FrancophonIA/ELRC3.0 huggingface dataset:
English: Additional endpoints included IDFS including second primary non-breast cancer, disease-free survival (DFS), overall survival (OS), and distant recurrence-free interval (DRFI).
Slovenian: Dodatni končni cilji so obsegali IDFS (vključno z drugim primarnim rakom, ki ni bil rak dojk), preživetje brez bolezni (DFS - disease-free survival), celokupno preživetje (OS) in interval brez oddaljene ponovitve (DRFI - distant recurrence-free interval).
English: What Kadcyla is and what it is used for 2.
Slovenian: Kaj je zdravilo Kadcyla in za kaj ga uporabljamo 2.
English: Peripheral Neuropathy Grade 3-4
Slovenian: Periferna nevropatija 3.-4. stopnja
English: Patients should be observed closely for infusion-related reactions, especially during the first infusion.
Slovenian: Bolnike je treba natančno opazovati zaradi možnih reakcij, povezanih z infundiranjem, zlasti med prvim infundiranjem.
English: · DM1 - an anti-cancer substance that becomes active once Kadcyla enters the cancer cell.
Slovenian: · DM1 - to je učinkovina proti raku, ki postane aktivna, ko zdravilo Kadcyla vstopi v rakavo celico.
English: Table 3 shows pooled data from the overall treatment period in the MBC studies (N= 1871; median number of cycles of trastuzumab emtansine was 10) and in KATHERINE (N=740; median number of cycles was 14).
Slovenian: Preglednica 3 prikazuje združene podatke iz celotnega obdobja zdravljenja v študijah MBC (n = 1871; mediano število ciklov trastuzumaba emtanzina je bilo 10) in v študiji KATHERINE (n = 740; mediano število ciklov je bilo 14).
English: Overall, the majority of hypersensitivity reactions were mild or moderate in severity and resolved upon treatment.
Slovenian: V celoti je bila večina preobčutljivostnih reakcij blagih ali zmernih in so med zdravljenjem izginile.
English: A change of 5 points in the TOI-B is considered clinically significant.
Slovenian: TOI-B velja za klinično pomembno.
English: · The other ingredients are succinic acid, sodium hydroxide (see section 2 under ‘Important information about some of the ingredients of Kadcyla'), sucrose, and polysorbate 20.
Slovenian: · Druge sestavine zdravila so sukcinska kislina, natrijev hidroksid (glejte poglavje 2 Pomembne informacije o nekaterih sestavinah zdravila Kadcyla), saharoza in polisorbat 20.
English: Patients should be observed closely for hypersensitivity/allergic reactions, which may have the same clinical presentation as an IRR.
Slovenian: Bolnike je treba skrbno opazovati zaradi možnosti pojava preobčutljivostnih/alergijskih reakcij, ki imajo lahko enako klinično sliko kot reakcije, povezane z infundiranjem.
English: The significance of reported adverse reactions such as fatigue, headache, dizziness and blurred vision on the ability to drive or use machines is unknown.
Slovenian: Pomen opisanih neželenih učinkov, kot so utrujenost, glavobol, omotica in zamegljen vid, na sposobnost vožnje in upravljanja s stroji ni znan.
English: Discard any unused portion.
Slovenian: Ves neporabljeni del zavrzite.
English: When trastuzumab binds to HER2 it can stop the cancer cells growth and cause them to die.
Slovenian: Ko se trastuzumab veže na HER2, zaustavi rast teh celic in povzroči njihovo smrt.
English: These may be signs of inflammation of your lung, which may be serious, and even fatal.
Slovenian: To so lahko znaki vnetja pljuč, ki je lahko resno in se lahko konča celo s smrtjo.
English: Table 6 Summary of efficacy from study BO27938 (KATHERINE) Trastuzumab N = 743
Slovenian: Preglednica 6: Povzetek učinkovitosti iz študije BO27938 (KATHERINE) trastuzumab n = 743
English: Do not freeze or shake the infusion during storage.
Slovenian: Infuzije med shranjevanjem ne smete zamrzniti ali stresati.
English: Your doctor or nurse will check to see whether you are having any of these side effects.
Slovenian: Zdravnik ali medicinska sestra bosta preverjala, ali imate katerega od teh neželenih učinkov.
English: The decision to administer trastuzumab emtansine in MBC patients with low LVEF must be made only after careful benefit risk assessment and cardiac function should be closely monitored in these patients (see section 4.8).
Slovenian: Odločitev o uporabi trastuzumaba emtanzina pri bolnikih z MBC in nizkim LVEF se lahko sprejme šele po natančni oceni tveganja in koristi; pri teh bolnikih je treba skrbno spremljati delovanje srca (glejte poglavje 4.8).
English: If a patient requires 2 delays due to thrombocytopenia, consider reducing dose by one level.
Slovenian: Če bolnik zaradi trombocitopenije potrebuje 2 zapoznitvi odmerka, pride v poštev zmanjšanje odmerka za eno stopnjo.
English: What you need to know before you are given Kadcyla 3.
Slovenian: Kaj morate vedeti, preden boste dobili zdravilo Kadcyla 3.
English: Tumor prognostic characteristics including hormone receptor status (positive: 72.3%, negative: 27.7%), clinical stage at presentation (inoperable: 25.3%, operable: 74.8%) and pathological nodal status after preoperative therapy (node positive: 46.4%, node negative or not evaluated: 53.6%) were similar in the study arms.
Slovenian: Tumorske prognostične značilnosti so vključevale stanje hormonskih receptorjev (pozitivno: 72,3 %, negativno 27,7 %), klinični stadij ob postavitvi diagnoze (neoperabilen: 25,3 %, operabilen 74,8 %) in patološko stanje bezgavk po predoperativnem zdravljenju (pozitivne bezgavke: 46,4 %, negativne bezgavke ali neocenjeno: 53,6 %) in so bile v skupinah študije podobne.
English: 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.
Slovenian: Če ga ne uporabimo takoj, je mogoče pripravljene viale shranjevati do 24 ur pri temperaturi od 2 do 8 °C, če je bilo zdravilo pripravljeno v nadzorovanih in preverjenih aseptičnih pogojih, po tem pa ga je treba zavreči.
English: If a pregnant woman is treated with trastuzumab emtansine, close monitoring by a multidisciplinary team is recommended.
Slovenian: Če noseča ženska dobiva trastuzumab emtanzin, je priporočljivo, da jo natančno spremlja multidisciplinarna strokovna skupina.
English: In KATHERINE, consistent treatment benefit of trastuzumab emtansine for IDFS was seen in all the pre-specified subgroups evaluated, supporting the overall result.
Slovenian: V študiji KATHERINE so konsistentno korist zdravljenja s trastuzumabom emtanzinom za IDFS ugotovili v vseh vnaprej opredeljenih ocenjenih podskupinah, kar potrjuje celokupen rezultat.
English: It must be verified that the non-proprietary name is trastuzumab emtansine.
Slovenian: Preveriti je treba, da je nezaščiteno ime trastuzumab emtanzin.
English: If the prior infusion was well tolerated, subsequent doses of trastuzumab emtansine may be administered as 30 minute infusions.
Slovenian: Če je bolnik predhodno infuzijo dobro prenesel, je mogoče poznejše odmerke trastuzumaba emtanzina dati kot 30-minutno infuzijo.
English: In most patients, these reactions resolved over the course of several hours to a day after the infusion was terminated.
Slovenian: Pri večini bolnikov so reakcije minile v nekaj urah do enega dneva po koncu infundiranja.
English: In some of the observed cases the patients had thrombocytopenia, or were also receiving anti-coagulant therapy or antiplatelet therapy; in others there were no known additional risk factors.
Slovenian: V nekaterih od opaženih primerov so imeli bolniki trombocitopenijo ali pa so prejemali tudi antikoagulantno ali antitrombotično zdravljenje, pri drugih pa ni bilo znanih dodatnih dejavnikov tveganja.
English: However, in most cases during Kadcyla treatment, liver enzyme levels are elevated mildly and temporarily, do not cause any symptoms, and do not affect liver function.
Slovenian: Toda v večini primerov so zvišanja jetrnih encimov med zdravljenjem z zdravilom Kadcyla blaga in prehodna, ne povzročajo simptomov in ne prizadenejo delovanja jeter.
English: Chemical and physical in-use stability of the reconstituted solution has been demonstrated for up to 24 hours at 2°C to 8°C.
Slovenian: Kemična in fizikalna stabilnost pripravljene raztopine med uporabo sta dokazani za do 24 ur pri temperaturi od 2 do 8 °C.
English: In the event of a true hypersensitivity reaction (in which severity of reaction increases with subsequent infusions), trastuzumab emtansine treatment must be permanently discontinued.
Slovenian: Pri dejanski preobčutljivostni reakciji (pri kateri se njena izrazitost pri nadaljnjih infuzijah povečuje) je treba zdravljenje s trastuzumabom emtanzinom dokončno ukiniti.
English: Patients (n = 110) received 3.6 mg/kg of trastuzumab emtansine intravenously every 3 weeks until disease progression or unacceptable toxicity.
Slovenian: Bolniki (n = 110) so prejemali 3,6 mg/kg trastuzumaba emtanzina intravensko na 3 tedne do napredovanja bolezni ali nesprejemljivih neželenih učinkov.
English: Figure 3 Kaplan-meier curve of overall survival
Slovenian: Slika 3: Kaplan-Meierjeva krivulja celokupnega preživetja
English: Patients develop multiple nodules in the liver that can change how the liver functions.
Slovenian: Bolnikom se v jetrih pojavijo številni vozliči, ki lahko spremenijo delovanje jeter.
English: Administration of trastuzumab emtansine to pregnant women is not recommended and women should be informed of the possibility of harm to the foetus before they become pregnant.
Slovenian: Uporaba trastuzumaba emtanzina pri nosečnicah ni priporočljiva in ženske je treba seznaniti z možnostjo za okvaro ploda, preden zanosijo.
English: Patients were randomized (1:1) to receive trastuzumab or trastuzumab emtansine.
Slovenian: Bolnike so (v razmerju 1:1) randomizirali na prejemanje trastuzumaba ali trastuzumaba emtanzina.
English: DM1 did not inhibit major CYP450 enzymes in vitro.
Slovenian: DM1 in vitro ni zavrl pomembnih encimov CYP450.
English: ALT = alanine transaminase; AST = aspartate transaminase, CHF = congestive heart failure, LVEF = left ventricular ejection fraction, LVSD = left ventricular systolic dysfunction, TBILI = Total Bilirubin, ULN = upper limit of normal * Prior to starting trastuzumab emtansine treatment.
Slovenian: ALT = alanin-transaminaza, AST = aspartat-transaminaza, CHF = kongestivno srčno popuščanje (congestive heart failure), LVEF = iztisni delež levega prekata (left ventricular ejection fraction), LVSD = sistolična disfunkcija levega prekata (left ventricular systolic dysfunction), ZNM = zgornja meja normale * Pred začetkom zdravljenja s trastuzumabom emtanzinom.
English: Kadcyla (trastuzumab emtansine) and Herceptin (trastuzumab) are two very different products with different active substances never to be used interchangeably.
Slovenian: Zdravili Kadcyla (trastuzumab emtanzin) in Herceptin (trastuzumab) sta dve zelo različni zdravili z različnima učinkovinama, ki se nikoli ne smeta uporabljati izmenljivo.
English: Independent of race, the incidence of Grade 3 or 4 events (< 50,000/mm3) was 8.7% in patients with MBC treated with trastuzumab emtansine and 5.7% in patients with EBC.
Slovenian: Neodvisno od rase je bila incidenca dogodkov 3. ali 4. stopnje (< 50.000/mm3) pri bolnikih z MBC, zdravljenih s trastuzumabom emtanzinom, 8,7 % in 5,7 % pri bolnikih z EBC.
English: Patients with treated brain metastases were eligible for enrollment if they did not require therapy to control symptoms.
Slovenian: Bolniki z zasevki na možganih so bili primerni za vključitev, če za obvladovanje simptomov niso potrebovali zdravljenja.
English: If concomitant use of strong CYP3A4 inhibitors is unavoidable, consider delaying trastuzumab emtansine treatment until the strong CYP3A4 inhibitors have cleared from the circulation (approximately 3 elimination half-lives of the inhibitors) when possible.
Slovenian: Če je sočasna uporaba močnih zaviralcev CYP3A4 neizogibna, pride v poštev odložitev zdravljenja s trastuzumabom emtanzinom, dokler se močni zaviralec CYP3A4 ne odstrani iz obtoka (približno 3 eliminacijski razpolovni časi zaviralca), če je to mogoče.
English: In more severe cases, swelling of your face or tongue, trouble swallowing or difficulty breathing may occur.
Slovenian: V hujših primerih se lahko pojavijo oteklost obraza ali jezika, težave s požiranjem ali dihanjem.
English: The infusion may be continued after the symptoms improve.
Slovenian: Po izboljšanju simptomov se lahko infundiranje nadaljuje.
English: The ADRs are listed below by MedDRA system organ class (SOC) and categories of frequency.
Slovenian: Neželeni učinki so spodaj navedeni po organskem sistemu (razvrstitvi MedDRA) in kategoriji pogostnosti.
English: For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja zdravila po pripravi in razredčenju glejte poglavje 6.3.
English: Patients should be clinically monitored on an ongoing basis for signs/symptoms of neurotoxicity.
Slovenian: Bolnike je treba stalno klinično kontrolirati zaradi možnih znakov ali simptomov nevrotoksičnosti.
English: If you are not sure, talk to your doctor or nurse before you are given Kadcyla.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom ali medicinsko sestro, preden boste dobili zdravilo Kadcyla.
English: · Heart problems: Kadcyla can weaken the heart muscle.
Slovenian: · Težave s srcem: Zdravilo Kadcyla lahko oslabi srčno mišico.
English: These reactions were usually mild or moderate and comprised erythema, tenderness, skin irritation, pain, or swelling at the infusion site.
Slovenian: Te reakcije so bile po navadi blage ali zmerne in so obsegale eritem, občutljivost, draženje kože, bolečino ali oteklost na mestu infundiranja.
English: The co-primary efficacy endpoints of the study were progression-free survival (PFS) as assessed by an independent review committee (IRC) and overall survival (OS) (see Table 7 and Figures 2 to 3).
Slovenian: progression-free survival) po oceni neodvisnega odbora za pregled (IRC - independent review committee) in celokupno preživetje (OS - overall survival) (glejte preglednico 7 in sliki 2 in 3).
English: 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.
Slovenian: Zdravilo Kadcyla uporabljamo za zdravljenje raka dojk pri odraslih: · če imajo rakave celice na svoji površini veliko beljakovine HER2 - zdravnik bo zato opravil preiskavo rakavih celic,
English: There are insufficient data to establish the safety and efficacy in patients ≥ 75 years due to limited data in this subgroup.
Slovenian: Za ugotovitev varnosti in učinkovitosti pri bolnikih, starih ≥ 75 let, ni dovolj podatkov.
English: · When prepared as a solution for infusion Kadcyla is stable for up to 24 hours at 2°C to 8°C, and must be discarded thereafter.
Slovenian: · Če je zdravilo Kadcyla pripravljeno kot raztopina za infundiranje, je stabilno do 24 ur pri temperaturi od 2 do 8 °C, potem pa ga je treba zavreči.
English: The primary efficacy endpoint of the study was Invasive Disease-Free Survival (IDFS).
Slovenian: Primarni končni cilj učinkovitosti v študiji je bilo preživetje brez invazivne bolezni (IDFS - invasive disease-free survival).
English: If you develop a reaction, they will slow down or stop the infusion and may give you treatment to counteract the side effects.
Slovenian: Če se pri vas pojavi reakcija, bodo infundiranje upočasnili ali ustavili in vas zdravili, da bi nevtralizirali neželene učinke.
English: Patients with thrombocytopenia (≤ 100,000/mm3) and patients on anti-coagulant treatment (e.g. warfarin, heparin, low molecular weight heparins) should be monitored closely while on trastuzumab emtansine treatment.
Slovenian: Bolnike s trombocitopenijo (≤ 100.000/mm3) in bolnike, ki prejemajo antikoagulante (npr. varfarin, heparin, nizkomolekularne heparine), je treba med zdravljenjem s trastuzumabom emtanzinom natančno kontrolirati.
English: Some of these bleeding events resulted in fatal outcomes.
Slovenian: Nekateri primeri teh krvavitev so se končali s smrtjo.
English: Patients were treated with trastuzumab emtansine or trastuzumab for a total of 14 cycles unless there was recurrence of disease, withdrawal of consent, or unacceptable toxicity, whichever occurred first.
Slovenian: Bolnike so zdravili s trastuzumabom emtanzinom ali trastuzumabom skupno 14 ciklov, razen v primeru ponovitve bolezni, umika privolitve ali nesprejemljive toksičnosti, kar od tega se je zgodilo najprej.
English: How much you will be given · You will be given 3.6 mg of Kadcyla for every kilogram of your body weight.
Slovenian: Koliko zdravila Kadcyla boste dobili · Dobili boste 3,6 mg zdravila Kadcyla na kilogram telesne mase.
English: · Neurological problems: Kadcyla can damage nerves.
Slovenian: · Nevrološke težave: Zdravilo Kadcyla lahko okvari živce.
English: (ECD), as well as to Fcγ receptors and complement C1q.
Slovenian: (ECD - extracellular domain) HER2 ter na receptorje Fcγ in komplement C1q.
English: However, the magnitude of effect of these covariates on trastuzumab emtansine exposure suggests that these covariates are unlikely to have any clinically meaningful effect on trastuzumab emtansine exposure.
Slovenian: Vendar velikost njihovega učinka na izpostavljenost trastuzumabu emtanzinu kaže, da ni verjetno, da bi te sospremenljivke kakor koli klinično pomembno vplivale na izpostavljenost trastuzumabu emtanzinu.
English: No significant difference was observed in the PK of trastuzumab emtansine among patients < 65 years (n = 577), patients between 65-75 years (n = 78) and patients > 75 years (n = 16).
Slovenian: Farmakokinetika trastuzumaba emtanzina se ni bistveno razlikovala med bolniki, starimi < 65 let (n = 577), bolniki, starimi od 65 do 75 let (n = 78), in bolniki, starimi > 75 let (n = 16).
English: Patients should be observed during the infusion and for at least 30 minutes after infusion.
Slovenian: Bolnike je treba opazovati med infundiranjem in vsaj še 30 minut po njem.
English: Description of the key differences between trastuzumab emtansine and trastuzumab in relation to indication, dose, administration and packaging differences.
Slovenian: Opis glavnih razlik med trastuzumabom emtanzinom in trastuzumabom glede indikacij, odmerka, aplikacije in ovojnine.
English: If a prescription for Kadcyla (trastuzumab emtansine) is written electronically, it is important to ensure that the medicinal product prescribed is trastuzumab emtansine and not trastuzumab.
Slovenian: Če je recept za zdravilo Kadcyla (trastuzumab emtanzin) elektronski, je pomembno zagotoviti, da je predpisano zdravilo trastuzumab emtanzin in ne trastuzumab.
English: The ORR was 32.7% (95% CI: 24.1, 42.1), n = 36 responders, by both IRC and investigator review.
Slovenian: Delež objektivnega odgovora je bil 32,7 % (95-% interval zaupanja: 24,1, 42,1), n = 36, tako po pregledu IRC kot po pregledu raziskovalca.
English: Kadcyla delayed patient-reported time to symptom progression for 7.1 months compared with 4.6 months for the control arm (Hazard Ratio 0.796 (0.667, 0.951); p-value 0.0121).
Slovenian: Zdravilo Kadcyla je zakasnilo čas do napredovanja simptomov, o katerem so poročali bolniki, za 7,1 meseca v primerjavi s 4,6 meseca v kontrolni skupini (razmerje ogroženosti 0,796 (0,667, 0,951); p-vrednost 0,0121).
English: Patients with baseline elevation of ALT (e.g. due to liver metastases) may be predisposed to liver injury with a higher risk of a Grade 3-5 hepatic event or liver function test increase.
Slovenian: Bolniki z izhodiščnim zvišanjem ALT (npr. zaradi jetrnih zasevkov) imajo lahko večje tveganje za poškodbo jeter z večjim tveganjem za jetrne neželene dogodke stopnje 3 do 5 ali zvišanje jetrnih testov.
English: You must not be given Kadcyla · if you are allergic to trastuzumab emtansine or any of the other ingredients of this medicine (listed in section 6).
Slovenian: · če ste alergični na trastuzumab emtanzin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: In clinical studies, patients had a LVEF ³ 50% at baseline.
Slovenian: V kliničnih študijah so imeli bolniki izhodiščni LVEF ³ 50 %.
English: - Plasma concentrations of DM1 and DM1-containing catabolites (Lys-MCC-DM1 and MCC-DM1) were low and comparable between patients with and without hepatic impairment.
Slovenian: - Plazemske koncentracije DM1 in DM1 vsebujočih presnovkov (Lys-MCC-DM1 in MCC-DM1) so bile nizke in primerljive med bolniki z jetrno okvaro ali brez nje.
English: Patients should receive treatment for a total of 14 cycles unless there is disease recurrence or unmanageable toxicity.
Slovenian: Bolniki naj prejmejo 14 ciklov zdravljenja v celoti, razen v primeru ponovitve bolezni ali neobvladljive toksičnosti.
English: The majority of the patients had Grade 1 or 2 events (≥ 50,000/mm3), with the nadir occurring by day 8 and generally improving to Grade 0 or 1 (≥ 75,000/mm3) by the next scheduled dose.
Slovenian: Pri večini bolnikov je bil ta dogodek 1. ali 2. stopnje (≥ 50.000/mm3); najnižja vrednost je bila dosežena do 8. dne in se je na splošno izboljšala na stopnjo 0 ali 1. stopnjo (≥ 75.000/mm3) do naslednjega predvidenega odmerka.
English: Because most of the patients in trastuzumab emtansine clinical studies were females, the effect of gender on the PK of trastuzumab emtansine was not formally evaluated.
Slovenian: Ker je bila večina oseb v kliničnih študijah trastuzumaba emtanzina žensk, vpliva spola na farmakokinetiko trastuzumaba emtanzina niso formalno ocenili.
English: Trastuzumab emtansine has the mechanisms of action of both trastuzumab and DM1:
Slovenian: Trastuzumab emtanzin ima mehanizem delovanja obeh, trastuzumaba in DM1:
English: Patients treated with trastuzumab emtansine are at increased risk of developing left ventricular dysfunction.
Slovenian: Bolniki, zdravljeni s trastuzumabom emtanzinom, imajo večje tveganje za pojav disfunkcije levega prekata.
English: The liver is a primary organ for eliminating DM1 and DM1-containing catabolites.
Slovenian: Jetra so primarni organ za izločanje DM1 in DM1 vsebujočih presnovkov.
English: Patients with elevated transaminases improved to Grade 1 or normal within 30 days of the last dose of trastuzumab emtansine in the majority of the cases (see section 4.8).
Slovenian: Bolnikom z zvišanimi transaminazami se je stanje v večini primerov izboljšalo na 1. stopnjo ali se je normaliziralo v 30 dneh po zadnjem odmerku trastuzumaba emtanzina (glejte poglavje 4.8).
English: · Liver problems: Kadcyla can cause inflammation or damage to cells in the liver that can stop the liver from functioning normally.
Slovenian: · Težave z jetri: Zdravilo Kadcyla lahko povzroči vnetje ali okvaro jetrnih celic, ki lahko prepreči normalno delovanje jeter.
English: If diluted aseptically, it may be stored for up to 24 hours at 2°C to 8°C.
Slovenian: Če je razredčena v aseptičnih pogojih, je lahko shranjena do 24 ur pri temperaturi 2 do 8 °C.
English: · DM1, the cytotoxic component of trastuzumab emtansine, binds to tubulin.
Slovenian: ● DM1, citotoksična komponenta trastuzumaba emtanzina, se veže na tubulin.
English: Increased transaminases were reported in 32.4% of patients with EBC.
Slovenian: O zvišanju transaminaz so poročali pri 32,4 % bolnikov z EBC.
English: Women of childbearing potential should use effective contraception while receiving trastuzumab emtansine and for 7 months following the last dose of trastuzumab emtansine.
Slovenian: Kontracepcija pri moških in ženskah Ženske v rodni dobi morajo med zdravljenjem s trastuzumabom emtanzinom in še 7 mesecev po zadnjem odmerku trastuzumaba emtanzina uporabljati učinkovito kontracepcijo.
English: Population pharmacokinetic analysis indicates that age does not have a clinically meaningful effect on the pharmacokinetics of trastuzumab emtansine (see sections 5.1 and 5.2).
Slovenian: Populacijska farmakokinetična analiza nakazuje, da starost nima klinično pomembnega vpliva na farmakokinetiko trastuzumaba emtanzina (glejte poglavji 5.1 in 5.2).
English: To be administered under the supervision of a physician experienced in the use of cytotoxic agents.
Slovenian: Uporabite pod nadzorom zdravnika, ki ima izkušnje z uporabo citotoksičnih zdravil.