FrancophonIA/ELRC3.0 huggingface dataset:
English: Skin and subcutaneous tissue disorders very common pruritus, rash common eczema, swelling face, exfoliative rash uncommon drug rash with eosinophilia and systemic symptoms (DRESS), urticaria rare
Danish: Hud og subkutane væv meget almindelige pruritus, udslæt almindelige eksem, hævelser i ansigtet, eksfoliativt udslæt ikke almindelige lægemiddelinduceret udslæt med eosinofili og systemiske symptomer (DRESS), urticaria sjældne
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).
Danish: Telaprevirs farmakokinetik blev vurderet efter indgift af en enkelt dosis på 750 mg til forsøgspersoner uden hepatitis C med stærkt nedsat nyrefunktion (kreatininclearance < 30 ml/min).
English: There are no clinical data on the use of INCIVO in HCV patients with moderate or severe renal impairment (CrCl ≤ 50 ml/min) (see section 4.4).
Danish: Der foreligger ingen kliniske data om anvendelse af INCIVO til HCV-patienter med moderat til svært nedsat nyrefunktion (CrCl ≤ 50 ml/min) (se pkt.
English: Most laboratory values return to levels observed with peginterferon alfa and ribavirin by week 24, except platelet counts, which remain at levels lower than observed with peginterferon alfa and ribavirin until week 48 (see section 4.4).
Danish: De fleste laboratorieværdier vendte tilbage til de værdier, som sås sammen med pegyleret interferon-alfa og ribavirin i uge 24, med undtagelse af trombocyttallene, som forblev lavere end observeret for pegyleret interferon-alfa og ribavirin frem til uge 48 (se pkt.
English: A total of 352 (65%) patients had undetectable HCV RNA (target not detected) at weeks 4 and 12.
Danish: I alt 352 (65%) af patienterne havde ikke-detekterbart HCV-RNA (HCV-RNA ikke påvist) i uge 4 og 12.
English: Patients were randomised to 1 of 4 treatment groups: - INCIVO 750 mg every 8 hours with peginterferon alfa-2a 180 g/week and ribavirin
Danish: Patienterne blev randomiseret til 1 ud af 4 behandlingsgrupper: - INCIVO 750 mg hver 8. time sammen med pegyleret interferon-alfa-2a 180 g/uge og ribavirin
English: Refer to the respective Summary of Product Characteristics of peginterferon alfa and ribavirin for guidelines on dose modifications, interruptions, discontinuations or resumption of those medicinal
Danish: Der henvises til de respektive produktresuméer for pegyleret interferon-alfa og ribavirin for vejledning om dosisændringer, midlertidig afbrydelse eller seponering eller genoptagelse af behandlingen med
English: Consultation with a specialist in dermatology is recommended.
Danish: Konsultation af speciallæge i dermatologi anbefales.
English: In the event that co-administration of such medicinal products with INCIVO is judged strictly necessary, clinical monitoring including ECG assessments is recommended.
Danish: Hvis samtidig anvendelse af sådanne lægemidler og INCIVO skønnes absolut nødvendig, anbefales klinisk kontrol inklusive ekg-vurderinger.
English: Sildenafil or tadalafil must not be used to treat a heart and lung disorder called pulmonary arterial hypertension.
Danish: Sildenafil eller tadalafil må ikke bruges til at behandle pulmonal arteriel hypertension - en sygdom, der berører hjerte og lunger.
English: The use of INCIVO in combination with peginterferon alfa-2b The Phase 3 studies were all conducted with peginterferon alfa-2a in combination with INCIVO and ribavirin.
Danish: Anvendelse af INCIVO i kombination med pegyleret interferon-alfa-2b Fase 3-studierne blev alle udført med pegyleret interferon-alfa-2a i kombination med INCIVO og ribavirin.
English: - severe rash, which may be accompanied by fever, fatigue, swelling of the face or lymph glands, increase of eosinophils (type of white blood cells), effects on liver, kidney or lung (a reaction called DRESS); - hives (urticaria) - dehydration.
Danish: - alvorligt udslæt, som kan være ledsaget af feber, træthed, hævelser i ansigtet eller hævede lymfekirtler, forhøjet antal af en bestemt type hvide blodlegemer (eosinofile celler), påvirkning af lever, nyrer eller lunger (en reaktion kendt som DRESS)
English: Common side effects (affects less than 1 in 10 people):
Danish: Ikke almindelige bivirkninger (forekommer hos færre end 1 ud af 100 behandlede)
English: It is not known whether telaprevir is dialyzable by peritoneal or haemodialysis.
Danish: Det vides ikke, om telaprevir kan fjernes ved peritoneal- eller hæmodialyse.
English: If your doctor stops INCIVO, it should not be restarted.
Danish: Hvis lægen stopper behandling med INCIVO, må du ikke starte med det igen.
English: 21.6% of patients receiving INCIVO combination treatment required ribavirin dose reduction for anaemia compared to 9.4% of patients receiving peginterferon alfa and ribavirin alone.
Danish: 21,6% af de patienter, som fik INCIVO-kombinationsbehandling, havde behov for dosisreduktion af ribavirin sammenlignet med 9,4% af de patienter, som fik pegyleret interferon-alfa og ribavirin alene.
English: ↑ midazolam (p.o.) AUC 8.96 (7.75-10.35) Cmax 2.86 (2.52-3.25)
Danish: ↑ midazolam (per os) AUC 8,96 (7,75-10,35) Cmax 2,86 (2,52-3,25)
English: All of these reactions resolved with treatment
Danish: Alle disse reaktioner forsvandt igen ved seponering
English: INCIVO is not recommended during pregnancy and in women of childbearing potential not using contraception.
Danish: Det anbefales ikke at anvende INCIVO under graviditeten eller til kvinder i den fertile alder, som ikke anvender sikker
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).
Danish: Klinisk-kemiske undersøgelser (elektrolytter, serumkreatinin, urat, leverenzymer, bilirubin, TSH) bør udføres lige så hyppigt som de hæmatologiske undersøgelser eller ved klinisk indikation (se pkt.
English: Table 13: SVR rates by week 4 response (< 1 log10 or ≥ 1 log10 reduction) in the T12(DS)/PR48
Danish: Tabel 13: SVR-rater ud fra response i uge 4 (< 1 log10 eller ≥ 1 log10 reduktion) i T12(DS)/PR48-gruppen: Studie C216
English: There are no clinical data on the use of INCIVO in patients on haemodialysis.
Danish: Der foreligger ingen kliniske data om anvendelse af INCIVO hos patienter i hæmodialyse.
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.
Danish: Ud fra resultater fra kliniske lægemiddelinteraktionsstudier (f.eks. med escitalopram, zolpidem, ethinylestradiol) kan det ikke udelukkes, at telaprevir inducerer metaboliske enzymer.
English: For patients receiving a total of 48 weeks of treatment, peginterferon alfa and ribavirin should be discontinued if HCV RNA is detectable at week 24 or week 36.
Danish: Hos patienter, der planlægges behandlet i 48 uger i alt, bør behandling med pegyleret interferon-alfa og ribavirin seponeres, hvis de har påviseligt HCV-RNA i uge 24 eller uge 36.
English: Study 107 was an open label, rollover study for patients who were treated in the control group (placebo, peginterferon alfa-2a, and ribavirin) of a Phase 2 study of telaprevir and who did not achieve SVR in the Phase 2 study.
Danish: Studie 107 var et åbent, ekstensionsstudie for patienter, som blev behandlet i kontrolgruppen (placebo, pegyleret interferon-alfa-2a og ribavirin) i et fase 2-studie med telaprevir, og som ikke opnåede SVR i fase 2-studiet.
English: All patients started with a dose of 600 mg/day of ribavirin and 180 µg/week of peginterferon alfa-2a.
Danish: Alle patienter startede med en dosis på 600 mg ribavirin daglig og 180 µg pegyleret interferon alfa-2a ugentligt.
English: Among patients treated with telaprevir, on-treatment virologic failure was more frequent in patients with genotype 1a than with genotype 1b and more frequent in prior null responders than in other populations (treatment-naïve, prior relapsers, prior partial responders; see section 5.1, Clinical Experience, Efficacy in Previously Treated Adults).
Danish: Blandt patienter, der fik telaprevir, var virologisk svigt under behandlingen hyppigere hos patienter med genotype 1a end med genotype 1b og hyppigere hos patienter med tidligere null response end i andre populationer (behandlingsnaive, personer med tidligere relapse, personer med tidligere partial response (se pkt.
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.
Danish: Eksponering for telaprevir ved steady state var 46% lavere hos forsøgspersoner med moderat nedsat leverfunktion (Child-Pugh-klasse B, score 7-9) sammenlignet med raske forsøgspersoner.
English: Increased dose of zolpidem may be required to maintain efficacy.
Danish: Der kan være behov for dosisøgning for at vedligeholde virkningen.
English: The appropriate dose of INCIVO in hepatitis C-infected patients with moderate hepatic impairment has not been determined.
Danish: Der er ikke fastsat en passende dosering af INCIVO til patienter inficeret med hepatitis C, som har moderat nedsat leverfunktion.
English: The study enrolled prior relapsers (patients with HCV RNA undetectable at end of treatment with a pegylated interferon-based regimen, but HCV RNA detectable within 24 weeks of treatment follow-up) and prior non-responders (patients who did not have undetectable HCV RNA levels during or at the end of a prior course of at least 12 weeks of treatment).
Danish: I studiet indgik patienter med tidligere relapse (med ikke-detekterbart HCV-RNA ved afslutning af behandling med et regime baseret på pegyleret interferon, men påviseligt HCV-RNA inden for 24 ugers opfølgning) og tidligere non-responders (patienter, som ikke havde ikke-detekterbart HCV-RNA under eller ved afslutning af et tidligere forløb på mindst 12 ugers behandling).
English: Predominant baseline resistance to telaprevir does not preclude successful treatment with telaprevir, peginterferon alfa, and ribavirin.
Danish: Overvejende resistens mod telaprevir ved baseline udelukker ikke vellykket behandling med telaprevir, pegyleret interferon-alfa og ribavirin.
English: Table 10 shows SVR rates by extent of liver fibrosis at baseline.
Danish: I tabel 10 vises SVR-rater ved forskellige grader af leverfibrose ved baseline.
English: alfentanil, fentanyl to treat pain (analgesics) or used during surgery to induce sleep digoxin, intravenous lidocaine to treat certain heart disorders such as abnormal heart beat (antiarrhythmics)
Danish: alfentanil, fentanyl til smertebehandling (analgesi) eller til indsovning i forbindelse med en operation digoxin, intravenøst lidocain til behandling af visse hjertesygdomme såsom unormal puls (antiarytmika)
English: Refer to the Summary of Product Characteristics for ribavirin for information regarding dose reduction and/or discontinuation of ribavirin.
Danish: Der henvises til produktresuméet for ribavirin for oplysninger om dosisreduktion og seponering af ribavirin.
English: T12P(2b)R48 N = 81 (%) n/N
Danish: T12P(2a)R48 N = 81 (%) n/N
English: Important information about some of the ingredients of INCIVO This medicinal product contains 2.3 mg sodium per tablet, which should be taken into consideration by patients on a controlled sodium diet.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i INCIVO Dette lægemiddel indeholder 2,3 mg natrium pr. tablet, og patienter som er på natrium- eller saltfattig
English: Co-administration of INCIVO and medicinal products that induce CYP3A and/or P-gp may markedly decrease telaprevir plasma concentrations.
Danish: Samtidig anvendelse af INCIVO og lægemidler, der inducerer CYP3A og/eller P-gp, kan nedsætte plasmakoncentrationen af telaprevir markant.
English: The denominator when calculating the relapse rate represents the number of patients with end-of-treatment response (HCV RNA < 25 IU/ml).
Danish: Nævneren ved beregning af relapse-raten er antallet af patienter med respons ved endt behandling (HCV-RNA
English: See the package leaflets for peginterferon alfa and ribavirin for a list of their contraindications (e.g. pregnancy precautions for men and women) since INCIVO must be used in combination with peginterferon alfa and ribavirin.
Danish: Se indlægssedlerne for pegyleret interferon-alfa og ribavirin, som giver en oversigt over, hvornår de ikke må anvendes (f.eks. forholdsregler mod graviditet for mænd og kvinder), eftersom INCIVO skal anvendes sammen med pegyleret interferon-alfa og ribavirin.
English: )/PR group and the T12(q8h)/PR group.
Danish: )/PR- og T12(q8h)/PR-gruppen.
English: Each tablet of INCIVO contains 375 mg of telaprevir.
Danish: En tablet INCIVO indeholder 375 mg telaprevir.
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.).
Danish: Eksponeringen for telaprevir var den samme, uanset om den totale døgndosis på 2.250 mg blev administreret som 750 mg hver 8. time eller som 1.125 mg to gange dagligt.
English: INCIVO should be administered in conjunction with ribavirin and either peginterferon alfa-2a or -2b.
Danish: INCIVO skal administreres i kombination med ribavirin og enten pegyleret interferon-alfa-2a eller -2b.
English: to treat migraine and headaches (ergot derivatives)
Danish: til at behandle migræne og hovedpine (sekalealkaloid)
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.
Danish: Hæmoglobinværdier på < 10 g/dl observeredes hos 34% af de patienter, der fik INCIVO-kombinationsbehandling, og hos 14% af de patienter, der fik pegyleret interferon-alfa og ribavirin.
English: Telaprevir had no effects on fertility or fecundity when evaluated in rats.
Danish: Telaprevir påvirkede ikke fertilitet eller frugtbarhed i dyrestudier med rotter.
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).
Danish: Resultaterne af et studie udført med raske forsøgspersoner viste en beskeden virkning af telaprevir i en dosis på 1.875 mg hver 8. time på QTcF-intervallet med en placebojusteret maksimal middelstigning på 8,0 millisekunder (90% konfidensinterval: 5,1-10,9) (se pkt.
English: INCIVO should be used with caution with Class Ic antiarrhythmics propafenone and flecainide, including appropriate clinical and ECG monitoring.
Danish: Forsigtighed tilrådes ved brug af INCIVO sammen med klasse Ic-antiarytmika propafenon og flecainid, og behandlingen skal følges med passende klinisk kontrol og ekg.
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
Danish: 5,8% af patienterne måtte afbryde behandlingen med INCIVO alene på grund af udslæt, og 2,6% af patienterne afbrød INCIVO-kombinationsbehandling pga. udslæt sammenlignet med ingen af dem, der fik pegyleret interferon-alfa og ribavirin.
English: INCIVO was given for the first 8 weeks of treatment (T8/PR regimen) or the first 12 weeks of treatment (T12/PR regimen) in combination with peginterferon alfa-2a and ribavirin for either 24 or 48 weeks.
Danish: Der blev givet INCIVO under de første 8 uger af behandlingen (T8/PR-regimet) eller de første 12 uger af behandlingen (T12/PR-regimet) i kombination med pegyleret interferon-alfa-2a og ribavirin i enten 24 eller 48 uger.
English: Selected laboratory abnormalities of at least moderate intensity (≥ Grade 2) that represent a worsening from baseline and are considered ADRs observed in HCV-infected patients treated with INCIVO combination treatment from the pooled data from the placebo-controlled Phase 2 and Phase 3 trials
Danish: Selekterede abnorme laboratoriefund med mindst moderat intensitet (≥ grad 2), som udgjorde en forværring fra baseline og ansås for bivirkninger observeret hos HCV-inficerede patienter, der blev behandlet med INCIVO-kombinationsbehandling, fra de poolede data fra de placebokontrollerede fase 2- og fase 3-studier fremgår af tabellen nedenfor:
English: Gastrointestinal disorders very common nausea, diarrhoea, vomiting, haemorrhoids, proctalgia common anal pruritus, rectal haemorrhage, anal fissure uncommon proctitis, pancreatitis
Danish: Mave-tarm-kanalen meget almindelige kvalme, diarré, opkastning, hæmorider, proktalgi almindelige anal pruritus, rektal blødning, analfissur ikke almindelige Proktitis, pancreatitis
English: Purpose of the medicine alfuzosin to treat symptoms of an enlarged prostate (alpha-1-adrenoreceptor antagonists)
Danish: Medicinens formål alfuzosin til behandling af symptomerne på forstørret blærehalskirtel (adrenergt alfa-receptorblokerende middel)
English: Serious skin reactions including rash with systemic symptoms, progressive severe rash,
Danish: Alvorlige hudreaktioner, herunder udslæt med systemiske symptomer, progredierende diagnosticeret generaliseret bulløst udslæt,
English: Because of the potential for adverse reactions in breastfed infants, due to the combined treatment of INCIVO with peginterferon alfa and ribavirin, breast-feeding must be discontinued prior to initiation of therapy.
Danish: På grund af risikoen for bivirkninger hos ammede børn ved kombination af INCIVO med pegyleret interferon-alfa og ribavirin skal amningen ophøre, inden behandlingen indledes.
English: Pregnancy and contraception requirements
Danish: Graviditet og amning
English: If the HCV RNA concentration is > 1,000 IU/ml, INCIVO, peginterferon alfa, and ribavirin should be discontinued.
Danish: Hvis HCV-RNA-koncentrationen er > 1.000 IE/ml, bør behandling med INCIVO, pegyleret interferon-alfa og ribavirin seponeres.
English: AUC 1.30 (1.22-1.39) Cmax 1.30 (1.16-1.45) Cmin 1.41 (1.29-1.54) effect on P-gp transport in the gut
Danish: Cmax 1,30 (1,16-1,45) Cmin 1,41 (1,29-1,54) effekt på P-gp-transport i tarmen
English: If ribavirin is permanently discontinued for the management of anaemia, INCIVO must also be permanently discontinued.
Danish: behandling af anæmi, skal INCIVO ligeledes seponeres permanent.
English: - painful inflammation of the joints most commonly in the foot (gout);
Danish: - smerteful betændelse i leddene - hyppigst i foden (urinsur gigt)
English: Signs might be yellowing of the skin or eyes (jaundice), swelling of the stomach (ascites) or legs due to fluid, and bleeding from swollen veins (varices) in the gullet (oesophagus).
Danish: De kan vise sig ved, at huden eller øjnene bliver gule (gulsot), maven bliver større (ascites) eller benene hæver på grund af væske, eller der opstår blødning på grund af hævede årer (åreknuder) i spiserøret.
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).
Danish: 4.3) INCIVO må ikke gives samtidig med aktive stoffer hvis clearance i høj grad er afhængige af CYP3A og hvor øget plasmakoncentration af disse aktive stoffer er forbundet med alvorlige og/eller livstruende reaktioner såsom hjertearytmi (amiodaron, astemizol, bepridil, cisaprid, pimozid, quinidin, terfenadin) eller perifer vasospasme eller iskæmi (dihydroergotamin, ergometrin, ergotamin, methylergometrin) eller myopati inklusive rabdomyolyse (lovastatin, simvastatin, atorvastatin) eller forlænget eller øget sedation eller respiratorisk depression (quetiapin, oralt midazolam eller triazolam) eller hypotension eller hjertearytmi (alfuzosin og sildenafil mod pulmonal arteriel hypertension).
English: The recommendations for monitoring of cutaneous reactions, and for discontinuation of INCIVO, ribavirin and peginterferon alfa are summarised in the table below:
Danish: Anbefalinger for overvågning af kutane reaktioner og for seponering af behandling med INCIVO, ribavirin og pegyleret interferon-alfa gengives i tabellen nedenfor:
English: No adjustment of methadone dose is required when initiating co-administration of telaprevir.
Danish: Det er ikke nødvendigt at justere doseringen af methadon ved indledning af samtidig behandling med telaprevir.
English: OUTER CARTON (4-bottle pack)
Danish: YDERKARTON (pakning med 4 beholdere)
English: INCIVO is available in packs containing 1 bottle (total of 42 film-coated tablets) or 4 bottles (total of
Danish: INCIVO fås i æsker, der indeholder 1 beholder (42 tabletter i alt) eller 4 beholdere (168 tabletter i alt).
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).
Danish: INCIVOs samlede sikkerhedsprofil hos patienter co-inficeret med HCV og hiv-1 (i eller ikke i antiretroviral behandling) svarede til sikkerhedsprofilen hos patienter, der kun var inficeret med HCV, med undtagelse af patienter, der fik atazanavir/ritonavir, som hyppigt oplevede en forbigående stigning i ukonjugeret (indirekte) bilirubin (herunder grad 3 til 4) til og med uge 2.
English: HCV RNA > 1,000 IU/ml at week 4 of treatment
Danish: HCV-RNA > 1.000 IE/ml i uge 4 af behandlingen
English: Each film-coated tablet contains 375 mg of telaprevir.
Danish: En filmovertrukket tablet indeholder 375 mg telaprevir.
English: Transporters In vitro studies demonstrated that telaprevir is an inhibitor of OATP1B1 and OATP2B1.
Danish: In vitro-studier har vist, at telaprevir hæmmer OATP1B1 og OATP2B1.
English: Clonal sequencing analysis of a subset of patients who had wild-type HCV by population sequencing (n=20), comparing the frequency of resistant variants before the start of telaprevir treatment and at follow-up, showed that the HCV variant population in all patients had returned to pre-treatment levels.
Danish: Hos en undergruppe af patienterne, som havde vildtype-HCV ved populationssekvensering (n=20), viste klonal sekvenseringsanalyse, at HCV-variantpopulationen var vendt tilbage til niveauet før behandlingen hos alle patienter ved sammenligning af frekvensen af resistente varianter før indledning af telaprevir-behandling og ved opfølgningen.
English: INCIVO 375 mg film-coated tablets telaprevir
Danish: INCIVO 375 mg filmovertrukne tabletter telaprevir
English: Patients were required to have an HIV-1 RNA < 50 copies/ml
Danish: Patienterne skulle have hiv-1-RNA < 50 kopier/ml og CD4-celletal > 300 celler/mm
English: HCV RNA < 25 IU/ml at End of Treatment
Danish: HCV-RNA < 25 IE/ml efter endt behandling
English: Co-administration with phenobarbital is contraindicated.
Danish: Co-administration af phenobarbital er kontraindiceret.
English: Co-administration with carbamazepine is contraindicated.
Danish: Co-administration af carbamazepin er kontraindiceret.
English: In vitro studies performed with human Caco-2 cells indicated that telaprevir is a substrate of P-glycoprotein (P-gp).
Danish: In vitro-studier udført med humane CaCo-2-celler indikerede, at telaprevir er et substrat for
English: Therefore, no dose adjustment is recommended for INCIVO in HCV patients with renal impairment.
Danish: Dosisjustering af INCIVO anbefales derfor ikke hos HCV-patienter med nedsat nyrefunktion.