FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 11 shows the response rates for the recommended simultaneous start (T12/PR48) and the Pbo/PR48 arms.
Danish: I tabel 11 vises responsraterne for studiearmen med den anbefalede samtidige start (T12/PR48-gruppen) og Pbo/PR48-gruppen.
English: Your doctor should check your rash to determine how to manage it.
Danish: Lægen skal kontrollere udslættet for at finde frem til den rette behandling.
English: Co-administration of sildenafil or tadalafil and telaprevir in the treatment of pulmonary arterial hypertension is contraindicated (see section 4.3).
Danish: Samtidig brug af telaprevir og sildenafil eller tadalafil til behandling af pulmonal arteriel hypertension er kontraindiceret (se pkt.
English: For additional information on mild to moderate rash, see section 4.8.
Danish: 4.8 vedrørende yderligere oplysninger om mildt til moderat udslæt.
English: If you belong to this age group, please discuss the use of INCIVO with your doctor.
Danish: Rådfør dig med din læge om brug af INCIVO, hvis du hører til denne aldersgruppe.
English: The Summary of Product Characteristics for peginterferon alfa and ribavirin must therefore be consulted before starting therapy with INCIVO.
Danish: Produktresuméerne for pegyleret interferon-alfa og ribavirin skal derfor gennemgås før indledning af behandling med INCIVO.
English: Severe rash: Extent of rash > 50% of body surface area or associated with vesicles,
Danish: Alvorligt udslæt: Udslættets omfang > 50% af legemsoverfladen eller associeret med vesikler, bullae og ulcerationer andre end
English: Effect on concentration of INCIVO or concomitant medicinal product and possible mechanism
Danish: Virkning på koncentration af INCIVO eller samtidigt
English: INCIVO is not recommended in patients with moderate to severe hepatic impairment (Child-Pugh B or C, score ≥ 7) or decompensated liver disease (ascites, portal hypertensive bleeding, encephalopathy, and/or jaundice other than Gilbert's Syndrome, see section 4.4).
Danish: INCIVO anbefales ikke til patienter med moderat til svært nedsat leverfunktion (Child-Pugh-klasse B eller C, score ≥ 7) eller dekompenseret leversygdom (ascites, portal hypertensiv blødning, encefalopati og/eller gulsot, der ikke er Gilberts syndrom, se pkt.
English: Alternatively, 750 mg (two 375 mg tablets) can be taken orally every 8 hours (q8h) with food.
Danish: Alternativt kan en dosis på 750 mg (to 375 mg filmovertrukne tabletter) indtages oralt hver 8. time i forbindelse med et måltid.
English: The primary objective of the study was to assess the antiviral efficacy of INCIVO, peginterferon alfa-2a, and ribavirin in HCV-infected liver transplant recipients as measured by SVR12.
Danish: Det primære formål med studiet var at vurdere den antivirale virkning af INCIVO, pegyleret interferon alfa-2a og ribavirin hos HCV-inficerede levertransplantatmodtagere målt ved SVR12.
English: Peginterferon alfa and ribavirin may be continued.
Danish: Pegyleret interferon-alfa og ribavirin kan fortsættes.
English: Fertility INCIVO had no effects on fertility or fecundity when evaluated in rats.
Danish: Fertilitet INCIVO påvirkede ikke fertiliteten i dyrestudier med rotter.
English: INCIVO, 1,125 mg (three 375 mg film-coated tablets) should be taken orally twice daily (b.i.d.)
Danish: INCIVO i en dosis på 1.125 mg (tre 375 mg filmovertrukne tabletter) bør indtages oralt to gange dagligt i forbindelse med et måltid.
English: Increased systemic exposures are expected if telaprevir is combined with drugs highly metabolised by this enzyme.
Danish: Hvis telaprevir gives sammen med lægemidler, der i omfattende grad metaboliseres af dette enzym, må der forventes øget systemisk eksponering.
English: Patients taking INCIVO may develop a skin rash.
Danish: Patienter, der tager INCIVO, kan få udslæt.
English: QT interval prolongation has been reported with ketoconazole (see section 4.4).
Danish: Forlænget QTinterval er rapporteret i forbindelse med ketoconazol (se pkt.
English: Among prior relapsers in the T12/PR24 treatment group who had undetectable HCV RNA (target not detected) at week 4 and 12 of treatment, the SVR rate was 100%
Danish: Blandt patienterne med tidligere relapse i T12/PR24-gruppen, som havde ikkedetekterbart HCV-RNA (HCV-RNA ikke påvist) i behandlingsuge 4 og 12, var SVR-raten 100%
English: Study HPC3008 was an open-label, Phase 3b study conducted in patients with chronic genotype 1 HCV/HIV-1 co-infection who were treatment-naïve for hepatitis C or who did not achieve SVR with prior treatment with peginterferon alfa (2a or 2b) and ribavirin (including prior relapsers, prior partial responders and prior null responders).
Danish: Studie HPC3008 var et åbent fase 3b-studie, der omfattede patienter med samtidig infektion med kronisk hepatitis C af genotype 1 og hiv-1, som var behandlingsnaive for hepatitis C, eller som ikke havde opnået SVR med tidligere behandling med peginterferon alfa (2a eller 2b) og ribavirin (herunder tidligere relapsers, tidligere partial responders og tidligere null responders).
English: The resistance profile observed in Study HPC3008 in HCV/HIV-1 co-infected patients was similar to the resistance profile in mono-infected HCV patients.
Danish: Den observerede resistensprofil i studie HPC3008 hos patienter med samtidig HCV/hiv-1-infektion svarede til resistensprofilen hos patienter, der kun havde HCV-infektion.
English: Refer also to the Summary of Product Characteristics for ribavirin for patients with CrCl < 50 ml/min.
Danish: Se også produktresuméet for ribavirin vedrørende patienter med CrCl < 50 ml/min.
English: On-treatment virologic failure was defined as meeting a virologic stopping rule or having viral breakthrough.
Danish: Virologisk svigt under behandlingen blev defineret som udløsning af en virologisk stopregel eller et viralt gennembrud.
English: Alternatively, telaprevir can be administered orally with food as 375 mg tablets, 750 mg every 8 hours (q8h) for 12 weeks, in combination with peginterferon alfa and ribavirin.
Danish: Alternativt kan telapravir indgives oralt med samtidig fødeindtagelse som 375 mg tabletter, 750 mg hver 8. time, i 12 uger i kombination med pegyleret interferon-alfa og ribavirin.
English: Co-administration with phenytoin is contraindicated.
Danish: Co-administration af phenytoin er kontraindiceret.
English: rifampicin to treat some infections like tuberculosis (antimycobacterial)
Danish: til at behandle visse infektioner såsom tuberkulose (antibiotikum)
English: Relapse was defined as having less than 25 IU/ml at the planned end of treatment followed by HCV RNA ≥ 25 IU/ml at the last observation within the SVR follow-up visit window.
Danish: Relapse blev defineret som havende mindre end 25 IE/ml på det planlagte tidspunkt for behandlingsafslutning efterfulgt af HCV- RNA ≥ 25 IE/ml ved den sidste observation inden for besøgsvinduet for SVR-opfølgning.
English: regimen results in the same daily dose with similar drug exposures of telaprevir, the relative drug interactions are expected to be similar.
Danish: I betragtning af, at et regime med 1.125 mg to gange dagligt resulterer i den samme døgndosis og tilsvarende eksponering for telapravir, forventes de respektive lægemiddelinteraktioner at være sammenlignelige.
English: No relevant inhibition by telaprevir of alcohol dehydrogenase was observed in vitro.
Danish: In vitro blev det ikke observeret, at telaprevir udøver relevant hæmning af alkoholdehydrogenase.
English: Study 110 was a phase II randomised, double-blind, placebo-controlled study conducted in patients with chronic genotype 1 HCV/HIV co-infection who were treatment-naïve for hepatitis C. Patients were either not on antiretroviral therapy (CD4 count ≥ 500 cells/mm
Danish: Studie 110 var et randomiseret, dobbeltblindt, placebokontrolleret fase 2-studie, som blev udført hos patienter, der var co-inficeret med kronisk hepatitis C af genotype 1 og hiv, og som var behandlingsnaive for hepatitis C. Enten fik disse patienter ikke antiretroviral behandling (CD4
English: ↑ midazolam (intravenous) AUC 3.40 (3.04-3.79) Cmax 1.02 (0.80-1.31)
Danish: ↑ midazolam (intravenøst) AUC 3,40 (3,04-3,79) Cmax 1,02 (0,80-1,31)
English: Tell your health care provider if you have problems swallowing whole tablets.
Danish: Tal med lægen, hvis du har problemer med at synke hele
English: Hepatobiliary disorders common hyperbilirubinaemia
Danish: Lever og galdeveje almindelige hyperbilirubinæmi
English: Most drug-drug interaction studies have been performed with a telaprevir dose of 750 mg every 8 hours (q8h).
Danish: I de fleste lægemiddelinteraktionsstudier anvendtes en telapravir-dosis på 750 mg hver 8. time.
English: The non-responder-population was comprised of 2 subgroups: prior partial responders (greater than or equal to 2 log10 reduction in HCV RNA at week 12, but not achieving HCV RNA undetectable at end of treatment with a peginterferon and ribavirin) and prior null responders (less than 2 log10 reduction in HCV RNA at week 12 of prior treatment with peginterferon and ribavirin).
Danish: Populationen af non-responders omfattede 2 undergrupper: patienter med tidligere partial response (≥ 2 log10 reduktion i HCV-RNA i uge 12, men uden ikkedetekterbart HCV-RNA ved afsluttet behandlingen med et pegyleret interferon og ribavirin) og patienter med tidligere null response (<2 log10 reduktion i HCV-RNA i uge 12 af den tidligere behandling med pegyleret interferon og ribavirin).
English: - swollen veins in the rectum or anus (haemorrhoids), pain in the anus or rectum;
Danish: - hævede blodårer i endetarmen eller dens udmunding (rektum eller anus) (hæmorider), smerter i
English: The denominator is the number of patients with HCV RNA < 25 IU/ml at planned end of treatment or a missing HCV RNA assessment at planned end of treatment and HCV RNA < 25 IU/ml during follow-up from planned end of treatment onwards.
Danish: Nævneren er antallet af patienter med HCV RNA < 25 IE/ml på det planlagte tidspunkt for behandlingsafslutning eller manglende vurdering af HCV RNA på det planlagte tidspunkt for behandlingsafslutning og HCV RNA < 25 IE/ml i opfølgningsperioden fra det planlagte tidspunkt for behandlingsafslutning og fremefter.
English: - itching around or near the anus, bleeding around or near the anus or rectum, a small tear in the skin that lines the anus that may cause pain and/or bleeding during bowel movements; - red, cracked, dry, scaly skin (eczema), rash with red, cracked, dry, scaly skin (exfoliative rash); - swelling of the face, swelling of the arms and/or legs (oedema);
Danish: - smagsforandringer - besvimelse - kløe omkring endetarmen, blødninger omkring eller nær endetarmen (anus eller rektum), en lille rift i huden inde i anus, som kan give smerter og/eller blødning under afføring, - rød, tør, skællende hud med revner (eksem), udslæt med rød, tør, skællende hud med revner
English: to decrease blood pressure (calcium channel blockers) to treat HIV infections (CCR5 antagonist)
Danish: til at behandle hiv-infektioner (CCR5antagonist)
English: ↑ ketoconazole (400 mg) AUC 1.46 (1.35-1.58) Cmax 1.23 (1.14-1.33)
Danish: ↑ ketoconazol (400 mg) AUC 1,46 (1,35-1,58) Cmax 1,23 (1,14-1,33)
English: Administration of INCIVO may increase systemic exposure to medicinal products that are substrates of CYP3A or P-gp, which could increase or prolong their therapeutic effect and adverse reactions.
Danish: Administration af INCIVO kan øge den systemiske eksponering for lægemidler, der er substrater for CYP3A eller P-gp.
English: HIV-ANTIVIRAL AGENTS: REVERSE TRANSCRIPTASE INHIBITORS If co-administered, telaprevir 1,125 mg q8h should be used (see section 4.4).
Danish: ANTIVIRALE MIDLER MOD HIV: REVERS TRANSKRIPTASEHÆMMERE Ved co-administration bør der gives telaprevir 1,125 mg hver 8. time (se pkt.
English: The study was designed to compare SVR rates in patients with undetectable HCV RNA ( target not detected) at weeks 4 and 12 who were treated with INCIVO for 12 weeks in combination with peginterferon alfa-2a and ribavirin for either 24 weeks (T12/PR24 regimen) or 48 weeks (T12/PR48 regimen).
Danish: Studiet var designet til sammenligning af SVR-rater hos patienter med ikke-detekterbart HCV-RNA (HCV-RNA ikke påvist) i uge 4 og 12, som blev behandlet med INCIVO i 12 uger i kombination med pegyleret interferon-alfa-2a og ribavirin i enten 24 uger (T12/PR24-regimet) eller 48 uger (T12/PR48-regimet).
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.
Danish: Patienterne blev randomiseret til en af de tre behandlingsgrupper i forholdet 2:2:1: Samtidig start (T12/PR48): INCIVO fra dag 1 til og med uge 12.
English: The concomitant use of rifabutin and telaprevir is not recommended.
Danish: Rifabutin og telaprevir anbefales ikke anvendt samtidig.
English: QT interval prolongation has been reported with telithromycin (see section 4.4).
Danish: Forlænget QTinterval er rapporteret i forbindelse med telithromycin (se pkt.
English: Increased clinical and laboratory monitoring are warranted (see section 4.4).
Danish: Øget klinisk monitorering med laboratorieundersøgelser tilrådes (se pkt.
English: All patients received peginterferon alfa-2a and ribavirin for 48 weeks.
Danish: Alle patienter fik pegyleret interferon-alfa-2a og ribavirin i 48 uger.
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).
Danish: Der foreligger ingen kliniske data om fornyet behandling af patienter, som oplevede svigt af behandling baseret på HCV-NS3-4A-proteasehæmmere (se pkt.
English: Take INCIVO with peginterferon alfa and ribavirin for 12 weeks.
Danish: Tag INCIVO sammen med pegyleret interferon-alfa og ribavirin i 12 uger.
English: See also the Summary of Product
Danish: Se også ribavirins produktresumé.
English: The primary objective of the study was to assess the antiviral efficacy of INCIVO, peginterferon alfa-2a, and ribavirin in HCV/HIV-1 co-infected patients as measured by SVR12.
Danish: Studiets primære formål var at vurdere den antivirale virkning af INCIVO, peginterferon alfa-2a og ribavirin hos patienter med samtidig HCV/hiv-1-infektion, målt som SVR12.
English: Men
Danish: IR
English: OUTER CARTON (1-bottle pack)
Danish: YDERKARTON (pakning med 1 beholder)
English: Haemoglobin values gradually improve after completion of INCIVO dosing.
Danish: Efter gennemførelse af behandlingen med INCIVO stiger hæmoglobinværdierne gradvist.
English: Toxic epidermal necrolysis (TEN) including fatal outcome has been observed in post-marketing experience (see section 4.8).
Danish: Efter markedsføring er der observeret toksisk epidermal nekrolyse (TEN), også med et dødeligt forløb (se pkt.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL
Danish: HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF
English: Your doctor will decide on the appropriate dose regimen for you.
Danish: Din læge fastsætter den rette behandling.
English: When administered every 8 hours (q8h), in case a dose of INCIVO is missed within 4 hours of the time it is usually taken, patients should be instructed to take the prescribed dose of INCIVO with food as soon as possible.
Danish: Patienter, der tager INCIVO hver 8. time, skal informeres om, at hvis de glemmer at tage en dosis INCIVO, og det opdages inden for 4 timer efter det sædvanlige tidspunkt, skal den foreskrevne dosis INCIVO tages hurtigst muligt sammen med føde.
English: Baseline liver fibrosis No fibrosis or minimal fibrosis
Danish: Leverfibrose ved baseline Ingen eller minimal fibrose Portal fibrose
English: Caution is warranted and clinical monitoring of patients is recommended.
Danish: Forsigtighed tilrådes, og klinisk monitorering af patienterne anbefales.
English: Increases in serum uric acid occur very commonly during treatment with INCIVO in combination with peginterferon alfa and ribavirin.
Danish: Stigninger i serumurat er meget almindelige under behandling med INCIVO i kombination med pegyleret interferon-alfa og ribavirin.
English: For outcomes obtained in HIV co-infected patients, see section 5.1.
Danish: 5.1 for oplysninger om resultater opnået med patienter med samtidig hiv-infektion.
English: If discontinued due to a skin reaction, INCIVO must not be restarted.
Danish: Hvis INCIVO seponeres på grund af en hudreaktion, må behandlingen ikke genoptages.
English: For specific dosage instructions for peginterferon alfa and ribavirin, the Summary of Product Characteristics for these medicinal products should be consulted.
Danish: Vedrørende særlige doseringsvejledninger for pegyleret interferon-alfa og ribavirin henvises til produktresuméerne for disse lægemidler.
English: General disorders and administration site conditions common oedema peripheral, product taste abnormal the placebo-controlled Phase 2 and Phase 3 Studies (pooled data) included 1,346 HCV-infected patients incidence rates are based on adverse event reporting rates (additionally, see Laboratory abnormalities below)
Danish: Nyrer og urinveje ikke almindelige forhøjet serumkreatinin b, prærenal azotæmi med eller uden akut nyresvigt perifert ødem, abnorm smag af lægemidlet de placebokontrollerede fase 2- og fase 3-studier (poolede data) omfattede 1.346 HCV-inficerede patienter incidensen er baseret på hyppigheden af indberetttede bivirkninger (se også Abnorme laboratorieundersøgelser
English: Telaprevir exposure is comparable during co-administration with either peginterferon alfa-2a and ribavirin or peginterferon alfa-2b and ribavirin.
Danish: Der ses sammenlignelig eksponering for telaprevir under samtidig brug af enten pegyleret interferon-alfa-2a og ribavirin eller pegyleret interferon-alfa-2b og ribavirin.
English: The control regimen (Pbo/PR) had a fixed treatment duration of 48 weeks, with telaprevir-matching placebo for the first 12 weeks and peginterferon alfa-2a and ribavirin for 48 weeks.
Danish: Kontrolregimet (Pbo/PR) havde en fast behandlingsvarighed på 48 uger med telaprevir-matchende placebo i de første 12 uger og pegyleret interferon-alfa-2a og ribavirin i 48 uger.
English: BOTTLE LABEL (4-bottle pack)
Danish: BEHOLDERENS ETIKET (pakning med 4 beholdere)
English: See also section 4.3 for medicinal products which are contraindicated with INCIVO.
Danish: 3 vedrørende lægemidler, som er kontraindiceret ved behandling med INCIVO.
English: INCIVO should be used with caution with Class Ic antiarrhythmics propafenone and flecainide, including appropriate clinical and ECG monitoring (see section 4.4).
Danish: Forsigtighed tilrådes ved brug af INCIVO sammen med klasse Ic-antiarytmika propafenon og flecainid, og behandlingen skal følges med passende klinisk kontrol inklusive ekg-vurderinger (se
English: ↑ ketoconazole (200 mg) AUC 2.25 (1.93-2.61) Cmax 1.75 (1.51-2.03)
Danish: ↑ ketoconazol (200 mg) AUC 2,25 (1,93-2,61) Cmax 1,75 (1,51-2,03)
English: HCV/Human immunodeficiency virus type (HIV)-1 co-infection HCV/HIV-1 co-infected patients should be treated in the same way as HCV mono-infected patients.
Danish: Samtidig infektion med HCV og hiv-1 (humant immundefektvirus) Patienter med samtidig HCV- og hiv-1-infektion skal behandles på samme måde som patienter, der kun er inficeret med HCV. Der skal omhyggeligt tages højde for lægemiddelinteraktioner, se pkt.
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).
Danish: I placebokontrollerede fase 2- og 3-studier holdt 1,9% af patienterne op med at tage INCIVO på grund af anæmi, og 0,9% af patienterne holdt op med at tage INCIVO kombinationsbehandling på grund af anæmi sammenlignet med 0,5% af dem, der fik pegyleret interferon-alfa og ribavirin (se pkt.
English: In the placebo-controlled Phase 2 and 3 trials, transfusions were reported during the INCIVO/placebo treatment phase in 2.5% of patients receiving INCIVO combination treatment and 0.7% in patients receiving peginterferon alfa and ribavirin alone.
Danish: I de placebokontrollerede fase 2- og 3-studier blev der rapporteret transfusion under behandlingsfasen med INCIVO/placebo hos 2,5% af de patienter, der fik kombinationsbehandling med INCIVO, og hos 0,7% af de patienter, der fik pegyleret interferon-alfa og ribavirin alene.
English: In patients who had undetectable HCV RNA (target not detected) at weeks 4 and 12, there was no additional benefit to extending peginterferon alfa-2a and ribavirin treatment to 48 weeks (difference in SVR rates of 2%; 95% confidence interval: -4%, 8%).
Danish: Hos patienter, som havde ikke-detekterbart HCV-RNA (HCVRNA ikke påvist) i uge 4 og 12, var der ingen yderligere fordel ved at udvide behandlingen med pegyleret interferon-alfa-2a og ribavirin til 48 uger (forskel i SVR-rater 2%, 95% konfidensinterval:
English: During the INCIVO/placebo treatment phase, the most frequently reported ADRs of at least Grade 2 in severity in the INCIVO group (incidence ≥ 5.0%) were anaemia, rash, pruritus, nausea, and
Danish: Under behandlingsfasen med INCIVO/placebo var de hyppigst rapporterede bivirkninger (incidens ≥ 5,0%) i INCIVO-gruppen, som havde en sværhedsgrad på mindst grad 2, anæmi, udslæt, pruritus,
English: QT interval prolongation and Torsade de Pointes have been reported with methadone (see section 4.4).
Danish: Der er rapporteret forlængelse af QT-intervallet og torsades de pointes ved brug af methadon (se pkt.
English: Study C216 was a randomised, double-blind, placebo-controlled, Phase 3 study conducted in patients who did not achieve SVR with prior treatment with peginterferon alfa-2a and ribavirin or peginterferon alfa-2b and ribavirin.
Danish: Studie C216 var et randomiseret, dobbeltblindt, placebokontrolleret, fase 3-studie, der omfattede patienter, som ikke opnåede SVR med tidligere behandling med pegyleret interferon-alfa-2a og ribavirin eller pegyleret interferon-alfa-2b og ribavirin.
English: There may be itching with the rash.
Danish: Udslættet kan være ledsaget af kløe.
English: Refer to their respective Summary of Product Characteristics for their associated adverse reactions.
Danish: Bivirkningerne af de enkelte produkter fremgår af de respektive produktresuméer.
English: To manage anaemia, at initiation of INCIVO treatment a lower starting dose of ribavirin (600 mg/day) was used; during the overall treatment phase the ribavirin dose was further reduced in 36.5% of patients, 41.9% received ESAs and 21.6% received blood transfusions (see sections 4.4 and 4.5, Immunosuppressants).
Danish: I løbet af den samlede behandlingsfase blev ribavirin-dosis yderligere nedsat hos 36,5% af patienterne, 41,9% fik ESA'er, og 21,6% fik blodtransfusioner (se pkt.
English: Histopathological findings in the liver were similar in both rat and dog studies, of which not all were fully resolved after recovery.
Danish: I studier med rotter og med hunde sås samme histopatologiske fund i leveren, og ikke alle forsvandt igen i observationsperioden.
English: to treat inflammatory arthritis (anti-gout agents) to treat certain infections (antimycobacterials) to help you sleep and/or relieve anxiety (benzodiazepines) to help you sleep and/or relieve anxiety (non-benzodiazepine sedatives)
Danish: til at behandle urinsur gigt (antiinflammatoriske midler mod akut arthritis) til at behandle visse infektioner (antibiotika mod mycobakterier) sovemidler og/eller angstdæmmende midler (benzodiazepiner) sovemidler og/eller angstdæmmende midler (ikke-benzodiazepiner)
English: • Grading and management of rash and severe cutaneous reactions, particularly with respect to criteria for the continuation or discontinuation of telaprevir and the other treatment components.
Danish: kriterier for fortsættelse eller seponering af behandling med telaprevir og de øvrige komponenter i behandlingen.