FrancophonIA/ELRC3.0 huggingface dataset:
English: Peripheral neuropathy was reported in 16.5 % of patients in the placebo arm and in 19.1 % of patients in the nintedanib arm.
Danish: Perifer neuropati blev indberettet hos 16,5 % af patienterne i placebogruppen og hos 19,1 % af patienterne i nintedanibgruppen.
English: This population included those adenocarcinoma patients identified at baseline as having progressed and entered the trial less than 9 months since start of their first-line therapy.
Danish: Denne population omfattede de adenokarcinom patienter, der ved baseline var blevet identificeret som havende udvist progression, og som var indgået i forsøget mindre end 9 måneder efter initiering af deres førstelinjebehandling.
English: Particular caution should be exercised when treating patients with previous abdominal surgery or a recent history of a hollow organ perforation.
Danish: Der skal udvises særlig forsigtighed ved behandling af patienter med tidligere abdominalkirurgi eller nylig perforation af et hulorgan i anamnesen.
English: Patients with a recent history of myocardial infarction or stroke were excluded from this trial.
Danish: Patienter med nyligt myokardieinfarkt eller slagtilfælde i anamnesen blev ekskluderet fra dette forsøg.
English: Before initiating Vargatef, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Danish: Inden indledning af behandling med Vargatef bør denne risiko overvejes nøje for patienter med risikofaktorer såsom hypertension eller tidligere aneurisme.
English: VEGFR inhibition might be associated with an increased risk of bleeding.
Danish: VEGFR-hæmning kan være forbundet med en øget risiko for blødning.
English: Hyperbilirubinaemia, Gammaglutamyltransferase (GGT) increased
Danish: Hyperbilirubinæmi, forhøjet gammaglutamyltransferase (GGT)
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 modermælk hos mennesker.
English: A pre-specified evaluation was performed in the population of adenocarcinoma patients considered to have entered the trial with a particularly poor treatment prognosis, namely, patients who progressed during or shortly after first-line therapy prior to trial entry.
Danish: Der blev foretaget en forudspecificeret evaluering i den population af adenokarcinom patienter, der ansås for at være indgået i forsøget med en særlig dårlig behandlingsprognose, nemlig de patienter, der havde udvist progression under eller kort efter førstelinjebehandling før indgang i forsøget.
English: The pharmacokinetics of nintedanib can be considered linear with respect to time (i.e. single-dose data can be extrapolated to multiple-dose data).
Danish: Nintedanibs farmakokinetik kan anses for at være lineær mht. tid (dvs. data for en enkeltdosis kan ekstrapoleres til data for gentagne doser).
English: AUCτ,ss decreased by 16 % for a 45-year old patient (5
Danish: AUCτ,ss faldt med 16 % hos en 45-årig patient
English: Elevation of liver enzymes (ALT, AST, ALKP, gammaglutamyltransferase (GGT)) and bilirubin were reversible upon dose reduction or interruption in the majority of cases.
Danish: Forhøjelse af leverenzymer (ALAT, ASAT, ALKP, gammaglutamyltransferase (GGT)) og bilirubin var i de fleste tilfælde reversible ved dosisreduktion eller dosisafbrydelse.
English: This result was confirmed in the follow-up PFS analysis (HR 0.85, 95 % CI: 0.75 - 0.96; p = 0.0070) which included all events collected at the time of the final OS analysis.
Danish: Dette resultat blev bekræftet i den opfølgende PFS-analyse (HR 0,85; 95 % CI: 0,75-0,96; p = 0,0070), der omfattede alle registrerede hændelser på tidspunktet for den endelige OS-analyse.
English: There are no human or animal data on potential effects of nintedanib on female fertility available.
Danish: Der foreligger ingen data fra mennesker eller dyr om nintedanibs mulige virkninger på den kvindelige fertilitet.
English: Collected blood samples from the LUME-Lung 1 and LUME-Lung 2 studies will be assessed for germline genetic variability in angiogenic factors, including VEGF or its downstream receptors.
Danish: De indsamlede blodprøver fra LUME-Lung 1- og LUME-Lung 2 studierne bliver analyseret for genetisk variation i kimcellelinjen med hensyn til angiogene faktorer, herunder VEGF eller dennes downstream receptorer.
English: Nintedanib is predominantly eliminated via biliary/faecal excretion (> 90 %).
Danish: Nintedanib elimineres primært ved udskillelse via galden/fæces (> 90 %).
English: It was not clearly dose dependent, but most responses were seen at doses of ≥ 200 mg. Logistic regression revealed a statistically significant association of the anti-angiogenic effect to nintedanib exposure.
Danish: Den var ikke klart dosisafhængig, men respons blev for det meste set ved doser ≥ 200 mg. Logistisk regression påviste en statistisk signifikant sammenhæng mellem antiangiogen virkning og eksponering for nintedanib.
English: Logistic regression revealed a statistically significant association between nintedanib exposure and DCE-MRI response.
Danish: Logistisk regression viste en statistisk signifikant sammenhæng mellem eksponering for nintedanib og DCE-MRI-respons.
English: The contribution of renal excretion to the total clearance was low (0.649 % of dose, 26.3 % gCV).
Danish: Den renale udskillelses bidrag til den totale clearance var lavt (0,649 % af dosis; 26,3 % gCV).
English: Patients should be monitored during nintedanib therapy, with particular attention to those patients exhibiting risk factors for renal impairment/failure.
Danish: Patienter bør overvåges under behandlingen med nintedanib, med særlig opmærksomhed på patienter med risikofaktorer for nedsat nyrefunktion/-svigt.
English: Termination of the treatment with Vargatef should be considered.
Danish: Ophør af behandlingen med Vargatef bør overvejes.
English: No increased frequency of cerebral bleeding in patients with adequately pre-treated brain metastases which were stable for ≥ 4 weeks before start of treatment with Vargatef was observed.
Danish: Der blev ikke observeret en øget hyppighed af cerebral blødning hos patienter med tilstrækkeligt forbehandlede hjernemetastaser, som var stabile i ≥ 4 uger før initiering af behandling med Vargatef.
English: Treatment with Vargatef should therefore only be initiated or - in case of perioperative interruption - resumed based on clinical judgement of adequate wound healing.
Danish: Behandling med Vargatef bør derfor kun initieres eller - i tilfælde af perioperativ afbrydelse - genoptages på grundlag af en klinisk vurdering af om sårhelingen er tilfredsstillende.
English: Dose reduction
Danish: Nedsættelse af dosis
English: Efficacy in the pivotal phase 3 trial LUME-Lung 1
Danish: Virkning i fase 3-hovedstudiet LUME-Lung 1
English: The rates of sepsis (1.3 %) and febrile neutropenia (7.5 %) were increased under treatment with nintedanib as compared to the placebo arm.
Danish: Hyppigheden af sepsis (1,3 %) og febril neutropeni (7,5 %) var større under behandling med nintedanib sammenlignet med placebogruppen.
English: The majority of adverse reactions appeared in close temporal relationship with the administration of docetaxel.
Danish: De fleste af bivirkningerne forekom i en tæt tidsmæssig sammenhæng med administration af docetaxel.
English: Swallow the capsules whole with water and do not chew or crush them.
Danish: Kapslerne skal synkes hele sammen med vand og må ikke tygges eller knuses.
English: Diarrhoea occurred in 43.4 % (≥ grade 3: 6.3 %) of adenocarcinoma patients in the nintedanib arm.
Danish: Diarré forekom hos 43,4 % (≥ grad 3: 6,3 %) af adenokarcinom patienterne i nintedanib gruppen.
English: Patients should be closely monitored for thromboembolic events.
Danish: Patienterne skal kontrolleres tæt for tromboemboliske hændelser.
English: Population pharmocokinetic analysis in special populations The pharmacokinetic properties of nintedanib were similar in healthy volunteers, cancer patients, and patients of the target population.
Danish: Farmakokinetisk populationsanalyse i særlige populationer Nintedanibs farmakokinetiske egenskaber var de samme hos raske frivillige, kræftpatienter og patienter fra målgruppen.
English: However, close monitoring is recommended in patients with several of these risk factors (see section 4.4).
Danish: Tæt kontrol af patienter med flere af disse risikofaktorer anbefales dog (se pkt.
English: Use caution when treating patients with a higher cardiovascular risk including known coronary artery disease.
Danish: Udvis forsigtighed ved behandling af patienter med en øget kardiovaskulær risiko, herunder kendt koronararteriesygdom.
English: Not known (cannot be estimated from the available data) Inflammation of the large bowel
Danish: Ikke kendt (hyppigheden kan ikke beregnes ud fra tilgængelige data) Betændelse i tyktarmen
English: Stratified Log-Rank Test p-value** Progression free survival (PFS)*** - follow-up analysis Patients, n
Danish: Stratificeret log-rank-test, p-værdi** Progressionsfri overlevelse (PFS)*** - opfølgende analyse Patienter, n
English: Do not use this medicine after the expiry date which is stated on the carton and blisters.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på kartonen og blisterne.
English: The recommended dose of nintedanib is 200 mg twice daily administered approximately 12 hours apart, on days 2 to 21 of a standard 21 day docetaxel treatment cycle.
Danish: Den anbefalede dosis nintedanib er 200 mg to gange daglig givet med ca. 12 timers mellemrum på dag 2 til 21 i en standard 21-dages behandlingscyklus med docetaxel.
English: Fertility The effect of this medicine on human fertility has not been investigated.
Danish: Frugtbarhed Dette lægemiddels virkning på frugtbarheden hos mennesker er ikke undersøgt.
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: Nintedanib har vist sig hverken at være et substrat for, eller en hæmmer af, OATP-1B1, OATP-1B3, OATP-2B1, OCT-2 eller MRP-2 in vitro.
English: Observed adverse events were consistent with the known safety profile of nintedanib, i.e. increased liver enzymes and gastrointestinal symptoms.
Danish: De observerede hændelser var forenelige med den kendte sikkerhedsprofil for nintedanib, dvs. forhøjede leverenzymer og gastrointestinale symptomer.
English: Nintedanib blocks the activity of a group of proteins which are involved in the development of new blood vessels that cancer cells need to supply them with food and oxygen.
Danish: Nintedanib blokerer aktiviteten af en gruppe proteiner, der har betydning for udviklingen af nye blodkar, som kræftcellerne skal bruge til at få næring og ilt.
English: In case of further persistence of the adverse reaction(s), i.e. if a patient does not tolerate 100 mg twice daily, treatment with Vargatef should be permanently discontinued.
Danish: Hvis en eller flere bivirkninger varer ved, dvs. hvis patienten ikke tåler 100 mg to gange daglig, skal behandlingen med Vargatef seponeres permanent.
English: Patients with active brain metastasis were excluded from clinical trials and are not recommended for treatment with Vargatef.
Danish: Patienter med aktive hjernemetastaser blev ekskluderet fra de kliniske studier, og behandling med Vargatef anbefales ikke.
English: Overall survival analysis in the overall population did not reach statistical significance (HR 0.94; 95 % CI: 0.83 - 1.05).
Danish: Analysen af samlet overlevelse i den samlede population påviste ikke statistisk signifikans (HR 0,94; 95 % CI: 0,83-1,05).
English: In patients on chronic low dose therapy with low molecular weight heparins or acetylsalicylic acid, no increased frequency of bleeding was observed.
Danish: Hos patienter i kronisk lavdosisbehandling med lavmolekylære hepariner eller acetylsalicylsyre blev der ikke observeret øget blødningshyppighed.
English: Vargatef must not be taken on the same day of docetaxel chemotherapy administration (= day 1).
Danish: Vargatef må ikke tages samme dag, som der bliver givet kemoterapimidlet docetaxel (= dag 1).
English: The HR for these patients for PFS and OS was 1.24 (95 % CI: 0.68, 2.28) and 1.09 (95 % CI: 0.70, 1.70), respectively.
Danish: Disse patienters HR for PFS og OS var henholdsvis 1,24 (95 % CI: 0,68; 2,28) og 1,09 (95 % CI: 0,70; 1,70).
English: Do not take Vargatef on the same day as your chemotherapy treatment with docetaxel.
Danish: Du må ikke tage Vargatef samme dag, som du får din kemoterapi med docetaxel.
English: Pregnancy testing should be conducted at least prior to treatment with Vargatef.
Danish: Der bør som minimum foretages en graviditetstest før behandling med Vargatef.
English: Alternative causes of the liver enzyme elevations should be investigated and respective action should be taken as necessary.
Danish: Andre årsager til de forhøjede leverenzymer skal undersøges, og der skal træffes relevante foranstaltninger efter behov.
English: Dose proportionality was shown by increase of nintedanib exposure (dose range 50 - 450 mg once daily and 150 - 300 mg twice daily).
Danish: Dosisproportionalitet blev påvist ved forøgelse af eksponeringen for nintedanib (dosisområde 50-450 mg én gang daglig og 150-300 mg to gange daglig).
English: It is for adult patients whose NSCLC is of a certain type (“adenocarcinoma”) and who had already received one treatment with another medicine to treat this cancer but whose tumour started to grow again.
Danish: Det er til voksne patienter, der har en bestemt type ikke-småcellet lungekræft (“adenokarcinom”), og som allerede har fået en behandling med et andet lægemiddel mod denne kræftform, men hvor kræftsvulsten er begyndt at vokse igen.
English: Patients who developed thromboembolic events during treatment and who required anticoagulant treatment were allowed to continue Vargatef and did not show an increased frequency of bleeding events.
Danish: Patienter, der udviklede tromboemboliske hændelser under behandlingen og som havde behov for antikoagulerende behandling, fik lov at fortsætte med Vargatef, og der blev ikke påvist nogen øget hyppighed af blødningshændelser.
English: Serious cases of diarrhoea leading to dehydration and electrolyte disturbances have been reported with nintedanib in the post-marketing period.
Danish: Der er rapporteret om alvorlige tilfælde af diarré, som har ført til dehydrering og elektrolytforstyrrelser, ved brug af nintedanib i perioden efter markedsføring.
English: Diarrhoea ≥ grade 3 despite anti-diarrhoeal treatment
Danish: Diarré ≥ grad 3 trods behandling mod diarré
English: Febrile neutropenia, Abscesses, Sepsis
Danish: Febril neutropeni, abscesser, sepsis
English: Events of pancreatitis have been reported in patients taking nintedanib for the treatment of IPF and NSCLC.
Danish: Der er rapporteret hændelser af pancreatitis hos patienter, der tager nintedanib til behandling af IPF og NSCLC.
English: A study of male fertility and early embryonic development 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 fosterudvikling indtil implantation hos rotter påviste ingen virkninger på hannernes reproduktionsorganer eller fertilitet.
English: Decreased appetite, Electrolyte imbalance
Danish: Nedsat appetit, elektrolytforstyrre lser
English: For the management of selected adverse reactions, see section 4.4.
Danish: Vedrørende håndtering af udvalgte bivirkninger, se pkt.
English: Supportive care for nausea and vomiting may include medicinal products with anti-emetic properties, e.g. glucocorticoids, anti-histamines or 5-HT3 receptor antagonists and adequate hydration.
Danish: Understøttende behandling mod kvalme og opkastning kan omfatte lægemidler med antiemetiske egenskaber, f.eks. glukokortikoider, antihistaminer eller 5-HT3-receptorantagonister, og tilstrækkelig hydrering.
English: As initial measure for the management of adverse reactions (see Tables 1 and 2) treatment with nintedanib should be temporarily interrupted until the specific adverse reaction has resolved to levels that allow continuation of therapy (to grade 1 or baseline).
Danish: Som første foranstaltning til håndtering af bivirkninger (se Tabel 1 og 2) skal behandlingen med nintedanib afbrydes midlertidigt, indtil den specifikke bivirkning er bedret til et niveau, der tillader fortsættelse af behandlingen (til grad 1 eller som niveauet ved baseline).
English: No adjustment of the initial dosing is required on the basis of a patient's age (see section 5.2).
Danish: Det er ikke nødvendigt at justere startdosis på baggrund af en patients alder (se pkt.
English: Total plasma clearance after intravenous infusion was high (CL: 1390 mL/min, 28.8 % gCV).
Danish: Den totale plasmaclearance efter intravenøs infusion var høj (CL: 1390 ml/min; 28,8 % gCV).
English: Patients may continue therapy with nintedanib after discontinuation of docetaxel for as long as clinical benefit is observed or until unacceptable toxicity occurs.
Danish: Patienter kan fortsætte behandlingen med Vargatef efter seponering af docetaxel, så længe der ses en gavnlig klinisk virkning, eller indtil der forekommer uacceptabel toksicitet.
English: The trial included 658 patients (50.1 %) with adenocarcinoma, 555 patients (42.2 %) with squamous cell carcinoma, and 101 patients (7.7 %) with other tumour histologies.
Danish: Studiet omfattede 658 patienter (50,1 %) med adenokarcinom, 555 patienter (42,2 %) med pladecellekarcinom og 101 patienter (7,7 %) med andre tumorhistologier.
English: If you cannot tolerate the recommended dose of 400 mg per day because of side effects (see section 4), your doctor may reduce the daily dose of Vargatef.
Danish: Hvis du ikke kan tåle den anbefalede dosis på 400 mg om dagen på grund af bivirkninger (se afsnit 4), kan din læge nedsætte den daglige dosis Vargatef.
English: Patients taking concomitant anticoagulation, such as warfarin or phenprocoumon should be monitored regularly for changes in prothrombin time, international normalised ratio (INR), and clinical bleeding episodes.
Danish: Patienter i samtidig behandling med antikoagulantia, som f.eks. warfarin eller phenprocoumon, skal kontrolleres regelmæssigt for ændringer i protrombintid, international normaliseret ratio (INR) og kliniske blødningsepisoder.
English: Liver-related adverse reactions occurred in 42.8 % of nintedanib-treated patients.
Danish: Lever-relaterede bivirkninger forekom hos 42,8 % af de nintedanib behandlede patienter.
English: Patients were randomized (1:1) to receive nintedanib 200 mg orally twice daily in combination with 75 mg/m of intravenous docetaxel every 21 days (n = 655) or placebo orally twice daily in combination with 75 mg/m2 of docetaxel every 21 days (n = 659).
Danish: Patienterne blev randomiseret (1:1) til at få nintedanib 200 mg oralt to gange daglig i kombination med 75 mg/m docetaxel intravenøst hver 21. dag (n = 655) eller placebo oralt to gange daglig i kombination med 75 mg/m2 docetaxel hver 21. dag (n = 659).
English: Caution should be used especially in patients with additional risk factors for thromboembolic events.
Danish: Der bør udvises forsigtighed, især hos patienter med yderligere risikofaktorer for tromboemboliske hændelser.
English: Single arm study to examine whether genetic/genomic markers (alone or combined with clinical covariates) could be used to predict overall survival (OS) in NSCLC patients eligible for treatment with nintedanib.
Danish: Et enkeltgruppestudie til undersøgelse af om genetiske- / genomiske markører (alene eller i kombination med kliniske kovariater) vil kunne bruges til at forudsige den samlede overlevelse (OS) hos NSCLC-patienter, der er egnede til behandling med Vargatef.
English: In rabbits, embryofoetal lethality was observed at an exposure approximately 8 times higher than at the MRHD.
Danish: Hos kaniner blev der observeret embryoføtal letalitet ved en eksponering, der var ca. 8 gange større end eksponeringen ved MRHD.
English: Based on the high inter-individual variability of exposure observed in the clinical LUME-Lung-1 trial these effects are not considered clinically relevant.
Danish: På grund af den høje interindividuelle variabilitet i eksponeringen, der blev observeret i det kliniske studie LUME-Lung-1, anses disse virkninger ikke for klinisk relevante.
English: There are no data available from clinical trials for patients with inherited predisposition to bleeding or for patients receiving a full dose of anticoagulative treatment prior to start of treatment with Vargatef (for post-marketing experience, see ‘Haemorrhage' above).
Danish: Der foreligger ingen data fra kliniske studier for patienter med hereditær disposition for blødning eller for patienter, der får en fuld dosis antikoagulerende behandling før initiering af behandling med Vargatef (for erfaring i perioden efter markedsføring, se 'Blødning' ovenfor).
English: 120 x 1 soft capsule
Danish: 120 x 1 bløde kapsler
English: If the patient becomes pregnant while receiving Vargatef, she should be apprised of the potential hazard to the foetus.
Danish: Hvis en patient bliver gravid under behandling med Vargatef, skal hun gøres opmærksom på den mulige risiko for fosteret.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Vargatef in all subsets of the paediatric population in non-small cell lung cancer (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Vargatef i alle undergrupper af den pædiatriske population ved ikke-småcellet lungekræft (se pkt.
English: Patients treated with Vargatef have an increased risk of venous thromboembolism including pulmonary embolism and deep vein thrombosis.
Danish: Patienter i behandling med Vargatef har en øget risiko for venøs tromboembolisme, herunder lungeemboli og dyb venøs trombose.
English: Exposure to nintedanib was not influenced by gender (body weight corrected), mild and moderate renal impairment (estimated by creatinine clearance), liver metastases, ECOG performance score, alcohol consumption, and P-gp genotype.
Danish: Eksponeringen for nintedanib blev ikke påvirket af køn (korrigeret for legemsvægt), let og moderat nedsat nyrefunktion (estimeret ved kreatininclearance), levermetastaser, ECOG-funktionsstatus, alkoholforbrug og P-gp-genotype.
English: Other information on drug-drug interactions
Danish: Andre oplysninger om lægemiddel-lægemiddel interaktioner
English: Nintedanib reached maximum plasma concentrations approximately 2 - 4 hours after oral administration as soft gelatin capsule under fed conditions (range 0.5 - 8 hours).
Danish: De maksimale plasmakoncentrationer af nintedanib blev opnået ca. 2-4 timer efter oral administration af en blød gelatinekapsel kort efter et måltid (variationsbredde 0,5-8 timer).
English: Female patients should be advised to notify their doctor or pharmacist if they become pregnant during therapy with Vargatef.
Danish: Kvindelige patienter skal rådes til at underrette deres læge eller apotekspersonalet, hvis de bliver gravide under behandling med Vargatef.
English: However, based on the mechanism of action patients treated with Vargatef may have an increased risk of gastrointestinal perforations.
Danish: Som følge af virkningsmekanismen kan patienter i behandling med Vargatef dog have en øget risiko for gastrointestinale perforationer.
English: This includes any possible side effects not listed in this leaflet.You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Dette gælder også mulige bivirkninger, som ikke er medtaget i denne indlægsseddel.Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.