FrancophonIA/ELRC3.0 huggingface dataset:
English: There are no data from the use of trastuzumab emtansine in pregnant women.
Croatian: Nema podataka o primjeni trastuzumab emtanzina u trudnica.
English: In clinical studies, the incidence and severity of thrombocytopenia were higher in Asian patients.
Croatian: U kliničkim su ispitivanjima incidencija i težina trombocitopenije bile veće u bolesnika azijskog podrijetla.
English: If diluted aseptically, it may be stored for up to 24 hours at 2°C to 8°C.
Croatian: Ako se razrijedi u aseptičkim uvjetima, može se čuvati tijekom najviše 24 sata na temperaturi od 2ºC - 8ºC.
English: Pulmonary Toxicity Interstitial lung disease (ILD) or pneumonitis
Croatian: Intersticijska bolest pluća ili pneumonitis
English: Inflamed or injured liver cells may leak higher than normal amounts of certain substances (liver enzymes) into the bloodstream, resulting in elevated liver enzymes in blood tests.
Croatian: Upaljene ili oštećene jetrene stanice mogu u krvotok otpuštati veću količinu određenih tvari (jetrenih enzima) nego inače, što može dovesti do povišenih vrijednosti jetrenih enzima u krvnim nalazima.
English: · Do not use this medicine after the expiry date which is stated on the outer carton and vial after EXP.
Croatian: • Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenoga na kutiji i bočici iza oznake "Rok valjanosti" odnosno „EXP“.
English: Important information about some of the ingredients of Kadcyla This medicine contains less than 1 mmol sodium (23 mg) per dose.
Croatian: Važna informacija o nekim sastojcima lijeka Kadcyla Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
English: The ORR was 32.7% (95% CI: 24.1, 42.1), n = 36 responders, by both IRC and investigator review.
Croatian: Stopa objektivnog odgovora iznosila je 32,7% (95% CI: 24,1; 42,1), n = 36 ispitanika, i prema ocjeni neovisnog ocjenjivačkog povjerenstva i prema ocjeni ispitivača.
English: The safety of trastuzumab emtansine has been evaluated in 2,611 breast cancer patients in clinical studies.
Croatian: Sigurnost trastuzumab emtanzina ocijenjena je u 2611 bolesnika s rakom dojke u kliničkim ispitivanjima.
English: Discontinue trastuzumab emtansine
Croatian: Trastuzumab emtanzin
English: Patients received radiotherapy and/or hormonal therapy concurrent with study treatment as per local guidelines.
Croatian: Istodobno s ispitivanim liječenjem bolesnici su primali radioterapiju i/ili hormonsku terapiju u skladu s nacionalnim smjernicama.
English: For patients randomised to trastuzumab emtansine, the median age was 53 years, most patients were female (99.8%), the majority were Caucasian (72%), and 57% had oestrogen-receptor and/or progesterone-receptor positive disease.
Croatian: Medijan dobi u bolesnika randomiziranih u skupinu koja je primala trastuzumab emtanzin iznosio je 53 godine, većina bolesnika bila je ženskoga spola (99,8%) i bijele rase (72%), a njih 57% imalo je bolest pozitivnu na estrogenske i/ili progesteronske receptore.
English: Grade 4 at any time < 25,000/mm3
Croatian: Stupanj 4 u bilo kojem trenutku (< 25 000/mm3)
English: The recommended dose of trastuzumab emtansine is 3.6 mg/kg bodyweight administered as an intravenous infusion every 3 weeks (21-day cycle).
Croatian: Preporučena doza trastuzumab emtanzina je 3,6 mg/kg tjelesne težine, a primjenjuje se intravenskom infuzijom svaka 3 tjedna (21-dnevni ciklus).
English: This abnormality causes the structure of the liver to change and can change how the liver functions.
Croatian: Taj poremećaj uzrokuje promjene u strukturi jetre i može promijeniti način na koji jetra funkcionira.
English: This abnormality causes the structure of the liver to change.
Croatian: Taj poremećaj uzrokuje promjene u strukturi jetre.
English: Your doctor will check your heart function before and regularly during treatment.
Croatian: Vaš će liječnik kontrolirati srčanu funkciju prije liječenja i redovito tijekom liječenja.
English: Patient demographics and baseline tumor characteristics were balanced between treatment arms.
Croatian: Demografske značajke bolesnika i početne tumorske značajke bile su ujednačene između liječenih skupina.
English: Trastuzumab emtansine should be discontinued in case of life-threatening infusion reactions.
Croatian: Primjenu trastuzumab emtanzina potrebno je prekinuti u slučaju po život opasnih reakcija na infuziju.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodiumfree'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
English: Independent of race, the incidence of Grade 3 or 4 events (< 50,000/mm3) was 8.7% in patients with MBC treated with trastuzumab emtansine and 5.7% in patients with EBC.
Croatian: Neovisno o rasi, incidencija događaja stupnja 3 ili 4 (< 50 000/mm3) iznosila je 8,7% u bolesnika s metastatskim rakom dojke liječenih trastuzumab emtanzinom te 5,7% u bolesnika s ranim rakom dojke.
English: Discontinue trastuzumab emtansine if not resolving with standard treatment
Croatian: Prekinuti liječenje trastuzumab emtanzinom ako se nuspojava ne povlači uz standardno liječenje.
English: Figure 1 Kaplan-Meier Curve of Invasive Disease-Free Survival in KATHERINE
Croatian: Slika 1 Kaplan-Meierova krivulja preživljenja bez invazivne bolesti u ispitivanju KATHERINE
English: Patients should be clinically monitored on an ongoing basis for signs/symptoms of neurotoxicity.
Croatian: Potreban je kontinuiran klinički nadzor bolesnika zbog moguće pojave znakova/simptoma neurotoksičnosti.
English: If a prescription for Kadcyla (trastuzumab emtansine) is written electronically, it is important to ensure that the medicinal product prescribed is trastuzumab emtansine and not trastuzumab.
Croatian: Ako se Kadcyla (trastuzumab emtanzin) propisuje elektroničkim putem, važno je provjeriti da je propisan lijek trastuzumab emtanzin, a ne trastuzumab.
English: Trastuzumab emtansine exposure (AUC) at Cycle 3 after repeated dosing in patients with mild or moderate hepatic dysfunction was within the range observed in patients with normal hepatic function.
Croatian: Izloženost trastuzumab emtanzinu (AUC) u 3. ciklusu nakon višekratne primjene u bolesnika s blagim ili umjerenim oštećenjem jetrene funkcije bila je unutar raspona primijećenog u bolesnika s normalnom jetrenom funkcijom.
English: If you experience flushing, shivering fits, fever, trouble breathing, low blood pressure or a rapid heartbeat (infusion-related reaction), blurred vision, tiredness, headache, or dizziness, do not drive, cycle, use tools or machines until these reactions stop.
Croatian: Ako primijetite navale crvenila, napadaje drhtanja, vrućicu, otežano disanje, nizak krvni tlak ili ubrzane otkucaje srca (reakcija povezana s infuzijom), zamagljen vid, umor, glavobolju ili omaglicu, nemojte upravljati automobilom, voziti bicikl, rukovati alatima niti raditi sa strojevima dok se te reakcije ne povuku.
English: White to off-white lyophilised powder.
Croatian: Liofilizirani prašak bijele do bjelkaste boje.
English: The reconstituted Kadcyla solution diluted in infusion bags containing sodium chloride 9 mg/mL (0.9%) solution for infusion, or sodium chloride 4.5 mg/mL (0.45%) solution for infusion, is stable for up to 24 hours at 2°C to 8°C, provided it was prepared under controlled and validated aseptic conditions.
Croatian: Rekonstituirana otopina lijeka Kadcyla razrijeđena u infuzijskoj vrećici otopinom natrijeva klorida za infuziju od 9 mg/ml (0,9%) ili otopinom natrijeva klorida za infuziju od 4,5 mg/ml (0,45%), stabilna je najdulje 24 sata na temperaturi od 2°C do 8°C, pod uvjetom da je pripremljena u kontroliranim i validiranim aseptičkim uvjetima.
English: Increased Transaminase (AST/ALT)
Croatian: Povišene vrijednosti transaminaza (AST/ALT)
English: Treatment with trastuzumab emtansine should be temporarily discontinued in patients experiencing Grade 3 or 4 peripheral neuropathy until symptoms resolve or improve to ≤ Grade 2.
Croatian: Liječenje trastuzumab emtanzinom potrebno je privremeno prekinuti u bolesnika s perifernom neuropatijom stupnja 3 ili 4 dok se simptomi ne povuku ili poboljšaju na vrijednost stupnja ≤ 2.
English: In patients with MBC, the overall incidence of peripheral neuropathy was 29.0% and 8.6% for Grade ≥ 2.
Croatian: U bolesnika s metastatskim rakom dojke ukupna je incidencija periferne neuropatije iznosila 29,0%, dok je incidencija događaja stupnja ≥ 2 iznosila 8,6%.
English: In clinical studies, patients had a LVEF ³ 50% at baseline.
Croatian: U kliničkim ispitivanjima bolesnici su na početku ispitivanja imali LVEF ≥ 50%.
English: Management of symptomatic adverse reactions may require temporary interruption, dose reduction, or treatment discontinuation of trastuzumab emtansine as per guidelines provided in text and Tables 1 and 2 .
Croatian: Liječenje simptomatskih nuspojava može zahtijevati privremeni prekid liječenja, smanjenje doze ili trajan prekid liječenja trastuzumab emtanzinom, u skladu sa smjernicama koje se navode u tekstu te u
English: The study compared the safety and efficacy of trastuzumab emtansine with that of lapatinib plus capecitabine.
Croatian: U ispitivanju su se uspoređivale sigurnost i djelotvornost trastuzumab emtanzina sa sigurnošću i djelotvornošću lapatiniba u kombinaciji s kapecitabinom.
English: METHOD OF ADMINISTRATION For intravenous use after reconstitution and dilution
Croatian: Za intravensku primjenu nakon rekonstitucije i razrjeđivanja
English: · you have any history of liver problems.
Croatian: • ako ste imali ikakvih problema s jetrom.
English: Kadcyla should only be prescribed by a physician and administered as an intravenous infusion under the supervision of a healthcare professional who is experienced in the treatment of cancer patients (i.e. prepared to manage allergic/anaphylactic infusion reactions and in an environment where full resuscitation facilities are immediately available (see section 4.4)).
Croatian: 4.2 Doziranje i način primjene Lijek Kadcyla smije propisati samo liječnik, a mora se primjenjivati intravenskom infuzijom pod nadzorom zdravstvenog radnika s iskustvom u liječenju onkoloških bolesnika (tj. zdravstvenog radnika koji zna kako zbrinuti alergijske/anafilaktičke reakcije na infuziju, i to u uvjetima u kojima je trenutno dostupno svo potrebno osoblje i oprema za oživljavanje (vidjeti dio 4.4))
English: Table 3 Tabulated list of ADRs in patients treated with trastuzumab emtansine in clinical trials
Croatian: Tablica 3 Tablični prikaz nuspojava u bolesnika liječenih trastuzumab emtanzinom u kliničkim ispitivanjima
English: ALT = alanine transaminase; AST = aspartate transaminase, CHF = congestive heart failure, LVEF = left ventricular ejection fraction, LVSD = left ventricular systolic dysfunction, TBILI = Total Bilirubin, ULN = upper limit of normal * Prior to starting trastuzumab emtansine treatment.
Croatian: ALT = alanin transaminaza; AST = aspartat transaminaza, GGN = gornja granica normale, LVEF (engl. left ventricular ejection fraction) = ejekcijska frakcija lijeve klijetke.
English: If LVEF < 45% is confirmed, discontinue trastuzumab emtansine.
Croatian: Ako se potvrdi da je LVEF < 45%, prekinuti liječenje trastuzumab emtanzinom.
English: In clinical studies, the incidence and severity of thrombocytopenia were higher in Asian patients (see section 4.8).
Croatian: U kliničkim su ispitivanjima incidencija i težina trombocitopenije bile veće u bolesnika azijskog podrijetla (vidjeti dio 4.8).
English: · If you have any further questions, ask your doctor, pharmacist or nurse.
Croatian: • Ako imate dodatnih pitanja, obratite se svom liječniku, ljekarniku ili medicinskoj sestri.
English: To be administered under the supervision of a physician experienced in the use of cytotoxic agents.
Croatian: Primjenjivati pod nadzorom liječnika s iskustvom u primjeni citotoksičnih lijekova.
English: All patients were previously treated with HER2-directed therapies (trastuzumab and lapatinib), and chemotherapy (anthracycline, taxane, and capecitabine) in the neoadjuvant, adjuvant, locally advanced, or metastatic setting.
Croatian: Svi su bolesnici prethodno primali terapije koje ciljano djeluju na HER2 (trastuzumab i lapatinib) i kemoterapiju (antraciklin, taksan i kapecitabin) kao neoadjuvantnu, adjuvantnu ili terapiju za lokalno uznapredovalu ili metastatsku bolest.
English: Nervous system disorders Neuropathy peripheral, Headache
Croatian: Poremećaji živčanog sustava periferna neuropatija,
English: The primary efficacy endpoint of the study was Invasive Disease-Free Survival (IDFS).
Croatian: Primarna mjera ishoda za djelotvornost bilo je preživljenje bez invazivne bolesti (engl.
English: Kadcyla can make some existing conditions worse, or cause side effects.
Croatian: Pripazite na nuspojave Kadcyla može pogoršati određene postojeće bolesti ili izazvati nuspojave.
English: Serum transaminases > 3 x ULN and concomitant total bilirubin > 2´ ULN
Croatian: Vrijednosti serumskih transaminaza > 3 × GGN uz ukupni bilirubin > 2 × GGN
English: If a strong CYP3A4 inhibitor is coadministered and trastuzumab emtansine treatment cannot be delayed, patients should be closely monitored for adverse reactions.
Croatian: Ako se istodobna primjena snažnog inhibitora CYP3A4 i trastuzumab emtanzina ne može odgoditi, bolesnike je potrebno pomno nadzirati zbog moguće pojave nuspojava.
English: The infusion site should be closely monitored for possible subcutaneous infiltration during administration (see section 4.8).
Croatian: Mjesto primjene infuzije treba pomno nadzirati zbog mogućeg supkutanog ulaska lijeka za vrijeme primjene (vidjeti dio 4.8).
English: A total of 991 patients were randomised to trastuzumab emtansine or lapatinib plus capecitabine as follows:
Croatian: 991 bolesnik randomiziran u skupinu koja je primala trastuzumab emtanzin ili u skupinu koja je primala lapatinib i kapecitabin na sljedeći način:
English: · the most common National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade ≥ 3 ADRs (> 2%) were thrombocytopenia, increased transaminases, anaemia, neutropenia, fatigue and hypokalaemia.
Croatian: • najčešće nuspojave lijeka stupnja ≥ 3 (> 2%) prema Zajedničkim terminološkim kriterijima za nuspojave Nacionalnog instituta za rak (NCI-CTCAE) bile su trombocitopenija, povišene vrijednosti transaminaza, anemija, neutropenija, umor i hipokalijemija.
English: A total of 1243 patients from seven clinical studies were tested at multiple time points for anti-drug antibody (ADA) responses to trastuzumab emtansine.
Croatian: 1243 bolesnika iz sedam kliničkih ispitivanja u više različitih vremenskih točaka testirana na stvaranje antiterapijskih protutijela kao odgovor na trastuzumab emtanzin.
English: Symptomatic CHF, Grade 3-4 LVSD or Grade 3-4 heart failure, or
Croatian: Simptomatsko kongestivno zatajenje srca, sistolička disfunkcija lijeve klijetke stupnja 3 - 4 ili zatajenje srca stupnja 3 - 4, odnosno zatajenje srca stupnja 2 uz
English: A Phase III, randomised, multicentre, international, open-label clinical study was conducted in patients with HER2-positive unresectable locally advanced breast cancer (LABC) or MBC who had received prior taxane and trastuzumab-based therapy, including patients who received prior therapy with trastuzumab and a taxane in the adjuvant setting and who relapsed during or within six months of completing adjuvant therapy.
Croatian: Randomizirano, multicentrično, međunarodno, otvoreno kliničko ispitivanje faze III provedeno je u bolesnika s HER2-pozitivnim neoperabilnim lokalno uznapredovalim ili metastatskim rakom dojke koji su prethodno liječeni taksanom i terapijom temeljenom na trastuzumabu, uključujući bolesnike koji su prethodno liječeni trastuzumabom i taksanom kao adjuvantnom terapijom i u kojih je došlo do povrata bolesti tijekom ili unutar šest mjeseci nakon završetka adjuvantnog liječenja.
English: Use caution with these agents and consider additional monitoring when concomitant use is medically necessary.
Croatian: Kod primjene tih lijekova potreban je oprez, a kada je njihova istodobna primjena medicinski nužna, treba razmotriti dodatan nadzor bolesnika.
English: If the LVEF remains < 50% and has not recovered to < 10% points from baseline, discontinue trastuzumab emtansine.
Croatian: Ako je LVEF i dalje < 50% i ako se nije vratio na < 10 postotnih bodova razlike od početne vrijednosti, prekinuti liječenje trastuzumab emtanzinom.
English: It is not known whether the ingredients in Kadcyla pass into breast-milk.
Croatian: Nije poznato izlučuju li se sastojci lijeka Kadcyla u majčino mlijeko.
English: The majority of events were asymptomatic Grade 1 or 2 decrease in LVEF.
Croatian: Većina događaja bila su asimptomatska smanjenja ejekcijske frakcije lijeve klijetke stupnja 1 ili 2.
English: Additional endpoints included IDFS including second primary non-breast cancer, disease-free survival (DFS), overall survival (OS), and distant recurrence-free interval (DRFI).
Croatian: Dodatne mjere ishoda uključivale su IDFS uključujući drugi primarni rak izvan dojke, preživljenje bez simptoma bolesti (engl. disease-free survival, DFS), ukupno preživljenje (engl. overall survival, OS) i razdoblje bez recidiva bolesti na udaljenom mjestu
English: Determine the volume of the reconstituted solution required based on a dose of 3.6 mg trastuzumab emtansine/kg body weight (see section 4.2):
Croatian: Odredite potreban volumen rekonstituirane otopine na temelju doze od 3,6 mg trastuzumab emtanzina/kg tjelesne težine (vidjeti dio 4.2):
English: Treatment of patients with hepatic impairment should be undertaken with caution due to known hepatotoxicity observed with trastuzumab emtansine (see section 4.4 and 5.2).
Croatian: Potreban je oprez pri liječenju bolesnika s oštećenjem jetrene funkcije zbog poznate hepatotoksičnosti primijećene kod primjene trastuzumab emtanzina (vidjeti dijelove 4.4 i 5.2).
English: Thrombocytopenia or decreased platelet counts were reported in 24.9% of patients in MBC clinical studies with trastuzumab emtansine and was the most common adverse reaction leading to treatment discontinuation (2.6%).
Croatian: Trombocitopenija ili snižen broj trombocita prijavljen je u 24,9% bolesnika u kliničkim ispitivanjima trastuzumab emtanzina kod metastatskog raka dojke i bio je najčešća nuspojava koja je zahtijevala prekid liječenja (2,6%).
English: Particulates may be observed on storage if diluted in 0.9% sodium chloride (see section 6.6).
Croatian: Pri čuvanju mogu biti vidljive krute čestice ako je lijek razrijeđen u otopini natrijeva klorida od 9 mg/ml (0,9%) (vidjeti dio 6.6).
English: Patients should receive treatment for a total of 14 cycles unless there is disease recurrence or unmanageable toxicity.
Croatian: Bolesnici trebaju primiti ukupno 14 ciklusa liječenja, osim u slučajevima kada dođe do povrata bolesti ili toksičnosti koja se ne može zbrinuti.
English: Radiotherapy-Related Pneumonitis
Croatian: Pneumonitis uzrokovan radioterapijom
English: If you stop Kadcyla treatment Do not stop treatment with this medicine without talking to your doctor first.
Croatian: Nemojte prekinuti liječenje ovim lijekom ako prethodno o tome niste razgovarali sa svojim liječnikom.
English: Treatment in patients with serum transaminases > 3 ´ ULN and concomitant total bilirubin > 2 ´ ULN should be permanently discontinued.
Croatian: Liječenje u bolesnika s vrijednostima serumskih transaminaza > 3 × GGN i istodobnom vrijednošću ukupnog bilirubina > 2 × GGN mora se trajno prekinuti.
English: Dry eye, Conjunctivitis, Vision blurred, Lacrimation increased
Croatian: Poremećaji oka suhoća oka, konjunktivitis, zamagljen vid, pojačano suzenje
English: Cases of overdose have been reported with trastuzumab emtansine treatment, most associated with thrombocytopenia, and there was one death.
Croatian: Kod liječenja trastuzumab emtanzinom prijavljeni su slučajevi predoziranja, većina povezana s trombocitopenijom, a zabilježen je i jedan smrtni slučaj.
English: · If the Kadcyla infusion solution leaks into the area around the infusion site you may develop tenderness or redness of your skin, or swelling at the infusion site.
Croatian: • Ako otopina lijeka Kadcyla za infuziju iscuri u područje oko mjesta infuzije, mogu se pojaviti osjetljivost na dodir, crvenilo kože ili oticanje na mjestu infuzije.
English: In study TDM4370g/BO21977, consistent treatment benefit of trastuzumab emtansine was seen in the majority of pre-specified subgroups evaluated, supporting the robustness of the overall result.
Croatian: U ispitivanju TDM4370g/BO21977, u većine ocijenjenih prethodno definiranih podskupina primijećen je dosljedan koristan učinak liječenja trastuzumab emtanzinom, što govori u prilog robusnosti ukupnog rezultata.
English: Your doctor will check your blood regularly for decreased platelets.
Croatian: Vaš će liječnik redovito provoditi krvne pretrage kako bi se provjerilo je li broj trombocita smanjen.
English: Another rare abnormality that can occur in the liver is a condition known as nodular regenerative hyperplasia (NRH).
Croatian: Još jedan rijedak poremećaj jetre koji se može pojaviti je bolest koja se naziva nodularnom regenerativnom hiperplazijom (NRH).
English: BO27938 (KATHERINE) was a randomized, multicenter, open-label trial of 1486 patients with HER2-positive, early breast cancer with residual invasive tumor (patients who had not achieved pathological complete response (pCR)) in the breast and/or axillary lymph nodes following completion of preoperative systemic therapy that included chemotherapy and HER2-targeted therapy.
Croatian: Ispitivanje BO27938 (KATHERINE) bilo je randomizirano, multicentrično, otvoreno ispitivanje koje je obuhvatilo 1486 bolesnika s HER2 pozitivnim, ranim rakom dojke koji su imali rezidualan invazivni tumor (bolesnici koji nakon završetka preoperativne sistemske terapije koja je uključivala kemoterapiju i HER2 ciljanu terapiju nisu ostvarili patološki potpun odgovor u dojci i/ili aksilarnim limfnim čvorovima).
English: · the cancer has spread to areas near the breast or to other parts of your body (metastasized) · the cancer has not spread to other parts of the body and treatment is going to be given after surgery
Croatian: • ako se rak nije proširio u druge dijelove tijela, a liječenje će se primijeniti nakon kirurškog zahvata
English: Over time, this may lead to symptoms such as a bloated sensation or swelling of the abdomen due to fluid accumulation or bleeding from abnormal blood vessels in the gullet or rectum.
Croatian: S vremenom to može dovesti do pojave simptoma poput osjećaja nadutosti ili oticanja trbuha zbog nakupljanja tekućine ili krvarenja iz abnormalnih krvnih žila u jednjak ili završni dio debelog crijeva.
English: Treatment of patients with hepatic impairment should be undertaken with caution (see sections 4.2 and 5.2).
Croatian: Potreban je oprez pri liječenju bolesnika s oštećenjem jetrene funkcije (vidjeti dijelove 4.2 i 5.2).
English: Trastuzumab emtansine when administered intravenously every 3 weeks exhibited linear PK across doses ranging from 2.4 to 4.8 mg/kg; patients who received doses less than or equal to 1.2 mg/kg had faster clearance.
Croatian: Kada se primjenjivao intravenski svaka 3 tjedna, trastuzumab emtanzin imao je linearnu farmakokinetiku u rasponu doza od 2,4 do 4,8 mg/kg; u bolesnika koji su primali doze od 1,2 mg/kg ili manje, klirens je bio brži.
English: When the heart muscle is weak, patients may develop symptoms such as shortness of breath at rest or when sleeping, chest pain, swollen legs or arms, and a sensation of rapid or irregular heartbeats.
Croatian: Kada je srčani mišić slab, u bolesnika se mogu pojaviti simptomi poput nedostatka zraka u mirovanju ili u snu, boli u prsima, oticanja nogu ili ruku te osjećaja ubrzanog ili nepravilnog kucanja srca.
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before you are given Kadcyla.
Croatian: Ako se nešto od navedenoga odnosi na Vas (ili niste sigurni), obratite se svom liječniku ili ljekarniku prije nego primite lijek Kadcyla.
English: · Use effective contraception to avoid becoming pregnant while you are being treated with Kadcyla.
Croatian: • Za vrijeme liječenja lijekom Kadcyla koristite učinkovitu kontracepciju kako biste izbjegli trudnoću.