natgillin/translations-raw huggingface dataset:
Other information on drug-drug interactions 
Drugi podatki o interakcijah med zdravili
Patients should maintain adequate oral hydration and patients who become dehydrated may require administration of intravenous fluids and electrolytes (see section 4.2). 
Bolniki morajo vzdrževati zadostno peroralno hidracijo, pri bolnikih, ki dehidrirajo, pa je lahko potrebno dajanje intravenskih tekočin in elektrolitov (glejte poglavje 4.2).
Other medicines and Vizimpro 
Druga zdravila in zdravilo Vizimpro
• Flushed or painful palms or soles 
• pordele ali boleče dlani ali stopala
Breast-feeding Do not breast-feed while taking this medicine because it is not known if it can harm your baby. 
Dojenje Med jemanjem tega zdravila ne smete dojiti, ker ni znano, ali lahko škoduje otroku.
Treat with anti-diarrhoeal medicinal products (e.g., loperamide), and adequate oral fluid intake or intravenous fluids or electrolytes as appropriate. 
Zdravite z antidiaroiki (npr. loperamid) in zadostnim uživanjem tekočin ali intravenskim dajanjem tekočin ali elektrolitov, kot je primerno.
Dacomitinib was tested using a series of genetic toxicology assays. 
Dakomitinib so testirali z vrsto genetskih toksikoloških preskusov.
Studies in animals have shown limited effects on reproductive toxicity (lower maternal body weight gain and food consumption in rats and rabbits, and lower foetal body weight and higher incidence of unossified metatarsals in rats only) (see section 5.3). 
Študije na živalih so pokazale omejene škodljive vplive na sposobnost razmnoževanja (manjše povečanje telesne mase samic-mater in manjše uživanje hrane pri samicah podgan in kuncev ter manjša telesna masa ploda in večja incidenca nezakostenelih metatarzalnih kosti samo pri podganah) (glejte poglavje 5.3).
Co-administration of dacomitinib and CYP2D6 substrates 
Sočasno dajanje dakomitiniba in substratov CYP2D6
Dacomitinib is a substrate for the membrane transport proteins P-gp and BCRP. 
Dakomitinib je substrat membranskih prenašalnih beljakovin P-gp in BCRP.
It is important to treat the rash early. 
Pomembno je, da izpuščaj zdravimo zgodaj.
Very common adverse reactions in Phase 3 Study ARCHER 1050 (N=451) Dacomitinib (N=227) 
Zelo pogosti neželeni učinki v študiji 3. faze ARCHER 1050 (n = 451)
In a clinical study, one patient (0.4%) had a fatal outcome (see section 4.4). 
V klinični študiji je pri 1 bolniku (0,4 %) prišlo do smrtnega izida (glejte poglavje 4.4).
Vizimpro contains the active substance dacomitinib, which belongs to a group of medicines called protein tyrosine kinase inhibitors which are used to treat cancer. 
Zdravilo Vizimpro vsebuje učinkovino dakomitinib, ki spada v skupino zdravil, imenovanih ''zaviralci beljakovin tirozin-kinaz'', ki jih uporabljamo za zdravljenje raka.
You should not become pregnant during treatment with Vizimpro because this medicine could harm the baby. 
Med zdravljenjem z zdravilom Vizimpro ne smete zanositi, saj bi to zdravilo lahko škodovalo otroku.
The aqueous solubility of dacomitinib is pH dependent, with low (acidic) pH resulting in higher solubility. 
Vodotopnost dakomitiniba je odvisna od vrednosti pH, pri čemer nižji (kisel) pH pomeni boljšo topnost.
The maternally toxic dose was foetotoxic in rats, resulting in reduced foetal body weights and higher incidence of unossified metatarsals. 
Odmerek, toksičen za mater, je bil pri podganah fetotoksičen in je povzročil zmanjšano telesno maso ploda ter večjo incidenco nezakostenelih metatarzalnih kosti.
Pharmacotherapeutic group: Anti-neoplastic agents, protein kinase inhibitors, ATC code: L01XE47 
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, zaviralci proteinskih kinaz, oznaka ATC: L01XE47
• For Grade 2 diarrhoea, if not improved to Grade ≤ 1 within 24 hours while using anti-diarrhoeal medicinal products (e.g., loperamide) and adequate oral fluid intake, withhold dacomitinib. 
• Pri diareji stopnje 2, ki se ne izboljša do stopnje ≤ 1 v 24 urah uporabe antidiaroikov (npr. loperamid) in zadostnega uživanja tekočin, prekinite zdravljenje z dakomitinibom.
If you become pregnant while taking this medicine, you should immediately talk to your doctor. 
Če med jemanjem tega zdravila zanosite, se takoj posvetujte z zdravnikom.
Vizimpro is for oral use. 
Zdravilo Vizimpro je za peroralno uporabo.
If you forget to take Vizimpro 
Če ste pozabili vzeti zdravilo Vizimpro
Dacomitinib should be administered 2 hours before or at least 10 hours after taking H2 receptor antagonists. 
Dakomitinib je treba dati 2 uri pred uporabo antagonistov receptorjev H2 ali vsaj 10 ur po tem.
Vizimpro is used to treat adults with a type of lung cancer called ‘non-small cell lung cancer'. 
Zdravilo Vizimpro uporabljamo za zdravljenje odraslih z vrsto pljučnega raka, ki ga imenujemo ''nedrobnocelični rak pljuč''.
• Diarrhoea (very common, may affect more than 1 in 10 people) Diarrhoea may lead to fluid loss (common), low blood potassium (very common), and worsening kidney function and can be fatal. 
• Driska (zelo pogosto, pojavi se lahko pri več kot 1 od 10 bolnikov) Driska lahko privede do izgube tekočine (pogosto), zmanjšanja vrednosti kalija v krvi (zelo pogosto) in poslabšanja delovanja ledvic ter je lahko usodna.
Dacomitinib showed a clearance of 20.0 L/hr with an inter-individual variability of 32% (CV%). 
Očistek dakomitiniba je znašal 20,0 l/h, z variabilnostjo med posamezniki v velikosti 32 % (KV%).
• The recommended dose is 45 mg taken by mouth each day. 
• Priporočeni odmerek je 45 mg peroralno enkrat na dan.
Across the dacomitinib program, hepatic failure led to a fatal outcome in 1 patient. 
V sklopu programa zdravljenja z dakomitinibom je odpoved jeter privedla do smrtnega izida pri 1 bolniku.
The pharmacokinetics in patients requiring haemodialysis have not been studied. 
Farmakokinetike pri bolnikih, ki potrebujejo hemodializo, niso preučevali.
Film coating: Opadry II Blue 85F30716 containing polyvinyl alcohol - partially hydrolysed (E1203), talc (E553b), titanium dioxide (E171), macrogol (E1521), Indigo carmine aluminium lake (E132). 
Filmska obloga: Opadry II modra 85F30716, ki vsebuje polivinilalkohol - delno hidroliziran (E1203), smukec (E553b), titanov dioksid (E171), makrogol (E1521), indigotin (E132).
C] radiolabeled dacomitinib, a median of 82% of the total administered radioactivity was recovered in 552 hours; faeces (79% of dose) was the major route of excretion, with 3% of the dose recovered in urine, of which < 1% of the administered dose was unchanged dacomitinib. 
C] dakomitiniba, se je povprečno 82 % celotne dane radioaktivnosti izločilo v 552 urah; glavna pot izločanja je bilo blato (79 % odmerka), medtem ko se je z urinom izločilo 3 % odmerka, pri čemer je bilo < 1 % danega odmerka v obliki nespremenjenega dakomitiniba.
These results suggest that dacomitinib may increase exposure of other medicinal products (or decrease exposure to active metabolites) primarily metabolised by CYP2D6. 
Ti rezultati kažejo, da dakomitinib lahko poveča izpostavljenost drugim zdravilom (ali zmanjša izpostavljenost aktivnim presnovkom), ki se pretežno presnavljajo preko CYP2D6.
Diarrhoea was the most frequently reported adverse reaction in patients receiving Vizimpro (88.6%) and Grade ≥ 3 diarrhoea adverse reactions were reported in 9.4% of patients. 
Diareja je bila neželeni učinek, o katerem so pri bolnikih, ki so prejemali zdravilo Vizimpro, poročali najpogosteje (88,6 %), pri čemer so o diareji stopnje ≥ 3 poročali pri 9,4 % bolnikov.
What you need to know before you take Vizimpro 
Kaj morate vedeti, preden boste vzeli zdravilo Vizimpro
Based on its mechanism of action, dacomitinib may cause foetal harm when administered to a pregnant woman. 
Glede na njegov mehanizem delovanja lahko dakomitinib škoduje plodu, če ga uporabljamo pri nosečnicah.
If you take H2 blocker medicine take your dose of Vizimpro at least 2 hours before or 10 hours after taking the H2 blocker medicine. 
Če jemljete zaviralec histaminskega receptorja H2, vzemite odmerek zdravila Vizimpro vsaj 2 uri pred ali pa 10 ur po jemanju zaviralca histaminskega receptorja H2.
Progression-Free Survival (per IRC) Number of patients with event, n (%) Median PFS in months (95% CI) HR (95% CI) 
Preživetje brez napredovanja bolezni (glede na IRC) število bolnikov z dogodkom, n (%) mediano PFS v mesecih (95 % IZ) HR (95% IZ)
If ILD/pneumonitis is confirmed, dacomitinib should be permanently discontinued and appropriate treatment instituted as necessary (see section 4.2). 
Če potrdite ILD/pnevmonitis, je treba zdravljenje z dakomitinibom trajno prekiniti in po potrebi uvesti ustrezno zdravljenje (glejte poglavje 4.2).
Hepatotoxicity and transaminases increased 
Hepatotoksičnost in zvečanje vrednosti transaminaz
• If Grade 2 rash, erythematous or exfoliative skin conditions persist for 72 hours despite treatment, withhold dacomitinib. 
• Če izpuščaj, eritematozne ali eksfoliativne kožne bolezni stopnje 2 kljub zdravljenju trajajo 72 ur, prekinite zdravljenje z dakomitinibom.
Based on pooled data in patients, there was no apparent effect of histamine-2 (H2) receptor antagonists on steady-state trough concentration of dacomitinib (geometric mean ratio of 86% (90% CI: 73; 101). 
Na podlagi združenih podatkov pri bolnikih ni bilo očitnega učinka antagonistov histaminskih-2 (H2) receptorjev na najmanjšo koncentracijo dakomitiniba v stanju dinamičnega ravnovesja (razmerje geometričnih srednjih vrednosti 86 % (90 % IZ: 73; 101).
From the small number of patients in the moderate group [total bilirubin > 1.5 to 3 × ULN and any AST; N=5], there is no evidence for a change in dacomitinib pharmacokinetics. 
Pri manjšem številu bolnikov iz skupine z zmerno okvaro jeter [celokupni bilirubin > 1,5 do 3 × ZMN in kakršnakoli AST; n = 5] ni dokazov za spremenjeno farmakokinetiko dakomitiniba.
Carcinogenicity studies have not been performed with dacomitinib. 
Študij kancerogenosti z dakomitinibom niso izvedli.
It is available in blister packs of 30 film-coated tablets (tablets). 
Zdravilo je na voljo v pretisnih omotih s 30 filmsko obloženimi tabletami (tabletami).
Vizimpro contains lactose and sodium 
Zdravilo Vizimpro vsebuje laktozo in natrij
Patients experiencing fatigue or ocular adverse reactions while taking dacomitinib should exercise caution when driving or operating machinery. 
Bolniki, pri katerih se med jemanjem dakomitiniba pojavijo utrujenost ali očesni neželeni učinki, morajo biti previdni pri vožnji ali upravljanju strojev.
In addition, based on a population pharmacokinetic analysis using data from 1381 patients, that included 158 patients with mild hepatic impairment defined by National Cancer Institute (NCI) criteria [total bilirubin ≤ Upper Limit of Normal (ULN) and Aspartate Aminotransferase (AST) > ULN, or total bilirubin > 1.0 to 1.5 × ULN and any AST; N=158], mild hepatic impairment had no effect on the pharmacokinetics of dacomitinib. 
Poleg tega na podlagi populacijske farmakokinetične analize, v kateri so uporabili podatke 1.381 bolnikov, vključno s 158 bolniki z blago okvaro jeter po merilih Nacionalnega inštituta za rakava obolenja (NCI - National Cancer Institute) [celokupni bilirubin ≤ zgornja meja normale (ZMN) in vrednost aspartat-aminotransferaze (AST) > ZMN, ali celokupni bilirubin > 1,0 do 1,5 × ZMN in kakršnakoli vrednost AST; n = 158], blaga okvara jeter ni vplivala na farmakokinetiko dakomitiniba.
Grade 3 exfoliative skin conditions were reported in 0.8% of patients (see section 4.4). 
O eksfoliativnih kožnih boleznih stopnje 3 so poročali pri 0,8 % bolnikov (glejte poglavje 4.4).
Vizimpro, as monotherapy, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations. 
Zdravilo Vizimpro v monoterapiji je indicirano za prvo linijo zdravljenja odraslih bolnikov z lokalno napredovalim ali metastatskim nedrobnoceličnim rakom pljuč (NSCLC - Non-Small Cell Lung Cancer) z aktivirajočimi mutacijami gena receptorja za epidermalni rastni dejavnik (EGFREpidermal Growth Factor Receptor).
Dacomitinib is not directly reactive toward DNA as evidenced by the negative response in the bacterial reverse mutation assay and did not induce chromosome damage in a bone marrow micronucleus assay at concentrations up to approximately 60-70 times the unbound AUC or Cmax at the recommended human dose. 
Dakomitinib ne reagira neposredno z DNA, kot so dokazali z negativnim odzivom v preskusu bakterijskih reverznih mutacij, in ni sprožil poškodb kromosomov v preskusu mikronukleusov v kostnem mozgu pri koncentracijah do približno 60-70-kratnika nevezane AUC ali Cmax pri priporočenem odmerku za človeka.
There was no effect on reproductive organs in male rats given ≤ 2 mg/kg/day for 6 months (approximately 1.1 times the unbound AUC at the recommended human dose), or in dogs given ≤ 1 mg/kg/day for 9 months (approximately 0.3 times the unbound AUC at the recommended human dose). 
Učinka na reprodukcijske organe pri samcih podgan, ki so 6 mesecev prejemali ≤ 2 mg/kg/dan (približno 1,1-kratnik nevezane AUC pri priporočenem odmerku za človeka), oziroma pri psih, ki so 9 mesecev prejemali ≤ 1 mg/kg/dan (približno 0,3-kratnik nevezane AUC pri priporočenem odmerku za človeka), ni bilo.
Tablet core: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, magnesium stearate (see section 2 Vizimpro contains lactose and sodium). 
Jedro tablete: laktoza monohidrat, mikrokristalna celuloza, natrijev karboksimetilškrob, magnezijev stearat (glejte poglavje 2 Zdravilo Vizimpro vsebuje laktozo in natrij).
Transaminases increased (alanine aminotransferase increased, aspartate aminotransferase increased, transaminases increased) were reported in 22.0% of patients receiving Vizimpro and were Grades 1 to 3, with the majority Grade 1 (18.4%) (see section 4.4). 
O zvečanju vrednosti transaminaz (zvečanje vrednosti alanin-aminotransferaze, zvečanje vrednosti aspartat-aminotransferaze, zvečanje vrednosti transaminaz) so poročali pri 22,0 % bolnikov, ki so prejemali zdravilo Vizimpro, bile pa so stopenj 1-3, večinoma stopnje 1 (18,4 %) (glejte poglavje 4.4).
• Inflammation of the lungs (common, may affect up to 1 in 10 people) Difficulty in breathing, shortness of breath, possibly with a cough or fever. 
• Vnetje pljuč (pogosto, pojavi se lahko pri največ 1 od 10 bolnikov) Težave z dihanjem, kratka sapa, ki jih lahko spremljata kašelj ali vročina.
Dacomitinib is a pan-human epidermal growth factor receptor (HER) (EGFR/HER1, HER2, and HER4) inhibitor, with activity against mutated EGFR with deletions in exon 19 or the L858R substitution in exon 21. 
Dakomitinib je panhumani zaviralec receptorjev za epidermalni rastni dejavnik (HER - Human Epidermal Growth Factor Receptor) (EGFR/HER1, HER2 in HER4), ki deluje proti mutiranemu EGFR z delecijami v eksonu 19 ali s substitucijo L858R v eksonu 21.
No clinical studies have been conducted in patients with impaired renal function. 
Kliničnih študij pri bolnikih z okvaro delovanja ledvic niso izvedli.
Data from a study in 24 healthy subjects indicated that co-administration of a single 45 mg dacomitinib dose with the PPI rabeprazole 40 mg once daily for 7 days decreased dacomitinib Cmax, AUC0-96h (area under the concentration-time curve from time 0 to 96 hours), and AUCinf (AUC from time 0 to infinity) (n=14) by approximately 51%, 39%, and 29%, respectively, when compared to a single 45 mg dose of dacomitinib administered alone. 
Podatki iz študije pri 24 zdravih preskušancih so pokazali, da sočasno dajanje enkratnega odmerka 45 mg dakomitiniba skupaj z zaviralcem protonske črpalke rabeprazolom, 40 mg enkrat na dan v obdobju 7 dni, zmanjša vrednosti Cmax, AUC0-96 h (površina pod krivuljo koncentracije zdravila v odvisnosti od časa, od časa 0 do 96 ur) in AUCinf (AUC od časa 0 do neskončno) (n= 14) dakomitiniba za približno 51 %, 39 % oziroma 29 % v primerjavi z enkratnim odmerkom 45 mg dakomitiniba, ki so ga dali samostojno.
• Procainamide, used to treat heart arrhythmias 
• prokainamid, ki se uporablja za zdravljenje aritmij;
This metabolite exhibited in vitro pharmacologic activity that was similar to that of dacomitinib in the in vitro biochemical assays. 
In vitro je imel ta presnovek farmakološko aktivnost, ki je bila podobna farmakološki aktivnosti dakomitiniba v biokemijskih preskusih in vitro.
In vitro studies indicated that CYP2D6 was the major CYP isozyme involved in the formation of O-desmethyl dacomitinib, while CYP3A4 contributed to the formation of other minor oxidative metabolites. 
Študije in vitro so pokazale, da je CYP2D6 glavni izoencim CYP, ki sodeluje pri nastajanju O-dezmetil dakomitiniba, CYP3A4 pa je prispeval k nastajanju drugih, manj pomembnih oksidativnih presnovkov.
You should not take these medicines during your treatment with Vizimpro. 
Med zdravljenjem z zdravilom Vizimpro teh zdravil ne smete jemati.
• Long-acting medicines for reducing stomach acid, such as proton pump inhibitors (for ulcers, indigestion and heartburn). 
• zdravila za zmanjševanje želodčne kisline z dolgotrajnim delovanjem, na primer zaviralci protonske črpalke (za razjede, prebavne motnje in zgago).
Based on population pharmacokinetic analyses, mild (60 mL/min ≤ CrCl < 90 mL/min; N=590) and moderate (30 mL/min ≤ CrCl < 60 mL/min; N=218) renal impairment, did not alter dacomitinib pharmacokinetics, relative to subjects with normal (CrCl ≥ 90 mL/min; N=567) renal function. 
Na podlagi populacijskih farmakokinetičnih analiz blaga (60 ml/min ≤ CrCl < 90 ml/min; n = 590) in zmerna (30 ml/min ≤ CrCl < 60 ml/min; n = 218) okvara ledvic nista spremenili farmakokinetike dakomitiniba v primerjavi s preskušanci z normalnim (CrCl ≥ 90 ml/min; n = 567) delovanjem ledvic.
In vitro, dacomitinib has a low potential to inhibit uridine-diphosphate glucuronosyltransferase (UGT)1A4, UGT1A6, UGT1A9, UGT2B7, and UGT2B15. 
In vitro ima dakomitinib majhen potencial za zaviranje uridin difosfat-glukuronoziltransferaze (UGT)1A4, UGT1A6, UGT1A9, UGT2B7 in UGT2B15.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium-free”. 
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na tableto, kar v bistvu pomeni 'brez natrija'.
Thirty percent had baseline Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 and 70% had ECOG PS 1; 59% had an exon 19 deletion, and 41% had a L858R mutation in exon 21. 
Stanje zmogljivosti (PS - Performance Status) po skupini ECOG (Eastern Cooperative Oncology Group) je bilo 0 pri 30 % in 1 pri 70 % bolnikov; 59 % jih je imelo delecijo v eksonu 19, 41 % pa mutacijo L858R v eksonu 21.
Dose modification and management guidelines for specific adverse reactions are provided in Table 2 (see sections 4.4 and 
Smernice za prilagajanje in uravnavanje odmerkov pri določenih neželenih učinkih so podane v preglednici 2 (glejte poglavji 4.4 in 4.8).
Limited pharmacokinetic data are available in patients with severe renal impairment (CrCl < 30 mL/min) (N=4). 
Na voljo so omejeni farmakokinetični podatki pri bolnikih s hudo okvaro ledvic (CrCl < 30 ml/min) (n = 4).
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE Dispose unused medicinal product in accordance with local requirements. 
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
If you stop taking Vizimpro 
Če ste prenehali jemati zdravilo Vizimpro
Adverse reactions reported in dacomitinib clinical studies (N=255) System organ class 
Neželeni učinki, o katerih so poročali v kliničnih študijah z dakomitinibom (n = 255)
A statistically significant improvement in PFS as determined by the IRC was demonstrated for patients randomised to dacomitinib compared with those randomised to gefitinib, see Table 5 and Figure 1. 
Pri bolnikih, ki so jih randomizirali na dakomitinib, so v primerjavi z bolniki, ki so jih randomizirali na gefitinib, dokazali statistično pomembno izboljšanje PFS, kot so ga določili s pregledom IRC; glejte preglednico 5 in sliko 1.
Grade 3 rash and erythematous skin condition adverse reactions were the most frequently reported Grade 3 adverse reactions (25.5%). 
Izpuščaj in eritematozne kožne bolezni stopnje 3 so bili neželeni učinki stopnje 3, o katerih so najpogosteje poročali (25,5 %).
If you miss a dose or vomit, take your next dose as scheduled. 
Če izpustite odmerek ali bruhate, vzemite naslednji odmerek ob običajnem času.
Following dacomitinib 45 mg daily dosing, steady-state was reached within 14 days. 
Po vsakodnevnem dajanju dakomitiniba 45 mg je do stanja dinamičnega ravnovesja prišlo v 14 dneh.
Non-clinical safety studies showed reversible epithelial atrophy in the cervix and vagina of rats (see section 5.3). 
Predklinične študije varnosti so pokazale reverzibilno atrofijo epitelija v materničnem vratu in nožnici podgan (glejte poglavje 5.3).
Abbreviations: CI=confidence interval; HR=hazard ratio; IRC=independent radiologic central; ITT=Intent-To-Treat; N=total number; PFS=progression-free survival. 
Okrajšave: IZ = interval zaupanja; HR = razmerje ogroženosti (hazard ratio); IRC = neodvisni centralni radiološki pregled (independent radiologic central); ITT = populacija, ki so jo nameravali zdraviti (intent-totreat); n = skupno število; PFS = preživetje brez napredovanja bolezni (progression-free survival).
No data are available in patients requiring haemodialysis. 
Podatkov pri bolnikih, ki potrebujejo hemodializo, ni na voljo.
Dacomitinib is extensively distributed throughout the body with a mean steady-state volume of distribution of 27 L/kg (patient of 70 kg) [coefficient of variation (CV%): 18%] following intravenous administration. 
Dakomitinib se po intravenskem dajanju obsežno porazdeli po vsem telesu s povprečnim volumnom porazdelitve v stanju dinamičnega ravnovesja 27 l/kg (pri bolniku s telesno maso 70 kg) (koeficient variance [KV%]: 18 %).
In Asian patients, median PFS was 16.5 months for dacomitinib arm and 9.3 months for gefitinib arm. 
Pri azijskih bolnikih je bilo mediano PFS 16,5 meseca v skupini, ki je prejemala dakomitinib, in 9,3 meseca v skupini, ki je prejemala gefitinib.
OS results from the final analysis (data cut-off date of 17-Feb-2017) when 48.7% of events had occurred showed a HR of 0.760 (95% CI: 0.582, 0.993) and a gain of 7.3 months in median OS (median OS: 34.1 months [95% CI: 29.5, 37.7] and 26.8 months [95% CI: 23.7, 32.1] in the dacomitinib and gefitinib arm, respectively). 
Rezultati OS iz končne analize (datum zaključka zbiranja podatkov: 17. februar 2017) - do takrat se je zgodilo 48,7 % dogodkov - so pokazali HR 0,760 (95 % IZ: 0,582; 0,993) ter za 7,3 meseca daljše mediano OS (mediano OS: 34,1 meseca [95 % IZ: 29,5; 37,7] in 26,8 meseca [95 % IZ: 23,7; 32,1] v skupini, ki je prejemala dakomitinib, oziroma skupini, ki je prejemala gefitinib).
Vizimpro may increase exposure (or decrease exposure of active metabolites) of other medicinal products metabolised by CYP2D6. 
Zdravilo Vizimpro lahko poveča izpostavljenost drugim zdravilom (ali zmanjša izpostavljenost aktivnim presnovkom drugih zdravil), ki se presnavljajo preko CYP2D6.
Maternal body weight gain and food intake were lower in pregnant rats and rabbits. 
Zvečanje telesne mase samic-mater in vnos hrane sta bila pri brejih samicah podgan in kuncev manjša.
Careful assessment of all patients with an acute onset or unexplained worsening of pulmonary symptoms (e.g., dyspnoea, cough, fever) should be performed to exclude ILD/pneumonitis. 
Za izključitev ILD/pnevmonitisa je treba opraviti temeljito oceno vseh bolnikov z akutnim pojavom ali nepojasnjenim poslabšanjem pljučnih simptomov (npr. dispneja, kašelj, zvišana telesna temperatura).
Adverse reactions leading to dose reductions were reported in 52.2% of patients treated with dacomitinib. 
O neželenih učinkih, zaradi katerih je bilo treba zmanjšati odmerek, so poročali pri 52,2 % bolnikov, ki so se zdravili z dakomitinibom.