FrancophonIA/ELRC3.0 huggingface dataset:
English: There were no imbalances of respiratory or fatal bleedings and no intracerebral bleeding was reported.
Danish: Der var ingen ubalancer med hensyn til respiratoriske eller fatale blødninger, og der blev ikke indberettet nogen tilfælde af intracerebral blødning.
English: The following terms are used to rank the ADRs by 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), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Følgende betegnelser anvendes til at rangordne bivirkningerne efter 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), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Your doctor will discuss the results of these tests with you and decide whether you can be given Vargatef.
Danish: Din læge taler med dig om resultaterne af disse undersøgelser og afgør, om du kan få Vargatef.
English: If you are allergic to peanut or soya, do not use this medicine.
Danish: Hvis du er allergisk over for jordnødder eller soja, må du ikke bruge dette lægemiddel.
English: High blood pressure (hypertension)
Danish: Højt blodtryk (hypertension)
English: Approximately one third of these patients had liver-related adverse reactions of ≥ grade 3 severity.
Danish: Cirka en tredjedel af disse patienter havde lever-relaterede bivirkninger af en sværhedsgrad ≥ grad 3.
English: Cases of pulmonary embolism have been reported.
Danish: Der er rapporteret tilfælde af lungeemboli.
English: Table 3 provides a summary of the adverse reactions by System Organ Class (SOC).
Danish: I Tabel 3 er der et sammendrag af bivirkningerne i henhold til systemorganklasse (SOC).
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og, alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: twice daily for 15 days did not prolong the QTcF interval.
Danish: to gange daglig i 15 dage forlængede QTcF-intervallet.
English: Co-administration with other medicinal products
Danish: Administration sammen med andre lægemidler
English: Patients with low body weight (< 65 kg), Asian and female patients have a higher risk of elevations in liver enzymes.
Danish: Patienter med lav legemsvægt (< 65 kg), asiatiske og kvindelige patienter har en større risiko for forhøjelser af leverenzymer.
English: Inform your doctor immediately while taking this medicine - if you get diarrhoea.
Danish: Kontakt omgående din læge, mens du tager dette lægemiddel - hvis du får diarré.
English: In the event of dehydration, administration of electrolytes and fluids is required.
Danish: I tilfælde af dehydrering er administration af elektrolytter og væske nødvendig.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 November 2014
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 21. november 2014 Dato for seneste fornyelse: 26. august 2019
English: Effect on QT interval
Danish: Virkning på QT-interval
English: Take your next dose of Vargatef as planned at the next scheduled time and at the dose recommended by your doctor or pharmacist.
Danish: Tag din næste dosis Vargatef efter planen på det næste fastlagte tidspunkt og i den dosis, som lægen eller apotekspersonalet har anbefalet.
English: Other efficacy outcomes included objective response, disease control, change in tumour size and health-related quality of life.
Danish: Andre effektresultater omfattede objektivt respons, sygdomskontrol, ændring i tumorstørrelse og helbredsrelateret livskvalitet.
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: The two doses should be taken at around the same time each day.
Danish: De to doser skal tages på nogenlunde samme tidspunkt hver dag.
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 gamle.
English: In patients with increased liver parameters, the use of the established stepwise dose reduction scheme was the appropriate measure and discontinuation of treatment was only necessary in 2.2 % of patients.
Danish: Hos patienter med forhøjede levertal var anvendelse af det fastlagte skema for trinvis dosisreduktion en passende foranstaltning, og seponering af behandlingen var kun nødvendig hos 2,2 % af patienterne.
English: As nintedanib may cause foetal harm also in humans, it should not be used during pregnancy unless the clinical condition requires treatment.
Danish: Da nintedanib måske også kan forårsage fosterskader hos mennesker, bør det ikke anvendes under graviditet, medmindre den kliniske tilstand kræver behandling.
English: However, the sample size was small, there was no significant interaction and the CI was wide and included the HR for OS of the overall adenocarcinoma population.
Danish: Men stikprøvestørrelsen var lille, der var ingen signifikant interaktion, og CI var bredt og omfattede HR for OS i den samlede adenokarcinom population.
English: Cytochrome (CYP)-enzymes
Danish: Cytokrom (CYP)-enzymer
English: Patient characteristics were balanced between treatment arms within the overall population and within subgroups according to histology.
Danish: Patientkarakteristika blev balanceret mellem behandlingsgrupperne inden for den samlede population og inden for undergrupperne i henhold til histologi.
English: In line with these observations, related trial endpoints such as disease control and change in tumour size showed significant improvements.
Danish: I tråd med disse observationer viste relaterede forsøgsendepunkter, som f.eks. sygdomskontrol og ændring i tumorstørrelse, signifikante forbedringer.
English: You need to pay special attention if you get the following side effects during treatment with Vargatef:
Danish: Du skal være særlig opmærksom, hvis du får følgende bivirkninger under behandlingen med Vargatef:
English: Neutropenia (includes febrile neutropenia)
Danish: Neutropeni (herunder febril neutropeni)
English: Median OS improved by 3 months (nintedanib: 10.9 months; placebo: 7.9 months).
Danish: Median OS blev forbedret med 3 måneder (nintedanib: 10,9 måneder; placebo: 7,9 måneder).
English: Absorption and bioavailability are decreased by transporter effects and substantial first-pass metabolism.
Danish: Absorption og biotilgængelighed nedsættes af transportør-virkninger og en betydelig førstepassagemetabolisme.
English: The disease stage was determined at the time of diagnosis using Union Internationale Contre le Cancer (UICC) / American Joint Committee on Cancer (AJCC) Edition 6 or Edition 7.
Danish: Sygdomsstadiet blev fastlagt på diagnosetidspunktet ved hjælp af 6. eller 7. udgave af Union Internationale Contre le Cancer (UICC)/American Joint Committee on Cancer (AJCC).
English: Start appropriate anti-diarrhoeal treatment, e.g. with loperamide, as soon as possible after having contacted your doctor.
Danish: Begynd på en egnet behandling mod diarré, f.eks. loperamid, så hurtigt som muligt efter at du har talt med lægen.
English: Do not stop taking Vargatef without consulting your doctor first.
Danish: Du må ikke holde op med at tage Vargatef uden at tale med lægen først.
English: Nevertheless, the overall treatment benefit of nintedanib was observed without adversely affecting self-reported quality of life.
Danish: Den overordnede behandlingsgevinst med nintedanib blev ikke desto mindre observeret uden negativ påvirkning af den selvrapporterede livskvalitet.
English: During treatment with Vargatef your doctor will regularly monitor your blood cells and examine you for signs of infection, such as inflammation, fever or tiredness.
Danish: Under behandlingen med Vargatef vil din læge regelmæssigt kontrollere dine blodceller og undersøge dig for tegn på infektion, som f.eks. betændelse, feber eller træthed.
English: Sepsis and febrile neutropenia have been reported as subsequent complications of neutropenia.
Danish: Sepsis og febril neutropeni er blevet indberettet som efterfølgende komplikationer til neutropeni.
English: Based on the high inter-individual variability of exposure these effects are not considered clinically relevant.
Danish: På grund af den høje interindividuelle variabilitet i eksponeringen anses disse virkninger ikke for klinisk relevante.
English: Mucositis (including stomatitis), Rash, Alopecia
Danish: Mucositis (herunder stomatitis), Udslæt, Alopeci
English: Cases of gastrointestinal perforations, some of which were fatal, have been reported in the post-marketing period.
Danish: Der er rapporteret om tilfælde med gastrointestinale perforationer, hvoraf nogle havde dødelig udgang, i perioden efter markedsføring.
English: In case your doctor has stopped your chemotherapy with docetaxel you should continue to take Vargatef twice daily.
Danish: Hvis din læge har stoppet din kemoterapi med docetaxel, skal du fortsætte med at tage Vargatef to gange daglig.
English: As a consequence of neutropenia, fever (febrile neutropenia) and blood poisoning (sepsis) may occur.
Danish: Som følge af neutropeni kan der opstå feber (febril neutropeni) og blodforgiftning (sepsis).
English: Subsequent complications such as sepsis or febrile neutropenia have been observed.
Danish: Efterfølgende komplikationer som f.eks. sepsis eller febril neutropeni er observeret.
English: The individual daily doses of nintedanib should not be increased beyond the recommended dose to make up for missed doses.
Danish: De individuelle daglige doser af nintedanib må ikke øges til over den anbefalede dosis for at råde bod på glemte doser.
English: However, the frequency of patients with gastrointestinal perforation was low.
Danish: Hyppigheden af patienter med gastrointestinal perforation var dog lav.
English: Soya lecithin (E322)
Danish: Sojalecithin (E322)
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: If a dose of nintedanib is missed, administration should resume at the next scheduled time at the recommended dose.
Danish: Hvis en dosis nintedanib springes over, skal administrationen genoptages på det næste planlagte tidspunkt og i den anbefalede dosis.
English: AUCτ,ss increased by 25 % for a 50 kg patient (5
Danish: AUCτ,ss steg med 25 % hos en patient på 50 kg (5 %
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 baseret på CYP-metabolisme anses derfor for at være lav.
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 et svagt hæmningspotentiale over for OCT-1, BCRP og P-gp in vitro, hvilket anses for at have en lille klinisk relevans.
English: Therapeutic anticoagulation
Danish: Terapeutisk antikoagulation
English: Nintedanib trough concentrations remained stable for more than one year.
Danish: Dalværdier for koncentrationen af nintedanib forblev stabile i mere end et år.
English: In the majority of patients, elevations of liver parameters were reversible.
Danish: Hos de fleste patienter var de forhøjede levertal reversible.
English: Treatment with Vargatef should be initiated and supervised by a physician experienced in the use of anticancer therapies.
Danish: Behandling med Vargatef skal initieres og superviseres af en læge med erfaring i anvendelse af kræftbehandlinger.
English: It is recommended to take the capsule with food, i.e. during or immediately before or after a meal.
Danish: Det anbefales at tage kapslen sammen med mad, dvs. under eller umiddelbart før eller efter et måltid.
English: Within each frequency grouping adverse reactions are presented in order of decreased seriousness.
Danish: Inden for de enkelte hyppighedskategorier er bivirkningerne opstillet efter faldende alvorlighed.
English: Therefore treatment with Vargatef will usually be interrupted if you are having surgery.
Danish: Din behandling med Vargatef bliver derfor som regel afbrudt, hvis du skal opereres.
English: Of note, pre-planned analyses according to histology showed statistically significant difference in OS between treatment arms in the adenocarcinoma population only (Table 4).
Danish: Det skal bemærkes, at de på forhånd planlagte analyser i henhold til histologi kun påviste en statistisk signifikant forskel i OS mellem behandlingsgrupperne i adenokarcinom-populationen (Tabel 4).
English: In preclinical in vivo experiments, BIBF 1202 did not show efficacy despite its activity at target receptors of the substance.
Danish: I prækliniske eksperimenter in vivo udviste BIBF 1202 ingen virkning på trods af dets aktivitet ved stoffets målreceptorer.
English: Dose adjustments in 100 mg steps per day (i.e. a 50 mg reduction per dosing) based on individual safety and tolerability are recommended as described in Table 1 and Table 2.
Danish: Det anbefales at justere dosis med 100 mg per dag (dvs. en reduktion på 50 mg per dosering), på grundlag af sikkerheden og tolerabiliteten hos den enkelte patient, som beskrevet i Tabel 1 og Tabel 2.
English: No correlation of the DCE-MRI response and subsequent clinically significant reduction in target lesion size was found, but DCE-MRI response was associated with disease stabilization.
Danish: Der blev ikke fundet nogen korrelation mellem DCE-MRI-respons og efterfølgende kliniske betydende reduktion af mållæsionsstørrelse, men DCE-MRI-respons var forbundet med sygdomsstabilisering.
English: It is recommended to take the capsules with food, i.e. during or immediately before or after a meal.
Danish: Det anbefales at tage kapslerne sammen med mad, dvs. under eller umiddelbart før eller efter et måltid.
English: Diarrhoea (very common, may affect more than 1 in 10 people) Diarrhoea may lead to a loss of fluid and important salts (electrolytes, such as sodium or potassium) in your body.
Danish: Diarré (meget almindelig, kan forekomme hos flere end 1 ud af 10 personer) Diarré kan medføre tab af væske og vigtige salte (elektrolytter, som f.eks. natrium eller kalium) i din krop.
English: Progression free survival (PFS)* - primary analysis Patients, n
Danish: Progressionsfri overlevelse (PFS)* - primær analyse Patienter, n
English: The primary endpoint was progression-free survival (PFS) as assessed by an independent review committee (IRC) based on the intent-to-treat (ITT) population and tested by histology.
Danish: Det primære endepunkt var progressionsfri overlevelse (PFS) bedømt af en uafhængig bedømmelseskomité (IRC) og baseret på intent-to-treat (ITT)-populationen og i forhold til histologisk diagnose.
English: The highest single dose of nintedanib administered in phase I studies was 450 mg once daily.
Danish: Den højeste enkeltdosis nintedanib, der blev givet i fase I-studier, var 450 mg én gang daglig.
English: The majority of fatal bleeding events were tumour-associated.
Danish: De fleste af de fatale blødningshændelser var tumorrelaterede.
English: `Locally recurrent´ was defined as local re-occurrence of the tumour without metastases at trial entry.
Danish: “Lokalt recidiverende” blev defineret som lokalt recidiv af tumor uden metastaser ved indgang i forsøget.
English: Transaminase, ALKP and bilirubin levels should be investigated before initiation of the combination treatment with Vargatef plus docetaxel.
Danish: Transaminase-, ALKP- og bilirubin-niveauer bør undersøges før initiering af kombinationsbehandling med Vargatef plus docetaxel.
English: Taking the medicine this way ensures that a steady amount of nintedanib is maintained in the body.
Danish: Når lægemidlet tages på den måde, så er man sikker på, at der hele tiden er en konstant mængde nintedanib i kroppen.
English: An inverse correlation between body weight and exposure to nintedanib was observed.
Danish: Der blev observeret en omvendt korrelation mellem legemsvægt og eksponering for nintedanib.
English: There is no information on the use of Vargatef in pregnant women, but preclinical studies in animals have shown reproductive toxicity of this active substance (see section 5.3).
Danish: Der er ingen information om anvendelse af Vargatef til gravide kvinder, men prækliniske dyrestudier har påvist reproduktionstoksicitet af dette aktive stof (se pkt.
English: The safety and efficacy of Vargatef in children aged 0-18 years have not been established.
Danish: Pædiatrisk population Vargatefs sikkerhed og virkning hos børn i alderen 0-18 år er ikke klarlagt.
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: Since the effect of nintedanib on the metabolism and efficacy of 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 der anvendes barrieremetoder som en ekstra præventionsmetode for at undgå graviditet.
English: The applicant will implement collection of material for biomarker investigation and analyses of biomarker data into the study protocol of all new oncology studies planned for nintedanib in the future, wherever clinically appropriate.
Danish: Ansøgeren vil implementere indsamlingen af materiale med henblik på undersøgelse af biomarkørdata i studieprotokollen for alle nye onkologiske studier, der er planlagt for Vargatef i fremtiden, når det er klinisk relevant.
English: Co-administration of nintedanib with docetaxel (75 mg/m²) did not alter the pharmacokinetics of either medicinal product to a relevant extent.
Danish: Samtidig administration af nintedanib og docetaxel (75 mg/m²) ændrede ingen af lægemidlernes farmakokinetik i relevant omfang.
English: It is not known if the medicine passes into breast milk and could cause harm to a breast-fed child.
Danish: Det vides ikke, om dette lægemiddel udskilles i modermælk og kan skade det ammede barn.
English: In order to investigate suitable bio-/tumour markers (including VEGF) to allow identification and selection of a more targeted population of patients most likely to benefit from the treatment of nintedanib, the Applicant will conduct and submit results from a Biomarkers research programme including: 1.
Danish: For at undersøge relevante biomarkører/tumormarkører (herunder VEGF), så det bliver muligt at identificere og udvælge en mere målrettet patientpopulation, der med stor sandsynlighed vil profitere af behandling med Vargatef, vil ansøgeren gennemføre og indsende resultaterne af et biomarkør-forskningsprogram, der omfatter:
English: Gastrointestinal perforations
Danish: Gastrointestinale perforationer
English: Treatment interruption should be considered in patients who develop signs or symptoms of acute myocardial ischaemia.
Danish: Afbrydelse af behandlingen skal overvejes hos patienter, der udvikler tegn eller symptomer på akut myokardieiskæmi.
English: This medicine is used in combination with another cancer medicine (docetaxel) to treat a cancer of the lung called non-small cell lung cancer (NSCLC).
Danish: Dette lægemiddel bruges i kombination med en anden kræftmedicin (docetaxel) til behandling af en type kræft i lungerne, der kaldes ikke-småcellet lungekræft (NSCLC).
English: Aluminium/aluminium blisters containing 10 capsules each.
Danish: Aluminium/aluminiumsblistere, der indeholder 10 kapsler hver.
English: Diarrhoea ≥ grade 2 for more than 7 consecutive days despite anti-diarrhoeal treatment OR
Danish: Diarré ≥ grad 2 i flere end 7 dage i træk trods behandling mod diarré ELLER
English: Treatment with nintedanib did not significantly change the time to deterioration of the pre-specified symptoms cough, dyspnoea and pain, but resulted in a significant deterioration in the diarrhoea symptom scale.
Danish: Behandling med nintedanib medførte ikke en signifikant ændring i tiden til forværring af de forud specificerede symptomer hoste, dyspnø og smerter, men medførte en signifikant forværring i symptomskalaen for diarré.
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: 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: 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 populationsmæssige gennemsnitlige eksponering for nintedanib var 33-50 % større hos kinesiske, taiwanesiske og indiske patienter, og 16 % større hos japanske patienter, mens den var 16-22 % lavere hos koreanere, sammenlignet med kaukasiere (korrigeret for legemsvægt).
English: Patients with recent pulmonary bleeding (> 2.5 ml of red blood) as well as patients with centrally located tumours with radiographic evidence of local invasion of major blood vessels or radiographic evidence of cavitary or necrotic tumours have been excluded from clinical trials.
Danish: Patienter med nylig pulmonal blødning (> 2,5 ml rødt blod) samt patienter med centralt lokaliserede tumorer med radiologisk evidens for lokal invasion af større blodkar eller radiologisk evidens for kavernøse eller nekrotiske tumorer blev ekskluderet fra de kliniske studier.
English: Data on bio-/tumour markers from all clinical studies in the clinical program for nintedanib.
Danish: Data vedrørende bio- / tumormarkører fra samtlige kliniske studier i det kliniske program for Vargatef.
English: For posology, methods of administration, and dose modifications of docetaxel, please refer to the corresponding product information for docetaxel.
Danish: For dosering, administration og dosisjustering af docetaxel henvises til den tilsvarende produktinformation for docetaxel.
English: Patients should be advised to be cautious when driving or using machines during treatment with Vargatef.
Danish: Patienterne skal rådes til at udvise forsigtighed, når de fører motorkøretøj eller betjener maskiner under behandling med Vargatef.
English: There is no specific antidote or treatment for nintedanib overdose.
Danish: Der findes ingen specifik antidot eller behandling efter overdosering med nintedanib.
English: After intravenous infusion, a high volume of distribution (Vss: 1050 L, 45.0 % gCV) was observed.
Danish: Efter intravenøs infusion blev der observeret et højt fordelingsvolumen (Vss: 1050 l; 45,0 % gCV).
English: In addition Fms-like tyrosine-protein kinase (Flt)-3, lymphocyte-specific tyrosine-protein kinase (Lck) and proto-oncogene tyrosine-protein kinase Src (Src) are inhibited.
Danish: Desuden hæmmes Fms-lignende tyrosin-proteinkinase (Flt)-3, lymfocytspecifik tyrosin-proteinkinase (Lck) og proto-onkogen tyrosin-proteinkinase Src (Src).