FrancophonIA/ELRC3.0 huggingface dataset:
English: To care for sensitive skin:
Croatian: Da biste njegovali osjetljivu kožu:
English: Don't take a double dose to make up for a forgotten dose.
Croatian: Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: Number (%) with event
Croatian: Broj (%) s događajem
English: • Swallow the tablets whole with water, one after the other, at the same time each day.
Croatian: • Progutajte cijele tablete s vodom, jednu za drugom, svakog dana u isto vrijeme.
English: In addition, 150 [50%] of patients were hormone receptor negative.
Croatian: Osim toga, 150 [50%] bolesnika bili su negativni na hormonske receptore.
English: Bottles 3 years
Croatian: Boce 3 godine
English: Ask your doctor to give you information about these other medicines.
Croatian: Upitajte svog liječnika za informaciju o ovim drugim lijekovima.
English: In most cases, the effect on your heart will not have any symptoms.
Croatian: U većini slučajeva učinak na rad srca neće stvarati nikakve simptome.
English: The median age was 51 years and 13% were 65 years or older.
Croatian: Medijan dobi je iznosio 51 godinu, a 13% bolesnika je bilo u dobi od 65 godina ili starije.
English: • severe allergic reactions (see the beginning of section 4)
Croatian: • teške alergijske reakcije (pogledajte početak odjeljka 4)
English: The safety and efficacy of Tyverb in children below the age of 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka Tyverb u djece mlađe od 18 godina nisu još ustanovljene.
English: The frequency of some side effects is not known (it cannot be estimated from the available data):
Croatian: Učestalost nekih nuspojava je nepoznata (ne može se procijeniti iz dostupnih podataka):
English: • drink plenty of fluids (8 to 10 glasses a day), such as water, sports drinks or other clear liquids
Croatian: • obilno pijte tekućinu (8 do 10 čaša na dan) kao što je voda, sportski napitci i druge bistre tekućine
English: It may slow or stop cancer cells from growing, or may kill them.
Croatian: Može usporiti ili zaustaviti rast stanica raka ili ih može ubiti.
English: even if their signs of illness seem the same as yours.
Croatian: Može im naškoditi, čak i ako su njihovi znakovi bolesti jednaki Vašima.
English: Component of a multipack, cannot to be sold separately.
Croatian: Sastavni dio višestrukog pakiranja, ne prodavati odvojeno.
English: CI= confidence interval
Croatian: CI = interval pouzdanosti
English: [folding box only] PC:
Croatian: [samo kutija] PC:
English: The daily dose of Tyverb should not be divided.
Croatian: Dnevna doza lijeka Tyverb ne smije se dijeliti.
English: There was no evidence of carcinogenicity in mice.
Croatian: Nije bilo dokaza o kancerogenosti u miševa.
English: Interactions with food and drink
Croatian: Interakcije s hranom i pićem
English: What Tyverb is and what it is used for
Croatian: Što je Tyverb i za što se koristi
English: HER2 receptor status was retrospectively determined by central laboratory testing.
Croatian: Status HER2 receptora određen je retrospektivno u centralnom laboratoriju.
English: The potential risk for humans is not known.
Croatian: Potencijalni rizik kod ljudi nije poznat.
English: The combination of lapatinib and trastuzumab may offer complementary mechanisms of action as well as possible non-overlapping mechanisms of resistance.
Croatian: Kombinacija lapatiniba i trastuzumaba može ponuditi komplementarne mehanizme djelovanja, kao i moguće mehanizme rezistencije koji se ne preklapaju.
English: • eat cooked vegetables instead of raw vegetables and remove the skin from fruits before eating
Croatian: • jedite kuhano povrće umjesto sirovog te uklonite koru s voća prije jela
English: The clinical relevance of this effect has not been evaluated.
Croatian: Klinički značaj ovog učinka nije procjenjivan.
English: Take the prescribed dose every day for as long as your doctor tells you to.
Croatian: Uzimajte propisanu dozu svakog dana sve dok Vam liječnik tako propisuje.
English: Capecitabine should be taken with food or within 30 minutes after food.
Croatian: Kapecitabin se uzima s hranom ili unutar 30 minuta nakon jela.
English: It can affect the way the medicine works.
Croatian: On može utjecati na način djelovanja lijeka.
English: The hepatotoxicity may occur days to several months after initiation of treatment.
Croatian: Hepatotoksičnost se može pojaviti nekoliko dana do više mjeseci nakon započinjanja liječenja.
English: Tyverb with food and drink
Croatian: Tyverb s hranom i pićem
English: Take Tyverb at the same time in relation to food each day - for example, you could always take your tablet one hour before breakfast.
Croatian: Uzmite Tyverb svakog dana u isto vrijeme u odnosu na hranu, na primjer, možete uvijek uzimati tabletu sat vremena prije doručka.
English: • pain in hands and feet
Croatian: • bol u rukama i nogama
English: Kaplan-Meier estimates
Croatian: Kaplan-Meierove procjene
English: The clinical significance of these effects on the pharmacokinetics of other medicinal products or the pharmacological activity of other anti-cancer medicinal products is not known.
Croatian: Klinički značaj ovih učinaka na farmakokinetiku drugih lijekova ili farmakološku aktivnost drugih antikancerogenih lijekova nije poznat.
English: Serious skin reactions
Croatian: Ozbiljne kožne reakcije
English: Other toxicities
Croatian: Ostale toksičnosti
English: Date of first authorisation: 10 June 2008 Date of latest renewal: 17 February 2015
Croatian: Datum posljednje obnove odobrenja: 17. veljače 2015.
English: • if you are allergic to lapatinib or any of the other ingredients of this medicine (listed in
Croatian: • ako ste alergični na lapatinib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Dose delay and dose reduction
Croatian: Odgađanje i smanjenje doze
English: What Tyverb looks like and contents of the pack
Croatian: Kako Tyverb izgleda i sadržaj pakiranja
English: A severe allergic reaction is a rare side effect (may affect up to 1 in 1,000 people) and may develop rapidly.
Croatian: Teške alergijske reakcije su rijetke nuspojave (mogu se javiti u do 1 na 1000 osoba) i mogu se brzo razviti.
English: An additional 75 patients were enrolled in the study between the time of the interim analysis and the end of the enrolment.
Croatian: Dodatnih 75 bolesnika uključeno je u ispitivanje u periodu od provedene privremene analize do kraja uključivanja.
English: Blister packs 2 years
Croatian: Blisteri 2 godine
English: Your doctor will review the medicines you are currently taking to make sure you are not taking something that can't be taken with the Tyverb.
Croatian: Liječnik će pregledati lijekove koje trenutno uzimate kako bi bio siguran da ne uzimate neki lijek koji se ne smije uzimati istodobno s lijekom Tyverb.
English: What Tyverb is and what it is used for What you need to know before you take Tyverb How to take Tyverb
Croatian: Što je Tyverb i za što se koristi Što morate znati prije nego počnete uzimati Tyverb Kako uzimati Tyverb
English: Hypokalemia or hypomagnesemia should be corrected prior to treatment.
Croatian: Hipokalijemiju ili hipomagnezijemiju je potrebno korigirati prije početka liječenja.
English: Pulmonary arterial hypertension**.
Croatian: Plućna arterijska hipertenzija**.
English: Most patients in both treatment arms had visceral disease (215 [73%] patients overall).
Croatian: Većina bolesnika u obje terapijske skupine imali su visceralnu bolest (ukupno 215 [73%] bolesnika).
English: Serum concentrations appear after a median lag time of 0.25 hours (range 0 to 1.5 hours).
Croatian: Koncentracije u serumu pojavljuju se nakon prosječnog vremena zaostajanja od 0,25 sati (raspon od 0 do 1,5 sati).
English: At ≥60 mg/kg/day there were decreased foetal body weights, and minor skeletal variations.
Croatian: Pri ≥ 60 mg/kg/dan došlo je do smanjene tjelesne težine fetusa i manjih promjena na skeletu.
English: What Tyverb contains
Croatian: Što Tyverb sadrži
English: The highest no-effect dose for this study was 20 mg/kg/day.
Croatian: Najviša doza bez učinaka u ovom ispitivanju bila je 20 mg/kg/dan.
English: • irregular heart-beat (change in the electrical activity of the heart)
Croatian: • nepravilni otkucaji srca (promjene u električnoj aktivnosti srca)
English: • pulmonary arterial hypertension (increased blood pressure in the arteries (blood vessels) of the lungs)
Croatian: • plućna arterijska hipertenzija (povišen krvni tlak u plućnim arterijama (krvnim žilama pluća))
English: The median number of prior trastuzumab-containing regimens was three.
Croatian: Medijan broja prethodnih terapija koje su sadržavale trastuzumab bio je tri.
English: This includes herbal medicines and other medicines you bought without a prescription.
Croatian: To uključuje i biljne pripravke i lijekove koji se nabavljaju bez recepta.
English: Ninety-four percent (94%) were Caucasian.
Croatian: Devedeset i četiri posto (94%) bolesnika bili su bijelci.
English: At the initiation of treatment, patients should be advised of the potential for hepatotoxicity.
Croatian: Prije početka liječenja bolesnike je potrebno savjetovati o potencijalnoj hepatotoksičnosti.
English: Missed doses should not be replaced and the dosing should resume with the next scheduled daily dose (see section 4.9).
Croatian: Propuštene doze ne smiju se nadomiještati, a doziranje je potrebno nastaviti sa sljedećom redovitom dnevnom dozom (vidjeti dio 4.9).
English: • blood tests results that show changes in liver function (usually mild and temporary) Rare side effects (may affect up to 1 in 1,000 people):
Croatian: • rezultate pretraga krvi koji pokazuju promjene u radu jetre (uglavnom blage i privremene) Rijetke nuspojave (mogu se javiti u do 1 na 1000 osoba):
English: HER2 overexpression = IHC 3+ and/or FISH positive; HER2 negative = IHC 0, 1+ or 2+ and/or FISH negative
Croatian: HER2 prekomjerna ekspresija = IHC3+ i/ili FISH pozitivan; HER2 negativan =IHC 0, 1+ ili 2+ i/ili FISH negativan
English: • use sunscreen (Sun Protection Factor [SPF] 30 or higher).
Croatian: • koristite kremu za sunčanje (faktor za zaštitu od sunca 30 ili viši).
English: Patients with extensive or persistent skin reactions should be referred to a dermatologist.
Croatian: Bolesnike s opsežnim ili perzistentnim kožnim reakcijama potrebno je uputiti na pregled dermatologu.
English: Hepatotoxicity has occurred with Tyverb use and may in rare cases be fatal.
Croatian: Hepatotoksičnost je uočena pri primjeni lijeka Tyverb, i može u rijetkim slučajevima biti fatalna.
English: Assessments were undertaken by the study investigators and by an independent review panel, blinded to treatment.
Croatian: Procjene su provodili ispitivači u studiji i nezavisna ocjenjivačka skupina za koju je liječenje bilo slijepo.
English: Carriage of the HLA risk alleles is common (15 to 25%) in Caucasian, Asian, African and Hispanic populations but lower (1%) in Japanese populations.
Croatian: Nositeljstvo HLA rizičnih alela je često (15 do 25%) u bjelačkim, azijskim, afričkim i hispanskim populacijama, a rjeđe (1%) u japanskoj populaciji.
English: Clinical benefit rate was defined as complete plus partial response plus stable disease for 6 months.
Croatian: Stopa kliničke dobiti definirana je kao potpuni plus djelomični odgovor plus stabilna bolest kroz ≥6 mjeseci
English: Died
Croatian: Umrlih
English: Tell your doctor if you have any heart problems before you take Tyverb.
Croatian: Obavijestite svog liječnika ako imate bilo kakvih problema sa srcem prije nego počnete uzimati Tyverb.
English: Fatal cases have been reported, causality of the deaths is uncertain.
Croatian: Prijavljeni su fatalni slučajevi, ali uzrok smrti nije sa sigurnošću utvrđen.
English: Cardiac events
Croatian: Kardiološki događaji
English: There is no specific antidote for the inhibition of EGFR (ErbB1) and/or HER2 (ErbB2) tyrosine phosphorylation.
Croatian: Ne postoji specifični antidot za inhibiciju EGFR (ErbB1) i/ili ErbB2 (HER2) tirozin fosforilacije.
English: Pulmonary toxicity may be severe and lead to respiratory failure.
Croatian: Plućna toksičnost može biti teška i voditi do zatajenja disanja.
English: Your doctor will decide on the correct dose of Tyverb depending on the type of breast cancer being treated.
Croatian: Liječnik će odlučiti o ispravnoj dozi lijeka Tyverb ovisno o vrsti raka dojke kojeg je potrebno liječiti.
English: • unusual wheezing, or difficulty in breathing
Croatian: • neuobičajeno piskanje ili poteškoće disanja
English: However, daily dosing of lapatinib results in achievement of steady state within 6 to 7 days, indicating an effective half-life of 24 hours.
Croatian: Međutim, dnevno doziranje lapatiniba rezultira postizanjem stanja dinamičke ravnoteže u roku 6 do 7 dana, upućujući na efektivni poluvijek od 24 sata.
English: Investigator analysis on data at the end of enrolment is presented in Table 1.
Croatian: Ispitivačeva analiza podataka nakon završetka uključivanja prikazana je u tablici 1.
English: Patients should be instructed to promptly report any change in bowel patterns.
Croatian: Bolesnike je potrebno uputiti da odmah prijave bilo kakve promjene u radu crijeva.
English: Tyverb should not be used during pregnancy unless clearly necessary.
Croatian: Tyverb se ne smije primjenjivati tijekom trudnoće, osim ako to nije izričito potrebno.
English: At the time of the final PFS analysis (with median follow-up of 2.64 years), the overall survival data were not mature and there was no significant difference between treatment groups in the HER2-positive population; this had not changed with additional follow-up (>7.5 years median followup time; Table 7).
Croatian: U trenutku završne analize PFS-a (s medijanom praćenja od 2,64 godine), podaci o ukupnom preživljenju nisu bili potpuni i nije bilo značajne razlike između liječenih skupina u HER2 pozitivnoj populaciji; to se nije promijenilo s dodatnim praćenjem (medijan vremena praćenja bio je > 7,5 godina; Tablica 7).
English: Your doctor will check your skin before and during treatment.
Croatian: Liječnik će pregledati Vašu kožu prije i tijekom liječenja.
English: Results of an updated analysis of the overall survival data to 28 September 2007 are presented in Table 2.
Croatian: U tablici 2, u nastavku, su predstavljeni rezultati ažurirane analize podataka ukupne stope preživljenja do 28. rujna 2007.
English: In some cases, LVEF decrease may be severe and lead to cardiac failure.
Croatian: U nekim slučajevima smanjenje LVEF može biti teško i dovesti do zatajenja srca.
English: There is a positive relationship between lapatinib plasma concentrations and ΔΔQTcF.
Croatian: Postoji pozitivna povezanost između plazmatske koncentracije lapatiniba i ΔΔQTcF.
English: The following convention has been utilised for the classification of frequency: 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) and very rare (<1/10,000), not known (cannot be estimated from the available data).
Croatian: Nuspojave su klasificirane na sljedeći način prema učestalosti: 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).
English: The majority of LVEF decreases (greater than 60 % of events) were observed during the first nine weeks of treatment, however limited data was available for long term exposure.
Croatian: Većina smanjenja vrijednosti LVEF-a (više od 60% događaja) primijećena je tijekom prvih devet tjedana liječenja, međutim dostupni podaci o dugotrajnoj izloženosti su ograničeni.
English: Some medicines may affect the way Tyverb works or Tyverb may affect how other medicines work.
Croatian: Pojedini lijekovi mogu utjecati na djelovanje lijeka Tyverb ili Tyverb može utjecati na djelovanje drugih lijekova.
English: Biliary excretion may also contribute to the elimination.
Croatian: Izlučivanje putem žuči također može sudjelovati u eliminaciji.
English: Electrocardiograms with QT measurement should be performed prior to and one to two weeks after the start of Tyverb therapy.
Croatian: Elektrokardiogram s mjerenjem QT intervala potrebno je napraviti prije i jedan do dva tjedna nakon početka terapije Tyverbom.
English: • Depending on the side effects you experience, your doctor may recommend lowering your dose or temporarily stopping your treatment.
Croatian: • Ovisno nuspojavama koje doživite, liječnik Vam može preporučiti snižavanje doze ili privremeni prekid liječenja.
English: When clinically indicated, e.g. after initiation of a concomitant treatment that might affect QT or that may interact with lapatinib, ECG measurement should also be considered.
Croatian: Kada je klinički indicirano, npr. nakon započinjanja istodobnog liječenja koje može utjecati na QT interval ili može biti u interakciji s lapatinibom, također je potrebno razmotriti mjerenje EKG-a.
English: There were 952 patients with HER2-negative tumours, and a total of 115 patients whose tumour HER2 status was unconfirmed (no tumour sample, no assay result, or other reason).
Croatian: 952 bolesnice imale su HER2negativne tumore, a ukupno 115 bolesnica je imalo tumor čiji HER2 status nije bio utvrđen (bez uzorka tumora, bez rezultata analize ili zbog drugih razloga).
English: These data are based on exposure to this combination in 149 patients in the pivotal trial.
Croatian: Ti se podaci temelje na izloženosti 149 bolesnika toj kombinaciji u pivotalnom ispitivanju.
English: The precise mechanism of this interaction is unknown, but it is assumed to be due to inhibition of one or more transport proteins by lapatinib.
Croatian: Točan mehanizam ove interakcije nije poznat, ali se pretpostavlja da lapatinib inhibira jedan ili više prijenosnih proteina.
English: • cyclosporine - a medicine used to suppress the immune system for example after organ transplantations
Croatian: • ciklosporin - lijek koji se primjenjuje za potiskivanje rada imunološkog sustava, na primjer nakon presađivanja organa
English: Patients experiencing skin reactions should be encouraged to avoid exposure to sunlight and apply broad spectrum sunscreens with a Sun Protection Factor (SPF)  30.
Croatian: Bolesnike koji imaju kožne reakcije treba savjetovati da izbjegavaju izlaganje sunčevom svjetlu te da koriste zaštitne kreme širokog spektra sa zaštitnim faktorom ≥ 30.
English: Nail disorders including paronychia.
Croatian: Poremećaji nokta uključujući paronihiju.
English: Taking your tablets
Croatian: Kako uzimati tablete
English: Median overall survival
Croatian: Medijan ukupnog preživljenja
English: Information about these medicines is described in separate patient information leaflets.
Croatian: Informacije o ovim lijekovima navedene su u odvojenim uputama koje su namijenjene bolesnicima.
English: A detrimental effect on such activities cannot be predicted from the pharmacology of lapatinib.
Croatian: Štetan utjecaj na ove aktivnosti nije predvidiv iz farmakologije lapatiniba.
English: The absolute bioavailability following oral administration of lapatinib is unknown, but it is incomplete and variable (approximately 70% coefficient of variation in AUC).
Croatian: Apsolutna bioraspoloživost nakon peroralne primjene lapatiniba nije poznata, ali je ona nepotpuna te varijabilna (približno 70% koeficijent varijacije u AUC).
English: If you forget to take Tyverb
Croatian: Ako ste zaboravili uzeti Tyverb
English: Do not use this medicine after the expiry date which is stated on the blister or bottle and the carton.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru ili boci i kutiji.
English: Table 5 Summary of PFS and OS in studies with hormone receptor negative
Croatian: Tablica 5 Sažetak PFS-a i OS-a u ispitivanjima bolesti uz negativne hormonske receptore
English: OUTER CARTON AND BOTTLE LABEL
Croatian: VANJSKA KUTIJA I NALJEPNICA ZA BOCU
English: This was followed by three doses of lapatinib 2000 mg administered in the same way.
Croatian: Nakon toga su tri doze lapatiniba od 2000 mg primijenjene na isti način.
English: • avoid herbal supplements (some may cause diarrhoea).
Croatian: • izbjegavajte biljne pripravke (neki mogu uzrokovati proljev).
English: • swollen eyelids, lips or tongue
Croatian: • oticanje očnih kapaka, usana ili jezika
English: The study was halted as the interim analysis (N=475) showed a low incidence of CNS events and, superior efficacy of the trastuzumab plus capecitabine arm in terms of progression-free survival and overall survival (see results of final analysis in Table 3).
Croatian: Studija je obustavljena kada je interim analiza (N=475) pokazala nisku incidenciju CNS događaja i superiornu djelotvornost u skupini trastuzumab plus kapecitabin obzirom na preživljenje bez progresije i ukupno preživljenje (vidjeti rezultate završne analize u Tablici 3).
English: Don't drink grapefruit juice while you are being treated with Tyverb.
Croatian: Nemojte piti sok od grejpa tijekom liječenja lijekom Tyverb.
English: • erythromycin, ketoconazole, itraconazole, posaconazole, voriconazole, rifabutin, rifampicin,
Croatian: • eritromicin, ketokonazol, itrakonazol, posakonazol, vorikonazol, rifabutin, rifampicin,
English: EU/1/07/440/004 70 tablets EU/1/07/440/005 140 tablets EU/1/07/440/006 84 tablets EU/1/07/440/007 105 tablets
Croatian: EU/1/07/440/004 70 tableta EU/1/07/440/005 140 tableta EU/1/07/440/006 84 tablete EU/1/07/440/007 105 tableta
English: P value
Croatian: p-vrijednost
English: The maximum oral dose of lapatinib that has been administered in clinical studies is 1800 mg once daily.
Croatian: Maksimalna oralna doza lapatiniba primijenjena u kliničkim ispitivanjima je 1800 mg jednom dnevno.
English: No data are available on the efficacy of this combination relative to trastuzumab in combination with an aromatase inhibitor in this patient population.
Croatian: Nisu dostupni podaci o djelotvornosti ove kombinacije u odnosu na trastuzumab u kombinaciji s inhibitorom aromataze u ovoj populaciji bolesnika.
English: Table 7 Overall survival (OS) results from study EGF30008 (in the HER2-positive population only)
Croatian: Tablica 7 Rezultati ukupnog preživljenja (OS) iz ispitivanja EGF30008 (isključivo u HER2-pozitivnoj populaciji)
English: Tyverb can cause skin rash
Croatian: Tyverb može uzrokovati kožni osip
English: CI = confidence interval a. PFS was defined as the time from randomisation to the earliest date of disease progression or death from any cause, or to the date of censor.
Croatian: Preživljenje bez progresije (PFS) bolesti definirano je kao vrijeme od randomizacije do datuma najranije progresije bolesti ili smrti zbog bilo kojeg uzroka ili do datuma cenzure.
English: Of the 148 patients who received monotherapy treatment, 77 (52%) patients elected at the time of disease progression to receive combination treatment.
Croatian: Od 148 bolesnika koji su primili monoterapiju, 77 (52%) ih se prilikom progrediranja bolesti odlučilo za kombiniranu terapiju.
English: In potentially severe cases of diarrhoea the measuring of neutrophil counts and body temperature should be considered.
Croatian: U potencijalno teškim slučajevima proljeva treba razmotriti određivanje broja neutrofila i mjerenje tjelesne temperature.
English: b. P-value from Cox regression model, stratifying for site of disease and prior anti-adjuvant therapy at screening.
Croatian: P-vrijednost iz Cox regresijskog modela, stratificirano prema mjestu bolesti i prethodnoj adjuvantnoj terapiji kod probira.
English: Data have shown that Tyverb combined with chemotherapy is less effective than trastuzumab when combined with chemotherapy.
Croatian: Podaci su pokazali da je Tyverb u kombinaciji s kemoterapijom manje učinkovit nego trastuzumab u kombinaciji s kemoterapijom.
English: • liver problems, which may cause itching, yellow eyes or skin (jaundice), or dark urine or pain or discomfort in the right upper area of the stomach.
Croatian: • problemi s jetrom koji mogu prouzročiti svrbež, žutilo očiju ili kože (žutica), ili tamnu boju urina ili bol ili neugodu u desnom gornjem dijelu trbuha.