FrancophonIA/ELRC3.0 huggingface dataset:
English: In vitro, CYP-dependent metabolism accounted for about 5% compared to about 25% ester cleavage.
Danish: In vitro kunne CYP-afhængig metabolisme tilskrives ca. 5 % sammenlignet med ca. 25 % ester-spaltning.
English: SGRQ total score measuring health related quality of life (HRQoL) was analysed at 52 weeks.
Danish: Den samlede score for SGRQ, der måler livskvalitet (health related quality of life, HRQoL), blev analyseret ved uge 52.
English: Do not stop taking Ofev without consulting your doctor first.
Danish: Du må ikke holde op med at tage Ofev uden først at have talt med din læge.
English: IPF is a condition in which the tissue in your lungs becomes thickened, stiff and scarred over time.
Danish: IPF er en tilstand, som forårsager, at vævet i dine lunger bliver fortykket, stift og arret med tiden.
English: Do not take this medicine during pregnancy, as it can harm your unborn baby and cause birth defects.
Danish: Du må ikke tage dette lægemiddel, hvis du er gravid, da det kan skade det ufødte barn og forårsage misdannelser.
English: Ofev should only be initiated at least 4 weeks after abdominal surgery.
Danish: Behandling med Ofev bør tidligst påbegyndes 4 uger efter abdominalkirurgi.
English: Not all pack sizes may be marketed.
Danish: Ikke alle pakningsstørrelser er ikke nødvendigvis markedsført.
English: The age range covered by the analysis was 29 to 85 years; approximately 5% of the population were older than 75 years.
Danish: Analysen omfattede et aldersinterval fra 29 til 85 år; ca. 5 % af populationen var over 75 år.
English: Exposure to nintedanib increased linearly with age.
Danish: Eksponeringen for nintedanib steg lineært med alderen.
English: There is no information on the excretion of nintedanib and its metabolites in human milk.
Danish: Der er ingen information om udskillelse af nintedanib og dets metabolitter i human mælk.
English: Start appropriate anti-diarrhoeal treatment, e.g. with loperamide, as soon as possible.
Danish: Begynd på en egnet behandling mod diarré, f.eks. loperamid, så hurtigt som muligt.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP Blister
English: Nintedanib has been studied in clinical trials of 1,529 patients suffering from IPF.
Danish: Nintedanib er blevet undersøgt i kliniske studier med 1.529 patienter, der lider af IPF.
English: Effect on QT interval
Danish: Effekt på QT-interval
English: Treatment with Ofev should therefore only be initiated or - in case of perioperative interruption - resumed based on clinical judgement of adequate wound healing.
Danish: Behandling med Ofev bør derfor kun påbegyndes eller - i tilfælde af perioperativ afbrydelse - genoptages på grundlag af en klinisk vurdering af, om sårhelingen er tilfredsstillende.
English: Termination of the treatment with Ofev should be considered.
Danish: Ophør af behandlingen med Ofev bør overvejes.
English: The below table provides a summary of the adverse reactions by MedDRA System Organ Class (SOC) and frequency category.
Danish: Nedenstående tabel er en oversigt over bivirkninger i henhold til MedDRA-systemorganklasse (SOC) og hyppighedskategori.
English: Pruritus, Alopecia
Danish: Pruritus Alopeci
English: The robustness of the effect of nintedanib in reducing the annual rate of decline in FVC was confirmed in all pre-specified sensitivity analyses.
Danish: Nintedanibs velfunderede virkning på reduktionen af den årlige grad af forværring i FVC blev bekræftet i alle præ-specificerede sensitivitetsanalyser.
English: Vascular endothelial growth factor receptor (VEGFR) inhibition might be associated with an increased risk of bleeding.
Danish: Vaskulær endotelial vækstfaktor-receptorhæmning (VEGFR-hæmning) kan være forbundet med en øget risiko for blødning.
English: Number of analysed patients
Danish: Antal analyserede patienter
English: Therefore your treatment with Ofev will usually be stopped for a while if you are having a surgery.
Danish: Din behandling med Ofev bliver derfor som regel afbrudt, hvis du skal opereres.
English: Store in the original package in order to protect from moisture.
Danish: Opbevares i original pakning for at beskytte mod fugt.
English: Cases of gastrointestinal perforations, some of which were fatal, have been reported in the post-marketing period.
Danish: Der er rapporteret om tilfælde af gastrointestinal perforation, blandt hvilke nogle havde dødelig udgang, i perioden efter markedsføringen.
English: A pre-specified sensitivity analysis of the time to first 'confirmed' or 'suspected' adjudicated acute IPF exacerbation was performed on the pooled data.
Danish: En præspecificeret sensitivitetsanalyse af tiden til første 'bekræftede' eller 'formodede' vurderede akutte IPF-eksacerbation blev udført på de samlede data.
English: Therefore, hepatic transaminase and bilirubin levels should be investigated before treatment initiation and during the first month of treatment with Ofev.
Danish: Derfor bør hepatisk aminotransferase- og bilirubin-niveauer måles før behandlingsinitiering og i løbet af den første måneds behandling med Ofev.
English: Nintedanib trough concentrations remained stable for more than one year.
Danish: Dalværdier for nintedanibkoncentrationen forblev stabile i mere end et år.
English: Two patients in the oncology programme had an overdose of maximum 600 mg twice daily up to eight days.
Danish: To patienter i onkologiprogrammet fik en overdosis på højst 600 mg to gange dagligt i op til otte dage.
English: There is no information on the use of Ofev in pregnant women, but pre-clinical studies in animals have shown reproductive toxicity of this active substance (see section 5.3).
Danish: Der er ingen information om anvendelse af Ofev til gravide kvinder, men prækliniske dyrestudier har vist reproduktionstoksicitet af dette aktive stof (se pkt.
English: SPECIAL STORAGE CONDITIONS Do not store above 25°C.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares over 25 °C.
English: Diarrhoea may lead to dehydration: a loss of fluid and important salts (electrolytes, such as sodium or potassium) from your body.
Danish: Diarré kan medføre dehydrering: tab af væske og vigtige salte (elektrolytter, som f.eks. natrium eller kalium) fra din krop.
English: As a result, scarring reduces the ability to transfer oxygen from the lungs into the bloodstream and it becomes difficult to breathe deeply.
Danish: Arvævet reducerer lungernes evne til at transportere ilt fra lungerne til blodet, og det bliver vanskeligt at trække vejret dybt.
English: All adverse events of acute IPF exacerbation reported by the investigator were adjudicated by a blinded adjudication committee.
Danish: Alle uønskede hændelser ved akut IPF-eksacerbation, der blev indberettet af investigatoren, blev vurderet af en blindet evalueringskomité.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 January 2015
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 15. januar 2015 Dato for seneste fornyelse: 23. september 2019
English: Treatment interruption should be considered in patients who develop signs or symptoms of acute myocardial ischemia.
Danish: Afbrydelse af behandlingen skal overvejes hos patienter, der udvikler tegn eller symptomer på akut myokardieiskæmi.
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Danish: ENTYDIG IDENTIFIKATOR - 2D-STREGKODE Der er anført en 2D-stregkode, som indeholder en entydig identifikator.
English: Patients at known risk for bleeding including patients with inherited predisposition to bleeding or patients receiving a full dose of anticoagulative treatment were not included in the INPULSIS studies.
Danish: Patienter med kendt risiko for blødning, herunder patienter med hereditær disposition for blødning eller patienter, der får en fuld dosis antikoagulerende behandling, var ikke inkluderet i INPULSISstudierne.
English: Only a weak inhibitory potential on OCT-1, BCRP, and P-gp was observed in vitro which is considered to be of low clinical relevance.
Danish: Der blev kun observeret potentiale for svag hæmning af OCT-1, BCRP og P-gp in vitro, hvilket anses for at have ringe klinisk relevans.
English: Figure 1:
Danish: Figur 1:
English: Treatment with Ofev should be initiated by physicians experienced in the diagnosis and treatment of IPF.
Danish: Behandling med Ofev bør initieres af læger, der har erfaring med diagnosticering og behandling af IPF.
English: Both patients recovered from these adverse reactions.
Danish: Begge patienter kom sig efter disse bivirkninger.
English: Children and adolescents Ofev should not be taken by children and adolescents under 18 years of age.
Danish: Børn og unge Børn og unge under 18 år må ikke tage Ofev.
English: • Periodic safety update reports
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: NAME OF THE MARKETING AUTHORISATION HOLDER Boehringer Ingelheim (logo)
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Boehringer Ingelheim (logo)
English: Therefore treatment with Ofev is not recommended in such patients (see section 4.2).
Danish: Behandling med Ofev anbefales derfor ikke til sådanne patienter (se pkt.
English: This ensures that a steady amount of nintedanib is maintained in your blood stream.
Danish: Dette sikrer, at der hele tiden er en konstant mængde nintedanib i blodbanen.
English: The terminal half-life of nintedanib was between 10 and 15 h (gCV % approximately 50%).
Danish: Nintedanibs terminale halveringstid var mellem 10 og 15 timer (gCV % ca. 50 %).
English: The benefit-risk balance of concomitant treatment with pirfenidone has not been established.
Danish: Benefit-risk-forholdet for samtidig behandling med pirfenidon er ikke klarlagt.
English: AUCτ,ss decreased by 16% for a 45-year old patient and increased by 13% for a 76-year old patient relative to a patient with the median age of 62 years.
Danish: AUCτ,ss faldt med 16 % hos en 45-årig patient og blev øget med 13 % hos en 76-årig patient i forhold til en patient med en gennemsnitsalder på 62 år.
English: An inverse correlation between body weight and exposure to nintedanib was observed.
Danish: Der blev observeret en omvendt korrelation mellem legemsvægt og nintedanib-eksponering.
English: In view of the limited number of patients, this study detected only the most frequent adverse events and showed an increase in gastrointestinal adverse events and a trend toward increased hepatic adverse events.
Danish: I betragtning af det begrænsede antal patienter detekterede dette studie kun de hyppigste bivirkninger, og viste en stigning i mavetarm-bivirkninger og en tendens til flere lever-bivirkninger.
English: Talk to your doctor if you get any side effects.
Danish: Kontakt lægen, hvis du får bivirkninger.
English: Patients should be advised to be cautious when driving or using machines during treatment with Ofev.
Danish: Patienterne skal rådes til at udvise forsigtighed, når de fører motorkøretøj eller betjener maskiner under behandling med Ofev.
English: Responder patients are those with no absolute decline greater than 5% or greater than 10% in FVC % predicted, depending on the threshold and with an FVC evaluation at 52 weeks.
Danish: Responderpatienter er dem, der ikke har noget absolut fald større end 5 % eller større end 10 % i FVC % forventet, afhængigt af tærskelværdien og med FVC-evaluering efter 52 uger.
English: The primary endpoint was the percentage of patients with gastrointestinal adverse events from baseline to week 12.
Danish: Det primære endepunkt var procentdelen af patienter med mave-tarm-bivirkninger fra baseline til uge 12.
English: Elevations of liver enzymes were reversible and not associated with clinically manifest liver disease.
Danish: Leverenzymforhøjelse var reversibel og ikke forbundet med klinisk manifest leversygdom.
English: Before initiating Ofev, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Danish: Inden indledning af behandling med Ofev bør denne risiko overvejes nøje for patienter med risikofaktorer såsom hypertension eller tidligere aneurisme.
English: Accumulation upon multiple administrations was 1.04-fold for Cmax and 1.38-fold for AUCτ.
Danish: Akkumuleringen efter gentagne administrationer var 1,04 gange for Cmax og 1,38 gange for AUCτ.
English: If symptoms persist despite appropriate supportive care (including anti-emetic therapy), dose reduction or treatment interruption may be required.
Danish: Hvis symptomerne varer ved på trods af behørig, støttende behandling (herunder antiemetisk behandling), kan dosisreduktion eller behandlingsafbrydelse være nødvendig.
English: Nintedanib is a small molecule tyrosine kinase inhibitor including the receptors platelet-derived growth factor receptor (PDGFR) α and β, fibroblast growth factor receptor (FGFR) 1-3, and VEGFR 1-3.
Danish: Nintedanib er en lav-molekylær tyrosinkinasehæmmer, herunder påvirkes trombocytderiverede vækstfaktor-receptorer (PDGFR) α og β, fibroblast vækstfaktor-receptorer (FGFR) 1-3 og VEGFR 1-3.
English: Within each frequency grouping adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for de enkelte hyppighedskategorier er bivirkningerne opstillet efter faldende alvorlighed.
English: There was no evidence of liver enzyme increases in rats, dogs, and Cynomolgus monkeys.
Danish: Der var ingen evidens for forhøjede leverenzymer hos rotter, hunde eller cynomolgusaber.
English: Patients with FVC baseline < 50% predicted or carbon monoxide diffusing capacity (DLCO, corrected for haemoglobin) < 30% predicted at baseline were excluded from the trials.
Danish: Patienter med FVC < 50 % af forventet ved baseline eller carbonmonooxid diffusionskapacitet (DLCO, korrigeret for hæmoglobin) < 30 % af forventet ved baseline, blev ekskluderet fra studierne.
English: Based on the high inter-individual variability of exposure observed moderate effects are considered not clinically relevant (see section 4.4).
Danish: På grund af den høje interindividuelle variabilitet i eksponeringen anses disse virkninger ikke for klinisk relevante (se pkt.
English: Based on a PopPK model, an increase in nintedanib exposure of approximately 20 - 25% was observed in patients ≥ 75 years compared with patients under 65 years.
Danish: Baseret på en PopPK-model blev der observeret en stigning i nintedanib-eksponeringen på omkring 20-25 % hos patienter i alderen ≥ 75 år sammenlignet med patienter under 65 år.
English: Patients with known allergy to peanut protein carry an enhanced risk for severe reactions to soya preparations.
Danish: Patienter med kendt allergi over for jordnøddeprotein har en øget risiko for svære reaktioner på sojapræparater.
English: The in vitro protein binding of nintedanib in human plasma was high, with a bound fraction of 97.8%.
Danish: In vitro proteinbindingen af nintedanib i humant plasma var høj, med en bundet fraktion på 97,8 %.
English: Nintedanib is preferentially distributed in plasma with a blood to plasma ratio of 0.869.
Danish: Nintedanib fordeles fortrinsvis i plasma med et blod/plasma-forhold på 0,869.
English: Since the effect of nintedanib on the metabolism and efficacy of hormonal contraceptives has not been investigated, barrier methods should be applied as a second form of contraception, to avoid pregnancy.
Danish: Da nintedanibs virkning på kontraceptivas metabolisme og virkning ikke er undersøgt, skal en barrieremetode anvendes som en ekstra præventionsmetode for at undgå graviditet.
English: Observed adverse reactions were consistent with the known safety profile of nintedanib, i.e. increased liver enzymes and gastrointestinal symptoms.
Danish: De observerede bivirkninger var forenelige med den kendte sikkerhedsprofil for nintedanib, dvs. forhøjede leverenzymer og gastrointestinale symptomer.
English: Weight decreased, Decreased appetite
Danish: Vægttab Nedsat appetit
English: Gastrointestinal perforations
Danish: Gastrointestinal perforation
English: In addition, similar effects were observed on other lung function endpoints e.g. change from baseline in FVC at week 52 and FVC responder analyses providing further substantiation of the effects of nintedanib on slowing disease progression.
Danish: Endvidere blev der observeret lignende effekt på andre endepunkter vedrørende lungefunktionen, f.eks. ændring fra baseline i FVC i uge 52 og FVC-responderanalyser, der yderligere understøttede nintedanibs forsinkende effekt på sygdomsprogression.
English: Diarrhoea and vomiting accompanied by reduced food consumption and loss of body weight were observed in toxicity studies in non-rodents.
Danish: Diarré og opkastning ledsaget af nedsat fødeindtagelse og vægttab blev observeret i toksicitetsstudier hos ikke-gnavere.
English: Selection of an alternate concomitant medicinal product with no or minimal Pgp induction potential should be considered.
Danish: Valg af et andet lægemiddel med intet eller kun svagt P-gp-induktionspotentiale skal overvejes.
English: A study of male fertility and early embryonic development up to implantation in rats did not reveal effects on the male reproductive tract and male fertility.
Danish: Et studie af fertiliteten hos hanner og tidlig embryonal udvikling indtil implantation hos rotter viste ingen virkninger på reproduktionsorganer eller fertilitet hos hanner.
English: In addition nintedanib inhibits Flt-3 (Fms-like tyrosine-protein kinase), Lck (lymphocyte-specific tyrosine-protein kinase), Lyn (tyrosine-protein kinase lyn) and Src (proto-oncogene tyrosine-protein kinase src) kinases.
Danish: Endvidere hæmmer nintedanib Flt-3 (Fms-lignende tyrosinproteinkinase), Lck (lymfocytspecifik tyrosinproteinkinease), Lyn (tyrosinproteinkinase lyn) og Src (proto-onkogen tyrosinproteinkinase src) -kinaser.
English: In this case your doctor will prescribe Ofev 100 mg capsules for your treatment.
Danish: I så fald vil din læge ordinere Ofev 100 mg bløde kapsler til din behandling.
English: Mild liver enzyme increases, which were not due to serious adverse effects such as diarrhoea were only observed in Rhesus monkeys.
Danish: Let forhøjede leverenzymer, der ikke skyldtes alvorlige bivirkninger som f.eks. diarré, blev kun observeret hos rhesusaber.
English: More than two thirds of patients experiencing diarrhoea reported its first onset already during the first three months of treatment.
Danish: Hos mere end totredjedel af de patienter, der fik diarré, var første forekomst allerede i de første tre måneder af behandlingen.
English: Nintedanib was shown to be not a substrate or inhibitor of OATP-1B1, OATP-1B3, OATP-2B1, OCT-2, or MRP-2 in vitro.
Danish: Det er vist, at nintedanib hverken er et substrat for eller en hæmmer af OATP-1B1, OATP1B3, OATP-2B1, OCT-2 eller MRP-2 in vitro.
English: The capsules should be taken with food, swallowed whole with water, and should not be chewed or crushed.
Danish: Kapslerne skal synkes hele sammen med vand og må ikke tygges eller knuses.
English: The key secondary endpoints were change from baseline in Saint George's Respiratory Questionnaire (SGRQ) total score at 52 weeks and time to first acute IPF exacerbation.
Danish: De væsentligste sekundære endepunkter var ændring fra baseline i den samlede score i Saint Georges spørgeskema (Saint George's Respiratory Questionnaire, SGRQ) ved 52 uger og tid til første akutte IPF-eksacerbation.
English: Odds ratio
Danish: Hazard ratio
English: Estimated based on a random coefficient regression model.
Danish: Estimat baseret på en tilfældig koefficientregressionsmodel.
English: Caution should be used when treating patients at higher cardiovascular risk including known coronary artery disease.
Danish: Der skal udvises forsigtighed ved behandling af patienter med øget kardiovaskulær risiko, herunder kendt koronararteriesygdom.
English: Nintedanib binds competitively to the adenosine triphosphate (ATP) binding pocket of these receptors and blocks the intracellular signalling.
Danish: Nintedanib binder kompetitivt til disse receptorers ATP-bindende lommer og blokerer den intracellulære signalvej.
English: p-value
Danish: p-værdi
English: In preclinical disease models of lung fibrosis nintedanib exerts potent anti-fibrotic and anti-inflammatory activity.
Danish: I prækliniske sygdomsmodeller af lungefibrose udviser nintedanib potent antifibrotisk og antiinflammatorisk aktivitet.
English: Adjustment of the starting dose in patients with mild to moderate renal impairment is not required.
Danish: Det er ikke nødvendigt at justere startdosis til patienter med let til moderat nedsat nyrefunktion.
English: The pharmacokinetics (PK) of nintedanib can be considered linear with respect to time (i.e. singledose data can be extrapolated to multiple-dose data).
Danish: Nintedanibs farmakokinetik kan anses for at være lineær med hensyn til tid (dvs. data for en enkeltdosis kan ekstrapoleres til data for gentagne doser).
English: For the interaction potential of nintedanib with this transporter, see section 4.5.
Danish: For nintedanibs potentiale for interaktion med denne transportør, se pkt.
English: The same applies for nintedanib being a substrate of OCT-1.
Danish: Det samme gælder for nintedanibs rolle som substrat for OCT-1.
English: Number at risk Patients with events, N (%) Comparison vs placebo p-value Hazard ratio 95% CI
Danish: Antal i risiko Patienter med hændelser, N (%) Sammenlignet med placebo p-værdi Hazard ratio 95 % CI
English: The European Medicines Agency has waived the obligation to submit the results of studies with Ofev in all subsets of the paediatric population in IPF (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Ofev i alle undergrupper af den pædiatriske population ved IPF (se pkt.
English: The likelihood of drug-drug interactions with nintedanib based on CYP metabolism is therefore considered to be low.
Danish: Sandsynligheden for lægemiddel-lægemiddel interaktioner med nintedanib på grundlag af CYP-metabolisme anses derfor for at være lav.
English: Serious bleeding events occurred with low and similar frequencies in the 2 treatment groups (placebo: 1.4%; Ofev: 1.3%).
Danish: Alvorlige blødningshændelser forekom med lav og samme hyppighed i de 2 behandlingsgrupper (placebo: 1,4 %; Ofev: 1,3 %).
English: The population mean exposure to nintedanib was 33 - 50% higher in Chinese, Taiwanese, and Indian patients and 16% higher in Japanese patients while it was 16 - 22% lower in Koreans compared to Caucasians (body weight corrected).
Danish: Den gennemsnitlige eksponering for nintedanib var 33-50 % højere hos kinesiske, taiwanesiske og indiske patienter, og 16 % højere hos japanske patienter, mens den var 16-22 % lavere hos koreanere, sammenlignet med kaukasiere (korrigeret for legemsvægt).
English: The absolute bioavailability of a 100 mg dose was 4.69% (90% CI: 3.615 - 6.078) in healthy volunteers.
Danish: Den absolutte biotilgængelighed af en dosis på 100 mg var 4,69 % (90 % CI: 3,615-6,078) hos raske frivillige.
English: Nintedanib is predominantly eliminated via biliary/faecal excretion (> 90%).
Danish: Nintedanib elimineres primært ved udskillelse via galde/fæces (> 90 %).
English: Co-administration with other medicinal products The potential for interactions of nintedanib with hormonal contraceptives was not explored.
Danish: Administration sammen med andre lægemidler Potentialet for interaktioner mellem nintedanib og hormonale kontraceptiva er ikke undersøgt.
English: Overall, the effect of nintedanib on health-related quality of life as measured by the SGRQ total score is modest, indicating less worsening compared to placebo.
Danish: Generelt er virkningen af nintedanib på livskvalitet, målt ved den samlede SGRQ-score, beskeden og indikerer mindre forværring sammenlignet med placebo.
English: After intravenous infusion, a high volume of distribution (Vss: 1,050 L, 45.0% gCV) was observed.
Danish: Efter intravenøs infusion blev der observeret et højt fordelingsvolumen (Vss: 1.050 l; 45,0 % gCV).