FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use this medicine after the expiry date which is stated on the carton and blister after "EXP".
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter “EXP”.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 August 2014
Danish: Dato for første markedsføringstilladelse: 22. august 2014
English: The serum digoxin concentrations should be monitored and used for titration of digoxin dose to obtain the desired clinical effect.
Danish: Serumkoncentrationen af digoxin bør monitoreres og anvendes ved titrering af digoxin-dosis for at opnå den ønskede kliniske effekt..
English: * the effect of 60 mg daclatasvir on lopinavir may be higher.
Danish: * effekten af 60 mg daclatasvir på lopinavir kan være højere.
English: Relapse includes observations through follow-up Week 24.
Danish: Recidiv omfatter observationer til opfølgningsuge 24.
English: Fibrosis stage F0
Danish: Fibrosestadium F0
English: Daklinza can be taken with or without a meal.
Danish: Daklinza kan tages med eller uden mad.
English: The relevance of including ribavirin as part of the 24-week regimen is unclear.
Danish: Relevansen af at inkludere ribavirin som en del af 24-ugers- behandlingsregimet er ukendt.
English: The studies presented in Table 4 were conducted in healthy adult subjects unless otherwise noted.
Danish: Studierne, der refereres til i tabel 4, er udført med raske voksne forsøgspersoner medmindre andet er angivet.
English: Interaction not studied for this fixed dose combination tablet.
Danish: Interaktion ikke undersøgt for denne fastdosis-kombinationstablet.
English: 0.180/0.215/0.250 mg is recommended with Daklinza.
Danish: 0,180/0,215/0,250 mg anbefales med Daklinza.
English: Embryo-foetal development
Danish: Embryo-føtal udvikling
English: Limited data are available from an ongoing follow-up study to assess durability of response up to 3 years after treatment with daclatasvir.
Danish: Der foreligger begrænsede data fra et igangværende opfølgningsstudie, der skal evaluere varigheden af respons op til 3 år efter behandling med daclatasvir.
English: GT: Genotype; CP: Child Pugh * Includes patients co-infected with human immunodeficiency virus (HIV).
Danish: GT: Genotype; CP: Child Pugh * Inkluderer patienter, som samtidig er inficeret med humant immundefektvirus (hiv).
English: The active transport is mediated by OCT1 and other unidentified uptake transporters.
Danish: Den aktive transport medieres af OCT1 og andre, uidentificerede optagelsestransportere.
English: These data indicate that the liver is the major clearance organ for daclatasvir in humans.
Danish: Disse data indikerer, at leveren er det primære clearance-organ for daclatasvir hos mennesker.
English: Carcinogenesis and mutagenesis
Danish: Karcinogenicitet og mutagenicitet
English: If you are pregnant you must not take Daklinza.
Danish: Hvis du er gravid, må du ikke tage Daklinza.
English: Metabolism and nutrition disorders common decreased appetite
Danish: Metabolisme og ernæring almindelig nedsat appetit
English: Patients who are identified as being at high risk of bradyarrhythmia should be continuously monitored for 48 hours in an appropriate clinical setting.
Danish: Patienter med kendt høj risiko for bradyarytmi bør overvåges kontinuerligt i 48 timer i passende kliniske omgivelser.
English: It is very important that you also read the package leaflets for the other medicines that you will be taking with Daklinza.
Danish: Det er meget vigtigt, at du også læser indlægssedlerne for de andre lægemidler, du skal tage sammen med Daklinza.
English: The duration of your treatment will depend on whether you have previously received treatment for your hepatitis C infection, the condition of your liver, and what other medicines you will take with Daklinza.
Danish: Behandlingsvarigheden vil afhænge af, om du tidligere er blevet behandlet for hepatitis C-infektion, din levers tilstand og, hvilken anden medicin du skal tage sammen med Daklinza.
English: Resistance in clinical studies
Danish: Resistens i kliniske studier
English: For 5 patients, cirrhosis status was indeterminate.
Danish: Hos 5 patienter var cirrosestatus uvis.
English: Treatment of overdose with daclatasvir should consist of general supportive measures, including monitoring of vital signs, and observation of the patient's clinical status.
Danish: Behandling af overdosering med daclatasvir bør bestå af almindelig understøttende behandling, herunder monitorering af vitale funktioner og observation af patientens kliniske status.
English: Daklinza is sometimes used together with ribavirin.
Danish: Daklinza anvendes nogle gange sammen med ribavirin.
English: Excretion into milk
Danish: Udskillelse i mælk
English: Age (years): median (range) Race: White Black/African American Other HCV genotype: 1a 1b
Danish: Alder (år): median (interval) Race: Kaukasisk Sort/afroamerikansk Andet HCV-genotype: 1a 1b
English: Warnings and precautions Talk to your doctor or pharmacist before taking Daklinza.
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apoteketspersonalet, før du tager Daklinza.
English: CCR5 receptor antagonist Maraviroc
Danish: CCR5-receptorantagonist Maraviroc
English: Itraconazole Posaconazole Voriconazole
Danish: Itraconazol Posaconazol Voriconazol
English: Expected:
Danish: Forventes:
English: Daklinza must be administered in combination with other medicinal products.
Danish: Daklinza skal administreres i kombination med andre lægemidler.
English: Grade 3 adverse reactions were reported in less than 1% of patients, and no patients had a Grade 4 adverse reaction.
Danish: Bivirkninger af sværhedsgrad 3 blev rapporteret hos færre end 1% af patienterne, og ingen patienter fik en grad 4-bivirkning.
English: In vitro studies indicate that daclatasvir is actively and passively transported into hepatocytes.
Danish: In vitro-studier viser, at daclatasvir transporteres aktivt og passivt ind i hepatocytter.
English: Antiviral activity in cell culture
Danish: Antiviral aktivitet i cellekulturer
English: Important information about some of the ingredients in Daklinza Daklinza contains lactose.
Danish: Vigtige oplysninger om nogle af indholdsstofferne i Daklinza Daklinza indeholder lactose.
English: Mainly interferon-based therapy +/-NS3/4 PI.
Danish: Hovedsageligt interferon-baseret behandling +/-NS3/4 PI.
English: However, as this is a limited effect, dose adjustment of concomitantly administered CYP3A4 substrates is not necessary.
Danish: Da dette imidlertid er en begrænset effekt, er dosisjustering af samtidigt administrerede CYP3A4-substrater ikke nødvendig.
English: All Genotype 3 N=18
Danish: Alle Genotype 3 N=18
English: Table 4 provides information from drug interaction studies with daclatasvir including clinical recommendations for established or potentially significant drug interactions.
Danish: Tabel 4 indeholder oplysninger fra interaktionsundersøgelser med daclatasvir, herunder kliniske anbefalinger for påviste eller potentielt signifikante lægemiddelinteraktioner.
English: Belgique/België/Belgien
Danish: Belgique/België/Belgien N.V.
English: It is used to treat adults with hepatitis C, an infectious disease that affects the liver, caused by the hepatitis C virus.
Danish: Det anvendes til behandling af voksne med hepatitis C, en smitsom sygdom, der angriber leveren og som forårsages af hepatitis C-viruset.
English: If the starting dose is not well-tolerated, the dose should be reduced as clinically indicated, based on haemoglobin and creatinine clearance measurements (see Table 2).
Danish: Hvis startdosis ikke tolereres godt, bør dosis reduceres som klinisk indiceret, baseret på måling af hæmoglobin og kreatininclearance (se tabel 2).
English: Study AI444010
Danish: Studie AI444010
English: Do not take a double dose (two doses close together).
Danish: Du må ikke tage en dobbeltdosis (to doser lige efter hinanden).
English: Patients with Child-Pugh C liver disease
Danish: Patienter med Child-Pugh C leversygdom
English: The mean score on the FibroTest (a validated non-invasive diagnostic assay) was 0.460 (range: 0.03 to 0.89).
Danish: Den gennemsnitlige score i FibroTest (en valideret non-invasiv diagnostisk analyse) var 0,460 (interval: 0,03 til 0,89).
English: This medicine works by stopping the hepatitis C virus from multiplying and infecting new cells.
Danish: Dette lægemiddel virker ved at forhindre hepatitis C-virus i at formere sig og inficere nye celler.
English: Emerging resistance
Danish: Opstået resistens
English: 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: Because daclatasvir is highly protein bound (99%) and has a molecular weight >500, dialysis is unlikely to significantly reduce plasma concentrations of daclatasvir.
Danish: Eftersom daclatasvir i udstrakt grad er proteinbundet (99%) og har en molekylevægt på >500, er det usandsynligt at dialyse kan reducere plasmakoncentrationen af daclatasvir i signifikant grad.
English: Outcomes by prior treatment experience are presented in Table 11.
Danish: Resultater opdelt efter tidligere behandlingserfaring er vist i tabel 11.
English: Blood and lymphatic system disorders very common anaemia
Danish: Blod og lymfesystem meget almindelig anæmi
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 detekteret i forbindelse med svigt.
English: Caution should be used if the medicinal product has a narrow therapeutic range (see Table 4).
Danish: Der skal udvises forsigtighed, hvis lægemidlet har et snævert terapeutisk virkningsområde (se tabel 4).
English: Uxbridge UB8 1DH United Kingdom
Danish: Uxbridge UB8 1DH Storbritannien
English: In genotype 4, amino acid substitutions at 30 and 93 (EC50 < 16 nM) were frequently selected.
Danish: I genotype 4 blev aminosyresubstitution ved 30 og 93 (EC50 < 16 nM) hyppigt selekteret.
English: SVR12 was achieved by 74% of patients in this study (genotype 1a: 70%, genotype 1b: 79%).
Danish: SVR12 blev opnået hos 74% af patienterne i dette studie (genotype 1a: 70%, genotype 1b: 79%).
English: Daclatasvir in vitro did not inhibit (IC50 >40 µM) CYP enzymes 1A2, 2B6, 2C8, 2C9, 2C19, or 2D6.
Danish: Daclatasvir in vitro hæmmede ikke (IC50 >40 µM) CYP enzymerne 1A2, 2B6, 2C8, 2C9, 2C19 eller 2D6.
English: Do not stop taking Daklinza unless your doctor told you to stop.
Danish: Du må ikke stoppe med at tage Daklinza, medmindre din læge har bedt dig om det.
English: Very common (may affect more than 1 in 10 people): headache, fatigue
Danish: Meget almindelig (kan forekomme hos flere end 1 ud af 10 personer): hovedpine, træthed
English: This regimen is an alternative recommended regimen for patients with genotype 4 infection, without cirrhosis or with compensated cirrhosis.
Danish: Dette regime anbefales som et alternativ hos patienter med genotype 4-infektion uden cirrose eller med kompenseret cirrose.
English: All 44 patients with HCV genotype 2 (n=26) or 3 (n=18) infection were treatment-naïve.
Danish: Alle 44 patienter med HCV-genotype 2 (n=26) eller 3 (n=18) infektion var behandlingsnaive.
English: Study AI444042
Danish: Studie AI444042
English: Psychiatric disorders common insomnia, irritability insomnia
Danish: Psykiske forstyrrelser almindelig insomni, irritabilitet insomni
English: The median viral load was 6.42 log10 IU/ml, and 21% of patients had compensated cirrhosis.
Danish: Median viral belastning var 6,42 log10 IE/ml, og 21% af patienterne havde kompenseret cirrose.
English: SVR12 was achieved in 90% of treatment-naïve patients and 86% of treatment-experienced patients.
Danish: SVR12 blev nået hos 90% af de behandlingsnaive patienter og hos 86% af de behandlingserfarne patienter.
English: Daklinza must not be administered as monotherapy.
Danish: Daklinza må ikke administreres som monoterapi.
English: Refer to section 4.3 for a listing of medicinal products that are contraindicated for use with Daklinza due to potential loss of therapeutic effect.
Danish: 4.3 for en liste over lægemidler, der er kontraindiceret sammen med Daklinza på grund af det potentielle tab af terapeutisk virkning.
English: Table 5: Adverse reactions in clinical studies System Organ Class
Danish: Tabel 5: Bivirkninger i kliniske studier Systemorganklasse
English: HORMONAL CONTRACEPTIVES
Danish: HORMONELLE KONTRACEPTIONSMIDLER
English: If you are taking any of these medicines, your doctor may decide to change your daily dose of Daklinza to ensure that the treatment is safe and effective for you.
Danish: Hvis du tager nogle af disse typer medicin, vil lægen muligvis ændre din daglige dosis af Daklinza for at sikre, at din behandling er sikker og effektiv.
English: The most frequently detected NS5A RAVs included Q30E or Q30R in combination with L31M.
Danish: De hyppigst detekterede NS5A-RAV'er omfattede Q30E eller Q30R i kombination med L31M.
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 for HCV.
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: At the highest dose (100 mg/kg/day), maternal toxicity included mortality and dystocia; developmental toxicity included slight reductions in offspring viability in the peri- and neonatal periods; and reductions in birth weight that persisted into adulthood.
Danish: Ved den højeste dosis (100 mg/kg/dag) omfattede maternel toksicitet mortalitet og dystoki; udviklingsmæssig toksicitet omfattede let nedsat levedygtighed hos afkommet i den peri- og neonatale periode; samt nedsat fødselsvægt, der vedvarede i voksenlivet.
English: In rats, malformations mainly affected the brain, skull, eyes, ears, nose, lip, palate or limbs and in rabbits, the ribs and cardiovascular area.
Danish: I rotter påvirkede misdannelserne hovedsageligt hjerne, kranie, øjne, ører, næse, læber, gane eller lemmer og i kaniner ribben og kardiovaskulære områder.
English: The relapse rate was around 15%, and similar for patients with Child-Pugh A, B and C. The programmes do not allow for a direct comparison of efficacy between the 12- and 24-week regimens.
Danish: Recidivraten var ca. 15% og var ens hos patienter med Child-Pugh A, B og C. Programmerne gør det ikke muligt at lave en direkte sammenligning af virkningen i 12- og 24-ugers-regimerne.
English: *Comparison for daclatasvir was to a historical reference (data from 3 studies of daclatasvir 60 mg once daily with peginterferon alfa and ribavirin).
Danish: *Sammenligning for daclatasvir var til en historisk reference (data fra 3 studier med daclatasvir 60 mg en gang dagligt sammen med peginterferon alfa og ribavirin).
English: SEDATIVES
Danish: SEDATIVA
English: All Genotype 2 N=26
Danish: Alle Genotype 2 N=26
English: Some patients have reported dizziness, difficulty concentrating, and vision problems while taking Daklinza with other medicines for their hepatitis C infection.
Danish: Nogle patienter har rapporteret om svimmelhed, koncentrationsbesvær og problemer med synet, mens de tager Daklinza sammen med anden medicin mod hepatitis C-infektion.
English: The HCV RNA thresholds that trigger discontinuation of treatment (i.e. treatment stopping rules) are presented in Table 3.
Danish: Grænseværdierne for HCV-RNA, som udløser seponering af behandlingen (dvs. regler for seponering), er vist i tabel 3.
English: The SVR12 rate in genotype-3 infected patients with this RAV is reduced (in practice as relapse after end of treatment response), especially in patients with cirrhosis.
Danish: SVR12-raten hos patienter med genotype 3-infektion med denne RAV er nedsat (i praksis recidiv efter respons ved afsluttet behandling), især hos patienter med cirrose.
English: Expected: ↔ Triazolam
Danish: Forventes: ↔ Triazolam
English: At steady state, protein binding of daclatasvir in HCV-infected patients was approximately 99% and independent of dose at the dose range studied (1 mg to 100 mg).
Danish: Ved steady-state var daclatasvirs proteinbinding hos HCV-inficerede patienter ca. 99% og uafhængig af dosis ved det undersøgte dosisområde (1 mg til 100 mg).
English: No dose adjustment of Daklinza or buprenorphine may be required, but it is recommended that patients should be monitored for signs of opiate toxicity.
Danish: Dosisjustering af Daklinza eller buprenorphin er ikke nødvendig, men det anbefales, at patienterne monitoreres for tegn på opiattoksicitet.
English: How long to take Daklinza Make sure you take Daklinza for as long as your doctor has told you to take it.
Danish: Så længe skal du tage Daklinza Du skal sørge for at tage Daklinza så længe, som din læge har bedt dig om at tage det.
English: There are no clinical data in patients with genotype 5 (see section 5.1).
Danish: Der foreligger ingen kliniske data for patienter med genotype 5 (se pkt.
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 medicine) you have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely your liver is damaged and not functioning properly (decompensated liver disease)
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)
English: Patients with HCV infection (across genotypes) at high risk of decompensation or death within 12 months if left untreated were treated under compassionate use programmes.
Danish: Patienter med HCV-infektion (uanset genotype) og med høj risiko for dekompensation eller død inden for 12 måneder uden behandling blev behandlet i compassionate use programmer.
English: Four patients discontinued the Daklinza regimen for adverse events, only one of which was considered related to study therapy.
Danish: Fire patienter seponerede Daklinza på grund af bivirkninger, hvoraf kun en blev vurderet til at være relateret til studiebehandlingen.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTONTEKST
English: The Summary of Product Characteristics for the other medicinal products in the regimen should also be consulted before initiation of therapy with Daklinza.
Danish: Produktresuméerne for de andre lægemidler i behandlingen bør ligeledes konsulteres, før behandling med Daklinza initieres.
English: Resistance in cell culture
Danish: Resistens i cellekulturer
English: Demographic and baseline characteristics of these 50 patients were generally comparable to those for patients who received 12 weeks of study treatment.
Danish: Demografiske data og baseline-karakteristika for disse 50 patienter var generelt sammenlignelige med demografiske data og baseline-karakteristika for patienter, som fik 12 ugers studiebehandling.
English: No evidence of mutagenic or clastogenic activity was observed in in vitro mutagenesis (Ames) tests, mammalian mutation assays in Chinese hamster ovary cells, or in an in vivo oral micronucleus study in rats.
Danish: Der blev ikke observeret evidens for mutagen eller clastogen aktivitet i in vitro mutagentest (Ames' test), mutationsprøver i pattedyr i ovarieceller fra kinesiske hamstre eller i et in vivo oralt mikronukleus-studie i rotter.
English: Daklinza has not yet been studied in children and adolescents.
Danish: Daklinza er endnu ikke tilstrækkeligt undersøgt hos børn og unge.
English: In vitro and in vivo studies showed that daclatasvir is a substrate of P-gp.
Danish: In vitro og in vivo studier viste, at daclatasvir er et P-gp-substrat.
English: and you notice 20 hours or more after the time you usually take Daklinza, wait and take the next dose at your usual time.
Danish: og du opdager det 20 timer eller mere efter det tidspunkt, hvor du normalt tager Daklinza, skal du vente og tage den næste dosis på det sædvanlige tidspunkt.
English: The most frequently reported adverse reactions were fatigue, headache, and nausea.
Danish: De hyppigst rapporterede bivirkninger var træthed, hovedpine og kvalme.
English: It may harm them, even if their signs of illness are the same as yours.
Danish: AUC: 1,05 (1,03; 1,07) Cmax: 1,07 (1,02; 1,12) Cmin: 1,10 (1,03; 1,19)
English: Digoxin should be used with caution when coadministered with Daklinza.
Danish: Digoxin bør anvendes med forsigtighed ved samtidig administration med Daklinza.
English: Elimination 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: Elimination 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: Ethinylestradiol 35 μg once daily for 21 days + norgestimate
Danish: Ethinylestradiol 35 μg en gang dagligt i 21 dage + norgestimat
English: In order to evaluate the recurrence of hepatocellular carcinoma associated with Daklinza, the MAH shall conduct and submit the results of a prospective safety study using data deriving from a cohort of a well-defined group of patients, based on an agreed protocol.
Danish: For at vurdere recidiv af hepatocellulært karcinom associeret med Daklinza skal indehaveren af markedsføringstilladelsen udføre og indsende resultaterne fra et prospektivt sikkerhedsstudie baseret på en vedtagen protokol med brug af data fra en kohorte af en veldefineret gruppe patienter.
English: The sofosbuvir resistance-associated substitution S282T emerged in only 1 non-SVR12 patient infected with genotype 3.
Danish: Den sofosbuvir-resistensassocierede substitution S282T opstod kun hos 1 non-SVR12 patient med genotype 3-infektion.
English: Clinically relevant increase in concentration is indicated as “↑”, clinically relevant decrease as “↓”, no clinically relevant change as “↔”.
Danish: Klinisk relevant koncentrationsstigning er angivet med “↑”, og klinisk relevant fald er angivet med “↓”, ingen klinisk relevant ændring er angivet med “↔”.
English: These substitutions conferred low level resistance (EC50 <1 nM) for genotype 1b, and higher levels of resistance for genotype 1a (EC50 up to 350 nM).
Danish: Disse substitutioner medførte lav resistens (EC50 <1 nM) for genotype 1b og højere grad af resistens for genotype 1a (EC50 op til 350 nM).
English: Patients should be instructed that, if they miss a dose of Daklinza, the dose should be taken as soon as possible if remembered within 20 hours of the scheduled dose time.
Danish: Patienterne bør informeres om at, hvis de glemmer at tage en dosis af Daklinza, skal de tage den så snart de kommer i tanke om det inden for 20 timer fra det planlagte tidspunkt.
English: The dose of daclatasvir was adjusted for concomitant antiretroviral use.
Danish: Dosis af daclatasvir blev tilpasset den samtidige antiretrovirale behandling.
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 undersøgt i denne population.