FrancophonIA/ELRC3.0 huggingface dataset:
English: Administration of Daklinza may increase systemic exposure to medicinal products that are substrates of P-gp, OATP 1B1, OCT1 or BCRP, which could increase or prolong their therapeutic effect and adverse reactions.
Danish: Administration af Daklinza kan øge den systemiske eksponering for lægemidler, der er substrater for P-gp, OATP 1B1, OCT1 eller BCRP, hvilket kan øge eller forlænge deres terapeutiske virkning og bivirkninger.
English: In vitro daclatasvir is an inhibitor of renal uptake transporters, OAT1 and 3, and OCT2, but is not expected to have a clinical effect on the pharmacokinetics of substrates of these transporters.
Danish: In vitro hæmmer daclatasvir de renale optagelsestransportere OAT1 og 3 og OCT2, men det forventes ikke at have nogen klinisk effekt på farmakokinetikken hos substraterne for disse transportere.
English: SVR12 rates were lower among patients with cirrhosis (see Table 12).
Danish: SVR12-raterne var lavere hos patienter med cirrose (se Tabel 12).
English: Pharmacotherapeutic group: Direct-acting antiviral, ATC code: J05AX14
Danish: Farmakoterapeutisk klassifikation: Direkte virkende antivirale midler, ATC-kode: J05AX14.
English: Conversion of the FibroTest score to the corresponding METAVIR score suggests that 35% of all patients (49% of patients with prior PI failure, 30% of patients with genotype 2 or 3) had ≥F3 liver fibrosis.
Danish: En omregning af FibroTest score til den tilsvarende METAVIR score indikerer, at 35% af alle patienter (49% af patienterne med tidligere mislykket PI-behandling, 30% af patienterne med genotype 2 eller 3) havde ≥F3 leverfibrose.
English: Treatment-naïve patients with HCV genotype 1 who received 12 weeks of treatment had a similar response as those treated for 24 weeks (Table 6).
Danish: Behandlingsnaive patienter med HCV-genotype 1, som fik 12 ugers behandling, viste lignende respons som de, der blev behandlet i 24 uger (Tabel 6).
English: Daclatasvir is a very weak inducer of CYP3A4 and caused a 13% decrease in midazolam exposure.
Danish: Daclatasvir er en meget svag CYP3A4-hæmmer og medførte en nedsættelse af midazolam eksponering på 13%.
English: Long term efficacy data
Danish: Langtidsdata
English: The most frequently reported adverse reactions of at least Grade 3 severity (frequency of 1% or greater) were neutropenia, anaemia, lymphopenia and thrombocytopenia.
Danish: De hyppigst rapporterede bivirkninger af en sværhedsgrad på minimum 3 (hyppighed på 1% eller mere) var neutropeni, anæmi, lymfopeni og trombocytopeni.
English: Population pharmacokinetic analysis of data from clinical studies indicated that age had no apparent effect on the pharmacokinetics of daclatasvir.
Danish: Farmakokinetiske populationsanalyser af data fra kliniske studier indikerer, at alder ikke havde nogen åbenbar effekt på daclatasvirs farmakokinetik.
English: Daclatasvir is an inhibitor of nonstructural protein 5A (NS5A), a multifunctional protein that is an essential component of the HCV replication complex.
Danish: Daclatasvir er en hæmmer af det ustrukturelle protein 5A (NS5A), som er et multifunktionelt protein, der udgør en vigtig del af HCV-replikationskomplekset.
English: Virologic breakthrough**
Danish: Virologisk gennembrud**
English: Regimen and duration HCV GT 1 or 4
Danish: Regime og behandlingsvarighed HCV-GT 1 eller 4
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: If you stop taking Daklinza
Danish: Hvis du holder op med at tage Daklinza
English: Indigo carmine aluminum lake (E132) Yellow iron oxide (E172)
Danish: Indigo carmine aluminum lake (E132) Gul jernoxid (E172)
English: In phase 1 clinical studies, healthy subjects who received up to 100 mg once daily for up to 14 days or single doses up to 200 mg had no unexpected adverse reactions.
Danish: I kliniske fase 1-studier fik raske forsøgspersoner, som fik op til 100 mg en gang dagligt i op til 14 dage eller enkeltdoser på op til 200 mg, ingen uventede bivirkninger.
English: Tabulated summary of interactions
Danish: Tabel over interaktioner
English: Protease inhibitors (PIs) Boceprevir
Danish: Proteasehæmmere (PI'ere) Boceprevir
English: Administration of daclatasvir 60 mg tablet after a light meal resulted in no reduction in daclatasvir exposure.
Danish: Administration af daclatasvir 60 mg tablet efter et let måltid medførte ingen reduktion i daclatasvir-eksponering.
English: The active transport is mediated by OCT1 and other unidentified uptake transporters, but not by organic anion transporter (OAT) 2, sodium-taurocholate cotransporting polypeptide (NTCP), or OATPs.
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: Mothers should be instructed not to breastfeed if they are taking Daklinza.
Danish: Mødre skal oplyses om, at de ikke må amme deres barn, hvis de tager Daklinza.
English: If you do miss a dose: and you notice within 20 hours of the time you usually take Daklinza, you must take the tablet as soon as possible.
Danish: Hvis du glemmer en dosis: 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: Min, Max ND: Not determined
Danish: ND: Ikke fastlagt
English: There is no known antidote for overdose of daclatasvir.
Danish: Der findes ingen kendt antidot mod overdosering af daclatasvir.
English: Substitutions conferring daclatasvir resistance in genotypes 1-4 were observed in the N-terminal 100 amino acid region of NS5A in a cell-based replicon system.
Danish: Substitutioner, der medførte daclatasvir-resistens i genotype 1-4, blev observeret i NS5A's aminosyreregion N-terminal 100 i et cellebaseret replikon-system.
English: Creatinine Clearance >50 mL/min
Danish: Kreatininclearance >50 ml/min
English: Treatment duration was 12 weeks for 82 treatment-naïve HCV genotype 1 patients, and 24 weeks for all other patients in the study.
Danish: Behandlingsvarigheden var 12 uger for 82 behandlingsnaive HCV-genotype 1-patienter og 24 uger for alle andre patienter i studiet.
English: Your doctor may need to adjust the dose of Daklinza or you may not be able to take Daklinza with certain medicines.
Danish: Din læge vil muligvis justere din dosis af Daklinza eller du vil muligvis ikke kunne tage Daklinza sammen med visse typer medicin.
English: For patients with Child-Pugh A, B, or C cirrhosis or recurrence of HCV infection after liver transplantation, the recommended initial dose of ribavirin is 600 mg daily with food.
Danish: Hos patienter med Child-Pugh A, B eller C cirrose eller recidiv af HCV-infektion efter levertransplantation er den anbefalede startdosis af ribavirin 600 mg dagligt sammen med mad.
English: Safety monitoring is advised when initiating treatment with Daklinza in patients receiving dabigatran etexilate or other intestinal P-gp substrates that have a narrow therapeutic range.
Danish: Sikkerhedsmonitorering tilrådes, når behandling med Daklinza initieres hos patienter, der får dabigatranetexilat eller andre intestinale P-gp substrater med et snævert terapeutisk virkningsområde.
English: There is limited experience of accidental overdose of daclatasvir in clinical studies.
Danish: Der er begrænset erfaring med uforsætlig overdosering af daclatasvir i kliniske studier.
English: Etravirine Nevirapine
Danish: Etravirin Nevirapin
English: Overall, SVR12 was achieved by 97% (149/153) of patients administered daclatasvir and sofosbuvir for 12 weeks in ALLY-2.
Danish: Samlet set blev SVR12 nået af 97% (149/153) af patienterne, der fik daclatasvir og sofosbuvir i 12 uger i ALLY-2.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with daclatasvir in one or more subsets of the paediatric population in the treatment of chronic hepatitis C (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med daclatasvir i en eller flere undergrupper af den pædiatriske population i behandlingen af kronisk hepatitis C (se pkt.
English: Treatment outcomes in study AI444042 are presented in Table 13.
Danish: Behandlingsresultaterne fra studie AI444042 er vist i tabel 13.
English: * Evaluated in opioid-dependent adults on stable methadone maintenance therapy.
Danish: * Undersøgt hos opioidafhængige voksne i stabil vedligeholdelsesbehandling med methadon.
English: Table 10: Demographics and baseline characteristics in Study ALLY-2
Danish: Tabel 10: Demografiske data og baseline-karakteristika i ALLY-2-studiet
English: All patients receiving Daklinza and sofosbuvir in combination with amiodarone with or without other drugs that lower heart rate should also be warned of the symptoms of bradycardia and heart block and should be advised to seek medical advice urgently should they experience them.
Danish: Alle patienter, som får Daklinza og sofosbuvir i kombination med amiodaron med eller uden andre hjertefrekvenssænkende lægemidler, skal ligeledes advares om symptomerne på bradykardi og hjerteblok og tilrådes at søge øjeblikkelig lægehjælp, hvis de kommer ud for dem.
English: For HCV genotype 1, SVR12 rates were 64% (54% for 1a; 84% for 1b) for patients treated with daclatasvir + pegIFN/RBV and 36% for patients treated with placebo + pegIFN/RBV.
Danish: For HCV-genotype 1 var SVR12 raterne 64% (54% for 1a; 84% for 1b) for patienter, der blev behandlet med daclatasvir + pegIFN/RBV og 36% for patienter, der blev behandlet med placebo + pegIFN/RBV.
English: Discontinue peginterferon alfa and ribavirin (treatment with Daklinza is complete at week 24)
Danish: Seponering af peginterferon alfa og ribavirin (behandling med Daklinza er komplet ved uge 24)
English: Observed emergent NS5A resistance-associated variants are reported in Table 14.
Danish: Observeret opståen af NS5A-resistensassocierede varianter er vist i tabel 14.
English: Daklinza must always be used together with other medicines against hepatitis C infection and must never be used by itself.
Danish: Daklinza skal altid anvendes sammen med anden medicin mod hepatitis C-infektion og må aldrig anvendes alene.
English: If available, ratios of geometric means are shown, with 90% confidence intervals (CI) in parentheses.
Danish: Forholdet mellem de geometriske middelværdier er vist med 90% konfidensinterval (KI) i parenteser, hvor det er muligt.
English: In a study of pre- and postnatal development in rats, there was neither maternal nor developmental toxicity at doses up to 50 mg/kg/day, associated with AUC values 2-fold the clinical AUC exposure.
Danish: I en undersøgelse af den præ- og postnatale udvikling i rotter, forekom der hverken maternel eller udviklingsmæssig toksicitet ved doser på op til 50 mg/kg/dag associeret med AUC-værdier 2 gange højere end klinisk AUC-eksponering.
English: There are no data from the use of daclatasvir in pregnant women.
Danish: Graviditet Der foreligger ingen data om anvendelse af daclatasvir til gravide kvinder.
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: Data from compassionate use programmes which included patients with genotype 3 infection and cirrhosis, support the use of Daklinza + sofosbuvir for 24 weeks in these patients.
Danish: Data fra compassionate use programmer, som inkluderer patienter med genotype 3-infektion og cirrose, understøtter anvendelse af Daklinza + sofosbuvir i 24 uger til disse patienter.
English: It is not known whether daclatasvir is excreted in human milk.
Danish: Det er ukendt, om daclatasvir udskilles i human mælk.
English: Study conducted in patients with chronic HCV infection
Danish: Studie udført med patienter med kronisk HCV-infektion
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 infektiøs genotype 2a (JFH-1) virus.
English: In vitro and in vivo studies demonstrate that daclatasvir is a substrate of CYP3A, with CYP3A4 being the major CYP isoform responsible for the metabolism.
Danish: In vitro og in vivo studier viser, at daclatasvir er substrat for CYP3A, idet CYP3A4 er den vigtigste CYP-isoform og ansvarlig for metabolismen.
English: Fusion inhibitor Enfuvirtide
Danish: Fusionshæmmer Enfuvirtid
English: Polyvinyl Chloride/poly-chloro-tri-fluoro-ethylene (PVC/PCTFE) clear blister/aluminum foil lidding.
Danish: Polyvinylchlorid/polychlortrifluorethylen(PVC/PCTFE) klart blister/aluminum folielåg.
English: The impact of baseline NS5A RAVs on cure rates of genotype 4 infection is not apparent.
Danish: Indvirkningen af NS5A-RAV'er ved baseline på helbredelsesraterne for genotype 4-infektion er ikke åbenbar.
English: Studies of daclatasvir in animals have shown embryotoxic and teratogenic effects (see section 5.3).
Danish: Studier med daclatasvir hos dyr har vist embryotoksiske og teratogene virkninger (se pkt.
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 patients in all subgroups.
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: L31V and Y93H were frequently observed resistance substitutions in genotype 1b, while M28T, L31V/M, Q30E/H/R, and Y93C/H/N were frequently observed resistance substitutions in genotype 1a.
Danish: L31V og Y93H var hyppigt observerede resistenssubstitutioner i genotype 1b, mens M28T, L31V/M, Q30E/H/R og Y93C/H/N var hyppigt observerede resistenssubstitutioner i genotype 1a.
English: If treatment interruption of components in the regimen is necessary because of adverse reactions, Daklinza must not be given as monotherapy.
Danish: Hvis det er nødvendigt at afbryde behandlingen med andre behandlingskomponenter på grund af bivirkninger, må Daklinza ikke gives som monoterapi.
English: However, if the missed dose is remembered more than 20 hours after the scheduled dose, the dose should be skipped and the next dose taken at the appropriate time.
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: ↔ Daclatasvir ↔ Immunosuppressant
Danish: ↔ Daclatasvir ↔ Immunosuppresiva
English: In clinical studies of Daklinza in combination with sofosbuvir with or without ribavirin, 2% of patients had Grade 3 haemoglobin decreases; all of these patients received Daklinza + sofosbuvir + ribavirin.
Danish: I kliniske studier med Daklinza i kombination med sofosbuvir med eller uden ribavirin oplevede 2% af patienterne fald i hæmoglobin grad 3; alle disse patienter fik Daklinza + sofosbuvir + ribavirin.
English: SVR12 was achieved by 83% (50/60) of patients in the cirrhosis cohort, with a marked difference between patients with Child-Pugh A or B (92-94%) as compared to those with Child-Pugh C and 94% of patients in the post-liver transplant cohort (Table 9).
Danish: SVR12 blev nået hos 83% (50/60) af patienterne i cirrosekohorten med en markant forskel mellem patienter med Child-Pugh A eller B (92-94%) sammenlignet med patienter med Child-Pugh C og 94% af patienterne i kohorten, der havde gennemgået en levertransplantation (tabel 9).
English: The recommended dose of Daklinza is 60 mg once a day.
Danish: Den anbefalede dosis af Daklinza er 60 mg en gang dagligt.
English: Emergent daclatasvir resistance-associated substitutions have been shown to persist for 2 years posttreatment and beyond for patients treated with other daclatasvir-based regimens.
Danish: Opståede daclatasvir-resistensassocierede substitutioner er vist at persistere i 2 år efter afsluttet behandling og endnu længere hos patienter, der blev behandlet med andre daclatasvir-baserede regimer.
English: If you can become pregnant, use effective contraception during and for 5 weeks after your treatment with Daklinza.
Danish: Hvis du er i den fødedygtige alder, skal du bruge sikker prævention under og 5 uger efter behandlingen med Daklinza.
English: Refer to the respective Summary of Product Characteristics for drug interaction information for other medicinal products in the regimen.
Danish: Se de respektive produktresuméer for de øvrige lægemidler i behandlingen for oplysninger om lægemiddelinteraktion.
English: Daklinza contains lactose
Danish: Daklinza indeholder lactose
English: With some of these medicines, your doctor may need to adjust your dose of Daklinza.
Danish: Med nogle af disse lægemidler skal lægen muligvis justere din dosis af Daklinza.
English: Daclatasvir is an inhibitor of HCV genotypes 1a and 1b replication in cell-based replicon assays with effective concentration (50% reduction, EC50) values of 0.003-0.050 and 0.001-0.009 nM, respectively, depending on the assay method.
Danish: Daclatasvir er en hæmmer af HCV-genotyper 1a- og 1b-replikation i cellebaserede replikon-tests med effektive koncentrationsværdier (50% reduktion, EC50) på henholdsvis 0,003-0,050 og 0,001-0,009 nM afhængig af testmetoden.
English: Relapse was defined as HCV RNA ≥LLOQ during follow-up after HCV RNA <LLOQ at end of treatment.
Danish: Recidiv blev defineret som HCV-RNA ≥LLOQ ved opfølgning efter HCV-RNA <LLOQ ved behandlingsafslutning.
English: Cases are potentially life threatening, therefore amiodarone should only be used in patients on Daklinza and sofosbuvir when other alternative antiarrhythmic treatments are not tolerated or are contraindicated.
Danish: Da disse tilfælde er potentielt livstruende, bør amiodaron kun anvendes hos patienter i behandling med Daklinza og sofosbuvir, når andre antiarytmika ikke tolereres eller er kontraindiceret.
English: Developmental toxicity consisted of increased embryofoetal lethality, reduced foetal body weights and increased incidence of foetal malformations and variations.
Danish: Udviklingsmæssig toksicitet bestod af øget embryo-føtal dødelighed, nedsat fostervægt og øget forekomst af føtale ribbensmisdannelser og afvigelser.
English: Response was rapid (viral load at Week 4 showed that more than 95% of patients responded to therapy) and was not influenced by IL28B genotype.
Danish: Respons indtraf hurtigt (viral belastning ved uge 4 viste, at mere end 95% af patienterne responderede på behandlingen), og var ikke påvirket af IL28B-genotype.
English: In healthy subjects, administration of daclatasvir 60 mg tablet after a high-fat meal decreased daclatasvir Cmax and AUC by 28% and 23%, respectively, compared with administration under fasting conditions.
Danish: Hos raske forsøgspersoner nedsatte administration af daclatasvir 60 mg tablet efter et måltid med højt fedtindhold daclatasvir Cmax og AUC med henholdsvis 28% og 23% sammenlignet med administration ved faste.
English: Tell your doctor if you are pregnant, think you may be pregnant or are planning to become pregnant.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du fortælle det til lægen.
English: SVR12 was achieved by 99% patients with HCV genotype 1, 96% of those with genotype 2 and 89% of those with genotype 3 (see Tables 6 and 7).
Danish: SVR12 blev nået hos 99% af patienterne med HCV-genotype 1, 96% af patienterne med genotype 2 og 89% af patienterne med genotype 3 (se Tabel 6 og 7).
English: Coadministration of medicines that inhibit P-gp or OCT1 activity is likely to have a limited effect on daclatasvir exposure.
Danish: Samtidig administration af lægemidler, der hæmmer P-gp- eller OCT1-aktivitet, har sandsynligivs kun en ringe virkning på eksponeringen af daclatasvir.
English: The efficacy of Daklinza as part of a retreatment regimen in patients with prior exposure to a NS5A inhibitor has not been established.
Danish: Daklinzas virkning som del af et genbehandlingsforløb hos patienter med tidligere eksponering for en NS5A-hæmmer er ikke klarlagt.
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 be assessed.
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: Patients with HCV genotype 1, 2, 3, 4, 5, or 6 infection were eligible to enroll, including patients with compenstated cirrhosis (ChildPugh A).
Danish: Patienter med HCV-genotype 1-, 2-, 3-, 4-, 5- eller 6-infektion var egnede til inklusion, herunder patienter med kompenseret cirrose (Child-Pugh A).
English: Response was rapid (at Week 4 91% of daclatasvir-treated patients had HCV RNA <LLOQ).
Danish: Respons indtraf hurtigt (ved uge 4 havde 91% af patienterne behandlet med daclatasvir HCV-RNA <LLOQ).
English: Daclatasvir unbound AUC was estimated to be 18%, 39% and 51% higher for subjects with creatinine clearance (CLcr) values of 60, 30 and 15 ml/min, respectively, relative to subjects with normal renal function.
Danish: Ubunden AUC for daclatasvir blev estimeret til at være 18%, 39% og 51% højere hos forsøgspersoner med kreatinin-clearance (CLcr)-værdier på henholdsvis 60, 30 og 15 ml/min i forhold til forsøgspersoner med normal nyrefunktion.
English: This leaflet was last revised in <{MM/YYYY}>.
Danish: Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ}.
English: Treatment-naïve
Danish: Behandlingsnaive
English: ANTIBACTERIALS Clarithromycin Telithromycin
Danish: ANTIBAKTERIELLE MIDLER Clarithromycin
English: Compensated cirrhosis Concomitant HIV therapy: PI-based
Danish: Kompenseret cirrose Samtidig hiv-behandling: PI-baseret
English: Modest increases in concentrations of daclatasvir are expected, but no dose adjustment of Daklinza or fluconazole is required.
Danish: Beskedne stigninger i koncentrationen af daclatasvir forventes, men dosisjustering er ikke nødvendig for Daklinza eller fluconazol.
English: Medicinal products by therapeutic areas
Danish: Lægemidler angivet efter terapeutisk område
English: NARCOTIC ANALGESICS
Danish: NARKOTISKE ANALGETIKA
English: 28 x 1 film-coated tablet
Danish: 28 x 1 filmovertrukket tablet
English: In one cohort the majority of patients were treated with daclatasvir + sofosbuvir + ribavirin for 12 weeks.
Danish: I en kohorte blev størstedelen af patienterne behandlet med daclatasvir + sofosbuvir + ribavirin i 12 uger.
English: The most resistant variants with single amino acid substitution in genotype 2a and genotype 3a were F28S (EC50 >300 nM) and Y93H (EC50 >1,000 nM), respectively.
Danish: De mest resistente varianter med enkelt aminosyresubstitution i genotype 2a og genotype 3a var henholdsvis F28S (EC50 >300 nM) og Y93H (EC50 >1.000 nM).
English: In dogs, bone marrow hypocellularity with correlating clinical pathology changes were observed at exposures 9-fold the clinical AUC exposure.
Danish: Hos hunde blev knoglemarvs-hypocellularitet med korrelerende kliniske patalogiændringer observeret ved eksponering, der var 9 gange højere end den kliniske AUC-eksponering.
English: General disorders and administration site conditions very common fatigue fatigue
Danish: Almene symptomer og reaktioner på administrationsstedet meget almindelig træthed træthed