FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on pharmacokinetic data no dose adjustments appear necessary in patients with mild or moderate renal impairment (see section 5.2).
Slovenian: Na osnovi farmakokinetičnih podatkov prilagajanje odmerkov pri bolnikih z blago do zmerno ledvično okvaro ni potrebno (glejte poglavje 5.2).
English: In a post-hoc analysis, patients on Tarceva who developed a rash had a longer overall survival compared to patients who did not develop rash (median OS 7.2 months vs 5 months, HR:0.61).
Slovenian: V post-hoc analizi so bolniki, ki so se zdravili z zdravilom Tarceva in pri katerih se je pojavil kožni izpuščaj, imeli daljše celokupno preživetje v primerjavi z bolniki, pri katerih se izpuščaj ni pojavil (mediana celokupnega preživetja 7,2 meseca v primerjavi s 5 meseci, razmerje ogroženosti 0,61).
English: The usual dose is one tablet of Tarceva 100 mg each day if you have metastatic pancreatic cancer.
Slovenian: Običajni odmerek je ena tableta zdravila Tarceva po 100 mg na dan, če imate metastatski rak trebušne slinavke.
English: Eye irritation due to conjunctivitis/keratoconjunctivitis (very common: may affect more than 1 out of 10 people) and keratitis (common: may affect up to 1 in 10 people).
Slovenian: • Vnetje oči zaradi konjunktivitisa/keratokonjunktivitisa (zelo pogosto: pojavi se lahko pri več kot 1 od 10 bolnikov) in keratitisa (pogosto: pojavi se lahko pri največ 1 od 10 bolnikov).
English: Progression Free Survival (PFS, median in months)* Investigator Assessed **
Slovenian: Primarni cilj študije: preživetje brez napredovanja bolezni (mediana v mesecih)* raziskovalčeva ocena**
English: Therefore, patients who are still smoking should be encouraged to stop smoking as early as possible before initiation of treatment with Tarceva, as plasma erlotinib concentrations are reduced otherwise.
Slovenian: Zato je treba bolnikom kadilcem svetovati, naj kajenje opustijo čim prej pred začetkom zdravljenja z zdravilom Tarceva, saj bodo sicer plazemske koncentracije zmanjšane.
English: In population pharmacokinetic analysis, increased serum concentrations of total bilirubin were associated with a slower rate of erlotinib clearance.
Slovenian: V populacijski farmakokinetični analizi so bile zvečane serumske koncentracije celokupnega bilirubina povezane z manjšo hitrostjo izločanja erlotiniba.
English: In a Phase Ib study, there were no significant effects of gemcitabine on the pharmacokinetics of erlotinib nor were there significant effects of erlotinib on the pharmacokinetics of gemcitabine.
Slovenian: V študiji faze Ib ni bilo pomembnih učinkov gemcitabina na farmakokinetiko erlotiniba, prav tako ni bilo pomembnih učinkov erlotiniba na farmakokinetiko gemcitabina.
English: These findings were observed at clinically relevant exposures.
Slovenian: Te učinke so opazili pri izpostavljenosti, primerljivi s klinično.
English: This corresponded to an overall average of 63% (range 5-161%) of the steady state observed peak plasma concentrations.
Slovenian: To je ustrezalo 63 % (razpon 5 - 161 %) celokupnega povprečja največjih plazemskih koncentracij, ki so jih opazili v stanju dinamičnega ravnovesja.
English: Patients with ECOG PS>1, significant hepatic or renal co-morbidities were not included in the study.
Slovenian: Bolniki, ki so imeli stanje zmogljivosti po ECOG višje od 1, ter tisti s hudimi ledvičnimi ali jetrnimi obolenji niso bili vključeni v študijo.
English: The efficacy and safety of Tarceva as second/third-line therapy was demonstrated in a randomised, double-blind, placebo-controlled trial (BR.21), in 731 patients with locally advanced or metastatic NSCLC after failure of at least one chemotherapy regimen.
Slovenian: Učinkovitost in varnost zdravila Tarceva v drugi/tretji liniji zdravljenja sta bili dokazani v randomiziranem, dvojno slepem, s placebom primerjanem preskušanju (BR.21), ki je vključevalo 731 bolnikov z lokalno napredovalim ali metastatskim nedrobnoceličnim rakom pljuč po neuspehu vsaj ene predhodne kemoterapije.
English: The median time to onset of rash was 10 days.
Slovenian: Mediana časa do pojava izpuščaja je bila 10 dni.
English: The tablet should be taken at least one hour before or two hours after the ingestion of food.
Slovenian: Tableto morate vzeti najmanj eno uro pred zaužitjem hrane ali dve uri po tem.
English: Updated Analysis (62% OS maturity) (n=173)
Slovenian: Posodobljena analiza (z 62 % podatkov za celokupno preživetje) (n = 173)
English: Erlotinib and Gemcitabine
Slovenian: Erlotinib in gemcitabin
English: Co-administration of rifampicin with a single 450 mg dose of Tarceva resulted in a mean erlotinib exposure (AUC) of 57.5% of that after a single 150 mg Tarceva dose in the absence of rifampicin treatment.
Slovenian: Po sočasnem dajanju rifampicina z enim 450 mg odmerkom zdravila Tarceva je povprečna izpostavljenost erlotinibu (AUC) znašala 57,5 % njene vrednosti po enem 150 mg odmerku zdravila Tarceva brez sočasnega zdravljenja z rifampicinom.
English: The usual dose is one tablet of Tarceva 150 mg each day if you have non-small cell lung cancer.
Slovenian: Običajni odmerek je ena tableta zdravila Tarceva po 150 mg na dan, če imate nedrobnocelični rak pljuč.
English: Roche Oy Puh/Tel: +358 (0) 10 554 500
Slovenian: Puh/Tel: +358 (0) 10 554 500
English: Confounding factors included pre-existing liver disease or concomitant hepatotoxic medications (see section 4.4).
Slovenian: K nastanku je lahko pripomogla predhodno obstoječa jetrna bolezen ali sočasno jemanje hepatotoksičnih zdravil (glejte poglavje 4.4).
English: Tumour regression is observed in mouse models of enforced expression of these EGFR activating mutations.
Slovenian: Regresijo tumorjev so opazili v mišjih modelih z izraženimi EGFR-aktivirajočimi mutacijami.
English: Chronic dosing effects observed in at least one animal species or study included effects on the cornea (atrophy, ulceration), skin (follicular degeneration and inflammation, redness, and alopecia), ovary (atrophy), liver (liver necrosis), kidney (renal papillary necrosis and tubular dilatation), and gastrointestinal tract (delayed gastric emptying and diarrhoea).
Slovenian: Učinki večkratnega odmerjanja, ki so jih opazili pri vsaj eni živalski vrsti ali v študiji, so bili učinki na roženico (atrofija, ulceracija), kožo (folikularna degeneracija in vnetje, rdečina in alopecija), jajčnike (atrofija), jetra (nekroza jeter), ledvice (renalna papilarna nekroza in tubularna dilatacija) in gastrointestinalni trakt (zakasnelo praznjenje želodca in driska).
English: There have been rare reports of hypokalaemia and renal failure (including fatalities).
Slovenian: O hipokaliemiji in ledvični odpovedi (vključno s smrtnimi primeri) so poročali redko.
English: The effect of Tarceva on overall survival was similar in patients with a baseline performance status (ECOG) of 2-3 (HR = 0.77, 95% CI 0.6-1.0) or 0-1 (HR = 0.73, 95% CI 0.6-0.9), male (HR = 0.76, 95% CI 0.6-0.9) or female patients (HR = 0.80, 95% CI 0.6-1.1), patients < 65 years of age (HR = 0.75, 95% CI 0.6-0.9) or older patients (HR = 0.79, 95% CI 0.6-1.0), patients with one prior regimen (HR = 0.76, 95% CI 0.6-1.0) or more than one prior regimen (HR = 0.75, 95% CI 0.6-1.0), Caucasian (HR = 0.79, 95% CI 0.6-1.0) or Asian patients (HR = 0.61, 95% CI 0.4-1.0), patients with adenocarcinoma (HR = 0.71, 95% CI 0.6-0.9) or squamous cell carcinoma (HR = 0.67, 95% CI 0.5-0.9), but not in patients with other histologies (HR 1.04, 95% CI 0.7-1.5), patients with stage IV disease at diagnosis (HR = 0.92, 95% CI 0.7-1.2) or < stage IV disease at diagnosis (HR = 0.65, 95% CI 0.5-0.8).
Slovenian: (HR = 0,80, 95-% interval zaupanja: 0,6-1,1), bolnikih, mlajših od 65 let (HR = 0,75, 95-% interval zaupanja: 0,6-0,9), ali starejših bolnikih (HR = 0,79, 95-% interval zaupanja: 0,6-1,0), bolnikih z enim predhodnim zdravljenjem (HR = 0,76, 95-% interval zaupanja: 0,6-1,0) ali več kot enim predhodnim zdravljenjem (HR = 0,75, 95-% interval zaupanja: 0,6-1,0), belcih (HR = 0,79, 95-% interval zaupanja: 0,6-1,0) ali Azijcih (HR = 0,61, 95-% interval zaupanja: 0,4-1,0), bolnikih z adenokarcinomom (HR = 0,71, 95-% interval zaupanja: 0,6-0,9) ali skvamoznim karcinomom (HR = 0,67, 95-% interval zaupanja: 0,5-0,9), toda ne pri bolnikih z drugimi histologijami (HR 1,04, 95-% interval zaupanja: 0,7-1,5), bolnikih s stadijem bolezni ob diagnozi IV (HR = 0,92, 95-% interval zaupanja: 0,7-1,2) ali stadijem bolezni ob diagnozi < IV (HR = 0,65, 95-% interval zaupanja: 0,5-0,8).
English: Lactose monohydrate Cellulose, microcrystalline (E460) Sodium starch glycolate Type A Sodium laurilsulfate Magnesium stearate (E470 b)
Slovenian: Jedro tablete laktoza monohidrat mikrokristalna celuloza (E460) natrijev karboksimetilškrob (vrsta A) natrijev lavrilsulfat magnezijev stearat (E470b)
English: Medicinal products that alter the pH of the upper Gastro-Intestinal (GI) tract, like proton pump inhibitors, H2 antagonists and antacids, may alter the solubility of erlotinib and hence its bioavailability.
Slovenian: Zdravila, ki spremenijo pH v zgornjem delu prebavil, kot so zaviralci protonske črpalke, H2 antagonisti in antacidi, lahko spremenijo topnost erlotiniba in posledično njegovo biološko uporabnost.
English: -Epistaxis
Slovenian: - epistaksa
English: The percent of patients alive at 12 months was 31.2% and 21.5%, for the Tarceva and placebo groups, respectively.
Slovenian: Odstotek preživelih bolnikov je pri 12 mesecih v skupini, ki je jemala zdravilo Tarceva, znašal 31,2 %, v placebo skupini pa 21,5 %.
English: Pre-planned Interim Analysis (35% OS maturity) (n=153)
Slovenian: Vnaprej načrtovana vmesna analiza (s 35 % podatkov za celokupno preživetje) (n = 153)
English: Glucuronidation disorder like Gilbert's syndrome Your doctor must treat you with caution if you have a glucuronidation disorder like Gilbert's syndrome.
Slovenian: Motnja glukuronidacije, kot je Gilbertov sindrom Če imate motnjo glukuronidacije, kot je Gilbertov sindrom, vas bo zdravnik moral zdraviti pazljivo.
English: The primary endpoint was overall survival.
Slovenian: Primarni cilj študije je bilo celokupno preživetje.
English: In a meta-analysis of NSCLC randomised controlled clinical trials (excluding phase I and single-arm phase II studies due to lack of control groups), the incidence of ILD-like events was 0.9% on Tarceva compared to 0.4% in patients in the control arms.
Slovenian: V metaanalizi randomiziranih kontroliranih kliničnih preskušanj nedrobnoceličnega raka pljuč (brez študij faze I in študij faze II z eno skupino, ker tam ni bilo kontrolnih skupin) je bila incidenca dogodkov, podobnih intersticijski bolezni pljuč, pri bolnikih, zdravljenih z zdravilom Tarceva, 0,9 % v primerjavi z 0,4 % pri bolnikih iz kontrolnih skupin.
English: Baseline demographic and disease characteristics of the patients were similar between the 2 treatment groups, 100 mg Tarceva plus gemcitabine or placebo plus gemcitabine, except for a slightly larger proportion of females in the erlotinib/gemcitabine arm compared with the placebo/gemcitabine arm:
Slovenian: Izhodiščne demografske značilnosti bolnikov in značilnosti njihove bolezni so bile podobne v obeh zdravljenih skupinah, v skupini, ki je prejemala zdravilo Tarceva 100 mg in gemcitabin, in skupini, ki je prejemala placebo in gemcitabin, razen nekoliko višjega deleža žensk v skupini, ki je prejemala erlotinib in gemcitabin, v primerjavi s skupino, ki je prejemala placebo in gemcitabin:
English: The adjusted hazard ratio (HR) for death in the Tarceva group relative to the placebo group was 0.73 (95% CI, 0.60 to 0.87) (p = 0.001).
Slovenian: Prilagojeno razmerje ogroženosti (HR, hazard ratio) za smrt v skupini, ki je jemala zdravilo Tarceva, je v primerjavi s placebo skupino znašalo 0,73 (95-% interval zaupanja: 0,60-0,87) (p = 0,001).
English: Women of childbearing potential must be advised to avoid pregnancy while on Tarceva.
Slovenian: Ženskam v rodni dobi je treba svetovati, naj v času zdravljenja z zdravilom Tarceva ne zanosijo.
English: If you experience more severe or persistent diarrhoea contact your doctor immediately as your doctor may need to treat you in the hospital.
Slovenian: V primeru hude ali dolgotrajne driske nemudoma obvestite zdravnika, ker boste morda potrebovali zdravljenje v bolnišnici.
English: Data from reproductive toxicology tests in rats and rabbits at doses near the maximum tolerated dose and/or maternally toxic doses showed reproductive (embryotoxicity in rats, embryo resorption and foetotoxicity in rabbits) and developmental (decrease in pup growth and survival in rats) toxicity, but was not teratogenic and did not impair fertility.
Slovenian: Podatki iz reproduktivnih toksikoloških testov pri podganah in kuncih pri odmerkih blizu maksimalnemu prenosljivemu odmerku in/ali toksičnemu odmerku za samice, kažejo vpliv na sposobnost razmnoževanja (embriotoksičnost pri podganah, resorpcija zarodka in fetotoksičnost pri kuncih) in razvoj (zmanjšana rast mladičev in preživetje pri podganah).
English: In some cases your doctor may need to reduce your dose of Tarceva or interrupt treatment:
Slovenian: V nekaterih primerih vam bo zdravnik moral zmanjšati odmerek zdravila Tarceva ali prekiniti zdravljenje.
English: Patients with pancreatic cancer
Slovenian: Bolniki z rakom trebušne slinavke
English: Potent inducers of CYP3A4 may reduce the efficacy of erlotinib whereas potent inhibitors of CYP3A4 may lead to increased toxicity.
Slovenian: Močni induktorji CYP3A4 lahko zmanjšajo učinkovitost erlotiniba, močni zaviralci CYP3A4 pa lahko povečajo toksičnost.
English: Concomitant treatment with these types of agents should be avoided (see section 4.5).
Slovenian: Sočasnemu zdravljenju s temi zdravili se je treba izogibati (glejte poglavje 4.5).
English: For patients who require concomitant treatment with Tarceva and a potent CYP3A4 inducer such as rifampicin an increase in dose to 300 mg should be considered while their safety (including renal and liver functions and serum electrolytes) is closely monitored, and if well tolerated for more than 2 weeks, further increase to 450 mg could be considered with close safety monitoring.
Slovenian: Pri bolnikih, ki potrebujejo sočasno zdravljenje z zdravilom Tarceva in močnim induktorjem CYP3A4, kot je rifampicin, je treba premisliti o povečanju odmerka do 300 mg ob skrbnem spremljanju njihove varnosti (vključno z ledvičnim in jetrnim delovanjem ter serumskimi elektroliti).
English: What Tarceva looks like and contents of the pack:
Slovenian: Izgled zdravila Tarceva in vsebina pakiranja
English: Tarceva treatment should be interrupted or discontinued if the patient develops severe bullous, blistering or exfoliating conditions.
Slovenian: Zdravljenje z zdravilom Tarceva je treba prekiniti ali ukiniti, če se pri bolniku pojavijo hude oblike mehurjev ali luščenja kože.
English: Patients who never smoked had a much greater benefit from erlotinib (survival HR = 0.42, 95% CI 0.28-0.64) compared with current or ex-smokers (HR = 0.87, 95% CI 0.71-1.05).
Slovenian: Bolnikom, ki niso nikoli kadili, je erlotinib veliko bolj koristil (HR preživetja = 0,42, 95-% interval zaupanja: 0,28-0,64) kakor bolnikom, ki še kadijo ali so kadili (HR = 0,87, 95-% interval zaupanja: 0,71-1,05).
English: The exposure after an oral dose may be increased by food.
Slovenian: Hrana lahko poveča izpostavljenost po peroralnem odmerku.
English: The efficacy and safety of Tarceva in combination with gemcitabine as a first-line treatment was assessed in a randomised, double-blind, placebo-controlled trial in patients with locally advanced, unresectable or metastatic pancreatic cancer.
Slovenian: Učinkovitost in varnost zdravila Tarceva v kombinaciji z gemcitabinom za zdravljenje v prvi liniji so ocenjevali v randomiziranem, dvojno slepem, s placebom primerjanem preskušanju pri bolnikih z lokalno napredovalim, neoperabilnim ali metastatskim rakom trebušne slinavke.
English: These findings were observed at exposures well below clinically relevant exposures.
Slovenian: Te učinke so opazili pri izpostavljenosti, ki je bila močno pod primerljivo stopnjo klinične izpostavljenosti.
English: This study was conducted in 889 patients with locally advanced or metastatic NSCLC who did not progress after 4 cycles of platinum-based doublet chemotherapy.
Slovenian: V študijo je bilo vključenih 889 bolnikov z lokalno napredovalim ali metastatskim nedrobnoceličnim rakom pljuč, pri katerih bolezen po 4 ciklih kemoterapije na osnovi platine s kombinacijo dveh kemoterapevtikov ni napredovala.
English: *** Rash included dermatitis acneiform.
Slovenian: *** Kožni izpuščaj vključuje dermatitis, podoben aknam.
English: ADRs occurring in ≥ 10% of patients in BR.21 (treated with Tarceva) and PA.3 (treated with Tarceva plus gemcitabine) studies and ADRs occurring more frequently (≥ 3%) than placebo in BR.21 (treated with Tarceva) and PA.3 (treated with Tarceva plus gemcitabine) studies Tarceva (BR.21) N = 485
Slovenian: Neželeni učinki, ki se se pojavili pri ≥ 10 % bolnikov v študijah BR.21 (zdravljenih z zdravilom Tarceva) in PA.3 (zdravljenih z zdravilom Tarceva in gemcitabinom), in neželeni učinki, ki se se pojavili pogosteje (≥ 3 %) kot pri placebu v študijah BR.21 (zdravljenih z zdravilom Tarceva) in PA.3 (zdravljenih z zdravilom Tarceva in gemcitabinom)
English: Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in škatli poleg oznake EXP oziroma Uporabno do. Rok uporabnosti se izteče na zadnji dan navedenega meseca.
English: Each 100 mg film-coated tablet contains 69.21 mg Lactose monohydrate.
Slovenian: Vsaka 100-mg filmsko obložena tableta vsebuje 69,21 mg laktoze monohidrata.
English: Each 150 mg film-coated tablet contains 103.82 mg Lactose monohydrate.
Slovenian: Vsaka 150-mg filmsko obložena tableta vsebuje 103,82 mg laktoze monohidrata.
English: Hazard Ratio (95% CI)
Slovenian: (95-% IZ)
English: What you need to know before you take Tarceva Do not take Tarceva:
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Tarceva
English: Erlotinib and coumarin-derived anticoagulants
Slovenian: Erlotinib in kumarinski antikoagulanti
English: Exploratory Analysis (40% OS maturity) (n=173)
Slovenian: Eksplorativna analiza (s 40 % podatkov za celokupno preživetje) (n = 173)
English: This study was conducted in Caucasian patients with metastatic or locally advanced NSCLC (stage IIIB and IV) who have not received previous chemotherapy or any systemic antitumour therapy for their advanced disease and who present mutations in the tyrosine kinase domain of the EGFR (exon 19 deletion or exon 21 mutation).
Slovenian: V študijo so bili vključeni belci z lokalno napredovalim ali metastatskim nedrobnoceličnim rakom pljuč (stopnja IIIB in IV), ki za napredovalo bolezen niso prejeli predhodne kemoterapije ali kakršnekoli druge sistemske protitumorne terapije in pri katerih so bile prisotne mutacije v tirozin kinazni domeni EGFR (delecija eksona 19 ali mutacija eksona 21).
English: Erlotinib and medicinal products altering pH
Slovenian: Z erlotinibom in zdravili spremenjen pH
English: In the 45% of patients with known EGFR-expression status, the hazard ratio was 0.68 (95% CI 0.49-0.94) for patients with EGFR-positive tumours and 0.93 (95% CI 0.63-1.36) for patients with EGFR-negative tumours (defined by IHC using EGFR pharmDx kit and defining EGFR-negative as less than 10% tumour cells staining).
Slovenian: Pri 45 % bolnikov z znanim statusom ekspresije EGFR, je bilo za bolnike z EGFR-pozitivnimi tumorji razmerje ogroženosti 0,68 (95-% interval zaupanja: 0,49-0,94), za bolnike z EGFR-negativnimi tumorji pa 0,93 (95-% interval zaupanja: 0,63-1,36); status ekspresije EGFR so določili z imunohistokemijo, z uporabo EGFR pharmDx kita.
English: Erlotinib is excreted predominantly as metabolites via the faeces (>90%) with renal elimination accounting for only a small amount (approximately 9%) of an oral dose.
Slovenian: Erlotinib se po peroralnem dajanju v glavnem izloča v obliki presnovkov z blatom (> 90 %), v manjšem obsegu pa tudi prek ledvic (približno 9 %).
English: No data are available regarding the influence of severe hepatic dysfunction on the pharmacokinetics of erlotinib.
Slovenian: Podatkov glede vpliva hude jetrne disfunkcije na farmakokinetiko erlotiniba ni.
English: Diarrhoea and vomiting (very common: may affect more than 1 out of 10 people).
Slovenian: • Driska in bruhanje (zelo pogosta: pojavita se lahko pri več kot 1 od 10 bolnikov).
English: • if you are also taking a statin and experience unexplained muscle pain, tenderness, weakness or cramps.
Slovenian: • sočasno jemljete statin in se pri vas pojavijo nerazložljive bolečine v mišicah, občutljivost mišic na dotik, mišična šibkost ali krči.
English: In the clinical studies doses were reduced by 50 mg steps.
Slovenian: V kliničnih študijah so odmerke zmanjševali v korakih po 50 mg. Zmanjševanja odmerkov po 25 mg niso proučili.
English: When considering the use of Tarceva as a first line or maintenance treatment for locally advanced or metastatic NSCLC, it is important that the EGFR mutation status of a patient is determined.
Slovenian: Pri odločanju o uporabi zdravila Tarceva v prvi liniji zdravljenja ali za vzdrževalno zdravljenje lokalno napredovalega ali metastatskega nedrobnoceličnega raka pljuč je pomembno, da se določi bolnikov status mutacij EGFR.
English: • Eyebrow changes
Slovenian: • spremembe trepalnic,
English: In the pivotal Phase III NSCLC trial, current smokers achieved erlotinib steady state trough plasma concentration of 0.65 µg/mL (n=16) which was approximately 2-fold less than the former smokers or patients who had never smoked (1.28 µg/mL, n=108).
Slovenian: V ključni študiji faze III pri nedrobnoceličnem raku pljuč je bila najmanjša koncentracija erlotiniba v stanju dinamičnega ravnovesja pri bolnikih, ki so med zdravljenjem kadili, 0,65 µg/ml (n = 16), kar je bilo približno 2-krat manj, kot pri nekdanjih kadilcih ali bolnikih, ki niso nikoli kadili (1,28 µg/ml, n = 108).
English: Liver or kidney disease
Slovenian: Bolezen jeter ali ledvic
English: How to take Tarceva
Slovenian: Kako jemati zdravilo Tarceva
English: EU/1/05/311/002
Slovenian: EU/1/05/311/001 EU/1/05/311/002 EU/1/05/311/003
English: In some cases these medicines may reduce the efficacy or increase the side effects of Tarceva and your doctor may need to adjust your treatment.
Slovenian: V nekaterih primerih lahko ta zdravila zmanjšajo učinkovitost ali pa povečajo neželene učinke zdravila Tarceva, zato bo morda zdravnik moral prilagoditi vaše zdravljenje ali pa vas med jemanjem zdravila Tarceva s temi zdravili ne bo zdravil;
English: If the use of ranitidine is considered, it should be used in a staggered manner; i.e. Tarceva must be taken at least 2 hours before or 10 hours after ranitidine dosing.
Slovenian: Če razmišljamo o uporabi ranitidina, moramo zdravili jemati ločeno: zdravilo Tarceva je treba vzeti najmanj 2 uri pred ali 10 ur po odmerku ranitidina.
English: If you are exposed to sun, protective clothing, and/or use of sunscreen (e.g. mineral-containing) may be advisable Infection
Slovenian: Če ste izpostavljeni soncu, je verjetno koristno uporabiti zaščitna oblačila in/ali zaščitno kremo za sonce (npr. na osnovi mineralov);
English: In patients who develop acute onset of new and/or progressive unexplained pulmonary symptoms such as dyspnoea, cough and fever, Tarceva therapy should be interrupted pending diagnostic evaluation.
Slovenian: Pri bolnikih, pri katerih se akutno pojavijo novi in/ali poslabšajo nepojasnjeni pljučni simptomi, kot so dispneja, kašelj in zvišana telesna temperatura, je treba zdravljenje z zdravilom Tarceva prekiniti, dokler ni znana diagnoza.
English: • Infection of hair follicles
Slovenian: • okužbe lasnih mešičkov,
English: Combination of erlotinib with proton pump inhibitors should be avoided.
Slovenian: Kombinaciji erlotiniba in zaviralcev protonske črpalke se je treba izogibati.
English: Use of Tarceva in patients with severe renal impairment is not recommended.
Slovenian: Uporaba zdravila Tarceva pri bolnikih s hudo ledvično okvaro ni priporočljiva.