FrancophonIA/ELRC3.0 huggingface dataset:
English: Steady-state exposure to telaprevir was 46% lower in subjects with moderate hepatic impairment (Child-Pugh Class B, score 7-9) compared to healthy subjects.
Maltese: Esponiment għal telaprevir fl-istat fiss kien 46% aktar baxx f'individwi b'indeboliment moderat tal-fwied (Child-Pugh Klassi B, punteġġ 7-9) meta mqabbel ma' individwi f'saħħithom.
English: These may be symptoms of anaemia.
Maltese: Dawn jistgħu jkunu sintomi ta' anemija.
English: Eesti filiaal Lõõtsa 2
Maltese: Бизнес Парк София, сграда 4
English: In the analysis of an additional study, Study C211, the safety profile of combination therapy with INCIVO 1,125 mg twice daily was similar to the safety profile for patients receiving combination therapy with INCIVO 750 mg every 8 hours.
Maltese: Fl-analiżi ta' studju addizzjonali, Studju C211, il-profil ta' sigurtà ta' terapija kkumbinata b'INCIVO 1,125 mg darbtejn kuljum kien simili għall-profil ta' sigurtà għal pazjenti li rċevew terapija kkumbinata b'INCIVO 750 mg kull 8 sigħat.
English: In the description of the Phase 3 study outcomes for Study C211, HPC3008 and HPC3006, SVR12, considered virologic cure, was defined based on HCV RNA below the limit of quantification (25 IU/ml) using the last measurement in the visit window 12 weeks after the planned end of
Maltese: Fid-deskrizzjoni tar-riżultati mill-istudji ta' Fażi 3 għall-Istudji C211, HPC3008 u HPC3006, SVR12, li huwa kkunsidrat bħala kura viroloġika, kien iddefinit skont kwantifikazzjoni ta' RNA ta' HCV taħt il-limitu (25IU/ml) permezz tal-aħħar kejl fil-viżta 12-il ġimgħa wara t-tmiem ippjanat tat-trattament.
English: Rifampicin reduces the telaprevir plasma AUC by approximately 92%.
Maltese: Rifampicin jnaqqas l-AUC ta' telaprevir fil-plażma b'madwar 92%.
English: 5.8% of patients discontinued INCIVO alone due to rash events and 2.6% of patients discontinued INCIVO combination treatment for rash events compared to none of those receiving peginterferon
Maltese: 5.8% tal-pazjenti waqqfu INCIVO biss minħabba każijiet ta' raxx u 2.6% tal-pazjenti waqqfu t-taħlita ta' kura li tinkludi INCIVO għal każijiet ta' raxx meta mqabbla mal-ebda persuna li kienet qed tieħu
English: Peginterferon alfa-2a/peginterferon alfa-2b and ribavirin were used according to their relevant Summary of Product Characteristics.
Maltese: Peginterferon alfa-2a/peginterferon alfa-2b u ribavirin intużaw skont is-Sommarju tal-Karatteristiċi tal-Prodott rilevant tagħhom.
English: INCIVO should be used with caution with Class Ic antiarrhythmics propafenone and flecainide, including appropriate clinical and ECG monitoring (see section 4.4).
Maltese: Ic propafenone u flecainide, inkluż monitoraġġ kliniku u monitoraġġ ECG xieraq (ara sezzjoni 4.4).
English: INCIVO 375 mg film-coated tablets telaprevir
Maltese: INCIVO 375 mg pilloli miksijin b'rita telaprevir
English: Maraviroc 150 mg twice daily when co-administered with telaprevir.
Maltese: Maraviroc 150 mg darbtejn kuljum meta jingħata flimkien ma' telaprevir.
English: The lower limit of the 95% CI (-4.9%) was greater than the pre-determined noninferiority margin of -11% and therefore the non inferiority of T12(b.i.d.
Maltese: Illimitu baxx tal-95% CI (-4.9%) kien ikbar mill-marġini pre-determinat ta' noninferiorità ta' -11% u għalhekk in-noninferiorità ta' T12(b.i.d.)/PR fuq T12(q8h)/PR ġie muri.
English: ANTIFUNGALS ketoconazole* itraconazole posaconazole voriconazole
Maltese: Għandu jkun hemm kawtela u huwa rrakkomandat monitoraġġ kliniku għal itraconazole, posaconazole, u voriconazole.
English: A lower ribavirin dose (600 mg/day) at initiation of INCIVO treatment is recommended (see section 5.1).
Maltese: Doża aktar baxxa ta' ribavirin (600 mg/jum) filbidu tat-trattament ta' INCIVO hi rakkomandata (ara sezzjoni 5.1).
English: In placebo-controlled Phase 2 and 3 trials, 0.4% of patients had suspected Drug Rash with Eosinophilia and Systemic Symptoms (DRESS).
Maltese: Fil-provi tal-Fażi 2 u 3 kkontrollati bi plaċebo, 0.4% tal-pazjenti kellhom dak li ġie ssuspettat li huwa Raxx mill-Mediċina b'Eosinofilja u Sintomi Sistemiċi (DRESS).
English: There are limited clinical data on the use of INCIVO in HCV patients aged ≥ 65 years.
Maltese: Hemm dejta klinika limitata dwar l-użu ta' INCIVO f'pazjenti b'HCV li għandhom ≥ 65 sena.
English: At the initiation and discontinuation of INCIVO treatment, doses of co-administered tacrolimus or cyclosporine A need to be markedly adjusted (see sections 4.4 and 4.5, Immunosuppressants).
Maltese: Fil-bidu u l-waqfien ta' trattament b'INCIVO, dożi amministrati flimkien ta' tacrolimus jew cyclosporine A għandhom jiġu aġġustati notevolment (ara sezzjonijiet 4.4 u 4.5, Immunosuppressanti).
English: 168 film-coated tablets (4 bottles containing 42 tablets each) The bottles are not to be distributed individually.
Maltese: 168 pillola miksijin b'rita (4 ifliexken b'42 tablets f'kull flixkun) Il-fliexken mhux qegħdin biex jiġu ddistribwiti individwalment.
English: QT interval prolongation has been reported with ketoconazole (see section 4.4).
Maltese: Titwil tal-intervall QT kien irrappurtat b'ketoconazole (ara sezzjoni 4.4).
English: Fertility INCIVO had no effects on fertility or fecundity when evaluated in rats.
Maltese: Fertilità INCIVO ma' kellu l-ebda effetti fuq il-fertilità meta kien evalwat fil-firien.
English: However, patients treated with peginterferon alfa-2b experienced more frequent viral breakthrough, and were less likely to meet the criteria for shortened total treatment duration (see section 5.1).
Maltese: Madankollu, pazjenti li kienu kkurati b'peginterferon alfa-2b reġa' tfaċċalhom il-virus aktar ta' spiss, u kellhom inqas probabbiltà li jissodisfaw il-kriterji għal żmien ta' kura mqassar (ara sezzjoni 5.1).
English: See package leaflet for further information.
Maltese: Sorsi oħra ta' Informazzjoni
English: rifampicin to treat some infections like tuberculosis (antimycobacterial)
Maltese: għal kura ta' xi infezzjonijiet bħat-tuberkulożi (antimikobatteriċi)
English: No fibrosis, minimal fibrosis, or portal fibrosis
Maltese: L-ebda fibrożi, ftit fibrożi, jew fibrożi
English: (< 25,000/mm absolute lymphocyte count
Maltese: (< 25,000/mm għadd assolut ta'
English: The median time for telaprevir-resistant variants to become undetectable by population sequencing was longer for variants NS3-36 (6 months), NS3-155 (9 months) and NS3-36M+NS3-155K (12 months) predominantly observed in patients with genotype 1a than for variants NS3-54 (2 months) and NS3-156 (3 months) predominantly observed in patients with genotype 1b.
Maltese: NS3-36 (6 xhur), NS3-155 (9 xhur) u NS3-36M+NS3-155K (12-il xahar) osservati l-biċċa l-kbira f'pazjenti bil-ġenotip 1a milli għall-varjanti NS3-54 (xahrejn) u NS3-156 (3 xhur) osservati l-biċċa l-kbira f'pazjenti bil-ġenotip 1b.
English: HCV RNA< 25 IU/ml in the week 12 follow-up window
Maltese: RNA ta' HCV < 25 IU/ml fil-perjodu ta' segwitu fil-ġimgħa 12
English: phenytoin*
Maltese: rilpivirine*
English: Refer to section 4.3 for HMG-CoA reductase inhibitors that are contraindicated with INCIVO.
Maltese: Irreferi għal sezzjoni 4.3 għal inibituri ta' HMG-CoA reductase li huma kontraindikati ma' INCIVO
English: Replicons with single substitutions at position 155 or 156 and double variants with substitutions at residues 36 and 155 showed cross-resistance to all protease inhibitors tested with a wide range of sensitivities.
Maltese: Replikazzjoni minn oriġini singola b'sostituzzjonijiet singoli fil-pożizzjonijiet 155 jew 156 u varjanti doppji b'sostituzzjonijiet fir-residwi 36 u 155 urew reżistenza inkroċjata għall-impedituri kollha ta' protease ittestjati b'firxa wiesa ta' sensittivitajiet.
English: Based on population sequencing analyses of HCV in these 215 patients, the emergence of telaprevir-resistant HCV variants was detected in 105 (84%) virologic failures and in 55 (61%) relapsers, and wild-type virus was detected in 15 (12%) virologic failures and in 24 (27%) relapsers.
Maltese: Fuq bażi ta' analiżi ta' sekwenzar tal-popolazzjoni ta' HCV f'dawn il-215-il pazjent, l-evoluzzjoni ta' varjanti ta' HCV reżisenti għal telaprevir instabet f'105 (84%) falliment viroloġiku u f'55 (61%) pazjent li rkadew, u l virus tat-tip li jinstab fin-natura nstab fi 15-il falliment viroloġiku (12%) u f'24 (27%) pazjent li rkadew.
English: Each tablet of INCIVO contains 375 mg of telaprevir.
Maltese: Kull pillola INCIVO fiha 375 mg ta' telaprevir.
English: Drug interactions need to be carefully taken into account, see sections 4.4 and 4.5.
Maltese: Interazzjonijiet bejn mediċina u oħra għandhom jitqiesu bir-reqqa, ara sezzjonijiet 4.4 u 4.5.
English: - INCIVO 750 mg every 8 hours with peginterferon alfa-2b 1.5 g/kg/week and ribavirin
Maltese: - INCIVO 750 mg kull 8 sigħat ma' peginterferon alfa-2b 1.5 g/kg/ġimgħa u ribavirin
English: Suppression by telaprevir and VRT-127394 of CYP enzymes regulated via CAR, PXR and Ah nuclear receptors was observed in vitro in human hepatocytes.
Maltese: Kienet osservata soppressjoni, tal-enzimi CYP irregolati permezz tar-riċetturi nukleari CAR, PXR u Ah, minn telaprevir u VRT-127394 fl-epatoċiti tal-bniedem in vitro.
English: to treat some stomach conditions (gastrointestinal motility agents)
Maltese: għal kura ta' xi kundizzjonijiet tal-istonku (sustanzi biex jgħinu l-motilità gastrointestinali)
English: Contraindications of concomitant use (see section 4.3) INCIVO must not be administered concurrently with active substances that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events such as cardiac arrhythmia (i.e., amiodarone, astemizole, bepridil, cisapride, pimozide, quinidine, terfenadine), or peripheral vasospasm or ischemia (i.e., dihydroergotamine, ergonovine, ergotamine, methylergonovine), or myopathy, including rhabdomyolysis (i.e., lovastatin, simvastatin, atorvastatin), or prolonged or increased sedation or respiratory depression (i.e., quetiapine, orally administered midazolam or triazolam), or hypotension or cardiac arrhythmia (i.e., alfuzosin and sildenafil for pulmonary arterial hypertension).
Maltese: Kontraindikazzjonijiet rigward użu ma' mediċini oħra (ara sezzjoni 4.3) INCIVO m'għandux jingħata flimkien ma' sustanzi attivi li huma dipendenti ħafna fuq is-CYP3A għat-tneħħija u li konċentrazzjonijiet għoljin tagħhom fil-plażma huma assoċjati ma' każijiet serji u/jew ta' periklu għall-ħajja bħal arritmija tal-qalb (i.e., amiodarone, astemizole, bepridil, cisapride, pimozide, quinidine, terfenadine), jew spażmu tal-arterji u tal-vini periferali jew iskemija (i.e., dihydroergotamine, ergonovine, ergotamine, methylergonovine), jew mijopatija, li tinkludi rabdomijolisi (i.e., lovastatin, simvastatin, atorvastatin), jew żieda fit-tul ta' ħin jew fl-ammont ta' sedazzjoni jew dipressjoni repiratorja (i.e. quetiapine, midazolam jew triazolam mogħtija mill-ħalq), jew pressjoni baxxa jew arritmija tal-qalb (i.e., alfuzosin u sildenafil meta jintuża għal pressjoni
English: Telaprevir exposure is comparable during co-administration with either peginterferon alfa-2a and ribavirin or peginterferon alfa-2b and ribavirin.
Maltese: Esponiment għal telaprevir kien jixxiebah kemm waqt l-għoti flimkien ma' peginterferon alfa-2a u ribavirin kif ukoll ma' peginterferon alfa-2b u ribavirin.
English: Results of a study conducted in healthy volunteers demonstrated a modest effect of telaprevir at a dose of 1,875 mg every 8 hours on the QTcF interval with a placebo-adjusted maximum mean increase of 8.0 msec (90% CI: 5.1-10.9) (see section 5.1).
Maltese: Riżultati minn studju li sar f'voluntiera f'saħħithom wera effett modest ta' telaprevir b'doża ta' 1,875 mg kull 8 sigħat fuq l-intervall QTcF b'żieda medja massima aġġustata bi plaċebo ta' 8.0 msek (90% CI: 5.1-10.9) (ara sezzjoni 5.1).
English: The highest documented INCIVO dose administered is 1,875 mg every 8 hours for 4 days in healthy volunteers.
Maltese: L-ogħla doża ddokumentata li ngħatat ta' INCIVO kienet 1,875 mg kull 8 sigħat għal 4 ijiem f'voluntiera f'saħħithom.
English: See also section 4.3 for medicinal products which are contraindicated with INCIVO.
Maltese: Ara wkoll sezzjoni 4.3 għal prodotti mediċinali li huma kontraindikati ma' INCIVO.
English: RNA levels ≥ 800,000 IU/ml; 10.8% had bridging fibrosis; none had cirrhosis; 38.9% had HCV genotype 1a; 58.3% had HCV genotype 1b; 2.8% had HCV genotype 1d; 21.6% had IL28B genotype CC; 54.1% had IL28B genotype CT; 24.3% had IL28B genotype TT; 28.4% (n = 21) were HCV treatment- naïve; 71.6% (n = 53) were treatment-experienced [14.9% (n = 11) were prior relapsers; 40.5% (n = 30) were prior non-responders; 16.2% (n = 12) could not be classified]; median time since liver transplantation was 2.5 years (range: 0.6 to 9.5 years); 67.6% (n = 50) received tacrolimus; 32.4% (n = 24) received cyclosporine A.
Maltese: 8% kellhom fibrosi li tipponta; ħadd ma kellu ċirrosi; 38.9% kellhom HCV ġenotip 1a; 58.3% kellhom ġenotip 1b; 2.8% kellhom HCV ġenotip 1d; 21.6% kellhom IL28B ġenotip CC; 54.1% kellhom IL28B ġenotip CT; 24.3% kellhom IL28B ġenotip TT; 28.4% (n = 21) ma kellhomx trattament qabel; 71.6% (n = 53) kellhom esperjenza ta' trattament qabel [14.9% (n=11) kienu rkadew qabel; 40.5% (n = 30) ma kinux rrispondew qabel; 16.
English: In placebo-controlled Phase 2 and 3 trials, severe rash (primarily eczematous, pruritic and involving more than 50% body surface area) was reported in 4.8% of patients who received INCIVO combination treatment compared to 0.4% receiving peginterferon alfa and ribavirin.
Maltese: Fil-provi kkontrollati bi paċebo tal-Fażi 2 u 3, raxx qawwi (primarjamennt ekżematuż, bil-ħakk u jinvolvi aktar minn 50% tal-erja tas-superfiċje tal-ġisem) kien irrappurtat f'4.8% tal-pazjenti li rċivew taħlita ta' kura li tinkludi INCIVO meta mqabbel ma' 0.4% li kienu qed jirċievu peginterferon alfa u ribavirin.
English: Table 6 shows SVR rates by IL28B genotype and the stage of liver fibrosis at baseline.
Maltese: Tabella 6 turi r-rati tal-SVR skont il-ġenotip IL28B u l-istadju tal-fibrożi tal-fwied fil-linja bażi.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Patients on an efavirenz-based regimen must receive INCIVO 1,125 mg every 8 hours.
Maltese: Ilpazjenti fuq skeda abbażi ta' efavirenz għandhom jirċievu INCIVO 1,125 mg kull 8 sigħat.
English: - INCIVO 1,125 mg every 12 hours with peginterferon alfa-2b 1.5 g/kg/week and ribavirin
Maltese: - INCIVO 1,125 mg kull 12-il siegħa ma' peginterferon alfa-2b 1.5 g/kg/ġimgħa u ribavirin
English: Prior Relapsers N = 29 % (n/N)
Maltese: Il-pazjenti kollha N = 74 % (n/N)
English: Most drug-drug interaction studies have been performed with a telaprevir dose of 750 mg every 8 hours (q8h).
Maltese: Il-maġġorparti tal-istudji dwar interazzjoni ta' mediċini twettqu b'doża ta' telaprevir ta' 750 mg kull 8 sigħat (q8h).
English: Study 108 was a randomised, double-blind, parallel-group, placebo-controlled, Phase 3 study conducted in treatment-naïve patients.
Maltese: L-istudju 108 kien studju tal-Fażi 3, randomised, double-blind, bi grupp parallel, ikkontrollat bi plaċebo li sar f'pazjenti li qatt ma kienu ħadu kura qabel.
English: Steady-state exposure to telaprevir was 15% lower in subjects with mild hepatic impairment (Child-Pugh Class A, score 5-6) compared to healthy subjects.
Maltese: Esponiment għal telaprevir fl-istat fiss kien 15% anqas f'individwi b'indeboliment ħafif tal-fwied (Child-Pugh Klassi A, punteġġ 5-6) meta mqabbel ma' individwi f'saħħithom.
English: See section 4.4 for recommendations for monitoring of rash and discontinuation of INCIVO, ribavirin, and peginterferon alfa.
Maltese: Ara sezzjoni 4.4 għal rakkomandazzjonijiet għall-monitoraġġ tar-raxx, u għat-twaqqif ta' INCIVO, ribavirin u peginterferon alfa.
English: AUC 0.80 (0.76-0.85) Cmax 0.79 (0.74-0.84) Cmin 0.85 (0.75-0.98) ↑ atazanavir AUC 1.17 (0.97-1.43) Cmax 0.85 (0.73-0.98) Cmin 1.85 (1.40-2.44) inhibition of CYP3A by telaprevir
Maltese: ↓ telaprevir 750 mg q8h AUC 0.84 (0.71-0.98) Cmax 0.90 (0.79-1.02) Cmin 0.75 (0.61-0.92) ↔ etravirine (+ TVR 750 mg q8h) AUC 0.94 (0.85-1.04) Cmax 0.93 (0.84-1.03) Cmin 0.97 (0.86-1.10)
English: In vitro studies performed with human Caco-2 cells indicated that telaprevir is a substrate of P-glycoprotein (P-gp).
Maltese: Studji in vitro li saru b'ċelluli Caco-2 talbniedem juru li telaprevir huwa sottostrat tal-glikoproteina-P (P-gp).
English: Plasma concentrations of telaprevir can be reduced by concomitant use of the herbal preparation St John's wort (Hypericum perforatum).
Maltese: Il-konċentrazzjonijiet ta' telaprevir fil-plażma jistgħu jonqsu permezz tal-użu flimkien mal-mediċina magħmula mill-ħxejjex St John's wort (Hypericum perforatum).
English: Based on the results of drug-drug clinical interaction studies (e.g., escitalopram, zolpidem, ethinylestradiol), induction of metabolic enzymes by telaprevir cannot be excluded.
Maltese: Skont ir-riżultati ta' studji kliniċi dwar l-interazzjoni bejn mediċina u oħra (e.ż., escitalopram, zolpidem, ethinylestradiol), ma tistax tiġi eskluża linduzzjoni ta' enzimi metaboliċi minn telaprevir.
English: Potent CYP3A inducers, such as carbamazepine, phenytoin and phenobarbital, are contraindicated
Maltese: L-użu ta' indutturi CYP3A qawwija, bħal carbamazepine, phenytoin u phenobarbital, huwa kontraindikat (ara sezzjoni 4.3).
English: Patients with HCV genotype 1a predominately had V36M and R155K single and combination variants, while patients with HCV genotype 1b predominately had V36A, T54A/S, and A156S/T/V variants.
Maltese: Pazjenti b'HCV tal-ġenotip 1a l-biċċa l-kbira kellhom varjanti V36M uR155K singoli u mħallta, filwaqt li pazjenti b'HCV tal-ġenotip 1b l-biċca l-kbira kellhom varjanti V36A, T54A/S, u A156S/T/V.
English: - INCIVO 1,125 mg every 12 hours with peginterferon alfa-2a 180 g/week and ribavirin
Maltese: - INCIVO 1,125 mg kull 12-il siegħa ma' peginterferon alfa-2a 180 g/ġimgħa u ribavirin
English: BOTTLE LABEL (4-bottle pack)
Maltese: KARTUNA TA' BARRA (pakkett b'4 fliexken)
English: AUC 0.53 (0.47-0.60) Cmax 0.68 (0.60-0.77) Cmin 0.32 (0.25-0.42) ↑ phenytoin
Maltese: AUC 0.60 (0.57-0.63) Cmax 0.60 (0.56-0.64) Cmin 0.58 (0.52-0.63) mekkaniżmu mhux magħruf
English: 73.8% (59/80) of patients in the pooled peginterferon alfa-2a group met the criteria (undetectable HCV RNA (target not detected) at week 4 through week 20) for the shortened 24 week peginterferon/ribavirin treatment duration versus 61.7% (50/81) of patients in the pooled
Maltese: 73.8% (59/80) tal-pazjenti fil-ġabra ta' gruppi ta' peginterferon alfa-2a issodisfaw il-kriterji (RNA ta' HCV li hija ftit wisq biex titkejjel (target ma jistax jitkejjel) filġimgħa 4 sal-ġimgħa 20) għaż-żmien ta' kura mqassar b'peginterferon/ribavirin għal 24 ġimgħa meta mqabbel ma' 61.7% (50/81) tal-pazjenti fil-ġabra ta' gruppi ta' peginterferon alfa-2b.
English: The pharmacokinetic properties of telaprevir have been evaluated in healthy adult volunteers and in subjects with chronic HCV infection.
Maltese: Il-kwalitajiet farmakokinetiċi ta' telaprevir ġew evalwati f'voluntiera adulti f'saħħithom u f'individwi b'infezzjoni kronika ta' HCV.
English: The difference in SVR rates (95% confidence interval) between the T12/PR and Pbo/PR groups were 63 (51, 74) for prior relapsers, 46 (27, 66) for prior partial responders, and 26 (13,
Maltese: Id-differenza fir-rati ta' SVR (95% confidence interval) bejn il-gruppi T12/PR u Pbo/PR kienet 63 (51, 74) għal dawk li qabel kienu rkadew, 46 (27, 66) għal dawk li qabel ma kinux irrispondew b'mod sħiħ, u 26 (13, 39) għal dawk li qabel ma kienu rrispondew xejn għal kura.
English: HORMONAL CONTRACEPTIVES/OESTROGEN ethinylestradiol* norethindrone*
Maltese: fosamprenavir/ritonavir*
English: HCV RNA levels should be monitored at weeks 4 and 12 and as clinically indicated (see also guidelines for discontinuation of INCIVO, section 4.2).
Maltese: Livelli tal-RNA ta' HCV għandhom jiġu mmonitorjati fil-ġimgħat 4 u 12 u kif indikat b'mod kliniku (ara wkoll il-Linji Gwida għat-Twaqqif ta' Kura b'INCIVO, sezzjoni 4.2).
English: Table 1: Guidelines for discontinuation of INCIVO, Peginterferon Alfa, and Ribavirin treatment
Maltese: Tabella 1: Linji Gwida għat-Twaqqif ta' Kura b'INCIVO, Peginterferon Alfa, u Ribavirin Prodotti mediċinali
English: The combination may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations, and sinus tachycardia (see section 4.4).
Maltese: It-taħlita tista' twassal għal żieda fir-riskju ta' każjiet kardjovaskulari avversi assoċjati ma' salmeterol, li jinkludu titwil tal-QT, palpitazzjonijiet, u takikardija tas-sinus (ara sezzjoni 4.4).
English: Concomitant administration of INCIVO with active substances that strongly induce CYP3A e.g. rifampicin, St John's wort (Hypericum perforatum), carbamazepine, phenytoin and phenobarbital and thus may lead to lower exposure and loss of efficacy of INCIVO.
Maltese: L-għoti konkomitanti ta' INCIVO flimkien ma' sustanzi attivi li jinduċu s-CYP3A b'mod qawwi, eż. rifampicin, St John's wort (Hypericum perforatum), carbamazepine, phenytoin u phenobarbital jistgħu jnaqqsu l-esponiment għal INCIVO u jtellfu mill-effikaċja tiegħu.
English: Treatment outcome
Maltese: TAL-PRODOTT MEDIĊINALI
English: Refer to the Summary of Product Characteristics for peginterferon alfa and ribavirin, including pregnancy testing requirements (see section 4.6).
Maltese: Ara s-Sommarju tal-Karatteristiċi tal-Prodott ta' peginterferon alfa u ribavirin, inkluż il-ħtieġa ta' ittestjar għat-tqala (ara sezzjoni 4.6).
English: Pharmacotherapeutic group: Direct-acting antiviral, ATC code: J05AE11.
Maltese: Antivirali b'azzjoni diretta, Kodiċi ATC:
English: Gastrointestinal disorders very common nausea, diarrhoea, vomiting, haemorrhoids, proctalgia common anal pruritus, rectal haemorrhage, anal fissure uncommon proctitis, pancreatitis
Maltese: Disturbi gastro-intestinali komuni ħafna nawsja, dijarea, rimettar, murliti, proktalġja komuni ħakk fl-anus, emorraġija mir-rektum, fissura fl-anus mhux komuni
English: abacavir
Maltese: ↑ telaprevir
English: In vitro studies demonstrated that telaprevir is not an inhibitor of UGT1A9 or UGT2B7.
Maltese: Studji in vitro wrew li telaprevir mhuwiex impeditur ta' UGT1A9 jew UGT2B7.
English: All patients started with a dose of 600 mg/day of ribavirin and 180 µg/week of peginterferon alfa-2a.
Maltese: Il-pazjenti kollha bdew b'doża ta' 600 mg/jum ta' ribavirin u 180 µg/ġimgħa ta' peginterferon alfa-2a.
English: Patients received INCIVO at a dosage of 750 mg every 8 hours.
Maltese: INCIVO f'dożaġġ ta' 750 mg kull 8 sigħat.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu/.
English: In treatment-naïve patients in the Phase 3 studies, 4/16 (25%) patients with HCV RNA levels between 100 IU/ml and 1,000 IU/ml at week 4 achieved SVR.
Maltese: F'pazjenti tal-istudji tal-Fażi 3 li qatt ma ħadu kura qabel, 4 minn kull 16-il pazjent (25%) b'livelli ta' RNA ta' HCV ta' bejn 100 IU/ml u 1,000 IU/ml fil-ġimgħa 4 kisbu SVR.