FrancophonIA/ELRC3.0 huggingface dataset:
English: In the Phase III studies, lower rilpivirine exposure, similar to that seen during pregnancy, has been associated with an increased risk of virological failure, therefore viral load should be monitored closely (see sections 4.6, 5.1 and 5.2).
Maltese: III, esponiment aktar baxx ta' rilpivirine, simili għal dak li jidher waqt it-tqala ġie assoċjat ma' riskju ogħla ta' falliment viroloġiku, għalhekk il-viral load għandu jiġi sorveljat mill-qrib (ara sezzjonijiet 4.6, 5.1 u 5.2).
English: The evidence of efficacy of rilpivirine is based on the analyses of 96 week data from 2 randomised, double-blinded, active-controlled, Phase III trials TMC278-C209 (ECHO) and TMC278-C215 (THRIVE).
Maltese: Pazjenti adulti infettati b'HIV-1 li qatt ma ħadu kura qabel L-evidenza tal-effikaċja ta' rilpivirine hija bbażata fuq l-analiżi ta' dejta ta' 96 ġimgħa minn żewġ provi tal-Fażi III randomised, double-blinded, ikkontrollati b'mod attiv, TMC278-C209 (ECHO) u TMC278-C215 (THRIVE).
English: Danmark Janssen-Cilag A/S Bregnerødvej 133 DK-3460 Birkerød Tlf: +45 4594 8282
Maltese: Janssen-Cilag A/S Bregnerødvej 133 DK-3460
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għall-galactose, defiċjenza ta' Lapp lactase jew assorbiment ħażin ta' glucose-galactose m'għandhomx jieħdu dan il-prodott mediċinal.
English: The K103N substitution did not result in reduced susceptibility to rilpivirine by itself, but the combination of K103N and L100I resulted in a 7-fold reduced susceptibility to rilpivirine.
Maltese: Is-sostituzzjoni K103N waħdu ma rriżultax f'nuqqas fis-suxxettibilità għal rilpivirine, imma l-kombinazzjoni ta' K103N u L100I irriżulta f'tnaqqis ta' 7 darbiet fis-suxxettibilità għal rilpivirine.
English: It belongs to a group of HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Maltese: Huwa jagħmel parti minn grupp ta' mediċini tal-HIV msejħa impedituri ta' reverse transcriptase mhux nucleoside (NNRTIs).
English: Interactions between rilpivirine and co-administered medicinal products are listed in table 1 (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, not applicable as “NA”, confidence interval as “CI”).
Maltese: Interazzjonijiet bejn rilpivirine u prodotti mediċinali li jingħataw miegħu huma elenkati fit-tabella 1 (żieda hija indikata bħala “↑”, tnaqqis bħala “↓”, l-ebda bidla bħala “↔”, ma japplikax bħala “NA”, intervall ta' kunfidenza bħala “CI”).
English: ND 0.1%
Maltese: SI-1000
English: EDURANT has not been studied in patients with severe hepatic impairment (Child-Pugh score C).
Maltese: EDURANT ma ġiex studjat f'pazjenti b'indeboliment qawwi talfwied (punteġġ Ċ ta' Child-Pugh).
English: In patients with a baseline viral load ≤ 100,000 copies/ml, 9 out of 27 patients with virologic failure on rilpivirine showed treatment-emergent resistance to rilpivirine (genotypic analysis), with the following frequency of phenotypic cross-resistance: etravirine 4/9, efavirenz 3/9, and nevirapine 1/9.
Maltese: F'pazjenti li għandhom tagħbija virali fil-linja bażi ta' ≤ 100,000 kopji/ml, 9 minn 27 pazjent b'falliment viroloġiku għal rilpivirine urew reżistenza li bdiet ħierġa waqt il-kura għal rilpivirine (analiżi ġenotipika), bil-frekwenza ta' reżistenza inkroċjata fenotipika kif imiss: etravirine 4/9, efavirenz 3/9, u nevirapine 1/9.
English: Baseline disease characteristics of antiretroviral treatment-naïve HIV-1 infected adult subjects in the ECHO and THRIVE trials (pooled analysis)
Maltese: Tabella 3: Karatteristiċi tal-marda fil-linja bażi ta' individwi adulti infettati b'HIV-1 li qatt ma ħadu kura antiretrovirali qabel fil-provi ECHO u THRIVE (ġabra ta' analiżi)
English: Each film-coated tablet contains rilpivirine hydrochloride equivalent to 25 mg rilpivirine.
Maltese: Kull pillola miksija b'rita fiha rilpivirine hydrochloride ekwivalenti għal 25 mg ta' rilpivirine.
English: By baseline viral load (copies/ml)
Maltese: Skont it-tagħbija virali fil-linja bażi (kopji/ml)
English: The mean increase from baseline in CD4+ counts was 146 × 10
Maltese: Iż-żieda medja mil-linja bażi fl-għadd ta' ċelluli CD4+ kienet ta' 146 x 10
English: Increase in CD4+ cell count (mean)
Maltese: Żieda fl-għadd taċ-ċelluli CD4+ (medja)
English: Considering all of the available in vitro and in vivo data in treatment-naïve subjects, the following resistance-associated mutations, when present at baseline, may affect the activity of rilpivirine: K101E, K101P, E138A, E138G, E138K, E138R, E138Q, V179L, Y181C, Y181I, Y181V, Y188L, H221Y, F227C, M230I, and M230L.
Maltese: K101E, K101P, E138A, E138G, E138K, E138R, E138Q, V179L, Y181C, Y181I, Y181V, Y188L, H221Y, F227C, M230I, u M230L.
English: 6 cells/l in patients receiving rilpivirine 25 mg and 160 × 10
Maltese: 6 ċellula/l f'pazjenti li kienu qed jingħataw 25 mg ta' rilpivirine u ta' 160 x 10
English: Rilpivirine is primarily metabolised by cytochrome P450 (CYP)3A.
Maltese: Prodotti mediċinali li jaffettwaw l-esponiment għal rilpivirine Il-biċċa l-kbira ta' rilpivirine hija metabolizzat permezz taċ-ċitokroma P450 (CYP)3A.
English: (reduced absorption due to gastric pH increase)
Maltese: (tnaqqis fl-assorbiment minħabba żieda fil-pH tal-istonku)
English: Rilpivirine in combination with a background regimen was evaluated in a clinical trial of 19 pregnant women during the second and third trimesters, and postpartum.
Maltese: Rilpivirine flimkien ma' programm ta' kura fl-isfond ġie valutat fi prova klinika ta' 19-il mara tqila waqt it-tieni u t-tielet trimestru, u wara l-ħlas.
English: In ECHO, the BR was fixed to the N(t)RTIs, tenofovir disoproxil fumarate plus emtricitabine.
Maltese: F'ECHO, il-BR kien dejjem l-istess bl-N(t)RTIs tenofovir disoproxil fumarate flimkien ma' emtricitabine.
English: The single resistance-associated mutations associated with a loss of susceptibility to rilpivirine were: K101P, Y181I and Y181V.
Maltese: Il-mutazzjonijiet singoli assoċjati ma' reżistenza li kienu assoċjati ma' telf ta' suxxettibbiltà għal rilpivirine kienu: K101P, Y181I u Y181V.
English: HIV PIs - without co-administration of low dose ritonavir Unboosted PIs (atazanavir, fosamprenavir, indinavir, nelfinavir)
Maltese: HIV PIs - mogħtija mingħajr doża baxxa ta' ritonavir PIs mhux rinforzati (atazanavir, fosamprenavir, indinavir, nelfinavir)
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 bl-HIV b'defiċjenza immuni qawwija fiż-żmien meta tinbeda terapija antiretrovali mħallta (CART), tista' sseħħ reazzjoni infjammatorja għal infezzjonijiet opportunistiċi asintomatiċi jew residwi.
English: Study TMC278-C204 was a randomised, active-controlled, Phase IIb trial in antiretroviral treatment-naïve HIV-1 infected adult patients consisting of 2 parts: an initial partially blinded dose-finding part [(rilpivirine) doses blinded] up to 96 weeks, followed by a long-term, open label part.
Maltese: L-istudju TMC278-C204 kienet prova randomised, ikkontrollata b'mod attiv, tal-Fażi IIb f'pazjenti adulti infettati b'HIV-1 li qatt ma ħadu kura antiretrovirali qabel li jikkonsisti minn żewg partijiet: parti inizjali blinded biex tinstab id-doża [dożi ta' rilpivirine blinded] sa 96 ġimgħa, segwita minn parti fuq perijodu twil ta' żmien open label.
English: Date of first authorisation: 28 November 2011 Date of latest renewal: 22 July 2016
Maltese: Data tal-aħħar tiġdid: 22 Lulju 2016
English: * The interaction between rilpivirine and the medicinal product was evaluated in a clinical study.
Maltese: L-interazzjoni bejn rilpivirine u l-prodott mediċinali ġiet evalwata fi studju kliniku.
English: Steady-state administration of rilpivirine 75 mg once daily and 300 mg once daily resulted in a mean Cmax approximately 2.6-fold and 6.7-fold, respectively, higher than the mean steady-state Cmax observed with the recommended 25 mg once daily dose of rilpivirine.
Maltese: L-għoti ta' 75 mg darba kuljum u 300 mg darba kuljum ta' rilpivirine fl-istat fiss wassal għal Cmax medja madwar 2.6-drabi u 6.7 drabi ogħla, rispettivament, mis-Cmax medja fl-istat fiss osservata bid-doża rrakkomandata ta' 25 mg darba kuljum ta' rilpivirine.
English: BR=background regimen
Maltese: BR=skeda ta' kura fl-isfond
English: In the week 240 resistance analysis of the TMC278-C213 trial, rilpivirine resistance-associated mutations (RAMs) were observed in 46.7% (7/15) of subjects with virologic failure and post-baseline genotypic data.
Maltese: F'individwi adolexxenti li qatt ma jkunu ħadu trattament qabel Fl-analiżi ta' reżistenza tal-ġimgħa 240 tal-prova TMC278-C213, mutazzjonijiet assoċjati ma' reżistenza (RAMs, resistance-associated mutations) għal rilpivirine ġew osservati f'46.7% (7/15) talindividwi b'falliment viroloġiku u data ġenotipika wara l-linja bażi.
English: In the rilpivirine arm in the week 96 analysis of the Phase III ECHO and THRIVE trials, mean change from baseline in total cholesterol (fasted) was 5 mg/dl, in HDL cholesterol (fasted) 4 mg/dl, in LDL cholesterol (fasted) 1 mg/dl, and in triglycerides (fasted) -7 mg/dl.
Maltese: III ECHO u THRIVE, il-bidla medja mil-linja bażi fil-kolesterol totali (stat ta' sawm) kienet ta' 5 mg/dl, fil-kolesterol HDL (stat ta' sawm) kienet ta' 4 mg/dl, fil-kolesterol LDL (stat ta' sawm) kienet ta' 1 mg/dl, u fit-triglicerides (stat ta' sawm) kienet ta' -7 mg/dl.
English: In the trials, the presence of the mutations V90I and V189I, at baseline, did not affect response.
Maltese: Fil-provi, il-preżenza talmutazzjonijiet V90I u V189I, fil-linja bażi, m'affetwatx ir-rispons.
English: Virologic failure
Maltese: Mingħajr rispons Falliment viroloġiku Total
English: There were no new safety findings compared with the known safety profile of rilpivirine in HIV-1 infected adults (see sections 4.2, 4.4 and 5.2).
Maltese: Ma kienx hemm riżultati ġodda dwar is-sigurtà meta mqabbla mal-profil ta' sigurtà magħruf ta' rilpivirine f'adulti infettati b'HIV-1 (ara sezzjonijiet 4.2, 4.4 u 5.2).
English: Virologic failure and development of resistance
Maltese: Falliment viroloġiku u żvilupp ta' reżistenza
English: Hepatitis B and/or hepatitis C virus co-infection
Maltese: Koinfezzjoni b'epatite B u/jew b'epatite Ċ
English: In vitro experiments indicate that rilpivirine primarily undergoes oxidative metabolism mediated by the cytochrome P450 (CYP) 3A system.
Maltese: Esperimenti in vitro jindikaw li l-biċċa l-kbira ta' rilpivirine tgħaddi minn metaboliżmu ossidattiv medjat mis-sistema taċ-ċitokroma P450 (CYP) 3A.
English: In a clinical study, rilpivirine did not significantly affect the pharmacokinetics of digoxin.
Maltese: Fi studju kliniku, rilpivirine m'affettwax sinifikament il-farmakokinetika ta' digoxin.
English: Rilpivirine is approximately 99.7% bound to plasma proteins in vitro, primarily to albumin.
Maltese: In vitro madwar 99.7% ta' rilpivirine huwa marbut ma' proteini tal-plażma, l-biċċa l-kbira malalbumin.
English: The median baseline plasma HIV-1 RNA was 4.8 log10 copies per ml, and the median baseline CD4+ cell count was 414 × 10
Maltese: Il-medjan tal- linja bażi ta' RNA ta' HIV-1 filplasma kien 4.8 log10 kopji kull ml, u l-medjan tal-linja bażi tal-għadd ta' ċelluli CD4+ kien 414 x 10
English: The exposures at the embryo-foetal No Observed Adverse Effects Levels (NOAELs) in rats and rabbits were respectively 15 and 70 times higher than the exposure in humans at the recommended dose of 25 mg once daily.
Maltese: Lesponimenti tal-embriju u l-fetu fil-Livelli Fejn Ma Kien Osservat l-Ebda Każ Avvers (NOAELs) filfirien u l-fniek kienu rispettivament 15 u 70 darba ogħla mill-esponiment tal-bnedmin bid-doża rrakkomandata ta' 25 mg darba kuljum
English: Table 2: ADRs reported in antiretroviral treatment-naïve HIV-1 infected adult patients treated with Rilpivirine (pooled data from the week 96 analysis of the Phase III ECHO and THRIVE trials) N=686 System Organ Class (SOC) Frequency Category ADRs (Rilpivirine + BR)
Maltese: Tabella 2: ADRs irrappurtati f'pazjenti adulti infettati b'HIV-1 li qatt ma ħadu kura b'mediċini antiretrovirali qabel ikkurati b'Rilpivirine (ġabra ta' dejta mill-analiżi tal-ġimgħa 96 mill-provi ta' fażi
English: Excipient with known effect Each film-coated tablet contains 56 mg lactose monohydrate.
Maltese: Eċċipjent b'effett magħruf Kull pillola miksija b'rita fiha 56 mg ta' lactose monohydrate.
English: Increased exposure of rilpivirine is expected.
Maltese: Hija mistennija żieda fl-esponiment ta' rilpivirine.
English: Famotidine* 40 mg single dose taken 2 hours before rilpivirine rilpivirine AUC ↓ 76% rilpivirine Cmin NA rilpivirine Cmax ↓ 85%
Maltese: Famotidine* Doża waħda ta' 40 mg li ttieħdet sagħtejn qabel rilpivirine rilpivirine AUC ↓ 76% rilpivirine Cmin NA rilpivirine Cmax ↓ 85%
English: The effect of rilpivirine at the recommended dose of 25 mg once daily on the QTcF interval was evaluated in a randomised, placebo and active (moxifloxacin 400 mg once daily) controlled crossover study in 60 healthy adults, with 13 measurements over 24 hours at steady-state.
Maltese: L-effett ta' rilpivirine fid-doża rrakkomandata ta' 25 mg darba kuljum fuq l-intervall QTcF kien evalwat fi studju randomised, crossover, ikkontrollat bi plaċebo u b'mod attiv (moxifloxacin 400 mg darba kuljum) f'60 adult f'saħħtu, bi 13-il kejl tul perijodu ta' 24 siegħa fl-istat fiss.
English: HIV treatment does not cure HIV infection!
Maltese: It-trattament tal-HIV ma jfejjaqx l-infezzjoni tal-HIV!
English: EDURANT has mainly been studied in patients with normal renal function.
Maltese: EDURANT ġie studjat prinċipalment f'pazjenti b'funzjoni tal-kliewi normali.
English: ND 11.5%
Maltese: 113.6 x 10
English: nd trimester of pregnancy, mean intraindividual values for total rilpivirine Cmax, AUC24h and Cmin values were, respectively, 21%, 29% and 35% lower as compared to postpartum; during the 3
Maltese: F'nisa li rċevew rilpivirine 25 mg darba kuljum waqt it-tieni trimestru ta' tqala, valuri intraindividwali medji għall-valuri totali ta' rilpivirine Cmax, AUC24h u Cmin kienu, rispettivament 21%, 29% u 35% inqas meta mqabbla ma' ta' wara l-ħlas; matul it-3 trimestru ta' tqala, il-valuri ta' Cmax, AUC24h u Cmin kienu, rispettivament, 20%, 31% u 42% inqas meta mqabbla ma' wara l-ħlas.
English: The pharmacokinetics of rilpivirine in antiretroviral treatment-naïve HIV-1 infected adolescent subjects receiving EDURANT 25 mg once daily were comparable to those in treatment-naïve HIV-1 infected adults receiving EDURANT 25 mg once daily.
Maltese: Popolazzjoni pedjatrika (b'età inqas minn 18-il sena) Il-farmakokinetika ta' rilpivirine f'individwi adolexxenti infettati b'HIV-1 li qatt ma kienu ħadu trattament antiretrovirali qabel li kienu qed jirċievu EDURANT 25 mg darba kuljum kienet kumparabbli ma' dik f'adulti infettati b'HIV-1 li qatt ma kienu ħadu trattament antiretrovirali qabel li kienu qed jirċievu EDURANT 25 mg darba kuljum.
English: EDURANT at the recommended dose of 25 mg once daily is not associated with a clinically relevant effect on QTc.
Maltese: EDURANT biddoża rrakkomandata ta' 25 mg darba kuljum ma kienx assoċjat ma' effett rilevanti b'mod kliniku fuq l-intervall QTc.
English: For those patients failing therapy with rilpivirine and who developed resistance to rilpivirine, cross-resistance to other approved NNRTIs (etravirine, efavirenz, nevirapine) was generally seen.
Maltese: Għal dawk il-pazjenti li fallew it-terapija b'rilpivirine u li żviluppaw reżistenza għal rilpivirine, ġeneralment irriżultat reżistenza inkroċjata għal NNRTIs (etravirine, efavirenz, nevirapine) approvati oħra.
English: Of these virologic failures, 9 out of 24 and 4 out of 14 were in subjects with a baseline viral load < 100,000 copies/ml, respectively.
Maltese: Minn dawn il-fallimenti viroloġiċi, 9 minn 24 u 4 minn 14 seħħew f'pazjenti b'tagħbija virali fil-linja bażi ta' < 100,000 kopji/ml, rispettivament.
English: In a study of healthy subjects, supratherapeutic doses of rilpivirine (75 mg once daily and 300 mg once daily) have been shown to prolong the QTc interval of the ECG (see section 5.1).
Maltese: Fi studju ta' individwi f'saħħithom, dożi ta' rilpivirine akbar mid-doża terapewtika (75 mg darba kuljum u 300 mg darba kuljum) intwerew li jtawlu l-intervall QTc tal-ECG (ara sezzjoni 5.1).
English: EDURANT 25 mg film-coated tablets
Maltese: EDURANT 25 mg pilloli miksijin b'rita
English: Co-administration of rilpivirine and medicinal products that induce CYP3A has been observed to decrease the plasma concentrations of rilpivirine, which could reduce the therapeutic effect of rilpivirine.
Maltese: L-għoti ta' rilpivirine flimkien ma' prodotti mediċinali li jinduċu CYP3A kien osservat li jnaqqas il-konċentrazzjonijiet mnaqqsa ta' rilpivirine fil-plażma, li jista' jkun li jnaqqsu leffett terapewtiku ta' rilpivirine.
English: Resistance to rilpivirine was determined as a fold change in EC50 value (FC) above the biological cut-off (BCO) of the assay.
Maltese: Reżistenza għal rilpivirine kienet stabbilità fil-bidla (FC- fold change) fil-valur EC50 'il-fuq mill-punt ta' riferiment (BCO - biological cut-off) tal-analiżi.
English: The safety assessment is based on the week 48 analysis of the single-arm, open-label, Phase II trial, TMC278-C213, in which 36 antiretroviral treatment-naïve HIV-1 infected adolescent patients weighing at least 32 kg received rilpivirine (25 mg once daily) in combination with other antiretroviral agents (see section 5.1).
Maltese: II b'fergħa waħda, fejn kemm l-investigaturi kif ukoll il-pazjenti kienu jafu liema sustanza qed tintuża, li fiha 36 pazjent adoloxxenti infettati b'HIV-1 li qatt ma kienu ħadu trattament b'antiretrovirali qabel u jiżnu mill-inqas 32 kg rċivew rilpivirine (25 mg darba kuljum) flimkien ma' sustanzi antiretrovirali oħra (ara sezzjoni 5.1).
English: EDURANT is used in combination with other HIV medicines to treat adolescents and adults 12 years of age and older who are infected with HIV and who have never been treated before with HIV medicines.
Maltese: EDURANT jintuża flimkien ma' mediċini oħra tal-HIV biex jittratta adolexxenti u adulti li b'età ta' 12-il sena u aktar li huma infettati bl-HIV u li qatt ma kienu kkurati b'mediċini tal-HIV qabel.
English: Common: - abnormal dreams - rash - stomach pain - depression - tiredness - vomiting - drowsiness - decreased appetite - sleep disorders - stomach discomfort - depressed mood - dry mouth
Maltese: Komuni: - ħolm mhux normali - raxx - uġigħ fl-istonku - depressjoni - għeja - rimettar - ħedla tan-ngħas - nuqqas ta' aptit
English: Psychiatric disorders very common insomnia common abnormal dreams depression sleep disorders depressed mood
Maltese: Komuni ħafna insomnja komuni ħolm mhux normali depressjoni disturbi fl-irqad burdata depressa
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections and Pneumocystis jiroveci pneumonia.
Maltese: Eżempji rilevanti huma retinite kkawżata minn ċitomegalovirus, infezzjonijiet mikobatteriċi mifruxa u/jew fokali u pulmonite kkawżata minn Pneumocystis jiroveci.
English: Subjects achieved virologic response (two consecutive viral loads < 50 copies/ml) and maintained it through week 48/96.
Maltese: L-individwi kisbu rispons viroloġiku (żewġ tagħbijiet virali konsekuttivi ta' < 50 kopja/ml) u żammewh salġimgħa 48/96.
English: Taking EDURANT in fasted condition or with only a nutritional drink may result in decreased plasma concentrations of rilpivirine, which could potentially reduce the therapeutic effect of EDURANT (see section 4.2).
Maltese: Meta wieħed jieħu EDURANT fi stat ta' sawm jew jieħdu ma' xarba ta' nutriment biss dan jista' jwassal għal tnaqqis fil-konċentrazzjonijiet ta' rilpivirine fil-plażma, li possibbilment jista' jnaqqas l-effett terapewtiku ta' EDURANT (ara sezzjoni 4.2).
English: Population pharmacokinetic analysis in HIV infected patients showed that rilpivirine pharmacokinetics are not different across the age range (18 to 78 years) evaluated, with only 3 subjects aged 65 years or older.
Maltese: Analiżi farmakokinetika tal-popolazzjoni f'pazjenti infettati bl-HIV uriet li l-farmakokinetika ta' rilpivirine mhijiex differenti tul il-medda ta' etajiet (18 sa 78 sena) li ġew evalwati, fejn 3 individwi biss kellhom 65 sena jew aktar.
English: Take the antacid either at least 2 hours before or at least 4 hours after EDURANT (see section 2 “Other medicines and EDURANT”).
Maltese: Ħu l-antaċidu mill-anqas sagħtejn qabel jew mill-anqas 4 sigħat wara EDURANT (ara sezzjoni 2 “Mediċini oħra u EDURANT”).
English: The requirements for submission of periodic safety update reports 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: Ir-rekwiżiti tar-biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkekwalunkwe aġġornament sussegwenti ppubblikatippubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: GLUCOCORTICOIDS Dexamethasone (systemic, except for single dose use)
Maltese: GLUKOKORTIKOJDI Dexamethasone (sistemiku, ħlief meta jintuża bħala doża waħda)
English: Hepatobiliary disorders very common increased transaminases common increased bilirubin
Maltese: Disturbi Epatobiljari komuni ħafna żieda fit-transaminases komuni żieda fil-bilirubin
English: Antiretroviral treatment-naïve HIV-1 infected patients were enrolled who had a plasma HIV-1 RNA ≥ 5,000 copies/ml and were screened for susceptibility to N(t)RTIs and for absence of specific NNRTI resistance-associated mutations.
Maltese: Pazjenti infettati b'HIV-1 li qatt ma ħadu kura antiretrovirali qabel u li kellhom RNA ta' HIV-1 ta' ≥ 5,000 kopja/ml iddaħħlu fl-istudju u sarilhom eżami dwar is-suxxettibbiltà tagħhom għal N(t)RTIs u għan-nuqqas ta' mutazzjonijiet speċifiċi assoċjati ma' reżistenza għal NNRTI.
English: 75 ml high density polyethylene (HDPE) bottle with a polypropylene (PP) child resistant closure and induction seal liner.
Maltese: Flixkun ta' 75 ml tal-polyethylene ta' densità għolja (HDPE) b'għatu tal-polypropylene (PP) li ma jistax jinfetaħ mit-tfal u b'siġill ġewwa mqabbad bis-sħana.
English: The terminal elimination half-life of rilpivirine is approximately 45 hours.
Maltese: Il-half life terminali ta' rilpivirine hija ta' madwar 45 siegħa.
English: - antacids (used to treat diseases related to the acid in the stomach; for example, aluminium / magnesium hydroxide, calcium carbonate).
Maltese: - antaċidi (jintużaw biex jikkuraw mard marbut mal-aċidu fl-istonku; pereżempju, aluminium / magnesium hydroxide, calcium carbonate).
English: The exposure to rilpivirine was approximately 40% lower when EDURANT was taken in a fasted condition as compared to a normal caloric meal (533 kcal) or high-fat high-caloric meal (928 kcal).
Maltese: L-esponiment għal rilpivirine kien madwar 40% anqas meta EDURANT ingħata fi stat ta' sawm meta mqabbel ma' ikla b'ammont normali ta' kaloriji (533 kkal) jew ikla b'ammont ogħli ta' xaħam u kaloriji (928 kkal).
English: Population pharmacokinetic analysis of rilpivirine in HIV infected patients indicated that race had no clinically relevant effect on the exposure to rilpivirine.
Maltese: Analiżi farmakokinetika tal-popolazzjoni għal rilpivirine f'pazjenti infettati bl-HIV indikat li r-razza ma kellha l-ebda effett rilevanti b'mod kliniku fuq l-esponiment ta' rilpivirine.
English: * compared to 25 mg once daily rilpivirine alone
Maltese: * meta mqabbla ma' 25 mg rilpivirine waħdu li jingħata darba kuljum
English: The pharmacokinetics of rilpivirine in paediatric patients less than 12 years of age are under investigation.
Maltese: Il-farmakokinetika ta' rilpivirine f'pazjenti pedjatriċi b'età ta' inqas minn 12-il sena għadha qed tiġi investigata.
English: Pregnancy
Maltese: IMPEDITURI