FrancophonIA/ELRC3.0 huggingface dataset:
English: After repeated oral administration, R-diastereomer of telaprevir (30-fold less active), pyrazinoic acid, and a metabolite that underwent reduction at the α-ketoamide bond of telaprevir (not active) were found to be the predominant
Maltese: Wara għoti ta' ħafna drabi mill-ħalq, R-diastereomer ta' telaprevir (30 darba anqas attiv), pyrazinoic acid, u metabolit li sarlu tnaqqis fir-rabta α-ketoamide ta' telaprevir (mhux attiv) instabu li kienu l-metaboliti prinċipali ta' telaprevir.
English: Do not
Maltese: Tista'
English: The NS3-4A protease inhibitor reduces the amount of hepatitis C virus in your body.
Maltese: L-impedituri ta' protease NS3-4A inaqqsu l-ammont talvirus tal-Epatite Ċ li jinsab fil-ġisem tiegħek.
English: Λεωφόρος Γιάννου Κρανιδιώτη 226 Λατσιά
Maltese: Effikaċja f adulti li qatt ma kienu ħadu kura qabel
English: In vitro studies with recombinant UGT1A3 suggested that telaprevir may inhibit this enzyme.
Maltese: Studji in vitro b'UGT1A3 rikombinanti jissuġerixxu li telprevir jista' jimpedixxi din l-enzima.
English: abacavir, efavirenz, tenofovir disoproxil to treat HIV infections (reverse transcriptase inhibitors) to lower cholesterol levels (HMG CoA reductase inhibitors) all types of hormonal contraceptives (‘the pill') hormonal contraceptives hormone replacement therapy to lower your immune system (immunosuppressants), medicines used in some rheumatic diseases or to avoid problems with organ transplants to improve breathing for asthma (inhaled beta agonists) to treat type II diabetes (blood glucose lowering medicine) for the treatment of opioid (narcotic) dependence to treat erectile dysfunction or to treat a heart and lung disorder called pulmonary arterial hypertension (PDE-5 inhibitors)
Maltese: nifs/mill-imnieħer, dexamethasone jekk jingħata għal kura tal-ażma jew għal kura ta' kundizzjonijiet infjammatorji jew awtoimmuni (kortikosterojdi) għal kura ta' disturb fil-qalb u l-pulmun imsejjaħ pressjoni għolja fl-arterji tal-pulmun (antagonist tar-riċettur ta' endothelin) għal kura ta' infezzjonijiet bl-HIV (impedituri tal-protease tal-HIV) għal kura ta' infezzjonijiet bl-HIV (impedituri ta' reverse transcriptase) biex jitnaqqas il-livell ta' kolesterol (impedituri ta' reductase HMG CoA)
English: INCIVO is not recommended in patients with moderate to severe hepatic impairment (Child-Pugh B or C, score ≥ 7) or decompensated liver disease (ascites, portal hypertensive bleeding, encephalopathy, and/or jaundice other than Gilbert's Syndrome, see section 4.4).
Maltese: INCIVO mhuwiex rrakkomandat f'pazjenti b'indeboliment minn moderat sa qawwi tal-fwied (Child-Pugh B jew Ċ, punteġġ ≥ 7) jew mard tal-fwied mhux kumpensat (axxite, emorraġija ipertensiva portali, enċefalopatija, u/jew suffejra li mhix is-Sindromu ta' Gilbert, ara sezzjoni 4.4).
English: Naïve patients treated with either peginterferon alfa-2a/ribavirin (n = 80) or peginterferon alfa-2b/ribavirin (n = 81) in combination with INCIVO, in an open label study, had comparable SVR rates.
Maltese: Pazjenti li qatt ma ħadu kura qabel li ngħataw kura jew b'peginterferon alfa-2a/ribavirin (n = 80) jew b'peginterferon alfa-2b/ribavirin (n = 81) flimkien ma' INCIVO, fi studju open label, kellhom rati ta' SVR kienu jixxiebħu.
English: This medicine contains 2.3 mg sodium per tablet, which should be taken into consideration by patients on a controlled sodium diet. Tell your doctor if you have to take care of your salt intake and follow a
Maltese: Din il-mediċina fiha 2.3 mg ta' sodium f'kull pillola, li għandu jitqies għal pazjenti li qegħdin fuq dieta b'kontroll fl-ammont ta' sodium.
English: to treat migraine and headaches (ergot derivatives)
Maltese: għal kura ta' emigranja u uġigħ ta' ras (derivattivi tal-ergot)
English: In HCV negative patients with moderate hepatic impairment, reduced exposure to telaprevir was observed.
Maltese: F'pazjenti li ma kellhomx HCV b'indeboliment moderat tal-kliewi, ġie osservat esponiment imnaqqas għal telaprevir.
English: In one of those studies, a telaprevir 1,875 mg every 8 hours regimen was evaluated and the placebo-adjusted maximum mean increase in QTcF was 8.0 msec (90% CI: 5.1-10.9).
Maltese: F'wieħed minn dawk l-istudji, kienet stmata skeda ta' għoti ta' 1,875 mg ta' telaprevir kull 8 sigħat u ż-żieda massima medja fil-QTcF aġġustata mal-plaċebo kienet ta' 8.0 msek (90% CI: 5.1-10.9).
English: INCIVO must be taken in combination with peginterferon alfa and ribavirin.
Maltese: Twaqqif immedjat u għalkollox ta' INCIVO, peginterferon alfa u ribavirin.
English: Mild rash: localised skin eruption and/or a skin eruption with a limited distribution (up to several isolated sites on the body)
Maltese: Raxx ħafif: eruzzjoni lokalizzata tal-ġilda u/jew eruzzjoni tal-ġilda b'distribuzzjoni limitata (anki f'diversi postijiet iżolati fuq
English: The non-responder-population was comprised of 2 subgroups: prior partial responders (greater than or equal to 2 log10 reduction in HCV RNA at week 12, but not achieving HCV RNA undetectable at end of treatment with a peginterferon and ribavirin) and prior null responders (less than 2 log10 reduction in HCV RNA at week 12 of prior treatment with peginterferon and ribavirin).
Maltese: Il-popolazzjoni ta' dawk li ma kinux irrispondew għall-kura kienet magħmula minn żewġ sottogruppi: dawk li qabel ma kinux rrispondew b'mod sħiħ għall-kura (tnaqqis ta' 2 log10 jew aktar fl-RNA ta' HCV filġimgħa 12, iżda li ma kisbux RNA ta' HCV li kienet ftit wisq biex titkejjel fi tmiem il-kura b'peginterferon u ribavirin) u dawk li ma kinux rrispondew għall-kura (tnaqqis ta' anqas minn 2 log10 fl-RNA ta' HCV fil-ġimgħa 12 meta qabel kienet ingħatatilhom kura b'peginterferon u ribavirin).
English: Refer also to the Summary of Product Characteristics for peginterferon alfa and ribavirin which are contraindicated in Child-Pugh score ≥ 6.
Maltese: Irreferi wkoll għas-Sommarju tal-Karatteristiċi tal-Prodott ta' peginterferon alfa u ribavirin li huma kontraindikati fil-punteġġ ≥ 6 ta' Child-Pugh.
English: All telaprevir-resistant variants studied remained fully sensitive to interferon-alfa, ribavirin, and representative HCV nucleoside and non-nucleoside polymerase inhibitors in the replicon system.
Maltese: Il-varjanti kollha reżistenti għal telaprevir li ġew studjati baqgħu kompletament sensittivi għal interferon-alfa, ribavirin, u għal-rapreżentattivi ta' impedituri talpolimerase ta' HCV li huma nukleoside u li mhumiex nukleoside fis-sistema ta' replikazzjoni minn oriġini singola.
English: The resistance profile observed in Study HPC3008 in HCV/HIV-1 co-infected patients was similar to the resistance profile in mono-infected HCV patients.
Maltese: Il-profil ta' reżistenza osservat fl-Istudju HPC3008 f'pazjenti koinfettati b'HCV/HIV-1 kien jixbah ilprofil ta' reżistenza f'pazjenti infettati b'HCV biss.
English: to treat psychiatric conditions (neuroleptics)
Maltese: għal kura ta' kundizzjonijiet psikjatriċi (newrolettiċi)
English: Among patients treated with telaprevir, on-treatment virologic failure was more frequent in patients with genotype 1a than with genotype 1b and more frequent in prior null responders than in other populations (treatment-naïve, prior relapsers, prior partial responders; see section 5.1, Clinical Experience, Efficacy in Previously Treated Adults).
Maltese: Fost il-pazjenti kkurati b'telaprevir, falliment viroloġiku meta tingħata l-kura kien aktar frekwenti f'pazjenti bil-ġenotip 1a milli f'dawk bil-ġenotip 1b u aktar frekwenti f'dawk li qabel ma rrispondewx għall-kura milli f'popolazzjonijiet oħra (dawk li qatt ma ħadu kura qabel, dawk li qabel kienu rkadew, dawk li qabel ma kinux irrispondew b'mod sħiħ; ara sezzjoni 5.1, Esperjenza Klinika, Effikaċja f'Adulti li kienu
English: Co-administration with inducers may lead to lower exposure of telaprevir with risk of lower efficacy.
Maltese: L-għoti flimkien ma' indutturi jista' jwassal għal espożizzjoni aktar baxxa għal telaprevir, b'riskju ta' effikaċja aktar baxxa.
English: Refer also to the Summary of Product Characteristics for ribavirin for patients with CrCL < 50 ml/min
Maltese: Ara wkoll is-Sommarju tal-Karatteristiċi tal-Prodott ta' Ribavirin għal pazjenti b'CrCl ≤ 50 ml/min (ara
English: - Skin rash
Maltese: - Raxx fil-ġilda
English: An effect of telaprevir on UDP-glucuronyltransferases cannot be ruled out and may affect the plasma concentrations of abacavir or zidovudine.
Maltese: Effett ta' telaprevir fuq UDP-glucuronyltransferases ma jistax jiġi eskluż, u jista' jaffettwa l-konċentrazzjonijiet ta' abacavir jew ta' zidovudine fil-plażma.
English: Refer to section 4.3 for a listing of medicinal products that are contraindicated for use with INCIVO due to potentially life-threatening adverse events or potential loss of therapeutic effect to INCIVO.
Maltese: Irreferi għal sezzjoni 4.3 għall-lista ta' prodotti mediċinali li huma kontraindikati għall-użu flimkien ma' INCIVO minħabba avvenimenti avversi potenzjalment ta' periklu għall-ħajja jew potenzjal ta' telf fl-effett terapewtiku għal INCIVO.
English: )/PR] in combination with peginterferon alfa-2a and ribavirin.
Maltese: Ħu INCIVO ma' peginterferon alfa u ribavirin għal 12-il ġimgħa.
English: The denominator is the number of patients with HCV RNA < 25 IU/ml at planned end of treatment or a missing HCV RNA assessment at planned end of treatment and HCV RNA < 25 IU/ml during follow-up from planned end of treatment onwards.
Maltese: Id-denominatur fl-għadd ta' pazjenti b'HCV RNA < 25 IU/ml fit-tmiem ippjanat ta' trattament jew stima ta' HCV RNA li ma nkisbitx fit-tmiem ippjanat ta' trattament u HCV RNA < 25 IU/ml waqt l-insegwutu mit-tmiem ippjanat ta'
English: Study HPC3006 was an open-label, Phase 3b study in treatment- naïve and treatment-experienced chronic genotype 1 HCV- infected patients who were first time liver transplant recipients and were on a stable regimen of the immunosuppressants tacrolimus or cyclosporine A. No patients had cirrhosis of the liver graft.
Maltese: Studju HPC3006 kien studju bit-tikketta tingħaraf, ta' Fażi 3 f'pazjenti b'infezzjoni kronika ta' HCV ta' ġenotip 1 li ma ngħatawx trattament qabel u b'esperjenza ta' trattament li kienu reċipjenti ta' trapjant tal-fwied għall-ewwel darba u kienu fuq programm ta' kura stabbli tal-immunosoppressanti tacrolimus jew cyclosporin A.
English: DRESS presents as a rash with eosinophilia associated with one or more of the following features: fever, lymphadenopathy, facial oedema, and internal organ involvement (hepatic, renal, pulmonary).
Maltese: DRESS timmanifesta ruħha bħala raxx b'eosinofilja assoċjata ma' wieħed jew aktar minn dawn li ġejjin: deni, limfadenopatija, edema fil-wiċċ u involviment tal-organi interni (tal-fwied, tal-kliewi, talpulmun).
English: Table 14: Pooled response rates: Study C208
Maltese: Studju C208
English: Study 111 was a Phase 3, randomised, open label study conducted in treatment-naïve patients.
Maltese: L-istudju 111 kien studju tal-Fażi 3, randomised, open-label, li sar f'pazjenti li qatt ma kienu ħadu kura qabel.
English: On-treatment virologic failure was defined as meeting a virologic stopping rule or having viral breakthrough.
Maltese: Falliment viroloġiku waqt it-trattament kien iddefinit bħala tintlaħaq regola ta' waqfien viroloġiku jew sfondament viroloġiku li ntlaħaq.
English: The time dependency indicates that inhibition of CYP3A4 may be intensified during the first 2 weeks of treatment.
Maltese: Id-dipendenza fuq il-ħin jindika illi l-inibizzjoni ta' CYP3A4 jista' jiġi intensifikat waqt lewwel ġimgħatejn tal-kura.
English: In patients who had undetectable HCV RNA (target not detected) at weeks 4 and 12, there was no additional benefit to extending peginterferon alfa-2a and ribavirin treatment to 48 weeks (difference in SVR rates of 2%; 95% confidence interval: -4%, 8%).
Maltese: F'pazjenti li kellhom ftit wisq RNA ta' HCV biex titkejjel (target ma jistax jitkejjel) fil-ġimgħat 4 u 12, ma kien hemm l-ebda benefiċċju addizzjonali li ttawwal iż-żmien ta' kura b'peginterferon alfa-2 u ribavirin għal 48 ġimgħa (differenza ta' 2%; 95% confidence interval:
English: Fatal cases have been reported in patients with progressive rash and systemic symptoms who continued to receive INCIVO combination treatment after a serious skin reaction was identified.
Maltese: Każijiet fatali ġew irrappurtati f'pazjenti li kellhom raxx progressiva u sintomi sistemiċi u li komplew jirċievu taħlita ta' kura li tinkludi INCIVO wara li reazzjoni serja tal-ġilda ġiet identifikata.
English: In the Pbo/PR arm, 2 (9%) patients had baseline bridging fibrosis and no patients had baseline cirrhosis.
Maltese: Fil-fergħa Pbo/PR, 2 (9%) pazjenti kellhom fibrożi li tgħaqqad il-vini flimkien fil-linja bażi u l-ebda pazjent ma' kellu ċirrożi fil-linja bażi.
English: If the HCV RNA concentration is > 1,000 IU/ml, INCIVO, peginterferon alfa, and ribavirin should be discontinued.
Maltese: Jekk il-konċentrazzjoni HCV RNA tkun ta' > 1,000 IU/ml, INCIVO, peginterferon
English: This difference is likely due to the higher genetic barrier for the V36M and R155K substitutions for genotype 1b than genotype 1a.
Maltese: Din id-differenza x'aktarx li ġejja minħabba barriera ġenetika ogħla għassostituzzjonijiet V36M u R155K għal ġenotip 1b milli għal ġenotip 1a.
English: Table 11 shows the response rates for the recommended simultaneous start (T12/PR48) and the Pbo/PR48 arms.
Maltese: It-tabella 11 turi li r-rati ta' rispons għal fergħat rrakkomandati ta' bidu l-istess ħin (T12/PR48) u tal-Pbo/PR48.
English: There are no clinical data on re-treating patients who have failed an HCV NS3-4A protease inhibitor-based therapy, such as telaprevir, nor are there data on repeated courses of telaprevir treatment.
Maltese: M'hemm l-ebda dejta klinika dwar il-kura mill-ġdid ta' pazjenti li fallew terapija bbażata fuq impeditur tal-protease ta' HCV NS3-4A, bħal ma hu telaprevir, u l-anqas ma hemm dejta dwar korsijiet ripetuti ta' kura b'telaprevir.
English: The following laboratory evaluations (complete blood count with white blood cell differential counts, electrolytes, serum creatinine, liver function tests, TSH, uric acid) must be conducted in all patients prior to initiating INCIVO combination treatment.
Maltese: L-istimi tal-laboratorju li ġejjin (għadd sħiħ tad-demm b'għadd divrenzjali taċ-ċelluli tad-demm bojod, elettroliti, kreatinina fis-serum, testijiet tal-funzjoni tal-fwied, TSH, aċidu uriku) għandhom isiru fil-pazjenti kollha qabel ma tinbeda kura mħallta li tinkludi INCIVO.
English: Consider consultation with a specialist in dermatology.
Maltese: Hija rakkomandata konsultazzjoni ma' speċjalista taddermatoloġija.
English: Patients receiving tacrolimus N = 50
Maltese: Il-pazjenti kollha N = 540
English: Co-administration with phenytoin is contraindicated.
Maltese: L-għoti flimkien ma' phenytoin huwa kontraindikat.
English: - itching around or near the anus, bleeding around or near the anus or rectum, a small tear in the skin that lines the anus that may cause pain and/or bleeding during bowel movements; - red, cracked, dry, scaly skin (eczema), rash with red, cracked, dry, scaly skin (exfoliative rash); - swelling of the face, swelling of the arms and/or legs (oedema);
Maltese: - ħass ħażin; ħakk madwar jew qrib l-anus, fsada madwar jew qrib l-anus jew ir-rektum, tiċrita żgħira fil-ġilda li tinforra l-anus li tista' tikkawża uġigħ u/jew fsada waqt l-ippurgar; - ġilda ħamra, maqsuma, xotta, li taqa' qxur qxur (ekżema), raxx b'ġilda ħamra, maqsuma, xotta,
English: At week 12, INCIVO dosing ended and patients continued on peginterferon alfa-2a and ribavirin treatment.
Maltese: Fil-ġimgħa 12, twaqqaf id-dożaġġ ta' INCIVO u l-pazjenti baqaw fuq kura bi peginterferon alfa-2a u ribavirin.
English: Pbo/PR48: placebo for 16 weeks in combination with peginterferon alfa-2a and ribavirin for 48 weeks
Maltese: Pbo/PR48: plaċebo għal 16-il ġimgħa flimkien ma' peginterferon alfa-2a u ribavirin għal 48 ġimgħa
English: Available data suggest that peginterferon alfa, and perhaps also ribavirin, may contribute to the frequency and severity of rash associated with INCIVO combination treatment.
Maltese: Dejta disponibbli tissuġġerixxi li peginterferon alfa, u forsi wkoll ribavirin, jistgħu jikkontribwixxu għall-frekwenza u għas-severità tar-raxx assoċjat ma' taħlita ta' kura li tinkludi
English: INCIVO co-administration with domperidone should be avoided (see section 4.5).
Maltese: L-għoti ta' INCIVO ma' domperidone għandu jiġi evitat (ara sezzjoni 4.5).
English: SVR in patients with undetectable HCV RNA (target not detected) at weeks 4 and 12
Maltese: Pazjenti li kellhom ftit wisq RNA ta'HCV biex titkejjel (target ma jistax jitkejjel) fil-ġimgħat 4 u 12
English: INCIVO should be used with caution with Class Ic antiarrhythmics propafenone and flecainide, including appropriate clinical and ECG monitoring.
Maltese: Ic propafenone u flecainide, inkluż monitoraġġ kliniku u monitoraġġ ECG xieraq.
English: (HIV RNA < 50 copies/ml, CD4 count ≥ 300 cells/mm
Maltese: Il-pazjenti kienu meħtieġa jkollhom < 50 kopja/ml ta' RNA ta' HIV-1 u għadd ta' ċelluli CD4 > 300 ċellula/mm
English: The response rate in the Pbo/PR arm was higher than that seen in other clinical studies of peginterferon bitherapy (historical SVR rates < 36%).
Maltese: Ir-rata ta' rispons fil-fergħa ta' Pbo/PR kienet ogħla minn dik li dehret fi studji kliniċi oħrajn ta' biterapija ma' peginterferon (rati storiċi ta' SVR < 36%).
English: In placebo-controlled Phase 2 and 3 trials, anaemia (all grades) was reported in 32.1% of patients who received INCIVO combination treatment and in 14.8% of patients who received peginterferon alfa and ribavirin.
Maltese: Fil-provi tal-fażi 2 u tal-fażi 3 kkontrollati bi plaċebo, l-anemija (il-gradi kollha) kienet irrappurtata f'32.1% tal-pazjenti li ħadu kura bit-taħlita li tinkludi INCIVO u f'14.8% tal-pazjenti li ħadu peginterferon alfa u ribavirin.
English: The direction of the arrow (↑ = increase, ↓ = decrease, ↔ = no change) for each pharmacokinetic parameter is based on the 90% confidence interval of the geometric mean ratio being within (↔), below (↓) or above (↑) the 80-125% range.
Maltese: Id-direzzjoni tal-vleġġa (↑ = żieda, ↓ = tnaqqis, ↔ = l-ebda tibdil) għal kull parametru farmakokinetiku hija bbażata fuq intervall ta' kunfideza ta' 90% li l-porzjon ġeometriku medju jkun fl-medda (↔), taħt il-medda (↓) jew fuq il-medda (↑) bejn 80-125%.
English: To manage anaemia, at initiation of INCIVO treatment a lower starting dose of ribavirin (600 mg/day) was used; during the overall treatment phase the ribavirin dose was further reduced in 36.5% of patients, 41.9% received ESAs and 21.6% received blood transfusions (see sections 4.4 and 4.5, Immunosuppressants).
Maltese: Sabiex tiġi ġestita l-anemija, fil-bidu ta' trattament ta' INCIVO intużat doża tal-bidu aktar baxxa ta' ribavirin (600 mg/jum): waqt il-fażi ta' trattament totali d-doża ta' ribavirin kienet mnaqqsa aktar f'36.5% tal-pazjenti, 41.9% jirċievu ESAs u 21.6% jirċievu trasfużjonijiet tad-demm (ara sezzjoni 4.4 u 4.5,
English: Table 13: SVR rates by week 4 response (< 1 log10 or ≥ 1 log10 reduction) in the T12(DS)/PR48
Maltese: Tabella 13: Rati ta' SVR skont ir-rispons fil-ġimgħa 4 (tnaqqis < 1 log10 jew ≥ 1 log10 fil-grupp
English: Refer to the Summary of Product Characteristics for ribavirin and peginterferon alpha for additional
Maltese: Ara s-Sommarju tal-Karatteristiċi tal-Prodott ta' ribavirin u peginterferon alpha għal aktar
English: CT
Maltese: C.
English: • Incidence of rash and severe cutaneous reactions
Maltese: • Inċidenza ta' raxx u reazzjonijiet qawwijin fil-ġilda
English: Refer also to the Summary of Product Characteristics for peginterferon alfa and ribavirin for further information.
Maltese: Ara wkoll is-Sommarju talKaratteristiċi tal-Prodott ta' peginterferon alfa u ribavirin għal aktar informazzjoni.
English: Renal impairment
Maltese: Reċipjenti fi fwied trapjantat
English: Effect on unbound telaprevir concentrations is unknown (see sections 4.2 and 4.4).
Maltese: Għalhekk, INCIVO mhuwiex irrakkomandat f'dawn il-pazjenti (ara sezzjonijiet 4.2 u 5.2).
English: At steady-state, the effective half-life is about 9-11 hours.
Maltese: Fl-istat fiss, il-halflife effettiv huwa ta' madwar 9 sigħat u 11-il siegħa.
English: parenterally administered midazolam*
Maltese: zolpidem (sedattiv li mhuwiex benzodiazepine)*
English: Table 12: SVR rates by extent of liver fibrosis at baseline: Study C216 T12/PR
Maltese: L-għan ewlieni kien li juru n-noninferiorità ta' T12(b.i.d.)/PR fuq T12(q8h)/PR.
English: ↑ alprazolam AUC 1.35 (1.23-1.49) Cmax 0.97 (0.92-1.03)
Maltese: ↓ telaprevir 750 mg q8h AUC 0.95 (0.76-1.18) Cmax 0.97 (0.79-1.21)
English: Telaprevir readily crosses the placenta in both rat and mouse giving a foetal: maternal exposure of 19 - 50%.
Maltese: Telaprevir jgħaddi mill-plaċenta kemm fil-firien kif ukoll fil-ġrieden u jikkawża esponiment fetali:matern ta' 19 - 50%.
English: The primary objective of the study was to assess the antiviral efficacy of INCIVO, peginterferon alfa-2a, and ribavirin in HCV/HIV-1 co-infected patients as measured by SVR12.
Maltese: L-oġġettiv primarju tal-istudju kien li tiġi stmata l-effikaċja antiretrovirali ta' INCIVO, peginterferon alfa-2a, u ribavirin f'pazjenti koinfettati b'HCV/HIV-1 skont kejl b'SVR12.
English: Transporters In vitro studies demonstrated that telaprevir is an inhibitor of OATP1B1 and OATP2B1.
Maltese: Studji in vitro wrew li telaprevir huwa impeditur għal OATP1B1 u OATP2B1 Ma kienet osservata l-ebda inibizzjoni rilevanti tat-trasportatur katjoniku organiku (OCT) OCT2
English: Exposure at this dose was comparable to the exposure in HCV-infected patients receiving a dose of 750 mg INCIVO every 8 hours plus peginterferon alfa and ribavirin.
Maltese: Esponiment b'din id-doża kien jixbah lil esponiment ta' pazjeni infettati b'HCV li kienu qed jingħataw doża ta' 750 mg INCIVO kull 8 sigħat flimkien ma' peginterferon alfa u ribavirin.
English: After weaning, rat pup body weight gain silica colloidal anhydrous sodium lauryl sulphate croscarmellose sodium sodium stearyl fumarate
Maltese: Telaprevir ma kellu l-ebda effetti fuq il-fertilità jew it-tgħammil meta kien evalwat fil-firien.
English: Treatment with INCIVO must be initiated in combination with peginterferon alfa and ribavirin and administered for 12 weeks with an additional 36 weeks of peginterferon alfa and ribavirin alone for a total treatment duration of 48 weeks.
Maltese: Trattament b'INCIVO għandu jiġi mibdi flimkien ma' peginterferon alfa u ribavirin u mogħti għal 12-il ġimgħa b'36 ġimgħa addizzjonali ta' peginterferon alfa u ribavirin waħedhom għal żmien totali ta' trattament ta' 48 ġimgħa.
English: INCIVO in combination with peginterferon alfa and ribavirin was evaluated in 74 HCV-1 infected, post-liver transplant patients without cirrhosis receiving either tacrolimus or cyclosporine A. At the initiation of INCIVO treatment, doses of co-administered tacrolimus or cyclosporine A need to be markedly reduced, including a prolongation in the dosing interval for tacrolimus, in order to maintain therapeutic plasma concentrations of the immunosuppressant.
Maltese: INCIVO f'kombinazzjoni ma' peginterferon alfa u ribavirin kien evalwat f'74 pazjent infettat b'HCV-1 wara trapjant tal-fwied mingħajr ċirrosi li rċevew jew tacrolimus jew cyclosporin A.
English: The safety and efficacy have not been established in patients with moderate or severe renal impairment (CrCl < 50 ml/min) or in patients on haemodialysis.
Maltese: Is-sigurtà u l-effikaċja ma ġewx stabbiliti f'pazjenti b'indeboliment moderat jew qawwi tal-kliewi (CrCl < 50 ml/min) jew f'pazjenti fuq emodijalisi.
English: It is recommended that the international normalised ratio (INR) be monitored when warfarin is co-administered with telaprevir.
Maltese: Huwa rrakkomandat li lproporzjon normalizzat internazzjonali (INR) jiġi mmonitorjat meta warfarin jingħata flimkien ma' telaprevir.
English: Multiple metabolites were detected in faeces, plasma, and urine.
Maltese: Ħafna metaboliti ġew innutati fl-ippurgar, fil-plażma u fl-awrina.
English: This leaflet was last revised in {MM/YYYY}.
Maltese: Deskrizzjoni ta' għażla ta' reazzjonijiet avvversi