FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: Kadcyla 160 mg prašek za koncentrat za raztopino za infundiranje Zdravilo Kadcyla je na voljo v 20-ml (160 mg) vialah iz stekla tipa 1, ki imajo zamašek iz sive butilne gume, prekrit s fluorosmolnim laminatom, in so zapečatene z aluminijsko zaporo z vijoličasto plastično snemno zaporko.
English: What you need to know before you are given Kadcyla
Slovenian: Kaj morate vedeti, preden boste dobili zdravilo Kadcyla Zdravila Kadcyla ne smete dobiti
English: 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.
Slovenian: vključno z nodularno regenerativno hiperplazijo jeter in nekaterimi primeri smrti zaradi z zdravili povzročene poškodbe jeter.
English: Table 4 Laboratory abnormalities observed in patients treated with trastuzumab emtansine in study TDM4370g/BO21977/EMILIA
Slovenian: Preglednica 4: Laboratorijske nepravilnosti, zabeležene pri bolnikih, zdravljenih s trastuzumabom emtanzinom v študiji TDM4370g/BO21977/EMILIA
English: Grade 3 and 4 increased transaminases were reported in 1.5% of patients with EBC.
Slovenian: 4. stopnje so poročali pri 1,5 % bolnikov z EBC.
English: 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.
Slovenian: Pri bolnikih z ugotovljeno intersticijsko boleznijo pljuč ali pnevmonitisom je priporočljivo zdravljenje s trastuzumabom emtanzinom dokončno ukiniti, razen v primeru pnevmonitisa zaradi obsevanja med adjuvantnim zdravljenjem, kjer je treba trastuzumab emtanzin dokončno ukiniti pri pnevmonitisu
English: A vial of Kadcyla reconstituted with water for injections (not supplied) is stable for 24 hours at 2ºC - 8 ºC after reconstitution and must not be frozen.
Slovenian: Po pripravi viale zdravila Kadcyla z vodo za injekcije (ni priložena) je pripravljena raztopina stabilna 24 ur pri temperaturi 2-8 °C.
English: Kadcyla should only be prescribed by a physician and administered as an intravenous infusion under the supervision of a healthcare professional who is experienced in the treatment of cancer patients (i.e. prepared to manage allergic/anaphylactic infusion reactions and in an environment where full resuscitation facilities are immediately available (see section 4.4)).
Slovenian: pripravljenega za obvladovanje alergijskih/anafilaktičnih infuzijskih reakcij in v okolju, kjer je takoj na voljo popolna oprema za oživljanje (glejte poglavje 4.4)).
English: Estimates of 3 years IDFS rates were 88.3% vs. 77.0% in trastuzumab emtansine vs. trastuzumab arms, respectively.
Slovenian: Ocenjeni 3-letni delež IDFS je bil v skupini s trastuzumabom emtanzinom 88,3 % in s trastuzumabom 77,0 %.
English: · Tell your doctor before using Kadcyla if you are pregnant, think you may be pregnant or are planning to have a baby.
Slovenian: · Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, morate to povedati zdravniku, preden boste prejeli zdravilo Kadcyla.
English: Increased bilirubin Increased AST Increased ALT Haematologic Decreased platelet count Decreased haemoglobin Decreased neutrophils Potassium
Slovenian: Hematološke zmanjšano število tromobocitov znižan hemoglobin zmanjšano število nevtrofilcev Kalij znižan kalij
English: A randomised, multicentre, open-label phase II study evaluated the effects of trastuzumab emtansine versus trastuzumab plus docetaxel in patients with HER2-positive MBC who had not received prior chemotherapy for metastatic disease.
Slovenian: Ocenjevala je učinke trastuzumaba emtanzina v primerjavi s kombinacijo trastuzumaba in docetaksela pri bolnikih s HER2-pozitivnim razsejanim rakom dojk, ki predhodno niso prejemale kemoterapije za razsejano bolezen.
English: In addition, trastuzumab emtansine, like trastuzumab, inhibits shedding of the HER2 ECD, inhibits signalling through the phosphatidylinositol 3-kinase (PI3-K) pathway, and mediates antibody-dependent cell-mediated cytotoxicity (ADCC) in human breast cancer cells that overexpress HER2.
Slovenian: Poleg tega trastuzumab emtanzin - tako kot trastuzumab - zavira odcepljanje ECD HER2, zavira signaliziranje po poti fosfatidilinozitol-3-kinaze (PI3-K) in posreduje od protiteles odvisno,
English: · Keep this leaflet.
Slovenian: · izpuščaj na koži
English: 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).
Slovenian: Zdravilo Kadcyla vsebuje učinkovino trastuzumab emtanzin; učinkovina je sestavljena iz dveh med seboj povezanih delov: · trastuzumaba - to je monoklonsko protitelo, ki se selektivno veže na antigen (tarčno beljakovino),
English: Kadcyla, as a single agent, is indicated for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination.
Slovenian: Razsejani rak dojk (MBC - metastatic breast cancer) Zdravilo Kadcyla je kot monoterapija indicirano za zdravljenje odraslih bolnikov s HER2-pozitivnim, neoperabilnim, lokalno napredovalim ali razsejanim rakom dojk, predhodno zdravljenih s trastuzumabom in taksanom, samostojno ali v kombinaciji.
English: 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.
Slovenian: 0,45-% (4,5 mg/ml) raztopino natrijevega klorida za infundiranje se lahko uporabi brez 0,20- ali 0,22-µm polietersulfonskega (PES) filtra v liniji.
English: Common: · chills or flu like symptoms · decrease in your potassium levels (shown in a blood test) · skin rashes · decreased white blood cells (shown in a blood test) · dry eyes, watery eyes or blurred vision · eye redness or infection · indigestion · swelling of legs and/or arms · bleeding from the gums · increase in blood pressure · feeling dizzy · taste disturbances · itching · difficulty in remembering · hair loss · hand-and-foot skin reaction (Palmar-plantar erythrodysaesthesia syndrome) · nail disorder
Slovenian: · težave z želodcem · oteklost nog ali rok ali obojih · krvavitev iz dlesni · zvišanje krvnega tlaka · omotica · motnje okusa · srbenje · težave s pomnjenjem · izpadanje las · kožna reakcija na dlaneh in podplatih (sindrom palmarno-plantarne eritrodizestezije) · bolezni nohtov
English: Thrombocytopenia Grade 3 (25,000 to < 50,000/mm3)
Slovenian: 3. stopnja (25.000 do < 50.000/mm3)
English: Dry eye, Conjunctivitis, Vision blurred, Lacrimation increased
Slovenian: Očesne bolezni suho oko, konjunktivitis, zamegljen vid,
English: Trastuzumab emtansine is an antibody-drug conjugate containing humanized anti-HER2 IgG1 antibody trastuzumab and DM1, a microtubule-inhibitory maytansinoid.
Slovenian: Trastuzumab emtanzin je konjugat protitelesa in zdravila, ki vsebuje humanizirano anti-HER2 IgG1 protitelo trastuzumab in DM1, zaviralec mikrotubulov (majtanzinski derivat).
English: For dose modifications in the event of increased transaminases, see sections 4.2 and 4.4.
Slovenian: Za prilagoditev odmerka pri zvišanju transaminaz glejte poglavji 4.2 in 4.4.
English: Thrombocytopenia was reported in 28.5% of patients in EBC clinical studies with trastuzumab emtansine and was the most common reported adverse reaction for all grades and grades ≥ 3, as well as the most common adverse reaction leading to treatment discontinuation (4.2%), dose interruptions, and dose reductions.
Slovenian: 28,5 % bolnikov poročali o trombocitopeniji, ki je bila najpogosteje poročani neželeni učinek vseh stopenj in ≥ 3. stopnje kot tudi najpogostejši neželeni učinek, ki je povzročil prenehanje zdravljenja
English: Invasive Disease-Free Survival (IDFS) Number (%) of patients with event HR [95% CI] p-value (Log-Rank test, unstratified) 3 year event-free rate2,% [95% CI] Secondary Endpoints
Slovenian: Preživetje brez invazivne bolezni (IDFS) število (%) bolnikov z dogodkom HR [95-% IZ] p-vrednost (log-rang test, nestratificirani) delež 3-letnega obdobja brez dogodka2, % [95-% IZ]
English: In order to prevent medicinal product errors it is important to check the vial labels to ensure that the medicinal product being prepared and administered is Kadcyla (trastuzumab emtansine) and not Herceptin (trastuzumab).
Slovenian: Za preprečitev napak pri dajanju zdravila je pomembno preveriti nalepke na vialah in tako zagotoviti, da je pripravljeno in uporabljeno zdravilo res zdravilo Kadcyla (trastuzumab emtanzin) in ne zdravilo Herceptin (trastuzumab).
English: (> 3.0 to ≤ 20´ ULN on day of scheduled treatment)
Slovenian: 2.-3. stopnja (> 3,0 do ≤ 20´ ZNM na dan načrtovanega zdravljenja)
English: 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.
Slovenian: Pri bolnikih, starih 75 let ali več, je bilo na podlagi ocen IRC razmerje ogroženosti za PFS 3,51 (95-% interval zaupanja: 1,22 do 10,13) in za celokupno preživetje 3,45 (95-% interval zaupanja: 0,94 do 12,65).
English: How to store Kadcyla
Slovenian: Shranjevanje zdravila Kadcyla
English: The population PK analysis showed that creatinine clearance does not affect the PK of trastuzumab emtansine.
Slovenian: Populacijska farmakokinetična analiza je pokazala, da očistek kreatinina ne vpliva na farmakokinetiko trastuzumaba emtanzina.
English: 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.
Slovenian: Če je za infundiranje uporabljena 0,9-% (9 mg/ml) raztopina natrijevega klorida za infundiranje, je treba uporabiti 0,20- ali 0,22-mikronski polietersulfonski (PES) filter v liniji.
English: · Keep this medicine out of the sight and reach of children.
Slovenian: · Zdravilo shranjujte nedosegljivo otrokom!
English: 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.
Slovenian: Pri bolnikih, starih od 65 do 74 let (n = 113), je bilo na podlagi ocen IRC razmerje ogroženosti za PFS 0,88 (95-% interval zaupanja: 0,53 do 1,45) in za celokupno preživetje 0,74 (95-% interval zaupanja: 0,37 do 1,47).
English: Patients treated with trastuzumab emtansine should have HER2 positive tumour status, defined as a score of 3 + by immunohistochemistry (IHC) or a ratio of ≥ 2.0 by in situ hybridization (ISH) or by fluorescence in situ hybridization (FISH) assessed by a CE-marked In Vitro Diagnostic (IVD) medical device.
Slovenian: imunohistokemično opredeljen kot 3+ ali razmerje pri in situ hibridizaciji (ISH) ali fluorescentni in situ hibridizaciji (FISH) > 2,0, določeno z validiranim testom (z diagnostičnim medicinskim pripomočkom in vitro z oznako CE).
English: Peripheral neuropathy Trastuzumab emtansine should be temporarily discontinued in patients experiencing Grade 3 or 4
Slovenian: Uporabo trastuzumaba emtanzina je treba prehodno prekiniti pri bolnikih s periferno nevropatijo 3. ali
English: 75,000/mm3)
Slovenian: (25.000 do < 75.000/mm3)
English: Grade 2
Slovenian: 4. stopnja
English: Do not administer trastuzumab emtansine until resolution £ Grade 2
Slovenian: Trastuzumaba emtanzina ne uporabite do izboljšanja na £ 2. stopnjo.
English: After reconstitution one vial of 8 mL solution contains 20 mg/mL of trastuzumab emtansine.
Slovenian: Po rekonstituciji vsebuje ena viala z 8 ml raztopine 20 mg/ml trastuzumaba emtanzina.
English: Concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole) with trastuzumab emtansine should be avoided due to the potential for an increase in DM1 exposure and toxicity.
Slovenian: Izogniti se je treba sočasni uporabi močnih zaviralcev CYP3A4 (npr. ketokonazola, itrakonazola, klaritromicina, atazanavirja,
English: How you are given Kadcyla
Slovenian: Kako boste dobili zdravilo Kadcyla
English: Transaminases increased
Slovenian: močnejše solzenje
English: 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.
Slovenian: 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
English: Serum transaminases > 3 x ULN and concomitant total bilirubin > 2´ ULN
Slovenian: > 3´ ZNM in sočasni skupni bilirubin > 2´ ZNM
English: Do not administer trastuzumab emtansine .
Slovenian: Trastuzumaba emtanzina ne uporabite.
English: No accumulation of trastuzumab emtansine was observed after repeated dosing of intravenous infusion every 3 weeks.
Slovenian: Po ponavljajoči se uporabi intravenskih infuzij na 3 tedne niso opažali akumulacije trastuzumaba emtanzina.
English: Grade 4 (> 10´ the ULN)
Slovenian: 4. stopnja (> 10´ ZNM)
English: Grade 3 (> 5 to ≤ 20´ the ULN)
Slovenian: 3. stopnja (> 5 do ≤ 20´ ZNM
English: Left ventricular dysfunction was reported in 2.2% of patients in MBC clinical studies with trastuzumab emtansine.
Slovenian: Disfunkcijo levega prekata so v kliničnih študijah MBC s trastuzumabom emtanzinom zabeležili pri 2,2 % bolnikov z MBC.
English: Increased transaminases were reported in 24.2% of patients in MBC clinical studies.
Slovenian: V kliničnih študijah MBC so zvišanje transaminaz zabeležili pri 24,2 % bolnikov.
English: Trastuzumab emtansine (N=490) All Grades (%) Grade 3 (%) Grade 4 (%)
Slovenian: Trastuzumab emtanzin (n = 490) Vse stopnje
English: · Kadcyla 100mg: One vial of powder for concentrate for solution for infusion contains 100 mg of trastuzumab emtansine.
Slovenian: · Kadcyla 100 mg: Ena viala praška za koncentrat za raztopino za infundiranje vsebuje 100 mg trastuzumaba emtanzina.
English: Trastuzumab emtansine has minor influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Trastuzumab emtanzin ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: No formal pharmacokinetic study has been conducted and no population PK data was collected in patients with severe hepatic impairment (Child-Pugh class C).
Slovenian: 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.
English: 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.
Slovenian: 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).
English: Grade 4 (> 20´ the ULN)
Slovenian: 4. stopnja (> 20´ ZNM)
English: The population pharmacokinetic analysis suggested no difference in trastuzumab emtansine exposure based on disease status (adjuvant vs. metastatic setting).
Slovenian: 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).
English: After reconstitution one vial of 5 mL solution contains 20 mg/mL of trastuzumab emtansine.
Slovenian: Po rekonstituciji vsebuje ena viala s 5 ml raztopine 20 mg/ml trastuzumaba emtanzina.
English: No reproductive and developmental toxicology studies have been conducted with trastuzumab emtansine.
Slovenian: S trastuzumabom emtanzinom niso izvedli študij reproduktivne in razvojne toksičnosti.
English: One vial of powder for concentrate for solution for infusion contains 160 mg of trastuzumab emtansine.
Slovenian: Ena viala praška za koncentrat za raztopino za infundiranje vsebuje 160 mg trastuzumaba emtanzina.
English: LVEF 45% to < 50% and decrease is < 10% points from baseline*
Slovenian: LVEF 45 % do < 50 % in zmanjšanje za < 10 % od izhodišča*
English: 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.
Slovenian: 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.
English: (> 5 to ≤ 20´ ULN on day of scheduled treatment)
Slovenian: 3. stopnja (> 5 do ≤ 20´ ZNM na dan načrtovanega zdravljenja
English: 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.
Slovenian: 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.
English: In a sensitivity analysis censoring patients at the time of cross-over, the hazard ratio was 0.69 (95% CI 0.59, 0.82).
Slovenian: 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).
English: For dose modifications in the event of infusion-related reactions, see sections 4.2 and 4.4.
Slovenian: Za prilagoditev odmerka pri z infundiranjem povezanimi reakcijami glejte poglavji 4.2 in 4.4.
English: 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.
Slovenian: Trastuzumab emtanzin ni raziskan pri bolnikih, pri katerih so predhodno zdravljenje s trastuzumabom trajno ukinili zaradi reakcij, povezanih z infundiranjem.
English: Tables 4 and 5 displays laboratory abnormalities observed in patients treated with trastuzumab emtansine in clinical study TDM4370g/BO21977/EMILIA and study BO27938/KATHERINE.
Slovenian: 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
English: If a CE-marked IVD is not available, the HER2-status should be assessed by an alternate validated test.
Slovenian: Če takšnega pripomočka z oznako CE ni na voljo, je treba stanje
English: 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.
Slovenian: 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),
English: TBILI > 2´ ULN at any time
Slovenian: Celokupni bilirubin > 2´ ZNM kadar koli
English: Instructions for reconstitution · Kadcyla 100mg: using a sterile syringe, slowly inject 5 mL of sterile water for injection into the
Slovenian: Navodila za pripravo · Kadcyla 100 mg: s sterilno injekcijsko brizgo počasi injicirajte 5 ml sterilne vode za injekcije v 100-mg vialo trastuzumaba emtanzina.
English: · Kadcyla 160mg: One vial of powder for concentrate for solution for infusion contains 160 mg of trastuzumab emtansine.
Slovenian: · Kadcyla 160 mg: Ena viala praška za koncentrat za raztopino za infundiranje vsebuje 160 mg trastuzumaba emtanzina.
English: · 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.
Slovenian: · Z infundiranjem povezane reakcije ali alergijske reakcije: Zdravilo Kadcyla lahko povzroči rdečico, napade mrazenja, zvišano telesno temperaturo, težave z dihanjem, nizek krvni tlak,
English: Blood alkaline phosphatase increased, blood bilirubin increased
Slovenian: Bolezni jeter, žolčnika in žolčevodov zvišanje transaminaz zvišanje alkalne fosfataze v krvi, zvišanje bilirubina v krvi hepatotoksičnost,
English: 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.
Slovenian: Trastuzumab emtanzin ni raziskan pri bolnikih, pri katerih so zdravljenje s trastuzumabom dokončno ukinili zaradi preobčutljivosti.
English: 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):
Slovenian: Glede na odmerek 3,6 mg trastuzumaba emtanzina na kilogram telesne mase določite potrebno količino pripravljene raztopine (glejte poglavje 4.2):
English: See section 4 for more details about what side effects to look out for.
Slovenian: Podrobnosti o tem, na katere neželene učinke morate biti pozorni, so zapisane v poglavju 4.
English: 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.
Slovenian: 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).
English: How you are given Kadcyla 4.
Slovenian: Shranjevanje zdravila Kadcyla 6.
English: 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).
Slovenian: Na živalih so opravili študije z majtanzinom, zelo podobno snovjo iz iste skupine kot DM1, citotoksične sestavine trastuzumaba emtanzina, ki zavira mikrotubule.
English: Trastuzumab emtansine must be reconstituted and diluted by a healthcare professional and administered as an intravenous infusion.
Slovenian: Trastuzumab emtanzin mora pripraviti in razredčiti zdravstveni delavec.
English: Number (%) of patients with event HR [95% CI] p-value (Log-Rank test, unstratified) 3 year event-free rate
Slovenian: Celokupno preživetje (OS) število (%) bolnikov z dogodkom HR [95-% IZ] p-vrednost (log-rang test, nestratificiran) delež 5-letnega preživetja
English: Your doctor will check your heart function before and regularly during treatment.
Slovenian: Pred zdravljenjem in redno med njim vam bo zdravnik preverjal srčno delovanje.