FrancophonIA/ELRC3.0 huggingface dataset:
English: Each film-coated tablet contains 25 mg, 100 mg or 150 mg of erlotinib (as erlotinib hydrochloride) depending on the strength.
Slovenian: Ena filmsko obložena tableta vsebuje 25 mg, 100 mg ali 150 mg erlotiniba (v obliki erlotinibijevega klorida), odvisno od jakosti.
English: There were no significant effects of erlotinib on the pharmacokinetics of capecitabine.
Slovenian: Pomembnih učinkov erlotiniba na farmakokinetiko kapecitabina ni bilo.
English: Increased serum concentrations of total bilirubin and AAG concentrations were associated with a reduced erlotinib clearance.
Slovenian: Zvišane serumske koncentracije celokupnega bilirubina in koncentracije alfa-1 kislega glikoproteina so bile povezane z zmanjšanjem očistka erlotiniba.
English: Tarceva contains the active substance erlotinib.
Slovenian: Zdravilo Tarceva vsebuje učinkovino erlotinib.
English: There were no significant effects of carboplatin or paclitaxel on the pharmacokinetics of erlotinib.
Slovenian: Pomembnih učinkov karboplatina ali paklitaksela na farmakokinetiko erlotiniba ni bilo.
English: The median time to onset of rash and diarrhoea was 10 days and 15 days, respectively.
Slovenian: Mediana časa do pojava kožnega izpuščaja je bila 10 dni, do pojava driske pa 15 dni.
English: Potent inhibitors of CYP3A4 activity decrease erlotinib metabolism and increase erlotinib plasma concentrations.
Slovenian: Močni zaviralci aktivnosti CYP3A4 zmanjšajo presnovo erlotiniba in zvečajo koncentracije erlotiniba v plazmi.
English: Tarceva is indicated for the first-line treatment of patients with locally advanced or metastatic nonsmall cell lung cancer (NSCLC) with EGFR activating mutations.
Slovenian: Zdravilo Tarceva je indicirano za prvo linijo zdravljenja bolnikov z lokalno napredovalim ali metastatskim nedrobnoceličnim rakom pljuč z EGFR-aktivirajočimi mutacijami.
English: Tablet core: lactose monohydrate, cellulose microcrystalline, sodium starch glycolate type A, sodium laurilsulfate, magnesium stearate (see also section 2 for lactose monohydrate).
Slovenian: • Druge sestavine zdravila (pomožne snovi) so: jedro tablete: laktoza monohidrat, mikrokristalna celuloza, natrijev karboksimetilškrob (vrsta A), natrijev lavrilsulfat, magnezijev stearat (za laktozo monohidrat glejte tudi poglavje 2); obloga tablete: hipromeloza, hidroksipropilceluloza, titanov dioksid, makrogol.
English: - NSCLC treatment after failure of at least one prior chemotherapy regimen (Tarceva administered as monotherapy)
Slovenian: - Zdravljenje nedrobnoceličnega raka pljuč po neuspehu vsaj ene predhodne kemoterapije (zdravilo Tarceva kot samostojno zdravljenje)
English: Use of Tarceva in paediatric patients is not recommended.
Slovenian: Uporaba zdravila Tarceva pri otrocih ni priporočljiva.
English: Contact lens use is also a risk factor for keratitis and ulceration.Very rare cases of corneal perforation or ulceration have been reported during use of Tarceva (see section 4.8).
Slovenian: Med uporabo zdravila Tarceva so zelo redko poročali o primerih perforacije ali ulceracije roženice (glejte poglavje 4.8).
English: Headache, altered skin sensation or numbness in the extremities Difficulty in breathing, cough
Slovenian: • glavobol, spremenjena občutljivost kože ali otrplost okončin,
English: Patients were randomised 1:1 to receive Tarceva 150 mg or placebo orally once daily until disease progression.
Slovenian: Bolniki so bili randomizirani v razmerju 1 : 1 v skupino, ki je prejemala 150 mg zdravila Tarceva, in v skupino, ki je prejemala placebo, peroralno enkrat na dan, do napredovanja bolezni.
English: Baseline demographic and disease characteristics were well balanced between the two treatment arms.
Slovenian: Izhodiščne demografske značilnosti bolnikov in značilnosti njihove bolezni so bile v obeh zdravljenih skupinah podobne.
English: Each 25 mg film-coated tablet contains 27.43 mg Lactose monohydrate.
Slovenian: Vsaka filmsko obložena tableta vsebuje 27,43 mg laktoze monohidrata.
English: If ILD is diagnosed, Tarceva should be discontinued and appropriate treatment initiated as necessary (see section 4.8).
Slovenian: Če je ugotovljena intersticijska bolezen pljuč, zdravilo Tarceva ukinemo in uvedemo ustrezno zdravljenje (glejte poglavje 4.8).
English: Tarceva 25 mg film-coated tablets Tarceva 100 mg film-coated tablets Tarceva 150 mg film-coated tablets Erlotinib
Slovenian: Tarceva 25 mg filmsko obložene tablete Tarceva 100 mg filmsko obložene tablete Tarceva 150 mg filmsko obložene tablete erlotinib
English: Your doctor may decide to permanently stop your treatment with Tarceva.
Slovenian: Zdravnik se lahko odloči za ukinitev zdravljenja z zdravilom Tarceva.
English: This medicine can be prescribed to you if you have non-small cell lung cancer at an advanced stage.
Slovenian: Zdravnik vam lahko to zdravilo predpiše, če imate napredovali nedrobnocelični rak pljuč.
English: Dose reduction for rash and diarrhoea was needed in 6% and 1% of patients, respectively.
Slovenian: Odmerek je bilo zaradi kožnega izpuščaja treba zmanjšati pri 6 % bolnikov, zaradi driske pa pri 1 % bolnikov.
English: Avoid pregnancy while being treated with Tarceva.
Slovenian: Med zdravljenjem z zdravilom Tarceva se izogibajte zanositvi.
English: Suomi/Finland
Slovenian: Suomi/Finland Roche Oy
English: Eye disorders Keratoconjunctivitis sicca Conjunctivitis very common very common
Slovenian: Očesne bolezni suhi keratokonjunktivitis konjunktivitis zelo pogosti zelo pogosti
English: In rare cases liver failure was observed (rare: may affect up to 1 in 1,000 people).
Slovenian: • Redko so poročali o jetrni odpovedi (redko: pojavi se lahko pri največ 1 od 1000 bolnikov).
English: Interaction with coumarin-derived anticoagulants including warfarin leading to increased International Normalized Ratio (INR) and bleeding events, which in some cases were fatal, have been reported in patients receiving Tarceva.
Slovenian: Pri bolnikih, ki so prejemali zdravilo Tarceva, so poročali o medsebojnem delovanju s kumarinskimi antikoagulanti, vključno z varfarinom, ki je vodilo do povišanja internacionalnega normaliziranega razmerja (INR) in krvavitev, ki so se v nekaterih primerih končale s smrtnim izidom.
English: Rigors very common very common very common
Slovenian: 3 < 1 zelo pogosti
English: Patients were randomised 1:1 to receive Tarceva 150 mg daily or up to 4 cycles of platinum based doublet chemotherapy.
Slovenian: Bolniki so bili randomizirani v razmerju 1 : 1 v skupino, ki je prejemala 150 mg zdravila Tarceva in v skupino, ki je prejemala kemoterapevtski dvojček na osnovi platine.
English: Results of a pharmacokinetic interaction study indicated a significant 2.8-, 1.5- and 9-fold reduced AUCinf, Cmax and plasma concentration at 24 hours, respectively, after administration of Tarceva in smokers as compared to non-smokers.
Slovenian: Izsledki študije o farmakokinetičnih interakcijah so pokazali, da so bili po aplikaciji zdravila Tarceva pri kadilcih v primerjavi z nekadilci pomembno zmanjšane AUC∞ (2,8-krat), Cmax (1,5-krat) in plazemske koncentracije po 24 urah (9-krat).
English: Erlotinib and Capecitabine
Slovenian: Erlotinib in kapecitabin
English: For the different dose regimens Tarceva is available in strengths of 25 mg, 100 mg or 150 mg.
Slovenian: Zdravnik vam lahko odmerek prilagodi v korakih po 50 mg. Za različno odmerjanje je zdravilo Tarceva na voljo v jakostih 25 mg, 100 mg ali 150 mg.
English: CI of HR
Slovenian: interval zaupanja HR
English: Erlotinib is eliminated by hepatic metabolism and biliary excretion.
Slovenian: Erlotinib se izloča z jetrno presnovo in žolčem.
English: Extrahepatic metabolism by CYP3A4 in intestine, CYP1A1 in lung, and CYP1B1 in tumour tissue also potentially contribute to the metabolic clearance of erlotinib.
Slovenian: Presnova zunaj jeter poteka s CYP3A4 v črevesju, CYP1A1 v pljučih, CYP1B1 v tumorskem tkivu ter tako lahko prispeva k presnovnemu očistku erlotiniba.
English: -Liver function test abnormalities
Slovenian: - nenormalnosti testov jetrne funkcije5
English: N.V. Roche S.A. Tél/Tel: +32 (0) 2 525 82 11
Slovenian: Tél/Tel: +32 (0) 2 525 82 11
English: Erlotinib and P-glycoprotein inhibitors
Slovenian: Erlotinib in zaviralci P-glikoproteina
English: Pancreatic cancer (Tarceva administered concurrently with gemcitabine)
Slovenian: Rak trebušne slinavke (zdravilo Tarceva v kombinaciji z gemcitabinom)
English: Grade 3 rash and diarrhoea occurred in 9% and 4% of patients, respectively.
Slovenian: Kožni izpuščaj stopnje 3 se je pojavil pri 9 % bolnikov, driska stopnje 3 pa pri 4 % bolnikov.
English: Alternate treatments lacking potent CYP3A4 inducing activity should be considered when possible.
Slovenian: Kadar je mogoče, je treba razmisliti tudi o drugih načinih zdravljenja, ki ne vključujejo močnega spodbujanja aktivnosti CYP3A4.
English: Non-small cell lung cancer (Tarceva administered as monotherapy)
Slovenian: Nedrobnocelični rak pljuč (zdravilo Tarceva kot samostojno zdravljenje)
English: Tarceva 150 mg film-coated tablets
Slovenian: Tarceva 150 mg filmsko obložene tablete
English: Tarceva 100 mg film-coated tablets
Slovenian: Tarceva 100 mg filmsko obložene tablete
English: The 300 mg dose did not show improved efficacy in second line treatment after failure of chemotherapy compared to the recommended 150 mg dose in patients who continue to smoke cigarettes.
Slovenian: Največji odmerek zdravila Tarceva, ki so ga bolniki z nedrobnoceličnim rakom pljuč, ki so med zdravljenjem kadili, še prenašali, je bil 300 mg. 300-mg odmerek v drugi liniji zdravljenja po odpovedi kemoterapije pri bolnikih, ki nadaljujejo s kajenjem, v primerjavi s priporočenim 150-mg odmerkom ni pokazal boljše učinkovitosti.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/05/311/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/05/311/001
English: Baseline ECOG performance status (PS) = 0 Baseline ECOG performance status (PS) = 1 Baseline ECOG performance status (PS) = 2 Metastatic disease at baseline
Slovenian: Tarceva placebo ženski spol stanje zmogljivosti po ECOG 0 pred začetkom zdravljenja stanje zmogljivosti po ECOG 1 pred začetkom zdravljenja stanje zmogljivosti po ECOG 2 pred začetkom zdravljenja metastatska bolezen pred začetkom zdravljenja
English: Tarceva (months)
Slovenian: Tarceva (PA.3)
English: Your doctor may need to interrupt or stop your treatment;
Slovenian: Zdravnik bo morda moral začasno prekiniti ali ukiniti vaše zdravljenje z zdravilom Tarceva;
English: NAME OF THE MEDICINAL PRODUCT Tarceva 25 mg film-coated tablets Tarceva 100 mg film-coated tablets Tarceva 150 mg film-coated tablets
Slovenian: Tarceva 25 mg filmsko obložene tablete Tarceva 100 mg filmsko obložene tablete Tarceva 150 mg filmsko obložene tablete
English: Tarceva (PA.3) N = 259
Slovenian: Tarceva (BR.21)
English: Table 1:
Slovenian: Preglednica 1.
English: Grade 3/4 rash and diarrhoea occurred in 9% and 6%, respectively in Tarceva-treated patients and each resulted in study discontinuation in 1% of patients.
Slovenian: Kožni izpuščaj stopnje 3/4 se je pojavil pri 9 % bolnikov, driska stopnje 3/4 pa pri 6 % bolnikov, ki so prejemali zdravilo Tarceva.
English: Depression
Slovenian: • depresija,
English: The primary active metabolites were present in tumour at concentrations averaging 160 ng/g tissue, which corresponded to an overall average of 113% (range 88-130%) of the observed steady state peak plasma concentrations.
Slovenian: Primarni aktivni presnovki so bili v tumorjih prisotni v koncentracijah, ki so v povprečju znašale 160 ng/g tkiva.
English: -Hirsutism -Eyebrow changes -Brittle and Loose nails -Mild skin reactions such as hyperpigmen tation
Slovenian: - blage reakcije na koži, kot je hiperpigmentacija
English: Frequency category of highest incidence
Slovenian: Kategorija pogostnosti največje incidence stopnja po lestvici NCI-CTC
English: MARKETING AUTHORISATION NUMBER(S) EU/1/05/311/002
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/05/311/002
English: Ninety-three percent and 92% of all patients in the Tarceva and placebo groups, respectively, had received a prior platinum-containing regimen and 36% and 37% of all patients, respectively, had received a prior taxane therapy.
Slovenian: Terapijo, ki je vključevala taksane, je predhodno prejelo 36 % bolnikov v skupini, ki je prejemala zdravilo Tarceva, in 37 % vseh bolnikov v skupini, ki je prejemala placebo.
English: Study endpoints included overall survival, progression-free survival (PFS), response rate, duration of response, time to deterioration of lung cancer-related symptoms (cough, dyspnoea and pain), and safety.
Slovenian: Bolniki so bili randomizirani v razmerju 2 : 1 v skupino, ki je prejemala 150 mg zdravila Tarceva, in v skupino, ki je prejemala placebo peroralno enkrat na dan. Cilji preskušanja so bili celokupno preživetje (OS, overall survival), preživetje brez napredovanja bolezni (PFS, progression-free survival), odgovor na zdravljenje, trajanje odgovora, čas do poslabšanja simptomov, povezanih z rakom pljuč (kašelj, dispneja in bolečina), in varnost.
English: No Grade 4 rash or diarrhoea was observed.
Slovenian: Kožnega izpuščaja in driske stopnje 4 niso opazili.
English: Tarceva 25 mg film coated tablets
Slovenian: Tarceva 25 mg filmsko obložene tablete
English: How to store Tarceva
Slovenian: Shranjevanje zdravila Tarceva
English: Cut-off date: Jan 2011
Slovenian: podatki do januarja 2011
English: -Interstitial lung disease (ILD)3
Slovenian: - intersticijska bolezen pljuč
English: What Tarceva contains:
Slovenian: Kaj vsebuje zdravilo Tarceva
English: MARKETING AUTHORISATION NUMBER(S) EU/1/05/311/003
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/05/311/003
English: Cut-off date: Aug 2010
Slovenian: podatki do avgusta 2010
English: p=0.003
Slovenian: p < 0,0001 p = 0,003
English: Tarceva should be permanently discontinued in patients who develop gastrointestinal perforation (see section 4.8).
Slovenian: Pri bolnikih, pri katerih se pojavi perforacija v prebavilih, je treba zdravljenje z zdravilom Tarceva dokončno ukiniti (glejte poglavje 4.8).
English: - Maintenance NSCLC therapy after first-line chemotherapy (Tarceva administered as monotherapy)
Slovenian: - Vzdrževalno zdravljenje nedrobnoceličnega raka pljuč po kemoterapiji v prvi liniji (zdravilo Tarceva kot samostojno zdravljenje)
English: -Hepatic failure 6
Slovenian: - ledvična insuficienca1
English: Erlotinib and Carboplatin/Paclitaxel
Slovenian: Erlotinib in karboplatin/paklitaksel
English: Each film-coated tablet contains 25 mg erlotinib (as erlotinib hydrochloride).
Slovenian: Vsaka filmsko obložena tableta vsebuje 25 mg erlotiniba (v obliki erlotinibijevega klorida).
English: NAME OF THE MEDICINAL PRODUCT Tarceva 25 mg film-coated tablets Erlotinib
Slovenian: Tarceva 25 mg filmsko obložene tablete erlotinib
English: Renal and urinary disorders insufficiency1 -Nephritis1 -Proteinuria1
Slovenian: - nefritis1 - proteinurija1
English: Pruritus
Slovenian: - driska
English: CR=complete response; PR=partial response * A 58% reduction in the risk of disease progression or death was observed ** Overall concordance rate between investigator and IRC assessment was 70% *** A high crossover was observed with 82% of the patients in the chemotherapy arm receiving subsequent therapy with an EGFR tyrosine kinase inhibitor and all but 2 of those patients had subsequent Tarceva.
Slovenian: *** Visok odstotek bolnikov (82 %) iz skupine, ki je prejemala kemoterapijo, je zdravljenje nadaljevalo z zaviralcem tirozinske kinaze EGFR, od tega so vsi razen 2 zdravljenje nadaljevali z zdravilom Tarceva.
English: demonstrating a substantial PFS benefit (HR=0.10, 95% CI, 0.04 to 0.25; p<0.0001) and an overall survival HR of 0.83 (95% CI, 0.34 to 2.02).
Slovenian: Največjo korist pa so opazili pri bolnikih z EGFRaktivirajočimi mutacijami (n = 49), za katere je bila eksplorativna analiza določena vnaprej, in pri katerih je bila korist v smislu preživentja brez napredovanja bolezni precejšnja (razmerje ogroženosti = 0,10, 95-% interval zaupanja: 0,04-0,25; p <0,0001), razmerje ogroženosti za celokupno preživetje pa 0,83 (95-% interval zaupanja: 0,34-2,02).
English: Each film-coated tablet contains 100 mg erlotinib (as erlotinib hydrochloride).
Slovenian: Vsaka filmsko obložena tableta vsebuje 100 mg erlotiniba (v obliki erlotinibijevega klorida).
English: Patients with Non-Small Cell Lung Cancer EGFR mutation testing should be performed in accordance with the approved indications (see section
Slovenian: V skladu z odobrenimi indikacijami je treba opraviti testiranje za določanje mutacij EGFR (glejte poglavje 4.1).
English: PFS (median in months)
Slovenian: Preživetje brez napredovanja bolezni (mediana v mesecih)
English: Tarceva 25 mg is supplied as a white to yellowish, round, film-coated tablet with ‘T 25' engraved on one side and is available in pack sizes of 30 tablets.
Slovenian: Zdravilo Tarceva 25 mg je v obliki filmsko obloženih tablet bele do rumenkaste barve, okrogle oblike, z vgraviranim napisom “T 25” na eni strani.
English: • Eyelash changes
Slovenian: - hirzutizem - spremembe obrvi
English: Each film-coated tablet contains 150 mg erlotinib (as erlotinib hydrochloride).
Slovenian: Vsaka filmsko obložena tableta vsebuje 150 mg erlotiniba (v obliki erlotinibijevega klorida).
English: NAME OF THE MEDICINAL PRODUCT Tarceva 100 mg film-coated tablets Erlotinib
Slovenian: Tarceva 100 mg filmsko obložene tablete erlotinib
English: Tarceva 100 mg is supplied as a white to yellowish, round, film-coated tablet with ‘T 100' engraved on one side and is available in pack sizes of 30 tablets.
Slovenian: Zdravilo Tarceva 100 mg je v obliki filmsko obloženih tablet bele do rumenkaste barve, okrogle oblike, z vgraviranim napisom “T 100” na eni strani.
English: Your doctor may need to interrupt or stop your treatment.
Slovenian: Zdravnik bo morda moral začasno prekiniti ali ukiniti vaše zdravljenje z zdravilom Tarceva.
English: Stomach pain, indigestion and flatulence
Slovenian: • bolečina v želodcu, slaba prebava, napenjanje,
English: Tarceva 150 mg is supplied as a white to yellowish, round, film-coated tablet with ‘T 150' engraved on one side and is available in pack sizes of 30 tablets.
Slovenian: Zdravilo Tarceva 150 mg je v obliki filmsko obloženih tablet bele do rumenkaste barve, okrogle oblike, z vgraviranim napisom “T 150” na eni strani.
English: Tiredness, fever, rigors
Slovenian: • utrujenost, povišana telesna temperatura, okorelost.
English: Gastrointestinal perforation
Slovenian: Perforacije v prebavilih
English: Gastrointestinal perforations have been observed (uncommon: may affect up to 1 in 100 people).
Slovenian: • Opazili so predrtja v prebavilih (občasno: pojavi se lahko pri največ 1 od 100 bolnikov).
English: NAME OF THE MEDICINAL PRODUCT Tarceva 150 mg film-coated tablets Erlotinib
Slovenian: Tarceva 150 mg filmsko obložene tablete erlotinib
English: Rare cases of hepatic failure (including fatalities) have been reported during use of Tarceva.
Slovenian: Pri uporabi zdravila Tarceva so poročali o redkih primerih jetrne odpovedi (vključno s smrtnimi).
English: Tarceva is not recommended for use in patients with severe hepatic dysfunction.
Slovenian: Uporaba zdravila Tarceva pri bolnikih s hudo jetrno disfunkcijo ni priporočljiva.
English: OS*** (months)
Slovenian: razlika (Δ) (meseci)
English: White to yellowish, round, biconvex tablets with ‘T 100' engraved on one side.
Slovenian: Tarceva 100 mg filmsko obložene tablete Bele do rumenkaste, okrogle, bikonveksne tablete z vgraviranim napisom “T 100” na eni strani.
English: Flatulence very common very common very common very common very common very common very common
Slovenian: Bolezni prebavil driska** navzea bruhanje stomatitis bolečina v trebuhu dispepsija flatulenca zelo pogosti zelo pogosti zelo pogosti zelo pogosti zelo pogosti zelo pogosti zelo pogosti
English: White to yellowish, round, biconvex tablets with ‘T 25' engraved on one side.
Slovenian: Tarceva 25 mg filmsko obložene tablete Bele do rumenkaste, okrogle, bikonveksne tablete z vgraviranim napisom “T 25” na eni strani.
English: White to yellowish, round, biconvex tablets with ‘T 150' engraved on one side.
Slovenian: Tarceva 150 mg filmsko obložene tablete Bele do rumenkaste, okrogle, bikonveksne tablete z vgraviranim napisom “T 150” na eni strani.
English: Dermatitis acneiform -Skin fissures
Slovenian: - alopecija - suha koža1 - paronihija - folikulitis - akne/ akneiformni dermatitis - fisure na koži
English: Cases of interstitial lung disease (ILD)-like events, including fatalities, have been reported uncommonly in patients receiving Tarceva for treatment of non-small cell lung cancer (NSCLC), pancreatic cancer or other advanced solid tumours.
Slovenian: Pri bolnikih, ki so zdravilo Tarceva prejemali za zdravljenje nedrobnoceličnega raka pljuč, raka trebušne slinavke ali drugih napredovalih solidnih tumorjev, so občasno poročali o dogodkih, podobnih intersticijski bolezni pljuč, vključno s smrtnimi primeri.
English: Median overall survival Mean overall survival
Slovenian: Celokupno preživetje - vsi bolniki
English: Both rash and diarrhoea resulted in discontinuation of Tarceva in 1% of patients.
Slovenian: Zdravljenje z zdravilom Tarceva so zaradi kožnega izpuščaja oziroma driske ukinili pri 1 % bolnikov.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 100 mg of erlotinib (as erlotinib hydrochloride).
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena filmsko obložena tableta vsebuje 100 mg erlotiniba (v obliki erlotinibijevega klorida).
English: Secondary efficacy endpoints were all consistent with the primary endpoint and no difference was detected for OS between patients treated with erlotinib 300 mg and 150 mg daily (HR 1.03, 95% CI 0.80 to 1.32).
Slovenian: Pri bolnikih, zdravljenih z erlotinibom 300 mg in 150 mg na dan (HR = 1,03, 95-% interval zaupanja: 0,80-1,32), so bili sekundarni cilji učinkovitosti skladni s primarnim ciljem; razlike v celokupnem preživetju niso ugotovili.
English: Caution should be observed when these active substances are combined with erlotinib.
Slovenian: Če te učinkovine kombiniramo z erlotinibom, je potrebna previdnost.
English: OTHER
Slovenian: Kύπρος
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 25 mg of erlotinib (as erlotinib hydrochloride).
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena filmsko obložena tableta vsebuje 25 mg erlotiniba (v obliki erlotinibijevega klorida).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 150 mg of erlotinib (as erlotinib hydrochloride).
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena filmsko obložena tableta vsebuje 150 mg erlotiniba (v obliki erlotinibijevega klorida).
English: Best Overall Response Rate (CR/PR)
Slovenian: Najboljši celokupni odgovor na zdravljenje (popolni odgovor, delni odgovor)
English: • immediately, if you have severe or persistent diarrhoea, nausea, loss of appetite, or vomiting because your doctor may need to interrupt your Tarceva treatment and may need to treat you in the hospital;
Slovenian: V teh primerih obvestite zdravnika nemudoma, ker bo morda moral prekiniti zdravljenje z zdravilom Tarceva in vas zdraviti v bolnišnici;
English: Very common side effects (may affect more than 1 in 10 people): Rash which may occur or worsen in sun exposed areas.
Slovenian: • Kožni izpuščaj, ki se lahko pojavi ali poslabša na delih, ki so izpostavljeni soncu.
English: WHAT VALEBO IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE ZDRAVILO VALEBO IN ZA KAJ GA UPORABLJAMO
English: [This section should be amended to reflect the following wording]
Slovenian: [To poglavje je treba spremeniti tako, da odraža naslednje besedilo]
English: What is alfacalcidol?
Slovenian: Kaj je alfakalcidol?
English: [The following wording should be deleted] “whilst alfacalcidol significantly reduces the frequency of falls in the elderly” [The following wording should be added]
Slovenian: [Naslednje besedilo se briše] “medtem ko alfakalcidol močno zmanjša pogostnost padca pri starejših” [Naslednje besedilo se doda]
English: Combination of alendronic acid and alfacalcidol (Valebo):
Slovenian: Kombinacija alendronske kisline in alfakalcidola (zdravilo Valebo):