FrancophonIA/ELRC3.0 huggingface dataset:
English: Etravirine (200 mg twice daily), evaluated in combination with other antiretroviral medicinal products in a study of 15 pregnant women during the second and third trimesters of pregnancy and postpartum, demonstrated that exposure to total etravirine was generally higher during pregnancy compared with postpartum, and less so for unbound etravirine exposure (see section 5.2).
Maltese: Etravirine (200 mg darbtejn kuljum), ivvalutat flimkien ma' prodotti mediċinali antiretrovirali oħra fi studju ta' 15-il mara tqila matul it-tieni u t-tielet trimestri tat-tqala u wara t-twelid, wera li l esponiment għal etravirine totali kien ġeneralment ogħla matul it-tqala meta mqabbel ma' wara ttwelid, u mhux daqshekk għoli għal esponiment għal etravirine mhux marbut (ara sezzjoni 5.2).
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal galactose, id-defiċjenza Lapp lactase jew assorbiment ħażin ta' glukożju-galattożju m'għandhomx jieħdu din il-mediċina.
English: Lovastatin, rosuvastatin and simvastatin are CYP3A4 substrates and co-administration with etravirine may result in lower plasma concentrations of the HMG Co-A reductase inhibitor.
Maltese: Lovastatin, rosuvastatin u simvastatin huma substrati ta' CYP3A4 u t-teħid tagħhom flimkien ma' etravirine jista' jwassal għal konċentrazzjonijiet fil-plażma iktar baxxi talimpeditur ta' HMG Co-A reductase.
English: It is recommended that digoxin levels be monitored when digoxin is combined with INTELENCE.
Maltese: INTELENCE u digoxin jistgħu jintużaw mingħajr aġġustament fid-doża.
English: Table 7: Population pharmacokinetic estimates of etravirine 200 mg twice daily in HIV-1 infected adult subjects (integrated data from Phase III trials at week 48)*
Maltese: Estimi farmakokinetiċi tal-popolazzjoni għal etravirine 200 mg darbtejn kuljum f'individwi adulti infettati b'HIV-1 (data integrata minn provi tal-fażi
English: Each tablet contains 160 mg of lactose monohydrate.
Maltese: Kull pillola fiha 160 mg ta' lactose monohydrate.
English: Immune system disorders common drug hypersensitivity uncommon immune reconstitution syndrome
Maltese: Disturbi fis-sistema immuni komuni sensittività eċċessiva għall-mediċina mhux komuni sindrome tar-rikostituzzjoni tas-sistema immuni
English: Cases of severe hypersensitivity syndromes, including DRESS (Drug Rash with Eosinophilia and Systemic Symptoms) and TEN (toxic epidermal necrolysis), sometimes fatal, have been reported with the use of etravirine (see section 4.8).
Maltese: Każijiet ta' sindromi ta' sensittività eċċessiva qawwija, li jinkludu DRESS (Raxx ikkawżat millMediċina b'Eosinofilja u Sintomi Sistemiċi) u TEN (nekroliżi epidermali tossika), xi kultant fatali, ġew irrapportati bl-użu ta' etravirine (ara sezzjoni 4.8).
English: Geometric Mean ± Standard Deviation Median (Range)
Maltese: Medja Ġeometrika ± Devjazzjoni Standard Medjan (Firxa)
English: Ear and labyrinth disorders uncommon vertigo
Maltese: Disturbi fl-widnejn u fis-sistema labirintika mhux komuni vertigo
English: The terminal elimination half-life of etravirine was approximately 30-40 hours.
Maltese: Il-half-life taleliminazzjoni terminali ta' etravirine kienet madwar 30-40 siegħa.
English: INTELENCE 25 mg tablets etravirine
Maltese: INTELENCE pilloli 25 mg etravirine
English: The type and incidence of adverse reactions in patients > 55 years of age were similar to the ones in younger patients (see sections 4.2 and 5.2).
Maltese: It-tip u inċidenza ta' reazzjonijiet avversi f'pazjenti ta' età > 55 sena kienu simili għal dawk ta' pazjenti iżgħar (ara sezzjonijiet 4.2 u 5.2)
English: Do not take INTELENCE - if you are allergic to etravirine or any of the other ingredients of this medicine (listed in section 6) - if you are taking elbasvir/grazoprevir (a medicine to treat hepatitis C infection).
Maltese: Tiħux INTELENCE - jekk inti allerġiku għal etravirine jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis sezzjoni 6) - jekk inti qed tieħu elbasvir/grazoprevir (mediċina biex titratta infezzjoni tal-epatite Ċ).
English: Etravirine 200 mg twice daily postpartum N = 10
Maltese: Etravirine 200 mg darbtejn kuljum fit et trimestru N = 10
English: Tablet White to off-white, oval tablet debossed with “T125” on one side and “100” on the other side.
Maltese: Pillola Pillola bajda tagħti fl-offwajt, ovali b'“T125” imnaqqxa fuq naħa u “100” fuq in-naħa l-oħra.
English: Table 5: Proportion of subjects with < 50 HIV-1 RNA copies/ml at week 48 by baseline number of etravirine RAMs in the non-viral failure excluded population of pooled DUET-1 and DUET-2 trials Baseline number of Etravirine RAMs*
Maltese: Proporzjon ta' individwi b'< 50 kopja/ml ta' HIV-1 RNA f'ġimgħa 48 skont innumru ta' RAMs ta' etravirine fil-linja bażi fil-popolazzjoni fejn huwa eskluż falliment mhux virali ta' provi miġbura fi DUET-1 u DUET-2 Numru ta' RAMs ta' Etravirine fil-linja bażi*
English: As a general rule, it is recommended that mothers infected by HIV do not breastfeed their babies under any circumstances in order to avoid transmission of HIV.
Maltese: Bħala regola ġenerali, huwa rakkomandat li ommijiet infettati bl-HIV ma jreddgħux lit-trabi tagħhom taħt l-ebda ċirkostanza sabiex jiġi evitat li l-HIV jiġi trasmess.
English: The evidence of efficacy of etravirine is based on 48-week data from 2 Phase III trials DUET-1 and DUET-2.
Maltese: L-evidenza tal-effikaċja ta' etravirine hija bbażata fuq tagħrif ta' 48 ġimgħa minn 2 provi tal-Fażi III DUET-1 u DUET-2.
English: This difference between treatment arms was statistically significant.
Maltese: Din iddifferenza bejn il-fergħat ta' trattament kienet statistikament sinifikanti.
English: Each tablet contains less than 1 mmol sodium (23 mg), and is essentially sodium-free.
Maltese: Kull pillola fiha inqas minn 1 mmol sodium (23 mg), u hija essenzjalment mingħajr sodium.
English: In a study comparing 8 patients with mild (Child-Pugh Class A) hepatic impairment to 8 matched controls and 8 patients with moderate (Child-Pugh Class B) hepatic impairment to 8 matched controls, the multiple dose pharmacokinetic disposition of etravirine was not altered in patients with mild to moderate hepatic impairment.
Maltese: Fi studju li qabbel 8 pazjenti b'indeboliment tal-fwied ħafif (Child-Pugh Klassi A) ma' 8 kontrolli mqabbla u 8 pazjenti b'indeboliment tal-fwied moderat (Child-Pugh Klassi B) ma' 8 kontrolli mqabbla, id-dispożizzjoni farmakokinetika għal doża multipla ta' etravirine ma nbidlitx f'pazjenti b'indeboliment tal-fwied ħafif għal moderat.
English: Etravirine arms N = 549
Maltese: Fergħat ta' etravirine N=549
English: Tell your doctor if you take: - dolutegravir, maraviroc, amprevanir/ritonavir and fosamprenavir/ritonavir (anti-HIV medicine) - amiodarone, bepridil, digoxin, disopyramide, flecainide, lidocaine, mexiletine, propafenone and quinidine (medicines to treat certain heart disorders, e.g., abnormal heart beat) - warfarin (a medicine used to reduce clotting of the blood).
Maltese: Għid lit-tabib tiegħek jekk qed tieħu: - dolutegravir, maraviroc, amprenavir/ritonavir u fosamprenavir/ritonavir (mediċini kontra l-HIV) - amiodarone, bepridil, digoxin, disopyramide, flecainide, lidocaine, mexiletine, propafenone u quinidine (mediċini li jitrattaw ċerti disturbi tal-qalb, eż. taħbit tal-qalb mhux normali - warfarin (mediċina li tintuża sabiex tnaqqas l-emboli tad-demm).
English: The incidence of rash was higher in women compared to men in the etravirine arm in the DUET trials (rash ≥ grade 2 was reported in 9/60 [15.0%] women versus 51/539 [9.5%] men; discontinuations due to rash were reported in 3/60 [5.0%] women versus 10/539 [1.9%] men) (see section 4.4).
Maltese: L-inċidenza tar-raxx kienet ogħla fin-nisa meta mqabbla mal-irġiel fil-fergħa ta' etravirine fil-provi DUET (raxx ≥ grad 2 ġie rrappuratat f'9/60 [15.0%] mara versus 51/539 [9.5%] raġel; twaqqif minħabba raxx ġie irrappurtat fi 3/60 [5.0%] mara versus 10/539 [1.9%] raġel) (ara sezzjoni 4.4).
English: INTELENCE 100 mg tablets etravirine
Maltese: INTELENCE pilloli 100 mg etravirine
English: INTELENCE 200 mg tablets etravirine
Maltese: INTELENCE pilloli 200 mg etravirine
English: Renal impairment No dose adjustment is required in patients with renal impairment (see section 5.2).
Maltese: M'hemmx bżonn ta' aġġustament fid-doża f'pazjenti b'indeboliment renali (ara sezzjoni 5.2).
English: Table 9: Pharmacokinetic results of total etravirine after administration of etravirine 200 mg twice daily as part of an antiretroviral regimen, during the 2
Maltese: Riżultati farmakokinetiċi ta' etravirine totali wara għoti ta' etravirine 200 mg darbtejn kuljum bħala parti minn kors terapewtiku ta' antiretrovirali, matul it-2
English: Fluvastatin, and rosuvastatin are metabolised by CYP2C9 and co-administration with etravirine may result in higher plasma concentrations of the HMG Co-A reductase inhibitor.
Maltese: Fluvastatin u rosuvastatin huma metabolizzati minn CYP2C9 u t-teħid flimkien ma' etravirine jista' jwassal għal konċentrazzjonijiet fil-plażma iktar għoljin tal-impeditur ta' HMG Co-A reductase.
English: Each tablet contains 40 mg of lactose monohydrate.
Maltese: Kull pillola fiha 40 mg ta' lactose monohydrate.
English: 40 mg once daily etravirine
Maltese: 40 mg darba kuljum etravirine
English: INTELENCE is expected to decrease plasma concentrations of these antiarrhythmics.
Maltese: INTELENCE huwa mistenni li jnaqqas il-konċentrazzjonijiet fil-plażma ta' dawn l-antiarritmiċi.
English: The systemic exposure (AUC) to etravirine was decreased by about 50% when etravirine was administered under fasting conditions, as compared to administration following a meal.
Maltese: L-espożizzjoni sistemika (AUC) għal etravirine tnaqqset b'50% meta etravirine ingħata taħt kundizzjonijiet ta' sawm, meta mqabbel ma' teħid wara ikla.
English: Co-infection with HBV (hepatitis B virus) or HCV (hepatitis C virus) Caution should be exercised in patients co-infected with hepatitis B or C virus due to the current limited data available.
Maltese: Ko-infezzjoni ma' HBV (virus epatite B) jew HCV (virus epatite C) Għandha tintuża l-kawtela f'pazjenti ko-infettati bil-virus epatite B jew C peress illi t-tagħrif attwali disponibbli huwa limitat.
English: * based on population pharmacokinetic analyses
Maltese: * ibbażat fuq analiżi tal-farmakokinetika talpopolazzjoni
English: INTELENCE and saquinavir/ritonavir can be used without dose adjustments.
Maltese: INTELENCE u saquinavir/ritonavir jistgħu jintużaw mingħajr aġġustament fid-doża.
English: Therefore, the pharmacokinetic parameter estimates shown in the table account for reductions in the pharmacokinetic parameters of etravirine due to co-administration of etravirine with darunavir/ritonavir.
Maltese: Għalhekk, l-estimi tal-parametri farmakokinetiċi li jidhru fittabella jagħtu kont ta' tnaqqis fil-parametri farmakokinetiċi ta' etravirine minħabba co-amministrazzjoni ta' etravirine ma' darunavir/ritonavir.
English: Vascular disorders common hypertension rare haemorrhagic stroke
Maltese: Disturbi vaskulari komuni pressjoni għolja rari puplesija emorraġika
English: Baseline genotype or phenotype and virologic outcome analyses In DUET-1 and DUET-2, the presence at baseline of 3 or more of the following mutations: V90I, A98G, L100I, K101E, K101P, V106I, V179D, V179F, Y181C, Y181I, Y181V, G190A and G190S, (etravirine RAMs) was associated with a decreased virologic response to etravirine (see table 5).
Maltese: V90I, A98G, L100I, K101E, K101P, V106I, V179D, V179F, Y181C, Y181I, Y181V, G190A u G190S, (RAMs ta' etravirine) kienet assoċjata ma' tnaqqis tar-rispons viroloġiku għal etravirine (ara ttabella 5).
English: Exploratory head to head comparison with protease inhibitor in protease inhibitor naïve patients (trial TMC125-C227)
Maltese: Paragun esploratorju ras għal ras b'impeditur ta' protease f'pazjenti li ma jafux li qed jieħdu impedituri ta' protease (prova TMC 125-C227)
English: The recommended dose of etravirine for adults is 200 mg (one 200 mg tablet or two 100 mg tablets) taken orally twice daily following a meal (see section 5.2).
Maltese: Id-doża rrakomandata ta' etravirine għall-adulti hija ta' 200 mg (pillola waħda ta' 200 mg jew żewġ pilloli ta' 100 mg) li jittieħdu mill-ħalq darbtejn kuljum wara ikla (ara sezzjoni 5.2).
English: Proportion of subjects with HIV-1 RNA < 50 copies/ml at week 48
Maltese: Proporzjon ta' individwi b'HIV-1 RNA < 50 kopja/ml f'ġimgħa 48
English: At week 12, virologic response was greater in the control-PI arm (-2.2 log10 copies/ml from baseline; n = 53) compared to the etravirine arm (-1.4 log10 copies/ml from baseline; n = 40).
Maltese: F'ġimgħa 12, ir-rispons viroloġiku kien ogħla fil-fergħa ta' kontroll-PI (-2.2 log10 kopji/ml mil-linja bażi; n=53) meta mqabbel mal-fergħa ta' etravirine (-1.4 log10 kopji/ml mill-linja bażi; n=40).
English: The clinical significance of the reductions in etravirine pharmacokinetic parameters and boceprevir Cmin in the setting of the combination therapy with HIV antiretroviral medicines which also affect the pharmacokinetics of etravirine and/or boceprevir has not been directly assessed.
Maltese: Is-sinifikat kliniku fit-tnaqqis tal-parametri farmakokinetiċi ta' etravirine u s-Cmin ta' boceprevir fil-qafas tatterapija ta' kombinazzjoni b'mediċini antiretrovirali ta' HIV li jaffettwaw ukoll ilfarmakokinetiċi ta' etravirine u/jew boceprevir ma ġewx analizzati b'mod dirett.
English: HIV infected mothers must not breast-feed, as there is a possibility of infecting the baby with HIV.
Maltese: Nisa infettati bl-HIV m'għandhomx ireddgħu, peress illi hemm il-possibbilità li t-tarbija tiġi infettata bl-HIV.
English: Uncommon side effects (may affect up to 1 in 100 people) - decreased number of white blood cells; - symptoms of infection (for example enlarged lymph nodes and fever); - abnormal dreams, confusion, disorientation, nervousness, nightmares; - drowsiness, trembling, fainting, seizures, disturbance in attention; - dizziness, sluggishness; - angina, irregular heart rhythm; - difficulty breathing; - retching, inflammation of the pancreas, vomiting blood; - liver problems such as hepatitis, enlarged liver; - excessive sweating, swelling of the face and/or throat; - swelling of breasts in men.
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa persuna waħda minn kull 100) - tnaqqis fin-numru ta' ċelluli bojod tad-demm; - sintomi ta' infezzjoni (per eżempju għoqod tal-limfa minfuħa u deni); - ħolm mhux normali, konfużjoni, diżorjentament, nervi, ħmar il-lejl; - ħedla tan-ngħas, rogħda, ħass ħażin, aċċessjonijiet, disturb fl-attenzjoni; - sturdament, indolenza; - anġina, ritmu tal-qalb irregolari; - diffikultà biex tieħu n-nifs; - tqalligħ, infjammazzjoni tal-frixa, tirremetti d-demm; - problemi fil-fwied bħal epatite, tkabbir fil-fwied; - ħruġ eċċessiv ta' għaraq, nefħa tal-wiċċ u/ jew griżmejn; - nefħa tas-sider fl-irġiel.
English: Baseline characteristics Median plasma HIV-1 RNA 4.8 log10copies/ml
Maltese: Bidla medja ta' HIV-1 RNA log10 mil-linja bażi (log10 kopji/ml)
English: As etravirine is highly bound to plasma proteins, it is unlikely that it will be significantly removed by haemodialysis or peritoneal dialysis (see section 4.2).
Maltese: Peress illi etravirine huwa marbut ħafna mal-proteina tal-plażma, huwa improbabbli li jitneħħa b'mod sinifikanti permezz tal-emodijalisi jew dijalisi tal-peritonew (ara sezzjoni 4.2).
English: With no associated boosted PI (out of the recommended indication for etravirine): rifabutin
Maltese: Mingħajr PI msaħħaħ assoċjat (barra millindikazzjoni indikata għal etravirine): rifabutin
English: INTELENCE has not been studied in patients with severe hepatic impairment (Child-Pugh Class C) and is therefore not recommended (see sections 4.2 and 4.4).
Maltese: INTELENCE ma ġiex studjat f'pazjenti b'indeboliment tal-fwied qawwi (Child-Pugh Klassi C) u għalhekk mhuwiex irrakkomandat (ara sezzjonijiet 4.2 u 4.4)
English: INTELENCE and atazanavir/ritonavir can be used without dose adjustment.
Maltese: INTELENCE u atazanavir/ritonavir jistgħu jintużaw mingħajr aġġustament fid-doża.
English: INTELENCE is a medicine used for the treatment of Human Immunodeficiency Virus (HIV) infection.
Maltese: INTELENCE huwa mediċina li tintuża għat-trattament tal-infezzjoni tal-virus tal-Immunodefiċjenza umana (HIV).
English: Etravirine is expected to increase plasma concentrations of warfarin.
Maltese: Etravirine huwa mistenni li jżid il-konċentrazzjonijiet fil-plażma ta' warfarin.
English: nd trimester of pregnancy as compared to postpartum, and 1.1-, 1.4- and 1.2-fold higher, respectively, based during the 3
Maltese: ni trimestru tat-tqala meta mqabbel ma' wara t-twelid, u 1.1, 1.4 u 1.2 drabi aktar, rispettivament, abbażi ta' matul it-3
English: No significant effect on tenofovir and etravirine PK parameters is seen.
Maltese: Ma ntwerewx effetti sinifikanti fuq ilfarmakokinetika ta'tenofovir u etravirine.
English: Patients co-infected with hepatitis B and/or hepatitis C virus In the pooled analysis for DUET-1 and DUET-2, the incidence of hepatic events tended to be higher in co-infected subjects treated with etravirine compared to co-infected subjects in the placebo group.
Maltese: Fl-analiżi miġbura għal DUET-1 u DUET-2, kien hemm tendenza għal żieda fl-inċidenza ta' avvenimenti epatiċi f'individwi ko-infettati trattati b'etravirine meta mqabbel ma' individwi koinfettati fil-grupp tal-plaċebo.
English: AUC ↓ 0.77 (0.66-0.91) Cmax ↓ 0.76 (0.68-0.85) Cmin ↓ 0.71 (0.54-0.95)
Maltese: 77 (0.66-0.91) Cmax ↓ 0.76 (0.68-0.85) Cmin ↓ 0.71 (0.54-0.95)
English: HIV Protease Inhibitors (PIs) - Unboosted (i.e. without co-administration of low-dose ritonavir) Indinavir
Maltese: Inibituri tal-Protease (PIs- Protease Inhibitors) tal-HIV - Mhux msaħħa (i.e.mingħajr ko-amministrazzjoni ta' ritonavir ta' doża baxxa)
English: Note: all patients in the DUET trials received a background regimen consisting of darunavir/rtv, investigator-selected NRTIs and optional enfuvirtide.
Maltese: Nota: il-pazjenti kollha fil-provi DUET irċevew reġimen ta' sfond li jikkonsisti f'darunavir/rtv, NRTIs magħżula millinvestigatur u enfuvirtide fakultattiv.
English: AUC ↓ 0.83 (0.75-0.94) Cmin ↓ 0.76 (0.66-0.87) Cmax ↓ 0.90 (0.78-1.03) 25-O-desacetyl-rifabutin AUC ↓ 0.83 (0.74-0.92) Cmin ↓ 0.78 (0.70-0.87) Cmax ↓ 0.85 (0.72-1.00) etravirine
Maltese: AUC ↓ 0.83 (0.75-0.94) Cmin ↓ 0.76 (0.66-0.87) Cmax ↓ 0.90 (0.78-1.03) 25-O-desacetyl-rifabutin AUC ↓ 0.83 (0.
English: Enfuvirtide concentrations not studied and no effect is expected.
Maltese: Konċentrazzjonijiet ta' enfuvirtide ma ġewx studjati u mhux mistennija effetti.
English: Nederland Janssen-Cilag B.V. Tel: +31 76 711 1111 janssen@jacnl.jnj.com
Maltese: Tel: +31 76 711 1111 janssen@jacnl.jnj.com
English: Concomitant systemic use of itraconazole or ketoconazole and etravirine may increase plasma concentrations of etravirine.
Maltese: Użu sistemiku konkomittanti ta' itraconazole jew ketoconazole u etravirine jistgħu jżidu l-konċentrazzjonijiet fil-plażma ta' etravirine.
English: Unchanged etravirine accounted for 81.2% to 86.4% of the administered dose in faeces.
Maltese: 2% sa 86.4% tad-doża meħuda fl-ippurgar.
English: Since there was a significant interaction effect between treatment and ENF, the primary analysis was done for 2 ENF strata (patients reusing or not using ENF versus patients using ENF de novo).
Maltese: Peress illi kien hemm effett ta' interazzjoni sinifikanti bejn it-trattament u ENF, l-analiżi primarja saret għal 2 strata ENF (pazjenti li reġgħu użaw jew mhux jużaw ENF kontra pazjenti li jużaw ENF de novo).
English: C-etravirine dose, 93.7% and 1.2% of the administered dose of C-etravirine could be retrieved in faeces and urine, respectively.
Maltese: C-etravirine radjutikkettata, 93.7% u 1.2% tad-doża meħuda ta'
English: Change from baseline in log10 viral load (copies/ml) at week 24, mean (SE) and median (range)
Maltese: Bidla fit-tagħbija virali log10 mill-linja bażi (kopji/ml) f'ġimgħa 24, medju (SE) u medjan (firxa)
English: Fusion Inhibitors Enfuvirtide 90 mg twice daily etravirine*
Maltese: 90 mg darbtejn kuljum etravirine*
English: The recommended dose for maraviroc when combined with INTELENCE and a PI is 150 mg twice daily, except for fosamprenavir/ritonavir which is not recommended with maraviroc.
Maltese: Id-doża rrakkomandata ta' maraviroc meta kkombinata ma' INTELENCE u PI hija 150 mg darbtejn kuljum, ħlief għal fosamprenavir/ritonavir li mhuwiex irrakkomandat ma' maraviroc.
English: Cmax ↓ 0.55 (0.40-0.75) N-desmethyl-sildenafil AUC ↓ 0.59 (0.52-0.68) Cmin ND
Maltese: N-desmethyl-sildenafil AUC ↓ 0.59 (0.52-0.68) Cmin ND
English: Conclusions regarding the relevance of particular mutations or mutational patterns are subject to change with additional data, and it is recommended to always consult current interpretation systems for analysing resistance test results.
Maltese: Konklużjonijiet dwar ir-rilevanza ta' mutazzjonijiet partikolari jew tendenzi ta' mutazzjoni huma soġġetti għal bdil b'informazzjoni addizzjonali, u huwa rrakkomandat li dejjem jiġu kkonsultati sistemi ta' interpretazzjoni attwali sabiex wieħed janalizza riżultati ta' testijiet ta' reżistenza.
English: The DRESS syndrome is characterised by rash, fever, eosinophilia and systemic involvement (including, but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis and eosinophilia).
Maltese: Is-sindromu DRESS huwa kkaratterizzat minn raxx, deni, eosinofilja u involviment sistemiku (li jinkludi, iżda mhuwiex limitat għal, raxx qawwi jew raxx flimkien ma' deni, sensazzjoni ġenerali li ma tħossokx tajjeb, għeja kbira, uġigħ fil-muskoli u filġogi, infafet, feriti fil-ħalq, konġuntivite, epatite u eosinofilja).
English: The median baseline plasma HIV-1 RNA was 3.9 log10 copies/ml, and the median baseline CD4 cell count was 385 x 10
Maltese: It-tagħbija medja ta' HIV-1 RNA fil-plażma fil-linja bażi kienet 3.9 log10 kopji/ml, u l-għadd medju taċ-ċelluli CD4 fil-linja bażi kien ta' 385 x 10
English: Itraconazole and ketoconazole are potent inhibitors as well as substrates of CYP3A4.
Maltese: Itraconazole u ketoconazole huma impedituri qawwija kif ukoll substrati ta' CYP3A4.
English: Etravirine binds directly to reverse transcriptase (RT) and blocks the RNA-dependent and DNA-dependent DNA polymerase activities by causing a disruption of the enzyme's catalytic site.
Maltese: Etravirine jintrabat direttament mar-reverse transcriptase (RT) u jimblokka l-attivitajiet tad-DNA polymerase, li huma
English: Immune reconstitution syndrome
Maltese: Sindromu tar-rikostituzzjoni immuni
English: Excipient with known effect Each tablet contains less than 1 mmol sodium (23 mg), and is essentially sodium-free.
Maltese: Eċċipjent b'effett magħruf Kull pillola fiha inqas minn 1 mmol sodium (23 mg), u hija essenzjalment mingħajr sodium.
English: Comparison based on historic control.
Maltese: Paragun ibbażat fuq kontroll storiku.
English: Close monitoring of antimalarial response is warranted when co-administering INTELENCE and artemether/lumefantrine as a significant decrease in exposure of artemether and its active metabolite, dihydroartemisinin, may result in decreased antimalarial efficacy.
Maltese: Huwa rrakkomandat monitoraġġ mill-qrib tarrispons antimalarju meta INTELENCE u artemether/lumefantrine jingħataw flimkien għaliex tnaqqis fl-esponiment ta' artemether u/jew il-metabolit attiv tiegħu dihydroartemisinin li ġie osservat, jista' jirriżulta fi tnaqqis fl-effikaċja antimalarju.
English: Treatment-experienced paediatric patients (6 years to less than 18 years of age) PIANO is a single-arm, Phase II trial evaluating the pharmacokinetics, safety, tolerability, and efficacy of etravirine in 101 antiretroviral treatment-experienced HIV-1 infected paediatric patients 6 years to less than 18 years of age and weighing at least 16 kg.
Maltese: II, ta' fergħa waħda li tevalwa l-farmakokinetika, sigurtà, tolerabilità, u leffikaċja ta' etravirine f'101 pazjenti pedjatriċi infettati b'HIV-1 li għandhom esperjenza ta' trattament antiretrovirali minn eta' ta' 6 snin sa inqas minn 18-il sena u li jiżnu mill-inqas 16-il kg.