FrancophonIA/ELRC3.0 huggingface dataset:
English: • You can take the capsules with or without food always avoiding grapefruit.
Croatian: • Kapsule možete uzimati s hranom ili bez nje, ali uvijek izbjegavajte grejp.
English: • Reduction in the number of white blood cells (including neutrophils) Tell your doctor right away if you experience fever or infection.
Croatian: • Smanjenje broja bijelih krvnih stanica (uključujući neutrofile) Recite svom liječniku ukoliko dobijete vrućicu ili infekciju.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: Patients should be informed of the first signs of gastrointestinal perforations and be advised to consult rapidly in case of occurrence.
Croatian: Bolesnike treba informirati o tome koji su prvi znakovi gastrointestinalne perforacije i savjetovati da u tom slučaju hitno zatraže savjet.
English: Both men and women should seek advice on fertility preservation before treatment.
Croatian: I muškarci i žene trebaju prije liječenja potražiti savjet o očuvanju plodnosti.
English: Permanently discontinue
Croatian: Trajno obustaviti.
English: • Alteration in sense of taste.
Croatian: • promjena osjeta okusa.
English: If you accidentally take too many capsules, tell your doctor or pharmacist right away.
Croatian: Ako slučajno uzmete previše kapsula, odmah obavijestite svog liječnika ili ljekarnika.
English: With twice daily dosing, steady state was achieved within 15 days.
Croatian: Kod doziranja dvaput na dan stanje dinamičke ravnoteže postiže se u roku od 15 dana.
English: There were 6 complete responses and 32 partial responses for an ORR of 72% (95% CI: 58%, 83%).
Croatian: Bilo je 6 potpunih odgovora i 32 parcijalna odgovora za ORR od 72% (95% CI: 58%, 83%).
English: XALKORI could harm a breast-fed baby.
Croatian: XALKORI bi mogao naškoditi dojenčetu.
English: You can take XALKORI with or without food; however, you should avoid drinking grapefruit juice or eating grapefruit while on treatment with XALKORI as they may change the amount of XALKORI in your body.
Croatian: XALKORI možete uzimati s hranom ili bez nje; međutim, trebate izbjegavati uzimanje grejpa i soka od grejpa dok se liječite lijekom XALKORI jer on može promijeniti količinu lijeka XALKORI u tijelu.
English: Patient brochure including a Patient Alert Card (text as agreed by the CHMP).
Croatian: Brošuru za bolesnika, uključujući Karticu s upozorenjima za bolesnika (tekst odobren od strane CHMP-a).
English: Warnings and precautions Talk to your doctor before taking XALKORI:
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku prije nego uzmete XALKORI:
English: Adequate contraceptive methods should be used during therapy, and for at least 90 days after completing therapy (see section 4.5).
Croatian: Potrebno je koristiti odgovarajuće metode kontracepcije tijekom liječenja i još najmanje 90 dana nakon završetka liječenja (vidjeti dio 4.5).
English: • Partial or complete loss of vision in one or both eyes Tell your doctor right away if you experience any loss of vision or any change in vision such as difficulty seeing out of one or both eyes.
Croatian: • Djelomični ili potpuni gubitak vida na jednom ili na oba oka Recite odmah svom liječniku ako iskusite bilo kakav gubitak vida ili bilo koju promjenu u vidu poput poteškoća gledanja na jedno ili na oba oka.
English: d. Updated based on final OS analysis.
Croatian: d. Ažurirano na temelju konačne analize OS-a.
English: If there is any possibility that the person taking this medicine may become pregnant or father a child, they must use adequate contraception during treatment, and for at least 90 days after completing therapy as oral contraceptives may be ineffective while taking XALKORI.
Croatian: Ako postoji bilo kakva mogućnost da osobe koje uzimaju ovaj lijek zatrudne ili začnu dijete, one moraju koristiti odgovarajuću kontracepciju tijekom liječenja i najmanje 90 dana nakon završetka liječenja jer oralni kontraceptivi mogu biti nedjelotvorni dok se uzima XALKORI.
English: The MAH should ensure that, at launch and thereafter, all Healthcare Professionals who are expected to use and/or prescribe XALKORI are provided with an educational pack.
Croatian: Nositelj odobrenja mora osigurati da u trenutku stavljanja lijeka na tržište i nakon toga svi zdravstveni radnici od kojih se očekuje da će koristiti i/ili propisivati XALKORI dobiju edukacijski paket.
English: No starting dose adjustment is required (see sections 5.1 and 5.2).
Croatian: Nije potrebno prilagoditi početnu dozu (vidjeti dijelove 5.1 i 5.2).
English: Of the 1084 patients who experienced vision disorder, 95% had events that were mild in severity.
Croatian: Od 1084 bolesnika koji su imali poremećaj vida, 95% njih imalo je događaje koji su bili umjereno teški.
English: The capsules should be swallowed whole preferably with water, and should not be crushed, dissolved, or opened.
Croatian: Kapsule treba progutati cijele, najbolje s vodom, a ne smiju se drobiti, otapati niti otvarati.
English: a. Per data cutoff date30 June 2018. b. Estimated using the Kaplan-Meier method.
Croatian: Prema zaključnom datumu prikupljanja podataka 30. lipnja 2018. b. Procijenjeno Kaplan-Meierovom metodom.
English: The median duration of treatment was 42 weeks.
Croatian: Medijan trajanja liječenja iznosio je 42 tjedna.
English: The final wording used on the educational material should be in line with the approved product information.
Croatian: Konačan tekst edukacijskog materijala mora biti usklađen s odobrenim podacima o lijeku.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including herbal medicines and medicine obtained over the counter.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući biljne lijekove i lijekove koje ste nabavili bez recepta.
English: When assessing either ALK or ROS1 status of a patient, it is important that a well-validated and robust methodology is chosen to avoid false negative or false positive determinations.
Croatian: Pri procjeni ALK ili ROS1 statusa bolesnika, važno je odabrati dobro validiranu i robusnu metodu kako bi se izbjeglo lažno negativno ili lažno pozitivno određivanje.
English: Dose reduction guidelines for haematological and non-haematological toxicities are provided in Tables 1 and 2.
Croatian: Smjernice za smanjenje doze u slučaju hematološke i nehematološke toksičnosti navedene su u Tablicama 1 i 2.
English: The safety and efficacy of crizotinib in paediatric patients has not been established.
Croatian: Sigurnost i djelotvornost krizotiniba u pedijatrijskih bolesnika nisu ustanovljene.
English: The median duration of treatment for these patients was 23 weeks.
Croatian: Medijan trajanja liječenja tih bolesnika iznosio je 23 tjedna.
English: Cases with fatal outcome, cases requiring hemodialysis and cases of grade 4 hyperkalemia were also observed.
Croatian: Također su uočeni slučajevi sa smrtnim ishodom, slučajevi koji zahtijevaju hemodijalizu i slučajevi hiperkalijemije 4. stupnja.
English: Grade 4 Ocular Disorder (Visual Loss)
Croatian: Okularni poremećaj stupnja 4 (gubitak vida)
English: • If your next dose is in 6 hours or more, take the missed capsule as soon as you remember.
Croatian: • Ako je do sljedeće doze preostalo 6 sati ili više, uzmite propuštenu kapsulu čim se sjetite.
English: Talk to your doctor right away after having taken XALKORI:
Croatian: Odmah se obratite svojem liječniku nakon uzimanja lijeka XALKORI:
English: Of the patients enrolled in these studies, the patients described below had received prior systemic therapy for locally advanced or metastatic disease.
Croatian: Među bolesnicima uključenima u ta ispitivanja, bolesnici opisani u nastavku prethodno su primali sustavnu terapiju za liječenje lokalno uznapredovale ili metastatske bolesti.
English: • Swallow the capsules whole and do not crush, dissolve or open the capsules.
Croatian: • Progutajte kapsule cijele; nemojte drobiti, otapati ni otvarati kapsule.
English: • If you have ever had stomach or intestine problems such as holes (perforation), or if you have conditions causing inflammation inside the abdomen (diverticulitis), or if you have spread of cancer inside the abdomen (metastasis).
Croatian: • ako ste ikada imali probleme sa želucem ili crijevima poput puknuća (perforacija) ili ako imate stanja koja uzrokuju upalu unutar trbuha (divertikulitis) ili Vam se rak proširio unutar trbuha (metastaze).
English: Your doctor may perform electrocardiograms to check there are no problems with your heart during treatment with XALKORI.
Croatian: Liječnik će možda učiniti elektrokardiogram kako bi provjerio da nemate nikakvih problema sa srcem tijekom liječenja lijekom XALKORI.
English: Some lung problems may get worse during treatment with XALKORI, as XALKORI may cause inflammation of the lungs during treatment.
Croatian: Neke tegobe s plućima mogu se pogoršati tijekom liječenja lijekom XALKORI jer XALKORI može izazvati upalu pluća tijekom liječenja.
English: • Anticholinesterases, used to restore muscle function.
Croatian: • antikolinesterazama - koriste se za vraćanje mišićne funkcije.
English: • Do not use this medicine after the expiry date which is stated on the bottle or blister foil and carton after “EXP”.
Croatian: • Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na boci ili foliji blistera i kutiji iza oznake „Rok valjanosti“ ili EXP.
English: The use of concomitant medicinal products associated with bradycardia should be carefully evaluated.
Croatian: Treba pažljivo razmotriti istodobnu primjenu lijekova povezanih s bradikardijom.
English: Terms actually reported in the study up to the data cutoff date and contributing to the relevant adverse drug reaction are indicated in parentheses, as listed below.
Croatian: Pojmovi uistinu prijavljeni u ispitivanju do zaključnog datuma prikupljanja podataka i koji doprinose relevantnoj nuspojavi lijeka navedeni su u zagradama kako je naznačeno u nastavku.
English: Crizotinib plasma concentrations may be increased in patients with severe renal impairment (CLcr <30 mL/min).
Croatian: Plazmatska koncentracija krizotiniba može biti povećana u bolesnika s teškim bubrežnim oštećenjem (CLcr <30 mL/min).
English: Talk to your doctor or pharmacist before taking this medicine if you are pregnant, may become pregnant or are breast-feeding.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete ovaj lijek ako ste trudni, možete zatrudnjeti ili dojite.
English: Dose modification is not required in cases of asymptomatic bradycardia.
Croatian: Nije potrebna prilagodba doze u slučajevima asimptomatske bradikardije.
English: It is recommended that women avoid becoming pregnant and that men do not father children during treatment with XALKORI because this medicine could harm the baby.
Croatian: Preporučuje se da žene izbjegavaju trudnoću i da muškarci ne začinju dijete tijekom liječenja lijekom XALKORI jer bi XALKORI mogao naškoditi djetetu.
English: If you vomit after taking a dose of XALKORI, do not take an extra dose; just take your next dose at your regular time.
Croatian: Ako povratite nakon što ste uzeli dozu lijeka XALKORI, nemojte uzeti dodatnu dozu, samo uzmite sljedeću dozu u predviđeno vrijeme.
English: Event terms that represent the same medical concept or condition were grouped together and reported as a single adverse drug reaction in Table 3.
Croatian: Pojmovi događaja koji predstavljaju isti medicinski koncept ili stanje grupirani su zajedno i prijavljeni kao pojedinačna nuspojava lijeka u Tablici
English: Of note, the effectiveness of concomitant administration of oral contraceptives may be reduced.
Croatian: Treba napomenuti da se može smanjiti djelotvornost istodobno primijenjenih oralnih kontraceptiva.
English: Oral contraceptives If you take XALKORI whilst using oral contraceptives, the oral contraceptives may be ineffective.
Croatian: Ako se liječite lijekom XALKORI dok koristite oralne kontraceptive, oralni kontraceptivi mogu biti neučinkoviti.
English: XALKORI as monotherapy is indicated for:
Croatian: XALKORI je kao monoterapija indiciran za:
English: Median times to onset for nausea and vomiting were 3 days, and these events declined in frequency after 3 weeks of treatment.
Croatian: Medijan vremena do nastupa mučnine i povraćanja bio je 3 dana a učestalost tih događaja je opadala nakon 3 tjedna liječenja.
English: Median time to onset of increased Grade 3 or 4 transaminases was 43 days.
Croatian: Medijan vremena do nastupa povišenja transaminaza stupnja 3 ili 4 bio je 43 dana.
English: • Light-headedness, fainting, or chest discomfort Tell your doctor right away if you experience these symptoms which could be signs of changes in the electrical activity (seen on electrocardiogram) or abnormal rhythm of the heart.
Croatian: • Ošamućenost, nesvjestica ili nelagoda u prsnom košu Odmah obavijestite svog liječnika ako osjetite ove simptome koji bi mogli biti znakovi promjena u električnoj aktivnosti srca (što se vidi na elektrokardiogramu) ili poremećaja srčanog ritma.
English: Seventeen (1%) patients required permanent discontinuation from treatment associated with elevated transaminases, suggesting that these events were generally manageable by dosing modifications as defined in Table 2 (see section 4.2).
Croatian: Sedamnaest (1%) bolesnika zahtijevalo je trajnu obustavu liječenja povezanu s povišenim transaminazama, što upućuje da su ti događaji općenito stavljani pod kontrolu promjenom doze kako je navedeno u Tablici 2 (vidjeti dio 4.2).
English: Tell your doctor right away if you experience difficulty in breathing, especially if associated with cough or fever.
Croatian: Odmah obavijestite svog liječnika ako imate poteškoća s disanjem, osobito ako su praćene kašljem ili vrućicom.
English: Because of the potential harm to the infant, mothers should be advised to avoid breast-feeding while receiving XALKORI (see section 5.3).
Croatian: Zbog mogućeg štetnog djelovanja na dojenče majkama treba savjetovati da izbjegavaju dojenje dok primaju XALKORI (vidjeti dio 5.3).
English: Treatment of overdose with the medicinal product consists of general supportive measures.
Croatian: Liječenje predoziranja ovim lijekom sastoji se od općih potpornih mjera.
English: a. Per data cutoff dates 01 June 2011 (Study 1001) and 15 February 2012 (Study 1005).
Croatian: Prema zaključnim datumima prikupljanja podataka 1. lipnja 2011. (Ispitivanje 1001) i 15. veljače 2012. (Ispitivanje 1005).
English: Seventeen (1%) patients required permanent discontinuation from treatment.
Croatian: Sedamnaest (1%) bolesnika moralo je trajno prekinuti liječenje.
English: What XALKORI contains
Croatian: Što XALKORI sadrži
English: Treatment with XALKORI should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
Croatian: Liječenje lijekom XALKORI mora započeti i nadzirati liječnik s iskustvom u primjeni lijekova za liječenje raka.
English: Crizotinib is an inhibitor of OCT1 and OCT2 in vitro.
Croatian: Krizotinib je inhibitor OCT1 i OCT2 in vitro.
English: Assessment of ALK and ROS1 status
Croatian: Procjena ALK i ROS1 statusa
English: Grade 3 or 4 leukopenia has been commonly (3%) reported (see section 4.8).
Croatian: Leukopenija stupnja 3 ili 4 često (3%) je prijavljivana (vidjeti dio 4.8).
English: • If your next dose is in less than 6 hours, skip the missed capsule.
Croatian: • Ako je do sljedeće doze preostalo manje od 6 sati, preskočite propuštenu kapsulu.
English: Withhold until recovery to Grade ≤1, check and if necessary correct electrolytes, then resume at the next lower doseb,c
Croatian: Privremeno prekinuti do poboljšanja na stupanj ≤1, provjeriti i, ako je potrebno, korigirati elektrolite, a zatim nastaviti u sljedećoj nižoj dozi b,c
English: XALKORI may increase side effects associated with the following medicines:
Croatian: XALKORI može pojačati nuspojave povezane sa sljedećim lijekovima:
English: • Alfentanil and other short acting opiates such as fentanyl (painkillers used for surgical procedures).
Croatian: • alfentanilom i drugim kratkodjelujućim opijatima poput fentanila (lijekovi protiv bolova koji se koriste pri kirurškim zahvatima).
English: Fifty-two (52) patients treated with crizotinib and 57 chemotherapy-treated patients with previously treated or untreated asymptomatic brain metastases were enrolled in randomised Phase 3 Study 1007.
Croatian: Pedeset dva (52) bolesnika liječena krizotinibom i 57 bolesnika liječena kemoterapijom s prethodno liječenim ili neliječenim asimptomatskim metastazama na mozgu bilo je uključeno u randomiziranom Ispitivanju 1007 faze 3.
English: There is no antidote for XALKORI.
Croatian: Ne postoji protulijek za XALKORI.
English: Limited data are available in this subgroup of patients (see sections 4.2 and 5.1).
Croatian: Ograničeni su podaci za ovu podskupinu bolesnika (vidjeti dijelove 4.2 i 5.1).
English: The disease characteristics were 94% metastatic, 96% adenocarcinoma histology, and 13% with no prior systemic therapy for metastatic disease.
Croatian: Karakteristike bolesti bile su: 94% metastatska bolest, 96% histologija adenokarcinoma i 13% bez prethodne sistemske terapije za metastatsku bolest.
English: • Stomach upset, including vomiting, diarrhoea, nausea.
Croatian: • nadražen želudac, uključujući povraćanje, proljev, mučninu.
English: Binding of crizotinib to human plasma proteins in vitro is 91% and is independent of medicinal product concentration.
Croatian: Vezivanje krizotiniba za proteine u plazmi in vitro iznosi 91% i ne ovisi o koncentraciji lijeka.
English: PVC-foil blisters containing 10 hard capsules.
Croatian: Blisteri od PVC folije koji sadrže 10 tvrdih kapsula.
English: If QTc increases to greater than or equal to 500 msec, cardiologist advice must be immediately sought.
Croatian: Ako se QTc poveća na 500 msek ili više, mora se odmah potražiti savjet kardiologa.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: . Unutar svake skupine učestalosti, nuspojave su prikazane u padajućem nizu prema ozbiljnosti.
English: The following medicines may reduce the effectiveness of XALKORI:
Croatian: Sljedeći lijekovi mogu umanjiti učinkovitost lijeka XALKORI:
English: Grade 3 and 4 transaminase elevations were generally reversible upon dosing interruption.
Croatian: Porasti vrijednosti transaminaza stupnja 3 ili 4 općenito su bili reverzibilni nakon prekida primjene lijeka.
English: • If you have moderate or severe liver disease.
Croatian: • ako imate umjerenu ili tešku bolest jetre.
English: No starting dose adjustment is recommended for patients with mild hepatic impairment.
Croatian: Ne preporučuje se prilagodba početne doze za bolesnike s blagim oštećenjem jetre.
English: • Quinidine, digoxin, disopyramide, amiodarone, sotalol, dofetilide, ibutilide, verapamil,
Croatian: • kinidinom, digoksinom, dizopiramidom, amiodaronom, sotalolom, dofetilidom, ibutilidom,
English: • Dabigatran, anticoagulant used to slow down clotting of the blood.
Croatian: • dabigatranom, antikoagulansom koji se koristi za usporavanje zgrušavanja krvi.
English: There was a numerical improvement in overall survival (OS) in the patients treated with crizotinib, although this improvement was not statistically significant.
Croatian: Opaženo je brojčano poboljšanje ukupnog preživljenja (engl. overall survival, OS) u bolesnika liječenih krizotinibom, iako to poboljšanje nije bilo statistički značajno.
English: The most common findings concerned slit lamp biomicroscopy (21.1%), fundoscopy (15.8%) and visual acuity (13.2%).
Croatian: Najčešći nalazi odnosili su se na biomikroskopski pregled slit lampom (21,1%), fundoskopiju (15,8%) i vidnu oštrinu (13,2%).
English: Uncommon side effects (may affect up to 1 in 100 people) • Hole (perforation) in stomach or intestine.
Croatian: Manje česte nuspojave (mogu se javiti u manje od 1 na 100 osoba) • puknuće (perforacija) u želucu ili crijevima.
English: g. Bradycardia (Bradycardia, Heart rate decreased, Sinus bradycardia).
Croatian: g. Bradikardija (bradikardija, usporen rad srca, sinusna bradikardija).
English: Tell your doctor right away if you feel more tired than usual, your skin and whites of your eyes turn yellow, your urine turns dark or brown (tea colour), you have nausea, vomiting, or decreased appetite, you have pain on the right side of your stomach, you have itching, or if you bruise more easily than usual.
Croatian: Odmah obavijestite svog liječnika ako se osjećate umornije nego inače, ako Vam koža i bjeloočnice požute, mokraća potamni ili posmeđi (boja čaja), imate mučninu, povraćate ili Vam je oslabljen apetit, imate bolove na desnoj strani trbuha, osjećate svrbež ili Vam modrice nastaju lakše nego inače.
English: l. Gastrointestinal perforation (Gastrointestinal perforation, Intestinal perforation, Large intestine perforation).
Croatian: l. Gastrointestinalna perforacija (gastrointestinalna perforacija, intestinalna perforacija, perforacija debelog crijeva).
English: Ophthalmological evaluation consisting of best corrected visual acuity, retinal photographs, visual fields, optical coherence tomography (OCT) and other evaluations as appropriate for new onset of severe visual loss, should be performed.
Croatian: Potrebno je napraviti oftalmološki pregled koji se sastoji od najbolje korigirane vidne oštrine, fotografija mrežnice, vidnih polja, optičke koherentne tomografije (OCT) i drugih pregleda prikladnih kod nove pojave teškog gubitka vida.
English: Caution should be exercised in administering crizotinib in combination with medicinal products that are predominantly metabolised by these enzymes.
Croatian: Potreban je oprez kada se krizotinib primjenjuje u kombinaciji s lijekovima koji se pretežno metaboliziraju pomoću tih enzima.
English: Assessment should be performed by laboratories with demonstrated proficiency in the specific technology being utilised (see section 4.4).
Croatian: Testiranje se mora provoditi u laboratoriju koji je dokazano stručan u primjeni odabrane tehnologije ispitivanja (vidjeti dio 4.4).
English: Median time to onset of any grade leukopenia was 85 days.
Croatian: Medijan vremena do nastupa leukopenije bilo kojeg stupnja bio je 85 dana.
English: Patients should not take 2 doses at the same time to make up for a missed dose.
Croatian: Bolesnici ne smiju uzeti dvije doze odjednom kako bi nadoknadili propuštenu dozu.
English: • Visual effects (seeing flashes of light, blurred vision, or double vision, often beginning soon after starting treatment with XALKORI).
Croatian: • poremećaji vida (bljeskovi svjetlosti, zamagljen vid ili dvoslike, koji često nastupaju ubrzo nakon početka liječenja lijekom XALKORI).
English: Neutropenia was associated with dose reduction or permanent treatment discontinuation for 3% and <1% of patients, respectively.
Croatian: Neutropenija je bila povezana sa smanjenjem doze ili trajnim prekidom liječenja kod 3%, odnosno <1% bolesnika.
English: The adverse reactions listed in Table 3 are presented by system organ class and frequency categories, defined 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), very rare (<1/10,000), not known (cannot be estimated from the available data).
Croatian: Nuspojave navedene u Tablici 3 prikazane su prema klasifikaciji organskih sustava i kategorijama učestalosti pojavljivanja, a definirane su na sljedeći način: vrlo često ( 1/10), često (1/100 i <1/10, manje često (1/1000 i <1/100), rijetko (1/10 000 i <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka)