FrancophonIA/ELRC3.0 huggingface dataset:
English: Rilpivirine exhibited activity against laboratory strains of wild-type HIV-1 in an acutely infected T-cell line with a median EC50 value for HIV-1/IIIB of 0.73 nM (0.27 ng/ml).
Maltese: Rilpivirine wera attività kontra razez ta' HIV-1 tal-laboratorju li jinsabu fin-natura f'linja ta' ċelluli T infettati b'mod akut b'valur EC50 medjan għal HIV-1/IIIB ta' 0.73 nM (0.27 ng/ml).
English: There is limited information available on the potential for a pharmacodynamic interaction between rilpivirine and medicinal products that prolong the QTc interval of the ECG.
Maltese: Hemm informazzjoni limitata disponibbli dwar il-possibbiltà ta' interazzjoni farmakodinamika bejn rilpivirine u prodotti mediċinali li jtawlu l-intervall QTc tal-ECG.
English: 300 mg once daily tenofovir AUC ↑ 23% tenofovir Cmin ↑ 24% tenofovir Cmax ↑ 19% rilpivirine AUC ↔ rilpivirine Cmin ↔ rilpivirine Cmax ↔
Maltese: 300 mg darba kuljum tenofovir AUC ↑ 23% tenofovir Cmin ↑ 24% tenofovir Cmax ↑ 19% rilpivirine AUC ↔ rilpivirine Cmin ↔ rilpivirine Cmax ↔
English: Resistance to rilpivirine % (n/N)
Maltese: Reżistenza għal rilpivirine % (n/N)
English: Although rilpivirine demonstrated limited in vitro activity against HIV-2 with EC50 values ranging from 2,510 to 10,830 nM (920 to 3,970 ng/ml), treatment of HIV-2 infection with rilpivirine is not recommended in the absence of clinical data.
Maltese: Għalkemm rilpivirine wera attività limitata in vitro kontra HIV-2 b'valuri EC50 fuq medda bejn 2,510 u 10,830 nM (920 sa 3,970 ng/ml), il-kura tal-infezzjoni ta' HIV-2 b'rilpivirine mhijiex rakkomandata fin-nuqqas ta' dejta klinika.
English: Each carton contains one bottle of 30 tablets.
Maltese: Kull kartuna fiha flixkun wieħed ta' 30 pillola.
English: Lopinavir/ritonavir (soft gel capsule)* 400/100 mg twice daily lopinavir AUC ↔ lopinavir Cmin ↓ 11% lopinavir Cmax ↔ rilpivirine AUC ↑ 52% rilpivirine Cmin ↑ 74% rilpivirine Cmax ↑ 29%
Maltese: Lopinavir/ritonavir (kapsula ratba tal-ġel)* 400/100 mg darbtejn kuljum lopinavir AUC ↔ lopinavir Cmin ↓ 11% lopinavir Cmax ↔ rilpivirine AUC ↑ 52% rilpivirine Cmin ↑ 74% rilpivirine Cmax ↑ 29%
English: Rifampicin* 600 mg once daily rifampicin AUC ↔ rifampicin Cmin NA rifampicin Cmax ↔ 25-desacetyl-rifampicin AUC ↓ 9% 25-desacetyl-rifampicin Cmin NA 25-desacetyl-rifampicin Cmax ↔ rilpivirine AUC ↓ 80% rilpivirine Cmin ↓ 89% rilpivirine Cmax ↓ 69%
Maltese: Rifampicin* 600 mg darba kuljum rifampicin AUC ↔ rifampicin Cmin NA rifampicin Cmax ↔ 25-desacetyl-rifampicin AUC ↓ 9% 25-desacetyl-rifampicin Cmin NA 25-desacetyl-rifampicin Cmax ↔ rilpivirine AUC ↓ 80% rilpivirine Cmin ↓ 89% rilpivirine Cmax ↓ 69%
English: Selected treatment emergent clinical laboratory abnormalities (grade 3 or grade 4), considered as ADRs, reported in EDURANT treated patients were increased pancreatic amylase (3.8%), increased AST (2.3%), increased ALT (1.6%), increased LDL cholesterol (fasted, 1.5%), decreased white blood cell count (1.2%), increased lipase (0.9%), increased bilirubin (0.7%), increased triglycerides (fasted, 0.6%), decreased haemoglobin (0.1%), decreased platelet count (0.1%), and increased total cholesterol (fasted, 0.1%).
Maltese: Anormalitajiet kliniċi tal-laboratorju magħżula li jitfaċċaw minħabba t-trattament (ta' grad 3 jew grad 4), meqjusa bħala ADRs, irrappurtati f'pazjenti ttrattati b'EDURANT kienu żieda fl-amylase tal-frixa (3.8%), żieda fl-AST (2.3%), żieda fl-ALT (1.6%), żieda fil-kolesterol LDL (stat ta' sawm, 1.5%), tnaqqis fin-numru ta' ċelluli tad-demm bojod (1.2%), żieda fil-lipase (0.9%), żieda fil-bilirubin (0.7%), żieda fit-trigliċeridi (stat ta' sawm, 0.6%), żieda fl-emoglobina (0.1%), tnaqqis fl-għadd talplejtlits (0.1%), u żieda fil-kolesterol totali (stat ta' sawm, 0.1%).
English: ANALGESICS Paracetamol* 500 mg single dose paracetamol AUC ↔ paracetamol Cmin NA paracetamol Cmax ↔ rilpivirine AUC ↔ rilpivirine Cmin ↑ 26% rilpivirine Cmax ↔
Maltese: ANALĠEŻIĊI Paracetamol* Doża waħda ta' 500 mg paracetamol AUC ↔ paracetamol Cmin NA paracetamol Cmax ↔ rilpivirine AUC ↔ rilpivirine Cmin ↑ 26% rilpivirine Cmax ↔
English: Postpartum (6-12 Weeks) (n=11)
Maltese: Wara l-Ħlas (6-12-il Ġimgħa) (n=11)
English: The 36 subjects had a median age of 14.5 years (range: 12 to 17 years), and were 55.6% female, 88.9% Black and 11.1% Asian.
Maltese: Is-36 individwu kellhom medjan ta' età ta' 14.5 snin (firxa: minn 12 sa 17-il sena), u 55.6% kienu nisa, 88.9% kienu Suwed u 11.1%kienu Asjatiċi.
English: Established and theoretical interactions with selected antiretrovirals and non-antiretroviral medicinal products are listed in table 1.
Maltese: Interazzjonijiet stabbiliti u teoretiċi b'għażla ta' prodotti mediċinali antiretrovirali u mhux antiretrovirali huma elenkati fit-tabella 1.
English: (induction of CYP3A enzymes)
Maltese: (induzzjoni tal-enzimi CYP3A)
English: 40 mg once daily atorvastatin AUC ↔ atorvastatin Cmin ↓ 15% atorvastatin Cmax ↑ 35% rilpivirine AUC ↔ rilpivirine Cmin ↔ rilpivirine Cmax ↓ 9%
Maltese: 40 mg darba kuljum atorvastatin AUC ↔ atorvastatin Cmin ↓ 15% atorvastatin Cmax ↑ 35% rilpivirine AUC ↔ rilpivirine Cmin ↔ rilpivirine Cmax ↓ 9%
English: During the clinical development program (1,368 patients in the Phase III controlled trials TMC278-C209 (ECHO) and TMC278-C215 (THRIVE)), 55.7% of subjects experienced at least one adverse drug reaction (see section 5.1).
Maltese: Matul il-programm ta' żvilupp kliniku (1,368 pazjent fil-provi kkontrollati tal-Fażi III TMC278-C209 (ECHO) u TMC278-C215 (THRIVE)) 55.7% tal-individwi kellhom mill-anqas reazzjoni avversa waħda għall-mediċina (ara sezzjoni 5.1).
English: Trimester of pregnancy (n=13)
Maltese: 3 Trimestru ta' tqala (n=13)
English: Didanosine*
Maltese: Kollha*
English: 50 mg single dose sildenafil AUC ↔ sildenafil Cmin NA sildenafil Cmax ↔ rilpivirine AUC ↔ rilpivirine Cmin ↔ rilpivirine Cmax ↔
Maltese: Doża waħda ta' 50 mg sildenafil AUC ↔ sildenafil Cmin NA sildenafil Cmax ↔ rilpivirine AUC ↔ rilpivirine Cmin ↔ rilpivirine Cmax ↔
English: EDURANT should not be co-administered with the following medicinal products, as significant decreases in rilpivirine plasma concentrations may occur (due to CYP3A enzyme induction or gastric pH increase), which may result in loss of therapeutic effect of EDURANT (see section 4.5): - the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin - the antimycobacterials rifampicin, rifapentine - proton pump inhibitors, such as omeprazole, esomeprazole, lansoprazole, pantoprazole,
Maltese: EDURANT m'għandux jingħata flimkien mal-prodotti mediċinali li ġejjin minħabba li jista' jseħħ tnaqqis sinifikanti fil-konċentrazzjonijiet ta' rilpivirine fil-plażma (minħabba induzzjoni tal-enzima CYP3A jew żieda fil-pH tal-istonku), li tista' twassal għal telf tal-effett terapewtiku ta' EDURANT (ara sezzjoni 4.5): - l-antikonvulżivi carbamazepine, oxcarbazepine, phenobarbital, phenytoin - l-antimikobatteriċi rifampicin, rifapentine - l-impedituri tal-pompa tal-proton, bħalma huma omeprazole, esomeprazole, lansoprazole,
English: Other Antiviral Agents Ribavirin
Maltese: Sustanzi antivirali oħrajn Ribavirin
English: 800/100 mg once daily darunavir AUC ↔ darunavir Cmin ↓ 11% darunavir Cmax ↔ rilpivirine AUC ↑ 130% rilpivirine Cmin ↑ 178% rilpivirine Cmax ↑ 79%
Maltese: 800/100 mg darba kuljum darunavir AUC ↔ darunavir Cmin ↓ 11% darunavir Cmax ↔ rilpivirine AUC ↑ 130% rilpivirine Cmin ↑ 178% rilpivirine Cmax ↑ 79%
English: NN: {number} [national reimbursement number or other national number identifying the medicinal product]
Maltese: {numru} [numru tar-rimborż nazzjonali jew numru nazzjonali tal-identifikazzjoni ieħor għallprodott mediċinali]>
English: 6 cells/l in the rilpivirine arm and +219 × 10
Maltese: 6 ċelluli/l fil fergħa ta' rilpivirine u +219 x 10
English: At supra-therapeutic doses (75 and 300 mg once daily), rilpivirine has been associated with prolongation of the QTc interval of the electrocardiogram (ECG) (see sections 4.5, 4.8 and 5.2).
Maltese: F'dożi akbar mid-doża terapewtika (75 u 300 mg darba kuljum), rilpivirine kien assoċjat ma' intervall tal-QTc tal-elettrokardjogramma (ECG) imtawwal (ara sezzjonijiet 4.5, 4.8 u 5.2).
English: (inhibition of intestinal P-gp)
Maltese: (inibizzjoni ta' P-gp tal-intestini)
English: EDURANT contains rilpivirine that is used for the treatment of Human Immunodeficiency Virus (HIV) infection.
Maltese: EDURANT fih rilpivirine li jintuża għat-trattament ta' infezzjoni bil-Virus tal-Immunodefiċjenza Umana.
English: The most common ADRs (all grades, greater than or equal to 10%) were headache (19.4%), depression (19.4%), somnolence (13.9%), and nausea (11.1%).
Maltese: L-aktar ADRs komuni (il-gradi kollha, aktar minn jew ta' 10%) kienu uġigħ ta' ras (19.4%), depressjoni (19.4%), ħedla tan-ngħas (13.9%), u nawsja (11.1%).
English: ADRs reported in adult patients treated with rilpivirine are summarised in Table 2.
Maltese: L-ADRs irrappurtati f'pazjenti adulti kkurati b'rilpivirine huma mqassra fit-Tabella 2.
English: In a panel of 67 HIV-1 recombinant laboratory strains with one resistance-associated mutation at RT positions associated with NNRTI resistance, including the most commonly found K103N and Y181C, rilpivirine showed antiviral activity against 64 (96%) of these strains.
Maltese: Fi grupp ta' 67 razza tal-laboratorju rikombinanti ta' HIV-1 b'mutazzjoni waħda assoċjata ma' reżistenza fil-pożizzjonijiet RT assoċjati ma' reżistenza għal NNRTI, inkluż K103N u Y181C li jinstabu bl-aktar mod komuni, rilpivirine wera attività antivirali kontra 64 (96%) waħda minn dawn irrazez.
English: Metabolism and nutrition disorders very common increased total cholesterol (fasted) increased LDL cholesterol (fasted)
Maltese: Disturbi fil-metaboliżmu u nnutrizzjoni komuni ħafna żieda fil-kolesterol totali (stat ta' sawm) żieda fil-kolesterol LDL (stat ta' sawm)
English: EDURANT, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve patients 12 years of age and older with a viral load ≤ 100,000 HIV-1 RNA copies/ml.
Maltese: EDURANT, flimkien ma' prodotti mediċinali antiretrovirali oħra, huwa indikat għall-kura ta' infezzjoni bil-virus tat-tip 1 tal-immunodefiċjenza umana (HIV-1) f'pazjenti b'età ta' 12-il sena jew aktar li qatt ma ħadu kura antiretrovirali qabel b'tagħbija virali ta' ≤ 100,000 kopja/ml ta' RNA ta' HIV-1.
English: It is not recommended to combine EDURANT with other non-nucleoside reverse transcriptase inhibitors (NNRTIs) such as delavirdine, efavirenz, etravirine, and nevirapine.
Maltese: Mhuwiex rakkomandat li tħallat EDURANT ma' impedituri oħra ta' reverse transcriptase li mhumiex nucleoside (NNRTIs) bħalma huma delavirdine, efavirenz, etravirine, u nevirapine.
English: When supratherapeutic doses of 75 mg once daily and 300 mg once daily of rilpivirine were studied in healthy adults, the maximum mean time-matched (95% upper confidence bound) differences in QTcF interval from placebo after baseline correction were 10.7 (15.3) and 23.3 (28.4) ms, respectively.
Maltese: Meta kienu studjati dożi sopraterapewtiċi ta' 75 mg darba kuljum u ta' 300 mg darba kuljum ta' rilpivirine f'adulti f'saħħithom, id-differenzi massimi medji mqabbla għall-ħin (95% upper confidence bound) fl-intervall QTcF mill-plaċebo wara li ġiet ikkoreġuta l-linja bażi kienu 10.7 (15.3) u 23.3 (28.4) ms, rispettivament.
English: Response (confirmed < 50 HIV-1 RNA copies/ml)
Maltese: Rispons (ikkonfermati < 50 kopja/ml ta' RNA ta' HIV-1)
English: EDURANT has only been used in a limited number of patients of 65 years or older.
Maltese: EDURANT intuża f'numru limitat biss ta' pazjenti ta' età ta' 65 sena jew aktar.
English: The most frequently reported adverse drug reactions (ADRs) (≥ 2%) that were at least of moderate intensity were depression (4.1%), headache (3.5%), insomnia (3.5%), rash (2.3%), and abdominal pain (2.0%).
Maltese: L-aktar reazzjonijiet avversi għall-mediċina rrappurtati b'mod frekwenti (ADRs - adverse drug reactions) (≥ 2%) li mill-anqas kienu ta' intensità moderata kienu depressjoni (4.1%), uġigħ ta' ras (3.5%), insomnja (3.5%), raxx (2.3%), u uġigħ fl-addome (2.0%).
English: Reproductive toxicology studies
Maltese: Studji dwar tossiċità riproduttiva
English: rabeprazole - the systemic glucocorticoid dexamethasone, except as a single dose treatment - St John's wort (Hypericum perforatum).
Maltese: pantoprazole, rabeprazole - il-glukokortikojd sistemiku dexamethasone, ħlief meta jingħata bħala kura b'doża waħda - St John's wort (Hypericum perforatum).
English: At 96 weeks, the proportion of patients with < 50 HIV-1 RNA copies/ml receiving rilpivirine 25 mg (N=93) compared to patients receiving efavirenz (N=89) was 76% and 71%, respectively.
Maltese: Fis-96 ġimgħa, il-proporzjon ta' pazjenti b'RNA ta' HIV-1 < 50 kopja/ml li kienu qed jingħataw 25 mg ta' rilpivirine (N=93) imqabbel ma' pazjenti li kienu qed jingħataw efavirenz (N=89) kien ta' 76% u 71%, rispettivament.
English: Virologic outcome in adult subjects in the ECHO and THRIVE trials (pooled data in the week 48 (primary) and week 96 analysis; ITT-TLOVR*) Outcome in the week 48 analysis
Maltese: Tabella 4: Riżultat viroloġiku f'individwi adulti mill-provi ECHO u THRIVE (ġabra ta' dejta fil-ġimgħa 48 (primarja) u analiżi fil-ġimgħa 96; ITT-TLOVR Riżultat fl-analiżi fil-ġimgħa 48
English: Do not take EDURANT in combination with any of the following medicines as they may affect the way EDURANT or the other medicine works: - carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines to treat epilepsy and prevent seizures) - rifampicin, rifapentine (medicines to treat some bacterial infections such as tuberculosis) - omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole, (proton pump inhibitors that are medicines to prevent and treat stomach ulcers, heartburn or acid reflux disease) - dexamethasone (a corticosteroid used in a variety of conditions such as inflammation and allergic reactions) when taken by mouth or injected, except as a single dose treatment - products that contain St John's wort (Hypericum perforatum) (a herbal product used for depression).
Maltese: Tiħux EDURANT flimkien ma' kwalunkwe waħda mill-mediċini li ġejjin minhabba li jistgħu jaffettwaw il-mod li bih jaħdem EDURANT jew il-mod li bih taħdem il-mediċina l-oħra: - carbamazepine, oxcarbazepine, phenobarbital, phenytoin (mediċini li jintużaw għall-kura talepilessija u li jilqgħu kontra aċċessjonijiet) - rifampicin, rifapentine (mediċini li jintużaw għall-kura ta' xi infezzjonijiet tal-batterji bħattuberkulożi) - omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole, (impedituri tal-pompa talproton li huma mediċini biex jilqgħu kontra u li jikkuraw ulċeri fl-istonku, ħruq ta' stonku jew mard ta' rifluss tal-aċidu) - dexamethasone (kortikosterojd użat f'varjetà ta' kundizzjonijiet bħal infjammazzjoni u reazzjonijiet allerġiċi) meta jittieħed mill-ħalq jew jiġi injettat, ħlief jekk jittieħed bħala doża waħda - prodotti li fihom St John's wort (Hypericum perforatum) (prodott magħmul mill-ħxejjex li jintuża għad-depressjoni).
English: The E138K substitution emerged most frequently during rilpivirine treatment, commonly in combination with the M184I substitution.
Maltese: Is-sostituzzjoni E138K ħarġet liktar frekwenti waqt il-kura b'rilpivirine, komunement ikkumbinat bis-sostituzzjoni M184I.
English: White to off-white, round, biconvex, film-coated tablet with a diameter of 6.4 mm, debossed with “TMC” on one side and “25” on the other side.
Maltese: Pillola minn bajda sa ofwajt, tonda, konvessa miż-żewġ naħat, miksija b'rita b'dijametru ta' 6.4 mm, imnaqqxa b'“TMC” fuq naħa waħda u b'“25” fuq in-naħa l-oħra.
English: ORAL CONTRACEPTIVES Ethinylestradiol* 0.035 mg once daily Norethindrone* 1 mg once daily ethinylestradiol AUC ↔ ethinylestradiol Cmin ↔ ethinylestradiol Cmax ↑ 17% norethindrone AUC ↔ norethindrone Cmin ↔ norethindrone Cmax ↔ rilpivirine AUC ↔* rilpivirine Cmin ↔* rilpivirine Cmax ↔* * based on historic controls
Maltese: 1 mg darba kuljum ethinylestradiol AUC ↔ ethinylestradiol Cmin ↔ ethinylestradiol Cmax ↑ 17% norethindrone AUC ↔ norethindrone Cmin ↔ norethindrone Cmax ↔ rilpivirine AUC ↔* rilpivirine Cmin ↔* rilpivirine Cmax ↔* * ibbażat fuq kontrolli storiċi
English: 400 mg once daily didanosine AUC ↑ 12% didanosine Cmin NA didanosine Cmax ↔ rilpivirine AUC ↔ rilpivirine Cmin ↔ rilpivirine Cmax ↔
Maltese: HIV NRTIs/N[t]RTIs Didanosine* 400 mg darba kuljum didanosine AUC ↑ 12% didanosine Cmin NA didanosine Cmax ↔ rilpivirine AUC ↔ rilpivirine Cmin ↔ rilpivirine Cmax ↔
English: In a study comparing 8 patients with mild hepatic impairment (Child-Pugh score A) to 8 matched controls, and 8 patients with moderate hepatic impairment (Child-Pugh score B) to 8 matched controls, the multiple dose exposure of rilpivirine was 47% higher in patients with mild hepatic impairment and 5% higher in patients with moderate hepatic impairment.
Maltese: Fi studju li qabbel 8 pazjenti b'indeboliment ħafif tal-fwied (punteġġ A ta' Child-Pugh) ma' 8 individwi jaqblu magħhom bħala kontroll, u 8 pazjenti b'indeboliment moderat tal-fwied (punteġġ B ta' Child-Pugh) ma' 8 individwi jaqblu magħhom bħala kontroll, l-esponiment ta' rilpivirine wara ħafna dożi kien 47% ogħla f'pazjenti b'indeboliment ħafif tal-fwied u 5% ogħla f'pazjenti b'indeboliment moderat tal-fwied.
English: Based on normal approximation.
Maltese: Fuq il-bażi ta' approssimazzjoni normali.
English: In the pooled efficacy analysis from the Phase III trials in adults through 96 weeks, patients treated with rilpivirine with a baseline viral load > 100,000 HIV-1 RNA copies/ml had a greater risk of virologic failure (18.2% with rilpivirine versus 7.9% with efavirenz) compared to patients with a baseline viral load ≤ 100,000 HIV-1 RNA copies/ml (5.7% with rilpivirine versus 3.6% with efavirenz).
Maltese: Fil-ġabra ta' analiżi tal-effikaċja mill-provi tal-Fażi III fl-adulti b'tul ta' 96 ġimgħa, il-pazjenti kkurati b'rilpivirine li kellhom tagħbija virali ta' > 100,000 kopja/ml ta' RNA tal-HIV-1 fil-linja bażi kellhom riskju akbar ta' falliment viroloġiku (18.2% b'rilpivirine versus 7.9% b'efavirenz) meta mqabbla ma' pazjenti b'tagħbija virali ta' ≤ 100,000 kopja/ml ta' RNA tal-HIV-1 fil-linja bażi (5.7% b'rilpivirine versus 3.6% b'efavirenz).
English: Rilpivirine did not induce chromosomal damage in the in vivo micronucleus test in mice.
Maltese: Rilpivirine ma kkawżax ħsara fil-kromosomi waqt it-test in vivo tal-mikronukleju fil-ġrieden.
English: BR=background regimen N=number of subjects
Maltese: BR=skeda ta' mediċini fl-isfond N=numru ta' individwi
English: In the week 48 analysis, 31 out of 62 of rilpivirine virologic failures had concomitant NNRTI and NRTI RAMs; 17 of those 31 had the combination of E138K and M184I.
Maltese: Fl-analiżi ta' ġimgħa 48, 31 minn 62 fallimenti viroloġiċi b'rilpivirine kellhom RAMs għal NNRTI u NRTI flistess ħin; 17 minn dawk il-31 kellhom il-kumbinazzjoni ta' E138K u M184I.
English: Rilpivirine-treated Resistance
Maltese: Ikkurati b'Rilpivirine Resistenza
English: There are limited amount of data (less than 300 pregnancy outcomes) from the use of rilpivirine in pregnant women (see sections 4.4, 5.1 and 5.2).
Maltese: Għall-rilpivirine m'hemmx dejta jew hemm dejta limitata (inqas minn 300 riżultat ta' tqala) dwar lużu f'nisa tqal (ara sezzjonijiet 4.4, 5.1 u 5.2).
English: By baseline CD4 count (× 10
Maltese: Skont l-għadd CD4 fil-linja bażi (x 10
English: Each tablet of EDURANT contains rilpivirine hydrochloride equivalent to 25 mg rilpivirine.
Maltese: Kull pillola ta' EDURANT fiha rilpivirine hydrochloride ekwivalenti għal 25 mg ta' rilpivirine.
English: In this analysis, the resistance-associated mutations (RAMs) associated with NNRTI resistance that developed in at least 2 rilpivirine virologic failures were: V90I, K101E, E138K, E138Q, V179I, Y181C, V189I, H221Y, and F227C.
Maltese: F'dan l-analiżi, il-mutazzjonijiet assoċjati ma' reżistenza (RAMs) għall-NNRTI li żviluppaw f'mill-inqas 2 fallimenti viroloġiċi b'rilpivirine kienu: V90I, K101E, E138K, E138Q, V179I,Y181C, V189I, H221Y u F227C.
English: The most commonly observed resistance-associated mutations that emerged included L100I, K101E, V108I, E138K, V179F, Y181C, H221Y, F227C and M230I.
Maltese: L-aktar mutazzjonijiet assoċjati ma' reżistenza li feġġew li kienu osservati b'mod komuni kienu jinkludu L100I, K101E, V108I, E138K, V179F, Y181C, H221Y, F227C u M230I.
English: Trimester of pregnancy (n=15)
Maltese: 2 Trimestru ta' tqala (n=15)
English: Rilpivirine has tested negative in the absence and presence of a metabolic activation system in the in vitro Ames reverse mutation assay and the in vitro clastogenicity mouse lymphoma assay.
Maltese: It-testijet għal rilpivirine irriżultaw fin-negattiv fin-nuqqas u l-preżenza ta' sistema ta' attivazzjoni metabolika fl-analiżi in vitro ta' tibdil ġenetiku bil-kontra Ames u l-klastoġeniċità in vitro fl-analiżi ta' limfoma fil-ġrieden.
English: Virologic outcome in adolescent subjects in the TMC278-C213 trial - week 48 and week 240 analysis; ITT-TLOVR* Week 48 N=36
Maltese: Tabella 6: Riżultat viroloġiku f'individwi adolexxenti fil-prova TMC278-C213 - analiżi f'ġimgħa 48 u ġimgħa 240;
English: However, it may not be completely excluded that rilpivirine can increase the exposure to other medicines transported by P-glycoprotein that are more sensitive to intestinal P-gp inhibition, e.g. dabigatran etexilate.
Maltese: Madankollu, ma jistax jiġi' kompletament eskluż li rilpivirine jista' jżid l-esponiment għal mediċini oħra trasportati minn P-glycoprotein li huma aktar sensittivi għal inibizzjoni ta' P-gp intestinali, e.ż. dabigatran etexilate.
English: Study TMC278-C204 enrolled 368 HIV-1 infected treatment-naïve adult patients who had a plasma HIV-1 RNA ≥ 5,000 copies/ml, previously received ≤ 2 weeks of treatment with an N(t)RTI or protease inhibitor, had no prior use of NNRTIs and were screened for susceptibility to N(t)RTI and for absence of specific NNRTI resistance-associated mutations.
Maltese: L-istudju TMC278-C204 ġabar fih 368 pazjent adult infettat b'HIV-1 li qatt ma kienu ħadu kura qabel li kellhom RNA ta' HIV-1 ta' ≥ 5,000 kopja/ml fil-plażma, u li qabel rċevew ≤ ġimagħtejn ta' kura b'N(t)RTI jew b'impeditur ta' protease, ma użaw l-ebda NNRTIs qabel u sarilhom eżami ta' suxxettibbiltà għal N(t)RTI u għan-nuqqas ta' mutazzjonijiet speċifiċi assoċjati ma' reżistenza għal NNRTI.
English: The most frequent serious treatment-related ADRs were reported in 7 (1.0%) patients receiving rilpivirine.
Maltese: L-aktar ADRs frekwenti serji marbuta mat-trattament ġew irrappurtati f'7 (1.0%) pazjenti li kienu qed jirċievu rilpivirine.
English: When EDURANT was taken with only a protein-rich nutritional drink, exposures were 50% lower than when taken with a meal.
Maltese: Meta EDURANT ingħata ma' xarba ta' nutriment li kien fiha ħafna proteini biss, lesponimenti kienu 50% aktar baxxi minn meta ngħata ma' ikla.
English: EDURANT 25 mg film-coated tablets rilpivirine
Maltese: EDURANT 25 mg pilloli miksijin b'rita rilpivirine
English: Six subjects discontinued due to virological failure up to week 48 and 3 subjects discontinued beyond week 48.
Maltese: Sitt individwi waqfu minħabba falliment viroloġiku sa ġimgħa 48 u 3 individwi waqfu wara ġimgħa 48.
English: EDURANT has not been evaluated in patients with previous virologic failure to any other antiretroviral therapy.
Maltese: EDURANT ma ġiex evalwat f'pazjenti li diġà kellhom falliment viroloġiku bi kwalunkwe waħda mitterapiji antiretrovirali l-oħra.
English: Table 6 summarizes the week 48 and week 240 virologic outcome results for trial TMC278-C213.
Maltese: Tabella 6 tiġbor fil-qosor ir-riżultati viroloġiċi ta' ġimgħa 48 u ġimgħa 240 għall-prova TMC278C213.
English: Recombinant clinical isolates
Maltese: Iżolati kliniċi rikombinanti
English: Famotidine* 40 mg single dose taken 4 hours after rilpivirine rilpivirine AUC ↑ 13% rilpivirine Cmin NA rilpivirine Cmax ↑ 21%
Maltese: Famotidine* Doża waħda ta' 40 mg li ttieħdet 4 sigħat wara rilpivirine rilpivirine AUC ↑ 13% rilpivirine Cmin NA rilpivirine Cmax ↑ 21%