natgillin/translations-raw huggingface dataset:
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.
In addition, renal function and serum electrolytes including potassium should be monitored in patients at risk of dehydration. 
Osim toga, u bolesnika za koje postoji rizik od dehidracije, potrebno je pratiti funkciju bubrega i elektrolite u serumu, uključujući kalij.
Erlotinib tested negative in conventional genotoxicity studies. 
Rezultat konvencionalnih ispitivanja genotoksičnosti erlotiniba bio je negativan.
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). 
Prijavljeni su vrlo rijetki slučajevi perforacije rožnice ili ulceracije tijekom uzimanja lijeka Tarceva (vidjeti dio 4.8).
-Stevens-Johnson syndrome/Toxic epidermal necrolysis7 
toksična epidermalna nekroliza 7
Non-small cell lung cancer (Tarceva administered as monotherapy) 
Rak pluća nemalih stanica (primjena lijeka Tarceva kao monoterapije)
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. 
Istovremeno uzimanje rifampicina s jednom dozom lijeka Tarceva od 450 mg rezultiralo je prosječnom raspoloživosti erlotiniba (AUC) od 57,5%
Erlotinib is metabolised in the liver by the hepatic cytochromes in humans, primarily CYP3A4 and to a lesser extent by CYP1A2. 
Erlotinib se metabolizira u jetri pomoću jetrenih citokroma u ljudi, prije svega CYP3A4 te nešto manje
Rash and diarrhoea resulted in discontinuation of Tarceva in 1% and <1% of patients, respectively, in study BO18192, while no patients discontinued for rash or diarrhoea in BO25460. 
Ni u jednom od ta dva ispitivanja nisu primijećeni osip ni proljev stupnja 4. Osip i proljev doveli su do prekida liječenja lijekom Tarceva u 1% odnosno < 1% bolesnika u ispitivanju BO18192, dok u ispitivanju BO25460 nijedan bolesnik nije prekinuo liječenje zbog osipa ili proljeva.
• The active substance of Tarceva is erlotinib. 
Što Tarceva sadrži · Djelatna tvar lijeka Tarceva je erlotinib.
In the pancreatic cancer study in combination with gemcitabine, the incidence of ILD-like events was 2.5% in the Tarceva plus gemcitabine group versus 0.4% in the placebo plus gemcitabine treated group. 
U ispitivanju provedenom u bolesnika s rakom gušterače, incidencija pojave simptoma nalik intersticijskoj bolesti pluća iznosila je 2,5% u grupi koja je primala lijek Tarceva u kombinaciji s gemcitabinom, odnosno 0,4% u grupi liječenoj placebom u kombinaciji s gemcitabinom.
LIST OF EXCIPIENTS Contains lactose monohydrate. 
Sadrži laktoza hidrat.
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. 
Tarceva 25 mg su bijele do žućkaste okrugle filmom obložene tablete s utisnutim natpisom "T 25" na jednoj strani, a dostupne su u pakiranju od 30 tableta.
Erlotinib and Capecitabine 
Erlotinib i kapecitabin
The primary endpoint was overall survival. 
Primarna mjera ishoda bila je ukupno preživljenje (OS).
In the pivotal study BR.21 in NSCLC, the incidence of ILD (0.8%) was the same in both the placebo and Tarceva groups. 
U pivotalnom ispitivanju BR.21 za rak pluća nemalih stanica, incidencija intersticijske bolesti pluća (0,8%) bila je jednaka u skupini koja je primala placebo i skupini koja je primala lijek Tarceva.
Rigors very common very common very common 
Kašalj vrlo često vrlo često
Diarrhoea, dehydration, electrolyte imbalance and renal failure Diarrhoea (including very rare cases with a fatal outcome) has occurred in approximately 50% of patients on Tarceva and moderate or severe diarrhoea should be treated with e.g. loperamide. 
Proljev (uključujući vrlo rijetko slučajeve sa smrtnim ishodom) se pojavio u otprilike 50% bolesnika koji su koristili lijek Tarceva, a umjereni ili težak proljev bilo je potrebno liječiti npr. loperamidom.
Name and address of the manufacturer responsible for batch release 
PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet Roche Pharma AG
There were no significant effects of carboplatin or paclitaxel on the pharmacokinetics of erlotinib. 
Nisu uočeni značajni učinci karboplatina ili paklitaksela na farmakokinetiku erlotiniba.
Glucuronidation disorder like Gilbert's syndrome Your doctor must treat you with caution if you have a glucuronidation disorder like Gilbert's syndrome. 
Ako patite od poremećaja glukuronidacije, kao što je Gilbertov sindrom, liječnik Vas mora liječiti uz povećani oprez.
Dermatitis acneiform -Skin fissures 
- paronihija - folikulitis - akne/ akneiformni dermatitis - kožne fisure
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. 
U bolesnika koji nastave pušiti cigarete, doza od 300 mg u usporedbi s preporučenom dozom od 150 mg nije pokazala bolju djelotvornost u drugoj liniji liječenja nakon neuspješne kemoterapije.
In a phase I dose escalation study in NSCLC patients who were current smokers, pharmacokinetic analyses at steady-state indicated a dose proportional increase in erlotinib exposure when the Tarceva dose was increased from 150 mg to the maximum tolerated dose of 300 mg. Steady-state trough plasma concentrations at a 300 mg dose in current smokers in this study was 1.22 µg/mL (n=17). 
I povećavanja doze u bolesnika pušača s rakom pluća nemalih stanica, farmakokinetička analiza u stanju dinamičke ravnoteže pokazala je proporcionalno povećanje u izloženosti erlotinibu kada je doza lijeka Tarceva povećana sa 150 mg do maksimalno podnošljive doze od 300 mg.
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. 
već je bilo primilo terapijski protokol s platinom, a 36% odnosno 37% svih bolesnika prethodno je bilo liječeno taksanima.
Each 25 mg film-coated tablet contains 27.43 mg Lactose monohydrate. 
Tarceva 25 mg filmom obložene tablete Jedna filmom obložena tableta od 25 mg sadrži 27,43 mg laktoza hidrata.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, 4.2). 
Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2)
The most frequent ADRs seen in patients treated with Tarceva in study ML20650 were rash and diarrhoea (any Grade 80% and 57%, respectively), most were Grade 1/2 in severity and manageable without intervention. 
bile su osip i proljev (bilo kojeg stupnja u 80% odnosno 57% bolesnika), koji su većinom bili stupnja težine 1/2 i mogli su se zbrinuti bez medicinske intervencije.
Δ 
U
- NSCLC treatment after failure of at least one prior chemotherapy regimen (Tarceva administered as monotherapy) 
- Liječenje raka pluća nemalih stanica nakon neuspjeha primjene barem jednog kemoterapijskog protokola (Tarceva primijenjena kao monoterapija)
The usual dose is one tablet of Tarceva 100 mg each day if you have metastatic pancreatic cancer. 
Ako imate metastatski rak gušterače, uobičajena doza je jedna Tarceva tableta od 100 mg dnevno.
Cut-off date: Aug 2010 
Podaci do: kolovoz 2010.
NAME OF THE MEDICINAL PRODUCT Tarceva 25 mg film-coated tablets Tarceva 100 mg film-coated tablets Tarceva 150 mg film-coated tablets 
Tarceva 25 mg filmom obložene tablete Tarceva 100 mg filmom obložene tablete Tarceva 150 mg filmom obložene tablete
Erlotinib is primarily cleared by the liver. 
Najvećim dijelom erlotinib se uklanja putem jetre.
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. 
Rak gušterače (primjena lijeka Tarceva u kombinaciji s gemcitabinom u ispitivanju PA.3) Djelotvornost i sigurnost primjene lijeka Tarceva u kombinaciji s gemcitabinom u prvoj liniji liječenja ispitivana je u randomiziranom, dvostruko slijepom, placebo kontroliranom ispitivanju u bolesnika s lokalno uznapredovalim, neoperabilnim ili metastatskim rakom gušterače.
In a post-hoc analysis, patients with favourable clinical status at baseline (low pain intensity, good QoL and good PS) may derive more benefit from Tarceva. 
(slab intenzitet boli, dobra kvaliteta života i dobrim funkcionalnim stanjem) imali više koristi od lijeka Tarceva.
• Bleeding from the nose 
Za primjenu kroz usta
If a diagnosis of ulcerative keratitis is confirmed, treatment with Tarceva should be interrupted or discontinued. 
Potvrdi li se dijagnoza ulceroznog keratitisa, liječenje lijekom
- Maintenance NSCLC therapy after first-line chemotherapy (Tarceva administered as monotherapy) 
- Terapija održavanja u raku pluća nemalih stanica nakon prve linije kemoterapije (Tarceva primijenjena kao monoterapija)
Including in-growing eyelashes, excessive growth and thickening of the eyelashes. 
u kliničkom ispitivanju PA.3. 2 uključujući rast trepavica prema oku, pojačan rast i zadebljanje trepavica.
Cut-off date: Jan 2011 
Podaci do: siječanj 2011.
Alopecia very common very common very common very common 
Pireksija Tresavica vrlo često vrlo često vrlo često
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). 
najveća je korist opažena u unaprijed definiranoj eksploracijskoj analizi provedenoj u bolesnika s aktivirajućim mutacijama EGFR-a (n = 49), koja je pokazala znatnu korist u smislu PFS-a (HR = 0,10, 95% CI: 0,04 - 0,25; p < 0,0001) i omjera hazarda (HR) za ukupno preživljenje od 0,83 (95% CI: 0,34 - 2,02).
Gastrointestinal perforations have been observed (uncommon: may affect up to 1 in 100 people). 
Opažena su puknuća (perforacije) u probavnom sustavu (manje često: mogu se javiti kod manje od 1 na 100 osoba).
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. 
Erlotinib i pušači Rezultati ispitivanja farmakokinetičkih interakcija u pušača i nepušača ukazuju na to da pušenje značajno smanjuje AUCinf , Cmax i koncentracije u plazmi mjereno 24 sata nakon primjene lijeka Tarceva (2,8 puta, 1,5 puta odnosno 9 puta).
• Eyebrow changes 
1 - promjene na trepavicama
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 
(≥ 3%) nego uz placebo u ispitivanjima BR.21 (liječenje lijekom Tarceva) i PA.3 (liječenje lijekom Tarceva i gemcitabinom)
Common side effects (may affect up to 1 in 10 people): 
Vrlo česte nuspojave (mogu se javiti kod više od 1 na 10 osoba):
Confounding or contributing factors such as concomitant or prior chemotherapy, prior radiotherapy, pre-existing parenchymal lung disease, metastatic lung disease, or pulmonary infections were frequent. 
Učestali su bili i šumovi ili neki potpomažući faktori, poput istovremene ili prethodne kemoterapije, prethodne terapije zračenjem,
-Hepatic failure 6 
- zatajenje jetre 6
• if you are also taking a statin and experience unexplained muscle pain, tenderness, weakness or cramps. 
Vam se neobjašnjiva bol u mišićima, osjetljivost, slabost mišića ili grčevi.
Cases were mainly mild to moderate in severity, transient in nature or associated with liver metastases. 
Ona su bila vrlo česta u kliničkom ispitivanju PA.3 i česta u ispitivanju BR.21.Uglavnom su bile blagog ili umjerenog intenziteta, prolazne ili povezane s metastazama u jetri.
In a clinical study, the concomitant use of erlotinib with ketoconazole (200 mg orally twice daily for 5 days), a potent CYP3A4 inhibitor, resulted in an increase of erlotinib exposure (86% of AUC and 69% of Cmax). 
U kliničkom ispitivanju pokazalo se da istovremena primjena erlotiniba s ketokonazolom (200 mg peroralno, dvaput dnevno, tijekom 5 dana), jakim CYP3A4 inhibitorom,
If you experience more severe or persistent diarrhoea contact your doctor immediately as your doctor may need to treat you in the hospital. 
Ako imate težak ili dugotrajan proljev, odmah se obratite svom liječniku jer
Extrahepatic metabolism by CYP3A4 in intestine, CYP1A1 in lung, and CYP1B1 in tumour tissue also potentially contribute to the metabolic clearance of erlotinib. 
Metabolizmu erlotiniba potencijalno pridonosi i metabolizam izvan jetre, putem CYP3A4 u crijevu, CYP1A1 u plućima i CYP1B1 u tumorskom tkivu.
Patients with Non-Small Cell Lung Cancer EGFR mutation testing should be performed in accordance with the approved indications (see section 
Treba provesti testiranje na mutacije EGFR-a sukladno odobrenim indikacijama (vidjeti dio 4.1).
Concomitant treatment with these types of agents should be avoided (see section 4.5). 
Stoga je potrebno izbjegavati njihovu istovremenu primjenu s lijekom Tarceva (vidjeti dio 4.5).
The geometric mean of the Cmax was 1056 ng/mL in the non-smokers and 689 ng/mL in the smokers with a mean ratio for smokers to non-smokers of 65.2% (95% CI: 44.3 to 95.9, p = 0.031). 
689 ng/ml u pušača, uz srednji omjer vrijednosti u pušača prema nepušačima od 65,2% (95% CI:
Assessment of EGFR mutation status 
DATUM REVIZIJE TEKSTA
NAME OF THE MEDICINAL PRODUCT Tarceva 25 mg film-coated tablets Erlotinib 
Tarceva 25 mg filmom obložene tablete erlotinib
In the event of severe or persistent diarrhoea, nausea, anorexia, or vomiting associated with dehydration, Tarceva therapy should be interrupted and appropriate measures should be taken to treat the dehydration (see section 4.8). 
U slučaju teškog ili dugotrajnog proljeva, mučnine, anoreksije ili povraćanja uz dehidraciju, potrebno je obustaviti terapiju lijekom
Hypersensitivity to erlotinib or to any of the excipients listed in section 6.1. 
Preosjetljivost na erlotinib ili neku od pomoćnih tvari navedenih u dijelu 6.1. 4.4 Posebna upozorenja i mjere opreza pri uporabi Procjena statusa EGFR mutacija
Both rash and diarrhoea resulted in discontinuation of Tarceva in 1% of patients. 
Nije zabilježen osip ni proljev stupnja 4. I osip i proljev doveli su do prekida liječenja lijekom Tarceva u 1% bolesnika.
Pre-planned Interim Analysis (35% OS maturity) (n=153) 
(sa 35% podataka za OS) (n=153)
MARKETING AUTHORISATION NUMBER(S) EU/1/05/311/001 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/05/311/001
Contact your doctor as soon as possible if you suffer from any of the below side effects. 
Ako patite od bilo koje od niže navedenih nuspojava obratite se liječniku što je moguće prije.
- First-line Non-Small Cell Lung Cancer (NSCLC) therapy for patients with EGFR activating mutations (Tarceva administered as monotherapy) 
Klinička djelotvornost - Prva linija liječenja raka pluća nemalih stanica (NSCLC-a) u bolesnika s aktivirajućim mutacijama
When erlotinib was co-administered with ciprofloxacin, a moderate CYP1A2 inhibitor, the erlotinib exposure [AUC] increased significantly by 39%, while no statistically significant change in Cmax was found. 
raspoloživost erlotiniba (AUC) značajno se povećala za 39%, dok nije uočena statistički značajna promjena vrijednosti Cmax.
Erlotinib and Carboplatin/Paclitaxel 
Erlotinib i karboplatin/paklitaksel
Medicinal products that alter the pH of the upper Gastro-Intestinal (GI) tract 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 u gornjem dijelu probavnog trakta mogu promijeniti topivost erlotiniba pa tako i njegovu bioraspoloživost.
CI of HR 
CI za D HR CI za HR pvrijednost
MARKETING AUTHORISATION NUMBER(S) EU/1/05/311/002 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/05/311/002
There were treatment-related increases in ALT, AST and bilirubin. 
Kao posljedica liječenja došlo je i do povećanja ALT, AST te bilirubina.
Rash and diarrhoea each resulted in dose reductions in 2% of patients, and resulted in study discontinuation in up to 1% of patients receiving Tarceva plus gemcitabine. 
U bolesnika koji su primali lijek Tarceva u kombinaciji s gemcitabinom,doza se morala smanjiti u 2% bolesnika zbog osipa i 2% zbog proljeva, koji su doveli do prekida ispitivanja u do 1% bolesnika.
NAME OF THE MEDICINAL PRODUCT Tarceva 150 mg film-coated tablets Erlotinib 
Tarceva 150 mg filmom obložene tablete erlotinib
MARKETING AUTHORISATION NUMBER(S) EU/1/05/311/003 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/05/311/003
Renal and urinary disorders insufficiency1 -Nephritis1 -Proteinuria1 
- nefritis1 - proteinurija1
The usual dose is one tablet of Tarceva 150 mg each day if you have non-small cell lung cancer. 
Ako imate rak pluća nemalih stanica, uobičajena doza je jedna Tarceva tableta od 150 mg dnevno.
NAME OF THE MEDICINAL PRODUCT Tarceva 100 mg film-coated tablets Erlotinib 
Tarceva 100 mg filmom obložene tablete erlotinib
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. 
U bolesnika koji su primali lijek Tarceva prijavljene su interakcije s kumarinskim antikoagulansima uključujući varfarin, koje su dovele do porasta INR-a (engl.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 25 mg of erlotinib (as erlotinib hydrochloride). 
NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 25 mg erlotiniba (u obliku erlotinibklorida).
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 150 mg of erlotinib (as erlotinib hydrochloride). 
NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 150 mg erlotiniba (u obliku erlotinibklorida).
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 100 mg of erlotinib (as erlotinib hydrochloride). 
NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 100 mg erlotiniba (u obliku erlotinibklorida).
-Rash 
- osip
• If you get any side effects, talk to your doctor or pharmacist. 
· Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
5.3 Preclinical safety data 
Podaci o sigurnosti za doze od
White to yellowish, round, biconvex tablets with ‘T 100' engraved on one side. 
Tarceva 100 mg filmom obložene tablete Bijele do žućkaste, okrugle, bikonveksne tablete s utisnutim natpisom "T 100" na jednoj strani.
Dose reduction or interruption of Tarceva should be considered if severe adverse reactions occur. 
Ako se pojave teške nuspojave, treba razmotriti smanjenje doze ili prekid liječenja lijekom Tarceva.
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. 
Tarceva 150 mg filmom obložene tablete Bijele do žućkaste, okrugle, bikonveksne tablete s utisnutim natpisom "T 150" na jednoj strani.
Hepatic impairment 
Mučnina Povraćanje
White to yellowish, round, biconvex tablets with ‘T 25' engraved on one side. 
Tarceva 25 mg filmom obložene tablete Bijele do žućkaste, okrugle, bikonveksne tablete s utisnutim natpisom "T 25" na jednoj strani.
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. 
Tarceva 100 mg su bijele do žućkaste okrugle filmom obložene tablete s utisnutim natpisom "T 100"
Vomiting 
Anoreksija
-Eyelash changes 2 
- proljev 7
Stomach pain, indigestion and flatulence 
Dijareja, dehidracija, neravnoteža elektrolita, zatajenje bubrega
Renal impairment 
- renalna insuficijencija1
[This section should be amended to reflect the following wording] 
[Ovaj dio treba prilagoditi kako bi odražavao sljedeći tekst]
What is alfacalcidol? 
Što je alfakalcidiol?
Combination of alendronic acid and alfacalcidol (Valebo): 
Kombinacija alendronatne kiseline i alfakalcidiola (Valebo):
Section 4.1: Therapeutic indications [The wording of this section should be read as below] Treatment of postmenopausal osteoporosis. 
Dio 4.1: Terapijske indikacije [Tekst ovog dijela treba glasiti kako je niže navedeno] Liječenje postmenopauzalne osteoporoze.