FrancophonIA/ELRC3.0 huggingface dataset:
English: Standard cardiac function testing (echocardiogram or multigated acquisition (MUGA) scanning) should be performed prior to initiation of treatment and also at regular intervals (e.g. every three months) during treatment.
Croatian: Prije početka liječenja i također u redovitim razmacima tijekom liječenja (npr. svaka tri mjeseca) treba provoditi standardne testove srčane funkcije (ehokardiogram ili ekvilibrijsku radionuklidnu ventrikulografiju (engl. multigated acquisition, MUGA)).
English: LVEF 45% to < 50% and decrease is < 10% points from baseline*
Croatian: LVEF od 45% do < 50% i smanjenje za ≥ 10 postotnih bodova od početne vrijednosti*
English: Kadcyla 160 mg powder for concentrate for solution for infusion Kadcyla is provided in 20 mL (160 mg) Type 1 glass vial closed with a grey-butyl rubber stopper coated with fluoro resin laminate, and sealed with an aluminium seal with a purple plastic flip-off cap.
Croatian: Kadcyla se nalazi u staklenoj bočici (staklo tipa 1) od 20 ml (160 mg), zatvorenoj sivim gumenim čepom (butilna guma obložena slojem fluorosmole) i zabrtvljenoj aluminijskim prstenom s plastičnim „flip-off“ poklopcem ljubičaste boje.
English: Grade ≥ 2.
Croatian: PRILOG II.
English: For dose modifications in the event of hypersensitivity reactions, see sections 4.2 and 4.4.
Croatian: Za prilagodbu doze u slučaju reakcija preosjetljivosti vidjeti dijelove 4.2 i 4.4.
English: In the subgroup of patients with hormone receptor-negative disease (n=426), the hazard ratios for PFS and OS were 0.56 (95% CI: 0.44, 0.72) and 0.75 (95% CI: 0.54, 1.03), respectively.
Croatian: U podskupini bolesnika s bolešću negativnom na hormonske receptore (n=426) omjer hazarda za PFS iznosio je 0,56 (95% CI: 0,44; 0,72), a za OS 0,75 (95% CI: 0,54, 1,03).
English: · 160 mg trastuzumab emtansine vial: Using a sterile syringe, slowly inject 8 mL of sterile water for injection into the vial.
Croatian: • Bočica sa 160 mg trastuzumab emtanzina: Sterilnom štrcaljkom polako ubrizgajte 8 ml sterilne vode za injekcije u bočicu.
English: The primary endpoint was investigator assessed Progression-Free Survival (PFS).
Croatian: Primarni ishod bilo je preživljenje bez progresije bolesti (PFS) prema ocjeni ispitivača.
English: Based on population PK analysis, body weight, albumin, sum of longest diameter of target lesions by Response Evaluation Criteria In Solid Tumors (RECIST), HER2 shed extracellular domain (ECD), baseline trastuzumab concentrations, and aspartate aminotransferase (AST) were identified as statistically significant covariates for trastuzumab emtansine PK parameters.
Croatian: Na temelju populacijske farmakokinetičke analize, kao statistički značajne kovarijante za farmakokinetičke parametre trastuzumab emtanzina određeni su tjelesna težina, albumin, zbroj najdužih promjera ciljnih lezija prema Kriterijima za ocjenu odgovora kod solidnih tumora (engl.
English: If sodium chloride 9 mg/mL (0.9%) solution for infusion is used for infusion, a 0.20 or 0.22 micron in-line polyethersulfone (PES) filter is required.
Croatian: Ako se za infuziju koristi otopina natrijeva klorida za infuziju od 9 mg/ml (0,9%), potreban je polietersulfonski (PES) ugrađeni filtar od 0,20 ili 0,22 μm.
English: In patients ≥ 65 years old (n=138 across both treatment arms) the hazard ratios for progression-free survival (PFS) and Overall Survival (OS) were 1.06 (95% CI: 0.68, 1.66) and 1.05 (95% CI: 0.58, 1.91), respectively.
Croatian: U bolesnika u dobi od ≥ 65 godina (n=138 ukupno u obje skupine) omjer hazarda iznosio je 1,06 za PFS (95% CI: 0,68; 1,66) i 1,05 za OS (95% CI: 0,58; 1,91).
English: In patients with EBC, the overall incidence was 32.3% and 10.3% for
Croatian: U bolesnika s ranim rakom dojke ukupna je incidencija periferne neuropatije iznosila 32,3%, dok je incidencija događaja stupnja ≥ 2 iznosila 10,3%.
English: Left ventricular dysfunction occurred in 3.0% of patients with EBC, with Grade 3 or 4 in 0.5% of patients.
Croatian: 3,0% bolesnika s ranim rakom dojke, pri čemu su događaji stupnja 3 ili 4 prijavljeni u 0,5% bolesnika.
English: Randomization was stratified by clinical stage at presentation (operable vs. inoperable), hormone receptor status, preoperative HER2-directed therapy (trastuzumab, trastuzumab plus additional HER2-directed agent[s]), and pathological nodal status evaluated after preoperative therapy.
Croatian: preoperativnoj ciljanoj HER2 terapiji (trastuzumab, trastuzumab plus dodatni lijek[ovi] s ciljanim djelovanjem na HER2) i patološkom statusu limfnih čvorova ocijenjenom nakon preoperativne terapije.
English: Breast tumor samples were required to show HER2 overexpression defined as 3+ IHC or ISH amplification ratio ≥ 2.0 determined at a central laboratory.
Croatian: koja se definirala kao imunohistokemijski nalaz 3+ ili omjer amplifikacije ≥ 2,0 utvrđen in situ hibridizacijom (ISH) u centralnom laboratoriju.
English: For patients 75 years or above, based on IRC assessments, the hazard ratios for PFS and OS were 3.51 (95% CI: 1.22, 10.13) and 3.45 (95% CI: 0.94, 12.65), respectively.
Croatian: U podskupini bolesnika u dobi od 75 i više godina, omjer hazarda prema ocjeni neovisnog ocjenjivačkog povjerenstva iznosio je 3,51 za PFS (95% CI: 1,22; 10,13) i 3,45 za OS (95% CI: 0,94, 12,65).
English: The infusion rate of trastuzumab emtansine should be slowed or interrupted if the patient develops infusion-related symptoms (see sections 4.4 and 4.8).
Croatian: Ako se u bolesnika pojave simptomi povezani s infuzijom, potrebno je smanjiti brzinu infuzije trastuzumab emtanzina ili privremeno prekinuti njezinu primjenu (vidjeti dijelove 4.4 i 4.8).
English: One vial of powder for concentrate for solution for infusion contains 160 mg of trastuzumab emtansine.
Croatian: Jedna bočica s praškom za koncentrat za otopinu za infuziju sadrži 160 mg trastuzumab emtanzina.
English: Increase in serum transaminases (Grade 1-4) has been observed during treatment with trastuzumab emtansine in clinical studies (see section 4.4).
Croatian: U kliničkim su ispitivanjima tijekom liječenja trastuzumab emtanzinom primijećene povišene vrijednosti transaminaza u serumu (stupnja 1-4) (vidjeti dio 4.4).
English: In the subgroup of patients with hormone receptor-positive disease (n=545), the hazard ratios for PFS and OS were 0.72 (95% CI: 0.58, 0.91) and 0.62 (95% CI: 0.46, 0.85), respectively.
Croatian: U podskupini bolesnika s bolešću pozitivnom na hormonske receptore (n=545) omjer hazarda za PFS iznosio je 0,72 (95% CI: 0,58; 0,91), a za OS 0,62 (95% CI: 0,46, 0,85).
English: Primary endpoints IRC-assessed progression-free survival (PFS) Number (%) of patients with event Median duration of PFS (months) Hazard ratio (stratified*) 95% CI for Hazard ratio p-value (Log-rank test, stratified*) Overall Survival (OS)** Number (%) of patients who died Median duration of survival (months) Hazard ratio (stratified*) 95% CI for Hazard ratio p-value (Log-rank test*) Key secondary endpoints Investigator-assessed PFS Number (%) of patients with event Median duration of PFS (months) Hazard ratio (95% CI) p-value (Log-rank test*) Objective response rate (ORR) Patients with measurable disease Number of patients with OR (%) Difference (95% CI) p-value (Mantel-Haenszel chi-squared test*) Duration of objective response (months) Number of patients with OR Median 95% CI OS: overall survival; PFS: progression-free survival; ORR: objective response rate; OR: objective response; IRC: independent review committee; HR: hazard ratios; CI: confidence interval * Stratified by: world region (United States, Western Europe, other), number of prior chemotherapeutic regimens for locally advanced or metastatic disease (0-1 vs. > 1), and visceral vs. non-visceral disease.
Croatian: OS: ukupno preživljenje; PFS: preživljenje bez progresije bolesti; ORR: stopa objektivnog odgovora; OR: objektivni odgovor; IRC: neovisno ocjenjivačko povjerenstvo; HR: omjeri hazarda; CI: interval pouzdanosti * Stratificirano prema: dijelu svijeta (Sjedinjene Američke Države, Zapadna Europa, drugo), broju prethodnih kemoterapijskih protokola za lokalno uznapredovalu ili metastatsku bolest (0-1 naspram
English: Infusion-related reactions were reported in 4.0% of patients in MBC clinical studies with trastuzumab emtansine, with six Grade 3 and no Grade 4 events reported.
Croatian: U kliničkim ispitivanjima trastuzumab emtanzina kod metastatskog raka dojke reakcije povezane s infuzijom prijavljene su u 4,0% bolesnika, pri čemu je prijavljeno šest događaja stupnja 3, a niti jedan stupnja 4.
English: Injury, poisoning and procedural complications
Croatian: Ozljede, trovanja i proceduralne komplikacije reakcije povezane s infuzijom radijacijski pneumonitis
English: Do not substitute or combine trastuzumab emtansine with or for trastuzumab 4.
Croatian: Trastuzumab emtanzin se ne smije koristiti umjesto trastuzumaba niti u kombinaciji s njime.
English: Tell your doctor or nurse straight away if you notice any of following serious side effects.
Croatian: Odmah se javite liječniku ili medicinskoj sestri ako primijetite neku od sljedećih ozbiljnih nuspojava.
English: The MAH shall ensure that in parallel to the launch of Kadcyla (trastuzumab emtansine), all health care professionals who may prescribe, dispense or administer Kadcyla (trastuzumab emtansine) and/or Herceptin (trastuzumab) are provided with a health care professional (HCP) educational pack.
Croatian: Nositelj odobrenja mora se pobrinuti da istodobno sa stavljanjem lijeka Kadcyla (trastuzumab emtanzin) na tržište svi zdravstveni radnici koji bi mogli propisivati, izdavati ili primjenjivati lijekove
English: LVEF 40% to ≤ 45% and decrease is ≥ 10%
Croatian: LVEF od 40% do ≤ 45% uz smanjenje za ≥ 10 postotnih bodova od početne vrijednosti
English: All but 5 patients were women; 3 men were included in the trastuzumab arm and 2 in the trastuzumab emtansine arm. 22.5 percent of patients were enrolled in North America, 54.2% in Europe and 23.3% throughout the rest of the world.
Croatian: Americi, njih 54,2% u Europi, a njih 23,3% u ostalim dijelovima svijeta.
English: Hypersensitivity was reported in 2.6% of patients in MBC clinical studies with trastuzumab emtansine, with one Grade 3 and one Grade 4 events reported.
Croatian: U kliničkim ispitivanjima trastuzumab emtanzina kod metastatskog raka dojke preosjetljivost je prijavljena u 2,6% bolesnika, pri čemu je jedan prijavljeni događaj bio stupnja 3 i jedan stupnja 4.
English: · Kadcyla 100mg: One vial of powder for concentrate for solution for infusion contains 100 mg of trastuzumab emtansine.
Croatian: • Kadcyla 100 mg: Jedna bočica s praškom za koncentrat za otopinu za infuziju sadrži 100 mg trastuzumab emtanzina.
English: 2,% [95% CI] Disease-Free Survival (DFS)3 Number (%) of patients with event HR [95% CI] p-value (Log-Rank test, unstratified) 3 year event-free rate2,% [95% CI] Distant recurrence-free interval (DRFI) Number (%) of patients with event HR [95% CI] p-value (Log-Rank test, unstratified) 3 year event-free rate
Croatian: Ukupno preživljenje (OS) Broj (%) bolesnika s događajem HR [95% CI] p-vrijednost (log-rang test, nestratificiran) 5-godišnja stopa preživljenja2,% [95% CI] IDFS uključujući drugi primarni rak izvan dojke3 Broj (%) bolesnika s događajem HR [95% CI] p-vrijednost (log-rang test, nestratificiran) 3-godišnja stopa bez događaja2,% [95% CI] Preživljenje bez simptoma bolesti (DFS)3 Broj (%) bolesnika s događajem HR [95% CI] p-vrijednost (log-rang test, nestratificiran) 3-godišnja stopa bez događaja2,% [95% CI] Razdoblje bez recidiva bolesti na udaljenom mjestu (DRFI)3 Broj (%) bolesnika s događajem HR [95% CI] p-vrijednost (log-rang test, nestratificiran) 3-godišnja stopa bez događaja2,% [95% CI] Podaci iz prve interim analize, provedene 25. srpnja 2018.
English: Thrombocytopenia Grade 2-3 on day of scheduled treatment (25,000 to <
Croatian: Trombocitopenija Stupanj 2 - 3 na dan kada je predviđena primjena terapije
English: Table 7 Summary of efficacy from study TDM4370g/BO21977 (EMILIA)
Croatian: Tablica 7 Sažetak rezultata djelotvornosti iz ispitivanja TDM4370g/BO21977 (EMILIA) Lapatinib + kapecitabin n = 496
English: Diarrhoea, Vomiting, Nausea,
Croatian: Mogu se pojaviti trnci, bol, utrnulost,
English: · Kadcyla 160mg: One vial of powder for concentrate for solution for infusion contains 160 mg of trastuzumab emtansine.
Croatian: • Kadcyla 160 mg: Jedna bočica s praškom za koncentrat za otopinu za infuziju sadrži 160 mg trastuzumab emtanzina.
English: Kadcyla100 mg powder for concentrate for solution for infusion Kadcyla 160 mg powder for concentrate for solution for infusion trastuzumab emtansine
Croatian: Kadcyla 100 mg prašak za koncentrat za otopinu za infuziju Kadcyla 160 mg prašak za koncentrat za otopinu za infuziju trastuzumab emtanzin
English: Increased bilirubin Increased AST Increased ALT Haematologic Decreased platelet count Decreased haemoglobin Decreased neutrophils Potassium
Croatian: Hematološki parametri snižene vrijednosti trombocita snižene vrijednosti hemoglobina snižene vrijednosti neutrofila Kalij snižene vrijednosti kalija
English: After reconstitution one vial of 5 mL solution contains 20 mg/mL of trastuzumab emtansine.
Croatian: Nakon rekonstitucije jedna bočica s 5 ml otopine sadrži 20 mg/ml trastuzumab emtanzina.
English: Tell your doctor or nurse straight away if you notice any of the serious side effects above.
Croatian: Odmah obavijestite liječnika ili medicinsku sestru ako primijetite neku od gore navedenih ozbiljnih nuspojava.
English: Cases of nodular regenerative hyperplasia (NRH) of the liver have been identified from liver biopsies in patients treated with trastuzumab emtansine.
Croatian: U bolesnika liječenih trastuzumab emtanzinom biopsijom jetre utvrđeni su slučajevi nodularne regenerativne hiperplazije (NRH) jetre.
English: 10.8 months and not reached, respectively, compared with 5.7 months and 27.9 months, respectively, for the lapatinib plus capecitabine group.
Croatian: U skupini koja je primala trastuzumab emtanzin medijan PFS-a iznosio je 10,8 mjeseci, a medijan OS-a nije postignut, dok je u skupini koja je primala lapatinib u kombinaciji s kapecitabinom medijan PFS-a iznosio 5,7 mjeseci, a medijan OS-a 27,9 mjeseci.
English: Biotransformation (trastuzumab emtansine and DM1) Trastuzumab emtansine is expected to undergo deconjugation and catabolism by means of proteolysis in cellular lysosomes.
Croatian: Očekuje se dekonjugacija i katabolizam trastuzumab emtanzina putem proteolize u staničnim lizosomima.
English: Your doctor will check your blood to test your liver function before and regularly during treatment.
Croatian: Vaš će liječnik provoditi krvne pretrage prije liječenja i redovito tijekom liječenja kako bi se ispitala funkcija jetre.
English: Blood alkaline phosphatase increased, blood bilirubin increased
Croatian: Poremećaji jetre i žuči povišene vrijednosti transaminaza povišene vrijednosti alkalne fosfataze u krvi, povišene vrijednosti bilirubina u krvi hepatotoksičnost, zatajenje jetre,
English: A Phase II, single-arm, open-label study evaluated the effects of trastuzumab emtansine in patients with HER2-positive incurable, LABC or MBC.
Croatian: U otvorenom ispitivanju faze II s jednom skupinom ocijenjeni su učinci trastuzumab emtanzina u bolesnika s HER2-pozitivnim neizlječivim lokalno uznapredovalim ili metastatskim rakom dojke.
English: Peripheral neuropathy, mainly Grade 1 and predominantly sensory, has been reported in clinical studies with trastuzumab emtansine.
Croatian: U kliničkim ispitivanjima trastuzumab emtanzina prijavljena je periferna neuropatija, uglavnom stupnja 1 i pretežno senzorna.
English: Consider an alternate medicinal product with no or minimal potential to inhibit CYP3A4.
Croatian: Treba razmotriti primjenu nekog drugog lijeka koji ima minimalan ili nikakav potencijal za inhibiciju
English: Continue treatment with trastuzumab emtansine.
Croatian: prekinuti liječenje trastuzumab emtanzinom.
English: Kadcyla will be given to you by a doctor or nurse in a hospital or clinic: · It is given by a drip into a vein (intravenous infusion).
Croatian: Kako ćete primati lijek Kadcyla Lijek Kadcyla dat će Vam liječnik ili medicinska sestra u bolnici ili poliklinici:
English: Constipation, Dry mouth, Abdominal pain bleeding
Croatian: Poremećaji probavnog sustava stomatitis, proljev, povraćanje, mučnina, konstipacija, suha usta, bol u abdomenu dispepsija, krvarenje iz gingiva
English: (flushing, chills, pyrexia, dyspnoea, hypotension, wheezing, bronchospasm, and tachycardia) should be advised not to drive and use machines until symptoms abate.
Croatian: bronhospazam i tahikardija) treba savjetovati da ne upravljaju vozilima i ne rade sa strojevima dok se simptomi ne povuku.
English: · Kadcyla (trastuzumab emtansine) SPC · Health care professional information The HCP information shall contain the following key messages:
Croatian: • Informacije za zdravstvene radnike Informacije za zdravstvene radnike moraju sadržavati sljedeće ključne poruke:
English: For dose modifications in the event of infusion-related reactions, see sections 4.2 and 4.4.
Croatian: Za prilagodbu doze u slučaju reakcija povezanih s infuzijom vidjeti dijelove 4.2 i
English: Kadcyla 160 mg powder for concentrate for solution for infusion.
Croatian: Kadcyla 160 mg prašak za koncentrat za otopinu za infuziju.
English: Developmental toxicity of trastuzumab has been identified in the clinical setting although it was not predicted in the non-clinical program.
Croatian: Iako nije bila predviđena u nekliničkom programu, u kliničkim je uvjetima utvrđena razvojna toksičnost kod primjene trastuzumaba.
English: In the subgroup of patients with non-measurable disease (n=205), based on IRC assessments, the hazard ratios for PFS and OS were 0.91 (95% CI: 0.59, 1.42) and 0.96 (95% CI: 0.54, 1.68),
Croatian: U podskupini bolesnika s nemjerljivom bolešću (n=205) omjer hazarda prema ocjeni neovisnog ocjenjivačkog povjerenstva iznosio je 0,91 za PFS (95% CI: 0,59; 1,42) i 0,96 za OS (95% CI: 0,54, 1,68).
English: Do not administer trastuzumab emtansine until total bilirubin recovers to ≤ 1.0× ULN, and then reduce one dose level
Croatian: Trastuzumab emtanzin ne smije se primijeniti dok se ukupni bilirubin ne vrati na vrijednost ≤ 1,0 × GGN, a zatim dozu treba smanjiti za jednu razinu.
English: After reconstitution one vial of 8 mL solution contains 20 mg/mL of trastuzumab emtansine.
Croatian: Nakon rekonstitucije jedna bočica s 8 ml otopine sadrži 20 mg/ml trastuzumab emtanzina.
English: Kadcyla, as a single agent, is indicated for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination.
Croatian: neoperabilnim lokalno uznapredovalim ili metastatskim rakom dojke koji su prethodno primali trastuzumab i taksan, odvojeno ili u kombinaciji.
English: Kadcyla 100 mg powder for concentrate for solution for infusion One vial of powder for concentrate for solution for infusion contains 100 mg of trastuzumab emtansine.
Croatian: Kadcyla 100 mg prašak za koncentrat za otopinu za infuziju Jedna bočica s praškom za koncentrat za otopinu za infuziju sadrži 100 mg trastuzumab emtanzina.
English: For dose modifications for thrombocytopenia, see sections 4.2 and 4.4.
Croatian: Za prilagodbu doze u slučaju trombocitopenije vidjeti dijelove 4.2 i 4.4.
English: Kadcyla 160 mg powder for concentrate for solution for infusion One vial of powder for concentrate for solution for infusion contains 160 mg of trastuzumab emtansine.
Croatian: Kadcyla 160 mg prašak za koncentrat za otopinu za infuziju Jedna bočica s praškom za koncentrat za otopinu za infuziju sadrži 160 mg trastuzumab emtanzina.
English: Do not administer trastuzumab emtansine until total bilirubin recovers to Grade ≤ 1, and then treat at the same dose level.
Croatian: Trastuzumab emtanzin ne smije se primijeniti dok se ukupni bilirubin ne vrati na vrijednost stupnja ≤ 1, a zatim liječenje treba nastaviti istom dozom.
English: Time to symptom progression, as defined by a 5-point decrease in the score derived from the Trials Outcome Index-Breast (TOI-B) subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life (FACT-B QoL) questionnaire was also assessed during the clinical study.
Croatian: Tijekom ovog kliničkog ispitivanja ocijenjeno je i vrijeme do progresije simptoma, definirano kao smanjenje rezultata za 5 bodova na podljestvici TOI-B (engl.
English: Both the invented name Kadcyla and its full non-proprietary name (trastuzumab emtansine) should be used and confirmed when prescribing, preparing the infusion solution and administering Kadcyla (trastuzumab emtansine) to patients.
Croatian: Prilikom propisivanja, pripremanja otopine za infuziju i primjene lijeka Kadcyla (trastuzumab emtanzin) bolesnicima, mora se koristiti i provjeriti kako zaštićeno ime Kadcyla, tako i puni međunarodni nezaštićeni naziv (trastuzumab emtanzin).
English: 6.6 Special precautions for disposal and other handling Appropriate aseptic technique should be used.
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom
English: · If you get any side effects, talk to your doctor, pharmacist or nurse.
Croatian: • Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
English: Kadcyla 100 mg powder for concentrate for solution for infusion.
Croatian: Kadcyla 100 mg prašak za koncentrat za otopinu za infuziju.
English: Reactions secondary to extravasation have been observed in clinical studies with trastuzumab emtansine.
Croatian: U kliničkim ispitivanjima trastuzumab emtanzina primijećene su reakcije kao posljedica ekstravazacije.
English: In order to prevent medicinal product errors it is important to review the Summary of Product Characteristics and to check the outer carton and vial labels to ensure that the medicinal product being prepared and administered is Kadcyla (trastuzumab emtansine) and not trastuzumab.
Croatian: Kako bi se spriječile pogreške zamjene lijekova, važno je pročitati Sažetak opisa svojstava lijeka te provjeriti kutiju i naljepnice na bočici kako bi se osiguralo da je lijek koji se priprema i primjenjuje Kadcyla (trastuzumab emtanzin), a ne trastuzumab.
English: Do not use if reconstituted solution is cloudy or discoloured.
Croatian: Rekonstituirana otopina ne smije se upotrijebiti ako je mutna ili ako je promijenila boju.
English: Based on population pharmacokinetic (PK) analysis, following intravenous administration of trastuzumab emtansine in patients with HER2-positive metastatic breast cancer, the clearance of trastuzumab emtansine was 0.68 L/day and the elimination half-life (t1/2) was approximately 4 days.
Croatian: Na temelju populacijske farmakokinetičke analize, nakon intravenske primjene trastuzumab emtanzina u bolesnika s HER2-pozitivnim metastatskim rakom dojke klirens trastuzumab emtanzina iznosio je
English: Do not administer trastuzumab emtansine until total bilirubin recovers to Grade ≤ 1 and then reduce one dose level.
Croatian: Trastuzumab emtanzin ne smije se primijeniti dok se ukupni bilirubin ne vrati na vrijednost stupnja ≤ 1, a zatim dozu treba smanjiti za jednu razinu.
English: Instructions for reconstitution · 100 mg trastuzumab emtansine vial: Using a sterile syringe, slowly inject 5 mL of sterile water for injection into the vial.
Croatian: Upute za rekonstituciju • Kadcyla 100 mg: sterilnom štrcaljkom polako ubrizgajte 5 ml sterilne vode za injekcije u bočicu koja sadrži 100 mg trastuzumab emtanzina.
English: LVEF 40% to ≤ 45% and decrease is < 10% points from baseline
Croatian: LVEF od 40% do ≤ 45% uz smanjenje za < 10 postotnih bodova od početne vrijednosti
English: Very common (may affect more than 1 in 10 people): · Kadcyla may cause inflammation or damage to cells in the liver, resulting in elevated liver enzymes in blood tests.
Croatian: • Kadcyla može uzrokovati upalu ili oštećenje stanica jetre, što dovodi do povišenih vrijednosti enzima u krvnim nalazima.