natgillin/translations-raw huggingface dataset:
Patients treated with trastuzumab emtansine should have HER2 positive tumour status, defined as a score of 3 + by immunohistochemistry (IHC) or a ratio of ≥ 2.0 by in situ hybridization (ISH) or by fluorescence in situ hybridization (FISH) assessed by a CE-marked In Vitro Diagnostic (IVD) medical device. 
Bolesnici liječeni trastuzumab emtanzinom moraju imati HER2 pozitivan tumor, koji se definira imunohistokemijskim rezultatom 3+ ili omjerom ≥ 2,0 dobivenim in situ hibridizacijom (ISH) ili fluorescentnom in situ hibridizacijom (FISH) korištenjem „in vitro“ dijagnostičkog medicinskog proizvoda s oznakom „CE“.
In the EMILIA study (TDM4370g/BO21977), 5.2% (24/466) of patients tested positive for anti-trastuzumab emtansine antibodies, of which 13 were also positive for neutralizing antibodies. 
ispitivanju EMILIA (TDM4370g/BO21977) nalaz testa na protutijela na trastuzumab emtanzin bio je pozitivan u 5,2% (24/466) bolesnika, od kojih je njih 13 bilo pozitivno i na neutralizirajuća protutijela.
Patients were randomised to receive trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks (n = 67) or trastuzumab 8 mg/kg intravenous loading dose followed by 6 mg/kg intravenously every 3 weeks plus docetaxel 75-100 mg/m2 intravenously every 
Bolesnici su randomizirani u skupinu koja je primala trastuzumab emtanzin u dozi od 3,6 mg/kg intravenski svaka 3 tjedna (n = 67) ili u skupinu koja je primila udarnu dozu trastuzumaba od 8 mg/kg intravenski, a nakon toga trastuzumab u dozi od 6 mg/kg intravenski svaka 3 tjedna u kombinaciji s docetakselom u dozi od 75-100 mg/m2 intravenski svaka 3 tjedna (n = 70).
By inhibiting tubulin polymerization, both DM1 and trastuzumab emtansine cause cells to arrest in the G2/M phase of the cell cycle, ultimately leading to apoptotic cell death. 
Inhibicijom polimerizacije tubulina, i DM1 i trastuzumab emtanzin zaustavljaju rast stanica u fazi G2/M staničnog ciklusa, što naposljetku dovodi do apoptotske stanične smrti.
Do not administer trastuzumab emtansine at doses greater than 3.6 mg/kg once every 3 weeks 6. 
Trastuzumab emtanzin se ne smije primjenjivati u dozama većima od 3,6 mg/kg jedanput svaka
Treatment should be interrupted in patients with a severe IRR until signs and symptoms resolve. 
Liječenje je potrebno privremeno prekinuti u bolesnika s teškom reakcijom povezanom s infuzijom do povlačenja znakova i simptoma.
In vitro, DM1 was a substrate of P-glycoprotein (P-gp). 
bio supstrat P-glikoproteina (P-gp).
A treatment benefit was seen in the subgroup of patients who had relapsed within 6 months of completing adjuvant treatment and had not received any prior systemic anti-cancer therapy in the metastatic setting (n=118); hazard ratios for PFS and OS were 0.51 (95% CI: 0.30, 0.85) and 0.61 (95% CI: 0.32, 1.16), respectively. 
Korist od liječenja primijećena je u podskupini bolesnika koji su doživjeli relaps unutar 6 mjeseci nakon završetka adjuvantnog liječenja i koji prethodno nisu primili nikakvu sistemsku antitumorsku terapiju za metastatsku bolest (n=118); omjer hazarda za PFS iznosio je 0,51 (95% CI: 0,30; 0,85), a za OS 0,61 (95% CI: 0,32, 1,16).
In the KATHERINE (BO27938) study, 3.7% (15/401) of patients tested positive for anti-trastuzumab emtansine antibodies, of which 5 were also positive for neutralizing antibodies. 
U ispitivanju KATHERINE (BO27938) nalaz testa na protutijela na trastuzumab emtanzin bio je pozitivan u 3,7% (15/401) bolesnika, od kojih je njih 5 bilo pozitivno i na neutralizirajuća protutijela.
Left ventricular ejection fraction (LVEF) < 40% has been observed in patients treated with trastuzumab emtansine, and therefore symptomatic congestive heart failure (CHF) is a potential risk (see section 4.8). 
U bolesnika liječenih trastuzumab emtanzinom primijećena je ejekcijska frakcija lijeve klijetke (LVEF) < 40%, pa postoji potencijalan rizik od simptomatskog kongestivnog zatajenja srca (vidjeti dio 4.8).
In addition, trastuzumab emtansine, like trastuzumab, inhibits shedding of the HER2 ECD, inhibits signalling through the phosphatidylinositol 3-kinase (PI3-K) pathway, and mediates antibody-dependent cell-mediated cytotoxicity (ADCC) in human breast cancer cells that overexpress HER2. 
Osim toga, trastuzumab emtanzin, kao i trastuzumab, inhibira otpuštanje HER2 ECD, inhibira signalizaciju signalnim putem fosfatidilinositol 3-kinaze (PI3-K) te posreduje u stanično posredovanoj citotoksičnosti ovisnoj o protutijelima (engl. antibody-dependent cell-mediated cytotoxicity, ADCC) u stanicama ljudskog raka dojke s prekomjernom ekspresijom HER2.
Trastuzumab emtansine has not been studied in patients with platelet counts ≤ 100,000/mm3 prior to initiation of treatment. 
Trastuzumab emtanzin nije ispitan u bolesnika u kojih je broj trombocita prije početka liječenja bio ≤ 100 000/mm3.
Do not administer trastuzumab emtansine in combination with chemotherapy 5. 
4. Trastuzumab emtanzin se ne smije primjenjivati u kombinaciji s kemoterapijom.
Grade 3 or 4 events were reported in 0.4% of patients with MBC. 
Događaji stupnja 3 ili 4 prijavljeni su u 0,4% bolesnika s metastatskim rakom dojke.
In the GLP toxicity studies, with the exception of irreversible peripheral axonal toxicity (observed only in monkeys at ³ 10 mg/kg) and reproductive organ toxicity (observed only in rats at 60 mg/kg), partially or completely reversible dose dependent toxicities were identified in both animal models. 
U ispitivanjima toksičnosti u skladu s dobrom laboratorijskom praksom u oba su životinjska modela primijećene djelomično ili potpuno reverzibilne toksičnosti ovisne o dozi, uz izuzetak ireverzibilne toksičnosti za aksone perifernih neurona (primijećene samo kod majmuna pri dozama od ≥ 10 mg/kg) i toksičnosti za reproduktivne organe (primijećene samo kod štakora kod doze od 60 mg/kg).
The reconstituted solution should be free of visible particulates, clear to slightly opalescent. 
Rekonstituirana otopina ne smije sadržavati vidljive čestice te mora biti bistra do blago opalescentna.
Infusion-related reactions are characterised by one or more of the following symptoms: flushing, chills, pyrexia, dyspnoea, hypotension, wheezing, bronchospasm and tachycardia. 
Reakcije povezane s infuzijom karakterizira jedan ili više sljedećih simptoma: navale crvenila, zimica, pireksija, dispneja, hipotenzija, piskanje pri disanju, bronhospazam i tahikardija.
In a sensitivity analysis censoring patients at the time of cross-over, the hazard ratio was 0.69 (95% CI 0.59, 0.82). 
U analizi osjetljivosti u kojoj su bolesnici cenzurirani u trenutku prijelaza u drugu skupinu, omjer hazarda iznosio je 0,69 (95% CI: 0,59; 0,82).
Upon binding to HER2, trastuzumab emtansine undergoes receptor-mediated internalization and subsequent lysosomal degradation, resulting in release of DM1-containing cytotoxic catabolites (primarily lysine-MCC-DM1). 
Nakon vezanja za HER2, trastuzumab emtanzin se posredstvom receptora internalizira, a zatim ga lizosomi razgrađuju, što dovodi do otpuštanja citotoksičnih katabolita koji sadrže DM1 (prvenstveno lizin-MCC-DM1).
(ECD), as well as to Fcγ receptors and complement C1q. 
Fcγ te komplement C1q.
Trastuzumab emtansine treatment has not been studied in patients who had trastuzumab permanently discontinued due to infusion-related reactions (IRR); treatment is not recommended for these patients. 
Liječenje trastuzumab emtanzinom nije ispitivano u bolesnika kojima je trajno prekinuto liječenje trastuzumabom zbog reakcija povezanih s infuzijom; u tih se bolesnika liječenje ne preporučuje.
No fertility studies in animals have been performed to evaluate the effect of trastuzumab emtansine. 
Nisu provedena ispitivanja na životinjama kojima bi se ocijenio učinak trastuzumab emtanzina na plodnost.
In nonclinical studies, trastuzumab emtansine catabolites including DM1, Lys-MCC-DM1, and MCC-DM1 are mainly excreted in the bile with minimal elimination in urine. 
U nekliničkim su se ispitivanjima kataboliti trastuzumab emtanzina, uključujući DM1, Lys-MCC-DM1 i MCC-DM1, uglavnom izlučivali putem žuči, dok se mokraćom eliminirala minimalna količina.
Trastuzumab emtansine treatment has not been studied in patients who had trastuzumab permanently discontinued due to hypersensitivity; treatment with trastuzumab emtansine is not recommended for these patients. 
Liječenje trastuzumab emtanzinom nije ispitivano u bolesnika kojima je trajno prekinuto liječenje trastuzumabom zbog preosjetljivosti; u tih se bolesnika ne preporučuje liječenje trastuzumab emtanzinom.
Table 6 Summary of efficacy from study BO27938 (KATHERINE) Trastuzumab N = 743 
Tablica 6 Sažetak podataka o djelotvornosti iz ispitivanja BO27938 (KATHERINE) Trastuzumab
DM1 was aneugenic or clastogenic in an in vivo single-dose rat bone marrow micronucleus assay at exposures that were comparable to mean maximum concentrations of DM1 measured in humans administered trastuzumab emtansine. 
DM1 je bio aneugen ili klastogen u mikronukleusnom testu na koštanoj srži štakora in vivo nakon jednokratne doze pri izloženostima koje su bile usporedive sa srednjom vrijednošću koncentracija DM1 izmjerenih u ljudi nakon primjene trastuzumab emtanzina.
Specific treatment for trastuzumab emtansine extravasation is unknown at this time. 
U ovom trenutku nije poznato specifično liječenje u slučaju ekstravazacije trastuzumab emtanzina.
In addition, developmental toxicity of maytansine has been identified in non-clinical studies which suggests that DM1, the microtubule-inhibiting cytotoxic maytansinoid component of trastuzumab emtansine, will be similarly teratogenic and potentially embryotoxic. 
Osim toga, u nekliničkim je ispitivanjima utvrđena razvojna toksičnost kod primjene maitanzina, što ukazuju na to da će i DM1, citotoksični sastojak trastuzumab emtanzina koji pripada skupini maitanzinoida i inhibira mikrotubule, imati slično teratogeno i potencijalno embriotoksično djelovanje.
SPECIAL STORAGE CONDITIONS Store in a refrigerator (2ºC - 8ºC) 
POSEBNE MJERE ČUVANJA Čuvati u hladnjaku (2ºC - 8ºC).
Animal toxicology and/or pharmacology 
5.3 Neklinički podaci o sigurnosti primjene Toksikologija i/ili farmakologija u životinja
· Trastuzumab emtansine arm: trastuzumab emtansine 3.6 mg/kg intravenously over 30-90 minutes on Day 1 of a 21-day cycle · Control arm (lapatinib plus capecitabine): lapatinib 1250 mg/day orally once per day of a 21-day cycle plus capecitabine 1000 mg/m2 orally twice daily on Days 1-14 of a 21-day cycle 
• kontrolna skupina (lapatinib i kapecitabin): 1250 mg/dan lapatiniba peroralno jedanput na dan tijekom 21-dnevnog ciklusa i 1000 mg/m2 kapecitabina peroralno dvaput na dan od 1. do 14. dana 21-dnevnog ciklusa
For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6. 
Za uputu o rekonstituciji i razrjeđivanju lijeka prije primjene vidjeti dio 6.6. 4.3 Kontraindikacije
Infusion-related reactions were reported in 1.6% of patients with EBC, with no Grade 3 or 4 events reported. 
Reakcije povezane s infuzijom prijavljene su u 1,6% bolesnika s ranim rakom dojke, pri čemu nije zabilježen nijedan događaj stupnja 3 ili 4.
Trastuzumab emtansine must be reconstituted and diluted by a healthcare professional and administered as an intravenous infusion. 
Trastuzumab emtanzin mora rekonstituirati i razrijediti zdravstveni radnik, a lijek se mora primijeniti u obliku intravenske infuzije.
In vitro metabolism studies in human liver microsomes suggest that DM1, a small molecule component of trastuzumab emtansine, is metabolised mainly by CYP3A4 and to a lesser extent by CYP3A5. 
In vitro ispitivanja metabolizma u mikrosomima ljudske jetre ukazuju na to da se DM1, mali molekularni sastojak trastuzumab emtanzina, metabolizira uglavnom putem CYP3A4 i u manjoj mjeri putem CYP3A5.
Thrombocytopenia, or decreased platelet counts, was commonly reported with trastuzumab emtansine and was the most common adverse reaction leading to treatment discontinuation, dose reduction, and dose interruption (see section 4.8). 
Trombocitopenija, ili smanjen broj trombocita, često je prijavljena kod primjene trastuzumab emtanzina te je bila najčešća nuspojava koja je zahtijevala trajan prekid liječenja, smanjenje doze ili privremeni prekid liječenja (vidjeti dio 4.8).
A randomised, multicentre, open-label phase II study evaluated the effects of trastuzumab emtansine versus trastuzumab plus docetaxel in patients with HER2-positive MBC who had not received prior chemotherapy for metastatic disease. 
U randomiziranom, multicentričnom, otvorenom ispitivanju faze II ocijenili su se učinci trastuzumab emtanzina u usporedbi s trastuzumabom i docetakselom u bolesnika s HER2-pozitivnim metastatskim rakom dojke koji prethodno nisu primali kemoterapiju za metastatsku bolest.
The population pharmacokinetic analysis suggested no difference in trastuzumab emtansine exposure based on disease status (adjuvant vs. metastatic setting). 
Populacijska farmakokinetička analiza nije ukazala na razlike u izloženosti trastuzumab emtanzinu s obzirom na status bolesti (adjuvantno liječenje u odnosu na liječenje metastatske bolesti).
· the most common serious ADRs (> 0.5% of patients) were haemorrhage, pyrexia, thrombocytopenia, dyspnoea, abdominal pain, musculoskeletal pain, and vomiting. 
• najčešće ozbiljne nuspojave na lijek (> 0,5% bolesnika) bile su krvarenje, pireksija, trombocitopenija, dispneja, bol u abdomenu, bol u mišićno-koštanom sustavu i povraćanje.
PAES: In order to further investigate the efficacy of trastuzumab emtansine in the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy, the MAH should submit the final analysis of OS from the phase 3, randomised, open-label study KATHERINE (BO27938). 
HER2 pozitivnim ranim rakom dojke koji imaju rezidualnu invazivnu bolest, u dojci i/ili limfnim čvorovima, nakon neoadjuvantne terapije utemeljene na taksanu i ciljane HER2 terapije, nositelj odobrenja treba dostaviti završnu analizu OS-a iz randomiziranog, otvorenog ispitivanja faze 3 pod nazivom KATHERINE (BO27938).
In vitro metabolism studies in human liver microsomes suggest that DM1, a component of trastuzumab emtansine, is metabolised mainly by CYP3A4 and, to a lesser extent, by CYP3A5. 
In vitro ispitivanja metabolizma na mikrosomima ljudske jetre ukazuju na to da se DM1, sastojak trastuzumab emtanzina, metabolizira uglavnom putem CYP3A4 i u manjoj mjeri putem CYP3A5.
Trastuzumab emtansine has not been studied in patients with serum transaminases > 2.5 ´ ULN or total bilirubin > 1.5 ´ ULN prior to initiation of treatment. 
Trastuzumab emtanzin nije ispitivan u bolesnika koji su prije početka liječenja imali vrijednosti serumskih transaminaza > 2,5 × GGN ili vrijednost ukupnog bilirubina > 1,5 × GGN.
In the post-marketing setting, cases of oligohydramnios, some associated with fatal pulmonary hypoplasia, have been reported in pregnant women receiving trastuzumab. 
Nakon stavljanja lijeka u promet, u trudnica koje su primale trastuzumab prijavljeni su slučajevi oligohidramniona, od kojih su neki bili povezani sa smrtonosnom hipoplazijom pluća.
Thrombocytopenia was reported in 28.5% of patients in EBC clinical studies with trastuzumab emtansine and was the most common reported adverse reaction for all grades and grades ≥ 3, as well as the most common adverse reaction leading to treatment discontinuation (4.2%), dose interruptions, and dose reductions. 
U kliničkim ispitivanjima primjene trastuzumab emtanzina kod ranog raka dojke trombocitopenija je prijavljena u 28,5% bolesnika te je bila najčešće prijavljena nuspojava među nuspojavama bilo kojeg stupnja i onima stupnja ≥ 3, kao i najčešća nuspojava koja je zahtijevala trajan prekid liječenja (4,2%), privremeni prekid liječenja i smanjenje doze.
Animal studies of maytansine, a closely related chemical entity of the same maytansinoid class as DM1, suggest that DM1, the microtubule inhibiting cytotoxic component of trastuzumab emtansine, is expected to be teratogenic and potentially embryotoxic (see section 5.3). 
Istraživanja na životinjama u kojima se ispitivao maitanzin, blisko srodan kemijski spoj koji pripada istoj skupini maitanzinoida kao i DM1, upućuju na to da se može očekivati teratogeno i potencijalno embriotoksično djelovanje DM1, citotoksičnog sastojka trastuzumab emtanzina koji inhibira mikrotubule.
Kadcyla must be reconstituted and diluted by a healthcare professional and administered as an intravenous infusion. 
Lijek Kadcyla mora rekonstituirati i razrijediti zdravstveni radnik, a mora se primijeniti u obliku intravenske infuzije.
In an observational study (BO39807), approximately 22% (7 out of 32) of MBC patients initiating trastuzumab emtansine with LVEF of 40-49% at baseline, experienced a LVEF drop of >10% from baseline and/or CHF; most of these patients had other cardiovascular risk factors. 
U opservacijskom ispitivanju (BO39807) približno 22% (7 od 32) bolesnika s metastatskim rakom dojke kojima je početni LVEF iznosio 40 - 49% i kojima je uvedeno liječenje trastuzumab emtanzinom doživjelo je pad LVEF-a za > 10% od početne vrijednosti i/ili kongestivno zatajenje srca;
3-year event-free rate and 5-year survival rate derived from Kaplan-Meier estimates 3. 
2. 3-godišnja stopa bez događaja i 5-godišnja stopa preživljenja temeljile su se na procjenama prema
Table 5 Laboratory abnormalities observed in patients treated with trastuzumab emtansine in study BO27938/KATHERINE 
Tablica 5 Poremećaji laboratorijskih vrijednosti primijećeni u bolesnika liječenih trastuzumab emtanzinom u ispitivanju BO27938/KATHERINE
Tables 4 and 5 displays laboratory abnormalities observed in patients treated with trastuzumab emtansine in clinical study TDM4370g/BO21977/EMILIA and study BO27938/KATHERINE. 
U Tablicama 4 i 5 prikazani su poremećaji laboratorijskih vrijednosti u bolesnika liječenih trastuzumab emtanzinom u kliničkom ispitivanju TDM4370g/BO21977/EMILIA i ispitivanju BO27938/KATHERINE.
In KATHERINE, consistent treatment benefit of trastuzumab emtansine for IDFS was seen in all the pre-specified subgroups evaluated, supporting the overall result. 
IDFS u svim unaprijed specificiranim podskupinama koje su se ocjenjivale, što govori u prilog cjelokupnim rezultatima.
Kadcyla, as a single agent, is indicated for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy. 
Kadcyla je u monoterapiji indicirana za adjuvantno liječenje odraslih bolesnika s HER2 pozitivnim ranim rakom dojke koji imaju rezidualnu invazivnu bolest, u dojci i/ili limfnim čvorovima, nakon neoadjuvantne terapije utemeljene na taksanu i ciljane HER2 terapije.
Grade 2 (> 2.5 to ≤ 5´ the ULN) 
Stupanj 2 (> 2,5 do ≤ 5 × GGN)
Trastuzumab, a component of trastuzumab emtansine, can cause foetal harm or death when administered to a pregnant woman. 
Trastuzumab, sastojak trastuzumab emtanzina, može uzrokovati oštećenje ili smrt ploda kada se primjenjuje u trudnica.
TBILI > 2´ ULN at any time 
Ukupni bilirubin > 2 × GGN u bilo kojem trenutku
Trastuzumab emtansine is administered intravenously. 
Trastuzumab emtanzin se primjenjuje intravenski.
Conjugation of DM1 to trastuzumab confers selectivity of the cytotoxic agent for HER2-overexpressing tumour cells, thereby increasing intracellular delivery of DM1 directly to malignant cells. 
Konjugacija DM1 s trastuzumabom čini citotoksični lijek selektivnim za stanice tumora s prekomjernom ekspresijom HER2, čime se povećava unutarstanična isporuka DM1 izravno u zloćudne stanice.
· Tingling, pain, numbness, itching, crawling sensation, pins and needles in your hands and feet. 
• trnci, bol, utrnulost, svrbež, mravinjanje, bockanje u šakama i stopalima.
· Store in a refrigerator at (2°C - 8°C). 
• Čuvati u hladnjaku (2°C - 8°C).
No adjustment to the starting dose is needed in patients with mild or moderate renal impairment (see section 5.2). 
U bolesnika s blagim ili umjerenim oštećenjem bubrežne funkcije nije potrebna prilagodba početne doze (vidjeti dio 5.2).
Rash, Pruritus, Alopecia, Nail disorder, Palmarplantar erythrodysaesthesia syndrome, Urticaria 
Poremećaji kože i potkožnog tkiva osip, pruritus, alopecija, poremećaj noktiju, sindrom palmarno-plantarne eritrodizestezije,
Patients with a history of congestive heart failure (CHF), serious cardiac arrhythmia requiring treatment, history of myocardial infarction or unstable angina within 6 months of randomization, or current dyspnoea at rest due to advanced malignancy were excluded from clinical studies. 
U klinička ispitivanja nisu bili uključeni bolesnici s kongestivnim zatajenjem srca u anamnezi, ozbiljnom srčanom aritmijom koja zahtijeva liječenje, infarktom miokarda u anamnezi ili nestabilnom anginom unutar 6 mjeseci prije randomizacije, kao ni bolesnici koji su u tom trenutku imali dispneju u mirovanju zbog uznapredovale zloćudne bolesti.
Very common: · decreased red blood cells (shown in a blood test) · being sick (vomiting) · diarrhoea · dry mouth 
• smanjen broj crvenih krvnih stanica (vidljivo iz nalaza krvnih pretraga)
Within each frequency grouping and SOC, adverse reactions are presented in order of decreasing seriousness. 
Unutar svake kategorije učestalosti i klase organskog sustava nuspojave su navedene u padajućem nizu prema ozbiljnosti.
Hepatic 
Hepatotoksičnost
Haemorrhagic events were reported in 29% of patients with EBC and the incidence of severe haemorrhagic events (Grade ≥3) was 0.4%, including one Grade 5 event. 
Među bolesnicima s ranim rakom dojke događaji krvarenja prijavljeni su u 29% bolesnika, dok je incidencija događaja teškog krvarenja (stupnja ≥ 3) iznosila 0,4%, uključujući jedan događaj 5. stupnja.
There is no known antidote for trastuzumab emtansine overdose. 
Nema poznatog protulijeka za predoziranje trastuzumab emtanzinom.
Administration of trastuzumab emtansine was well tolerated in rats and monkeys at doses up to 20 and 10 mg/kg, respectively, corresponding to 2040 mg DM1/m2 in both species, which is approximately equivalent to the clinical dose of trastuzumab emtansine in patients. 
10 mg/kg, koje kod obje vrste odgovaraju dozi od 2040 µg DM1/m2, što je približno jednako kliničkoj dozi trastuzumab emtanzina koja se primjenjuje u bolesnika.
What Kadcyla looks like and contents of the pack · Kadcyla is a white to off-white lyophilised powder for concentrate for solution for infusion supplied in glass vials. 
• Kadcyla je bijel do bjelkasti liofilizirani prašak za koncentrat za otopinu za infuziju koji dolazi u staklenoj bočici.
Trastuzumab was given intravenously at 6 mg/kg on Day 1 of a 21-day cycle. 
Trastuzumab se primjenjivao intravenski u dozi od 6 mg/kg 1. dana 21-dnevnog ciklusa.
In particular, tell your doctor or pharmacist if you are taking: · any medicines to thin your blood such as warfarin or decrease the ability to form blood clot such as aspirin · medicines for fungal infections called ketoconazole, itraconazole or voriconazole · antibiotics for infections called clarithromycin or telithromycin · medicines for HIV called atazanavir, indinavir, nelfinavir, ritonavir or saquinavir. 
• bilo koje lijekove za razrjeđivanje krvi, poput varfarina ili lijekove za smanjenje sposobnosti krvi da se zgruša, poput aspirina • lijekove za gljivične infekcije koji se zovu ketokonazol, itrakonazol ili vorikonazol
Infusion-related reactions (due to cytokine release), characterized by one or more of the following symptoms have been reported: flushing, chills, pyrexia, dyspnoea, hypotension, wheezing, bronchospasm, and tachycardia. 
U kliničkim su ispitivanjima prijavljene reakcije povezane s infuzijom (uzrokovane otpuštanjem citokina), koje karakterizira jedan ili više sljedećih simptoma: navale crvenila, zimica, pireksija, dispneja, hipotenzija, piskanje pri disanju, bronhospazam i tahikardija.
Figure 2 Kaplan-meier curve of IRC-assessed progression-free survival 
Slika 2 Kaplan-Meierova krivulja preživljenja bez progresije bolesti prema ocjeni neovisnog ocjenjivačkog povjerenstva