natgillin/translations-raw huggingface dataset:
There are three main metabolic pathways identified: 1) O-demethylation of either side chain or both, followed by oxidation to the carboxylic acids; 2) oxidation of the acetylene moiety followed by hydrolysis to the aryl carboxylic acid; and 3) aromatic hydroxylation of the phenyl-acetylene moiety.
O-demetilacija jednog ili oba postranična lanca, nakon kojeg nastupa oksidacija karboksilnih kiselina, 2) oksidacija acetilenskog dijela, nakon koje slijedi hidroliza aril karboksilne kiseline i 3) aromatska hidroksilacija fenil-acetilenskog dijela.
Baseline ECOG performance status (PS) = 0 Baseline ECOG performance status (PS) = 1 Baseline ECOG performance status (PS) = 2 Metastatic disease at baseline
Početni ECOG funkcionalni status (PS) = 0 Početni ECOG funkcionalni status (PS) = 1 Početni ECOG funkcionalni status (PS) = 2
Based on pharmacokinetic data no dose adjustments appear necessary in patients with mild or moderate renal impairment (see section 5.2).
Na temelju farmakokinetičkih podataka čini se da nije potrebna prilagodba doze u bolesnika s blagim ili umjerenim oštećenjem bubrega (vidjeti dio 5.2).
Date of first authorization: 19 September 2005 Date of latest renewal: 2 July 2010
Datum prvog odobrenja: 19. rujna 2005.
The recommended daily dose of Tarceva is 100 mg taken at least one hour before or two hours after the ingestion of food, in combination with gemcitabine (see the summary of product characteristics of gemcitabine for the pancreatic cancer indication).
Preporučena dnevna doza lijeka Tarceva iznosi 100 mg i treba ju uzimati najmanje jedan sat prije ili dva sata nakon obroka, u kombinaciji s gemcitabinom (pogledajte sažetak opisa svojstava gemcitabina za indikaciju rak gušterače).
See sections 4.2, 4.4, 4.5 and 5.1.
Vidjeti dijelove 4.2, 4.4, 4.5 i 5.1.
The potent effectiveness of erlotinib in blocking EGFR-mediated signalling in these EGFR mutation positive tumours is attributed to the tight binding of erlotinib to the ATP-binding site in the mutated kinase domain of the EGFR.
Snažno blokirajuće djelovanje erlotiniba na EGFR-om posredovanu signalizaciju u tumorima pozitivnim na EGFR mutaciju pripisuje se snažnom vezanju erlotiniba na mjesto vezanja ATP-a u mutiranoj domeni EGFR kinaze.
In two other double-blind, randomised, placebo-controlled Phase III studies BO18192 (SATURN) and BO25460 (IUNO); Tarceva was administered as maintenance after first-line chemotherapy.
U druga dva dvostruko slijepa, randomizirana, placebom kontrolirana ispitivanja faze III - BO18192 (SATURN) i BO25460 (IUNO) - Tarceva se primjenjivala kao terapija održavanja nakon prve linije kemoterapije.
Your doctor may adjust your dose in 50 mg steps.
Liječnik će Vam možda prilagoditi dozu smanjivanjem doze za po 50 mg.
In a clinical study, the concomitant use of erlotinib with carboplatin and paclitaxel led to an increase of total platinum AUC0-48 of 10.6%.
U kliničkom je ispitivanju istovremeno uzimanje erlotiniba uz karboplatin i paklitaksel prouzročilo povećanje ukupnog AUC0-48 platine od 10,6%.
• if you are taking other medicines that may increase or decrease the amount of erlotinib in your blood or influence its effect (for example antifungals like ketoconazole, protease inhibitors, erythromycin, clarithromycin, phenytoin, carbamazepine, barbiturates, rifampicin, ciprofloxacin, omeprazole, ranitidine, St. John's Wort or proteasome inhibitors), talk to your doctor.
· ako uzimate druge lijekove koji mogu povećati ili smanjiti razinu erlotiniba u krvi ili utjecati na njegov učinak (kao što su lijekovi protiv gljivica poput ketokonazola, inhibitori proteaze, eritromicin, klaritromicin, fenitoin, karbamazepin, barbiturati, rifampicin, ciprofloksacin, omeprazol, ranitidin, gospina trava ili inhibitori proteasoma) obratite se svom liječniku.
For patients who are exposed to sun, protective clothing, and/or use of sunscreen (e.g. mineral-containing) may be advisable.
Za bolesnike koji su izloženi suncu poželjna je zaštitna odjeća, i/ili upotreba sredstva za zaštitu od sunca (npr. koje sadrže minerale).
4 In clinical studies, some cases have been associated with concomitant warfarin administration and some with concomitant NSAID administration (see section 4.5).
4 u kliničkim ispitivanjima neki slučajevi povezani su s istovremenom primjenom varfarina, a neki s istovremenom primjenom NSAIL-a (vidjeti dio 4.5).
Therefore, the time to reach steady state plasma concentration would be expected to occur in approximately 7-8 days.
Prema tome, vrijeme dostizanja koncentracije stanja dinamičke ravnoteže u plazmi očekuje se u roku od 7 do
In the clinical studies doses were reduced by 50 mg steps.
U kliničkim ispitivanjima doze su smanjene postupno za po 50 mg.
Similarly, the exposure to the active metabolite increased by about 60% and 48% for AUC and Cmax, respectively.
Slično tome, raspoloživost aktivnog metabolita se povećala za oko 60% (AUC) i 48% (Cmax).
No studies on the effects on the ability to drive and use machines have been performed; however erlotinib is not associated with impairment of mental ability.
Nisu provedena ispitivanja o utjecaju na sposobnost upravljanja motornim vozilima i rada sa strojevima, ali se erlotinib ne povezuje sa smanjenjem mentalnih sposobnosti.
This corresponded to an overall average of 63% (range 5-161%) of the steady state observed peak plasma concentrations.
To je odgovaralo ukupnom prosjeku od 63% (u rasponu od 5 do 161%) opaženih vršnih koncentracija u plazmi u stanju dinamičke ravnoteže.
Based on the data from the BO25460 (IUNO) study, Tarceva use is not recommended for first-line maintenance treatment in patients without an EGFR activating mutation.
Temeljem podataka iz ispitivanja BO25460 (IUNO), ne preporučuje se primjena lijeka Tarceva za prvu liniju terapije održavanja u bolesnika bez aktivirajuće mutacije EGFR-a.
Pharmacotherapeutic group: antineoplastic agent protein kinase inhibitor, ATC code: L01XE03
5.1 Farmakodinamička svojstva Farmakoterapijska skupina: antineoplastični lijekovi; inhibitor protein kinaze, ATK oznaka: L01XE03
Pre-treatment or co-administration of Tarceva did not alter the clearance of the prototypical CYP3A4 substrates, midazolam and erythromycin, but did appear to decrease the oral bioavailability of midazolam by up to 24%.
Prethodno ili istovremeno uzimanje lijeka Tarceva nije utjecalo na klirens prototipnih supstrata CYP3A4, midazolama i eritromicina, ali čini se da je smanjilo peroralnu bioraspoloživost midazolama za do 24%.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Tarceva.
Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite mu se prije uzimanja lijeka Tarceva.
The primary metabolites OSI-420 and OSI-413 of erlotinib produced by O-demethylation of either side chain have comparable potency to erlotinib in non-clinical in vitro assays and in vivo tumour models.
Osnovni metaboliti erlotiniba OSI-420 i OSI-413 dobiveni O-demetilacijom bilo kojeg postraničnog lanca imaju potenciju usporedivu s erlotinibom u nekliničkim analizama in vitro i tumorskim modelima in vivo.
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.
Budući da potencijalna opasnost za dojenče nije poznata, majke je potrebno savjetovati da ne doje za vrijeme primjene lijeka Tarceva i još najmanje 2 tjedna nakon posljednje doze lijeka.
The objective of the study was to compare the overall survival of first line maintenance therapy with erlotinib versus erlotinib administered at the time of disease progression.
Cilj ispitivanja bio je usporediti ukupno preživljenje (OS) uz erlotinib primijenjen u prvoj liniji terapije održavanja u odnosu na OS kod primjene erlotiniba u trenutku progresije bolesti.
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).
Oštećenje bubrega Sigurnost i djelotvornost erlotiniba nije ispitana u bolesnika s oštećenjem bubrega (koncentracija serumskog kreatinina > 1,5 puta od gornje granice normale).
You are advised to stop smoking if you are treated with Tarceva as smoking could decrease the amount of your medicine in the blood.
Ako se liječite lijekom Tarceva preporučuje se da prestanete pušiti jer pušenje može smanjiti razinu lijeka u krvi.
Dose reductions by 25 mg steps have not been investigated.
Nisu ispitani slučajevi smanjenja doze za po 25 mg.
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.
Bolesnici koji istovremeno primaju antiangiogene lijekove, kortikosteroide, nesteroidne protuupalne lijekove, i/ili kemoterapiju baziranu na taksanima, ili oni koji u anamnezi imaju peptične ulceracije ili divertikuloznu bolest, imaju povećani rizik.
-Diarrhoea7 -Gastrointestinal bleeding4, 7
- gastrointestinalno krvarenje 4, 7
When prescribing Tarceva, factors associated with prolonged survival should be taken into account (see sections 4.2 and 5.1).
Prilikom propisivanja lijeka Tarceva treba uzeti u obzir faktore povezane s produljenim preživljenjem (vidjeti dio 4.2 i 5.1).
Hydroxypropyl cellulose (E463) Titanium dioxide (E171)
Ovojnica tablete hidroksipropilceluloza (E463) titanijev dioksid (E171) makrogol hipromeloza (E464)
• if you use contact lenses and/or have a history of eye problems such as severe dry eyes, inflammation of the front part of the eye (cornea) or ulcers involving the front part of the eye, tell your doctor.
· ako koristite kontaktne leće i/ili ste već imali tegobe s očima poput izuzetno suhih očiju, upale prednjega dijela oka (rožnice) odnosno ulceracije na prednjem dijelu oka, svakako o tome obavijestite svog liječnika.
The effects of concomitant administration of erlotinib with H2 antagonists and antacids are unknown; however, reduced bioavailability is likely.
Učinci istovremene primjene erlotiniba s H2 antagonistima i antacidima nisu poznati, no vjerojatna je smanjena bioraspoloživost.
Single oral doses of Tarceva up to 1000 mg erlotinib in healthy subjects, and up to 1600 mg in cancer patients have been tolerated.
Pojedinačna peroralna doza lijeka Tarceva do 1000 mg erlotiniba u zdravih osoba i do 1600 mg u bolesnika s rakom dobro se podnosi.
Your doctor may decide to permanently stop your treatment with Tarceva.
Vaš će liječnik odlučiti treba li trajno prekinuti liječenje lijekom Tarceva.
A survival benefit of Tarceva was also observed in patients who did not achieve an objective tumour response (by RECIST).
Prednost u preživljenju s lijekom Tarceva primijećena je također i u bolesnika koji nisu imali objektivan odgovor tumora (prema RECIST).
If you develop symptoms such as sudden difficulty in breathing associated with cough or fever contact your doctor immediately as you could suffer from this disease.
Ako Vam se pojave simptomi kao što su iznenadne poteškoće s disanjem popraćene kašljem ili vrućicom, odmah se obratite liječniku jer možda patite od te bolesti.
If you stop taking Tarceva
Ako prestanete uzimati lijek Tarceva
This was confirmed in a pharmacokinetic study in non-smoking and currently cigarette smoking healthy subjects receiving a single oral dose of 150 mg erlotinib.
Ovo je potvrđeno u farmakokinetičkom ispitivanju u zdravih dobrovoljaca nepušača i pušača cigareta koji su primili jednokratnu dozu od 150 mg erlotiniba.
• If you have further questions, ask your doctor or pharmacist.
· Ako imate dodatnih pitanja, obratite se liječniku ili ljekarniku.
Tarceva is available in strengths of 25 mg, 100 mg and 150 mg.
Tarceva je dostupna u jačinama od 25 mg, 100 mg i 150 mg.
Patients with low expression levels of UGT1A1 or genetic glucuronidation disorders (e.g. Gilbert's disease) may exhibit increased serum concentrations of bilirubin and must be treated with caution.
U bolesnika s niskim razinama ekspresije UGT1A1 ili genetičkim glukuronidacijskim bolestima (npr. Gilbertova bolest) može doći do povećane koncentracije bilirubina u serumu, pa je potreban oprez pri liječenju.
Tarceva is given in combination with gemcitabine treatment.
Tarceva se daje u kombinaciji s terapijom gemcitabinom.
These findings were observed at exposures well below clinically relevant exposures.
Ti su učinci opaženi pri izloženostima znatno nižima od klinički relevantnih izloženosti.
67% of placebo patients in the EGFR mutation positive subgroup received second or further line treatment with EGFR-TKIs.
Šezdeset i sedam posto (67%) bolesnika iz podskupine pozitivne na mutaciju EGFR-a koji su primali placebo primilo je i drugu ili daljnju liniju liječenja inhibitorima tirozin kinaze EGFR-a.
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.
Ocjena sigurnosti lijeka Tarceva temelji se na podacima prikupljenima u više od 1500 bolesnika liječenih najmanje jednom dozom lijeka Tarceva od 150 mg u monoterapiji te više od 300 bolesnika koji su primali lijek Tarceva u dozi od 100 ili 150 mg u kombinaciji s gemcitabinom.
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).
U 45% bolesnika s poznatim statusom ekspresije EGFR, omjer rizika bio je 0,68 (95% CI 0,49-0,94) za bolesnike s EGFR pozitivnim tumorima i 0,93 (95% CI 0,63-1,36) za bolesnike s EGFR negativnim tumorima (definirano na temelju imunohistokemije pomoću EGFR pharmDx i definirano EGFR-negativno kao manje od 10% bojanja stanica tumora).
In another clinical study, erlotinib was shown not to affect pharmacokinetics of the concomitantly administered CYP3A4/2C8 substrate paclitaxel.
U drugom kliničkom ispitivanju pokazalo se da erlotinib ne utječe na farmakokinetiku istovremeno primijenjenog CYP3A4/2C8 supstrata paklitaksela.
Based on the mode of action, erlotinib has the potential to be a teratogen.
Erlotinib bi, na temelju djelovanja, mogao biti teratogen.
If adverse reactions related to erlotinib are observed, the dose of erlotinib may be reduced.
Ako se primijete nuspojave vezane uz erlotinib, doza erlotiniba može se smanjiti.
Concomitant administration of inhibitors of Pgp, e.g. cyclosporine and verapamil, may lead to altered distribution and/or altered elimination of erlotinib.
Pgp inhibitora, npr. ciklosporina i verapamila, može dovesti do promjene raspodjele i/ili uklanjanja erlotiniba.
Erlotinib and statins
Erlotinib i statini
Some cases were secondary to severe dehydration due to diarrhoea, vomiting and/or anorexia, while others were confounded by concomitant chemotherapy.
Do nekih je slučajeva došlo nakon teške dehidracije uslijed proljeva, povraćanja i/ili anoreksije, dok su neki uzroci nejasni zbog istovremenog primanja kemoterapije.
Manufacturer Roche Pharma AG Emil-Barell-Strasse 1
Roche Pharma AG Emil-Barell-Strasse 1
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.
Mjere ishoda ispitivanja uključivale su ukupno preživljenje, preživljenje bez pogoršanja bolesti (PFS), stopu odgovora, trajanje odgovora, vrijeme do pogoršanja simptoma vezanih uz rak pluća (kašalj, zaduha i bol) te sigurnost liječenja.
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.
Ta su ispitivanja provedena u ukupno 1532 bolesnika s uznapredovalim, rekurentnim ili metastatskim NSCLC-om nakon prve linije standardne kemoterapije utemeljene na platini; nisu uočeni novi sigurnosni signali.
• if you are allergic to erlotinib or any of the ingredients of this medicine (listed in section 6).
Nemojte uzimati lijek Tarceva · ako ste alergični na erlotinib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
This effect was accompanied by a 24% increase in apparent erlotinib plasma clearance.
Ovaj učinak praćen je 24%-tnim povećanjem prividnog klirensa erlotiniba u plazmi.
The BO25460 (IUNO) study was conducted in 643 patients with advanced NSCLC whose tumors did not harbor an EGFR-activating mutation (exon 19 deletion or exon 21 L858R mutation) and who had not experienced disease progression after four cycles of platinum-based chemotherapy.
Ispitivanje BO25460 (IUNO) provedeno je u 643 bolesnika s uznapredovalim NSCLC-om čiji tumor nije imao aktivirajuću mutaciju EGFR-a (deleciju eksona 19 ili mutaciju L858R na eksonu 21) i koji nisu doživjeli progresiju bolesti nakon četiri ciklusa kemoterapije na bazi platine.
A mild phototoxic skin reaction was observed in rats after UV irradiation.
U štakora je nakon UV zračenja primijećena blaga fototoksična reakcija na koži.
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.
Kada je erlotinib davan u kombinaciji s kapecitabinom, došlo je do statistički značajnog povećanja AUCa erlotiniba i granično značajnog povećanja vrijednosti Cmax u usporedbi s vrijednostima uočenima u drugom ispitivanju u kojem je erlotinib davan sam.
Current smokers should be advised to stop smoking, as plasma concentrations of erlotinib in smokers as compared to non-smokers are reduced.
Pušačima treba savjetovati da prestanu pušiti jer je ustanovljeno da je koncentracija erlotiniba u plazmi pušača značajno manja u usporedbi s koncentracijom u nepušača.
Two-year carcinogenicity studies with erlotinib conducted in rats and mice were negative up to exposures exceeding human therapeutic exposure (up to 2-fold and 10-fold higher, respectively, based on Cmax and/or AUC).
Dvogodišnja ispitivanja karcinogenosti erlotiniba provedena na štakorima i miševima čije su izloženosti prelazile terapijske izloženosti kod ljudi (do 2 puta odnosno 10 puta više, temeljeno na Cmax i/ili AUC) dala su negativan rezultat.
The recommended daily dose of Tarceva is 150 mg taken at least one hour before or two hours after the ingestion of food.
Preporučena dnevna doza lijeka Tarceva iznosi 150 mg, a uzima se najmanje sat vremena prije ili dva sata nakon obroka.
When prescribing Tarceva, factors associated with prolonged survival should be taken into account.
Prilikom propisivanja lijeka Tarceva treba uzeti u obzir faktore povezane s produljenim preživljenjem.
Capecitabine may increase erlotinib concentrations.
Kapecitabin može povećati koncentracije erlotiniba.
Erlotinib and other CYP substrates
Erlotinib i ostali CYP supstrati
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.
U bolesnika koji razviju akutne nove i/ili progresivne neobjašnjene plućne simptome, poput zaduhe, kašlja ili vrućice, potrebno je obustaviti terapiju lijekom Tarceva dok se ne učini dijagnostička obrada.
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).
U dvostruko slijepom, randomiziranom ispitivanju faze III (MO22162, CURRENTS), u kojem su se uspoređivale dvije doze lijeka Tarceva (300 mg naspram 150 mg) u bolesnika pušača (srednja vrijednost 38 kutija-godina) s lokalno uznapredovalim ili metastatskim NSCLC-om u drugoj liniji liječenja nakon neuspješne kemoterapije, doza lijeka Tarceva od 300 mg nije ostvarila dodatne korisne učinke na PFS u odnosu na preporučenu dozu (7,00 naspram 6,86 tjedana).
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.
U bolesnika sa solidnim tumorima i umjerenim oštećenjem funkcije jetre (Child-Pugh indeks 7 - 9) geometrijska sredina AUC0-t erlotiniba iznosila je 27 000 ng•h/ml, a Cmax 805 ng/ml u usporedbi s 29 300 ng•h/ml odnosno 1090 ng/ml u bolesnika s odgovarajućom funkcijom jetre, uključujući bolesnike s primarnim rakom jetre ili metastazama u jetri.
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.
Primarni aktivni metaboliti u tumoru bili su prisutni u koncentracijama od oko 160 ng/g tkiva, što je odgovaralo ukupnom prosjeku od 113% (u rasponu od 88 do 130%) opaženih vršnih koncentracija u plazmi u stanju dinamičke ravnoteže.
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.
Bolesnike sa znakovima i simptomima koji ukazuju na keratitis, poput akutne ili pogoršanja postojeće: upale oka, suzenja, osjetljivosti na svjetlost, zamućenoga vida, boli u oku i/ili crvenila oka, treba odmah uputiti specijalistu oftalmologu.
You may have increased side effects and your doctor may interrupt your treatment.
Nuspojave se mogu pojačati, pa će Vam liječnik možda zaustaviti liječenje.
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.
U meta-analizi randomiziranih kontroliranih kliničkih ispitivanja kod NSCLC-a (isključujući ispitivanja faze I i ispitivanja faze II s jednom skupinom jer nije bilo kontrolne skupine), incidencija događaja nalik IBP-u iznosila je 0,9% uz lijek Tarceva, u usporedbi s 0,4% u bolesnika u kontrolnim skupinama.
Combination of erlotinib with proton pump inhibitors should be avoided.
Treba izbjegavati kombinaciju erlotiniba i inhibitora protonske pumpe.
Table 3: Efficacy results of Tarceva versus chemotherapy in trial ML20650 (EURTAC)
Tablica 3: Rezultati djelotvornosti lijeka Tarceva naspram kemoterapiji u ispitivanju ML20650 (EURTAC)
Do not breast-feed if you are being treated with Tarceva, and for at least 2 weeks after taking the last tablet.
Ne dojite dijete dok se liječite lijekom Tarceva i još najmanje 2 tjedna nakon što uzmete posljednju tabletu.
Dose modifications (interruptions or reductions) for rash and diarrhoea were needed in 11% and 7% of patients, respectively.
Prilagodbe doze (privremeni prekid primjene ili smanjenje doze) zbog osipa i proljeva bile su potrebne u 11% odnosno 7% bolesnika.
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).
Bolesnici koji nikada nisu pušili imali su veću korist od erlotiniba (preživljenje HR = 0,42; 95% CI 0,28-0,64) u usporedbi s onima koji puše ili su pušili (HR = 0,87; 95% CI 0,71-1,05).
Erlotinib and medicinal products altering pH
Erlotinib i lijekovi koji mijenjaju pH vrijednost
-Palmar plantar erythrodysaesthesia syndrome
- sindrom palmarnoplantarne eritrodizestezije
However, smokers had an increased rate of erlotinib clearance.
Međutim, pušači su imali povećanu brzinu klirensa erlotiniba.
Tarceva dosing should be interrupted if changes in liver function are severe (see section 4.8).
Uzimanje lijeka Tarceva valja prekinuti ako su promjene funkcije jetre teške (vidjeti dio 4.8).