natgillin/translations-raw huggingface dataset:
The safety and efficacy of erlotinib has not been studied in patients with severe hepatic dysfunction (AST/SGOT and ALT/SGPT> 5 x ULN).
Sigurnost i djelotvornost erlotiniba u bolesnika s teškim poremećajima funkcije jetre (AST/SGOT i ALT/SGPT > 5 x gornja granica normalnih vrijednosti) nije ispitana.
Progression Free Survival (PFS, median in months)* Investigator Assessed **
Primarna mjera ishoda: Preživljenje bez progresije bolesti (PFS, medijan u mjesecima)*
The efficacy and safety of Tarceva as maintenance after first-line chemotherapy for NSCLC was investigated in a randomised, double-blind, placebo-controlled trial (BO18192, SATURN).
Djelotvornost i sigurnost lijeka Tarceva u terapiji održavanja nakon prve linije kemoterapije raka pluća nemalih stanica ispitivale su se u randomiziranom, dvostruko slijepom, placebo kontroliranom ispitivanju (BO18192, SATURN).
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).
U pivotalnom ispitivanju faze III raka pluća nemalih stanica pušači su ostvarili najnižu koncentraciju erlotiniba u plazmi u stanju dinamičke ravnoteže od 0,65 µg/ml (n=16) što je približno bilo dva puta manje od bolesnika koji su bivši pušači ili koji nikad nisu pušili (1,28 µg/ml, n=108).
Hepatitis, hepatic failure
Hepatitis, zatajenje jetre
Alternate treatments lacking potent CYP3A4 inducing activity should be considered when possible.
Potrebno je uzeti u obzir alternativna liječenja bez jake CYP3A4 indukcijske aktivnosti.
Loss of appetite, decreased weight
· infekcija, · gubitak apetita, smanjenje tjelesne težine, · depresija,
Metastatic Population
Populacija s metastatskom bolešću
Each film-coated tablet contains 25 mg, 100 mg or 150 mg of erlotinib (as erlotinib hydrochloride) depending on the strength.
Jedna filmom obložena tableta sadrži 25 mg, 100 mg ili 150 mg erlotiniba (u obliku erlotinibklorida), ovisno o jačini.
No data are available regarding the influence of severe hepatic dysfunction on the pharmacokinetics of erlotinib.
Nema dostupnih podataka o utjecaju teškog poremećaja funkcije jetre na farmakokinetiku erlotiniba.
Erlotinib is a substrate for the P-glycoprotein active substance transporter.
Erlotinib je supstrat P-glikoproteina (Pgp), prijenosnika aktivnih tvari.
Co-administration of erlotinib with omeprazole, a proton pump inhibitor (PPI), decreased the erlotinib exposure [AUC] and maximum concentration [Cmax] by 46% and 61%, respectively.
Istovremenom primjenom erlotiniba i omeprazola, inhibitora protonske pumpe, došlo je do smanjenja raspoloživosti erlotiniba [AUC] za 46% i vršne koncentracije [Cmax] za 61%.
If you could become pregnant, use adequate contraception during treatment, and for at least 2 weeks after taking the last tablet.
Ako biste mogli zatrudnjeti, tijekom liječenja i barem još 2 tjedna nakon uzimanja posljednje tablete koristite odgovarajuću kontracepciju.
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.
Incidencija nuspojava lijeka prijavljenih u kliničkim ispitivanjima kod primjene lijeka Tarceva u monoterapiji ili u kombinaciji s kemoterapijom sažeto je prikazana u Tablici 1 prema stupnju toksičnosti sukladno Zajedničkim kriterijima toksičnosti Nacionalnog instituta za rak (National Cancer Institute-Common Toxicity Criteria, NCI-CTC).
Abnormal blood tests for the liver function
- abnormalnosti nalaza testova funkcije jetre 5
There were no significant effects of erlotinib on the pharmacokinetics of capecitabine.
Nije bilo značajnih učinaka erlotiniba na farmakokinetiku kapecitabina.
In an open-label, randomised phase III study, ML20650 conducted in 154 patients, the safety of Tarceva for first-line treatment of NSCLC patients with EGFR activating mutations was assessed in 75 patients; no new safety signals were observed in these patients.
154 bolesnika, sigurnost lijeka Tarceva u prvoj liniji liječenja bolesnika s NSCLC-om i aktivirajućim mutacijama EGFR-a ocijenjena je u 75 bolesnika; nisu uočeni novi sigurnosni signali u tih bolesnika.
Increased serum concentrations of total bilirubin and AAG concentrations were associated with a reduced erlotinib clearance.
Povećane koncentracije ukupnog bilirubina i AAG u serumu povezane su sa smanjenim klirensom erlotiniba.
Erlotinib is an epidermal growth factor receptor/human epidermal growth factor receptor type 1 (EGFR also known as HER1) tyrosine kinase inhibitor.
Mehanizam djelovanja Erlotinib je inhibitor tirozin kinaze receptora za epidermalni faktor rasta/humanog receptora za epidermalni faktor rasta tipa 1 (EGFR poznat i kao HER1).
The median time to onset of rash and diarrhoea was 10 days and 15 days, respectively.
Medijan vremena do pojave osipa i proljeva iznosio je 10 odnosno 15 dana.
Dose reduction for rash and diarrhoea was needed in 6% and 1% of patients, respectively.
Smanjenje doze zbog osipa i proljeva bilo je potrebno u 6% odnosno 1% bolesnika.
In a study of 4 patients (3 with non-small cell lung cancer [NSCLC], and 1 with laryngeal cancer) receiving 150 mg daily oral doses of Tarceva, tumour samples from surgical excisions on Day 9 of treatment revealed tumour concentrations of erlotinib that averaged 1185 ng/g of tissue.
ispitivanju provedenom u 4 bolesnika (3 s rakom pluća nemalih stanica i jedan s rakom grkljana) koji su peroralno primali 150 mg lijeka Tarceva, uzorci tumora uzeti kirurškom ekscizijom devetog dana liječenja pokazali su prosječnu tumorsku koncentraciju erlotiniba od 1185 ng/g tkiva.
The objective response rate by RECIST in the Tarceva group was 8.9% (95% CI, 6.4 to 12.0).
Response Evaluation Criteria in Solid Tumors) u skupini koja je primala lijek Tarceva bila je 8,9% (95% CI, 6,4 - 12,0).
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]).
Bolesnici su randomizirani da primaju lijek Tarceva ili placebo jedanput dnevno kontinuiranim rasporedom, zajedno s i.v. gemcitabinom (1000 mg/m2, ciklus 1 - dani 1, 8, 15, 22, 29, 36 i 43 tijekom osmotjednog ciklusa,
The listed ADRs were those reported in at least 10% (in the Tarceva group) of patients and occurred more frequently (≥3%) in patients treated with Tarceva than in the comparator arm. Other ADRs including those from other studies are summarized in Table 2.
Navedene su nuspojave koje su prijavljene u najmanje 10% bolesnika (u skupini liječenoj lijekom Tarceva) i koje su se javljale češće (³ 3%) u bolesnika liječenih lijekom Tarceva nego u usporednoj skupini.
Headache, altered skin sensation or numbness in the extremities Difficulty in breathing, cough
· glavobolja, promjena osjeta na koži ili osjećaj obamrlosti u udovima, · poteškoće s disanjem, kašalj, · mučnina,
How to take Tarceva
Kako uzimati lijek Tarceva
Liver or kidney disease
Bolest jetre ili bubrega
• 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).
zamućenja vida i/ili osjetljivosti na svjetlo, odmah obavijestite svojega liječnika ili medicinsku sestru, jer Vam je možda potrebno hitno liječenje (vidjeti niže dio "Moguće nuspojave").
Eye disorders
Očni poremećaji
Table 2: Summary of ADRs per frequency category: Body System Very common
Tablica 2: Sažeti prikaz nuspojava lijeka prema kategoriji učestalosti: Tjelesni sustav
Confounding factors included pre-existing liver disease or concomitant hepatotoxic medications (see section 4.4).
Pri tom su pridruženi čimbenici uključivali postojeću bolest jetre ili istovremeno uzimanje hepatotoksičnih lijekova (vidjeti dio 4.4). uključujući smrtne slučajeve (vidjeti dio 4.4).
Co-administration of gemcitabine had no effect on erlotinib plasma clearance.
Istovremeno davanje gemcitabina nije imalo utjecaja na klirens erlotiniba u plazmi.
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.
U bolesnika kojima je potrebno istovremeno liječenje lijekom Tarceva i snažnim induktorom CYP3A4 poput rifampicina, valja razmisliti o povećanju doze na 300 mg pri čemu je potrebno paziti na sigurnosti bolesnika (uključujući bubrežnu i jetrenu funkciju te elektrolite u serumu).
INFORMATION IN BRAILLE tarceva 25 mg
16. PODACI NA BRAILLEOVOM PISMU tarceva 25 mg
Erlotinib and proteasome inhibitors
Erlotinib i inhibitori proteasoma
For the different dose regimens Tarceva is available in strengths of 25 mg, 100 mg or 150 mg.
Tarceva je dostupna u jačinama od 25 mg, 100 mg ili 150 mg.
The maximum tolerated dose of Tarceva in NSCLC patients who currently smoke cigarettes was 300 mg.
Maksimalna podnošljiva doza lijeka Tarceva u bolesnika pušača s rakom pluća nemalih stanica iznosi 300 mg.
Interstitial Lung Disease
- intersticijska bolest pluća
Tarceva treatment should be interrupted or discontinued if the patient develops severe bullous, blistering or exfoliating conditions.
Liječenje lijekom Tarceva mora se prekinuti ukoliko bolesnik razvije teške bulozne, eksfolijativne te vezikulozne promjene na koži.
No survival advantage could be shown for patients with locally advanced disease.
U bolesnika s lokalno uznapredovalom bolešću nije dokazano produljenje preživljenja.
Patients were randomised 1:1 to receive Tarceva 150 mg daily or up to 4 cycles of platinum based doublet chemotherapy.
Bolesnici su randomizirani u omjeru 1:1 da primaju ili lijek Tarceva u dozi od 150 mg na dan, ili 4 ciklusa dvostruke kemoterapije na bazi platine.
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.
uzimanjem doza većih od preporučenih može doći do teških nuspojava, poput proljeva, osipa i moguće povećane aktivnosti jetrenih aminotransferaza.
Confounding factors have included pre-existing liver disease or concomitant hepatotoxic medications.
Pri tom su pridruženi čimbenici koji otežavaju tumačenje uključivali postojeću bolest jetre ili pak istovremeno uzimanje hepatotoksičnih lijekova.
INFORMATION IN BRAILLE tarceva 100 mg
16. PODACI NA BRAILLEOVOM PISMU tarceva 100 mg
Eye disorders Keratoconjunctivitis sicca Conjunctivitis very common very common
Keratokonjunktivitis sicca Konjunktivitis vrlo često vrlo često
Bullous and exfoliative skin disorders
Bulozne i eksfolijativne promjene na koži
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).
5.3 Neklinički podaci o sigurnosti primjene Učinci dugotrajnog uzimanja lijeka opaženi na najmanje jednoj životinjskoj vrsti ili u ispitivanju uključivali su promjene na rožnici (atrofija, ulceracija), koži (degeneracija i upala folikula, crvenilo i alopecija), jajnicima (atrofija), jetri (nekroza jetre), bubrezima (bubrežna papilarna nekroza i tubularna dilatacija) te probavnom traktu (odgođeno pražnjenje želuca i proljev).
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.
U nekim slučajevima ti lijekovi mogu umanjiti djelotvornost ili pojačati nuspojave lijeka Tarceva,
Potent inducers of CYP3A4 activity increase erlotinib metabolism and significantly decrease erlotinib plasma concentrations.
Jaki induktori CYP3A4 aktivnosti povećavaju metabolizam erlotiniba i znatno smanjuju koncentraciju erlotiniba u plazmi.
Erlotinib is eliminated by hepatic metabolism and biliary excretion.
Erlotinib se eliminira metaboliziranjem u jetri i izlučivanjem putem žuči.
Patient factors, which correlated with erlotinib pharmacokinetics, were serum total bilirubin, AAG and current smoking.
Faktori od strane bolesnika koji su korelirali s farmakokinetikom erlotiniba bili su ukupni bilirubin u serumu, razina kiselog glikoproteina alfa-1 (AAG) i pušenje.
• 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;
· odmah, ako patite od jakog i dugotrajnog proljeva, mučnine, gubitka apetita ili povraćanja, jer će Vam liječnik možda morati obustaviti liječenje lijekom Tarceva i uputiti Vas na bolničko liječenje, · ukoliko imate jake bolove u trbuhu, jako stvaranje mjehura na koži ili ljuštenje kože.
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.
Najčešće nuspojave u pivotalnom ispitivanju PA.3 u bolesnika s rakom gušterače koji su primali lijek Tarceva 100 mg u kombinaciji s gemcitabinom bile su umor, osip i proljev.
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.
U ispitivanju faze Ib nisu ustanovljeni značajni učinci gemcitabina na farmakokinetiku erlotiniba ni erlotiniba na farmakokinetiku gemcitabina.
If you are exposed to sun, protective clothing, and/or use of sunscreen (e.g. mineral-containing) may be advisable Infection
Ako ste izloženi suncu, preporučljivo je nošenje zaštitne odjeća, i/ili primjena sredstva za zaštitu od sunca
Nervous system disorders Neuropathy Headache very common very common
Neuropatija Glavobolja vrlo često vrlo često
-Keratitis -Conjunctivitis1
- keratitis - konjunktivitis
Most were Grade 1/2 in severity and manageable without intervention.
Većina bolesnika imala je nuspojave stupnja 1/2 te ih je moguće otkloniti i bez upotrebe lijekova.
If ILD is diagnosed, Tarceva should be discontinued and appropriate treatment initiated as necessary (see section 4.8).
Ako se dijagnosticira IBP, potrebno je prekinuti terapiju lijekom Tarceva i započeti odgovarajuće liječenje (vidjeti dio 4.8).
Erlotinib and P-glycoprotein inhibitors
Erlotinib i inhibitori P-glikoproteina
INFORMATION IN BRAILLE tarceva 150 mg
16. PODACI NA BRAILLEOVOM PISMU tarceva 150 mg
See sections 4.2, 4.4, 4.5, and
Vidjeti dijelove 4.2, 4.4, 4.5 i 5.2.
Grade 3 rash and diarrhoea occurred in 9% and 4% of patients, respectively.
Osip i proljev stupnja 3 javili su se u 9% odnosno 4% bolesnika.
Potent inhibitors of CYP3A4 activity decrease erlotinib metabolism and increase erlotinib plasma concentrations.
Jaki inhibitori CYP3A4 aktivnosti smanjuju metabolizam erlotiniba i povećavaju koncentraciju erlotiniba u plazmi.
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.
** Ukupna stopa suglasnosti u ocjeni između ispitivača i nezavisnoga povjerenstva bila je 70% *** Visok postotak bolesnika (82%) iz skupine na kemoterapiji prešao je u nastavku liječenja na inhibitor EGFR tirozin kinaze i svi su oni, izuzev 2 bolesnika, liječenje nastavili lijekom Tarceva
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).
U bolesnika s EGFR-IHC negativnim tumorima (EGFR - receptor za epidermalni faktor rasta) nije dokazano produljenje preživljenja ni drugi klinički relevantni učinci liječenja (vidjeti dio 5.1).
Avoid pregnancy while being treated with Tarceva.
Tijekom liječenja lijekom Tarceva izbjegavajte trudnoću.
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).
ili starijih bolesnika (HR = 0,79; 95% CI 0,6-1,0), bolesnika koji su već bili primili jedan terapijski protokol (HR = 0,76; 95% CI 0,6-1,0) ili više terapijskih protokola (HR = 0,75; 95% CI 0,6-1,0), bijelaca (HR = 0,79; 95% CI 0,6-1,0) ili Azijata (HR = 0,61; 95% CI 0,4-1,0), bolesnika s adenokarcinomom (HR = 0,71; 95% CI 0,6-0,9) ili karcinomom skvamoznih stanica (HR = 0,67;
PFS (median in months), Investigator assessed p<0.0001
Prema procjeni ispitivača p<0,0001
Tarceva is indicated for the first-line treatment of patients with locally advanced or metastatic nonsmall cell lung cancer (NSCLC) with EGFR activating mutations.
Tarceva je indicirana za prvu liniju liječenja bolesnika s lokalno uznapredovalim ili metastatskim rakom pluća nemalih stanica (engl. non-small cell lung cancer, NSCLC) s aktivirajućim mutacijama
Patients were randomised 1:1 to receive Tarceva 150 mg or placebo orally once daily until disease progression.
Randomizacijom u omjeru 1:1 bolesnici su primali lijek Tarceva od 150 mg ili placebo, peroralno, jednom dnevno do progresije bolesti.
• 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;
Trebate obavijestiti liječnika: · u slučaju iznenadne pojave poteškoća s disanjem popraćenih kašljem ili vrućicom, jer će Vam liječnik možda morati propisati druge lijekove i obustaviti liječenje lijekom Tarceva,
Very rare side effects (may affect up to 1 in 10,000 people):
Vrlo rijetke nuspojave (mogu se javiti kod manje od 1 na 10 000 osoba):
Tarceva is not recommended for use in patients with severe hepatic dysfunction.
Ne preporučuje se primjena lijeka Tarceva u bolesnika s teškim poremećajem funkcije jetre.
Concomitant use of CYP3A4 substrates and modulators may require dose adjustment (see section 4.5).
Pri istovremenoj primjeni CYP3A4 supstrata i modulatora možda će biti potrebno prilagoditi dozu
Pancreatic cancer (Tarceva administered concurrently with gemcitabine)
Rak gušterače (primjena lijeka Tarceva u kombinaciji s gemcitabinom)
Management In case of suspected overdose, Tarceva should be withheld and symptomatic treatment initiated.
Ako se posumnja na predoziranje, potrebno je obustaviti primjenu lijeka Tarceva i započeti odgovarajuće liječenje.
Tiredness, fever, rigors
· umor, vrućica, tresavica
Tarceva is also indicated for switch maintenance treatment in patients with locally advanced or metastatic NSCLC with EGFR activating mutations and stable disease after first-line chemotherapy.
Tarceva je također indicirana u terapiji održavanja bolesnika s lokalno uznapredovalim ili metastatskim NSCLC-om s aktivirajućim mutacijama EGFR-a i stabilnom bolešću nakon prve linije kemoterapije koja nije uključivala erlotinib (engl. switch maintenance).
Each 100 mg film-coated tablet contains 69.21 mg Lactose monohydrate.
Tarceva 100 mg filmom obložene tablete Jedna filmom obložena tableta od 100 mg sadrži 69,21 mg laktoza hidrata.
The primary endpoint of the study included progression free survival (PFS) in all patients.
Primarna mjera ishoda bila je preživljenje bez progresije bolesti (PFS) prema procjeni ispitivača
Your doctor may need to interrupt or stop your treatment.
Vaš liječnik će možda odlučiti da trebate privremeno ili stalno prekinuti terapiju.
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.
To je ispitivanje provedeno na 889 bolesnika s lokalno uznapredovanim ili metastatskim rakom pluća nemalih stanica kod kojih, nakon 4 ciklusa kombinacijske kemoterapije na bazi platine, nije došlo do progresije bolesti.
How to store Tarceva
Kako čuvati lijek Tarceva
Patients were randomised 2:1 to receive Tarceva 150 mg or placebo orally once daily.
bolesnici su primali lijek Tarceva od 150 mg ili placebo peroralno jednom dnevno.
Lactose monohydrate Cellulose, microcrystalline (E460) Sodium starch glycolate Type A Sodium laurilsulfate Magnesium stearate (E470 b)
A natrijev laurilsulfat magnezijev stearat (E470 b)
Tumour regression is observed in mouse models of enforced expression of these EGFR activating mutations.
Na mišjim modelima s pojačanom ekspresijom ovih aktivirajućih mutacija EGFR, zamijećena je regresija tumora.
Locally Advanced Population
Populacija s lokalno uznapredovalom bolešću
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.
intersticijska upala pluća, intersticijska bolest pluća, obliterirajući bronhiolitis, plućna fibroza, akutni respiratorni distres sindrom (ARDS), alveolitis i plućni infiltrat.
The geometric mean of the C24h was 288 ng/mL in the non-smokers and 34.8 ng/mL in the smokers with a mean ratio of 12.1% (95% CI: 4.82 to 30.2, p = 0.0001).
Geometrijska sredina C24h iznosila je 288 ng/ml u nepušača i 34,8 ng/ml u pušača uz srednji omjer od 12,1%
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.
Karakteristika je erlotiniba smanjena topivost pri pH vrijednost iznad 5. Lijekovi koji mijenjaju pH vrijednost gornjeg dijela gastrointestinalnog trakta, poput inhibitora protonske pumpe, H2 antagonista i antacida, mogu promijeniti topivost erlotiniba, a time i njegovu bioraspoloživost.
Each 150 mg film-coated tablet contains 103.82 mg Lactose monohydrate.
Tarceva 150 mg filmom obložene tablete Jedna filmom obložena tableta od 150 mg sadrži 103,82 mg laktoza hidrata.
Caution should be observed when these active substances are combined with erlotinib.
Pri kombiniranju ovih supstanci s erlotinibom potreban je oprez.
Tarceva is also indicated for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen.
Tarceva je također indicirana u liječenju bolesnika s lokalno uznapredovanim ili metastatskim rakom pluća nemalih stanica nakon neuspjelog liječenja najmanje jednim kemoterapijskim protokolom.
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.
Podaci o sigurnosti za doze od 300 mg i 150 mg bili su usporedivi; međutim, u bolesnika koji su primali višu dozu erlotiniba zabilježeno je brojčano povećanje incidencije osipa, intersticijske bolesti pluća i proljeva.