natgillin/translations-raw huggingface dataset:
Tilfælde med fatale udfald har været rapporteret.
Cases with fatal outcomes have been reported.
Indeholder lactose og natrium, se indlægsseddel for yderligere information.
Contains lactose and sodium, see package leaflet for further information.
Der er identificeret 5 metabolitter i ekskret og 8 metabolitter i plasma.
Five metabolites have been fully identified in excreta and 8 metabolites in plasma.
Fænotypisk skift til småcellet lungecancer er rapporteret i 5-10 % af tilfældene.
Phenotypic switch to small cell lung cancer has also been reported in 5-10% of cases.
4.4 v. 4.6 Mænd
4.4 v. 4.6 Male
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).
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).
Resultater vedrørende livskvalitet varierede afhængig af status for EGFR-mutationen.
Quality of life outcomes differed according to EGFR mutation status.
Dosisjustering på grund af toksicitet
Dose adjustment due to toxicity
Nogle lungeproblemer kan blive værre under behandling med IRESSA.
Some lung problems may get worse during treatment with IRESSA.
0,0397 1,7 gange højere hos kvinder end hos mænd
0.0397 1.7 times higher in females than males
Gastrointestinal perforation er blevet rapporteret hos patienter, der tager gefitinib.
Gastrointestinal perforation has been reported in patients taking gefitinib.
• Heftige hudreaktioner (sjælden) på store dele af kroppen.
Severe skin reactions (rare) affecting large areas of your body.
N patienter
N patients
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.
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.
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.
It is recommended that you avoid becoming pregnant during treatment with IRESSA because IRESSA could harm your baby.
Hazard Ratio (Gefitinib versus Docetaxel) og 95% CI
Hazard Ratio (Gefitinib versus Docetaxel) and 95% CI
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.
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.
Patienter, der tager warfarin og gefitinib samtidig, bør monitoreres regelmæssigt for ændringer i protrombintiden (PT) eller INR.
Patients taking warfarin and gefitinib concomitantly should be monitored regularly for changes in prothrombin time (PT) or INR.
IRESSAs sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
The safety and efficacy of IRESSA in children and adolescents aged less than 18 years have not been established.
IRESSA bruges til at behandle voksne med ikke-småcellet lungekræft.
IRESSA is used to treat adults with non-small cell lung cancer.
Der må ikke anvendes andre væsker.
No other liquids should be used.
Perforeret PVC/Aluminiumsfolieblistre indeholdende 10 tabletter eller PVC/Aluminiumsfolieblistre indeholdende 10 tabletter.
PVC/Aluminium perforated blister containing 10 tablets or PVC/Aluminium non-perforated blister containing 10 tablets.
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.
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.
Børn og unge IRESSA er ikke beregnet til børn og teenagere under 18 år.
Children and adolescents IRESSA is not indicated in children and adolescents under 18 years.
** Inkluderer isolerede rapporter om leversvigt, som i nogle tilfælde havde letalt udfald.
**This includes isolated reports of hepatic failure which in some cases led to fatal outcomes.
Gefitinibs totale plasmaclearance er omkring 500 ml/min og den gennemsnitlige terminale halveringstid er 41 timer hos cancerpatienter.
Gefitinib total plasma clearance is approximately 500 ml/min and the mean terminal half-life is 41 hours in cancer patients.
Tabletfilmovertræk: Hypromellose (E464) Macrogol 300
Tablet coating Hypromellose (E464) Macrogol 300
Den gennemsnitlige absolutte biotilgængelighed hos cancerpatienter er 59 %.
Mean absolute bioavailability is 59% in cancer patients.
Gefitinib plus den bedste understøttende behandling blev sammenlignet med placebo plus den bedste understøttende behandling.
Gefitinib plus best supportive care was compared to placebo plus best supportive care.
Hvis der er mindre end 12 timer til den næste dosis, skal patienten ikke tage den glemte dosis.
If it is less than 12 hours to the next dose, the patient should not take the missed dose.
Glasset skal renses med et halvt glas vand, som også skal drikkes.
The glass should be rinsed with half a glass of water, which should also be drunk.
Tid til behandlingsstandsning ab
Time to treatment failure ab
Disse lægemidler kan påvirke virkningen af IRESSA.
These medicines may affect the way IRESSA works.
Har aldrig røget
Never smoker
40/235 (17 %) af kvinderne er M+ 35/551 (6 %) af mændene er M+
40/235 (17%) of females are M+ 35/551 (6%) of males are M+
Gefitinib har et gennemsnitligt steady-state-volumen på 1400 l, hvilket tyder på, at der sker en omfattende distribution til væv.
Gefitinib has a mean steady-state volume of distribution of 1400 l indicating extensive distribution into tissue.
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:
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:
Asymptomatisk stigning i kreatinin i blodprøver Proteinuri
Asymptomatic laboratory elevations in blood creatinine Proteinuria
Yderligere forholdsregler ved brug
Further precautions for use
Symptomer herpå kan blandt andet være generel utilpashed med eller uden mulig gulsot (gullig hud og øjne).
Symptoms may include a general feeling of being unwell, with or without possible jaundice (yellowing of the skin and eyes).
Resultaterne for overlevelse varierede efter rygningsprofil og etnisk oprindelse (se tabel 6).
Survival outcomes differed by smoking status and ethnicity (see Table 6).
Cirka 8 % af patienterne havde en alvorlig bivirkning (common toxicity criteria (CTC), grad 3 eller 4).
Approximately 8% of patients had a severe ADR (common toxicity criteria (CTC) grade 3 or 4).
Cirkulerende tumor-DNA (ctDNA)
Circulating Tumour DNA (ctDNA)
Læger og sundhedspersonale anmodes om at indberette alle bivirkninger via det nationale rapporteringssystem anført i Appendiks V.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Gefitinib bør anvendes med forsigtighed ved lette til moderate ændringer i leverfunktionen.
Gefitinib should be used cautiously in the presence of mild to moderate changes in liver function.
Gefitinib metaboliseres i stort omfang hos mennesker.
Gefitinib is extensively metabolised in humans.
IRESSA findes i en blisterpakning med 30 tabletter.
IRESSA comes in blister packs of 30 tablets.
Høje doser af korttidsvirkende antacida kan have den samme effekt, hvis de tages tidsmæssig tæt på administration af gefitinib.
High doses of short-acting antacids may have a similar effect if taken regularly close in time to administration of gefitinib.
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.
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.
• Svær åndenød eller pludselig forværring af åndenød, muligvis med hoste og feber.
Serious breathlessness, or sudden worsening breathlessness, possibly with a cough or fever.
Omkring 3 % af patienterne stoppede behandlingen på grund af en bivirkning.
Approximately 3% of patients stopped therapy due to an ADR.
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.
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.
Tegn herpå er blandt andre meget stærke smerter i området ved den øverste del af maven, stærk kvalme og opkastning.
The signs include very severe pain in the upper part of the stomach area and severe nausea and vomiting.
Patienterne skal ikke tage en dobbeltdosis (to doser på samme tid) som erstatning for den glemte dosis.
Patients should not take a double dose (two doses at the same time) to make up for a forgotten dose.
Tag den næste dosis på samme tid, som du plejer.
Then take the next dose as usual.
63/396 (16 %) af patienterne med adenokarcinom histologitype er M+ 12/390 (3 %) af patienterne der ikke har adenokarcinom histologitype er M+
63/396 (16%) of patients with adenocarcinoma histology are M+ 12/390 (3%) of patients with non-adenocarcinoma histology are M+
Bivirkninger, der er associeret med overdosering, skal behandles symptomatisk; specielt svær diarré bør behandles i henhold til klinisk praksis.
Adverse reactions associated with overdose should be treated symptomatically; in particular severe diarrhoea should be managed as clinically indicated.
Dette resulterede i en let forøget (35 %) metoprolol-eksponering.
This resulted in a 35% increase in exposure to metoprolol.
Da gefitinib blev administreret til rotter under organogenese, sås der ingen effekt på fosterudviklingen ved den højeste dosis (30 mg/kg/dag).
When gefitinib was administered to rats during organogenesis, there were no effects on embryofoetal development at the highest dose (30 mg/kg/day).
Dette kan betyde, at du har en form for betændelse i lungerne, som kaldes 'interstitiel lungesygdom'.
This may mean that you have an inflammation of the lungs called ‘interstitial lung disease'.
Der sås ingen lægemiddelinducerede misdannelser hos nogen af dyrearterne.
There were no compound-induced malformations in either species.
Andel af tumor M+, der er M+ i ctDNA
Proportion of tumour M+ that are M+ by ctDNA
NC Ikke udregnet (not calculated) for HR ved total overlevelse, fordi antal tilfælde er for lavt.
NC Not calculated for overall survival HR as the number of events is too few NR Not reached
Gefitinib hæmmer transportproteinet BCRP in vitro, men den kliniske relevans heraf er ukendt.
Gefitinib inhibits the transporter protein BCRP in vitro, but the clinical relevance of this finding is unknown.
Administration af gefitinib en gang dagligt resulterer i en 2 til 8 gange akkumulering, og steady-state-eksponering opnås efter 7 til 10 doser.
Administration of gefitinib once daily results in 2- to 8-fold accumulation, with steady state exposures achieved after 7 to 10 doses.
Hos personer med nedsat metabolisme blev der ikke dannet målbare mængder af O-desmethyl-gefitinib.
In poor metabolisers no measurable levels of O-desmethyl gefitinib were produced.
Patienter skal rådes til straks at søge lægehjælp, såfremt de oplever svær eller vedvarende diarré, kvalme, opkastning eller appetitløshed, da dette indirekte kan føre til dehydrering.
Patients should be advised to seek medical advice immediately if they experience severe or persistent diarrhoea, nausea, vomiting or anorexia as these may indirectly lead to dehydration.
Dette kan betyde, at du har et sår på overfladen af øjet (hornhinden).
This may mean that you have an ulcer on the surface of the eye (cornea).
Der blev observeret en gennemsnitlig 3,1-gange forøget eksponering af gefitinib hos patienter med moderat og svær hepatisk insufficiens.
An average 3.1-fold increase in exposure to gefitinib in patients with moderate and severe hepatic impairment was observed.
Hver tablet indeholder 163,5 mg lactose (som monohydrat).
Each tablet contains 163.5 mg of lactose (as monohydrate).
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).
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).
Data fra 4 patienter med svært nedsat leverfunktion på grund af levermetastaser, tyder på, at steady-state-eksponeringen hos disse patienter også er sammenlignelig med eksponeringen hos patienter med normal hepatisk funktion.
Data from 4 patients with severe hepatic impairment due to liver metastases suggested that steady-state exposures in these patients are also similar to those in patients with normal hepatic function.
Derfor betragtes det som usandsynligt, at den bidrager til gefitinibs kliniske effekt.
It is therefore considered unlikely that it contributes to the clinical activity of gefitinib.
28/70 (40 %) af de der aldrig har røget er M+ 47/716 (7 %) af de der har røget på et tidspunkt M+
28/70 (40%) of never smokers are M+ 47/716 (7%) of ever smokers are M+
2.8 v. 5.0 Ikke-adenocarcinoma
2.8 v. 5.0 Non-adenocarcinoma
Efter oral administration af gefitinib er absorptionen moderat langsom og den maksimale plasmakoncentration opnås typisk 3 til 7 timer efter administration.
Following oral administration of gefitinib, absorption is moderately slow and peak plasma concentrations of gefitinib typically occur at 3 to 7 hours after administration.
Filmovertrukne tabletter (tablet).
Film-coated tablets (tablet).
Tre blistre er sampakket i aluminiumsfolielaminat i en karton.
Three blisters are combined with an aluminium foil laminate over-wrap in a carton.
Sving forsigtigt glasset rundt, indtil tabletten er opslæmmet.
Swirl the water until the tablet has dissolved.
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 IRESSA.
If any of the above applies to you, or if you are not sure, check with your doctor or pharmacist before taking IRESSA.
EGFRaktiverede mutationer i cancerceller er en vigtig, understøttende faktor ved tumorcellevækst, blokering af apoptose, forøgelse af produktionen af angiogene faktorer og facilitering af metastaseprocesser.
EGFR activating mutation within a cancer cell is an important factor in promotion of tumour cell growth, blocking of apoptosis, increasing the production of angiogenic factors and facilitating the processes of metastasis.
Den kliniske erfaring har ikke vist en kausal sammenhæng mellem QT-forlængelse og gefitinib.
Clinical experience has not shown a causal association between QT prolongation and gefitinib.
• Rød eller øm mund
Red or sore mouth
Ved diagnosticering af keratitis ulcerosa bør behandlingen med gefitinib afbrydes, og hvis symptomerne ikke forsvinder, eller hvis de vender tilbage ved genoptagen behandling med gefitinib, bør permanent seponering overvejes.
If a diagnosis of ulcerative keratitis is confirmed, treatment with gefitinib should be interrupted, and if symptoms do not resolve, or if symptoms recur on reintroduction of gefitinib, permanent discontinuation should be considered.
Analyser, der er baseret på farmakokinetiske populationsdata fra cancerpatienter, viste ingen sammenhæng mellem den forudsete steady-state-koncentration og patientens alder, vægt, køn, etnisk oprindelse eller kreatininclearance (over 20 ml/min).
From analyses of population pharmacokinetic data in cancer patients, no relationships were identified between predicted steady-state trough concentration and patient age, body weight, gender, ethnicity or creatinine clearance (above 20 ml/min).
Det er ikke relevant at bruge gefitinib på indikationen NSCLC i den pædiatriske population.
There is no relevant use of gefitinib in the paediatric population in the indication of NSCLC.
Resultaterne af et in vitro-fototoksicitetsforsøg viste, at gefitinib kan have fototoksisk potentiale.
The results of an in vitro phototoxicity study demonstrated that gefitinib may have phototoxicity potential.
Dosisjustering er ikke nødvendig hos patienter med nedsat nyrefunktion med kreatininclearance > 20 ml/min.
No dose adjustment is required in patients with impaired renal function at creatinine clearance > 20 ml/min.
Disse symptomer bør behandles som klinisk indiceret (se pkt.
These symptoms should be managed as clinically indicated (see section 4.8).
IRESSA indeholder det aktive stof gefitinib.
What IRESSA contains The active substance is gefitinib.
I de fleste tilfælde er det i forbindelse med andre kendte risikofaktorer, f.eks. samtidig behandling med andre medikamenter såsom steroider eller NSAID, anamnese med gastrointestinal ulceration, alder, rygning, metastaser på perforationsstedet i tarmen.
In most cases this is associated with other known risk factors, including concomitant medications such as steroids or NSAIDS, underlying history of GI ulceration, age, smoking or bowel metastases at sites of perforation.
Der sås en forøget relativ risiko for ILS hos patienter behandlet med IRESSA 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).
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).
Bulløse tilstande, inklusive toksisk epidermal nekrolyse, Stevens-Johnsons syndrom og erythema multiforme
Bullous conditions including toxic epidermal necrolysis, Stevens Johnson syndrome and erythema multiforme Cutaneous vasculitis
• Hvis der er 12 timer eller mere til din næste dosis: Tag den glemte tablet, så snart du kommer i tanke om det.
If it is 12 hours or more until your next dose: take the missed tablet as soon as you remember.
Farmakoterapeutisk klassifikation: Antineoplastiske stoffer, proteinkinasehæmmere; ATC-kode: L01XE02
Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitors; ATC code: L01XE02
For at være sikker på, at du har drukket al medicinen, skylles glasset omhyggeligt med et halvt glas vand, som drikkes.
To make sure that you have drunk all of the medicine, rinse the glass very well with half a glass of water and drink it.
I INTEREST-studiet var forekomsten af ILS-bivirkninger 1,4 % (10 patienter) i gefitinib-gruppen versus 1,1 % (8 patienter) i docetaxel-gruppen.
In the INTEREST trial, the incidence of ILD type events was 1.4% (10) patients in the gefitinib group versus 1.1% (8) patients in the docetaxel group.
Indtagelse af mad ændrer ikke eksponeringen for gefitinib signifikant.
Exposure to gefitinib is not significantly altered by food.
Publicerede studier har vist, at genmodificerede mus, der mangler ekspression af EGFR, udviser udviklingsfejl relateret til umodent epitel i forskellige organer inklusive hud, den gastrointestinale kanal samt lunger.
Published studies have shown that genetically modified mice, lacking expression of EGFR, exhibit developmental defects, related to epithelial immaturity in a variety of organs including the skin, gastrointestinal tract and lung.
Førstelinjebehandling Det randomiserede fase III-førstelinjeforsøg IPASS blev gennemført med patienter fra Asien
First line treatment The randomised phase III first line IPASS study was conducted in patients in Asia
Hvis du føler dig svag, mens du tager denne medicin, skal du dog være forsigtig med at føre motorkøretøjer eller bruge værktøj og maskiner.
Driving and using machines If you feel weak whilst taking this medicine, take care driving or using tools or machines.
Når det overvejes at anvende IRESSA til behandling af lokalt fremskredent eller metastatisk NSCLC, er det vigtigt, at EGFR-mutation i tumorvævet forsøges vurderet hos alle patienter.
When considering the use of IRESSA 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.
I ISEL-studiet var forekomsten af bivirkninger af ILS-typen i hele populationen ca. 1 % i begge behandlingsarme.
In the ISEL trial, the incidence of ILD-type events in the overall population was approximately 1% in both treatment arms.
Ældre Dosisjustering er ikke nødvendig på grund af patienternes alder (se pkt.
Elderly No dose adjustment is required on the basis of patient age (see section 5.2).
Såfremt patienter oplever forværring af respiratoriske symptomer såsom dyspnø, hoste og feber, skal IRESSA-behandlingen afbrydes, og en øjeblikkelig undersøgelse initieres.
If patients experience worsening of respiratory symptoms such as dyspnoea, cough and fever, IRESSA should be interrupted and the patient should be promptly investigated.
Du må ikke tage en dobbeltdosis (to tabletter på samme tid) som erstatning for den glemte tablet.
Do not take a double dose (two tablets at the same time) to make up for a forgotten dose.
Ikke-asiatere
Non-Asians
Gefitinib udviser ingen enzym-induktionseffekter i dyreforsøg og ingen signifikant hæmning (in vitro) af nogen andre CYP-enzymer.
Gefitinib shows no enzyme induction effects in animal studies and no significant inhibition (in vitro) of any other cytochrome P450 enzyme.
Tag ikke IRESSA - hvis du er allergisk over for gefitinib eller et af de øvrige indholdsstoffer (angivet i punkt 6,
Do not take IRESSA if you are allergic to gefitinib or any of the other ingredients of this medicine (listed in section6, ‘What IRESSAcontains').
I et overvågningsstudie efter markedsføringen med 3.350 patienter i Japan, var den rapporterede frekvens af bivirkninger af ILS-typen hos patienter, der fik gefitinib, 5,8 %.
In a post-marketing surveillance study in Japan (3350 patients) the reported rate of ILD-type events in patients receiving gefitinib was 5.8%.
Dispersionen kan også administreres gennem en naso-gastrisk sonde eller gastrostomi-sonde.
The dispersion can also be administered through a naso-gastric or gastrostomy tube.
Gefitinib udskilles primært som metabolitter via fæces, ved renal eliminering af gefitinib og metabolitter, som udgør mindre end 4 % af den administrerede dosis.
Gefitinib is excreted mainly as metabolites via the faeces, with renal elimination of gefitinib and metabolites accounting for less than 4% of the administered dose.
Andre potentielle resistensmekanismer, som er rapporteret efter behandling med EGFR-signalblokerende midler, omfatter: bypass-signalering såsom amplifikation af HER2- og MET-genet samt PIK3CA-mutationer.
Other potential mechanisms of resistance that have been reported following treatment with EGFR signal blocking agents include: bypass signalling such as HER2 and MET gene amplification and PIK3CA mutations.
* Denne bivirkning forekommer i forbindelse med andre tørre tilstande (fortrinsvis hudreaktioner) i forbindelse med gefitinib.
*This adverse reaction can occur in association with other dry conditions (mainly skin reactions) seen with gefitinib.