natgillin/translations-raw huggingface dataset:
I et japansk farmakoepidemiologisk studie hos 3.159 NSCLC-patienter, der blev fulgt i 12 uger, mens de fik gefitinib eller kemoterapi, fandt man følgende risikofaktorer for at udvikle ILS (uanset om patienterne blev behandlet med gefitinib eller kemoterapi): Rygning, dårlig performance status (PS  2), reduceret normalt lungevæv ( 50 %) dokumenteret ved CT-scanning, nylig diagnosticeret NSCLC (< 6 måneder), tidligere ILS, ældre ( 55 år gammel) og samtidig hjertesygdom.
In a Japanese pharmacoepidemiological case control study in 3,159 patients with NSCLC receiving gefitinib or chemotherapy who were followed up for 12 weeks, the following risk factors for developing ILD (irrespective of whether the patient received IRESSA or chemotherapy) were identified: smoking, poor performance status (PS ≥ 2), CT scan evidence of reduced normal lung (≤ 50%), recent diagnosis of NSCLC (< 6 months), pre-existing ILD, older age (≥ 55 years old) and concurrent cardiac disease.
HR 0,68 [0,58 til 0,81] 6,6 m vs. 5,8 m p<0,0001
HR 0.68 [0.58 to 0.81] 6.6 m vs 5.8 m p<0.0001
QoL Livskvalitet (Quality of life) FACT-L Functional assessment of cancer therapy-lung LCS Lungecancer subskala
FACT-LFunctional assessment of cancer therapy-lung LCS Lung cancer subscale
Forekomsten af ILS blandt de asiatiske patienter, der fik enten gefitinib eller placebo, var henholdsvis ca. 3 % og 4 %.
The majority of ILD-type events reported was from patients of Asian ethnicity and the ILD incidence among patients of Asian ethnicity receiving gefitinib therapy and placebo was approximately 3% and 4% respectively.
Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Dog sås der en reduceret fostervægt hos kaniner ved dosering af 20 mg/kg/dag og derover.
However, in the rabbit, there were reduced foetal weights at 20 mg/kg/day and above.
Hver tablet indeholder 250 mg gefitinib.
Each tablet contains 250 mg gefitinib.
Samtidig administration af gefitinib og ranitidin i en dosis, der forårsagede vedvarende forhøjet gastrisk pH ≥ 5, resulterede i en gennemsnitlig reducering af gefitinibs AUC på 47 % hos raske frivillige (se pkt.
Concomitant administration of gefitinib with ranitidine at a dose that caused sustained elevations in gastric pH ≥ 5 resulted in a reduced mean gefitinib AUC by 47% in healthy volunteers (see section 4.4 and 5.2).
Andel af tumor M-, der er M- i ctDNA)
Proportion of tumour M- that are Mby ctDNA)
Eksponeringsgraden af gefitinib var bred, og overlappede hos både dem, der havde en normal metabolisme og dem, der havde nedsat metabolisme, men den gennemsnitlige eksponering af gefitinib var 2 gange højere hos gruppen af personer med dårlig metabolisme.
The levels of exposure to gefitinib achieved in both the extensive and the poor metaboliser groups were wide and overlapping but the mean exposure to gefitinib was 2-fold higher in the poor metaboliser group.
• Tørre, røde og kløende øjne
Dry, red or itchy eyes
In vitro-data indikerer, at CYP34A og CYP2D6 er de CYP-isozymer, der overvejende er involveret i den oxidative metabolisering af gefitinib.
In vitro data indicate that CYP3A4 and CYP2D6 are the major P450 isozyme involved in the oxidative metabolism of gefitinib.
Hepatocellulære adenomer sås også i et 2årigt carcinogenicitetsstudie med mus, som viste en let forøget forekomst i hanmus ved middel dosis og i både han- og hunmus ved den høje dosis.
The hepatocellular adenomas were also seen in a 2-year carcinogenicity study in mice, which demonstrated a small increased incidence of this finding in male mice at the mid dose, and in both male and female mice at the highest dose.
- hvis du ammer.
if you are breast-feeding.
• Øvrige indholdsstoffer (hjælpestoffer): lactosemonohydrat; mikrokrystallinsk cellulose (E460); croscarmellosenatrium; povidon (K29-32) (E1201); natriumlaurilsulfat; magnesiumstearat; hypromellose (E464); macrogol 300; titandioxid (E171); jernoxid, gul (E172) og jernoxid, rød (E172).
The other ingredients (excipients) are lactose monohydrate, microcrystalline cellulose (E460), croscarmellose sodium, povidone (K29-32) (E1201), sodium laurilsulfate, magnesium stearate, hypromellose (E464), macrogol 300, titanium dioxide (E171), yellow iron oxide (E172) and red iron oxide (E172).
Hos individuelle patienter med ringe metabolisme via CYP2D6 kan behandling med en potent CYP3A4-hæmmer medføre øgede plasmaniveauer af gefitinib.
In individual patients with CYP2D6 poor metaboliser genotype, treatment with a potent CYP3A4 inhibitor might lead to increased plasma levels of gefitinib.
Interstitiel lungesygdom (ILS) er forekommet hos 1,3 % af patienterne, ofte i alvorlig grad (CTC grad 3-4).
Interstitial lung disease (ILD) has occurred in 1.3% of patients, often severe (CTC grade 3-4).
Plasmakoncentrationerne var ikke forhøjede hos patienter med forhøjet aspartataminotransferase (ASAT), basisk fosfatase eller bilirubin på grund af levermetastaser (se pkt.
Plasma concentrations were not increased in patients with elevated aspartate transaminase (AST), alkaline phosphatase or bilirubin due to liver metastases (see section 5.2).
Den er 14 gange mindre potent end gefitinib til at hæmme EGFR-stimuleret cellevækst, og har ingen hæmmende effekt på tumorcellevækst i mus.
The major metabolite identified was O-desmethyl gefitinib, which is 14-fold less potent than gefitinib at inhibiting EGFR stimulated cell growth and has no inhibitory effect on tumour cell growth in mice.
Hvis du har glemt at tage en tablet, skal du gøre som beskrevet nedenfor (afhængig af hvor længe, der er til næste dosis):
If you forget to take IRESSA What to do if you forget to take a tablet depends on how long it is until your next dose.
• Blødning (såsom næseblod eller blod i urinen)
Bleeding (such as nose bleed or blood in your urine) Protein in your urine (shown in a urine test)
Hvis du har problemer med at sluge tabletten, kan den opslæmmes i et halvt glas vand (uden brus).
If you have trouble swallowing the tablet, dissolve it in half a glass of still (non-fizzy) water.
Hud og subkutane væv Meget almindelig Hudreaktioner, hovedsageligt let eller moderat (CTC grad 1 eller 2) pustuløst udslæt, til tider kløende med tør hud, inklusive hudfissurer, på erytematøs basis
Skin reactions, mainly a mild or moderate (CTC grade 1 or 2) pustular rash, sometimes itchy with dry skin, including skin fissures, on an erythematous base
IPASS-forsøget viste, at IRESSA var carboplatin/paclitaxel overlegen i forhold til PFS, ORR, QoL og mht. symptomlindring, uden at der var nogen signifikant forskel på den samlede overlevelse hos behandlingsnaive patienter med lokalt fremskredent eller metastatisk NSCLC, hvis tumorer indeholdt aktiverende mutationer af EGFR-tyrosinkinase.
In the IPASS trial, IRESSA demonstrated superior PFS, ORR, QoL and symptom relief with no significant difference in overall survival compared to carboplatin/paclitaxel in previously untreated patients, with locally advanced or metastatic NSCLC, whose tumours harboured activating mutations of the EGFR tyrosine kinase.
Uden at knuse tabletten, puttes den i et halvt glas drikkevand.
Without crushing it, the tablet should be dropped in half a glass of drinking water.
Lægemidler, som forårsager vedvarende forhøjet gastrisk pH, såsom protonpumpehæmmere og h2-antagonister kan reducere biotilgængeligheden og plasmakoncentrationen af gefitinib, og kan derfor reducere effekten.
Medicinal products that cause significant sustained elevation in gastric pH, such as proton-pump inhibitors and h2-antagonists may reduce bioavailability and plasma concentrations of gefitinib and, therefore, may reduce efficacy.
Tal i de kvadratiske parenteser er 96 % konfidensinterval (CI) for total overlevelses-HR i den totale population, ellers 95 % konfidensinterval for HR. c Konfidensinterval udelukkende under non-inferioritet-margen på 1,154.
HR in the overall population, or otherwise 95% confidence intervals for HR c Confidence interval entirely below non-inferiority margin of 1.154
a Værdierne er for IRESSA versus carboplatin/paclitaxel.
Values presented are for IRESSA versus carboplatin/paclitaxel.
Forøgelsen kan være højere hos individuelle patienter med ringe metabolisme via CYP2D6.
The increase might be higher in individual patients with CYP2D6 poor metaboliser genotype.
Forøgelsen kan være klinisk relevant, idet bivirkninger er relaterede til dosis og eksponering.
The increase may be clinically relevant since adverse reactions are related to dose and exposure.
Samtidig behandling med lægemidler, der inducerer CYP3A4 (fx phenytoin, carbamazepin, rifampicin, barbiturater eller perikon/hypericum perforatum), bør undgås.
Concomitant medicinal products that induce CYP3A4 (e.g. phenytoin, carbamazepine, rifampicin, barbiturates or St John's wort/ Hypericum perforatum) should be avoided.
ILS, der kan optræde akut, har været observeret hos 1,3 % af patienterne, der har fået gefitinib og har i nogle tilfælde været dødelig (se pkt.
Interstitial lung disease (ILD) which may be acute in onset, has been observed in 1.3% of patients receiving gefitinib, and some cases have been fatal (see section 4.8).
Samtidig administration af potente CYP3A4-hæmmere (fx ketoconazol, posaconazol, voriconazol, proteasehæmmere, clarithromycin, telithromycin) kan forøge gefitinibs plasmakoncentration.
Concomitant administration with potent inhibitors of CYP3A4 activity (e.g. ketoconazole, posaconazole, voriconazole, protease inhibitors, clarithromycin, telithromycin) may increase gefitinib plasma concentrations.
Der findes ingen data for samtidig behandling med CYP2D6-hæmmere, men potente hæmmere af dette enzym kan forårsage en ca. dobbelt forøgelse af gefitinibs plasmakoncentration hos patienter med normal metabolisme via CYP2D6 (se pkt.
There are no data on concomitant treatment with an inhibitor of CYP2D6 but potent inhibitors of this enzyme might cause increased plasma concentrations of gefitinib in CYP2D6 extensive metabolisers by about 2-fold (see section 5.2).
In vitro har det vist sig, at dannelsen af O-desmethyl-gefitinib sker via CYP2D6.
The formation of O-desmethyl gefitinib has been shown, in vitro, to be via CYP2D6.
Der blev observeret en reduktion i fertiliteten i hunrotter ved en dosis på 20 mg/kg/dag.
A reduction in female fertility was observed in the rat at a dose of 20 mg/kg/day.
Hvis du tager nogen af disse lægemidler, skal du især huske at fortælle det til din læge eller på apoteket: - Phenytoin eller carbamazepin (mod epilepsi) - Rifampicin (mod tuberkulose) - Itraconazol (mod svampeinfektion)
In particular, tell your doctor or pharmacist if you are taking any of the following medicines: Phenytoin or carbamazepine (for epilepsy).
Total
Overall
Unormale værdier ved leverfunktionsundersøgelser (inklusive øget alaninaminotransferase, aspartataminotransferase, bilirubin) blev observeret og blev registreret som hepatitis med frekvensen "ikke almindelig" (se pkt.
Liver function test abnormalities (including increases in alanine aminotransferase, aspartate aminotransferase, bilirubin) have been observed, uncommonly presenting as hepatitis (see section 4.8).
Ved steady-state er den cirkulerende plasmakoncentration fastholdt, så Cmax typisk er 2-3 gange højere end Cmin inden for doseringsintervallet på 24 timer.
At steady state, circulating plasma concentrations are typically maintained within a 2- to 3-fold range over the 24-hour dosing interval.
Behandling med itraconazol (en potent CYP3A4-hæmmer) forud for gefitinib resulterede i en gennemsnitlig AUC-forøgelse på 80 % hos raske frivillige.
Pre-treatment with itraconazole (a potent CYP3A4 inhibitor) resulted in an 80% increase in the mean AUC of gefitinib in healthy volunteers.
Patienter med ringe CYP2D6-aktivitet
CYP2D6 poor metabolisers
IRESSA indeholder natrium
IRESSA contains sodium
Titandioxid (E171) Jernoxid, gul (E172) Jernoxid, rød (E172)
Titanium dioxide (E171) Yellow iron oxide (E172) Red iron oxide (E172)
Der er rapporteret INR-forøgelse og/eller blødningstilfælde hos nogle patienter, som tager warfarin samtidig (se pkt.
INR elevations and/or bleeding events have been reported in some patients concomitantly taking warfarin (see section 4.4).
Meget almindelig: kan forekomme hos flere end 1 ud af 10 personer
Very common: side effects (may affect more than 1 in 10 people) Diarrhoea
Behandling med rifampicin (en potent CYP3A4-inducer) forud for gefitinib reducerede den gennemsnitlige AUC for gefitinib med 83 % hos raske frivillige (se pkt.
Pre-treatment with rifampicin (a potent CYP3A4 inducer) in healthy volunteers reduced mean gefitinib AUC by 83% (see section 4.4).
Pakningsstørrelse: 30 filmovertrukne tabletter.
Pack size of 30 film-coated tablets.
Asiatere
Asians
Derfor kan samtidig administration af CYP3A4inducere (fx phenytoin, carbamazepin, rifampicin, barbiturater eller planteformuleringer indeholdende perikon/hypericum perforatum) reducere behandlingseffekten og bør derfor undgås (se pkt.
Therefore, concomitant administration of CYP3A4 inducers (e.g. phenytoin, carbamazepine, rifampicin, barbiturates or herbal preparations containing St John's wort/Hypericum perforatum) may reduce efficacy of the treatment and should be avoided (see section 4.5).
N Antal patienter, der kan evalueres ved livskvalitetsanalyser.
N Number of patients evaluable for quality of life analyses QoL Quality of life
Tabel 5 Data for virkning af gefitinib versus docetaxel fra INTEREST-studiet
Table 5 Efficacy outcomes for gefitinib versus docetaxel from the INTEREST study
Hvis du har taget for mange IRESSA tabletter Kontakt din læge eller apoteket straks, hvis du har taget flere tabletter end du må.
If you take more IRESSA than you should If you have taken more tablets than you should, talk to a doctor or pharmacist straight away.
Nedsat leverfunktion, på grund af cirrose, er vist at medføre øgede plasmakoncentrationer af gefitinib (se pkt.
Impaired liver function due to cirrhosis has been shown to lead to increased plasma concentrations of gefitinib (see section 5.2).
Ved påbegyndelse af behandling med en CYP3A4-hæmmer skal patienterne monitoreres tæt for bivirkninger relateret til gefitinib (se pkt.
At initiation of treatment with a CYP3A4 inhibitor, patients should be closely monitored for gefitinib adverse reactions (see section 4.5).
Substanser, der hæmmer CYP3A4, kan nedsætte gefitinibs clearance.
Substances that inhibit CYP3A4 may decrease the clearance of gefitinib.
Hepatisk insufficiens
Hepatic impairment
• Den sædvanlige dosis er én tablet på 250 mg daglig.
The recommended dose is one 250mg tablet per day.
Hvis tabletten ikke kan synkes hel, kan den gives som opslæmning i vand (uden kulsyre).
The tablet can be swallowed whole with some water or if dosing of whole tablets is not possible, tablets may be administered as a dispersion in water (non-carbonated).
Antacida, som administreres tidsmæssigt tæt på gefitinib, kan have samme effekt (se pkt.
Antacids if taken regularly close in time to administration of gefitinib may have a similar effect (see sections 4.5 and 5.2).
Aktive substanser, hvis plasmakoncentration kan ændres gefitinib In vitro-studier har vist, at gefitinib potentielt hæmmer CYP2D6 i et begrænset omfang.
Active substances that may have their plasma concentrations altered by gefitinib In vitro studies have shown that gefitinib has limited potential to inhibit CYP2D6.
• Dehydrering (almindelig) som følge af længerevarende diarré, opkastning, kvalme eller appetitløshed.
Dehydration (common) caused by long term or severe diarrhoea, vomiting (being sick), nausea (feeling sick) or loss of appetite.
Eksponeringsforøgelsen kan være klinisk relevant, da uønskede hændelser er relaterede til dosis og eksponering af gefitinib.
This increase in exposure may be of clinical relevance since adverse experiences are related to dose and exposure to gefitinib.
Se punkt.
Keep this leaflet.
Tabel 4 Resultatet for livskvalitet for gefitinib versus carboplatin/paclitaxel fra IPASSstudiet
Table 4 Quality of life outcomes for gefitinib versus carboplatin/paclitaxel from the IPASS study Population
Konjunktivit, øjenlågsbetændelse og tørre øjne*, hovedsageligt lette (CTC-grad 1)
Conjunctivitis, blepharitis, and dry eye*, mainly mild (CTC grade 1)
Substanser, der forårsager signifikant vedvarende forhøjet gastrisk pH kan reducere gefitinibs plasmakoncentration og derved reducere effekten af gefitinib.
Substances that cause significant sustained elevation in gastric pH may reduce gefitinib plasma concentrations and thereby reduce the efficacy of gefitinib.
EGFR-mutation ukendt
EGFR mutationunknown
Aktive substanser der kan reducere gefitinibs plasmakoncentration Substanser, der inducerer CYP3A4-aktivitet, kan forøge metaboliseringen og nedsætte gefitinibs plasmakoncentration og derved reducere gefitinibs effekt.
Active substances that may reduce gefitinib plasma concentrations Substances that are inducers of CYP3A4 activity may increase metabolism and decrease gefitinib plasma concentrations and thereby reduce the efficacy of gefitinib.
Denne indlægsseddel blev senest ændret MM/ÅÅÅÅ
This leaflet was last revised in {MM/YYYY}
• Betændelse (inflammation) i hudens blodkar.
Inflammation of the liver.
I situationer med samtidig behandling med en potent CYP3A4-hæmmer skal patienten monitoreres tæt for bivirkninger forårsaget af gefitinib.
In situations of concomitant treatment with potent inhibitors of CYP3A4 the patient should be closely monitored for gefitinib adverse reactions.
Tabel 1 Bivirkninger
Table 1 Adverse reactions
Hos 652 ud af 1.060 screenede patienter var både ctDNA- og tumorprøverne vurderbare.
Both ctDNA and tumour samples were evaluable for 652 patients out of 1060 screened.
IRESSA indeholder lactose.
IRESSA contains lactose.
IRESSA indeholder lactose
IRESSA contains lactose
• Gastrointestinel perforation.
Gastrointestinal perforation
Tidligere behandlede patienter
Pretreated patients
Hornhindeerosion, reversibel og til tider i forbindelse med abnorm øjenvippevækst
Corneal erosion, reversible and sometimes in association with aberrant eyelash growth Keratitis (0.12%)
Det kan fremtræde som blå mærker eller plettet hududslæt, der ikke forsvinder ved fingertryk.
This may give the appearance of bruising or patches of non-blanching rash on the skin.
• Appetitmangel
Loss of appetite
Status for EGFR-mutation og kliniske karakteristika I en multivariat analyse med 786 kaukasiske patienter fra gefitinib-studierne* (se tabel 7) har kliniske karakteristika i form af aldrig at have røget, at have en adenocarcinom histologitype og at være kvinde vist sig at være uafhængige indikatorer for positiv EGFR-mutation.
EGFR mutation status and clinical characteristics Clinical characteristics of never smoker, adenocarcinoma histology, and female gender have been shown to be independent predictors of positive EGFR mutation status in a multivariate analysis of 786 Caucasian patients from gefitinib studies* (see Table 7).
Forøgelse af aspartataminotransferase, hovedsagligt let til moderat Forøgelse af total bilirubin, hovedsagligt let til moderat
Elevations in total bilirubin, mainly mild to moderate
IRESSA 250 mg tabletter gefitinib
IRESSA 250 mg tablets gefitinib
Et 2-årigt carcinogenicitetsstudie i rotter resulterede i en lille, men signifikant øget forekomst af hepatocellulære adenomer i både han- og hunrotter.
A 2-year carcinogenicity study in rats resulted in a small but statistically significant increased incidence of hepatocellular adenomas in both male and female rats and mesenteric lymph node haemangiosarcomas in female rats at the highest dose (10 mg/kg/day) only.
IRESSA 250 mg filmovertrukne tabletter gefitinib
IRESSA 250 mg film-coated tablets gefitinib
- corneaepitel atrofi og translucens af cornea - nyrepapilnekrose - hepatocellulær nekrose og eosinofil sinusoidal makrofag infiltration
Hepatocellular necrosis and eosinophilic sinusoidal macrophage infiltration
Tabel 6 Data for virkning af gefitinib versus placebo fra ISEL-studiet
Table 6 Efficacy outcomes for gefitinib versus placebo from the ISEL study Population
Tabel 3 Virkningen af gefitinib versus carboplatin/paclitaxel fra IPASS-studiet
Table 3 Efficacy outcomes for gefitinib versus carboplatin/paclitaxel from the IPASS study Population
Hæmoragisk cystitis
Haemorrhagic cystitis
• Forhøjet niveau af bilirubin og det andet leverenzym, som kaldes aspartat-aminotransferase, i en blodprøve; hvis antallet er for højt, vil din læge muligvis fortælle dig, at du skal stoppe med at tage IRESSA.
• Increase of bilirubin and the other liver enzyme known as aspartate aminotransferase in a blood test; if too high, your doctor may tell you to stop taking IRESSA Increase of creatinine levels in a blood test (related to kidney function) Cystitis (burning sensations during urination and frequent, urgent need to urinate)
Opkastning, hovedsageligt let eller moderat (CTC grad 1 eller 2)
Anorexia mild or moderate (CTC grade 1 or 2)
I et åbent, klinisk fase III-forsøg (IPASS) med 1.217 patienter, blev IRESSA sammenlignet med kemoterapi med to lægemidler, carboplatin og paclitaxel, som førstelinjebehandling hos udvalgte patienter med avanceret NSCLC i Asien.
In a phase III open-label clinical trial (IPASS) in 1217 patients comparing IRESSA to carboplatin/paclitaxel doublet chemotherapy as first-line treatment in selected patients with advanced NSCLC in Asia, the incidence of ILD-type events was 2.6% on the IRESSA treatment arm versus 1.4% on the carboplatin/paclitaxel treatment arm.
• Svaghed
Weakness
Primært endepunkt total overlevelse ab
Primary endpoint overall survival ab
Gefitinib-behandlingen skal ophøre, og en alternativ behandling bør overvejes til de patienter, der ikke tåler behandlingen efter det korte behandlingsophør.
For patients unable to tolerate treatment after a therapy interruption, gefitinib should be discontinued and an alternative treatment should be considered.
Har røget på et eller andet tidspunkt
Ever smoker
Tal i de kvadratiske parenteser er 95 % konfidensinterval (CI) for HR. c Stratificeret log-rank test for samlede resultater ellers er Cox Proportional Hazard Model anvendt.
Numbers in square brackets are 95% confidence intervals for HR c Stratified log-rank test for overall; otherwise cox proportional hazards model d Asian ethnicity excludes patients of Indian origin and refers to the racial origin of a patient group and not necessarily their place of birth
HR 0,82 [0,70 til 0,96] 18,9 m vs. 17,2 m a Værdier for IRESSA versus carboplatin/paclitaxel.
HR 0.82 [0.70 to 0.96] 18.9 m vs. 17.2 m
Almindelig: kan forekomme hos op til 1 ud af 10 personer)
Common: side effects (may affect up to 1 in 10 people) Dry mouth
Det skal du vide, før du begynder at tage IRESSA Sådan skal du tage IRESSA Bivirkninger
What IRESSA is and what it is used for What you need to know before you take IRESSA How to take IRESSA
• Hvis der er mindre end 12 timer til din næste dosis: Spring den glemte tablet over, og tag den næste tablet på samme tid, som du plejer.
If it is less than 12 hours until your next dose: skip the missed tablet.
Ikke almindelig: kan forekomme hos op til 1 ud af 100 personer
Uncommon: side effects (may affect up to 1 in 100 people) Inflammation of the pancreas.
23.7 v. 13.3 Har aldrig røget 3.9 v. 6.5 Har røget på et eller andet tidspunkt
23.7 v. 13.3 Never-smoker
IRESSA 250 mg, filmovertrukne tabletter
IRESSA 250 mg film-coated tablets
Primært endepunkt Progressionsfri overlevelse ab
Primary endpoint Progression free survival (PFS)
Asteni er rapporteret under behandling med gefitinib.
During treatment with gefitinib, asthenia has been reported.
- Barbiturater (en type af medicin, der bruges mod søvnproblemer) - Naturlægemidler, som indeholder perikon (Hypericum Perforatum, mod depression og angst) - Protonpumpe-hæmmere, H2-antagonister og antacida (mod mavesår, sure opstød, halsbrand og til at mindske syre i maven)
Proton-pump inhibitors, H2-antagonists and antacids (for ulcers, indigestion, heartburn and to reduce acids in the stomach).
EGFR-mutation positiv
EGFR mutation-positive