FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor will decide with you whether treatment should be continued or not.
Danish: Lægen afgør sammen med dig, om behandlingen skal fortsætte eller ej.
English: Ask your doctor if you are unsure of when to take these medicines.
Danish: Spørg din læge hvis du er usikker på, hvornår du skal tage disse lægemidler.
English: % of patients improved a, c
Danish: Andel af patienter, der oplevede forbedring a, c
English: Do not give this medicine to children or adolescents under the age of 18 years.
Danish: Du må ikke give dette lægemiddel til børn eller unge under 18 år.
English: This medicinal product is for oral use.
Danish: Dette lægemiddel er til oral anvendelse.
English: No interruption
Danish: Ingen afbrydelse
English: This makes it easier to remember to take this medicine.
Danish: Det gør det nemmere at huske at tage tabletterne.
English: Then fill the glass again with water and drink it to make sure all medicine is taken.
Danish: Fyld derefter glasset med vand igen og drik det, så du er sikker på, at du har fået al medicinen.
English: The individual effect sizes of these covariates were considered not clinically relevant.
Danish: De individuelle effektstørrelser for disse kovariater blev ikke anset for klinisk relevante.
English: See also section 4 “Possible side effects”.
Danish: Se også punkt 4, ”Bivirkninger”.
English: It is important to take this medicine every day, as long as your doctor prescribes it for you.
Danish: Det er vigtigt at tage det hver dag, så længe lægen ordinerer det til dig.
English: Then carry on taking your tablets at regular times as usual.
Danish: Derefter skal du fortsætte med at tage dine tabletter på faste tidspunkter, ligesom du plejer.
English: Diarrhoea can be treated.
Danish: Diarré kan behandles.
English: The median PFS was 12.0 months by independent review.
Danish: Den mediane PFS var 12,0 måneder ved en uafhængig vurdering.
English: Closer monitoring is recommended in patients with these risk factors.
Danish: Tæt kontrol af patienter med disse risikofaktorer anbefales.
English: They should therefore be taken as far apart in time as possible from GIOTRIF.
Danish: De skal derfor tages så lang tid som muligt fra Giotrif.
English: Therefore, treatment of children or adolescents with this medicinal product is not recommended.
Danish: Behandling af børn eller unge med dette lægemiddel anbefales ikke.
English: CR=complete response; PR=partial response
Danish: CR = komplet respons; PR = partielt respons
English: Do not take a double dose (two tablets instead of one at the same time) to make up for a missed dose.
Danish: Du må ikke tage en dobbeltdosis (to tabletter på samme tid i stedet for én tablet) som erstatning for en glemt dosis.
English: When assessing the EGFR mutation status of a patient, it is important that a well-validated and robust methodology is chosen to avoid false negative or false positive determinations.
Danish: Ved vurdering af en patients EGFR-mutationsstatus er det vigtigt, at der bliver valgt en solidt valideret og robust metodologi for at undgå falsk negative eller falsk positive resultater.
English: Interrupt until Grade 0/1
Danish: Afbydelse indtil grad 0/1
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 September 2013
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 25. september 2013 Dato for seneste fornyelse:
English: The glass should be rinsed with approximately 100 ml of water which should also be consumed.
Danish: Glasset skal skylles med ca. 100 ml vand, der også drikkes.
English: In some cases your doctor may need to interrupt treatment and reduce your dose or stop treatment:
Danish: I nogle tilfælde kan lægen være nødt til at afbryde behandlingen og nedsætte din dosis eller stoppe behandlingen:
English: Randomization was stratified by race (Eastern Asian vs non Eastern Asian).
Danish: Randomiseringen blev stratificeret efter etnisk oprindelse (østasiatisk versus ikke-østasiatisk).
English: No starting dose adjustment was considered necessary for any of the following covariates tested.
Danish: Det blev ikke anset for nødvendigt at justere startdosis for nogen af nedenstående undersøgte kovariater.
English: GIOTRIF has not been studied in children or adolescents.
Danish: Giotrif er ikke blevet undersøgt hos børn eller unge.
English: Interactions with BCRP
Danish: Interaktioner med BCRP
English: The updated median OS for first- and second-line was 31.7 months and 23.6 months, respectively.
Danish: Den opdaterede mediane OS for førstelinjebehandling og andenlinjebehandling var henholdsvis 31,7 måneder og 23,6 måneder.
English: If patient cannot tolerate 20 mg/day, permanent discontinuation of GIOTRIF should be considered
Danish: Hvis patienten ikke kan tåle 20 mg/dag, skal permanent seponering af Giotrif overvejes.
English: Secondary endpoints include ORR and DCR.
Danish: De sekundære endepunkter omfatter ORR og DCR.
English: Contact your doctor or pharmacist immediately.
Danish: Kontakt lægen eller apotekspersonalet med det samme.
English: The tablets should be swallowed whole with water.
Danish: Tabletterne skal synkes hele sammen med vand.
English: GIOTRIF has minor influence on the ability to drive and use machines.
Danish: Giotrif påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: Other patient characteristics/intrinsic factors
Danish: Andre patientkarakteristika/indre faktorer
English: Based on this, it is likely that afatinib is excreted in human milk.
Danish: Ud fra dette er det sandsynligt, at afatinib udskilles i human mælk.
English: Any Grade
Danish: Alle grader
English: If keratitis is diagnosed, the benefits and risks of continuing treatment should be carefully considered.
Danish: Hvis der påvises keratitis, skal fordele og risici ved fortsat behandling nøje overvejes.
English: Depending on the finding, these changes occurred at exposures below, in the range of or above clinically relevant levels.
Danish: Afhængigt af fundet forekom disse ændringer ved eksponeringer under, på niveau med eller over klinisk betydende niveauer.
English: In patients treated with afatinib for more than 6 months a terminal half-life of 344 h was estimated.
Danish: Hos patienter, der blev behandlet med afatinib i over 6 måneder, vurderedes den terminale halveringstid at være 344 timer.
English: GIOTRIF is to be taken by mouth.
Danish: Giotrif skal tages gennem munden.
English: % of patients improved
Danish: % af patienter med bedring
English: The following medicines may reduce the effectiveness of GIOTRIF:
Danish: Følgende lægemidler kan gøre, at Giotrif bliver mindre effektivt:
English: Warnings and precautions Talk to your doctor or pharmacist before taking this medicine:
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apotekspersonalet, før du tager dette lægemiddel:
English: Polysorbate 80 (E433)
Danish: Polysorbat 80 (E433)
English: > 48 hours of diarrhoea and/or > 7 days of rash
Danish: > 48 timer med diarré og/eller > 7 dage med udslæt.
English: Grade 2 (prolonged c or intolerable) or
Danish: Grad 2 (langvarig c eller intolerabel) eller grad ≥ 3
English: Infections and infestations
Danish: Infektioner og infestationer
English: • if you are female, have a low body weight of less than 50 kg or have kidney problems.
Danish: • hvis du er kvinde, hvis du vejer under 50 kg, eller hvis du har problemer med nyrerne.
English: This medicine is used on its own to treat adult patients with a specific type of cancer of the lung (non-small cell lung cancer):
Danish: Dette lægemiddel bruges alene til at behandle voksne patienter med en bestemt type lungekræft (ikke-småcellet lungekræft):
English: Less than 5% of a single dose of afatinib is excreted via the kidneys.
Danish: Under 5 % af en enkeltdosis afatinib udskilles via nyrerne.
English: Carcinogenicity Carcinogenicity studies have not been conducted with GIOTRIF.
Danish: Karcinogenicitet Der er ikke udført karcinogenicitetsstudier med Giotrif.
English: However, based on clinical data it is considered unlikely that GIOTRIF treatment will result in changes of the plasma concentrations of other P-gp substrates.
Danish: Ud fra kliniske data anses det dog for usandsynligt, at behandling med Giotrif vil medføre ændringer i plasmakoncentrationen af andre P-gp-substrater.
English: Antidiarrhoeal medicinal products (e.g. loperamide) should be used and if necessary their dose should be escalated to the highest recommended approved dose.
Danish: Midler mod diarré (f.eks. loperamid) skal anvendes, og om nødvendigt skal dosis af disse øges til den højst anbefalede, godkendte dosis.
English: If swallowing of whole tablets is not possible, these can be dispersed in approximately 100 ml of non-carbonated drinking water.
Danish: Hvis det ikke er muligt at synke tabletterne hele, kan de opslæmmes i ca. 100 ml vand uden kulsyre.
English: Assessment of EGFR mutation status
Danish: Vurdering af EGFR-mutationsstatus
English: Available non-clinical toxicology data have shown effects on reproductive organs at higher doses.
Danish: De foreliggende ikke-kliniske toksikologidata har påvist virkninger på forplantningsorganer ved høje doser.
English: NCI-CTC Grade
Danish: NCI-CTC-grad
English: The efficacy results are summarized in Table 9.
Danish: Effektresultaterne er opsummeret i Tabel 9.
English: Afatinib binds to proteins both non-covalently (traditional protein binding) and covalently.
Danish: Afatinib binder til proteiner, både ikke-kovalent (traditionel proteinbinding) og kovalent.
English: • Take this medicine once daily about the same time each day.
Danish: • Du skal tage Giotrif én gang daglig på omtrent samme tidspunkt hver dag.
English: Mean scores over time for overall quality of life, global health status and physical, role, cognitive, social and emotional functioning were significantly better for GIOTRIF.
Danish: Gennemsnitlige scorer over tid for overordnet livskvalitet, overordnet helbredsstatus og fysisk funktion, fysisk betingede begrænsninger samt kognitiv, social og psykisk funktion var signifikant bedre for Giotrif.
English: GIOTRIF may increase the blood levels of other medicines including but not limited to:
Danish: Giotrif kan øge indholdet af andre lægemidler i blodet, herunder (men ikke begrænset til):
English: Do not open before use.
Danish: Må ikke åbnes før brug.
English: Contact lens use is also a risk factor for keratitis and ulceration (see section 4.8).
Danish: Brug af kontaktlinser er også en risikofaktor for keratitis og ulceration (se pkt.
English: The following terms are used to rank the ADRs by frequency: 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).
Danish: Der bruges følgende betegnelser til at inddele bivirkningerne efter hyppighed: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000) og meget sjælden (< 1/10.000).
English: Diarrhoea may result in dehydration with or without renal impairment, which in rare cases has resulted in fatal outcomes.
Danish: Diarré kan medføre dehydrering med eller uden nedsat nyrefunktion, og i sjældne tilfælde har dette medført døden.
English: If a dose is missed, it should be taken within the same day as soon as the patient remembers.
Danish: Hvis en patient glemmer at tage en dosis, skal den tages, så snart patienten kommer i tanker om det, inden for samme dag.
English: Your doctor may want to monitor you more closely.
Danish: Lægen skal måske kontrollere dig oftere.
English: The primary endpoint was PFS; OS was the key secondary endpoint.
Danish: Det primære endepunkt var PFS; OS var det vigtigste sekundære endepunkt.
English: Mutation in EGFR defines a distinct molecular subtype of lung cancer.
Danish: EGFR-mutation definerer en bestemt molekylær undertype af lungekræft.
English: There are no or limited amount of data from the use of this medicinal product in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af Giotrif til gravide kvinder.
English: Drink the liquid straight away.
Danish: Drik indholdet med det samme.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedskategori er bivirkningerne anført efter faldende alvorlighed.
English: Periodic liver function testing is recommended in patients with pre-existing liver disease.
Danish: Regelmæssig kontrol af leverfunktionen anbefales hos patienter med eksisterende leversygdom.
English: GIOTRIF contains lactose
Danish: Giotrif indeholder lactose
English: Efficacy in EGFR-negative tumours has not been established.
Danish: Virkningen ved EGFR-negative tumorer er ikke klarlagt.
English: These could be symptoms of an inflammation of the lungs (interstitial lung disease) and can be lifethreatening.
Danish: Dette kan være symptomer på inflammation i lungerne (interstitiel lungesygdom), og det kan være livsfarligt.
English: GIOTRIF treatment should be continued until disease progression or until no longer tolerated by the patient (see Table 1 below).
Danish: Behandling med Giotrif bør fortsætte indtil sygdomsprogression, eller indtil patienten ikke længere tåler behandlingen (se Tabel 1 nedenfor).
English: Afatinib is a potent and selective, irreversible ErbB Family Blocker.
Danish: Afatinib er en potent og selektiv, irreversibel hæmmer af ErbB-familien.
English: The efficacy results at the time of the primary analysis of OS including all randomized patients are summarized in Figure 2 and Table 10.
Danish: Resultaterne for virkning på tidspunktet for den primære analyse af OS på basis af alle randomiserede patienter er opstillet i Figur 2 og Tabel 10.
English: Following oral administration of GIOTRIF, Cmax of afatinib were observed approximately 2 to 5 hours post dose.
Danish: Ved oral administration af Giotrif blev Cmax for afatinib set efter ca. 2 til 5 timer.
English: Conjunctivitis Dry eye
Danish: Conjunctivitis Tørre øjne
English: Cmax and AUC0-∞ values increased slightly more than proportionally in the dose range from 20 mg to 50 mg GIOTRIF.
Danish: Cmax og AUC0-∞ blev øget lidt mere end proportionalt i dosisintervallet fra 20 mg til 50 mg Giotrif.
English: No significant impact of age (range: 28 years - 87 years) on the pharmacokinetics of afatinib could be observed.
Danish: Der blev ikke set nogen signifikant indvirkning af alder (interval: 28-87 år) på afatinibs farmakokinetik.
English: Diarrhoea usually occurred within the first 2 weeks of treatment.
Danish: Diarré forekom sædvanligvis inden for de første 2 uger af behandlingen.
English: Proactive management of diarrhoea including adequate hydration combined with anti-diarrhoeal medicinal products especially within the first 6 weeks of the treatment is important and should start at first signs of diarrhoea.
Danish: Proaktiv behandling af diarré, herunder passende hydrering i kombination med midler mod diarré, især inden for de første 6 behandlingsuger, er vigtig og skal påbegyndes ved de første tegn på diarré.
English: Both individuals recovered from these adverse events.
Danish: Begge personer kom sig.
English: The maximum daily dose is 50 mg.
Danish: Den højeste daglige dosis er 50 mg.
English: • Rosuvastatin, used for lowering cholesterol.
Danish: • Rosuvastatin, der bruges til at sænke kolesterol.
English: Median PFS (months), Overall Trial Population 18-months PFS rate 24-months PFS rate
Danish: Median PFS (måneder), samlet forsøgspopulation 18-måneders PFS 24-måneders PFS
English: Afatinib may increase the bioavailability of orally administered BCRP substrates (including but not limited to rosuvastatin and sulfasalazine).
Danish: Afatinib kan øge biotilgængeligheden af oralt indgivne BCRP-substrater (herunder, men ikke begrænset til, rosuvastatin og sulfasalazin).
English: Left ventricular dysfunction has been associated with HER2 inhibition.
Danish: Dysfunktion af venstre ventrikel er blevet sat i forbindelse med HER2-hæmning.
English: It works by blocking the activity of a group of proteins called the ErbB family (including EGFR [epidermal growth factor receptor or ErbB1], HER2 [ErbB2], ErbB3 and ErbB4).
Danish: Det virker ved at blokere aktiviteten af en gruppe proteiner, der kaldes for ErbB-familien (inklusive EGFR [epidermal vækstfaktorreceptor eller ErbB1], HER2 [ErbB2], ErbB3 og ErbB4).
English: Gender Female patients had a 15% higher plasma exposure (AUCτ,ss, body weight corrected) than male patients.
Danish: Kvindelige patienter havde en 15 % højere plasmaeksponering (AUCτ,ss, korrigeret for legemsvægt) end mandlige patienter.
English: Objective Response Rate (CR+PR)
Danish: Objektiv responsrate (CR+PR)
English: Oral administration of single doses to mice and rats indicated a low acute toxic potential of afatinib.
Danish: Oral administration af enkeltdoser til mus og rotter tydede på, at afatinib har et lavt, akut toksisk potentiale.
English: If you do not take this medicine as prescribed by your doctor your cancer may grow again.
Danish: Hvis ikke du tager Giotrif som foreskrevet af lægen, begynder din kræft måske at vokse igen.
English: GIOTRIF can be prescribed to you as your first treatment or if prior chemotherapy treatment has been insufficient.
Danish: Lægen kan ordinere Giotrif til dig som din første behandling, eller hvis tidligere behandling med kemoterapi har været utilstrækkelig.
English: If used during pregnancy or if the patient becomes pregnant while or after receiving GIOTRIF, she should be informed of the potential hazard to the foetus.
Danish: Ved brug under graviditet, eller hvis patienten bliver gravid under eller efter behandling med Giotrif, skal hun informeres om den mulige risiko for fosteret.
English: Other secondary endpoints included ORR, DCR, change in tumour size and HRQOL.
Danish: Andre sekundære endepunkter var ORR, DCR, ændring i tumorstørrelse og HRQoL.
English: • that is identified by a change (mutation) in the gene for EGFR.
Danish: • der er kendetegnet ved en ændring (mutation) i det gen, der koder for stoffet EGFR.
English: Therefore, this medicinal product is unlikely to interact with other medicines that modulate or are metabolised by CYP enzymes.
Danish: Derfor er det usandsynligt, at Giotrif interagerer med andre lægemidler, der modulerer eller metaboliseres af CYP-enzymer.
English: Patients were enrolled in the first-line (N=61) or second-line setting (N=68) (i.e. after failure of 1 prior chemotherapy regimen).
Danish: Patienterne blev indrulleret til førstelinjebehandling (N = 61) eller andenlinjebehandling (N = 68) (dvs. efter svigt af 1 tidligere kemoterapiregime).
English: • Rifampicin, an antibiotic used to treat tuberculosis.
Danish: • Rifampicin, som er et antibiotikum, der bruges til at behandle tuberkulose.
English: If you have difficulties swallowing the tablet, dissolve it in a glass of still water.
Danish: Hvis du har svært ved at synke tabletten, kan du opløse/opslæmme den i et glas almindeligt vand.
English: This is consistent with population pharmacokinetic data derived from clinical trials in various tumour types (see “Population pharmacokinetic analysis in special populations” below).
Danish: Dette er foreneligt med populationsfarmakokinetiske data fra kliniske forsøg med forskellige tumorformer (se “Populationsfarmakokinetisk analyse hos særlige populationer” nedenfor).
English: Aberrant ErbB signalling triggered by receptor mutations, and/or amplification, and/or receptor ligand overexpression contributes to the malignant phenotype.
Danish: Aberrant ErbB-signalering, der skyldes receptormutationer og/eller amplifikation og/eller overekspression af receptor-ligand-komplekset, bidrager til den maligne fænotype.
English: Approximately 2% of the afatinib dose was metabolized by FMO3 and the CYP3A4-dependent N-demethylation was too low to be quantitatively detected.
Danish: Cirka 2 % af afatinibdosis blev metaboliseret af FMO3, og CYP3A4-afhængig N-demetylering kunne ikke påvises kvantitativt.
English: Interactions with drug transport systems
Danish: Interaktioner med lægemiddeltransportsystemer
English: Patients with a history of ILD have not been studied.
Danish: Der er ikke foretaget studier hos patienter med ILD i anamnesen.
English: If you experience any of the symptoms above, contact your doctor as soon as possible.
Danish: Hvis du får nogle af ovenstående symptomer, skal du kontakte lægen snarest muligt.
English: PFS Months (median)
Danish: PFS Måneder (median)
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Oral anvendelse.
English: If you could become pregnant, you should use adequate birth control methods during treatment and for at least 1 month after taking the last dose of this medicine.
Danish: Hvis du kan blive gravid, skal du bruge sikre præventionsmetoder under behandlingen og i mindst 1 måned efter indtagelse af den sidste dosis.
English: The adverse reactions observed at these doses were primarily dermatological (rash/acne) and gastrointestinal events (especially diarrhoea).
Danish: De bivirkninger, der blev set ved disse doser, var hovedsagelig dermatologiske (udslæt/akne) og gastrointestinale (især diarré).
English: Afatinib is not an inhibitor or an inducer of CYP enzymes.
Danish: Afatinib er ikke en hæmmer eller en induktor af CYP-enzymer.
English: • Do not break, chew or crush the tablet.
Danish: • Du må ikke brække tabletten over, tygge den eller knuse den.
English: Additionally, in various organs pharmacodynamically mediated atrophy of epithelia was observed in both species.
Danish: Endvidere blev der set farmakodynamisk medieret epitelatrofi i forskellige organer hos begge arter.
English: Phototoxicity An in vitro 3T3 test showed that afatinib may have phototoxicity potential.
Danish: Fototoksicitet En in vitro 3T3-test viste, at afatinib potentielt kan være fototoksisk.
English: In vitro binding of afatinib to human plasma proteins is approximately 95%.
Danish: In vitro bindes ca. 95 % af afatinib til humane plasmaproteiner.
English: • Skin rash (very common).
Danish: • Hududslæt (meget almindeligt)
English: The efficacy results are summarized in Figure 1 (LUX-Lung 3) and Tables 6 and 7 (LUX-Lung 3 and 6).
Danish: Effektresultaterne er opsummeret i Figur 1 (LUX-Lung 3) og i Tabel 6 og 7 (LUX-Lung 3 og 6).
English: Delay of time to deterioration (months)
Danish: Forlængelse af tid til forværring (måneder)
English: Missed dose
Danish: Glemte doser
English: Following administration of an oral solution of 15 mg afatinib, 85.4% of the dose was recovered in the faeces and 4.3% in urine.
Danish: Efter oral administration af en opløsning med 15 mg afatinib blev 85,4 % af dosis genfundet i fæces og 4,3 % i urinen.
English: If treatment for rash is not working and the rash is getting more severe (for example, you have peeling or blistering of the skin) you should notify your doctor immediately, since your doctor may decide to stop your treatment with GIOTRIF.
Danish: Hvis behandlingen mod udslættet ikke virker, og udslættet bliver værre (hvis f.eks. huden skaller af, eller du får blærer på huden), skal du straks fortælle det til lægen, da din læge kan beslutte at stoppe din behandling med Giotrif.
English: GIOTRIF as monotherapy is indicated for the treatment of
Danish: Giotrif som monoterapi er indiceret til behandling af:
English: ILD-like adverse reactions were reported in 0.7% of afatinib treated patients.
Danish: ILD-lignende bivirkninger blev rapporteret hos 0,7 % af de patienter, der blev behandlet med afatinib.
English: Left ventricular function
Danish: Venstre ventrikels funktion
English: Smoking history, alcohol consumption (limited data), or presence of liver metastases had no significant impact on the pharmacokinetics of afatinib.
Danish: Tobaksanamnese, alkoholforbrug (begrænsede data) eller tilstedeværelse af levermetastaser havde ingen signifikant indvirkning på afatinibs farmakokinetik.