FrancophonIA/ELRC3.0 huggingface dataset:
English: In a pre- and post-natal development rat study, maternal toxicity was evident based on mortality/moribund condition, decreased body weight and food consumption, total litter loss, prolonged parturition, decreased length of gestation, and increased number of unaccounted for implantation sites at a dose equivalent to 22.5 mg/kg per day free base (approximately 1.2 times the recommended human dose on a body surface area basis).
Maltese: Fi studju tal-iżvilupp tal-firien qabel u wara t-twelid, l-effett tossiku fl-omm kien evidenti abbażi talkundizzjoni ta' mortalità/moribonda, it-tnaqqis fil-piż tal-ġisem u fil-konsum tal-ikel, it-telf totali talboton, it-twelid fit-tul, it-tnaqqis fit-tul tat-tqala, u ż-żieda fin-numru ta' siti ta' impjantazzjoni mhux spjegati b'doża ekwivalenti għal 22.5 mg/kg kuljum bażi libera (madwar 1.2 darbiet id-doża rakkomandata fil-bniedem abbażi tal-erja ts-superfiċje tal-ġisem).
English: Dizziness Disturbance in attention Dysgeusia Somnolence
Maltese: Disturbi fl għajnejn
English: 71.6 63.0 0.037 72.7 67.8 N.S. a Primary endpoint was complete response in the delayed phase.
Maltese: 71.6 63.0 0.037 72.7 67.8 N.S.
English: The efficacy and safety of rolapitant with concurrent use of another NK1 receptor antagonist (e.g. aprepitant and a combination of netupitant and palonosetron hydrochloride) is not established and therefore not recommended (see section 4.4).
Maltese: L-effikaċja u s-sigurtà ta' rolapitant flimkien ma' antagonist ieħor tar-riċettur NK1 (eż. aprepitant u kombinazzjoni ta' netupitant u palonosetron hydrochloride) mhijiex stabbilita u għalhekk mhuwiex rakkomandat (ara sezzjoni 4.4).
English: Alopecia
Maltese: Stitikezza
English: Neutrophil count decreased Thrombocytopenia
Maltese: KONDIZZJONIJIET U REKWIŻITI OĦRA TAL-AWTORIZZAZZJONI
English: Rolapitant is an inhibitor of Breast-Cancer-Resistance Protein (BCRP).
Maltese: Substrati tal-BCRP Rolapitant huwa inibitur tal-Proteina ta' Reżistenza għall-Kanċer tas-Sider (BCRP - Breast Cancer
English: - feeling dizzy, difficulty concentrating, lack of energy, feeling sleepy (somnolence) or trouble sleeping (insomnia) - stomach problems including stomach discomfort, bloating, nausea, pain, indigestion, and diarrhoea - low levels of white blood cells which fight infections (shown in blood tests) - infection in the mouth - mouth sores - decreased appetite - hiccups - weakness
Maltese: • tħossok stordut, diffikultà tikkonċentra, nuqqas ta' enerġija, tħossok bi ngħas (sonnolenza) jew diffikultà biex torqod (insomnja)
English: The following regimens are recommended for the prevention of nausea and vomiting associated with emetogenic cancer therapy:
Maltese: Il-programmi ta' kura li ġejjin huma rakkomandati għall-prevenzjoni ta' dardir u rimettar assoċjati ma' terapija tal-kanċer emetoġenika:
English: P-Valueb
Maltese: Valur Pb
English: P-Valuec
Maltese: Valur-Pb
English: Following administration of a single dose of 180 mg rolapitant to patients with mild hepatic impairment (Child-Pugh Class A), the pharmacokinetics of rolapitant were comparable with those of healthy subjects.
Maltese: (Child-Pugh Klassi A), il-farmakokinetika ta' rolapitant kienet komparabbli ma' dik ta' individwi b'saħħithom.
English: How Varuby works
Maltese: Tiħux Varuby:
English: On Day 2 to 4, patients received 8 mg twice daily of oral dexamethasone.
Maltese: F'Jum 2 sa 4, il-pazjenti rċevew 8 mg darbtejn kuljum ta' dexamethasone orali.
English: At a maternal dose equivalent to 9 mg/kg per day rolapitant free base (approximately 0.5 times the recommended human dose on a body surface area basis), there was a decrease in memory in female pups in a maze test and a decrease in pup body weight.
Maltese: B'doża fl-omm ekwivalenti għal 9 mg/kg kuljum ta' rolapitant bażi libera (madwar 0.5 darbiet id-doża rakkomandata fil-bniedem abbażi tal-erja tas-superfiċje tal-ġisem), kien hemm tnaqqis fil-memorja fil-frieħ nisa f'test tal-labirint u tnaqqis filpiż tal-ġisem tal-frieħ.
English: In vitro studies suggest that rolapitant is not an inhibitor of CYP2E1.
Maltese: Studji in vitro jissuġġerixxu li rolapitant mhuwiex inibitur ta' CYP2E1.
English: Nausea
Maltese: Dispneja
English: In rodents, rolapitant was tested in repeated dose oral toxicity studies up to 26 weeks in duration, and the liver, thyroid, kidneys, epididymis and uterus were identified as target organs.
Maltese: 26 ġimgħa, u l-fwied, it-tirojde, il-kliewi, l-epididime u l-utru kienu identifikati bħala organi fil-mira.
English: Overall a Unadjusted P-values are obtained from Cochran-Mantel-Haenszel test. N.S.=Not significant (p>0.05) The estimated time to first emesis or use of rescue medicinal product in patients receiving a MEC regimen is depicted by the Kaplan-Meier plot in Figure 2.
Maltese: Iż-żmien stmat sal-ewwel rimettar jew l-użu ta' prodott mediċinali ta' salvataġġ f'pazjenti li kienu qegħdin jirċievu programm ta' kura ta' MEC huwa ppreżentat mill-plott ta' Kaplan-Meier f'Figura 2.
English: Concomitant administration of rifampicin, a strong enzyme inducer significantly decreased the systemic exposure to rolapitant and to its active metabolite.
Maltese: L-għoti fl-istess ħin ta' rifampicin, induttur qawwi tal-enzimi naqqas b'mod sinifikanti l-esponiment sistemiku għal rolapitant u għall-metabolit attiv tiegħu.
English: Ondansetron
Maltese: Dijarea
English: Retching
Maltese: Treddigħ
English: Therefore, caution should be taken when rolapitant is combined with a medicinal product metabolised by CYP2D6, notably those having a narrow therapeutic margin (e.g. propafenone, tamoxifen, metoprolol used in heart failure, thioridazine, pimozide).
Maltese: Għalhekk, għandha ssir attenzjoni meta rolapitant jingħata flimkien ma' prodott mediċinali metabolizzat minn CYP2D6, b'mod partikolari dawk li għandhom marġini terapewtiku dejjaq (eż. propafenone, tamoxifen, metoprolol li jintuża f'insuffiċjenza tal-qalb, thioridazine, pimozide).
English: Rolapitant, the active substance in Varuby, blocks substance P from attaching to these nerve cells and this helps prevent nausea and vomiting.
Maltese: Rolapitant, issustanza attiva f'Varuby jimblokka s-sustanza P milli teħel ma' dawn iċ-ċelluli tan-nervi u dan jgħin jipprevjeni d-dardir u r-remettar.
English: Treatment difference (95% CI)
Maltese: Differenza fittrattament (95% CI)
English: ≥ 50 and < 200 ≥ 200 and < 350
Maltese: ≥ 50 u < 200 ≥ 200 u < 350
English: Possible side effects').
Maltese: Effetti sekondarji possibbli').
English: ANTI-INFECTIVES Antiretrovirals NRTIs
Maltese: ANTI-INFETTIVI Antiretrovirali NRTIs
English: IMMUNOSUPPRESSANTS Cyclosporin
Maltese: IMMUNOSUPPRESSANTI Cyclosporin
English: CORTICOSTEROIDS Dexamethasone (systemic)
Maltese: KORTIKOSTEROJDI Dexamethasone (sistemiku)
English: Lopinavir/ritonavir (tablet)
Maltese: Lopinavir/ritonavir (pillola)
English: Cmin, ng/mL Cmax, ng/mL AUC12h, h*ng /mL
Maltese: Cmin, ng/mL Cmax, ng/mL AUC12h, siegħa*ng/mL
English: 4.8 log10 copies/ml
Maltese: 4.8 log10 kopji/ml
English: n = 9 for AUC12h
Maltese: n = 9 għal AUC12h
English: - Main inclusion criteria:
Maltese: - Kriterji prinċipali ta' inklużjoni:
English: Trial characteristics - Design: randomised (1:1), double-blinded, placebo-controlled.
Maltese: Karatteristiċi tal-provi - Disinn: randomised (1:1), double-blinded, ikkontrollati bil-plaċebo.
English: Tenofovir disoproxil 245 mg once daily tenofovir
Maltese: Tenofovir disoproxil 245 mg darba kuljum tenofovir
English: ANTICONVULSANTS Carbamazepine Phenobarbital Phenytoin
Maltese: ANTIKONVULSANTI Carbamazepine Phenobarbital Phenytoin
English: de novo ENF
Maltese: ENF de novo
English: Disopyramide Flecainide Lidocaine (systemic) Mexiletine Propafenone Quinidine
Maltese: Lidocaine (sistemiċi) Mexiletine Propafenone Quinidine
English: ANTIMALARIALS Artemether/ Lumefantrine 80/480 mg, 6 doses at 0, 8, 24, 36, 48, and 60 hours artemether
Maltese: ANTIMALARJI Artemether/ Lumefantrine 80/480 mg, 6 dożi fissigħat 0, 8, 24, 36, 48, u 60
English: PHOSPHODIESTERASE, TYPE 5 (PDE-5) INHIBITORS Sildenafil 50 mg single dose
Maltese: IMPEDITURI PHOSPHODIESTERASE, TIP 5 (PDE-5) Sildenafil 50 mg doża singola
English: HMG CO-A REDUCTASE INHIBITORS Atorvastatin
Maltese: IMPEDITURI TA' HMG CO-A REDUCTASE Atorvastatin
English: INTELENCE contains lactose
Maltese: INTELENCE fih lactose
English: Sími: +354 535 7000 janssen@vistor.is
Maltese: +354 535 7000 janssen@vistor.is
English: Placebo + BR N = 604
Maltese: Plaċebo + BR N=604
English: Etravirine is approximately 99.9% bound to plasma proteins, primarily to albumin (99.6%) and α1-acid glycoprotein (97.66%-99.02%) in vitro.
Maltese: Etravirine bejn wieħed u ieħor huwa 99.9% marbut ma' proteini tal-plażma, primarjament ma' albumina (99.6%) u 1-acid glycoprotein (97.66% - 99.02%) in vitro.
English: INTELENCE contains the active substance etravirine.
Maltese: INTELENCE fih is-sustanza attiva etravirine.
English: ANTIBIOTICS Azithromycin
Maltese: ANTIBIJOTIĊI Azithromycin
English: In clinical trials, Stevens-Johnson Syndrome and erythema multiforme have been rarely (< 0.1%) reported.
Maltese: Fi provi kliniċi, is-Sindromu ta' Stevens-Johnson u eritema multiforme ġew irrapportati rarament (< 0.1%).
English: Stevens-Johnson Syndrome a, erythema multiforme very rare toxic epidermal necrolysis a, DRESS
Maltese: Sindrom ta' Stevens-Johnson a, eritema multiforme rari ħafna nekroliżi tossika tal-epidermide a, DRESS
English: Etravirine is an NNRTI of human immunodeficiency virus type 1 (HIV-1).
Maltese: Etravirine huwa NNRTI tal-virus tal-immunodefiċjenza umana tat-tip 1 (HIV-1).
English: ANTIARRHYTHMICS Digoxin
Maltese: ANTIARRITMIĊI Digoxin
English: 6 cells/l.
Maltese: 6 ċelluli/l.
English: Integrase Strand Transfer Inhibitors Dolutegravir
Maltese: Impedituri ta' Trasferiment ta' Integrase Strand Dolutegravir
English: PROTON PUMP INHIBITORS Omeprazole
Maltese: TA' PROTON PUMP Omeprazole
English: 0.5 mg single dose digoxin
Maltese: Doża singola 0.5 mg digoxin
English: Immunologic parameters
Maltese: Parametri immunoloġiċi
English: HEPATITIS C VIRUS (HCV) DIRECT-ACTING ANTIVIRALS Ribavirin
Maltese: ANTIVIRALI LI JAĦDMU DIRETTAMENT KONTRA L-VIRUS TA' EPATITE C (HCV) Ribavirin
English: Confidence interval around observed difference of response rates; P-value = 0.0408.
Maltese: Intervall ta' fiduċja madwar differenzi osservati tar-rati ta' rispons; Valur-P = 0.0408.
English: Marketing Authorisation Holder Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
Maltese: Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, il-Belġju
English: Raltegravir 400 mg twice daily raltegravir
Maltese: Raltegravir 400 mg darbtejn kuljum raltegravir
English: croscarmellose sodium, magnesium stearate and lactose (as monohydrate).
Maltese: croscarmellose sodium, magnesium stearate u lactose (bħala monohydrate).
English: All ranges * Etravirine RAMs = V90I, A98G, L100I, K101E/P, V106I, V179D/F, Y181C/I/V, G190A/S
Maltese: * RAMs ta' etravirine = V90I, A98G, L100I, K101E/P, V106I, V179D/F, Y181C/I/V, G190A/S
English: The rash is usually mild to moderate.
Maltese: Ir-raxx normalment ikun ħafif għal moderat.
English: HIV PIs - Boosted with cobicistat Atazanavir/cobicistat Darunavir/cobicistat
Maltese: PIs tal-HIV -Msaħħa b'cobicistat Atazanavir/cobicistat Darunavir/cobicistat
English: St John's wort is expected to decrease the plasma concentrations of etravirine.
Maltese: St John's wort huwa mistenni li jnaqqas il-konċentrazzjonijiet fil-plażma ta' etravirine.
English: Saquinavir/ritonavir 1,000/100 mg twice daily saquinavir
Maltese: Saquinavir/ritonavir 1,000/100 mg darbtejn kuljum saquinavir
English: TMC125-C227 was an exploratory, randomised, active-controlled open-label trial, which investigated the efficacy and safety of etravirine in a treatment regimen, which is not approved under the current indication.
Maltese: TMC125-C227 kienet prova esploratorja, randomizzata, ikkontrollata-attiva, b'tikketta open-label, li investigat l-effikaċja u s-sikurezza ta' etravirine f'reġimen ta' trattament, li mhuwiex approvat taħt lindikazzjoni attwali.
English: 300/100 mg once daily atazanavir
Maltese: 300/100 mg darba kuljum atazanavir
English: 150/600/100 mg twice daily maraviroc
Maltese: 150/600/100 mg darbtejn kuljum maraviroc
English: In vitro and in vivo studies with etravirine revealed no evidence of a mutagenic potential.
Maltese: Studji in vitro u in vivo b'etravirine ma urewx evidenza ta' potenzjal mutaġeniku.
English: Effects on drug levels Least Squares Mean Ratio (90% CI; 1.00 = No effect)
Maltese: Effetti fuq livelli mediċinali Proporzjon Medju tal-Inqas Kwadrati (90% CI; 1.00 = Mingħajr effett)
English: Non-completer is failure (NC = F) imputation.
Maltese: Mhux komplut huwa imputazzjoni ta' falliment (NC=F).
English: INTELENCE contains sodium
Maltese: INTELENCE fih sodium
English: V179F was never present without Y181C.
Maltese: V179F qatt ma kien preżenti mingħajr Y181C.
English: • Risk Management plan (RMP)
Maltese: • Pjan tal-Ġestjoni tar-Riskju (RMP)
English: Etravirine exhibits activity against wild type HIV-1 in T-cell lines and primary cells with median EC50 values ranging from 0.9 to 5.5 nM. Etravirine demonstrates activity against HIV-1 group M (subtypes A, B, C, D, E, F, and G) and HIV-1 group O primary isolates with EC50 values ranging from 0.3 to 1.7 nM and from 11.5 to 21.7 nM, respectively.
Maltese: Etravirine jeżibixxi attività kontra HIV-1 ta' tip selvaġġ f'linji taċ-ċelloli-T u ċelloli primarji b'medja ta' figuri ta' EC50 f'marġini bejn 0.9 u 5.5nM. Etravirine juri attività kontra HIV-1 grupp M (sottotipi A, B, C, D, E, F u G) u HIV-1 grupp O iżolati primarji b'figuri ta' EC50 f'marġini bejn 0.3 u 1.7 nM u bejn 11.5 u 21.7 nM rispettivament.
English: 6 cells/l
Maltese: 6 ċelloli/l
English: Etravirine is metabolised by CYP3A4, CYP2C9 and CYP2C19 followed by glucuronidation of the metabolites by uridine diphosphate glucuronosyl transferase (UDPGT).
Maltese: Etravirine huwa metabolizzat b'CYP3A4, CYP2C9 u CYP2C19 segwit minn glukuronidazzjoni talmetaboliti minn uridine diphosphate glucuronosyl transferase (UDPGT).
English: Tipranavir/ritonavir 500/200 mg twice daily tipranavir
Maltese: Tipranavir/ritonavir 500/200 mg darbtejn kuljum tipranavir
English: (Hypericum perforatum)
Maltese: St John's wort (Hypericum perforatum)
English: Baseline HIV-1 RNA < 30,000 copies/ml ≥ 30,000 and < 100,000 copies/ml ≥ 100,000 copies/ml Baseline CD4 count (x 10
Maltese: HIV-1 RNA fil-linja bażi < 30,000 kopja/ml ≥ 30,000 u < 100,000 kopja/ml ≥ 100,000 kopja/ml Għadd ta' CD4 fil-linja bażi (x10
English: The proportion of paediatric patients with < 400 HIV-1 RNA copies/ml was 63.4%.
Maltese: Il-proporzjon ta' pazjenti pedjatriċi li kellhom < 400 HIV-1 RNA kopji/ml kien ta' 63.4%.
English: 40 mg once daily atorvastatin
Maltese: 40 mg darba kuljum atorvastatin
English: Etravirine retains activity against HIV-1 viral strains resistant to nucleoside reverse transcriptase and/or protease inhibitors.
Maltese: Etravirine jibqa' jżomm attività kontra razzez virali ta' HIV-1 li huma reżistenti għal impedituri tan-nucleoside reverse transcriptase u/jew protease.
English: The combination of etravirine with simeprevir, daclatasvir, atazanavir/cobicistat or darunavir/cobicistat is not recommended (see section 4.5).
Maltese: Il-kombinazzjoni ta' etravirine ma' simeprevir, daclatasvir, atazanavir/cobicistat jew darunavir/cobicistat mhijiex rrakkomandata (ara sezzjoni 4.5).
English: No significant pharmacokinetic differences have been observed between males and females.
Maltese: Ma ġewx osservati differenzi farmakokinetiċi sinifikanti bejn individwi maskili u femminili.
English: Experience in geriatric patients is limited: in the Phase III trials, 6 patients aged 65 years or older and 53 patients aged 56-64 years received etravirine.
Maltese: III, 6 pazjenti ta' età ta' 65 sena jew ikbar u 53 pazjent ta' età ta' 56-64 sena irċevew etravirine.
English: It is not recommended to combine INTELENCE with any of the following medicines: - tipranavir/ritonavir, efavirenz, nevirapine, rilpivirine, indinavir, nelfinavir, atazanavir/cobicistat,
Maltese: Mhuwiex rakkomandat li INTELENCE jiġi kkombinat ma' kwalunkwe mill-mediċini li ġejjin - tipranavir/ritonavir, efavirenz, nevirapine, rilpivirine, indinavir, nelfinavir, atazanavir/cobicistat,
English: Table 4: DUET-1 and DUET-2 pooled data
Maltese: Tabella 4: Tagħrif miġbur DUET-1 u DUET-2
English: 800 mg 3 times daily + etravirine 200 mg every 12 hours boceprevir
Maltese: Boceprevir 800 mg 3 darbiet kuljum + etravirine 200 mg kull 12-il siegħa boceprevir
English: In the TMC125-C227 study, etravirine (N = 59) was administered with 2 investigator-selected NRTIs (i.e. without a ritonavir-boosted PI) and compared to an investigator-selected combination of a PI with 2 NRTIs (N = 57).
Maltese: Fl-istudju TMC125-C227, etravirine (N=59) kien amministrat ma' 2 NRTIs (i.e. mingħajr PI msaħħaħ b'ritonavir) magħżula mill-investigatur u mqabbel ma' kombinazzjoni ta' PI magħżula mill-investigatur ma' żewġ NRTIs (N=57).
English: Note: The median protein binding adjusted EC50 for MT4 cells infected with HIV-1/IIIB in vitro = 4 ng/ml.
Maltese: Nota: Ir-rabta mal-proteini medja aġġustata EC50 għal ċelluli MT4 infettati b'HIV-1/IIIB in vitro = 4 ng/ml.
English: The adverse reactions are listed by system organ class (SOC) and frequency.
Maltese: Irreazzjonijiet avversi huma elenkati skont il-klassi tas-sistema u tal-organu (SOC) u l-frekwenza.
English: Overall de novo ENF
Maltese: Ġenerali de novo ENF
English: ANTIFUNGALS Fluconazole 200 mg once in the morning fluconazole
Maltese: ANTIFUNGALI Fluconazole 200 mg darba filgħodu fluconazole
English: Etravirine 200 mg twice daily N = 575
Maltese: Etravirine 200 mg darbtejn kuljum N = 575
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections and Pneumocystis jiroveci pneumonia.
Maltese: Eżempji rilevanti huma cytomegalovirus retinitis, infezzjonijiet mikobatterjali ġeneralizzati u/jew fokali u pnewmonja Pneumocystis jiroveci.
English: Didanosine 400 mg once daily didanosine
Maltese: 400 mg darba kuljum didanosine
English: Table 3: DUET-1 and DUET-2 pooled 48-week data Etravirine + BR N = 599
Maltese: Tabella 3: Tagħrif miġbur minn DUET-1 u DUET-2 ġimgħa 48 Etravirine + BR N=599
English: For further information on interactions with medicinal products see section 4.5.
Maltese: Għal iktar informazzjoni dwar interazzjonijiet ma' prodotti mediċinali ara sezzjoni 4.5.
English: Lactose intolerance and lactase deficiency
Maltese: Intolleranza għal lactose jew defiċjenza ta' lactase
English: In vitro experiments with human liver microsomes (HLMs) indicate that etravirine primarily undergoes oxidative metabolism by the hepatic cytochrome CYP450 (CYP3A) system and, to a lesser extent, by the CYP2C family, followed by glucuronidation.
Maltese: Esperimenti in vitro b'mikrosomi tal-fwied uman (HLMs) jindikaw li etravirine primarjament jgħaddi minn metaboliżmu ossidativ mis-sistema taċ-ċitokromju epatiku CYP450 (CYP3A) u, b'inqas, millfamilja CYP2C, segwit minn glukuronidazzjoni.
English: INTELENCE belongs to a group of anti-HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Maltese: INTELENCE tifforma parti minn grupp ta' mediċini li jaħdmu kontra l-HIV hekk msejħa inibituri ta'non-nucleoside reverse transcriptase (NNRTIs).
English: Janssen-Cilag SpA Via C. Janssen 04100 Borgo San Michele Latina
Maltese: Janssen 04100 Borgo San Michele Latina
English: Cardiac disorders common myocardial infarction uncommon atrial fibrillation, angina pectoris
Maltese: Disturbi fil-qalb komuni infart mijokardijaku mhux komuni fibrillazjoni atrijali, angina pectoris
English: INTELENCE 25 mg tablets INTELENCE 100 mg tablets INTELENCE 200 mg tablets
Maltese: INTELENCE pilloli ta' 25 mg INTELENCE pilloli ta' 100 mg INTELENCE pilloli ta' 200 mg
English: In addition, etravirine demonstrates a fold change (FC) in EC50 ≤ 3 against 60% of 6,171 NNRTI-resistant clinical isolates.
Maltese: Barra minn hekk, etravirine juri bidla (FC) f' EC50 ta' ≤ 3 kontra 60% ta' 6,171 iżolati kliniċi reżistenti għal NNRTI.
English: INTELENCE, in combination with a boosted protease inhibitor and other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients and in antiretroviral treatment-experienced paediatric patients from 6 years of age (see sections 4.4, 4.5 and 5.1).
Maltese: INTELENCE, flimkien ma' impeditur ta' protease msaħħaħ u prodotti mediċinali antiretrovirali oħrajn, huwa indikat għat-trattament ta' infezzjoni ta' human immunodeficiency virus tip 1 (HIV-1) f'pazjenti adulti li għandhom esperjenza ta' trattament antiretrovirali u f'pazjenti pedjatriċi minn eta' ta' 6 snin li għandhom esperjenza ta' trattament antiretrovirali (ara sezzjonijiet 4.4, 4.5 u 5.1).
English: Dolutegravir + darunavir/ritonavir 50 mg once daily + 600/100 mg twice daily
Maltese: Dolutegravir + darunavir/ritonavir 50 mg darba kuljum + 600/100 mg darbtejn kuljum
English: N = number of subjects with data; n = number of observations.
Maltese: N = numru ta' suġġetti bid-data;
English: Not studied, but no interaction expected based on the primary renal elimination route for other NRTIs (e.g., abacavir, emtricitabine, lamivudine, stavudine and zidovudine).
Maltese: Mhux studjat, iżda mhux mistennija interazzjoni fuq il-bażi tal-mezz ta' eliminazzjoni primarju renali għal NRTIs oħrajn (p.e., abacavir, emtricitabine, lamivudine, stavudine u zidovudine).
English: Etravirine is primarily metabolised and eliminated by the liver.
Maltese: Etravirine huwa primarjament metabolizzat u eliminat mill-fwied.
English: TMC125-C213 6 to < 18 years ETR N = 101
Maltese: TMC125-C213 6 to < 18-il sena ETR N=101
English: Metabolism and nutrition disorders common diabetes mellitus, hyperglycaemia, hypercholesterolaemia, increased low density lipoprotein (LDL), hypertriglyceridaemia, hyperlipidaemia, dyslipidaemia, anorexia
Maltese: Disturbi filmetaboliżmu u nnutrizzjoni komuni dijabete mellitus, ipergliċemija, iperkolesterolemija, żieda fil-lipoproteina ta' densità baxxa (LDL), ipertrigliċeridemija, iperlipidimja, dislipidimja, anoreksja
English: HIV PIs - Boosted with low-dose ritonavir Atazanavir/ritonavir
Maltese: PIs tal-HIV - Msaħħa b'doża baxxa ritonavir Atazanavir/ritonavir
English: Population pharmacokinetic analysis in HIV infected patients showed that etravirine pharmacokinetics are not considerably different in the age range (18 to 77 years) evaluated, with 6 subjects aged 65 years or older (see sections 4.2 and 4.4).
Maltese: Analiżi tal-farmakokinetika tal-popolazzjoni f'pazjenti infettati bl-HIV uriet illi l-farmakokinetika ta' etravirine mhijiex differenti konsiderevolment fil-marġini tal-etajiet (18 sa 77 sena) evalwati, b'6 individwi ta' età ta' 65 sena jew iktar (ara sezzjonijiet 4.2 u 4.4).
English: Other medicines and INTELENCE
Maltese: Mediċini oħra u INTELENCE
English: The pharmacokinetics of etravirine have not been studied in patients with severe hepatic impairment (Child-Pugh Class C).
Maltese: Il-farmakokinetika ta' etravirine ma ġietx studjata f'pazjenti b'indeboliment epatiku qawwi (Child-Pugh Klassi Ċ).
English: Date of first authorisation: 28 August 2008 Date of latest renewal: 23 August 2018
Maltese: Data tal-aħħar tiġdid: 23 ta' Awwissu 2018
English: TMC125-C213 6 to < 12 years ETR N = 41
Maltese: TMC125-C213 6 sa < 12-il sena ETR N=41
English: INTELENCE should optimally be combined with other antiretrovirals that exhibit activity against the patient's virus (see section 5.1).
Maltese: INTELENCE għandu jiġi kkombinat b'mod ottimali ma' antiretrovirali oħrajn li juru attività kontra lvirus tal-pazjent (ara sezzjoni 5.1).
English: Etravirine is expected to decrease plasma concentrations of cyclosporine, sirolimus and tacrolimus.
Maltese: Etravirine huwa mistenni li jnaqqas il-konċentrazzjonijiet fil-plażma ta' cyclosporin, sirolimus u tacrolimus.
English: OESTROGEN-BASED CONTRACEPTIVES Ethinylestradiol
Maltese: TA' ESTROGEN Ethinylestradiol
English: Treatment-experienced adult patients
Maltese: Pazjenti adulti esperjenzati bit-trattament
English: 0.035 mg once daily
Maltese: 0.035 mg darba kuljum
English: ANNEX II
Maltese: Matul it-2