FrancophonIA/ELRC3.0 huggingface dataset:
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: Non-serious and serious bleeding events, some of which were fatal, have been reported in the postmarketing period (including patients with or without anticoagulant therapy or other medicinal products that could cause bleeding).
Danish: Der er rapporteret om ikke-alvorlige og alvorlige blødninger, hvoraf nogle havde dødelig udgang i perioden efter markedsføringen (både hos patienter, der blev behandlet med koagulationshæmmende lægemidler eller andre lægemidler, der kan forårsage blødning og hos patienter, der ikke blev behandlet med sådanne lægemidler).
English: Gastrointestinal adverse events were frequent and in line with the established safety profile of each component.
Danish: Mave-tarm-bivirkninger var hyppige og på niveau med med den fastlagte sikkerhedsprofil for hver komponent.
English: The safety and efficacy of Ofev in children aged 0-18 years have not been established.
Danish: Pædiatrisk population Ofevs sikkerhed og virkning hos børn i alderen 0-18 år er ikke klarlagt.
English: Population pharmocokinetic analysis in special populations The PK properties of nintedanib were similar in healthy volunteers, patients with IPF, and cancer patients.
Danish: Farmakokinetiske populationsanalyser i særlige populationer Nintedanibs farmakokinetiske egenskaber var de samme hos raske frivillige personer, patienter med IPF og patienter med kræft.
English: Drug-drug interactions between nintedanib and CYP substrates, CYP inhibitors, or CYP inducers are therefore not expected.
Danish: Lægemiddel-lægemiddel-interaktioner mellem nintedanib og CYP-substrater, CYP-hæmmere eller CYP-induktorer forventes derfor ikke.
English: Not known (cannot be estimated from the available data) - Renal failure - An enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections)
Danish: Ikke kendt (kan ikke estimeres ud fra forhåndenværende data) - Nyresvigt - En udvidelse og svækkelse af en blodårevæg eller en rift i en blodårevæg (aneurismer og arterielle dissektioner)
English: The most frequently reported adverse reactions associated with the use of nintedanib included diarrhoea, nausea and vomiting, abdominal pain, decreased appetite, weight decreased and hepatic enzyme increased.
Danish: De hyppigst indberettede bivirkninger forbundet med nintedanib omfattede diarré, kvalme og opkastning, abdominalsmerter, nedsat appetit, vægttab og forhøjede leverenzymer.
English: Particular caution should be exercised when treating patients with previous abdominal surgery, previous history of peptic ulceration, diverticular disease or receiving concomitant corticosteroids or NSAIDs.
Danish: Der skal udvises særlig forsigtighed ved behandling af patienter, der tidligere har undergået abdominalkirurgi, hvis anamnese omfatter ulcus pepticum, diverticulosis coli eller som samtidigt modtager kortikosteroider eller NSAIDs.
English: Given the similarity in safety profiles for both medicinal products, additive adverse events, including gastrointestinal and hepatic adverse events, may be expected.
Danish: Da der er ligheder i sikkerhedsprofilerne for begge lægemidler, kan additive bivirkninger, herunder mave-tarm- og lever-bivirkninger forventes.
English: th percentile) and decreased by 19% for a 100 kg patient th percentile) relative to a patient with the median weight of 71.5 kg.
Danish: .percentilen) og faldt med 19 % hos en patient på 100 kg (95 % percentilen) i forhold til en patient med en medianvægt på 71,5 kg.
English: Blood and lymphatic system disorders
Danish: Blod- og lymfesystem
English: In most patients the adverse reaction was of mild to moderate intensity and occurred within the first 3 months of treatment.
Danish: Hos de fleste patienter havde bivirkningen let til moderat intensitet og opstod inden for de første 3 behandlingsmåneder.
English: Do not breast-feed during the treatment with Ofev since there may be a risk for harm to the breastfeeding child.
Danish: Du må ikke amme under behandlingen med Ofev, da der kan være en risiko for det ammede barn.
English: Nintedanib was also not a substrate of BCRP.
Danish: Nintedanib var heller ikke et substrat for BCRP.
English: They should be advised to use adequate contraception during and at least 3 months after the last dose of Ofev.
Danish: De skal informeres om at anvende sikker prævention under behandlingen med Ofev og i mindst 3 måneder efter den sidste dosis.
English: If a patient does not tolerate 100 mg twice daily, treatment with Ofev should be discontinued.
Danish: Hvis patienten ikke tåler 100 mg to gange dagligt, bør Ofev seponeres.
English: Patients were randomized in a 3:2 ratio to treatment with Ofev 150 mg or placebo twice daily for 52 weeks.
Danish: Patienterne blev randomiseret i forholdet 3:2 til behandling med Ofev 150 mg eller placebo to gange dagligt i 52 uger.
English: Myocardial infarction
Danish: Myokardieinfarkt
English: In repeat dose toxicology studies in rats, adverse effects (e.g. thickening of epiphyseal plates, lesions of the incisors) were mostly related to the mechanism of action (i.e. VEGFR-2 inhibition) of nintedanib.
Danish: I toksikologistudier med gentagne doser til rotter var virkningerne (f.eks. fortykkelse af epifyseskiver, læsioner på fortænder) for det meste relaterede til nintedanibs virkningsmekanisme (dvs. VEGFR-2-hæmning).
English: If transaminase (AST or ALT) elevations > 3x ULN are measured, dose reduction or interruption of the therapy with Ofev is recommended and the patient should be monitored closely.
Danish: Hvis de målte aminotransferaseniveauer (ASAT eller ALAT) er > 3 x ULN, anbefales dosisreduktion eller afbrydelse af behandlingen med Ofev, og patienten skal monitorers nøje.
English: 60 x 1 soft capsules
Danish: 60 x 1 bløde kapsler
English: The estimated difference between the treatment groups was 0.131 L/year (95% CI 0.027, 0.235).
Danish: Den estimerede forskel mellem behandlingsgrupperne var 0,131 l/år (95 % CI 0,027-0,235).
English: This indicates that the risk of having a first acute adjudicated IPF exacerbation was statistically significantly lower in the nintedanib group than in the placebo group at any time point.
Danish: Dette indikerer, at risikoen for at få en første akut IPF-eksacerbation statistisk var signifikant lavere i nintedanib-gruppen end i placebogruppen på et hvilket som helst tidspunkt.
English: The contribution of renal excretion to the total clearance was low (0.649% of dose, 26.3% gCV).
Danish: Bidraget fra renal udskillelse til den totale clearance var lavt (0,649 % af dosis; 26,3 % gCV).
English: Elevations of liver enzymes (ALT, AST, blood alkaline phosphatase (ALKP), gamma-glutamyltransferase (GGT)) and bilirubin were reversible upon dose reduction or interruption in the majority of cases.
Danish: Forhøjelse af leverenzymer (ALAT, ASAT, basisk fosfatase i blodet (ALKP), gammaglutamyltransferase (GGT)) og bilirubin var i de fleste tilfælde reversible ved dosisreduktion eller dosisafbrydelse.
English: The prevalent metabolic reaction for nintedanib is hydrolytic cleavage by esterases resulting in the free acid moiety BIBF 1202.
Danish: Den dominerende metaboliske reaktion for nintedanib er hydrolytisk spaltning ved hjælp af esteraser, som resulterer i den frie syredel BIBF 1202.
English: If the patient becomes pregnant while receiving Ofev, she should be apprised of the potential hazard to the foetus.
Danish: Hvis en patient bliver gravid under behandling med Ofev, skal hun gøres opmærksom på den mulige risiko for fosteret.
English: Alternative causes of the liver enzyme elevations should be investigated.
Danish: Andre årsager til de forhøjede leverenzymer bør undersøges.
English: The estimated mean change from baseline in SGRQ total score at 52 weeks was 5.46 for placebo, indicating worsening of the health-related quality of life and -0.66 for nintedanib, indicating stable health-related quality of life.
Danish: Den estimerede middelændring fra baseline i den samlede SGRQ-score i uge 52 var 5,46 for placebo, hvilket indikerer en forværring af livskvalitet, og -0,66 for nintedanib, hvilket indikerer en stabil livskvalitet.
English: In most patients with nausea and vomiting, the event was of mild to moderate intensity.
Danish: Hos de fleste patienter med kvalme og opkastning havde bivirkningen let til moderat intensitet.
English: From the 2-year carcinogenicity studies in mice and rats, there was no evidence for a carcinogenic potential of nintedanib.
Danish: I de 2-årige karcinogenicitetsstudier hos mus og rotter var der ingen evidens for et karcinogent potentiale af nintedanib.
English: Based on results of a Population PK (PopPK) analysis in patients with IPF and non small cell lung cancer (NSCLC) (N=1,191) and descriptive investigations, exposure to nintedanib was not influenced by sex (body weight corrected), mild and moderate renal impairment (estimated by creatinine clearance), alcohol consumption, or P-gp genotype.
Danish: Baseret på resultaterne fra en populationsfarmakokinetisk (PopPK) analyse hos patienter med IPF og småcellet lungekræft (NSCLC) (N=1.191) og beskrivende undersøgelser, blev eksponeringen for nintedanib ikke påvirket af køn (korrigeret for legemsvægt), let og moderat nedsat nyrefunktion (estimeret ved kreatininclearance), alkoholforbrug eller P-gpgenotype.
English: Nintedanib reached maximum plasma concentrations approximately 2 - 4 h after oral administration as soft gelatine capsule under fed conditions (range 0.5 - 8 h).
Danish: De maksimale plasmakoncentrationer af nintedanib blev nået ca. 2-4 timer efter oral administration af en blød gelatinekapsel kort efter et måltid (variationsbredde 0,5-8 timer).
English: Therapy with Ofev should be permanently discontinued in patients who develop gastrointestinal perforation.
Danish: Ofev bør seponeres permanent hos patienter, der udvikler gastrointestinal perforation.
English: The clinical efficacy of nintedanib has been studied in patients with IPF in two phase III, randomised, double-blind, placebo-controlled studies with identical design (INPULSIS-1 (1199.32) and INPULSIS-2 (1199.34)).
Danish: Nintedanibs kliniske virkning er blevet undersøgt hos patienter med IPF i to randomiserede, dobbeltblindede, placebokontrollerede fase III-studier med identisk design (INPULSIS-1 (1199.32) og INPULSIS-2 (1199.34)).
English: The potential impact of VEGFR inhibition by nintedanib and the antiangiogenic activity of nintedanib on IPF pathology are currently not fully elucidated.
Danish: Den mulige virkning af VEGFR-hæmning vha. nintedanib og nintedanibs antiangiogene aktivitet på IPF-patogeneseer på nuværende tidspunkt ikke fuldt klarlagt.
English: Concomitant treatment with pirfenidone
Danish: Samtidig behandling med pirfenidon
English: Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with Ofev.
Danish: Fertile kvinder skal rådes til at undgå at blive gravide, mens de er i behandling med Ofev.
English: 1 (SE) of decline over 52 weeks Comparison vs placebo Difference 95% CI
Danish: 1 (SE) af forværring i 52 uger Sammenlignet med placebo Forskel 95 % CI
English: PHARMACEUTICAL FORM AND CONTENTS 30 x 1 soft capsules
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 30 x 1 bløde kapsler
English: Capsule fill:
Danish: Kapselskal:
English: In INPULSIS-2, patients receiving placebo had a larger increase from baseline SGRQ total score as compared to patients receiving nintedanib 150 mg twice daily.
Danish: I INPULSIS-2 havde patienterne, der fik placebo, en større stigning i den samlede SGRQ-score fra baseline sammenlignet med patienter, der fik nintedanib 150 mg to gange dagligt.
English: In patients with mild hepatic impairment (Child Pugh A), the recommended dose of Ofev is 100 mg twice daily approximately 12 hours apart.
Danish: Hos patienter med let nedsat leverfunktion (Child Pugh A) er den anbefalede dosis af Ofev 100 mg to gange dagligt med ca. 12 timers mellemrum.
English: As some other tyrosine kinase inhibitors are known to exert an effect on QT, caution should be exercised when nintedanib is administered in patients who may develop QTc prolongation.
Danish: Eftersom nogle tyrosinkinasehæmmere vides at have effekt på QT, skal der udvises forsigtighed, når nintedanib administreres til patienter i risikogruppe for at udvikle QT-forlængelse.
English: - if you have high blood pressure - if you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall
Danish: - hvis du har eller har haft et aneurisme (udvidelse og svækkelse af en blodårevæg) eller en rift i en blodårevæg.
English: Nintedanib inhibits proliferation, migration and fibroblast to myofibroblast transformation of human lung fibroblasts from patients with IPF.
Danish: Nintedanib hæmmer proliferation, migration og transformation af fibroblast til myofibroblast af humane lungefibroplaster fra patienter med IPF.
English: Table 1 summarizes the frequencies of adverse drug reactions (ADRs) that were reported in the nintedanib group (638 patients) pooled from the two placebo-controlled Phase III clinical trials of 52 weeks duration or from the post-marketing period.
Danish: Tabel 1 opsummerer hyppigheden for bivirkninger, der blev indberettet i nintedanib-grupperne (638 patienter) i de to placebokontrollerede kliniske fase III-studier af 52 ugers varighed eller efter markedsføring.
English: Do not take Ofev - if you are allergic to nintedanib, peanut or soya, or any of the other ingredients of this medicine
Danish: Tag ikke Ofev - hvis du er allergisk over for nintedanib, jordnødder, soja eller et af de øvrige indholdsstoffer i
English: For the management of selected adverse reactions please also refer to section 4.4.
Danish: Vedrørende håndtering af udvalgte bivirkninger henvises også til pkt.
English: The 100 mg twice daily dose is only recommended to be used in patients who do not tolerate the 150 mg twice daily dose.
Danish: En dosis på 100 mg to gange dagligt anbefales udelukkende til patienter, der ikke tolererer en dosis på 150 mg to gange dagligt.
English: Co-administration with pirfenidone
Danish: Administration sammen med pirfenidon
English: Female patients should be advised to notify their doctor or pharmacist if they become pregnant during therapy with Ofev.
Danish: Kvindelige patienter skal informeres om at underrette deres læge eller apotekspersonalet, hvis de bliver gravide under behandling med Ofev.
English: C] nintedanib was via faecal/biliary excretion (93.4% of dose, 2.61% gCV).
Danish: C]nintedanib var udskillelse med fæces/galde (93,4 % af dosis; 2,61 % gCV).
English: In rats, small amounts of radiolabelled nintedanib and/or its metabolites were excreted into the milk (≤ 0.5% of the administered dose).
Danish: Hos rotter blev små mængder radioaktivt mærket nintedanib og/eller dets metabolitter udskilt i mælken (≤ 0,5 % af den administrerede dosis).
English: Nintedanib exposure increased linearly with patient age, which may also result in a higher risk of developing liver enzyme elevations (see section 5.2).
Danish: Eksponeringen for nintedanib steg lineært med patienternes alder, hvilket også kan medføre en øget risiko for udviklingen af forhøjede leverenzymer (se pkt.
English: See Figure 1 for the evolution of change from baseline over time in both treatment groups, based on the pooled analysis of studies INPULSIS-1 and INPULSIS-2.
Danish: Se Figur 1 for udvikling i ændringen over tid fra baseline i de 2 behandlingsgrupper, baseret på den samlede analyse af studierne INPULSIS-1 og INPULSIS-2.
English: Total plasma clearance after intravenous infusion was high (CL: 1,390 mL/min, 28.8% gCV).
Danish: Den totale plasmaclearance efter intravenøs infusion var høj (CL: 1.390 ml/min; 28,8 % gCV).
English: Post-marketing bleeding events include but are not limited to gastrointestinal, respiratory and central nervous organ systems, with the most frequent being gastrointestinal.
Danish: Blødningshændelser set i perioden efter markedsføringen omfatter, men er ikke begrænset til, mave-tarm-kanalen, åndedrætsorganerne og centralnervesystemet, og hyppigst mave-tarm-kanalen.
English: For further information about special populations, recommended measures and dosing adjustments in case of diarrhoea and hepatic enzyme increased, refer additionally to sections 4.4 and 4.2, respectively.
Danish: For yderligere information om særlige populationer, anbefalede foranstaltninger og dosisjustering i tilfælde af diarré og forhøjede leverenzymer henvises til henholdsvis pkt.
English: Pre-clinical studies showed that small amounts of nintedanib and its metabolites (≤ 0.5% of the administered dose) were secreted into milk of lactating rats.
Danish: Prækliniske studier viste, at små mængder nintedanib og dets metabolitter (≤ 0,5 % af den administrerede dosis) blev udskilt i mælken hos diegivende rotter.
English: If you forget to take Ofev
Danish: Hvis du har glemt at tage Ofev
English: In the INPULSIS trials, the frequency of patients with perforation was very low in both treatment groups: 0% placebo, 0.3% Ofev (involving two patients).
Danish: I INPULSIS-studierne var hyppigheden af patienter med perforation meget lav i begge behandlingsgrupper; 0 % placebo, 0,03 % Ofev (involverede to patienter).
English: In a dedicated study in renal cell cancer patients, QT/QTc measurements were recorded and showed that a single oral dose of 200 mg nintedanib as well as multiple oral doses of 200 mg nintedanib administered twice daily for 15 days did not prolong the QTcF interval.
Danish: I et specifikt studie med patienter med nyrecellecancer blev QT/QTc-målinger registreret og viste, at hverken orale enkeltdoser på 200 mg nintedanib eller gentagne orale doser på 200 mg nintedanib givet to gange dagligt i 15 dage forlængede QTcF-intervallet.
English: Due to the mechanism of action of nintedanib patients might have an increased risk of gastrointestinal perforation.
Danish: På grund af nintedanibs virkningsmekanisme kan patienter have en øget risiko for gastrointestinal perforation.
English: If any liver test elevations are associated with clinical signs or symptoms of liver injury, e.g. jaundice, treatment with Ofev should be permanently discontinued.
Danish: Hvis eventuelle leverenzymforhøjelser forbindes med kliniske tegn eller symptomer på leverskade, f.eks. gulsot, skal Ofev seponeres permanent.
English: The majority of hepatic events occur within the first three months of treatment.
Danish: Hovedparten af leverhændelserne opstår i løbet af de første 3 måneders behandling.
English: Diarrhoea led to permanent treatment discontinuation in 4.4% of patients; otherwise the events were managed by antidiarrhoeal therapy, dose reduction or treatment interruption (see section 4.4).
Danish: Diarré førte til permanent seponering hos 4,4 % af patienterne; hos resten blev bivirkningen behandlet med obstipantia, dosisreduktion eller behandlingsafbrydelse (se pkt.
English: The following medicines are examples that may increase the levels of nintedanib in your blood, and hence may increase the risk for side effects (see section 4): - a medicine used to treat fungal infections (ketoconazole) - a medicine used to treat bacterial infections (erythromycin) - a medicine that affects your immune system (cyclosporine)
Danish: Følgende lægemidler kan øge blodets indhold af nintedanib og kan derfor øge risikoen for bivirkninger (se afsnit 4): - et lægemiddel, der bruges til behandling af svampeinfektioner (ketoconazol) - et lægemiddel, der bruges til behandling af bakterieinfektioner (erythromycin) - et lægemiddel, der indvirker på dit immunsystem (ciclosporin).
English: In both INPULSIS trials, the proportion of FVC responders, defined as patients with an absolute decline in FVC % predicted no greater than 5% (a threshold indicative of the increasing risk of mortality in IPF), was significantly higher in the nintedanib group as compared to placebo.
Danish: I begge INPULSIS-studier var andelen af FVC-respondere, defineret som patienter med en absolut forværring i FVC % af forventet ikke højere end 5 % (en tærskelværdi indikativ for den øgede risiko for mortalitet ved IPF), signifikant højere i nintedanib-gruppen sammenlignet med placebo.
English: The safety, efficacy, and pharmacokinetics of nintedanib have not been studied in patients with severe renal impairment (<30 ml/min creatinine clearance).
Danish: Nintedanibs sikkerhed, virkning og farmakokinetik er ikke undersøgt hos patienter med svært nedsat nyrefunktion (kreatininclearance < 30 ml/min).
English: Diarrhoea led to dose reduction in 10.7% of the patients and to discontinuation of nintedanib in 4.4% of the patients in clinical trials.
Danish: Diarré resulterede i dosisreduktion hos 10,7 % af patienterne og seponering af nintedanib hos 4,4 % af patienterne i kliniske studier.
English: Based on these results, there is no evidence of a relevant pharmacokinetic drug-drug interaction between nintedanib and pirfenidone when administered in combination (see section 5.2).
Danish: Baseret på disse resultater er der ikke evidens for en relevant farmakokinetisk lægemiddelinteraktion mellem nintedanib og pirfenidon, når de administreres i kombination (se pkt.
English: BIBF 1202 is subsequently glucuronidated by uridine 5'-diphosphoglucuronosyltransferase enzymes (UGT) enzymes, namely UGT 1A1, UGT 1A7, UGT 1A8, and UGT 1A10 to BIBF 1202 glucuronide.
Danish: BIBF 1202 glukuronideres efterfølgende til BIBF 1202-glukuronid af uridin 5'-diphosphat-glucuronosyltransferase-enzymer (UGT-enzymer), nærmere bestemt UGT 1A1, UGT 1A7, UGT 1A8 og UGT 1A10.
English: Cases of drug-induced liver injury have been observed with nintedanib treatment, including severe liver injury with fatal outcome.
Danish: Der er observeret tilfælde af lægemiddelinduceret leverskade under behandling med nintedanib, herunder svær leverskade med dødelig udgang.
English: If you stop taking Ofev
Danish: Hvis du holder op med at tage Ofev
English: The recommended dose is 150 mg nintedanib twice daily administered approximately 12 hours apart.
Danish: Den anbefalede dosis er 150 mg nintedanib to gange dagligt med ca. 12 timers mellemrum.
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 vist ved forøgelse af eksponeringen for nintedanib (dosisområde 50-450 mg én gang dagligt og 150-300 mg to gange dagligt).
English: What Ofev contains - The active substance is nintedanib.
Danish: Ofev indeholder: - Aktivt stof: nintedanib.
English: Ofev contains the active substance nintedanib and it is used for the treatment of idiopathic pulmonary fibrosis (IPF) in adults.
Danish: Ofev indeholder det aktive stof nintedanib og bruges til behandling af idiopatisk lungefibrose (IPF) hos voksne.
English: Less than 1% of a single dose of nintedanib is excreted via the kidney (see section 5.2).
Danish: Mindre end 1 % af en enkeltdosis nintedanib udskilles via nyrerne (se pkt.
English: In a dedicated pharmacokinetic study, concomitant treatment of nintedanib with pirfenidone was investigated in patients with IPF.
Danish: I et målrettet farmakokinetisk studie blev samtidig behandling med nintedanib og pirfenidon undersøgt hos patienter med IPF.
English: Always take this medicine exactly as your doctor or pharmacist has told you.
Danish: Tag altid lægemidlet nøjagtigt efter lægens eller apotekspersonalets anvisning.
English: Diarrhoea, nausea and vomiting were the most frequent adverse events reported in 20 (37.7%) versus 16 (31.4%), in 22 (41.5%) versus 6 (11.8%) and in 15 (28.3%) versus 6 (11.8%) patients, treated with pirfenidone added to nintedanib versus nintedanib alone, respectively.
Danish: Diarré, kvalme og opkastning var de hyppigst rapporterede bivirkninger hos hhv. 20 (37,7 %) versus 16 (31,4 %), hos 22 (41,5 %) versus 6 (11,8 %) og hos 15 (28,3 %) versus 6 (11,8 %) patienter, der blev behandlet med pirfenidon som tillægsbehandling til nintedanib versus nintedanib alene.
English: Ofev 150 mg twice daily
Danish: Ofev 150 mg to gange dagligt