FrancophonIA/ELRC3.0 huggingface dataset:
English: These studies were conducted in a total of 1532 patients with advanced, recurrent or metastatic NSCLC following first-line standard platinum-based chemotherapy, no new safety signals were identified.
Slovenian: Ti študiji so izvedli pri skupno 1532 bolnikih z napredovalim, ponavljajočim se ali metastatskim nedrobnoceličnim rakom pljuč po standardni kemoterapiji na osnovi platine v prvi liniji zdravljenja; novih varnostnih signalov niso ugotovili.
English: See also section 3 ‘How to take Tarceva'
Slovenian: Glejte tudi poglavje 3 ʻKako jemati zdravilo Tarceva'.
English: Although statistically significant, the magnitude of this difference is not considered to be clinically relevant.
Slovenian: Čeprav je razlika statistično značilna, je zaradi njene majhnosti ne štejemo za klinično pomembno.
English: • if you have sudden difficulty in breathing associated with cough or fever because your doctor may need to treat you with other medicines and interrupt your Tarceva treatment;
Slovenian: • imate nenadoma težave z dihanjem, ki so povezane s kašljem ali zvišano telesno temperaturo, ker vas bo morda zdravnik moral zdraviti z drugimi zdravili in prekiniti zdravljenje z zdravilom Tarceva;
English: Tarceva in combination with gemcitabine is indicated for the treatment of patients with metastatic pancreatic cancer.
Slovenian: Zdravilo Tarceva je v kombinaciji z gemcitabinom indicirano za zdravljenje bolnikov z metastatskim rakom trebušne slinavke.
English: Tarceva is indicated for adults.
Slovenian: Zdravilo Tarceva je indicirano za zdravljenje odraslih.
English: Erlotinib tested negative in conventional genotoxicity studies.
Slovenian: Erlotinib se v običajnih študijah genotoksičnosti ni izkazal kot genotoksičen.
English: Safety evaluation of Tarceva is based on the data from more than 1500 patients treated with at least one 150 mg dose of Tarceva monotherapy and more than 300 patients who received Tarceva 100 or 150 mg in combination with gemcitabine.
Slovenian: Varnost zdravila Tarceva so vrednotili na osnovi podatkov pri več kot 1500 bolnikih, ki so prejeli najmanj en 150-mg odmerek zdravila Tarceva kot samostojno zdravilo, in več kot 300 bolnikih, ki so prejemali zdravilo Tarceva 100 mg ali 150 mg v kombinaciji z gemcitabinom.
English: In the remaining 55% of patients with unknown EGFR-expression status, the hazard ratio was 0.77 (95% CI 0.61-0.98).
Slovenian: Pri preostalih 55 % bolnikov z neznanim statusom ekspresije EGFR je bilo razmerje ogroženosti 0,77 (95-% interval zaupanja: 0,61-0,98).
English: Based on the mode of action, erlotinib has the potential to be a teratogen.
Slovenian: Glede na mehanizem delovanja obstaja možnost, da bi erlotinib lahko imel teratogeno delovanje.
English: You may have increased side effects and your doctor may interrupt your treatment.
Slovenian: Lahko se pojavijo bolj izraziti neželeni učinki in vam bo zdravnik morda prekinil zdravljenje.
English: In another clinical study, erlotinib was shown not to affect pharmacokinetics of the concomitantly administered CYP3A4/2C8 substrate paclitaxel.
Slovenian: V drugi klinični študiji erlotinib ni vplival na farmakokinetiko paklitaksela, substrata CYP3A4/2C8, ki so ga jemali sočasno.
English: For patients who are exposed to sun, protective clothing, and/or use of sunscreen (e.g. mineral-containing) may be advisable.
Slovenian: Za bolnike, ki so izpostavljeni soncu, je verjetno koristna uporaba zaščitnih oblačil in/ali zaščitne kreme (npr. na osnovi mineralov).
English: Studies in animals have shown no evidence of teratogenicity or abnormal parturition.
Slovenian: Študije na živalih niso pokazale znakov teratogenosti ali nenormalnosti pri porodu.
English: The proportion of patients who experienced complete response, partial response or stable disease was 44.0% and 27.5%, respectively, for the Tarceva and placebo groups (p = 0.004).
Slovenian: Delež bolnikov, ki so dosegli popolni odgovor, delni odgovor ali stabilno bolezen, je znašal 44,0 % v skupini, ki je jemala zdravilo Tarceva in 27,5 % v skupini, ki je jemala placebo (p = 0,004).
English: In a post-hoc analysis, patients with favourable clinical status at baseline (low pain intensity, good QoL and good PS) may derive more benefit from Tarceva.
Slovenian: V post-hoc analizi so ugotovili, da imajo lahko bolniki z ugodnim kliničnim stanjem pred začetkom zdravljenja (nizka jakost bolečine, dobra kakovost življenja in dobro stanje zmogljivosti), večjo korist od zdravljenja z zdravilom Tarceva.
English: The effects of concomitant administration of erlotinib with H2 antagonists and antacids are unknown; however, reduced bioavailability is likely.
Slovenian: Učinki sočasnega dajanja erlotiniba in H2 antagonistov ali antacidov niso znani, vendar je zmanjšana biološka uporabnost verjetna.
English: Overall Survival (OS) (months)
Slovenian: Celokupno preživetje (meseci)
English: Erlotinib is an epidermal growth factor receptor/human epidermal growth factor receptor type 1 (EGFR also known as HER1) tyrosine kinase inhibitor.
Slovenian: Erlotinib je zaviralec tirozinske kinaze receptorja za epidermalni rastni dejavnik/humanega receptorja za epidermalni rastni dejavnik tipa 1 (EGFR, prav tako poznan kot HER1).
English: Less than 2% of the orally administered dose is excreted as parent substance.
Slovenian: Manj kot 2 % peroralno zaužitega odmerka se izloča v nespremenjeni obliki.
English: • if you develop acute or worsening redness and pain in the eye, increased eye watering, blurred vision and/or sensitivity to light, please tell your doctor or nurse immediately as you may need urgent treatment (see Possible Side Effects below).
Slovenian: • pride do akutnega izbruha ali poslabšanja rdečih oči in bolečin v očesu, povečanega solzenja oči, zamegljenega vida in/ali občutljivosti na svetlobo, o tem takoj obvestite zdravnika, ker boste morda potrebovali nujno zdravljenje (glejte poglavje Možni neželeni učinki, spodaj);
English: • Inflammation of the coloured part of the eye
Slovenian: • vnetje obarvanega dela očesa.
English: This medicine can also be prescribed to you in combination with another treatment called gemcitabine if you have cancer of the pancreas at a metastatic stage.
Slovenian: Zdravnik vam lahko to zdravilo predpiše tudi v kombinaciji z drugim zdravilom, imenovanim gemcitabin, če imate rak trebušne slinavke v metastatski obliki.
English: Patients treated concurrently with erlotinib and gemcitabine should be monitored carefully for the possibility to develop ILD-like toxicity.
Slovenian: Bolnike, ki se sočasno zdravijo z erlotinibom in gemcitabinom, je treba skrbno spremljati zaradi možnosti pojava toksičnosti, podobni intersticijski bolezni pljuč.
English: About two-thirds of the patients were male and approximately one-third had a baseline ECOG performance status (PS) of 2, and 9% had a baseline ECOG PS of 3.
Slovenian: Približno dve tretjini bolnikov sta bili moškega spola, ena tretjina je imela pred začetkom zdravljenja splošno stanje zmogljivosti po ECOG (Eastern Cooperative Oncology Group) 2,9 % pa jih je imelo splošno stanje zmogljivosti po ECOG 3.
English: Although erlotinib exposure was similar in patients with moderately impaired hepatic function (Child-Pugh score 7-9) compared with patients with adequate hepatic function, caution should be used when administering Tarceva to patients with hepatic impairment.
Slovenian: Čeprav je bila izpostavljenost erlotinibu pri bolnikih z zmerno jetrno okvaro (7-9 točk po Child-Pughovi lestvici) in bolnikih z ustreznim delovanjem jeter podobna, je pri dajanju zdravila Tarceva bolnikom z jetrno okvaro potrebna previdnost.
English: Based on the data from these studies, severe adverse reactions such as diarrhoea, rash and possibly increased activity of liver aminotransferases may occur above the recommended dose.
Slovenian: Na osnovi podatkov teh študij se lahko pri odmerkih, ki so večji od priporočenega, pojavijo resni neželeni učinki, kot so driska, kožni izpuščaj in morebiti povečanje aktivnosti jetrnih aminotransferaz.
English: The combination of Tarceva and a statin may increase the potential for statin-induced myopathy, including rhabdomyolysis, which was observed rarely.
Slovenian: Sočasno zdravljenje z zdravilom Tarceva in statinom lahko poveča tveganje za miopatijo, povzročeno s statini, vključno z rabdomiolizo; to so opazili redko.
English: The recommended daily dose of Tarceva is 150 mg taken at least one hour before or two hours after the ingestion of food.
Slovenian: Priporočeni dnevni odmerek zdravila Tarceva je 150 mg, ki ga vzamemo najmanj eno uro pred zaužitjem hrane ali dve uri po tem.
English: Pharmacotherapeutic group: antineoplastic agent protein kinase inhibitor, ATC code: L01XE03
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, zaviralci proteinske kinaze, oznaka ATC: L01XE03.
English: -Corneal perforations -Corneal ulcerations -Uveitis
Slovenian: - perforacije roženice - ulceracije roženice - uveitis
English: In study BR.21, the median time to onset of rash was 8 days, and the median time to onset of diarrhoea was 12 days.
Slovenian: V študiji BR.21 je bila mediana časa do pojava kožnega izpuščaja 8 dni, do pojava driske pa 12 dni.
English: When erlotinib was given in combination with capecitabine, there was a statistically significant increase in erlotinib AUC and a borderline increase in Cmax when compared with values observed in another study in which erlotinib was given as single agent.
Slovenian: Ko so erlotinib dajali v kombinaciji s kapecitabinom, je prišlo do statistično značilnega povečanja AUC in mejnega povečanja Cmax erlotiniba v primerjavi z vrednostmi, ki so jih opazili v drugi študiji, kjer so erlotinib dajali samostojno.
English: Tarceva dosing should be interrupted if changes in liver function are severe (see section 4.8).
Slovenian: Dajanje zdravila Tarceva je treba prekiniti, če so spremembe jetrnega delovanja hude (glejte poglavje 4.8).
English: Tarceva should be used with caution in patients with a history of keratitis, ulcerative keratitis or severe dry eye.
Slovenian: Zdravilo Tarceva je treba pri bolnikih, ki so v preteklosti imeli keratitis, ulcerativni keratitis ali zelo suhe oči, uporabljati previdno.
English: Capecitabine may increase erlotinib concentrations.
Slovenian: Kapecitabin lahko poveča koncentracijo erlotiniba.
English: In patients with solid tumours and with moderately impaired hepatic function (Child-Pugh score 7-9), geometric mean erlotinib AUC0-t and Cmax was 27000 ng•h/mL and 805 ng/mL, respectively, as compared to 29300 ng•h/mL and 1090 ng/mL in patients with adequate hepatic function including patients with primary liver cancer or hepatic metastases.
Slovenian: Pri bolnikih s solidnimi tumorji in zmerno jetrno okvaro (7-9 točk po Child-Pughovi lestvici) je bila geometrijska sredina AUC0-t erlotiniba 27.000 ng•h/ml in Cmax erlotiniba 805 ng/ml, v primerjavi z AUC0-t 29.300 ng•h/ml in Cmax 1.090 ng/ml pri bolnikih z ustreznim delovanjem jeter, vključno z bolniki s primarnim rakom jeter ali zasevki v jetrih.
English: Patients were randomised to receive Tarceva or placebo once daily on a continuous schedule plus gemcitabine IV (1000 mg/m2, Cycle 1 - Days 1, 8, 15, 22, 29, 36 and 43 of an 8 week cycle; Cycle 2 and subsequent cycles - Days 1, 8 and 15 of a 4 week cycle [approved dose and schedule for pancreatic cancer, see the gemcitabine SPC]).
Slovenian: Bolniki so bili randomizirani v skupino, ki je prejemala zdravilo Tarceva, in v skupino, ki je prejemala placebo enkrat na dan neprekinjeno ter gemcitabin intravensko (1.000 mg/m2, cikel 1: na 1., 8., 15., 22., 29., 36. in 43. dan 8-tedenskega cikla; cikel 2 in nadaljnji cikli: 1., 8. in 15. dan 4-tedenskega cikla [odobreni odmerek in shema za rak trebušne slinavke, glejte Povzetek glavnih značilnosti zdravila za gemcitabin]).
English: 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.
Slovenian: Bolniki, pri katerih se pojavijo znaki in simptomi, ki nakazujejo na keratitis in so lahko akutni ali se poslabšujejo: vnetje očesa, solzenje, občutljivost na svetlobo, zamegljen vid, bolečine v očesu in/ali rdeče oči, se morajo takoj obrniti na specialista oftalmologije.
English: Tarceva is available in strengths of 25 mg, 100 mg and 150 mg.
Slovenian: Zdravilo Tarceva je na voljo v jakostih 25 mg, 100 mg in 150 mg.
English: Erlotinib is primarily cleared by the liver.
Slovenian: Erlotinib se v glavnem izloča prek jeter.
English: Figure 1: Kaplan-Meier curve for investigator assessed PFS in trial ML20650 (EURTAC) (April 2012 cut-off)
Slovenian: Slika 1: Kaplan-Meierjeva krivulja za preživetje brez napredovanja bolezni po raziskovalčevi oceni v preskušanju ML20650 (EURTAC) (podatki, zbrani do aprila 2012)
English: No Grade 4 rash or diarrhoea was observed in either study.
Slovenian: Kožnega izpuščaja ali driske stopnje 4 niso opazili v nobeni od študij.
English: Management In case of suspected overdose, Tarceva should be withheld and symptomatic treatment initiated.
Slovenian: V primeru suma na preveliko odmerjanje je treba zdravilo Tarceva ukiniti in začeti s simptomatskim zdravljenjem.
English: The efficacy of Tarceva in first-line treatment of patients with EGFR activating mutations in NSCLC was demonstrated in a phase III, randomised, open-label trial (ML20650, EURTAC).
Slovenian: Učinkovitost zdravila Tarceva v prvi liniji zdravljenja pri bolnikih z EGFR-aktivirajočimi mutacijami pri nedrobnoceličnem raku pljuč je bila dokazana v odprti, randomizirani študiji faze III (ML20650, EURTAC).
English: As the potential for harm to the nursing infant is unknown, mothers should be advised against breast-feeding while receiving Tarceva and for at least 2 weeks after the final dose.
Slovenian: Ker možen škodljiv vpliv na dojenega otroka ni znan, naj doječe matere med zdravljenjem z zdravilom Tarceva in še najmanj 2 tedna po zadnjem odmerku zdravila ne dojijo.
English: If adverse reactions related to erlotinib are observed, the dose of erlotinib may be reduced.
Slovenian: V primeru pojava neželenih učinkov, povezanih z erlotinibom, lahko odmerek erlotiniba zmanjšamo.
English: Single oral doses of Tarceva up to 1000 mg erlotinib in healthy subjects, and up to 1600 mg in cancer patients have been tolerated.
Slovenian: Zdrave osebe so dobro prenašale enkratne peroralne odmerke erlotiniba do 1.000 mg, bolniki z rakom pa do 1.600 mg.
English: • Cases of perforation or ulceration of the cornea
Slovenian: • primeri predrtja ali razjed roženice,
English: First-Line Treatment of Patients with EGFR Mutations
Slovenian: Prva linija zdravljenja pri bolnikih z EGFR-aktivirajočimi mutacijami
English: No survival benefit or other clinically relevant effects of the treatment have been demonstrated in patients with Epidermal Growth Factor Receptor (EGFR)-IHC negative tumours (see section 5.1).
Slovenian: Koristnega vpliva na podaljšanje preživetja ali drugih klinično pomembnih učinkov zdravljenja niso dokazali pri bolnikih z EGFR-negativnimi tumorji (glede na rezultat imunohistokemije; EGFRreceptor za epidermalni rastni dejavnik) (glejte poglavje 5.1).
English: Reported diagnoses in patients suspected of having ILD-like events included pneumonitis, radiation pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, pulmonary fibrosis, Acute Respiratory Distress Syndrome (ARDS), alveolitis, and lung infiltration.
Slovenian: Diagnoze, o katerih so poročali pri bolnikih, pri katerih je obstajal sum na dogodke, povezane z intersticijsko boleznijo pljuč, so vključevale pneumonitis, radiacijski pneumonitis, preobčutljivostni pneumonitis, intersticijsko pljučnico, intersticijsko bolezen pljuč, obliterativni bronhiolitis, pljučno fibrozo, akutni respiratorni distresni sindrom (ARDS), alveolitis in infiltracijo pljuč.
English: The most common adverse reactions in pivotal study PA.3 in pancreatic cancer patients receiving Tarceva 100 mg plus gemcitabine were fatigue, rash and diarrhoea.
Slovenian: Najbolj pogosti neželeni učinki v ključni študiji PA.3 pri bolnikih z rakom trebušne slinavke, ki so prejemali zdravilo Tarceva 100 mg in gemcitabin, so bili utrujenost, kožni izpuščaj in driska.
English: Bullous, blistering and exfoliative skin conditions have been reported, including very rare cases suggestive of Stevens-Johnson syndrome/Toxic epidermal necrolysis, which in some cases were fatal (see section 4.8).
Slovenian: Kožne bolezni, pri katerih so prisotni mehurji in luščenje kože Poročali so o primerih kožnih bolezni z mehurji in luščenjem kože, vključno z zelo redkimi primeri, ki so nakazovali na Stevens-Johnsonov sindrom/toksično epidermalno nekrolizo in so bili v nekaterih primerih smrtni (glejte poglavje 4.8).
English: In a double-blind, randomised phase III study (MO22162, CURRENTS) comparing two doses of Tarceva (300 mg versus 150 mg) in current smokers (mean of 38 pack years) with locally advanced or metastatic NSCLC in the second-line setting after failure on chemotherapy, the 300 mg dose of Tarceva demonstrated no PFS benefit over the recommended dose (7.00 vs 6.86 weeks, respectively).
Slovenian: V dvojno slepi, randomizirani študiji faze III (MO22162, CURRENTS), v kateri so primerjali dva odmerka zdravila Tarceva (300 mg v primerjavi s 150 mg) pri kadilcih (povprečno 38 škatel-let) z lokalno napredovalim ali metastatskim nedrobnoceličnim rakom pljuč v drugi liniji zdravljenja po odpovedi kemoterapije, odmerek 300 mg zdravila Tarceva v primerjavi s priporočenim odmerkom ni pokazal koristi glede preživetja brez napredovanja bolezni (7,00 tednov proti 6,86 tednov).
English: A second population pharmacokinetic analysis was conducted that incorporated erlotinib data from 204 pancreatic cancer patients who received erlotinib plus gemcitabine.
Slovenian: Izvedli so še drugo populacijsko farmakokinetično analizo na osnovi podatkov o erlotinibu, pridobljenih pri 204 bolnikih z rakom trebušne slinavke, ki so prejemali erlotinib in gemcitabin.
English: Paediatric population There have been no specific studies in paediatric patients.
Slovenian: Pediatrična populacija Specifičnih študij pri otrocih niso izvedli.
English: Based on the results of pharmacokinetic studies, current smokers should be advised to stop smoking while taking Tarceva, as plasma concentrations could be reduced otherwise.
Slovenian: Na osnovi rezultatov farmakokinetičnih študij je treba kadilcem svetovati, naj prekinejo kajenje, medtem ko se zdravijo z zdravilom Tarceva, ker so sicer lahko plazemske koncentracije zmanjšane.
English: • if you are taking statins (medicines to lower your blood cholesterol), Tarceva may increase the risk of statin related muscle problems, which on rare occasions can lead to serious muscle breakdown (rhabdomyolysis) resulting in kidney damage, talk to your doctor.
Slovenian: • če jemljete statine (zdravila za zniževanje ravni holesterola v krvi), se posvetujte z zdravnikom, saj lahko zdravilo Tarceva poveča tveganje za pojav s statini povezanih težav z mišicami, ki lahko v redkih primerih vodijo do hudega razpadanja mišic (rabdomiolize) ter poškodb ledvic;
English: The most frequent ADRs seen in patients treated with Tarceva in study ML20650 were rash and diarrhoea (any Grade 80% and 57%, respectively), most were Grade 1/2 in severity and manageable without intervention.
Slovenian: Najpogostejša neželena učinka, ki so ju opazili pri bolnikih, zdravljenih z zdravilom Tarceva v študiji ML20650, sta bila kožni izpuščaj (katera koli stopnja 80 %) in driska (katera koli stopnja 57 %); po izrazitosti so bili večinoma stopnje 1/2 in zdravljenje ni bilo potrebno.
English: Erlotinib and statins
Slovenian: Erlotinib in statini
English: Dose modifications (interruptions or reductions) for rash and diarrhoea were needed in 11% and 7% of patients, respectively.
Slovenian: Sprememba odmerka (prekinitev ali zmanjšanje) je bila potrebna pri 11 % zaradi kožnega izpuščaja in pri 7 % zaradi driske.
English: If you stop taking Tarceva
Slovenian: Če ste prenehali jemati zdravilo Tarceva
English: Hepatitis, hepatic failure
Slovenian: Hepatitis, jetrna odpoved
English: Dose modifications (interruptions or reductions) for rash and diarrhoea were needed in 8.3% and 3% of patients, respectively, in study BO18192 and 5.6% and 2.8% of patients, respectively, in study BO25460.
Slovenian: Sprememba odmerka (prekinitev ali zmanjšanje) je bila v študiji BO18192 potrebna pri 8,3 % bolnikov zaradi kožnega izpuščaja in pri 3 % bolnikov zaradi driske, v študiji BO25460 pa pri 5,6 % bolnikov zaradi kožnega izpuščaja in pri 2,8 % bolnikov zaradi driske.
English: The benefit is mostly driven by the presence of a low pain intensity score.
Slovenian: Največji vpliv na korist ima nizka vrednost jakosti bolečine.
English: • if you are allergic to erlotinib or any of the ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila Tarceva: • če ste alergični na erlotinib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: The safety and efficacy of erlotinib has not been studied in patients with renal impairment (serum creatinine concentration >1.5 times the upper normal limit).
Slovenian: Varnosti in učinkovitosti erlotiniba pri bolnikih z ledvično okvaro (koncentracija kreatinina v serumu > 1,5-kratna zgornji referenčni vrednosti) niso proučevali.
English: very common
Slovenian: Zelo pogosti
English: Form of lung irritation called interstitial lung disease (uncommon in European patients; common in Japanese patients: may affect up to 1 in 100 people in Europe and up to 1 in 10 in Japan).
Slovenian: • Oblika vnetja pljuč, ki se imenuje intersticijska bolezen pljuč (občasna pri evropskih bolnikih: pojavi se lahko pri največ 1 od 100 bolnikov; pogosta pri japonskih bolnikih: pojavi se lahko pri največ 1 od 10 bolnikov).
English: The incidence of adverse drug reactions (ADRs) from clinical trials reported with Tarceva alone or in combination with chemotherapy are summarised by National Cancer Institute-Common Toxicity Criteria (NCI-CTC) Grade in Table 1.
Slovenian: Incidenca neželenih učinkov zdravila iz kliničnih preskušanj, o katerih so poročali pri zdravilu Tarceva samem ali v kombinaciji s kemoterapijo, je povzeta glede na stopnjo izrazitosti po lestvici skupnih kriterijev toksičnosti Nacionalnega inštituta za raka (NCI-CTC - National Cancer Institute-Common Toxicity Criteria) v preglednici 1.
English: Patients receiving concomitant anti-angiogenic agents, corticosteroids, NSAIDs, and/or taxane based chemotherapy, or who have prior history of peptic ulceration or diverticular disease are at increased risk.
Slovenian: Pri bolnikih, ki sočasno prejemajo zdravila, ki zavirajo angiogenezo, kortikosteroide, nesteroidna protivnetna zdravila (NSAID) in/ali kemoterapijo na osnovi taksanov, ali so v preteklosti imeli peptični ulkus ali divertikularno bolezen, je tveganje večje.
English: • if you have severe pain in the abdomen, severe blistering or peeling of skin.
Slovenian: • imate hude bolečine v trebuhu, hude mehurje na koži ali se vam koža zelo lušči.
English: Co-administration of Tarceva with CYP3A4 inducers should therefore be avoided.
Slovenian: Sočasnemu dajanju zdravila Tarceva in induktorjev CYP3A4 se je zato treba izogibati.
English: 3 Including fatalities, in patients receiving Tarceva for treatment of NSCLC or other advanced solid tumours (see section 4.4).
Slovenian: Vključno s smrtnimi primeri pri bolnikih, ki so prejemali zdravilo Tarceva za zdravljenje nedrobnoceličnega raka pljuč ali drugih napredovalih solidnih tumorjev (glejte poglavje 4.4).
English: Safety data were comparable between the 300 mg and 150 mg doses; however, there was a numerical increase in the incidence of rash, interstitial lung disease and diarrhoea, in patients receiving the higher dose of erlotinib (see sections 4.2, 4.4, 5.1 and 5.2).
Slovenian: Podatki o varnosti so bili med odmerkoma 300 mg in 150 mg primerljivi; vendar pa je bilo pri bolnikih, ki so prejemali večji odmerek erlotiniba, številčno več pojavnosti izpuščaja, intersticijske bolezni pljuč in driske (glejte poglavja 4.2, 4.4, 5.1 in 5.2).