natgillin/translations-raw huggingface dataset:
Kontakt din læge hurtigst muligt, hvis du oplever en af nedenstående bivirkninger. 
Contact your doctor as soon as possible if you suffer from any of the below side effects.
Denne sygdom kan også kædes sammen med den naturlige fremadskriden af din sygdom og kan i nogle tilfælde have dødelig udgang. 
This disease can also be linked to the natural progression of your medical condition and can have a fatal outcome in some cases.
Der blev ikke fundet nye kovariante virkninger. 
No new covariate effects were identified.
Virkningen på samlet overlevelse blev undersøgt i forskellige patientundergrupper. 
The effect on overall survival was explored across different patient subsets.
NCI-CTC grad 
NCI-CTC Grade
De røde blodlegemeparametre var nedsatte og antallet af hvide blodlegemer, primært neutrofile, var forøget. 
Red blood cell parameters were decreased and white blood cells, primarily neutrophils, were increased.
EGFR udtrykkes på celleoverfladen af normale celler og cancerceller. 
EGFR is expressed on the cell surface of normal cells and cancer cells.
I klinisk studie PA.3. 
1 In clinical study PA.3.
Behandlingen bør kun fortsættes hos gravide, hvis fordelen for moderen opvejer risikoen for fostret. 
Treatment should only be continued in pregnant women if the potential benefit to the mother outweighs the risk to the foetus.
Et studie hos raske frivillige estimerede den absolutte biotilgængelighed til 59 %. 
A study in normal healthy volunteers provided an estimate of the absolute bioavailability of 59%.
Disse var meget almindelige i klinisk studie PA.3 og almindelige i klinisk studie BR.21. 
These were very common in clinical study PA.3 and common in clinical study BR.21.
Den kliniske relevans af disse forskelle er uklar. 
The clinical relevance of these differences is unclear.
Patienterne som indgik i dette studie var ikke valgt baseret på deres EGFR mutationsstatus. 
Patients in this study were not selected based on EGFR mutation status.
Baseret på populationsfarmakokinetiske analyser synes tilstedeværelsen af et opioid at øge eksponeringen med ca. 11 %. 
Based on population pharmacokinetic analysis, the presence of an opioid appeared to increase exposure by about 11%.
Der er ikke lavet studier for at undersøge virkningen af Tarceva på mælkeproduktionen eller tilstedeværelsen i human mælk. 
No studies have been conducted to assess the impact of Tarceva on milk production or its presence in breast milk.
Tarceva er ikke undersøgt hos patienter under 18 år. 
Tarceva has not been studied in patients under the age of 18 years.
Det vides ikke, om Tarceva virker anderledes, hvis din lever eller nyrer ikke fungerer normalt. 
It is not known whether Tarceva has a different effect if your liver or kidneys are not functioning normally.
Mindre end 2 % af den oralt administrerede dosis udskilles som moderstoffet. 
Less than 2% of the orally administered dose is excreted as parent substance.
PFS (median i måneder) 
PFS (median in months)
Den gavnlige virkning ses ved tilstedeværelsen af en lav smerte-intensitetsscore. 
The benefit is mostly driven by the presence of a low pain intensity score.
De første 330 patienter blev vurderet centralt (responsrate 6,2 %); 401 patienter blev vurderet af investigator (responsrate 11,2 %). 
The first 330 patients were centrally assessed (response rate 6.2%); 401 patients were investigatorassessed (response rate 11.2%).
Overlevelsen blev evalueret hos intent-to-treat-populationen på grundlag af follow-upoverlevelsesdata. 
Survival was evaluated in the intent-to-treat population based on follow-up survival data.
Ca. to tredjedele af patienterne var mænd og ca. en tredjedel havde en baseline ECOG performance status (PS) på 2 og 9 % havde en baseline ECOG PS på 3. 
About two-thirds of the patients were male and approximately one-third had a baseline ECOG performance status (PS) of 2, and 9% had a baseline ECOG PS of 3.
Den kliniske betydning af denne stigning er ikke blevet fastslået. 
The clinical relevance of this increase has not been established.
Om nødvendigt skal dosis af erlotinib reduceres, specielt hvis der observeres toksicitet. 
If necessary the dose of erlotinib should be reduced, particularly if toxicity is observed.
Progressionsfri overlevelse (PFS, median i måneder)* Investigatorvurderet ** 
Progression Free Survival (PFS, median in months)* Investigator Assessed **
Hvis du bliver gravid, mens du behandles med Tarceva, skal du omgående informere din læge, som vil beslutte, om behandlingen skal stoppes. 
If you become pregnant while you are being treated with Tarceva, immediately inform your doctor who will decide if the treatment should be continued.
Erlotinib blev testet negativ i konventionelle genotoksicitetsstudier. 
Erlotinib tested negative in conventional genotoxicity studies.
PFS (median i måneder), Investigatorvurderet p<0,0001 
PFS (median in months), Investigator assessed p<0.0001
Forekomsten af ILD var højere (ca. 5 % med dødelighed på 1,5 %) hos patienter i studier, som blev udført i Japan. 
A higher incidence of ILD (approximately 5% with a mortality rate of 1.5%) is seen among patients in studies conducted in Japan.
Symptomerne opstod få dage til flere måneder efter påbegyndelsen af behandlingen med Tarceva. 
Symptoms started from a few days to several months after initiating Tarceva therapy.
Det kan også ordineres, hvis tidligere kemoterapi ikke har kunnet stoppe sygdommen. 
It can also be prescribed if previous chemotherapy has not helped to stop your disease.
Konsekvenserne af denne interaktion for f.eks. CNS-toksicitet kendes ikke. 
The consequences of this interaction for e.g. CNS toxicity have not been established.
Hos disse patienter bør det derfor overvejes at teste leverfunktionen periodisk. 
Therefore, in such patients, periodic liver function testing should be considered.
I klinisk praksis kan der være andre co-faktorer, der medfører en øget eksponering for carboplatin, så som nyreinsufficiens. 
In clinical practice, there may be other co-factors leading to an increased exposure to carboplatin like renal impairment.
Der kan forekomme potentielle interaktioner med aktive stoffer, som metaboliseres af eller er hæmmere eller induktorer af disse enzymer. 
Potential interactions may occur with active substances which are metabolised by, or are inhibitors or inducers of, these enzymes.
Der er utilstrækkelige data for anvendelse af erlotinib til gravide kvinder. 
There are no adequate data for the use of erlotinib in pregnant women.
Du tilrådes at stoppe med at ryge, hvis du behandles med Tarceva, da rygning kan nedsætte mængden af medicin i blodet. 
You are advised to stop smoking if you are treated with Tarceva as smoking could decrease the amount of your medicine in the blood.
ECOG performance status (PS)= 0 ved baseline ECOG performance status (PS)= 1 ved baseline ECOG performance status (PS)= 2 ved baseline Metastserende sygdom ved baseline 
Baseline ECOG performance status (PS) = 0 Baseline ECOG performance status (PS) = 1 Baseline ECOG performance status (PS) = 2 Metastatic disease at baseline
PVC-blister forseglet med alufolie indeholdende 30 tabletter. 
PVC blister sealed with aluminium foil containing 30 tablets.
Den ældre population Der foreligger ingen specifikke studier hos ældre patienter. 
Elderly population There have been no specific studies in elderly patients.
Tarceva eller placebo blev taget oralt én gang daglig indtil sygdomsprogression eller uacceptabel toksicitet. 
Tarceva or placebo was taken orally once daily until disease progression or unacceptable toxicity.
90 % af patienterne, der blev behandlet med Tarceva, fik udslæt inden for de første 44 dage. 
90% of patients on Tarceva developed rash within the first 44 days.
Det forventes derfor, at plasmakoncentrationen i steady-state opnås efter ca. 7-8 dage. 
Therefore, the time to reach steady state plasma concentration would be expected to occur in approximately 7-8 days.
Resultaterne er vist i nedenstående tabel (resultater for gruppen af patienter med metastatisk og lokalt fremskreden sygdom er taget fra en eksploratorisk undergruppeanalyse). 
Results are shown in the table below (results for the group of metastatic and locally advanced patients are derived from exploratory subgroup analysis).
Undgå graviditet, mens du bliver behandlet med Tarceva. 
Avoid pregnancy while being treated with Tarceva.
Hvis dine blodprøver viser alvorlige ændringer i din leverfunktion, kan din læge være nødt til at afbryde behandlingen 
If your blood tests indicate severe changes in your liver function, your doctor may need to interrupt your treatment.
Skæringsdato: April 2012 
Cut-off date: April 2012
Der er observeret en let fototoksisk hudreaktion hos rotter efter UV-bestråling. 
A mild phototoxic skin reaction was observed in rats after UV irradiation.
Tarceva (måneder) 
Tarceva (months)
Første-linje behandling af patienter med EGFR mutationer 
First-Line Treatment of Patients with EGFR Mutations
- Stevens-Johnsons syndrom/ toksisk epidermal nekrolyse7 
-Stevens-Johnson syndrome/Toxic epidermal necrolysis7
Der skal iagttages forsigtighed, når disse aktive stoffer kombineres med erlotinib. 
Caution should be observed when these active substances are combined with erlotinib.
Glukuronideringssygdom, såsom Gilberts syndrom Din læge vil behandle dig med forsigtighed, hvis du lider af en glukuronideringssygdom som Gilberts syndrom. 
Glucuronidation disorder like Gilbert's syndrome Your doctor must treat you with caution if you have a glucuronidation disorder like Gilbert's syndrome.
Det vides ikke, om erlotinib udskilles i human mælk. 
It is not known whether erlotinib is excreted in human milk.
Patienter med pancreascancer 
Patients with pancreatic cancer
Placebo (måneder) 
Placebo (months)
Selvom det er statistisk signifikant, bliver størrelsen af denne forskel ikke betragtet som klinisk relevant. 
Although statistically significant, the magnitude of this difference is not considered to be clinically relevant.
På grund af blokering af den videre signalering stoppes celledelingen, og celledød induceres via den indre apoptotiske vej. 
Due to the blocking of downstream-signaling, the proliferation of cells is stopped, and cell death is induced through the intrinsic apoptotic pathway.
Hvis du glemmer en eller flere doser af Tarceva, skal du kontakte din læge eller apotek så snart som muligt. 
If you miss one or more doses of Tarceva, contact your doctor or pharmacist as soon as possible.
Tarceva er et lægemiddel, som anvendes til behandling af kræft ved at forhindre aktiviteten af et protein, som kaldes epidermal vækstfaktorreceptor (EGFR). 
Tarceva is a medicine used to treat cancer by preventing the activity of a protein called epidermal growth factor receptor (EGFR).
Hvis en plasma-baseret cfDNA-test anvendes og resulstatet er negativt for aktiverende mutationer skal en vævsprøve foretages når det er muligt pga. potentielfalsk positive bestemmelser ved en plasmabaseret test. 
If a plasma-based cfDNA test is used and the result is negative for activating mutations, perform a tissue test wherever possible due to the potential for false negative results from a plasma-based test.
Ligeledes blev den aktive metabolits eksponering øget med 60 % og 48 % for henholdsvis AUC og Cmax. 
Similarly, the exposure to the active metabolite increased by about 60% and 48% for AUC and Cmax, respectively.
• Periodiske, opdaterede sikkerhedsindberetninger (PSUR`er) 
• Periodic Safety Update Reports
Hos patienter, som ikke får udslæt inden for de første 4-8 uger af behandlingen, skal den videre behandling med Tarceva genovervejes (se pkt. 
In patients who do not develop rash within the first 4 - 8 weeks of treatment, further Tarceva treatment should be re-assessed (see section 5.1).
Skæringsdato: Aug 2010 
Cut-off date: Aug 2010
Skæringsdato: Jan 2011 
Cut-off date: Jan 2011
- Keratitis - Konjunctivitis1 
-Keratitis -Conjunctivitis1
Det kan ordineres, som indledende behandling eller som behandling, hvis din sygdom stort set forbliver uændret efter indledende kemoterapi, forudsat at dine kræftceller har specifikke EGFR-mutationer. 
It can be prescribed as initial therapy or as therapy if your disease remains largely unchanged after initial chemotherapy, provided your cancer cells have specific EGFR mutations.
Indsendelsen af PSUR`er for dette lægemiddel skal være i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og enhver efterfølgende opdatering offentliggjort på den europæiske webportal for lægemidler. 
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Lokalt fremskreden population 
Locally Advanced Population
Hvis diagnosen ulcerativ keratitis bekræftes, skal behandlingen med Tarceva afbrydes eller seponeres. 
If a diagnosis of ulcerative keratitis is confirmed, treatment with Tarceva should be interrupted or discontinued.
Svære infektioner, med eller uden neutropeni, har omfattet pneumoni, sepsis og cellulitis. 
* Severe infections, with or without neutropenia, have included pneumonia, sepsis, and cellulitis.
Metastatisk population 
Metastatic Population
Den mediane responsvarighed var 34,3 uger, spændvidde: 9,7 til 57,6+ uger. 
The median duration of response was 34.3 weeks, ranging from 9.7 to 57.6+ weeks.
Hvis du har glemt at tage Tarceva 
If you forget to take Tarceva
Disse lægemidler kan i nogle tilfælde nedsætte virkningen eller øge bivirkningerne af Tarceva, og lægen kan blive nødt til at justere din behandling. 
In some cases these medicines may reduce the efficacy or increase the side effects of Tarceva and your doctor may need to adjust your treatment.
Denne påvirkning understøttes af begrænsede kliniske data og prækliniske studier, som viser nedbrydning af EGFR i proteasomet. 
Such influence is supported by limited clinical data and preclinical studies showing EGFR degradation through the proteasome.
- Interstitiel lungesygdom (ILD)3 
-Interstitial lung disease (ILD)3
Kvinder i den fertile alder skal rådes til at undgå graviditet, mens de tager Tarceva. 
Women of childbearing potential must be advised to avoid pregnancy while on Tarceva.
Fortæl det til din læge, hvis du får stærke smerter i maven. 
Tell your doctor if you have severe pain in your abdomen.
Når der ordineres Tarceva, skal der tages hensyn til faktorer forbundet med forlænget overlevelse. 
When prescribing Tarceva, factors associated with prolonged survival should be taken into account.
• Alvorlig blæredannelse eller afskalning af huden (kan tyde på Stevens-Johnson syndrom) 
• Severe blistering or peeling of skin (suggestive of Stevens-Johnson syndrome)
Denne virkning var ledsaget af en 24 % stigning i erlotinibs tilsyneladende plasmaclearance. 
This effect was accompanied by a 24% increase in apparent erlotinib plasma clearance.
Der er identificeret tre hovedmetaboliske udskillelsesveje: 1) O-demetylering af en eller begge sidekæder, efterfulgt af oxidering til carboxylsyre; 2) oxidering af acetylengruppen efterfulgt af hydrolyse til arylcarboxylsyre; og 3) aromatisk hydroxylering af phenyl-acetylengruppen. 
There are three main metabolic pathways identified: 1) O-demethylation of either side chain or both, followed by oxidation to the carboxylic acids; 2) oxidation of the acetylene moiety followed by hydrolysis to the aryl carboxylic acid; and 3) aromatic hydroxylation of the phenyl-acetylene moiety.
EGFR-mutationer kan føre til vedvarende aktivering af anti-apoptotiske og proliferative signalveje. 
EGFR mutations may lead to constitutive activation of anti-apoptotic and proliferation signaling pathways.
• Nedsat nyrefunktion (når lægemidlet anvendes udenfor godkendt indikation i kombination med kemoterapi) 
• Reduced kidney function (when given outside the approved indications in combination with chemotherapy)
Signifikante interaktioner ved clearance af andre CYP3A4-substrater er derfor usandsynlig. 
Significant interactions with the clearance of other CYP3A4 substrates are therefore unlikely.
Hvis keratitis diagnosticeres skal fordele og risici ved fortsat behandling overvejes nøje. 
If keratitis is diagnosed, the benefits and risks of continuing treatment should be carefully considered.
Dosisreduktion med 25 mg ad gangen er ikke undersøgt. 
Dose reductions by 25 mg steps have not been investigated.
Indehaveren af markedsføringstilladelsen skal udføre de påkrævedeaktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP. 
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Formålet med studiet var at sammeligne den samlede overlevelse for første-linjevedligeholdelsesbehandling med erlotinib versus erlotinib administreret ved sygdomsprogression. 
The objective of the study was to compare the overall survival of first line maintenance therapy with erlotinib versus erlotinib administered at the time of disease progression.
Samtidig anvendelse af CYP3A4-substrater og modulatorer kan kræve justering af dosis (se pkt. 
Concomitant use of CYP3A4 substrates and modulators may require dose adjustment (see section 4.5).
• hvis du også tager et statin og oplever uforklarlig muskelsmerte, ømhed, svaghed eller kramper. 
• if you are also taking a statin and experience unexplained muscle pain, tenderness, weakness or cramps.
Patienter, som tager coumarin-antikoagulantia, skal kontrolleres regelmæssigt for enhver ændring i protrombintid eller INR. 
Patients taking coumarin-derived anticoagulants should be monitored regularly for any changes in prothrombin time or INR.
Erlotinibs sikkerhed og virkning i de godkendte indikationer er ikke klarlagt hos børn under 18 år. 
The safety and efficacy of erlotinib in the approved indications has not been established in patients under the age of 18 years.
Patienter med ECOG Performance Status >1 eller signifikant lever- eller nyre-co-morbiditet blev ikke inkluderet i studiet. 
Patients with ECOG PS>1, significant hepatic or renal co-morbidities were not included in the study.
Patienter med bulløse og eksfoliative hudsygdomme bør undersøges for hudinfektion og behandles ifølge lokale retningslinjer. 
Patients with bullous and exfoliative skin disorders should be tested for skin infection and treated according to local management guidelines.
CR=komplet respons; PR=partiel respons * Der blev observeret 58% reduktion i risikoen for sygdomsprogression eller død ** Den samlede overensstemmelse mellem vurderinger fra investigator og uafhængig komité var på 70% *** Der blev observeret en høj overkrysning, idet 82% af patienterne i kemoterapi-armen efterfølgende fik behandling med en EGFR-tyrosinkinasehæmmer,, og alle undtagen 2 af disse patienter efterfølgendefik Tarceva 
CR=complete response; PR=partial response * A 58% reduction in the risk of disease progression or death was observed ** Overall concordance rate between investigator and IRC assessment was 70% *** A high crossover was observed with 82% of the patients in the chemotherapy arm receiving subsequent therapy with an EGFR tyrosine kinase inhibitor and all but 2 of those patients had subsequent Tarceva.
En post-hoc analyse viste, at patienter med god klinisk status ved baseline (lav smerte intensitet, god QoL og god PS) kunne opnå mest gavn af behandling med Tarceva. 
In a post-hoc analysis, patients with favourable clinical status at baseline (low pain intensity, good QoL and good PS) may derive more benefit from Tarceva.
Inklusive øget alaninaminotransferase [ALAT], aspartataminotransferase [ASAT] og bilirubin. 
5 Including increased alanine aminotransferase [ALT], aspartate aminotransferase [AST] and bilirubin.
På basis af data fra disse studier kan der forekomme svære bivirkninger som f.eks. diarré, udslæt og muligvis øget aktivitet af leveraminotransferaser i doser over den anbefalede dosis. 
Based on the data from these studies, severe adverse reactions such as diarrhoea, rash and possibly increased activity of liver aminotransferases may occur above the recommended dose.
Patienter med lavt ekspressionsniveau af UGT1A1 eller med genetiske glukoronidiseringssygdomme (f.eks. Gilberts sygdom) kan have forhøjede serumkoncentrationer af bilirubin og skal behandles med forsigtighed. 
Patients with low expression levels of UGT1A1 or genetic glucuronidation disorders (e.g. Gilbert's disease) may exhibit increased serum concentrations of bilirubin and must be treated with caution.
Henholdsvis 93 % og 92 % af alle patienter i Tarceva- og placebogrupperne havde tidligere fået et platin-indeholdende regime, og hhv. 36 % og 37 % af alle patienter havde tidligere fået taxan-terapi. 
Ninety-three percent and 92% of all patients in the Tarceva and placebo groups, respectively, had received a prior platinum-containing regimen and 36% and 37% of all patients, respectively, had received a prior taxane therapy.
Du kan få ordineret dette lægemiddel, hvis du har ikke-småcellet lungekræft i et fremskredent stadium. 
This medicine can be prescribed to you if you have non-small cell lung cancer at an advanced stage.
Figur 1: Kaplan-Meier-kurve for investigatorvurderet PFS i studiet ML20650 (EURTAC) (skæringsdato april 2012) 
Figure 1: Kaplan-Meier curve for investigator assessed PFS in trial ML20650 (EURTAC) (April 2012 cut-off)
Desuden skal nyrefunktionen og serumelektrolytter herunder kalium kontrolleres hos patienter med risiko for dehydrering. 
In addition, renal function and serum electrolytes including potassium should be monitored in patients at risk of dehydration.
Gentagne doser á 200 mg to gange daglig blev tolereret dårligt af raske frivillige efter kun få dages administration. 
Repeated twice daily doses of 200 mg in healthy subjects were poorly tolerated after only a few days of dosing.
På basis af populationsfarmakokinetiske analyser var der ingen klinisk, signifikant sammenhæng mellem den forventede tilsyneladende clearance og patienternes alder, legemsvægt, køn og etnisk herkomst. 
Based on population pharmacokinetic analysis, no clinically significant relationship between predicted apparent clearance and patient age, bodyweight, gender and ethnicity were observed.
Hæmningen af glukoronidiseringen kan forårsage interaktioner med lægemidler, som er substrater for UGT1A1, og som kun elimineres via denne udskillelsesvej. 
The inhibition of glucuronidation may cause interactions with medicinal products which are substrates of UGT1A1 and exclusively cleared by this pathway.
I de kliniske studier blev dosis reduceret med 50 mg ad gangen. 
In the clinical studies doses were reduced by 50 mg steps.
De fleste var af sværhedsgrad 1/2 og intervention var ikke nødvendig. 
Most were Grade 1/2 in severity and manageable without intervention.
Hvis du har fået at vide af din læge, at du ikke tåler visse sukkerarter, skal du kontakte lægen, inden du begynder at tage Tarceva. 
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Tarceva.
Analysen viste, at de kovarianter, som påvirkede clearance af erlotinib hos patienter fra pancreasstudiet var meget lig med dem, som blev set i den tidligere enkeltstof-farmakokinetiske analyse. 
This analysis demonstrated that covariants affecting erlotinib clearance in patients from the pancreatic study were very similar to those seen in the prior single agent pharmacokinetic analysis.
Der er observeret højere forekomst hos patienter i Japan (se pkt. 
A higher incidence has been observed in patients in Japan (see section 4.4).
Andelen af patienter, som oplevede komplet respons, partiel respons eller stabil sygdom var hhv. 44,0 % og 27,5 % i Tarceva- og placebo-gruppen (p = 0,004). 
The proportion of patients who experienced complete response, partial response or stable disease was 44.0% and 27.5%, respectively, for the Tarceva and placebo groups (p = 0.004).