FrancophonIA/ELRC3.0 huggingface dataset:
English: In the dog, changes were observed in the liver and gall bladder at exposures approximately 8-fold higher than human exposure observed at the recommended dose (200 mg twice daily).
Maltese: Fil-klieb, ġew osservati bidliet fil-fwied u fil-marrara f'espożizzjonijiet madwar 8 darbiet ogħla mill-espożizzjoni umana osservata fid-doża rrakkomandata (200 mg darbtejn kuljum).
English: For instructions on dispersion of the medicinal product before administration, see section 6.6.
Maltese: Għal struzzjonijiet fuq kif tinħall il-prodott mediċinali qabel l-amministrazzjoni, ara sezjoni 6.6.
English: The pharmacokinetic properties of etravirine have been evaluated in adult healthy subjects and in adult and paediatric treatment-experienced HIV-1 infected patients.
Maltese: Il-karatteristiċi farmakokinetiċi ta' etravirine ġew evalwati fuq individwi adulti b'saħħithom u f'pazjenti adulti u pedjatriċi b'esperjenza fit-trattament infettati b'HIV-1.
English: Carbazamepine, phenobarbital and phenytoin are expected to decrease plasma concentrations of etravirine.
Maltese: Carbazamepine, phenobarbital u phenytoin huma mistennija li jnaqqsu lkonċentrazzjonijiet fil-plażma ta' etravirine.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu/
English: The presence of K103N alone, which was the most prevalent NNRTI mutation in DUET-1 and DUET-2 at baseline, was not identified as a mutation associated with resistance to etravirine.
Maltese: Il-preżenza ta' K103N waħdu, li kien il-mutazzjoni ta' NNRTI l-iktar prevalenti fil-provi DUET-1 u DUET-2 fil-linja bażi, ma kienx identifikat bħala mutazzjoni assoċjata ma' reżistenza għal etravirine.
English: In the Phase III studies, the rates of discontinuation due to any adverse reaction were 7.2% in patients receiving etravirine.
Maltese: III, ir-rati ta' dawk li waqqfu t trattament minħabba kwalunkwe reazzjoni avversa kienu 7.2% f'pazjenti li kienu qed jirċievuetravirine.
English: The bottle is a high-density polyethylene (HDPE) plastic bottle containing 120 tablets and 2 desiccant pouches, fitted with a polypropylene (PP) child resistant closure.
Maltese: Il-flixkun huwa tal-plastik tal-polyethylene ta' densità għolja (HDPE) li fih 120 pillola u 2 qratas desikkanti, li għandu għatu tal-polypropylene (PP) reżistenti għat-tfal.
English: No unchanged drug was detected in urine so the impact of renal impairment on etravirine elimination is expected to be minimal.
Maltese: Ma ġietx traċċata mediċina mhux mibdula fl-awrina u għalhekk huwa mistenni li l-impatt ta' indeboliment renali fuq l-eliminazzjoni ta' etravirine huwa minimu.
English: SELECTIVE SEROTONIN REUPTAKE INHIBITORS (SSRIS) Paroxetine
Maltese: TAL-ĠBIR MILL-ĠDID TA' SEROTONIN (SSRIS) Paroxetine
English: The bottle is a high-density polyethylene (HDPE) plastic bottle containing 60 tablets and 3 desiccant pouches, fitted with a polypropylene (PP) child resistant closure.
Maltese: Il-flixkun huwa tal-plastik tal-polyethylene ta' densità għolja (HDPE) li fih 60 pillola u 3 qratas desikkanti, li għandu għatu tal-polypropylene (PP) reżistenti għat-tfal.
English: Placebo arms N = 569
Maltese: Fergħat tal-plaċebo N=569
English: It is therefore possible that etravirine may inhibit the metabolism of clopidogrel to its active metabolite by such inhibition of CYP2C19 in vivo.
Maltese: Għalhekk jista' jkun li etravirine jinibixxi l-metaboliżmu ta' clopidogrel għal metabolu attiv tiegħu permezz ta' din l-inibizzjoni ta' CYP2C19 in vivo.
English: 150 mg twice daily six 25 mg tablets twice daily or one 100 mg tablet and two 25 mg tablets twice daily
Maltese: ≥ 25 sa < 30 kg 150 mg darbtejn kuljum sitt pilloli ta' 25 mg darbtejn kuljum jew pillola waħda ta'100 mg u żewġ pilloli ta' 25 mg darbtejn kuljum
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free'.
Maltese: Din il-mediċina fiha inqas minn 1 mmol sodium (23 mg) f'kull pillola, li tista' tgħid hija ‘mingħajr sodium'.
English: Co-administration of etravirine with medicinal products primarily metabolised by CYP3A4 may result in decreased plasma concentrations of such medicinal products, which could decrease or shorten their therapeutic effects.
Maltese: Teħid ta' etravirine flimkien ma' prodotti mediċinali metabolizzati primarjament minn CYP3A4 jistgħu jwasslu għal tnaqqis fil-konċentrazzjonijiet filplażma ta' dawn il-prodotti mediċinali, li jistgħu jnaqqsu jew iqassru l-effetti terapewtiċi tagħhom.
English: AUC ↔ 0.94 (0.88-1.01) Cmin ↔ 0.91 (0.84-0.98) Cmax ↔ 0.92 (0.85-1.00) etravirine
Maltese: AUC ↔ 0.94 (0.88-1.01) Cmin ↔ 0.91 (0.84-0.98) Cmax ↔ 0.
English: Renal and urinary disorders common renal failure, blood creatinine increased
Maltese: Disturbi fil-kliewi u fissistema urinarja komuni insuffiċjenza renali, żieda fil-kreatinina fid-demm
English: The most frequent (incidence ≥ 10%) adverse reactions of all intensities reported for etravirine were rash, diarrhoea, nausea and headache.
Maltese: L-iktar reazzjonijiet avversi frekwenti (inċidenza ≥ 10%) tal-intensitajiet kollha rrappurtati għal etravirine kienu raxx, dijarea, nawsja u uġigħ ta' ras.
English: The breakpoints for reduced efficacy with etravirine (> 2 etravirine-associated mutations at baseline, see clinical results section) applies when etravirine is given in combination with a boosted protease inhibitor.
Maltese: Il-breakpoints ta' effikaċja ridotta b'etravirine (> 2 mutazzjonijiet assoċjati ma' etravirine fil-linja bażi, ara sezzjoni tar-riżultati kliniċi) japplikaw meta etravirine jingħata f'kombinazzjoni ma' impeditur ta' protease msaħħaħ.
English: Increased clinical and laboratory monitoring for HIV and HCV suppression is recommended.
Maltese: Aktar monitoraġġ kliniku u tallaboratorju għal trażżin ta' HIV u HCV hu rakkomandat.
English: Gastrointestinal very common diarrhoea, nausea disorders common gastrooesophageal reflux disease, vomiting, abdominal pain, abdominal distension, flatulence, gastritis, constipation, dry mouth, stomatitis, lipase increased, blood amylase increased uncommon pancreatitis, haematemesis, retching Hepatobiliary disorders common increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST) uncommon hepatitis, hepatic steatosis, cytolytic hepatitis, hepatomegaly
Maltese: Disturbi gastrointestinali komuni ħafna dijarea, nawsja komuni mard ta' rifluss gastroesofagali, rimettar, uġigħ addominali, nefħa fl-addome, gass fl-istonku, gastrite, stitikezza, ħalq xott, stomatite, żieda fil-lipase, żieda flamylase fid-demm mhux komuni pankreatite, ematemesi, tqalligħ
English: Janssen-Cilag AB Tfn: +46 8 626 50 00 jacse@its.jnj.com
Maltese: +46 8 626 50 00 jacse@its.jnj.com
English: Boosted protease inhibitors, like darunavir/ritonavir, show a higher barrier to resistance compared to other classes of antiretrovirals.
Maltese: Impedituri ta' protease msaħħa bħal darunavir/ritonavir, juru barriera ogħla għal reżistenza meta mqabbla ma' klassijiet oħrajn ta' antiretrovirali.
English: The total etravirine exposure after intake of etravirine 200 mg twice daily as part of an antiretroviral regimen was generally higher during pregnancy compared with postpartum (see Table 9).
Maltese: L-esponiment għal etravirine totali wara t-teħid ta' etravirine 200 mg darbtejn kuljum bħala parti minn kors terapewtiku ta' antiretrovirali kien ġeneralment ogħla matul it-tqala meta mqabbel ma' wara t-twelid (ara Tabella 9).
English: Unchanged etravirine in faeces is likely to be unabsorbed drug.
Maltese: Etravirine mhux mibdul fl-ippurgar probabbilment huwa mediċina mhux assorbita.
English: The bottle is a high-density polyethylene (HDPE) plastic bottle containing 120 tablets and 3 desiccant pouches, fitted with a polypropylene (PP) child resistant closure.
Maltese: Il-flixkun huwa tal-plastik tal-polyethylene ta' densità għolja (HDPE) li fih 120 pillola u 3 qratas desikkanti, li għandu għatu tal-polypropylene (PP) reżistenti għat-tfal.
English: INTELENCE tablets contain lactose.
Maltese: Il-pilloli ta' INTELENCE fihom il-lactose.
English: 125 mg twice daily five 25 mg tablets twice daily or one 100 mg tablet and one 25 mg tablet twice daily
Maltese: ≥ 20 sa < 25 kg 125 mg darbtejn kuljum ħames pilloli ta' 25 mg darbtejn kuljum jew pillola waħda ta'100 mg u pillola waħda ta' 25 mg darbtejn kuljum
English: Since etravirine is highly protein bound, dialysis is unlikely to result in significant removal of the active substance.
Maltese: Peress illi etravirine huwa marbut ħafna mal-proteina, huwa improbabbli li d-dijaliżi twassal għal tneħħija sinifikanti tas-sustanza attiva.
English: Severe cutaneous and hypersensitivity reactions
Maltese: Reazzjonijiet severi fil-ġilda u reazzjonijiet ta' sensittività eċċessiva
English: C-etravirine showed that < 1.2% of the administered dose of etravirine is excreted in the urine.
Maltese: C-etravirine radjoattiv wera li < 1.2% tad-doża li tittieħed toħroġ flawrina.
English: Paediatric population (less than 6 years of age)
Maltese: Popolazzjoni pedjatrika (eta'ta'inqas minn 6 snin)
English: 150 mg twice daily etravirine
Maltese: 150 mg darbtejn kuljum etravirine
English: Each tablet of INTELENCE contains 25 mg of etravirine.
Maltese: Kull pillola INTELENCE fiha 25 mg ta' etravirine.
English: The study enrolled patients on a stable but virologically failing antiretroviral treatment regimen, with a confirmed HIV-1 RNA plasma viral load ≥ 500 copies/ml.
Maltese: L-istudju kien jinkludi pazjenti fuq kors ta' trattament antiretrovirali li kien stabbli iżda li kien qed ifalli mill-lat viroloġiku, b'tagħbija ta' HIV-1 RNA virali fil-plażma kkonfermata ta' ≥ 500 kopji/ml.
English: Rash has been reported with etravirine.
Maltese: Raxx ġie rrappurtat b'etravirine.
English: Interactions between etravirine and co-administered medicinal products are listed in table 1 (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, not done as “ND”, confidence interval as “CI”).
Maltese: Interazzjonijiet bejn etravirine u prodotti mediċinali meħuda flimkien huma elenkati f'tabella 1 (żieda hija indikata bħala “↑”, tnaqqis bħala “↓”, l-ebda tibdil bħala “↔”, mhux magħmul bħala “ND”, intervall ta' fiduċja bħala “CI”).
English: Each tablet of INTELENCE contains 100 mg of etravirine.
Maltese: Kull pillola INTELENCE fiha 100 mg ta' etravirine.
English: < 400 HIV-1 RNA copies/ml n (%)
Maltese: Mhux de novo ENF < 400 kopja/ml a ta' HIV-1 RNA
English: The week 48 results from the pooled analysis of DUET-1 and DUET-2 demonstrated that the etravirine arm was superior to the placebo arm irrespective of whether ENF was used de novo (p = 0.0199) or not (p < 0.0001).
Maltese: Ir-riżultati tat-48 ġimgħa mill-analiżi miġbura ta' DUET-1 u DUET-2 urew li l-fergħa ta' etravirine kienet superjuri għall-fergħa ta' plaċebo irrispettivament minn jekk ENF kienx użat de novo (p = 0.0199) jew le (p < 0.0001).
English: INTELENCE should only be used with dolutegravir when co-administered with atazanavir/ritonavir, darunavir/ritonavir, or lopinavir/ritonavir.
Maltese: INTELENCE għandu jintuża ma' dolutegravir biss meta jingħata flimkien ma' atazanavir/ritonavir, darunavir/ritonavir, jew lopinavir/ritonavir.
English: P-value < 0.0001 for mean decrease in HIV-1 RNA; P-value = 0.0006 for mean change in CD4 cell count.
Maltese: Valur-P = 0.0006 għal bidla medja fl-għadd ta' ċelloli C4.
English: Elderly
Maltese: Didanosine
English: The pharmacokinetics of etravirine have not been studied in patients with renal insufficiency.
Maltese: Il-farmakokinetika ta' etravirine ma ġietx studjata f'pazjenti b'indeboliment renali.
English: Dexamethasone is expected to decrease plasma concentrations of etravirine
Maltese: Dexamethasone huwa mistenni li jnaqqas il-konċentrazzjonijiet fil-plażma ta' etravirine
English: Severe cutaneous adverse reactions have been reported with etravirine.
Maltese: Ġew irrapportati reazzjonijiet avversi qawwija fil-ġilda b'etravirine.
English: INTELENCE 200 mg tablets
Maltese: INTELENCE pilloli ta' 200 mg
English: In rats, there was no effect on mating or fertility with etravirine treatment (see section 5.3).
Maltese: Fil-firien, ma kienx hemm effetti fuq tgħammir jew fertilità bi trattament ta' etravirine (ara sezzjoni 5.3).
English: FC subgroups are based on the select patient populations in DUET-1 and DUET-2 and are not meant to represent definitive clinical susceptibility breakpoints for etravirine.
Maltese: FC huma bbażati fuq il-popolazzjonijiet ta' pazjenti magħżula f'DUET-1 u DUET-2 u mhumiex intiżi sabiex jirrapreżentaw breakpoints definittivi kliniċi ta' suxxettibilità għal etravirine.
English: Change from baseline in CD4 cell count (x 10
Maltese: Bidla fl-għadd taċ-ċelluli CD4 mill-linja bażi (x 10
English: Co-administration of etravirine with daclatasvir may decrease daclatasvir concentrations.
Maltese: INTELENCE u dawn lantifungali jistgħu jintużaw mingħajr aġġustament fiddoża.
English: - Virologic response was defined as achieving a confirmed undetectable viral load (< 50 HIV-1 RNA copies/ml).
Maltese: - Rispons viroloġiku kien definit bħala li jilħaq tagħbija virali li ma tistax titkejjel ikkonfermat (< 50 kopja/ml ta' HIV-1 RNA)
English: Medicinal products that induce CYP3A4, CYP2C9 or CYP2C19 may increase the clearance of etravirine, resulting in lowered plasma concentrations of etravirine.
Maltese: CYP3A4, CYP2C9 u CYP2C19 jistgħu jżidu t-tneħħija ta' etravirine, li jwasslu għal tnaqqis filkonċentrazzjonijiet ta' etravirine fil-plażma.
English: In HIV infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Maltese: F'pazjenti infettati b'HIV b'defiċjenza qawwija tas-sistema immuni fiż-żmien meta tkun inbdiet itterapija antiretrovirali kombinata (CART), tista' tirriżulta reazzjoni infjammatorja għal infezzjonijiet asintomatiċi jew residwali.
English: These adverse reactions were observed in other clinical trials than DUET-1 and DUET-2.
Maltese: Dawn ir-reazzjonijiet avversi ġew osservati fi provi kliniċi oħra minbarra fi DUET-1 u DUET-2.
English: The population pharmacokinetic estimates for etravirine AUC12h and C0h are summarised in the table below.
Maltese: L-estimi farmakokinetiċi tal-popolazzjoni għal etravirine AUC12h u C0h huma mqassra fit-tabella hawn taħt.
English: What INTELENCE looks like and contents of the pack This medicinal product is presented as white to off-white, oval tablet, with “T125” on one side and “100” on the other side.
Maltese: Dan il-prodott mediċinali jiġi preżentat bħala pillola ovali bajda tagħti fl-offwajt, b'“T125” fuq naħa u “100” fuq in-naħa l-oħra.
English: The effects of INTELENCE or other medicines might be influenced if you take INTELENCE together with any of the following medicines.
Maltese: L-effetti ta' INTELENCE jew tal-mediċini l-oħrajn jistgħu jiġu influwenzati jekk tieħu INTELENCE flimkien ma' xi waħda mill-mediċini li ġejjin.
English: ANTICOAGULANTS Warfarin
Maltese: Disopyramide Flecainide
English: Etravirine is expected to increase nelfinavir plasma concentrations.
Maltese: Etravirine huwa mistenni li jżid il-konċentrazzjonijiet fil-plażma ta' nelfinavir.
English: Etravirine has not been studied in patients with severe hepatic impairment (Child-Pugh Class C) and its use is therefore not recommended in this group of patients (see sections 4.2 and 5.2).
Maltese: Etravirine ma ġiex studjat f'pazjenti b'mard epatiku qawwi (Child-Pugh Klassi C) u għalhekk mhux irrakkomandat l-użu tiegħu f'dan il-grupp ta' pazjenti (ara sezzjonijiet 4.2 u 5.2).
English: Amprenavir/ritonavir and fosamprenavir/ritonavir may require dose reduction when co-administered with INTELENCE.
Maltese: INTELENCE u lopinavir/ritonavir jistgħu jintużaw mingħajr aġġustament fid-doża.
English: INTELENCE 25 mg tablets
Maltese: INTELENCE pilloli ta' 25 mg
English: The safety and efficacy of etravirine in children less than 6 years of age and weighing less than 16 kg have not yet been established (see section 5.2).
Maltese: Is-sigurtà u l-effikaċja ta' etravirine fit-tfal ta' età inqas minn 6 snin u li jiżnu inqas minn 16-il kg għadhom ma ġewx determinati s'issa (ara sezzjoni 5.2).
English: Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section 4.4)
Maltese: Il-piż u l-livelli ta' lipidi u glukożju fid-demm jistgħu jiżdiedu matul it-terapija antiretrovirali (ara sezzjoni 4.4).
English: Use in adults Other form(s) of this medicine may be more suitable for adults.
Maltese: Forom oħra ta' din il-mediċina jistgħu jkunu aktar addattati għall-adulti.
English: INTELENCE 100 mg tablets
Maltese: INTELENCE pilloli ta' 100 mg
English: A potential increased risk of liver enzymes increase cannot be excluded.
Maltese: Ma jistax jiġi eskluż il-potenzjal ta' żieda fir-riskju ta' żieda fl-enzimi talfwied.
English: Janssen-Cilag Polska Sp. z o.o.
Maltese: Manifattur Janssen-Cilag SpA, Via C.
English: Each subject served as her own control, and with an intra-individual comparison, the total etravirine Cmin, Cmax and AUC12h values were 1.2-, 1.4- and 1.4-fold higher, respectively, during the 2
Maltese: Kull individwa serviet bħala l-kontroll tagħha nnifisha, u bi tqabbil bejn l-istess individwa, il-valuri ta' Cmin, Cmax u AUC12h għal etravirine totali kienu 1.2, 1.4 u 1.4 drabi aktar, rispettivament, matul it-2
English: In most cases, INTELENCE can be combined with anti-HIV medicines belonging to another class.
Maltese: Fil-maġġoranza tal-każijiet, INTELENCE jista' jiġi kkombinat ma' mediċini oħrajn kontra l-HIV li jappartjenu għal klassi oħra.
English: Therapy should be initiated by a physician experienced in the management of HIV infection.
Maltese: It-terapija għandha tinbeda minn tabib li għandu esperjenza fl-immaniġġjar tal-infezzjoni HIV.
English: Fosamprenavir/ritonavir 700/100 mg twice daily amprenavir
Maltese: 700/100 mg darbtejn kuljum amprenavir
English: Each tablet contains 25 mg of etravirine.
Maltese: Kull pillola fiha 25 mg ta' etravirine.
English: The mean change in plasma HIV-1 RNA from baseline to week 48 was -1.53 log10 copies/ml, and the mean CD4 cell count increase from baseline was 156 x 10
Maltese: Il-bidla medja fl-HIV-1 RNA fil-plażma milllinja bażi sa ġimgħa 48 kienet ta' -1.53 log10 kopji/ml, u ż-żieda medja fl-għadd taċ-ċelluli CD4 milllinja bażi kienet ta' 156 x 10
English: AUC ↓ 0.62 (0.48-0.80) Cmin ↓ 0.82 (0.67-1.01) Cmax ↓ 0.72 (0.55-0.94) dihydroartemisinin AUC ↓ 0.85 (0.75-0.97) Cmin ↓ 0.83 (0.71-0.97) Cmax ↓ 0.84 (0.71-0.99) lumefantrine AUC ↓ 0.87 (0.77-0.98) Cmin ↔ 0.97 (0.83-1.15) Cmax ↔ 1.07 (0.94-1.23) etravirine
Maltese: 72 (0.55-0.94) dihydroartemisinin AUC ↓ 0.85 (0.75-0.97) Cmin ↓ 0.83 (0.71-0.97) Cmax ↓ 0.84 (0.71-0.99) lumefantrine AUC ↓ 0.
English: INTELENCE and tenofovir can be used without dose adjustments.
Maltese: INTELENCE u tenofovir jistgħu jintużaw mingħajr aġġustamenti fiddoża.
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: KONTRAĊETTIVI B'BAŻI
English: Each tablet contains 200 mg of etravirine.
Maltese: Kull pillola fiha 200 mg ta' etravirine.
English: Common side effects (may affect up to 1 in 10 people) - allergic reactions (hypersensitivity); - diabetes, decrease of appetite; - anxiety, sleepiness, sleeplessness, sleep disorders; - tingling or pain in hands or feet, numbness, loss of skin sensibility, loss of memory tiredness; - blurred vision; - kidney failure, high blood pressure, heart attack, shortness of breath when exercising; - vomiting, heartburn, abdominal pain, distension of the abdomen, inflammation of the stomach,
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa persuna waħda minn kull 10) - reazzjonijiet allerġiċi (sensittività eċċessiva); - dijabete, tnaqqis fl-aptit; - ansjeta, ngħas, nuqqas ta' rqad, disturbi fl-irqad; - tnemnim jew uġigħ fl-idejn jew saqajn, tirżiħ, telf ta' sensibilità tal-ġilda, telf tal-memorja,
English: Resistance
Maltese: IMPEDITURI
English: Co-administration of etravirine and medicinal products that inhibit CYP3A4, CYP2C9 or CYP2C19 may decrease the clearance of etravirine and may result in increased plasma concentrations of etravirine.
Maltese: Teħid ta' etravirine flimkien ma' prodotti mediċinali li jinibixxu CYP3A4, CYP2C9 jew CYP2C19 jistgħu jnaqqsu t-tneħħija ta' etravirine u jistgħu jwasslu għal żieda fil-konċentrazzjonijiet fil-plażma ta' etravirine.
English: AUC ↔ 0.87 (0.83-0.92) Cmin ↓ 0.80 (0.73-0.88) Cmax ↔ 0.89 (0.82-0.96) etravirine
Maltese: 73-0.88) Cmax ↔ 0.89 (0.82-0.96) etravirine
English: Pharmacokinetics of etravirine
Maltese: Il-farmakokinetika ta' etravirine Medja ± SD (medjan)
English: Instructions for taking INTELENCE for all patients It is important that you take INTELENCE following a meal.
Maltese: Id-doża rakkomandata ta' INTELENCE hija ta' żewġ pilloli darbtejn kuljum.
English: Each tablet contains 100 mg of etravirine.
Maltese: Kull pillola fiha 100 mg ta' etravirine.
English: • 3 or more primary PI mutations at screening
Maltese: • 3 mutazzjonijiet jew iżjed ta' PI primarji waqt eżami
English: Treatment differences are based on Least Square Means from an ANCOVA model including the stratification factors.
Maltese: Differenzi fit-trattament huma bbażati fuq Medja tal-Inqas Kwadrati minn mudell ANCOVA inkluż il-fatturi ta' stratifikazzjoni.
English: Tablet White to off-white, biconvex, oblong tablet debossed with “T200” on one side.
Maltese: Pillola Pillola bajda tagħti fl-offwajt, bikonvessa, ovali tawwalija b'“T200” imnaqqxa fuq naħa waħda.
English: Each tablet of INTELENCE contains 200 mg of etravirine.
Maltese: Kull pillola INTELENCE fiha 200 mg ta' etravirine.
English: INTELENCE and fluconazole can be used without dose adjustments.
Maltese: INTELENCE u fluconazole jistgħu jintużaw mingħajr aġġustamenti fid-doża.
English: Data from the DUET studies suggest that baseline fold change (FC) in EC50 to etravirine was a predictive factor of virologic outcome, with gradually decreasing responses observed above FC 3 and FC 13.
Maltese: Tagħrif mill-istudji DUET jissuġgerixxi illi l-bidla (FC) fil-linja bażi f'EC50 għal etravirine kien fattur li jbassar ir-riżultat viroloġiku, b'risponsi li jonqsu b'mod gradwali osservati 'l fuq minn FC3 u FC13.
English: Furthermore, the presence of this mutation alone did not affect the response in the etravirine arm. Additional data is required to conclude on the influence of K103N when associated with other NNRTIs mutations.
Maltese: Hemm bżonn ta' iktar tagħrif sabiex wieħed jikkonkludi fuq l-influwenza ta' K103N meta assoċjat ma' mutazzjonijiet ta' NNRTIs oħrajn.
English: This breakpoint might be lower in antiretroviral combination therapy not including a boosted protease inhibitor.
Maltese: Dan il-breakpoint jista' jkun iktar baxx f'terapija antiretrovirali kkombinata li ma tinkludix impeditur ta' protease msaħħaħ.
English: AUC ↓ 0.24 (0.18-0.33) Cmin ↓ 0.18 (0.13-0.25) Cmax ↓ 0.29 (0.22-0.40)
Maltese: AUC ↓ 0.24 (0.18-0.33) Cmin ↓ 0.18 (0.
English: In mice, the key target organs identified were the liver and the coagulation system.
Maltese: Fi ġrieden lorgani prinċipali mmirati identifikati kienu l-fwied u s-sistema ta' koagulazzjoni.
English: Concomitant use of etravirine with indinavir may cause a significant decrease in the plasma concentration of indinavir and loss of therapeutic effect of indinavir.
Maltese: Użu konkomittanti ta' etravirine ma' indinavir jista' jwassal għal tnaqqis sinifikanti filkonċentrazzjonijiet fil-plażma ta' indinavir u telfien tal-effetti terapewtiċi ta' indinavir.
English: INTELENCE and voriconazole can be used without dose adjustments.
Maltese: INTELENCE u voriconazole jistgħu jintużaw mingħajr aġġustamenti fid-doża.