FrancophonIA/ELRC3.0 huggingface dataset:
English: ADRs are listed by system organ class (SOC) and frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and rare (≥ 1/10,000 to < 1/1,000).
Maltese: L-ADRs huma elenkati skont il-klassi tas-sistemi u tal-organi (SOC) u l-frekwenza: komuni ħafna, (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100) u rari (≥ 1/10,000 sa < 1/1,000).
English: Table 4: Selected laboratory abnormalities (DAIDS
Maltese: Tabella 4: Anormalitajiet tal-laboratorju magħżula (DAIDS
English: Telaprevir is approximately 59% to 76% bound to plasma proteins.
Maltese: Madwar 59% sa 76% ta' telaprevir huwa marbut ma' proteini tal-plażma.
English: Johnson & Johnson România SRL Str. Tipografilor nr. 11-15 Clădirea S-Park, Corp A2, Etaj 5 013714 Bucureşti, ROMÂNIA Tel: +40 21 207 1800
Maltese: Tipografilor nr. 11-15 Clădirea S-Park, Corp A2, Etaj 5 013714 Bucureşti, ROMÂNIA Tel: +40 21 207 1800
English: The SVR rate for the T8/PR group was 72% (261/364) (P < 0.0001 compared to Pbo/PR48 group).
Maltese: Ir-rata ta' SVR għall-grupp T8/PR kienet 72% (261/364) (P < 0.0001 meta mqabbel mal-grupp Pbo/PR48).
English: Table 8:
Maltese: Tabella 16:
English: Nagyenyed u. 8-14 H-Budapest, 1123
Maltese: Nagyenyed u. 8-14
English: For additional information, see sections 4.5 and 4.6.
Maltese: Għal aktar informazzjoni, ara sezzjonijiet 4.5 u 4.6.
English: Hepatobiliary disorders common hyperbilirubinaemia
Maltese: Hyperbilirubinaemia
English: Clinical comment
Maltese: Kumment kliniku
English: astemizole, terfenadine to treat allergy symptoms (antihistamines)
Maltese: astemizole, terfenadine għal kura tas-sintomi tal-allerġija (antiistamini)
English: Telaprevir is a weak in vitro inhibitor of the transporters multidrug and toxin extrusion (MATE) MATE1 and MATE2-K with an IC50 of 28.3 μM and 32.5 μM, respectively.
Maltese: In vitro telaprevir huwa inibitur dgħajjef tat-trasportaturi ta' estrużjoni ta' mediċini multipli u tossini (MATE - multidrug and toxin extrusion) MATE1 u MATE2-K b'IC50 ta' 28.3 μM u 32.5 μM, rispettivament.
English: The SVR rate for Black patients was 62% (45/73).
Maltese: Ir-rata ta' SVR għall-pazjenti Suwed kienet ta' 62% (45/73).
English: For the full list of excipients, see section 6.1.
Maltese: Għal-lista kompluta ta' sustanzi eċċipjenti, ara sezzjoni 6.1.
English: For additional information on mild to moderate rash, see section 4.8.
Maltese: Għal aktar informazzjoni dwar raxx minn ħafif sa moderat, ara sezzjoni 4.8.
English: Transfusion rates over the whole study period were 4.6% and 1.6%, respectively.
Maltese: Ir-rati ta' trasfużjoni tul ilperjodu ta' studju kollu kienu ta' 4.6% u 1.6% rispettivament.
English: T12(DS)/PR % (n/N) ≥ 1 log10 reduction in HCV RNA at week 4
Maltese: T12(DS)/PR % (n/N) Tnaqqis ≥ 1 log10 fl-HCV RNA fil-ġimgħa 4
English: No relevant inhibition by telaprevir of alcohol dehydrogenase was observed in vitro.
Maltese: Ma ġie osservat l-ebda impediment rilevanti għall-alcohol dehydrogenase minn telaprevir in vitro.
English: C - telaprevir and VRT-127394 towards total radioactivity recovered in faeces was 31.8% and 18.7%, respectively.
Maltese: C mhux mibdul u VRT-127394 għat-total ta' radjuattivita rkuprata fl-ippurgar kienet ta' 31.8% u 18.7%,
English: ↑ triazolam inhibition of CYP3A
Maltese: ↑ colchicine impediment ta' CYP3A
English: to decrease blood pressure (calcium channel blockers) to treat HIV infections (CCR5 antagonist)
Maltese: biex inaqqsu l-pressjoni (imblokkaturi tal-kanali tal-kalċju) għal kura ta' infezzjonijiet bl-HIV (antagonisti ta' CCR5)
English: QT interval prolongation and Torsade de Pointes have been reported with clarithromycin and erythromycin.
Maltese: Titwil tal-intervall QT u Torsade de Pointes kienu rrappurtati bi clarithromycin u erythromycin.
English: Variants V36A/M, T54A/S, R155K/T, and A156S conferred lower levels of in vitro resistance to telaprevir (3- to 25-fold increase in telaprevir IC50), and the A156V/T and V36M+R155K variants conferred higher levels of in vitro resistance to telaprevir (> 25-fold increase in telaprevir IC50).
Maltese: Il-varjanti V36A/M, T54A/S, R155K/T, u A156S taw livelli aktar baxxi ta' reżistenza in vitro għal telaprevir (żjieda ta' 3 darbiet sa 25 darba aktar fl-IC50 ta' telaprevir), u l-varjanti A156V/T u V36M+R155K taw livelli ogħla ta' reżistenza in vitro għal telaprevir (żieda ta' > 25 darba fl-IC50 ta' telaprevir).
English: Purpose of the medicine alfuzosin to treat symptoms of an enlarged prostate (alpha-1-adrenoreceptor antagonists)
Maltese: Skop tal-mediċina alfuzosin għal kura ta' sintomi ta' tkabbir tal-prostata (antagonisti ta' alpha-1-adrenoreceptor)
English: Population pharmacokinetic analysis of INCIVO in HCV-infected subjects indicated that the exposure to telaprevir was similar in Blacks/African-Americans and Caucasians.
Maltese: Analiżi farmakokinetika ta' popolazzjoni ta' INCIVO f'individwi infettati bl-HIV indikaw li lesponiment għal telaprevir kien simili fis-Suwed/Amerikani-Afrikani u fil-Kawkasi.
English: (< 350/mm potassium
Maltese: (< 350/mm
English: Median (range) CD4 cell count at baseline was 651 (277 to 1,551 cells/mm
Maltese: Il-medjan (firxa) tal-għadd taċ-ċelluli CD4 fil-linja bażi kien 651 (277 sa 1,551 ċellula/mm
English: A total of 215 of 1,169 patients treated with a T12/PR regimen in a Phase 3 clinical trial had on-treatment virologic failure (n = 125) or relapse (n = 90).
Maltese: Total ta' 215 minn 1,169 pazjent ikkurati bi skeda ta' T12/PR fi prova klinika tal-Fażi 3 kellhom falliment viroloġiku meta ngħatat il-kura jew (n = 125) jew irkadar (n = 90).
English: Tacrolimus may prolong the QT interval (see section 4.4).
Maltese: Tacrolimus jista' jtawwal l-intervall QT (ara sezzjoni 4.4).
English: Other enzymes are also involved in the metabolism such as aldo-ketoreductases and other proteolytic enzymes.
Maltese: Enzimi oħra huma wkoll involuti fil-metaboliżmu bħal aldo-ketoreductases u enzimi proteolitiċi oħra.
English: P < 0.001, T12/PR compared to Pbo/PR48.
Maltese: P < 0.001, T12/PR imqabbel ma' Pbo/PR48.
English: QT interval prolongation and Torsade de Pointes have been reported with voriconazole and posaconazole.
Maltese: Titwil tal-intervall QT u Torsade de Pointes kienu rrappurtati b'voriconazole u posaconazole.
English: Refer to sections 4.4 and 4.6.
Maltese: Irreferi għal sezzjonijiet 4.4 u 4.6.
English: INCIVO has not been studied in HCV-infected patients with moderate hepatic impairment (Child-Pugh B, score 7-9).
Maltese: INCIVO ma ġiex studjat f'pazjenti b'indeboliment moderat tal-fwied infettati b'HCV (Child-Pugh B, punteġġ 7-9).
English: The mean elimination half-life after single-dose oral administration of telaprevir 750 mg typically ranged from about 4.0 to 4.7 hours.
Maltese: Il-half-life medja ta' eliminazzjoni wara għoti ta' doża singola ta' telaprevir 750 mg mill-ħalq kienet tipikament fuq medda ta' bejn 4.0 u 4.7 sigħat.
English: Sequence analyses of the telaprevir-resistant variants identified substitutions at 4 positions in the NS3-4A protease region, consistent with the mechanism of action for telaprevir (V36A/M, T54A/S, R155K/T, and A156S/T/V).
Maltese: L-analiżi tassekwenza tal-varjanti reżistenti għal telaprevir identifikat sostituzzjonijiet f'4 pożizzjonijiet fil-qasam NS3-4A tal-protease, konsistenti mal-mekkaniżmu ta' azzjoni ta' telaprevir (V36A/M, T54A/S, R155K/T, u A156S/T/V).
English: No relevant inhibition by telaprevir of CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP2E1 isozymes was observed in vitro.
Maltese: L-ebda impediment rilevanti tal-isozimi CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 u CYP2E1 permezz ta' telaprevir ma kien osservat in vitro.
English: These are recommended baseline values for initiation of INCIVO combination treatment: - Haemoglobin: ≥ 12 g/dl (females); ≥ 13 g/dl (males)
Maltese: - Emoglobina: ≥ 12 g/dl (nisa); ≥ 13 g/dl (rġiel)
English: PL-02-135 Warszawa Tel: +48 22 237 60 00
Maltese: Warszawa Tel: +48 22 237 60 00
English: A total of 352 (65%) patients had undetectable HCV RNA (target not detected) at weeks 4 and 12.
Maltese: Total ta' 352 (65%) pazjent kellhom ftit wisq RNA tal-HCV biex titkejjel (target ma jistax jitkejjel) fil-ġimgħat 4 u 12.
English: No relevant induction by telaprevir of CYP1A2, CYP2B6, CYP2C, and CYP3A isozymes was observed in vitro.
Maltese: L-ebda induzzjoni rilevanti tal-isozimi CYP1A2, CYP2B6, CYP2C, and CYP3A permezz ta' telaprevir ma kien osservat in vitro.
English: The total dose is 6 tablets per day.
Maltese: Id-doża totali hija 6 pilloli kuljum.
English: Other enzymes are also involved in the metabolism (see section 5.2).
Maltese: Enzimi oħra huma involuti wkoll fil-metaboliżmu (ara sezzjoni 5.2).
English: ↑ PDE-5 inhibitors inhibition of CYP3A
Maltese: ↑ impedituri PDE-5 impediment ta' CYP3A
English: CYP3A4 is partly responsible for the metabolism of telaprevir.
Maltese: CYP3A4 huwa parzjalment reponsabbli għall-metaboliżmu ta' telaprevir.
English: Yellow caplet-shaped tablets of approximately 20 mm in length, marked with ‘T375' on one side.
Maltese: Pilloli sofor forma ta' kapsula twal madwar 20 mm, immarkati ‘T375' fuq naħa
English: The mean telaprevir Cmax and AUC were 10% and 21% greater, respectively, compared to healthy subjects (see section 4.2).
Maltese: Il-medja tas-Cmax u l-AUC ta' telaprevir kienu 10% u 21% ogħla, rispettivament, meta mqabbla ma' individwi f'saħħithom (ara sezzjoni 4.2).
English: In Study HPC3008 (see sections 4.8 and 5.1), transient grade 3 (2.5 to ≤5 X ULN) and grade 4 (>5 X ULN) bilirubin increases during INCIVO treatment were seen in 39% and in 22% of the 59 patients on atazanavir/ritonavir, respectively.
Maltese: Fl-Istudju HPC3008 (ara sezzjonijiet 4.8 u 5.1), żidiet temporanji ta' grad 3 (2.5 sa ≤ 5 X ULN) u ta' grad 4 (> 5 X ULN) fil-bilirubin waqt kura b'INCIVO dehru f'39% u fi 22% mill-59 pazjent fuq atazanavir/ritonavir, rispettivament.
English: tenofovir disoproxil fumarate*
Maltese: tenofovir disoproxil fumarate* ↔ telaprevir
English: In patients who have an inadequate viral response, treatment should be discontinued (see sections 4.2 and 4.4, Laboratory tests).
Maltese: F'pazjenti li ma kellhomx rispons viroloġiku suffiċjenti, il-kura għandha titwaqqaf (ara sezzjonijiet 4.2 u 4.4, Testijiet tal-laboratorju).
English: Clinical relevance unknown.
Maltese: Rilevanza klinika mhux magħrufa.
English: Consult with a specialist in dermatology.
Maltese: Ikkunsidra konsultazzjoni ma' speċjalista tad-dermatoloġija.
English: The safety and efficacy of INCIVO in children aged < 18 years have not yet been established.
Maltese: Is-sigurtà u effikaċja ta' INCIVO fi tfal ta' < 18 years ma ġewx determinati s'issa.
English: Caution is recommended when prescribing INCIVO concurrently with medicinal products known to induce QT prolongation and which are CYP3A substrates such as erythromycin, clarithromycin, telithromycin, posaconazole, voriconazole, ketoconazole, tacrolimus, salmeterol (see section 4.5).
Maltese: Hija rrakkomandata l-kawtela meta wieħed jordna INCIVO flimkien ma' prodotti mediċinali magħrufa li jinduċu titwil tal-intervall QT u li huma sottostrati ta' CYP3A bħal ma huma erythromycin, clarithromycin, telithromycin, posaconazole, voriconazole, ketoconazole, tacrolimus, salmeterol, (ara sezzjoni 4.5).
English: HCV sequencing data were not available for 16 (7%) patients.
Maltese: Dejta ta' sekwenzar ta' HCV ma kinitx disponibbli għal 16-il individwu (7%).
English: Telaprevir is a strong inhibitor of the important drug metabolising enzyme CYP3A4.
Maltese: Telaprevir huwa inibitur qawwi tal-enżima CYP3A4 importanti għal metabolizzazzjoni tal-mediċini.
English: In an HCV subtype 1b replicon assay, the telaprevir IC50 value against wild-type HCV was 0.354 µM similar to a subtype 1a infectious virus assay IC50 of 0.28 µM.
Maltese: F'analiżi ta' replikazzjoni minn oriġini singola tas-sottotip 1b ta' HCV, il-valur IC50 ta' telaprevir kontra HCV li jinstab fin-natura kien 0.354 µM li jixbah lill-analiżi ta' virus infettiv tas-sottotip 1a
English: Study 108 (ADVANCE)
Maltese: Studju 111 (ILLUMINATE)
English: Based upon population pharmacokinetic modelling of telaprevir steady-state exposures, the Geometric Mean Least Square Ratios (90% CI) of 1,125 mg twice daily (b.i.d.)
Maltese: Fuq bażi ta' mudelli farmakokinetiċi tal-poplu għall-esponiment ‘steady-state' għal telaprevir, il-‘Geometric Mean Least Square Ratios' (90% CI) ta' 1,125 mg darbtejn kuljum (b.i.d.) kontra 750 mg kull 8 sighat (q8h)
English: alprazolam*
Maltese: digoxin*
English: Based on in vitro studies, telaprevir may potentially increase plasma concentrations of medicinal products in which excretion is dependent upon multidrug and toxin extrusion (MATE)-1 and MATE2-K (see table 2).
Maltese: Ibbażat fuq lis-studji in vitro, telaprevir jista potenzjalment iżid il- konċentrazzjonijiet fil-plażma talprodotti mediċinali fejn it-tneħħija hija dependenti fuq estrużjoni ta' mediċini multipli u tossini (multidrug and toxin extrusion, MATE-1) u MATE2-K (ara tabella 2).
English: Studies using recombinant human CYP supersomes showed that telaprevir was a CYP3A4 inhibitor, and a time- and concentration-dependent inhibition of CYP3A4 by telaprevir was observed in human liver microsomes.
Maltese: Studji li użaw supersomi rikombinanti ta' CYP umani wrew li telaprevir kien impeditur ta' CYP3A4, u impediment ta' CYP3A4 dipendenti mill-ħin u mill-konċentrazzjoni permezz ta' telaprevir kien osservat fil-mikrosomi tal-fwied uman.
English: Haemoglobin values of < 8.5 g/dl were observed in 8% of INCIVO combination treatment compared to 2% of patients receiving peginterferon alfa and ribavirin.
Maltese: Valuri tal-emoglobina ta' < 8.5 g/dl kienu osservati fi 8% tat-taħlita ta' kura li tinkludi INCIVO meta mqabbla ma' 2% talpazjenti li rċivew peginterferon alfa u ribavirin.
English: In INCIVO clinical experience, less than 0.1% of patients had Stevens-Johnson Syndrome (SJS).
Maltese: F'esperjenza klinika b'INCIVO, anqas minn 0.1% tal-pazjenti kellhom is-Sindrome ta' Stevens-Johnson (SJS).
English: HCV RNA > 1,000 IU/ml at week 12 of treatment
Maltese: HCV RNA > 1,000 IU/ml filġimgħa 12 ta' kura
English: The Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (DAIDS, version 1.0, December 2004) was used in the pooled laboratory datasets.
Maltese: Id-Diviżjoni tat-Tabella tal-AIDS għall-Gradi ta' Qawwa ta' Każijiet Avversi fl-Adulti u fit-Tfal (DAIDS, verżjoni 1.0, Diċembru 2004) intużat fis-settijiet tal-ġabra ta' dejta tal-laboratorju.
English: The pharmacokinetics of telaprevir were assessed after administration of a single dose of 750 mg to HCV-negative subjects with severe renal impairment (CrCl < 30 ml/min).
Maltese: Il-farmakokinetika ta' telaprevir kienet stmata wara għoti ta' doża waħda ta' 750 mg lil individwi li ma kellhomx HCV b'indeboliment qawwi tal-kliewi (CrCl < 30 ml/min).
English: )/PR group was 74% (274/369) compared to 73% (270/371) in the T12(q8h)/PR group with 95% confidence interval of the difference: -4.9%, 12.0%.
Maltese: Ir-rata ta' SVR12 għall-grupp T12(b.i.d.)/PR kienet ta' 74% (274/369) meta mqabbla ma' 73% (270/371) fil-grupp T12(q8h)/PR b'95% intervall tal-kunfidenza tad-differenza: -4.9%, 12.0%.
English: Severe, potentially life-threatening and fatal skin reactions have been reported with INCIVO combination treatment, including DRESS, SJS, and TEN (see section 4.4).
Maltese: Reazzjonijiet severi tal-ġilda potenzjalment ta' periklu għall-ħajja u fatali ġew irrappurtati b'taħlita ta' kura li tinkludi INCIVO, inkluż DRESS, SJS u TEN (ara sezzjoni 4.4).
English: There are no clinical data on re-treating patients who have failed an HCV NS3-4A protease inhibitor-based therapy (see section 5.1).
Maltese: M'hemm l-ebda dejta klinika dwar kura mill-ġdid ta' pazjenti li jkunu fallew terapija bbażata fuq impeditur protease HCV NS3-4A (ara sezzjoni 5.1).
English: Patients were randomised in a 2:2:1 ratio to one of three treatment groups: simultaneous start (T12/PR48): INCIVO from day 1 through week 12; delayed start (T12(DS)/PR48): INCIVO from week 5 through week 16; Pbo/PR48: placebo through week 16.
Maltese: Il-pazjenti kienu radomised fi proporzjon ta' 2:2:1 għal wieħed mit-tliet gruppi ta' kura: bidu fl-istess ħin (T12/PR48): INCIVO minn jum 1 sa ġimgħa 12; bidu mdewwem (T12(DS)/PR48): INCIVO millġimgħa 5 sal-ġimgħa 16; Pbo/PR48: plaċebo sal-ġimgħa 16.
English: Table 8 shows SVR rates for patient subgroups.
Maltese: Tabella 8 turi r-rati ta' SVR għas-sottogruppi ta' pazjenti.
English: Telaprevir is partly metabolised in the liver by CYP3A and is a P-glycoprotein (P-gp) substrate.
Maltese: Telaprevir huwa parzjalment immetabolizzat fil-fwied permezz ta' CYP3A u huwa sottostrat talglikoproteina P ( P-gp).
English: Efficacy in adults with HCV/HIV-1 co-infection
Maltese: Effikaċja fl-adulti b'koinfezzjoni ta' HCV/HIV-1
English: Co-administration with carbamazepine is contraindicated.
Maltese: L-għoti flimkien ma' carbamazepine huwa kontraindikat.
English: QT interval prolongation and Torsade de Pointes have been reported with methadone (see section 4.4).
Maltese: Titwil tal-intervall QT u Torsade de Pointes kienu rrappurtati b'methadone (ara sezzjoni 4.4).
English: Chemistry evaluations (electrolytes, serum creatinine, uric acid, hepatic enzymes, bilirubin, TSH) are recommended as frequently as the haematology evaluations or as clinically indicated (see section 4.8).
Maltese: Stimi kimiċi (elettroliti, kreatinina fis-serum, aċidu uriku, enzimi tal-fwied, bilirubin, TSH) huma rrakkomandati bl-istess frekwenza bħall-istimi ematoloġiċi jew kif indikat b'mod kliniku (ara sezzjoni 4.8).
English: Clinical and laboratory monitoring for hyperbilirubinaemia is recommended (see section 4.4 and 4.8).
Maltese: Huwa rrakkomandat il-monitoraġġ kliniku u tal-laboratorju għal iperbilirubinemija (ara sezzjoni 4.4 u 4.8).
English: INCIVO contains a substance called telaprevir and belongs to a group of medicines called ‘NS3-4A protease inhibitors'.
Maltese: INCIVO fih sustanza msejħa telaprevir u jagħmel parti minn grupp ta' mediċini msejħa‘impedituri ta' protease NS3-4A'.
English: When compared to administration following a standard normal caloric meal, exposure (AUC) decreased by 73% when telaprevir was taken on an empty stomach, by 26% following a low-calorie high-protein meal (9 g fat, 260 kcal), and by 39% following a low-calorie low-fat meal (3.6 g fat, 249 kcal).
Maltese: Meta tqabbel ma' għoti wara ikla normali b'ammont ta' kaloriji standard, l-esponiment (AUC) naqas b'73% meta telaprevir ittieħed fuq stonku vojt, b'26% wara ikla b'ammont għoli ta' proteini u bi ftit kaloriji (9 g ta' xaħam, 260 kkal), u b'39% wara ikla b'ammont baxx ta' kaloriji u ta' xaħam (3.6 g ta' xaħam, 249 kkal).
English: Excipient: 2.3 mg of sodium per film-coated tablet.
Maltese: 2.3 mg sodium f'kull pillola miksija b'rita.
English: In placebo-controlled Phase 2 and 3 trials, 1.9% of patients discontinued INCIVO alone due to anaemia, and 0.9% of patients discontinued INCIVO combination treatment due to anaemia compared to 0.5% receiving peginterferon alfa and ribavirin (see section 4.4).
Maltese: Fil-provi tal-Fażi 2 u tal-Fażi 3 kkontrollati bi plaċebo, 1.9% tal-pazjenti waqqfu INCIVO biss minħabba anemija, u 0.9% tal-pazjenti waqqfu il-kura bit-taħlita li tinkludi INCIVO minħabba anemija meta mqabbla ma' 0.5% ta' dawk li kienu qed jirċievu peginterferon alfa u ribavirin (ara sezzjoni 4.4).
English: Clinical drug-drug interaction studies with substrates of CYP2B6, CYP2C8, CYP2D6, CYP2C19 and UGT1A1, UGT2B7 and UGT1A3 indicate no clinically relevant impact of the suppression observed in vitro.
Maltese: Studji kliniċi ta' interazzjoni bejn mediċina u oħra b'sottostrati ta' CYP2B6, CYP2C8, CYP2D6, CYP2C19 u UGT1A1, UGT2B7 u UGT1A3 ma jindikaw l-ebda impatt rilevanti b'mod kliniku tas-soppressjoni osservata in vitro.
English: SVR rates were higher (absolute difference of at least 28%) for the T12/PR group than for the Pbo/PR48 group across subgroups by sex, age, race, ethnicity, body mass index, HCV genotype subtype, baseline HCV RNA (< 800,000, ≥ 800,000 IU/ml), and extent of liver fibrosis.
Maltese: Ir-rati ta' SVR kienu ogħla (differenza assoluta ta' mill-anqas 28%) għall-grupp ta' T12/PR milli għall-grupp ta' Pbo/PR48 fost is-sottogruppi skont is-sess, l-età, ir-razza, l-etniċità, l-indiċi tal-massa tal-ġisem, is-sottotip tal-ġenotip ta' HCV, l-RNA ta' HCV fil-linja bażi (< 800,000, ≥ 800,000
English: The overall safety profile of INCIVO in HCV/HIV-1 co-infected patients (either not on antiretroviral therapy or on antiretroviral therapy) was similar to the safety profile in mono-infected HCV patients, except for patients receiving atazanavir/ritonavir who frequently experienced a transient increase in indirect bilirubin levels (including grades 3 to 4) through week 2, returning to near baseline by week 12 (see section 4.4).
Maltese: Il-profil ta' sigurtà totali ta' INCIVO f'pazjenti koinfettati b'HCV/HIV-1 (li jew mhumiex fuq terapija antiretrovirali jew li qegħdin fuq terapija antiretrovirali) kien simili għall-profil ta' sigurtà f'pazjenti infettati b'HCV biss, ħlief għal pazjenti li kienu qed jirċievu atazanavir/ritonavir li ta' spiss kellhom żieda temporanja fil-livelli indiretti ta' bilirubin (inkluż il-gradi 3 sa 4) sa ġimgħa 2, li reġgħu lura viċin il-linja bażi sal-ġimgħa 12 (ara sezzjoni 4.4).
English: (7.0-8.9 g/dl or any decrease ≥ 4.5 g/dl)
Maltese: (7.0-8.9 g/dl jew kwalunkwe tnaqqis ≥ 4.5 g/dl)
English: ↑ alfentanil ↑ fentanyl
Maltese: Popolazzjonijiet speċjali
English: Telaprevir exposure was similar regardless of whether the total daily dose of 2,250 mg was administered as 750 mg every 8 hours (q8h) or 1,125 mg twice daily (b.i.d.).
Maltese: L-esponiment għal telaprevir kien simili irrispettivament jekk id-doża totali ta' kuljum ta' 2,250 mg ġiet mgħotija bħala 750 mg kull 8 sighat (q8h) jew 1,125 mg darbtejn kuljum (b.i.d.).
English: Antiretroviral therapy regimens included efavirenz, atazanavir/ritonavir, raltegravir, etravirine, or darunavir/ritonavir in combination with tenofovir or abacavir and either lamivudine or emtricitabine.
Maltese: Skedi ta' terapija antirertovirali kienu jinkludu efavirenz, atazanavir/ritonavir, raltegravir, etravirine, jew darunavir/ritonavir flimkien ma' tenofovir jew abacavir u jew lamivudine jew inkella emtricitabine.
English: Interactions between telaprevir and HIV antiretroviral agents are frequent, and the recommendations in table 2, section 4.5, should be carefully followed.
Maltese: Interazzjonijiet bejn telaprevir u sustanzi antiretrovirali tal-HIV huma frekwenti, u rrakkomandazzjonijiet f'tabella 2, fis-sezzjoni 4.5, għandhom jiġu segwiti b'attenzjoni.
English: Haemoglobin values of < 10 g/dl were observed in 34% of patients who received INCIVO combination treatment and in 14% of patients who received peginterferon alfa and ribavirin.
Maltese: Valuri tal-emoglobina ta' < 10 g/dl kienu osservati f'34% tal-pazjenti li rċivew taħlita ta' kura li tinkludi INCIVO u f'14% tal-pazjenti li rċivew peginterferon alfa u ribavirin.
English: Table 7 shows the response rates for the recommended T12/PR and the Pbo/PR48 groups.
Maltese: Tabella 7 turi r-rati ta' rispons għall-gruppi rrakkomandati ta' T12/PR u Pbo/PR48.
English: dihydroergotamine, ergonovine, ergotamine,
Maltese: clarithromycin, erythromycin, telithromycin,
English: HCV RNA > 1,000 IU/ml at week 4 of treatment
Maltese: HCV RNA > 1,000 IU/ml filġimgħa 4 ta' kura
English: These active substances include alfuzosin, amiodarone, bepridil, quinidine, astemizole, terfenadine, cisapride, pimozide, ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine), lovastatin, simvastatin, atorvastatin, sildenafil or tadalafil (only when used for treatment of pulmonary arterial hypertension), quetiapine and orally administered midazolam or triazolam (see section 4.5).
Maltese: Dawn is-sustanzi attivi jikludu alfuzosin, amiodarone, bepridil, quinidine, astemizole, terfenadine, cisapride, pimozide, derivati tal-ergot (dihydroergotamine, ergonovine, ergotamine, methylergonovine), lovastatin, simvastatin, atorvastatin, sildenafil jew tadalafil (meta jintuża għall-kura ta' pressjoni għolja fl-arterji tal-pulmun biss) u midazolam jew triazolam mogħtija mill-ħalq.