FrancophonIA/ELRC3.0 huggingface dataset:
English: Symptoms may be similar to those from lung cancer.
Croatian: Simptomi mogu biti slični simptomima raka pluća.
English: • The recommended dose is 45 mg taken by mouth each day.
Croatian: • Preporučena doza je 45 mg koja se uzima svaki dan kroz usta.
English: These effects were reversible with the exception of hair follicles and kidney changes.
Croatian: Ti učinci su bili reverzibilni s iznimkom folikula dlaka i bubrežnih promjena.
English: The tablets should be swallowed with water and can be taken with or without meals.
Croatian: Tablete treba progutati s vodom i mogu se uzeti uz hranu ili bez nje.
English: What Vizimpro is and what it is used for 2.
Croatian: Što je Vizimpro i za što se koristi 2.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Vizimpro:
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Vizimpro:
English: • You can take the tablet with or without meals.
Croatian: • Možete uzeti tabletu s hranom ili bez nje.
English: • Alteration in taste
Croatian: • Promjena okusa
English: b. Based on the stratified log-rank test.
Croatian: b. Na temelju stratificiranog log-rang testa.
English: What Vizimpro is and what it is used for
Croatian: Što je Vizimpro i za što se koristi
English: Vizimpro has not been studied in children or adolescents and it must not be given to patients under the age of 18 years.
Croatian: Djeca i adolescenti Vizimpro nije ispitivan u djece ili adolescenata te se ne smije dati bolesnicima mlađim od 18 godina.
English: This may mean that you have an inflammation of the lungs called interstitial lung disease and can be fatal.
Croatian: To može značiti da imate upalu pluća koja se naziva intersticijska plućna bolest i koja može biti smrtonosna.
English: The median duration of treatment with Vizimpro across the pooled data set was 66.7 weeks.
Croatian: Medijan trajanja liječenja lijekom Vizimpro u cjelokupnim objedinjenim podacima iznosio je 66,7 tjedana.
English: Decreased appetite Hypokalaemiaa
Croatian: Smanjen apetit Hipokalijemija
English: Dacomitinib should be administered 2 hours before or at least 10 hours after taking H2 receptor antagonists.
Croatian: Dakomitinib treba primijeniti 2 sata prije ili najmanje 10 sati nakon uzimanja antagonista H2 receptora.
English: The following medicines may reduce how well Vizimpro works:
Croatian: Sljedeći lijekovi mogu smanjiti djelovanje lijeka Vizimpro:
English: This leaflet was last revised in MM/YYYY
Croatian: Ova uputa je zadnji puta revidirana u {MM/GGGG}.
English: The treatment of dacomitinib overdose should consist of symptomatic treatment and general supportive measures.
Croatian: Liječenje predoziranja dakomitinibom treba se sastojati od simptomatskog liječenja i općih suportivnih mjera.
English: In 6 healthy male subjects given a single-oral dose of [
Croatian: Kod 6 zdravih muških ispitanika koji su primili jednokratnu peroralnu dozu [
English: • Abnormal amount of body hair growth
Croatian: • Abnormalan rast dlaka na tijelu
English: Diarrhoea may result in dehydration with or without renal impairment, which could be fatal if not adequately treated.
Croatian: Proljev može dovesti do dehidracije uz oštećenje bubrega ili bez njega, što može biti smrtonosno ako se ne liječi na odgovarajući način.
English: Aluminium/aluminium blister containing 10 film-coated tablets.
Croatian: Aluminij/aluminij blister koji sadrži 10 filmom obloženih tableta.
English: Other forms of interactions
Croatian: Drugi oblici interakcija
English: Tell your doctor immediately while taking this medicine:
Croatian: Odmah obavijestite svog liječnika ako tijekom uzimanja ovog lijeka:
English: If a test has shown that your cancer has certain changes (mutations) in a gene called ‘EGFR' (epidermal growth factor receptor) and has spread to your other lung or other organs, your cancer is likely to respond to treatment with Vizimpro.
Croatian: Ako je ispitivanje pokazalo da Vaš rak ima određene promjene (mutacije) u genu poznatom pod nazivom „EGFR“ (receptor epidermalnog čimbenika rasta) i da se proširio na drugo plućno krilo ili druge organe, vjerojatno je da će Vaš rak odgovoriti na liječenje lijekom Vizimpro.
English: Treatment was administered orally on a continuous daily basis until disease progression, institution of new anticancer therapy, intolerable toxicity, withdrawal of consent, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Croatian: Liječenje se kontinuirano primjenjivalo peroralno i to svakodnevno do progresije bolesti, uvođenja nove terapije protiv raka, nepodnošljive toksičnosti, povlačenja pristanka, smrti ili odluke ispitivača vođene protokolom, što god da se dogodi prvo.
English: Other medicines and Vizimpro
Croatian: Drugi lijekovi i Vizimpro
English: The plasma half-life of dacomitinib ranges from 54 to 80 hours.
Croatian: Poluvijek dakomitiniba u plazmi kreće se od 54 do 80 sati.
English: • If you are being treated with any of the medicines listed in section Other medicines and Vizimpro.
Croatian: • Ako uzimate bilo koji od lijekova navedenih u dijelu Drugi lijekovi i Vizimpro.
English: Food does not alter bioavailability to a clinically meaningful extent.
Croatian: Hrana ne mijenja bioraspoloživost u klinički značajnoj mjeri.
English: Advise patients to use protective clothing and sunscreen before exposure to the sun.
Croatian: Savjetujte bolesnike da se prije izlaganja suncu zaštite odjećom i preparatima za zaštitu od sunca.
English: Treatment in this population is not recommended (see section 5.2).
Croatian: Liječenje se ne preporučuje u ovoj populaciji (vidjeti dio 5.2).
English: Do not stop taking Vizimpro unless your doctor tells you to.
Croatian: Ako prestanete uzimati lijek Vizimpro Nemojte prestati uzimati Vizimpro osim ako Vam to nije rekao liječnik.
English: A phototoxicity study with dacomitinib in pigmented rats showed no phototoxicity potential.
Croatian: Ispitivanje fototoksičnosti s dakomitinibom u pigmentiranih štakora nije pokazalo potencijal za fototoksičnost.
English: All effects occurred at systemic exposure below that in humans at the recommended dose of 45 mg once daily.
Croatian: Svi učinci su se pojavili pri sistemskom izlaganju nižem od onog koje se javlja u ljudi pri preporučenoj dozi od 45 mg primijenjenoj svaki dan.
English: Consider adding broad spectrum oral or intravenous antibiotics if any of these conditions worsen to greater than or equal to Grade 2 severity.
Croatian: Razmotrite uvođenje i peroralnih ili intravenskih antibiotika širokog spektra ako se bilo koje od navedenih stanja pogorša na stupanj veći ili jednak stupnju 2 prema težini.
English: Some lung problems may get worse during treatment with Vizimpro, as Vizimpro may cause inflammation of the lungs during treatment.
Croatian: Neki problemi s plućima se mogu pogoršati tijekom liječenja lijekom Vizimpro, jer Vizimpro može prouzrokovati upalu pluća tijekom liječenja.
English: Assessment of EGFR mutation status
Croatian: Procjena statusa mutacije EGFR-a
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.
Croatian: Ako uzmete H2 blokator, uzmite svoju dozu lijeka Vizimpro najmanje 2 sata prije ili 10 sati nakon uzimanja H2 blokatora.
English: If the patient vomits or misses a dose, an additional dose should not be taken and the next prescribed dose should be taken at the usual time the next day.
Croatian: Ako bolesnik povraća ili propusti dozu, ne smije se uzeti dodatna doza, već je potrebno uzeti sljedeću propisanu dozu u uobičajeno vrijeme sljedeći dan.
English: If there is any possibility that you may become pregnant you must use effective contraception during treatment, and for at least 17 days afterwards.
Croatian: Ako postoji mogućnost da zatrudnite, morate koristiti učinkovitu kontracepciju tijekom liječenja i najmanje 17 dana nakon završetka terapije.
English: In particular, the effects of some medicines may increase when taken with Vizimpro.
Croatian: Posebice jer se učinci nekih lijekova mogu povećati ako se uzimaju zajedno s lijekom Vizimpro.
English: Dacomitinib should not be used during pregnancy.
Croatian: Dakomitinib se ne smije koristiti u trudnoći.
English: Vizimpro can be used as your first treatment once your lung cancer has spread to your other lung or other organs.
Croatian: Vizimpro se može koristiti kao Vaše prvo liječenje kada se rak pluća proširio na drugo plućno krilo ili druge organe.
English: Women of childbearing potential who are receiving this medicinal product should use adequate contraceptive methods during therapy and for at least 17 days (5 half-lives) after completing therapy.
Croatian: Žene reproduktivne dobi koje uzimaju ovaj lijek moraju koristiti odgovarajuće metode kontracepcije tijekom terapije i tijekom barem 17 dana (5 poluvijekova) nakon završetka terapije.
English: If treatment for rash is not working or the rash is getting worse (for example, you have peeling or cracking of the skin) you should tell your doctor immediately, since your doctor may decide to stop your treatment with Vizimpro.
Croatian: Ako liječenje osipa nije uspješno ili ako se osip pogoršava (na primjer ako Vam se koža guli ili puca) morate o tome odmah obavijestiti svog liječnika, jer on može odlučiti prekinuti liječenje lijekom Vizimpro.
English: As an alternative, you can take a short-acting medicine, such as an antacid, or an H2 blocker medicine.
Croatian: Kao zamjenu možete uzeti kratkodjelujući lijek poput antacida ili H2 blokator.
English: Recommended starting dose
Croatian: Preporučena početna doza
English: Other information on drug-drug interactions
Croatian: Druge informacije o interakcijama između lijekova
English: • Pimozide and thioridazine, used to treat schizophrenia and psychosis
Croatian: • pimozid i tioridazin koji se koriste za liječenje shizofrenije i psihoze.
English: The demographic characteristics of the overall study population were 60% female; median age at enrolment was 62 years with 10.8% being ≥ 75 years old.
Croatian: Demografske karakteristike ukupne ispitivane populacije: 60 % su bile žene; srednja dob u vrijeme uključenja u ispitivanje bila je 62 godine te je 10,8 % ispitanika imalo ≥ 75 godina.
English: a. From stratified Cox Regression.
Croatian: Iz stratificiranog Coxovog regresijskog modela.
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).
Croatian: Nuspojave opažene kod primjene doza većih od 45 mg jednom na dan bile su prvenstveno gastrointestinalne, dermatološke i konstitucijske (npr. umor, malaksalost i gubitak tjelesne težine).
English: Vizimpro has minor influence on the ability to drive and use machines.
Croatian: Vizimpro malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: The European Medicines Agency has waived the obligation to submit the results of studies with dacomitinib in all subsets of the paediatric population in NSCLC indication (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja dakomitiniba u svim podskupinama pedijatrijske populacije za indikaciju NSCLC-a (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Anti-diarrhoeal medicinal products (e.g., loperamide) should be used and, if necessary, escalated to the highest recommended approved dose.
Croatian: Potrebno je primijeniti lijekove protiv proljeva (npr. loperamid) i, prema potrebi, povećavati njihovu dozu do najviše preporučene odobrene doze.
English: Based on data from observations in 8 patients in Study A7471001, there was no apparent effect of local antacid administration on Cmax and AUCinf of dacomitinib.
Croatian: Podaci dobiveni iz opažanja u 8 bolesnika tijekom ispitivanja A7471001 pokazuju da nema vidljivog učinka primjene lokalnih antacida na Cmax i AUCinf dakomitiniba.
English: There is no known antidote for dacomitinib.
Croatian: Ne postoji poznati antidot za dakomitinib.
English: You should not take these medicines during your treatment with Vizimpro.
Croatian: Ne smijete uzimati ove lijekove tijekom liječenja lijekom Vizimpro.
English: • Dry, red, or itchy eyes
Croatian: • Suhe, crvene oči ili svrbež očiju
English: Following oral administration of a single 45-mg dose of [
Croatian: Nakon peroralne primjene jednokratne doze od 45 mg [
English: Effect of Dacomitinib on UGT Enzymes
Croatian: Učinak dakomitiniba na UGT enzime
English: Thus, dacomitinib is not expected to be genotoxic at clinically relevant exposure concentrations.
Croatian: Stoga se ne očekuje da dakomitinib bude genotoksičan pri klinički relevantnim koncentracijama izlaganja.
English: However, based on the oral bioavailability of 80%, these membrane transport proteins are unlikely to have any impact on dacomitinib absorption.
Croatian: Međutim, na temelju peroralne bioraspoloživosti od 80 %, nije vjerojatno da će navedeni membranski proteini s funkcijom prijenosa imati utjecaj na apsorpciju dakomitiniba.
English: The recommended dose of Vizimpro is 45 mg taken orally once daily, until disease progression or unacceptable toxicity occurs.
Croatian: Preporučena doza lijeka Vizimpro iznosi 45 mg i uzima se peroralno jednom na dan do progresije bolesti ili razvoja neprihvatljive toksičnosti.
English: If you feel tired or your eyes are irritated, you should use caution when driving or using machines.
Croatian: Ako osjećate umor ili su Vam nadražene oči, trebate biti oprezni kada upravljate vozilima ili strojevima.
English: Tell your doctor as soon as possible if you notice any of the other following side effects:
Croatian: Obavijestite svog liječnika što je prije moguće ako primijetite bilo koju od sljedećih nuspojava:
English: Treatment with Vizimpro should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
Croatian: Liječenje lijekom Vizimpro treba započeti i nadzirati liječnik iskusan u primjeni lijekova protiv raka.
English: If you become pregnant while taking this medicine, you should immediately talk to your doctor.
Croatian: Ako zatrudnite tijekom liječenja ovim lijekom, odmah obavijestite o tome svog liječnika
English: • Inflammation of the mouth and lips
Croatian: • Upala usta i usana
English: Pharmacotherapeutic group: Anti-neoplastic agents, protein kinase inhibitors, ATC code: L01XE47
Croatian: Farmakoterapijska skupina: Antineoplastici, inhibitori protein kinaze, ATK oznaka: L01XE47
English: Vizimpro contains lactose and sodium
Croatian: Vizimpro sadrži laktozu i natrij
English: Contact your doctor immediately if you notice any of the following side effects - you may need urgent medical treament:
Croatian: Odmah obavijestite svog liječnika ako se u Vas pojave sljedeće nuspojave - možda će Vam trebati hitna medicinska pomoć:
English: Within each SOC, the adverse reactions are ranked by frequency, with the most frequent reactions first, using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000).
Croatian: Unutar svake klasifikacije organskih sustava nuspojave su rangirane prema učestalosti tako da su najčešće reakcije prve po redu, uz primjenu sljedeće podjele: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000).
English: • Nausea or vomiting
Croatian: • Mučnina ili povraćanje
English: Based on population pharmacokinetic analyses, patient age, race (Asian and non-Asian), gender, and body weight do not have a clinically relevant effect on predicted steady-state exposure of dacomitinib.
Croatian: Na temelju farmakokinetičke analize populacije, dob, rasa (azijska i neazijska rasa), spol i tjelesna težina bolesnika nemaju klinički relevantan učinak na predviđeno izlaganje dakomitinibu u stanju dinamičke ravnoteže.
English: The inhibition of CYP2D6 translated into approximately a 90% reduction in metabolite exposure and an approximate 37% increase in dacomitinib exposure.
Croatian: Inhibicija CYP2D6 dovela je do približno 90 %-tnog smanjenja izloženosti metabolitu i približno 37 %-tnog povećanja izloženosti dakomitinibu.
English: • Skin rash (very common)
Croatian: • osip na koži (vrlo često)
English: In plasma, dacomitinib binds to albumin and 1-acid glycoprotein and the fraction unbound is approximately 2% in vitro and ex vivo in healthy volunteers.
Croatian: U plazmi se dakomitinib veže na albumin i 1-kiseli glikoprotein, a nevezana frakcija iznosi približno 2 % in vitro i ex vivo u zdravih dobrovoljaca.
English: A total of 452 patients were randomised 1:1 to dacomitinib or gefitinib in a multicentre, multinational, randomised, open-label Phase 3 study.
Croatian: Ukupno je 452 bolesnika bilo randomizirano 1:1 u skupinu liječenu dakomitinibom ili skupinu liječenu gefitinibom u multicentričnom, multinacionalnom, randomiziranom, otvorenom ispitivanju faze 3.
English: 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.
Croatian: Odmah obavijestite svog liječnika ako imate neki novi simptom ili ako se simptomi pogoršavaju, uključujući otežano disanje, nedostatak zraka, kašalj s (sluzavim) iskašljajem ili bez njega, ili vrućicu.
English: Patients should maintain adequate oral hydration and patients who become dehydrated may require administration of intravenous fluids and electrolytes (see section 4.2).
Croatian: Bolesnici se moraju pridržavati odgovarajuće oralne hidracije, a bolesnicima koji dehidriraju možda će biti potrebna i intravenska primjena tekućina i elektrolita (vidjeti dio 4.2).
English: Woman of childbearing potential/Contraception
Croatian: Žene reproduktivne dobi/kontracepcija
English: Dacomitinib has the potential to be a very persistent, bioaccumulative and toxic substance (see section 5.3).
Croatian: Dakomitinib ima potencijal biti vrlo perzistentna, bioakumulativna i toksična tvar (vidjeti dio 5.3).
English: Maternal body weight gain and food intake were lower in pregnant rats and rabbits.
Croatian: Dobivanje na tjelesnoj težini i unos hrane bili su manji u gravidnih ženki štakora i kunića.
English: At first signs of increased frequency of bowel movements, contact your doctor immediately, drink plenty of fluids, and start antidiarrhoea treatment as soon as possible.
Croatian: Na prve znakove povećane učestalosti stolice odmah obavijestite svog liječnika, pijte puno tekućine i što prije započnite terapiju protiv proljeva.
English: Rash, erythematous and exfoliative skin conditions may occur or worsen in areas exposed to the sun.
Croatian: Osip, eritematozna i eksfolijativna stanja kože mogu se pojaviti ili pogoršati na mjestima na koži koja su izložena suncu.
English: What you need to know before you take Vizimpro 3.
Croatian: Što morate znati prije nego počnete uzimati lijek Vizimpro 3.
English: Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake „EXP“.
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.
Croatian: U ispitivanjima toksičnosti ponovljene peroralne doze u trajanju do 6 mjeseci u štakora i 9 mjeseci u pasa, primarne toksičnosti pronađene su u koži/dlaci (kožne promjene u štakora i pasa, atrofija/displazija folikula dlaka u štakora), bubregu (papilarna nekroza koja je često popraćena tubularnom degeneracijom, regeneracijom, proširenjem i/ili atrofijom i promjenama u urinarnim markerima koje ukazuju na oštećenje bubrega u štakora, erozija ili ulceracija epitela bubrežne nakapnice s povezanom upalom bez promjena koje ukazuju na bubrežnu disfunkciju u pasa), oku (atrofija epitela rožnice u štakora i pasa, ulkusi/erozije rožnice s crvenom/natečenom konjunktivom (konjunktivama), konjunktivitis, uzdignuta treća vjeđa, povećana škiljavost, djelomično zatvorene oči, suzenje i/ili iscjedak iz oka u pasa) i probavnom sustavu (enteropatija u štakora i pasa, erozije/ulkusi usta s crvenilom sluznice u pasa) te je zabilježena atrofija epitelnih stanica ili drugih organa u štakora.
English: Female patients taking dacomitinib during pregnancy or who become pregnant while taking dacomitinib should be apprised of the potential hazard to the foetus.
Croatian: Bolesnice koje uzimaju dakomitinib tijekom trudnoće ili koje zatrudne tijekom liječenja dakomitinibom treba obavijestiti o mogućoj opasnosti za fetus.
English: Medicinal products metabolised by cytochrome P450 (CYP)2D6
Croatian: Lijekovi koji se metaboliziraju putem citokroma P450 (CYP)2D6
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).
Croatian: Ispitivanja na životinjama pokazala su ograničene učinke na reproduktivnu toksičnost (manji dobitak na tjelesnoj težini u majke i manji unos hrane u štakora i kunića te niža tjelesna težina fetusa i veća incidencija neokoštalog metatarzusa samo u štakora) (vidjeti dio 5.3).
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.
Croatian: Vizimpro sadrži djelatnu tvar dakomitinib koja spada u skupinu lijekova koji se nazivaju „inhibitori protein-tirozin kinaze“ i primjenjuju se u liječenju raka.
English: If you forget to take Vizimpro
Croatian: Ako ste zaboravili uzeti lijek Vizimpro
English: It is not known whether dacomitinib and its metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se dakomitinib i njegovi metaboliti u majčino mlijeko.
English: Treatment with dacomitinib should be withheld pending investigation of these symptoms.
Croatian: Liječenje dakomitinibom treba privremeno prekinuti dok se ne provede ispitivanje ovih simptoma.
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).
Croatian: Film ovojnica: Opadry II Blue 85F30716 sadrži djelomično hidroliziran poli(vinilni alkohol) (E1203), talk (E553b), titanijev dioksid (E171), makrogol (E1521), Indigo carmine aluminium lake (E132).
English: C] dacomitinib, the most abundant circulating metabolite was O-desmethyl dacomitinib.
Croatian: C] dakomitiniba, najobilniji cirkulirajući metabolit bio je O-dezmetil dakomitinib.
English: You should not become pregnant during treatment with Vizimpro because this medicine could harm the baby.
Croatian: Ne smijete zatrudnjeti tijekom liječenja lijekom Vizimpro jer ovaj lijek može naškoditi Vašem djetetu.
English: Dacomitinib showed a clearance of 20.0 L/hr with an inter-individual variability of 32% (CV%).
Croatian: Dakomitinib je pokazao klirens od 20,0 l/h s interindividualnom varijabilnošću od 32 % (koeficijent varijacije %).