FrancophonIA/ELRC3.0 huggingface dataset:
English: Macrophage activation syndrome (MAS) is a known, life-threatening disorder that may develop in patients with autoimmune conditions, in particular with inflammatory bowel disease (IBD) (unlicensed indication), and there could potentially be an increased susceptibility for developing the condition with the use of mercaptopurine.
Slovenian: Sindrom aktivacije makrofagov je znana, življenjsko nevarna motnja, ki se lahko pojavi pri bolnikih z avtoimunskimi boleznimi, zlasti pri bolnikih z vnetno črevesno boleznijo (neodobrena indikacija).
English: Macrophage activation syndrome (MAS) is a known, life-threatening disorder that may develop in patients with autoimmune conditions, in particular with inflammatory bowel disease (IBD), and there could potentially be an increased susceptibility for developing the condition with the use of azathioprine.
Slovenian: Sindrom aktivacije makrofagov je znana, življenjsko nevarna motnja, ki se lahko pojavi pri bolnikih z avtoimunskimi boleznimi, zlasti pri bolnikih z vnetno črevesno boleznijo.
English: 4 x 10 mg + 4 x 20 mg + 19 x 30 mg tablets
Slovenian: 4 x 10 mg + 4 x 20 mg + 19 x 30 mg tablete
English: 10 mg + 20 mg + 30 mg blister (PVC/alu) in a card
Slovenian: 10 mg + 20 mg + 30 mg filmsko obložena tableta peroralna uporaba pretisni omot (PVC/alu) v zgibanki
English: These include, among others:
Slovenian: Mednje med drugim sodijo:
English: Approximately 90% of patients included in this analysis were Asian or White.
Slovenian: Približno 90 % bolnikov, ki so bili vključeno v to analizo, je bilo Azijcev ali belcev.
English: Therefore, the statistical significance of OS improvement could not be formally assessed.
Slovenian: Zato statistične pomembnosti izboljšanja OS ni bilo mogoče formalno oceniti.
English: • Swallow the tablet whole with a glass of water.
Slovenian: • Tableto pogoltnite celo, s kozarcem vode.
English: • if you ever had any other lung problems.
Slovenian: • če ste kadarkoli imeli druge težave s pljuči.
English: • Take the tablet at about the same time each day.
Slovenian: • Tableto vzemite vsak dan ob približno istem času.
English: Dose (once daily)
Slovenian: Odmerek (enkrat na dan)
English: * Fatal events were reported.
Slovenian: * Poročali so o dogodkih s smrtnim izidom.
English: Data based on data cut-off date of 29 July 2016.
Slovenian: Podatki temeljijo na podatkih, zbranih do datuma zaključka zbiranja podatkov: 29. julij 2016.
English: Patients should be encouraged to take their dose at approximately the same time each day.
Slovenian: Bolnike je treba spodbujati, da vzamejo odmerek vsak dan ob približno istem času.
English: Age, race, gender, body weight
Slovenian: Starost, rasa, spol, telesna masa
English: This medicine may pose a risk for the environment.
Slovenian: To zdravilo je lahko okolju nevarno.
English: Assessment of EGFR mutation status
Slovenian: Določanje statusa mutacij EGFR
English: When assessing the EGFR mutation status of a patient, it is important that a well-validated and robust methodology is chosen to avoid false negative or false positive determinations.
Slovenian: Pri določanju statusa mutacij EGFR pri bolniku je pomembno, da izberete dobro validirano in robustno metodologijo, da se izognete lažno negativnim ali lažno pozitivnim rezultatom.
English: Vizimpro has not been studied in children or adolescents and it must not be given to patients under the age of 18 years.
Slovenian: Zdravila Vizimpro niso preučevali pri otrocih ali mladostnikih in ga ne smemo dajati bolnikom, mlajšim od 18 let.
English: This medicine contains lactose (found in milk or dairy products).
Slovenian: To zdravilo vsebuje laktozo (ki je prisotna v mleku ali mlečnih izdelkih).
English: Food does not alter bioavailability to a clinically meaningful extent.
Slovenian: Hrana ne spremeni biološke uporabnosti v klinično pomembnem obsegu.
English: However, according to the hierarchical testing approach, the analysis was stopped with the testing of ORR as the statistical significance was not reached.
Slovenian: Vendar pa so analizo skladno s pristopom hierarhičnega testiranja ustavili pri testiranju ORR, saj niso dosegli statistične pomembnosti.
English: Symptoms may be similar to those from lung cancer.
Slovenian: Simptomi so lahko podobni tistim, ki spremljajo pljučnega raka.
English: Do not stop taking Vizimpro unless your doctor tells you to.
Slovenian: Zdravila Vizimpro ne prenehajte jemati, razen če vam to naroči zdravnik.
English: EGFR mutation status was determined by a standardised and commercially available test kit.
Slovenian: Status mutacij EGFR so določili s standardiziranim in komercialno dostopnim testnim kompletom.
English: The tablets should be swallowed with water and can be taken with or without meals.
Slovenian: Tablete je treba pogoltniti z vodo in se jih lahko jemlje s hrano ali brez nje.
English: c. Based on the stratified Cochran-Mantel-Haenszel test.
Slovenian: c. Na podlagi stratificiranega Cochran-Mantel-Haenszelovega testa.
English: Dose modifications may be required based on individual safety and tolerability.
Slovenian: Odmerek bo morda treba prilagoditi glede na posameznikovo varnost in prenašanje.
English: Race was 23% White, 77% Asian, and < 1% Black.
Slovenian: Kar zadeva raso, je bilo 23 % belcev, 77 % Azijcev in < 1 % temnopoltih.
English: • You can take the tablet with or without meals.
Slovenian: • Tableto lahko vzamete s hrano ali brez nje.
English: The other ingredients are:
Slovenian: - Druge sestavine zdravila so:
English: Advise patients to use protective clothing and sunscreen before exposure to the sun.
Slovenian: Bolnikom svetujte, naj pred izpostavitvijo soncu uporabijo zaščitna oblačila in kremo za zaščito pred soncem.
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.
Slovenian: Če obstaja kakršnakoli možnost, da zanosite, morate med zdravljenjem in še najmanj 17 dni po njem uporabljati učinkovito kontracepcijo.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Slovenian: Znotraj vsake skupine pogostnosti so neželeni učinki predstavljeni po padajoči resnosti.
English: In particular, the effects of some medicines may increase when taken with Vizimpro.
Slovenian: Predvsem se učinki nekaterih zdravil lahko povečajo, kadar jih jemljete skupaj z zdravilom Vizimpro.
English: a. From stratified Cox Regression.
Slovenian: a. Iz stratificirane Coxove regresijske analize.
English: All effects occurred at systemic exposure below that in humans at the recommended dose of 45 mg once daily.
Slovenian: Vsi učinki so se pojavili pri sistemski izpostavljenosti, ki je bila manjša od tiste pri človeku pri priporočenem odmerku 45 mg enkrat na dan.
English: • If you are being treated with any of the medicines listed in section Other medicines and Vizimpro.
Slovenian: • če se zdravite s katerimkoli izmed zdravil, ki so navedena v poglavju Druga zdravila in zdravilo Vizimpro.
English: The safety and efficacy of Vizimpro in the paediatric population (< 18 years of age) have not been established.
Slovenian: Pediatrična populacija Varnost in učinkovitost zdravila Vizimpro pri pediatrični populaciji (starost < 18 let) nista bili dokazani.
English: Contact your doctor immediately if you notice any of the following side effects - you may need urgent medical treament:
Slovenian: Takoj obvestite zdravnika, če opazite kateregakoli izmed naslednjih neželenih učinkov - morda boste potrebovali nujno zdravniško pomoč:
English: The median duration of treatment with Vizimpro across the pooled data set was 66.7 weeks.
Slovenian: Mediano trajanje zdravljenja z zdravilom Vizimpro v združeni zbirki podatkov je bilo 66,7 tedna.
English: Diarrhoea may result in dehydration with or without renal impairment, which could be fatal if not adequately treated.
Slovenian: Diareja lahko povzroči dehidracijo z ledvično okvaro ali brez nje, ki je lahko smrtna, če je ne zdravimo ustrezno.
English: Anti-diarrhoeal medicinal products (e.g., loperamide) should be used and, if necessary, escalated to the highest recommended approved dose.
Slovenian: Treba je uporabiti antidiaroike (npr. loperamid) in po potrebi odmerek povečevati do največjega priporočenega odobrenega odmerka.
English: b. Based on the stratified log-rank test.
Slovenian: b. Na podlagi stratificiranega log-rank testa.
English: The following medicines may reduce how well Vizimpro works:
Slovenian: Naslednja zdravila lahko zmanjšajo učinkovitost zdravila Vizimpro:
English: A phototoxicity study with dacomitinib in pigmented rats showed no phototoxicity potential.
Slovenian: Študija fototoksičnosti z dakomitinibom pri pigmentiranih podganah ni pokazala potenciala za fototoksičnost.
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).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z dakomitinibom za vse podskupine pediatrične populacije pri indikaciji NSCLC (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: However, based on the oral bioavailability of 80%, these membrane transport proteins are unlikely to have any impact on dacomitinib absorption.
Slovenian: Na podlagi peroralne biološke uporabnosti, ki znaša 80 %, ni verjetno, da bi te membranske prenašalne beljakovine imele vpliv na absorpcijo dakomitiniba.
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.
Slovenian: Če bolnik bruha ali izpusti odmerek, ta dan ne sme vzeti dodatnega odmerka, naslednji predpisani odmerek pa mora vzeti naslednji dan ob običajnem času.
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.
Slovenian: Demografske značilnosti celokupne študijske populacije so bile naslednje: 60 % žensk, mediana starost ob vključitvi pa je bila 62 let, pri čemer je bilo 10,8 % bolnikov starih ≥ 75 let.
English: Subgroup analyses of PFS per IRC review based on baseline characteristics were consistent with those from the primary analysis of PFS.
Slovenian: Analize PFS po podskupinah glede na pregled IRC na podlagi izhodiščnih značilnosti so bile skladne z rezultati primarne analize PFS.
English: Key secondary endpoints included objective response rate (ORR), duration of response (DoR), and overall survival (OS).
Slovenian: Ključni sekundarni opazovani dogodki so vključevali objektivni odziv na zdravljenje (ORR - Objective Response Rate), trajanje odziva (DoR - Duration of Response) in celokupno preživetje (OS - Overall Survival).
English: • Dry, red, or itchy eyes
Slovenian: • suhe, rdeče ali srbeče oči
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.
Slovenian: Če preiskava pri vašem raku pokaže določene spremembe (mutacije) v genu, ki ga imenujemo ''EGFR'' (receptor za epidermalni rastni dejavnik), in se je vaš rak razširil na drugo pljučno krilo ali na druge organe, je verjetno, da se bo vaš rak odzval na zdravljenje z zdravilom Vizimpro.
English: The plasma half-life of dacomitinib ranges from 54 to 80 hours.
Slovenian: Plazemski razpolovni čas dakomitiniba je v razponu od 54 do 80 ur.
English: Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake ''EXP''.
English: This may mean that you have an inflammation of the lungs called interstitial lung disease and can be fatal.
Slovenian: To lahko pomeni, da imate vnetje pljuč, imenovano intersticijska pljučna bolezen, ki je lahko usodna.
English: If you feel tired or your eyes are irritated, you should use caution when driving or using machines.
Slovenian: Če ste utrujeni ali imate razdražene oči, morate biti pri upravljanju vozil ali strojev previdni.
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.
Slovenian: Na podlagi podatkov iz opažanj pri 8 bolnikih v Študiji A7471001 ni bilo očitnega učinka dajanja lokalnega antacida na vrednosti Cmax in AUCinf dakomitiniba.
English: Early treatment of skin rash is important.
Slovenian: Zgodnje zdravljenje izpuščaja na koži je pomembno;
English: Vizimpro can be used as your first treatment once your lung cancer has spread to your other lung or other organs.
Slovenian: Zdravilo Vizimpro lahko uporabljamo kot prvo zdravljenje, ko se je vaš rak pljuč že razširil na drugo pljučno krilo ali na druge organe.
English: If you take more Vizimpro than you should If you have taken too much Vizimpro, see a doctor or go to a hospital immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Vizimpro, kot bi smeli Če ste vzeli preveč zdravila Vizimpro, takoj obiščite zdravnika ali pojdite v bolnišnico.
English: The recommended dose of Vizimpro is 45 mg taken orally once daily, until disease progression or unacceptable toxicity occurs.
Slovenian: Priporočeni odmerek zdravila Vizimpro je 45 mg peroralno enkrat na dan do napredovanja bolezni ali nesprejemljive toksičnosti.
English: Treatment in this population is not recommended (see section 5.2).
Slovenian: Zdravljenje pri tej populaciji ni priporočljivo (glejte poglavje 5.2).
English: Effect of Dacomitinib on UGT Enzymes
Slovenian: Učinek dakomitiniba na encime UGT
English: What Vizimpro is and what it is used for 2.
Slovenian: Kaj je zdravilo Vizimpro in za kaj ga uporabljamo 2.
English: Dacomitinib binds selectively and irreversibly to its HER family targets thereby providing prolonged inhibition.
Slovenian: Dakomitinib se selektivno in ireverzibilno veže na svoja prijemališča družine HER in tako zagotavlja dolgotrajno zaviranje.
English: The primary endpoint of the study was progression-free survival (PFS) as determined by blinded Independent Radiology Central (IRC) review.
Slovenian: Primarni opazovani dogodek študije je bilo preživetje brez napredovanja bolezni (PFS - ProgressionFree Survival), kot so ga določili s slepim neodvisnim centralnim radiološkim (IRC - Independent Radiology Central) pregledom.
English: These effects were reversible with the exception of hair follicles and kidney changes.
Slovenian: Ti učinki so bili reverzibilni, z izjemo sprememb lasnih mešičkov in ledvic.
English: Skin-related adverse reactions were Grades 1 to 3.
Slovenian: S kožo povezani neželeni učinki so bili stopnje 1-3.
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.
Slovenian: Če zdravljenje izpuščaja ni učinkovito ali se izpuščaj poslabšuje (na primer se vam koža lušči ali poka), takoj obvestite zdravnika, saj se zdravnik lahko odloči za prekinitev vašega zdravljenja z zdravilom Vizimpro.
English: Recommended starting dose
Slovenian: priporočeni začetni odmerek
English: • Pimozide and thioridazine, used to treat schizophrenia and psychosis
Slovenian: • pimozid in tioridazin, ki se uporabljata za zdravljenje shizofrenije in psihoze.
English: Treatment with Vizimpro should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
Slovenian: Zdravljenje z zdravilom Vizimpro mora uvesti in nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje rakavih bolezni.
English: Thus, dacomitinib is not expected to be genotoxic at clinically relevant exposure concentrations.
Slovenian: Zato ni pričakovati, da bi bil dakomitinib genotoksičen pri klinično pomembnih koncentracijah izpostavljenosti.
English: Immediate treatment of diarrhoea is important.
Slovenian: Takojšnje zdravljenje driske je pomembno;
English: If dose reduction is necessary, then the dose of Vizimpro should be reduced as described in Table 1.
Slovenian: Če je treba odmerek zmanjšati, odmerek zdravila Vizimpro zmanjšajte, kot je opisano v preglednici 1.
English: • Abnormal liver enzyme blood tests
Slovenian: • nenormalni izvidi krvnih preiskav jetrnih encimov
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.
Slovenian: Zdravljenje je bilo peroralno, dajali pa so ga neprekinjeno vsak dan do napredovanja bolezni, uvedbe novega zdravila za zdravljenje novotvorb, nesprejemljive toksičnosti, umika soglasja, smrti ali odločitve raziskovalca za zagotovitev skladnosti s protokolom, kar je bilo prej.
English: Among NSCLC patients treated with dacomitinib 45 mg daily, there have been isolated reports of hepatotoxicity in 4 (1.6%) patients.
Slovenian: Pri bolnikih z NSCLC, ki so se zdravili z dakomitinibom v odmerku 45 mg na dan, obstajajo posamezna poročila o hepatotoksičnosti pri 4 (1,6 %) bolnikih.
English: As an alternative, you can take a short-acting medicine, such as an antacid, or an H2 blocker medicine.
Slovenian: Kot alternativo lahko vzamete zdravilo s kratkotrajnim delovanjem, na primer antacid, ali zaviralec histaminskega receptorja H2.
English: Medicinal products metabolised by cytochrome P450 (CYP)2D6
Slovenian: Zdravila, ki se presnavljajo preko citokroma P450 (CYP)2D6
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.
Slovenian: Ženske v rodni dobi, ki prejemajo to zdravilo, morajo med zdravljenjem in še vsaj 17 dni (5 razpolovnih časov) po koncu zdravljenja uporabljati ustrezne kontracepcijske metode.
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).
Slovenian: Znotraj vsakega organskega sistema so neželeni učinki navedeni po pogostnosti na naslednji način, pri čemer so najprej navedeni najpogostejši neželeni učinki: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000).
English: No clear relationship between dacomitinib exposure and efficacy could be characterised over the exposure range studied.
Slovenian: Jasne povezave med izpostavljenostjo dakomitinibu in njegovo učinkovitostjo pri preučevanem razponu izpostavljenosti ni bilo mogoče ugotoviti.
English: Therefore, periodic liver function testing is recommended.
Slovenian: Zato priporočamo redne preiskave delovanja jeter.
English: • Inflammation of the mouth and lips
Slovenian: • vnetje ust in ustnic
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.
Slovenian: Na podlagi populacijskih farmakokinetičnih analiz starost, rasa (Azijci in Neazijci), spol in telesna masa bolnika nimajo klinično pomembnega učinka na predvideno izpostavljenost dakomitinibu v stanju dinamičnega ravnovesja.
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.
Slovenian: Ob prvih znakih pogostejšega odvajanja blata se takoj obrnite na zdravnika, pijte veliko tekočine in čim prej začnite zdravljenje z zdravili proti driski.
English: Dacomitinib should not be used during pregnancy.
Slovenian: Dakomitiniba ne smete uporabljati med nosečnostjo.
English: What Vizimpro is and what it is used for
Slovenian: Kaj je zdravilo Vizimpro in za kaj ga uporabljamo
English: What you need to know before you take Vizimpro 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Vizimpro 3.
English: Patients with brain metastases or leptomeningeal disease or ECOG PS ≥ 2 were excluded from the trial.
Slovenian: Bolnike z možganskimi metastazami ali leptomeningealno boleznijo ali PS po ECOG ≥ 2 so izključili iz preskušanja.
English: • Loss of appetite
Slovenian: • pomanjkanje apetita
English: ARCHER 1050 - Kaplan-Meier curve for PFS per IRC review - ITT population
Slovenian: Preskušanje ARCHER 1050 - Kaplan-Meierjeva krivulja PFS glede na pregled IRCpopulacija ITT
English: If concomitant use of such medicinal products is considered necessary, they should follow their respective labels for dose recommendation regarding co-administration with strong CYP2D6 inhibitors.
Slovenian: Če je sočasna uporaba takih zdravil nujna, je treba upoštevati priporočila o odmerjanju v informacijah o zdravilu glede sočasnega dajanja z močnimi zaviralci CYP2D6.
English: There are no data on the use of dacomitinib in pregnant women.
Slovenian: Podatkov o uporabi dakomitiniba pri nosečnicah ni.
English: Vizimpro has minor influence on the ability to drive and use machines.
Slovenian: Zdravilo Vizimpro ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: Rash, erythematous and exfoliative skin conditions may occur or worsen in areas exposed to the sun.
Slovenian: Izpuščaj ter eritematozne in eksfoliativne kožne bolezni se lahko pojavijo ali poslabšajo na predelih, izpostavljenih soncu.
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.
Slovenian: V plazmi se dakomitinib veže na albumin in 1-kisli glikoprotein, nevezana frakcija pa je približno 2 % in vitro in ex vivo pri zdravih prostovoljcih.
English: Tell your doctor immediately while taking this medicine:
Slovenian: Takoj obvestite zdravnika, če se vam med jemanjem tega zdravila:
English: The treatment of dacomitinib overdose should consist of symptomatic treatment and general supportive measures.
Slovenian: Znanega antidota za dakomitinib ni. Zdravljenje prevelikega odmerjanja dakomitiniba mora obsegati simptomatsko zdravljenje in splošne podporne ukrepe.
English: Local antacids and H2 receptor antagonists may be used if needed.
Slovenian: Po potrebi lahko uporabimo lokalne antacide in antagoniste receptorjev H2.
English: Because many medicinal products are excreted in human milk, and because of the potential for serious adverse reactions in breast-fed infants from exposure to dacomitinib, mothers should be advised against breast-feeding while receiving this medicinal product.
Slovenian: Ker se številna zdravila izločajo v materino mleko in ker zaradi izpostavljenosti dakomitinibu lahko pride do resnih neželenih učinkov pri dojenih otrocih, je treba materam odsvetovati dojenje med jemanjem tega zdravila.
English: Significant exposure-safety relationship was defined for Grade ≥ 3 rash/dermatitis acneiform, other skin toxicities, diarrhoea and Grade ≥ 1 stomatitis.
Slovenian: Pomembno povezavo med izpostavljenostjo in varnostjo so določili pri izpuščaju/akneiformnem dermatitisu stopnje ≥ 3, drugih toksičnostih za kožo, diareji in stomatitisu stopnje ≥ 1.
English: • Abnormal amount of body hair growth
Slovenian: • nenormalna količina rasti las in dlak