FrancophonIA/ELRC3.0 huggingface dataset:
English: EGFR mutations may lead to constitutive activation of anti-apoptotic and proliferation signaling pathways.
Danish: EGFR-mutationer kan føre til vedvarende aktivering af anti-apoptotiske og proliferative signalveje.
English: • Reduced kidney function (when given outside the approved indications in combination with chemotherapy)
Danish: • Nedsat nyrefunktion (når lægemidlet anvendes udenfor godkendt indikation i kombination med kemoterapi)
English: Significant interactions with the clearance of other CYP3A4 substrates are therefore unlikely.
Danish: Signifikante interaktioner ved clearance af andre CYP3A4-substrater er derfor usandsynlig.
English: If keratitis is diagnosed, the benefits and risks of continuing treatment should be carefully considered.
Danish: Hvis keratitis diagnosticeres skal fordele og risici ved fortsat behandling overvejes nøje.
English: Dose reductions by 25 mg steps have not been investigated.
Danish: Dosisreduktion med 25 mg ad gangen er ikke undersøgt.
English: 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.
Danish: 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.
English: 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.
Danish: Formålet med studiet var at sammeligne den samlede overlevelse for første-linjevedligeholdelsesbehandling med erlotinib versus erlotinib administreret ved sygdomsprogression.
English: Concomitant use of CYP3A4 substrates and modulators may require dose adjustment (see section 4.5).
Danish: Samtidig anvendelse af CYP3A4-substrater og modulatorer kan kræve justering af dosis (se pkt.
English: • if you are also taking a statin and experience unexplained muscle pain, tenderness, weakness or cramps.
Danish: • hvis du også tager et statin og oplever uforklarlig muskelsmerte, ømhed, svaghed eller kramper.
English: Patients taking coumarin-derived anticoagulants should be monitored regularly for any changes in prothrombin time or INR.
Danish: Patienter, som tager coumarin-antikoagulantia, skal kontrolleres regelmæssigt for enhver ændring i protrombintid eller INR.
English: The safety and efficacy of erlotinib in the approved indications has not been established in patients under the age of 18 years.
Danish: Erlotinibs sikkerhed og virkning i de godkendte indikationer er ikke klarlagt hos børn under 18 år.
English: Patients with ECOG PS>1, significant hepatic or renal co-morbidities were not included in the study.
Danish: Patienter med ECOG Performance Status >1 eller signifikant lever- eller nyre-co-morbiditet blev ikke inkluderet i studiet.
English: Patients with bullous and exfoliative skin disorders should be tested for skin infection and treated according to local management guidelines.
Danish: Patienter med bulløse og eksfoliative hudsygdomme bør undersøges for hudinfektion og behandles ifølge lokale retningslinjer.
English: 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.
Danish: 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
English: 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.
Danish: 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.
English: 5 Including increased alanine aminotransferase [ALT], aspartate aminotransferase [AST] and bilirubin.
Danish: Inklusive øget alaninaminotransferase [ALAT], aspartataminotransferase [ASAT] og bilirubin.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: This medicine can be prescribed to you if you have non-small cell lung cancer at an advanced stage.
Danish: Du kan få ordineret dette lægemiddel, hvis du har ikke-småcellet lungekræft i et fremskredent stadium.
English: Figure 1: Kaplan-Meier curve for investigator assessed PFS in trial ML20650 (EURTAC) (April 2012 cut-off)
Danish: Figur 1: Kaplan-Meier-kurve for investigatorvurderet PFS i studiet ML20650 (EURTAC) (skæringsdato april 2012)
English: In addition, renal function and serum electrolytes including potassium should be monitored in patients at risk of dehydration.
Danish: Desuden skal nyrefunktionen og serumelektrolytter herunder kalium kontrolleres hos patienter med risiko for dehydrering.
English: Repeated twice daily doses of 200 mg in healthy subjects were poorly tolerated after only a few days of dosing.
Danish: Gentagne doser á 200 mg to gange daglig blev tolereret dårligt af raske frivillige efter kun få dages administration.
English: Based on population pharmacokinetic analysis, no clinically significant relationship between predicted apparent clearance and patient age, bodyweight, gender and ethnicity were observed.
Danish: På basis af populationsfarmakokinetiske analyser var der ingen klinisk, signifikant sammenhæng mellem den forventede tilsyneladende clearance og patienternes alder, legemsvægt, køn og etnisk herkomst.
English: The inhibition of glucuronidation may cause interactions with medicinal products which are substrates of UGT1A1 and exclusively cleared by this pathway.
Danish: Hæmningen af glukoronidiseringen kan forårsage interaktioner med lægemidler, som er substrater for UGT1A1, og som kun elimineres via denne udskillelsesvej.
English: In the clinical studies doses were reduced by 50 mg steps.
Danish: I de kliniske studier blev dosis reduceret med 50 mg ad gangen.
English: Most were Grade 1/2 in severity and manageable without intervention.
Danish: De fleste var af sværhedsgrad 1/2 og intervention var ikke nødvendig.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Tarceva.
Danish: 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.
English: 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.
Danish: 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.
English: A higher incidence has been observed in patients in Japan (see section 4.4).
Danish: Der er observeret højere forekomst hos patienter i Japan (se pkt.
English: 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).
Danish: 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).
English: Form of lung irritation called interstitial lung disease (uncommon in European patients; common in Japanese patients: may affect up to 1 in 100 people in Europe and up to 1 in 10 in Japan).
Danish: • En form for lungeirritation, som kaldes interstitiel lungesygdom (ikke almindelig hos europæiske patienter; almindelig hos japanske patienter: kan påvirke op til 1 ud af 100 behandlede i Europa og op til 1 ud af 10 i Japan ).
English: • if you are allergic to erlotinib or any of the ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for erlotinib eller et af de øvrige indholdsstoffer i Tarceva (angivet i punkt 6).
English: These findings were observed at clinically relevant exposures.
Danish: Disse fund observeredes ved klinisk relevante eksponeringer.
English: A population pharmacokinetic analysis in 591 patients receiving single agent Tarceva shows a mean apparent clearance of 4.47 l/hour with a median half-life of 36.2 hours.
Danish: En populationsfarmakokinetisk analyse hos 591 patienter, som fik Tarceva som enkeltstof, viste en gennemsnitlig tilsyneladende clearance på 4,47 l/time med en median halveringstid på 36,2 timer.
English: Abnormal blood tests for the liver function
Danish: • Unormale blodprøver for leverfunktion
English: Two-year carcinogenicity studies with erlotinib conducted in rats and mice were negative up to exposures exceeding human therapeutic exposure (up to 2-fold and 10-fold higher, respectively, based on Cmax and/or AUC).
Danish: 2-årige karcinogenenicitetsstudier med erlotinib udført på rotter og mus var negative op til eksponeringer, som overstiger den humane terapeutiske eksponering (op til 2 gange og 10 gange højere baseret på henholdsvis Cmax og/eller AUC).
English: This was evidenced by a hazard ratio for death of 0.82 (95% CI, 0.68 to 0.99) among patients whose best response was stable disease or progressive disease.
Danish: Evidensen herfor var en hazard ratio for død på 0,82 (95 % konfidensinterval; 0,68 til 0,99) hos patienter, hvis bedste respons var stabil eller progredierende sygdom.
English: Tarceva in combination with gemcitabine is indicated for the treatment of patients with metastatic pancreatic cancer.
Danish: Tarceva er i kombination med gemcitabin indiceret til behandling af patienter med metastatisk pancreascancer.
English: Pre-treatment or co-administration of Tarceva did not alter the clearance of the prototypical CYP3A4 substrates, midazolam and erythromycin, but did appear to decrease the oral bioavailability of midazolam by up to 24%.
Danish: Forbehandling eller samtidig administration af Tarceva ændrede ikke clearance af de prototypiske CYP3A4-substrater, midazolam og erythromycin, men nedsatte tilsyneladende den orale biotilgængelighed af midazolam med op til 24 %.
English: However, an adverse effect on the fertility can not be excluded as animal studies have shown effects on reproductive parameters (see section 5.3).
Danish: En uønsket virkning på fertiliteten kan dog ikke udelukkes, da dyreforsøg har vist påvirkning af reproduktive parametre (se pkt.
English: Cigarette smoking has been shown to reduce erlotinib exposure by 50-60%.
Danish: Det er vist, at erlotinib-eksponeringen reduceres med 50-60 % ved cigaretrygning.
English: Erlotinib is an epidermal growth factor receptor/human epidermal growth factor receptor type 1 (EGFR also known as HER1) tyrosine kinase inhibitor.
Danish: Erlotinib er en epidermal vækstfaktorreceptor/human epidermal vækstfaktorreceptor type 1 (EGFR også kendt som HER1) tyrosinkinase-hæmmer.
English: In population pharmacokinetic analysis, no clinically significant relationship was observed between erlotinib clearance and creatinine clearance, but there are no data available for patients with creatinine clearance <15 ml/min.
Danish: I populationsfarmakokinetiske analyser blev der ikke observeret sammenhæng mellem erlotinib-clearance og creatinin-clearance, men der er ingen data tilgængelige hos patienter med creatinin-clearance <15 ml/min.
English: See also below “Other medicines and Tarceva”
Danish: Se også ”Brug af anden medicin sammen med Tarceva” nedenfor.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Danish: Yderligere oplysninger om dette lægemiddel er tilgængeligt på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/
English: In general, rash manifests as a mild or moderate erythematous and papulopustular rash, which may occur or worsen in sun exposed areas.
Danish: Som regel forekommer udslæt som milde eller moderate erytematøse eller papulopustuløse udslæt, som kan forekomme eller forværres på soleksponerede områder.
English: Tarceva has not been studied for its possible effects on the ability to drive and use machines but it is very unlikely that your treatment will affect this ability.
Danish: Tarceva er ikke undersøgt for dets mulige virkninger på evnen til at køre bil, motorcykel, cykle eller betjene værktøj eller maskiner, men det er meget usandsynligt, at behandlingen vil påvirke denne evne.
English: The treatment with this medicine is not recommended if you have a severe liver disease or severe kidney disease.
Danish: Behandling med denne medicin anbefales ikke, hvis du har en svær lever- eller nyresygdom.
English: The physiological relevance of the strong inhibition of CYP1A1 is unknown due to the very limited expression of CYP1A1 in human tissues.
Danish: Den fysiologiske relevans af den stærke hæmning af CYP1A1 kendes ikke på grund af en meget begrænset ekspression af CYP1A1 i humant væv.
English: Bullous, blistering and exfoliative skin conditions have been reported, including very rare cases suggestive of Stevens-Johnson syndrome/Toxic epidermal necrolysis, which in some cases were fatal (see section 4.8).
Danish: Tilfælde af bulløs, blærefyldt og eksfoliativ hud er set, inklusive meget sjældne tilfælde, angiveligvis af Stevens-Johnsons syndrom/toksisk epidermal nekrolyse, som i visse tilfælde var fatal (se pkt 4.8).
English: Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen.
English: Study endpoints included overall survival, progression-free survival (PFS), response rate, duration of response, time to deterioration of lung cancer-related symptoms (cough, dyspnoea and pain), and safety.
Danish: Studiets endepunkter omfattede samlet overlevelse, progressionsfri overlevelse (PFS), responsrate, varighed af respons, tid indtil forværring af lungecancerrelaterede symptomer (hoste, dyspnø og smerter), og sikkerhed.
English: Erlotinib has a mean apparent volume of distribution of 232 l and distributes into tumour tissue of humans.
Danish: Erlotinib har et gennemsnitlig tilsyneladende distributionsvolumen på 232 l og fordeles i tumorvæv hos mennesker.
English: Patients treated concurrently with erlotinib and gemcitabine should be monitored carefully for the possibility to develop ILD-like toxicity.
Danish: Patienter, der bliver behandlet samtidig med erlotinib og gemcitabin, bør kontrolleres omhyggeligt for risikoen for udvikling af ILD-lignende toksicitet.
English: Also, tell your doctor if you had peptic ulcers or diverticular disease in the past, as this may increase this risk.
Danish: Du skal også fortælle lægen, hvis du tidligere har haft mavesår eller udposninger (divertikler) f.eks. på tarmen, da det kan øge denne risiko.
English: Erlotinib and its metabolites are not significantly excreted by the kidney, as less than 9% of a single dose is excreted in the urine.
Danish: Erlotinib og dets metabolitter udskilles i mindre udstrækning gennem nyrerne, da mindre end 9 % af en enkeltdosis udskilles i urinen.
English: Although the Cmax was statistically significant lower in moderately hepatic impaired patients, this difference is not considered clinically relevant.
Danish: Selvom Cmax var statistisk signifikant lavere hos patienter med moderat nedsat leverfunktion, anses forskellen ikke for at være klinisk relevant.
English: -Corneal perforations -Corneal ulcerations -Uveitis
Danish: - Corneaperforationer - Corneaulcerationer - Uveitis
English: Rare side effects (may affect up to 1 in 1,000 people): • Flushed or painful palms or soles (Palmar plantar erythrodysaesthesia syndrome)
Danish: Sjældne bivirkninger (kan påvirke op til 1 ud af 1.000 behandlede): • Rødme eller smerte i håndfladerne eller fodsålerne (palmoplantar erytrodysæstesi)
English: Co-administration of Tarceva with CYP3A4 inducers should therefore be avoided.
Danish: Samtidig administration af Tarceva med induktorer af CYP3A4 bør derfor undgås.
English: In non-clinical models, inhibition of EGFR phosphotyrosine results in cell stasis and/or death.
Danish: I ikke-kliniske modeller medfører hæmning af EGFR phosphortyrosin cellestase og/eller celledød.
English: The combination of Tarceva and a statin may increase the potential for statin-induced myopathy, including rhabdomyolysis, which was observed rarely.
Danish: Kombinationen af Tarceva og et statin kan øge risikoen for statin-induceret myopati, inklusive rabdomyolyse, som blev observeret med frekvensen ”sjælden”.
English: In a clinical study, the concomitant use of erlotinib with carboplatin and paclitaxel led to an increase of total platinum AUC0-48 of 10.6%.
Danish: I et klinisk studie førte samtidig anvendelse af erlotinib med carboplatin og paclitaxel til en øget total platinum AUC0-48 på 10,6 %.
English: Your doctor may decide to permanently stop your treatment with Tarceva.
Danish: Din læge kan beslutte at stoppe behandlingen med Tarceva permanent.
English: In study BR.21, the median time to onset of rash was 8 days, and the median time to onset of diarrhoea was 12 days.
Danish: I studie BR.21 var den mediane tid indtil starten af udslæt 8 dage og den mediane tid indtil starten af diarré 12 dage.
English: Current smokers should be advised to stop smoking, as plasma concentrations of erlotinib in smokers as compared to non-smokers are reduced.
Danish: Rygere skal rådes til at stoppe med at ryge, da plasmakoncentrationerne af erlotinib hos rygere er væsentligt reduceret sammenlignet med ikke-rygere.
English: The tablet should be taken at least one hour before or two hours after the ingestion of food.
Danish: Tabletten skal tages mindst én time før eller to timer efter indtagelse af mad.
English: Your doctor may adjust your dose in 50 mg steps.
Danish: Din læge kan ændre på dosis med 50 mg ad gangen.
English: -Diarrhoea7 -Gastrointestinal bleeding4, 7
Danish: - Gastrointestinal blødning4, 7
English: It is important to keep taking Tarceva every day, as long as your doctor prescribes it for you.
Danish: Hvis du holder op med at tage Tarceva Det er vigtigt, at du bliver ved med at tage Tarceva hver dag så længe, som din læge har ordineret det.
English: Therefore, patients who are still smoking should be encouraged to stop smoking as early as possible before initiation of treatment with Tarceva, as plasma erlotinib concentrations are reduced otherwise.
Danish: Patienter, som stadig ryger, skal derfor opfordres til at stoppe med at ryge så tidligt så muligt inden behandlingen med Tarceva initieres, idet plasmakoncentrationerne ellers reduceres.
English: Persistent and severe diarrhoea may lead to low blood potassium and impairment of your kidney function, particularly if you receive other chemotherapy treatments at the same time.
Danish: Vedvarende og alvorlig diarré kan føre til lavt indhold af kalium i blodet samt nedsat nyrefunktion, specielt hvis du samtidig får anden kemoterapibehandling.
English: Rare cases of hepatic failure (including fatalities) have been reported during use of Tarceva.
Danish: Sjældne tilfælde af leverinsufficiens (herunder fatale) er blevet rapporteret under anvendelsen af Tarceva.
English: Tablet coat: hypromellose, hydroxypropyl cellulose, titanium dioxide, macrogol.
Danish: Tabletovertræk: hypromellose, hydroxypropylcellulose, titandioxid, macrogol
English: The recommended daily dose of Tarceva is 100 mg taken at least one hour before or two hours after the ingestion of food, in combination with gemcitabine (see the summary of product characteristics of gemcitabine for the pancreatic cancer indication).
Danish: Den anbefalede daglige dosis af Tarceva er 100 mg, som tages mindst én time før eller to timer efter indtagelse af føde, i kombination med gemcitabin (se produktresuméet for gemcitabin for pancreascancer-indikationen).
English: ** Can lead to dehydration, hypokalemia and renal failure.
Danish: Kan føre til dehydrering, hypokaliæmi og nyreinsufficiens.
English: Some cases were secondary to severe dehydration due to diarrhoea, vomiting and/or anorexia, while others were confounded by concomitant chemotherapy.
Danish: Nogle tilfælde var sekundære til svær dehydrering på grund af diarré, opkastning og/eller appetitløshed mens andre tilfælde opstod i forbindelse med konkomitant kemoterapi.
English: There were treatment-related increases in ALT, AST and bilirubin.
Danish: Der var behandlingsrelaterede stigninger af ALAT, ASAT og bilirubin.
English: If ILD is diagnosed, Tarceva should be discontinued and appropriate treatment initiated as necessary (see section 4.8).
Danish: Hvis diagnosen ILD stilles, skal Tarceva seponeres, og passende behandling om nødvendigt initieres (se pkt.
English: If you develop symptoms such as sudden difficulty in breathing associated with cough or fever contact your doctor immediately as you could suffer from this disease.
Danish: Hvis du får symptomer som f.eks. pludseligt åndedrætsbesvær, ledsaget af hoste eller feber, skal du omgående kontakte din læge, da det kan være, du lider af denne sygdom.
English: Your doctor might avoid treating you with these medicines while you are receiving Tarceva.
Danish: Din læge vil måske undgå at behandle dig med disse lægemidler, mens du får Tarceva.
English: The incidence of adverse drug reactions (ADRs) from clinical trials reported with Tarceva alone or in combination with chemotherapy are summarised by National Cancer Institute-Common Toxicity Criteria (NCI-CTC) Grade in Table 1.
Danish: Hyppigheden af bivirkninger fra kliniske studier rapporteret med Tarceva alene eller i kombination med kemoterapi, er sammenfattet i henhold til National Cancer Institute-Common Toxicity Criteria (NCI-CTC) Grade i tabel 1.
English: Tarceva should be used with caution in patients with a history of keratitis, ulcerative keratitis or severe dry eye.
Danish: Tarceva skal anvendes med forsigtighed til patienter med en anamnese med keratitis, ulcerativ keratitis eller svært tørre øjne.
English: Tarceva contains the active substance erlotinib.
Danish: Tarceva indeholder det aktive stof erlotinib.
English: Tell your doctor or pharmacist if you are taking, have recently taken any other medicines or might take any other medicines.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.