FrancophonIA/ELRC3.0 huggingface dataset:
English: Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first.
Danish: Inden for hver systemorganklasse er bivirkningerne opstillet efter frekvens med de hyppigste bivirkninger først.
English: Changes in cardiac contractility
Danish: Ændringer i hjertets kontraktilitet
English: Median follow-up time was 15.0 months for patients receiving TAGRISSO and 9.7 months for patients receiving EGFR TKI comparator
Danish: Median opfølgningstid var 15,0 måneder for patienter, der fik TAGRISSO, og 9,7 måneder for patienter, der fik EGFR TKIkomparator
English: It should be dropped in the water, without crushing, stirred until dispersed and immediately swallowed.
Danish: Den skal lægges i vandet uden at blive knust, omrøres, indtil den er faldet hen, og blandingen straks synkes.
English: When possible, the use of osimertinib in patients with congenital long QT syndrome should be avoided.
Danish: Når det er muligt, skal osimertinib undgås til patienter med medfødt langt QT-syndrom.
English: Cardiac QTc interval greater than 500 msec on at least 2 separate ECGs
Danish: Hjerte QTc-interval over 500 msek på mindst 2 forskellige EKG'er
English: There are no clinical data available to recommend a dose adjustment of TAGRISSO.
Danish: Der er ingen kliniske data tilgængelige til at anbefale justering af TAGRISSO-dosis.
English: At steady-state, circulating plasma concentrations are typically maintained within a 1.6 fold range over the 24-hour dosing interval.
Danish: Ved steady state opretholdes en cirkulerende plasmakoncentration typisk inden for et interval på 1,6 gange i løbet af et 24-timers doseringsinterval.
English: • Efavirenz and etravirine - used to treat HIV infections/AIDS.
Danish: • Efavirenz og etravirin - bruges til behandling af HIV-infektioner/AIDS
English: • This medicine does not require any special storage conditions.
Danish: • Dette lægemiddel kræver ingen særlige forholdregler vedrørende opbevaringen.
English: The findings present following 1 month of dosing were largely reversible within 1 month of cessation of dosing with the exception of partial recovery for some of the corneal changes.
Danish: Fundene efter 1 måneds dosering var stort set reversible inden for 1 måned efter seponering med undtagelse af delvis bedring for nogle af forandringerne i cornea.
English: The tablet should be swallowed whole with water and it should not be crushed, split or chewed.
Danish: Tabletten skal synkes hel med vand; den må ikke knuses, deles eller tygges.
English: QTc interval prolongation
Danish: Forlænget QTc-interval
English: There are no or limited amount of data from the use of osimertinib in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af osimertinib til gravide kvinder.
English: Findings in the ovaries seen following 1 month dosing were reversible.
Danish: Fund i ovarierne, der blev observeret efter 1 måneds dosering, var reversible.
English: In FLAURA and AURA3 the median time to onset was 19 days and 22 days, respectively, and the median duration of the Grade 2 events was 19 days and 6 days, respectively.
Danish: I FLAURA og AURA3 var mediantiden til indtræden henholdsvis 19 dage og 22 dage, og medianvarigheden af grad 2-tilfælde var henholdsvis 19 dage og 6 dage.
English: • If your cancer has progressed while you were being treated with other protein kinase inhibitor medicines, it means that your cancer contains a gene defect called ‘T790M'.
Danish: • Hvis din kræft har udviklet sig, mens du blev behandlet med andre proteinkinasehæmmende lægemidler, betyder det, at din kræft indeholder en gendefekt kaldet ”T790M”.
English: A risk to the suckling child cannot be excluded.
Danish: Det kan ikke udelukkes, at der er en risiko for det ammede barn.
English: Second PFS after start of first subsequent therapy (PFS2)
Danish: Anden PFS efter start af første efterfølgende behandling (PFS2)
English: Objective response rates by BICR above 50% were observed in all predefined subgroups analysed, including line of therapy, ethnicity, age and region.
Danish: Objektive responsrater i henhold til BICR over 50 % blev observeret i alle analyserede prædefinerede undergrupper, herunder antal tidligere behandlinger, etnicitet, alder og region.
English: However, if it is less than 12 hours until your next dose is due, skip the missed dose.
Danish: Hvis der er under 12 timer til din næste dosis, skal du dog springe den glemte dosis over.
English: If administration via nasogastric tube is required, the same process as above should be followed but using volumes of 15 mL for the initial dispersion and 15 mL for the residue rinses.
Danish: Hvis administration via nasogastrisk sonde er nødvendig, skal ovenstående proces følges, men med brug af et volumen på 15 ml til den første suspension og 15 ml til at skylle efter med.
English: Effects of osimertinib on P-gp and BCRP
Danish: Virkning af osimertinib på P-gp og BCRP
English: Do not give this medicine to children or adolescents under the age of 18 years.
Danish: Børn og unge under 18 år må ikke få denne medicin.
English: Non-clinical data indicate that osimertinib and its metabolite (AZ5104) inhibit the h-ERG channel, and QTc prolonging effect cannot be excluded.
Danish: Ikke-kliniske data indikerer, at osimertinib og dets metabolit (AZ5104) hæmmer h-ERG-kanalen, og en QTc-forlængende effekt kan ikke udelukkes.
English: Adjusted mean and estimated differences obtained from a Mixed Model Repeated Measures (MMRM) analysis.
Danish: Justeret middelværdi og estimeret forskel beregnet ved en MMRM-analyse (blandet model for gentagne målinger (Mixed Model Repeated Measures)).
English: Randomisation was stratified by EGFR mutation type (Ex19del or L858R) and ethnicity (Asian or non-Asian).
Danish: Randomiseringen blev stratificeret efter EGFR-mutationstype (Ex19del eller L858R) og etnicitet (asiatisk eller ikke-asiatisk).
English: • Stomatitis - inflammation of the inner lining of the mouth.
Danish: • Stomatitis - betændelse i slimhinden i munden.
English: All patients received TAGRISSO at a dose of 80 mg once daily.
Danish: Alle patienter fik TAGRISSO i en dosis på 80 mg én gang dagligt.
English: If a dose of TAGRISSO is missed, the dose should be made up unless the next dose is due within 12 hours.
Danish: Hvis en TAGRISSO dosis glemmes, skal den tages, medmindre der er mindre end 12 timer til, næste dosis skal tages.
English: Recommended dose modifications for TAGRISSO
Danish: Anbefalede dosisjusteringer for TAGRISSO
English: Close monitoring is recommended in these patients (see section 4.8).
Danish: Tæt monitorering er anbefalet til disse patienter (se pkt.
English: TAGRISSO contains the active substance osimertinib, which belongs to a group of medicines called protein kinase inhibitors which are used to treat cancer.
Danish: TAGRISSO indeholder det aktive stof osimertinib, som tilhører en gruppe lægemidler kaldet proteinkinasehæmmere, der anvendes til behandling af kræft.
English: If ILD is diagnosed, TAGRISSO should be discontinued and appropriate treatment initiated as necessary.
Danish: Hvis ILD bliver diagnosticeret, skal TAGRISSO seponeres, og passende behandling indledes efter behov.
English: Exposure at doses of 20 mg/kg and above during organogenesis caused reduced foetal weights but no adverse effects on external or visceral foetal morphology.
Danish: Eksponering ved doser på 20 mg/kg og derover under organogenese forårsagede nedsat fostervægt, men ingen negative virkninger på eksterne eller viscerale oganer hos fosteret.
English: These effects were seen at a maternally tolerated dose of 20 mg/kg where exposure was equivalent to the human exposure at the recommended dose of 80 mg daily (based on total AUC).
Danish: Disse virkninger blev observeret ved en maternelt tolereret dosis på 20 mg/kg, hvor eksponeringen svarede til den humane eksponering ved den anbefalede dosis på 80 mg dagligt (baseret på samlet AUC).
English: A greater proportion of patients treated with TAGRISSO were alive at 12 months and 18 months (89% and 83%, respectively) compared to patients treated with EGFR TKI comparator (83% and 71%, respectively).
Danish: En større andel af patienter behandlet med TAGRISSO var i live efter 12 måneder og 18 måneder (henholdsvis 89 % og 83 %) sammenlignet med patienter behandlet med EGFR TKI-komparator (henholdsvis 83 % og 71 %).
English: Carcinogenicity studies have not been performed with osimertinib.
Danish: Der er ikke udført karcinogenicitetsstudier med osimertinib.
English: It is not known whether osimertinib or its metabolites are excreted in human milk.
Danish: Det vides ikke, om osimertinib eller dets metabolitter udskilles i human mælk.
English: 10 FILM-COATED TABLET BLISTERS (PERFORATED) 7 FILM-COATED TABLET BLISTERS (PERFORATED)
Danish: 10 FILMOVERTRUKNE TABLETTER, BLISTER (PERFOREREDE) 7 FILMOVERTRUKNE TABLETTER, BLISTER (PERFOREREDE)
English: If signs and symptoms suggestive of SJS appear, TAGRISSO should be interrupted or discontinued immediately.
Danish: Hvis der opstår tegn og symptomer, der tyder på SJS, skal TAGRISSO straks afbrydes eller seponeres.
English: Limited data are available in patients with severe renal impairment.
Danish: Der er begrænsede data tilgængelige for patienter med alvorligt nedsat nyrefunktion.
English: The median time to onset of ILD or ILD-like adverse reactions was 85 days (see section 4.4).
Danish: Mediantiden til indtræden af ILD eller ILD-lignende bivirkninger var 85 dage (se pkt.
English: Pathology findings in the testes seen following 1 month dosing were reversible in rats; however, a definitive statement on reversibility of these lesions in dogs cannot be made.
Danish: Patologiske fund i testiklerne observeret efter 1 måneds dosering var reversible hos rotter, mens der ikke kan drages en definitiv konklusion for reversibiliteten af disse læsioner hos hunde.
English: Subjects on the chemotherapy arm who had objective radiological progression (by the investigator and confirmed by independent central imaging review) were given the opportunity to begin treatment with TAGRISSO.
Danish: Forsøgspersoner i kemoterapiarmen, som havde objektiv radiologisk progression (ifølge investigator og bekræftet ved uafhængig central billedvurdering), fik mulighed for at starte behandling med TAGRISSO.
English: In human plasma, parent osimertinib accounted for 0.8%, with the 2 metabolites contributing 0.08% and 0.07% of the total radioactivity with the majority of the radioactivity being covalently bound to plasma proteins.
Danish: I humant plasma udgjorde det uomdannede osimertinib 0,8 %, og de 2 metabolitter bidrog med henholdsvis 0,08 % og 0,07 % af den samlede radioaktivitet, hvor størstedelen af radioaktiviteten er kovalent bundet til plasmaproteiner.
English: Tell your doctor before taking TAGRISSO if you are taking any of the following medicines:
Danish: Fortæl det til lægen, før du tager TAGRISSO, hvis du tager nogle af følgende lægemidler:
English: A BICR assessment of these scans resulted in a subgroup of 128/556 (23%) patients with CNS metastases and these data are summarised in Table 4.
Danish: En BICR-vurdering af disse scanninger resulterede i en undergruppe på 128/556 (23 %) patienter med CNS-metastaser, og disse data er opsummeret i tabel 4.
English: • Rifabutin or rifampicin - used for tuberculosis (TB).
Danish: • Rifabutin og rifampicin - bruges mod tuberkulose (TB).
English: TAGRISSO has no or negligible influence on the ability to drive and use machines.
Danish: TAGRISSO har ingen eller kun en ubetydelig indvirkning på evnen til at køre bil og anvende maskiner.
English: Most adverse reactions were Grade 1 or 2 in severity.
Danish: Alvorligheden af de fleste bivirkninger var af grad 1 eller 2.
English: • Add 50 mL (about two-thirds of a tumblerful) of still (non-fizzy) water - do not use any other liquids.
Danish: • Tilsæt 50 ml postevand (uden brus) - brug ikke andre væsker.
English: Moderate CYP3A4 inducers (e.g. bosentan, efavirenz, etravirine, modafinil) may also decrease osimertinib exposure and should be used with caution, or avoided when possible.
Danish: Moderate CYP3A4-induktorer (f.eks. bosentan, efavirenz, etravirin, modafinil) kan ligeledes nedsætte osimertinibeksponeringen og bør anvendes med forsigtighed eller om muligt undgås.
English: Based on clinical studies, no dose adjustments are necessary in patients with mild hepatic impairment (Child Pugh A) or moderate hepatic impairment (Child Pugh B).
Danish: Baseret på kliniske studier, er dosisjustering ikke nødvendig hos patienter med let nedsat leverfunktion (Child Pugh A) eller moderat nedsat leverfunktion (Child Pugh B).
English: Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitors; ATC code: L01XE35.
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske midler, proteinkinasehæmmere, ATC-kode: L01XE35.
English: Tell your doctor straight away while taking this medicine if:
Danish: Fortæl det straks til lægen under behandlingen med denne medicin, hvis:
English: The geometric mean exposure of both AZ5104 and AZ7550, based on AUC, was approximately 10% each of the exposure of osimertinib at steady-state.
Danish: Den geometrisk gennemsnitlige eksponering af både AZ5104 og AZ7550, baseret på AUC, var for hver ca. 10 % af osimertinib-eksponeringen ved steady state.
English: Other side effects Very common (may affect more than 1 in 10 people)
Danish: Meget almindelig (kan påvirke mere end 1 ud af 10 personer)
English: Tell your doctor straight away if you notice the serious side effects listed above.
Danish: Fortæl det straks til lægen, hvis du bemærker ovenstående alvorlige bivirkninger.
English: The most commonly reported adverse drug reactions (ADRs) were diarrhoea (49%) and rash (47%).
Danish: De hyppigst rapporterede bivirkninger var diarré (49 %) og udslæt (47 %).
English: QTc interval prolongation with signs/symptoms of serious arrhythmia
Danish: Forlænget QTc-interval med tegn/symptomer på alvorlig arytmi
English: QTc interval prolongation occurs in patients treated with TAGRISSO.
Danish: Forlænget QTc-interval forekommer hos patienter, der er i behandling med TAGRISSO.
English: Additional efficacy outcome measures included ORR, DoR and overall survival (OS) as assessed by investigator.
Danish: Yderligere effektmål inkluderede ORR, DoR og samlet overlevelse (OS), vurderet af investigator.
English: Do not breast-feed while taking this medicine.
Danish: Du må ikke amme, mens du tager denne medicin.
English: The absolute bioavailability of TAGRISSO is 70% (90% CI 67, 73).
Danish: Den absolutte biotilgængelighed af TAGRISSO er 70 % (90 % CI 67-73).
English: Both metabolites appeared slowly in plasma after administration of TAGRISSO to patients, with a median (min-max) tmax of 24 (4-72) and 24 (6-72) hours, respectively.
Danish: Begge metabolitter viste sig langsomt i plasma efter administration af TAGRISSO til patienter med en median (min-max) tmax på henholdsvis 24 (4-72) og 24 (6-72) timer.
English: Patients in the TAGRISSO arm received TAGRISSO 80 mg orally once daily until intolerance to therapy, or the investigator determined that the patient was no longer experiencing clinical benefit.
Danish: Patienterne i TAGRISSO-armen fik TAGRISSO 80 mg oralt én gang dagligt indtil intolerance over for behandlingen, eller indtil investigator vurderede, at patienten ikke længere havde klinisk fordel af behandlingen.
English: Clinical PK interactions with CYP3A4 substrates are unlikely.
Danish: Kliniske farmakokinetiske interaktioner med CYP3A4-substrater er usandsynlige.
English: Osimertinib has also been demonstrated to bind covalently to rat and human plasma proteins, human serum albumin and rat and human hepatocytes.
Danish: Det er også påvist, at osimertinib binder kovalent til rotte- og humane plasmaproteiner, humant serumalbumin og rotte- og humane hepatocytter.
English: • The other ingredients are mannitol, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, sodium stearyl fumarate, polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, yellow iron oxide, red iron oxide, black iron oxide (see section 2 “Information on other ingredients in this medicine”).
Danish: • Øvrige indholdsstoffer: mannitol, mikrokrystallinsk cellulose, lavsubstitueret hydroxypropylcellulose, natriumstearylfumarat, polyvinylalkohol, titandioxid, macrogol 3350, talkum, gul jernoxid, rød jernoxid, sort jernoxid (se afsnit 2 ”Information om andre indholdsstoffer i denne medicin”).
English: Patients received study therapy until intolerance to therapy, or the investigator determined that the patient was no longer experiencing clinical benefit.
Danish: Patienterne fik studiemedicin indtil behandlingsintolerance eller investigator fastslog, at patienten ikke længere havde en klinisk fordel.
English: • If you plan to become pregnant after taking the last dose of this medicine, ask your doctor for advice.
Danish: • Hvis du planlægger at blive gravid, efter du har taget den sidste dosis af denne medicin, skal du spørge lægen om råd.
English: TAGRISSO has not been studied in children or adolescents.
Danish: Børn og unge TAGRISSO er ikke undersøgt hos børn og unge.
English: Chemotherapy consisted of pemetrexed 500 mg/m2 with carboplatin AUC5 or pemetrexed 500 mg/m2 with cisplatin 75 mg/m2 on Day 1 of every 21-day cycle for up to 6 cycles.
Danish: Kemoterapi bestod af pemetrexed 500 mg/m2 med carboplatin AUC5 eller pemetrexed 500 mg/m2 med cisplatin 75 mg/m2 på dag 1 i hver 21-dages cyklus i op til 6 cyklusser.
English: Serial ECGs were collected following a single dose and at steady-state to evaluate the effect of osimertinib on QTc intervals.
Danish: Serie-EKG'er blev indsamlet efter en enkelt dosis og ved steady state for at vurdere osimertinibs indvirkning på QTc-intervallet.
English: • Skin and nail problems - signs may include pain, itching, dry skin, rash, redness around the fingernails.
Danish: • Problemer med hud og negle - tegnene kan omfatte smerte, kløe, tør hud, udslæt, rødme omkring fingerneglene.
English: Pregnancy - information for women
Danish: Graviditet - information til kvinder
English: If you do become pregnant during treatment, tell your doctor straight away.
Danish: Hvis du bliver gravid under behandlingen, skal du straks fortælle det til lægen.
English: If you are taking any of the medicines listed above, tell your doctor before taking TAGRISSO.
Danish: Hvis du tager noget af ovenstående medicin, skal du fortælle det til din læge, inden du tager TAGRISSO.
English: Positive determination of EGFR mutation status using either a tissue-based or plasma-based test indicates eligibility for treatment with TAGRISSO.
Danish: Positiv bestemmelse af EGFR-mutationsstatus, hvor der enten er anvendt en vævsbaseret eller en plasmabaseret test, indikerer egnethed for behandling med TAGRISSO.
English: Using moisturisers regularly on your skin and nails can help with this.
Danish: Det kan hjælpe at bruge fugtighedscreme på hud og negle regelmæssigt.
English: The C30 was assessed every 6 weeks before and after progression.
Danish: C30 blev vurderet hver 6. uge før og efter progression.
English: • Women-keep using contraception for 2 months after.
Danish: • Kvinder - brug prævention i 2 måneder efter.
English: QTc interval prolongation may lead to an increased risk for ventricular tachyarrhythmias (e.g. torsade de pointes) or sudden death.
Danish: Forlænget QTc-interval kan medføre en øget risiko for ventrikulære takyarytmier (fx torsades de pointes) eller pludselig død.
English: This analysis demonstrated a consistent treatment effect (HR 0.28; 95% CI: 0.20, 0.38) with that observed by investigator assessment.
Danish: Denne analyse viste en behandlingseffekt (HR 0,28; 95 % CI: 0,20; 0,38), der var i overensstemmelse med den, der blev observeret i henhold til investigators vurdering.
English: Dose reduction guidelines for adverse reactions toxicities are provided in Table 1.
Danish: Retningslinjer for dosisreduktion på grund af bivirkninger/toksicitet kan ses i Tabel 1.
English: Case reports of Stevens-Johnson syndrome (SJS) have been reported rarely in association with TAGRISSO treatment.
Danish: Der er i sjældne tilfælde rapporteret om tilfælde af Stevens-Johnsons syndrom (SJS) i forbindelse med behandling med TAGRISSO.
English: The QTc interval prolongation potential of TAGRISSO was assessed in 210 patients who received osimertinib 80 mg daily in AURA2.
Danish: TAGRISSOs potentielle forlængelse af QTc-intervallet blev vurderet hos 210 patienter, som fik 80 mg osimertinib dagligt i AURA2.
English: 4.4 Special warnings and precautionsfor use
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen
English: • you are taking St. John's Wort (Hypericum perforatum).
Danish: • du tager perikon (Hypericum perforatum)
English: • Sudden difficulty in breathing together with a cough or fever - this may be a sign of inflamed lungs (a condition called ‘interstitial lung disease').
Danish: • Pludseligt besvær med at trække vejret samtidig med hoste eller feber - dette kan være tegn på en betændelseslignende reaktion (inflammation) i lungerne (en sygdom, der hedder "interstitiel lungesygdom").
English: This side effect is uncommon: it may affect up to 1 in 100 people.
Danish: Denne bivirkning er ikke almindelig: kan forekomme hos op til 1 ud af 100 personer.
English: Adverse events of leukopenia, lymphopenia, neutropenia and thrombocytopenia have been reported, most of which were mild or moderate in severity and did not lead to dose interruptions.
Danish: Bivirkningerne leukopeni, lymfopeni, neutropeni og trombocytopeni er blevet rapporteret, hvoraf de fleste var af lette eller moderat sværhedsgrad og ikke medførte dosisafbrydelser.
English: Thirty-one percent (31%) (N=129) had received 1 prior line of therapy (EGFR-TKI treatment only), 69% (N=282) had received 2 or more prior lines.
Danish: 31 % (n=129) havde fået mindst 1 tidligere behandling (kun EGFR-TKI-behandling), 69 % (n=282) havde fået 2 eller flere tidligere behandlingstyper.
English: In these studies, patients who were treated with TAGRISSO daily doses of 160 mg and 240 mg experienced an increase in the frequency and severity of a number of typical EGFR TKI-induced AEs (primarily diarrhoea and skin rash) compared to the 80 mg dose.
Danish: I disse studier oplevede patienter, som blev behandlet med daglige TAGRISSO-doser på 160 mg og 240 mg, en stigning i hyppighed og sværhedsgrad af en række typiske EGFR TKI-inducerede bivirkninger (primært diarré og hududslæt) sammenlignet med 80 mg-dosen.
English: Osimertinib should be permanently discontinued in patients who develop QTc interval prolongation in combination with any of the following: Torsade de pointes, polymorphic ventricular tachycardia, signs/symptoms of serious arrhythmia.
Danish: Osimertinib bør seponeres permanent hos patienter, som udvikler forlænget QTc-intervallet i kombination med noget af følgende: Torsades de pointes, polymorf ventrikulær takykardi eller tegn/symptomer på alvorlig arytmi.
English: In patients with a confirmed response by BICR, the median DoR was 12.5 months (95% CI: 11.1, NE).
Danish: Hos patienter med et bekræftet respons i henhold til BICR var den mediane DoR 12,5 måneder (95 % CI: 11,1; NC).
English: The European Medicines Agency has waived the obligation to submit the results of studies with TAGRISSO in all subsets of the paediatric population in NSCLC (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med TAGRISSO i alle undergrupper af den pædiatriske population ved NSCLC (se pkt.
English: Patients with asymptomatic, stable brain metastases not requiring steroids for at least 4 weeks prior to the start of study treatment were eligible to be randomised in the study.
Danish: Patienter med asymptomatiske, stabile hjernemetastaser, der ikke havde haft brug for steroider i mindst 4 uger inden studiets start, var egnede til at blive randomiseret i studiet.
English: Microcrystalline cellulose Low-substituted hydroxypropyl cellulose Sodium stearyl fumarate
Danish: Mikrokrystallinsk cellulose Lavsubstitueret hydroxypropylcellulose Natriumstearylfumarat