FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: bolnikov z EBC; incidenca hudih krvavitev (≥ 3. stopnje) je bila 0,4 %, vključno z enim dogodkom 5. stopnje.
English: In the subgroup of patients with non-measurable disease (n=205), based on IRC assessments, the hazard ratios for PFS and OS were 0.91 (95% CI: 0.59, 1.42) and 0.96 (95% CI: 0.54, 1.68),
Slovenian: 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).
English: Injury, poisoning and procedural complications
Slovenian: Poškodbe, zastrupitve in zapleti postopkov z infundiranjem povezane reakcije pnevmonitis, povezan z obsevanjem
English: Neurotoxicity
Slovenian: Nevrotoksični učinki
English: 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.
Slovenian: 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,
English: Early Breast Cancer
Slovenian: Zgodnji rak dojk (EBC - early breast cancer)
English: 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.
Slovenian: večina belk (72 %) in 57 % jih je imelo bolezen s pozitivnimi estrogenskimi in/ali progesteronskimi receptorji.
English: Infections and infestations Urinary tract infection
Slovenian: Infekcijske in parazitske bolezni okužba sečil
English: Do not administer trastuzumab emtansine until total bilirubin recovers to Grade ≤ 1, and then treat at the same dose level.
Slovenian: Trastuzumaba emtanzina ne uporabite, dokler se skupni bilirubin ne vrne na ≤ 1. stopnjo, nato nadaljujte zdravljenje z enakim odmerkom.
English: In the subgroup of patients with hormone receptor-negative disease (n=426), the hazard ratios for PFS and OS were 0.56 (95% CI: 0.44, 0.72) and 0.75 (95% CI: 0.54, 1.03), respectively.
Slovenian: 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).
English: Sodium content in excipients
Slovenian: OVOJNINAH NALEPKA NA VIALI
English: Trastuzumab, a component of trastuzumab emtansine, can cause foetal harm or death when administered to a pregnant woman.
Slovenian: Pri nosečnici uporabljeni trastuzumab, ki je sestavina trastuzumaba emtanzina, lahko škoduje plodu ali povzroči njegovo smrt.
English: Trastuzumab emtansine (N=740) All Grade % Grade 3 (%) Grade 4 (%)
Slovenian: Trastuzumab emtanzin (n = 740) Vse stopnje
English: · Kadcyla 160mg: using a sterile syringe, slowly inject 8 mL of sterile water for injection into the
Slovenian: · Kadcyla 160 mg: s sterilno injekcijsko brizgo počasi injicirajte 8 ml sterilne vode za injekcije v 160-mg vialo trastuzumaba emtanzina.
English: Cases of nodular regenerative hyperplasia (NRH) of the liver have been identified from liver biopsies in patients treated with trastuzumab emtansine.
Slovenian: Z biopsijo jeter so pri bolnikih, zdravljenih s trastuzumabom emtanzinom, ugotovili primere nodularne regenerativne hiperplazije jeter.
English: 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.
Slovenian: 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.
English: Diarrhoea, Vomiting, Nausea,
Slovenian: Bolezni prebavil stomatitis, driska, bruhanje, navzea, zaprtost, suhost ust,
English: All but 5 patients were women; 3 men were included in the trastuzumab arm and 2 in the trastuzumab emtansine arm. 22.5 percent of patients were enrolled in North America, 54.2% in Europe and 23.3% throughout the rest of the world.
Slovenian: 22,5 odstotka bolnikov je bilo vključenih v Severni Ameriki, 54,2 % v
English: For dose modifications in the event of hypersensitivity reactions, see sections 4.2 and 4.4.
Slovenian: Za prilagoditev odmerka pri preobčutljivostnih reakcijah glejte poglavji 4.2 in 4.4.
English: You should not be given Kadcyla if the above applies to you.
Slovenian: Če kaj od navedenega velja za vas, ne smete dobiti zdravila Kadcyla.
English: 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.
Slovenian: Bolniki, ki so prenehali zdravljenje s trastuzumabom emtanzinom, so lahko dokončali predvidenih 14 ciklov proti
English: Constipation, Dry mouth, Abdominal pain bleeding
Slovenian: bolečine v trebuhu dispepsija, krvavitev iz dlesni
English: In the subgroup of patients with hormone receptor-positive disease (n=545), the hazard ratios for PFS and OS were 0.72 (95% CI: 0.58, 0.91) and 0.62 (95% CI: 0.46, 0.85), respectively.
Slovenian: 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).
English: The primary endpoint was investigator assessed Progression-Free Survival (PFS).
Slovenian: Primarni končni cilj je bilo preživetje brez napredovanja bolezni (PFS) po oceni raziskovalca.
English: · 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
Slovenian: · zvišana telesna temperatura · glavobol · utrujenost · šibkost
English: The reconstituted Kadcyla solution should be diluted in polyvinyl chloride (PVC) or latex-free PVC-free polyolefin infusion bags.
Slovenian: (PVC) ali brezlateksnega brez-PVC poliolefina.
English: 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.
Slovenian: 4.4 Posebna opozorila in previdnostni ukrepi Z namenom izboljšanja sledljivosti bioloških zdravil je treba jasno zabeležiti ime in številko serije uporabljenega zdravila.
English: Serious, anaphylactic reactions have been observed in clinical studies with trastuzumab emtansine.
Slovenian: V kliničnih študijah s trastuzumabom emtanzinom so zabeležili resne anafilaktične reakcije.
English: Musculoskeletal pain, Arthralgia, Myalgia
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva mišično-skeletne bolečine, artralgija,
English: Kadcyla 100 mg powder for concentrate for solution for infusion One vial of powder for concentrate for solution for infusion contains 100 mg of trastuzumab emtansine.
Slovenian: Kadcyla 100 mg prašek za koncentrat za raztopino za infundiranje Ena viala praška za koncentrat za raztopino za infundiranje vsebuje 100 mg trastuzumaba emtanzina.
English: Infusion-related reactions were reported in 4.0% of patients in MBC clinical studies with trastuzumab emtansine, with six Grade 3 and no Grade 4 events reported.
Slovenian: infundiranjem povezane reakcije so opazili pri 4,0 % bolnikov z MBC v kliničnih študijah s trastuzumabom emtanzinom.
English: The median PFS and OS for the trastuzumab emtansine group were
Slovenian: V kliničnih študijah EBC s trastuzumabom emtanzinom so pri
English: Kadcyla 160 mg powder for concentrate for solution for infusion One vial of powder for concentrate for solution for infusion contains 160 mg of trastuzumab emtansine.
Slovenian: Kadcyla 160 mg prašek za koncentrat za raztopino za infundiranje Ena viala praška za koncentrat za raztopino za infundiranje vsebuje 160 mg trastuzumaba emtanzina.
English: Kadcyla100 mg powder for concentrate for solution for infusion Kadcyla 160 mg powder for concentrate for solution for infusion trastuzumab emtansine
Slovenian: Kadcyla 100 mg prašek za koncentrat za raztopino za infundiranje Kadcyla 160 mg prašek za koncentrat za raztopino za infundiranje
English: Do not administer trastuzumab emtansine until total bilirubin recovers to Grade ≤ 1 and then reduce one dose level.
Slovenian: Trastuzumaba emtanzina ne uporabite, dokler se skupni bilirubin ne vrne na ≤ 1. stopnjo, nato zmanjšajte odmerek za eno stopnjo.
English: Nervous system disorders Neuropathy peripheral, Headache
Slovenian: Bolezni živčevja periferna nevropatija, glavobol omotica, spremenjen okus, okvara spomina
English: · 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.
Slovenian: ● MCC je vezalec, zasnovan tako, da omeji sistemsko sproščanje in poveča ciljno oddajanje
English: 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.
Slovenian: Nodularna regenerativna hiperplazija jeter je redka bolezen, za katero je značilna obsežna benigna preobrazba jetrnega parenhima v majhne regenerativne nodule.
English: There is no known antidote for trastuzumab emtansine overdose.
Slovenian: 4.9 Preveliko odmerjanje Za preveliko odmerjanje trastuzumaba emtanzina ni znanega antidota.
English: 10.8 months and not reached, respectively, compared with 5.7 months and 27.9 months, respectively, for the lapatinib plus capecitabine group.
Slovenian: 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.
English: Trastuzumab emtansine should be discontinued in case of life-threatening infusion reactions.
Slovenian: Pri življenje ogrožujočih infuzijskih reakcijah je treba trastuzumab emtanzin prenehati uporabljati.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Kadcyla 160 mg powder for concentrate for solution for infusion trastuzumab emtansine
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Kadcyla 160 mg prašek za koncentrat za raztopino za infundiranje trastuzumab emtanzin intravenska uporaba
English: Standard cardiac function testing (echocardiogram or multigated acquisition (MUGA) scanning) should be performed prior to initiation of treatment and also at regular intervals (e.g. every three months) during treatment.
Slovenian: 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]).
English: Reactions secondary to extravasation have been observed in clinical studies with trastuzumab emtansine.
Slovenian: V kliničnih študijah s trastuzumabom emtanzinom so opažali reakcije zaradi ekstravazacije.
English: 2,% [95% CI] Disease-Free Survival (DFS)3 Number (%) of patients with event HR [95% CI] p-value (Log-Rank test, unstratified) 3 year event-free rate2,% [95% CI] Distant recurrence-free interval (DRFI) Number (%) of patients with event HR [95% CI] p-value (Log-Rank test, unstratified) 3 year event-free rate
Slovenian: 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
English: Do not administer trastuzumab emtansine until AST recovers to Grade £ 1, and then treat at the same dose level
Slovenian: Trastuzumaba emtanzina ne uporabite, dokler se AST ne vrne na ≤ 1. stopnjo, nato nadaljujte zdravljenje z enakim odmerkom.
English: For dose modifications for thrombocytopenia, see sections 4.2 and 4.4.
Slovenian: Za prilagoditve odmerka pri pojavu trombocitopenije glejte poglavji 4.2 in 4.4.
English: The population PK analysis showed that age did not affect the PK of trastuzumab emtansine.
Slovenian: Populacijska farmakokinetična analiza je pokazala, da starost ne vpliva na farmakokinetiko trastuzumaba emtanzina.
English: Reconstituted solution should be inspected visually for particulate matter and discolouration prior to administration.
Slovenian: Pripravljeno raztopino je treba pred uporabo vizualno pregledati, da ne vsebuje delcev in nima spremenjene barve.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Kadcyla 100 mg powder for concentrate for solution for infusion trastuzumab emtansine
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Kadcyla 100 mg prašek za koncentrat za raztopino za infundiranje trastuzumab emtanzin intravenska uporaba
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja izpuščaj, srbenje,
English: 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.
Slovenian: anevgeničen ali klastogen ob izpostavljenostih, primerljivih povprečni največji koncentraciji DM1,
English: Do not administer trastuzumab emtansine until total bilirubin recovers to ≤ 1.0× ULN, and then reduce one dose level
Slovenian: Trastuzumaba emtanzina ne uporabite, dokler se celokupni bilirubin ne vrne na ≤ 1,0´
English: LVEF 40% to ≤ 45% and decrease is < 10% points from baseline
Slovenian: LVEF 40 % do ≤ 45 % in zmanjšanje za < 10 % od izhodišča
English: (see section 4.2).
Slovenian: 1. do 4. stopnje) (glejte poglavje 4.8).
English: Thrombocytopenia
Slovenian: Serumske transaminaze
English: 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).
Slovenian: Med zdravljenjem s trastuzumabom emtanzinom so v kliničnih študijah opažali hepatotoksičnost, predvsem v obliki asimptomatskega zvečanja koncentracije serumskih transaminaz (transaminitis
English: The recommended dose of trastuzumab emtansine is 3.6 mg/kg bodyweight administered as an intravenous infusion every 3 weeks (21-day cycle).
Slovenian: Priporočeni odmerek trastuzumaba emtanzina je 3,6 mg/kg telesne mase v intravenski infuziji na
English: Cases of haemorrhagic events, including central nervous system, respiratory and gastrointestinal haemorrhage, have been reported with trastuzumab emtansine treatment.
Slovenian: Pri zdravljenju s trastuzumabom emtanzinom so poročali o primerih krvavitev, vključno s krvavitvami v osrednje živčevje, dihalih in prebavilih.
English: The population PK analysis showed that race did not appear to influence the PK of trastuzumab emtansine.
Slovenian: Populacijska farmakokinetična analiza je pokazala, da rasa po vsem sodeč ne vpliva na farmakokinetiko trastuzumaba emtanzina.
English: Primary endpoints IRC-assessed progression-free survival (PFS) Number (%) of patients with event Median duration of PFS (months) Hazard ratio (stratified*) 95% CI for Hazard ratio p-value (Log-rank test, stratified*) Overall Survival (OS)** Number (%) of patients who died Median duration of survival (months) Hazard ratio (stratified*) 95% CI for Hazard ratio p-value (Log-rank test*) Key secondary endpoints Investigator-assessed PFS Number (%) of patients with event Median duration of PFS (months) Hazard ratio (95% CI) p-value (Log-rank test*) Objective response rate (ORR) Patients with measurable disease Number of patients with OR (%) Difference (95% CI) p-value (Mantel-Haenszel chi-squared test*) Duration of objective response (months) Number of patients with OR Median 95% CI OS: overall survival; PFS: progression-free survival; ORR: objective response rate; OR: objective response; IRC: independent review committee; HR: hazard ratios; CI: confidence interval * Stratified by: world region (United States, Western Europe, other), number of prior chemotherapeutic regimens for locally advanced or metastatic disease (0-1 vs. > 1), and visceral vs. non-visceral disease.
Slovenian: PFS po oceni raziskovalca število (%) bolnikov z dogodkom 335 (67,5 %) mediano PFS (meseci) razmerje ogroženosti (95-% interval zaupanja) vrednost p (test log-rang*) Delež objektivnega odgovora na zdravljenje (ORR) bolniki z merljivo boleznijo število bolnikov z objektivnim odgovorom na zdravljenje (%) razlika (95-% interval zaupanja) vrednost p (Mantel-Haenszelov test hikvadrat*) Trajanje objektivnega odgovora (meseci) število bolnikov z objektivnim odgovorom mediana 95-% intervala zaupanja
English: (flushing, chills, pyrexia, dyspnoea, hypotension, wheezing, bronchospasm, and tachycardia) should be advised not to drive and use machines until symptoms abate.
Slovenian: Bolnikom je treba naročiti, naj ne vozijo ali upravljajo strojev, če se jim pojavijo z infundiranjem povezane reakcije (zardevanje, mrzlica, pireksija, dispneja, hipotenzija, sopenje, bronhospazem in tahikardija), dokler simptomi ne minejo.
English: 6.6 Special precautions for disposal and other handling Appropriate aseptic technique should be used.
Slovenian: Uporabiti je treba ustrezen aseptični postopek in tudi ustrezne postopke za pripravo kemoterapevtikov.
English: Do not administer trastuzumab emtansine until platelet count recovers to £ Grade 1 (≥ 75,000/mm3), and then reduce one dose level.
Slovenian: Trastuzumaba emtanzina ne uporabite, dokler se število trombocitov ne vrne na £ 1. stopnjo (≥ 75.000/mm3), nato zmanjšajte odmerek za eno stopnjo.
English: Hypersensitivity was reported in 2.6% of patients in MBC clinical studies with trastuzumab emtansine, with one Grade 3 and one Grade 4 events reported.
Slovenian: Preobčutljivostne reakcije Preobčutljivost so opazili pri 2,6 % bolnikov z MBC v kliničnih študijah s trastuzumabom emtanzinom.
English: Peripheral neuropathy, mainly as Grade 1 and predominantly sensory, was reported in clinical trials of trastuzumab emtansine.
Slovenian: V kliničnih preskušanjih s trastuzumabom emtanzinom so poročali o periferni nevropatiji, ki je bila v glavnem 1. stopnje in pretežno senzorična.
English: Do not administer trastuzumab emtansine until platelet count recovers to £ Grade 1 (≥ 75,000/mm3), and then treat at the same dose level.
Slovenian: Trastuzumaba emtanzina ne uporabite, dokler se število trombocitov ne vrne na £ 1. stopnjo (≥ 75.000/mm3), nato zdravljenje nadaljujte z enakim odmerkom.
English: Mutagenicity
Slovenian: mialgija
English: PHARMACEUTICAL FORM Powder for concentrate for solution for infusion.
Slovenian: FARMACEVTSKA OBLIKA prašek za koncentrat za raztopino za infundiranje Bel do skoraj bel liofiliziran prašek.
English: · Developed disease recurrence during or within six months of completing adjuvant therapy.
Slovenian: Bolniki so pred tem: · prejemali predhodno zdravljenje za lokalno napredovalo ali razsejano bolezen ali · se jim je bolezen ponovila med adjuvantnim zdravljenjem ali v šestih mesecih po koncu adjuvantnega zdravljenja.
English: · Periodic Safety Update Reports
Slovenian: · Informacije za zdravstvene delavce
English: 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.
Slovenian: 0,45-% (4,5 mg/ml) raztopine natrijevega klorida za infundiranje ali 0,9-% (9 mg/ml) raztopine natrijevega klorida za infundiranje.
English: Peripheral neuropathy, mainly Grade 1 and predominantly sensory, has been reported in clinical studies with trastuzumab emtansine.
Slovenian: V kliničnih študijah s trastuzumabom emtanzinom so poročali o periferni nevropatiji, ki je bila v glavnem 1. stopnje in pretežno senzorična.
English: Do not administer trastuzumab emtansine until platelet count recovers to £ Grade 1 (≥ 75,000/mm3), and then reduce one dose level
Slovenian: Trastuzumaba emtanzina ne uporabite, dokler se število trombocitov ne vrne na £ 1. stopnjo (to je ≥ 75.000/mm3), nato zmanjšajte odmerek za eno stopnjo.
English: Determine the volume of the reconstituted solution required based on a dose of 3.6 mg trastuzumab emtansine/kg body weight:
Slovenian: Glede na odmerek 3,6 mg trastuzumaba emtanzina na kilogram telesne mase določite potrebno količino pripravljene raztopine:
English: · 160 mg trastuzumab emtansine vial: Using a sterile syringe, slowly inject 8 mL of sterile water for injection into the vial.
Slovenian: · 160-mg viala trastuzumaba emtanzina: S sterilno injekcijsko brizgo počasi injicirajte v vialo
English: Blood and lymphatic system disorders
Slovenian: Žilne bolezni krvavitev hipertenzija
English: Talk to your doctor or nurse before you are given Kadcyla if: · you have ever had a serious infusion-related reaction from using trastuzumab characterised by symptoms such as flushing, chills, fever, shortness of breath, difficulty breathing, rapid heartbeat or a drop in blood pressure.
Slovenian: za katero so značilni simptomi, kot so rdečica, mrazenje, povišana telesna temperatura, kratka sapa, težave pri dihanju, hiter srčni utrip ali padec krvnega tlaka,
English: Other side effects include
Slovenian: Drugi neželeni učinki Zelo pogosti:
English: Do not administer trastuzumab emtansine.
Slovenian: Prenehajte uporabljati trastuzumab emtanzin.
English: Excipients:
Slovenian: PC:
English: NAME OF THE MEDICINAL PRODUCT Kadcyla 160 mg powder for concentrate for solution for infusion trastuzumab emtansine
Slovenian: Kadcyla 160 mg prašek za koncentrat za raztopino za infundiranje trastuzumab emtanzin
English: Cardiac disorders
Slovenian: Simptomatsko kongestivno srčno popuščanje
English: You should tell your doctor immediately if you notice any of the above symptoms.
Slovenian: Če opazite katerega od navedenih neželenih učinkov, morate to nemudoma povedati zdravniku.
English: NAME OF THE MEDICINAL PRODUCT Kadcyla 100 mg powder for concentrate for solution for infusion trastuzumab emtansine
Slovenian: Kadcyla 100 mg prašek za koncentrat za raztopino za infundiranje trastuzumab emtanzin
English: The use of 0.20 or 0.22 micron in-line polyethersulfone (PES) filter is required for the infusion when the concentrate for infusion is diluted with sodium chloride 9 mg/mL (0.9%) solution for infusion.
Slovenian: Če je koncentrat za infundiranje razredčen z 0,9-% (9 mg/ml) raztopino natrijevega klorida za infundiranje, je treba za infundiranje uporabiti 0,20- ali 0,22-mikronski polietersulfonski (PES) filter v liniji.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial of powder for concentrate for solution for infusion contains 100 mg of trastuzumab emtansine.
Slovenian: Ena viala praška za koncentrat za raztopino za infundiranje vsebuje 100 mg trastuzumaba emtanzina.
English: Instructions for reconstitution · 100 mg trastuzumab emtansine vial: Using a sterile syringe, slowly inject 5 mL of sterile water for injection into the vial.
Slovenian: · 100-mg viala trastuzumaba emtanzina: S sterilno injekcijsko brizgo počasi injicirajte v vialo
English: Posology
Slovenian: Izrazitost
English: Do not substitute or combine trastuzumab emtansine with or for trastuzumab 4.
Slovenian: Ne zamenjujte trastuzumaba emtanzina s trastuzumabom, obeh zdravil ne uporabljajte sočasno.