FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 1 Recommended dose level reductions
Croatian: Tablica 1 Preporučene razine smanjivanja doze
English: If your doctor decides that you will receive treatment with the combination of Tafinlar and trametinib, read the trametinib leaflet carefully as well as this leaflet.
Croatian: Ako Vaš liječnik odluči da ćete primati terapiju s kombinacijom Tafinlara i trametiniba, pažljivo pročitajte uputu o trametinibu kao i ovu uputu.
English: Animal studies have shown that the active substance dabrafenib may permanently reduce male fertility.
Croatian: Ispitivanja na životinjama su pokazala da djelatna tvar dabrafenib može trajno smanjiti plodnost muškaraca.
English: Tafinlar is for oral use.
Croatian: Tafinlar je za peroralnu primjenu.
English: Terminal half-life of dabrafenib following an intravenous single microdose is 2.6 hours.
Croatian: Poluvrijeme dabrafeniba nakon intravenske primjene jedne mikrodoze je 2,6 sati.
English: 18.2 (14.3, NE)
Croatian: 18,2 (14,3; NO)
English: When you take Tafinlar and trametinib together you may get any of the side effects given in the lists above, although the frequency may change (increase or decrease).
Croatian: Kada uzimate zajedno Tafinlar i trametinib mogli biste dobiti bilo koju od nuspojava navedenih na prethodnim popisima, iako bi njihova učestalost mogla biti drugačija (veća ili manja).
English: The bottles are opaque white plastic with threaded plastic closures.
Croatian: Boce su od neprozirne bijele plastike s plastičnim zatvaračem na navoj.
English: In some cases, people with fever may develop low blood pressure, dizziness or other symptoms.
Croatian: U nekim slučajevima u osoba s vrućicom mogu se razviti niski krvni tlak, omaglica ili drugi simptomi.
English: Animal studies have shown reproductive toxicity and embryo-foetal developmental toxicities, including teratogenic effects (see section 5.3).
Croatian: Ispitivanja provedena na životinjama pokazala su reproduktivnu toksičnost kao i embriofetalnu razvojnu toksičnost, uključujući teratogene učinke (vidjeti dio 5.3).
English: Unresectable or metastatic melanoma
Croatian: Neoperabilni ili metastatski melanom
English: Of the specimens from the non-clinical and clinical trials (n=876) that were mutation positive by the THxID BRAF assay and subsequently were sequenced using the reference method, the specificity of the assay was 94%.
Croatian: Iz uzoraka iz nekliničkih i kliničkih ispitivanja (N=876) koji su bili pozitivni na mutaciju prema THxID BRAF testu i kasnije su sekvencionirani korištenjem referentne metode, specifičnost testa je iznosila 94%.
English: • Statins metabolised by CYP3A4 (e.g. atorvastatin, simvastatin)
Croatian: • Statine koji se metaboliziraju putem CYP3A4 (npr. atorvastatin, simvastatin)
English: New primary melanoma
Croatian: Novi primarni melanom
English: Subjects were enrolled into Cohort A (subjects with no prior local therapy for brain metastasis) or Cohort B (subjects who received prior local therapy for brain metastasis).
Croatian: Ispitanici su grupirani u Kohortu A (ispitanici koji ranije nisu primali lokalnu terapiju za metastaze u mozgu) ili Kohortu B (ispitanici koji su ranije primili lokalnu terapiju za metastaze u mozgu).
English: All treated patients population
Croatian: Populacija svih liječenih bolesnika
English: These results did not meet the pre-specified boundary to claim statistical significance at this first OS interim analysis (HR=0.50; p=0.000019).
Croatian: Ti rezultati nisu dostigli unaprijed određenu granicu koja potvrđuje statističku značajnost pri toj prvoj interim analizi OS-a (HR=0,50; p=0,000019).
English: • New melanoma
Croatian: • novi melanom
English: Part B of study BRF113220 included a cohort of 26 patients that had progressed on a BRAF inhibitor.
Croatian: Dio B ispitivanja BRF113220 uključivao je kohortu od 26 bolesnika u kojih je došlo do progresije tijekom terapije BRAF inhibitorom.
English: The efficacy of the combination with trametinib was superior when indirectly compared to dabrafenib monotherapy in Cohort A.
Croatian: Djelotvornost kombinacije s trametinibom bila je superiorna u neizravnoj usporedbi s monoterapijom dabrafenibom u kohorti A.
English: The primary endpoint was ORR using the RECIST 1.1 assessed by the investigator.
Croatian: Primarna mjera ishoda bio je ORR određen pomoću RECIST 1.1 prema procjeni ispitivača.
English: Table 13 Efficacy data in patients with brain metastases (BREAK-MB Study)
Croatian: Tablica 13 Podaci o djelotvornosti u bolesnika s metastazama u mozgu (ispitivanje BREAK-MB)
English: A total of 423 subjects were randomised 1:1 to either combination (N=211) or dabrafenib (N=212).
Croatian: Randomizirano je ukupno 423 ispitanika u omjeru 1:1 na kombinaciju (N=211) ili na dabrafenib (N=212).
English: Cases were managed with excision and did not require treatment modification (see section 4.4).
Croatian: Slučajevi su riješeni ekscizijom i nisu zahtijevali prilagodbu terapije (vidjeti dio 4.4).
English: If you forget to take Tafinlar
Croatian: Ako ste zaboravili uzeti Tafinlar
English: Dabrafenib may decrease the efficacy of oral or any systemic hormonal contraceptives and an effective alternative method of contraception should be used (see section 4.5).
Croatian: Dabrafenib može smanjiti djelotvornost oralnih ili bilo kojih drugih sistemskih hormonskih kontraceptiva pa je potrebno koristiti učinkovitu zamjensku metodu kontracepcije (vidjeti dio 4.5).
English: All Treated Subjects Population BRAF V600E (Primary)
Croatian: Populacija svih ispitanika koji su primali lijek BRAF V600E (Primarni)
English: The European Medicines Agency has deferred the obligation to submit the results of studies with dabrafenib in one or more subsets of the paediatric population in melanoma and solid malignant tumours (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka dabrafenib u jednoj ili više podskupina pedijatrijske populacije za melanom i solidne zloćudne tumore (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Caution should be used in this setting (see section 4.4).
Croatian: Potreban je oprez u takvim uvjetima (vidjeti dio 4.4).
English: Desmethyl-dabrafenib may also be formed in the gut and reabsorbed.
Croatian: Desmetildabrafenib se također može stvarati u crijevima i reapsorbirati.
English: Compared with younger subjects (<65), more subjects 65 years old had adverse reactions that led to study drug dose reductions (22% versus 12%) or interruptions (39% versus 27%).
Croatian: U usporedbi s mlađim ispitanicima (< 65), više je ispitanika od 65 godina ili starijih imalo nuspojave koje su dovele do smanjenja doze ispitivanog lijeka (22% prema 12%) ili prekid liječenja (39% prema 27%).
English: Studies in juvenile animals have shown adverse effects of dabrafenib which had not been observed in adult animals (see section 5.3).
Croatian: Ispitivanja provedena na juvenilnim životinjama pokazala su štetne učinke dabrafeniba koji nisu zamijećeni kod odraslih životinja (vidjeti dio 5.3).
English: These checks are to detect if any other cancer, including squamous cell carcinoma, develops inside your body.
Croatian: Ovi pregledi se vrše u svrhu otkrivanja je li došlo do razvoja nekog drugog oblika raka, uključujući karcinom pločastih stanica, u Vašem tijelu.
English: Subjects with brain metastases were not included in the trial.
Croatian: Ispitanici s metastazama na mozgu nisu bili uključeni u ispitivanje.
English: Abdominal pain upper and abdominal pain lower h
Croatian: Bol u gornjem dijelu abdomena i bol u donjem dijelu abdomena h
English: Read the information about fever, changes in your skin and eye problems in section 4 of this leaflet.
Croatian: Pročitajte informacije o vrućici, promjenama na koži i očima u dijelu 4 ove Upute o lijeku.
English: These met the statistical significance to reject the null hypothesis that the ORR of dabrafenib in combination with trametinib for this NSCLC population was less than or equal to 30%.
Croatian: Tim je postotcima postignuta statistička značajnost za odbacivanje nulte hipoteze da je ORR za dabrafenib u kombinaciji s trametinibom za ovu populaciju s NSCLC-om iznosio manje od 30% ili 30%.
English: Tafinlar can have side effects that may affect your ability to drive or use machines.
Croatian: Tafinlar može uzrokovati nuspojave koje mogu utjecati na Vašu sposobnost vožnje ili upravljanja strojevima.
English: The majority of subjects had Stage IV M1c disease (61% overall).
Croatian: Većina ispitanika imala je bolest stadija IV M1c (61% ukupno).
English: Data as of June 25, 2012
Croatian: Podaci do 25. lipnja 2012.
English: Possible side effects when Tafinlar and trametinib are taken together
Croatian: Moguće nuspojave kada se Tafinlar i trametinib uzimaju zajedno
English: During treatment patients should be monitored as clinically appropriate which may include a head and neck examination every 3 months and a chest/abdomen CT scan every 6 months.
Croatian: Tijekom liječenja bolesnike je potrebno klinički pratiti odgovarajućim postupcima, koji mogu uključivati pregled glave i vrata svaka 3 mjeseca, te CT prsnog koša/abdomena svakih 6 mjeseci.
English: Secondary endpoints include overall survival (OS; key secondary endpoint), freedom from relapse (FFR) and distant metastasis-free survival (DMFS).
Croatian: Mjere sekundarnog ishoda uključuju ukupno preživljenje (OS; ključna mjera sekundarnog ishoda), slobodu od relapsa (engl. freedom from relapse, FFR) i preživljenje bez udaljenih metastaza (engl. distant metastasis-free survival, DMFS).
English: Cutaneous squamous cell carcinoma (cu SCC): SCC, SCC of the skin, SCC in situ (Bowen's disease) and keratoacanthoma c
Croatian: Planocelularni karcinom kože (cu SCC): SCC, SCC kože, SCC in situ (Bowenova bolest) i keratoakantom c
English: Includes drug hypersensitivity f
Croatian: Uključuje preosjetljivost na lijek f
English: Results were also consistent across stratification factors for disease stage and BRAF V600 mutation type.
Croatian: Rezultati su također bili konzistentni među stratifikacijskim faktorima za stadij bolesti i tip BRAF V600 mutacije.
English: Hole in the stomach or intestine (perforation)
Croatian: Proboj želuca ili crijeva (perforacija)
English: - The other ingredients are: microcrystalline cellulose, magnesium stearate, colloidal silicone dioxide, red iron oxide (E172), titanium dioxide (E171), and hypromellose (E464).
Croatian: - Drugi sastojci su: mikrokristalična celuloza, magnezijev stearat, koloidni silicijev dioksid, crveni željezov oksid (E172), titanijev dioksid (E171) i hipromeloza (E464).
English: Taking Tafinlar in combination with trametinib can cause serious bleeding including in your brain, the digestive system (such as stomach, rectum or intestine), lungs, and other organs, and can lead to death.
Croatian: Uzimanje Tafinlara u kombinaciji s trametinibom može uzrokovati ozbiljno krvarenje uključujući i u Vašem mozgu, probavnom sustavu (kao što je želudac, rektum ili crijeva), plućima i drugim organima te može dovesti do smrti.
English: Further, the capsules are printed with black ink that contains black iron oxide (E172) shellac and propylene glycol.
Croatian: Nadalje, kapsule su otisnute crnom tintom koja sadrži crni željezov oksid (E172), šelak i propilenglikol.
English: Your doctor may decide that you should take a lower dose if you get side effects.
Croatian: Vaš liječnik može odlučiti da biste trebali uzimati manju dozu ako se pojave nuspojave.
English: The primary endpoint of the study was intracranial response in Cohort A, defined as the percentage of patients with a confirmed intracranial response assessed by the investigator using modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Croatian: Mjera primarnog ishoda ispitivanja bio je intrakranijalni odgovor u Kohorti A, definiran kao postotak bolesnika s potvrđenim intrakranijalnim odgovorom, određen pomoću modificiranog „Kriterija za ocjenu odgovora kod solidnih tumora“, verzija 1.1 (engl.
English: Very common side effects that may show up in your blood tests • Abnormal blood test results related to the liver
Croatian: Vrlo česte nuspojave koje se mogu vidjeti na krvnim pretragama • poremećeni rezultati krvnih pretraga povezanih s jetrom
English: Taking Tafinlar with trametinib: trametinib may impair fertility in both men and women.
Croatian: Uzimanje Tafinlara s trametinobom: trametinib može štetno utjecati na plodnost muškaraca i žena.
English: • Swelling of the hands or feet (oedema peripheral)
Croatian: • oticanje šaka ili stopala (periferni edem)
English: 3) The following adverse reaction has occurred in MEK116513 and BRF115532 but not in MEK115306 and BRF113928: rhabdomyolysis (uncommon)
Croatian: 3) Sljedeća nuspojava se pojavila u MEK116513 i BRF115532, ali ne u MEK115306 i BRF113928: rabdomioliza (manje često)
English: Your doctor will check your skin before you start taking Tafinlar, then check it again every month while you are taking this medicine and for 6 months after you stop taking it.
Croatian: Prije nego što počnete uzimati Tafinlar, Vaš liječnik će pregledati Vašu kožu, te ju opet prekontrolirati svaki mjesec tijekom uzimanja ovog lijeka te tijekom 6 mjeseci nakon uzimanja ovog lijeka.
English: Male patients taking dabrafenib as monotherapy or in combination with trametinib should be informed of the potential risk for impaired spermatogenesis, which may be irreversible.
Croatian: Muški bolesnici koji uzimaju dabrafenib kao monoterapiju ili u kombinaciji s trametinibom trebaju biti informirani o potencijalnom riziku od narušene spermatogeneze, koja bi mogla biti nepovratna.
English: Patients taking Tafinlar alone can uncommonly (may affect up to 1 in 100 people) develop an eye problem called uveitis, which could damage your vision if it is not treated.
Croatian: Bolesnici koji uzimaju samo Tafinlar mogu manje često (može se javiti u do 1 na 100 osoba) razviti problem s očima koji se naziva uveitis, a koji ako se ne liječi može oštetiti vid.
English: These melanomas are usually removed by surgery and treatment with Tafinlar can be continued without interruption.
Croatian: Ovi melanomi se obično uklanjaju kirurški te se terapija lijekom Tafinlar može nastaviti bez prekida.
English: Primary tumour or tumour from a metastatic site was tested with an investigational use only assay (IUO).
Croatian: Primarni tumor ili uzorak metastaze ispitivan je pomoću testa samo za istraživačke svrhe (IUO).
English: Patients on the DTIC arm were allowed to cross over to dabrafenib after independent radiographic confirmation of initial progression.
Croatian: Bolesnici skupine DTIC su smjeli prijeći na liječenje dabrafenibom nakon nezavisne radiološke potvrde početne progresije.
English: • Inflammation of the eye (uveitis, see “Eye problems” earlier in section 4))
Croatian: • upala oka (uveitis, pogledajte "Problemi s očima" ranije u dijelu 4)
English: The median duration of follow-up (time from randomisation to last contact or death) was 2.83 years in the dabrafenib and trametinib combination arm and 2.75 years in the placebo arm.
Croatian: Medijan trajanja praćenja (vrijeme od randomizacije do posljednjeg kontakta ili smrti) bio je 2,83 godine u skupini koja je primala kombinaciju dabrafeniba i trametiniba i 2,75 godina u skupini koja je primala placebo.
English: Don't take the morning and evening doses of Tafinlar at the same time.
Croatian: Nemojte uzeti dnevnu i večernju dozu lijeka Tafinlar istovremeno.
English: Dabrafenib is an inducer of metabolising enzymes which may lead to loss of efficacy of many commonly used medicinal products (see examples in section 4.5).
Croatian: Dabrafenib inducira metabolizirajuće enzime što može dovesti do gubitka djelotvornosti mnogih lijekova koji se uobičajeno koriste (vidjeti primjere u dijelu 4.5).
English: However, these transporters have minimal impact on dabrafenib oral bioavailability and elimination and the risk for clinically relevant drug-drug interactions with inhibitors of Pgp or BCRP is low.
Croatian: Međutim, ovi prijenosnici imaju minimalni učinak na oralnu bioraspoloživost i eliminaciju dabrafeniba te je rizik od klinički značajne interakcije lijekova s inhibitorima Pgp-a ili BCRP-a nizak.
English: Unexplained abdominal pain should be promptly investigated to include measurement of serum amylase and lipase.
Croatian: Neobjašnjive bolove u abdomenu potrebno je hitno ispitati, a pretrage trebaju uključivati mjerenje amilaza i lipaza u serumu.
English: The management of adverse reactions may require treatment interruption, dose reduction, or treatment discontinuation (see Tables 1 and 2).
Croatian: Zbog nuspojava će možda biti potrebno privremeno prekinuti liječenje, smanjiti dozu ili trajno prekinuti liječenje (vidjeti tablice 1 i 2).
English: It is recommended that the doses of dabrafenib be taken at similar times every day, leaving an interval of approximately 12 hours between doses.
Croatian: Preporučuje se uzimati dozu dabrafeniba svakoga dana u približno isto vrijeme, s razmakom od približno 12 sati između doza.
English: • have had a different type of cancer other than melanoma or NSCLC, as you may be at greater risk of developing other skin and non-skin cancers when taking Tafinlar.
Croatian: • ste imali neku drugu vrstu raka osim melanoma ili raka pluća nemalih stanica, budući da biste mogli biti izloženi većem riziku od razvoja raka koji zahvaća i ne zahvaća kožu dok uzimate Tafinlar.
English: • Allergic reactions (hypersensitivity)
Croatian: • alergijske reakcije (preosjetljivost)
English: They should not be chewed or opened and should not be mixed with food or liquids due to chemical instability of dabrafenib.
Croatian: Ne smiju se žvakati ili otvarati, a zbog kemijske nestabilnosti dabrafeniba niti miješati s hranom ili tekućinama.
English: Interstitial lung disease (ILD)/Pneumonitis
Croatian: Intersticijska bolest pluća (IBP)/pneumonitis
English: Patients presenting with malignancies with confirmed activating RAS mutations were not eligible.
Croatian: Bolesnici sa zloćudnim bolestima s potvrđenim aktivirajućim RAS mutacijama nisu mogli sudjelovati u ispitivanju.
English: Upon resolution of pyrexia dabrafenib should be restarted with appropriate anti-pyretic prophylaxis, either 1) at the same dose level, or 2) reduced by one dose level if the pyrexia is recurrent and/or was accompanied by other severe symptoms including dehydration, hypotension or renal failure.
Croatian: Nakon prestanka pireksije, potrebno je ponovo započeti dabrafenib uz prikladnu antipiretsku profilaksu, ili 1) pri istoj razini doze, ili 2) u dozi smanjenoj za jednu razinu ako je pireksija recidivirajuća i/ili je udružena s drugim teškim simptomima uključujući dehidraciju, hipotenziju ili zatajenje bubrega.
English: The primary endpoint of the study was overall intracranial response rate (OIRR) in the V600E patient population, as assessed by investigators.
Croatian: Mjera primarnog ishoda ispitivanja bila je ukupna stopa intrakranijalnog odgovora (OIRR) u populaciji bolesnika s V600E mutacijom, prema procjeni ispitivača.
English: Table 10 Efficacy data by investigator assessment from COMBI-MB study
Croatian: Tablica 10 Podaci o djelotvornosti prema procjeni ispitivača u ispitivanju COMBI-MB
English: Tafinlar in combination with trametinib is also used to prevent melanoma from coming back after it has been removed by surgery.
Croatian: Tafinlar u kombinaciji s trametinibom koristi se i za sprječavanje povratka melanoma nakon što je odstranjen operacijom.
English: Continue treatment and monitor as clinically indicated.
Croatian: Nastaviti s liječenjem i praćenjem sukladno kliničkoj indikaciji.
English: In addition, mild hepatic impairment as defined by bilirubin and AST did not have a significant effect on dabrafenib metabolite plasma concentrations.
Croatian: Dodatno, blago oštećenje jetre definirano bilirubinom i AST nije imalo značajan učinak na plazmatske koncentracije metabolita dabrafeniba.
English: They may arrange for you to see a specialist eye doctor for a complete eye examination.
Croatian: Oni Vam mogu dogovoriti pregled oka kod specijaliste oftalmologa.
English: One of the events occurred on the first day of dabrafenib dosing of a metastatic melanoma patient and recurred following re-challenge at a reduced dose.
Croatian: Jedan od događaja zabilježen je prvog dana doziranja dabrafeniba u bolesnika s metastatskim melanomom i ponovio se nakon ponovnog uvođenja smanjene doze.
English: The primary endpoint was investigator-assessed relapse-free survival (RFS), defined as the time from randomisation to disease recurrence or death from any cause.
Croatian: Mjera primarnog ishoda bilo je preživljenje bez relapsa prema procjeni ispitivača (engl. relapse-free survival, RFS), definirano kao vrijeme od randomizacije do ponovne pojave bolesti ili smrti zbog bilo kojeg uzroka.
English: Patients should be routinely monitored for visual signs and symptoms (such as change in vision, photophobia and eye pain) while on therapy.
Croatian: Tijekom terapije bolesnike treba rutinski pratiti zbog znakova i simptoma povezanih s vidom (poput promjena vida, fotofobije i bolnosti u očima).
English: If patients develop symptoms of pulmonary embolism or deep vein thrombosis such as shortness of breath, chest pain, or arm or leg swelling, they should immediately seek medical care.
Croatian: Ako se u bolesnika razviju simptomi plućne embolije ili duboke venske tromboze kao što su nedostatak zraka, bol u prsima ili oticanje ruke ili noge, moraju odmah zatražiti liječničku pomoć.
English: Number of patients Died (event), n
Croatian: Broj bolesnika Umrli (događaj), n (%)
English: Carboxy-dabrafenib can be decarboxylated via a non-enzymatic process to form desmethyl-dabrafenib.
Croatian: Karboksidabrafenib se može dekarboksilirati kroz neenzimatski proces pri čemu se stvara desmetildabrafenib.
English: Although limited by the low number of patients, median OS appeared consistent with data in patients with BRAF V600E positive tumours.
Croatian: Iako ograničeno malim brojem bolesnika, medijan ukupnog preživljenja je bio u skladu s podacima o bolesnicima s BRAF V600E pozitivnim tumorima.
English: The increased Cmax of rosuvastatin is unlikely to have clinical relevance.
Croatian: Nije vjerojatno da je povećani Cmax rosuvastatina klinički značajan.
English: Patients should be instructed to immediately inform their physician if new lesions develop.
Croatian: Bolesnike je potrebno savjetovati da o pojavi novih lezija odmah obavijeste svog liječnika.
English: Overall, 54% of subjects had <3 disease sites at baseline.
Croatian: Ukupno je 54% ispitanika imalo < 3 mjesta bolesti na početku.
English: Hydroxy-dabrafenib terminal half-life parallels that of parent with a half-life of 10 hrs while the carboxy- and desmethyl-metabolites exhibited longer half-lives (21-22 hours).
Croatian: Poluvrijeme hidroksidabrafeniba usporedivo je s ishodišnim spojem koji ima poluvrijeme od 10 sati, dok karboksi- i desmetil- metaboliti imaju duže poluvrijeme (21-22 sata).
English: The risk for liver injury after paracetamol administration is suspected to be higher in patients concomitantly treated with enzyme inducers.
Croatian: Sumnja se da je rizik od oštećenja jetre nakon primjene paracetamola veći u bolesnika koji istovremeno primaju induktore enzima.
English: Patients with LVEF lower than the institutional lower limit of normal were not included in clinical trials with dabrafenib.
Croatian: Bolesnici čija je vrijednost LVEF bila niža od donje granice normalnih vrijednosti za ustanovu nisu bili uključivani u klinička ispitivanja s dabrafenibom.
English: Taking the combination of Tafinlar and trametinib may increase the risk of developing holes in the gut wall.
Croatian: Uzimanje kombinacije Tafinlara i trametiniba može povećati rizik od nastanka proboja u stijenci crijeva.
English: A decision should be made whether to discontinue breast-feeding or discontinue dabrafenib, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Odluku o prekidu dojenja ili terapije dabrafenibom treba donijeti uzevši u obzir korist dojenja za dijete te korist terapije za ženu.
English: IV plasma clearance is 12 l/hr.
Croatian: i.v. klirens plazme je 12 l/h.