FrancophonIA/ELRC3.0 huggingface dataset:
English: Vial of 80 ml Vial of 200 ml
Danish: Hætteglas med 80 ml Hætteglas med 200 ml
English: Veterinary medicinal product subject to prescription.
Danish: Dyrearter, som lægemidlet er beregnet til
English: 4.9 Amounts to be administered and administration route
Danish: Dosering og indgivelsesvej
English: ↑ Concentration of statin
Danish: ↑ Koncentration af statin
English: SVR12 (overall)* 70 (100%) 12 weeks treatment duration
Danish: SVR12 (samlet)* 70 (100%) 12 ugers behandlingsvarighed
English: * Includes patients co-infected with human immunodeficiency virus (HIV).
Danish: * Inkluderer patienter, som samtidig er inficeret med humant immundefektvirus (hiv).
English: Do not take a double dose (two doses close together).
Danish: Du må ikke tage en dobbeltdosis (to
English: Data are available from a completed follow-up study to assess durability of response for approximately 3 years after treatment with daclatasvir.
Danish: Der foreligger data fra et færdiggjort opfølgningsstudie til evaluering af varigheden af respons i cirka 3 år efter behandling med daclatasvir.
English: Close monitoring of INR values is recommended with all vitamin K antagonists.
Danish: Tæt monitorering af INR anbefales ved alle vitamin K-antagonister.
English: Tell your doctor immediately if you are taking any medicines for heart problems and during treatment
Danish: Sig det straks til lægen, hvis du tager et lægemiddel mod hjerteproblemer, og du under behandlingen
English: 24 weeks
Danish: 14 dage.
English: Daklinza has not yet been studied in
Danish: Daklinza er endnu ikke tilstrækkeligt undersøgt
English: This lowers the amount of hepatitis C virus in your body and removes the virus from your blood over a
Danish: På den måde nedsættes mængden af hepatitis C-virus i kroppen, og viruset fjernes fra blodet efter et
English: Category/ Substitution, n (%) Genotype 1a Genotype 1b Genotype 2 Genotype 3 N=79
Danish: Kategori/ Substitution, n (%) Genotype 1a Genotype 1b Genotype 2 Genotype 3 N=79
English: ** One patient considered a protocol failure (non-SVR) achieved SVR *** NS5A RAVs monitored at amino acid positions are 28, 29, 30, 31, 32, 58, 62, 92, and 93
Danish: ** En patient blev anset som at have opnået SVR på grund af en protokolfejl (non-SVR) *** NS5A-RAV'er monitoreret ved aminosyrepositioner er 28, 29, 30, 31, 32, 58, 62, 92 og 93
English: • Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures:
Danish: • Forpligtelse til at gennemføre foranstaltninger efter udstedelse af Indehaveren af markedsføringstilladelsen skal inden for den fastsatte tidsramme gennemføre følgende
English: CP B CP C
Danish: CP A CP B
English: As liver function may change during treatment with Daklinza, a close monitoring of International Normalized Ratio (INR) values is recommended.
Danish: Da leverfunktionen kan ændre sig under behandling med Daklinza, anbefales tæt monitorering af INR (international normaliseret ratio).
English: The film-coated tablet should not be chewed or crushed due the unpleasant taste of the
Danish: Den filmovertrukne tablet må ikke tygges eller knuses på grund af det aktive stofs ubehagelige smag.
English: There are no data from the use of daclatasvir in pregnant women.
Danish: Der foreligger ingen data om anvendelse af daclatasvir til gravide kvinder.
English: Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines
Danish: Nogle patienter med diabetes har oplevet lavt blodsukker (hypoglykæmi) efter påbegyndelse af behandling med
English: This is due to liver function that may change during treatment with Daklinza.
Danish: Dette skyldes, at leverfunktionen kan ændre sig under behandling med Daklinza.
English: Adverse reactions are listed in Table 5 by regimen, system organ class and frequency: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000)
Danish: Bivirkningerne er anført i Tabel 5 efter behandlingsregime, systemorganklasse og hyppighed: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000) og meget sjælden (<1/10.000).
English: Not all packages may be marketed in your country.
Danish: Ikke alle pakningsstørrelser er nødvendigvis markedsført.
English: The HCV RNA thresholds that trigger discontinuation of treatment (i.e. treatment stopping rules) are
Danish: Grænseværdierne for HCV-RNA, som udløser seponering af behandlingen (dvs. regler for
English: * 2 patients had detectable HCV RNA at end of treatment; 1 of these patients achieved SVR.
Danish: * 2 patienter havde detekterbart HCV-RNA ved afslutning af behandlingen; 1 af disse patienter nåede SVR.
English: NARCOTIC ANALGESICS Buprenorphine/naloxone, 8/2 mg to 24/6 mg once daily
Danish: NARKOTISKE ANALGETIKA Buprenorphin/naloxon, 8/2 mg til 24/6 mg en gang
English: Cirrhotic cohort N=60
Danish: Cirrosekohorte N=60
English: Seventy-seven (77 [98.7%]) of treated patients in this study were infected with HCV GT-3a, and 1 patient (1.3%) was infected with HCV GT-3b.
Danish: 77 [98,7%] af de behandlede patienter i dette studie var smittet med HCV-GT-3a, og 1 patient (1,3%) var smittet med HCV-GT-3b.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release Bristol-Myers Squibb S.r.l.
Danish: A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE Navn og adresse på den fremstiller (de fremstillere), der er ansvarlig(e) for batchfrigivelse Bristol-Myers Squibb S.r.l.
English: The final study report shall be submitted by:
Danish: Den endelige studierapport
English: ** The patient with virologic breakthrough met the original protocol definition of confirmed HCV RNA <LLOQ, detectable at treatment Week 8.
Danish: ** Patienten med virologisk gennembrud opfyldte den oprindelige protokoldefinition på bekræftet HCVRNA <LLOQ, detekterbart ved uge 8.
English: When Daklinza is used together with sofosbuvir (without ribavirin), the following side effects have
Danish: Når Daklinza anvendes sammen med sofosbuvir (uden ribavirin), er følgende bivirkninger blevet
English: Pharmacotherapeutic group: Direct-acting antiviral, ATC code: J05AP07
Danish: Farmakoterapeutisk klassifikation: Direkte virkende antivirale midler, ATC-kode: J05AP07.
English: No clinically relevant antiviral activity was observed against a variety of RNA and DNA viruses, including HIV, confirming that daclatasvir, which inhibits a HCV-specific target, is highly selective
Danish: Der blev ikke obsveret relevant antiviral aktivitet mod en række RNA- og dna-vira, herunder hiv, hvilket bekræfter, at daclatasvir, som hæmmer et HCV specifikt mål, er stærkt selektivt for HCV.
English: If you can become pregnant, use effective contraception during and for 5 weeks after your treatment
Danish: Hvis du er i den fødedygtige alder, skal du bruge sikker prævention under og 5 uger efter
English: Treatment outcomes in study AI444042 are presented in Table 14.
Danish: Behandlingsresultaterne fra studie AI444042 er vist i tabel 14.
English: Following single-dose oral administration of 14C-daclatasvir in healthy subjects, 88% of total radioactivity was recovered in feces (53% as unchanged drug) and 6.6% was excreted in the urine (primarily as unchanged drug).
Danish: Efter oral administration af en enkeltdosis på of 14C-daclatasvir til raske forsøgspersoner blev 88% af den totale radioaktivitet genfundet i fæces (53% som uomdannet lægemiddel) og 6,6% blev udskilt i urin (primært som uomdannet lægemiddel).
English: Regimen and duration
Danish: Regime og behandlingsvarighed
English: HORMONAL CONTRACEPTIVES Ethinylestradiol 35 μg once daily for 21 days + norgestimate
Danish: HORMONELLE KONTRACEPTIONSMIDLER Ethinylestradiol 35 μg en gang dagligt i 21 dage +
English: and you notice within 20 hours of the time you usually take Daklinza, you must take the tablet as soon as possible.
Danish: og du opdager det inden for 20 timer efter det tidspunkt, hvor du normalt tager Daklinza, skal du tage tabletten så hurtigt som muligt.
English: Tell your doctor if any of the following applies: you currently take, or have taken in the last few months, the medicine amiodarone to treat irregular heartbeats (your doctor may consider alternative treatments if you have taken this you have a current or previous infection with the hepatitis B virus, since your doctor may want to your liver is damaged and not functioning properly (decompensated liver disease) you have diabetes.
Danish: Fortæl det til lægen, hvis et eller flere af følgende punkter gælder for dig: du får eller inden for de seneste måneder har du fået lægemidlet amiodaron mod uregelmæssig hjerterytme (lægen kan overveje andre behandlinger, hvis du har taget dette lægemiddel) du har eller har haft en infektion med hepatitis B-virus, da din læge måske vil overvåge dig tættere din lever er skadet og virker ikke, som den skal (dekompenseret leversygdom) hvis du har diabetes.
English: ANTIVIRALS, HIV or HBV Protease inhibitors (PIs) Atazanavir 300 mg/ritonavir
Danish: ANTIVIRALE MIDLER, hiv eller HBV Proteasehæmmere (PI'ere) Atazanavir 300 mg/ritonavir
English: In limited numbers of genotype 4-infected patients with non-response, substitutions L28M and L30H/S were detected at failure.
Danish: Hos et begrænset antal genotype 4-inficerede patienter med manglende respons, blev substitutionerne L28M og L30H/S
English: Observed emergent NS5A resistance-associated variants are reported in Table 15.
Danish: Observeret opståen af NS5A-resistensassocierede varianter er vist i tabel 15.
English: You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medication after starting Daklinza.
Danish: Det kan være, at dit blodsukker skal overvåges tættere, og/eller at din diabetesmedicin skal justeres efter påbegyndelse af behandling med Daklinza.
English: * One treatment-experienced patient achieved SVR12 per local HCV RNA results.
Danish: * 1 behandlingserfaren patient opnåede SVR12 i henhold til lokale HCV-RNA-resultater.
English: Glucose levels of diabetic patients initiating DAA therapy should be closely monitored, particularly within the first 3 months, and their diabetic medication modified when necessary.
Danish: Blodsukkeret hos patienter med diabetes, der påbegynder behandling med direkte virkende antivirale lægemidler, bør overvåges nøje, navnlig inden for de første 3 måneder, og patienternes diabetesmedicinering bør om nødvendigt ændres.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Danish: FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE
English: The dose of ribavirin, when combined with Daklinza, is weight-based (1,000 or 1,200 mg in patients <75 kg or ≥75 kg, respectively).
Danish: Dosis af ribavirin er vægtbaseret ved kombination med Daklinza (1.000 eller 1.200 mg hos patienter på henholdsvis <75 kg eller ≥75 kg).
English: Patients with HCV genotype 1, 2, 3, 4, 5 or 6 infection were eligible to enroll.
Danish: Patienter med HCV-genotype 1-, 2-, 3-, 4-, 5- eller 6-infektion var egnede til inklusion.
English: ** Other non-responders included 4 patients with HCV RNA < LLOQ target not detected (TND) at end of treatment, but who were lost to follow-up at post-treatment Week 12 and subsequent time points, and 1 patient who had no on-treatment HCV RNA results due to early discontinuation.
Danish: ** Andre ikke-responderende omfattede 4 patienter med HCV-RNA <LLOQ ikke detekteret (target not detected) ved afslutning af behandling, men som var tabt ved opfølgningsuge 12 efter behandling og de efterfølgende tidspunkter, og 1 patient, som ikke havde nogen HCV-RNA-resultater under behandlingen
English: SVR was the primary endpoint to determine the HCV cure rate, which was defined as HCV RNA less than LLOQ at 12 weeks after the end of treatment (SVR12) for studies AI444040, ALLY-1 (AI444215), ALLY-2 (AI444216), ALLY-3 (AI444218), ALLY-3C (AI444379), AI444042 and AI444043 and as HCV RNA undetectable at 24 weeks after the end of treatment (SVR24) for study
Danish: SVR var det primære endepunkt til bestemmelse af HCV-helbredelsesraten, som blev defineret som HCV-RNA mindre end LLOQ ved uge 12 efter afsluttet behandling (SVR12) for studierne AI444040, ALLY-1 (AI444215), ALLY-2 (AI444216), ALLY-3 (AI444218), ALLY-3C (AI444379), AI444042 og AI444043 og som HCV-RNA ikke-detekterbart ved uge 24 efter afsluttet behandling (SVR24) for studie AI444010.
English: HCV RNA values in the ALLY-3C (AI444379) study were measured using the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test (version 2.0), with an LLOQ of 15 IU/mL.
Danish: HCV-RNA-værdierne i studiet ALLY-3C (AI444379) blev målt ved hjælp af Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test (version 2.0), med en LLOQ på 15 IE/ml.
English: The efficacy of Daklinza as part of a retreatment regimen in patients with prior exposure to a NS5A
Danish: Daklinzas virkning som del af et genbehandlingsforløb hos patienter med tidligere eksponering for en
English: The pharmacokinetics of daclatasvir in paediatric patients have not been evaluated.
Danish: Pædiatrisk population Daclatasvirs farmakokinetik hos pædiatriske patienter er ikke blevet undersøgt.
English: Treatment outcomes in study AI444010 for patients with HCV genotype 4 are presented in Table 14.
Danish: Behandlingsresultaterne fra studie AI444010 for patienter med HCV-genotype 4 er vist i tabel 14.
English: None of these effects have been observed in humans.
Danish: Ingen af disse påvirkninger er
English: This medicine contains less than 1 mmol sodium (23 mg) per maximum dose of 90 mg, that is to say
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. maksimal dosis af 90 mg, dvs.
English: The efficacy and safety of daclatasvir 60 mg once daily in combination with sofosbuvir 400 mg once daily in the treatment of patients with chronic HCV infection were evaluated in five open-label studies (AI444040, ALLY-1, ALLY-2, ALLY-3, and ALLY-3C).
Danish: Sikkerheden og virkningen af daclatasvir 60 mg en gang dagligt i kombination med sofosbuvir 400 mg en gang dagligt til behandling af patienter med kronisk HCV-infektion blev undersøgt i fem åbne studier (AI444040, ALLY-1, ALLY-2, ALLY-3 og ALLY-3C).
English: However, if the missed dose is remembered more than 20 hours after the scheduled dose, the dose should be skipped and the next
Danish: Hvis de imidlertid først kommer i tanke om den glemte dosis mere end 20 timer efter det planlagte tidspunkt, skal de springe den over og tage den næste dosis på det planlagte tidspunkt.
English: Non-nucleoside reverse transcriptase inhibitors (NNRTIs)
Danish: Non-nukleosid revers transkriptasehæmmere (NNRTI'er)
English: 4.2 Posology and method of administration Treatment with Daklinza should be initiated and monitored by a physician experienced in the management of chronic hepatitis C.
Danish: Behandling med Daklinza skal initieres og monitoreres af en læge med erfaring i behandling af kronisk hepatitis C.
English: - Tablet core: anhydrous lactose (see section 2), microcrystalline cellulose, croscarmellose sodium, silicon dioxide (E551) and magnesium stearate - Film-coating: hypromellose, titanium dioxide (E171), macrogol 400, indigo carmine aluminum lake (E132), yellow iron oxide (E172)
Danish: - Tabletkerne: vandfri lactose (se afsnit 2), mikrokrystallinsk cellulose, croscarmellosenatrium, siliconedioxid (E551) og magnesiumstearat - Filmovertræk: hypromellose, titandioxid (E171), macrogol 400, indigo carmine aluminum lake (E132), gul jernoxid (E172)
English: * Patients who had missing data at follow-up Week 12 were considered responders if their next available HCV RNA value was <LLOQ.
Danish: * Patienter, som havde manglende data ved opfølgningsuge 12, blev betragtet som responderende patienter, hvis deres næste tilgængelige HCV-RNA værdi var <LLOQ.
English: There was no Y93H RAV present at baseline for genotype-3 infected patients treated for 12-weeks with sofosbuvir + daclatasvir + ribavirin, and thus SVR outcomes cannot
Danish: Der var ikke Y93H-RAV til stede ved baseline hos patienter med genotype 3-infektion, som blev behandlet i 12 uger med sofosbuvir + daclatasvir + ribavirin, og derfor kan SVR-resultatet ikke vurderes.
English: The daclatasvir EC50 values in the replicon system were 0.003-1.25 nM for genotypes 3a, 4a, 5a and 6a, and 0.034-19 nM for genotype 2a as well as 0.020 nM for infectious genotype 2a (JFH-1) virus.
Danish: Daclatasvir EC50-værdierne i replikonsystemet var 0,003-1,25 nM for genotype 3a, 4a, 5a og 6a og 0,034-19 nM for genotype 2a samt 0,020 nM for
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Bristol-Myers Squibb Pharma EEIG
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Bristol-Myers Squibb Pharma EEIG
English: Daklinza must always be used together with other medicines against hepatitis C infection and must
Danish: Daklinza skal altid anvendes sammen med anden medicin mod hepatitis C-infektion og må aldrig
English: In the majority of clinical studies of daclatasvir in combination with sofosbuvir or with peginterferon alfa and ribavirin, plasma HCV RNA values were measured using the COBAS TaqMan HCV test (version 2.0), for use with the High Pure System, with a lower limit of quantification (LLOQ) of 25 IU/ ml.
Danish: I størstedelen af de kliniske studier med daclatasvir i kombination med sofosbuvir eller med peginterferon alfa og ribavirin blev plasmaværdierne for HCV-RNA målt ved hjælp af COBAS TaqMan HCV-testen (version 2.0), med High Pure-systemet, med en nedre kvantificeringsgrænse (LLOQ) på 25 IE/ml.
English: Lamivudine Zidovudine Emtricitabine Abacavir
Danish: Lamivudin Zidovudin Emtricitabin Abacavir
English: Daklinza contains less than 1 mmol sodium (23 mg) per maximum dose of 90 mg, that is to say
Danish: Daklinza indeholder mindre end 1 mmol (23 mg) natrium pr. maksimal dosis af 90 mg, dvs. det er i
English: The active substance is daclatasvir.
Danish: Aktivt stof: daclatasvir.
English: Daklinza is not recommended for use in children and adolescents aged below 18 years because the safety and efficacy have not been established in this population.
Danish: Daklinza anbefales ikke til børn og unge under 18 år, da sikkerhed og virkning ikke er blevet
English: Among 258 patients who achieved SVR12 with daclatasvir and sofosbuvir (± ribavirin) with a median duration of post-SVR12 follow-up of 38 months, no relapses occurred (with relapses defined as confirmed or last available HCV RNA ≥ LLOQ).
Danish: Blandt de 258 patienter, som nåede SVR12 med daclatasvir og sofosbuvir (± ribavirin), og hvor den gennemsnitlige opfølgningstid var 38 måneder post SVR12, er der ikke observeret recidiv (hvor recidiv er defineret som bekræftet eller sidste tilgængelige HCV RNA ≥ LLOQ).
English: The active transport is mediated by OCT1 and other unidentified uptake transporters, but not by organic anion transporter (OAT) 2, sodium-taurocholate cotransporting
Danish: Den aktive transport medieres af OCT1 og andre, uidentificerede optagelsestransportere, men ikke af organisk aniontransporter (OAT) 2, natrium-taurocholat co-transporterende polypeptid (NTCP) eller OATP'er.
English: Table 10: Demographics and baseline characteristics in Study ALLY-2 daclatasvir + sofosbuvir 12 weeks N = 153
Danish: Tabel 10: Demografiske data og baseline-karakteristika i ALLY-2-studiet daclatasvir + sofosbuvir 12 uger N = 153
English: SVR12 rates were higher for patients with the IL-28B CC genotype than for those with non-CC genotypes and for patients with baseline HCV RNA less than 800,000 IU/ml but consistently higher in the daclatasvir-treated patients than for placebo-treated
Danish: SVR12-rater var højere for patienter med IL-28B CC-genotypen end for dem med non-CC genotyper og for patienter med HCV-RNA under 800,000 IU/ml ved baseline men konsekvent højere hos daclatasvir-behandlede patienter end hos placebo-behandlede patienter i alle undergrupper.
English: Population pharmacokinetic analysis of data from clinical studies identified race (categories “other” [patients who are not white, black or Asian] and “black”) as a statistically significant covariate on daclatasvir apparent oral clearance (CL/F) and apparent volume of distribution (Vc/F) resulting in slightly higher exposures compared to white patients, but the magnitude of the effect on daclatasvir
Danish: Farmakokinetiske populationsanalyser af data fra kliniske studier identificerede race (kategorierne “andet” [patienter, som ikke er hvide, sorte eller asiater] og “sorte”) som en klinisk signifikant co-variat for daclatasvirs synlige orale clearance CL/F) og synlige fordelingsvolumen (Vc/F), hvilket medfører en anelse højere eksponering sammenlignet med hvide patienter, men betydningen af effekten på daclatasvir-eksponering er ikke klinisk vigtig.
English: SVR12 rates were consistently high across most subgroups including gender, age, race, baseline HCV RNA, and IL28B genotype.
Danish: SVR12-raterne var konsekvent høje på tværs af de fleste undergrupper, inklusive køn, alder, race, baseline HCV-RNA og IL28B-genotype.
English: Age (years): median (range) Race: White
Danish: Alder (år): median (interval) Race: Kaukasisk Sort/afroamerikansk Andet
English: Subjects with end-stage renal disease requiring haemodialysis had a 27% increase in daclatasvir AUC and a 20% increase in unbound AUC compared to subjects with normal renal function (see section 4.2).
Danish: Forsøgspersoner med nyresygdom i slutstadiet med behov for hæmodialyse havde en 27% stigning i AUC for daclatasvir og en 20% stigning i ubunden AUC sammenlignet med forsøgspersoner med normal nyrefunktion (se
English: Grade 3/4 increases in total bilirubin were observed in 5% of patients (all in patients with HIV coinfection who were receiving concomitant atazanavir, with Child-Pugh A, B, or C cirrhosis, or who
Danish: Der blev observeret grad 3/4 stigning i total-bilirubin hos 5% af patienterne (alle tilfælde optrådte hos patienter, som samtidigt var inficeret med hiv-infektion og fik atazanavir, patienter med Child-Pugh A, B eller C cirrose eller patienter, som havde gennemgået en levertransplantation).
English: No dose adjustment of Daklinza is required for patients with mild (Child-Pugh A, score 5-6), moderate (Child-Pugh B, score 7-9) or severe (Child-Pugh C, score ≥10) hepatic impairment (see sections 4.4
Danish: Dosisjustering af Daklinza er ikke nødvendig hos patienter med let (Child-Pugh A, score 5-6), moderat (Child-Pugh B, score 7-9) eller alvorligt (Child-Pugh, score ≥10) nedsat leverfunktion (se pkt.
English: The SVR12 rates were achieved by 88.5% of patients, including 92.6% of treatment-naïve and 79.2% of treatment-experienced patients (see Table 13).
Danish: 88,5% af patienterne opnåede SVR12-rater, inklusive 92,6% af de behandlingsnaive og 79,2% af de behandlingserfarne patienter (se Tabel 13).
English: Four patients discontinued the Daklinza regimen for adverse events, only one of which was considered
Danish: Fire patienter seponerede Daklinza på grund af bivirkninger, hvoraf kun en blev vurderet til at være relateret til studiebehandlingen.
English: Among 302 patients who achieved SVR12 with daclatasvir + pegIFN/RBV with a median duration of post-SVR12 follow-up of 44 months, 2% (n=6) of patients relapsed.
Danish: Blandt de 302 patienter, som nåede SVR12 med daclatasvir + pegIFN/RBV, og hvor den gennemsnitlige opfølgningstid var 44 måneder post SVR12, oplevede 2% (n=6) af patienterne
English: HCV Treatmentexperienced* N=52
Danish: HCV-behandlingserfarne* N=52
English: Table 1: Recommended treatment for Daklinza interferon-free combination therapy
Danish: Tabel 1: Anbefalinger for Daklinza-kombinationsbehandling uden interferon