natgillin/translations-raw huggingface dataset:
The most common (> 20%) adverse reactions in patients receiving dacomitinib were diarrhoea (88.6%), rash (79.2%), stomatitis (71.8%), nail disorder (65.5%), dry skin (33.3%), decreased appetite (31.8%), conjunctivitis (24.7%), weight decreased (24.3%), alopecia (23.1%), pruritus (22.4%), transaminases increased (22.0%), and nausea (20.4%). 
(88,6 %), izpuščaj (79,2 %), stomatitis (71,8 %), bolezni nohtov (65,5 %), suha koža (33,3 %), pomanjkanje apetita (31,8 %), konjunktivitis (24,7 %), zmanjšanje telesne mase (24,3 %), alopecija (23,1 %), pruritus (22,4 %), zvečanje vrednosti transaminaz (22,0 %) in navzea (20,4 %).
This medicinal product contains < 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium-free”. 
To zdravilo vsebuje < 1 mmol natrija (23 mg) na tableto, kar v bistvu pomeni 'brez natrija'.
j Transaminases increased includes the following PTs: Alanine aminotransferase increased, Aspartate aminotransferase increased, Transaminases increased. 
Zvečanje vrednosti transaminaz vključuje naslednje priporočene izraze: zvečanje vrednosti alaninaminotransferaze, zvečanje vrednosti aspartat-aminotransferaze, zvečanje vrednosti transaminaz.
i Skin exfoliation (also referred to as Exfoliative skin conditions) includes the following PTs: Exfoliative rash, Skin exfoliation. 
Eksfoliacija kože (imenovana tudi eksfoliativne kožne bolezni) vključuje naslednja priporočena izraza: eksfoliativni izpuščaj, eksfoliacija kože.
Women of childbearing potential should be advised to avoid becoming pregnant while receiving Vizimpro. 
Ženskam v rodni dobi je treba svetovati, naj se med zdravljenjem z zdravilom Vizimpro izogibajo zanositvi.
Elderly population No starting dose adjustment of Vizimpro in elderly (≥ 65 years of age) patients is required (see section 
Začetnega odmerka zdravila Vizimpro pri starejših (≥ 65 let) bolnikih ni treba prilagajati (glejte poglavje 5.2).
Thus no dosing recommendations can be made for either patient population (see section 5.2). 
Priporočil o odmerjanju pri teh dveh populacijah bolnikov zato ni mogoče dati (glejte poglavje 5.2).
Table 3 presents adverse reactions for Vizimpro. 
V preglednici 3 so predstavljeni neželeni učinki zdravila Vizimpro.
In non-Asian patients, median PFS was 9.3 months for dacomitinib arm and 9.2 months for gefitinib arm. 
Pri neazijskih bolnikih je bilo mediano PFS 9,3 meseca v skupini, ki je prejemala dakomitinib, in 9,2 meseca v skupini, ki je prejemala gefitinib.
Concomitant use of medicinal products predominantly metabolised by CYP2D6 should be avoided unless such products are considered necessary (see section 4.5). 
Izogibati se je treba sočasnem dajanju zdravil, ki se pretežno presnavljajo preko CYP2D6, razen če je uporaba takih zdravil nujna (glejte poglavje 4.5).
For prevention of dry skin, initiate treatment with moisturizers, and upon development of rash, initiate treatment with topical antibiotics, emollients, and topical steroids. 
Za preprečitev suhe kože začnite zdravljenje z vlažilnimi kremami, po pojavu izpuščaja pa začnite zdravljenje s topikalnimi antibiotiki, emolienti in topikalnimi steroidi.
Patients may require dosing interruption and/or dose reduction of therapy with dacomitinib. 
Pri bolnikih bo morda treba prekiniti zdravljenje z dakomitinibom in/ali zmanjšati odmerek dakomitiniba.
In embryo-foetal development studies in rats and rabbits, pregnant animals received oral doses up to approximately 2.4 times and 0.3 times, respectively, the unbound AUC at the recommended human dose during the period of organogenesis. 
V študijah razvoja zarodka in ploda pri podganah in kuncih so breje živali v obdobju organogeneze prejemale peroralne odmerke do približno 2,4-kratnika oziroma 0,3-kratnika nevezane AUC pri priporočenem odmerku za človeka.
Each pack contains 30 film-coated tablets. 
Eno pakiranje vsebuje 30 filmsko obloženih tablet.
Serious adverse reactions were reported in 6.7% of patients treated with dacomitinib. 
O resnih neželenih učinkih so poročali pri 6,7 % bolnikov, ki so se zdravili z dakomitinibom.
• if you are allergic to dacomitinib or any of the other ingredients of this medicine (listed in section 6). 
Ne jemljite zdravila Vizimpro: • če ste alergični na dakomitinib ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
In a dedicated hepatic impairment trial, following a single-oral dose of 30 mg Vizimpro, dacomitinib exposure (AUCinf and Cmax) was unchanged in mild hepatic impairment (Child-Pugh A; N=8) and decreased by 15% and 20%, respectively in moderate hepatic impairment (Child-Pugh B; N=9) when compared to subjects with normal hepatic function (N=8). 
V namenskem preskušanju pri okvari jeter je bila po enkratnem peroralnem odmerku 30 mg zdravila Vizimpro izpostavljenost dakomitinibu (AUCinf in Cmax) nespremenjena pri blagi okvari jeter (Child-Pugh A; n = 8) in zmanjšana za 15 % oziroma 20 % pri zmerni okvari jeter (Child-Pugh B; n = 9) v primerjavi s preskušanci z normalnim delovanjem jeter (n = 8).
Concomitant use of proton pump inhibitors (PPIs) with dacomitinib should be avoided (see section 4.5). 
Izogibati se je treba sočasni uporabi zaviralcev protonske črpalke (PPI - Proton Pump Inhibitor) in dakomitiniba (glejte poglavje 4.5).
Interstitial lung disease (ILD)/Pneumonitis 
Intersticijska bolezen pljuč (ILD - Interstitial Lung Disease)/pnevmonitis
• Weakness 
• oslabelost
Dacomitinib was not mutagenic in a bacterial reverse mutation (Ames) assay, and not clastogenic or aneugenic in the in vivo bone marrow micronucleus assay in male and female rats. 
Dakomitinib ni bil mutagen v (Amesovem) preskusu bakterijskih reverznih mutacij in ni bil klastogen ali anevgen v preskusu mikronukleusov v kostnem mozgu in vivo pri samcih in samicah podgan.
Conjunctivitis includes the following PTs: Blepharitis, Conjunctivitis, Dry eye, Noninfective conjunctivitis. 
Konjunktivitis vključuje naslednje priporočene izraze: blefaritis, konjunktivitis, suhe oči, neinfektivni konjunktivitis.
Effect of dacomitinib on drug transporters 
Učinek dakomitiniba na prenašalce zdravil
Objective Response Rate (per IRC) Objective Response Rate % (95% CI) 
Objektivni odziv na zdravljenje (glede na IRC) objektivni odziv na zdravljenje % (95 % IZ) 2-stranska vrednostp
Initiate or continue treatment and/or provide additional treatment (e.g., broad spectrum oral or intravenous antibiotics and topical steroids). 
Začnite ali nadaljujte zdravljenje in/ali zagotovite zdravljenje z dodatnimi zdravili (npr. širokospektralni peroralni ali intravenski antibiotiki in topikalni steroidi).
Co-administration of single 45 mg oral dose of dacomitinib increased the mean exposure (AUClast and Cmax) of dextromethorphan, a probe CYP2D6 substrate, 855% and 874%, respectively, compared with administration of dextromethorphan alone. 
Sočasno dajanje dakomitiniba v enkratnem peroralnem odmerku 45 mg je povečalo povprečno izpostavljenost (AUCzadnji in Cmax) dekstrometorfanu, testnemu substratu CYP2D6, za 855 % oziroma 874 % v primerjavi s samostojno danim dekstrometorfanom.
ILD/pneumonitis adverse reactions were reported in 2.7% of patients receiving Vizimpro, and Grade ≥ 3 ILD/pneumonitis adverse reactions were reported in 0.8%, including a fatal event (0.4%) (see section 4.4). 
Intersticijska bolezen pljuč (ILD - Interstitial Lung Disease)/pnevmonitis O ILD/pnevmonitisu kot neželenem učinku so poročali pri 2,7 % bolnikov, ki so prejemali zdravilo Vizimpro, od tega so pri 0,8 % bolnikov poročali o ILD/pnevmonitisu stopnje ≥ 3, vključno z dogodkom s smrtnim izidom (0,4 %) (glejte poglavje 4.4).
Fertility studies have not been performed with dacomitinib. 
Študij plodnosti z dakomitinibom niso izvedli.
Effect of dacomitinib and O-desmethyl dacomitinib on CYP enzymes In vitro, dacomitinib and its metabolite O-desmethyl dacomitinib have a low potential to inhibit the activities of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, or CYP3A4/5 at clinically relevant concentrations. 
Učinek dakomitiniba in O-dezmetil dakomitiniba na encime CYP In vitro imata dakomitinib in njegov presnovek O-dezmetil dakomitinib v klinično pomembnih koncentracijah majhen potencial za zaviranje aktivnosti CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 ali CYP3A4/5.
Following the administration of a single 45 mg dose of dacomitinib tablets, the mean oral bioavailability of dacomitinib is 80% (range: 65% to 100%) compared to intravenous administration, with Cmax occurring 5 to 6 hours after oral dosing. 
Po dajanju tablet dakomitiniba v enkratnem odmerku 45 mg je v primerjavi z intravenskim dajanjem povprečna peroralna biološka uporabnost dakomitiniba 80 % (razpon: 65 % do 100 %), pri čemer do Cmax pride 5 do 6 ur po peroralnem odmerjanju.
The most frequently (≥ 1%) reported serious adverse reactions in patients receiving dacomitinib were diarrhoea (2.0%), interstitial lung disease (1.2%), rash (1.2%), and decreased appetite (1.2%). 
Resni neželeni učinki, o katerih so najpogosteje (≥ 1 %) poročali pri bolnikih, ki so prejemali dakomitinib, so bili diareja (2,0 %), intersticijska bolezen pljuč (1,2 %), izpuščaj (1,2 %) in pomanjkanje apetita
In patients who develop severe elevations in transaminases while taking dacomitinib, treatment should be interrupted (see section 4.2). 
Pri bolnikih, pri katerih se med jemanjem dakomitiniba pojavi hudo zvečanje vrednosti transaminaz, je treba zdravljenje z dakomitinibom prekiniti (glejte poglavje 4.2).
Based on in vitro data, dacomitinib may have the potential to inhibit the activity of P-glycoprotein (P-gp) (in the gastrointestinal [GI] tract), Breast Cancer Resistance Protein (BCRP) (systemically and GI tract), and organic cation transporter (OCT)1 at clinically relevant concentrations (see section 5.2). 
Na podlagi podatkov in vitro ima dakomitinib v klinično pomembnih koncentracijah lahko potencial za zaviranje aktivnosti P-glikoproteina (P-gp) (v prebavilih), beljakovine odpornosti pri raku dojke (BCRP - Breast Cancer Resistance Protein) (sistemsko in v prebavilih) in prenašalca organskih kationov (OCT - Organic Cation Transporter)1 (glejte poglavje 5.2).
EGFR mutation status should be established prior to initiation of dacomitinib therapy (see section 4.4). 
Pred uvedbo zdravljenja z dakomitinibom je treba določiti status mutacij EGFR (glejte poglavje 4.4).
You should have an anti-diarrhoeal medicine available before you start taking Vizimpro. 
Pred začetkom jemanja zdravila Vizimpro morate imeti na voljo zdravilo proti driski.
Dacomitinib pharmacokinetics has not been studied in subjects with severe hepatic impairment (Child-Pugh class C). 
Farmakokinetike dakomitiniba pri bolnikih s hudo okvaro jeter (Child-Pugh C) niso preučevali.
In vitro, dacomitinib has a low potential to inhibit the activities of drug transporters P-gp (systemically), organic anion transporters (OAT)1 and OAT3, OCT2, organic anion transporting polypeptide (OATP)1B1, and OATP1B3, but may inhibit the activity of P-gp (in the GI tract), BCRP (systemically and GI tract), and OCT1 at clinically relevant concentrations. 
In vitro ima dakomitinib v klinično pomembnih koncentracijah majhen potencial za zaviranje aktivnosti prenašalcev zdravil P-gp (sistemsko), prenašalca organskih anionov (OAT - Organic Anion Transporter)1 in OAT3, OCT2, polipeptidnega prenašalca organskih anionov (OATP - Organic Anion Transporting Polipeptyde)1B1 in OATP1B3, lahko pa zavira aktivnost P-gp (v prebavilih), BCRP (sistemsko in v prebavilih) in OCT1.
The most common (> 0.5%) reasons for permanent discontinuations associated with adverse reactions in patients receiving dacomitinib were: rash (2.4%), interstitial lung disease (2.0%), and diarrhoea (0.8%). 
Najpogostejši (> 0,5 %) razlogi za trajno prekinitev zdravljenja, povezani z neželenimi učinki pri bolnikih, ki so prejemali dakomitinib, so bili: izpuščaj (2,4 %), intersticijska bolezen pljuč (2,0 %) in diareja (0,8 %).
In repeat-dose toxicity studies with dacomitinib, effects on reproductive organs were observed in female rats given approximately 0.3 times the unbound AUC at the recommended human dose (for 6 months) and were limited to reversible epithelial atrophy in the cervix and vagina. 
V študijah toksičnost pri ponavljajočih odmerkih z dakomitinibom so pri samicah podgan, ki so jim dali približno 0,3-kratnik nevezane AUC pri priporočenem odmerku za človeka (6 mesecev), opazili učinke na reprodukcijske organe, ki so bili omejeni na reverzibilno atrofijo epitelija v materničnem vratu in nožnici.
Limited data are available in patients with severe renal impairment (CrCl < 30 mL/min). 
Pri bolnikih s hudo okvaro ledvic (CrCl < 30 ml/min) so na voljo omejeni podatki.
Adverse reactions leading to permanent discontinuation were reported in 6.7% of patients treated with dacomitinib. 
O neželenih učinkih, zaradi katerih je bilo treba zdravljenje trajno prekiniti, so poročali pri 6,7 % bolnikov, ki so se zdravili z dakomitinibom.
• For Grade 1 or 2 toxicity, no dose modification is required. 
• Pri toksičnosti stopnje 1 ali 2 prilagajanje odmerka ni potrebno.
• Hair loss 
• izguba las in dlak
How to take Vizimpro 
Kako jemati zdravilo Vizimpro
Vizimpro in first-line treatment of NSCLC patients with EGFR-activating mutations (ARCHER 1050) The efficacy and safety of Vizimpro was studied in a Phase 3 trial (ARCHER 1050) conducted in patients with locally advanced, not amenable to curative surgery or radiotherapy, or metastatic NSCLC harbouring activating mutations of EGFR, to demonstrate the superiority of dacomitinib versus gefitinib. 
Učinkovitost in varnost zdravila Vizimpro so proučevali v preskušanju 3. faze (ARCHER 1050), ki so ga izvedli pri bolnikih z lokalno napredovalim NSCLC, z NSCLC, pri katerem ni bila možna ozdravitev s kirurškim posegom ali obsevanjem, ali z metastatskim NSCLC s prisotnimi EGFRaktivirajočimi mutacijami, da bi dokazali superiornost dakomitiniba v primerjavi z gefitinibom.
The median duration of any grade and Grade ≥ 3 ILD/pneumonitis was 13 weeks and 1.5 weeks, respectively (see section 4.4). 
Mediano trajanje ILD/pnevmonitisa katerekoli stopnje je bilo 13 tednov, mediano trajanje ILD/pnevmonitisa stopnje ≥ 3 pa 1,5 tedna (glejte poglavje 4.4).
Efficacy results from ARCHER 1050 in patients with previously untreated NSCLC with EGFR-activating mutations - ITT population Dacomitinib N=227 
Rezultati učinkovitosti v preskušanju ARCHER 1050 pri bolnikih s predhodno nezdravljenim NSCLC z EGFR-aktivirajočimi mutacijami - populacija, ki so jo nameravali zdraviti (ITT - Intent-To-Treat)
Dacomitinib has not been studied in patients with severe (Child-Pugh class C) hepatic impairment. 
Dakomitiniba pri bolnikih s hudo (razred C po klasifikaciji Child-Pugh) okvaro jeter niso preučevali.
NAME OF THE MARKETING AUTHORISATION HOLDER Pfizer Europe MA EEIG (as MA holder logo) 
Pfizer Europe MA EEIG (kot logotip imetnika dovoljenja za promet z zdravilom)
How to store Vizimpro 6. 
Shranjevanje zdravila Vizimpro 6.
Patients may require dosing interruption and/or dose reduction of therapy with dacomitinib (see section 4.2). 
Pri bolnikih bo morda treba prekiniti zdravljenje z dakomitinibom in/ali zmanjšati odmerek dakomitiniba (glejte poglavje 4.2).
The median duration of any grade and Grade ≥ 3 diarrhoea was 20 weeks and 1 week, respectively (see section 4.4). 
Mediano trajanje diareje katerekoli stopnje je bilo 20 tednov, mediano trajanje diareje stopnje ≥ 3 pa 1 teden (glejte poglavje 4.4).
Dacomitinib was clastogenic in the in vitro human lymphocyte chromosome aberration assay at cytotoxic concentrations. 
Dakomitinib je bil klastogen v preskusu kromosomskih aberacij v človeških limfocitih in vitro pri citotoksičnih koncentracijah.
Dry skin includes the following PTs: Dry skin, Xerosis. 
Suha koža vključuje naslednja priporočena izraza: suha koža, kseroza.
Patients with a history of ILD have not been studied. 
Bolnikov z ILD v anamnezi niso preučevali.
c Interstitial lung disease includes the following PTs: Interstitial lung disease, Pneumonitis. 
Intersticijska bolezen pljuč vključuje naslednja priporočena izraza: intersticijska bolezen pljuč, pnevmonitis.
The stratification factors were Race (Japanese vs mainland Chinese and other East Asian vs non-East Asian) and EGFR mutation status (exon 19 deletion vs the L858R mutation in exon 21) at randomisation per IWRS. 
Stratifikacijski dejavniki so bili rasa (Japonci v primerjavi s celinskimi Kitajci in drugi Vzhodnoazijci v primerjavi z Nevzhodnoazijci) in status mutacij EGFR (delecija v eksonu 19 v primerjavi z mutacijo L858R v eksonu 21) ob randomizaciji glede na IWRS.
Your doctor may decrease the dose of your medicine depending on how well you tolerate it. 
Glede na to, kako dobro prenašate zdravilo, vam zdravnik lahko zmanjša odmerek zdravila.
• Alteration in taste 
• sprememba okušanja
In 6 healthy male subjects given a single-oral dose of [ 
Pri 6 zdravih moških preskušancih, ki so prejeli enkraten peroralni odmerek radioaktivno označenega [
Concomitant use of medicinal products predominantly metabolised by CYP2D6 should be avoided (see section 4.4). 
Izogibati se je treba sočasni uporabi zdravil, ki se pretežno presnavljajo preko CYP2D6 (glejte poglavje 4.).
a Hypokalaemia includes the following preferred terms (PTs): Blood potassium decreased, Hypokalaemia. 
Hipokaliemija vključuje naslednja priporočena izraza: zmanjšanje vrednosti kalija v krvi, hipokaliemija.
Upon recovery to Grade ≤ 1, resume dacomitinib at the same dose level or consider a reduction of 1 dose level. 
Po izboljšanju na stopnjo ≤ 1 nadaljujte zdravljenje z dakomitinibom v enakem odmerku ali pa razmislite o zmanjšanju za 1 odmerno raven.
Interstitial lung disease (ILD/Pneumonitis) 
Prilagajanje odmerka intersticijska bolezen pljuč (ILD - Interstitial Lung Disease/pnevmonitis)
Metabolism and nutrition disorders Decreased appetite Hypokalemia b 
Presnovne in prehranske motnje pomanjkanje apetita hipokaliemija
A total of 452 patients were randomised 1:1 to dacomitinib or gefitinib in a multicentre, multinational, randomised, open-label Phase 3 study. 
V multicentrični, multinacionalni, randomizirani, odprti študiji 3. faze so randomizirali skupno 452 bolnikov v razmerju 1 : 1 na dakomitinib ali gefitinib.
Diarrhoea, including severe diarrhoea, has been very commonly reported during treatment with Vizimpro (see section 4.8). 
Med zdravljenjem z zdravilom Vizimpro so zelo pogosto poročali o diareji, vključno s hudo diarejo (glejte poglavje 4.8).
Stratification factors at randomisation were race (Japanese versus mainland Chinese versus other East Asian versus non-East Asian, as stated by the patient), and EGFR mutation status (exon 19 deletion versus the L858R mutation in exon 21). 
Stratifikacijski dejavniki ob randomizaciji so bili rasa (Japonci v primerjavi s celinskimi Kitajci v primerjavi z drugimi Vzhodnoazijci v primerjavi z Nevzhodnoazijci po navedbah bolnikov) in status mutacij EGRF (delecija v eksonu 19 v primerjavi z mutacijo L858R v eksonu 21).
In vitro, dacomitinib has a low potential to induce CYP1A2, CYP2B6, or CYP3A4 at clinically relevant concentrations. 
In vitro ima dakomitinib v klinično pomembnih koncentracijah majhen potencial za indukcijo CYP1A2, CYP2B6 ali CYP3A4.
Initiate treatment with anti-diarrhoeal medicinal products (e.g., loperamide) at first onset of diarrhoea. 
Ob prvem pojavu diareje začnite zdravljenje z antidiaroiki (npr. loperamid).
Tell your doctor right away if you have any new or worsening symptoms including difficulty in breathing, shortness of breath, or cough with or without phlegm (mucous), or fever. 
Če se vam pojavijo kakršnikoli novi simptomi ali se simptomi poslabšajo, vključno s težavami pri dihanju, kratko sapo ali kašljem s sluzjo ali brez nje ali vročino, o tem takoj obvestite zdravnika.
The median time to the first episode of any grade exfoliative skin conditions was 6 weeks and the median time to the worst episode of exfoliative skin conditions was 6 weeks. 
Mediani čas do prve epizode eksfoliativnih kožnih bolezni katerekoli stopnje je bil 6 tednov, mediani čas do najhujše epizode eksfoliativnih kožnih bolezni pa 6 tednov.
Transaminases increased (alanine aminotransferase increased, aspartate aminotransferase increased, transaminases increased) have been reported during treatment with Vizimpro (see section 4.8). 
Med zdravljenjem z zdravilom Vizimpro so poročali o zvečanju vrednosti transaminaz (zvečanje vrednosti alanin-aminotransferaze, zvečanje vrednosti aspartat-aminotransferaze, zvečanje vrednosti transaminaz) (glejte poglavje 4.8).
Initiate treatment (e.g., antibiotics, topical steroids, and emollients). 
Začnite zdravljenje (npr. antibiotiki, topikalni steroidi in emolienti).
• For Grade ≥ 3 diarrhoea, withhold dacomitinib. 
• Pri diareji stopnje ≥ 3 prekinite zdravljenje z dakomitinibom.
Weight decreased a Only adverse reactions with ≥ 10% incidence in the dacomitinib arm are included. 
Vključeni so samo neželeni učinki z incidenco ≥ 10 % v skupini, ki je prejemala dakomitinib.
In addition, hepatocellular necrosis with transaminase increases and hepatocellular vacuolation were observed in rats only. 
Poleg tega so samo pri podganah opazili hepatocelično nekrozo z zvečanimi vrednostmi transaminaz in vakuolizacijo jetrnih celic.
Encourage adequate oral fluid intake during diarrhoea. 
V času trajanja diareje bolnika spodbujajte k zadostnemu uživanju tekočin.
Recommended dose modifications for Vizimpro adverse reactions Dose level 
Priporočeno prilagajanje odmerkov v primeru neželenih učinkov zdravila Vizimpro
g Pruritus includes the following PTs: Pruritus, Rash pruritic. 
Pruritus vključuje naslednja priporočena izraza: pruritus, pruritični izpuščaj.
• Nausea or vomiting 
• občutek siljenja na bruhanje ali bruhanje
Co-administration of dacomitinib with agents that increase gastric pH 
Sočasno dajanje dakomitiniba in zdravil, ki povečajo vrednost pH v želodcu
In faeces, dacomitinib, O-desmethyl dacomitinib, a cysteine conjugate of dacomitinib, and a mono-oxygenated metabolite of dacomitinib were the major drug-related components. 
V blatu so bile glavne iz zdravila izhajajoče komponente dakomitinib, O-dezmetil dakomitinib, cisteinski konjugat dakomitiniba in monooksigenirani presnovek dakomitiniba.
2-sided p-valueb 
2-stranska vrednostp
OTHER 
drugo
The most frequently reported (> 5%) reasons for dose reductions due to any adverse reactions in patients receiving dacomitinib were rash (32.2%), nail disorder (16.5%), and diarrhoea 
Razlogi za zmanjšanje odmerka zaradi kateregakoli neželenega učinka, o katerih so najpogosteje poročali (> 5 %) pri bolnikih, ki so prejemali dakomitinib, so bili izpuščaj (32,2 %), bolezni nohtov (16,5 %) in diareja (7,5 %).
Consider adding broad spectrum oral or intravenous antibiotics if any of these conditions worsen to greater than or equal to Grade 2 severity. 
Če se resnost katere od teh bolezni poslabša do stopnje 2 ali višje stopnje, razmislite o dodajanju širokospektralnih peroralnih ali intravenskih antibiotikov.
ILD/pneumonitis, which could be fatal, has been reported in patients receiving Vizimpro (see section 4.8). 
Pri bolnikih, ki so prejemali zdravilo Vizimpro, so poročali o ILD/pnevmonitisu, ki sta lahko smrtna (glejte poglavje 4.8).
• For Grade ≥ 3 rash, erythematous or exfoliative skin conditions, withhold dacomitinib. 
• Pri izpuščaju, eritematoznih ali eksfoliativnih kožnih boleznih stopnje ≥ 3 prekinite zdravljenje z dakomitinibom.
The median time to the first episode of any grade ILD/pneumonitis was 16 weeks and the median time to the worst episode of ILD/pneumonitis was 16 weeks in patients receiving dacomitinib. 
Mediani čas do prve epizode ILD/pnevmonitisa katerekoli stopnje pri bolnikih, ki so prejemali dakomitinib, je bil 16 tednov, mediani čas do najhujše epizode ILD/pnevmonitisa pa je bil 16 tednov.
Diarrhoea* Stomatitis d 
Bolezni prebavil diareja* stomatitis bruhanje navzea
Transaminases increased 
Zvečanje vrednosti transaminaz
Vizimpro 15 mg film-coated tablets Vizimpro 30 mg film-coated tablets Vizimpro 45 mg film-coated tablets dacomitinib 
Vizimpro 15 mg filmsko obložene tablete Vizimpro 30 mg filmsko obložene tablete Vizimpro 45 mg filmsko obložene tablete dakomitinib