natgillin/translations-raw huggingface dataset:
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. 
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).
Giotrif 20 mg filmovertrukne tabletter Giotrif 30 mg filmovertrukne tabletter Giotrif 40 mg filmovertrukne tabletter Giotrif 50 mg filmovertrukne tabletter 
GIOTRIF 20 mg film-coated tablets GIOTRIF 30 mg film-coated tablets GIOTRIF 40 mg film-coated tablets GIOTRIF 50 mg film-coated tablets
Afatinib elimineres primært via udskillelse i galde/fæces. 
Afatinib is eliminated mainly by biliary/faecal excretion.
In vitro studier tydede på, at afatinib er substrat for og hæmmer af transportøren BCRP. 
In vitro studies indicated that afatinib is a substrate and an inhibitor of the transporter BCRP.
Giotrif indeholder: - Aktivt stof: afatinib. 
What GIOTRIF contains - The active substance is afatinib.
Lægen skal måske tage blodprøver for at undersøge din leverfunktion. 
Your doctor may do some liver tests.
Tabel 5: Meget almindelige bivirkninger i studiet LUX-Lung 8* Giotrif (40 mg/dag) 
Table 5: Very common ADRs in trial LUX-Lung 8* GIOTRIF (40 mg/day)
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. 
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.
Dosering Den anbefalede dosis er 40 mg én gang daglig. 
Posology The recommended dose is 40 mg once daily.
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). 
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).
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. 
In 61 patients treated in the first-line setting, confirmed ORR was 65.6% and DCR was 86.9% according to independent review.
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). 
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.
Hos patienter med en uddrivningsfraktion under afdelingens nedre normalgrænse skal kardiologisk tilsyn samt midlertidig eller permanent seponering overvejes. 
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.
Brug af anden medicin sammen med Giotrif 
Other medicines and GIOTRIF
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. 
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.
Giotrif (40 mg/dag) N= 229 
GIOTRIF (40 mg/day) N=229
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)). 
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)).
Figur 1: Kaplan-Meier-kurve over progressionsfri overlevelse (PFS) på grundlag af en uafhængig vurdering, efter behandlingsgruppe i LUX-Lung 3 forsøget (samlet population) 
Figure 1: Kaplan-Meier curve for PFS by independent review by treatment group in trial LUX-Lung 3 (Overall Population)
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. 
Bullous, blistering and exfoliative skin conditions have been reported including rare cases suggestive of Stevens-Johnson syndrome and toxic epidermal necrolysis.
4.2) en lavere hyppighed af almindelige bivirkninger. 
Overall, dose reduction (see section 4.2) led to a lower frequency of common adverse reactions.
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. 
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.
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. 
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.
• hvis du har eller har haft problemer med hjertet. 
• if you have a history of heart problems.
Ud fra virkningsmekanismen har alle EGFR-rettede lægemidler potentialet til at skade et foster. 
Mechanistically, all EGFR targeting medicinal products have the potential to cause foetal harm.
Der forelå begrænsede data vedrørende sorte patienter. 
Data on Black racial groups was limited.
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. 
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
• Perikon (Hypericum perforatum), som er et naturlægemiddel mod depression. 
• St. John's wort (Hypericum perforatum), a herbal medicine to treat depression.
• hvis du har eller har haft inflammation (en betændelseslignende tilstand) i lungerne (interstitiel lungesygdom). 
• if you have a history of lung inflammation (interstitial lung disease).
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. 
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.
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. 
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.
Hvis der påvises ILD, skal Giotrif seponeres permanent og den nødvendige behandling iværksættes (se pkt. 
If ILD is diagnosed, GIOTRIF should be permanently discontinued and appropriate treatment initiated as necessary (see section 4.2).
Dette lægemiddel skal seponeres midlertidigt eller permanent, hvis patienten får svære bulløse, blisterdannende eller eksfoliative tilstande (se pkt. 
Treatment with this medicinal product should be interrupted or discontinued if the patient develops severe bullous, blistering or exfoliating conditions (see section 4.8).
Opsummeringen af samtlige bivirkninger er vist i Tabel 2. 
The summary of all ADRs is shown in Table 2.
14 x 1 filmovertrukne tabletter 
14 x 1 film-coated tablets
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. 
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).
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. 
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).
Dette lægemiddel kan hæmme vækst og spredning af kræftceller ved at blokere aktiviteten af disse proteiner. 
By blocking the activity of these proteins this medicine can inhibit growth and spread of cancer cells.
Grad 2-ALAT-stigning sås hos 1 %, og grad 3-stigning sås hos 0,8 % af patienterne i Giotrifbehandling (se pkt. 
Grade 2 ALT elevations occurred in 1% and Grade 3 elevations occurred in 0.8% of patients treated with GIOTRIF (see section 4.4).
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. 
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.
Derfor kan det ikke udelukkes, at Giotrif har en uønsket virkning på fertiliteten hos mennesker. 
Therefore, an adverse effect of this medicinal product on human fertility cannot be excluded.
Intravenøs administration af elektrolytter og væske kan være nødvendig hos patienter, som bliver dehydrerede. 
Patients who become dehydrated may require administration of intravenous electrolytes and fluids.
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. 
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.
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. 
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.
Tabel 9: Effektresultater for Giotrif vs. gefitinib (LUX-Lung 7) på grundlag af den primære analyse fra august 2015. 
Table 9: Efficacy results of GIOTRIF vs. gefitinib (LUX-Lung 7) based on primary analysis as of August
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. 
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
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) 
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)
Opslæmningen kan også gives gennem en ventrikelsonde. 
The dispersion can also be administered through a gastric tube.
• Appetitløshed 
• Decreased appetite
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. 
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.
Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig. 
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.
• 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. 
• if you develop acute or worsening redness and pain in the eye, increased eye watering, blurred vision and/or sensitivity to light.
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. 
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).
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. 
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.
Eksponeringen for afatinib er vist at være forøget hos patienter med moderat eller svært nedsat nyrefunktion (se pkt. 
Exposure to afatinib was found to be increased in patients with moderate or severe renal impairment (see section 5.2).
Dette lægemiddel skal tages uden mad (se pkt. 
This medicinal product should be administered without food (see sections 4.2 and 5.2).
In vitro data viser, at afatinib er en moderat P-gp-hæmmer. 
Based on in vitro data, afatinib is a moderate inhibitor of P-gp.
Forhøjet alanin-aminotransferase Hud og subkutane væv 
Alanine aminotransferase increased Skin and subcutaneous tissue disorders Rash
Eksponeringen for afatinib hos patienter med nedsat nyrefunktion blev sammenlignet med eksponeringen hos raske forsøgspersoner efter administration af en enkeltdosis på 40 mg Giotrif. 
Exposure to afatinib in subjects with renal impairment was compared to healthy volunteers following a single dose of 40 mg GIOTRIF.
Forhøjet alanin-aminotransferase Forhøjet aspartat-aminotransferase 
Aspartate aminotransferase increased
Hos patienter med svær diarré kan midlertidig seponering og dosisreduktion eller permanent seponering af Giotrif være nødvendig (se pkt. 
Patients with severe diarrhoea may require interruption and dose reduction or discontinuation of therapy with GIOTRIF (see section 4.2).
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). 
Patients were screened for the presence of 29 different EGFR mutations using a polymerase chain reaction (PCR)-based method (TheraScreen
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. 
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).
4.4) samt stomatitis og paronykie (se også Tabel 3, 4 og 5). 
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).
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). 
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.
28 x 1 filmovertrukne tabletter 
28 x 1 film-coated tablets
De væsentligste cirkulerende afatinibmetabolitter var kovalente addukter med proteiner. 
Covalent adducts to proteins were the major circulating metabolites of afatinib.
Amning Du må ikke amme, mens du tager Giotrif, da det ikke kan udelukkes, at der er en risiko for barnet. 
Breast-feeding Do not breast-feed while taking this medicine as a risk to the breast-fed child cannot be excluded.
• hvis du får et udslæt på huden. 
• if you develop skin rash.
Mødre skal frarådes at amme, mens de får Giotrif. 
Mothers should be advised against breast-feeding while receiving this medicinal product.
Afatinibs farmakokinetik er ikke undersøgt hos personer med svær (Child-Pugh C) leverdysfunktion (se pkt. 
The pharmacokinetics of afatinib have not been studied in subjects with severe (Child Pugh C) hepatic dysfunction (see section 4.4).
Du skal undgå at blive gravid, mens du tager Giotrif. 
You should avoid becoming pregnant while taking this medicine.
Responsvarighed Måneder (median) 
Duration of response Months (median)
Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 patienter): 
Rare side effects (may affect up to 1 in 1,000 people):
Andenlinjebehandling med Giotrif medførte signifikant forbedret PFS og OS for patienter med planocellulær NSCLC sammenlignet med erlotinib. 
Second-line GIOTRIF significantly improved PFS and OS of patients with squamous NSCLC compared to erlotinib.
Omfatter akne, pustuløs akne, akneiform dermatitis. 
Includes Acne, Acne pustular, Dermatitis acneiform
Ved de første tegn på diarré skal du drikke rigeligt med væske og kontakte lægen med det samme. 
At the first signs of diarrhoea drink plenty of fluids.
Der kan forekomme irritation eller inflammation i øjnene (inflammation i bindehinden/samtidig inflammation i hornhinden og bindehinden er almindeligt, inflammation i hornhinden er ikke almindeligt). 
Eye irritation or inflammation may occur (conjunctivitis/keratoconjunctivitis occurs commonly and keratitis uncommonly).
Giotrif forbedrede signifikant PFS og OS hos EGFR-mutationspositive patienter sammenlignet med gefitinib. 
GIOTRIF significantly improved PFS and ORR in EGFR mutation positive patients compared to gefitinib.
Lactosemonohydrat Mikrokrystallinsk cellulose (E460) Kolloid vandfri silica (E551) Crospovidon (type A) Magnesiumstearat (E470b) 
Lactose monohydrate Cellulose, microcrystalline (E460) Silica, colloidal anhydrous (E551) Crospovidone (type A) Magnesium stearate (E470b)
ErbB-familiemedlemmerne EGFR (ErbB1), HER2 (ErbB2), ErbB3 og ErbB4. 
Afatinib covalently binds to and irreversibly blocks signalling from all homo- and heterodimers formed by the ErbB family members EGFR (ErbB1), HER2 (ErbB2), ErbB3 and ErbB4.
- Øvrige indholdsstoffer: lactosemonohydrat, mikrokrystallinsk cellulose (E460), kolloid vandfri silica (E551), crospovidon type A, magnesiumstearat (E470b), hypromellose (E464), macrogol 400, titandioxid (E171), talcum (E553b), polysorbat 80 (E433), indigotin (E132)aluminiumhydroxid. 
- The other ingredients are lactose monohydrate, microcrystalline cellulose (E460), colloidal anhydrous silica (E551), crospovidone type A, magnesium stearate (E470b), hypromellose (E464), macrogol 400, titanium dioxide (E171), talc (E553b), polysorbate 80 (E433), indigo carmine (E132) aluminium hydroxide.
Giotrifs virkning og sikkerhed hos asiatiske patienter med stadium IIIB/IV EGFR-mutationspositiv, lokalt fremskredent eller metastaserende adenokarcinom i lungen blev evalueret i et randomiseret, ikke-blindet multicenterforsøg. 
The efficacy and safety of GIOTRIF in Asian patients with Stage IIIB/IV EGFR mutation-positive locally advanced or metastatic adenocarcinoma of the lung was evaluated in a randomised, multicentre, open-label trial.
Hazard ratio/ Oddsratio (95 %-CI) 
Hazard Ratio/ Odds Ratio (95%CI)
Tabel 3: Meget almindelige bivirkninger i LUX-Lung 3-forsøget 
Table 3: Very common ADRs in trial LUX-Lung 3
Tabel 11: Resultater for Giotrif vs. erlotinib for symptomer i LUX-Lung 8-studiet (EORTC QLQ-C30 & QLQ-LC13) 
Table 11: Symptom outcomes for GIOTRIF vs. erlotinib in trial LUX-Lung 8 (EORTC QLQ-C30 & QLQ-LC13)
Anbefalet dosering 
Recommended dosing
Giotrif er ikke undersøgt hos patienter med eGFT < 15 ml/min/1,73 m2 eller patienter i dialyse. 
GIOTRIF has not been studied in patients with eGFR <15 mL/min/1.73m² or on dialysis.
Giotrif hos patienter med planocellulær NSCLC 
GIOTRIF in patients with NSCLC of squamous histology
Omfatter kløe, generaliseret kløe. 
Includes Pruritus, Pruritus generalised
Akneiform dermatitis Tør hud 
Dermatitis acneiform Pruritus Dry skin
Lægen kan ændre din dosis (sætte den op eller ned). 
Your doctor may adjust (increase or decrease) your dose depending on how well you tolerate this medicine.
Tabel 6: Effektresultater for Giotrif vs.pemetrexed/cisplatin (LUX-Lung 3) og vs. gemcitabin/cisplatin (LUX-Lung 6) (uafhængig vurdering) 
Table 6: Efficacy results of GIOTRIF vs. pemetrexed/cisplatin (LUX-Lung 3) gemcitabine/cisplatin (LUX-Lung 6) (Independent review)
Dette lægemiddel indeholder lactose og bør ikke anvendes til patienter med arvelig galactoseintolerans, total lactasemangel eller glucose/galactosemalabsorption. 
Patients with rare hereditary conditions of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Generelt var typen af bivirkninger relateret til afatinibs virkningsmekanisme i form af hæmning af EGFR. 
The types of adverse reactions (ADRs) were generally associated with the EGFR inhibitory mode of action of afatinib.
Oddsratio (OR) (95 % CI) p-værdi 
Odds Ratio (OR) (95%CI) p-value
Hvornår skal du tage Giotrif 
When to take GIOTRIF