natgillin/translations-raw huggingface dataset:
Adverse reactions have been assigned to the frequency categories in Table 2 where possible based on the incidence of comparable adverse event reports in a pooled dataset from the 1142 EGFR mutation positive NSCLC patients who received TAGRISSO at a dose of 80 mg daily in the FLAURA, AURA3, AURAex, AURA 2 and AURA1 studies. 
Neželeni učinki v preglednici 2 so razvrščeni po kategorijah pogostnosti, kjer je bilo mogoče, na podlagi incidence primerljivih poročil o neželenih učinkih v združeni analizi podatkov 1142 bolnikov z NSCLC in pozitivno mutacijo EGFR, ki so prejemali zdravilo TAGRISSO v odmerku 80 mg na dan v študijah FLAURA, AURA3, AURAex, AURA2 in AURA1.
Findings in the ovaries seen following 1 month dosing were reversible. 
Spremembe, opažene na jajčnikih po 1-mesečni uporabi, so bile reverzibilne.
Following a single oral dose of 20 mg, 67.8% of the dose was recovered in faeces (1.2% as parent) while 14.2% of the administered dose (0.8% as parent) was found in urine by 84 days of sample collection. 
Po enkratnem peroralnem odmerku 20 mg se je 67,8 % odmerka pojavilo v blatu (1,2 % kot matična spojina), 14,2 % uporabljenega odmerka (0,8 % kot matična spojina) pa v urinu do 84. dne zbiranja.
4.4 Special warnings and precautionsfor use 
4.4 Posebna opozorila in previdnostni ukrepi
• Stomatitis - inflammation of the inner lining of the mouth. 
• Stomatitis - vnetje sluznice ust.
A BICR assessment of these scans resulted in a subgroup of 128/556 (23%) patients with CNS metastases and these data are summarised in Table 4. 
Na podlagi ocene BICR (Blinded Independent Central Review) teh posnetkov je bila oblikovana podskupina 128/556 (23 %) bolnikov z metastazami v CNS; ti podatki so povzeti v preglednici 4.
In patients treated with TAGRISSO 80 mg once daily, dose reductions due to adverse reactions occurred in 2.1% of the patients. 
Med bolniki, ki so prejemali zdravilo TAGRISSO 80 mg enkrat na dan, so zaradi neželenih učinkov odmerek zmanjšali 2,1 % bolnikom.
Yellow iron oxide (E 172) Red iron oxide (E 172) Black iron oxide (E 172) 
Obloga tablete polivinilalkohol titanov dioksid (E171) makrogol 3350 smukec rumeni železov oksid (E 172) rdeči železov oksid (E 172) črni železov oksid (E 172)
• TAGRISSO may pass into semen. 
• Zdravilo TAGRISSO lahko prehaja v spermo.
Patients were evaluated for LVEF at screening and every 12 weeks thereafter. 
LVEF so pri bolnikih ocenili ob presejanju in so ga nato ocenjevali na 12 tednov.
10 FILM-COATED TABLET BLISTERS (PERFORATED) 7 FILM-COATED TABLET BLISTERS (PERFORATED) 
10 FILMSKO OBLOŽENIH TABLET V PRETISNEM OMOTU (PERFORIRANI) 7 FILMSKO OBLOŽENIH TABLET V PRETISNEM OMOTU (PERFORIRANI)
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking this medicine. 
Če kaj od naštetega velja za vas (ali če ste negotovi), se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, preden začnete jemati to zdravilo.
Note: The intensity of clinical adverse events graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. 
Opomba: Izrazitost kliničnih neželenih učinkov je ocenjena po Terminološko poenotenih kriterijih za neželene dogodke (CTCAE - Common Terminology Criteria for Adverse Events) ameriškega Nacionalnega inštituta za raka (NCI - National Cancer Institute), verzija 4.0.
Analysis of post-progression end-points demonstrated that the PFS benefit was preserved through subsequent lines of therapy. 
Analiza opazovanih dogodkov po napredovanju je pokazala, da se je korist za preživetje brez napredovanja bolezni ohranila med nadaljnjimi linijami zdravljenja.
Strong CYP3A4 inducers can decrease the exposure of osimertinib. 
Močni induktorji CYP3A lahko zmanjšajo izpostavljenost osimertinibu.
Keratitis was reported in 0.7% (n=8) of the 1142 patients treated with TAGRISSO in the FLAURA and AURA studies. 
O keratitisu so poročali pri 0,7 % (n = 8) od 1142 bolnikov, zdravljenih z zdravilom TAGRISSO v študijah FLAURA in AURA.
A pharmacokinetic study in patients with renal impairment has not been conducted. 
Farmakokinetične študije pri bolnikih z okvaro ledvic niso izvedli.
• Aliskiren-used for high blood pressure. 
• aliskiren - uporablja se za zdravljenje visokega krvnega tlaka.
The hepatic impairment marker serum albumin showed an effect on the PK of osimertinib. 
Označevalec okvare jeter serumski albumin je pokazal vpliv na farmakokinetiko osimertiniba.
Therefore, CYP3A4 inhibitors are not likely to affect the exposure of osimertinib. 
Zato ni verjetno, da bi zaviralci CYP3A4 vplivali na izpostavljenost osimertinibu.
At steady-state, circulating plasma concentrations are typically maintained within a 1.6 fold range over the 24-hour dosing interval. 
V stanju dinamičnega ravnovesja se koncentracija v krožeči plazmi v 24-urnem odmernem intervalu praviloma ohrani znotraj 1,6-kratnega območja.
• Dabigatran - used to prevent blood clots. 
• dabigatran - uporablja se za preprečevanje krvnih strdkov.
Population estimated mean volume of distribution at steady-state (Vss/F) of osimertinib is 918 L indicating extensive distribution into tissue. 
Populacijsko ocenjen povprečni volumen porazdelitve osimertiniba v stanju dinamičnega ravnovesja (Vss/F) je 918 l; to kaže na obsežno porazdelitev v tkiva.
See also Section 2. 
Glejte tudi poglavje 2.
A sensitivity analysis of PFS was conducted by a Blinded Independent Central Review (BICR) and showed a median PFS of 11.0 months with TAGRISSO compared with 4.2 months with chemotherapy. 
Analiza senzitivnosti PFS, opravljena s slepljenim neodvisnim centralnim pregledom (BICR - Blinded Independent Central Review), je pokazala mediano vrednost PFS 11,0 mesecev z zdravilom TAGRISSO in 4,2 meseca s kemoterapijo.
A consistent pattern in safety and efficacy results was observed in the analysis of AURA Phase 2 studies. 
V analizi študij AURA 2. faze so opažali skladnost rezultatov o varnosti in učinkovitosti.
National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0. 
Terminološko poenoteni kriteriji za neželene učinke ameriškega Nacionalnega inštituta za raka (National Cancer Institute Common Terminology Criteria for Adverse Events), verzija 4.0.
The median duration of follow up for PFS was 12.6 months. 
Spremljanje glede preživetja brez napredovanja bolezni je mediano trajalo 12,6 meseca.
Based on in vitro studies, osimertinib is a competitive inhibitor of CYP 3A4/5 but not CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6 and 2E1 at clinically relevant concentrations. 
Na podlagi študij in vitro osimertinib v klinično pomembnih koncentracijah kompetitivno zavira CYP 3A4/5, ne pa CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6 in 2E1.
When osimertinib was administered to pregnant female rats throughout gestation and then through early lactation, there was demonstrable exposure to osimertinib and its metabolites in suckling pups plus a reduction in pup survival and poor pup growth (at doses of 20 mg/kg and above). 
Ko so osimertinib uporabili pri brejih podganah med gestacijo in nato med zgodnjim obdobjem dojenja, so dokazali izpostavljenost dojenih mladičev osimertinibu in njegovim presnovkom ter zmanjšano preživetje mladičev in njihovo slabo rast (ob odmerkih 20 mg/kg ali več).
Driving and using machines TAGRISSO has no or no marked influence on the ability to drive and use machines. 
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo TAGRISSO nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Patient-reported symptoms and health-related quality of life (HRQL) were electronically collected using the EORTC QLQ-C30 and its lung cancer module (EORTC QLQ-LC13). 
Izidi po navedbi bolnikov (PRO - patient reported outcomes) Simptomi po navedbi bolnikov in z zdravjem povezana kakovost življenja so bili evidentirani elektronsko z uporabo EORTC QLQ-C30 in njegovega modula za raka pljuč (EORTC QLQ-LC13).
There is no specific treatment in the event of TAGRISSO overdose. 
Specifičnega zdravljenja za preveliko odmerjanje zdravila TAGRISSO ni.
Patients were randomised 1:1 to receive either TAGRISSO (n=279, 80 mg orally once daily) or EGFR TKI comparator (n=277; gefitinib 250 mg orally once daily or erlotinib 150 mg orally once daily). 
Bolnike so v razmerju 1:1 randomizirali na prejemanje zdravila TAGRISSO (n = 279, 80 mg peroralno enkrat na dan) ali primerjalnega EGFR TKI (n = 277, gefitinib 250 mg peroralno enkrat na dan ali erlotinib 150 mg peroralno enkrat na dan).
St. John's Wort should not be used together with TAGRISSO (see section 4.5). 
Šentjanževke se ne sme uporabljati skupaj z zdravilom TAGRISSO (glejte poglavje 4.5).
Based on a clinical pharmacokinetic study in patients at 80 mg, food does not alter osimertinib bioavailability to a clinically meaningful extent. 
Na podlagi klinične farmakokinetične študije pri bolnikih z odmerkom 80 mg hrana ne vpliva na biološko uporabnost osimertiniba v klinično pomembni meri.
In a modified embryofoetal development study in the rat, osimertinib caused embryolethality when administered to pregnant rats prior to embryonic implantation. 
V prilagojeni študiji embriofetalnega razvoja pri podganah je osimertinib povzročil smrt zarodkov, če so ga uporabili pri brejih podganah pred implantacijo zarodkov.
In the FLAURA and AURA studies, diarrhoea was reported in 49% of patients of which 39% were Grade 1 events, 8.0% Grade 2 and 1.2% were Grade 3; no Grade 4 or 5 events were reported. 
V študijah FLAURA in AURA so o driski poročali pri 49 % bolnikov: 39 % primerov je bilo 1. stopnje, 8,0 % 2. stopnje in 1,2 % 3. stopnje; o driski 4. ali 5. stopnje niso poročali.
Based on a population pharmacokinetic analysis of 593 patients with mild renal impairment (CLcr 60 to less than 90 mL/min), 254 patients with moderate renal impairment (CLcr 30 to <than 60 mL/min), 5 patients with severe renal impairment (CLcr 15 to <than 30 mL/min) and 502 patients with normal renal function (greater than or equal to 90 mL/min), osimertinib exposures were similar. 
Na podlagi populacijske farmakokinetične analize 593 bolnikov z blago okvaro ledvic (očistek kreatinina od 60 do manj kot 90 ml/min), 254 bolnikov z zmerno okvaro ledvic (očistek kreatinina od 30 do manj kot 60 ml/min), 5 bolnikov s hudo okvaro ledvic (očistek kreatinina od 15 do manj kot 30 ml/min) ter 502 bolnikov z normalnim delovanjem ledvic (več kot ali enako 90 ml/min) so bile izpostavljenosti osimertinibu podobne.
The incidence of ILD was 10.4% in patients of Japanese ethnicity, 1.8% in patients of Asian ethnicity and 2.8% in non-Asian patients (see section 4.8). 
Pojavnost IBP je bila pri bolnikih japonske etnične pripadnosti 10,4 %, pri bolnikih azijske etnične pripadnosti 1,8 % in pri neazijskih bolnikih 2,8 % (glejte poglavje 4.8).
In patients who develop relevant cardiac signs/symptoms during treatment, cardiac monitoring including LVEF assessment should be considered. 
Pri bolnikih, ki se jim med zdravljenjem pojavijo pomembni srčni znaki ali simptomi, je treba razmisliti o nadziranju delovanja srca, vključno z ocenjevanjem LVEF.
If ILD is diagnosed, TAGRISSO should be discontinued and appropriate treatment initiated as necessary. 
Če je diagnosticirana IBP, je treba ukiniti zdravljenje z zdravilom TAGRISSO in uvesti ustrezno zdravljenje, kot je potrebno.
At least 12 components were observed in the pooled urine and faecal samples in humans with 5 components accounting for >1% of the dose of which unchanged osimertinib, AZ5104 and AZ7550, accounted for approximately 1.9, 6.6 and 2.7% of the dose while a cysteinyl adduct (M21) and an unknown metabolite (M25) accounted for 1.5% and 1.9% of the dose, respectively. 
V združenih vzorcih urina in blata pri človeku so ugotovili vsaj 12 sestavin; 5 sestavin je bilo zastopanih v deležih, ki so predstavljali > 1 % odmerka, pri čemer so nespremenjeni osimertinib, AZ5104 in AZ7550 predstavljali približno 1,9, 6,6 in 2,7 % odmerka, cisteinilni adukt (M21) in neznan presnovek (M25) pa 1,5 % oz. 1,9 % odmerka.
In a female fertility study in rats, administration of osimertinib at 20 mg/kg/day (approximately equal to the recommended daily clinical dose of 80 mg) had no effects on oestrus cycling or the number of females becoming pregnant, but caused early embryonic deaths. 
V študiji plodnosti samic pri podganah uporaba osimertiniba v odmerku 20 mg/kg/dan (to je približno enakovredno priporočenemu kliničnemu dnevnemu odmerku 80 mg) ni vplivala na estrus ali na število brejih samic, povzročila pa je zgodnje smrti zarodkov.
However, osimertinib and its metabolites were detected in the suckling pups and there were adverse effects on pup growth and survival (see section 5.3). 
Vendar so osimertinib in njegove presnovke našli pri dojenih mladičih in ugotovili so neželene učinke na rast in preživetje mladičev (glejte poglavje 5.3).
Patients were randomised in a 2:1 (TAGRISSO: platinum-based doublet chemotherapy) ratio to receive TAGRISSO (n=279) or platinum-based doublet chemotherapy (n=140). 
Bolnike so v razmerju 2:1 (zdravilo TAGRISSO:dvojna kemoterapija na podlagi platine) randomizirali na prejemanje zdravila TAGRISSO (n = 279) ali dvojne kemoterapije na podlagi platine (n = 140).
• you have suffered from inflammation of your lungs (a condition called ‘interstitial lung disease'). 
• če ste imeli vnetje pljuč (bolezen, ki jo imenujemo “intersticijska bolezen pljuč”),
The most commonly reported adverse drug reactions (ADRs) were diarrhoea (49%) and rash (47%). 
Najpogostejša neželena učinka zdravila sta bila driska (49 %) in izpuščaj (47 %).
There is insufficient information on the excretion of osimertinib or its metabolites in animal milk. 
Informacij o izločanju osimertiniba ali njegovih presnovkov v mleko pri živalih ni dovolj.
Active substances whose plasma concentrations may be altered by TAGRISSO Based on in vitro studies, osimertinib is a competitive inhibitor of BCRP transporters. 
Učinkovine, katerih koncentracijo v plazmi lahko spremeni zdravilo TAGRISSO Na podlagi študij in vitro je osimertinib kompetitivni zaviralec prenašalcev BCRP.
The C30 was assessed every 6 weeks before and after progression. 
C30 so ocenili na vsakih 6 tednov pred napredovanjem in po njem.
This side effect is uncommon: it may affect up to 1 in 100 people. 
Ta neželeni učinek je občasen: pojavi se lahko pri največ 1 od 100 bolnikov.
If you forget to take TAGRISSO 
Če ste pozabili vzeti zdravilo TAGRISSO
However, if a plasma-based ctDNA test is used and the result is negative, it is advisable to follow-up with a tissue test wherever possible due to the potential for false negative results using a plasma-based test. 
A če je uporabljena preiskava za ctDNA iz plazme in je izvid negativen, je priporočljivo opraviti še preiskavo tkivnega vzorca, če je le mogoče.
In patients with cardiac risk factors and those with conditions that can affect LVEF, cardiac monitoring, including an assessment of LVEF at baseline and during treatment, should be considered. 
Pri bolnikih s srčnimi dejavniki tveganja in bolnikih s stanji, ki prizadenejo LVEF, je treba razmisliti o nadziranju delovanja srca, vključno z ocenjevanjem LVEF izhodiščno in med zdravljenjem.
In FLAURA and AURA3 the median time to onset was 19 days and 22 days, respectively, and the median duration of the Grade 2 events was 19 days and 6 days, respectively. 
Mediani čas do pojava je bil v študiji FLAURA 19 dni in v študiji AURA3 22 dni, mediani čas trajanja učinkov 2. stopnje pa je bil v prvi 19 dni in v drugi 6 dni.
Irrespective of CNS lesion status at study entry, patients in the TAGRISSO arm demonstrated an efficacy benefit over those in the EGFR TKI comparator arm and there were fewer patients with new CNS lesions in the TAGRISSO arm compared to the EGFR TKI comparator arm (TAGRISSO, 11/279 [3.9%] compared to EGFR TKI comparator, 34/277 [12.3%]). 
Ne glede na stanje lezij v CNS ob vstopu v študijo je bila pri bolnikih v skupini z zdravilom TAGRISSO ugotovljena korist glede učinkovitosti v primerjavi s skupino s primerjalnim EGFR TKI; v skupini z zdravilom TAGRISSO je bilo manj bolnikov z novimi lezijami v CNS kot v skupini s primerjalnim EGFR TKI (TAGRISSO 11/279 [3,9 %], primerjalni EGFR TKI 34/277 [12,3 %]).
Patients presenting with signs and symptoms suggestive of keratitis such as acute or worsening: eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain and/or red eye should be referred promptly to an ophthalmology specialist (see section 4.2 Table 1). 
Bolnike z znaki in simptomi, ki nakazujejo keratitis (na primer vnetje očesa, solzenje, občutljivost na svetlobo, zamegljen vid, bolečine v očesu in/ali pordelost očesa), je treba nemudoma napotiti k specialistu oftalmologu (glejte poglavje 4.2, preglednica 1).
The first analysis of OS was performed approximately 4 months after the primary analysis of PFS. 
Prva analiza celokupnega preživetja je bila opravljena približno 4 mesece po primarni analizi preživetja brez napredovanja bolezni.
Active substances that may increase osimertinib plasma concentrations In vitro studies have demonstrated that the Phase I metabolism of osimertinib is predominantly via CYP3A4 and CYP3A5. 
Učinkovine, ki lahko povečajo koncentracijo osimertiniba v plazmi Študije in vitro so pokazale, da poteka presnova I. faze osimertiniba pretežno s CYP3A4 in CYP3A5.
In the FLAURA and AURA studies, the incidence of ILD was 10.4% in patients of Japanese ethnicity, 1.8% in patients of non-Japanese Asian ethnicity and 2.8% in non-Asian patients. 
V študijah FLAURA in AURA je bila pojavnost intersticijske bolezni pljuč pri bolnikih japonske etnične pripadnosti 10,4 %, pri bolnikih nejaponske azijske etnične pripadnosti 1,8 % in pri neazijskih bolnikih 2,8 %.
Key lung cancer symptoms analysis 
Analiza ključnih simptomov raka pljuč
In a population based pharmacokinetic analyses (n=1367), no clinically significant relationships were identified between predicted steady-state exposure (AUCss) and patient's age (range: 25 to 91 years), gender (65% female), ethnicity (including White, Asian, Japanese, Chinese and non-Asian-non-White patients), line of therapy and smoking status (n=34 current smokers, n=419 former smokers). 
V populacijskih farmakokinetičnih analizah (n = 1367) niso ugotovili klinično pomembne povezanosti med predvideno izpostavljenostjo v stanju dinamičnega ravnovesja (AUCss) in bolnikovo starostjo (razpon: od 25 do 91 let), spolom (65 % žensk), etnično pripadnostjo (vključno z belci, Azijci, Japonci, Kitajci in neazijskimi nebelskimi bolniki), linijo zdravljenja in kadilskim statusom (n = 34 trenutnih kadilcev, n = 419 nekdanjih kadilcev).
Other medicines and TAGRISSO 
Druga zdravila in zdravilo TAGRISSO
A pharmacokinetic/pharmacodynamic analysis predicted a drug-related QTc interval prolongation at 80 mg of 14 msec with an upper bound of 16 msec (90% CI). 
Farmakokinetična/farmakodinamična analiza je ob odmerku 80 mg predvidela z zdravilom povezano podaljšanje intervala QTc za 14 msec, z zgornjo mejo 16 msec (90 % IZ).
• You should not become pregnant while taking this medicine. 
• Med jemanjem tega zdravila ne smete zanositi.
Efficacy results from AURA3 by investigator assessment 
Rezultati učinkovitosti v študiji AURA3 po oceni raziskovalca
There are no data available on patients with severe hepatic impairment (see section 4.2). 
O bolnikih s hudo okvaro jeter ni podatkov (glejte poglavje 4.2).
A validated test should be performed using either tumour DNA derived from a tissue sample or circulating tumour DNA (ctDNA) obtained from a plasma sample. 
Opraviti je treba validirano preiskavo tumorske DNK, dobljene iz vzorca tkiva, ali tumorske DNK v obtoku (ctDNA - circulating tumor DNA), dobljene iz vzorca plazme.
In vitro studies have demonstrated that osimertinib has high potency and inhibitory activity against EGFR across a range of all clinically relevant EGFR sensitising-mutant and T790M mutant non-small cell lung cancer (NSCLC) cell lines (apparent IC50s from 6 nM to 54 nM against phospho-EGFR). 
Študije in vitro so pokazale, da osimertinib zelo močno in učinkovito zaviralno deluje na EGFR v celičnih linijah nedrobnoceličnega raka pljuč (NSCLC) z vsemi klinično pomembnimi aktivacijskimi mutacijami in mutacijo T790M EGFR (navidezne IC50 proti fosfo EGFR so od 6 nM do 54 nM).
• Sudden difficulty in breathing together with a cough or fever - this may be a sign of inflamed lungs (a condition called ‘interstitial lung disease'). 
• Nenadno težko dihanje skupaj s kašljem ali vročino - to je lahko znak vnetja pljuč (bolezni, ki jo imenujemo “intersticijska bolezen pljuč”); Večino primerov je mogoče zdraviti, a nekateri primeri so lahko smrtni.
The geometric mean exposure of both AZ5104 and AZ7550, based on AUC, was approximately 10% each of the exposure of osimertinib at steady-state. 
Geometrična srednja izpostavljenost AZ5104 in AZ7550 je bila na podlagi AUC približno 10 % (vsak od presnovkov) izpostavljenosti osimertinibu v stanju dinamičnega ravnovesja.
Efficacy results from FLAURA by investigator assessment 
Rezultati učinkovitosti v študiji FLAURA po oceni raziskovalca
EGFR TKI comparator (gefitinib or erlotinib) N=67 
Primerjalni EGFR TKI (gefitinib ali erlotinib) N = 67
Mixed Model Repeated Measures - Key lung cancer symptoms - mean change from baseline in TAGRISSO patients compared with chemotherapy 
Mešani model s ponavljajočimi se meritvami - Ključni simptomi raka pljučpovprečna sprememba od izhodišča z zdravilom TAGRISSO v primerjavi s kemoterapijo
Discontinue TAGRISSO (see Section 4.4) 
Ukinite zdravljenje z zdravilom TAGRISSO (glejte poglavje 4.4).
No clinical studies have been conducted to specifically evaluate the effect of renal impairment on the pharmacokinetics of osimertinib. 
Kliničnih študij za specifično ovrednotenje vpliva okvare ledvic na farmakokinetiko osimertiniba niso izvedli.
Al/Al perforated unit dose blisters. 
Al/Al perforirani pretisni omoti za enkratni odmerek.
The resulting 30 mL of liquid should be administered as per the naso-gastric tube manufacturer's instructions with appropriate water flushes. 
Tako dobljenih 30 ml tekočine je treba dati po nazogastrični sondi v skladu z navodili izdelovalca sonde in z ustreznim izpiranjem sonde z vodo.
• the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations. 
• prvo linijo zdravljenja odraslih bolnikov z lokalno napredovalim ali metastatskim nedrobnoceličnim rakom pljuč (NSCLC - non-small-cell lung cancer), katerega receptor za epidermalni rastni faktor (EGFR - epidermal growth factor receptor) ima aktivirajoče mutacije.
Patients with clinically important abnormalities in rhythm and conduction as measured by resting electrocardiogram (ECG) (e.g. QTc interval greater than 470 ms) were excluded from these studies. 
Bolniki s klinično pomembnimi nepravilnostmi srčnega ritma oziroma prevajanja, izmerjenimi na elektrokardiogramu (EKG) v mirovanju (npr. interval QTc, daljši od 470 ms) niso bili vključeni v te študije.
Treatment with this medicinal product should be interrupted pending investigation of these symptoms. 
V času preiskovanja teh simptomov je treba zdravljenje s tem zdravilom prekiniti.
Do not crush, split or chew the tablet. 
Tablet ne drobite, ne lomite in ne zgrizite.
It is an irreversible inhibitor of Epidermal Growth Factor Receptors (EGFRs) harboring sensitising-mutations (EGFRm) and TKI-resistance mutation T790M. 
Je ireverzibilni zaviralec receptorjev za epidermalni rastni faktor (EGFR), ki imajo aktivacijske mutacije (EGFRm) in mutacijo za odpornost proti TKI T790M.
Studies in EGFR mutation-positive NSCLC patients The data described below reflect exposure to TAGRISSO in 1142 patients with EGFR mutationpositive non-small cell lung cancer. 
Študije pri bolnikih z NSCLC in pozitivno mutacijo EGFR Spodaj prikazani podatki povzemajo izpostavljenost zdravilu TAGRISSO pri 1142 bolnikih z nedrobnoceličnim rakom pljuč in pozitivno mutacijo EGFR.
Serious side effects Tell your doctor straight away if you notice the following serious side effects: 
Zdravnika morate takoj obvestiti, če opazite naslednje resne neželene učinke: