FrancophonIA/ELRC3.0 huggingface dataset:
English: Voriconazole 200 mg twice daily voriconazole AUC ↑ 1.14 (0.88-1.47) Cmin ↑ 1.23 (0.87-1.75) Cmax ↓ 0.95 (0.75-1.21) etravirine
Maltese: Voriconazole 200 mg darbtejn kuljum voriconazole AUC ↑ 1.14 (0.88-1.47) Cmin ↑ 1.23 (0.87-1.75) Cmax ↓ 0.95 (0.75-1.21) etravirine
English: Etravirine efficacy in relation to NNRTI resistance at baseline has mainly been analysed with etravirine given in combination with darunavir/ritonavir (DUET-1 and DUET-2).
Maltese: L-effikaċja ta' etravirine relatata ma' reżistenza ta' NNRTI fil-linja bażi ġiet prinċipalment analizzata b'etravirine mogħti f'kombinazzjoni ma' darunavir/ritonavir (DUET-1 u DUET-2).
English: - Treatment: Etravirine vs. placebo, in addition to a background regimen (BR) including darunavir/ritonavir (DRV/rtv), investigator-selected N(t)RTIs and optional enfuvirtide (ENF).
Maltese: Etravirine vs plaċebo, flimkien ma' reġimen ta' sfond (BR, background regimen) li jinkludi darunavir/ ritonavir (DRV/rtv), N(t)RTIs magħżula mill-investigatur u enfuvirtide fakultattiv.
English: Etravirine is a weak inducer of CYP3A4.
Maltese: Etravirine huwa induttur dgħajjef ta' CYP3A4.
English: • on a stable antiretroviral regimen for at least 8 weeks.
Maltese: • Fuq reġimen antiretrovirali stabbli għal mill-inqas 8 ġimgħat.
English: • HIV-1 plasma viral load > 5,000 HIV-1 RNA copies/ml at screening
Maltese: • Tagħbija virali ta' HIV-1 > 5,000 kopja/ml ta' HIV-1 RNA waqt eżami
English: Exposure to etravirine was lower (35-50%) in HIV-1 infected patients than in healthy subjects.
Maltese: L-espożizzjoni għal etravirine kienet inqas (35-50%) f'pazjenti infettati b'HIV-1 milli f'suġġetti f'saħħithom.
English: Co-administration with elbasvir/grazoprevir (see section 4.5).
Maltese: L-għoti ta' INTELENCE flimkien ma' elbasvir/grazoprevir (ara sezzjoni 4.5).
English: Pivotal studies
Maltese: Studji ċentrali
English: Manufacturer Janssen-Cilag SpA, Via C. Janssen, 04100 Borgo San Michele, Latina, Italy
Maltese: Janssen, 04100 Borgo San Michele, Latina, l-Italja
English: Etravirine is a weak inhibitor of CYP2C9 and CYP2C19.
Maltese: Etravirine huwa impeditur dgħajjef ta' CYP2C9 u CYP2C19.
English: Darunavir/ritonavir 600/100 mg twice daily darunavir
Maltese: Darunavir/ritonavir 600/100 mg darbtejn kuljum darunavir
English: Study TMC114HIV3015 evaluated etravirine 200 mg twice daily in combination with other antiretroviral medicinal products in 15 pregnant women during the second and third trimesters of pregnancy and postpartum.
Maltese: L-istudju TMC114HIV3015 ivvaluta etravirine 200 mg darbtejn kuljum flimkien ma' prodotti mediċinali antiretrovirali oħra fi 15-il mara tqila matul it-tieni u t-tielet trimestri tat-tqala u wara ttwelid.
English: Not studied, but no interaction expected based on the renal elimination pathway of ribavirin.
Maltese: Mhux studjat, imma mhux mistennija interazzjoni fuq bażi tal-mezz ta' eliminazzjoni renali ta' ribavirin.
English: Any AIDS defining illness and/or death n (%)
Maltese: Mard li jiddefinixxi AIDS u/jew mewt n(%)
English: In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
Maltese: F'ċerti pazjenti b'infezzjoni ta' HIV avvanzata u b'passat ta' infezzjoni opportunistika, jista' jkun hemm sinjali u sintomi ta' infjammazzjonijiet minn infezzjonijiet tal-passat ftit wara li jinbeda ttrattament kontra l-HIV.
English: Description of selected adverse reactions
Maltese: IMPEDITURI SELETTIVI
English: Rifabutin 300 mg once daily
Maltese: Rifabutin 300 mg darba kuljum
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000).
Maltese: Il-frekwenzi huma definiti bħala komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10) u mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000) u rari ħafna
English: Pharmacotherapeutic group: Antivirals for systemic use, non-nucleoside reverse transcriptase inhibitors, ATC code: J05AG04.
Maltese: Antivirali għal użu sistemiku, impedituri tan-non-nucleoside reverse transcriptase, Kodiċi ATC:
English: Virologic parameters
Maltese: Parametri viroloġiċi
English: No interaction between pravastatin and etravirine is expected.
Maltese: Mhux mistennija interazzjonijiet bejn pravastatin u etravirine.
English: H2-RECEPTOR ANTAGONISTS Ranitidine
Maltese: TAR-RIĊETTUR-H2 Ranitidine
English: Confirmed undetectable viral load (< 50 HIV-1 RNA copies/ml) n (%)
Maltese: Tagħbija virali li ma tistax titkejjel ikkonfermata (< 50 kopja/ml ta' HIV-1 RNA) n (%)
English: Each tablet contains 160 mg lactose (as monohydrate).
Maltese: Kull pillola fiha 160 mg lactose (bħala monohydrate).
English: TMC125-C213 12 to < 18 years ETR N = 60
Maltese: TMC125-C213 12 sa < 18-il sena ETR N=60
English: 400/100 mg twice daily lopinavir
Maltese: 400/100 mg darbtejn kuljum lopinavir
English: Etravirine is primarily metabolised and eliminated by the liver and highly bound to plasma proteins.
Maltese: Etravirine huwa primarjament metabolizzat u eliminat mill-fwied u jeħel sewwa mal-proteini talplażma.
English: Posaconazole, a potent inhibitor of CYP3A4, may increase plasma concentrations of etravirine.
Maltese: Posaconazole, impeditur qawwi ta' CYP3A4, jista' jżid il-konċentrazzjonijiet fil-plażma ta' etravirine.
English: Clarithromycin 500 mg twice daily clarithromycin AUC ↓ 0.61 (0.53-0.69) Cmin ↓ 0.47 (0.38-0.57) Cmax ↓ 0.66 (0.57-0.77) 14-OH-clarithromycin AUC ↑ 1.21 (1.05-1.39) Cmin ↔ 1.05 (0.90-1.22) Cmax ↑ 1.33 (1.13-1.56) etravirine
Maltese: Clarithromycin 500 mg darbtejn kuljum clarithromycin AUC ↓ 0.61 (0.53-0.69) Cmin ↓ 0.47 (0.38-0.57) Cmax ↓ 0.66 (0.57-0.77) 14-OH-clarithromycin AUC ↑ 1.21 (1.05-1.39) Cmin ↔ 1.05 (0.90-1.22) Cmax ↑ 1.33 (1.13-1.56) etravirine
English: Rash was reported more frequently in female subjects than in male subjects (rash ≥ grade 2 was reported in 13/64 [20.3%] females versus 2/37 [5.4%] males; discontinuations due to rash were reported in 4/64 [6.3%] females versus 0/37 [0%] males) (see section 4.4).
Maltese: Ir-raxx ġie rrappurtat b'mod iktar frekwenti flindividwi femminili meta mqabbel mal-individwi maskili (raxx ≥ grad 2 ġie rrappurtat f'13/64 [20.3%] nisa meta mqabbel ma' 2/37 [5.4%] rġiel; it- twaqqif minħabba r-raxx ġie rrappurtat f'4/64 [6.3%] nisa meta mqabbel ma' 0/37 [0%] rġiel) (ara sezzjoni 4.4).
English: Outcomes
Maltese: PRODOTTI
English: In vitro data show that etravirine has inhibitory properties on CYP2C19.
Maltese: Data in vitro turi li etravirine għandu kwalitajiet li jinibixxu CYP2C19.
English: The pharmacokinetics in other races have not been sufficiently evaluated.
Maltese: Ilfarmakokinetika f'razez oħrajn ma ġewx evalwati suffiċjentement.
English: 1 mg once daily ethinylestradiol AUC ↑ 1.22 (1.13-1.31) Cmin ↔ 1.09 (1.01-1.18) Cmax ↑ 1.33 (1.21-1.46) norethindrone AUC ↔ 0.95 (0.90-0.99) Cmin ↓ 0.78 (0.68-0.90) Cmax ↔ 1.05 (0.98-1.12) etravirine
Maltese: 1 mg darba kuljum ethinylestradiol AUC ↑ 1.22 (1.13-1.31) Cmin ↔ 1.09 (1.01-1.18) Cmax ↑ 1.33 (1.21-1.46) norethindrone AUC ↔ 0.95 (0.90-0.99) Cmin ↓ 0.78 (0.68-0.90) Cmax ↔ 1.05 (0.98-1.12) etravirine
English: INTELENCE and darunavir/ritonavir can be used without dose adjustments (see also section 5.1).
Maltese: INTELENCE u darunavir/ritonavir jistgħu jintużaw mingħajr aġġustament fid-doża (ara wkoll sezzjoni 5.1).
English: The most frequent side effects of INTELENCE are rash, diarrhoea, nausea, and headache (see section ‘4.
Maltese: L-effetti sekondarji ta' INTELENCE l-iktar frekwenti huma raxx, dijarrea, nawsija, u uġigħ ta' ras (ara sezzjoni ‘4.
English: Note: Imputations according to the TLOVR algorithm (TLOVR = Time to Loss of Virologic Response)
Maltese: Nota: Imputazzjonijiet skont l-alogaritmu TLOVR (TLOVR = Ħin għan-nuqqas ta' rispons viroloġiku)
English: Your doctor will have to check your blood - fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole (medicines to treat fungal infections) - clarithromycin, rifabutin (antibiotics) - artemether/lumefantrine (a medicine to treat malaria) - diazepam (medicines to treat trouble with sleeping and/or anxiety) - dexamethasone (a corticosteroid used in a variety of conditions such as inflammation and allergic reactions) - boceprevir (a medicine to treat hepatitis C infection) - atorvastatin, fluvastatin, lovastatin, rosuvastatin, simvastatin (cholesterol-lowering medicines) - cyclosporine, sirolimus, tacrolimus (immunosuppressants - medicines used to dampen down your immune system) - sildenafil, vardenafil, tadalafil (medicines to treat erectile dysfunction and/or pulmonary arterial hypertension) - clopidogrel (a medicine to prevent blood clots).
Maltese: - fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole (mediċini biex jitrattaw infezzjonijiet fungali) - clarithromycin, rifabutin (antibijotiċi) - artemether/lumefantrine (mediċina biex tikkura l-malarja) - diazepam (mediċini li jitrattaw problemi ta' rqad u/jew ansjetà) - dexamethasone (kortikosterojdi li jintużaw f'firxa ta' kundizzjonijiet bħal infjammazzjoni u reazzjonijiet allerġiċi) - boceprevir (mediċina biex tikkura infezzjoni tal-epatite Ċ) - atorvastatin, fluvastatin, lovastatin, rosuvastatin, simvastatin (mediċini li jbaxxu l-kolesterol) - cyclosporine, sirolimus, tacrolimus (immunosoppressanti- mediċini użati biex itaffu l-qawwa tas-sistema immuni tiegħek) - sildenafil, vardenafil, tadalafil (mediċini li jitrattaw anormalità fil-funzjoni erettili u/jew pressjoni għolja arterjali u pulmonari) - clopidogrel (mediċina li tevita li jiffurmaw biċciet ta' demm magħqud).
English: The clinical data do not raise safety concern but are very limited.
Maltese: Id-data klinika ma jqanqlux tħassib dwar is-sigurtà iżda huma limitati ħafna.
English: Therefore, INTELENCE is not recommended in patients with severe hepatic impairment (see sections 4.4 and 5.2).
Maltese: Għalhekk INTELENCE mhux irrakkomandat f'pazjenti b'indeboliment epatiku qawwi (ara sezzjonijiet 4.4 u 5.2).
English: Paediatric population (6 years to less than 18 years of age)
Maltese: Popolazzjoni pedjatrika (minn età ta' 6 snin sa inqas minn 18-il sena)
English: NARCOTIC ANALGESICS Methadone individual dose ranging from 60 mg to 130 mg once daily
Maltese: Doża individwali filmarġini bejn 60 mg u 130 mg darba kuljum
English: Virologic responses (ITT - TLOVR), change from baseline in log10 viral load (NC = F), and change from baseline in CD4 percentage and cell count (NC = F) at week 24 in the TMC125-C213 and pooled DUET studies
Maltese: Tabella 6: Risponsi viroloġiċi (ITT - TLOVR), bidla fit-tagħbija viroloġika log10 mill-linja bażi (NC = F), u bidla fil-persentaġġ CD4 u għadd taċ-ċelluli mill-linja bażi (NC = F) f'ġimgħa 24 fl-istudji TMC125-C213 u DUET miġbura
English: Each tablet contains 40 mg lactose (as monohydrate).
Maltese: Kull pillola fiha 40 mg lactose (bħala monohydrate).
English: AUC12h (ng•h/ml) Geometric Mean ± Standard Deviation Median (Range) C0h (ng/ml) Geometric Mean ± Standard Deviation Median (Range) * All HIV-1 infected subjects enrolled in Phase III clinical trials received darunavir/ritonavir 600/100 mg twice daily as part of their background regimen.
Maltese: AUC12h (ng•h/ml) Medja Ġeometrika ± Devjazzjoni Standard Medjan (Firxa) C0h (ng/ml) Medja Ġeometrika ± Devjazzjoni Standard Medjan (Firxa) * L-individwi kollha infettati b'HIV-1 li pparteċipaw fil-provi kliniċi tal-fażi
English: Because 14-OH-clarithromycin has reduced activity against Mycobacterium avium complex (MAC), overall activity against this pathogen may be altered; therefore alternatives to clarithromycin should be considered for the treatment of MAC.
Maltese: Minħabba li 14-OH-clarithromycin għandu attività mnaqqsa kontra Mycobacterium avium complex (MAC), jista' jagħti l-każ illi l-attività ġenerali kontra dan il-patoġen tinbidel; għalhekk għandhom jiġu kkunsidrati alternattivi għal clarithromycin għattrattament ta' MAC
English: ≥ 1 log10 decrease from baseline at week 24, n (%)
Maltese: ≥ 1 log10 tnaqqis mill-linja bażi f'ġimgħa 24, n (%)
English: Table 8: Population pharmacokinetic estimates for etravirine (all doses combined) in treatment-experienced HIV-1 infected paediatric patients 6 years to less than 18 years of age (PIANO 48 week analysis)
Maltese: Tabella 8: Estimi farmakokinetiċi tal-popolazzjoni għal etravirine (dożi kollha kkumbinati) f'pazjenti pedjatriċi infettati b'HIV-1 li għandhom esperjenza ta' trattament minn eta' ta' 6 snin sa inqas minn 18-il sena (PIANO analiżi fil-ġimgħa 48) Parametru
English: It is not recommended to combine etravirine with tipranavir/ritonavir, due to a marked pharmacokinetic interaction (76% decrease of etravirine AUC) that could significantly impair the virologic response to etravirine.
Maltese: Mhuwiex irrakkomandat li tikkombina etravirine ma' tipranavir/ritonavir, minħabba interazzjoni farmakokinetika evidenti (tnaqqis ta' 76% tal-AUC ta' etravirine) li jista' jdgħajjef b'mod sinifikanti rrispons viroloġiku għal etraviine.
English: Tabulated list of adverse reactions
Maltese: Lista tar-reazzjonijiet avversi miġbura f'tabella
English: INTELENCE has only been used in a limited number of patients of 65 years or older.
Maltese: INTELENCE intuża f'numru limitat ta' pazjenti ta' 65 sena jew akbar.
English: A decreased virologic response to etravirine was observed in patients with viral strains harbouring 3 or more among the following mutations V90I, A98G, L100I, K101E/P, V106I, V179D/F, Y181C/I/V, and G190A/S (see section 5.1).
Maltese: Ġie nnutat tnaqqis fir-rispons viroloġiku għal etravirine f'pazjenti b'razez virali li fihom 3 jew iżjed mill-mutazzjonijiet li ġejjin V90I, A98G, L100I, K101E/P, V106I, V179D/F, Y181C/I/V, u G190A/S (ara sezzjoni 5.1).
English: 6 cells/l), mean (SE) and median (range) Change from baseline in CD4 percentage, median (range)
Maltese: 6 ċelluli/l), medju (SE) u medjan (firxa) Bidla fil-persentaġġ ta' CD4 mill-linja bażi, medjan (firxa)
English: Viral load < 400 copies/ml at week 24, n (%)
Maltese: Tagħbija virali < 400 kopji/ml f'ġimgħa 24, n (%)
English: Population pharmacokinetic analysis of etravirine in HIV infected patients indicated no apparent difference in the exposure to etravirine between Caucasian, Hispanic and Black subjects.
Maltese: Analiżi tal-farmakokinetika tal-popolazzjoni ta' etravirine f'pazjenti infettati bl-HIV ma indikatx differenzi apparenti fl-espożizzjoni għal etravirine bejn individwi Kawkasi, Ispaniċi u Suwed.
English: Confidence interval around observed difference of response rates; P-value < 0.0001 from logistic regression model, including stratification factors.
Maltese: Intervall ta' fiduċja madwar differenzi osservati tar-rati ta' rispons; Valur-P < 0.0001 minn mudell ta' rigressjoni loġistika, inkluż fatturi ta' stratifikazzjoni.
English: Dolutegravir + Lopinavir/ritonavir 50 mg once daily + 400/100 mg twice daily dolutegravir AUC ↓ 0.29 (0.26-0.34) Cmin ↓ 0.12 (0.09-0.16) Cmax ↓ 0.48 (0.43-0.54) etravirine
Maltese: Dolutegravir + Lopinavir/ritonavir 50 mg darba kuljum + 400/100 mg darbtejn kuljum dolutegravir AUC ↓ 0.29 (0.26-0.34) Cmin ↓ 0.
English: Pooled DUET Studies ≥ 18 years ETR N = 599
Maltese: Studji miġbura DUET ≥ 18-il sena ETR N=599
English: - The other ingredients are hypromellose, microcrystalline cellulose, colloidal anhydrous silica,
Maltese: - Is-sustanzi l-oħra huma hypromellose, microcrystalline cellulose, colloidal anhydrous silica,
English: Based on historical data, a decrease in etravirine exposure may be expected whereas an increase in rifabutin exposure and especially in 25-O-desacetyl-rifabutin may be expected.
Maltese: Minn data storika, jista' jkun mistenni tnaqqis flesponiment ta' etravirine filwaqt li tista' tkun mistennija żieda fl-esponiment għal rifabutin u speċjalment f'25-O-desactyl-rifabutin.
English: In the Phase III trials DUET-1 and DUET-2, mutations that developed most commonly in patients with virologic failure to the etravirine containing regimen were V108I, V179F, V179I, Y181C and Y181I, which usually emerged in a background of multiple other NNRTI resistance-associated mutations (RAMs).
Maltese: Fil-provi ta' Fażi III DUET-1 u DUET-2, mutazzjonijiet li żviluppaw l-iktar komuni f'pazjenti b'falliment viroloġiku għal reġimen li fih etravirine kienu V108I, V179F, V179I, Y181C u Y181I, li ġeneralment tfaċċaw fi sfond ta' mutazzjonijiet multipli oħrajn assoċjati ma' reżistenza għal NNRTI (RAMs).
English: Viral load < 50 copies/ml at week 24, n (%)
Maltese: Tagħbija virali < 50 kopji/ml f'ġimgħa 24, n (%)
English: It is not recommended to co-administer tipranavir/ritonavir and INTELENCE (see section 4.4).
Maltese: Mhux irrakkomandat li tipranavir/ritonavir jittieħed flimkien ma' INTELENCE (ara sezzjoni 4.4).
English: - The other ingredients are hypromellose, silicified microcrystalline cellulose, microcrystalline cellulose, colloidal anhydrous silica, croscarmellose sodium and magnesium stearate.
Maltese: - Is-sustanzi l-oħra huma hypromellose, silicified microcrystalline cellulose, microcrystalline cellulose, colloidal anhydrous silica, croscarmellose sodium and magnesium stearate.
English: Although etravirine demonstrates in vitro activity against wild type HIV-2 with median EC50 values ranging from 5.7 to 7.2 µM, treatment of HIV-2 infection with etravirine is not recommended in the absence of clinical data.
Maltese: Għalkemm etravirine juri attività in vitro kontra HIV-2 ta' tip selvaġġ b'medja ta' figuri ta' EC50 f'marġini bejn 5.7 u 7.2 μM, trattament tal-infezzjoni ta' HIV2 b'etravirine m'huwiex irrakkomandat fin-nuqqas ta' tagħrif kliniku.
English: In a postmarketing retrospective cohort study aiming at substantiating the long-term safety profile of etravirine in HIV-1-infected children and adolescents receiving etravirine with other HIV-1 antiretrovirals (N = 182), Stevens-Johnson Syndrome was reported at a higher incidence (1%) than has been reported in adult clinical trials (<0.1%).
Maltese: Fi studju retrospettiv ta' koorti wara t-tqegħid fis-suq li l-mira tiegħu kienet li jipprovdi evidenza biex juri l-profil ta' sigurtà fit-tul ta' etravirine fi tfal u adolexxenti infettati b'HIV-1 li kienu qed jirċievu etravirine flimkien ma' antiretrovirali oħra għall-HIV-1 (N = 182), is-Sindrome ta' Stevens-Johnson ġie rrappurtat b'inċidenza ogħla (1%) minn dak li ġie rrapputat fi provi kliniċi fl-adulti (< 0.1%).
English: PLATELET AGGREGGATION INHIBITORS Clopidogrel
Maltese: TAL-AGRREGAZZJONI TAL-PLEJTLITS Clopidogrel
English: Population pharmacokinetic analysis of the DUET-1 and DUET-2 trials showed reduced clearance (potentially leading to increased exposure and alteration of the safety profile) for etravirine in HIV-1 infected patients with hepatitis B and/or hepatitis C virus co-infection.
Maltese: Analiżi tal-farmakokinetika tal-popolazzjoni tal-provi DUET-1 u DUET-2 wrew tnaqqis fit-tneħħija ridotta (potenzjalment iwassal għal żieda fl-espożizzjoni u bidla fil-profil ta' sigurtà) għal etravirine f'pazjenti infettati kemm b'HIV-1 kif ukoll bil-virus tal-epatite B u/jew tal-epatite Ċ.
English: In all the other trials conducted with etravirine in HIV-1 infected patients, the following mutations emerged most commonly: L100I, E138G, V179F, V179I, Y181C and H221Y.
Maltese: Fil-provi l-oħrajn kollha magħmula b'etravirine f'pazjenti infettati b'HIV-1, tfaċċaw ilmutazzjonijiet segwenti l-iktar komuni: L100I, E138G, V179F, V179I, Y181C u H221Y.
English: Confidence interval around observed difference of response rates; P-value from CMH test controlling for stratification factors = 0.0199 for de novo, and < 0.0001 for not de novo.
Maltese: Intervall ta' fiduċja madwar differenzi osservati tar-rati ta' rispons; Valur-P minn test CMH jikkontrolla għall-fatturi ta' stratifikazzjoni = 0. 0199 għal de novo, u < 0.0001 għal mhux de novo.
English: • 1 or more NNRTI resistance-associated mutations (RAMs) at screening or from prior genotypic analysis (i.e., archived resistance)
Maltese: • mutazzjoni 1 jew iżjed assoċjata ma' reżistenza (RAMs) għal NNRTI waqt eżami jew minn analiżi ġenotipika preċedenti (i.e. reżistenza arkivjata)
English: Hepatitis B and/or hepatitis C virus co-infection
Maltese: Ko-infezzjoni ta' virus Epatite B u/jew Epatite C
English: CCR5 Antagonists Maraviroc 300 mg twice daily
Maltese: Antagonisti ta' CCR5 Maraviroc
English: The clinical data are limited and an increased risk of cutaneous reactions in patients with a history of NNRTI-associated cutaneous reaction cannot be excluded (see section 4.4).
Maltese: Id-data klinika hija limitata u żieda fir-riskju ta' reazzjonijiet fil-ġilda f'pazjenti bi storja ta' reazzjoni fil-ġilda assoċjata ma' NNRTI ma tistax tiġi eskluża (ara sezzjoni 4.4).
English: A subgroup analysis of the virologic response (defined as a viral load < 50 HIV-1 RNA copies/ml) at week 48 by baseline viral load and baseline CD4 count (pooled DUET data) is presented in table 4.
Maltese: Analiżi ta' sottogrupp tar-rispons viroloġiku (definit bħala tagħbija virali, < 50 kopja/ml ta' HIV1 RNA) f'ġimgħa 48 b'tagħbija virali ta' linja bażi u għadd CD4 ta' linja bażi (tagħrif DUET miġbur) huwa ppreżentat f'tabella 4.
English: It is recommended that the international normalised ratio (INR) be monitored when warfarin is combined with INTELENCE.
Maltese: Huwa rrakkomandat li lproporzjon normalizzat internazzjonali (international normalised ratio - INR) jiġi mmonitorjat meta warfarin jiġi kkombinat ma' INTELENCE.
English: Clarithromycin exposure was decreased by etravirine; however, concentrations of the active metabolite, 14-OH-clarithromycin, were increased.
Maltese: Espożizzjoni għal clarithromycin ġiet imnaqqsa b'etravirine; iżda, ilkonċentrazzjonijiet talmetabolit attiv, 14-OH-clarithromycin, żdiedu.
English: Janssen-Cilag SpA Tel: 800.688.777 / +39 02 2510 1 janssenita@its.jnj.com
Maltese: 688.777 / +39 02 2510 1 janssenita@its.jnj.com
English: The combination of INTELENCE with a boosted PI and rifabutin should be used with caution due to the risk of decrease in etravirine exposure and the risk of increase in rifabutin and 25-O-desacetyl-rifabutin exposures.
Maltese: Il-kombinazzjoni ta' INTELENCE b'PI msaħħaħ ma' rifabutin għandha tintuża b'kawtela minħabba r-riskju ta' tnaqqis ta' espożizzjoni ta' etravirine u r-riskju ta' żieda fl-espożizzjonijiet ta' rifabutin u ta' 25-O-desctylrifabutin.
English: Treatment of overdose with INTELENCE consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
Maltese: Trattament għal doża eċċessiva b'INTELENCE jikkonsisti f'miżuri ta' support ġenerali inkluż monitoraġġ tas-sinjali vitali u osservazzjoni tal-istat kliniku tal-pazjent.
English: Known and theoretical interactions with selected antiretrovirals and non-antiretroviral medicinal products are listed in table 1.
Maltese: Interazzjonijiet magħrufa jew tejoretiċi ma' ċerti antiretrovirali u prodotti mediċinali li m'humiex antiretrovirali huma elenkati f'tabella 1.
English: Paediatric population (6 years to less than 18 years of age) The pharmacokinetics of etravirine in 101 treatment-experienced HIV-1 infected paediatric patients, 6 years to less than 18 years of age and weighing at least 16 kg, showed that the administered weight-based dosages resulted in etravirine exposure comparable to that in adults receiving etravirine 200 mg twice daily (see sections 4.2 and 5.2) when administered at a dose corresponding to 5.2 mg/kg twice daily.
Maltese: Pazjenti pedjatriċi (minn eta' ta' 6 snin sa inqas minn 18-il sena) Il-farmakokinetika ta' etravirine f'101 pazjenti pedjatriċi infettati b'HIV-1 li għandhom esperjenza ta' trattament, minn eta' ta' 6 snin sa inqas minn 18-il sena u li jiżnu mill-inqas 16-il kg, wriet li d-dożi bbażati fuq il-piż li ngħataw irriżultaw f'esponiment ta' etravirine kumparabbli ma' dik fl-adulti li jirċievu etravirine 200 mg darbtejn kuljum (ara sezzjonijiet 4.2 u 5.2) meta mogħti f'doża li tikkorrespondi għal 5.2 mg/kg darbtejn kuljum.