FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety profile presented in Table 1 is based on the gefitinib clinical development programme and post-marketed experience.
Danish: Sikkerhedsprofilen, som fremgår af Tabel 1, er baseret på det kliniske udviklingsprogram med gefitinib og postmarketing-erfaringer.
English: • Do not take antacids (to reduce the acid level of your stomach) 2 hours before or 1 hour after taking Gefitinib Mylan.
Danish: • Tag ikke antacida (for at mindske syre i din mave) 2 timer før og 1 time efter du tager Gefitinib
English: Do not take Gefitinib Mylan if you are breast-feeding for the safety of your baby.
Danish: Tag ikke Gefitinib Mylan, hvis du ammer af hensyn til dit barns sikkerhed.
English: Do not take Gefitinib Mylan: - if you are allergic to gefitinib or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Gefitinib Mylan: - hvis du er allergisk over for gefitinib eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: Only robust, reliable and sensitive test(s) with demonstrated utility for the determination of EGFR mutation status of tumours or ctDNA should be used to avoid false negative or false positive determinations (see section 5.1).
Danish: Kun robuste, pålidelige, sensitive test(s) med påvist anvendelighed til bestemmelse af EGFRmutationsstatus af tumorer eller ctDNA bør anvendes for at undgå falsk negative eller falsk positive bestemmelser (se pkt 5.1).
English: N Objective response rates and 95% CI for difference between treatmentsa
Danish: N Objektive responsrater og 95 % CI for forskel mellem behandlingernea
English: Trial outcome index results were supportive of FACT-L and LCS results a
Danish: Trial outcome index-resultater understøttede FACT-L- og LCS-resultaterne a
English: The blisters may be packed into aluminium pouches.
Danish: Blisterpakningerne kan pakkes ind i aluminiumsposer.
English: 117 Allée des Parcs 69800 Saint-Priest France
Danish: 117 Allée des Parcs 69800 Saint Priest Frankrig
English: • Severe skin reactions (rare) affecting large areas of your body.
Danish: • Heftige hudreaktioner (sjælden) på store dele af kroppen.
English: Following oral administration of C-14 labelled gefitinib to lactating rats 14 days post-partum, concentrations of radioactivity in milk were 11-19 fold higher than in blood.
Danish: Efter oral administration af C14-mærket gefitinib til diende rotter 14 dage post partum var koncentrationen af radioaktivitet i mælken 11 til 19 gange højere end i blodet.
English: Some lung problems may get worse during treatment with Gefitinib Mylan.
Danish: Nogle lungeproblemer kan blive værre under behandling med Gefitinib Mylan.
English: **This includes isolated reports of hepatic failure which in some cases led to fatal outcomes.
Danish: **Inkluderer isolerede rapporter om leversvigt, som i nogle tilfælde havde letalt udfald.
English: • Gastrointestinal perforation.
Danish: • Gastrointestinel perforation.
English: Gefitinib has a mean steady-state volume of distribution of 1400 L indicating extensive distribution into tissue.
Danish: Gefitinib har et gennemsnitligt steady-state-volumen på 1400 l, hvilket tyder på, at der sker en omfattende distribution til væv.
English: Approximately 8% of patients had a severe ADR (common toxicity criteria, (CTC) grade 3 or 4).
Danish: Cirka 8 % af patienterne havde en alvorlig bivirkning (common toxicity criteria (CTC), grad 3 eller 4).
English: Risk of mortality among patients who developed ILD on gefitinib or chemotherapy was higher in patients with the following risk factors:
Danish: Risikoen for dødelighed blandt patienter, der udviklede ILS, efter behandling med gefitinib eller kemoterapi, var højere hos patienter med følgende risikofaktorer:
English: Gefitinib response data is more sparse in patients whose tumours contain the less common mutations; the available data indicates that G719X, L861Q and S7681 are sensitising mutations; and T790M alone or exon 20 insertions alone are resistance mechanisms.
Danish: Gefitinibresponsdata er mere sparsomme hos patienter, hvis tumorer indeholder mindre almindelige mutationer; de tilgængelige data tyder på, at G719X, L861Q og S7681 er sensibiliserende mutationer; og T790M alene eller exon 20-insertioner alene er resistensmekanismer.
English: Bullous conditions including Toxic epidermal necrolysis, Stevens Johnson syndrome and erythema multiforme.
Danish: Bulløse tilstande, inklusive toksisk epidermal nekrolyse, Stevens-Johnsons syndrom og erythema multiforme.
English: HR in the overall population, or otherwise 95% confidence intervals for HR c Confidence interval entirely below non-inferiority margin of 1.154
Danish: (CI) for total overlevelses-HR i den totale population, ellers 95 % konfidensinterval for HR c Konfidensinterval udelukkende under non-inferioritet-margen på 1,154
English: Treatment with Gefitinib Mylan should be initiated and supervised by a physician experienced in the use of anticancer therapies.
Danish: Behandling med Gefitinib Mylan skal initieres og superviseres af en læge med erfaring inden for cancer-behandling.
English: The dispersion can also be administered through a naso-gastric or gastrostomy tube.
Danish: Dispersionen kan også administreres gennem en naso-gastrisk sonde eller gastrostomisonde.
English: Mechanism of action and pharmacodynamic effects The epidermal growth factor (EGF) and its receptor (EGFR [HER1; ErbB1]) have been identified as key drivers in the process of cell growth and proliferation for normal and cancer cells.
Danish: Virkningsmekanisme og farmakodynamisk virkning Den epidermale vækstfaktor (EGF) og dens receptor (EGFR [HER1; ErbB1]) er blevet identificeret som de vigtigste faktorer under cellevækst og proliferation for normale celler og cancerceller.
English: • Red or sore mouth.
Danish: • Rød eller øm mund.
English: • Increase of creatinine levels in a blood test (related to kidney function).
Danish: • Forhøjet mængde af stoffet kreatinin i en blodprøve (hænger sammen med nyrefunktionen).
English: It is recommended that you avoid becoming pregnant during treatment with this medicine because Gefitinib Mylan could harm your baby.
Danish: Det anbefales, at du undgår at blive gravid, og/eller at du ammer, mens du er i behandling med Gefitinib Mylan, fordi Gefitinib Mylan kan skade dit barn.
English: • Bleeding (such as nose bleed or blood in your urine).
Danish: • Blødning (såsom næseblod eller blod i urinen).
English: Children and adolescents Gefitinib Mylan is not indicated in children and adolescents under 18 years.
Danish: Børn og unge Gefitinib Mylan er ikke beregnet til børn og teenagere under 18 år.
English: LSC Lung cancer subscale.
Danish: Lungecancer subskala.
English: Gefitinib shows no enzyme induction effects in animal studies and no significant inhibition (in vitro) of any other cytochrome P450 enzyme.
Danish: Gefitinib udviser ingen enzym-induktionseffekter i dyreforsøg og ingen signifikant hæmning (in vitro) af nogen andre cytokrome P450-enzymer.
English: Gefitinib Mylan is used to treat adults with non-small cell lung cancer.
Danish: Gefitinib Mylan bruges til at behandle voksne med ikke-småcellet lungekræft.
English: • Serious breathlessness, or sudden worsening breathlessness, possibly with a cough or fever.
Danish: • Svær åndenød eller pludselig forværring af åndenød, muligvis med hoste og feber.
English: Asymptomatic laboratory elevations in blood creatinine.
Danish: Asymptomatisk stigning i kreatinin i blodprøver.
English: Talk to your doctor or pharmacist before taking Gefitinib Mylan - if you have ever had any other lung problems.
Danish: Kontakt lægen eller apotekspersonalet, før du tager Gefitinib Mylan - hvis du nogensinde har haft andre problemer med lungerne.
English: 28/70 (40%) of never smokers are M+.
Danish: 28/70 (40 %) af de der aldrig har røget er M+.
English: An increased risk of ILD on gefitinib relative to chemotherapy was seen predominantly during the first 4 weeks of treatment (adjusted OR 3.8; 95% CI 1.9 to 7.7); thereafter the relative risk was lower (adjusted OR 2.5; 95% CI 1.1 to 5.8).
Danish: Der sås en forøget relativ risiko for ILS hos patienter behandlet med gefitinib i forhold til kemoterapi i løbet af de første 4 ugers behandling (justeret OR 3,8; 95 % CI 1,9 til 7,7); derefter var den relative risiko lavere (justeret OR 2,5; 95 % CI 1,1 til 5,8).
English: FACT-L QoL improvement ratea
Danish: FACT-L QoLforbedringshyppigheda
English: In the overall population, no statistically significant difference between gefitinib and docetaxel (75 mg/m2) was observed for overall survival, progression free survival and objective response rates (see Table 5).
Danish: Hos den totale population blev der ikke observeret nogen statistisk signifikant forskel mellem gefitinib og docetaxel (75 mg/m²), målt som total overlevelse, progressionsfri overlevelse eller objektiv responsrate (se tabel 5).
English: • Increase of a liver enzyme known as alanine aminotransferase in a blood test; if too high, your doctor may tell you to stop taking this medicine.
Danish: • Forøget antal leverenzymer, som kaldes alanin-aminotransferase, ved en blodprøve; hvis antallet er for højt, vil din læge muligvis fortælle dig, at du skal stoppe med at tage dette lægemiddel.
English: • If it is 12 hours or more until your next dose: take the missed tablet as soon as you remember.
Danish: • Hvis der er 12 timer eller mere til din næste dosis: Tag den glemte tablet, så snart du kommer i tanke om det.
English: Women of childbearing potential Women of childbearing potential must be advised not to get pregnant during therapy.
Danish: Fertilitet Kvinder i den fertile alder skal tilrådes ikke at blive gravide under behandlingen.
English: Table 7 - Summary of multivariate logistic regression analysis to identify factors that independently predicted for the presence of EGFR mutations in 786 Caucasian patients* Factors that predicted for presence of EGFR mutation p-value
Danish: Tabel 7 - Opsummering af multivariat logistisk regressionsanalyse for at identificere faktorer, som uafhængigt forudsiger tilstedeværelsen af EGFR-mutationer hos 786 kaukasiske patienter* Faktorer som forudsiger tilstedeværelse af EGFRmutation p-værdi
English: In most cases this is associated with other known risk factors, including concomitant medicinal products such as steroids or NSAIDS, underlying history of GI ulceration, age, smoking or bowel metastases at sites of perforation.
Danish: I de fleste tilfælde er det i forbindelse med andre kendte risikofaktorer, f.eks. samtidig behandling med andre lægemidler såsom steroider eller NSAID, anamnese med gastrointestinal ulceration, alder, rygning, metastaser på perforationsstedet i tarmen.
English: 63/396 (16%) of patients with adenocarcinoma histology are M+.
Danish: 63/396 (16 %) af patienterne med adenokarcinom histologitype er M+.
English: Table 2 - Summary of baseline mutation status for tumour and ctDNA samples in all screened patients evaluable for both samples
Danish: Tabel 2 - Sammenfatning af baseline mutationsstatus for tumor og ctDNA prøver for alle screenede patienter, hvor begge prøver var evaluerbare
English: • Loss of appetite.
Danish: • Appetitmangel.
English: Time to treatment failurea,b
Danish: Tid til behandlingsstandsninga,b
English: 4.4 times higher in adenocarcinoma than in non-adenocarcinoma
Danish: <0,0001 4,4 gange højere hos dem med adenokarcinom end hos dem, der ikke har adenokarcinom
English: • Dry mouth.
Danish: • Tør mund.
English: Pre-treated patients
Danish: Tidligere behandlede patienter
English: If any of the above applies to you, or if you are not sure, check with your doctor or pharmacist before taking Gefitinib Mylan.
Danish: Hvis et eller flere af ovennævnte punkter gælder for dig, eller hvis du er i tvivl, skal du spørge din læge eller på apoteket, før du tager Gefitinib Mylan.
English: When considering the use of Gefitinib Mylan as a treatment for locally advanced or metastatic NSCLC, it is important that EGFR mutation assessment of the tumour tissue is attempted for all patients.
Danish: Når det overvejes at anvende Gefitinib Mylan til behandling af lokalt fremskredent eller metastatisk NSCLC, er det vigtigt, at EGFR-mutation i tumorvævet forsøges vurderet hos alle patienter.
English: *This adverse reaction can occur in association with other dry conditions (mainly skin reactions) seen with gefitinib.
Danish: *Denne bivirkning forekommer i forbindelse med andre tørre tilstande (fortrinsvis hudreaktioner) i forbindelse med gefitinib.
English: The common EGFR activating mutations (Exon 19 deletions; L858R) have robust response data supporting sensitivity to gefitinib; for example a progression free survival HR (95% CI) of 0.489 (0.336, 0.710) for gefitinib vs. doublet chemotherapy [WJTOG3405].
Danish: De almindelige EGFR-aktiverende mutationer (Exon-19-deletioner; L858R) har robuste responsdata, der understøtter sensitiviteten for gefitinib; for eksempel en HR (95 % CI) for progressionsfri overlevelse på 0,489 (0,336 - 0,710) for gefitinib versus dublet-kemoterapi [WJTOG3405].
English: • Increase of bilirubin and the other liver enzyme known as aspartate aminotransferase in a blood test; if too high, your doctor may tell you to stop taking Gefitinib Mylan.
Danish: • Forhøjet niveau af bilirubin og det andet leverenzym, som kaldes aspartat-aminotransferase, i en blodprøve; hvis antallet er for højt, vil din læge muligvis fortælle dig, at du skal stoppe med at tage Gefitinib Mylan.
English: If patients experience worsening of respiratory symptoms such as dyspnoea, cough and fever, Gefitinib Mylan should be interrupted and the patient should be promptly investigated.
Danish: Såfremt patienter oplever forværring af respiratoriske symptomer såsom dyspnø, hoste og feber, skal Gefitinib Mylan-behandlingen afbrydes, og en øjeblikkelig undersøgelse initieres.
English: - Proton-pump inhibitors, H2-antagonists and antacids (for ulcers, indigestion, heartburn and to reduce acids in the stomach).
Danish: - Protonpumpe-hæmmere, H2-antagonister og antacida (mod mavesår, sure opstød, halsbrand og til at mindske syre i maven).
English: 12/390 (3%) of patients with non-adenocarcinoma histology are M+.
Danish: 12/390 (3 %) af patienterne der ikke har adenokarcinom histologitype er M+.
English: Do not use this medicine after the expiry date which is stated on the blister and carton or pouch after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på blisterpakningen og kartonen eller posen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to the clinical exposure levels and with possible relevance to clinical use were as follows: - Corneal epithelia atrophy and corneal translucencies - Renal papillary necrosis - Hepatocellular necrosis and eosinophilic sinusoidal macrophage infiltration.
Danish: Bivirkninger, der ikke er observeret i kliniske forsøg, men i dyr, når de eksponeres for niveauer magen til de kliniske eksponeringsniveauer og med mulig relevans for klinisk brug, var som følger: - corneaepitel atrofi og translucens af cornea - nyrepapilnekrose - hepatocellulær nekrose og eosinofil sinusoidal makrofag infiltration.
English: • Dry, red or itchy eyes.
Danish: • Tørre, røde og kløende øjne.
English: • The recommended dose is one 250 mg tablet per day.
Danish: • Den sædvanlige dosis er én tablet på 250 mg daglig.
English: Numbers in square brackets are 96% confidence interval for overall survival
Danish: Tal i de kvadratiske parenteser er 96 % konfidensinterval
English: The safety and efficacy of Gefitinib Mylan in children and adolescents aged less than 18 years have not been established.
Danish: Gefitinib Mylans sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: • Skin reactions such as an acne-like rash, which is sometimes itchy with dry and/or cracked skin.
Danish: • Hudreaktioner såsom akne-lignende udslæt, som til tider er kløende og med tør og/eller sprukken hud.
English: In vitro data indicate that gefitinib is a substrate for the membrane transport protein P-gp.
Danish: In vitro-data indikerer, at gefitinib er et substrat for membrantransportproteinet P gp.
English: Dehydration, secondary to diarrhoea, nausea, vomiting or anorexia.
Danish: Dehydrering, som følge af diarré, kvalme, opkastning eller anoreksi.
English: Proportion of tumour M- that are M- by ctDNA)
Danish: Andel af tumor M-, der er M- i ctDNA)
English: The IFUM study was a single-arm, multicentre study conducted in Caucasian patients (n=106) with activating, sensitizing EGFR mutation positive NSCLC to confirm that the activity of gefitinib is similar in Caucasian and Asian populations.
Danish: IFUM-studiet var et enkeltarmet multicenter-studie, der blev gennemført med kaukasiske patienter (n = 106) med følsom NSCLC med aktiverede EGFR-mutationer for at bekræfte, at aktiviteten af gefitinib er ens i kaukasiske og asiatiske populationer.
English: The tablet coating contains polyvinyl alcohol (E1203), macrogol 4000 (E1521), talc (E553b), titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172).
Danish: Tabletovertrækket indeholder polyvinylalkohol (E1203), macrogol 4000 (E1521), talkum (E553b), titandioxid (E171), jernoxid, rød (E172), jernoxid, gul (E172).
English: Uncommon Pancreatitis Gastrointestinal perforation
Danish: Ikke almindelig Pankreatit Gastrointestinel perforation
English: Uncommon Corneal erosion, reversible and sometimes in association with aberrant eyelash growth.
Danish: Ikke almindelig Hornhindeerosion, reversibel og til tider i forbindelse med abnorm øjenvippevækst.
English: Most NSCLC tumours with sensitising EGFR kinase mutations eventually develop resistance to gefitinib treatment, with a median time to disease progression of 1 year.
Danish: De fleste NSCLC-tumorer med sensibiliserende EGFR-kinasemutationer kan med tiden udvikle resistens over for gefitinib-behandling, og mediantiden til sygdomsprogression er 1 år.
English: • Allergic reaction (common), particularly if symptoms include swollen face, lips, tongue or throat, difficulty to swallow, hives, nettle rash and difficulty breathing.
Danish: • Allergisk reaktion (almindelig), specielt hvis du får hævet ansigt, læber, tunge eller hals, du har svært ved at synke, nældefeber og har svært ved at trække vejret.
English: Very common Skin reactions, mainly a mild or moderate (CTC grade 1 or 2) pustular rash, sometimes itchy with dry skin, including skin fissures, on an erythematous base.
Danish: Hudreaktioner, hovedsageligt let eller moderat (CTC-grad 1 eller 2) pustuløst udslæt, til tider kløende med tør hud, inklusive hudfissurer, på erytematøs basis.
English: In that study ctDNA derived from serum, not plasma was used for EGFR mutation analysis using the EGFR Mutation Test Kit (DxS) (N= 86).
Danish: I dette studie blev der anvendt ctDNA fra serum, ikke plasma, til EGFRmutationsanalyse under anvendelse af EGFR-mutationstestsættet (DxS) (N = 86).
English: Only limited data are available in patients with creatinine clearance ≤ 20 ml/min and caution is advised in these patients (see section 5.2).
Danish: Der findes kun begrænsede data for patienter med kreatininclearance ≤ 20 ml/min, og derfor anbefales det, at der udvises forsigtighed over for disse patienter (se pkt.
English: Brown, round, biconvex film-coated tablets with approximately 11.1 mm x 5.6 mm of dimension and marked with “250” on one side and plain on the other.
Danish: Brune, runde, bikonvekse, filmovertrukne tabletter med dimensionerne ca. 11,1 mm × 5,6 mm og mærket med “250” på den ene side og uden mærkning på den anden.
English: In vitro data indicate that CYP3A4 and CYP2D6 are the major P450 isozyme involved in the oxidative metabolism of gefitinib.
Danish: In vitro-data indikerer, at CYP3A4 og CYP2D6 er de P450-isozymer, der overvejende er involveret i den oxidative metabolisering af gefitinib.
English: - The other ingredients are lactose monohydrate, microcrystalline cellulose (101), crospovidone (type A), povidone (K30), sodium laurilsulfate, magnesium stearate in the tablet core.
Danish: - Øvrige indholdsstoffer: lactosemonohydrat; mikrokrystallinsk cellulose (101), crospovidon (type A), polyvidon (K30), natriumlaurilsulfat, magnesiumstearat i tabletkerne.
English: If ILD is confirmed, Gefitinib Mylan should be discontinued and the patient treated appropriately.
Danish: Hvis interstitiel lungesygdom bekræftes, bør Gefitinib Mylanbehandlingen stoppes, og patienten behandles på behørig vis.
English: In EGFR mutation-positive patients, significantly more gefitinib-treated patients experienced an improvement in quality of life and lung cancer symptoms vs carboplatin/paclitaxel (see Table 4).
Danish: Hos patienter med positivt testresultat for EGFR-mutation var der signifikant flere gefitinib-behandlede patienter, som oplevede en forbedring i livskvalitet og symptomer på lungecancer i forhold til dem, der blev behandlet med carboplatin/paclitaxel (se tabel 4).
English: 47/716 (7%) of ever smokers are M+.
Danish: 47/716 (7 %) af de der har røget på et tidspunkt M+.
English: 30x1 film-coated tablets
Danish: 30×1 filmovertrukne tabletter
English: In the pooled dataset from the ISEL, INTEREST and IPASS phase III clinical trials (2462 gefitinib-treated patients), the most frequently reported adverse drug reactions (ADRs), occurring in more than 20% of the patients, are diarrhoea and skin reactions (including rash, acne, dry skin and pruritus).
Danish: I det samlede datasæt fra de kliniske fase III-forsøg ISEL, INTEREST og IPASS (2462 gefitinibbehandlede patienter) er de hyppigst rapporterede bivirkninger, der forekommer hos mere end 20 % af patienterne, diarré og hudreaktioner (omfattende hududslæt, akne, tør hud og kløe).
English: What to do if you forget to take a tablet depends on how long it is until your next dose.
Danish: Hvis du har glemt at tage en tablet, skal du gøre som beskrevet nedenfor (afhængig af hvor længe, der er til næste dosis):
English: If you forget to take Gefitinib Mylan
Danish: Hvis du glemmer at tage Gefitinib Mylan
English: In a Japanese pharmacoepidemiological case control study in 3,159 patients with NSCLC receiving gefitinib or chemotherapy who were followed up for 12 weeks, the following risk factors for developing ILD (irrespective of whether the patient received gefitinib or chemotherapy) were identified: smoking, poor performance status (PS≥ 2), CT scan evidence of reduced normal lung (≤ 50%), recent diagnosis of NSCLC (< 6 months), pre-existing ILD, older age (≥ 55 years old) and concurrent cardiac disease.
Danish: I et japansk farmakoepidemiologisk studie hos 3.159 NSCLC-patienter, der blev fulgt i 12 uger, mens de fik gefitinib eller kemoterapi, fandt man følgende risikofaktorer for at udvikle ILS (uanset om patienterne blev behandlet med gefitinib eller kemoterapi): Rygning, dårlig performance status (PS ≥ 2), reduceret normalt lungevæv (≤ 50 %) dokumenteret ved CT-scanning, nylig diagnosticeret NSCLC (< 6 måneder), tidligere ILS, ældre (≥ 55 år gammel) og samtidig hjertesygdom.
English: Each tablet contains 161.0 mg of lactose (as monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver tablet indeholder 161,0 mg lactose (som monohydrat).
English: Adverse reactions have been assigned to the frequency categories in Table 1 where possible based on the incidence of comparable adverse reactions reports in a pooled dataset from the ISEL, INTEREST and IPASS phase III clinical trials (2462 gefitinib-treated patients).
Danish: Hvor det er muligt, er frekvenserne baseret på forekomsten af sammenlignelige bivirkningsrapporter ud fra et samlet datasæt fra fase III-studierne ISEL, INTEREST og IPASS (2.462 gefitinib-behandlede patienter).
English: • Eye problems (uncommon), such as pain, redness, watery eyes, light sensitivity, changes in vision or ingrowing eyelashes.
Danish: • Øjenproblemer (ikke almindelig), såsom smerte, røde øjne, øjne der løber i vand, lysfølsomhed, forandret syn eller indgroede øjenvipper.