FrancophonIA/ELRC3.0 huggingface dataset:
English: Population pharmacokinetic analysis in special populations A population pharmacokinetic analysis was performed in 927 cancer patients (764 with NSCLC) receiving GIOTRIF monotherapy.
Danish: Populationsfarmakokinetisk analyse hos særlige populationer Der er udført en populationsfarmakokinetisk analyse af 927 kræftpatienter (764 med NSCLC), der fik Giotrif monoterapi.
English: There is no relevant use of GIOTRIF in the paediatric population in the indication of NSCLC.
Danish: Det er ikke relevant at anvende Giotrif hos den pædiatriske population til indikationen NSCLC.
English: If you plan to become pregnant after taking the last dose of this medicine, you should ask your doctor for advice as your body may not have fully eliminated this medicine.
Danish: Hvis du planlægger at blive gravid, efter du har taget den sidste dosis af Giotrif, skal du spørge din læge til råds, da din krop muligvis ikke fuldstændigt har udskilt dette lægemiddel.
English: Tell your doctor before taking these medicines together with GIOTRIF.
Danish: Du skal tale med lægen, før du tager disse lægemidler sammen med Giotrif.
English: Adequate contraceptive methods should be used during therapy and for at least 1 month after the last dose.
Danish: Der skal bruges sikker antikonception under behandlingen og i mindst 1 måned efter den sidste dosis.
English: • Sulfasalazine, used to treat inflammation/infection.
Danish: • Sulfasalazin, der bruges til at behandle inflammation/infektion i tarmen.
English: Pack sizes of 7 x 1, 14 x 1 or 28 x 1 film-coated tablets.
Danish: Pakningsstørrelser på 7 x 1, 14 x 1 eller 28 x 1 filmovertrukne tabletter.
English: If any of these apply to you, your doctor may monitor you more closely as the side effects may be more pronounced.
Danish: Hvis du opfylder et eller flere af disse kriterier, skal lægen måske kontrollere dig oftere, da bivirkningerne kan være mere udtalte.
English: In vitro data indicated that drug-drug interactions with afatinib due to inhibition of OATB1B1, OATP1B3, OATP2B1, OAT1, OAT3, OCT1, OCT2, and OCT3 transporters are considered unlikely.
Danish: Interaktioner med transportsystemer for lægemiddeloptagelse In vitro data tydede på, at lægemiddelinteraktioner med afatinib som følge af hæmning af transportørerne OATB1B1, OATP1B3, OATP2B1, OAT1, OAT3, OCT1, OCT2 og OCT3 kan anses for usandsynlige.
English: Anti-diarrhoeal medicinal products should be readily available to the patients so that treatment can be initiated at first signs of diarrhoea and continued until loose bowel movements cease for 12 hours.
Danish: Midler mod diarré skal være umiddelbart tilgængelige for patienterne, så behandlingen kan iværksættes ved de første tegn på diarré og fortsætte, indtil diarréen har været ophørt i 12 timer.
English: Adverse changes were restricted to toxic dose levels.
Danish: Uønskede virkninger var begrænset til toksiske dosisniveauer.
English: Treatment in this population is not recommended (see section 4.4).
Danish: Behandling frarådes hos denne population (se pkt.
English: • If you have already eaten, wait at least 3 hours before taking this medicine.
Danish: • Hvis du allerede har spist, skal du vente mindst 3 timer, før du tager Giotrif.
English: Figure 2: Kaplan-Meier Curve for OS by treatment group in LUX-Lung 8
Danish: Figur 2: Kaplan-Meier-kurve for OS pr. behandlingsgruppe i LUX-Lung 8
English: Patients with common EGFR mutations accounted for 89% of the study population.
Danish: Patienter med almindelige EGFR-mutationer udgjorde 89 % af forsøgspopulationen.
English: • Ritonavir, ketoconazole (except in shampoo), itraconazole, erythromycin, nelfinavir, saquinavir - used to treat different kinds of infections.
Danish: • Ritonavir, ketoconazol (undtagen i shampoo), itraconazol, erythromycin og nelfinavir og saquinavir, som bruges til at behandle forskellige typer infektioner.
English: Interstitial Lung Disease (ILD)
Danish: Interstitiel lungesygdom (ILD)
English: • Pain, redness, swelling or peeling of the skin of your hands and feet
Danish: • Ondt i hænder og fødder eller rødme, hævelse eller afskalning af huden på hænder og fødder
English: In these patients, confounding factors have included pre-existing liver disease and/or comorbidities associated with progression of underlying malignancy.
Danish: Hos disse patienter har konfunderende faktorer omfattet allerede eksisterende leversygdom og/eller tilstedeværelse af samtidige sygdomme i forbindelse med progression af den tilgrundliggende maligne sygdom.
English: Careful assessment of all patients with an acute onset and/or unexplained worsening of pulmonary symptoms (dyspnoea, cough, fever) should be performed to exclude ILD.
Danish: Der skal foretages en grundig vurdering af alle patienter med akut debut og/eller uforklarlig forværring af lungesymptomer (dyspnø, hoste, feber) for at udelukke ILD.
English: The highest dose of afatinib studied in a limited number of patients in Phase I clinical trials was 160 mg once daily for 3 days and 100 mg once daily for 2 weeks.
Danish: De højeste afatinibdoser, der er undersøgt hos et begrænset antal patienter i kliniske fase I forsøg, er 160 mg én gang daglig i 3 dage og 100 mg én gang daglig i 2 uger.
English: The co-primary endpoints include PFS by independent review and OS.
Danish: De primære endepunkter omfatter PFS ved uafhængig gennemgang og OS.
English: You may experience increased side effects and your doctor may interrupt your treatment and provide supportive care.
Danish: Du får måske mere udtalte bivirkninger, og lægen afbryder måske behandlingen og giver dig hensigtsmæssig behandling.
English: No dose adjustment
Danish: Ingen dosisjustering
English: • Eye irritation or inflammation
Danish: • Irritation eller inflammation i øjnene
English: The parent compound afatinib accounted for 88% of the recovered dose.
Danish: Uomdannet lægemiddelstof (afatinib) udgjorde 88 % af den genfundne dosis.
English: There was limited data available for moderate and severe hepatic impairment.
Danish: Der forelå begrænsede data vedrørende moderat og svært nedsat leverfunktion.
English: In cases of suspected overdose, GIOTRIF should be withheld and supportive care initiated.
Danish: I tilfælde af mistænkt overdosering skal Giotrif midlertidigt seponeres, og der skal iværksættes understøttende behandling.
English: If you experience treatment-related symptoms affecting your eye sight (e.g. redness and/or irritation of the eye, dry eye, tearing, light-sensitivity) or your ability to concentrate and react, it is recommended that you do not drive or use machines until the side effect disappears (see section 4 Possible side effects).
Danish: Hvis du i forbindelse med behandlingen får bivirkninger, der vedrører dit syn (f.eks. røde øjne og/eller irritation i øjet, tørre øjne, at øjnene løber i vand, lysfølsomhed), eller din evne til at koncentrere dig og reagere påvirkes, anbefales det, at du ikke kører bil eller betjener maskiner, før bivirkningen er væk igen (se punkt 4, Bivirkninger).
English: Indigo carmine aluminium hydroxide (E132)
Danish: Indigotin-aluminiumhydroxid (E132)
English: Hepatic failure, including fatalities, has been reported during treatment with this medicinal product in less than 1% of patients.
Danish: Hos færre end 1 % af patienterne er der rapporteret om leversvigt, herunder tilfælde med dødelig udgang, under behandling med dette lægemiddel.
English: Limited non-clinical and/or clinical activity was observed in NSCLC tumours with insertion mutations in exon 20.
Danish: I ikke-kliniske og/eller kliniske sammenhænge blev der set begrænset aktivitet mod NSCLC-tumorer med insertionsmutationer i exon 20.
English: Treatment with this medicine is not recommended if you have a severe liver disease.
Danish: Behandling med Giotrif anbefales ikke, hvis du har en svær leversygdom.
English: If P-gp inhibitors need to be taken, they should be administered using staggered dosing, i.e. the P-gp inhibitor dose should be taken as far apart in time as possible from the GIOTRIF dose.
Danish: Hvis samtidig behandling med en P-gp-hæmmer er nødvendig, skal denne doseres forskudt, dvs. at dosis af P-gp-hæmmeren skal tages så lang tid som muligt fra Giotrif- dosis.
English: GIOTRIF film-coated tablets are available in packs containing 1, 2 or 4 perforated unit dose blisters.
Danish: Giotrif filmovertrukne tabletter findes i pakninger med 1, 2 eller 4 perforerede enkeltdosis-blisterkort.
English: Other patient characteristics/intrinsic factors found with a significant impact on afatinib exposure were: ECOG performance score, lactate dehydrogenase levels, alkaline phosphatase levels and total protein.
Danish: Andre påviste patientkarakteristika/indre faktorer med en signifikant indvirkning på eksponeringen for afatinib var: ECOG-funktionsstatus, niveauet af laktatdehydrogenase og basisk fosfatase samt total-protein.
English: Effect of UDP-glucuronosyltransferase 1A1 (UGT1A1) inhibition on afatinib In vitro data indicated that drug-drug interactions with afatinib due to inhibition of UGT1A1 are considered unlikely.
Danish: Virkning af UDP-glukuronosyltransferase 1A1 (UGT1A1)-hæmning på afatinib In vitro data tydede på, at lægemiddelinteraktioner med afatinib som følge af hæmning af UGT1A1 er usandsynlige.
English: Uncommon side effects (may affect up to 1 in 100 people): • Inflammation of the pancreas (pancreatitis)
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 patienter): • Betændelse i bugspytkirtlen (pancreatitis)
English: At the time of the analysis, 14 Nov 2013, 176 patients (76.5%) in the afatinib arm and 70 patients (60.9%) in the chemotherapy arm experienced an event contributing to the PFS analysis, i.e. disease progression as determined by central independent review or death.
Danish: På analysetidspunktet, 14. november 2013, havde 176 patienter (76,5 %) i afatinib-armen og 70 patienter (60,9 %) i kemoterapi-armen en hændelse, der bidrog til PFS-analysen, dvs. sygdomsprogression (bestemt ud fra central, uafhængig vurdering) eller død.
English: Like all medicines, GIOTRIF can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: It is important to treat the rash early.
Danish: Det er vigtigt at behandle udslættet tidligt.
English: Other potential mechanisms of resistance to afatinib have been suggested preclinically and MET gene amplification has been observed clinically.
Danish: Præklinisk er andre potentielle resistensmekanismer over for afatinib blevet foreslået, og klinisk er MET-genforstærkning observeret.
English: Patients were treated with GIOTRIF 40 mg (all three trials) or 50 mg (LUX-Lung 2) orally once daily.
Danish: Patienterne blev behandlet med GIOTRIF 40 mg (alle tre studier) eller 50 mg (LUX-Lung 2) oralt én gang dagligt.
English: A study in rats up to the maximum tolerated doses revealed no significant impact on pre-/postnatal development.
Danish: Et rottestudie med administration af op til de højeste tålte doser viste ingen signifikant indvirkning på præ/postnatal udvikling.
English: Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitors, ATC code: L01XE13.
Danish: Farmakoterapeutisk klassifikation: antineoplastiske midler, proteinkinasehæmmere, ATC-kode: L01XE13.
English: • of squamous type if prior chemotherapy treatment has been insufficient.
Danish: • af pladecelle-type, hvis tidligere kemoterapi har været utilstrækkelig.
English: The respective total systemic exposure (AUC) was either slightly above (2.2 times in rats) or below (0.3 times in rabbits) compared with levels in patients.
Danish: Den respektive totale systemiske eksponering (AUC) var enten let over (2,2 gange hos rotter) eller under (0,3 gange hos kaniner) sammenlignet med niveauet hos patienterne.
English: In non-clinical disease models with ErbB pathway deregulation, afatinib as a single agent effectively blocks ErbB receptor signalling resulting in tumour growth inhibition or tumour regression.
Danish: I ikke-kliniske sygdomsmodeller med dysregulering af ErbB-reaktionsvejen blokerer afatinib som enkeltstof effektivt ErbB-receptorsignalering, hvilket medfører hæmning af tumorvækst eller tumorregression.
English: This means preferably 6 hours (for medicines taken twice daily) or 12 hours (for medicines taken once daily) apart from GIOTRIF:
Danish: Dette betyder helst 6 timer (for lægemidler, der tages to gange daglig) eller 12 timer (for lægemidler, der tages en gang daglig) fra, du tager Giotrif.
English: Patients had a tumour sample with an EGFR mutation categorised as either exon 19 deletion (58%) or exon 21 L858R substitutions (42%).
Danish: Patienterne havde en tumorprøve med en EGFR-mutation, der var kategoriseret som enten exon 19-deletion (58 %) eller exon 21L858R-substitutioner (42 %).
English: GIOTRIF is a medicine which contains the active substance afatinib.
Danish: Giotrif er et lægemiddel, der indeholder det virksomme stof afatinib.
English: Animal studies with afatinib did not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Danish: Dyrestudier med afatinib tydede ikke på direkte eller indirekte skadelige virkninger med hensyn til reproduktionstoksicitet (se pkt.
English: Other information on drug-drug interactions
Danish: Andre oplysninger om lægemiddelinteraktioner
English: Resume with dose reduction by 10 mg decrements a
Danish: Genoptag med dosisreduktion i trin på 10 mg
English: • Take this medicine at least 1 hour before eating, or
Danish: • Du skal tage Giotrif mindst 1 time før, du spiser noget, eller
English: Do not use this medicine after the expiry date which is stated on the carton, the pouch and the blister after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen, folieposen og blisterkortet efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: • if you develop diarrhoea.
Danish: • hvis du får diarré.
English: Similar to LUX-Lung 3, patients with previously untreated NSCLC were screened for EGFR mutations using TheraScreen
Danish: Som i LUX-Lung 3 blev patienter med tidligere ubehandlet NSCLC undersøgt for EGFR-mutationer ved hjælp af TheraScreen
English: 1-year PFS Rate Objective Response Rate (CR+PR)
Danish: 1-års PFS-rate Objektiv responsrate (CR+PR)
English: The efficacy results are provided in Figure 1, Tables 6 and 7.
Danish: Effektresultaterne er vist i Figur 1, Tabel 6 og Tabel 7.
English: In contrast, when ritonavir was administered simultaneously or 6 hours after 40 mg GIOTRIF, the relative bioavailability of afatinib was 119% (AUC0-∞) and 104% (Cmax) and 111% (AUC0-∞) and 105% (Cmax), respectively.
Danish: Når ritonavir blev givet samtidig med eller 6 timer efter 40 mg Giotrif, var den relative biotilgængelighed af afatinib derimod henholdsvis 119 % (AUC0-∞) og 104 % (Cmax) og 111 % (AUC0-∞) og 105 % (Cmax).
English: Among randomized patients, 65% were female, the median age was 58 years and all patients were of Asian ethnicity.
Danish: Af de randomiserede patienter var 65 % kvinder, medianalderen var 58 år, og samtlige patienter var af asiatisk oprindelse.
English: The T790M mutation is found in approximately 50% of patients' tumours upon disease progression on afatinib, for which T790M targeted EGFR TKIs may be considered as a next line treatment option.
Danish: T790M-mutationen findes i ca. 50 % af patienternes tumorer ved sygdomsprogression på afatinib, og en T790M-målrettet EGFR-TK-hæmmer kan overvejes som en næste behandlingsmulighed.
English: Effects of afatinib on P-gp substrates
Danish: Afatinibs virkning på P-gp-substrater
English: Radiolabelled afatinib administered orally to rats on Day 11 of lactation was excreted in the breast milk of the dams.
Danish: Radioaktivt mærket afatinib givet oralt til rotter dag 11 i ammeperioden blev udskilt i mælk.
English: The dose should not be escalated in any patients with a prior dose reduction.
Danish: Dosis bør ikke øges hos patienter, hvor dosis tidligere er blevet reduceret.
English: As a precautionary measure, women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with GIOTRIF.
Danish: Som en forholdsregel skal kvinder i den fertile alder frarådes at blive gravide under behandling med Giotrif.
English: These proteins are involved in the growth and spread of cancer cells, and can be affected by changes (mutations) in the genes that produce them.
Danish: Proteinerne kan påvirkes af ændringer (mutationer) i de gener, der producerer dem.
English: • Swallow the tablet whole with a glass of still water.
Danish: • Du skal synke tabletten hel sammen med et glas almindeligt vand.
English: Based on population pharmacokinetic data derived from clinical trials in various tumour types, an average decrease of 26% in AUCτ,ss was observed when food was consumed within 3 hours before or 1 hour after taking GIOTRIF.
Danish: Populationsfarmakokinetiske data fra kliniske forsøg med forskellige tumorformer viste et gennemsnitligt fald i AUCτ,ss på 26 % ved fødeindtagelse inden for 3 timer før eller 1 time efter indtagelse af Giotrif.
English: The European Medicines Agency has waived the obligation to submit the results of trials with this medicinal product in all subsets of the paediatric population in NSCLC indications (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med dette lægemiddel i alle undergrupper af den pædiatriske population ved indikationen NSCLC (se pkt.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du tager Giotrif.
English: • Cyclosporine A, tacrolimus - medicines that affect your immune system.
Danish: • Ciclosporin og tacrolimus, som er lægemidler, der påvirker immunsystemet.
English: If you are not able to swallow and have a gastric tube your doctor might suggest that the medicine is given to you via the tube.
Danish: Hvis du ikke kan synke og har en sonde, foreslår lægen måske, at du får lægemidlet gennem sonden.
English: Systemic exposure to afatinib is decreased by 50% (Cmax) and 39% (AUC0-∞), when administered with a high-fat meal compared to administration in the fasted state.
Danish: Den systemiske eksponering for afatinib blev reduceret med 50 % (Cmax) og 39 % (AUC0-∞), når afatinib blev givet sammen med et måltid med højt fedtindhold, sammenlignet med administration i fastende tilstand.
English: Efficacy was similarly high in the group of patients who had received prior chemotherapy (N=68; ORR 57.4%; median PFS by independent review 8 months).
Danish: Virkningen var lige så god i gruppen af patienter, der tidligere havde fået kemoterapi (N= 68; ORR 57,4 %; median PFS ved en uafhængig vurdering efter 8 måneder).
English: Early intervention (such as emollients, antibiotics) of dermatologic reactions can facilitate continuous GIOTRIF treatment.
Danish: Tidlig behandling af dermatologiske reaktioner (med f.eks. blødgørende cremer, antibiotika) kan muliggøre fortsat behandling med Giotrif.
English: The embryo-foetal development studies performed on afatinib revealed no indication of teratogenicity.
Danish: De studier af embryoføtal udvikling, der er udført med afatinib, viste ingen tegn på teratogenicitet.
English: However, if the next scheduled dose is due within 8 hours then the missed dose must be skipped.
Danish: Hvis den næste, planlagte dosis skal tages inden for 8 timer, skal den glemte dosis dog springes over.
English: Do not stop taking this medicine without first consulting your doctor.
Danish: Du må ikke holde op med at tage dette lægemiddel, før du har talt med lægen.
English: SPECIAL STORAGE CONDITIONS Store in the original package in order to protect from moisture and light.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i original emballage for at beskytte mod fugt og lys.
English: EGFR mutation status should be established prior to initiation of GIOTRIF therapy (see section 4.4).
Danish: EGFR-mutationsstatus bør fastslås før initiering af behandling med Giotrif (se pkt.
English: Table 2 summarises the frequencies of ADRs from all NSCLC trials and from post-marketing experience with daily GIOTRIF doses of 40 mg or 50 mg as monotherapy.
Danish: Tabel 2 giver en oversigt over hyppigheden af bivirkninger fra alle NSCLC-forsøg og erfaringer gjort efter markedsføring med Giotrif 40 mg eller 50 mg daglig som monoterapi.
English: • Increased levels of the liver enzymes (aspartate aminotransferase and alanine aminotransferase) in blood tests.
Danish: • Forhøjede værdier for leverenzymerne aspartat-amino-transferase og alanin-amino-transferase i en blodprøve
English: Effects of P-gp and breast cancer resistance protein (BCRP) inhibitors on afatinib In vitro studies have demonstrated that afatinib is a substrate of P-gp and BCRP.
Danish: P-glykoprotein (P-gp) og brystcancer-resistensprotein (BCRP) -hæmmeres virkninger på afatinib In vitro studier har påvist, at afatinib er substrat for P-gp og BCRP.
English: Dyspepsia Cheilitis
Danish: Dyspepsi Cheilitis
English: In patients who develop relevant cardiac signs/symptoms during treatment, cardiac monitoring including LVEF assessment should be considered.
Danish: Hos patienter, som får relevante kardiale tegn/symptomer under behandlingen, skal kardiologisk monitorering, herunder måling af LVEF, overvejes.
English: ILD-like adverse reactions were reported in 0.7% of patients treated with GIOTRIF across all clinical trials (including 0.5% of patients with CTCAE Grade ≥ 3 ILD-like adverse reactions).
Danish: ILD-lignende bivirkninger blev rapporteret hos 0,7 % af de Giotrifbehandlede patienter i alle kliniske studier (inklusive 0,5 % med ILD-lignende bivirkninger af CTCAE-grad ≥ 3).
English: Do not take GIOTRIF - if you are allergic to afatinib or any of the other ingredients of this medicine (listed in section 6).
Danish: Det skal du vide, før du begynder at tage Giotrif Tag ikke Giotrif - hvis du er allergisk over for afatinib eller et af de øvrige indholdsstoffer i Giotrif (angivet i punkt 6).
English: Based on the mechanism of action, all EGFR targeting medicinal products including GIOTRIF have the potential to cause foetal harm.
Danish: Ud fra virkningsmekanismen har alle EGFR-rettede lægemidler, herunder Giotrif, potentialet til at skade et foster.
English: There is no specific antidote for overdose with this medicinal product.
Danish: Der findes ingen specifik antidot til brug efter overdosering med Giotrif.
English: No other liquids should be used.
Danish: Der må ikke bruges andre drikkevarer hertil.
English: Therefore, it is recommended to administer strong P-gp inhibitors (including but not limited to ritonavir, cyclosporine A, ketoconazole, itraconazole, erythromycin, verapamil, quinidine, tacrolimus, nelfinavir, saquinavir, and amiodarone) using staggered dosing, preferably 6 hours or 12 hours apart from GIOTRIF (see section 4.2).
Danish: Det anbefales derfor at administrere kraftige P-gp-hæmmere (herunder, men ikke begrænset til, ritonavir, ciclosporin, ketoconazol, itraconazol, erythromycin, verapamil, quinidin, tacrolimus, nelfinavir, saquinavir og amiodaron) ved forskudt dosering, helst 6 eller 12 timer fra Giotrif (se pkt.
English: Dosage The recommended dose is 40 mg each day.
Danish: Dosering Den anbefalede dosis er 40 mg hver dag.
English: Randomisation was stratified according to EGFR mutation status (Del 19; L858R) and presence of brain metastases (yes; no).
Danish: Randomiseringen var stratificeret i henhold til EGFR-mutationsstatus (Del 19, L858R) og tilstedeværelse af hjernemetastaser (ja; nej).
English: Patients who received at least 4 cycles of platinum-based therapy in the first line setting were subsequently randomized 1:1 to daily GIOTRIF 40 mg or erlotinib 150 mg until progression.
Danish: Patienter, der fik mindst 4 cyklusser platinbaseret førstelinjebehandling, blev efterfølgende randomiseret i forholdet 1:1 til 40 mg Giotrif eller 150 mg erlotinib daglig indtil progression.