FrancophonIA/ELRC3.0 huggingface dataset:
English: SVR rates with “missing=failure” approach were similar to those in the table: 69.9% (174/249) for subjects randomized to receive ribavirin dose reduction; 68.5% (172/251) for subjects randomized to receive
Maltese: Ir-rati ta' SVR (SVR bil-metodu “nieqes=falliment”) kienu jixxiebhu ma' dawk fit-tabella: 69.9% (174/249) għal individwi li ntgħażlu b'mod każwali biex jirċievu tnaqqis fid-doża ta' ribavirin; 68.5% (172/251) għal individwi li ntgħażlu b'mod
English: Tachycardia*, arrhythmia, cardiovascular disorder
Maltese: Takikardija*, arritmija, disturb kardjovaskulari
English: 9/L) was higher in boceprevir-treated patients (29%) than in placebo-treated patients (17%), in combination with peginterferon alfa-2b and ribavirin.
Maltese: 9/L) kien ogħla f'pazjenti ikkurati b'boceprevir (29%) milli f'pazjenti ikkurati bil-plaċebo (17%), flimkien ma' taħlita ta' peginterferon alfa-2b u ribavirin.
English: The race distribution of subjects was as follows: 85% White, 12% Black, 1% Asian, < 1% multiracial, < 1% Native Hawaiian or Other Pacific Islander.
Maltese: Iddistribuzzjoni tar-razza tal-individwi kienet kif ġej: 85% Bojod, 12% Suwed, 1% Asjatiċi, < 1% taħlita ta' razez, < 1% Indiġeni tal-Hawajj jew minn Gżejjer Oħrajn tal-Paċifiku.
English: Aggression*, homicidal ideation*, panic attack*, paranoia*, substance abuse*, suicidal ideation*, abnormal behaviour, anger, apathy, confusional state, mental status changes, restlessness Bipolar disorder*, completed suicide*, suicide attempt*, hallucination auditory, hallucination visual, psychiatric
Maltese: Aggressjoni*, ħsibijiet ta' omiċidju*, attakk ta' paniku*paranojja*, abbuż ta' sustanzi*, ħsibijiet ta' suwiċidju*, komportament mhux normali, rabja, apatija, stat ta' konfużjoni, tibdiliet fl-istat mentali, irrikwitezza Disturb bipolari*, twettieq ta' suwiċidju*, attentat ta' suwiċidju*, alluċinazzjoni tas-smigħ, alluċinazzjoni viżwali, dikumpens psikjatriku
English: The following double amino acid substitutions conferred more than 10-fold reduced sensitivity to boceprevir: V55A+I170V, T54S+R155K, R155K+D168N, R155T+D168N and
Maltese: V55A + I170V , T54S + R155K , R155K + D168N , R155T + D168N u V36M + R155K .
English: The antiviral activity of boceprevir was evaluated in a biochemical assay for slow binding inhibitors of NS3 protease and in the genotype 1a and 1b HCV replicon system.
Maltese: L-attività antivirali ta' boceprevir kienet evalwata f'analiżi bijokimika għal impedituri ta' protease NS3 li jintrabtu bil-mod u fis-sistema ta' replikazzjoni bħala unità awtonoma ta' HCV tal-ġenotip 1a u 1b.
English: Fifty-seven percent (208/368) of subjects in the Victrelis-RGT arm and 56% (204/366) of subjects in the Victrelis-PR48 arm had undetectable HCV-RNA at TW 8 compared with 17% (60/363) of
Maltese: Sebgħa u ħamsin fil-mija (208/368) tal-individwi fil-fergħa ta' Victrelis-RGT u 56% (204/366) tal-individwi fil-fergħa ta' Victrelis-PR48 kellhom RNA ta' HCV li ma setgħetx titkejjel f'TW 8 meta mqabbla ma' 17% (60/363) tal-individwi fil-fergħa PR.
English: The median times for the most relevant boceprevir-resistant variants observed in genotype 1a patients (> 10%) to become undetectable were as follows: R155K+V36M, 0.69 years; V36M, 0.89 years; R155K+T54S, 1.05 years; R155K, 1.08 years; and T54S, 1.14 years.
Maltese: Iż-żminijiet medjana għall-aktar varjanti rilevanti reżistenti għal boceprevir osservati f'pazjenti bil-ġenotip 1a (>10%) biex jaslu f'punt fejn ma jkunux jistgħu jitkejlu kienu kif ġej: R155K+V36M, 0.69 sena; V36M, 0.89 snin; R155K+T54S, 1.05 snin; R155K, 1.08 snin; u T54S, 1.14-il sena.
English: In clinical trials with the combination of Victrelis, peginterferon alfa-2b and ribavirin compared to peginterferon alfa-2b and ribavirin alone, the median time from the initiation of therapy to onset of haemoglobin less than 10 g/dL was similar (71 days with a range of 15-337 days, and 71 days with a range of 8-337 days, respectively).
Maltese: Fi provi kliniċi bil-kombinazzjoni ta' Victrelis, peginterferon alfa-2b u ribavirin kienu simili għal peginterferon alfa-2b u ribavirin waħdu, il-ħin medjan mill-bidu tal-kura sal-feġġa ta' emoglobulina inqas minn 10 g/dL kien simili (71 jum b'medda ta' 15-337 jum, u 71 jum b'medda ta' 8-337 jum, rispettivament).
English: The addition of boceprevir to peginterferon alfa-2b and ribavirin resulted in higher incidences of neutropenia and Grade 3-4 neutropenia compared with peginterferon alfa-2b and ribavirin alone (see section 4.8).
Maltese: Iż-żieda ta' boceprevir ma' peginterferon alfa-2b u ribavirin irriżultat f'aktar każijiet ta' newtropenija u newtropenija ta' Grad 3-4 meta mqabbla ma' peginterferon alfa-2b u ribavirin biss (ara sezzjoni 4.8).
English: Evaluation of varying combinations of boceprevir and interferon alfa-2b that produced 90% suppression of replicon RNA showed additivity of effect; no evidence of synergy or antagonism was
Maltese: L-evalwazzjoni ta' kombinazzjonijiet differenti ta' boceprevir u interferon alfa-2b li pproduċew soppressjoni ta' 90% tal-RNA li tirreplika bħala unità awtonoma wriet effett addittiv; ma ġiet innutata l-ebda evidenza ta' sinerġija jew antagoniżmu.
English: The clinical significance of the reductions in etravirine pharmacokinetic parameters and boceprevir Cmin in the setting of combination therapy with HIV antiretroviral medicines, which also affect the pharmacokinetics of etravirine and/or boceprevir, has not been directly assessed.
Maltese: Is-sinifikat kliniku tattnaqqis fil-parametri farmakokinetiċi ta' etavirine u boceprevir Cmin fl-issettjar tat-terapija kombinata ma' mediċini antiretrovirali tal-HIV, li jaffettwaw ukoll ilfarmakokinetika ta' etravirine u/jew boceprevir, ma ġietx evalwata direttament.
English: Boceprevir covalently, yet reversibly, binds to the NS3 protease active site serine (Ser139) through a (alpha)-ketoamide functional group to inhibit viral replication in HCV-infected host cells.
Maltese: Boceprivir jintrabat b'mod kovalenti, iżda riversibbli, mas-sit attiv tal-protease NS3 serine (Ser139) permezz ta' grupp ta' funzjoni (alfa)ketoamide biex jimpedixxi r-replikazzjoni tal-virus fiċ-ċelluli infettati b'HCV tal-individwu.
English: Patients should be informed that fatigue, dizziness, syncope, blood pressure fluctuations and blurred vision have been reported (see section 4.8).
Maltese: Il-pazjenti għandhom jiġu infurmati li kienu rrappurtati għeja, sturdament, sinkope, bidliet fil-pressjoni u vista mċajpra (ara sezzjoni 4.8).
English: Sustained Virologic Response (SVR) in patients receiving similar therapy up to treatment week 36
Maltese: Rispons Viroloġiku Miżmum (SVR) f'pazjenti li kienu qed jirċievu terapija simili sa ġimgħa 36
English: In rats, boceprevir induced reversible effects on fertility and early embryonic development in female rats at exposures 1.2-fold the human exposure at the recommended therapeutic dose.
Maltese: Fil-firien, boceprevir induċa effetti riversibbli fuq il-fertilità u l-iżvilupp bikri tal-embriju f'firien femminili b'esponimenti ta' 1.2 drabi aktar mill-esponiment uman bid-doża terapewtika rrakkomandata.
English: In subjects with < 1-log10 decline in viral load at TW 4 (poor interferon-responsiveness), treatment with the combination of Victrelis with peginterferon alfa-2b and ribavirin resulted in SVR rates of 28 38%, respectively, compared to 4% in subjects treated with standard of care.
Maltese: F'individwi bi tnaqqis ta' < 1-log10 fit-tagħbija fi TW 4 (rispons dgħajjef għal interferon), kura bit-taħlita ta' Victrelis ma' peginterferon alfa-2b u ribavirin wasslet għal rati ta' SVR ta' 28 38%, rispettivament, meta mqabbla ma' 4% f'individwi kkurati b'kura standard.
English: A greater than 10-fold reduction in boceprevir susceptibility was conferred by the amino acid substitutions A156S/T/V, V170A, R155W+A156G and V36M+R155K.
Maltese: Is-sostituzzjonijiet A156S/T/V, V170A, R155W + A156G u V36M + R155K tal-aċidu amminiku naqqsu s-suxxettibilità għal boceprevir b'aktar minn 10 darbiet.
English: Of 314 treatment-naïve and previously treated subjects who did not achieve SVR from Phase 2/3 studies (P03523, P03659, P05216, and P05101) in whom boceprevir-resistant variants had emerged during treatment, 73% (228/314) of subjects no longer had any RAVs detected at the boceprevir-resistance associated loci by population sequencing within 3 years post-therapy.
Maltese: Minn 314-il individwu li ma kinux ħadu kura qabel u li kienu ħadu kura qabel li ma kisbux SVR minn studji ta' Fażi 2/3 (P03523, P03659, P05216 u P05101) u li fihom feġġu varjanti reżistenti għal boceprevir waqt il-kura, 73% (228/314) tal-individwi ma kienx fadlilhom RAVs li setgħu jitkejlu fil-postijiet assoċjati ma' reżistenza għal boceprevir permezz ta' sekwenzar tal-popolazzjoni fi żmien 3 snin wara t-terapija.
English: In subjects treated with boceprevir, interferon responsiveness (as defined by ≥ 1-log10 decline in viral load at Treatment Week 4) was associated with detection of fewer RAVs, with 6% of these subjects having RAVs compared to 41% of subjects with < 1-log10 decline in viral load at Treatment Week 4 (poorly interferon responsive).
Maltese: F'individwi kkurati b'boceprevir, ir-rispons għal interferon (iddefinit bħala tnaqqis ta' ≥ 1-log10 fit-tagħbija virali fil-Ġimgħa ta' Kura 4) kien assoċjat ma' inqas RAVs li setgħu jitkejlu, b'6% ta' dawn l-individwi li kellhom RAVs meta mqabbla ma' 41% tal-individwi bi tnaqqis ta' < 1-log10 fittagħbija virali fil-Ġimgħa ta' Kura 4 (jirrispondu għal interferon b'mod dgħajjef).
English: If the patient has hepatitis C virus ribonucleic acid (HCV-RNA) results greater than or equal to 1,000 IU/mL at TW 8; then discontinue three-medicine regimen.
Maltese: Jekk il-pazjent ikollu riżultati ta' ribonucleic acid tal-virus tal-epatite Ċ (RNA ta' HCV) ogħla minn jew daqs 1,000 IU/mL fil-Ġimgħa ta' Kura 8; waqqaf l-iskeda bi tliet mediċini.
English: lopinavir AUC ↓ 34% lopinavir Cmax ↓ 30% lopinavir Cmin ↓ 43%
Maltese: etravirine AUC ↓ 23% etravirine Cmax ↓ 24% etravirine Cmin ↓ 29%
English: The most frequently reported adverse reactions were fatigue, anaemia (see section 4.4), nausea,
Maltese: L-aktar reazzjonijiet avversi rrappurati b'mod frekwenti kienu għeja, anemija (ara sezzjoni 4.4),
English: Studies in vitro indicate that boceprevir primarily undergoes metabolism through the aldoketoreductase (AKR)-mediated pathway to ketone-reduced metabolites that are inactive against HCV.
Maltese: Studji in vitro jindikaw li boceprevir primarjament jgħaddi minn metaboliżmu permezz tar-rotta medjata minn aldo-ketoreductase (AKR) u jsir metaboliti mnaqqsa minn ketone li mhumiex attivi kontra HCV.
English: These are called peginterferon alfa and ribavirin.
Maltese: Dawn jissejħu peginterferon alfa u ribavirin.
English: • have a condition called ‘autoimmune hepatitis'
Maltese: • għandek kundizzjoni msejħa ‘epatite awtoimmuni'
English: escitalopram AUC ↓ 21% escitalopram Cmax ↓ 19%
Maltese: L-AUC ta' escitalopram ↓ 21% Is-Cmax ta' escitalopram ↓19%
English: Treatment at IC90 for 72 hours resulted in a 1-log10 drop in replicon RNA.
Maltese: Kura f'IC90 għal 72 siegħa wasslet għal tnaqqis ta' log10 flRNA li tirreplika bħala unità awtonoma.
English: Papilloedema
Maltese: VictrelisRGT
English: Musculoskeletal chest pain*, arthritis, bone pain, joint swelling, musculoskeletal pain
Maltese: Uġigħ muskolu-skeletriku fis-sider*, artrite, uġigħ flgħadam, nefħa fil-ġogi, uġigħ muskolu-skeletriku
English: (effect on P-gp transport in the
Maltese: (effett fuq it-trasport ta' P-gp flimsaren)
English: Mean age of subjects randomized was 49 years.
Maltese: L-età medja talindividwi magħżula b'mod każwali kienet ta' 49 sena.
English: The addition of boceprevir to peginterferon alfa and ribavirin is associated with an additional decrease in haemoglobin concentrations of approximately 1 g/dL by Treatment Week 8 compared to standard of care (see section 4.8).
Maltese: Iż-żieda ta' boceprevir ma' peginterferon alfa u ribavirin hija assoċjata ma' aktar tnaqqis filkonċentrazzjonijiet tal-emoglobina fis-serum ta' madwar 1 g/dL sal-Ġimgħa ta' Kura 8 meta mqabbel ma' kura standard (ara sezzjoni 4.8).
English: Relapse %(n/N) * The Full Analysis Set (FAS) consisted of all randomized subjects (N=98) who received at least one dose of any study medicine (peginterferon alfa-2b, ribavirin, or Victrelis).
Maltese: Relapse %(n/N) * Is-Sett Sħiħ ta' Analiżi (FAS) kien jikkonsisti mill-individwi randomizzati kollha (N=98) li rċevew mill-anqas doża waħda ta' xi mediċina tal-istudju (peginterferon alfa-2b, ribavirin, jew Victrelis).
English: The race distribution of subjects was as follows: 77% White, 19% Black, and 4% others.
Maltese: Id-distribuzzjoni tar-razza tal-individwi kienet kif ġej: 77% Bojod, 19% Suwed, u 4% oħrajn.
English: The addition of Victrelis to the peginterferon alfa-2b and ribavirin therapy significantly increased the SVR rates compared to peginterferon alfa-2b and ribavirin therapy alone (59% to 66% Victreliscontaining arms vs. 21% PR48 control) for randomized subjects who received at least one dose of any study medicine (Full-Analysis-Set population) and decreased the length of therapy to 36 weeks for many previous treatment failures (see Table 7).
Maltese: Iż-żieda ta' Victrelis mat-terapija ta' peginterferon alfa-2b u ribavirin żiedet ir-rati ta' SVR b'mod sinifikanti meta mqabbla ma' terapija b'peginterferon alfa-2b u ribavirin biss (59% sa 66% fil-fergħat li kien fihom Victrelis vs. 21% fil-kontroll PR48) għal individwi randomised li rċevew mill-inqas doża waħda ta' kwalunkwe waħda mill-mediċini tal-istudju (popolazzjoni tas-Sett Sħiħ ta' Analiżi) u naqqset it-tul ta' żmien ta' kura għal 36 ġimgħa għal ħafna minn dawk li qabel il-kura ma kinitx ħadmet fuqhom (ara Tabella 7).
English: Victrelis may be used in adults who are previously untreated for HCV infection or who have previously used medicines called ‘interferons' and ‘pegylated interferons'.
Maltese: Victrelis jista' jintuża f'adulti li qatt ma ħadu kura għall-infezzjoni ta' HCV jew li qabel użaw mediċini imsejħa ‘interferons' u ‘interferons pegilati'.
English: Victrelis in combination with ribavirin and peginterferon alfa is contraindicated in women who are
Maltese: Victrelis flimkien ma' ribavirin u peginterferon alfa, huwa kontraindikat f'nisa li huma tqal (ara
English: Eyes or ears: pink eye; eye pain; deafness; trouble hearing; swelling around the eyelid; increased tearing; fluid draining from the ear or eye; abnormal feeling around the eye, red patch on the white of the eye; yellowing of the white part of the eyes or of the skin Mouth, nose or throat: hoarseness, dry throat or lips; painful or bleeding gums; sensitive tooth or toothache; tongue swollen, discoloured, or has sores; blistering by the tongue; severe pain when swallowing; chest pain close to the lungs; chest pain worsens when taking a deep breath; uncontrolled salivating; overactive thyroid gland Skin and hair: hives; open sore; intolerance to heat; markedly red face; pale face; yellow skin; rash due to sunlight; wound not healing normally Feet or hands or legs or arms: sensation of pain, numbness, tingling or prickling; blood clot in a vein; feeling cold in an arm or leg; painful inflammation of the joints most commonly in the foot (gout)
Maltese: Ħalq, imnieħer jew ġriżmejn: uġigħ fil-ħalq, uġigħ fis-snien; uġigħ meta tibla'; l-imnieħer jinfaraġ, imnieħer imblukkat; tibdil fil-mod ta' kif jinxtammu l-affarijiet; partijiet misluħin u mqabbżin fil-ħalq; tħossok bil-għatx ħafna b'ħalq xott jew ġilda xotta; nefħa fil-glandola tattirojde, l-għonq, jew il-larinġi; glandola tat-tirojde taħdem bil-mod; selħiet jew nefħa fil-ħalq, tħoss ħruq fl-ilsien; sensazzjoni ta' tensjoni jew imblukkar fl-imnieħer, fil-ħaddejn u wara lgħajnejn - xi kultant b'ras ittektek bl-uġigħ, deni jew imnieħer imblukkat (sinożite) Ġilda u xagħar: ponot fix-xufftejn, tnemnim jew titrix fil-ġilda; tnaqqis fil-ħass jew fis-sens tal-mess; raxx fil-ġilda, rqajja' ta' raxx fil-ġilda, ġilda ħamra; raxx imqabbeż u aħmar fil-ġilda xi drabi bi nfafet mimlijin bil-materja; ġilda ħamra, sħuna u sensittiva, xi drabi bid-deni u tkexkix ta' bard; żieda fl-għaraq; mard tal-ġilda bi rqajja' ħoxnin ta' ġilda ħamra - spiss bi qxur
English: Victrelis is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy (see sections 4.4 and 5.1).
Maltese: Victrelis huwa indikat għall-kura ta' infezzjoni kronika bl-epatite Ċ (CHC) tal-ġenotip 1, flimkien ma' peginterferon alfa u ribavirin, f'pazjenti adulti b'mard kumpensat tal-fwied li ma kienux ħadu kura qabel jew li t-terapija li ħadu qabel ma kienitx ħadmet fuqhom (ara sezzjonijiet 4.4 u 5.1).
English: Boceprevir has a mean apparent volume of distribution (Vd/F) of approximately 772 l at steady state.
Maltese: Boceprevir għandu volum medju ta' distribuzzjoni li jidher (Vd/F) ta' madwar 772 l fl-istat fiss.
English: boceprevir AUC ↓ 45% boceprevir Cmax ↓ 50% boceprevir Cmin ↓ 57%
Maltese: L-AUC ta' boceprevir ↓ 45% Is-Cmax ta' boceprevir↓ 50% Is-Cmin ta' boceprevir ↓ 57%
English: Acute myocardial infarction*, atrial fibrillation*, coronary artery disease*, pericarditis*, pericardial
Maltese: Infart mijokardijaku akut*, fibrillazzjoni tal-atriju*, mard tal-arterji tal-qalb*, perikardite*, effużjoni tal
English: If permanent discontinuation of ribavirin is required, then peginterferon alfa and Victrelis must also be discontinued.
Maltese: Jekk ikun meħtieġ twaqqif permanenti ta' ribavirin, allura peginterferon alfa u Victrelis għandhom jitwaqqfu wkoll.
English: The onset of anaemia has been reported with peginterferon alfa and ribavirin therapy by Treatment Week 4.
Maltese: Il-bidu tal-anemija kien irrappurtat bit-terapija ta' peginterferon alfa u ribavirin sal-Ġimgħa ta' Kura 4.
English: Refer to Summary of Product Characteristics for ribavirin and peginterferon alfa for additional information.
Maltese: Irreferi għas-Sommarju tal-Karatteristiċi tal-Prodott ta' ribavirin u peginterferon alfa għal aktar informazzjoni.
English: ‡ % (n/N) Relapse % (n/N)
Maltese: ‡ % (n/N) Irkadar % (n/N)
English: C-boceprevir, approximately 79% and 9% of the dose was excreted in faeces and urine, respectively, with approximately 8% and 3% of the dosed radiocarbon eliminated as boceprevir in faeces and urine.
Maltese: C, madwar 79% u 9% tad-doża tneħħiet mal-ippurgar u mal-awrina, rispettivament, b'madwar 8% u 3% tad-doża tal-karbonju radjutikkettat li ngħatat kienet eliminata bħala boceprevir fl-ippurgar u l-awrina.
English: The absolute bioavailability of Victrelis has not been studied.
Maltese: Il-bijodisponibbiltà assoluta ta' Victrelis ma ġietx studjata.
English: Prolonged exposure resulted in a 2-log decrease in RNA levels by Day 15.
Maltese: Esponiment għal tul ta' żmien wassal għal tnaqqis ta' log 2 fil-livelli tal-RNA sa Jum 15.
English: 9/L (Grade 4 neutropenia) compared to 4% of subjects receiving only peginterferon alfa-2b and ribavirin.
Maltese: 9/L (newtropenija ta' Grad 4) meta mqabbla ma' 4% tal-individwi li kienu qed jirċievu peginterferon alfa
English: o Subjects with undetectable HCV-RNA at TW 8 (early responders) and who also had undetectable HCV-RNA through TW 24 discontinued therapy and entered o Subjects with detectable HCV-RNA at TW 8 or any subsequent treatment week but subsequently undetectable at TW 24 (late responders) were changed in a blinded fashion to placebo at the TW 28 visit and continued therapy with peginterferon alfa-2b + ribavirin for an additional 20 weeks, for a total treatment
Maltese: Il-pazjenti kollha f'din il-fergħa ta' kura kienu ristretti għal o Individwi b'RNA ta' HCV li ma setgħetx titkejjel fi TW 8 (irrispondew malajr) u li kellhom ukoll RNA ta' HCV li ma setgħetx titkejjel sa TW 24 waqqfu l-kura u fil-vista o Individwi b'RNA ta' HCV li setgħet titkejjel fi TW 8 jew kwalunkwe ġimgħa ta' kura sussegwenti iżda sussegwentement kellhom RNA ta' HCV li ma setgħetx titkejjel fi TW 24 (irrispondew tard) inqalbu b'mod blindfolded għal plaċebo fil-vista ta' TW 28 u komplew it-terapija b'peginterferon alfa-2b + ribavirin għal 20 ġimgħa oħra, għal tul ta'
English: Safety and efficacy of Victrelis, in combination with peginterferon alfa and ribavirin, have not been studied in patients with decompensated cirrhosis.
Maltese: Is-sigurtà u l-effikaċja ta' Victrelis, f'kombinazzjoni ma' peginterferon alfa u ribavirin, ma ġewx studjati f'pazjenti b'ċirrożi dekompensata.
English: Steady state AUC, Cmax and Cmin increased in a less-than dose-proportional manner and individual exposures overlapped substantially at 800 mg and 1,200 mg, suggesting diminished absorption at higher doses.
Maltese: L-AUC, is-Cmax u s-Cmin flistat fiss żdiedu b'mod inqas minn fi proporzjon mad-doża u l-esponimenti individwali trikkbu b'mod sostanzjali bi 800 mg u 1,200 mg, li jissuġġerixxu tnaqqis fl-assorbiment b'dożi ogħla.
English: Exposure to atorvastatin was increased when administered with Victrelis.
Maltese: Esponiment għal atorvastatin żdied meta ngħata ma' Victrelis.
English: The safety and efficacy of Victrelis alone or in combination with peginterferon alfa and ribavirin for the treatment of chronic hepatitis C genotype 1 infection in patients co-infected with hepatitis B virus
Maltese: Is-sigurtà u l-effikaċja ta' Victrelis waħdu jew flimkien ma' peginterferon alfa u ribavirin għall-kura ta' infezzjoni kronika bl-epatite Ċ ta' ġenotip 1 f'pazjenti ko-infettati bil-virus tal-epatite B (HBV) u
English: The addition of Victrelis to peginterferon alfa-2b and ribavirin was associated to higher incidences of increase in uric acid, triglycerides and cholesterol total compared to peginterferon alfa-2b and
Maltese: Iż-żieda ta' Victrelis ma' peginterferon alfa-2b u ribavirin kienet assoċjata ma' aktar każijiet ta' żieda tal-uric acid, trigliċeridi u kolesterol totali meta mqabbel ma' peginterferon alfa-2b u ribavirin biss.
English: boceprevir AUC ↑ 131% boceprevir Cmax ↑ 41% boceprevir Cmin N/A
Maltese: L-AUC ta' boceprevir ↑ 131% Is-Cmax ta' boceprevir ↑ 41%
English: Administer peginterferon alfa and ribavirin for 4 weeks, and then
Maltese: Agħti peginterferon alfa u ribavirin għal 4 ġimgħat, u imbagħad
English: Subjects randomized to receive erythropoietin (N=251)
Maltese: Individwi li ntgħażlu b'mod każwali biex jirċievu erythropoietin (N=251)
English: The race distribution of subjects was as follows: 82% White, 18% Non-White, 14% Black, 3% Asian, and 1% Multiracial.
Maltese: Id-distribuzzjoni tar-razez tal-individwi kienet kif ġej: 82% Bojod, 18% Mhux Bojod, 14% Suwed, 3% Asjatiċi, u 1% Multirazzjali.
English: Abdominal pain lower*, gastritis*, pancreatitis*, anal pruritus, colitis, dysphagia, faeces discoloured, frequent bowl movements, gingival bleeding, gingival pain, gingivitis, glossitis, lip dry, odynophagia, proctalgia, rectal haemorrhage, salivary hypersecretion, sensitivity of teeth, tongue discolouration, tongue ulceration Pancreatic insufficiency
Maltese: Uġigħ fin-naħa t'isfel tal-addome*, gastrite*, pankrejatite*, ħakk fl-anus, kolite, disfaġja, bidla filkulur tal-ippurgar, ippurgar frekwenti, fsada mill-ħanek, uġigħ fil-ħanek, ġenġivite, glossite, xufftejn xotti, uġigħ meta tibla', proktalġja, emorraġija mir-rektum, tnixxija qawwija ta' bżieq, sensittività fis-snien, bidla fil-kulur tal-ilsien, ulċeri fl-ilsien
English: PROVIDE (P05514) was an open-label, single-arm study of Victrelis 800 mg orally three times daily in combination with PR [peginterferon alfa-2b 1.5 µg/kg/week subcutaneously and weight-based ribavirin (600 1,400 mg BID) orally divided twice daily] in adult subjects with chronic hepatitis C (HCV) genotype 1 infection who did not achieve SVR while in the PR control arms of previous Phase 2 and 3 studies of combination therapy with Victrelis.
Maltese: PROVIDE (P05514) kien studju open-label, b'fergħa waħda ta' Victrelis 800 mg li ttieħed mill-ħalq tliet darbiet kuljum flimkien ma' PR [peginterferon alfa-2b 1.5 µg/kg/ġimgħa taħt il-ġilda u doża ta' ribavirin (600 1,400 mg BID) skont il-piż, mill-ħalq, maqsuma f'darbtejn kuljum] f'individwi adulti b'infezzjoni kronika tal-epatite Ċ (HCV) ta' ġenotip 1 li ma kisbux SVR waqt li kienu fil-fergħat ta' kontroll ta' PR fl-istudji preċedenti ta' Fażi 2 u 3 ta' terapija kkombinata b'Victrelis.