta' dasabuvir (bħala sodju monohydrate).
English: 0.75 mg single dose
Maltese: Everolimus 0.75 mg doża waħda Mekkaniżmu:
English: Resistance
Maltese: KONTRAĊETTIVI
English: Sirolimus 2 mg was dosed alone, 0.5 mg administered with dasabuvir + ombitasvir/paritaprevir/ritonavir.
Maltese: Sirolimus 2 mg kien mogħti waħdu, 0.5 mg mogħti ma' dasabuvir + ombitasvir/paritaprevir/ritonavir.
English: Sirolimus blood concentrations should be monitored every 4 to 7 days until 3 consecutive trough levels have shown stable concentrations of sirolimus.
Maltese: Il konċentrazzjonijiet ta' sirolimus fid demm għandhom jiġu monitorjati kull 4 sa 7 ijiem sakemm 3 livelli ta' doża l-iktar minimi (troughs) konsekuttivi juru konċentrazzjonijiet stabbli ta' sirolimus.
English: paritaprevir used together with dasabuvir + ombitasvir/paritaprevir/ ritonavir, administer sirolimus 0.2 mg twice a week (every 3 or 4 days on the same two days each week).
Maltese: Jekk sirolimus jintuża flimkien ma' dasabuvir + ombitasvir / paritaprevir / ritonavir, amministra sirolimus 0.2 mg darbtejn fil-ġimgħa (kull 3 jew 4 ijiem fuq l-istess jumejn kull ġimgħa).
English: EFFECT Cmax
Maltese: .8 Effetti mhux mixtieqa
English: Selected treatment emergent laboratory abnormalities
Maltese: Tabella 4: Anormalitajiet tal-laboratorju emerġenti minn kura magħżula
English: Tacrolimus 2 mg was dosed alone and 2 mg was administered with dasabuvir + ombitasvir/paritaprevir/ritonavir.
Maltese: Tacrolimus 2 mg ingħata waħdu u 2 mg ingħataw ma' dasabuvir + ombitasvir/paritaprevir/ritonavir.
English: Emtricitabine/ tenofovir 200 mg once daily/300 mg once daily dasabu vir + ombitas vir/parit aprevir/ ritonavi r
Maltese: 200 mg darba kuljum /300 mg darba kuljum dasabuvir ombitasvir/ paritaprevi r/ritonavir
English: Genotype 1a, with compensated cirrhosis dasabuvir + ombitasvir/paritaprevir/ritonavir + ribavirin*
Maltese: Ġenotip 1b, b'ċirrożi kkumpensata dasabuvir + ombitasvir/paritaprevir/ritonavir + ribavirin*
English: Dasabuvir M1 AUC values were 6% lower, 10% lower, and 13% lower, respectively.
Maltese: Valuri medja ta' AUC ta' dasabuvir M1 kienu 6% inqas, 10%
English: Arm A: dasabuvir and ombitasvir/paritaprevir/ritonavir + RBV
Maltese: Fergħa A: dasabuvir u ombitasvir/paritaprevir/ritonavir + RBV
English: Exviera 250 mg film-coated tablets
Maltese: Exviera 250 mg pilloli miksijin b'rita
English: Endpoint dasabuvir and ombitasvir/paritaprevir/ritonavir with or without ribavirin for 12 or 24 Weeks N = 200a
Maltese: Endpoint dasabuvir u ombitasvir/paritaprevir/ritonavir bi u mingħajr ribavirin ghal 12 or 24
English: 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: Co-administration of dasabuvir with ombitasvir/paritaprevir/ritonavir combines three direct-acting antiviral medicinal products with distinct mechanisms of action and non-overlapping resistance profiles to target HCV at multiple steps in the viral lifecycle.
Maltese: Ko-amministrazzjoni ta' dasabuvir ma' ombitasvir/paritaprevir/ritonavir tikkombina tlett prodotti mediċinali anti-virali li jaħdmu b'mod dirett b' mekkanizmi differenti ta' kif jaħdmu u profili ta' reżistenza differenti sabiex jaħdmu fuq HCV fi stadji differenti tal-ħajja tal-virus.
English: Genotype-specific activity
Maltese: Attività speċifika għall-ġenotip
English: In the 7 genotype 1b infected subjects, treatment-emergent variants were observed in NS3 in 4 subjects, in NS5A in 2 subjects, and in both NS3 and NS5A in 1 subject.
Maltese: Fis-7 individwi infettati bil-ġenotip 1b, kienu osservati varjanti emerġenti mill-kura f'NS3 f'4 individwi, f'NS5A f'2 individwi, u kemm NS3 kif ukoll NS5A
English: IRON CHELATORS Deferasirox dasabu vir + ombitas vir/parit aprevir/ ritonavi r
Maltese: TAL-ĦADID Deferasirox dasabuvir ombitasvir/ paritaprevi r/ritonavir
English: For dosing recommendations with calcineurin inhibitors refer to section 4.5.
Maltese: Għal rakkomandazzjonijiet ta' dożaġġ flimkien ma' inibituri ta' calcineurin irreferi għal sezzjoni 4.5.
English: SVR12 for genotype 1-infected treatment-naïve subjects in SAPPHIRE-I
Maltese: Tabella 7 SVR12 għal individwi naïve għall-kura, infettati bil-ġenotip 1 f'SAPPHIRE-I
English: CYP3A4 inhibition by ritonavir.
Maltese: Inibizzjoni ta' CYP3A4 minn ritonavir.
English: Nevirapine etravirine dasabu vir + ombitas vir/parit aprevir/ ritonavi r
Maltese: Nevirapine etravirine dasabuvir ombitasvir/ paritaprevi r/ritonavir
English: Based on population pharmacokinetic analysis of data from Phase 3 clinical studies, a 10 year increase or decrease in age from 54 years (median age in the Phase 3 studies) would results in <10% change in dasabuvir exposures.
Maltese: 10 snin jew tnaqqis fl-età minn 54 sena (l-età medjana fl-istudji f'Fażi 3) tirriżulta f'bidla < 10 % flespożizzjonijiet ta' dasabuvir.
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: elevazzjonijiet ta' 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: BIGUANIDE ORAL ANTIHYPERGLYCEMICS Metformin
Maltese: ANTI-IPERGLIĊEMIĊI ORALI
English: dasabu vir + ombitas vir/parit aprevir/ ritonavi r atazanavir
Maltese: dasabuvir ombitasvir/ paritaprevi r/ritonavir atazanavir
English: SVR12 for genotype 1b-infected treatment-naïve subjects in PEARL III
Maltese: Tabella 8 SVR12 għal individwi naïve għall-kura, infettati bil-ġenotip 1b f'PEARL III
English: A temporary suspension of fluvastatin and pitavastatin is recommended for the duration of treatment.
Maltese: Sospensjoni temporanja ta' fluvastatin u pitavastatin huwa rrakkomandat matul il-kura.
English: Exviera is an antiviral medicine used to treat adults with chronic (long-term) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus).
Maltese: Exviera hija mediċina antivirali użata biex tikkura adulti blepatite Ċ (marda infettiva li taffettwa l-fwied, ikkawżata mill-virus ta' l-epatite Ċ) kronika (fit-tul).
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 ethinyloestradiol bħal dawk li jinsabu f'ħafna mil-kontraċettivi orali kkombinati jew ċrieki vaġinali kontraċettivi (ara sezzjoni 4.4 u 4.5).
English: Medicinal products that inhibit CYP2C8
Maltese: Inibituri qawwija ta' CYP2C8
English: Drug interaction studies
Maltese: Studji ta' interazzjoni tal-prodotti mediċinali
English: dasabuvir and ombitasvir/paritaprevir/ritonavir for 12 or 24 weeks with or without ribavirin (investigator chosen dose) for GT1 and GT4 infection
Maltese: dasabuvir u ombitasvir/paritaprevir/ritonavir għal 12 jew 24 ġimgħa b'ribavirin jew mingħajrha (doża magħżula mill-investigatur) għall-infezzjoni GT1 u GT4
English: Enzyme inducers
Maltese: Indutturi tal-enżimi
English: Sirolimus
Maltese: Furosemide
English: Subjects with HCV GT4 received ombitasvir/paritaprevir/ritonavir with ribavirin for 12 or 24 Weeks.
Maltese: Suġġetti b'HCV GT4 irċivew ombitasvir/paritaprevir/ritonavir ma' ribavirin għal 12 jew 24 Ġimgħa.
English: If rosuvastatin treatment is required during the treatment period, the maximum daily dose of rosuvastatin should be 5 mg (see section 4.5, Table 2).
Maltese: Jekk il-kura b'rosuvastatin huwa meħtieġ waqt il-perjodu ta' kura, id-doża massima ta' kuljum ta' rosuvastatin għandha tkun ta' 5 mg (ara sezzjoni 4.5, Tabella 2).
English: Liver transplant subjects with cirrhosis were dosed with dasabuvir and ombitasvir/paritaprevir/ritonavir with RBV (GT1a for 24 weeks [n=4], GT1b for 12 weeks [n=2]).
Maltese: Suġġetti bi trapjant tal-fwied u b'infezzjoni GT4 ġew dożati b'ombitasvir/paritaprevir/ritonavir ma' RBV (mhux ċirrotiċi għal 12-il ġimgħa [n=2] u ċirrotiċi għal 24 ġimgħa [n=1].
English: A temporary suspension of pitavastatin/fluvastatin is recommended for the duration of treatment with ombitasvir/paritaprevir/ritonavir.
Maltese: Sospensjoni temporanja ta' pitavastatin/fluvastatin hija rrakkomandata għal-matul il-kura b'ombitasvir/paritaprevir/ritonavir.
English: In Phase 3 clinical trials, 1075 subjects (including 181 with compensated cirrhosis) received the recommended regimen (see section 4.2).
Maltese: Analiżi tal-effikaċja miġbura Fi provi kliniċi ta' Fażi 3, 1075 individwu (inkluż 181 b'ċirrożi kkumpensata) rċevew il-kors irrakkomandat (ara sezzjoni 4.2).
English: Prior pegIFN/RBV relapser
Maltese: Pazjent li rkada qabel pegIFN/RBV
English: Co-administration of dasabuvir with medicinal products that are primarily metabolized by UGT1A1 result in increased plasma concentrations of such medicinal products; routine clinical monitoring is recommended for narrow therapeutic index medicinal products (i.e. levothyroxine).
Maltese: L-għoti ta' dasabuvir ma' prodotti mediċinali li huma primarjament metabolizzati minn UGT1A1 jirriżultaw f'żieda fil-konċentrazzjonijiet fil-plażma ta' prodotti mediċinali bħal dawn; monitoraġġ kliniku ta' rutina huwa rrakkomandat għal prodotti mediċinali b'indiċi terapewtiku dejjaq (bħal levothyroxine).
English: Dasabuvir was 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 rat micronucleus assays.
Maltese: 5.3 Tagħrif ta' qabel l-użu kliniku dwar is-sigurtà Dasabuvir ma kienx ġenotossiku f'sensiela ta' testijiet in vitro jew in vivo, inkluż mutaġeniċità batterika, aberrazzjoni fil-kromożomju billi ntużaw limfoċiti tad-demm periferali umani u testijiet in vivo fuq il-mikronuklei tal-firien.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Inner carton of multipack of 14 film-coated tablets - without blue box
Maltese: Kartun intern ta' pakkett multiplu li fih 14-il pillola miksijin b'rita - mingħajr kaxxa blu
English: Based on population pharmacokinetic analysis of data from Phase 3 clinical studies, female subjects would have approximately 14 to 30% higher dasabuvir exposures than male subjects.
Maltese: Ibbażata fuq analiżi farmakokinetika tal-popolazzjoni ta' dejta minn studji kliniċi ta' fażi 3, suġġetti nisa jkollhom esponimenti għal dasabuvir madwar 14 sa 30% ogħla minn suġġetti rġiel.
English: Ethinyloestradiol containing oral contraceptives are contraindicated (see section 4.3).
Maltese: Kontraċettivi orali li fihom ethinyloestradiol huma kontraindikati (ara sezzjoni 4.3).
English: Lopinavir/ritonavir 400/100 mg twice daily or 800/200 mg once daily is contraindicated dasabuvir
Maltese: Lopinavir/ritonavir 400/100 mg darbtejn kuljum jew 800/200 mg darba kuljum huwa kontraindikat ma' dasabuvir u ombitasvir/ paritaprevir/ritonavir minħabba żieda flespożizzjonijiet ta'
English: Treated subjects (N=394) had a median age of 54 years (range: 19 to 71); 49.0% were prior pegIFN/RBV null responders; 21.8/% were prior pegIFN/RBV partial responders; and 29.2% were prior pegIFN/RBV relapsers; 57.6% were male; 8.1% were Black; 20.6% had a history of depression or bipolar disorder; 87.1% had baseline HCV RNA levels of at least 800,000 IU per mL; 17.8% had portal fibrosis (F2) and 14.5% had bridging fibrosis (F3); 58.4% had HCV genotype 1a infection; 41.4% had HCV genotype 1b infection.
Maltese: Il-pazjenti kkurati (N=394) kellhom età medja ta' 54 sena (medda: 19 sa 71); 49.0% kienu pazjenti li ma rrispondew xejn preċedentement għal pegIFN/RB; 21.8/% kienu pazjenti li preċedentement irrispondew b'mod parzjali għal pegIFN/RBV, u 29.2% kienu pazjenti li preċedentement irkadew għal pegIFN/RBV; 57.6% kienu rġiel; 8.1% kienu Suwed; 20.
English: Ritonavir dose in ombitasvir/paritaprevir/ ritonavir will provide atazanavir pharmacokinetic enhancement.
Maltese: ombitasvir /paritaprevir /ritonavir se tipprovdi żieda farmakokinetika ta' darunavir).
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
English: In biochemical assays, dasabuvir inhibited a panel of genotype 1a and 1b polymerases with a mean IC50 value of 4.2 nM (range 2.2 to 10.7 nM; n=7).
Maltese: 1a u 1b b'valur medju ta' IC50 ta' 4.2 nM (firxa ta' 2.2 sa 10.
English: Genotype 1a, without cirrhosis dasabuvir + ombitasvir/paritaprevir/ritonavir + ribavirin*
Maltese: Ġenotip 1a, mingħajr ċirrożi dasabuvir + ombitasvir/paritaprevir/ritonavir + ribavirin
English: DIURETICS Furosemide 20 mg single dose
Maltese: 20 mg doża waħda Mekkaniżmu:
English: dasabuvir and ombitasvir/paritaprevir/ritonavir
Maltese: dasabuvir u ombitasvir/paritaprevir/ritonavir
English: dasabuvir and ombitasvir/paritaprevir /ritonavir
Maltese: dasabuvir u ombitasvir/paritaprevir /ritonavir
English: Dasabuvirderived material was minimally transferred through the placenta in pregnant rats.
Maltese: Materjal derivat minn dasabuvir ġie trasferit b'mod minimu mill-plaċenta f'firien tqal.
English: SAPPHIRE-I - genotype 1, treatment-naïve, without cirrhosis
Maltese: Provi kliniċi f'adulti naïve għall-kura SAPPHIE-I - ġenotip 1,‘naïve'għall-kura, mingħajr ċirrożi
English: Sustained virologic response (SVR) was the primary endpoint to determine the HCV cure rate in the Phase 3 studies and was defined as unquantifiable or undetectable HCV RNA 12 weeks after the end of treatment (SVR12).
Maltese: Rispons viroloġiku sostnut (SVR) kien il-punt ta' tmiem primarju biex tiġi ddeterminata r-rata ta' kura HCV fl-istudji tal-Fażi 3 u kien iddefinit bħala HCV RNA mhux skopert 12-il ġimgħa wara tmiem il kura (SVR12).
English: All treatment-emergent variants in NS5A remained detectable at posttreatment Week 48.
Maltese: Il-varjanti emerġenti għall-kura kollha fl-NS5A baqgħu identifikabbli wara l-kura fit-48 Ġimgħa.
English: Darunavir/ ritonavir 800/100 mg once daily (administere d in the evening)
Maltese: Darunavir 800 mg darba kuljum (mogħti fl istess ħin) Mekkaniżmu:
English: ANTIFUNGALS Ketoconazol e
Maltese: AĠENTI KONTRA L-KANĊER
English: 10 of 34 subjects (29.4%) dose modified ribavirin due to decrease in haemoglobin and 2.9% (1/34) had an interruption of ribavirin.
Maltese: 10 individwi(29.4 %) kellhom mill-inqas linja ta' bażi waħda ta' emoglobina ta' anqas minn 10 g/dL. 10 individwi minn 34 (29.4 %) kellhom doża ta' ribavirin modifikata minħabba tnaqqis fl-emoglobina u 2.9 % (1/34) kellhom interruzzjoni ta' ribavirin.
English: • Treatment should be discontinued in patients who develop evidence of hepatic decompensation.
Maltese: • It-trattament għandu jitwaqqaf f'pazjenti li jiżviluppaw evidenza ta' dekompensazzjoni epatika.
English: Dasabuvir was absorbed after oral administration with mean Tmax of approximately 4 to 5 hours.
Maltese: Dasabuvir, ġie assorbit wara amministrazzjoni orali b'Tmass medju ta' bejn wieħed u ieħor 4 sa 5 sigħat.
English: Dasabuvir exposures increased in a dose proportional manner and accumulation is minimal.
Maltese: Espożizzjonijiet ta' dasabuvir żdiedu b'mod proporzjonali u l-akkumulazzjoni hija minima.
English: Interactions between dasabuvir with ombitasvir/paritaprevir/ritonavir and other medicinal products
Maltese: Tabella 2 Interazzjonijiet bejn dasabuvir ma' ombitasvir/paritaprevir/ritonavir u prodotti mediċinali oħrajn
English: MEDICINAL PRODUCTS USED IN MULTIPLE SCLEROSIS Teriflunomid e dasabu vir +
Maltese: Karatteristiċi tal-Prodott tal-prodotti mediċinali li jintużaw flimkien ma' dasabuvir.
English: SVR12 for genotype 1a-infected treatment-naïve subjects in PEARL IV
Maltese: Tabella 9 SVR12 għal individwi naïve għall-kura, infettati bil-ġenotip 1b f'PEARL IV
English: For a general comment on treatment of HIV co-infected patients, including a discussion on different antiretroviral regimens that may be used, please see section 4.4 (Treatment of HIV co-infected patients) and the Summary of Product Characteristics of ombitasvir/ paritaprevir /ritonavir.
Maltese: Għal kumment ġenerali dwar il-kura ta' pazjenti ko-infettati bl-HIV, inkluż diskussjoni dwar korsijiet antiretrovirali differenti li jistgħu jintużaw, jekk jogħġbok ara sezzjoni 4.4 (Kura ta' pazjenti ko-infettati bl-HIV) u s-Sommarju talKaratteristiċi tal -Prodott ta' ombitasvir/paritaprevir/ritonavir.
English: Concomitant use is contra-indicated (see section 4.3).
Maltese: Użu konkomitanti huwa kontraindikat (ara sezzjoni 4.3).
English: 50 mg once daily
Maltese: 50 mg darba kuljum
English: No dose adjustment of dasabuvir is required in patients with mild hepatic impairment (Child-Pugh A).
Maltese: Ebda aġġustament tad-doża ta' dasabuvir ma huwa meħtieġ f'pazjenti b'indeboliment epatiku ħafif (Child-Pugh A).
English: Arm B: dasabuvir and ombitasvir/paritaprevir/ritonavir
Maltese: Fergħa B: dasabuvir u ombitasvir/paritaprevir/ritonavir
English: Fertility
Maltese: Duloxetine
English: Apalutamide, enzalutamide for prostate cancer ethinyloestradiol containing medicines such as those contained in most contraceptive pills and vaginal rings used for contraception for contraception gemfibrozil to lower cholesterol and other fats in the blood mitotane for some tumours of the adrenal glands rifampicin for bacterial infections
Maltese: Apalutamide, enzalutamide għall-kanċer tal-prostata mediċini li fihom ethinyloestradiol bħal dawk li jinsabu f'ħafna mil -pilloli kontraċettivi u ċrieki vaġinali użati għall-kontraċezzjoni għall-kontraċezzjoni
English: Concerning genotype-specific virological and clinical activity, see section 5.1.
Maltese: Rigward attività klinika u viroloġika speċifika għall-ġenotip, ara sezzjoni 5
English: For interactions with ombitasvir/ paritaprevir /ritonavir refer to the Summary of Product Characteristics.
Maltese: Għallinterazzjonijiet ma ombitasvir / paritaprevir / ritonavir irreferi għas-Sommarju tal-Karatteristiċi talProdott .
English: 5 mg single dose dasabu vir +
Maltese: 5 mg doża waħda Mekkaniżmu:
English: Treatment-emergent amino acid substitutions in the pooled analysis of dasabuvir and ombitasvir/paritaprevir/ritonavir, with and without RBV regimens in Phase 2b and Phase 3 clinical trials (N=2510)
Maltese: Sostituzzjonijiet tal-aċidi amminiċi li joħroġu mill-kura f'analiżi miġbura ta' disabuvir uombitasvir/paritaprevir/ritonavir, bi u mingħajr korsijiet RBV fi provi kliniċi ta' Fażi 2b u Fażi 3 (N=2510)
English: OATP1B1 inhibition by gemfibrozil.
Maltese: individwi b'infezzjoni tal-ġenotip 1b HCV esperjenzaw rikaduta.
English: dasabu vir + paritapr evir/ ritonavi r
Maltese: dasabuvir +ombitasvi r/paritapre vir/ritonavi r
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: 17.8% kellhom fibrożi portali (F2) u 14.5% kellhom fibrożi li tgħaqqad (F3); 58.4 % kellhom infezzjoni tal-ġenotip 1a HCV; 41.4% kellhom infezzjoni tal-ġenotip 1b HCV.
English: Among the GT1 subjects who were post renal transplant, 9/12 (75%) achieved SVR12; however, there were no virologic failures.
Maltese: (75%) kisbu SVR12; madankollu, ma kienx hemm fallimenti viroloġiċi.
English: ANTICONVULSANTS carbamazepine dasabu vir +
Maltese: ↓ carbamaze pine 10, 11epoxide dasabuvir
English: In subjects with mild, moderate and severe hepatic impairment, dasabuvir AUC values were 17% higher, 16% lower and 325% higher, respectively.
Maltese: F'suġġetti b'indeboliment epatiku ħafif, moderat u sever, valuri AUC ta' dasabuvir kienu 17% ogħla,
English: CONTRACEPTIVES ethinyloestra diol/ norgestimate 0.035/0.25 m g once daily
Maltese: 0.035/0.25 mg darba kuljum
English: Serum bilirubin elevations
Maltese: Elevazzjonijet f'bilirubin tas-serum
English: At steady-state the exposures ratio of M1 to dasabuvir is approximately 0.6.
Maltese: Fi stat fiss il-proporzjon ta' espożizzjonijiet ta' M1 għal dasabuvir huwa madwar 0.6.
English: 600 mg twice daily
Maltese: 600/300 mg
English: If ribavirin is co-administered with dasabuvir and ombitasvir/paritaprevir/ritonavir, the contraindications regarding use of ribavirin during pregnancy apply (see also the Summary of Product Characteristics of ribavirin).
Maltese: Jekk ribavirin jingħata flimkien ma' dasabuvir u ombitasvir/paritaprevir/ritonavir, japplikaw ilkontraindikazzjonijiet dwar l-użu ta' ribavirin waqt it-tqala japplikaw (ara wkoll is-Sommarju talKaratteristiċi tal-Prodott ta' ribavirin).
English: Enzalutamid e
Maltese: Indutturi ta' l- enżimi:
English: Adverse reactions identified with dasabuvir in combination with ombitasvir/paritaprevir/ritonavir or ombitasvir/paritaprevir/ritonavir and ribavirin
Maltese: Tabella 3. Reazzjonijiet avversi identifikati b'dasabuvir f'kombinazzjoni ma' ombitasvir/paritaprevir/ritonavir jew ombitasvir/paritaprevir/ritonavir u ribavirin
English: buprenorphin e/ naloxone 4-24 mg/16 mg once daily8
Maltese: 4-24 mg/ 1-6 mg darba kuljum 5
English: Pharmacokinetics of the combination of dasabuvir 400 mg, with ombitasvir 25 mg, paritaprevir 200 mg, and ritonavir 100 mg were evaluated in subjects with mild (Child-Pugh A), moderate (ChildPugh B) and severe (Child-Pugh C) hepatic impairment, relative to subjects with normal hepatic function.
Maltese: Wara doża ta' 400 mg 14C-dasabuvir fil-bnedmin, dasabuvir mhux mibdul kien il-komponent ewlieni (madwar 60%) tar-radjuattività relatata mal-mediċina fil-plażma.
English: Concerning recommended regimens with different HCV genotypes, see section 4.2.
Maltese: Rigward korsijiet irrakkomandati b'ġenotipi differenti ta' HCV, ara sezzjoni 4.2.