FrancophonIA/ELRC3.0 huggingface dataset:
English: Due to the working mechanism, proteasome inhibitors including bortezomib may be expected to influence the effect of EGFR inhibitors including erlotinib.
Danish: Proteasomhæmmere, inklusiv bortezomib, kan forventes at påvirke effekten af EGFR hæmmere, inklusiv erlotinib, på grund af virkningsmekanismen.
English: Tarceva treatment should be supervised by a physician experienced in the use of anti-cancer therapies.
Danish: Tarceva skal administreres under opsyn af en læge med erfaring i anvendelsen af antineoplastiske lægemidler.
English: The safety and efficacy of erlotinib has not been studied in patients with severe hepatic dysfunction (AST/SGOT and ALT/SGPT> 5 x ULN).
Danish: Sikkerheden og virkningen af erlotinib er ikke undersøgt hos patienter med svær leverdysfunktion (ASAT og ALAT > 5 x ULN).
English: Both rash and diarrhoea resulted in discontinuation of Tarceva in 1% of patients.
Danish: Både udslæt og diarré medførte seponering af Tarceva hos 1 % af patienterne.
English: In a phase I dose escalation study in NSCLC patients who were current smokers, pharmacokinetic analyses at steady-state indicated a dose proportional increase in erlotinib exposure when the Tarceva dose was increased from 150 mg to the maximum tolerated dose of 300 mg. Steady-state trough plasma concentrations at a 300 mg dose in current smokers in this study was 1.22 µg/mL (n=17).
Danish: I et fase I-dosiseskaleringsstudie hos NSCLC-patienter, som var rygere, indikerede en farmakokinetisk analyse ved steady-state en dosis-proportional stigning i erlotinibeksponeringen, når Tarceva-dosis blev øget fra 150 mg til den maksimale toleransdosis på 300 mg. I dette studie var steady-stateplasmakoncentrationen ved en dosis på 300 mg hos rygere 1,22 µg/ml (n=17).
English: Rash and diarrhoea resulted in discontinuation of Tarceva in 1% and <1% of patients, respectively, in study BO18192, while no patients discontinued for rash or diarrhoea in BO25460.
Danish: Udslæt og diarré medførte seponering af Tarceva hos henholdsvis 1 % og < 1 % af patienterne i studie BO18192, mens ingen patienter seponerede Tarceva pga. udslæt og diarré i studie BO25460.
English: Erlotinib and Capecitabine
Danish: Erlotinib og capecitabin
English: The efficacy and safety of Tarceva as second/third-line therapy was demonstrated in a randomised, double-blind, placebo-controlled trial (BR.21), in 731 patients with locally advanced or metastatic NSCLC after failure of at least one chemotherapy regimen.
Danish: Virkning og sikkerhed af Tarceva som anden- og tredje-linje behandling blev dokumenteret i et randomiseret, dobbeltblindet, placebokontrolleret studie (BR.21) hos 731 patienter med lokalt fremskreden eller metastatisk NSCLC efter behandlingssvigt af mindst et kemoterapiregime.
English: The efficacy and safety of Tarceva in combination with gemcitabine as a first-line treatment was assessed in a randomised, double-blind, placebo-controlled trial in patients with locally advanced, unresectable or metastatic pancreatic cancer.
Danish: Virkning og sikkerhed af Tarceva i kombination med gemcitabin som 1. linje behandling blev vurderet i et randomiseret, dobbeltblindt, placebokontrolleret studie hos patienter med lokalt fremskreden inoperabel eller metastaserende pancreascancer.
English: N.V. Roche S.A. Tél/Tel: +32 (0) 2 525 82 11
Danish: Roche S.A. Tél/Tel: +32 (0) 2 525 82 11
English: In rare cases liver failure was observed (rare: may affect up to 1 in 1,000 people).
Danish: • I sjældne tilfælde blev der observeret leversvigt (sjælden: kan påvirke op til 1 ud af 1.000 behandlede).
English: If you are exposed to sun, protective clothing, and/or use of sunscreen (e.g. mineral-containing) may be advisable Infection
Danish: Hvis du udsættes for sollys, er beskyttende påklædning og/eller solcreme (f.eks. mineralholdig)
English: Erlotinib and Gemcitabine
Danish: Erlotinib og gemcitabin
English: Erlotinib is primarily cleared by the liver.
Danish: Erlotinib nedbrydes primært i leveren.
English: • Inflammation of the coloured part of the eye
Danish: • En betændelseslignende reaktion (inflammation) i den farvede del af øjet.
English: In the pivotal Phase III NSCLC trial, current smokers achieved erlotinib steady state trough plasma concentration of 0.65 µg/mL (n=16) which was approximately 2-fold less than the former smokers or patients who had never smoked (1.28 µg/mL, n=108).
Danish: I det pivotale fase III-NSCLC-studie opnåede rygere en erlotinibplasmakoncentration ved steady-state på 0,65 µg/ml (n=16), hvilket var ca. 2 gange mindre end koncentrationen, som blev opnået hos tidligere rygere eller hos patienter, der aldrig havde røget (1,28 µg/ml, n=108).
English: Itching, dry skin and loss of hair
Danish: • Kløe, tør hud og hårtab
English: They are present in plasma at levels that are <10% of erlotinib and display similar pharmacokinetics as erlotinib.
Danish: Plasmakoncentrationerne af metabolitterne er <10 % af erlotinibs plasmakoncentrationer, og har samme farmakokinetik som erlotinib.
English: In an open-label, randomised phase III study, ML20650 conducted in 154 patients, the safety of Tarceva for first-line treatment of NSCLC patients with EGFR activating mutations was assessed in 75 patients; no new safety signals were observed in these patients.
Danish: I et åbent, randomiseret fase III-studie, ML20650, som inkluderede 154 patienter, blev sikkerheden af Tarceva til første-linje-behandling af NSCLC-patienter med EGFR-aktiverende mutationer undersøgt hos 75 patienter.
English: However, smokers had an increased rate of erlotinib clearance.
Danish: Rygere havde dog en øget clearance-hastighed.
English: Updated Analysis (62% OS maturity) (n=173)
Danish: Opdateret analyse (62% af data tilgængelige for den samlede overlevelse) (n=173)
English: In the event of severe or persistent diarrhoea, nausea, anorexia, or vomiting associated with dehydration, Tarceva therapy should be interrupted and appropriate measures should be taken to treat the dehydration (see section 4.8).
Danish: Hvis der kommer svær eller persisterende diarré, kvalme, anoreksi eller opkastning, ledsaget af dehydrering, skal behandlingen med Tarceva stoppes, og dehydreringen skal behandles på passende måde (se pkt.
English: In this study, the overall population showed a benefit for the primary PFS end-point (HR= 0.71 p< 0.0001) and the secondary OS end-point (HR= 0.81 p=0.0088).
Danish: I dette studie havde den samlede population fordel af behandlingen vist ved det primære endepunkt, progressionsfri overlevelse (hazard ratio= 0,71; p< 0,0001) og det sekundære endepunkt, samlet overlevelse (hazard ratio= 0,81; p=0,0088).
English: Chronic dosing effects observed in at least one animal species or study included effects on the cornea (atrophy, ulceration), skin (follicular degeneration and inflammation, redness, and alopecia), ovary (atrophy), liver (liver necrosis), kidney (renal papillary necrosis and tubular dilatation), and gastrointestinal tract (delayed gastric emptying and diarrhoea).
Danish: Virkninger af kronisk behandling, som observeredes hos mindst en dyreart eller i et studie, omfattede virkninger på cornea (atrofi, ulceration), hud (follikulær degeneration og inflammation, rødme og alopeci), ovarier (atrofi), lever (levernekrose), nyre (renal papillær nekrose og tubulær dilatation), mave-tarmkanalen (forsinket gastrisk tømning og diarré).
English: Concomitant treatment with these types of agents should be avoided (see section 4.5).
Danish: Samtidig behandling med disse stoffer skal undgås (se pkt.
English: Tablet core: lactose monohydrate, cellulose microcrystalline, sodium starch glycolate type A, sodium laurilsulfate, magnesium stearate (see also section 2 for lactose monohydrate).
Danish: • Øvrige indholdsstoffer: Tabletkerne: lactosemonohydrat, mikrokrystallinsk cellulose, natriumstivelsesglycolat type A, natriumlaurilsulfat, magnesiumstearat (se også punkt 2 vedrørende lactosemonohydrat).
English: Secondary efficacy endpoints were all consistent with the primary endpoint and no difference was detected for OS between patients treated with erlotinib 300 mg and 150 mg daily (HR 1.03, 95% CI 0.80 to 1.32).
Danish: Sekundære endepunkt var alle i overensstemmelse med det primære endepunkt og ingen forskel var observeret for samlet overlevelse mellem patienter behandlet med erlotinib 300 mg og 150 mg daglig (hazard ratio 1,03; 95 % konfidensinterval 0,80 til 1,32).
English: The median overall survival was 6.7 months in the Tarceva group (95% CI, 5.5 to 7.8 months) compared with 4.7 months in the placebo group (95% CI, 4.1 to 6.3 months).
Danish: Den mediane overlevelse var 6,7 måneder i Tarceva-gruppen (95 % konfidensinterval: 5,5 til 7,8 måneder) sammenlignet med 4,7 måneder i placebogruppen (95 % konfidensinterval: 4,1 til 6,3 måneder).
English: Psychiatric disorders Depression very common
Danish: Psyk iske forstyrrelser Depression
English: In a Phase Ib study, there were no significant effects of gemcitabine on the pharmacokinetics of erlotinib nor were there significant effects of erlotinib on the pharmacokinetics of gemcitabine.
Danish: I et fase 1b-studie var der ingen signifikant virkning af gemcitabin på erlotinibs farmakokinetik og heller ingen signifikant virkning af erlotinib på gemcitabins farmakokinetik.
English: How to take Tarceva
Danish: Sådan skal du tage Tarceva
English: A validated, robust, reliable and sensitive test with a prespecified positivity threshold and demonstrated utility for the determination of EGFR mutation status, using either tumor DNA derived from a tissue sample or circulating free DNA (cfDNA) obtained from a blood (plasma) sample, should be performed according to local medical practice.
Danish: Der skal udføres en valideret, robust, pålidelig og sensitiv test med præspecificeret grænseværdi for positivitet og påvist anvendelighed til bestemmelse af EGFR-mutationsstatus ifølge lokal klinisk praksis.
English: The maximum tolerated dose of Tarceva in NSCLC patients who currently smoke cigarettes was 300 mg.
Danish: Hos NSCLCpatienter, som er rygere, var den maksimale tolererede dosis af Tarceva 300 mg.
English: Including fatalities.
Danish: 6 Inklusive letale tilfælde.
English: Confounding factors have included pre-existing liver disease or concomitant hepatotoxic medications.
Danish: Konfunderende faktorer har indbefattet tidligere leversygdom eller samtidig administration af hepatotoksiske lægemidler.
English: Potent inducers of CYP3A4 may reduce the efficacy of erlotinib whereas potent inhibitors of CYP3A4 may lead to increased toxicity.
Danish: Potente CYP3A4-induktorer kan nedsætte virkningen af erlotinib, mens potente CYP3A4-hæmmere kan medføre øget toksicitet.
English: Erlotinib is characterised by a decrease in solubility at pH above 5.
Danish: Erlotinibs opløselighed reduceres ved pH over 5.
English: Grade 3 rash and diarrhoea occurred in 9% and 4% of patients, respectively.
Danish: Udslæt og diarré af grad 3 opstod hos henholdsvis 9 % og 4 % af patienterne.
English: For patients who require concomitant treatment with Tarceva and a potent CYP3A4 inducer such as rifampicin an increase in dose to 300 mg should be considered while their safety (including renal and liver functions and serum electrolytes) is closely monitored, and if well tolerated for more than 2 weeks, further increase to 450 mg could be considered with close safety monitoring.
Danish: For patienter, som behøver samtidig behandling med Tarceva og en potent CYP3A4-induktor, som f.eks. rifampicin, bør det overvejes at hæve dosis til 300 mg, med tæt monitorering af patienterne (herunder nyre- og leverfunktionen samt serumelektrolytter).
English: Capecitabine may increase erlotinib concentrations.
Danish: Capecitabin kan øge koncentrationen af erlotinib.
English: Medicinal products that alter the pH of the upper Gastro-Intestinal (GI) tract, like proton pump inhibitors, H2 antagonists and antacids, may alter the solubility of erlotinib and hence its bioavailability.
Danish: Lægemidler, der ændrer pH i den øvre del af mavetarmkanalen, som eksempelvis protonpumpehæmmere, H2-antagonister og antacida, kan ændre erlotinibs opløselighed og derved dets biotilgængelighed.
English: Including fatalities (see section 4.4).
Danish: Inklusive letale tilfælde (se pkt.
English: The median PFS was 9.7 weeks in the Tarceva group (95% CI, 8.4 to 12.4 weeks) compared with 8.0 weeks in the placebo group (95% CI, 7.9 to 8.1 weeks).
Danish: Den mediane PFS var 9,7 uger i Tarceva-gruppen (95 % konfidensinterval; 8,4 til 12,4 uger) sammenlignet med 8,0 uger i placebo-gruppen (95 % konfidensinterval; 7,9 til 8,1 uger).
English: In a clinical study, the concomitant use of erlotinib with ketoconazole (200 mg orally twice daily for 5 days), a potent CYP3A4 inhibitor, resulted in an increase of erlotinib exposure (86% of AUC and 69% of Cmax).
Danish: I et klinisk studie medførte samtidig anvendelse af erlotinib og ketoconazol (200 mg oralt to gange daglig i 5 dage), en potent CYP3A4-hæmmer, en øgning af erlotinib-eksponeringen (86 % af AUC og 69 % af Cmax).
English: Erlotinib is a potent inhibitor of CYP1A1, and a moderate inhibitor of CYP3A4 and CYP2C8, as well as a strong inhibitor of glucuronidation by UGT1A1 in vitro.
Danish: Erlotinib er en potent hæmmer af CYP1A1 og en moderat hæmmer af CYP3A4 og CYP2C8 samt en stærk hæmmer af glukoronidiseringen af UGT1A1 in vitro.
English: The efficacy and safety of Tarceva as maintenance after first-line chemotherapy for NSCLC was investigated in a randomised, double-blind, placebo-controlled trial (BO18192, SATURN).
Danish: Virkningen og sikkerheden af Tarceva som vedligeholdelsesbehandling efter første-linjekemoterapibehandling afNSCLC blev undersøgt i et randomiseret, dobbeltblindet, placebokontrolleret studie (BO18192, SATURN).
English: Any Grade
Danish: Alle grader 3
English: See also section 4 “Possible side effects”.
Danish: 4 ”Bivirkninger”.
English: Increasing the dose of Tarceva when co-administered with such agents is not likely to compensate for the loss of exposure.
Danish: Når Tarceva administreres samtidig med disse stoffer, vil en øget dosis af Tarceva sandsynligvis ikke kompensere for eksponeringstabet.
English: The most common adverse reactions in pivotal study PA.3 in pancreatic cancer patients receiving Tarceva 100 mg plus gemcitabine were fatigue, rash and diarrhoea.
Danish: De mest almindelige bivirkninger hos patienter med pancreascancer, som fik Tarceva 100 mg plus gemcitabin i det pivotale studie PA.3, var træthed, udslæt og diarré.
English: Pre-planned Interim Analysis (35% OS maturity) (n=153)
Danish: Forudplanlagt interimanalyse (35% af data tilgængelige for den samlede overlevelse) (n=153)
English: Tarceva is also indicated for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen.
Danish: Tarceva er også indiceret til behandling af patienter med lokalt fremskreden eller metastatisk NSCLC efter behandlingssvigt af mindst et tidligere kemoterapiregime.
English: See sections 4.2, 4.4, 4.5 and 5.1.
Danish: 4.2, 4.4, 4.5 og 5.2.
English: Erlotinib is metabolised in the liver by the hepatic cytochromes in humans, primarily CYP3A4 and to a lesser extent by CYP1A2.
Danish: Erlotinib metaboliseres i leveren af de hepatiske, humane cytokromer, primært af CYP3A4 og i mindre udstrækning af CYP1A2.
English: Tarceva treatment should be interrupted or discontinued if the patient develops severe bullous, blistering or exfoliating conditions.
Danish: Behandling med Tarceva skal pauseres eller seponeres, hvis patienten får alvorlig bulløs, blærefyldt eller eksfoliativ hud.
English: -Palmar plantar erythrodysaesthesia syndrome
Danish: - Palmoplantar erytrodysæstesi
English: The most frequent ADRs seen in patients treated with Tarceva in study ML20650 were rash and diarrhoea (any Grade 80% and 57%, respectively), most were Grade 1/2 in severity and manageable without intervention.
Danish: De hyppigste bivirkninger, der blev observeret hos patienter behandlet med Tarceva i studie ML20650, var udslæt og diarré (henholdsvis 80 % og 57 % for alle grader).
English: Non-small cell lung cancer (Tarceva administered as monotherapy)
Danish: Ikke-småcellet lungecancer (administration af Tarceva som monoterapi)
English: OS of Tarceva in first line maintenance was not superior to Tarceva as second line treatment in patients whose tumor did not harbor an EGFR-activating mutation (HR= 1.02, 95% CI, 0.85 to 1.22, p=0.82).
Danish: Den samlede overlevelse med Tarceva i første-linjevedligeholdelsesbehandling var ikke bedre end Tarceva som anden-linje-behandling hos patienter, hvor tumoren ikke havde EGFR-aktiverende mutation (hazard ratio= 1,02; 95 % konfidensinterval, 0,85-1,22; p=0,82).
English: See also section 3 ‘How to take Tarceva'
Danish: 3 ”Sådan skal du tage Tarceva”.
English: Use of Tarceva in patients with severe hepatic dysfunction is not recommended (see section 5.2).
Danish: Anvendelse af Tarceva til patienter med svær leverdysfunktion anbefales ikke (se pkt.
English: Medicinal products that alter the pH of the upper Gastro-Intestinal (GI) tract may alter the solubility of erlotinib and hence its bioavailability.
Danish: Lægemidler, der ændrer pH i den øvre del af mavetarmkanalen, kan ændre erlotinibs opløselighed og derved dets biotilgængelighed.
English: Rash and diarrhoea each resulted in dose reductions in 2% of patients, and resulted in study discontinuation in up to 1% of patients receiving Tarceva plus gemcitabine.
Danish: Både udslæt og diarré medførte dosisreduktion hos 2 % af patienterne og udtrædelse af studiet hos op til 1 % af patienterne, som fik Tarceva plus gemcitabin.
English: These studies were conducted in a total of 1532 patients with advanced, recurrent or metastatic NSCLC following first-line standard platinum-based chemotherapy, no new safety signals were identified.
Danish: Disse studier blev gennemført med i alt 1532 patienter med fremskreden, recidiverende eller metastatisk NSCLC som opfølgning på første-linje standard platinbaseret kemoterapi.
English: No Grade 4 rash or diarrhoea was observed.
Danish: Der blev ikke observeret udslæt og diarré af grad 4.
English: Each 100 mg film-coated tablet contains 69.21 mg Lactose monohydrate.
Danish: Hver 100 mg filmovertrukken tablet indeholder 69,21 mg lactosemonohydrat.
English: There were no significant effects of erlotinib on the pharmacokinetics of capecitabine.
Danish: Der var ingen signifikant virkning af erlotinib på capecitabins farmakokinetik.
English: Tarceva is given in combination with gemcitabine treatment.
Danish: Tarceva gives i kombination med gemcitabin.
English: Although erlotinib exposure was similar in patients with moderately impaired hepatic function (Child-Pugh score 7-9) compared with patients with adequate hepatic function, caution should be used when administering Tarceva to patients with hepatic impairment.
Danish: Dette bør udvises, selvom eksponeringen af erlotinib hos patienter med moderat nedsat leverfunktion (Child-Pugh score 7-9) var lignende den, der blev set hos patienter med sufficient leverfunktion.
English: Tarceva is indicated for the first-line treatment of patients with locally advanced or metastatic nonsmall cell lung cancer (NSCLC) with EGFR activating mutations.
Danish: Tarceva er indiceret til første-linje-behandling af patienter med lokalt fremskreden eller metastatisk ikke-småcellet lungecancer (NSCLC) med EGFR-aktiverende mutationer.
English: When prescribing Tarceva, factors associated with prolonged survival should be taken into account (see sections 4.2 and 5.1).
Danish: Når der ordineres Tarceva, skal der tages hensyn til faktorer forbundet med forlænget overlevelse (se pkt.
English: There have been rare reports of hypokalaemia and renal failure (including fatalities).
Danish: Hypokaliæmi og nyreinsufficiens (herunder fatale tilfælde) er sjældent rapporteret.
English: Loss of appetite, decreased weight
Danish: • Appetitmangel, vægttab
English: - NSCLC treatment after failure of at least one prior chemotherapy regimen (Tarceva administered as monotherapy)
Danish: - Behandling af NSCLC efter svigt af mindst et tidligere kemoterapiregime (administration af Tarceva som monoterapi)
English: There were no significant effects of carboplatin or paclitaxel on the pharmacokinetics of erlotinib.
Danish: Der var ingen signifikante virkninger af carboplatin eller paclitaxel på erlotinibs farmakokinetik.
English: Patients were randomised 1:1 to receive Tarceva 150 mg or placebo orally once daily until disease progression.
Danish: Patienterne blev randomiserede i forholdet 1:1 til behandling med Tarceva 150 mg eller placebo oralt én gang dagligt indtil sygdomsprogression.
English: Nervous system disorders Neuropathy Headache very common very common
Danish: Nervesystemet Neuropati Hovedpine
English: Eye disorders Keratoconjunctivitis sicca Conjunctivitis very common very common
Danish: Keratoconjunctivitis sicca Conjunctivitis
English: Each 150 mg film-coated tablet contains 103.82 mg Lactose monohydrate.
Danish: Hver 150 mg filmovertrukken tablet indeholder 103,82 mg lactosemonohydrat.
English: Alternate treatments lacking potent CYP3A4 inducing activity should be considered when possible.
Danish: Om muligt bør der overvejes andre behandlinger uden kraftig CYP3A4-inducerende aktivitet.
English: -Pancreatic cancer (Tarceva administered concurrently with gemcitabine in study PA.3)
Danish: Pancreascancer (samtidig administration af Tarceva og gemcitabin i studie PA.3)
English: The secondary endpoint of PFS showed no difference between Tarceva and placebo in maintenance treatment (HR=0.94, 95 % CI, 0.80 to 1.11; p=0.48).
Danish: Det sekundære endepunkt, progressionsfri overlevelse, viste ingen forskel mellem Tarceva og placebo ved vedligeholdelsesbehandling (hazard ratio=0,94, 95 % konfidensinterval 0,801,11; p=0,48).
English: Tarceva is also indicated for switch maintenance treatment in patients with locally advanced or metastatic NSCLC with EGFR activating mutations and stable disease after first-line chemotherapy.
Danish: Tarceva er også indiceret til switch-vedligeholdelsesbehandling hos patienter med lokalt fremskreden eller metastatisk NSCLC med EGFR-aktiverende mutationer og stabil sygdom efter første-linjekemoterapibehandling.
English: • if you are taking anticoagulants (a medicine which helps to prevent thrombosis or blood clotting e.g. warfarin), Tarceva may increase your tendency to bleed.
Danish: • hvis du tager antikoagulantia (medicin som forebygger blodpropper og størkning af blodet, f.eks. warfarin), kan Tarceva øge din tendens til at bløde, og din læge vil have brug for at kontrollere dig regelmæssigt ved hjælp af nogle blodprøver.
English: The listed ADRs were those reported in at least 10% (in the Tarceva group) of patients and occurred more frequently (≥3%) in patients treated with Tarceva than in the comparator arm. Other ADRs including those from other studies are summarized in Table 2.
Danish: De listede bivirkninger optrådte hos mindst 10 % af patienterne i Tarceva-gruppen og optrådte hyppigere (≥3 %) hos Tarceva-behandlede patienter end hos patienterne i kontrolgruppen.
English: The objective response rate by RECIST in the Tarceva group was 8.9% (95% CI, 6.4 to 12.0).
Danish: RECIST var 8,9 % i Tarceva-gruppen (95 % konfidensinterval; 6,4 til 12,0 %).
English: The usual dose is one tablet of Tarceva 100 mg each day if you have metastatic pancreatic cancer.
Danish: Den normale dosis er én Tarceva 100 mg tablet hver dag, hvis du har kræft i bugspytkirtlen i et metastatisk stadie.
English: Patients were randomised to receive Tarceva or placebo once daily on a continuous schedule plus gemcitabine IV (1000 mg/m2, Cycle 1 - Days 1, 8, 15, 22, 29, 36 and 43 of an 8 week cycle; Cycle 2 and subsequent cycles - Days 1, 8 and 15 of a 4 week cycle [approved dose and schedule for pancreatic cancer, see the gemcitabine SPC]).
Danish: (1.000 mg/m2, serie 1 på dag 1, 8, 15, 22, 29, 36 og 43 i en 8 ugers serie; serie 2 og efterfølgende serier på dag 1, 8 og 15 i en 4 ugers serie [vedr.
English: Frequency category of highest incidence
Danish: Frekvensgruppe (hyppighed)
English: Tarceva is not recommended for use in patients with severe hepatic dysfunction.
Danish: Tarceva anbefales ikke til patienter med svær leverdysfunktion.