FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should be advised to seek medical advice immediately if they experience severe or persistent diarrhoea, nausea, vomiting or anorexia as these may indirectly lead to dehydration.
Danish: Patienter skal rådes til straks at søge lægehjælp, såfremt de oplever svær eller vedvarende diarré, kvalme, opkastning eller appetitløshed, da dette indirekte kan føre til dehydrering.
English: This may mean that you have an ulcer on the surface of the eye (cornea).
Danish: Dette kan betyde, at du har et sår på overfladen af øjet (hornhinden).
English: An average 3.1-fold increase in exposure to gefitinib in patients with moderate and severe hepatic impairment was observed.
Danish: Der blev observeret en gennemsnitlig 3,1-gange forøget eksponering af gefitinib hos patienter med moderat og svær hepatisk insufficiens.
English: Each tablet contains 163.5 mg of lactose (as monohydrate).
Danish: Hver tablet indeholder 163,5 mg lactose (som monohydrat).
English: In the overall population, no statistically significant difference between gefitinib and docetaxel (75 mg/m2) was observed for overall survival, progression free survival and objective response rates (see Table 5).
Danish: Hos den totale population blev der ikke observeret nogen statistisk signifikant forskel mellem gefitinib og docetaxel (75 mg/m2), målt som total overlevelse, progressionsfri overlevelse eller objektiv responsrate (se tabel 5).
English: Data from 4 patients with severe hepatic impairment due to liver metastases suggested that steady-state exposures in these patients are also similar to those in patients with normal hepatic function.
Danish: Data fra 4 patienter med svært nedsat leverfunktion på grund af levermetastaser, tyder på, at steady-state-eksponeringen hos disse patienter også er sammenlignelig med eksponeringen hos patienter med normal hepatisk funktion.
English: It is therefore considered unlikely that it contributes to the clinical activity of gefitinib.
Danish: Derfor betragtes det som usandsynligt, at den bidrager til gefitinibs kliniske effekt.
English: 28/70 (40%) of never smokers are M+ 47/716 (7%) of ever smokers are M+
Danish: 28/70 (40 %) af de der aldrig har røget er M+ 47/716 (7 %) af de der har røget på et tidspunkt M+
English: 2.8 v. 5.0 Non-adenocarcinoma
Danish: 2.8 v. 5.0 Ikke-adenocarcinoma
English: Following oral administration of gefitinib, absorption is moderately slow and peak plasma concentrations of gefitinib typically occur at 3 to 7 hours after administration.
Danish: Efter oral administration af gefitinib er absorptionen moderat langsom og den maksimale plasmakoncentration opnås typisk 3 til 7 timer efter administration.
English: Film-coated tablets (tablet).
Danish: Filmovertrukne tabletter (tablet).
English: Three blisters are combined with an aluminium foil laminate over-wrap in a carton.
Danish: Tre blistre er sampakket i aluminiumsfolielaminat i en karton.
English: Swirl the water until the tablet has dissolved.
Danish: Sving forsigtigt glasset rundt, indtil tabletten er opslæmmet.
English: If any of the above applies to you, or if you are not sure, check with your doctor or pharmacist before taking IRESSA.
Danish: Hvis et eller flere af ovennævnte punkter gælder for dig, eller hvis du er i tvivl, skal du spørge din læge eller på apoteket, før du tager IRESSA.
English: EGFR activating mutation within a cancer cell is an important factor in promotion of tumour cell growth, blocking of apoptosis, increasing the production of angiogenic factors and facilitating the processes of metastasis.
Danish: EGFRaktiverede mutationer i cancerceller er en vigtig, understøttende faktor ved tumorcellevækst, blokering af apoptose, forøgelse af produktionen af angiogene faktorer og facilitering af metastaseprocesser.
English: Clinical experience has not shown a causal association between QT prolongation and gefitinib.
Danish: Den kliniske erfaring har ikke vist en kausal sammenhæng mellem QT-forlængelse og gefitinib.
English: Red or sore mouth
Danish: • Rød eller øm mund
English: If a diagnosis of ulcerative keratitis is confirmed, treatment with gefitinib should be interrupted, and if symptoms do not resolve, or if symptoms recur on reintroduction of gefitinib, permanent discontinuation should be considered.
Danish: Ved diagnosticering af keratitis ulcerosa bør behandlingen med gefitinib afbrydes, og hvis symptomerne ikke forsvinder, eller hvis de vender tilbage ved genoptagen behandling med gefitinib, bør permanent seponering overvejes.
English: From analyses of population pharmacokinetic data in cancer patients, no relationships were identified between predicted steady-state trough concentration and patient age, body weight, gender, ethnicity or creatinine clearance (above 20 ml/min).
Danish: Analyser, der er baseret på farmakokinetiske populationsdata fra cancerpatienter, viste ingen sammenhæng mellem den forudsete steady-state-koncentration og patientens alder, vægt, køn, etnisk oprindelse eller kreatininclearance (over 20 ml/min).
English: There is no relevant use of gefitinib in the paediatric population in the indication of NSCLC.
Danish: Det er ikke relevant at bruge gefitinib på indikationen NSCLC i den pædiatriske population.
English: The results of an in vitro phototoxicity study demonstrated that gefitinib may have phototoxicity potential.
Danish: Resultaterne af et in vitro-fototoksicitetsforsøg viste, at gefitinib kan have fototoksisk potentiale.
English: No dose adjustment is required in patients with impaired renal function at creatinine clearance > 20 ml/min.
Danish: Dosisjustering er ikke nødvendig hos patienter med nedsat nyrefunktion med kreatininclearance > 20 ml/min.
English: These symptoms should be managed as clinically indicated (see section 4.8).
Danish: Disse symptomer bør behandles som klinisk indiceret (se pkt.
English: What IRESSA contains The active substance is gefitinib.
Danish: IRESSA indeholder det aktive stof gefitinib.
English: In most cases this is associated with other known risk factors, including concomitant medications such as steroids or NSAIDS, underlying history of GI ulceration, age, smoking or bowel metastases at sites of perforation.
Danish: I de fleste tilfælde er det i forbindelse med andre kendte risikofaktorer, f.eks. samtidig behandling med andre medikamenter såsom steroider eller NSAID, anamnese med gastrointestinal ulceration, alder, rygning, metastaser på perforationsstedet i tarmen.
English: An increased risk of ILD on gefitinib relative to chemotherapy was seen predominantly during the first 4 weeks of treatment (adjusted OR 3.8; 95% CI 1.9 to 7.7); thereafter the relative risk was lower (adjusted OR 2.5; 95% CI 1.1 to 5.8).
Danish: Der sås en forøget relativ risiko for ILS hos patienter behandlet med IRESSA i forhold til kemoterapi i løbet af de første 4 ugers behandling (justeret OR 3,8; 95 % CI 1,9 til 7,7); derefter var den relative risiko lavere (justeret OR 2,5; 95 % CI 1,1 til 5,8).
English: Bullous conditions including toxic epidermal necrolysis, Stevens Johnson syndrome and erythema multiforme Cutaneous vasculitis
Danish: Bulløse tilstande, inklusive toksisk epidermal nekrolyse, Stevens-Johnsons syndrom og erythema multiforme
English: If it is 12 hours or more until your next dose: take the missed tablet as soon as you remember.
Danish: • Hvis der er 12 timer eller mere til din næste dosis: Tag den glemte tablet, så snart du kommer i tanke om det.
English: Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitors; ATC code: L01XE02
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske stoffer, proteinkinasehæmmere; ATC-kode: L01XE02
English: To make sure that you have drunk all of the medicine, rinse the glass very well with half a glass of water and drink it.
Danish: For at være sikker på, at du har drukket al medicinen, skylles glasset omhyggeligt med et halvt glas vand, som drikkes.
English: In the INTEREST trial, the incidence of ILD type events was 1.4% (10) patients in the gefitinib group versus 1.1% (8) patients in the docetaxel group.
Danish: I INTEREST-studiet var forekomsten af ILS-bivirkninger 1,4 % (10 patienter) i gefitinib-gruppen versus 1,1 % (8 patienter) i docetaxel-gruppen.
English: Exposure to gefitinib is not significantly altered by food.
Danish: Indtagelse af mad ændrer ikke eksponeringen for gefitinib signifikant.
English: Published studies have shown that genetically modified mice, lacking expression of EGFR, exhibit developmental defects, related to epithelial immaturity in a variety of organs including the skin, gastrointestinal tract and lung.
Danish: Publicerede studier har vist, at genmodificerede mus, der mangler ekspression af EGFR, udviser udviklingsfejl relateret til umodent epitel i forskellige organer inklusive hud, den gastrointestinale kanal samt lunger.
English: First line treatment The randomised phase III first line IPASS study was conducted in patients in Asia
Danish: Førstelinjebehandling Det randomiserede fase III-førstelinjeforsøg IPASS blev gennemført med patienter fra Asien
English: Driving and using machines If you feel weak whilst taking this medicine, take care driving or using tools or machines.
Danish: Hvis du føler dig svag, mens du tager denne medicin, skal du dog være forsigtig med at føre motorkøretøjer eller bruge værktøj og maskiner.
English: When considering the use of IRESSA as a treatment for locally advanced or metastatic NSCLC, it is important that EGFR mutation assessment of the tumour tissue is attempted for all patients.
Danish: Når det overvejes at anvende IRESSA til behandling af lokalt fremskredent eller metastatisk NSCLC, er det vigtigt, at EGFR-mutation i tumorvævet forsøges vurderet hos alle patienter.
English: In the ISEL trial, the incidence of ILD-type events in the overall population was approximately 1% in both treatment arms.
Danish: I ISEL-studiet var forekomsten af bivirkninger af ILS-typen i hele populationen ca. 1 % i begge behandlingsarme.
English: Elderly No dose adjustment is required on the basis of patient age (see section 5.2).
Danish: Ældre Dosisjustering er ikke nødvendig på grund af patienternes alder (se pkt.
English: If patients experience worsening of respiratory symptoms such as dyspnoea, cough and fever, IRESSA should be interrupted and the patient should be promptly investigated.
Danish: Såfremt patienter oplever forværring af respiratoriske symptomer såsom dyspnø, hoste og feber, skal IRESSA-behandlingen afbrydes, og en øjeblikkelig undersøgelse initieres.
English: Do not take a double dose (two tablets at the same time) to make up for a forgotten dose.
Danish: Du må ikke tage en dobbeltdosis (to tabletter på samme tid) som erstatning for den glemte tablet.
English: Non-Asians
Danish: Ikke-asiatere
English: Gefitinib shows no enzyme induction effects in animal studies and no significant inhibition (in vitro) of any other cytochrome P450 enzyme.
Danish: Gefitinib udviser ingen enzym-induktionseffekter i dyreforsøg og ingen signifikant hæmning (in vitro) af nogen andre CYP-enzymer.
English: Do not take IRESSA if you are allergic to gefitinib or any of the other ingredients of this medicine (listed in section6, ‘What IRESSAcontains').
Danish: Tag ikke IRESSA - hvis du er allergisk over for gefitinib eller et af de øvrige indholdsstoffer (angivet i punkt 6,
English: In a post-marketing surveillance study in Japan (3350 patients) the reported rate of ILD-type events in patients receiving gefitinib was 5.8%.
Danish: I et overvågningsstudie efter markedsføringen med 3.350 patienter i Japan, var den rapporterede frekvens af bivirkninger af ILS-typen hos patienter, der fik gefitinib, 5,8 %.
English: The dispersion can also be administered through a naso-gastric or gastrostomy tube.
Danish: Dispersionen kan også administreres gennem en naso-gastrisk sonde eller gastrostomi-sonde.
English: Gefitinib is excreted mainly as metabolites via the faeces, with renal elimination of gefitinib and metabolites accounting for less than 4% of the administered dose.
Danish: Gefitinib udskilles primært som metabolitter via fæces, ved renal eliminering af gefitinib og metabolitter, som udgør mindre end 4 % af den administrerede dosis.
English: Other potential mechanisms of resistance that have been reported following treatment with EGFR signal blocking agents include: bypass signalling such as HER2 and MET gene amplification and PIK3CA mutations.
Danish: Andre potentielle resistensmekanismer, som er rapporteret efter behandling med EGFR-signalblokerende midler, omfatter: bypass-signalering såsom amplifikation af HER2- og MET-genet samt PIK3CA-mutationer.
English: *This adverse reaction can occur in association with other dry conditions (mainly skin reactions) seen with gefitinib.
Danish: * Denne bivirkning forekommer i forbindelse med andre tørre tilstande (fortrinsvis hudreaktioner) i forbindelse med gefitinib.
English: Data from phase II clinical trials, where gefitinib and vinorelbine have been used concomitantly, indicate that gefitinib may exacerbate the neutropenic effect of vinorelbine.
Danish: Data fra et klinisk fase-II-forsøg, hvor gefitinib og vinorelbin blev givet samtidig, indikerer, at gefitinib kan forværre den neutropene effekt af vinorelbin.
English: An increased risk of cerebral haemorrhage in adult patients with NSCLC receiving gefitinib has not been established.
Danish: Der er ikke fastlagt nogen forøget risiko for cerebral blødning hos voksne patienter med NSCLC, som får gefitinib.
English: If a tumour sample is not evaluable, then circulating tumour DNA (ctDNA) obtained from a blood (plasma) sample may be used.
Danish: Hvis en tumorprøve ikke kan vurderes, kan der anvendes cirkulerende tumor-DNA (ctDNA) fra en blodprøve (plasma).
English: ORR (%) Gefitinib v. Docetaxel
Danish: Objektiv respons rate (%) Gefitinib v. Docetaxel
English: Gefitinib and metabolites of gefitinib accumulated in milk of lactating rats (see section 5.3).
Danish: Gefitinib og metabolitter heraf akkumuleres i mælken hos diende rotter (se pkt.
English: Asian patients also have a higher incidence of EGFR mutation-positive tumours.
Danish: Asiatiske patienter har en højere incidens af tumorer med positiv EGFR-mutation.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Bivirkningerne er inden for hver frekvensgruppe opstillet i rækkefølge med aftagende alvorlighed.
English: The common EGFR activating mutations (Exon 19 deletions; L858R) have robust response data supporting sensitivity to gefitinib; for example a progression free survival HR (95% CI) of 0.489 (0.336, 0.710) for gefitinib vs. doublet chemotherapy [WJTOG3405].
Danish: De almindelige EGFR-aktiverende mutationer (Exon-19-deletioner; L858R) har robuste responsdata, der understøtter sensitiviteten for gefitinib; for eksempel en HR (95 % CI) for progressionsfri overlevelse på 0,489 (0,336-0,710) for gefitinib versus dublet-kemoterapi [WJTOG3405].
English: 1 with advanced (stage IIIB or IV) NSCLC of adenocarcinoma histology who were ex-light smokers (ceased smoking > 15 years ago and smoked < 10 pack years) or never smokers (see Table 3).
Danish: 1, som havde avanceret NSCLC (i stadie IIIB eller IV) med adenocarcinom-histologi og var tidligere lette rygere (rygeophør > 15 år siden og cigaretforbrug < 10 pakkeår), eller som aldrig havde røget (se tabel 3).
English: However, in phase I clinical trials, a limited number of patients were treated with daily doses of up to 1000 mg. An increase of frequency and severity of some adverse reactions was observed, mainly diarrhoea and skin rash.
Danish: Dog er et begrænset antal patienter i kliniske fase I-forsøg blevet behandlet med daglige doser på op til 1.000 mg. Der blev observeret en øget frekvens og sværhedsgrad af nogle af bivirkningerne, hovedsageligt diarré og hududslæt.
English: Smoking status <0.0001 6.5 times higher in never smokers than ever-smokers
Danish: <0,0001 6,5 gange højere hos dem, der aldrig har røget end hos dem, der har røget på et tidspunkt
English: IRESSA is a round brown tablet marked with ‘IRESSA 250' on one side and plain on the other.
Danish: IRESSA er en rund brun tablet mærket med ”IRESSA 250” på den ene side og uden mærkning på den anden.
English: N Objective response rates and 95% CI for difference between treatments
Danish: Objektive responsrater og 95 % CI for forskel mellem behandlingerne
English: Increase of a liver enzyme known as alanine aminotransferase in a blood test; if too high, your doctor may tell you to stop taking IRESSA
Danish: • Forøget antal leverenzymer, som kaldes alanin-aminotransferase, ved en blodprøve; hvis antallet er for højt, vil din læge muligvis fortælle dig, at du skal stoppe med at tage IRESSA.
English: It was shown that following daily administration of 250 mg gefitinib, time to steady-state, total plasma clearance (CmaxSS) and steady-state exposure (AUC24SS) were similar for the groups with normal and moderately impaired hepatic function.
Danish: Ved daglig administration af 250 mg gefitinib, blev det vist, at tiden til steady-state, total plasmaclearance (CmaxSS) og steady-state-eksponering (AUC24SS) var sammenlignelig for grupperne med normal og moderat nedsat leverfunktion.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Danish: Forsøg i dyr har vist reproduktionstoksicitet (se pkt.
English: If ILD is confirmed, IRESSA should be discontinued and the patient treated appropriately.
Danish: Hvis interstitiel lungesygdom bekræftes, bør IRESSA-behandlingen stoppes, og patienten behandles på behørig vis.
English: The higher average exposures that could be achieved by individuals with no active CYP2D6 may be clinically relevant since adverse effects are related to dose and exposure.
Danish: Den højere gennemsnitlige eksponering, som kan opnås hos personer uden CYP2D6aktivitet, kan være klinisk relevant, idet bivirkninger er relateret til dosis og eksponering.
English: Cases with fatal outcomes have been reported
Danish: Fatale tilfælde har været rapporteret
English: Tablets are brown, round, biconvex, impressed with “IRESSA 250” on one side and plain on the other.
Danish: Tabletterne er brune, runde, bikonvekse, mærkede med “IRESSA 250” på den ene side og uden mærkning på den anden.
English: Patients presenting with signs and symptoms suggestive of keratitis such as acute or worsening: eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain and/or red eye should be referred promptly to an ophthalmology specialist.
Danish: Patienter med tegn og symptomer, der tyder på keratitis, såsom akut eller tiltagende øjeninflammation, tåreflåd, fotosensibilitet, uskarpt syn, øjensmerter og/eller røde øjne, skal omgående henvises til en øjenspecialist.
English: What you need to know before you take IRESSA
Danish: Det skal du vide, før du begynder at tage IRESSA
English: IRESSAcontains the active substance gefitinib which blocks a protein called ‘epidermal growth factor receptor' (EGFR).
Danish: Gefitinib blokerer et protein, der kaldes EGFR (epidermal vækstfaktorreceptor).
English: Most NSCLC tumours with sensitising EGFR kinase mutations eventually develop resistance to IRESSA treatment, with a median time to disease progression of 1 year.
Danish: De fleste NSCLC-tumorer med sensibiliserende EGFR-kinasemutationer kan med tiden udvikle resistens over for IRESSA-behandling mediantiden til sygdomsprogression er 1 år.
English: This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say it is essentially ‘sodium-free'.
Danish: Denne medicin indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. den er i det væsentlige natriumfri.
English: In that study ctDNA derived from serum, not plasma was used for EGFR mutation analysis using the EGFR Mutation Test Kit (DxS) (N= 86).
Danish: I dette studie blev der anvendt ctDNA fra serum, ikke plasma, til EGFR-mutationsanalyse under anvendelse af EGFR-mutationstestsættet (DxS) (N= 86).
English: Table 2 Summary of baseline mutation status for tumour and ctDNA samples in all screened patients evaluable for both samples
Danish: Tabel 2: Sammenfatning af baseline-mutationsstatus for tumor- og ctDNA-prøver for alle screenede patienter, hvor begge prøver var evaluerbare Mål
English: The signs may include redness, pain, ulcers, blisters, and shedding of the skin.
Danish: Dette kan også omfatte rødme, smerter, sår, blister og afskalning af huden.
English: Non-adenocarcinoma
Danish: Ikke-adenocarcinoma
English: Do not use this medicine after the expiry date which is stated on the carton, blister and overwrap foil after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken, blisterpakningen og folieindpakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The role of CYP2D6 in the metabolic clearance of gefitinib has been evaluated in a clinical trial in healthy volunteers genotyped for CYP2D6 status.
Danish: CYP2D6's rolle i den metaboliske clearance af gefitinib er blevet evalueret i et klinisk forsøg med raske frivillige, der var genotypebestemt for CYP2D6.
English: The metabolism of gefitinib is via the cytochrome P450 isoenzyme CYP3A4 (predominantly) and via CYP2D6.
Danish: Metaboliseringen af gefitinib sker via cytokrom P450-isoenzymerne CYP3A4 (overvejende) og CYP2D6.
English: Gefitinib has been evaluated in a clinical trial conducted in 41 patients with solid tumours and normal hepatic function, or moderate or severe hepatic impairment (classified according to baseline Common Toxicity Criteria grades for AST, alkaline phosphatase and bilirubin) due to liver metastases.
Danish: Gefitinib er undersøgt i et klinisk forsøg, der blev udført på 41 patienter med solide tumorer og normal leverfunktion eller moderat eller svær nedsat leverfunktion (klassificeret i henhold til grader af baseline Common Toxicity Criteria for AST, basisk phosphatase og bilirubin) på grund af levermetastaser.
English: Histology <0.0001 4.4 times higher in adenocarcinoma than in non-adenocarcinoma
Danish: <0,0001 4,4 gange højere hos dem med adenokarcinom end hos dem, der ikke har adenokarcinom
English: Pancreatitis Gastrointestinal perforation
Danish: Pankreatit Gastrointestinal perforation
English: Available data do not suggest any clinical consequences to this in vitro finding.
Danish: Ud fra tilgængelige data er der ikke tegn på, at disse in vitro-resultater har nogen kliniske konsekvenser.
English: IRESSA contains less than 1 mmol (23 mg) of sodium per tablet, that is to say it is essentially ‘sodium-free.'
Danish: IRESSA indeholder mindre end 1 mmol (23 mg) natrium pr. tablet, dvs. den er i det væsentlige natriumfri.
English: Patients with poorly tolerated diarrhoea or skin adverse reactions may be successfully managed by providing a brief (up to 14 days) therapy interruption followed by reinstatement of the 250 mg dose (see section 4.8).
Danish: Patienter, der tåler bivirkningerne diarré eller hudreaktioner dårligt, kan håndteres ved at foretage et kort behandlingsophør (op til 14 dage), hvorefter behandling med doseringen på 250 mg genoptages (se pkt.
English: The effects reached statistical significance for the female mice, but not for the males.
Danish: Effekten opnåede statistisk signifikans for hunmus, men ikke for hanmus.
English: The IFUM study was a single-arm, multicentre study conducted in Caucasian patients (n=106) with activating, sensitising EGFR mutation positive NSCLC to confirm that the activity of gefitinib is similar in Caucasian and Asian populations.
Danish: IFUM-studiet var et enkeltarmet multicenter-studie, der blev gennemført med kaukasiske patienter (n=106) med følsom NSCLC med aktiverede EGFR-mutationer for at bekræfte, at aktiviteten af gefitinib er ens i kaukasiske og asiatiske populationer.
English: The objective response rate (ORR) in those patients who were tumour and ctDNA mutation positive was 77% (95% CI: 66% to 86%) and in those who were tumour only mutation positive 60% (95% CI: 44% to 74%).
Danish: Den objektive responsrate (ORR) hos de patienter, som var tumor- og ctDNA-mutationspositive, var 77 % (95 % CI: 66 % til 86 %) og 60 % (95 % CI: 44 % til 74 %) hos dem, som kun var tumormutationspositive.