FrancophonIA/ELRC3.0 huggingface dataset:
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.
Estonian: Rohkem kui 10-kordne vähenemine tundlikkuses botsepreviirile saavutati aminohappe asendustega A156S/T/V, V170A, R155W + A156G ja V36M + R155K.
English: Boceprevir, in combination with peginterferon alfa and ribavirin, was evaluated in a total of 98 patients (64 in the boceprevir arm) co-infected with Human Immunodeficiency Virus (HIV) and HCV genotype 1 who were previously untreated for chronic HCV infection (see section 4.8 and 5.1).
Estonian: Botsepreviiri kombinatsioonis alfapeginterferooni ja ribaviriiniga hinnati kokku 98-l inimese immuunpuudulikkuse viiruse (HIV) ja HCV genotüübi 1 koinfektsiooniga patsiendil (64-l botsepreviiri võtnud harus), kellel ei olnud varem ravitud kroonilist HCV infektsiooni (vt lõigud 4.8 ja 5.1).
English: The concomitant use of Victrelis with doxazosin and tamsulosin is not recommended (see section 4.5).
Estonian: Victrelise kasutamine koos doksasosiini ja tamsulosiiniga ei ole soovitatav (vt lõik 4.5).
English: Concomitant administration of pravastatin with Victrelis increased exposure to pravastatin.
Estonian: Pravastatiini samaaegne manustamine Victrelisega suurendas pravastatiini ekspositsiooni.
English: In clinical trials, the proportion of subjects who received erythropoietin for the management of anaemia was 43% (667/1,548) of subjects in the Victrelis-containing arms compared to 24% (131/547) of subjects receiving peginterferon alfa-2b and ribavirin alone.
Estonian: Kliinilistes uuringutes oli patsientide osakaal, kellele anti aneemia kontrolli all hoidmiseks erütropoetiini, 43% (667/1548) Victrelise haru patsientidest, võrreldes 24% (131/547) patsientidega, kes said ainult alfa-2b-peginterferooni ja ribaviriini.
English: Chest: being short of breath when lying flat; serious lung infection like pneumonia; sharp chest pains which are worse when breathing; pain behind breast bone which can spread to neck and
Estonian: Rindkere: hingamisraskused lamades; raske kopsuinfektsioon nagu näiteks kopsupõletik; terav rindkerevalu, mis hingamisel süveneb; valu rinnaku taga, mis võib levida kaela ja õlgadesse.
English: While taking the combination of Victrelis with ribavirin and peginterferon alpha, serious allergic reactions have been reported.
Estonian: Victrelise võtmise ajal kombinatsioonis ribaviriini ja alfapeginterferooniga on teatatud tõsistest allergilistest reaktsioonidest.
English: Exposure of escitalopram was slightly decreased when co-administered with Victrelis.
Estonian: Estsitalopraami ekspositsioon vähenes veidi manustamisel koos Victrelisega.
English: In clinical trials, HCV-RNA in plasma was measured with a Roche COBAS Taqman assay with a limit of detection of 9.3 IU/mL and a limit of quantification of 25 IU/mL.
Estonian: Kliinilistes uuringutes mõõdeti HCV-RNA taset plasmas Roche COBAS Taqman analüüsiga tuvastamispiiriga 9,3 RÜ/ml ja kvantifikatsioonipiiriga 25 RÜ/ml.
English: Tel: 0800 673 673 673 (+49 (0) 89 4561 2612)
Estonian: Tél/Tel: 0800 38 693 (+32(0)27766211)
English: • medicine used to treat symptoms of an enlarged prostate - doxazosin and tamsulosin
Estonian: • suurenenud eesnäärme sümptomite ravis kasutatavat ravimit - doksasosiini või tamsulosiini;
English: General: difficult breathing and swallowing; tumour of the thyroid; infection of the blood; swelling or lumps in organs of the body; disease which leads to increasing muscle paralysis; disease of the brain - signs may include headache and fever, paralysis of a part of the body, a stiff neck or being sensitive to light
Estonian: Üldine: raskused hingamisel ja neelamisel; kilpnäärmekasvaja; infektsioon veres; paistetus või tükkide teke kehaorganites; haigus, mis viib lihaste halvatuse arenguni; ajuhaigus - tunnuste hulka võib kuuluda peavalu ja palavik, kehaosa halvatus, kange kael või valgustundlikkus.
English: Dose reduction of Victrelis is not recommended.
Estonian: Annuse vähendamine Victrelise annust ei ole soovitatav vähendada.
English: Stomach and gut: lower stomach pain; pancreatitis Urinary: painful when urinating; burning feeling or difficulty urinating; get up several times during the night to urinate
Estonian: Kuseteed: valu urineerimisel; põletustunne või raskused urineerimisel; vajadus urineerida mitmeid kordi öö jooksul.
English: If such reaction occurs, combination therapy should be discontinued and appropriate medical therapy immediately instituted
Estonian: Kui selline reaktsioon ilmneb, tuleb kombinatsioonravi lõpetada ja viivitamatult rakendada asjakohaseid ravimeetodeid (vt lõigud 4.3 ja 4.8).
English: Caution should be exercised with medicines known to prolong QT interval such as amiodarone, quinidine, methadone, pentamidine and some neuroleptics.
Estonian: Ettevaatlik tuleb olla ravimitega, nagu amiodaroon, kinidiin, metadoon, pentamidiin ja mõned neuroleptikumid, millede kohta on teada, et need pikendavad QT-intervalli.
English: • Victrelis is always taken in combination with peginterferon alfa and ribavirin.
Estonian: • Victrelist võetakse alati kombinatsioonis alfapeginterferooni ja ribaviriiniga.
English: In subjects treated with boceprevir who did not achieve SVR and with post-baseline samples analysed for RAVs, interferon responsiveness was associated with detection of fewer RAVs, with 31% of these subjects having post-baseline RAVs compared to 69% of subjects with < 1-log10 decline in viral load at Treatment Week 4.
Estonian: Botsepreviiriga ravitud patsientide hulgas, kes ei saavutanud SVR-i ja kellel analüüsiti algväärtuse järgseid proove RAV-ide suhtes, seostus interferoonitundlikkus väiksema hulga RAV-ide tuvastamisega; algväärtusega võrreldes tekkinud RAV-e esines 31%-l neist patsientidest, võrreldes 69% patsientidega, kellel oli viiruskoormuse langus 4. ravinädalal < 1-log10.
English: • Peginterferon alfa-2b + ribavirin for 48 weeks (PR48).
Estonian: • alfa-2b-peginterferoon + ribaviriin 48 nädala vältel (PR48);
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).
Estonian: Botsepreviiri lisamisega alfapeginterferoonile ja ribaviriinile seostub hemoglobiinitaseme täiendav langus umbes 1 g/dl 8. ravinädalaks võrreldes standardraviga (vt lõik 4.8).
English: Subjects who were not able to enrol in this study within 2 weeks received PR for 4 weeks followed by Victrelis 800 mg three times daily + PR for 44 weeks.
Estonian: Patsiendid, kes ei saanud selle uuringuga liituda 2 nädala jooksul, said PR-i 4 nädalat, millele järgnes 800 mg Victrelist kolm korda ööpäevas + PR-i 44 nädalat.
English: In the limited number of co-infected subjects who did not achieve SVR and for whom population sequencing was performed, the prevalence of post-baseline RAVs was higher than that in mono
Estonian: Piiratud arvul koinfektsiooniga patsientidel, kes ei saavutanud SVR-i ja kelle jaoks tehti populatsiooni sekveneerimist, tuvastati algväärtusega võrreldes RAV-e rohkem kui monoinfektsiooniga patsientidel
English: Table 5 presents sustained virologic response per treatment arm in previously untreated patients who were early responders and late responders and that received similar therapy up to treatment week 28.
Estonian: Tabel 5 näitab SVR-i raviharu kohta eelnevalt ravimata patsientidel, kes vastasid ravile vara ja kes vastasid ravile hilja ning kes said sarnast ravi 28. nädalani.
English: Table 6 Sustained Virologic Response (SVR)*, End of Treatment (EOT) and HCV Relapse Rates
Estonian: Tabel 6 Püsiv viroloogiline vastus (SVR)*, ravi lõpetamine (EOT) ja HCV retsidiveerumise
English: Boceprevir has a mean total body clearance (CL/F) of approximately 161 l/hr.
Estonian: Botsepreviiri keskmine üldine kehakliirens on ligikaudu 161 l/h.
English: Boceprevir is primarily metabolized by aldoketo reductase (AKR).
Estonian: Peamiselt metaboliseerib botsepreviiri aldoketoreduktaas (AKR).
English: 9/L (Grade 4 neutropenia) compared to 4% of subjects receiving only peginterferon alfa-2b and ribavirin.
Estonian: 9/l (4. astme neutropeenia) võrreldes 4% patsientidega, kes said ainult alfa-2b-peginterferooni ja ribaviriini.
English: If a patient misses a dose and it is less than 2 hours before the next dose is due, the missed dose
Estonian: Kui patsient annuse sissevõtmisega hilineb ja järgmise annuse manustamise ajani on alla 2 tunni, tuleb hilinenud annus vahele jätta.
English: Mean age of subjects randomized was 49 years.
Estonian: Randomiseeritud uuritavate keskmine vanus oli 49 eluaastat.
English: Individual patients may require additional titration of their methadone dosage when Victrelis is started or stopped to ensure clinical effect of methadone.
Estonian: Victrelise ravi alustamisel või lõpetamisel võivad mõned patsiendid vajada metadooni annuse lisatiitrimist, et tagada metadooni kliiniline toime.
English: The safety profile represented by approximately 1,500 patients for the combination of Victrelis with peginterferon alfa-2b and ribavirin was based on pooled safety data in two clinical trials: one in patients who were previously untreated, and one in patients who had failed prior therapy (see
Estonian: Ligikaudu 1500 patsienti hõlmav ohutusprofiil Victrelise kombinatsiooni kohta alfa-2b-peginterferooni ja ribaviriiniga põhines kogutud ohutusandmetel kahest kliinilisest uuringust: ühest varem ravi mittesaanud patsientidega ja ühest eelnevale ravile mitteallunud patsientidega (vt
English: The most frequently (> 25% of subjects) detected post-baseline RAVs in these subjects were amino acid substitutions V36M (61%) and R155K (68%) in subjects infected with genotype 1a viruses and T54A (42%), T54S (37%), A156S (26%) and V170A (32%) in subjects infected with genotype 1b
Estonian: Kõige sagedamini (> 25%-l uuritavatest) tuvastatud algväärtusega võrreldes tekkinud RAV-id olid nendel patsientidel aminohappeasendused V36M (61%) ja R155K (68%) genotüüp 1a viirustega nakatunud patsientidel ja T54A (42%), T54S (37%), A156S (26%) ja V170A (32%) genotüüp 1b viirustega nakatunud patsientidel.
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).
Estonian: Botsepreviiriga ravitud patsientide hulgas seostus interferoonitundlikkus (määratletuna viiruskoormuse langusena ≥ 1-log10 4. ravinädalal) väiksema arvu RAV-ide tuvastamisega; RAV-e esines 6%-l neist patsientidest, võrreldes 41% patsientidega, kellel oli viiruskoormuse langus 4. ravinädalal < 1-log10 (nõrga interferoonitundlikkusega).
English: Patients who have failed previous therapy: previous partial responders and relapsers to interferon and
Estonian: Eelnevale ravile mitteallunud patsiendid: varasemalt ravile osaliselt allunud ning interferooni ja
English: Boceprevir was shown to be devoid of embryonic or teratogenic potential in both rats and rabbits at maternotoxic dose levels.
Estonian: Botsepreviiril puudus teratogeenne toime või mõju lootele nii rottidel kui jänestel annuste maternotoksiliste tasemete korral.
English: No dose adjustment of Victrelis is required in patients with any degree of renal impairment (see
Estonian: Mis tahes raskusastmega neerukahjustusega patsientidel ei ole Victrelise annust vaja kohandada (vt
English: • were a patient who has previously failed treatment with an HCV protease inhibitor
Estonian: • te olite patsient, kelle eelnev ravi CHC proteaasi inhibiitoriga ebaõnnestus;
English: Blood: low red blood cell count (anaemia), drop in the number of red blood cells - the signs may include feeling tired, headaches, being short of breath when exercising; low neutrophil count (neutropenia), low number of white blood cells - the signs may include getting more infections than usual - including fever, severe chills, a sore throat or mouth ulcers
Estonian: Veri: madal vere punaliblede arv (aneemia), punaliblede arvu langus - tunnuste hulka võib kuuluda väsimustunne, peavalu, õhupuudus kehalisel tegevusel; madal neutrofiilide arv (neutropeenia), valgeliblede vähesus - tunnuste hulka võib kuuluda tavalisest suurem infektsioonide arv - sealhulgas palavik, tugevad külmavärinad, kurguvalu või suuhaavandid.
English: Victrelis, in combination with peginterferon alfa and ribavirin, is used for chronic hepatitis C virus infection in adults (also called HCV infection).
Estonian: Kombinatsioonis alfapeginterferooni ja ribaviriiniga kasutatakse Victrelist kroonilise C-hepatiidi viirusinfektsiooni (seda nimetatakse ka CHC infektsiooniks) ravimiseks täiskasvanutel.
English: Available pharmacodynamic/toxicological data in rats have shown effects of boceprevir/metabolites on fertility, which in females have been shown to
Estonian: Olemasolevad rotte puudutavad farmakodünaamilised/toksikoloogilised andmed on näidanud botsepreviiri/metaboliitide mõju fertiilsusele, mis emastel on pöörduv (vt lõik 5.3).
English: The race distribution of subjects was as follows: 85% White, 12% Black, 1% Asian, < 1% multiracial, < 1% Native Hawaiian or Other Pacific Islander.
Estonian: Uuritavate rassiline jaotus oli järgmine: 85% valged, 12% mustanahalised, 1% Aasia päritoluga, < 1% mitmerassilised, < 1% Havai või muude Vaikse ookeani saarte põliselanikud.
English: Boceprevir is not eliminated by dialysis.
Estonian: Dialüüs ei eemalda botsepreviiri.
English: C-boceprevir, the most abundant circulating metabolites were a diasteriomeric mixture of ketone-reduced metabolites with a mean exposure approximately 4 fold greater than that of boceprevir.
Estonian: Pärast ühekordset 800 mg C-botsepreviiri suukaudse annuse manustamist oli kõige suurema ringlusega metaboliidiks ketoonredutseeritud metaboliitide diastereomeerne segu, mille keskmine toime oli botsepreviiri omast ligikaudu 4 korda suurem.
English: • However, if it is less than 2 hours before your next dose is due, skip the missed dose.
Estonian: • Siiski, kui järgmise annuse manustamise ajani jääb alla 2 tunni, jätke annus vahele.
English: • oral midazolam or oral triazolam - a sedative, given by mouth
Estonian: • suukaudne midasolaam või suukaudne triasolaam - rahusti, mida manustatakse suukaudu;
English: Each capsule has a yellowish-brown, opaque cap with an "MSD" logo imprinted in red ink and offwhite, opaque body with the code "314" imprinted in red ink.
Estonian: Kõvakapslitel on kollakaspruun ülaosa punase „MSD” logoga ja valkjas alaosa punase koodiga „314”.
English: Please refer to the Summary of Product Characteristics for peginterferon alfa.
Estonian: Palun vt alfapeginterferooni ravimi omaduste kokkuvõtet.
English: (tacrolimus 0.5 mg single dose + Victrelis 800 mg three times daily multiple doses)
Estonian: (takroliimus 0,5 mg üksikannus + Victrelis 800 mg kolm korda ööpäevas mitme annusena)
English: ANTI-INFECTIVES Antifungals
Estonian: SUUKAUDSED RASESTUMISVASTASED PREPARAADID
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
Estonian: Järgmiste paaris tehtud aminohappe asenduste korral saavutati rohkem kui 10 korda väiksem tundlikkus botsepreviirile: V55A + I170V, T54S + R155K, R155K + D168N, R155T +
English: All subjects with detectable HCV-RNA in plasma at TW 12 were discontinued from treatment.
Estonian: Kõik patsiendid, kelle HCV-RNA tase plasmas oli 12. ravinädalal tuvastatav, kõrvaldati ravilt.
English: • HIV non-nucleoside reverse transcriptase inhibitor - efavirenz, etravirine
Estonian: • mittenukleosiidset HIV pöördtranskriptaasi inhibiitorit - efavirensi, etraviriini;
English: Treatment with Victrelis should be initiated and monitored by a physician experienced in the
Estonian: Ravi Victrelisega peab alustama ja jälgima arst, kellel on kogemusi kroonilise C-hepatiidi kontrolli all
English: As a conservative measure in view of the limitations of the data, in treatment naïve patients-late responders, the treatment duration of the tritherapy is recommended to be prolonged to 32 weeks as compared to the tested 24 weeks duration of the tritherapy, for a total treatment duration of 48 weeks.
Estonian: Pidades silmas andmete piiratust, on konservatiivse meetmena soovitatav pikendada kolmikravi kestust 32 nädalani võrreldes testitud kolmikravi kestusega 24 nädalat, nii et kogu ravi kestus oleks 48 nädalat eelnevalt ravi mittesaanud patsientidel ja hilja ravile vastanutel.
English: The transfusion rate was 4% (10/249) in subjects randomized to receive ribavirin dose reduction and 2% (5/251) in subjects randomized to receive erythropoietin.
Estonian: Vereülekannet tehti 4%-le (10/249) vähendatud annuses ribaviriini saama randomiseeritud patsientidest ja 2%-le (5/251) erütropoetiini saama randomiseeritud patsientidest.
English: † in previously untreated subjects with HIV co-infection
Estonian: † määrad eelnevalt ravi mittesaanud HIV koinfektsiooniga patsientide hulgas
English: If haemoglobin is < 10 g/dL (or < 6.2 mmol/L) management of anaemia may be warranted (see
Estonian: Aneemia kontrolli all hoidmine võib olla vajalik, kui seerumi hemoglobiinitase on < 10 g/dl (või < 6,2 mmol/l) (vt lõik 4.8).
English: This is not observed in mice
Estonian: Seda ei ole täheldatud hiirtel või ahvidel.
English: Heart or circulation: abnormal or rapid heart rate; heart disease caused by poor blood flow in
Estonian: Süda või vereringe: ebanormaalne või kiire südame löögisagedus; südame nõrgast verevoolust
English: Concomitant administration of Victrelis with sirolimus requires significant dose reduction and prolongation of the dosing interval for sirolimus, with close monitoring of sirolimus blood concentrations and frequent assessments of renal function and sirolimus-related side effects.
Estonian: Siroliimuse samaaegsel manustamisel koos Victrelisega on vaja siroliimuse annust oluliselt vähendada ja pikendada manustamisintervalli ning hoolikalt jälgida siroliimuse kontsentratsiooni veres ja sageli hinnata neerutalitlust ning siroliimusega seotud kõrvaltoimeid.
English: Exposure to atorvastatin was increased when administered with Victrelis.
Estonian: Atorvastatiini ekspositsioon suurenes manustamisel koos Victrelisega.
English: No dose adjustment of Victrelis or rilpivirine is recommended.
Estonian: Victrelise või rilpiviriini annust ei ole soovitatav kohandada.
English: Subjects were on an antiretroviral regimen with stable HIV disease (HIV-1 viral load < 50 copies/mL and CD4 count ≥ 200 cells/µL).
Estonian: Stabiilse HIV-haigusega (HIV-1 viiruskoormus < 50 koopia/ml ja CD4 arv ≥ 200 rakku/mikroliitris) patsiendid said retroviirusvastast ravi.
English: The number of subjects with cirrhosis is limited (where 40 subjects were treated with Victrelis of the
Estonian: Tsirroosiga patsientide arv on piiratud (kus kõigist 53 patsiendist raviti Victrelisega 40 patsienti).
English: Victrelis 200 mg hard capsules boceprevir
Estonian: Victrelis 200 mg kõvakapslid Botsepreviir
English: The activity of boceprevir against the HCV genotype 1a replicon was reduced (2- to 6-fold) by the following amino acid substitutions in the NS3 protease domain: V36A/L/M, Q41R, T54A/S, V55A, R155K and V158I.
Estonian: Botsepreviiri aktiivsust HCV genotüübi 1a replikoni suhtes vähendati (2…6-kordselt) järgmiste aminohappe asendustega NS3 proteaasi domeenis: V36A/L/M, Q41R, T54A/S, V55A, R155K ja V158I.
English: Pleural fibrosis*, orthopnoea, respiratory failure
Estonian: Harv pleurafibroos*, ortopnoe, hingamispuudulikkus Seedetrakti häired
English: • antiarrhythmic medicines- amiodarone, quinidine
Estonian: • arütmiavastaseid ravimeid - amiodarooni, kinidiini;
English: Table 5 Sustained Virologic Response (SVR), End of Treatment (EOT), and Relapse in previously untreated patients (early and late responders)
Estonian: Tabel 5 Püsiv viroloogiline vastus (SVR), ravi lõpetamine (EOT) ja retsidiveerumine eelnevalt ravi mittesaanud patsientide (vara ja hilja ravile vastanute) hulgas
English: The treatment discontinuation rate due to anaemia was 2% (5/249) in subjects randomized to receive ribavirin dose reduction and 2% (6/251) in subjects randomized to receive erythropoietin.
Estonian: Aneemia tõttu lõpetas ravi 2% (5/249) vähendatud annuses ribaviriini saama randomiseeritud patsiente ja 2% (6/251) erütropoetiini saama randomiseeritud patsiente.
English: You or your partner must use an effective birth control during the time you are taking ribavirin and for 7 months after stopping treatment.
Estonian: Teie ja teie partner peate kasutama efektiivseid rasestumisvastaseid vahendeid ribaviriini võtmise ajal ja 7 kuul pärast ravi lõpetamist.
English: The activity of boceprevir against the HCV genotype 1b replicon was reduced (2- to 8-fold) by the following amino acid substitutions in the NS3 protease domain: V36A/M, F43S, T54A/G/S, V55A, R155K/G, V158I, V170M and M175L.
Estonian: Botsepreviiri aktiivsust HCV genotüübi 1b replikoni suhtes vähendati (2…8-kordselt) järgmiste aminohappe asendustega NS3 proteaasi domeenis: V36A/M, F43S, T54A/G/S, V55A, R155K/G, V158I, V170M ja M175L.
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.
Estonian: Kui patsiendi HCV-RNA tulemused on suuremad või võrdsed kui 1000 RÜ/ml 8. ravinädalal, siis lõpetage kolme ravimiga skeem.
English: Caution should be exercised when boceprevir is combined with ketoconazole or azole antifungals (itraconazole, posaconazole, voriconazole).
Estonian: Ettevaatlik tuleb olla botsepreviiri kombineerimisel ketokonasooli või seenevastaste asoolidega (itrakonasooli, posakonasooli, vorikonasooliga).
English: (CYP3A inhibition - effect on
Estonian: (CYP3A inhibeerimine - toime
English: Victrelis 200 mg hard capsules
Estonian: Victrelis 200 mg kõvakapslid
English: If the patient has HCV-RNA results greater than or equal to 100 IU/mL at TW 12; then discontinue
Estonian: Kui patsiendi HCV-RNA tulemused on suuremad või võrdsed kui 100 RÜ/ml 12. ravinädalal, siis lõpetage kolme ravimiga skeem.
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.
Estonian: Genotüübiga 1a patsientidel täheldatud kõige olulisemate botsepreviiri suhtes resistentsete variantide (> 10%) tuvastamatuks muutumise aja mediaanid olid järgmised: R155K + V36M-l 0,69 aastat, V36M-l 0,89 aastat, R155K + T54S-l 1,05 aastat, R155K-l 1,08 aastat ja T54S-l 1,14 aastat.
English: Dose modifications due to anaemia/haemolytic anaemia occurred twice as often in patients treated with the combination of Victrelis with peginterferon alfa-2b and ribavirin (26%) compared to peginterferon alfa-2b and ribavirin alone (13%).
Estonian: Annuse muutmine aneemia/hemolüütilise aneemia tõttu toimus Victrelise ning alfa-2b-peginterferooni ja ribaviriini kombinatsiooniga ravitud patsientide hulgas kaks korda sagedamini (26%) kui patsientide hulgas, keda raviti ainult alfa-2b-peginterferooni ja ribaviriiniga (13%).
English: Co-administration of Victrelis with alfuzosin and silodosin is contraindicated (see section 4.3).
Estonian: Victrelise manustamine koos alfusosiini ja silodosiiniga on vastunäidustatud (vt lõik 4.3).
English: Anaemia was observed in 49% of subjects treated with the combination of Victrelis with peginterferon alfa-2b and ribavirin compared with 29% of subjects treated with peginterferon alfa-2b and ribavirin alone.
Estonian: Aneemiat täheldati 49% patsientidest, keda raviti Victrelise ning alfa-2b-peginterferooni ja ribaviriini kombinatsiooniga, võrreldes 29% patsientidega, keda raviti ainult alfa-2b-peginterferooni ja ribaviriiniga.
English: In healthy subjects who received 800 mg three times daily alone, boceprevir medicine exposure was characterized by AUC(т) of 6,147 ng
Estonian: Tervetel isikutel, kes said 800 mg kolm korda ööpäevas ainult kõnealust ravimit, oli botsepreviiri ekspositsioonile iseloomulik AUC(т) 6,147 ng/h/ml, Cmax 1,913 ng/ml ja Cmin 90 ng/ml.