natgillin/translations-raw huggingface dataset:
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. 
bolnikov s HER2-pozitivnim zgodnjim rakom dojk in rezidualnim invazivnim tumorjem (bolniki, ki niso dosegli patološkega popolnega odziva (pCR)) v dojkah in/ali pazdušnih bezgavkah po dokončanju predoperativnega sistemskega zdravljenja, ki je vključevalo kemoterapijo in proti HER2
Serum transaminases > 3 x ULN and concomitant total bilirubin > 2´ ULN 
> 3´ ZNM in sočasni skupni bilirubin > 2´ ZNM
Do not administer trastuzumab emtansine . 
Trastuzumaba emtanzina ne uporabite.
No accumulation of trastuzumab emtansine was observed after repeated dosing of intravenous infusion every 3 weeks. 
Po ponavljajoči se uporabi intravenskih infuzij na 3 tedne niso opažali akumulacije trastuzumaba emtanzina.
Grade 4 (> 10´ the ULN) 
4. stopnja (> 10´ ZNM)
Grade 3 (> 5 to ≤ 20´ the ULN) 
3. stopnja (> 5 do ≤ 20´ ZNM
Left ventricular dysfunction was reported in 2.2% of patients in MBC clinical studies with trastuzumab emtansine. 
Disfunkcijo levega prekata so v kliničnih študijah MBC s trastuzumabom emtanzinom zabeležili pri 2,2 % bolnikov z MBC.
Increased transaminases were reported in 24.2% of patients in MBC clinical studies. 
V kliničnih študijah MBC so zvišanje transaminaz zabeležili pri 24,2 % bolnikov.
Trastuzumab emtansine (N=490) All Grades (%) Grade 3 (%) Grade 4 (%) 
Trastuzumab emtanzin (n = 490) Vse stopnje
· Kadcyla 100mg: One vial of powder for concentrate for solution for infusion contains 100 mg of trastuzumab emtansine. 
· Kadcyla 100 mg: Ena viala praška za koncentrat za raztopino za infundiranje vsebuje 100 mg trastuzumaba emtanzina.
Trastuzumab emtansine has minor influence on the ability to drive and use machines. 
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Trastuzumab emtanzin ima blag vpliv na sposobnost vožnje in upravljanja strojev.
No formal pharmacokinetic study has been conducted and no population PK data was collected in patients with severe hepatic impairment (Child-Pugh class C). 
Pri bolnikih s hudo jetrno okvaro (razred C po Child-Pughovi lestvici) formalne farmakokinetične študije niso bile izvedene in populacijski farmakokinetični podatki niso bili zbrani.
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. 
Pri bolnikih ≥ 65 let (n = 138 v obeh skupinah) je bilo razmerje ogroženosti za PFS 1,06 (95-% interval zaupanja: 0,68 do 1,66) in za celokupno preživetje 1,05 (95-% interval zaupanja: 0,58 do 1,91).
Grade 4 (> 20´ the ULN) 
4. stopnja (> 20´ ZNM)
The population pharmacokinetic analysis suggested no difference in trastuzumab emtansine exposure based on disease status (adjuvant vs. metastatic setting). 
5.2 Farmakokinetične lastnosti Populacijska farmakokinetična analiza ni pokazala razlike v izpostavljenosti trastuzumabu emtanzinu glede na stadij bolezni (adjuvantno zdravljenje v primerjavi z zdravljenjem razsejane bolezni).
After reconstitution one vial of 5 mL solution contains 20 mg/mL of trastuzumab emtansine. 
Po rekonstituciji vsebuje ena viala s 5 ml raztopine 20 mg/ml trastuzumaba emtanzina.
No reproductive and developmental toxicology studies have been conducted with trastuzumab emtansine. 
S trastuzumabom emtanzinom niso izvedli študij reproduktivne in razvojne toksičnosti.
One vial of powder for concentrate for solution for infusion contains 160 mg of trastuzumab emtansine. 
Ena viala praška za koncentrat za raztopino za infundiranje vsebuje 160 mg trastuzumaba emtanzina.
LVEF 45% to < 50% and decrease is < 10% points from baseline* 
LVEF 45 % do < 50 % in zmanjšanje za < 10 % od izhodišča*
The median duration of overall survival was 29.9 months in the trastuzumab emtansine arm compared with 25.9 months in the lapatinib plus capecitabine arm. At the time of the descriptive follow-up overall survival analysis, a total of 27.4% of the patients had crossed over from the lapatinib plus capecitabine arm to the trastuzumab emtansine arm. 
V skupini bolnikov, ki je prejemala trastuzumab emtanzin, je bila mediana celokupnega preživetja 29,9 meseca, v primerjavi s 25,9 meseca v skupini bolnikov, ki je prejemala kombinacijo lapatiniba in kapecitabina.
(> 5 to ≤ 20´ ULN on day of scheduled treatment) 
3. stopnja (> 5 do ≤ 20´ ZNM na dan načrtovanega zdravljenja
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. 
Če se pojavi periferna nevropatija 3. ali 4. stopnje, je treba zdravljenje s trastuzumabom emtanzinom prehodno prekiniti, dokler simptomi ne izginejo ali se ne zmanjšajo na ≤ 2. stopnjo.
In a sensitivity analysis censoring patients at the time of cross-over, the hazard ratio was 0.69 (95% CI 0.59, 0.82). 
V občutljivostni analizi, v kateri so bili podatki krnjeni za bolnike, ki so prešli iz skupine s kombinacijo lapatiniba in kapecitabina v skupino s trastuzumabom emtanzinom, je bilo razmerje ogroženosti 0,69 (95-% interval zaupanja: 0,59 do 0,82).
For dose modifications in the event of infusion-related reactions, see sections 4.2 and 4.4. 
Za prilagoditev odmerka pri z infundiranjem povezanimi reakcijami glejte poglavji 4.2 in 4.4.
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. 
Trastuzumab emtanzin ni raziskan pri bolnikih, pri katerih so predhodno zdravljenje s trastuzumabom trajno ukinili zaradi reakcij, povezanih z infundiranjem.
Tables 4 and 5 displays laboratory abnormalities observed in patients treated with trastuzumab emtansine in clinical study TDM4370g/BO21977/EMILIA and study BO27938/KATHERINE. 
Laboratorijske nepravilnosti V preglednicah 4 in 5 so naštete laboratorijske nepravilnosti, opažene pri bolnikih, zdravljenih s trastuzumabom emtanzinom v klinični študiji TDM4370g/BO21977/EMILIA in v študiji
If a CE-marked IVD is not available, the HER2-status should be assessed by an alternate validated test. 
Če takšnega pripomočka z oznako CE ni na voljo, je treba stanje
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. 
Na podlagi populacijske farmakokinetične analize so bili kot statistično značilne sospremenljivke za farmakokinetične parametre trastuzumaba emtanzina ugotovljeni telesna masa, albumin, vsota najdaljšega premera ciljne spremembe po RECIST (Response Evaluation Criteria In Solid Tumors),
TBILI > 2´ ULN at any time 
Celokupni bilirubin > 2´ ZNM kadar koli
Instructions for reconstitution · Kadcyla 100mg: using a sterile syringe, slowly inject 5 mL of sterile water for injection into the 
Navodila za pripravo · Kadcyla 100 mg: s sterilno injekcijsko brizgo počasi injicirajte 5 ml sterilne vode za injekcije v 100-mg vialo trastuzumaba emtanzina.
· Kadcyla 160mg: One vial of powder for concentrate for solution for infusion contains 160 mg of trastuzumab emtansine. 
· Kadcyla 160 mg: Ena viala praška za koncentrat za raztopino za infundiranje vsebuje 160 mg trastuzumaba emtanzina.
· Infusion-related reactions or allergic reactions: Kadcyla can cause flushing, shivering fits, fever, trouble breathing, low blood pressure, rapid heartbeat, sudden swelling of your face, tongue, or trouble swallowing during the infusion or after the infusion on the first day of treatment. 
· Z infundiranjem povezane reakcije ali alergijske reakcije: Zdravilo Kadcyla lahko povzroči rdečico, napade mrazenja, zvišano telesno temperaturo, težave z dihanjem, nizek krvni tlak,
Blood alkaline phosphatase increased, blood bilirubin increased 
Bolezni jeter, žolčnika in žolčevodov zvišanje transaminaz zvišanje alkalne fosfataze v krvi, zvišanje bilirubina v krvi hepatotoksičnost,
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. 
Trastuzumab emtanzin ni raziskan pri bolnikih, pri katerih so zdravljenje s trastuzumabom dokončno ukinili zaradi preobčutljivosti.
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): 
Glede na odmerek 3,6 mg trastuzumaba emtanzina na kilogram telesne mase določite potrebno količino pripravljene raztopine (glejte poglavje 4.2):
See section 4 for more details about what side effects to look out for. 
Podrobnosti o tem, na katere neželene učinke morate biti pozorni, so zapisane v poglavju 4.
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. 
Pri predpisovanju, pripravi infuzijske raztopine in aplikaciji zdravila Kadcyla (trastuzumab emtanzin) se mora uporabljati oziroma potrjevati zaščiteno ime Kadcyla in celotno nezaščiteno ime (trastuzumab emtanzin).
How you are given Kadcyla 4. 
Shranjevanje zdravila Kadcyla 6.
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). 
Na živalih so opravili študije z majtanzinom, zelo podobno snovjo iz iste skupine kot DM1, citotoksične sestavine trastuzumaba emtanzina, ki zavira mikrotubule.
Trastuzumab emtansine must be reconstituted and diluted by a healthcare professional and administered as an intravenous infusion. 
Trastuzumab emtanzin mora pripraviti in razredčiti zdravstveni delavec.
Number (%) of patients with event HR [95% CI] p-value (Log-Rank test, unstratified) 3 year event-free rate 
Celokupno preživetje (OS) število (%) bolnikov z dogodkom HR [95-% IZ] p-vrednost (log-rang test, nestratificiran) delež 5-letnega preživetja
Your doctor will check your heart function before and regularly during treatment. 
Pred zdravljenjem in redno med njim vam bo zdravnik preverjal srčno delovanje.
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. 
bolnikov z EBC; incidenca hudih krvavitev (≥ 3. stopnje) je bila 0,4 %, vključno z enim dogodkom 5. stopnje.
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), 
V podskupini bolnikov z nemerljivo boleznijo (n = 205) je bilo na podlagi ocen IRC razmerje ogroženosti za PFS 0,91 (95-% interval zaupanja: 0,59 do 1,42) in za celokupno preživetje 0,96 (95-% interval zaupanja: 0,54 do 1,68).
Injury, poisoning and procedural complications 
Poškodbe, zastrupitve in zapleti postopkov z infundiranjem povezane reakcije pnevmonitis, povezan z obsevanjem
Neurotoxicity 
Nevrotoksični učinki
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. 
Opisane so bile z infundiranjem povezane reakcije (zaradi sproščanja citokinov), za katere je značilen eden ali več od naslednjih simptomov: rdečica, mrzlica, zvišana telesna temperatura, dispneja,
Early Breast Cancer 
Zgodnji rak dojk (EBC - early breast cancer)
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. 
večina belk (72 %) in 57 % jih je imelo bolezen s pozitivnimi estrogenskimi in/ali progesteronskimi receptorji.
Infections and infestations Urinary tract infection 
Infekcijske in parazitske bolezni okužba sečil
Do not administer trastuzumab emtansine until total bilirubin recovers to Grade ≤ 1, and then treat at the same dose level. 
Trastuzumaba emtanzina ne uporabite, dokler se skupni bilirubin ne vrne na ≤ 1. stopnjo, nato nadaljujte zdravljenje z enakim odmerkom.
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. 
V podskupini bolnikov s hormonsko neodvisnim rakom (n = 426) je bilo razmerje ogroženosti za PFS 0,56 (95-% interval zaupanja: 0,44 do 0,72) in za celokupno preživetje 0,75 (95-% interval zaupanja: 0,54 do 1,03).
Sodium content in excipients 
OVOJNINAH NALEPKA NA VIALI
Trastuzumab, a component of trastuzumab emtansine, can cause foetal harm or death when administered to a pregnant woman. 
Pri nosečnici uporabljeni trastuzumab, ki je sestavina trastuzumaba emtanzina, lahko škoduje plodu ali povzroči njegovo smrt.
Trastuzumab emtansine (N=740) All Grade % Grade 3 (%) Grade 4 (%) 
Trastuzumab emtanzin (n = 740) Vse stopnje
· Kadcyla 160mg: using a sterile syringe, slowly inject 8 mL of sterile water for injection into the 
· Kadcyla 160 mg: s sterilno injekcijsko brizgo počasi injicirajte 8 ml sterilne vode za injekcije v 160-mg vialo trastuzumaba emtanzina.
Cases of nodular regenerative hyperplasia (NRH) of the liver have been identified from liver biopsies in patients treated with trastuzumab emtansine. 
Z biopsijo jeter so pri bolnikih, zdravljenih s trastuzumabom emtanzinom, ugotovili primere nodularne regenerativne hiperplazije jeter.
Events of LVEF drop of >10% from baseline and/or CHF were observed in an observational study (BO39807) of MBC patients with baseline LVEF of 40-49% in a real world setting. 
V opazovalni študiji (BO39807) bolnikov z MBC z izhodiščnim LVEF 40-49 % v realnem okolju so opazili primere zmanjšanja LVEF za > 10 % od izhodišča in/ali kongestivno srčno popuščanje.
Diarrhoea, Vomiting, Nausea, 
Bolezni prebavil stomatitis, driska, bruhanje, navzea, zaprtost, suhost ust,
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. 
22,5 odstotka bolnikov je bilo vključenih v Severni Ameriki, 54,2 % v
For dose modifications in the event of hypersensitivity reactions, see sections 4.2 and 4.4. 
Za prilagoditev odmerka pri preobčutljivostnih reakcijah glejte poglavji 4.2 in 4.4.
You should not be given Kadcyla if the above applies to you. 
Če kaj od navedenega velja za vas, ne smete dobiti zdravila Kadcyla.
Patients who discontinued trastuzumab emtansine could complete the duration of their intended study treatment up to 14 cycles of HER2-directed therapy with trastuzumab if appropriate based on toxicity considerations and investigator discretion. 
Bolniki, ki so prenehali zdravljenje s trastuzumabom emtanzinom, so lahko dokončali predvidenih 14 ciklov proti
Constipation, Dry mouth, Abdominal pain bleeding 
bolečine v trebuhu dispepsija, krvavitev iz dlesni
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. 
V podskupini bolnikov s hormonsko odvisnim rakom (n = 545) je bilo razmerje ogroženosti za PFS 0,72 (95-% interval zaupanja: 0,58 do 0,91) in za celokupno preživetje 0,62 (95-% interval zaupanja: 0,46 do 0,85).
The primary endpoint was investigator assessed Progression-Free Survival (PFS). 
Primarni končni cilj je bilo preživetje brez napredovanja bolezni (PFS) po oceni raziskovalca.
· urinary tract infection · constipation · stomach ache · cough · shortness of breath · inflammation of the mouth · difficulty sleeping · muscle or joint pain · fever · headache · feeling tired · weakness 
· zvišana telesna temperatura · glavobol · utrujenost · šibkost
The reconstituted Kadcyla solution should be diluted in polyvinyl chloride (PVC) or latex-free PVC-free polyolefin infusion bags. 
(PVC) ali brezlateksnega brez-PVC poliolefina.
In order to improve traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded (or stated) in the patient file. 
4.4 Posebna opozorila in previdnostni ukrepi Z namenom izboljšanja sledljivosti bioloških zdravil je treba jasno zabeležiti ime in številko serije uporabljenega zdravila.
Serious, anaphylactic reactions have been observed in clinical studies with trastuzumab emtansine. 
V kliničnih študijah s trastuzumabom emtanzinom so zabeležili resne anafilaktične reakcije.
Musculoskeletal pain, Arthralgia, Myalgia 
Bolezni mišično-skeletnega sistema in vezivnega tkiva mišično-skeletne bolečine, artralgija,
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. 
Kadcyla 100 mg prašek za koncentrat za raztopino za infundiranje Ena viala praška za koncentrat za raztopino za infundiranje vsebuje 100 mg trastuzumaba emtanzina.
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. 
infundiranjem povezane reakcije so opazili pri 4,0 % bolnikov z MBC v kliničnih študijah s trastuzumabom emtanzinom.
The median PFS and OS for the trastuzumab emtansine group were 
V kliničnih študijah EBC s trastuzumabom emtanzinom so pri
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. 
Kadcyla 160 mg prašek za koncentrat za raztopino za infundiranje Ena viala praška za koncentrat za raztopino za infundiranje vsebuje 160 mg trastuzumaba emtanzina.
Kadcyla100 mg powder for concentrate for solution for infusion Kadcyla 160 mg powder for concentrate for solution for infusion trastuzumab emtansine 
Kadcyla 100 mg prašek za koncentrat za raztopino za infundiranje Kadcyla 160 mg prašek za koncentrat za raztopino za infundiranje
Do not administer trastuzumab emtansine until total bilirubin recovers to Grade ≤ 1 and then reduce one dose level. 
Trastuzumaba emtanzina ne uporabite, dokler se skupni bilirubin ne vrne na ≤ 1. stopnjo, nato zmanjšajte odmerek za eno stopnjo.
Nervous system disorders Neuropathy peripheral, Headache 
Bolezni živčevja periferna nevropatija, glavobol omotica, spremenjen okus, okvara spomina
· The MCC linker is designed to limit systemic release and increase targeted delivery of DM1, as demonstrated by detection of very low levels of free DM1 in plasma. 
● MCC je vezalec, zasnovan tako, da omeji sistemsko sproščanje in poveča ciljno oddajanje
NRH is a rare liver condition characterised by widespread benign transformation of hepatic parenchyma into small regenerative nodules; NRH may lead to non-cirrhotic portal hypertension. 
Nodularna regenerativna hiperplazija jeter je redka bolezen, za katero je značilna obsežna benigna preobrazba jetrnega parenhima v majhne regenerativne nodule.
There is no known antidote for trastuzumab emtansine overdose. 
4.9 Preveliko odmerjanje Za preveliko odmerjanje trastuzumaba emtanzina ni znanega antidota.
10.8 months and not reached, respectively, compared with 5.7 months and 27.9 months, respectively, for the lapatinib plus capecitabine group. 
V skupini, ki je prejemala trastuzumab emtanzin, je bila mediana PFS 10,8 meseca, mediana celokupnega preživetja pa ni bila dosežena; v skupini, ki je prejemala kombinacijo lapatiniba in kapecitabina, je bila mediana PFS 5,7 meseca in mediana celokupnega preživetja 27,9 meseca.
Trastuzumab emtansine should be discontinued in case of life-threatening infusion reactions. 
Pri življenje ogrožujočih infuzijskih reakcijah je treba trastuzumab emtanzin prenehati uporabljati.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Kadcyla 160 mg powder for concentrate for solution for infusion trastuzumab emtansine 
IME ZDRAVILA IN POT(I) UPORABE Kadcyla 160 mg prašek za koncentrat za raztopino za infundiranje trastuzumab emtanzin intravenska uporaba
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. 
Pred uvedbo zdravljenja in tudi ob rednih intervalih med zdravljenjem (npr. na 3 mesece) je treba opraviti standardno preiskavo delovanja srca (ultrazvok srca ali izotopno ventrikulografijo - multiplo proženo angiografijo [MUGA, Multigated acqusition scanning]).
Reactions secondary to extravasation have been observed in clinical studies with trastuzumab emtansine. 
V kliničnih študijah s trastuzumabom emtanzinom so opažali reakcije zaradi ekstravazacije.
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 
2, % [95-% IZ] IDFS, vključno z drugim primarnim rakom, ki ni rak dojke3 število (%) bolnikov z dogodkom HR [95-% IZ] p-vrednost (log-rang test, nestratificiran) delež 3-letnega obdobja brez dogodka2, % [95-% IZ] Preživetje brez bolezni (DFS) število (%) bolnikov z dogodkom HR [95-% IZ] p-vrednost (log-rang test, nestratificiran) delež 3-letnega obdobja brez dogodka IZ] Interval brez oddaljene ponovitve (DRFI)3 število (%) bolnikov z dogodkom HR [95-% IZ] p-vrednost (log-rang test, nestratificiran) delež 3-letnega obdobja brez dogodka2, % [95-% IZ] Podatki iz prve vmesne analize z dne 25. julij 2018 Razlaga okrajšav (preglednica 6): HR: razmerje ogroženosti; IZ: interval zaupanja
Do not administer trastuzumab emtansine until AST recovers to Grade £ 1, and then treat at the same dose level 
Trastuzumaba emtanzina ne uporabite, dokler se AST ne vrne na ≤ 1. stopnjo, nato nadaljujte zdravljenje z enakim odmerkom.
For dose modifications for thrombocytopenia, see sections 4.2 and 4.4. 
Za prilagoditve odmerka pri pojavu trombocitopenije glejte poglavji 4.2 in 4.4.
The population PK analysis showed that age did not affect the PK of trastuzumab emtansine. 
Populacijska farmakokinetična analiza je pokazala, da starost ne vpliva na farmakokinetiko trastuzumaba emtanzina.
Reconstituted solution should be inspected visually for particulate matter and discolouration prior to administration. 
Pripravljeno raztopino je treba pred uporabo vizualno pregledati, da ne vsebuje delcev in nima spremenjene barve.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Kadcyla 100 mg powder for concentrate for solution for infusion trastuzumab emtansine 
IME ZDRAVILA IN POT(I) UPORABE Kadcyla 100 mg prašek za koncentrat za raztopino za infundiranje trastuzumab emtanzin intravenska uporaba
Skin and subcutaneous tissue disorders 
Bolezni kože in podkožja izpuščaj, srbenje,
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. 
anevgeničen ali klastogen ob izpostavljenostih, primerljivih povprečni največji koncentraciji DM1,
Do not administer trastuzumab emtansine until total bilirubin recovers to ≤ 1.0× ULN, and then reduce one dose level 
Trastuzumaba emtanzina ne uporabite, dokler se celokupni bilirubin ne vrne na ≤ 1,0´
LVEF 40% to ≤ 45% and decrease is < 10% points from baseline 
LVEF 40 % do ≤ 45 % in zmanjšanje za < 10 % od izhodišča
(see section 4.2). 
1. do 4. stopnje) (glejte poglavje 4.8).