FrancophonIA/ELRC3.0 huggingface dataset:
English: Thus, steady state plasma concentrations of afatinib were achieved within 8 days of multiple dosing of afatinib resulting in an accumulation of 2.77-fold (AUC0-∞) and 2.11-fold (Cmax).
Danish: Steady state plasmakoncentrationer af afatinib blev således nået inden for 8 dage ved gentagen dosering, og det medførte en akkumulering på 2,77 gange (AUC0-∞) og 2,11 gange (Cmax).
English: If a diagnosis of ulcerative keratitis is confirmed, treatment should be interrupted or discontinued.
Danish: Hvis diagnosen keratitis ulcerosa bekræftes, skal behandlingen seponeres midlertidigt eller permanent.
English: A fertility study in male and female rats up to the maximum tolerated dose revealed no significant impact on fertility.
Danish: Et fertilitetsstudie med hanrotter og hunrotter med administration af op til den højeste tålte dosis viste ingen signifikant indvirkning på fertiliteten.
English: Table 7 shows outcomes in the subgroups of patients with two common EGFR mutations - Del 19 and L858R.
Danish: Tabel 7 viser resultaterne i undergrupper af patienter med to almindelige EGFR-mutationer - Del 19 og L858R.
English: Interstitial Lung Disease (ILD) should be considered if a patient develops acute or worsening of respiratory symptoms in which case treatment should be interrupted pending evaluation.
Danish: Interstitiel lungesygdom (ILD) skal overvejes, hvis en patient får akutte eller forværrede luftvejssymptomer, og i en sådan situation skal behandlingen seponeres, indtil der er foretaget en evaluering.
English: Adjustments to the starting dose are not necessary in patients with mild or moderate hepatic impairment.
Danish: Justering af startdosis er ikke nødvendig hos patienter med let eller moderat nedsat leverfunktion.
English: In humans it was found that enzyme-catalyzed metabolic reactions play a negligible role for the metabolism of afatinib.
Danish: Hos mennesker er det blevet vist, at enzymkatalyserede metaboliske reaktioner spiller en ubetydelig rolle for metaboliseringen af afatinib.
English: Afatinib is eliminated with an effective half-life of approximately 37 hours.
Danish: Afatinibs effektive halveringstid er ca. 37 timer.
English: MDRD formula) had an exposure of 122% (Cmax) and 150% (AUC0-tz) in comparison to their healthy controls.
Danish: MDRD-formlen havde en eksponering på 122 % (Cmax) og 150 % (AUC0-tz) i forhold til de raske forsøgspersoner.
English: Fertility studies in humans have not been performed with afatinib.
Danish: Der er ikke foretaget fertilitetsundersøgelser med afatinib hos mennesker.
English: Discontinuation due to ADRs diarrhoea and rash/acne was 1.3% and 0% in LUX-Lung 3 and 3.8% and 2.0% in LUX-Lung 8, respectively.
Danish: Giotrif blev seponeret på grund af diarré og udslæt/akne hos henholdsvis 1,3 % og 0 % i LUX-Lung 3 og hos 3,8 % og 2,0 % i LUX-Lung 8.
English: This could result in a higher risk of developing adverse reactions in particular diarrhoea, rash/acne and stomatitis.
Danish: Dette kan medføre en højere risiko for at få bivirkninger, især diarré, udslæt/akne og stomatitis.
English: Female gender, lower body weight, and underlying renal impairment Higher exposure to afatinib has been observed in female patients, patients with lower body weight and those with underlying renal impairment (see section 5.2).
Danish: Kvindelige patienter, lav legemsvægt og underliggende nedsat nyrefunktion Der er set en højere eksponering for afatinib hos kvindelige patienter, patienter med lav legemsvægt og patienter med underliggende nedsat nyrefunktion (se pkt.
English: • Periodic safety update reports
Danish: • Periodiske, opdaterede sikkerhedsforanstaltnnger (PSUR'er)
English: Both trials demonstrated significant improvement in PFS of EGFR mutation positive patients treated with GIOTRIF compared to chemotherapy.
Danish: Begge forsøg demonstrerede signifikant forbedring i PFS for EGFR-mutationspositive patienter, der blev behandlet med Giotrif, sammenlignet med kemoterapi.
English: Patients were screened for the presence of activating EGFR mutations (Del 19 and/or L858R) using the TheraScreen
Danish: Patienterne blev screenet for tilstedeværelse af aktiverende EGFR-mutationer (Del 19 og/eller L858R) ved hjælp af TheraScreen
English: Subjects with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment had similar exposure in comparison to healthy volunteers following a single dose of 50 mg GIOTRIF.
Danish: Personer med let (Child-Pugh A) eller moderat (Child-Pugh B) nedsat leverfunktion havde samme eksponering som raske frivillige forsøgspersoner efter en enkeltdosis på 50 mg Giotrif.
English: Available pharmacokinetic data in animals have shown excretion of afatinib in milk (see section 5.3).
Danish: De foreliggende farmakokinetiske data fra dyr har vist, at afatinib udskilles i mælk (se pkt.
English: • Nail problems
Danish: • Negleproblemer
English: • if you have liver problems.
Danish: • hvis du har problemer med leveren.
English: • Severe blistering or peeling of skin (suggestive of Stevens-Johnson syndrome and toxic epidermal necrolysis)
Danish: • Svær blisterdannelse eller afskalning af huden (der kan være tegn på Stevens-Johnsons syndrom og toksisk epidermal nekrolyse)
English: • if you have a history of eye problems such as severe dry eyes, inflammation of the transparent layer at the front of the eye (cornea) or ulcers involving the outer part of the eye, or if you use contact lenses.
Danish: • hvis du har eller har haft problemer med øjnene, som f.eks. meget tørre øjne, inflammation i hornhinden (det transparente ydre lag af øjet) eller sår på den ydre del af øjet, eller hvis du bruger kontaktlinser.
English: However, systemic exposures achieved in animals were either in a similar range or below the levels observed in patients (see section 5.3).
Danish: Systemiske eksponeringer opnået hos dyr lå dog inden for et interval, der enten svarede til eller lå under de niveauer, der blev set hos patienter (se pkt.
English: Patients with mild and moderate hepatic impairment as identified by abnormal liver tests did not correlate with any significant change in afatinib exposure.
Danish: Hos patienter med let og moderat nedsat leverfunktion, påvist ved unormale leverfunktionsværdier, var der ikke korrelation med nogen signifikant ændring i eksponeringen for afatinib.
English: • Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s);
Danish: • epidermal vækstfaktorreceptor (EGFR)-tyrosinkinasehæmmer (TKI)-naive voksne patienter med lokalt fremskreden eller metastaserende ikke-småcellet lungekræft (NSCLC) med aktiverende EGFR-mutation(er)
English: Co-administration of a high-fat meal with GIOTRIF resulted in a significant decrease of exposure to afatinib by about 50% in regard to Cmax and 39% in regard to AUC0-∞.
Danish: Indtagelse af et måltid med højt fedtindhold samtidig med Giotrif medførte en signifikant reduktion af eksponeringen for afatinib på ca. 50 % med hensyn til Cmax og 39 % med hensyn til AUC0-∞.
English: In patients with cardiac risk factors and those with conditions that can affect LVEF, cardiac monitoring, including an assessment of LVEF at baseline and during treatment, should be considered.
Danish: Hos patienter med kardiale risikofaktorer eller med tilstande, der kan påvirke LVEF, skal kardiologisk monitorering, herunder måling af LVEF ved baseline og under behandlingen, overvejes.
English: GIOTRIF 20 mg film-coated tablets Hypromellose (E464) Macrogol 400
Danish: Giotrif 20 mg filmovertrukne tabletter Hypromellose (E464) Macrogol 400
English: PFS benefit was accompanied by improvement in disease-related symptoms and delayed time to deterioration (see Table 11).
Danish: PFS-fordelen blev ledsaget af forbedring i sygdomsrelaterede symptomer og forlængelse af tid til forværring (se Tabel 11).
English: Includes Dry skin, Skin chapped
Danish: Omfatter tør hud, sprækker i huden.
English: Overdose in 2 healthy adolescents involving the ingestion of 360 mg each of afatinib (as part of a mixed drug ingestion) was associated with adverse events of nausea, vomiting, asthenia, dizziness, headache, abdominal pain and elevated amylase (< 1.5 times ULN).
Danish: En overdosis hos 2 raske unge personer, der hver indtog en dosis på 360 mg afatinib (som led i indtagelse af flere forskellige lægemidler), var ledsaget af kvalme, opkastning, asteni, svimmelhed, hovedpine, abdominalsmerter og forhøjet amylase (< 1,5 gange ULN).
English: Food effect on afatinib
Danish: Virkning af fødeindtagelse på afatinib
English: 89% of patients had common EGFR mutations (Del 19 or L858R).
Danish: 89 % af patienterne havde almindeligt forekommende EGFR-mutationer (Del 19 eller L858R).
English: Table 1: Dose adjustment information for adverse reactions
Danish: Tabel 1: Dosisjustering i tilfælde af bivirkninger
English: Grade 3 diarrhoea most frequently occurred within the first 6 weeks of treatment.
Danish: Grad 3 diarré forekom hyppigst inden for de første 6 behandlingsuger.
English: Treatment at the first signs of diarrhoea is important.
Danish: Det er vigtigt at behandle diarré ved de første tegn.
English: • Verapamil, quinidine, amiodarone - used to treat heart conditions.
Danish: • Verapamil, quinidin og amiodaron, som bruges til at behandle hjertesygdomme.
English: You should have antidiarrhoeal medicine available prior to taking GIOTRIF.
Danish: Du skal have medicin mod diarré liggende, før du begynder at tage Giotrif.
English: The highest total systemic exposure (AUC0-24) in female rats was less than that observed in patients (0.23 times).
Danish: Den højeste totale systemiske eksponering (AUC0-24) hos hunrotter var mindre end den, der blev set hos patienter (0,23 gange).
English: Patients were randomised (2:1) to receive GIOTRIF 40 mg once daily or up to 6 cycles of pemetrexed/cisplatin.
Danish: Patienterne blev randomiseret (2:1) til at få Giotrif 40 mg én gang daglig eller op til 6 serier med pemetrexed/cisplatin.
English: • Adult patients with locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy (see section 5.1).
Danish: • voksne patienter med lokalt fremskreden eller metastaserende NSCLC med planocellulær histologi, der progredierer under eller efter platinbaseret kemoterapi (se pkt.
English: Titanium dioxide (E171) Talc (E553b)
Danish: Titandioxid (E171) Talcum (E553b)
English: Enzyme-catalyzed metabolic reactions play a negligible role for afatinib in vivo.
Danish: Enzymkatalyserede metaboliske reaktioner spiller en ubetydelig rolle for afatinib in vivo.
English: Each blister contains 7 x 1 film-coated tablets and is packed in an aluminium pouch together with a desiccant sachet that should not be swallowed.
Danish: Hvert blisterkort indeholder 7 x 1 filmovertrukne tabletter og er pakket i en foliepose sammen med en pose tørremiddel, som ikke må sluges.
English: Strong P-gp inducers (including but not limited to rifampicin, carbamazepine, phenytoin, phenobarbital or St. John's wort (Hypericum perforatum)) may decrease exposure to afatinib (see section 4.4).
Danish: Kraftige P-gp-induktorer (herunder, men ikke begrænset til, rifampicin, carbamazepin, phenytoin, phenobarbital eller perikon (Hypericum perforatum)) kan reducere eksponeringen for afatinib (se pkt.
English: If you stop taking GIOTRIF
Danish: Hvis du holder op med at tage Giotrif
English: In the pivotal trials Grade 3 alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevations were observed in 2.4% (LUX-Lung-3) and 1.6% (LUX-Lung 8) of patients with normal baseline liver tests treated with 40 mg/day.
Danish: Der blev i de pivotale studier set grad 3-stigning i alaninaminotransferase (ALAT) og aspartataminotransferase (ASAT) hos 2,4 % (LUX-Lung 3) og 1,6 % (LUX-Lung 8) af patienterne med normale leverfunktionsværdier ved baseline, som fik behandling med 40 mg/dag.
English: Contact your doctor immediately and start appropriate antidiarrhoeal treatment as soon as possible.
Danish: Du skal starte en passende behandling mod diarré så hurtigt som muligt.
English: In humans, excretion of afatinib is primarily via the faeces.
Danish: Hos mennesker udskilles afatinib primært via fæces.
English: This medicinal product should be used with caution in patients with a history of keratitis, ulcerative keratitis or severe dry eye.
Danish: Dette lægemiddel skal bruges med forsigtighed til patienter med keratitis, keratitis ulcerosa eller meget tørre øjne i anamnesen.
English: OS results based on primary OS analysis as of April 2016 at event rates of 109 (68.1%) and 117 (73.6%) in the GIOTRIF and gefitinib arms, respectively p-value for PFS/OS based on stratified log-rank test; p-value for Objective Response Rate based on stratified logistic regression
Danish: OS-resultater baseret på den primære OS-analyse pr. april 2016 med hændelsesrater på hhv. 109 (68,1 %) og 117 (73,6 %) i Giotrif- og gefitinib-grupperne p-værdi for PFS/OS baseret på stratificeret log-rank-test; p-værdi for objektiv responsrate baseret på stratificeret logistisk regression
English: Dose interruption may become necessary in patients who experience worsening of liver function (see section 4.2).
Danish: Midlertidig seponering kan blive nødvendig hos patienter, hvor leverfunktionen forværres (se pkt.
English: • if you develop new or sudden worsening of shortness of breath, possibly with a cough or fever.
Danish: • hvis du får åndenød eller pludselig forværring af åndenød, der måske er ledsaget af hoste eller feber.
English: Food should not be consumed for at least 3 hours before and at least 1 hour after taking this medicinal product (see sections 4.5 and 5.2).
Danish: Patienterne bør ikke spise noget i mindst 3 timer før og mindst 1 time efter, at de har taget dette lægemiddel (se pkt.
English: The acquisition of a secondary T790M mutation is a major mechanism of acquired resistance to afatinib and gene dosage of the T790M-containing allele correlates with the degree of resistance in vitro.
Danish: Erhvervelse af en sekundær T790M-mutation er en væsentlig mekanisme for erhvervet resistens over for afatinib, og allel-frekvensen (hyppigheden) af den allel, der indeholder T790M, korrelerer med graden af in vitro-resistens.
English: In oral repeated-dose studies for up to 26 weeks in rats or 52 weeks in minipigs the main effects were identified in the skin (dermal changes, epithelial atrophy and folliculitis in rats), the gastrointestinal tract (diarrhoea, erosions in the stomach, epithelial atrophy in rats and minipigs) and the kidneys (papillary necrosis in rats).
Danish: I studier med gentagne orale doser i op til 26 uger til rotter eller 52 uger til minigrise blev de væsentligste virkninger set på huden (hudforandringer, epitelial atrofi og folliculitis hos rotter), i mave-tarm-kanalen (diarré, erosioner i ventriklen og epitelial atrofi hos rotter og minigrise) og i nyrerne (papillær nekrose hos rotter).
English: Symptoms such as acute or worsening eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain and/or red eye should be referred promptly to an ophthalmology specialist.
Danish: Hvis en patient får symptomer som f.eks. akut eller forværret øjeninflammation, tåreflåd, lysfølsomhed, uklart syn, øjensmerter og/eller et rødt øje, skal patienten omgående henvises til en øjenlæge.
English: A risk to the breast-feeding child cannot be excluded.
Danish: Det kan ikke udelukkes, at der er en risiko for det ammede barn.
English: The primary endpoint was progression free survival (PFS) by independent review; the secondary endpoints included overall survival and objective response rate.
Danish: Det primære endepunkt var progressionsfri overlevelse (PFS) på grundlag af en uafhængig vurdering; de sekundære endepunkter omfattede samlet overlevelse (OS) og objektiv responsrate (ORR).
English: A dose escalation to a maximum of 50 mg/day may be considered in patients who tolerate a 40 mg/day starting dose (i.e. absence of diarrhoea, skin rash, stomatitis, and other adverse reactions with CTCAE Grade > 1) in the first cycle of treatment (21 days for EGFR mutation positive NSCLC and 28 days for squamous NSCLC).
Danish: Dosisøgning til højst 50 mg/dag kan overvejes hos patienter, som tåler en startdosis på 40 mg/dag (dvs. fravær af diarré, hududslæt, stomatitis og andre bivirkninger af CTCAE-grad > 1) i den første behandlingscyklus (21 dage for EGFR-mutationspositiv NSCLC og 28 dage for planocellulær NSCLC).
English: • If your next scheduled dose is more than 8 hours away, take the missed dose as soon as you remember.
Danish: • Hvis din næste planlagte dosis er om mere end 8 timer, skal du tage den glemte dosis, så snart du kommer i tanker om det.
English: GIOTRIF in patients with Non-Small Cell Lung Cancer (NSCLC) with EGFR mutations
Danish: Giotrif hos patienter med ikke-småcellet lungekræft (NSCLC) med EGFR-mutationer.
English: Diarrhoea lasting more than 2 days or more severe diarrhoea may lead to fluid loss (common, may affect up to 1 in 10 people), low blood potassium (common) and worsening kidney function (common).
Danish: • Diarré (meget almindeligt, kan forekomme hos flere end 1 ud af 10 personer) Diarré, der varer over 2 dage, eller svær diarré kan medføre væsketab (almindeligt, kan forekomme hos op til 1 ud af 10 personer), lavt kalium i blodet (almindeligt) og forværring af nyrefunktionen (almindeligt).
English: • Nail infection
Danish: • Negleinfektion
English: PVC/PVDC perforated unit dose blister.
Danish: Perforeret enkeltdosis-blisterkort af PVC/PVDC.
English: Studies in animals have shown no signs of teratogenicity up to and including maternally lethal dose levels.
Danish: Dyrestudier har ikke påvist tegn på teratogenicitet ved dosisniveauer til og med niveauer, der medførte moderens død.
English: OS Months (median)
Danish: OS Måneder (median)
English: Use of P-glycoprotein (P-gp) inhibitors
Danish: Brug af P-glykoprotein (P-gp)-hæmmere
English: Table 2: Summary of ADRs per frequency category
Danish: Tabel 2: Oversigt over bivirkninger efter hyppighed Organklasse
English: Treatment with GIOTRIF should be initiated and supervised by a physician experienced in the use of anticancer therapies.
Danish: Behandling med Giotrif bør iværksættes og superviseres af en læge med særligt kendskab til maligne lidelser og deres behandling.
English: LUX-Lung 2 was a single arm Phase II trial in 129 EGFR TKI-naïve patients with stage IIIB or IV lung adenocarcinoma with EGFR mutations.
Danish: LUX-Lung 2 var et fase II-enkeltgruppeforsøg med 129 EGFR-TKI-naive patienter med stadium IIIB eller IV lungeadenokarcinom med EGFR-mutationer.
English: The dispersion should be consumed immediately.
Danish: Opslæmningen skal drikkes med det samme.
English: Therefore, food should not be consumed for at least 3 hours before and at least 1 hour after taking GIOTRIF (see sections 4.2 and 4.5).
Danish: Fødeindtagelse skal derfor undgås i mindst 3 timer før og mindst 1 time efter indtagelse af Giotrif (se pkt.
English: The primary endpoint was PFS as assessed by central independent review; secondary endpoints included OS and ORR.
Danish: Det primære endepunkt var PFS på grundlag af en central, uafhængig vurdering; sekundære endepunkter omfattede OS og ORR.
English: Exposure to afatinib is not significantly changed in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment (see section 5.2).
Danish: Eksponeringen for afatinib ændres ikke signifikant hos patienter med let (Child-Pugh A) eller moderat (Child-Pugh B) nedsat leverfunktion (se pkt.
English: Drop the tablet into the water without crushing it, and occasionally stir for up to 15 min until the tablet is broken up into very small particles.
Danish: Læg tabletten ned i vandet uden at knuse den og rør rundt en gang imellem, indtil tabletten er blevet til meget små korn (i op til 15 minutter).
English: 3 4 Any Grade
Danish: 3 Grad 4 Alle grader
English: • If your next scheduled dose is due within 8 hours, skip the missed dose and take your next dose at the usual time.
Danish: • Hvis din næste planlagte dosis er inden for 8 timer, skal du springe den glemte dosis over og i stedet tage den næste dosis på det tidspunkt, du plejer.
English: If indicated, elimination of unabsorbed afatinib may be achieved by emesis or gastric lavage.
Danish: Om nødvendigt kan uabsorberet afatinib elimineres ved at fremkalde opkastning eller ved ventrikelskylning.
English: CR=complete response; PR=partial response p-value for PFS/OS based on stratified log-rank test; p-value for Objective Response Rate based on logistic regression
Danish: CR = komplet respons, PR = partielt respons p-værdien for PFS/OS baseret på stratificeret log-rank-test; p-værdi for objektiv responsrate baseret på logistisk regression
English: Store in the original package in order to protect from moisture and light.
Danish: Opbevares i den originale emballage for at beskytte mod fugt og lys.
English: Dehydration Hypokalaemia
Danish: Appetitløshed Dehydrering Hypokaliæmi
English: values presented for GIOTRIF vs. erlotinib, p-value based on logistic regression b p-value for time to deterioration based on stratified log-rank test c p-values were not adjusted for multiplicity
Danish: værdier for Giotrif vs. erlotinib, p-værdi baseret på logistisk regression b p-værdi for tid til forværring baseret på stratificeret log-rank test c p-værdier blev ikke justeret for multiplicitet
English: The tablet should be dropped into the water without crushing it, and stirred occasionally for up to 15 min until it is broken up into very small particles.
Danish: Tabletten lægges hele ned i vandet, og der røres rundt en gang imellem i de næste op til 15 minutter, indtil den er blevet til meget små partikler.
English: GIOTRIF 30, 40 and 50 mg film-coated tablets Hypromellose (E464)
Danish: Giotrif 30, 40 og 50 mg filmovertrukne tabletter Hypromellose (E464)
English: PFS benefit was accompanied by improvement in disease-related symptoms and delayed time to deterioration (see Table 8).
Danish: Den forlængede PFS var ledsaget af en bedring af sygdomsrelaterede symptomer og forlængelse af tiden indtil forværring (se Tabel 8).
English: Liver function test abnormalities (including elevated ALT and AST) were observed in patients receiving GIOTRIF 40 mg.
Danish: Der blev set unormale leverfunktionsværdier (herunder forhøjet ALAT og ASAT) hos patienter, der fik Giotrif 40 mg.
English: If you become pregnant while receiving this medicine, you should immediately inform your doctor.
Danish: Hvis du bliver gravid, mens du får Giotrif, skal du fortælle det til lægen med det samme.
English: PHARMACEUTICAL FORM AND CONTENTS 7 x 1 film-coated tablets
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 7 x 1 filmovertrukne tabletter
English: In particular, if taken before GIOTRIF, the following medicines may increase the blood levels of GIOTRIF and therefore the risk of side effects.
Danish: Især nedenstående lægemidler kan øge indholdet af Giotrif i blodet og dermed risikoen for bivirkninger, hvis du tager dem, før du tager Giotrif.
English: In LUX-Lung-3 Grade 3 ALT/AST elevations were about 3.5 fold higher in patients with abnormal baseline liver tests.
Danish: I LUX-Lung 3 var grad 3-stigningerne i ALAT/ASAT ca. 3,5 gange højere hos patienter med unormale leverfunktionsværdier ved baseline.
English: Dermatitis acneiform
Danish: Akneiform dermatitis
English: Among 795 patients randomized, the majority were males (84%), white (73%), current or former smokers (95%) with baseline performance status ECOG 1 (67%) and ECOG 0 (33%).
Danish: Af de 795 randomiserede patienter var størstedelen mænd (84 %), hvide (73 %), nuværende eller tidligere rygere (95 %) med ECOG-performancestatus 1 (67 %) eller ECOG 0 (33 %) ved baseline.