FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Actrapid, human insulin, is produced by a method known as ‘recombinant technology': the insulin is made by a yeast that has received a gene (DNA), which makes it able to produce insulin.
Danish: Insulinen er fremstillet af gær, der har modtaget et gen (DNA), som sætter den i stand til at producere insulin.
English: How does Actrapid work?
Danish: Hvordan virker Actrapid?
English: 1 bottle 24 hours
Danish: Æske med 6 flasker 24 timer
English: Cattle: 46 days Dogs: not applicable injection
Danish: Hunde: Ikke relevant
English: Bottle (HDPE) 1,000 ml Pack of 6 bottles
Danish: EU/2/97/003/003 Dicural 100 mg Oral opløsning Kyllinger og kalkuner I drikkevand HDPE-flaske 1000 ml
English: 24 hours
Danish: Kvæg: 46 dage
English: This may take up to 20 minutes.
Danish: Dette kan tage op til 20 minutter.
English: if you have ever had problems with your liver.
Danish: - hvis du nogensinde har haft problemer med din lever.
English: China, Hong Kong, Indonesia, Japan, Malaysia, Philippines, Singapore, Taiwan and Thailand.
Danish: Kina, Hong Kong, Indonesien, Japan, Malaysia, Filippinerne, Singapore, Taiwan og Thailand
English: The potential risk for humans is unknown.
Danish: Den potentielle risiko hos mennesker er ikke kendt.
English: An updated RMP shall be submitted:
Danish: En opdateret RMP skal fremsendes:
English: Date of first authorisation: 24/06/2009 Date of latest renewal: 23/04/2014
Danish: Dato for første markedsføringstilladelse: 24/06/2009 Dato for seneste fornyelse: 23/04/2014
English: *from the following studies: INTEREST, ISEL, INTACT 1&2, IDEAL 1&2, INVITE
Danish: * fra følgende studier: INTEREST, ISEL, INTACT 1&2, IDEAL 1&2, INVITE
English: Drink the liquid straight away.
Danish: Drik væsken med det samme.
English: IRESSA did not prolong survival in the overall population.
Danish: IRESSA forlængede ikke overlevelsen hos den totale population.
English: The ORR according to investigator review was 70% and the median PFS was 9.7 months.
Danish: ORR var i henhold til investigators gennemgang 70 % og median-PFS var 9,7 måneder.
English: LCS symptom improvement rate
Danish: LCS symptomforbedringsrate
English: These data are consistent with the pre-planned exploratory Japanese subgroup analysis in IPASS (Goto 2012).
Danish: Disse data er i overensstemmelse med den planlagte eksploratoriske japanske subgruppeanalyse i IPASS (Goto 2012).
English: This may affect about 1 in 100 patients taking IRESSA and can be life-threatening.
Danish: Dette kan ramme cirka 1 ud af 100 patienter, som tager IRESSA, og kan være livstruende.
English: This protein is involved in the growth and spread of cancer cells.
Danish: Dette protein er involveret i vækst og spredning af kræftceller.
English: IRESSA should not be used during pregnancy unless clearly necessary.
Danish: IRESSA må derfor ikke anvendes under graviditet, medmindre det er strengt nødvendigt.
English: Allergic reactions (1.1%), including angioedema and urticaria
Danish: Allergiske reaktioner (1,1 %), inklusive angioødem og urticaria
English: HR Hazard ratio (hazard ratios <1 favour IRESSA)
Danish: HR Hazard ratio (hazard ratio <1 favoriserer IRESSA)
English: These data are similar to those reported in the IPASS study.
Danish: Disse data svarer til dem, der blev rapporteret i IPASS-studiet.
English: None of the patients had cancer, all had cirrhosis and some had hepatitis.
Danish: Ingen af patienterne led af cancer, alle led af cirrose, og nogle havde hepatitis.
English: The lips, nose, eyes and genitals may also be affected.
Danish: Læberne, næsen, øjnene og kønsorganerne kan også være påvirkede.
English: This side effect is uncommon; however, some patients have died from this.
Danish: Denne bivirkning er ikke almindelig, men nogle patienter er døde af den.
English: Plasma protein binding is approximately 90%.
Danish: Plasma-proteinbindingen er ca. 90 %.
English: Therefore, periodic liver function testing is recommended.
Danish: Derfor anbefales periodisk kontrol af leverfunktionen.
English: There are no data from the use of gefitinib in pregnant women.
Danish: Der er ingen data for anvendelse af gefitinib hos gravide kvinder.
English: Like all medicines this medicine 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: b “m” is medians in months.
Danish: b ”m” er medianer i måneder.
English: Tell your doctor as soon as possible if you notice any of the following side effects:
Danish: Fortæl hurtigst muligt din læge, hvis du lægger mærke til en af følgende bivirkninger:
English: Do not take antacids (to reduce the acid level of your stomach) 2 hours before or 1 hour after taking IRESSA.
Danish: • Tag ikke antacida (for at mindske syre i din mave) 2 timer før og 1 time efter du tager IRESSA.
English: If a dose is missed, it should be taken as soon as the patient remembers.
Danish: Hvis en dosis glemmes, skal den tages, så snart patienten husker det.
English: Summary of the safety profile
Danish: Samlet resumé af sikkerhedsprofilen
English: Other potential interactions
Danish: Andre potentielle interaktioner
English: In that study, sensitivity was 43.1%, specificity was
Danish: I dette studie var sensibiliteten 43,1 % og specificiteten 100 %.
English: Gefitinib showed no genotoxic potential.
Danish: Gefitinib udviste ikke genotoksisk potentiale.
English: Frequencies of occurrence of undesirable effects are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Frekvenser for forekomsten af bivirkninger er defineret som: Meget almindelige (≥ 1/10); almindelige (≥ 1/100 til < 1/10); ikke almindelige (≥ 1/1.000 til < 1/100); sjældne (≥ 1/10.000 til < 1/1.000); meget sjældne (< 1/10.000), ikke kendte (kan ikke estimeres ud fra forhåndenværende data).
English: If you are taking a medicine containing this active substance, your doctor may need to do blood tests more often.
Danish: Hvis du tager et lægemiddel, der indeholder dette aktive stof, kan det være, at din læge vil tage blodprøver oftere end normalt.
English: The glass should be swirled occasionally, until the tablet is dispersed (this may take up to 20 minutes).
Danish: Glasset skal svinges forsigtigt rundt af og til, indtil tabletten er opslæmmet (det kan tage op til 20 minutter).
English: Discontinuation should be considered if changes are severe.
Danish: Det bør overvejes at afbryde behandlingen, hvis ændringerne er alvorlige.
English: ADRs usually occur within the first month of therapy and are generally reversible.
Danish: Bivirkningerne forekommer normalt inden for den første måned af behandlingen og er generelt reversible.
English: Unadjusted analysis PP population for clinical factors ITT population for biomarker factors
Danish: Ikke-justeretanalyse PP population for kliniske faktorer ITT population for biomarkøre faktorer
English: The tablet may be taken orally with or without food, at about the same time each day.
Danish: Tabletten tages oralt sammen med eller uden mad på cirka det samme tidspunkt hver dag.
English: Unadjusted analysis EFR population
Danish: Ikke-justeretanalyse EFR population
English: The blister foil may be perforated or non-perforated.
Danish: Blisterfolien kan være perforeret eller ikkeperforeret.
English: 9.8 v. 13.1 Female
Danish: 9.8 v. 13.1 Kvinder
English: Therefore, patients who experience this symptom should be cautious when driving or using machines.
Danish: Patienter, der oplever dette symptom, bør derfor være forsigtige, når de fører motorkøretøj eller betjener maskiner.
English: Take the tablet at about the same time each day.
Danish: • Tag tabletten på ca. samme tidspunkt hver dag.
English: Trial outcome index results were supportive of FACT-L and LCS results
Danish: Trial outcome index-resultater understøttede FACT-L- og LCS-resultaterne.
English: The dispersion should be drunk immediately after dispersion is complete (i.e. within 60 minutes).
Danish: Opslæmningen skal drikkes umiddelbart herefter (dvs. inden for 60 minutter).
English: There is no specific treatment in the event of overdose of gefitinib.
Danish: Der er ingen specifik behandling i tilfælde af overdosering af gefitinib.
English: You can take the tablet with or without food.
Danish: • Du kan tage tabletten sammen med mad eller uden mad.
English: Treatment with IRESSA should be initiated and supervised by a physician experienced in the use of anti-cancer therapies.
Danish: Behandling med IRESSA skal initieres og superviseres af en læge med erfaring inden for cancerbehandling.
English: Warfarin (a so-called oral anticoagulant, to prevent blood clots).
Danish: - Warfarin (et såkaldt oralt antikoagulationsmiddel, til forebyggelse af blodpropper).
English: Positive predictive value (9.5% of the overall population are EGFR mutation-positive (M+))
Danish: Positiv indikator (9,5 % af den totale population har positiv EGFR-mutation (M+))
English: Do not take IRESSA if you are breast-feeding for the safety of your baby.
Danish: Tag ikke IRESSA hvis du ammer af hensyn til dit barns sikkerhed.
English: Do not use any other liquids.
Danish: Brug ikke andre væsker.
English: Figures 1 and 2 Efficacy outcomes in subgroups of non-Asian patients in the INTEREST study (N patients = Number of patients randomised)
Danish: Figur 1 og 2 Data for virkning i undergrupper af ikke-asiatiske patienter i INTEREST-studiet (N patienter = antal randomiserede patienter)
English: These patients should be closely monitored for adverse events.
Danish: Disse patienter skal monitoreres tæt for bivirkninger.
English: N FACT-L QoL improvement rate
Danish: FACT-L QoLforbedringshyppighed
English: Do not crush the tablet.
Danish: Knus ikke tabletten.
English: The safety profile presented in Table 1 is based on the gefitinib clinical development programme and postmarketed experience.
Danish: Sikkerhedsprofilen, som fremgår af Tabel 1, er baseret på det kliniske udviklingsprogram med gefitinib og postmarketing-erfaringer.
English: Tell your doctor immediately if you notice any of the following side effects - you may need urgent medical treatment:
Danish: Fortæl det straks til din læge, hvis du oplever en af følgende bivirkninger - det kan være, du behøver akut medicinsk behandling:
English: Women of childbearing potential must be advised not to get pregnant during therapy.
Danish: Kvinder i den fertile alder skal tilrådes ikke at blive gravide under behandlingen.
English: N Number of patients randomised.
Danish: N Antal randomiserede patienter.
English: AstraZeneca UK Limited Macclesfield Cheshire SK10 2NA United Kingdom
Danish: AstraZeneca UK Limited Macclesfield Cheshire SK10 2NA Storbritannien
English: Cases with fatal outcomes have been reported.
Danish: Tilfælde med fatale udfald har været rapporteret.
English: Contains lactose and sodium, see package leaflet for further information.
Danish: Indeholder lactose og natrium, se indlægsseddel for yderligere information.
English: Five metabolites have been fully identified in excreta and 8 metabolites in plasma.
Danish: Der er identificeret 5 metabolitter i ekskret og 8 metabolitter i plasma.
English: Phenotypic switch to small cell lung cancer has also been reported in 5-10% of cases.
Danish: Fænotypisk skift til småcellet lungecancer er rapporteret i 5-10 % af tilfældene.
English: 4.4 v. 4.6 Male
Danish: 4.4 v. 4.6 Mænd
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 EGFR-mutationsstatus af tumorer eller ctDNA bør anvendes for at undgå falsk negative eller falsk positive bestemmelser (se pkt 5.1).
English: Quality of life outcomes differed according to EGFR mutation status.
Danish: Resultater vedrørende livskvalitet varierede afhængig af status for EGFR-mutationen.
English: Dose adjustment due to toxicity
Danish: Dosisjustering på grund af toksicitet
English: Some lung problems may get worse during treatment with IRESSA.
Danish: Nogle lungeproblemer kan blive værre under behandling med IRESSA.
English: 0.0397 1.7 times higher in females than males
Danish: 0,0397 1,7 gange højere hos kvinder end hos mænd
English: Gastrointestinal perforation has been reported in patients taking gefitinib.
Danish: Gastrointestinal perforation er blevet rapporteret hos patienter, der tager gefitinib.
English: Severe skin reactions (rare) affecting large areas of your body.
Danish: • Heftige hudreaktioner (sjælden) på store dele af kroppen.
English: N patients
Danish: N patienter
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 C-14-mærket gefitinib til diende rotter 14 dage post partum var koncentrationen af radioaktivitet i mælken 11 til 19 gange højere end i blodet.
English: It is recommended that you avoid becoming pregnant during treatment with IRESSA because IRESSA could harm your baby.
Danish: Det anbefales, at du undgår at blive gravid og/eller at du ammer, mens du er i behandling med IRESSA, fordi IRESSA kan skade dit barn.
English: Hazard Ratio (Gefitinib versus Docetaxel) and 95% CI
Danish: Hazard Ratio (Gefitinib versus Docetaxel) og 95% CI
English: In about 60% of cases, resistance is associated with a secondary T790M mutation for which T790M targeted EGFR TKIs may be considered as a next line treatment option.
Danish: I ca. 60 % af tilfældene er resistens associeret med en sekundær T790M-mutation, for hvilke T790M-målrettede EGFR TKI'er kan overvejes som næste behandlingsmulighed.
English: Patients taking warfarin and gefitinib concomitantly should be monitored regularly for changes in prothrombin time (PT) or INR.
Danish: Patienter, der tager warfarin og gefitinib samtidig, bør monitoreres regelmæssigt for ændringer i protrombintiden (PT) eller INR.
English: The safety and efficacy of IRESSA in children and adolescents aged less than 18 years have not been established.
Danish: IRESSAs sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: IRESSA is used to treat adults with non-small cell lung cancer.
Danish: IRESSA bruges til at behandle voksne med ikke-småcellet lungekræft.
English: No other liquids should be used.
Danish: Der må ikke anvendes andre væsker.
English: PVC/Aluminium perforated blister containing 10 tablets or PVC/Aluminium non-perforated blister containing 10 tablets.
Danish: Perforeret PVC/Aluminiumsfolieblistre indeholdende 10 tabletter eller PVC/Aluminiumsfolieblistre indeholdende 10 tabletter.
English: 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: 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: Children and adolescents IRESSA is not indicated in children and adolescents under 18 years.
Danish: Børn og unge IRESSA er ikke beregnet til børn og teenagere under 18 år.
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: Gefitinib total plasma clearance is approximately 500 ml/min and the mean terminal half-life is 41 hours in cancer patients.
Danish: Gefitinibs totale plasmaclearance er omkring 500 ml/min og den gennemsnitlige terminale halveringstid er 41 timer hos cancerpatienter.
English: Tablet coating Hypromellose (E464) Macrogol 300
Danish: Tabletfilmovertræk: Hypromellose (E464) Macrogol 300
English: Mean absolute bioavailability is 59% in cancer patients.
Danish: Den gennemsnitlige absolutte biotilgængelighed hos cancerpatienter er 59 %.
English: Gefitinib plus best supportive care was compared to placebo plus best supportive care.
Danish: Gefitinib plus den bedste understøttende behandling blev sammenlignet med placebo plus den bedste understøttende behandling.
English: If it is less than 12 hours to the next dose, the patient should not take the missed dose.
Danish: Hvis der er mindre end 12 timer til den næste dosis, skal patienten ikke tage den glemte dosis.
English: The glass should be rinsed with half a glass of water, which should also be drunk.
Danish: Glasset skal renses med et halvt glas vand, som også skal drikkes.
English: Time to treatment failure ab
Danish: Tid til behandlingsstandsning ab
English: These medicines may affect the way IRESSA works.
Danish: Disse lægemidler kan påvirke virkningen af IRESSA.
English: Never smoker
Danish: Har aldrig røget
English: 40/235 (17%) of females are M+ 35/551 (6%) of males are M+
Danish: 40/235 (17 %) af kvinderne er M+ 35/551 (6 %) af mændene er M+
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: 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:
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:
English: Asymptomatic laboratory elevations in blood creatinine Proteinuria
Danish: Asymptomatisk stigning i kreatinin i blodprøver Proteinuri
English: Further precautions for use
Danish: Yderligere forholdsregler ved brug
English: Symptoms may include a general feeling of being unwell, with or without possible jaundice (yellowing of the skin and eyes).
Danish: Symptomer herpå kan blandt andet være generel utilpashed med eller uden mulig gulsot (gullig hud og øjne).
English: Survival outcomes differed by smoking status and ethnicity (see Table 6).
Danish: Resultaterne for overlevelse varierede efter rygningsprofil og etnisk oprindelse (se tabel 6).
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: Circulating Tumour DNA (ctDNA)
Danish: Cirkulerende tumor-DNA (ctDNA)
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Læger og sundhedspersonale anmodes om at indberette alle bivirkninger via det nationale rapporteringssystem anført i Appendiks V.
English: Gefitinib should be used cautiously in the presence of mild to moderate changes in liver function.
Danish: Gefitinib bør anvendes med forsigtighed ved lette til moderate ændringer i leverfunktionen.
English: Gefitinib is extensively metabolised in humans.
Danish: Gefitinib metaboliseres i stort omfang hos mennesker.
English: IRESSA comes in blister packs of 30 tablets.
Danish: IRESSA findes i en blisterpakning med 30 tabletter.
English: High doses of short-acting antacids may have a similar effect if taken regularly close in time to administration of gefitinib.
Danish: Høje doser af korttidsvirkende antacida kan have den samme effekt, hvis de tages tidsmæssig tæt på administration af gefitinib.
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: Gefitinib-responsdata 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: 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: Approximately 3% of patients stopped therapy due to an ADR.
Danish: Omkring 3 % af patienterne stoppede behandlingen på grund af en bivirkning.
English: The frequency of adverse drug reactions relating to abnormal laboratory values is based on patients with a change from baseline of 2 or more CTC grades in the relevant laboratory parameters.
Danish: Frekvensen af bivirkninger, der er relateret til unormale laboratorieværdier, er baseret på patienter med en ændring fra baseline på to eller flere CTC-grader i de relevante laboratorieparametre.
English: The signs include very severe pain in the upper part of the stomach area and severe nausea and vomiting.
Danish: Tegn herpå er blandt andre meget stærke smerter i området ved den øverste del af maven, stærk kvalme og opkastning.
English: Patients should not take a double dose (two doses at the same time) to make up for a forgotten dose.
Danish: Patienterne skal ikke tage en dobbeltdosis (to doser på samme tid) som erstatning for den glemte dosis.
English: Then take the next dose as usual.
Danish: Tag den næste dosis på samme tid, som du plejer.
English: 63/396 (16%) of patients with adenocarcinoma histology are M+ 12/390 (3%) of patients with non-adenocarcinoma histology are M+
Danish: 63/396 (16 %) af patienterne med adenokarcinom histologitype er M+ 12/390 (3 %) af patienterne der ikke har adenokarcinom histologitype er M+
English: Adverse reactions associated with overdose should be treated symptomatically; in particular severe diarrhoea should be managed as clinically indicated.
Danish: Bivirkninger, der er associeret med overdosering, skal behandles symptomatisk; specielt svær diarré bør behandles i henhold til klinisk praksis.
English: This resulted in a 35% increase in exposure to metoprolol.
Danish: Dette resulterede i en let forøget (35 %) metoprolol-eksponering.
English: When gefitinib was administered to rats during organogenesis, there were no effects on embryofoetal development at the highest dose (30 mg/kg/day).
Danish: Da gefitinib blev administreret til rotter under organogenese, sås der ingen effekt på fosterudviklingen ved den højeste dosis (30 mg/kg/dag).
English: This may mean that you have an inflammation of the lungs called ‘interstitial lung disease'.
Danish: Dette kan betyde, at du har en form for betændelse i lungerne, som kaldes 'interstitiel lungesygdom'.
English: There were no compound-induced malformations in either species.
Danish: Der sås ingen lægemiddelinducerede misdannelser hos nogen af dyrearterne.
English: Proportion of tumour M+ that are M+ by ctDNA
Danish: Andel af tumor M+, der er M+ i ctDNA
English: NC Not calculated for overall survival HR as the number of events is too few NR Not reached
Danish: NC Ikke udregnet (not calculated) for HR ved total overlevelse, fordi antal tilfælde er for lavt.
English: Gefitinib inhibits the transporter protein BCRP in vitro, but the clinical relevance of this finding is unknown.
Danish: Gefitinib hæmmer transportproteinet BCRP in vitro, men den kliniske relevans heraf er ukendt.
English: Administration of gefitinib once daily results in 2- to 8-fold accumulation, with steady state exposures achieved after 7 to 10 doses.
Danish: Administration af gefitinib en gang dagligt resulterer i en 2 til 8 gange akkumulering, og steady-state-eksponering opnås efter 7 til 10 doser.
English: In poor metabolisers no measurable levels of O-desmethyl gefitinib were produced.
Danish: Hos personer med nedsat metabolisme blev der ikke dannet målbare mængder af O-desmethyl-gefitinib.