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