natgillin/translations-raw huggingface dataset:
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.
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.