FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients receiving Tarceva are at increased risk of developing gastrointestinal perforation, which was observed uncommonly (including some cases with a fatal outcome).
Danish: Patienter, som får Tarceva, har en øget risiko for udvikling af gastrointestinal perforation, hvilket blev observeret med frekvensen ”ikke almindelig” (inklusive visse letale tilfælde).
English: Erlotinib binds to serum albumin and alpha-1 acid glycoprotein (AAG).
Danish: Erlotinib bindes til serumalbumin og alfa-1 glykoproteinsyre (AAG).
English: Erlotinib and medicinal products altering pH
Danish: Erlotinib og lægemidler, som ændrer pH
English: Safety evaluation of Tarceva is based on the data from more than 1500 patients treated with at least one 150 mg dose of Tarceva monotherapy and more than 300 patients who received Tarceva 100 or 150 mg in combination with gemcitabine.
Danish: Sikkerhedsevalueringen af Tarceva er baseret på data fra mere end 1.500 patienter, der blev behandlet med mindst en dosis Tarceva på 150 mg som monoterapi, og fra mere end 300 patienter, som fik Tarceva 100 eller 150 mg i kombination med gemcitabin.
English: • Bleeding from the stomach or the intestines
Danish: • Blødning fra mave eller tarm
English: In the pivotal study BR.21 in NSCLC, the incidence of ILD (0.8%) was the same in both the placebo and Tarceva groups.
Danish: I det pivotale studie BR.21 ved NSCLC var hyppigheden af ILD-lignende hændelser (0,8 %) den samme i både placebo- og Tarceva-gruppen.
English: Based on pharmacokinetic data no dose adjustments appear necessary in patients with mild or moderate renal impairment (see section 5.2).
Danish: På basis af farmakokinetiske data er dosisjustering ikke nødvendig hos patienter med let eller moderat nedsat nyrefunktion (se pkt.
English: These findings were observed at exposures well below clinically relevant exposures.
Danish: Disse fund blev observeret ved eksponeringer, som lå betydeligt under klinisk relevante eksponeringer.
English: The median time to onset of rash and diarrhoea was 10 days and 15 days, respectively.
Danish: Den mediane tid til starten af udslæt og diarré var henholdsvis 10 og 15 dage.
English: The effect of antacids on the absorption of erlotinib has not been investigated but absorption may be impaired, leading to lower plasma levels.
Danish: Virkningen af antacida på absorptionen af erlotinib er ikke undersøgt, men absorptionen kan nedsættes, hvilket medfører lavere plasmakoncentrationer.
English: • Cracked skin (skin fissures)
Danish: • Sprækket hud (hudrevner)
English: The potent effectiveness of erlotinib in blocking EGFR-mediated signalling in these EGFR mutation positive tumours is attributed to the tight binding of erlotinib to the ATP-binding site in the mutated kinase domain of the EGFR.
Danish: Erlotinibs potente effektivitet til at blokere EGFR-medieret signalering i tumorer med EGFRmutationer kan tilskrives den tætte binding af erlotinib til ATP-bindingsstedet i det muterede kinasedomæne i EGFR.
English: • if you use contact lenses and/or have a history of eye problems such as severe dry eyes, inflammation of the front part of the eye (cornea) or ulcers involving the front part of the eye, tell your doctor.
Danish: • hvis du bruger kontaktlinser og/eller har haft øjenproblemer såsom meget tørre øjne, betændelse i den forreste del af øjet (hornhinden) eller sårdannelse, som involverer den forreste del af øjet.
English: Studies in animals have shown no evidence of impaired fertility.
Danish: Dyreforsøg har vist, at der ikke er evidens for forringet fertilitet.
English: Based on the results of pharmacokinetic studies, current smokers should be advised to stop smoking while taking Tarceva, as plasma concentrations could be reduced otherwise.
Danish: På grundlag af resultaterne af disse farmakokinetiske studier skal rygere rådes til at stoppe med at ryge, mens de tager Tarceva, da plasmakoncentrationerne ellers kan nedsættes.
English: Single oral doses of Tarceva up to 1000 mg erlotinib in healthy subjects, and up to 1600 mg in cancer patients have been tolerated.
Danish: Orale enkeltdoser af Tarceva på op til 1000 mg erlotinib til raske frivillige og op til 1600 mg til cancerpatienter er blevet tolereret.
English: Safety data were comparable between the 300 mg and 150 mg doses; however, there was a numerical increase in the incidence of rash, interstitial lung disease and diarrhoea, in patients receiving the higher dose of erlotinib.
Danish: Sikkerhedsdata var sammenlignelige mellem doserne 300 mg og 150 mg, dog var der en øget numerisk stigning i forekomsten af udslæt, interstitiel lungesygdom og diarré hos patienter, der modtog højeste dosis af erlotinib.
English: This corresponded to an overall average of 63% (range 5-161%) of the steady state observed peak plasma concentrations.
Danish: Det svarer til et samlet gennemsnit på 63 % (spændvidde: 5-161 %) af peak-plasmakoncentrationerne i steady-state.
English: The corresponding frequency category for each adverse drug reaction is based on the following convention: 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).
Danish: 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).
English: Data from reproductive toxicology tests in rats and rabbits at doses near the maximum tolerated dose and/or maternally toxic doses showed reproductive (embryotoxicity in rats, embryo resorption and foetotoxicity in rabbits) and developmental (decrease in pup growth and survival in rats) toxicity, but was not teratogenic and did not impair fertility.
Danish: Data fra reproduktionstoksikologiske tests på rotter og kaniner i doser i nærheden af maksimum tolererbar dosis og/eller maternale toksiske doser viste reproduktionstoksiske (embryotoksicitet hos rotte, embryoresorption og foetotoksicitet hos kaniner) og udviklingstoksiske (nedsat vækst af unger og nedsat overlevelse hos rotter) virkninger, men ingen teratogenicitet og ingen påvirkning af fertiliteten.
English: Concomitant administration of inhibitors of Pgp, e.g. cyclosporine and verapamil, may lead to altered distribution and/or altered elimination of erlotinib.
Danish: Samtidig administration af Pglykoproteinhæmmere, f.eks. ciclosporin og verapamil kan medføre ændret distribution og/eller ændret elimination af erlotinib.
English: You may have increased side effects and your doctor may interrupt your treatment.
Danish: Du kan få øgede bivirkninger, og din læge vil måske afbryde behandlingen.
English: The 300 mg dose did not show improved efficacy in second line treatment after failure of chemotherapy compared to the recommended 150 mg dose in patients who continue to smoke cigarettes.
Danish: Dosis på 300 mg viste ikke forbedret virkning i anden-linje behandling efter svigt af kemoterapi sammenlignet med den anbefalede dosis på 150 mg hos patienter, der fortsætter med at ryge.
English: 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.
Danish: Hvid 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 Tarceva.
English: • Excess body and facial hair of a male distribution pattern
Danish: • Øget krops- og ansigtsbehåring fordelt på en mandlig facon
English: In the remaining 55% of patients with unknown EGFR-expression status, the hazard ratio was 0.77 (95% CI 0.61-0.98).
Danish: Hos de resterende 55 % af patienterne med ukendt EGFR-ekspressionsstatus var hazard ratio 0,77 (95 % konfidensinterval 0,61-0,98).
English: As the potential for harm to the nursing infant is unknown, mothers should be advised against breast-feeding while receiving Tarceva and for at least 2 weeks after the final dose.
Danish: Da den potentielle fare for fostret ved amning er ukendt, skal mødre rådes til ikke at amme, mens de tager Tarceva og mindst 2 uger efter sidste dosis.
English: The most frequent ADRs seen in patients treated with Tarceva in studies BO18192 and BO25460 were rash (BO18192: all grades 49.2%, grade 3: 6.0%; BO25460: all grades 39.4%, grade 3: 5.0%) and diarrhoea (BO18192: all grades 20.3%, grade 3: 1.8%; BO25460: all grades 24.2%, grade 3: 2.5%).
Danish: De hyppigste bivirkninger, der blev observeret hos patienter behandlet med Tarceva i studie BO18192 og BO25460, var udslæt (BO18192: alle grader 49,2%, grad 3: 6,0%; BO25460: alle grader 39,4%, grad 3: 5,0%) og diarré (BO18192: alle grader 20,3%, grad 3: 1,8%; BO25460: alle grader 24,2%, grad 3: 2,5%).
English: Pharmacotherapeutic group: antineoplastic agent protein kinase inhibitor, ATC code: L01XE03
Danish: Farmakoterapeutisk klassifikation: antineoplastisk stof, proteinkinasehæmmer, ATC-kode: L01XE03
English: Hydroxypropyl cellulose (E463) Titanium dioxide (E171)
Danish: Hydroxypropylcellulose (E463) Titandioxid (E171) Macrogol
English: This was confirmed in a pharmacokinetic study in non-smoking and currently cigarette smoking healthy subjects receiving a single oral dose of 150 mg erlotinib.
Danish: Dette blev bekræftet i et farmakokinetisk studie hos ikkerygere og hos cigaretrygende raske forsøgspersoner, der fik en enkelt oral erlotinib dosis på 150 mg.
English: Paediatric population There have been no specific studies in paediatric patients.
Danish: Pædiatrisk population Der foreligger ingen specifikke studier hos børn.
English: Second and Further Line Treatment
Danish: Anden-linje behandling og efterfølgende linjer
English: In another clinical study, erlotinib was shown not to affect pharmacokinetics of the concomitantly administered CYP3A4/2C8 substrate paclitaxel.
Danish: I et andet klinisk studie blev det vist, at erlotinib ikke påvirkede farmakokinetikken af det samtidigt administrerede CYP3A4/2C8-substrat paclitaxel.
English: Dose modifications (interruptions or reductions) for rash and diarrhoea were needed in 8.3% and 3% of patients, respectively, in study BO18192 and 5.6% and 2.8% of patients, respectively, in study BO25460.
Danish: Dosisjustering (afbrydelse eller reduktion) på grund af udslæt eller diarré var nødvendig hos henholdsvis 8,3 % og 3 % af patienterne i studie BO18192 og hos henholdsvis 5,6 % og 2,8% af patienterne i studie BO25460.
English: Your doctor may need to interrupt or stop your treatment.
Danish: Din læge kan være nødt til at afbryde eller stoppe din behandling.
English: Reduced exposure may also occur with other inducers e.g. phenytoin, carbamazepine, barbiturates or St. John's Wort (hypericum perforatum).
Danish: Nedsat eksponering kan også forekomme med andre induktorer f.eks. phenytoin, carbamazepin, barbiturater eller perikon (hypericum perforatum).
English: The tablets contain lactose and should not be administered to patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Danish: Tabletterne indeholder lactose og bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form for hereditær lactasemangel (Lapp lactase deficiency) eller glucose-/galactosemalabsorption.
English: In two other double-blind, randomised, placebo-controlled Phase III studies BO18192 (SATURN) and BO25460 (IUNO); Tarceva was administered as maintenance after first-line chemotherapy.
Danish: I to andre dobbeltblindede, randomiserede, placebokontrollerede fase-III studier BO18192 (SATURN) og BO25460 (IUNO), blev Tarceva administreret som vedligeholdelsesbehandling efter første-linje kemoterapi.
English: The recommended daily dose of Tarceva is 150 mg taken at least one hour before or two hours after the ingestion of food.
Danish: Den anbefalede daglige dosis af Tarceva er 150 mg, som tages mindst en time før eller to timer efter indtagelse af føde.
English: A survival benefit of Tarceva was also observed in patients who did not achieve an objective tumour response (by RECIST).
Danish: Der blev også set en forøget overlevelse med Tarceva hos patienter, som ikke opnåede et objektivt tumorrespons (iht.
English: Studies in animals have shown no evidence of teratogenicity or abnormal parturition.
Danish: Dyreforsøg har vist, at der ikke er evidens for teratogenicitet eller unormal fødsel.
English: Tarceva should be permanently discontinued in patients who develop gastrointestinal perforation (see section 4.8).
Danish: Tarceva skal seponeres permanent hos patienter, som udvikler gastrointestinal perforation (se pkt.
English: Based on the data from the BO25460 (IUNO) study, Tarceva use is not recommended for first-line maintenance treatment in patients without an EGFR activating mutation.
Danish: På baggrund af data fra BO25460 (IUNO) studiet anbefales Tarceva ikke som første-linjevedligeholdelsesbehandling til patienter uden EGFR-aktiverende mutation.
English: The primary endpoint was survival.
Danish: Det primære endepunkt var overlevelse.
English: Median overall survival Mean overall survival
Danish: Median samlet overlevelse Middel s amlet overlevelse
English: Increased serum concentrations of total bilirubin and AAG concentrations were associated with a reduced erlotinib clearance.
Danish: Forhøjede serumkoncentrationer af total bilirubin og AAG-koncentrationer var ledsaget af en reduceret erlotinib-clearance.
English: The effects of concomitant administration of erlotinib with H2 antagonists and antacids are unknown; however, reduced bioavailability is likely.
Danish: Virkningen af samtidig administration af erlotinib med H2-antagonister og antacida kendes ikke; men det er sandsynligt, at biotilgængeligheden vil være mindsket.
English: Patient factors, which correlated with erlotinib pharmacokinetics, were serum total bilirubin, AAG and current smoking.
Danish: Patientfaktorer, som korrelerede med erlotinibs farmakokinetik, var total serumbilirubin, AAG og rygning.
English: Other medicines and Tarceva
Danish: Brug af anden medicin sammen med Tarceva
English: When dose adjustment is necessary, the dose should be reduced in 50 mg steps (see section 4.4).
Danish: Hvis dosisjustering er nødvendig, bør dosis reduceres trinvist med 50 mg ad gangen (se pkt.
English: If you experience more severe or persistent diarrhoea contact your doctor immediately as your doctor may need to treat you in the hospital.
Danish: Hvis du får mere alvorlig eller vedvarende diarré skal du omgående kontakte din læge, idet der kan være behov for at du behandles på et hospital.
English: If you could become pregnant, use adequate contraception during treatment, and for at least 2 weeks after taking the last tablet.
Danish: Hvis du kan blive gravid, skal du anvende sikker prævention under behandlingen og i mindst 2 uger efter, du har taget den sidste tablet.
English: Based on the data from the CURRENTS study, no evidence was seen for any benefit of a higher erlotinib dose of 300 mg when compared with the recommended dose of 150 mg in active smokers.
Danish: Baseret på data fra CURRENTS studiet sås der ingen evidens for nogen effekt af en højere dosis erlotinib på 300 mg sammenlignet med den anbefalede dosis på 150 mg hos aktive rygere.
English: Overall Survival (OS) (months)
Danish: Samlet overlevelse*** (måneder)
English: Erlotinib and other CYP substrates
Danish: Erlotinib og andre CYP-substrater
English: CI of Δ HR
Danish: Konfidensinterval af Δ HR
English: 4 In clinical studies, some cases have been associated with concomitant warfarin administration and some with concomitant NSAID administration (see section 4.5).
Danish: I kliniske studier har nogle tilfælde været i forbindelse med samtidig administration af warfarin og nogle gange med samtidig administration af NSAIDs (se pkt.
English: The safety and efficacy of erlotinib has not been studied in patients with renal impairment (serum creatinine concentration >1.5 times the upper normal limit).
Danish: Sikkerheden og virkningen af erlotinib er ikke undersøgt hos patienter med nedsat nyrefunktion (koncentrationen af serumkreatinin >1,5 gang den øvre referencegrænse).
English: Results of a pharmacokinetic interaction study indicated a significant 2.8-, 1.5- and 9-fold reduced AUCinf, Cmax and plasma concentration at 24 hours, respectively, after administration of Tarceva in smokers as compared to non-smokers.
Danish: Resultaterne fra et farmakokinetisk interaktionsstudie indikerede efter 24 timer en signifikant reduktion af AUCinf, Cmax samt plasmakoncentration på henholdsvis 2,8; 1,5 og 9 gange efter administration af Tarceva hos rygere sammenlignet med ikke-rygere.
English: For patients who are exposed to sun, protective clothing, and/or use of sunscreen (e.g. mineral-containing) may be advisable.
Danish: For patienter, som udsættes for sollys, vil brug af beskyttende påklædning og/eller solbeskyttelsescreme (fx mineralholdig) være tilrådelig.
English: Bullous and exfoliative skin disorders
Danish: Bulløse og eksfoliative hudsygdomme
English: This medicine can also be prescribed to you in combination with another treatment called gemcitabine if you have cancer of the pancreas at a metastatic stage.
Danish: Du kan også få ordineret dette lægemiddel i kombination med et andet lægemiddel ved navn gemcitabin, hvis du har kræft i bugspytkirtlen i et metastatisk stadie.
English: Adverse drug reactions from clinical trials (Table 1) are listed by MedDRA system organ class.
Danish: Bivirkninger observeret i kliniske studier (tabel 1) er listet i henhold til MedDRA systemet.
English: Patients with Non-Small Cell Lung Cancer EGFR mutation testing should be performed in accordance with the approved indications (see section
Danish: Patienter med ikke-småcellet lungecancer (NSCLC) Der skal udføres EGFR-mutationstest i overensstemmelse med de godkendte indikationer (se pkt.
English: A second population pharmacokinetic analysis was conducted that incorporated erlotinib data from 204 pancreatic cancer patients who received erlotinib plus gemcitabine.
Danish: Der blev lavet en anden populationsfarmakokinetisk analyse, hvori der indgik erlotinibdata fra 204 patienter med pancreascancer, som fik erlotinib plus gemcitabin.
English: Tarceva with food and drink Do not take Tarceva with food.
Danish: Brug af Tarceva sammen med mad og drikke
English: 67% of placebo patients in the EGFR mutation positive subgroup received second or further line treatment with EGFR-TKIs.
Danish: 67 % af placebo- patienterne i den EGFR-mutationspositive undergruppe fik anden-linje-behandling eller efterfølgende behandlingslinjer med EGFR-tyrosinkinasehæmmere (EGFR-TKIer).
English: Tumour regression is observed in mouse models of enforced expression of these EGFR activating mutations.
Danish: Der er observeret tumorregression i musemodeller med fremtvunget ekspression af disse EGFR-aktiverende mutationer.
English: The usual dose is one tablet of Tarceva 150 mg each day if you have non-small cell lung cancer.
Danish: Den normale dosis er én Tarceva 150 mg tablet hver dag, hvis du har ikke-småcellet lungekræft.
English: The median time to onset of rash was 10 days.
Danish: Den mediane tid indtil udslæt var 10 dage.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Tarceva in all subsets of the paediatric population in Non Small Cell Lung Cancer and Pancreatic cancer indications (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur (EMA) har dispenseret fra kravet om fremlæggelse af resultaterne af studier med Tarceva hos alle undergrupper af den pædiatriske population ved indikationerne ikke småcellet lungecancer og pancreascancer (se pkt.
English: Lactose monohydrate Cellulose, microcrystalline (E460) Sodium starch glycolate Type A Sodium laurilsulfate Magnesium stearate (E470 b)
Danish: Lactosemonohydrat Cellulose, mikrokrystallinsk (E460) Natriumstivelsesglycolat type A Natriumlaurilsulfat Magnesiumstearat (E470 b)
English: However, an adverse effect on the pregnancy can not be excluded as rat and rabbit studies have shown increased embryo/foetal lethality (see section 5.3).
Danish: En uønsket virkning på graviditeten kan dog ikke udelukkes, da dyreforsøg med rotter og kaniner har vist øget embryo/føtal letalitet (se pkt.
English: Cases were mainly mild to moderate in severity, transient in nature or associated with liver metastases.
Danish: Tilfældene var hovedsagligt af let eller moderat sværhedsgrad, forbigående eller forbundet med levermetastaser.
English: • if you are taking statins (medicines to lower your blood cholesterol), Tarceva may increase the risk of statin related muscle problems, which on rare occasions can lead to serious muscle breakdown (rhabdomyolysis) resulting in kidney damage, talk to your doctor.
Danish: • hvis du tager statiner (medicin som sænker dit kolesterol i blodet), kan Tarceva øge risikoen for statin-relaterede muskelproblemer, som i sjældne tilfælde kan medføre alvorlig nedbrydning af musklerne (rabdomyolyse), hvilket kan resultere i nyreskader.
English: Dose modifications (interruptions or reductions) for rash and diarrhoea were needed in 11% and 7% of patients, respectively.
Danish: Dosisjustering (afbrydelse eller reduktion) på grund af udslæt eller diarré var nødvendig hos henholdsvis 11 % og 7 % af patienterne.
English: Diarrhoea, dehydration, electrolyte imbalance and renal failure Diarrhoea (including very rare cases with a fatal outcome) has occurred in approximately 50% of patients on Tarceva and moderate or severe diarrhoea should be treated with e.g. loperamide.
Danish: Diarré, dehydrering, elektrolytforstyrrelser, nyreinsufficiens Diarré (inklusive meget sjældne letale tilfælde) er forekommet hos ca. 50 % af patienterne, der får Tarceva, og moderat eller svær diarré bør behandles med f.eks. loperamid.
English: The primary active metabolites were present in tumour at concentrations averaging 160 ng/g tissue, which corresponded to an overall average of 113% (range 88-130%) of the observed steady state peak plasma concentrations.
Danish: De primære, aktive metabolitter blev observeret i tumor i en gennemsnitlig koncentration på 160 ng/g væv, hvad der svarer til et samlet gennemsnit på 113 % (spændvidde: 88-130 %) af peak-plasmakoncentrationerne i steady-state.
English: Females
Danish: Kvinder
English: No survival advantage could be shown for patients with locally advanced disease.
Danish: Hos patienter med lokalt fremskreden sygdom er der ikke vist en forlænget overlevelse.
English: Always take this medicine exactly as your doctor has told you.
Danish: Tag altid Tarceva nøjagtigt efter lægens anvisning.
English: In a post-hoc analysis, patients on Tarceva who developed a rash had a longer overall survival compared to patients who did not develop rash (median OS 7.2 months vs 5 months, HR:0.61).
Danish: En post-hoc analyse viste, at patienter, der blev behandlet med Tarceva og fik udslæt, havde en længere samlet overlevelse sammenlignet med patienter, som ikke fik udslæt (median samlet overlevelse 7,2 måneder versus 5 måneder, HR:0,61).
English: When erlotinib was given in combination with capecitabine, there was a statistically significant increase in erlotinib AUC and a borderline increase in Cmax when compared with values observed in another study in which erlotinib was given as single agent.
Danish: Ved administration af erlotinib i kombination med capecitabin er der set en statistisk signifikant stigning i erlotinib AUC og en mindre stigning i Cmax sammenlignet med de værdier, der blev observeret i et andet studie, hvor erlotinib blev administreret som enkeltstof.
English: The percent of patients alive at 12 months was 31.2% and 21.5%, for the Tarceva and placebo groups, respectively.
Danish: Efter 12 måneder var hhv. 31,2 % og 21,5 % i live i Tarceva- og placebogruppen.
English: Co-administration of rifampicin with a single 450 mg dose of Tarceva resulted in a mean erlotinib exposure (AUC) of 57.5% of that after a single 150 mg Tarceva dose in the absence of rifampicin treatment.
Danish: Samtidig administration af rifampicin med en enkelt 450 mg Tarceva-dosis medførte en middel erlotinib-eksponering (AUC) på 57,5 % af den eksponering, der blev opnået efter en enkelt 150 mg Tarceva-dosis uden behandling med rifampicin.