FrancophonIA/ELRC3.0 huggingface dataset:
English: In oral repeated-dose toxicity studies for up to 6 months in rats and 9 months in dogs, the primary toxicities were identified in the skin/hair (dermal changes in rats and dogs, atrophy/dysplasia of hair follicles in rats), kidney (papillary necrosis often accompanied by tubular degeneration, regeneration, dilatation and/or atrophy and changes in urinary markers indicative of renal injury in rats, erosion or ulceration of the pelvic epithelium with associated inflammation without changes indicative of renal dysfunction in dogs), eye (cornea epithelial atrophy in rats and dogs, corneal ulcers/erosions with red/swollen conjunctiva(e), conjunctivitis, elevated third eyelid, increased squinting, partially closed eyes, lacrimation, and/or ocular discharge in dogs), and digestive system (enteropathy in rats and dogs, erosions/ulcers of the mouth with reddened mucous membranes in dogs), and atrophy of epithelial cells of other organs in rats.
Slovenian: V študijah toksičnosti pri ponavljajočih peroralnih odmerkih, ki so trajale do 6 mesecev pri podganah in 9 mesecev pri psih, so primarno toksičnost ugotovili na koži/v dlaki (dermalne spremembe pri podganah in psih, atrofija/displazija lasnih mešičkov pri podganah), ledvicah (papilarna nekroza pri podganah, ki jo pogosto spremljajo tubulna degeneracija, regeneracija, dilatacija in/ali atrofija ter spremembe označevalcev v urinu, ki kažejo na poškodbe ledvic, ter erozija ali razjede medeničnega epitelija s povezanim vnetjem pri psih, brez sprememb, ki bi kazale na motnjo delovanja ledvic), očeh (atrofija roženičnega epitelija pri podganah in psih, razjede na roženici/erozije z rdečo/oteklo veznico, konjunktivitis, dvignjena tretja veka, povečano mežikanje, delno zaprte oči, solzenje, in/ali očesni izcedek pri psih) in prebavilih (enteropatija pri podganah in psih, erozije/razjede v ustih s pordelo sluznico pri psih), pri podganah pa so ugotovili tudi atrofijo epitelijskih celic v drugih organih.
English: Woman of childbearing potential/Contraception
Slovenian: Ženske v rodni dobi/kontracepcija
English: Data based on pool of 255 patients who received Vizimpro 45 mg once daily as starting dose for first-line treatment of NSCLC with EGFR-activating mutations across clinical studies.
Slovenian: Podatki temeljijo na združenih podatkih 255 bolnikov, ki so prejemali zdravilo Vizimpro 45 mg enkrat na dan kot začetni odmerek v prvi liniji zdravljenja NSCLC z EGFR-aktivirajočimi mutacijami v kliničnih študijah.
English: Environmental risk assessment studies have shown that dacomitinib has the potential to be very persistent, bioaccumulative and toxic to the environment (see section 6.6).
Slovenian: Študije ocene tveganja za okolje so pokazale, da je dakomitinib potencialno lahko zelo obstojen, bioakumulativen in strupen za okolje (glejte poglavje 6.6).
English: Rash, erythematous and exfoliative skin condition adverse reactions were reported in 79.2% and 5.5%, respectively, of patients receiving Vizimpro.
Slovenian: O izpuščaju ter o eritematoznih in eksfoliativnih kožnih boleznih so poročali pri 79,2 % oziroma 5,5 % bolnikov, ki so prejemali zdravilo Vizimpro.
English: It is not known whether dacomitinib and its metabolites are excreted in human milk.
Slovenian: Ni znano, ali se dakomitinib in njegovi presnovki izločajo v materino mleko.
English: Vizimpro tablets come in different strengths.
Slovenian: Tablete zdravila Vizimpro so na voljo v različnih jakostih.
English: The adverse reactions observed at doses greater than 45 mg once daily were primarily gastrointestinal, dermatological, and constitutional (e.g., fatigue, malaise, and weight loss).
Slovenian: Neželeni učinki, ki so jih opazili pri odmerkih, večjih od 45 mg enkrat na dan, so bili predvsem gastrointestinalni, dermatološki in splošni (npr. utrujenost, splošno slabo počutje in zmanjšanje telesne mase).
English: Exposure response relationships
Slovenian: Povezava med izpostavljenostjo in odzivom
English: Aluminium/aluminium blister containing 10 film-coated tablets.
Slovenian: Pretisni omot iz aluminija/aluminija, ki vsebuje 10 filmsko obloženih tablet.
English: Very common adverse reactions in patients occurring in at least 10% of patients in Study ARCHER 1050 are summarised by National Cancer Institute-Common Toxicity Criteria (NCI-CTC) Grade in Table 4.
Slovenian: Zelo pogosti neželeni učinki pri bolnikih, ki so se pojavili pri vsaj 10 % bolnikov v Študiji ARCHER 1050, so povzeti v preglednici 4 po stopnjah glede na poenotena merila toksičnosti Nacionalnega inštituta za rakava obolenja (NCI-CTC - National Cancer Institute-Common Toxicity Criteria).
English: • Skin rash (very common)
Slovenian: • Izpuščaj na koži (zelo pogosto)
English: Proactive management of diarrhoea should start at the first sign of diarrhoea especially within the first 2 weeks of starting dacomitinib, including adequate hydration combined with anti-diarrhoeal medicinal products and continued until loose bowel movements cease for 12 hours.
Slovenian: Proaktivna obravnava diareje je potrebna že ob prvem znaku diareje, zlasti v prvih 2 tednih po začetku zdravljenja z dakomitinibom, vključno z zadostno hidracijo v kombinaciji z antidiaroiki, kar je treba nadaljevati, dokler se izločanje mehkega blata ne zaustavi za 12 ur.
English: Female patients taking dacomitinib during pregnancy or who become pregnant while taking dacomitinib should be apprised of the potential hazard to the foetus.
Slovenian: Bolnice, ki jemljejo dakomitinib med nosečnostjo ali med jemanjem dakomitiniba zanosijo, je treba seznaniti s potencialno nevarnostjo za plod.
English: O-desmethyl dacomitinib accounted for 16% of human plasma radioactivity and is formed mainly by CYP2D6 and to a lesser extent CYP2C9.
Slovenian: O-dezmetil dakomitinib je prispeval 16 % radioaktivnosti v človeški plazmi, nastaja pa pretežno preko CYP2D6 in v manjši meri preko CYP2C9.
English: The inhibition of CYP2D6 translated into approximately a 90% reduction in metabolite exposure and an approximate 37% increase in dacomitinib exposure.
Slovenian: Zaviranje CYP2D6 je privedlo do približno 90 % zmanjšanja izpostavljenosti presnovkom in približno 37 % povečanja izpostavljenosti dakomitinibu.
English: Some lung problems may get worse during treatment with Vizimpro, as Vizimpro may cause inflammation of the lungs during treatment.
Slovenian: Določene težave s pljuči se med zdravljenjem z zdravilom Vizimpro lahko poslabšajo, saj lahko zdravilo Vizimpro med zdravljenjem povzroči vnetje pljuč.
English: • For Grade ≥ 3 toxicity, withhold dacomitinib until symptoms resolve to Grade ≤ 2.
Slovenian: • Pri toksičnosti stopnje ≥ 3 prekinite zdravljenje z dakomitinibom, dokler simptomi ne izzvenijo do stopnje ≤ 2.
English: Dacomitinib has the potential to be a very persistent, bioaccumulative and toxic substance (see section 5.3).
Slovenian: Dakomitinib je potencialno lahko zelo obstojna, bioakumulativna in toksična snov (glejte poglavje 5.3).
English: Other information on drug-drug interactions
Slovenian: Drugi podatki o interakcijah med zdravili
English: Patients should maintain adequate oral hydration and patients who become dehydrated may require administration of intravenous fluids and electrolytes (see section 4.2).
Slovenian: Bolniki morajo vzdrževati zadostno peroralno hidracijo, pri bolnikih, ki dehidrirajo, pa je lahko potrebno dajanje intravenskih tekočin in elektrolitov (glejte poglavje 4.2).
English: Other medicines and Vizimpro
Slovenian: Druga zdravila in zdravilo Vizimpro
English: • Flushed or painful palms or soles
Slovenian: • pordele ali boleče dlani ali stopala
English: Breast-feeding Do not breast-feed while taking this medicine because it is not known if it can harm your baby.
Slovenian: Dojenje Med jemanjem tega zdravila ne smete dojiti, ker ni znano, ali lahko škoduje otroku.
English: Treat with anti-diarrhoeal medicinal products (e.g., loperamide), and adequate oral fluid intake or intravenous fluids or electrolytes as appropriate.
Slovenian: Zdravite z antidiaroiki (npr. loperamid) in zadostnim uživanjem tekočin ali intravenskim dajanjem tekočin ali elektrolitov, kot je primerno.
English: Dacomitinib was tested using a series of genetic toxicology assays.
Slovenian: Dakomitinib so testirali z vrsto genetskih toksikoloških preskusov.
English: 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).
Slovenian: 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).
English: Co-administration of dacomitinib and CYP2D6 substrates
Slovenian: Sočasno dajanje dakomitiniba in substratov CYP2D6
English: Dacomitinib is a substrate for the membrane transport proteins P-gp and BCRP.
Slovenian: Dakomitinib je substrat membranskih prenašalnih beljakovin P-gp in BCRP.
English: It is important to treat the rash early.
Slovenian: Pomembno je, da izpuščaj zdravimo zgodaj.
English: Very common adverse reactions in Phase 3 Study ARCHER 1050 (N=451) Dacomitinib (N=227)
Slovenian: Zelo pogosti neželeni učinki v študiji 3. faze ARCHER 1050 (n = 451)
English: In a clinical study, one patient (0.4%) had a fatal outcome (see section 4.4).
Slovenian: V klinični študiji je pri 1 bolniku (0,4 %) prišlo do smrtnega izida (glejte poglavje 4.4).
English: Vizimpro contains the active substance dacomitinib, which belongs to a group of medicines called protein tyrosine kinase inhibitors which are used to treat cancer.
Slovenian: Zdravilo Vizimpro vsebuje učinkovino dakomitinib, ki spada v skupino zdravil, imenovanih ''zaviralci beljakovin tirozin-kinaz'', ki jih uporabljamo za zdravljenje raka.
English: You should not become pregnant during treatment with Vizimpro because this medicine could harm the baby.
Slovenian: Med zdravljenjem z zdravilom Vizimpro ne smete zanositi, saj bi to zdravilo lahko škodovalo otroku.
English: The aqueous solubility of dacomitinib is pH dependent, with low (acidic) pH resulting in higher solubility.
Slovenian: Vodotopnost dakomitiniba je odvisna od vrednosti pH, pri čemer nižji (kisel) pH pomeni boljšo topnost.
English: The maternally toxic dose was foetotoxic in rats, resulting in reduced foetal body weights and higher incidence of unossified metatarsals.
Slovenian: Odmerek, toksičen za mater, je bil pri podganah fetotoksičen in je povzročil zmanjšano telesno maso ploda ter večjo incidenco nezakostenelih metatarzalnih kosti.
English: Pharmacotherapeutic group: Anti-neoplastic agents, protein kinase inhibitors, ATC code: L01XE47
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, zaviralci proteinskih kinaz, oznaka ATC: L01XE47
English: • 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.
Slovenian: • 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.
English: If you become pregnant while taking this medicine, you should immediately talk to your doctor.
Slovenian: Če med jemanjem tega zdravila zanosite, se takoj posvetujte z zdravnikom.
English: Vizimpro is for oral use.
Slovenian: Zdravilo Vizimpro je za peroralno uporabo.
English: If you forget to take Vizimpro
Slovenian: Če ste pozabili vzeti zdravilo Vizimpro
English: Dacomitinib should be administered 2 hours before or at least 10 hours after taking H2 receptor antagonists.
Slovenian: Dakomitinib je treba dati 2 uri pred uporabo antagonistov receptorjev H2 ali vsaj 10 ur po tem.
English: Vizimpro is used to treat adults with a type of lung cancer called ‘non-small cell lung cancer'.
Slovenian: Zdravilo Vizimpro uporabljamo za zdravljenje odraslih z vrsto pljučnega raka, ki ga imenujemo ''nedrobnocelični rak pljuč''.
English: • 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.
Slovenian: • 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.
English: Dacomitinib showed a clearance of 20.0 L/hr with an inter-individual variability of 32% (CV%).
Slovenian: Očistek dakomitiniba je znašal 20,0 l/h, z variabilnostjo med posamezniki v velikosti 32 % (KV%).
English: • The recommended dose is 45 mg taken by mouth each day.
Slovenian: • Priporočeni odmerek je 45 mg peroralno enkrat na dan.
English: Across the dacomitinib program, hepatic failure led to a fatal outcome in 1 patient.
Slovenian: V sklopu programa zdravljenja z dakomitinibom je odpoved jeter privedla do smrtnega izida pri 1 bolniku.
English: The pharmacokinetics in patients requiring haemodialysis have not been studied.
Slovenian: Farmakokinetike pri bolnikih, ki potrebujejo hemodializo, niso preučevali.
English: Film coating: Opadry II Blue 85F30716 containing polyvinyl alcohol - partially hydrolysed (E1203), talc (E553b), titanium dioxide (E171), macrogol (E1521), Indigo carmine aluminium lake (E132).
Slovenian: Filmska obloga: Opadry II modra 85F30716, ki vsebuje polivinilalkohol - delno hidroliziran (E1203), smukec (E553b), titanov dioksid (E171), makrogol (E1521), indigotin (E132).
English: 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.
Slovenian: 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.
English: These results suggest that dacomitinib may increase exposure of other medicinal products (or decrease exposure to active metabolites) primarily metabolised by CYP2D6.
Slovenian: Ti rezultati kažejo, da dakomitinib lahko poveča izpostavljenost drugim zdravilom (ali zmanjša izpostavljenost aktivnim presnovkom), ki se pretežno presnavljajo preko CYP2D6.
English: 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.
Slovenian: 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.
English: What you need to know before you take Vizimpro
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Vizimpro
English: Based on its mechanism of action, dacomitinib may cause foetal harm when administered to a pregnant woman.
Slovenian: Glede na njegov mehanizem delovanja lahko dakomitinib škoduje plodu, če ga uporabljamo pri nosečnicah.
English: 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.
Slovenian: Če jemljete zaviralec histaminskega receptorja H2, vzemite odmerek zdravila Vizimpro vsaj 2 uri pred ali pa 10 ur po jemanju zaviralca histaminskega receptorja H2.
English: Progression-Free Survival (per IRC) Number of patients with event, n (%) Median PFS in months (95% CI) HR (95% CI)
Slovenian: Preživetje brez napredovanja bolezni (glede na IRC) število bolnikov z dogodkom, n (%) mediano PFS v mesecih (95 % IZ) HR (95% IZ)
English: If ILD/pneumonitis is confirmed, dacomitinib should be permanently discontinued and appropriate treatment instituted as necessary (see section 4.2).
Slovenian: Če potrdite ILD/pnevmonitis, je treba zdravljenje z dakomitinibom trajno prekiniti in po potrebi uvesti ustrezno zdravljenje (glejte poglavje 4.2).
English: Hepatotoxicity and transaminases increased
Slovenian: Hepatotoksičnost in zvečanje vrednosti transaminaz
English: • If Grade 2 rash, erythematous or exfoliative skin conditions persist for 72 hours despite treatment, withhold dacomitinib.
Slovenian: • Če izpuščaj, eritematozne ali eksfoliativne kožne bolezni stopnje 2 kljub zdravljenju trajajo 72 ur, prekinite zdravljenje z dakomitinibom.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: Carcinogenicity studies have not been performed with dacomitinib.
Slovenian: Študij kancerogenosti z dakomitinibom niso izvedli.
English: It is available in blister packs of 30 film-coated tablets (tablets).
Slovenian: Zdravilo je na voljo v pretisnih omotih s 30 filmsko obloženimi tabletami (tabletami).
English: Vizimpro contains lactose and sodium
Slovenian: Zdravilo Vizimpro vsebuje laktozo in natrij
English: Patients experiencing fatigue or ocular adverse reactions while taking dacomitinib should exercise caution when driving or operating machinery.
Slovenian: Bolniki, pri katerih se med jemanjem dakomitiniba pojavijo utrujenost ali očesni neželeni učinki, morajo biti previdni pri vožnji ali upravljanju strojev.
English: 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.
Slovenian: 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.
English: Grade 3 exfoliative skin conditions were reported in 0.8% of patients (see section 4.4).
Slovenian: O eksfoliativnih kožnih boleznih stopnje 3 so poročali pri 0,8 % bolnikov (glejte poglavje 4.4).
English: 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.
Slovenian: 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).
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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.
English: Tablet core: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, magnesium stearate (see section 2 Vizimpro contains lactose and sodium).
Slovenian: Jedro tablete: laktoza monohidrat, mikrokristalna celuloza, natrijev karboksimetilškrob, magnezijev stearat (glejte poglavje 2 Zdravilo Vizimpro vsebuje laktozo in natrij).
English: 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).
Slovenian: 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).
English: • 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.
Slovenian: • Vnetje pljuč (pogosto, pojavi se lahko pri največ 1 od 10 bolnikov) Težave z dihanjem, kratka sapa, ki jih lahko spremljata kašelj ali vročina.
English: 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.
Slovenian: 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.
English: No clinical studies have been conducted in patients with impaired renal function.
Slovenian: Kliničnih študij pri bolnikih z okvaro delovanja ledvic niso izvedli.
English: 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.
Slovenian: 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.
English: • Procainamide, used to treat heart arrhythmias
Slovenian: • prokainamid, ki se uporablja za zdravljenje aritmij;