FrancophonIA/ELRC3.0 huggingface dataset:
English: No clinically relevant activity has been shown in patients with known EGFR mutation-negative tumours.
Danish: Der er ikke påvist nogen relevant klinisk aktivitet hos patienter med kendt EGFRmutationsnegative tumorer.
English: Table 7 Summary of multivariate logistic regression analysis to identify factors that independently predicted for the presence of EGFR mutations in 786 Caucasian patients*
Danish: Tabel 7 Opsummering af multivariat logistisk regressionsanalyse for at identificere faktorer, som uafhængigt forudsiger tilstedeværelsen af EGFR-mutationer hos 786 kaukasiske patienter* Faktorer som forudsiger tilstedeværelse af EGFRmutation p-værdi
English: Such an increase might potentially be relevant for CYP2D6 substrates with narrow therapeutic index.
Danish: En sådan forøgelse kan potentielt være relevant for CYP2D6-substrater med et snævert terapeutisk vindue.
English: Numbers in square brackets are 95% confidence intervals for HR N Number of patients randomised.
Danish: Tal i kvadratiske parenteser er 95 % konfidensinterval (CI) for HR. N Antal randomiserede patienter.
English: Patients with moderate to severe hepatic impairment (Child-Pugh B or C) due to cirrhosis have increased plasma concentrations of gefitinib.
Danish: Patienter med moderat til svær nedsat leverfunktion (Child-Pugh B eller C) som følge af cirrose har forøgede plasmakoncentrationer af gefitinib.
English: Each tablet contains 3.86 mg of sodium.
Danish: Hver tablet indeholder 3,86 mg natrium.
English: In vitro data indicate that gefitinib is a substrate for the membrane transport protein P-gp.
Danish: In vitro-data indikerer, at gefitinib er et substrat for membrantransportproteinet Pg-p.
English: Talk to your doctor before taking this medicine if you are pregnant, may become pregnant or are breast-feeding.
Danish: Spørg din læge eller apoteket til råds, før du tager nogen form for medicin, hvis du er gravid, har chance for at blive gravid, eller hvis du ammer.
English: Primary endpoint overall survival abc
Danish: Primært endepunkt total overlevelse abc
English: The randomised phase III ISEL study was conducted in patients with advanced NSCLC who had received 1 or 2 prior chemotherapy regimens and were refractory or intolerant to their most recent regimen.
Danish: Det randomiserede fase III-forsøg ISEL blev gennemført med patienter med avanceret NSCLC, som tidligere havde modtaget 1 eller 2 gange kemoterapiregimer, og som var refraktære eller intolerante over for det sidste modtagne regime.
English: In a clinical trial in patients, gefitinib was co-administered with metoprolol (a CYP2D6 substrate).
Danish: I et klinisk forsøg hos patienter blev gefitinib givet sammen med metoprolol (et CYP2D6-substrat).
English: Adverse reactions have been assigned to the frequency categories in Table 1 where possible based on the incidence of comparable adverse event reports in a pooled dataset from the ISEL, INTEREST and IPASS phase III clinical trials (2462 IRESSA-treated patients).
Danish: Hvor det er muligt, er frekvenserne baseret på forekomsten af sammenlignelige bivirkningsrapporter ud fra et samlet datasæt fra fase III-studierne ISEL, INTEREST og IPASS (2.462 IRESSA-behandlede patienter).
English: Only limited data are available in patients with creatinine clearance  20 ml/min and caution is advised in these patients (see section 5.2).
Danish: Der findes kun begrænsede data for patienter med kreatininclearance ≤ 20 ml/min, og derfor anbefales det, at der udvises forsigtighed over for disse patienter (se pkt.
English: The randomised phase III INTEREST study was conducted in patients with locally advanced or metastatic NSCLC who had previously received platinum-based chemotherapy.
Danish: Det randomiserede fase III-forsøg INTEREST blev gennemført hos patienter med lokal-avanceret eller metastatisk NSCLC, der tidligere har fået platinbaseret kemoterapi.
English: The recommended posology of IRESSA is one 250 mg tablet once a day.
Danish: Den anbefalede dosering af IRESSA er én tablet a 250 mg én gang dagligt.
English: This cancer is a disease in which malignant (cancer) cells form in the tissues of the lung.
Danish: Ved denne form for kræftsygdom dannes der ondartede (kræft)celler i lungevævet.
English: It is not known whether gefitinib is secreted in human milk.
Danish: Det vides ikke, om gefitinib udskilles i modermælk.
English: In a phase I/II trial studying the use of gefitinib and radiation in paediatric patients, with newly diagnosed brain stem glioma or incompletely resected supratentorial malignant glioma, 4 cases (1 fatal) of Central Nervous System (CNS) haemorrhages were reported from 45 patients enrolled.
Danish: I et fase-I/II-studie, som undersøgte brug af gefitinib og stråling hos pædiatriske patienter med nyligt diagnosticeret hjernestammegliom eller ufuldstændig frastødning af supratentorielt malignt gliom, blev der rapporteret fire tilfælde (ét fatalt) af blødning i centralnervesystemet (CNS) ud af 45 indrullerede patienter.
English: In the pooled dataset from the ISEL, INTEREST and IPASS phase III clinical trials (2462 IRESSA-treated patients), the most frequently reported adverse drug reactions (ADRs), occurring in more than 20% of the patients, are diarrhoea and skin reactions (including rash, acne, dry skin and pruritus).
Danish: I det samlede datasæt fra de kliniske fase III-forsøg ISEL, INTEREST og IPASS (2462 IRESSAbehandlede patienter) er de hyppigst rapporterede bivirkninger, der forekommer hos mere end 20 % af patienterne, diarré og hudreaktioner (omfattende hududslæt, akne, tør hud og kløe).
English: Allergic reaction (common), particularly if symptoms include swollen face, lips, tongue or throat, difficulty to swallow, hives, nettle rash and difficulty breathing.
Danish: • Allergisk reaktion (almindelig), specielt hvis du får hævet ansigt, læber, tunge eller hals, du har svært ved at synke, nældefeber og har svært ved at trække vejret.
English: Interstitial lung disease (ILD)
Danish: Interstitiel lungesygdom (ILS)
English: Gefitinib binds to serum albumin and alpha 1-acid glycoprotein.
Danish: Gefitinib bindes til serumalbumin og surt -1- -glykoprotein.
English: Gefitinib is a selective small molecule inhibitor of the epidermal growth factor receptor tyrosine kinase and is an effective treatment for patients with tumours with activating mutations of the EGFR tyrosine kinase domain regardless of line of therapy.
Danish: Gefitinib er en selektiv lav-molekylær hæmmer af EGFR-tyrosinkinasen og er en effektiv behandling af patienter med tumorer med aktiverede mutationer af EGFR-tyrosinkinasedomæner uanset behandlingslinje.
English: In a phase I open-label study of single dose gefitinib 250 mg in patients with mild, moderate or severe hepatic impairment due to cirrhosis (according to Child-Pugh classification), there was an increase in exposure in all groups compared with healthy controls.
Danish: I et åbent fase I-forsøg med en enkeltdosis 250 mg gefitinib til patienter med let, moderat eller svær hepatisk insufficiens på grund af cirrose (ifølge Child-Pugh klassifikationen) var der en forøget eksponering hos alle patientgrupper sammenlignet med den raske kontrolgruppe.
English: Lactose monohydrate Microcrystalline cellulose (E460) Croscarmellose sodium Povidone (K29-32) (E1201) Sodium laurilsulfate Magnesium stearate
Danish: Lactosemonohydrat Cellulose, mikrokrystallinsk (E460) Croscarmellosenatrium Polyvidon (K29-32) (E1201) Natriumlaurilsulfat Magnesiumstearat
English: A further case of CNS haemorrhage has been reported in a child with an ependymoma from a trial with gefitinib alone.
Danish: Yderligere et tilfælde af blødning i centralnervesystemet er rapporteret hos et barn med et ependymom fra et forsøg med gefitinib alene.
English: In vitro studies have shown that gefitinib has limited potential to inhibit CYP2D6.
Danish: In vitro-studier har vist, at gefitinib har begrænset potentiale for at hæmme CYP2D6.
English: At no-effect levels in both mice and rats there was no margin in clinical exposure.
Danish: De fundne nul-effekt-niveauer i både mus og rotter var ikke højere end dem, der ses ved klinisk eksponering.
English: Risk of mortality among patients who developed ILD on IRESSA or chemotherapy was higher in patients with the following risk factors: smoking, CT scan evidence of reduced normal lung (≤ 50%), pre-existing ILD, older age (≥ 65 years old), and extensive areas adherent to pleura (≥ 50%).
Danish: Risikoen for dødelighed blandt patienter, der udviklede ILS, efter behandling med IRESSA eller kemoterapi, var højere hos patienter med følgende risikofaktorer: Rygning, reduceret normalt lungevæv ( 50 %) dokumenteret ved CT-scanning, tidligere ILS, ældre patienter ( 65 år gammel) og udtalte områder med pleural adhærence ( 50 %).
English: In the IFUM trial, mutation status was assessed in tumour and ctDNA samples derived from plasma, using the Therascreen EGFR RGQ PCR kit (Qiagen).
Danish: I IFUM-studiet blev mutationsstatus vurderet i tumor- og ctDNA-prøver indsamlet fra plasma under anvendelse af Therascreen EGFR-RGQ-PCR-sættet (Qiagen).
English: No specific dose adjustment is recommended in patients with known CYP2D6 poor metaboliser genotype, but these patients should be closely monitored for adverse events (see section 5.2).
Danish: Der anbefales ingen specifik dosisjustering hos patienter med ringe CYP2D6-aktivitet (poor metabolisers), men disse patienter bør monitoreres tæt for bivirkninger (se pkt.
English: a Values presented are for IRESSA versus placebo.
Danish: a Værdier for IRESSA versus placebo.
English: One ILD-type event was fatal, and this occurred in a patient receiving gefitinib.
Danish: Et ILS-tilfælde var fatalt, og dette forekom hos en patient, der fik gefitinib.
English: Active substances that may increase gefitinib plasma concentrations In vitro studies have shown that gefitinib is a substrate of p-glycoprotein (Pgp).
Danish: Aktive substanser der kan øge gefitinibs plasmakoncentration In vitro-studier har vist, at gefitinib er et substrat for p-glycoprotein (Pgp).
English: When the use of CYP2D6 substrates are considered in combination with gefitinib, a dose modification of the CYP2D6 substrate should be considered especially for products with a narrow therapeutic window.
Danish: Når brug af CYP2D6-substrater overvejes samtidig med gefitinib, bør det overvejes at ændre dosis af CYP2D6-substratet, specielt for præparater med et snævert terapeutisk vindue.
English: Elevations in alanine aminotransferase, mainly mild to moderate
Danish: Meget almindelig Forøgelse af alaninaminotransferase, hovedsageligt let til moderat
English: One ILD-type event was fatal, and this occurred in a patient receiving placebo.
Danish: En ILS-bivirkning var fatal, og den forekom hos en patient, der fik placebo.
English: IRESSA is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK (see section
Danish: IRESSA som monoterapi er indiceret til behandling af voksne patienter med lokalt avanceret eller metastatisk ikke-småcellet lungecancer (NSCLC) med aktiverede EGFR-TK-mutationer (se pkt.
English: Data from non-clinical (in vitro) studies indicate that gefitinib has the potential to inhibit the cardiac action potential repolarisation process (e.g. QT interval).
Danish: Data fra prækliniske (in vitro) forsøg indikerer, at gefitinib potentielt kan hæmme den kardielle aktionspotentiale-repolariseringsproces (fx QT-interval).
English: In EGFR mutation-positive patients, significantly more IRESSA-treated patients experienced an improvement in quality of life and lung cancer symptoms vs. carboplatin/paclitaxel (see Table 4).
Danish: Hos patienter med positivt testresultat for EGFR-mutation var der signifikant flere IRESSA-behandlede patienter, som oplevede en forbedring i livskvalitet og symptomer på lungecancer i forhold til dem, der blev behandlet med carboplatin/paclitaxel (se tabel 4).
English: Eye problems (uncommon), such as pain, redness, watery eyes, light sensitivity, changes in vision or ingrowing eyelashes.
Danish: • Øjenproblemer (ikke almindelig), såsom smerte, røde øjne, øjne der løber i vand, lysfølsomhed, forandret syn eller indgroede øjenvipper.
English: 42.9 v. 20.0 EGFR Mutation+
Danish: 6.2 v. 7.3 Total 42.9 v. 20.0 EGFR-mutation+
English: Skin reactions such as an acne-like rash, which is sometimes itchy with dry and/or cracked skin
Danish: • Hudreaktioner såsom akne-lignende udslæt, som til tider er kløende og med tør og/eller sprukken hud
English: 30 film-coated tablets.
Danish: 30 filmovertrukne tabletter.
English: There have been isolated reports of hepatic failure which in some cases led to fatal outcomes.
Danish: Der har været isolerede rapporter af leversvigt, som i nogle tilfælde var letal.
English: How to take IRESSA
Danish: Sådan skal du tage IRESSA
English: Gefitinib is contraindicated during breast-feeding and therefore breast-feeding must be discontinued while receiving gefitinib therapy (see section 4.3).
Danish: Gefitinib er kontraindiceret under ammeperioden, og derfor skal amning ophøre under gefitinib-behandling (se pkt.
English: Interstitial lung disease (1.3%), often severe (CTC grade 3-4).
Danish: Interstitiel lungesygdom (1,3 %), ofte svær (CTC grad 3-4).
English: Progression-free Survival
Danish: Progressionsfri overlevelse ab
English: Warnings and precautions Talk to your doctor or pharmacist before taking IRESSA if you have ever had any other lung problems.
Danish: Kontakt lægen eller apotekspersonalet, før du tager IRESSA: - hvis du nogensinde har haft andre problemer med lungerne.
English: In a Japanese pharmacoepidemiological case control study in 3,159 patients with NSCLC receiving gefitinib or chemotherapy who were followed up for 12 weeks, the following risk factors for developing ILD (irrespective of whether the patient received IRESSA or chemotherapy) were identified: smoking, poor performance status (PS ≥ 2), CT scan evidence of reduced normal lung (≤ 50%), recent diagnosis of NSCLC (< 6 months), pre-existing ILD, older age (≥ 55 years old) and concurrent cardiac disease.
Danish: I et japansk farmakoepidemiologisk studie hos 3.159 NSCLC-patienter, der blev fulgt i 12 uger, mens de fik gefitinib eller kemoterapi, fandt man følgende risikofaktorer for at udvikle ILS (uanset om patienterne blev behandlet med gefitinib eller kemoterapi): Rygning, dårlig performance status (PS  2), reduceret normalt lungevæv ( 50 %) dokumenteret ved CT-scanning, nylig diagnosticeret NSCLC (< 6 måneder), tidligere ILS, ældre ( 55 år gammel) og samtidig hjertesygdom.
English: HR 0.68 [0.58 to 0.81] 6.6 m vs 5.8 m p<0.0001
Danish: HR 0,68 [0,58 til 0,81] 6,6 m vs. 5,8 m p<0,0001
English: FACT-LFunctional assessment of cancer therapy-lung LCS Lung cancer subscale
Danish: QoL Livskvalitet (Quality of life) FACT-L Functional assessment of cancer therapy-lung LCS Lungecancer subskala
English: The majority of ILD-type events reported was from patients of Asian ethnicity and the ILD incidence among patients of Asian ethnicity receiving gefitinib therapy and placebo was approximately 3% and 4% respectively.
Danish: Forekomsten af ILS blandt de asiatiske patienter, der fik enten gefitinib eller placebo, var henholdsvis ca. 3 % og 4 %.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: However, in the rabbit, there were reduced foetal weights at 20 mg/kg/day and above.
Danish: Dog sås der en reduceret fostervægt hos kaniner ved dosering af 20 mg/kg/dag og derover.
English: Each tablet contains 250 mg gefitinib.
Danish: Hver tablet indeholder 250 mg gefitinib.
English: Concomitant administration of gefitinib with ranitidine at a dose that caused sustained elevations in gastric pH ≥ 5 resulted in a reduced mean gefitinib AUC by 47% in healthy volunteers (see section 4.4 and 5.2).
Danish: Samtidig administration af gefitinib og ranitidin i en dosis, der forårsagede vedvarende forhøjet gastrisk pH ≥ 5, resulterede i en gennemsnitlig reducering af gefitinibs AUC på 47 % hos raske frivillige (se pkt.
English: Proportion of tumour M- that are Mby ctDNA)
Danish: Andel af tumor M-, der er M- i ctDNA)
English: The levels of exposure to gefitinib achieved in both the extensive and the poor metaboliser groups were wide and overlapping but the mean exposure to gefitinib was 2-fold higher in the poor metaboliser group.
Danish: Eksponeringsgraden af gefitinib var bred, og overlappede hos både dem, der havde en normal metabolisme og dem, der havde nedsat metabolisme, men den gennemsnitlige eksponering af gefitinib var 2 gange højere hos gruppen af personer med dårlig metabolisme.
English: Dry, red or itchy eyes
Danish: • Tørre, røde og kløende øjne
English: In vitro data indicate that CYP3A4 and CYP2D6 are the major P450 isozyme involved in the oxidative metabolism of gefitinib.
Danish: In vitro-data indikerer, at CYP34A og CYP2D6 er de CYP-isozymer, der overvejende er involveret i den oxidative metabolisering af gefitinib.
English: The hepatocellular adenomas were also seen in a 2-year carcinogenicity study in mice, which demonstrated a small increased incidence of this finding in male mice at the mid dose, and in both male and female mice at the highest dose.
Danish: Hepatocellulære adenomer sås også i et 2årigt carcinogenicitetsstudie med mus, som viste en let forøget forekomst i hanmus ved middel dosis og i både han- og hunmus ved den høje dosis.
English: if you are breast-feeding.
Danish: - hvis du ammer.
English: The other ingredients (excipients) are lactose monohydrate, microcrystalline cellulose (E460), croscarmellose sodium, povidone (K29-32) (E1201), sodium laurilsulfate, magnesium stearate, hypromellose (E464), macrogol 300, titanium dioxide (E171), yellow iron oxide (E172) and red iron oxide (E172).
Danish: • Øvrige indholdsstoffer (hjælpestoffer): lactosemonohydrat; mikrokrystallinsk cellulose (E460); croscarmellosenatrium; povidon (K29-32) (E1201); natriumlaurilsulfat; magnesiumstearat; hypromellose (E464); macrogol 300; titandioxid (E171); jernoxid, gul (E172) og jernoxid, rød (E172).
English: In individual patients with CYP2D6 poor metaboliser genotype, treatment with a potent CYP3A4 inhibitor might lead to increased plasma levels of gefitinib.
Danish: Hos individuelle patienter med ringe metabolisme via CYP2D6 kan behandling med en potent CYP3A4-hæmmer medføre øgede plasmaniveauer af gefitinib.
English: Interstitial lung disease (ILD) has occurred in 1.3% of patients, often severe (CTC grade 3-4).
Danish: Interstitiel lungesygdom (ILS) er forekommet hos 1,3 % af patienterne, ofte i alvorlig grad (CTC grad 3-4).
English: Plasma concentrations were not increased in patients with elevated aspartate transaminase (AST), alkaline phosphatase or bilirubin due to liver metastases (see section 5.2).
Danish: Plasmakoncentrationerne var ikke forhøjede hos patienter med forhøjet aspartataminotransferase (ASAT), basisk fosfatase eller bilirubin på grund af levermetastaser (se pkt.
English: The major metabolite identified was O-desmethyl gefitinib, which is 14-fold less potent than gefitinib at inhibiting EGFR stimulated cell growth and has no inhibitory effect on tumour cell growth in mice.
Danish: Den er 14 gange mindre potent end gefitinib til at hæmme EGFR-stimuleret cellevækst, og har ingen hæmmende effekt på tumorcellevækst i mus.
English: If you forget to take IRESSA What to do if you forget to take a tablet depends on how long it is until your next dose.
Danish: Hvis du har glemt at tage en tablet, skal du gøre som beskrevet nedenfor (afhængig af hvor længe, der er til næste dosis):
English: Bleeding (such as nose bleed or blood in your urine) Protein in your urine (shown in a urine test)
Danish: • Blødning (såsom næseblod eller blod i urinen)
English: If you have trouble swallowing the tablet, dissolve it in half a glass of still (non-fizzy) water.
Danish: Hvis du har problemer med at sluge tabletten, kan den opslæmmes i et halvt glas vand (uden brus).
English: Skin reactions, mainly a mild or moderate (CTC grade 1 or 2) pustular rash, sometimes itchy with dry skin, including skin fissures, on an erythematous base
Danish: Hud og subkutane væv Meget almindelig Hudreaktioner, hovedsageligt let eller moderat (CTC grad 1 eller 2) pustuløst udslæt, til tider kløende med tør hud, inklusive hudfissurer, på erytematøs basis
English: In the IPASS trial, IRESSA demonstrated superior PFS, ORR, QoL and symptom relief with no significant difference in overall survival compared to carboplatin/paclitaxel in previously untreated patients, with locally advanced or metastatic NSCLC, whose tumours harboured activating mutations of the EGFR tyrosine kinase.
Danish: IPASS-forsøget viste, at IRESSA var carboplatin/paclitaxel overlegen i forhold til PFS, ORR, QoL og mht. symptomlindring, uden at der var nogen signifikant forskel på den samlede overlevelse hos behandlingsnaive patienter med lokalt fremskredent eller metastatisk NSCLC, hvis tumorer indeholdt aktiverende mutationer af EGFR-tyrosinkinase.
English: Without crushing it, the tablet should be dropped in half a glass of drinking water.
Danish: Uden at knuse tabletten, puttes den i et halvt glas drikkevand.
English: Medicinal products that cause significant sustained elevation in gastric pH, such as proton-pump inhibitors and h2-antagonists may reduce bioavailability and plasma concentrations of gefitinib and, therefore, may reduce efficacy.
Danish: Lægemidler, som forårsager vedvarende forhøjet gastrisk pH, såsom protonpumpehæmmere og h2-antagonister kan reducere biotilgængeligheden og plasmakoncentrationen af gefitinib, og kan derfor reducere effekten.
English: HR in the overall population, or otherwise 95% confidence intervals for HR c Confidence interval entirely below non-inferiority margin of 1.154
Danish: Tal i de kvadratiske parenteser er 96 % konfidensinterval (CI) for total overlevelses-HR i den totale population, ellers 95 % konfidensinterval for HR. c Konfidensinterval udelukkende under non-inferioritet-margen på 1,154.
English: Values presented are for IRESSA versus carboplatin/paclitaxel.
Danish: a Værdierne er for IRESSA versus carboplatin/paclitaxel.
English: The increase might be higher in individual patients with CYP2D6 poor metaboliser genotype.
Danish: Forøgelsen kan være højere hos individuelle patienter med ringe metabolisme via CYP2D6.
English: The increase may be clinically relevant since adverse reactions are related to dose and exposure.
Danish: Forøgelsen kan være klinisk relevant, idet bivirkninger er relaterede til dosis og eksponering.
English: Concomitant medicinal products that induce CYP3A4 (e.g. phenytoin, carbamazepine, rifampicin, barbiturates or St John's wort/ Hypericum perforatum) should be avoided.
Danish: Samtidig behandling med lægemidler, der inducerer CYP3A4 (fx phenytoin, carbamazepin, rifampicin, barbiturater eller perikon/hypericum perforatum), bør undgås.
English: Interstitial lung disease (ILD) which may be acute in onset, has been observed in 1.3% of patients receiving gefitinib, and some cases have been fatal (see section 4.8).
Danish: ILS, der kan optræde akut, har været observeret hos 1,3 % af patienterne, der har fået gefitinib og har i nogle tilfælde været dødelig (se pkt.
English: Concomitant administration with potent inhibitors of CYP3A4 activity (e.g. ketoconazole, posaconazole, voriconazole, protease inhibitors, clarithromycin, telithromycin) may increase gefitinib plasma concentrations.
Danish: Samtidig administration af potente CYP3A4-hæmmere (fx ketoconazol, posaconazol, voriconazol, proteasehæmmere, clarithromycin, telithromycin) kan forøge gefitinibs plasmakoncentration.
English: There are no data on concomitant treatment with an inhibitor of CYP2D6 but potent inhibitors of this enzyme might cause increased plasma concentrations of gefitinib in CYP2D6 extensive metabolisers by about 2-fold (see section 5.2).
Danish: Der findes ingen data for samtidig behandling med CYP2D6-hæmmere, men potente hæmmere af dette enzym kan forårsage en ca. dobbelt forøgelse af gefitinibs plasmakoncentration hos patienter med normal metabolisme via CYP2D6 (se pkt.