natgillin/translations-raw huggingface dataset:
Den anbefalede dosis er 80 mg osimertinib én gang dagligt indtil sygdomsprogression eller uacceptabel toksicitet. 
The recommended dose is 80 mg osimertinib once a day until disease progression or unacceptable toxicity.
• Du må ikke blive gravid, mens du tager denne medicin. 
• You should not become pregnant while taking this medicine.
Hvis du har taget for mange TAGRISSO Hvis du har taget mere end din normale dosis, skal du straks kontakte lægen eller nærmeste skadestue. 
If you take more TAGRISSO than you should If you take more than your normal dose, contact your doctor or nearest hospital straight away.
TAGRISSO må ikke anvendes under graviditet, medmindre kvindens kliniske tilstand kræver behandling med osimertinib. 
TAGRISSO should not be used during pregnancy unless the clinical condition of the woman requires treatment with osimertinib.
Dosisreduktion var nødvendig hos 0,2 % af patienterne og doseringsafbrydelse hos 1,4 %. 
Dose reduction was required in 0.2% of patients and dose interruption in 1.4%.
Alle patienter havde fået mindst én type behandling tidligere. 
All patients received at least one prior line of therapy.
Lægen vil sammen med dig beslutte, om du skal fortsætte med at tage TAGRISSO. 
Your doctor will decide with you whether you should carry on taking TAGRISSO.
Patienter med CLcr under 15 ml/min blev ikke inkluderet i de kliniske studier. 
Patients with CLcr less than 15 mL/min were not included in the clinical trials.
Tal med lægen om de bedst egnede præventionsmetoder. 
Discuss with your doctor the most appropriate methods of contraception.
Hvis en prøve har vist, at din kræftsygdom har visse ændringer (mutationer) i et gen kaldet ”EGFR” (epidermal vækstfaktorreceptor) og har spredt sig til din anden lunge eller andre organer, vil din kræft sandsynligvis reagere på behandling med TAGRISSO. 
If a test has shown that your cancer has certain changes (mutations) in a gene called ‘EGFR' (epidermal growth factor receptor) and has spread to your other lung or other organs, your cancer is likely to respond to treatment with TAGRISSO.
• Mænd - brug prævention i 4 måneder efter. 
• Men - keep using contraception for 4 months after.
Der er ingen data om TAGRISSOs indvirkning på fertiliteten hos mennesker. 
There are no data on the effect of TAGRISSO on human fertility.
• Om nødvendigt kan lægen nedsætte din dosis til én 40 mg tablet hver dag. 
• If necessary, your doctor may reduce your dose to one 40 mg tablet each day.
• under visse omstændigheder, hvis du tidligere har været behandlet for kræft med andre proteinkinasehæmmende lægemidler. 
• in certain circumstances if you have beentreated for your cancer before with other protein kinase inhibitor medicines.
Behandling med TAGRISSO skal igangsættes af en læge med erfaring i anvendelse af anticancerbehandling. 
Treatment with TAGRISSO should be initiated by a physician experienced in the use of anticancer therapies.
Ældre patienter (>65 år) eller patienter med en lav legemsvægt (<50 kg) kan have øget risiko for at udvikle bivirkninger af grad 3 eller højere. 
Elderly patients (>65 years) or patients with low body weight (<50 kg) may be at increased risk of developing adverse events of Grade 3 or higher.
Et tilfælde blev rapporteret i et postmarketingstudie, og hyppigheden er afledt af FLAURA- og AURA-studiet og postmarketingstudiet (N=4720). 
One event was reported in a post-marketing study, and the frequency has been derived from the FLAURA and AURA studies and the post-marketing study (N=4720).
Den vigtigste metaboliseringsvej for osimertinib var oxidation og dealkylering. 
The main metabolic pathway of osimertinib was oxidation and dealkylation.
Suspensionen og efterskylningerne bør administreres inden for 30 minutter efter, tabletten er lagt i vandet. 
The dispersion and residues should be administered within 30 minutes of the addition of the tablets to water.
• din hud skaller i alvorlig grad. 
• you have severe peeling of your skin.
En HR<1 favoriserer TAGRISSO 
A HR<1 favours TAGRISSO
• Nedsat antal hvide blodlegemer (leukocytter, lymfocytter eller neutrofile granulocytter). 
• Reduction in the number of white blood cells (leukocytes, lymphocytesor neutrophils).
• Hvis TAGRISSO er den første proteinkinasehæmmende medicin, du får, betyder det, at din kræftsygdom indeholder defekter i EGFR-genet, for eksempel ”exon 19-deletioner” eller ”exon 21-substitutionsmutationer”. 
• If TAGRISSO is the first protein kinase inhibitor medicine you are receiving, it means that your cancer contains defects in the EGFR gene, for example ‘exon 19 deletions' or ‘exon 21 substitution mutations'.
(Fund baseret på testresultater præsenteret som skift af 
(Findings based on test results presented as CTCAE grade shifts)
Modellen omfattede patient, behandling, besøg, treatment-by-visit interaction, baselinesymptomscore og baseline symptom score-by-visit interaction og anvendte en ustruktureret kovariansmatrix. 
The model included patient, treatment, visit, treatment-by-visit interaction, baseline symptom score, and baseline symptom score-by-visit interaction and used an unstructured covariance matrix.
TAGRISSO som monoterapi er indikeret til: 
TAGRISSO as monotherapy is indicated for:
• Den anbefalede dosis er én 80 mg tablet hver dag. 
• The recommended dose is one 80 mg tablet each day.
Analyse af postprogressionsendepunkter viste, at PFS-fordelen var bevaret gennem efterfølgende behandlingsforløb. 
Analysis of post-progression end-points demonstrated that the PFS benefit was preserved through subsequent lines of therapy.
Disse fund forekom ved plasmakoncentrationer, der var lavere end dem, der ses hos patienter ved den terapeutiske dosis på 80 mg. 
These findings occurred at plasma concentrations that were below those seen in patients at the 80 mg therapeutic dose.
Administration af osimertinib én gang dagligt resulterer i ca. 3 gange akkumulering med steady state-eksponering nået efter 15 dages dosering. 
Administration of osimertinib once daily results in approximately 3 fold accumulation with steady-state exposures achieved by 15 days of dosing.
Dette skal du gøre efter afslutning af behandling med TAGRISSO: 
You must also do this after completing treatment with TAGRISSO:
Der er ingen specifik behandling i tilfælde af overdosering med TAGRISSO. 
There is no specific treatment in the event of TAGRISSO overdose.
Analyse af HRQL og af forbedring af fysiske funktioner Begge grupper rapporterede lignende forbedringer i de fleste fungerende domæner og almen helbredstilstand/HRQL, hvilket tyder på, at patienternes generelle helbredstilstand blev forbedret. 
HRQL and physical functioning improvement analysis Both groups reported similar improvements in most functioning domains and global health status/HRQL, indicating that patients' overall health status improved.
• du er allergisk over for osimertinib eller et af de øvrige indholdsstoffer i dette lægemiddel 
• you are allergic (hypersensitive) to osimertinib or any of the other ingredients of this medicine
72 % af patienterne havde aldrig røget, 100 % af patienterne havde World Health Organization (WHO)-funktionsstatus 0 eller 1. 
Seventy-two percent (72%) of patients were never smokers, 100% of patients had a World Health Organization (WHO) performance status of 0 or 1.
TAGRISSO anvendes til behandling af voksne med en type lungekræft, som kaldes "ikke-småcellet lungecancer". 
TAGRISSO is used to treat adults with a type of lung cancer called ‘non-small cell lung cancer.'
Alle tilfælde var isolerede hændelser hos patienter, der ved en fejl har taget en ekstra daglig dosis af TAGRISSO, uden nogen kliniske konsekvenser. 
All cases were isolated incidents of patients taking an additional daily dose of TAGRISSO in error, without any resulting clinical consequences.
Hvis der anvendes en plasmabaseret ctDNA-test, og resultatet er negativt, anbefales det så vidt muligt at følge op med en vævsbaseret test på grund af potentialet for falsk negative resultater ved en plasmabaseret test. 
However, if a plasma-based ctDNA test is used and the result is negative, it is advisable to follow-up with a tissue test wherever possible due to the potential for false negative results using a plasma-based test.
Ligeledes faldt eksponeringen af metabolit AZ5104 med 82 % for AUC og 78 % for Cmax. 
Similarly, the exposure to metabolite AZ5104 decreased by 82% for the AUC and 78% for Cmax.
De sekundære effektmål omfattede varighed af respons (DoR) og progressionsfri overlevelse (PFS). 
Secondary efficacy outcome measures included Duration of Response (DoR) and Progression-Free Survival (PFS).
Hvis dosisreduktion er nødvendig, skal dosis reduceres til 40 mg én gang dagligt. 
If dose reduction is necessary, then the dose should be reduced to 40 mg taken once daily.
Bivirkning af grad 3 eller højere, som ikke forbedres til grad 0-2 efter afbrydelse i op til 3 uger 
Grade 3 or higher adverse reaction that does not improve to Grade 0-2 after withholding for up to 3 weeks
TAGRISSOs sikkerhed og virkning hos børn og unge i alderen under 18 år er ikke klarlagt. 
The safety and efficacy of TAGRISSO in children or adolescents aged less than 18 years have not been established.
Osimertinib kan øge eksponeringen af brystcancerresistent protein (BCRP) og P-glykoprotein (P-gp) substrater. 
Osimertinib may increase the exposure of breast cancer resistant protein (BCRP) and P-glycoprotein (P-gp) substrates.
Note: Intensiteten af kliniske bivirkninger klassificeret af National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. 
Note: The intensity of clinical adverse events graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
I populationen, der var evaluerbar for respons, havde 85 % (223/262) dokumenteret respons på tidspunktet for første scanning (6 uger); 94 % (247/262) havde dokumentation for respons på tidspunktet for anden scanning (12 uger). 
In the evaluable for response population, 85% (223/262) had documentation of response at the time of the first scan (6 weeks); 94% (247/262) had documentation of response at the time of the second scan (12 weeks).
Det primære effektmål i disse to studier var ORR ifølge RECIST v1.1, evalueret ved en blindet uafhængig central gennemgang (BICR). 
The primary efficacy outcome measure of these two trials was ORR according to RECIST v1.1 as evaluated by a Blinded Independent Central Review (BICR).
Derudover er den tilhørende frekvenskategori for hver bivirkning anført, baseret på CIOMS III-konventionen og defineret som: meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data). 
In addition, the corresponding frequency category for each adverse reaction is based on the CIOMS III convention and is defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from available data).
Bivirkninger af grad 3 og grad 4 på tværs af de 2 studier var henholdsvis 9,7 % og 0,9 %. 
Grade 3 and Grade 4 adverse reactions across both studies were 9.7% and 0.9%, respectively.
Intestinal hæmning af UGT1A1 er mulig, men den kliniske relevans er ukendt. 
Intestinal inhibition of UGT1A1 is possible but the clinical impact is unknown.
Inden for hver systemorganklasse er bivirkningerne opstillet efter frekvens med de hyppigste bivirkninger først. 
Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first.
Ændringer i hjertets kontraktilitet 
Changes in cardiac contractility
Median opfølgningstid var 15,0 måneder for patienter, der fik TAGRISSO, og 9,7 måneder for patienter, der fik EGFR TKIkomparator 
Median follow-up time was 15.0 months for patients receiving TAGRISSO and 9.7 months for patients receiving EGFR TKI comparator
Den skal lægges i vandet uden at blive knust, omrøres, indtil den er faldet hen, og blandingen straks synkes. 
It should be dropped in the water, without crushing, stirred until dispersed and immediately swallowed.
Når det er muligt, skal osimertinib undgås til patienter med medfødt langt QT-syndrom. 
When possible, the use of osimertinib in patients with congenital long QT syndrome should be avoided.
Hjerte QTc-interval over 500 msek på mindst 2 forskellige EKG'er 
Cardiac QTc interval greater than 500 msec on at least 2 separate ECGs
Der er ingen kliniske data tilgængelige til at anbefale justering af TAGRISSO-dosis. 
There are no clinical data available to recommend a dose adjustment of TAGRISSO.
Ved steady state opretholdes en cirkulerende plasmakoncentration typisk inden for et interval på 1,6 gange i løbet af et 24-timers doseringsinterval. 
At steady-state, circulating plasma concentrations are typically maintained within a 1.6 fold range over the 24-hour dosing interval.
• Efavirenz og etravirin - bruges til behandling af HIV-infektioner/AIDS 
• Efavirenz and etravirine - used to treat HIV infections/AIDS.
• Dette lægemiddel kræver ingen særlige forholdregler vedrørende opbevaringen. 
• This medicine does not require any special storage conditions.
Fundene efter 1 måneds dosering var stort set reversible inden for 1 måned efter seponering med undtagelse af delvis bedring for nogle af forandringerne i cornea. 
The findings present following 1 month of dosing were largely reversible within 1 month of cessation of dosing with the exception of partial recovery for some of the corneal changes.
Tabletten skal synkes hel med vand; den må ikke knuses, deles eller tygges. 
The tablet should be swallowed whole with water and it should not be crushed, split or chewed.
Forlænget QTc-interval 
QTc interval prolongation
Der er ingen eller utilstrækkelige data fra anvendelse af osimertinib til gravide kvinder. 
There are no or limited amount of data from the use of osimertinib in pregnant women.
Fund i ovarierne, der blev observeret efter 1 måneds dosering, var reversible. 
Findings in the ovaries seen following 1 month dosing were reversible.
I FLAURA og AURA3 var mediantiden til indtræden henholdsvis 19 dage og 22 dage, og medianvarigheden af grad 2-tilfælde var henholdsvis 19 dage og 6 dage. 
In FLAURA and AURA3 the median time to onset was 19 days and 22 days, respectively, and the median duration of the Grade 2 events was 19 days and 6 days, respectively.
• Hvis din kræft har udviklet sig, mens du blev behandlet med andre proteinkinasehæmmende lægemidler, betyder det, at din kræft indeholder en gendefekt kaldet ”T790M”. 
• If your cancer has progressed while you were being treated with other protein kinase inhibitor medicines, it means that your cancer contains a gene defect called ‘T790M'.
Det kan ikke udelukkes, at der er en risiko for det ammede barn. 
A risk to the suckling child cannot be excluded.
Anden PFS efter start af første efterfølgende behandling (PFS2) 
Second PFS after start of first subsequent therapy (PFS2)
Objektive responsrater i henhold til BICR over 50 % blev observeret i alle analyserede prædefinerede undergrupper, herunder antal tidligere behandlinger, etnicitet, alder og region. 
Objective response rates by BICR above 50% were observed in all predefined subgroups analysed, including line of therapy, ethnicity, age and region.
Hvis der er under 12 timer til din næste dosis, skal du dog springe den glemte dosis over. 
However, if it is less than 12 hours until your next dose is due, skip the missed dose.
Hvis administration via nasogastrisk sonde er nødvendig, skal ovenstående proces følges, men med brug af et volumen på 15 ml til den første suspension og 15 ml til at skylle efter med. 
If administration via nasogastric tube is required, the same process as above should be followed but using volumes of 15 mL for the initial dispersion and 15 mL for the residue rinses.
Virkning af osimertinib på P-gp og BCRP 
Effects of osimertinib on P-gp and BCRP
Børn og unge under 18 år må ikke få denne medicin. 
Do not give this medicine to children or adolescents under the age of 18 years.
Ikke-kliniske data indikerer, at osimertinib og dets metabolit (AZ5104) hæmmer h-ERG-kanalen, og en QTc-forlængende effekt kan ikke udelukkes. 
Non-clinical data indicate that osimertinib and its metabolite (AZ5104) inhibit the h-ERG channel, and QTc prolonging effect cannot be excluded.
Justeret middelværdi og estimeret forskel beregnet ved en MMRM-analyse (blandet model for gentagne målinger (Mixed Model Repeated Measures)). 
Adjusted mean and estimated differences obtained from a Mixed Model Repeated Measures (MMRM) analysis.
Randomiseringen blev stratificeret efter EGFR-mutationstype (Ex19del eller L858R) og etnicitet (asiatisk eller ikke-asiatisk). 
Randomisation was stratified by EGFR mutation type (Ex19del or L858R) and ethnicity (Asian or non-Asian).
• Stomatitis - betændelse i slimhinden i munden. 
• Stomatitis - inflammation of the inner lining of the mouth.
Alle patienter fik TAGRISSO i en dosis på 80 mg én gang dagligt. 
All patients received TAGRISSO at a dose of 80 mg once daily.
Hvis en TAGRISSO dosis glemmes, skal den tages, medmindre der er mindre end 12 timer til, næste dosis skal tages. 
If a dose of TAGRISSO is missed, the dose should be made up unless the next dose is due within 12 hours.
Anbefalede dosisjusteringer for TAGRISSO 
Recommended dose modifications for TAGRISSO
Tæt monitorering er anbefalet til disse patienter (se pkt. 
Close monitoring is recommended in these patients (see section 4.8).
TAGRISSO indeholder det aktive stof osimertinib, som tilhører en gruppe lægemidler kaldet proteinkinasehæmmere, der anvendes til behandling af kræft. 
TAGRISSO contains the active substance osimertinib, which belongs to a group of medicines called protein kinase inhibitors which are used to treat cancer.
Hvis ILD bliver diagnosticeret, skal TAGRISSO seponeres, og passende behandling indledes efter behov. 
If ILD is diagnosed, TAGRISSO should be discontinued and appropriate treatment initiated as necessary.
Eksponering ved doser på 20 mg/kg og derover under organogenese forårsagede nedsat fostervægt, men ingen negative virkninger på eksterne eller viscerale oganer hos fosteret. 
Exposure at doses of 20 mg/kg and above during organogenesis caused reduced foetal weights but no adverse effects on external or visceral foetal morphology.
Disse virkninger blev observeret ved en maternelt tolereret dosis på 20 mg/kg, hvor eksponeringen svarede til den humane eksponering ved den anbefalede dosis på 80 mg dagligt (baseret på samlet AUC). 
These effects were seen at a maternally tolerated dose of 20 mg/kg where exposure was equivalent to the human exposure at the recommended dose of 80 mg daily (based on total AUC).
En større andel af patienter behandlet med TAGRISSO var i live efter 12 måneder og 18 måneder (henholdsvis 89 % og 83 %) sammenlignet med patienter behandlet med EGFR TKI-komparator (henholdsvis 83 % og 71 %). 
A greater proportion of patients treated with TAGRISSO were alive at 12 months and 18 months (89% and 83%, respectively) compared to patients treated with EGFR TKI comparator (83% and 71%, respectively).
Der er ikke udført karcinogenicitetsstudier med osimertinib. 
Carcinogenicity studies have not been performed with osimertinib.
Det vides ikke, om osimertinib eller dets metabolitter udskilles i human mælk. 
It is not known whether osimertinib or its metabolites are excreted in human milk.
10 FILMOVERTRUKNE TABLETTER, BLISTER (PERFOREREDE) 7 FILMOVERTRUKNE TABLETTER, BLISTER (PERFOREREDE) 
10 FILM-COATED TABLET BLISTERS (PERFORATED) 7 FILM-COATED TABLET BLISTERS (PERFORATED)
Hvis der opstår tegn og symptomer, der tyder på SJS, skal TAGRISSO straks afbrydes eller seponeres. 
If signs and symptoms suggestive of SJS appear, TAGRISSO should be interrupted or discontinued immediately.
Der er begrænsede data tilgængelige for patienter med alvorligt nedsat nyrefunktion. 
Limited data are available in patients with severe renal impairment.
Mediantiden til indtræden af ILD eller ILD-lignende bivirkninger var 85 dage (se pkt. 
The median time to onset of ILD or ILD-like adverse reactions was 85 days (see section 4.4).
Patologiske fund i testiklerne observeret efter 1 måneds dosering var reversible hos rotter, mens der ikke kan drages en definitiv konklusion for reversibiliteten af disse læsioner hos hunde. 
Pathology findings in the testes seen following 1 month dosing were reversible in rats; however, a definitive statement on reversibility of these lesions in dogs cannot be made.
Forsøgspersoner i kemoterapiarmen, som havde objektiv radiologisk progression (ifølge investigator og bekræftet ved uafhængig central billedvurdering), fik mulighed for at starte behandling med TAGRISSO. 
Subjects on the chemotherapy arm who had objective radiological progression (by the investigator and confirmed by independent central imaging review) were given the opportunity to begin treatment with TAGRISSO.
I humant plasma udgjorde det uomdannede osimertinib 0,8 %, og de 2 metabolitter bidrog med henholdsvis 0,08 % og 0,07 % af den samlede radioaktivitet, hvor størstedelen af radioaktiviteten er kovalent bundet til plasmaproteiner. 
In human plasma, parent osimertinib accounted for 0.8%, with the 2 metabolites contributing 0.08% and 0.07% of the total radioactivity with the majority of the radioactivity being covalently bound to plasma proteins.
Fortæl det til lægen, før du tager TAGRISSO, hvis du tager nogle af følgende lægemidler: 
Tell your doctor before taking TAGRISSO if you are taking any of the following medicines:
En BICR-vurdering af disse scanninger resulterede i en undergruppe på 128/556 (23 %) patienter med CNS-metastaser, og disse data er opsummeret i tabel 4. 
A BICR assessment of these scans resulted in a subgroup of 128/556 (23%) patients with CNS metastases and these data are summarised in Table 4.
• Rifabutin og rifampicin - bruges mod tuberkulose (TB). 
• Rifabutin or rifampicin - used for tuberculosis (TB).
TAGRISSO har ingen eller kun en ubetydelig indvirkning på evnen til at køre bil og anvende maskiner. 
TAGRISSO has no or negligible influence on the ability to drive and use machines.
Alvorligheden af de fleste bivirkninger var af grad 1 eller 2. 
Most adverse reactions were Grade 1 or 2 in severity.
• Tilsæt 50 ml postevand (uden brus) - brug ikke andre væsker. 
• Add 50 mL (about two-thirds of a tumblerful) of still (non-fizzy) water - do not use any other liquids.
Moderate CYP3A4-induktorer (f.eks. bosentan, efavirenz, etravirin, modafinil) kan ligeledes nedsætte osimertinibeksponeringen og bør anvendes med forsigtighed eller om muligt undgås. 
Moderate CYP3A4 inducers (e.g. bosentan, efavirenz, etravirine, modafinil) may also decrease osimertinib exposure and should be used with caution, or avoided when possible.
Baseret på kliniske studier, er dosisjustering ikke nødvendig hos patienter med let nedsat leverfunktion (Child Pugh A) eller moderat nedsat leverfunktion (Child Pugh B). 
Based on clinical studies, no dose adjustments are necessary in patients with mild hepatic impairment (Child Pugh A) or moderate hepatic impairment (Child Pugh B).
Farmakoterapeutisk klassifikation: Antineoplastiske midler, proteinkinasehæmmere, ATC-kode: L01XE35. 
Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitors; ATC code: L01XE35.
Fortæl det straks til lægen under behandlingen med denne medicin, hvis: 
Tell your doctor straight away while taking this medicine if:
Den geometrisk gennemsnitlige eksponering af både AZ5104 og AZ7550, baseret på AUC, var for hver ca. 10 % af osimertinib-eksponeringen ved steady state. 
The geometric mean exposure of both AZ5104 and AZ7550, based on AUC, was approximately 10% each of the exposure of osimertinib at steady-state.
Meget almindelig (kan påvirke mere end 1 ud af 10 personer) 
Other side effects Very common (may affect more than 1 in 10 people)
Fortæl det straks til lægen, hvis du bemærker ovenstående alvorlige bivirkninger. 
Tell your doctor straight away if you notice the serious side effects listed above.
De hyppigst rapporterede bivirkninger var diarré (49 %) og udslæt (47 %). 
The most commonly reported adverse drug reactions (ADRs) were diarrhoea (49%) and rash (47%).