FrancophonIA/ELRC3.0 huggingface dataset:
English: Exposure to afatinib moderately increased with lowering of the creatinine clearance (CrCL, calculated according to Cockcroft Gault), i.e. for a patient with a CrCL of 60 mL/min or 30 mL/min exposure (AUCτ,ss) to afatinib increased by 13% and 42%, respectively, and decreased by 6% and 20% for a patient with CrCL of 90 mL/min or 120 mL/min, respectively, compared to a patient with the CrCL of 79 mL/min (median CrCL of patients in the overall patient population analysed).
Danish: Eksponeringen for afatinib blev moderat øget i takt med nedsat kreatininclearance (CrCL, beregnet i henhold til Cockcroft-Gault-formlen), dvs. hos en patient med en CrCL på 60 ml/min eller 30 ml/min blev eksponeringen (AUCτ,ss) for afatinib øget med henholdsvis 13 % og 42 %, og hos en patient med en CrCL på 90 ml/min eller 120 ml/min blev eksponeringen reduceret med henholdsvis 6 % og 20 %, sammenlignet med en patient med en CrCL på 79 ml/min (median CrCL for patienter i den samlede, analyserede patientpopulation).
English: Delay of median time to deterioration (months)
Danish: Forlængelse af mediantiden indtil forværring (måneder)
English: titanium dioxide (E171), talc (E553b), polysorbate 80 (E433).
Danish: 400, titandioxid (E171), talcum (E553b), polysorbat 80 (E433).
English: • Carbamazepine, phenytoin, phenobarbital - used to treat seizures.
Danish: • Carbamazepin, phenytoin og phenobarbital, som bruges til at behandle epilepsi (kramper).
English: • Inflammation of the lining of the bladder with burning sensations during urination and frequent,
Danish: • Blærebetændelse med en brændende fornemmelse ved vandladning og hyppig og presserende trang til at lade vandet
English: Diarrhoea, including severe diarrhoea, has been reported during treatment with GIOTRIF (see section 4.8).
Danish: Der er rapporteret om diarré, herunder svær diarré, under behandling med Giotrif (se pkt.
English: This medicine contains a sugar called lactose.
Danish: Dette lægemiddel indeholder sukkerstoffet lactose.
English: Among the patients randomised, 65% were female, the median age was 61 years, the baseline ECOG performance status was 0 (39%) or 1 (61%), 26% were Caucasian and 72% were Asian.
Danish: Blandt de randomiserede patienter var 65 % kvinder, medianalderen var 61 år, ECOG-funktionsstatus ved baseline var 0 (39 %) eller 1 (61 %), 26 % var kaukasere, og 72 % var asiater.
English: In patients with tumours harbouring either G719X (N=18), L861Q (N=16), or S768I substitution mutation (N=8), the confirmed ORR was 72.2%, 56.3%, 75.0%, respectively, and the median duration of response was 13.2 months, 12.9 months and 26.3 months, respectively.
Danish: Hos patienter med tumorer, der indeholdt enten G719X- (N=18), L861Q- (N=16) eller S768I-substitutionsmutation (N=8), var den bekræftede ORR hhv. 72,2 %, 56,3 % og 75,0 %, og den mediane responsvarighed var hhv. 13,2 måneder, 12,9 måneder og 26,3 måneder.
English: If you forget to take GIOTRIF
Danish: Hvis du har glemt at tage Giotrif
English: Table 10: Efficacy results for GIOTRIF vs erlotinib in LUX-Lung 8, based on primary analysis of OS, including all randomized patients
Danish: Tabel 10: Resultater for virkning af Giotrif vs. erlotinib i LUX-Lung 8 baseret på den primære analyse af OS inkluderende alle randomiserede patienter
English: Effects of P-gp inducers on afatinib
Danish: P-gp-induktorers virkninger på afatinib
English: Monitor patients with severe renal impairment (eGFR 15-29 mL/min/1.73m²) and adjust GIOTRIF dose if not tolerated.
Danish: Overvåg patienter med svært nedsat nyrefunktion (15-29 ml/min/1,73 m 2), og justér dosen af Giotrif, hvis den ikke tolereres.
English: Bullous, blistering and exfoliative skin conditions have been reported including rare cases suggestive of Stevens-Johnson syndrome and toxic epidermal necrolysis although in these cases there were potential alternative aetiologies (see section 4.4).
Danish: Der er rapporteret om bulløse, blisterdannende og eksfoliative hudlidelser, herunder sjældne tilfælde, der kunne tyde på Stevens-Johnsons syndrom og toksisk epidermal nekrolyse, selvom der i disse tilfælde var mulige alternative ætiologier (se pkt.
English: GIOTRIF 20 mg film-coated tablets GIOTRIF 30 mg film-coated tablets GIOTRIF 40 mg film-coated tablets GIOTRIF 50 mg film-coated tablets
Danish: Giotrif 20 mg filmovertrukne tabletter Giotrif 30 mg filmovertrukne tabletter Giotrif 40 mg filmovertrukne tabletter Giotrif 50 mg filmovertrukne tabletter
English: Afatinib is eliminated mainly by biliary/faecal excretion.
Danish: Afatinib elimineres primært via udskillelse i galde/fæces.
English: In vitro studies indicated that afatinib is a substrate and an inhibitor of the transporter BCRP.
Danish: In vitro studier tydede på, at afatinib er substrat for og hæmmer af transportøren BCRP.
English: What GIOTRIF contains - The active substance is afatinib.
Danish: Giotrif indeholder: - Aktivt stof: afatinib.
English: Your doctor may do some liver tests.
Danish: Lægen skal måske tage blodprøver for at undersøge din leverfunktion.
English: Table 5: Very common ADRs in trial LUX-Lung 8* GIOTRIF (40 mg/day)
Danish: Tabel 5: Meget almindelige bivirkninger i studiet LUX-Lung 8* Giotrif (40 mg/dag)
English: In patients with tumours harbouring de-novo T790M mutations (N=14) the confirmed ORR was 14.3% and the median duration of response was 8.3 months.
Danish: Hos patienter med tumorer, der indeholdt de-novo T790M-mutationer (N=14) var den bekræftede ORR 14,3 %, og den mediane responsvarighed var 8,3 måneder.
English: Posology The recommended dose is 40 mg once daily.
Danish: Dosering Den anbefalede dosis er 40 mg én gang daglig.
English: The total systemic exposure (AUC0-24) in male and female rats was in the range or less than that observed in patients (1.3 times and 0.51 times, respectively).
Danish: Den totale systemiske eksponering (AUC0-24) hos hanrotter og hunrotter var på niveau med eller under den eksponering, der blev set hos patienter (henholdsvis 1,3 gange og 0,51 gange).
English: In 61 patients treated in the first-line setting, confirmed ORR was 65.6% and DCR was 86.9% according to independent review.
Danish: Hos 61 patienter, som fik førstelinjebehandling, var den verificerede objektive responsrate (ORR) 65,6 %, og sygdomskontrolraten (disease control rate, DCR) var 86,9 % ved en uafhængig vurdering.
English: Very common ADRs in GIOTRIF-treated patients occurring in at least 10% of patients in trial LUX-Lung 8 are summarised by National Cancer Institute-Common Toxicity Criteria (NCI-CTC) Grade in Table 5.
Danish: De meget almindelige bivirkninger, der sås hos mindst 10 % af de Giotrifbehandlede patienter i LUX-Lung 8-studiet, er opstillet i Tabel 5 i henhold til NCI-CTC (National Cancer Institute-Common Toxicity Criteria).
English: In patients with an ejection fraction below the institution's lower limit of normal, cardiac consultation as well as treatment interruption or discontinuation should be considered.
Danish: Hos patienter med en uddrivningsfraktion under afdelingens nedre normalgrænse skal kardiologisk tilsyn samt midlertidig eller permanent seponering overvejes.
English: Other medicines and GIOTRIF
Danish: Brug af anden medicin sammen med Giotrif
English: In patients with tumours harbouring exon 20 insertions (N=23) the confirmed ORR was 8.7% and the median duration of response was 7.1 months.
Danish: Hos patienter med tumorer, der indeholdt exon 20-indsættelser (N=23) var den bekræftede ORR 8,7 %, og den mediane responsvarighed var 7,1 måneder.
English: GIOTRIF (40 mg/day) N=229
Danish: Giotrif (40 mg/dag) N= 229
English: When the strong P-gp and BCRP inhibitor ritonavir (200 mg twice a day for 3 days) was administered 1 hour before a single dose of 20 mg GIOTRIF, exposure to afatinib increased by 48% (area under the curve (AUC0-∞)) and 39% (maximum plasma concentration (Cmax)).
Danish: Administration af den kraftige P-gp- og BCRP-hæmmer ritonavir (200 mg to gange daglig i 3 dage) 1 time før en enkeltdosis på 20 mg Giotrif øgede eksponeringen for afatinib med 48 % (areal under kurven (AUC0-∞)) og 39 % (maksimal plasmakoncentration (Cmax)).
English: Figure 1: Kaplan-Meier curve for PFS by independent review by treatment group in trial LUX-Lung 3 (Overall Population)
Danish: Figur 1: Kaplan-Meier-kurve over progressionsfri overlevelse (PFS) på grundlag af en uafhængig vurdering, efter behandlingsgruppe i LUX-Lung 3 forsøget (samlet population)
English: Bullous, blistering and exfoliative skin conditions have been reported including rare cases suggestive of Stevens-Johnson syndrome and toxic epidermal necrolysis.
Danish: Der er rapporteret om bulløse, blisterdannende og eksfoliative tilstande på huden, herunder sjældne tilfælde, der kunne tyde på Stevens-Johnsons syndrom og toksisk epidermal nekrolyse.
English: Overall, dose reduction (see section 4.2) led to a lower frequency of common adverse reactions.
Danish: 4.2) en lavere hyppighed af almindelige bivirkninger.
English: LUX-Lung 7 is a randomised, global, open label Phase IIb trial investigating the efficacy and safety of GIOTRIF in patients with locally advanced or metastatic lung adenocarcinoma (stage IIIB or IV) with EGFR mutations in the first-line setting.
Danish: LUX-Lung 7 er et randomiseret, globalt, åbent fase IIb-forsøg, der har til formål at undersøge virkningen og sikkerheden ved Giotrif som førstelinjebehandling hos patienter med lokalt fremskreden eller metastatisk lunge-karcinom (stadie IIIB eller IV) med EGFR-mutationer.
English: In patients treated with once daily GIOTRIF 40 mg, dose reductions due to ADRs occurred in 57% of the patients in the LUX-Lung 3 trial and in 25% of the patients in the LUX-Lung 8 trial.
Danish: Dosis blev reduceret hos 57 % af patienterne behandlet med Giotrif 40 mg én gang daglig på grund af bivirkninger i LUX-Lung 3-studiet og hos 25 % af patienterne i LUX-Lung 8-studiet.
English: • if you have a history of heart problems.
Danish: • hvis du har eller har haft problemer med hjertet.
English: Mechanistically, all EGFR targeting medicinal products have the potential to cause foetal harm.
Danish: Ud fra virkningsmekanismen har alle EGFR-rettede lægemidler potentialet til at skade et foster.
English: Data on Black racial groups was limited.
Danish: Der forelå begrænsede data vedrørende sorte patienter.
English: Overall Survival (OS) Months (median) Hazard Ratio (HR) (95%CI) p-value p-value for PFS/OS based on stratified log-rank test; p-value for Objective Response Rate based on logistic regression CR=complete response; PR=partial response
Danish: Samlet overlevelse (OS) Måneder (median) Hazard ratio (HR) (95 % CI) p-værdi p-værdien for PFS/OS baseret på stratificeret log-rank test; p-værdi for objektiv responsrate baseret på logistisk regression CR=komplet respons, PR=partielt respons.
English: • St. John's wort (Hypericum perforatum), a herbal medicine to treat depression.
Danish: • Perikon (Hypericum perforatum), som er et naturlægemiddel mod depression.
English: • if you have a history of lung inflammation (interstitial lung disease).
Danish: • hvis du har eller har haft inflammation (en betændelseslignende tilstand) i lungerne (interstitiel lungesygdom).
English: In the pre-defined subgroup of common mutations (combined Del 19 and L858R) for GIOTRIF and chemotherapy, the median PFS was 13.6 months vs. 6.9 months (HR 0.48; 95% CI 0.35-0.66; p<0.0001; N=307) in LUX-Lung 3, and 11.0 months vs. 5.6 months (HR 0.24; 95% CI 0.17-0.35; p<0.0001; N=324) in LUX-Lung 6, respectively.
Danish: I den foruddefinerede undergruppe med almindelige mutationer (kombineret Del 19 og L858R) for Giotrif og kemoterapi var den mediane PFS henholdsvis 13,6 måneder vs. 6,9 måneder (HR 0,48; 95 % CI 0,35-0,66; p< 0,0001; N=307) i LUX-Lung 3 og henholdsvis 11,0 måneder vs. 5,6 måneder (HR 0,24; 95 % CI 0,17-0,35; p< 0,0001; N=324) i LUX-Lung 6.
English: Pre-treatment with rifampicin (600 mg once daily for 7 days), a potent inducer of P-gp, decreased the plasma exposure to afatinib by 34% (AUC0-∞) and 22% (Cmax) after administration of a single dose of 40 mg GIOTRIF.
Danish: Forbehandling med rifampicin, der er en kraftig P-gp-induktor, i en dosis på 600 mg én gang daglig i 7 dage, reducerede plasmaeksponeringen for afatinib med 34 % (AUC0-∞) og 22 % (Cmax) efter administration af en enkeltdosis på 40 mg Giotrif.
English: If ILD is diagnosed, GIOTRIF should be permanently discontinued and appropriate treatment initiated as necessary (see section 4.2).
Danish: Hvis der påvises ILD, skal Giotrif seponeres permanent og den nødvendige behandling iværksættes (se pkt.
English: Treatment with this medicinal product should be interrupted or discontinued if the patient develops severe bullous, blistering or exfoliating conditions (see section 4.8).
Danish: Dette lægemiddel skal seponeres midlertidigt eller permanent, hvis patienten får svære bulløse, blisterdannende eller eksfoliative tilstande (se pkt.
English: The summary of all ADRs is shown in Table 2.
Danish: Opsummeringen af samtlige bivirkninger er vist i Tabel 2.
English: 14 x 1 film-coated tablets
Danish: 14 x 1 filmovertrukne tabletter
English: Symptomatic adverse reactions (e.g. severe/persistent diarrhoea or skin related adverse reactions) may be successfully managed by treatment interruption and dose reductions or treatment discontinuation of GIOTRIF as outlined in Table 1 (see sections 4.4 and 4.8).
Danish: Symptomgivende bivirkninger (f.eks. svær/vedvarende diarré eller bivirkninger relateret til huden) kan håndteres med et godt resultat ved behandlingsafbrydelse og dosisreduktion eller permanent seponering, som beskrevet i Tabel 1 (se pkt.
English: Based on this trial and population pharmacokinetic analysis of data derived from clinical trials in various tumour types, it is concluded, that adjustments to the starting dose in patients with mild (eGFR 60-89 mL/min/1.73m²), moderate (eGFR 30-59 mL/min/1.73m²), or severe (eGFR 15-29 mL/min/1.73m²) renal impairment are not necessary, but patients with severe impairment should be monitored (see “Population pharmacokinetic analysis in special populations” below and section 4.2).
Danish: På grundlag af dette forsøg og populationsfarmakokinetiske data fra kliniske forsøg ved forskellige typer tumorer er det påvist, at justering af startdosen hos patienter med let nedsat nyrefunktion (eGFR 60-89 ml/min/1,73 m2), moderat nedsat nyrefunktion (eGFR 30-59 ml/min/1,73 m2) eller svært nedsat nyrefunktion (eGFR 15-29 ml/min/1,73 m2) ikke er nødvendig, mens patienter med svært nedsat nyrefunktion bør overvåges (se ”Populationsfarmakokinetisk analyse hos særlige populationer” nedenfor og pkt.
English: By blocking the activity of these proteins this medicine can inhibit growth and spread of cancer cells.
Danish: Dette lægemiddel kan hæmme vækst og spredning af kræftceller ved at blokere aktiviteten af disse proteiner.
English: Grade 2 ALT elevations occurred in 1% and Grade 3 elevations occurred in 0.8% of patients treated with GIOTRIF (see section 4.4).
Danish: Grad 2-ALAT-stigning sås hos 1 %, og grad 3-stigning sås hos 0,8 % af patienterne i Giotrifbehandling (se pkt.
English: NSCLC tumours with common activating EGFR mutations (Del 19, L858R) and several less common EGFR mutations in exon 18 (G719X) and exon 21 (L861Q) are particularly sensitive to afatinib treatment in non-clinical and clinical settings.
Danish: I ikke-kliniske og kliniske sammenhænge er NSCLC-tumorer med almindelige aktiverende EGFR-mutationer (Del 19, L858R) og flere mindre almindelige EGFR-mutationer i exon 18 (G719X) og exon 21 (L861Q) specielt følsomme for afatinib.
English: Therefore, an adverse effect of this medicinal product on human fertility cannot be excluded.
Danish: Derfor kan det ikke udelukkes, at Giotrif har en uønsket virkning på fertiliteten hos mennesker.
English: Patients who become dehydrated may require administration of intravenous electrolytes and fluids.
Danish: Intravenøs administration af elektrolytter og væske kan være nødvendig hos patienter, som bliver dehydrerede.
English: The PFS hazard ratio for patients with DEL 19 mutations and L858R mutations was 0.76 (95% CI [0.55, 1.06]; p=0.1071), and 0.71 (95% CI [0.47, 1.06]; p=0.0856) respectively for afatinib vs gefitinib.
Danish: Hazard ratio for PFS for patienter med Del 19-mutationer og L858R-mutationer var hhv. 0,76 (95 %-CI [0,55; 1,06]; p = 0,1071) og 0,71 (95 %-CI [0,47; 1,06]; p = 0,0856) for afatinib vs. gefitinib.
English: Among the patients randomised, 62% were female, the median age was 63 years, 16% of patients had brain metastases, the baseline ECOG performance status was 0 (31%) or 1 (69%), 57% were Asian and 43% were non-Asian.
Danish: Blandt de randomiserede patienter var 62 % kvinder, gennemsnitsalderen var 63 år, 16 % havde hjernemetastaser, baseline-ECOG-performancestatus var 0 (31 %) eller 1 (69 %), 57 % var af asiatisk oprindelse, og 43 % var af ikke-asiatisk oprindelse.
English: Table 9: Efficacy results of GIOTRIF vs. gefitinib (LUX-Lung 7) based on primary analysis as of August
Danish: Tabel 9: Effektresultater for Giotrif vs. gefitinib (LUX-Lung 7) på grundlag af den primære analyse fra august 2015.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: DATO FOR ÆNDRING AF TEKSTEN Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu og på Lægemiddelstyrelsens hjemmeside http://www.laegemiddelstyrelsen.dk.
English: Table 7: PFS and OS efficacy results of GIOTRIF vs pemetrexed/cisplatin (LUX-Lung 3) gemcitabine/cisplatin (LUX-Lung 6) in the pre-defined EGFR mutation subgroups Del 19 and L858R (Independent review)
Danish: Tabel 7: PFS og OS effektresultater for Giotrif vs. pemetrexed/cisplatin (LUX-Lung 3) og vs. gemcitabin/cisplatin (LUX-Lung 6) i de foruddefinerede EGFR-mutationundergrupper Del 19 og L858R (uafhængig vurdering)
English: The dispersion can also be administered through a gastric tube.
Danish: Opslæmningen kan også gives gennem en ventrikelsonde.
English: • Decreased appetite
Danish: • Appetitløshed
English: In three clinical trials of GIOTRIF with prospective tumour genotyping (Phase 3 trials LUX-Lung 3 and -6, and single arm Phase 2 trial LUX-Lung 2), an analysis was conducted of data from a total of 75 TKI-naïve patients with advanced (stage IIIb-IV) lung adenocarcinomas harbouring uncommon EGFR mutations, which were defined as all mutations other than Del 19 and L858R mutations.
Danish: Analyse af GIOTRIFs virkning hos EGFR TKI-naive patienter med tumorer, der indeholder ikkealmindelige EGFR-mutationer (LUX-Lung 2, -3og -6) I tre kliniske studier af GIOTRIF med prospektiv tumor-genotyping (fase III-studierne LUX Lung 3 og -6, og fase II-enkeltgruppestudiet LUX-Lung 2) blev der udført en analyse af data fra i alt 75 TKI-naive patienter med fremskredne (trin IIIb-IV) lungeadenokarcinomer, der indeholdt ikkealmindelige EGFR-mutationer, der blev defineret som alle andre mutationer end Del 19- og L858R-mutationer.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including herbal medicines and medicines obtained without a prescription.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: • if you develop acute or worsening redness and pain in the eye, increased eye watering, blurred vision and/or sensitivity to light.
Danish: • hvis du pludselig får røde øjne og ondt i øjet (eller forværring af dette), oplever, at øjnene løber mere i vand eller får uklart syn og/eller lysfølsomhed.
English: This means preferably 6 hours (for P-gp inhibitors dosed twice daily) or 12 hours (for P-gp inhibitors dosed once daily) apart from GIOTRIF (see section 4.5).
Danish: Dette betyder helst 6 timer (for P-gp-hæmmere, der doseres to gange daglig) eller 12 timer (for P-gp-hæmmere, der doseres en gang daglig) fra Giotrif (se pkt.
English: Grade 2 (> 2.5 to 5.0 times upper limit of normal (ULN)) ALT elevations occurred in < 8% of patients treated with this medicinal product.
Danish: Grad 2 (> 2,5 til 5,0 gange øvre normalgrænse (ULN)) ALAT-forhøjelser forekom hos < 8 % af patienter, og grad 3 (> 5,0 til 20,0 gange ULN) forhøjelser forekom hos < 4 % af patienterne (se pkt.
English: Exposure to afatinib was found to be increased in patients with moderate or severe renal impairment (see section 5.2).
Danish: Eksponeringen for afatinib er vist at være forøget hos patienter med moderat eller svært nedsat nyrefunktion (se pkt.
English: This medicinal product should be administered without food (see sections 4.2 and 5.2).
Danish: Dette lægemiddel skal tages uden mad (se pkt.
English: Based on in vitro data, afatinib is a moderate inhibitor of P-gp.
Danish: In vitro data viser, at afatinib er en moderat P-gp-hæmmer.
English: Alanine aminotransferase increased Skin and subcutaneous tissue disorders Rash
Danish: Forhøjet alanin-aminotransferase Hud og subkutane væv
English: Exposure to afatinib in subjects with renal impairment was compared to healthy volunteers following a single dose of 40 mg GIOTRIF.
Danish: Eksponeringen for afatinib hos patienter med nedsat nyrefunktion blev sammenlignet med eksponeringen hos raske forsøgspersoner efter administration af en enkeltdosis på 40 mg Giotrif.
English: Aspartate aminotransferase increased
Danish: Forhøjet alanin-aminotransferase Forhøjet aspartat-aminotransferase
English: Patients with severe diarrhoea may require interruption and dose reduction or discontinuation of therapy with GIOTRIF (see section 4.2).
Danish: Hos patienter med svær diarré kan midlertidig seponering og dosisreduktion eller permanent seponering af Giotrif være nødvendig (se pkt.
English: Patients were screened for the presence of 29 different EGFR mutations using a polymerase chain reaction (PCR)-based method (TheraScreen
Danish: Patienterne blev screenet for tilstedeværelse af 29 forskellige EGFR-mutationer ved hjælp af en polymerasekædereaktions (PCR) -baseret metode (TheraScreen®: EGFR29 Mutation Kit, Qiagen Manchester Ltd).
English: The overall survival hazard ratio in patients < 65 years of age was 0.68 (95% CI 0.55, 0.85) and in patients 65 years of age and older it was 0.95 (95% CI 0.76, 1.19).
Danish: Den samlede hazard ratio for overlevelse var 0,68 (95 % CI: 0,55-0,85) for patienter under 65 år og 0,95 (95 % CI: 0,76-1,19) for patienter på 65 år og derover.
English: The most frequent ADRs were diarrhoea and skin related adverse events (see section 4.4) as well as stomatitis and paronychia (see also Table 3, 4 and 5).
Danish: 4.4) samt stomatitis og paronykie (se også Tabel 3, 4 og 5).
English: The efficacy and safety of GIOTRIF as second-line treatment for patients with advanced NSCLC of squamous histology was investigated in a randomized open-label global Phase III trial LUX-Lung 8.
Danish: Virkningen af og sikkerheden ved Giotrif som andenlinjebehandling hos patienter med fremskreden planocellulær NSCLC blev undersøgt i et randomiseret, åbent, globalt fase 3-studie (LUX-Lung 8).
English: 28 x 1 film-coated tablets
Danish: 28 x 1 filmovertrukne tabletter
English: Covalent adducts to proteins were the major circulating metabolites of afatinib.
Danish: De væsentligste cirkulerende afatinibmetabolitter var kovalente addukter med proteiner.
English: Breast-feeding Do not breast-feed while taking this medicine as a risk to the breast-fed child cannot be excluded.
Danish: Amning Du må ikke amme, mens du tager Giotrif, da det ikke kan udelukkes, at der er en risiko for barnet.
English: • if you develop skin rash.
Danish: • hvis du får et udslæt på huden.
English: Mothers should be advised against breast-feeding while receiving this medicinal product.
Danish: Mødre skal frarådes at amme, mens de får Giotrif.
English: The pharmacokinetics of afatinib have not been studied in subjects with severe (Child Pugh C) hepatic dysfunction (see section 4.4).
Danish: Afatinibs farmakokinetik er ikke undersøgt hos personer med svær (Child-Pugh C) leverdysfunktion (se pkt.
English: You should avoid becoming pregnant while taking this medicine.
Danish: Du skal undgå at blive gravid, mens du tager Giotrif.
English: Duration of response Months (median)
Danish: Responsvarighed Måneder (median)