natgillin/translations-raw huggingface dataset:
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.
19,5 % bolnikov je poleg trastuzumaba kot sestavino neoadjuvantnega zdravljenja prejemala še eno proti HER2 usmerjeno zdravilo; 93,8 % teh bolnikov je prejelo pertuzumab.
However, based on results from general animal toxicity studies, adverse effects on fertility can be expected.
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.
If LVEF <40% is confirmed, discontinue trastuzumab emtansine
Če je potrjen LVEF < 40 %, prenehajte uporabljati trastuzumab emtanzin.
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.
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.
PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion 1 vial of 160 mg
FARMACEVTSKA OBLIKA IN VSEBINA prašek za koncentrat za raztopino za infundiranje 1 viala s 160 mg
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.
· 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.
A Phase II, single-arm, open-label study evaluated the effects of trastuzumab emtansine in patients with HER2-positive incurable, LABC or MBC.
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.
No adjustment to the starting dose is required for patients with mild or moderate hepatic impairment.
Bolnikom z blago ali zmerno jetrno okvaro začetnega odmerka ni treba prilagoditi.
Thrombocytopenia Grade 2-3 on day of scheduled treatment (25,000 to <
Trombocitopenija 2.-3. stopnja na dan načrtovanega zdravljenja
Biotransformation (trastuzumab emtansine and DM1) Trastuzumab emtansine is expected to undergo deconjugation and catabolism by means of proteolysis in cellular lysosomes.
Pričakovano je, da se trastuzumab emtanzin dekonjugira in katabolizira s proteolizo v celičnih lizosomih.
PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion 1 vial of 100 mg
FARMACEVTSKA OBLIKA IN VSEBINA prašek za koncentrat za raztopino za infundiranje 1 viala s 100 mg
Kadcyla 100 mg powder for concentrate for solution for infusion Kadcyla is provided in 15 mL (100 mg) Type 1 glass vial closed with a grey-butyl rubber stopper coated with fluoro-resin laminate, and sealed with an aluminium seal with a white plastic flip-off cap.
Kadcyla 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.
In human plasma, trastuzumab emtansine catabolites MCC-DM1, Lys-MCC-DM1, and DM1 were detected at low levels.
V človeški plazmi so odkrili majhne koncentracije katabolitov trastuzumaba emtanzina MCC-DM1, Lys-MCC-DM1 in DM1.
If you miss a Kadcyla treatment
Če ste prenehali zdravljenje z zdravilom Kadcyla
Trastuzumab was given intravenously at 6 mg/kg on Day 1 of a 21-day cycle.
Trastuzumab je bil dan intravensko v odmerku 6 mg/kg 1. dan 21-dnevnega cikla.
· Allergic reactions can occur and most patients will have mild symptoms such as itching or tightness in the chest.
Večina bolnikov bo imela blage simptome, kot so srbenje ali stiskanje v prsih.
For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Za navodila o pripravi in redčenju zdravila pred dajanjem glejte poglavje 6.6. 4.3 Kontraindikacije
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.
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.
In patients with EBC, the overall incidence was 32.3% and 10.3% for
Pri bolnikih z EBC je bila skupna incidenca perifernih nevropatij 32,3 % in perifernih nevropatij ³ 2. stopnje 10,3 %.
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 .
zmanjšanje odmerka ali prenehanje zdravljenja s trastuzumabom emtanzinom v skladu s smernicami v besedilu in preglednicah 1 in 2.
The majority of ADRs reported were of Grade 1 or 2 severity.
Večina opisanih neželenih učinkov je bila 1. ali 2. stopnje.
Your doctor will check your blood to test your liver function before and regularly during treatment.
Zdravnik vam bo pred in redno med zdravljenjem kontroliral kri, da bo preveril delovanje jeter.
You may experience tingling, pain, numbness, itching, crawling sensation, pins and needles in your hands and feet.
Pojavijo se lahko mravljinčenje, bolečine, omrtvičenost, srbenje, občutek gomazenja ali zbadanje v dlaneh in stopalih.
Succinic acid Sodium hydroxide Sucrose
Sukcinska kislina Natrijev hidroksid Saharoza Polisorbat 20
Grade 3 (> 3 to ≤ 10´ the ULN)
3. stopnja (> 3 do ≤ 10´ ZNM)
Grade 4 at any time < 25,000/mm3
4. stopnja kadar koli (< 25.000/mm3)
The dosing should be delayed, or treatment discontinued as necessary in cases of left ventricular dysfunction (see section 4.2).
V primerih disfunkcije levega prekata je treba odmerek preložiti ali zdravljenje prenehati, če je to potrebno (glejte poglavje 4.2).
Upon diagnosis of NRH, trastuzumab emtansine treatment must be permanently discontinued.
Pri diagnosticirani nodularni regenerativni hiperplaziji jeter je treba zdravljenje s trastuzumabom emtanzinom dokončno ukiniti.
After reconstitution one vial of 8 mL solution contains 20 mg/mL of trastuzumab emtansine (see section 6.6).
Po rekonstituciji vsebuje ena viala z 8 ml raztopine 20 mg/ml trastuzumaba emtanzina (glejte poglavje 6.6).
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.
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.
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).
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).
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.
V smrtnem primeru je bolnik nepravilno prejemal trastuzumab emtanzin 6 mg/kg in umrl približno 3
Do not use if the reconstituted solution contains visible particulates, or is cloudy or discoloured.
Če pripravljena raztopina vsebuje vidne delce, je motna ali spremenjene barve, je ne uporabite.
MBC patients with Grade ³ 3 and EBC patients with Grade ³ 2 peripheral neuropathy at baseline were excluded from clinical studies.
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,
You should tell your doctor immediately if you notice any unexpected bruising or bleeding.
Če opazite nepričakovane modrice ali krvavitve, morate to nemudoma povedati zdravniku.
After reconstitution one vial of 5 mL solution contains 20 mg/mL of trastuzumab emtansine (see section 6.6).
Po rekonstituciji vsebuje ena viala s 5 ml raztopine 20 mg/ml trastuzumaba emtanzina (glejte poglavje 6.6).
(> 3.0 to ≤ 5´ ULN on day of scheduled treatment)
2. stopnja (> 3,0 do ≤ 5´ ZNM na dan načrtovanega zdravljenja)
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).
Če se pojavijo z infundiranjem povezani simptomi, je treba hitrost infundiranja trastuzumaba emtanzina upočasniti ali infundiranje prekiniti (glejte poglavji 4.4 in 4.8).
Kadcyla 160 mg powder for concentrate for solution for infusion Kadcyla is provided in 20 mL (160 mg) Type 1 glass vial closed with a grey-butyl rubber stopper coated with fluoro resin laminate, and sealed with an aluminium seal with a purple plastic flip-off cap.
Kadcyla 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.
What you need to know before you are given Kadcyla
Kaj morate vedeti, preden boste dobili zdravilo Kadcyla Zdravila Kadcyla ne smete dobiti
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.
vključno z nodularno regenerativno hiperplazijo jeter in nekaterimi primeri smrti zaradi z zdravili povzročene poškodbe jeter.
Table 4 Laboratory abnormalities observed in patients treated with trastuzumab emtansine in study TDM4370g/BO21977/EMILIA
Preglednica 4: Laboratorijske nepravilnosti, zabeležene pri bolnikih, zdravljenih s trastuzumabom emtanzinom v študiji TDM4370g/BO21977/EMILIA
Grade 3 and 4 increased transaminases were reported in 1.5% of patients with EBC.
4. stopnje so poročali pri 1,5 % bolnikov z EBC.
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.
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
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.
Po pripravi viale zdravila Kadcyla z vodo za injekcije (ni priložena) je pripravljena raztopina stabilna 24 ur pri temperaturi 2-8 °C.
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)).
pripravljenega za obvladovanje alergijskih/anafilaktičnih infuzijskih reakcij in v okolju, kjer je takoj na voljo popolna oprema za oživljanje (glejte poglavje 4.4)).
Estimates of 3 years IDFS rates were 88.3% vs. 77.0% in trastuzumab emtansine vs. trastuzumab arms, respectively.
Ocenjeni 3-letni delež IDFS je bil v skupini s trastuzumabom emtanzinom 88,3 % in s trastuzumabom 77,0 %.
· Tell your doctor before using Kadcyla if you are pregnant, think you may be pregnant or are planning to have a baby.
· Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, morate to povedati zdravniku, preden boste prejeli zdravilo Kadcyla.
Increased bilirubin Increased AST Increased ALT Haematologic Decreased platelet count Decreased haemoglobin Decreased neutrophils Potassium
Hematološke zmanjšano število tromobocitov znižan hemoglobin zmanjšano število nevtrofilcev Kalij znižan kalij
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.
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.
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.
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,
· Keep this leaflet.
· izpuščaj na koži
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).
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),
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.
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.
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.
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.
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
· 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
Thrombocytopenia Grade 3 (25,000 to < 50,000/mm3)
3. stopnja (25.000 do < 50.000/mm3)
Dry eye, Conjunctivitis, Vision blurred, Lacrimation increased
Očesne bolezni suho oko, konjunktivitis, zamegljen vid,
Trastuzumab emtansine is an antibody-drug conjugate containing humanized anti-HER2 IgG1 antibody trastuzumab and DM1, a microtubule-inhibitory maytansinoid.
Trastuzumab emtanzin je konjugat protitelesa in zdravila, ki vsebuje humanizirano anti-HER2 IgG1 protitelo trastuzumab in DM1, zaviralec mikrotubulov (majtanzinski derivat).
For dose modifications in the event of increased transaminases, see sections 4.2 and 4.4.
Za prilagoditev odmerka pri zvišanju transaminaz glejte poglavji 4.2 in 4.4.
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.
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
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
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]
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).
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).
(> 3.0 to ≤ 20´ ULN on day of scheduled treatment)
2.-3. stopnja (> 3,0 do ≤ 20´ ZNM na dan načrtovanega zdravljenja)
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.
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).
How to store Kadcyla
Shranjevanje zdravila Kadcyla
The population PK analysis showed that creatinine clearance does not affect the PK of trastuzumab emtansine.
Populacijska farmakokinetična analiza je pokazala, da očistek kreatinina ne vpliva na farmakokinetiko trastuzumaba emtanzina.
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.
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.
· Keep this medicine out of the sight and reach of children.
· Zdravilo shranjujte nedosegljivo otrokom!
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.
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).
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.
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).
Peripheral neuropathy Trastuzumab emtansine should be temporarily discontinued in patients experiencing Grade 3 or 4
Uporabo trastuzumaba emtanzina je treba prehodno prekiniti pri bolnikih s periferno nevropatijo 3. ali
75,000/mm3)
(25.000 do < 75.000/mm3)
Grade 2
4. stopnja
Do not administer trastuzumab emtansine until resolution £ Grade 2
Trastuzumaba emtanzina ne uporabite do izboljšanja na £ 2. stopnjo.
After reconstitution one vial of 8 mL solution contains 20 mg/mL of trastuzumab emtansine.
Po rekonstituciji vsebuje ena viala z 8 ml raztopine 20 mg/ml trastuzumaba emtanzina.
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.
Izogniti se je treba sočasni uporabi močnih zaviralcev CYP3A4 (npr. ketokonazola, itrakonazola, klaritromicina, atazanavirja,
How you are given Kadcyla
Kako boste dobili zdravilo Kadcyla
Transaminases increased
močnejše solzenje
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.
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
Serum transaminases > 3 x ULN and concomitant total bilirubin > 2´ ULN
> 3´ ZNM in sočasni skupni bilirubin > 2´ ZNM
Do not administer trastuzumab emtansine .
Trastuzumaba emtanzina ne uporabite.
No accumulation of trastuzumab emtansine was observed after repeated dosing of intravenous infusion every 3 weeks.
Po ponavljajoči se uporabi intravenskih infuzij na 3 tedne niso opažali akumulacije trastuzumaba emtanzina.
Grade 4 (> 10´ the ULN)
4. stopnja (> 10´ ZNM)
Grade 3 (> 5 to ≤ 20´ the ULN)
3. stopnja (> 5 do ≤ 20´ ZNM
Left ventricular dysfunction was reported in 2.2% of patients in MBC clinical studies with trastuzumab emtansine.
Disfunkcijo levega prekata so v kliničnih študijah MBC s trastuzumabom emtanzinom zabeležili pri 2,2 % bolnikov z MBC.
Increased transaminases were reported in 24.2% of patients in MBC clinical studies.
V kliničnih študijah MBC so zvišanje transaminaz zabeležili pri 24,2 % bolnikov.
Trastuzumab emtansine (N=490) All Grades (%) Grade 3 (%) Grade 4 (%)
Trastuzumab emtanzin (n = 490) Vse stopnje
· Kadcyla 100mg: One vial of powder for concentrate for solution for infusion contains 100 mg of trastuzumab emtansine.
· Kadcyla 100 mg: Ena viala praška za koncentrat za raztopino za infundiranje vsebuje 100 mg trastuzumaba emtanzina.
Trastuzumab emtansine has minor influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Trastuzumab emtanzin ima blag vpliv na sposobnost vožnje in upravljanja strojev.
No formal pharmacokinetic study has been conducted and no population PK data was collected in patients with severe hepatic impairment (Child-Pugh class C).
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.