FrancophonIA/ELRC3.0 huggingface dataset:
English: In the case of a serious skin reaction, discontinuation of other medicinal products known to be associated with serious skin reactions should be considered.
Danish: I tilfælde af en alvorlig hudreaktion bør det overvejes at seponere andre lægemidler, som vides at være associeret med
English: After the end of INCIVO treatment, uric acid values typically decrease over the following 8 weeks and are comparable to those observed in patients receiving peginterferon alfa and ribavirin alone.
Danish: Efter afslutning på INCIVO-behandling faldt uratværdierne typisk i løbet af de næste 8 uger og er sammenlignelige med de værdier, der sås hos patienter, der fik pegyleret interferon-alfa og ribavirin alene.
English: Table 13 shows the SVR rates by week 4 response (< 1 log10 or ≥ 1 log10 reduction in HCV RNA) for prior partial responders and for prior null responders in the T12(DS)/PR group.
Danish: I tabel 13 vises SVR-raterne ud fra response i uge 4 (< 1 log10 eller ≥ 1 log10 reduktion i HCV-RNA) for tidligere partial responders og for tidligere null responders i T12(DS)/PR-gruppen.
English: SVR rates were higher (absolute difference of at least 28%) for the T12/PR group than for the Pbo/PR48 group across subgroups by sex, age, race, ethnicity, body mass index, HCV genotype subtype, baseline HCV RNA (< 800,000, ≥ 800,000 IU/ml), and extent of liver fibrosis.
Danish: SVR-raterne var højere (absolut forskel mindst 28%) i T12/PR-gruppen end i Pbo/PR48-gruppen på tværs af undergrupperne fordelt efter køn, alder, race, etnisk afstamning, body mass index, HCV-genotype subtype, baseline HCV-RNA (< 800.000, ≥ 800.000 IE/ml) og omfanget af leverfibrose.
English: Table 16: Treatment outcome in adult patients with genotype 1 HCV infection and HIV-1 co-infection in Study HPC3008)
Danish: Tabel 16: Behandlingsresultater hos voksne patienter med samtidig infektion med hepatitis C af genotype 1 og hiv-1 i studie HPC3008
English: For all populations in the study (prior relapsers, prior partial responders, and prior null responders), SVR rates were higher for the T12/PR group than for the Pbo/PR48 group across subgroups by sex, age, race, ethnicity, body mass index, HCV genotype subtype, baseline HCV RNA level, and extent of liver fibrosis.
Danish: For alle populationer i studiet (tidligere relapsers, tidligere partial responders eller tidligere null responders) var SVR-raterne højere for T12/PR-gruppen end for Pbo/PR48-gruppen på tværs af undergrupper inddelt efter køn, alder, race, etnisk afstamning, body mass index, HCV-genotype subtype, HCV-RNA-niveau ved baseline og omfang af leverfibrose.
English: HIV-ANTIVIRAL AGENTS: HIV-PROTEASE INHIBITORS (PIs) atazanavir/ritonavir*
Danish: ANTIVIRALE MIDLER MOD HIV: HIV-PROTEASEHÆMMERE atazanavir/ritonavir*
English: Severe, potentially life-threatening and fatal skin reactions have been reported with INCIVO combination treatment, including DRESS, SJS, and TEN (see section 4.4).
Danish: I forbindelse med INCIVO-kombinationsbehandling er der indberettet alvorlige, potentielt livstruende og fatale hudreaktioner, der omfatter DRESS, SJS og TEN (se pkt.
English: Mechanism of action Telaprevir is an inhibitor of the HCV NS3•4A serine protease, which is essential for viral replication.
Danish: Telaprevir hæmmer HCV-NS3•4A-serinprotease, som er essentielt for viral replikation.
English: Patients received INCIVO at a dosage of 750 mg every 8 hours.
Danish: Patienterne fik INCIVO i doser på 750 mg hver 8. time.
English: HCV RNA< 25 IU/ml in the week 12 follow-up window
Danish: HCV-RNA < 25 IE/ml i uge 12 opfølgningsvinduet
English: Table 16 shows the response rates in treatment-naïve patients and in treatment-experienced patients by subgroup (treatment-naïve, prior relapsers and prior non-responders).
Danish: Tabel 16 viser responsrater hos behandlingsnaive patienter og tidligere behandlede patienter inddelt i undergrupper (behandlingsnaive, tidligere relapsers og tidligere non-responders).
English: INCIVO has not been studied in HCV-infected patients with moderate hepatic impairment (Child-Pugh B, score 7-9).
Danish: INCIVO er ikke undersøgt hos HCV-inficerede patienter med moderat nedsat leverfunktion (Child-Pugh-klasse B, score 7-9).
English: If you notice the missed dose within 4 hours, you must take two tablets immediately.
Danish: Hvis du inden for 4 timer opdager, at du har glemt en dosis, skal du straks tage to tabletter.
English: Prior Non-responders N = 69 % (n/N)
Danish: Tidligere non-responders N = 69 % (n/N)
English: ↑ PDE-5 inhibitors inhibition of CYP3A
Danish: ↑ PDE-5-hæmmere hæmning af CYP3A
English: )/PR over T12(q8h)/PR.
Danish: )/PR i forhold til T12(q8h)/PR.
English: The SVR12 rate for the T12(b.i.d.
Danish: SVR12-raten for T12(b.i.d.
English: In the description of Phase 3 study outcomes for Studies 108, 111, and C216, SVR, considered virologic cure, was defined based on the HCV RNA assessment in the study week 72 visit window, using the last measurement in the window.
Danish: I beskrivelsen af resultaterne af fase 3-studierne 108, 111 og C216 blev SVR, hvilket anses som virologisk helbredelse, defineret på basis af HCV-RNA-vurderingen ved besøget i studiets uge 72 ved hjælp af den sidste måling i dette vindue.
English: The difference in SVR rates (95% confidence interval) between the T12/PR and Pbo/PR groups were 63 (51, 74) for prior relapsers, 46 (27, 66) for prior partial responders, and 26 (13,
Danish: Forskellen i SVR-rater (95% konfidensinterval) mellem T12/PR- og Pbo/PR-gruppen var 63 (51, 74) for tidligere relapsers, 46 (27, 66) for tidligere partial responders og 26 (13, 39) for
English: Administration of activated charcoal may also be used to aid in the removal of
Danish: Indgift af aktivt kul kan også anvendes for at understøtte fjernelse af ikke-absorberet aktivt stof.
English: to treat a heart and lung disorder called pulmonary arterial hypertension (endothelin receptor antagonist)
Danish: mod hjerte- og lungesygdommen pulmonal arteriel hypertension (endothelinreceptorantagonist)
English: Concomitant administration of INCIVO and drugs transported by these transporters such as fluvastatin, pravastatin, rosuvastatin, pitavastatin, bosentan and repaglinide should be undertaken with caution (see table 2).
Danish: Der skal udvises forsigtighed ved samtidig administration af INCIVO og lægemidler, der transporteres af disse transportører, såsom fluvastatin, pravastatin, rosuvastatin, pitavastatin, bosentan og repaglinid (se tabel 2).
English: HCV RNA levels should be monitored at weeks 4 and 12 and as clinically indicated (see also guidelines for discontinuation of INCIVO, section 4.2).
Danish: HCV-RNA-niveauerne bør kontrolleres i uge 4 og 12 samt når der er klinisk indikation for dette (se også vejledningen i seponering af behandling med INCIVO, pkt.
English: If you are taking any of the above, ask your doctor about switching to another medicine.
Danish: Hvis du tager et af disse midler, skal du bede din læge om at finde en anden medicin til dig.
English: Refer to section 4.3 for HMG-CoA reductase inhibitors that are contraindicated with INCIVO.
Danish: 4.3 vedrørende HMG-CoA-reduktasehæmmere, som er kontraindicerede ved behandling med INCIVO.
English: If a patient achieved undetectable HCV RNA (target not detected) at week 4, the total treatment duration was 24 weeks.
Danish: Hvis en patient havde ikke-detekterbart HCV-RNA (HCV-RNA ikke påvist) i uge 4, var den samlede behandlingsvarighed 24 uger.
English: No new safety findings were identified.
Danish: Der blev ikke påvist nye
English: Your doctor will explain these to you.
Danish: Lægen vil gennemgå resultaterne med dig.
English: It is recommended that the international normalised ratio (INR) be monitored when warfarin is co-administered with telaprevir.
Danish: Monitorering af INR (international normalised ratio) anbefales ved samtidig anvendelse af telaprevir.
English: Store in the original bottle.
Danish: Opbevares i den originale beholder.
English: You should contact your doctor immediately if you develop a rash or have a rash that gets worse.
Danish: Kontakt straks lægen, hvis du får et udslæt, eller hvis dit udslæt forværres.
English: There are no clinical data on re-treating patients who have failed an HCV NS3-4A protease inhibitor-based therapy, such as telaprevir, nor are there data on repeated courses of telaprevir treatment.
Danish: Der foreligger ingen kliniske data om genbehandlede patienter, som oplevede behandlingssvigt med HCV-NS3-4A-proteasehæmmere såsom telaprevir, ligesom der heller ikke foreligger data om gentagne behandlingsforløb med telaprevir.
English: There are other uses for sildenafil and tadalafil.
Danish: Sildenafil og tadalafil anvendes også til andre formål.
English: Concomitant administration of INCIVO with active substances that strongly induce CYP3A e.g. rifampicin, St John's wort (Hypericum perforatum), carbamazepine, phenytoin and phenobarbital and thus may lead to lower exposure and loss of efficacy of INCIVO.
Danish: Samtidig administration af INCIVO og aktive stoffer med stærk CYP3A-induktion, f.eks. rifampicin, perikon (Hypericum perforatum), carbamazepin, phenytoin og phenobarbital, hvilket kan føre til lavere eksponering og nedsat virkning af INCIVO.
English: In the description of the Phase 3 study outcomes for Study C211, HPC3008 and HPC3006, SVR12, considered virologic cure, was defined based on HCV RNA below the limit of quantification (25 IU/ml) using the last measurement in the visit window 12 weeks after the planned end of
Danish: I beskrivelsen af resultaterne af fase 3-studierne C211, HPC3008 og HPC3006 blev SVR12, hvilket anses som virologisk helbredelse, defineret på basis af HCV-RNA under kvantificeringsgrænsen (25 IE/ml) ved hjælp af den sidste måling i besøgsvinduet 12 uger efter behandlingens planlagte
English: Doses may need to be increased when combined with telaprevir.
Danish: Der kan være behov for dosisøgning ved kombination med telaprevir.
English: DRESS presents as a rash with eosinophilia associated with one or more of the following features: fever, lymphadenopathy, facial oedema, and internal organ involvement (hepatic, renal, pulmonary).
Danish: DRESS viser sig som et udslæt med eosinofili og associeres med et eller flere af følgende symptomer: feber, lymfadenopati, ansigtsødem og påvirkning af indre organer (lever, nyrer, lunger).
English: (< 350/mm potassium
Danish: (< 350/mm kalium
English: Furthermore, high rates of anaemia have been seen when using INCIVO with peginterferon and ribavirin in patients with these characteristics.
Danish: Endvidere er der set en høj hyppighed af anæmi ved anvendelse af INCIVO sammen med peginterferon og ribavirin hos patienter med disse karakteristika.
English: Antiretroviral therapy regimens included efavirenz, atazanavir/ritonavir, raltegravir, etravirine, or darunavir/ritonavir in combination with tenofovir or abacavir and either lamivudine or emtricitabine.
Danish: Antiretrovirale behandlingsregimer inkluderede efavirenz, atazanavir/ritonavir, raltegravir, etravirin eller darunavir/ritonavir i kombination med tenofovir eller abacavir og enten lamivudin eller emtricitabin.
English: Marketing Authorisation Holder Janssen Cilag International NV Turnhoutseweg 30
Danish: Janssen Cilag International NV Turnhoutseweg 30
English: Since INCIVO must be used in combination with ribavirin and ribavirin can be very damaging to an unborn baby, both female and male patients must take special precautions in order to prevent pregnancy.
Danish: Eftersom INCIVO skal anvendes i kombination med ribavirin, og ribavirin kan give alvorlige fosterskader, skal både kvindelige og mandlige patienter tage særlige forholdsregler for at undgå graviditet.
English: Patients receiving cyclosporine A N = 24 % (n/N)
Danish: Patienter, der fik ciclosporin N = 24 % (n/N)
English: To prevent treatment failure, the dose of INCIVO must not be reduced or interrupted.
Danish: For at forebygge behandlingssvigt må doseringen af INCIVO ikke reduceres, og behandlingen må ikke
English: If INCIVO treatment is discontinued due to adverse drug reactions or because of insufficient virologic response, INCIVO treatment should not be reinitiated.
Danish: Hvis behandlingen med INCIVO seponeres på grund af bivirkninger eller på grund af et utilstrækkeligt virologisk respons, må den ikke genoptages.
English: Telaprevir inhibits organic anion transporter polypeptides (OATPs) OATP1B1 and OATP2B1.
Danish: Telaprevir hæmmer de 2 organisk anion-transportpolypeptider (OATP) OATP1B1 og OATP2B1.
English: Efficacy in adults with HCV/HIV-1 co-infection
Danish: Virkning hos voksne med samtidig infektion med HCV/hiv-1
English: Co-administration of oral midazolam or triazolam with telaprevir is contraindicated.
Danish: Samtidig brug af oralt midazolam eller triazolam og telaprevir er kontraindiceret.
English: Please consult sections 4.4 and 5.1 regarding the selection of peginterferon alfa-2a or -2b.
Danish: 4.4 og 5.1 vedrørende valg af pegyleret interferon-alfa-2a eller -2b.
English: amiodarone, bepridil, quinidine, other Class Ia or III antiarrhythmics to treat certain heart disorders such as irregular heart beat (antiarrhythmics)
Danish: amiodaron, bepridil, quinidin, andre klasse Iaeller III-antiarytmika til behandling af visse hjertesygdomme såsom uregelmæssig puls (antiarytmika)
English: In one of those studies, a telaprevir 1,875 mg every 8 hours regimen was evaluated and the placebo-adjusted maximum mean increase in QTcF was 8.0 msec (90% CI: 5.1-10.9).
Danish: I et af disse studier blev et regime med telaprevir 1.875 mg hver 8. time evalueret, og den placebojusterede maksimale middelstigning i QTcF var 8,0 millisekunder (90% KI: 5,1-10,9).
English: After repeated oral administration, R-diastereomer of telaprevir (30-fold less active), pyrazinoic acid, and a metabolite that underwent reduction at the α-ketoamide bond of telaprevir (not active) were found to be the predominant
Danish: Efter gentagen indgift per oralt blev det påvist, at telaprevirs hovedmetabolitter er dens R-diastereomer (30 gange mindre aktiv), pyrazinoinsyre og en metabolit, der gennemgik reduktion ved telaprevirs α-ketoamid-binding (ikke aktiv).
English: Ask your doctor if you are unsure about any contraindications
Danish: Spørg din læge hvis du er usikker på nogle af de forhold hvor medicinen ikke må anvendes (kontraindikationer) der nævnes i
English: QT interval prolongation and Torsade de Pointes have been reported with voriconazole and posaconazole.
Danish: Forlænget QT-interval og torsades de pointes er rapporteret i forbindelse med voriconazol og posaconazol.
English: 3) being treated with efavirenz or atazanavir/ritonavir in combination with tenofovir disoproxil fumarate and emtricitabine or lamivudine.
Danish: 3), som blev behandlet med efavirenz eller atazanavir/ritonavir i kombination med tenofovirdisoproxilfumarat og emtricitabin eller lamivudin.
English: Table 12: SVR rates by extent of liver fibrosis at baseline: Study C216 T12/PR
Danish: Tabel 12: SVR-rater ved forskellige grader af leverfibrose: Studie C216 T12/PR
English: Caution is recommended when prescribing INCIVO concurrently with medicinal products known to induce QT prolongation and which are CYP3A substrates such as erythromycin, clarithromycin, telithromycin, posaconazole, voriconazole, ketoconazole, tacrolimus, salmeterol (see section 4.5).
Danish: Forsigtighed tilrådes ved ordination af INCIVO samtidig med lægemidler, som er kendt for at inducere QT-forlængelse, og som er substrater for CYP3A, såsom erythromycin, clarithromycin, telithromycin, posaconazol, voriconazol, ketoconazol, tacrolimus og salmeterol (se pkt.
English: Study 108 (ADVANCE)
Danish: Studie 112 (EXTEND)
English: Refer to section 4.4, Laboratory tests.
Danish: 4.4 under Laboratorieundersøgelser.
English: Use INCIVO with caution in patients with: - a history of acquired QT prolongation; - clinically relevant bradycardia (persistent heart rate < 50 bpm); - a history of heart failure with reduced left-ventricular ejection fraction; - a requirement for medicinal products known to prolong the QT interval but the metabolism of which is not mainly CYP3A4 dependent (e.g. methadone, see section 4.5).
Danish: Forsigtighed tilrådes ved anvendelse af INCIVO hos patienter med: - erhvervet QT-forlængelse i anamnesen - klinisk relevant bradykardi (vedvarende hjertefrekvens < 50 slag i minuttet) - hjertesvigt i anamnesen med nedsat ejection fraction i venstre ventrikel - behov for lægemidler, der vides at forlænge QT-intervallet, men hvis metabolisme ikke hovedsageligt beror på CYP3A4 (f.eks. methadon, se pkt.
English: Tablet film-coat polyvinyl alcohol macrogol talc titanium dioxide (E171) iron oxide yellow (E172)
Danish: Filmovertræk Polyvinylalkohol, macrogol, talcum, titandioxid (E171), jernoxid, gul (E172).
English: Follow-up analysis of INCIVO-treated patients who did not achieve an SVR showed that the population of wild-type virus increased and the population of telaprevir-resistant variants became undetectable over time after the end of telaprevir treatment.
Danish: Opfølgende analyse af INCIVO-behandlede patienter, som ikke opnåede et vedvarende virologisk respons (SVR) viste, at med tiden efter endt behandling med telaprevir øgedes populationen af vildtype-virus, og populationen af telaprevir-resistente varianter blev upåviselige.
English: INCIVO, in combination with peginterferon alfa and ribavirin, is indicated for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease (including cirrhosis):
Danish: INCIVO i kombination med pegyleret interferon-alfa og ribavirin er indiceret til behandling af genotype 1 kronisk hepatitis C hos voksne patienter med kompenseret leversygdom (inklusive
English: In Phase 2 and 3 clinical trials of telaprevir, treatment-naïve and prior treatment-failure patients with predominant telaprevir-resistant variants at baseline (pre-treatment) were rare (V36M, T54A and R155K < 1% and T54S 2.7%).
Danish: I kliniske fase 2- og fase 3-studier med telaprevir sås sjældne tilfælde af behandlingsnaive patienter samt patienter med tidligere behandlingssvigt med overvejende telaprevir-resistente varianter ved baseline (før behandlingen) (V36M, T54A og R155K < 1% og T54S 2,7%).
English: Treatment outcome
Danish: Behandlingsvirkning
English: Consult with a specialist in dermatology.
Danish: Konsultation af speciallæge i dermatologi.
English: Exposure at this dose was comparable to the exposure in HCV-infected patients receiving a dose of 750 mg INCIVO every 8 hours plus peginterferon alfa and ribavirin.
Danish: Eksponeringen ved denne dosis var sammenlignelig med eksponeringen hos HCV-inficerede patienter, der fik en dosis INCIVO på 750 mg hver 8. time plus pegyleret interferon-alfa og ribavirin.
English: INCIVO 375 mg film-coated tablets
Danish: INCIVO 375 mg filmovertrukne tabletter
English: Steady-state exposure to telaprevir was 15% lower in subjects with mild hepatic impairment (Child-Pugh Class A, score 5-6) compared to healthy subjects.
Danish: Eksponering for telaprevir ved steady state var 15% lavere hos forsøgspersoner med let nedsat leverfunktion (Child-Pugh-klasse A, score 5-6) sammenlignet med raske forsøgspersoner.
English: In treatment-naïve patients in the Phase 3 studies, 4/16 (25%) patients with HCV RNA levels between 100 IU/ml and 1,000 IU/ml at week 4 achieved SVR.
Danish: Hos behandlingsnaive patienter i fase 3-studier opnåedes SVR hos 4 ud af 16 patienter (25%) med HCV-RNA-niveauer mellem 100 IE/ml og 1.000 IE/ml i uge 4.
English: ADRs to INCIVO are presented in table 3.
Danish: INCIVOs bivirkninger er opstillet i tabel 3.
English: dihydroergotamine, ergonovine, ergotamine,
Danish: dihydroergotamin, ergometrin, ergotamin,
English: In the Phase 3 studies, none of the patients with HCV RNA > 1,000 IU/ml at either week 4 or week 12 achieved SVR with continued peginterferon alfa and ribavirin treatment.
Danish: I fase 3-studier opnåede ingen af patienterne med HCV-RNA > 1.000 IE/ml i enten uge 4 eller uge 12 SVR ved fortsat behandling med pegyleret interferon-alfa og ribavirin.
English: In HCV-negative patients with severe renal impairment, no clinically relevant change in telaprevir exposure was observed (see section 5.2).
Danish: Hos HCV-negative patienter med svært nedsat nyrefunktion observeredes ingen klinisk relevante forandringer i eksponeringen for telaprevir (se pkt.
English: SVR rates for the T12(DS)/PR group were 88% (124/141) for prior relapsers, 56% (27/48) for prior partial responders, and 33% (25/75) for prior null responders.
Danish: SVR-raterne for T12(DS)/PR-gruppen var 88% (124/141) for deltagere med tidligere relapse, 56% (27/48) for deltagere med tidligere partial response og 33% (25/75) for deltager med tidligere null response.
English: Plasma concentrations with the telaprevir 1,875 mg every 8 hours dose used in this trial were comparable to those observed in studies in HCV-infected patients who received telaprevir 750 mg every 8 hours in combination with peginterferon alfa-2a and ribavirin.
Danish: Plasmakoncentrationer med telaprevir-dosen på 1.875 mg hver 8. time, som blev anvendt i dette studie, var sammenlignelig med koncentrationerne i studier med HCV-inficerede patienter, som fik telaprevir 750 mg hver 8. time i kombination med pegyleret interferon-alfa-2a og ribavirin.
English: INCIVO has not been studied in patients with severe hepatic impairment (Child-Pugh C, score ≥ 10) or decompensated liver disease (ascites, portal hypertensive bleeding, encephalopathy, and/or jaundice other than Gilbert's Syndrome) and is not recommended in these populations.
Danish: INCIVO er ikke undersøgt hos patienter med svært nedsat leverfunktion (Child-Pugh-klasse C, score ≥ 10) eller dekompenseret leversygdom (ascites, portal hypertensiv blødning, encefalopati og/eller gulsot, der ikke er Gilberts syndrom), og anbefales ikke til disse populationer.
English: Refer also to the Summary of Product Characteristics for peginterferon alfa and ribavirin which are contraindicated in Child-Pugh score ≥ 6.
Danish: Der henvises endvidere til produktresuméerne for pegyleret interferon-alfa og ribavirin, som er kontraindiceret ved Child-Pugh-score ≥ 6.
English: )/PR] in combination with peginterferon alfa-2a and ribavirin.
Danish: )/PR] i kombination med pegyleret interferonalfa-2a and ribavirin.
English: After oral administration, the typical apparent volume of distribution (Vd) was estimated to be 252 l, with an inter-individual variability of 72.2%.
Danish: Efter oral indtagelse estimeres den typiske tilsyneladende fordelingsvolumen (Vd) til 252 l med en
English: Purpose of the medicine flecainide, propafenone to treat certain heart disorders such as irregular heart beat (antiarrhythmics)
Danish: Medicinens formål flecainid, propafenon til behandling af visse hjertesygdomme såsom uregelmæssig puls (antiarytmika)
English: No clinical data are available regarding the treatment of pre- or peri-liver or other transplant patients with INCIVO in combination with peginterferon alfa and ribavirin.
Danish: Der foreligger ingen kliniske data om behandling af patienter før eller under transplantation af lever eller andre organer med INCIVO i kombination med pegyleret interferon-alfa og ribavirin.
English: In Study HPC3008 (see sections 4.8 and 5.1), transient grade 3 (2.5 to ≤5 X ULN) and grade 4 (>5 X ULN) bilirubin increases during INCIVO treatment were seen in 39% and in 22% of the 59 patients on atazanavir/ritonavir, respectively.
Danish: 4.8 og 5.1) blev der observeret forbigående bilirubin-stigning af grad 3 (2,5 til ≤ 5 X ULN) og grad 4 (> 5 X ULN) under behandling med INCIVO hos henholdsvis 39% og 22% af de 59 patienter, der fik atazanavir/ritonavir.
English: The dose of INCIVO must not be reduced, and INCIVO must not be restarted if discontinued.
Danish: Doseringen af INCIVO må ikke reduceres, og hvis behandlingen med INCIVO seponeres, må den ikke genoptages.
English: Ribavirin can damage your unborn baby.
Danish: Ribavirin kan give fosterskader.