natgillin/translations-raw huggingface dataset:
Determine the volume of the reconstituted solution required based on a dose of 3.6 mg trastuzumab emtansine/kg body weight: 
Upute za razrjeđivanje Odredite potreban volumen rekonstituirane otopine na temelju doze od 3,6 mg trastuzumab emtanzina/kg tjelesne težine:
If a patient requires 2 delays due to thrombocytopenia, consider reducing dose by one level. 
Ako bolesniku treba dvaput odgoditi primjenu doze zbog trombocitopenije,
The MAH shall agree the content and format of the Kadcyla (trastuzumab emtansine) educational material and a communication plan with the National Competent Authority in the Member State before Kadcyla (trastuzumab emtansine) is launched in each Member State. 
Prije stavljanja lijeka Kadcyla (trastuzumab emtanzin) na tržište u svakoj državi članici, nositelj odobrenja će s nacionalnim nadležnim tijelom pojedine države članice dogovoriti sadržaj i oblik edukacijskih materijala za lijek Kadcyla (trastuzumab emtanzin) te komunikacijski plan.
Common (may affect up to 1 in 10 people): · Flushing, shivering fits, fever, trouble breathing, low blood pressure or a rapid heartbeat during the infusion or up to 24 hours after the infusion - these are so-called infusion-related reactions. 
• navale crvenila, napadaji drhtanja, vrućica, otežano disanje, nizak krvni tlak ili ubrzano kucanje srca tijekom infuzije ili unutar 24 sata nakon infuzije - to su takozvane reakcije povezane s infuzijom
Dyspepsia, Gingival 
artralgija, mialgija
The appropriate amount of solution should be withdrawn from the vial and added to an infusion bag containing 250 mL of sodium chloride 4.5 mg/mL (0.45%) solution for infusion or sodium chloride 9 mg/mL (0.9%) solution for infusion. 
Odgovarajuću količinu otopine treba izvući iz bočice i dodati u infuzijsku vrećicu koja sadrži 250 ml otopine natrijeva klorida za infuziju od 4,5 mg/ml (0,45%) ili otopine natrijeva klorida za infuziju od
No reproductive and developmental toxicology studies have been conducted with trastuzumab emtansine. 
Nisu provedena ispitivanja reproduktivne i razvojne toksičnosti trastuzumab emtanzina.
Uncommon: · Another abnormality that can be caused by Kadcyla is a condition known as nodular regenerative hyperplasia of the liver. 
• Još jedan poremećaj koji Kadcyla može izazvati je bolest koja se naziva nodularnom regenerativnom hiperplazijom jetre.
No accumulation of trastuzumab emtansine was observed after repeated dosing of intravenous infusion every 3 weeks. 
Nakon ponovljenih doza primijenjenih intravenskom infuzijom svaka 3 tjedna nije primijećena kumulacija trastuzumab emtanzina.
(> 3.0 to ≤ 5´ ULN on day of scheduled treatment) 
(> 3,0 do ≤ 5 × GGN na dan kada je predviđena primjena terapije)
Table 2 Dose Modification Guidelines Dose Modifications for Patients with EBC Adverse reaction Severity 
Tablica 2 Smjernice za prilagodbu doze Prilagodbe doze u bolesnika s ranim rakom dojke
· Trastuzumab emtansine, like trastuzumab, binds to domain IV of the HER2 extracellular domain 
• Kao i trastuzumab, trastuzumab emtanzin se veže za domenu IV izvanstanične domene receptora HER2 (ECD), ali i za receptore
Table 4 Laboratory abnormalities observed in patients treated with trastuzumab emtansine in study TDM4370g/BO21977/EMILIA 
Tablica 4 Poremećaji laboratorijskih vrijednosti primijećeni u bolesnika liječenih trastuzumab emtanzinom u ispitivanju TDM4370g/BO21977/EMILIA
Prior to enrolment, breast tumour samples were required to be centrally confirmed for HER2-positive status defined as a score of 3 + by IHC or gene amplification by ISH. 
Prije uključivanja u ispitivanje, trebalo je u centralnom laboratoriju potvrditi HER2-pozitivan status uzoraka raka dojke, koji se definirao kao imunohistokemijski rezultat 3+ ili amplifikacija gena utvrđena in situ hibridizacijom.
A clinically meaningful and statistically significant improvement in IDFS was observed in patients who received trastuzumab emtansine compared with trastuzumab (HR = 0.50, 95% CI [0.39, 0.64], p <0.0001. 
U bolesnika koji su primali trastuzumab emtanzin opaženo je klinički važno i statistički značajno poboljšanje IDFS-a u usporedbi s bolesnicima koji su primali trastuzumab (HR = 0,50; 95% CI [0,39;
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. 
Medijan trajanja ukupnog preživljenja bio je 29,9 mjeseci u skupini liječenoj trastuzumab emtanzinom u usporedbi s 25,9 mjeseci u skupini koja je primala lapatinib i kapecitabin.
If symptoms do occur, cough shortness of breath at rest or when sleeping flat, chest pain and swollen ankles or arms, a sensation of rapid or irregular heartbeats may be observed. 
Ako se pojave simptomi, to mogu biti kašalj, nedostatak zraka u mirovanju ili pri spavanju na leđima, bolovi u prsima i oticanje gležnjeva ili ruku, osjećaj ubrzanog ili nepravilnog kucanja srca.
After reconstitution one vial of 5 mL solution contains 20 mg/mL of trastuzumab emtansine (see section 6.6). 
Nakon rekonstitucije jedna bočica s 5 ml otopine sadrži 20 mg/ml trastuzumab emtanzina (vidjeti dio 6.6).
You will be observed by a doctor or nurse while it is being given and for at least 30 minutes following the dose, in case you have any side effects. 
Zbog moguće pojave nuspojava, liječnik ili medicinska sestra nadzirat će Vas za vrijeme primjene doze te još najmanje 30 minuta nakon toga.
Trastuzumab emtansine was given intravenously at 3.6 mg/kg on Day 1 of a 21-day cycle. 
Trastuzumab emtanzin primjenjivao se intravenski u dozi od 3,6 mg/kg 1. dana 21-dnevnog ciklusa.
After reconstitution one vial of 8 mL solution contains 20 mg/mL of trastuzumab emtansine (see section 6.6). 
Nakon rekonstitucije jedna bočica s 8 ml otopine sadrži 20 mg/ml trastuzumab emtanzina (vidjeti dio 6.6).
The ADRs are listed below by MedDRA system organ class (SOC) and categories of frequency. 
Nuspojave lijeka u nastavku su navedene prema MedDRA klasifikaciji organskih sustava i kategorijama učestalosti.
MARKETING AUTHORISATION NUMBER(S) EU/1/13/885/001 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/885/001
Dedicated embryo-foetal development studies have not been conducted in animals with trastuzumab emtansine. 
Nisu provedena posebna istraživanja embriofetalnog razvoja kod primjene trastuzumab emtanzina u životinja.
It is not known whether trastuzumab emtansine is excreted in human milk. 
Nije poznato izlučuje li se trastuzumab emtanzin u majčino mlijeko.
· the most common adverse drug reactions (ADRs) (≥25%) with trastuzumab emtansine were nausea, fatigue, musculoskeletal pain, haemorrhage, headache, transaminases increased, thrombocytopenia, and peripheral neuropathy. 
• najčešće nuspojave (≥ 25%) trastuzumab emtanzina bile su mučnina, umor, bol u mišićno-koštanom sustavu, krvarenje, glavobolja, povišene vrijednosti transaminaza, trombocitopenija i periferna neuropatija.
Tell your doctor or nurse straight away if you notice any of the following serious side effects while you are given Kadcyla: 
Odmah obavijestite svog liječnika ili medicinsku sestru ako tijekom liječenja lijekom Kadcyla primijetite neku od sljedećih ozbiljnih nuspojava:
Kadcyla is used to treat breast cancer in adults when: · the cancer cells have many HER2 proteins on them - your doctor will test your cancer cells for this. 
• kada stanice raka na sebi imaju mnogo HER2 proteina - liječnik će to utvrditi pretragama stanica raka
Sodium chloride 4.5 mg/mL (0.45%) solution for infusion may be used without a polyethersulfone (PES) 0.20 or 0.22-μm in-line filter. 
Otopina natrijeva klorida za infuziju od 4,5 mg/ml (0,45%) može se koristiti bez polietersulfonskog (PES) ugrađenog filtra od 0,20 ili 0,22 μm.
Increased Aspartate Transaminase (AST) 
Povišene vrijednosti aspartat transaminaze
Estimates of 3 years IDFS rates were 88.3% vs. 77.0% in trastuzumab emtansine vs. trastuzumab arms, respectively. 
Procijenjene 3-godišnje stope IDFS-a iznosile su 88,3% u skupini koja je primala trastuzumab emtanzin te 77,0% u skupini koja je primala trastuzumab.
Contents of the pack and other information 
Kako čuvati lijek Kadcyla Sadržaj pakiranja i druge informacije
Cases of interstitial lung disease (ILD), including pneumonitis, some leading to acute respiratory distress syndrome or a fatal outcome, have been reported in clinical studies with trastuzumab emtansine (see section 4.8). 
U kliničkim ispitivanjima trastuzumab emtanzina prijavljeni su slučajevi intersticijske bolesti pluća, uključujući pneumonitis, od kojih su neki doveli do sindroma akutnog respiratornog distresa ili smrti (vidjeti dio 4.8).
STATEMENT OF ACTIVE SUBSTANCE(S) 
Trajanje objektivnog odgovora (mjeseci)
Hyperbilirubinemia TBILI 
Hiperbilirubinemija
Hepatotoxicity, predominantly in the form of asymptomatic increases in the concentrations of serum transaminases (Grade 1-4 transaminitis), has been observed during treatment with trastuzumab emtansine in clinical studies (see section 4.8). 
Tijekom liječenja trastuzumab emtanzinom u kliničkim ispitivanjima opažena je hepatotoksičnost, prvenstveno u obliku asimptomatskog povećanja koncentracija serumskih transaminaza (transaminitis stupnja 1-4) (vidjeti dio 4.8).
In human plasma, trastuzumab emtansine catabolites MCC-DM1, Lys-MCC-DM1, and DM1 were detected at low levels. 
U plazmi ljudi pronađene su male količine katabolita trastuzumab emtanzina MCC-DM1, Lys-MCC-DM1 i DM1.
Grade 3 (> 5 to ≤ 20´ the ULN) 
Stupanj 3 (> 5 do ≤ 20 × GGN)
No formal pharmacokinetic study has been conducted and no population PK data was collected in patients with severe hepatic impairment (Child-Pugh class C). 
U bolesnika s teškim oštećenjem jetrene funkcije (Child-Pugh stadij C) nisu provedena formalna farmakokinetička ispitivanja niti su prikupljeni populacijski farmakokinetički podaci.
You will be observed by a doctor or nurse while it is being given and for at least 90 minutes following the initial dose, in case you have any side effects. 
Zbog moguće pojave nuspojava, liječnik ili medicinska sestra nadzirat će Vas za vrijeme prve infuzije te još najmanje 90 minuta nakon toga.
Uncommon (may affect up to 1 in 100 people): · Inflammation of your lungs can cause breathing problems such as shortness of breath (either at rest or while performing any type of activity), coughing or coughing spells with a dry coughthese are signs of inflammation of your lung tissue. 
• upala pluća može uzrokovati probleme s disanjem poput nedostatka zraka (u mirovanju ili pri izvođenju bilo kakve vrste aktivnosti), kašlja ili napadaja suhog kašlja - to su znakovi upale plućnoga tkiva
It is recommended that treatment with trastuzumab emtansine be permanently discontinued in patients who are diagnosed with ILD or pneumonitis, except for radiation pneumonitis in the adjuvant setting, where trastuzumab emtansine should be permanently discontinued for ³ Grade 3 or for Grade 2 not responding to standard treatment. 
Preporučuje se trajno prekinuti liječenje trastuzumab emtanzinom u bolesnika u kojih se dijagnosticiraju intersticijska bolest pluća ili pneumonitis, uz izuzetak radijacijskog pneumonitisa kod adjuvantnog liječenja.
Trastuzumab emtansine is an antibody-drug conjugate that contains trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture, covalently linked to DM1, a microtubule inhibitor, via the stable thioether linker MCC (4-[N-maleimidomethyl] cyclohexane-1-carboxylate). 
Trastuzumab emtanzin je konjugat protutijela i lijeka koji sadrži trastuzumab, humanizirano IgG1 monoklonsko protutijelo proizvedeno u kulturi stanica sisavaca (jajnika kineskog hrčka) u suspenziji, kovalentno povezano s DM1, inhibitorom mikrotubula, preko stabilne tioeterske poveznice MCC (4
Haemorrhage Haemorrhagic events were reported in 34.8% of patients in MBC clinical trials with trastuzumab emtansine and the incidence of severe haemorrhagic events (Grade ≥3) occurred in 2.2%. 
U kliničkim ispitivanjima trastuzumab emtanzina kod metastatskog raka dojke slučajevi krvarenja prijavljeni su u 34,8% bolesnika, dok je incidencija slučajeva teškog krvarenja (stupnja ≥ 3) iznosila 2,2%.
If not used immediately, the reconstituted vials can be stored for up to 24 hours at 2°C to 8°C, provided it was reconstituted under controlled and validated aseptic conditions, and must be discarded thereafter. 
2°C do 8°C, pod uvjetom da se postupak rekonstitucije proveo u kontroliranim i validiranim aseptičkim uvjetima, a nakon tog razdoblja lijek se mora baciti.
The ADRs in 2,611 patients treated with trastuzumab emtansine are presented in Table 3. 
Nuspojave lijeka u 2611 bolesnika liječenih trastuzumab emtanzinom prikazane su u Tablici
Excipients: 
Česte:
MARKETING AUTHORISATION NUMBER(S) EU/1/13/885/002 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/885/002
Kadcyla 100 mg powder for concentrate for solution for infusion Kadcyla is provided in 15 mL (100 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 white plastic flip-off cap. 
Kadcyla se nalazi u staklenoj bočici (staklo tipa 1) od 15 ml (100 mg), zatvorenoj sivim gumenim čepom (butilna guma obložena slojem fluorosmole) i zabrtvljenoj aluminijskim prstenom s plastičnim „flip-off“ poklopcem bijele boje.
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. 
Bolesnici koji su prekinuli liječenje trastuzumab emtanzinom mogli su tijekom preostalog planiranog liječenja u sklopu ispitivanja od najviše 14 ciklusa terapije koja ciljano djeluje na HER2
Trastuzumab emtansine is an antibody-drug conjugate containing humanized anti-HER2 IgG1 antibody trastuzumab and DM1, a microtubule-inhibitory maytansinoid. 
Trastuzumab emtanzin je konjugat protutijela i lijeka koji sadrži trastuzumab, humanizirano IgG1 protutijelo za HER2, i DM1, maitanzinoid koji inhibira mikrotubule.
The dosing should be delayed, or treatment discontinued as necessary in cases of left ventricular dysfunction (see section 4.2). 
U slučajevima disfunkcije lijeve klijetke treba odgoditi primjenu doze ili po potrebi prekinuti liječenje (vidjeti dio 4.2).
Increased transaminases were reported in 32.4% of patients with EBC. 
Povišene vrijednosti transaminaza prijavljene su u 32,4% bolesnika s ranim rakom dojke.
· Tell your doctor before using Kadcyla if you are pregnant, think you may be pregnant or are planning to have a baby. 
• Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku prije nego uzmete lijek Kadcyla.
For dose modifications in the event of increased transaminases, see sections 4.2 and 4.4. 
Za prilagodbu doze u slučaju povišenih vrijednosti transaminaza vidjeti dijelove 4.2 i 4.4.
In the Phase I and Phase II studies, 6.4% (24/376) of patients tested positive for anti- trastuzumab emtansine antibodies. 
6,4% (24/376) bolesnika imalo je pozitivan nalaz testa na protutijela na trastuzumab emtanzin.
In the descriptive follow-up overall survival analysis, the hazard ratio was 0.75 (95% CI 0.64, 0.88). 
U deskriptivnoj naknadnoj analizi ukupnog preživljenja, omjer hazarda iznosio je 0,75 (95% CI:
How to store Kadcyla 
Kako čuvati lijek Kadcyla
Serious hepatobiliary disorders, including nodular regenerative hyperplasia (NRH) of the liver and some with a fatal outcome due to drug-induced liver injury have been observed in patients treated with trastuzumab emtansine. 
U bolesnika liječenih trastuzumab emtanzinom primijećeni su ozbiljni poremećaji jetre i žuči, uključujući nodularnu regenerativnu hiperplaziju (NRH) jetre, u nekim slučajevima sa smrtnim ishodom zbog oštećenja jetre izazvanog primjenom lijeka.
In patients 65 to 74 years old (n=113), based on IRC assessments, the hazard ratios for PFS and OS were 0.88 (95% CI: 0.53, 1.45) and 0.74 (95% CI: 0.37, 1.47), respectively. 
U bolesnika u dobi od 65 do 74 godine (n=113) omjer hazarda prema ocjeni neovisnog ocjenjivačkog povjerenstva iznosio je 0,88 za PFS (95% CI: 0,53; 1,45) i 0,74 za OS (95% CI: 0,37, 1,47).
Early Breast Cancer 
Rani rak dojke
The population PK analysis showed that creatinine clearance does not affect the PK of trastuzumab emtansine. 
Populacijska farmakokinetička analiza pokazala je da klirens kreatinina ne utječe na farmakokinetiku trastuzumab emtanzina.
Kadcyla is not recommended for anyone under the age of 18 years. 
Kadcyla se ne preporučuje za osobe mlađe od 18 godina, jer nema podataka o tome kako lijek djeluje u toj dobnoj skupini.
Kadcyla contains the active substance trastuzumab emtansine, which is made up of two parts that are linked together: · trastuzumab - a monoclonal antibody that binds selectively to an antigen (a target protein) called human epidermal growth factor receptor 2 (HER2). 
• trastuzumaba - monoklonskog protutijela koje se selektivno veže za antigen (ciljni protein) koji se zove receptor humanog epidermalnog faktora rasta 2 (HER2).
Hierarchical testing applied for IDFS and OS 2. 
Za IDFS i OS primijenjeno je hijerarhijsko testiranje.
INFORMATION IN BRAILLE Justification for not including Braille accepted 
15. UPUTE ZA UPORABU 16. PODACI NA BRAILLEOVOM PISMU Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma.
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. 
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)).
LVEF 45% to < 50% and decrease is < 10% points from baseline* 
LVEF od 45% do < 50% i smanjenje za ≥ 10 postotnih bodova od početne vrijednosti*
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. 
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.
Grade ≥ 2. 
PRILOG II.
For dose modifications in the event of hypersensitivity reactions, see sections 4.2 and 4.4. 
Za prilagodbu doze u slučaju reakcija preosjetljivosti vidjeti dijelove 4.2 i 4.4.
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. 
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).
· 160 mg trastuzumab emtansine vial: Using a sterile syringe, slowly inject 8 mL of sterile water for injection into the vial. 
• Bočica sa 160 mg trastuzumab emtanzina: Sterilnom štrcaljkom polako ubrizgajte 8 ml sterilne vode za injekcije u bočicu.
The primary endpoint was investigator assessed Progression-Free Survival (PFS). 
Primarni ishod bilo je preživljenje bez progresije bolesti (PFS) prema ocjeni ispitivača.
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 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.
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. 
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.
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. 
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).
In patients with EBC, the overall incidence was 32.3% and 10.3% for 
U bolesnika s ranim rakom dojke ukupna je incidencija periferne neuropatije iznosila 32,3%, dok je incidencija događaja stupnja ≥ 2 iznosila 10,3%.
Left ventricular dysfunction occurred in 3.0% of patients with EBC, with Grade 3 or 4 in 0.5% of patients. 
3,0% bolesnika s ranim rakom dojke, pri čemu su događaji stupnja 3 ili 4 prijavljeni u 0,5% bolesnika.
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. 
preoperativnoj ciljanoj HER2 terapiji (trastuzumab, trastuzumab plus dodatni lijek[ovi] s ciljanim djelovanjem na HER2) i patološkom statusu limfnih čvorova ocijenjenom nakon preoperativne terapije.
Breast tumor samples were required to show HER2 overexpression defined as 3+ IHC or ISH amplification ratio ≥ 2.0 determined at a central laboratory. 
koja se definirala kao imunohistokemijski nalaz 3+ ili omjer amplifikacije ≥ 2,0 utvrđen in situ hibridizacijom (ISH) u centralnom laboratoriju.
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. 
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).
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). 
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).
One vial of powder for concentrate for solution for infusion contains 160 mg of trastuzumab emtansine. 
Jedna bočica s praškom za koncentrat za otopinu za infuziju sadrži 160 mg trastuzumab emtanzina.
Increase in serum transaminases (Grade 1-4) has been observed during treatment with trastuzumab emtansine in clinical studies (see section 4.4). 
U kliničkim su ispitivanjima tijekom liječenja trastuzumab emtanzinom primijećene povišene vrijednosti transaminaza u serumu (stupnja 1-4) (vidjeti dio 4.4).
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. 
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).