FrancophonIA/ELRC3.0 huggingface dataset:
English: If you do not tolerate the recommended dose of two Ofev 100 mg capsules per day (see possible side effects in section 4) your doctor may advise you to stop taking this medicine.
Danish: Hvis du ikke kan tåle den anbefalede dosis på to Ofev 100 mg kapsler om dagen (se bivirkninger i afsnit 4), kan din læge bede dig om at holde op med at tage dette lægemiddel.
English: Only a minor extent of the biotransformation of nintedanib consisted of CYP pathways, with CYP 3A4 being the predominant enzyme involved.
Danish: Biotransformationen af nintedanib omfatter kun i mindre grad CYP-metaboliseringsveje med CYP 3A4 som det dominerende af de involverede enzymer.
English: Ofev has minor influence on the ability to drive and use machines.
Danish: Ofev påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: While adverse events reflecting ischaemic heart disease were balanced between the nintedanib and placebo groups, a higher percentage of patients experienced myocardial infarctions in the nintedanib group (1.6%) compared to the placebo group (0.5%).
Danish: Mens uønskede hændelser, der afspejlede iskæmisk hjertesygdom, var jævnt fordelt mellem nintedanib- og placebogrupperne, oplevede en højere procentdel af patienterne i nintedanib-gruppen myokardieinfarkt (1,6 %) sammenlignet med placebogruppen (0,5 %).
English: The annual rate of decline of FVC (in mL) was significantly reduced in patients receiving nintedanib compared to patients receiving placebo.
Danish: Den årlige grad af forværring i FVC (i ml) blev signifikant reduceret hos patienter, der fik nintedanib, sammenlignet med patienter, der fik placebo.
English: Time to progression (≥ 10% absolute decline of FVC % predicted or death) In both INPULSIS trials, the risk of progression was statistically significantly reduced for patients treated with nintedanib compared with placebo.
Danish: Tid indtil progression (≥ 10 % absolut fald i FVC % forventet eller død) I begge INPULSIS-studier var risikoen for progression statistisk signifikant reduceret hos patienter, der blev behandlet med nintedanib, i forhold til placebogruppen.
English: In a drug-drug interaction study with the potent P-gp inducer rifampicin, exposure to nintedanib decreased to 50.3% based on AUC and to 60.3% based on Cmax upon co-administration with rifampicin compared to administration of nintedanib alone.
Danish: I et lægemiddel-lægemiddel interaktionsstudie med den potente P-gp-induktor rifampicin faldt eksponeringen for nintedanib til 50,3 % baseret på AUC og til 60,3 % baseret på Cmax ved administration sammen med rifampicin sammenlignet med administration af nintedanib alene.
English: Management of side effects may require interruption, dose reduction, or discontinuation of therapy with Ofev (see section 4.2).
Danish: Håndtering af bivirkninger kan kræve behandlingsafbrydelse, dosisreduktion eller seponering af Ofev (se pkt.
English: You should take your next 100mg dose of Ofev as planned at the next scheduled time recommended by your doctor or pharmacist.
Danish: Tag din næste dosis Ofev på 100 mg efter planen på det næste fastlagte tidspunkt og i den dosis, som lægen eller apotekspersonalet har anbefalet.
English: Placebo Ofev 150 mg twice daily
Danish: Placebo Ofev 150 mg to gange dagligt
English: Ofev may have minor influence on your ability to drive and use machines.
Danish: Ofev kan have en mindre virkning på evnen til at føre motorkøretøj og betjene maskiner.
English: Aneurysms and artery dissections
Danish: Aneurismer og arterielle dissektioner
English: In a pre- and postnatal development study in rats, effects on pre- and post-natal development were seen at an exposure below the MRHD.
Danish: Der blev set virkninger på den præ- og postnatale udvikling i et studie af præ- og postnatal udvikling hos rotter ved en eksponering, der var lavere end eksponeringen ved MRHD.
English: Thrombocytopenia
Danish: Trombocytopeni
English: Patients with a recent history of myocardial infarction or stroke were excluded from the INPULSIS trials.
Danish: Patienter med nyligt myokardieinfarkt eller apopleksi i anamnesen blev ekskluderet fra INPULSISstudierne.
English: Patients should be treated at first signs with adequate hydration and anti-diarrhoeal medicinal products, e.g. loperamide, and may require treatment interruption.
Danish: Ved de første tegn på diarré skal der iværksættes behandling i form af tilstrækkelig hydrering og lægemidler mod diarré, f.eks. loperamid, og afbrydelse af behandlingen kan være nødvendig.
English: Nintedanib inhibits the activation of FGFR and PDGFR signalling cascades which are critically involved in proliferation, migration and differentiation of lung fibroblasts/myofibroblasts, the hallmark cells in the pathology of IPF.
Danish: Nintedanib hæmmer aktiveringen af FGFR- og PDGFR-signaleringskaskader, som er en væsentlig del af proliferation, migration og differentering af lungefibroblaster/myofribroblaster, som er de kendetegnende celler i patagenese for IPF.
English: Potent P-gp inducers (e.g. rifampicin, carbamazepine, phenytoin, and St. John's Wort) may decrease exposure to nintedanib.
Danish: Potente P-gp-induktorer (f.eks. rifampicin, carbamazepin, phenytoin og perikon) kan reducere eksponeringen for nintedanib.
English: After food intake, nintedanib exposure increased by approximately 20% compared to administration under fasted conditions (CI: 95.3 - 152.5%) and absorption was delayed (median tmax fasted: 2.00 h; fed: 3.98 h).
Danish: Eksponeringen for nintedanib steg med ca. 20 % efter fødeindtagelse sammenlignet med administration under faste (CI: 95,3-152,5 %), og absorptionen blev forsinket (median tmax fastende: 2,00 timer; kort efter et måltid: 3,98 timer).
English: This could be symptoms of serious liver problems; - if you have severe pain in your stomach, fever, chills, sickness, vomiting, or abdominal rigidity or bloating, as these could be symptoms of a hole in the wall of your gut (‘gastrointestinal perforation').
Danish: Dette kan være symptomer på alvorlige leverproblemer; - hvis du får stærke mavesmerter, feber, kulderystelser, kvalme, opkastning eller hårdhed/oppustning af maven, da det kan være et tegn på et hul i tarmvæggen (gastrointestinal perforation).
English: You should discuss the most appropriate methods of contraception for you with your doctor.
Danish: Du skal tale med din læge om, hvilke præventionsmetoder der er de bedste for dig.
English: Exposure increased in patients with hepatic impairment (Child Pugh A, Child Pugh B; see section 5.2).
Danish: Eksponeringen øgedes hos patienter med nedsat leverfunktion (Child Pugh A, Child Pugh B; se pkt.
English: In patients with mild hepatic impairment (Child Pugh A), treatment interruption or discontinuation for management of adverse reactions should be considered.
Danish: Hos patienter med let nedsat leverfunktion (Child Pugh A) kan seponering eller behandlingsafbrydelse overvejes i forbindelse med håndtering af bivirkninger.
English: (listed in section 6).
Danish: Ofev (angivet i afsnit 6).
English: Diarrhoea was reported in 62.4% of patients treated with nintedanib.
Danish: Diarré blev rapporteret hos 62,4 % af de patienter, der blev behandlet med nintedanib.
English: The safety data provided in the following are based on the two Phase III, randomised, double-blind, placebo-controlled studies in 1,061 patients comparing treatment with nintedanib 150 mg twice daily to placebo for 52 weeks (INPULSIS-1 and INPULSIS-2) and based on data observed during the post-marketing period.
Danish: De sikkerhedsdata, der er inkluderet i det følgende, er baseret på de to randomiserede, dobbeltblinde, placebokontrollerede fase III-studier med 1.061 patienter, hvor behandling med nintedanib 150 mg to gange dagligt sammenlignes med placebo i 52 uger (INPULSIS-1 og INPULSIS-2), og baseret på data observeret i perioden efter markedsføring.
English: Based on increased exposure, the risk for adverse reactions may be increased in patients with mild hepatic impairment (Child Pugh A).
Danish: På grund af øget eksponering kan der være øget risiko for bivirkninger hos patienter med let nedsat leverfunktion (Child Pugh A).
English: Uncommon side effects (may affect up to 1 in 100 people) - Pancreatitis - Inflammation of the large bowel - Serious liver problems - Low platelet count (thrombocytopenia) - High blood pressure (hypertension) - Jaundice, that is a yellow colour to the skin and whites of the eyes due to high levels of bilirubin - Itching - heart attack - Hair loss (alopecia)
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 patienter) - Betændelse i bugspytkirtlen (pancreatitis) - Betændelse i tyktarmen - Alvorlige leverproblemer - Lavt antal blodplader (trombocytopeni) - Højt blodtryk (hypertension) - Gulsot, der viser sig som en gulfarvning af huden og det hvide i øjnene pga. forhøjet indhold af bilirubin - Kløe - Hjerteanfald - Hårtab (alopeci)
English: In the pooled analysis, the HR was 0.60 indicating a 40% reduction in the risk of progression for patients treated with nintedanib compared with placebo.
Danish: I den samlede analyse var HR 0,60, hvilket indikerede en 40 % risikoreduktion for progression hos patienter, der blev behandlet med nintedanib, i forhold til placebogruppen.
English: Single dose toxicity studies in rats and mice indicated a low acute toxic potential of nintedanib.
Danish: Toksicitetsstudier med enkeltdoser til rotter og mus tydede på, at nintedanib har et lavt potentiale for akut toksicitet.
English: Body weight
Danish: Legemsvægt
English: Due to the mechanism of action of nintedanib patients might have an increased risk of thromboembolic events.
Danish: På grund af nintedanibs virkningsmekanisme kan patienter have en øget risiko for tromboemboliske hændelser.
English: General toxicology
Danish: Generel toksikologi
English: Co-administration with the potent P-gp inhibitor ketoconazole increased exposure to nintedanib 1.61-fold based on AUC and 1.83-fold based on Cmax in a dedicated drug-drug interaction study.
Danish: Administration sammen med den potente P-gphæmmer ketoconazol øgede eksponeringen for nintedanib 1,61 gange baseret på AUC og 1,83 gange baseret på Cmax i et specifikt lægemiddel-lægemiddel interaktionsstudie.
English: Genotoxicity studies indicated no mutagenic potential for nintedanib.
Danish: Genotoksicitetsstudier tydede ikke på, at nintedanib har et mutagent potentiale.
English: Reproduction toxicity
Danish: Reproduktionstoksicitet
English: Urinary excretion of the unchanged active substance within 48 h was about 0.05% of the dose (31.5% gCV) after oral and about 1.4% of the dose (24.2% gCV) after intravenous administration; the renal clearance was 20 mL/min (32.6% gCV).
Danish: Urinudskillelsen af uomdannet aktivt stof inden for 48 timer var ca. 0,05 % af dosis (31,5 % gCV) efter oral administration og ca. 1,4 % af dosis (24,2 % gCV) efter intravenøs administration.
English: In the INPULSIS-2 trial, the risk of first acute IPF exacerbation over 52 weeks was significantly reduced in patients receiving nintedanib compared to placebo, in the INPULSIS-1 trial there was no difference between the treatment groups.
Danish: I INPULSIS-2-studiet var risikoen for den første akutte IPF-eksacerbation i løbet af 52 uger signifikant reduceret hos patienter, der fik nintedanib, sammenlignet med placebo; i INPULSIS-1studiet var der ingen forskel mellem behandlingsgrupperne.
English: Arterial thromboembolic events
Danish: Arterielle tromboemboliske hændelser
English: Nintedanib, BIBF 1202, and BIBF 1202 glucuronide did not inhibit or induce CYP enzymes in preclinical studies, either.
Danish: Nintedanib, BIBF 1202 og BIBF 1202-glukuronid hverken hæmmede eller inducerede CYP-enzymer i prækliniske studier.
English: If you do not tolerate the recommended dose of two Ofev 150 mg capsules per day (see possible side effects in section 4) your doctor may reduce the daily dose of Ofev.
Danish: Hvis du ikke kan tåle den anbefalede dosis på to Ofev 150 mg kapsler om dagen (se bivirkninger i afsnit 4), kan din læge nedsætte den daglige dosis Ofev.
English: The deterioration of HRQoL was smaller in the nintedanib group; the difference between the treatment groups was statistically significant (-2.69; 95% CI: -4.95, -0.43; p=0.0197).
Danish: Forværringen af HRQoL var mindst i nintedanib-gruppen; forskellen mellem behandlingsgrupperne var statistisk signifikant (-2,69 %; 95 % CI:-4,95;-0,43; p=0,0197).
English: Pancreatitis, Colitis
Danish: Opkastning Pancreatitis Colitis
English: Number of analysed patients Rate
Danish: Antal analyserede patienter Grad
English: LIST OF EXCIPIENTS Contains soya lecithin.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder sojalecithin.
English: Treating diarrhoea early is important (see section 4); - if you vomit or feel sick (nausea); - if you have unexplained symptoms such as yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea coloured) urine, pain on the upper right side of your stomach area (abdomen), bleeding or bruising more easily than normal, or feeling tired.
Danish: Det er vigtigt at behandle diarré, lige så snart den opstår (se afsnit 4); - hvis du kaster op eller har kvalme; - hvis du oplever uforklarlige symptomer, såsom gulfarvning af huden eller det hvide i øjnene (gulsot), mørk eller brun (tefarvet) urin, smerter i den øverste, højre side af maven (abdomen), større tendens til blødninger eller blå mærker end normalt eller du føler dig træt.
English: In a sensitivity analysis which assumed that in patients with missing data at week 52 the FVC decline after the last observed value would be the same as in all placebo patients, the adjusted difference in the annual rate of decline between nintedanib and placebo was 113.9 mL/year (95% CI 69.2, 158.5) in INPULSIS-1 and 83.3 mL/year (95% CI 37.6, 129.0) in INPULSIS-2.
Danish: I en sensitivitetsanalyse, der antog, at faldet i FVC efter den sidst observerede værdi hos patienter med manglende data ved uge 52 ville være sammenligneligt med værdierne, der fandtes hos alle patienter i placebogruppen, var den justerede forskel i den årlige faldrate mellem nintedanib og placebo 113,9 ml/år (95 % CI 69,2-158,5) i INPULSIS-1 og 83,3 ml/år (95 % CI 37,6-129,0) i INPULSIS-2.
English: Mean (SE) absolute changes from baseline in FVC at week 12 were −13.3 (17.4) mL in patients treated with nintedanib with add-on pirfenidone (n=48) compared to −40.9 (31.4) mL in patients treated with nintedanib alone (n=44).
Danish: Gennemsnitlige (SE) absolutte ændringer fra baseline i FVC ved uge 12 var −13,3 (17,4) ml hos patienter i behandling med nintedanib med tillægsbehandling med pirfenidon (N=48), sammenlignet med −40,9 (31,4) ml hos patienter i behandling med nintedanib alene (N=44).
English: Talk to your doctor or pharmacist before taking Ofev, - if you have or ever had liver problems, - if you have or ever had problems with your kidney, - if you have or ever had bleeding problems, - if you take blood-thinning medicines (such as warfarin, phenprocoumon or heparin) to prevent blood clotting, - if you take pirfenidone as this may increase the risk of having diarrhoea, nausea, vomiting and liver problems, - if you have or ever had problems with your heart (for example a heart attack), - if you have recently had surgery.
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apotekspersonalet, før du tager Ofev, - hvis du har eller har haft problemer med leveren, - hvis du har eller har haft problemer med nyrerne, - hvis du har eller har haft problemer med blødning, - hvis du tager blodfortyndende medicin (f.eks. warfarin, phenprocoumon eller heparin) for at forebygge blodpropper, hvis du tager pirfenidon, da dette kan øge risikoen for at få diarré, kvalme, opkastning og leverproblemer, - hvis du har eller har haft problemer med hjertet (for eksempel et hjerteanfald), - hvis du for nylig har fået foretaget et kirurgisk indgreb.
English: In the INPULSIS trials with Ofev, the frequency of patients who experienced bleeding AEs was slightly higher in the Ofev arm (10.3%) than in the placebo arm (7.8%).
Danish: I INPULSIS-studierne med Ofev var andelen af patienter, der fik blødningshændelser, lidt højere i Ofev-gruppen (10,3 %) end i placebogruppen (7,8 %).
English: Dietary soya products are known to cause allergic reactions including severe anaphylaxis in persons with soya allergy.
Danish: Indtagelse af soja med kosten vides at forårsage allergiske reaktioner, herunder svær anafylaksi, hos personer med sojaallergi.
English: Diarrhoea
Danish: Diarré
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children.
Danish: SÆRLIG ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN
English: In rabbits, embryo-foetal lethality and teratogenic effects were observed at an exposure approximately 3 times higher than at the MRHD but equivocal effects on the embryo-foetal development of the axial skeleton and the heart were noted already at an exposure below that at the MRHD of 150 mg twice daily.
Danish: Hos kaniner blev der observeret embryoføtal letalitet og teratogene virkninger ved en eksponering, der var ca. 3 gange højere end eksponeringen ved MRHD, men tilsvarende virkninger på den embryoføtale udvikling af det aksiale skelet og hjertet blev registreret allerede ved en eksponering, der var lavere end den ved MRHD på 150 mg to gange dagligt.
English: The event was reported to be of severe intensity in 3.3% of nintedanib treated patients.
Danish: Bivirkningen blev indberettet som værende af alvorlig intensitet hos 3,3 % af de patienter, der blev behandlet med nintedanib.
English: Ofev can interact with certain other medicines.
Danish: Ofev kan påvirke virkningen af visse andre lægemidler, og andre lægemidler kan påvirke virkningen af Ofev.
English: If you take more Ofev than you should Contact your doctor or pharmacist immediately.
Danish: Hvis du har taget for meget Ofev Kontakt omgående lægen eller apotekspersonalet.
English: Ofev 150 mg soft capsules EU/1/14/979/003
Danish: Ofev 150 mg bløde kapsler EU/1/14/979/003
English: Group 1 received a single dose of 150 mg nintedanib before and after uptitration to 801 mg pirfenidone three times a day at steady state (N=20 patients treated).
Danish: Gruppe 1 fik en enkelt dosis med 150 mg nintedanib før og efter optitrering til 801 mg pirfenidon 3 gange dagligt ved steady state (N=20 behandlede patienter).
English: Ofev is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF).
Danish: Ofev er indiceret til behandling af idiopatisk lungefibrose (IPF) hos voksne.
English: Nintedanib is a substrate of P-gp.
Danish: Nintedanib er et substrat for P-gp.
English: Also, tell your doctor if you had peptic ulcers or diverticular disease in the past, or are concomitantly treated with anti-inflammatory drugs (NSAIDs) (used to treat pain relief and swelling) or steroids (used for inflammation and allergies), as this may increase this risk; - if you have pain, swelling, reddening, warmth of a limb as this could be symptoms of a blood clot in one of your veins (a type of blood vessel); - if you have chest pressure or pain, typically on the left side of the body, pain in the neck, jaw, shoulder or arm, a fast heartbeat, shortness of breath, nausea, vomiting, as this could be symptoms of a heart attack; - if you have any major bleeding.
Danish: Du skal også fortælle det til lægen, hvis du tidligere har haft mavesår eller divertikelsygdom eller modtager samtidig behandling med anti-inflammatoriske lægemidler (NSAIDs) (bruges til behandling mod smerter og hævelse) eller steroider (bruges mod betændelse og allergier), da dette kan forøge denne risiko; - hvis du oplever smerte, hævelse, rødme eller varme i en arm eller et ben, da det kan være et tegn på en blodprop i en vene (en type blodkar); - hvis du oplever smerter eller trykken for brystet, typisk i venstre side af kroppen, smerter i halsen, kæben, skuldrene eller armene, hurtige hjerteslag (puls), åndenød, kvalme, opkastning, da dette kan være symptomer på et hjerteanfald; - hvis du får en større blødning.
English: Arterial thromboembolic events were infrequently reported: in 0.7% of patients in the placebo and 2.5% in the nintedanib treated group.
Danish: Arterielle tromboemboliske hændelser blev indberettet hos 0,7 % af patienterne i placebogruppen og hos 2,5 % af patienterne i nintedanib-gruppen.
English: In group 2, the adjusted geometric mean ratios (90% CI)) were 97% (86% - 110%) and 95% (86% - 106%) for Cmax,ss and AUCτ,ss of pirfenidone, respectively (n=12 for intraindividual comparison).
Danish: I gruppe 2 var de justerede geometriske gennemsnitsratioer (90 % konfidensinterval (CI)) hhv. 97 % (86 % - 110 %) og 95 % (86 % - 106 %) for Cmax,ss og AUCτ,ss for pirfenidon (N=12 for intraindividuel sammenligning).
English: The number of patients with acute IPF exacerbations over 52 weeks was lower in the nintedanib group (2.3%, N=86) compared to placebo (13.8%, N=87).
Danish: Antallet af patienter med akutte IPF-eksacerbationer i løbet af 52 uger var lavere i nintedanib-gruppen (2,3 %, N=86) sammenlignet med placebo (13,8 %, N=87).
English: Breast-feeding should be discontinued during treatment with Ofev.
Danish: Amning bør ophøre under behandling med Ofev.
English: In the pre-specified pooled analysis of survival data of the INPULSIS trials, overall mortality over 52 weeks was lower in the nintedanib group (5.5%) compared with the placebo group (7.8%).
Danish: I den præ-specificerede samlede analyse af overlevelsesdata fra INPULSIS-studierne var den generelle mortalitet i løbet af 52 uger lavere i nintedanib-gruppen (5,5 %) sammenlignet med placebogruppen (7,8 %).
English: Nintedanib follows at least bi-phasic disposition kinetics.
Danish: Nintedanib følger som minimum en bifasisk fordelingskinetik.
English: Your doctor may reduce your recommended dose to two times 100 mg per day (a total of 200 mg per day).
Danish: Din læge kan nedsætte din anbefalede dosis til to gange 100 mg om dagen (i alt 200 mg pr. dag).
English: In case of persisting severe diarrhoea despite symptomatic treatment, therapy with Ofev should be discontinued.
Danish: Ved vedvarende, alvorlig diarré på trods af symptomatisk behandling bør Ofev seponeres.
English: Ofev helps to reduce scarring and stiffening of the lungs.
Danish: Ofev hjælper med at reducere dannelsen af arvæv, og at lungerne bliver mindre stive.
English: Comparison vs placebo
Danish: Sammenlignet med placebo
English: Serious cases of diarrhoea leading to dehydration and electrolyte disturbances have been reported in the post-marketing.
Danish: I perioden efter markedsføring er der rapporteret om alvorlige tilfælde af diarré, som har ført til dehydrering og elektrolytforstyrrelser.
English: Common side effects (may affect up to 1 in 10 people) - Vomiting - Loss of appetite - Weight loss - Bleeding - Rash - Headache
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 patienter) - Opkastning - Appetitløshed - Vægttab - Blødning - Udslæt - Hovedpine
English: The safety and efficacy of nintedanib have not been investigated in patients with hepatic impairment classified as Child Pugh B and C. Treatment of patients with moderate (Child Pugh B) and severe (Child Pugh C) hepatic impairment with Ofev is not recommended (see section 5.2).
Danish: Nintedanibs sikkerhed og virkning er ikke undersøgt hos patienter med nedsat leverfunktion klassificeret som Child Pugh B og C. Behandling med Ofev anbefales ikke til patienter med moderat (Child Pugh B) og svært (Child Pugh C) nedsat leverfunktion (se pkt.
English: In addition to symptomatic treatment if applicable, the management of adverse reactions to Ofev (see sections 4.4 and 4.8) could include dose reduction and temporary interruption until the specific adverse reaction has resolved to levels that allow continuation of therapy.
Danish: 4.4 og 4.8), hvis det er relevant, omfatte dosisreduktion og midlertidig seponering, indtil den specifikke bivirkning er bedret til et niveau, der tillader fortsættelse af behandlingen.
English: Nonserious epistaxis was the most frequent bleeding event.
Danish: Den hyppigste blødningshændelse var ikke-alvorlig epistaxis.