FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Z namenom preprečevanja napak pri uporabi zdravila je pomembno pregledati Povzetek glavnih značilnosti zdravila ter preveriti škatlo zdravila in nalepko na viali, da se zagotovi, da je pripravljeno in aplicirano zdravilo Kadcyla (trastuzumab emtanzin) in ne trastuzumab.
English: Increased Alanine Transaminase (ALT)
Slovenian: Zvišanje alanintransaminaze (ALT)
English: 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.
Slovenian: Pri bolnikih, ki so prejemali trastuzumab emtanzin, so v primerjavi s prejemniki trastuzumaba opažali klinično pomembno in statistično značilno izboljšanje IDFS (HR = 0,50, 95-% IZ [0,39; 0,64],
English: Symptomatic CHF, Grade 3-4 LVSD or Grade 3-4 heart failure, or
Slovenian: Srčno popuščanje Simptomatsko kongestivno srčno popuščanje, 3.-4. stopnja LVSD ali 3.-4. stopnja srčnega popuščanja ali 2. stopnja srčnega popuščanja, ki ga spremlja LVEF < 45 %
English: If LVEF < 45% is confirmed, discontinue trastuzumab emtansine.
Slovenian: Če je potrjen LVEF < 45 %, prenehajte uporabljati trastuzumab emtanzin.
English: 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.
Slovenian: Izgled zdravila Kadcyla in vsebina pakiranja · Zdravilo Kadcyla je bel ali skoraj bel liofiliziran prašek za koncentrat za raztopino za infundiranje v steklenih vialah.
English: 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).
Slovenian: Trombocitopenija Trombocitopenija ali zmanjšano število trombocitov je bila med uporabo trastuzumaba emtanzina opisana pogosto in je bila najpogostejši neželeni učinek, ki je povzročil prenehanje zdravljenja, zmanjšanje odmerka ali prekinitev odmerjanja (glejte poglavje 4.8).
English: If a strong CYP3A4 inhibitor is coadministered and trastuzumab emtansine treatment cannot be delayed, patients should be closely monitored for adverse reactions.
Slovenian: Če zdravljenja s trastuzumabom emtanzinom med sočasno uporabo močnega zaviralca CYP3A4 ni mogoče odložiti, je treba bolnike natančno kontrolirati zaradi možnih neželenih učinkov.
English: Rash, Pruritus, Alopecia, Nail disorder, Palmarplantar erythrodysaesthesia syndrome, Urticaria
Slovenian: alopecija, bolezni nohtov, sindrom palmarno-plantarne eritrodizestezije, urtikarija
English: Patients should receive treatment until disease progression or unmanageable toxicity.
Slovenian: Razsejani rak dojk (MBC) Bolniki naj prejemajo zdravljenje do napredovanja bolezni ali neobvladljive toksičnosti.
English: 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.
Slovenian: V klinične študije niso bili vključeni bolniki z anamnezo kongestivnega srčnega popuščanja, resno motnjo srčnega ritma, ki je zahtevala zdravljenje, anamnezo miokardnega infarkta ali nestabilne angine pektoris v 6 mesecih pred randomizacijo ali s trenutno dispnejo v mirovanju zaradi napredovale maligne bolezni.
English: · 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
Slovenian: ● kontrolna skupina (lapatinib in kapecitabin): lapatinib 1250 mg/dan peroralno enkrat na dan med 21-dnevnim ciklom ter kapecitabin 1000 mg/m2 peroralno dvakrat na dan od 1. do 14. dne
English: A total of 991 patients were randomised to trastuzumab emtansine or lapatinib plus capecitabine as follows:
Slovenian: V celoti je bilo 991 bolnikov randomiziranih v dve skupini - skupino s trastuzumabom emtanzinom in skupino s kombinacijo lapatiniba in kapecitabina:
English: · If you get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: · Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: What Kadcyla is used for
Slovenian: Za kaj uporabljamo zdravilo Kadcyla
English: Continue treatment with trastuzumab emtansine.
Slovenian: Nadaljujte zdravljenje s trastuzumabom emtanzinom.
English: Talk to your doctor before stopping your contraception.
Slovenian: Pred prenehanjem uporabe kontracepcije se posvetujte z zdravnikom.
English: Trastuzumab emtansine dose should not be re-escalated after a dose reduction is made.
Slovenian: Odmerka trastuzumaba emtanzina se po zmanjšanju ne sme več povečati.
English: The safety and efficacy in children and adolescents below 18 years of age have not been established as there is no relevant use in the paediatric population for the indication of breast cancer .
Slovenian: Varnost in učinkovitost pri otrocih in mladostnikih do 18. leta starosti nista ugotovljeni.
English: 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.
Slovenian: Študije presnove in vitro v človeških jetrnih mikrosomih kažejo, da se DM1, malomolekulska sestavina trastuzumaba emtanzina, presnovi v glavnem s CYP3A4 in v manjši meri s CYP3A5.
English: Increase in serum transaminases (Grade 1-4) has been observed during treatment with trastuzumab emtansine in clinical studies (see section 4.4).
Slovenian: Med zdravljenjem s trastuzumabom emtanzinom so v kliničnih študijah opažali zvišanje serumskih transaminaz (1. do 4. stopnje) (glejte poglavje 4.4).
English: 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.
Slovenian: Zdravilo Kadcyla je kot monoterapija indicirano za adjuvantno zdravljenje odraslih bolnikov s HER2-pozitivnim zgodnjim rakom dojk, ki imajo rezidualno invazivno bolezen v dojki in/ali bezgavkah, po neoadjuvantnem zdravljenju na osnovi taksanov in proti HER2 usmerjene terapije.
English: Cases of overdose have been reported with trastuzumab emtansine treatment, most associated with thrombocytopenia, and there was one death.
Slovenian: Opisani so primeri prevelikega odmerjanja med zdravljenjem s trastuzumabom emtanzinom; večino je spremljala trombocitopenija in zabeležili so en smrtni primer.
English: Grade 2 (> 2.5 to ≤ 5´ the ULN)
Slovenian: 2. stopnja (> 2,5 do ≤ 5´ ZNM)
English: · the cancer has spread to areas near the breast or to other parts of your body (metastasized) · the cancer has not spread to other parts of the body and treatment is going to be given after surgery
Slovenian: · če se rak ni razširil v druge dele telesa in bo zdravljenje potekalo po operaciji (zdravljenje po operaciji se imenuje adjuvantno zdravljenje).
English: Principal toxicities included liver (liver enzyme elevations) at ³ 20 mg/kg and ³ 10 mg/kg, bone marrow (reduced platelet and white blood cell count)/hematologic at ³ 20 mg/kg and ³ 10 mg/kg, and lymphoid organs at ³ 20 mg/kg and ³ 3 mg/kg, in rat and monkey, respectively.
Slovenian: (zvišanje jetrnih encimov) ob uporabi ³ 20 mg/kg oz. ³ 10 mg/kg, kostni mozeg (zmanjšanje števila trombocitov in belih krvnih celic)/hematološke vrednosti ob uporabi ³ 20 mg/kg oz. ³ 10 mg/kg ter limfatične organe ob uporabi ³ 20 mg/kg oz. ³ 3 mg/kg (vse prve vrednosti veljajo za podgane in vse druge za opice).
English: · Store in a refrigerator at (2°C - 8°C).
Slovenian: · Shranjujte v hladilniku (pri temperaturi 2-8 °C).
English: Dose Modifications for Patients with MBC Adverse reaction Severity
Slovenian: Prilagoditve odmerka pri bolnikih z MBC
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before you are given Kadcyla.
Slovenian: Če kaj od naštetega velja za vas (ali če niste prepričani), se posvetujte z zdravnikom ali farmacevtom,
English: This HCP educational pack shall consist of the following:
Slovenian: Informacije za zdravstvene delavce morajo vsebovati naslednje ključne poudarke:
English: · the most common serious ADRs (> 0.5% of patients) were haemorrhage, pyrexia, thrombocytopenia, dyspnoea, abdominal pain, musculoskeletal pain, and vomiting.
Slovenian: · najpogostejši resni neželeni učinki (> 0,5 % bolnikov): krvavitev, pireksija, trombocitopenija, dispneja, bolečine v trebuhu, mišično-skeletne bolečine in bruhanje.
English: No formal PK study has been conducted in patients with renal impairment.
Slovenian: Formalnih farmakokinetičnih študij pri bolnikih z ledvično okvaro niso izvedli.
English: What Kadcyla is and what it is used for
Slovenian: Kaj je zdravilo Kadcyla in za kaj ga uporabljamo Kaj je zdravilo Kadcyla
English: · Tingling, pain, numbness, itching, crawling sensation, pins and needles in your hands and feet.
Slovenian: · Mravljinčenje, bolečine, omrtvičenost, srbenje, občutek gomazenja ali zbadanja v dlaneh in stopalih.
English: 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%.
Slovenian: O krvavitvah so poročali pri 34,8 % bolnikov v kliničnih preskušanjih MBC s trastuzumabom emtanzinom; incidenca hudih krvavitev (≥ 3. stopnje) je bila 2,2 %.
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.
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): · Zdravilo Kadcyla lahko povzroči vnetje ali okvaro jetrnih celic.
English: Succinic acid, sodium hydroxide, sucrose, polysorbate 20.
Slovenian: SEZNAM POMOŽNIH SNOVI Pomožne snovi: sukcinska kislina, natrijev hidroksid, saharoza, polisorbat 20.
English: Uncommon: · Another abnormality that can be caused by Kadcyla is a condition known as nodular regenerative hyperplasia of the liver.
Slovenian: Občasni: · Zdravilo Kadcyla lahko povzroči tudi stanje, imenovano nodularna regenerativna hiperplazija jeter.
English: Hepatic
Slovenian: Hepatotoksičnost
English: The colour of the reconstituted solution should be colourless to pale brown.
Slovenian: Pripravljena raztopina mora biti brezbarvna do bledo rjave barve.
English: 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.
Slovenian: Poleg tega so v predkliničnih študijah ugotovili razvojno toksičnost majtanzina, zaradi česar lahko predvidevamo, da bo DM1, citotoksična majtanzinoidna sestavina trastuzumaba emtanzina, ki zavira mikrotubule, podobno teratogen in potencialno embriotoksičen.
English: Tell your doctor or nurse straight away if you notice any of the following serious side effects while you are given Kadcyla:
Slovenian: Zdravniku ali medicinski sestri morate takoj povedati, če med prejemanjem zdravila Kadcyla opazite katerega od naslednjih resnih neželenih učinkov:
English: Very common: · decreased red blood cells (shown in a blood test) · being sick (vomiting) · diarrhoea · dry mouth
Slovenian: · zmanjšanje števila rdečih krvnih celic (pokaže se na preiskavi krvi)
English: Trastuzumab emtansine was given intravenously at 3.6 mg/kg on Day 1 of a 21-day cycle.
Slovenian: Trastuzumab emtanzin je bil dan intravensko v odmerku 3,6 mg/kg 1. dan 21-dnevnega cikla.
English: Since many medicinal products are excreted in human milk and because of the potential for serious adverse reactions in breast-feeding infants, women should discontinue breast-feeding prior to initiating treatment with trastuzumab emtansine.
Slovenian: Zaradi možnosti za resne neželene učinke pri dojenih dojenčkih morajo ženske prenehati dojiti pred uvedbo zdravljenja s trastuzumabom emtanzinom.
English: · the most common adverse drug reactions (ADRs) (≥25%) with trastuzumab emtansine were nausea, fatigue, musculoskeletal pain, haemorrhage, headache, transaminases increased, thrombocytopenia, and peripheral neuropathy.
Slovenian: · najpogostejši neželeni učinki (≥ 25 %) s trastuzumabom emtanzinom: navzea, utrujenost, mišičnoskeletne bolečine, krvavitev, glavobol, zvišanje transaminaz, trombocitopenija in periferna nevropatija.
English: Primary Endpoint
Slovenian: Primarni končni cilj
English: LVEF 40% to ≤ 45% and decrease is ≥ 10%
Slovenian: LVEF 40 % do ≤ 45 % in zmanjšanje za ≥ 10 % od izhodišča
English: Trastuzumab emtansine is administered intravenously.
Slovenian: Trastuzumab emtanzin se daje intravensko.
English: The majority of the patients (76.9%) had received an anthracycline-containing neoadjuvant chemotherapy regimen.19.5% percent of patients received another HER2-targeted agent in addition to trastuzumab as a component of neoadjuvant therapy; 93.8% of these patients received pertuzumab.
Slovenian: 19,5 % bolnikov je poleg trastuzumaba kot sestavino neoadjuvantnega zdravljenja prejemala še eno proti HER2 usmerjeno zdravilo; 93,8 % teh bolnikov je prejelo pertuzumab.
English: However, based on results from general animal toxicity studies, adverse effects on fertility can be expected.
Slovenian: Poslabšanje plodnosti in teratogenost Študij plodnosti pri živalih za oceno učinka trastuzumaba emtanzina niso izvedli, vendar je na podlagi rezultatov splošnih študij toksičnosti na živalih mogoče pričakovati neželene učinke na plodnost.
English: If LVEF <40% is confirmed, discontinue trastuzumab emtansine
Slovenian: Če je potrjen LVEF < 40 %, prenehajte uporabljati trastuzumab emtanzin.
English: 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.
Slovenian: Če se simptomi pojavijo, lahko opazite kašelj, kratko sapo v mirovanju ali med spanjem z ravnim vzglavjem, bolečino v prsih in otekle gležnje ali roke, občutek hitrega ali nerednega bitja srca.
English: PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion 1 vial of 160 mg
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA prašek za koncentrat za raztopino za infundiranje 1 viala s 160 mg
English: 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.
Slovenian: · Zardevanje, napadi mrazenja, zvišana telesna temperatura, težave z dihanjem, nizek krvni tlak ali hitro bitje srca med infundiranjem zdravila ali do 24 ur po njem - to so tako imenovane z infundiranjem povezane reakcije.
English: A Phase II, single-arm, open-label study evaluated the effects of trastuzumab emtansine in patients with HER2-positive incurable, LABC or MBC.
Slovenian: To je bila odprta študija faze II z eno skupino, ki je ocenila učinke trastuzumaba emtanzina pri bolnikih s HER2-pozitivnim, neozdravljivim lokalno napredovalim ali razsejanim rakom dojk.
English: No adjustment to the starting dose is required for patients with mild or moderate hepatic impairment.
Slovenian: Bolnikom z blago ali zmerno jetrno okvaro začetnega odmerka ni treba prilagoditi.
English: Thrombocytopenia Grade 2-3 on day of scheduled treatment (25,000 to <
Slovenian: Trombocitopenija 2.-3. stopnja na dan načrtovanega zdravljenja
English: Biotransformation (trastuzumab emtansine and DM1) Trastuzumab emtansine is expected to undergo deconjugation and catabolism by means of proteolysis in cellular lysosomes.
Slovenian: Pričakovano je, da se trastuzumab emtanzin dekonjugira in katabolizira s proteolizo v celičnih lizosomih.
English: PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion 1 vial of 100 mg
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA prašek za koncentrat za raztopino za infundiranje 1 viala s 100 mg
English: 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.
Slovenian: Kadcyla 100 mg prašek za koncentrat za raztopino za infundiranje Zdravilo Kadcyla je na voljo v 15-ml (100 mg) vialah iz stekla tipa 1, ki imajo zamašek iz sive butilne gume, prekrit s fluorosmolnim laminatom, in so zapečatene z aluminijsko zaporo z belo plastično snemno zaporko.
English: In human plasma, trastuzumab emtansine catabolites MCC-DM1, Lys-MCC-DM1, and DM1 were detected at low levels.
Slovenian: V človeški plazmi so odkrili majhne koncentracije katabolitov trastuzumaba emtanzina MCC-DM1, Lys-MCC-DM1 in DM1.
English: If you miss a Kadcyla treatment
Slovenian: Če ste prenehali zdravljenje z zdravilom Kadcyla
English: Trastuzumab was given intravenously at 6 mg/kg on Day 1 of a 21-day cycle.
Slovenian: Trastuzumab je bil dan intravensko v odmerku 6 mg/kg 1. dan 21-dnevnega cikla.
English: · Allergic reactions can occur and most patients will have mild symptoms such as itching or tightness in the chest.
Slovenian: Večina bolnikov bo imela blage simptome, kot so srbenje ali stiskanje v prsih.
English: For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Slovenian: Za navodila o pripravi in redčenju zdravila pred dajanjem glejte poglavje 6.6. 4.3 Kontraindikacije
English: A Phase III, randomised, multicentre, international, open-label clinical study was conducted in patients with HER2-positive unresectable locally advanced breast cancer (LABC) or MBC who had received prior taxane and trastuzumab-based therapy, including patients who received prior therapy with trastuzumab and a taxane in the adjuvant setting and who relapsed during or within six months of completing adjuvant therapy.
Slovenian: Izvedli so jo pri bolnikih s HER2-pozitivnim, neoperabilnim, lokalno napredovalim ali razsejanim rakom dojk, ki so predhodno prejemali zdravljenje na osnovi taksana in trastuzumaba, vključno z bolniki, ki so trastuzumab in taksan predhodno dobivali med adjuvantnim zdravljenjem in se jim je bolezen ponovila med njim ali v 6 mesecih po njem.
English: In patients with EBC, the overall incidence was 32.3% and 10.3% for
Slovenian: Pri bolnikih z EBC je bila skupna incidenca perifernih nevropatij 32,3 % in perifernih nevropatij ³ 2. stopnje 10,3 %.
English: Management of symptomatic adverse reactions may require temporary interruption, dose reduction, or treatment discontinuation of trastuzumab emtansine as per guidelines provided in text and Tables 1 and 2 .
Slovenian: zmanjšanje odmerka ali prenehanje zdravljenja s trastuzumabom emtanzinom v skladu s smernicami v besedilu in preglednicah 1 in 2.
English: The majority of ADRs reported were of Grade 1 or 2 severity.
Slovenian: Večina opisanih neželenih učinkov je bila 1. ali 2. stopnje.
English: Your doctor will check your blood to test your liver function before and regularly during treatment.
Slovenian: Zdravnik vam bo pred in redno med zdravljenjem kontroliral kri, da bo preveril delovanje jeter.
English: You may experience tingling, pain, numbness, itching, crawling sensation, pins and needles in your hands and feet.
Slovenian: Pojavijo se lahko mravljinčenje, bolečine, omrtvičenost, srbenje, občutek gomazenja ali zbadanje v dlaneh in stopalih.
English: Succinic acid Sodium hydroxide Sucrose
Slovenian: Sukcinska kislina Natrijev hidroksid Saharoza Polisorbat 20
English: Grade 3 (> 3 to ≤ 10´ the ULN)
Slovenian: 3. stopnja (> 3 do ≤ 10´ ZNM)
English: Grade 4 at any time < 25,000/mm3
Slovenian: 4. stopnja kadar koli (< 25.000/mm3)
English: The dosing should be delayed, or treatment discontinued as necessary in cases of left ventricular dysfunction (see section 4.2).
Slovenian: V primerih disfunkcije levega prekata je treba odmerek preložiti ali zdravljenje prenehati, če je to potrebno (glejte poglavje 4.2).
English: Upon diagnosis of NRH, trastuzumab emtansine treatment must be permanently discontinued.
Slovenian: Pri diagnosticirani nodularni regenerativni hiperplaziji jeter je treba zdravljenje s trastuzumabom emtanzinom dokončno ukiniti.
English: After reconstitution one vial of 8 mL solution contains 20 mg/mL of trastuzumab emtansine (see section 6.6).
Slovenian: Po rekonstituciji vsebuje ena viala z 8 ml raztopine 20 mg/ml trastuzumaba emtanzina (glejte poglavje 6.6).
English: 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.
Slovenian: Pred vključitvijo bolnika v študijo je moral centralni laboratorij na vzorcih tumorja potrditi HER2-pozitivnost, ki je bila imunohistokemično opredeljena kot 3+ ali potrjena z amplifikacijo gena HER2 z metodo hibridizacije in situ.
English: Kadcyla, trastuzumab emtansine, is a HER2-targeted antibody-drug conjugate which contains the humanised anti-HER2 IgG1, trastuzumab, covalently linked to the microtubule inhibitor DM1 (a maytansine derivative) via the stable thioether linker MCC (4-[N-maleimidomethyl] cyclohexane-1-carboxylate).
Slovenian: Zdravilo Kadcyla, trastuzumab emtanzin, je proti HER2 usmerjeno konjugirano zdravilo, ki vsebuje humanizirano anti-HER2 IgG1 protitelo trastuzumab, kovalentno vezan na zaviralec mikrotubulov DM1 (majtanzinski derivat) s stabilnim tioetrskim vezalcem MCC (4-[N-maleimidometil] cikloheksan-1-karboksilat).
English: In the fatal case, the patient incorrectly received trastuzumab emtansine 6 mg/kg and died approximately 3 weeks following the overdose; a causal relationship to trastuzumab emtansine was not established.
Slovenian: V smrtnem primeru je bolnik nepravilno prejemal trastuzumab emtanzin 6 mg/kg in umrl približno 3
English: Do not use if the reconstituted solution contains visible particulates, or is cloudy or discoloured.
Slovenian: Če pripravljena raztopina vsebuje vidne delce, je motna ali spremenjene barve, je ne uporabite.
English: MBC patients with Grade ³ 3 and EBC patients with Grade ³ 2 peripheral neuropathy at baseline were excluded from clinical studies.
Slovenian: Bolniki z MBC, ki so izhodiščno imeli periferno nevropatijo ³ 3. stopnje, in bolniki z EBC, ki so izhodiščno imeli periferno nevropatijo ³ 2. stopnje,
English: You should tell your doctor immediately if you notice any unexpected bruising or bleeding.
Slovenian: Če opazite nepričakovane modrice ali krvavitve, morate to nemudoma povedati zdravniku.
English: After reconstitution one vial of 5 mL solution contains 20 mg/mL of trastuzumab emtansine (see section 6.6).
Slovenian: Po rekonstituciji vsebuje ena viala s 5 ml raztopine 20 mg/ml trastuzumaba emtanzina (glejte poglavje 6.6).
English: (> 3.0 to ≤ 5´ ULN on day of scheduled treatment)
Slovenian: 2. stopnja (> 3,0 do ≤ 5´ ZNM na dan načrtovanega zdravljenja)
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).
Slovenian: Če se pojavijo z infundiranjem povezani simptomi, je treba hitrost infundiranja trastuzumaba emtanzina upočasniti ali infundiranje prekiniti (glejte poglavji 4.4 in 4.8).