natgillin/translations-raw huggingface dataset:
Discontinue treatment
Prenehanje zdravljenja
Figure 1 Kaplan-Meier Curve of Invasive Disease-Free Survival in KATHERINE
Slika 1: Kaplan-Meierjeva krivulja preživetja brez invazivne bolezni v študiji KATHERINE
In clinical studies, the incidence and severity of thrombocytopenia were higher in Asian patients.
V kliničnih študijah sta bili incidenca in izrazitost trombocitopenije večji pri azijskih bolnikih.
It must not be administered as an intravenous push or bolus.
Ne sme se ga dajati kot hiter intravenski odmerek ali bolus.
You should not breast-feed during treatment with Kadcyla.
Med zdravljenjem z zdravilom Kadcyla ne smete dojiti.
Infusion-related reactions were reported in 1.6% of patients with EBC, with no Grade 3 or 4 events reported.
O reakcijah, povezanih z infundiranjem, so poročali pri 1,6 % bolnikov z EBC; dogodkov 3. ali 4. stopnje ni bilo.
If you stop Kadcyla treatment Do not stop treatment with this medicine without talking to your doctor first.
Zdravljenja s tem zdravilom ne prenehajte, ne da bi se prej posvetovali z zdravnikom.
The objective response rate (ORR) was 58.0% with trastuzumab plus docetaxel and 64.2% with trastuzumab emtansine.
Delež objektivnega odgovora na zdravljenje je bil 58,0-% s kombinacijo trastuzumaba in docetaksela ter 64,2-% s trastuzumabom emtanzinom.
NRH should be considered in all patients with clinical symptoms of portal hypertension and/or cirrhosis-like pattern seen on the computed tomography (CT) scan of the liver but with normal transaminases and no other manifestations of cirrhosis.
Na nodularno regenerativno hiperplazijo jeter je treba pomisliti pri vseh bolnikih s kliničnimi simptomi portalne hipertenzije in/ali s cirozi podobno sliko na računalniški tomografiji (CT) jeter, a z normalnimi vrednostmi transaminaz in brez drugih znakov ciroze.
Treatment of patients with hepatic impairment should be undertaken with caution due to known hepatotoxicity observed with trastuzumab emtansine (see section 4.4 and 5.2).
Pri zdravljenju bolnikov z jetrno okvaro moramo biti previdni zaradi znane hepatotoksičnosti, opažene pri uporabi trastuzumaba emtanzina (glejte poglavji 4.4 in 5.2).
The MAH shall agree the content and format of the Kadcyla (trastuzumab emtansine) educational material and a communication plan with the National Competent Authority in the Member State before Kadcyla (trastuzumab emtansine) is launched in each Member State.
Imetnik dovoljenja za promet z zdravilom se mora o vsebini in obliki izobraževalnega gradiva za zdravilo Kadcyla (trastuzumab emtanzin) dogovoriti s pristojnim nacionalnim organom v vsaki državi članici pred prihodom zdravila Kadcyla (trastuzumaba emtanzina) na trg.
OTHER SPECIAL WARNING(S), IF NECESSARY Cytotoxic
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Citotoksično zdravilo
MARKETING AUTHORISATION NUMBER(S) EU/1/13/885/001
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/885/001
· If you have any further questions, ask your doctor, pharmacist or nurse.
· Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
It is recommended that platelet counts are monitored prior to each trastuzumab emtansine dose.
Število trombocitov je priporočljivo kontrolirati pred vsakim odmerkom trastuzumaba emtanzina.
Baseline patient and tumour characteristics were well balanced between treatment groups.
Izhodiščne značilnosti bolnikov in tumorjev so bile med terapevtskima skupinama dobro uravnotežene.
A cumulative effect of trastuzumab emtansine on transaminases has been observed, and generally recovered when treatment was discontinued.
Opažali so kumulativni učinek trastuzumaba emtanzina na transaminaze; na splošno so se vrednosti normalizirale po prenehanju zdravljenja.
Platelets help your blood to clot so you might get unexpected bruising or bleeding (such as nose bleeds, bleeding from gums).
Krvne ploščice sodelujejo pri strjevanju krvi, zato se lahko pojavijo nepričakovane modrice ali krvavitve (na primer iz nosu ali dlesni).
No dose relationship was observed in clinical studies.
niso bili vključeni v klinične študije.
A total of 1243 patients from seven clinical studies were tested at multiple time points for anti-drug antibody (ADA) responses to trastuzumab emtansine.
V sedmih kliničnih študijah so skupno 1243 bolnikom ob različnih časih testirali odziv protiteles proti zdravilu (ADA - anti-drug antibody) na trastuzumab emtanzin.
Patients with dyspnoea at rest due to complications of advanced malignancy, co-morbidities, and receiving concurrent pulmonary radiation therapy may be at increased risk of pulmonary events.
Bolniki z dispnejo v mirovanju zaradi zapletov napredovale maligne bolezni, sočasnih bolezni in sočasnega obsevanja pljuč imajo lahko večje tveganje za pljučne neželene dogodke.
· If the Kadcyla infusion solution leaks into the area around the infusion site you may develop tenderness or redness of your skin, or swelling at the infusion site.
· Če raztopina za infundiranje Kadcyla pronica v predel okrog mesta infundiranja, se lahko pojavi občutljivost ali pordelost kože ali oteklost na mestu infundiranja.
Hepatotoxicity, Hepatic failure, Nodular regenerative hyperplasia, Portal hypertension
odpoved jeter, nodularna regenerativna hiperplazija, portalna hipertenzija
Pulmonary Toxicity Interstitial lung disease (ILD) or pneumonitis
Intersticijska bolezen pljuč ali pnevmonitis
Pharmacokinetics of trastuzumab emtansine in patients with mild (creatinine clearance CLcr 60 to 89 mL/min, n = 254) or moderate (CLcr 30 to 59 mL/min, n = 53) renal impairment were similar to those in patients with normal renal function (CLcr ³ 90 mL/min, n = 361).
[CLcr] od 60 do 89 ml/min, n = 254) ali zmerno (CLcr od 30 do 59 ml/min, n = 53) ledvično okvaro podobna kot pri bolnikih z normalnim delovanjem ledvic (CLcr ³ 90 ml/min, n = 361).
Increased Transaminase (AST/ALT)
Zvišanje transaminaz (AST/ALT)
Hyperbilirubinemia Grade 2 (> 1.5 to ≤ 3´ the ULN)
Hiperbilirubinemija 2. stopnja (> 1,5 do ≤ 3´ ZNM)
In an observational study (BO39807), approximately 22% (7 out of 32) of MBC patients initiating trastuzumab emtansine with LVEF of 40-49% at baseline, experienced a LVEF drop of >10% from baseline and/or CHF; most of these patients had other cardiovascular risk factors.
V opazovalni študiji (BO39807) se je pri približno 22 % (7 od 32) bolnikov z MBC, ki so imeli ob začetku zdravljenja s trastuzumabom emtanzinom izhodiščno vrednost LVEF 40-49%, pojavilo zmanjšanje LVEF za > 10 % od izhodišča in/ali kongestivno srčno popuščanje; večina teh bolnikov je imela druge srčno-žilne dejavnike tveganja.
By inhibiting tubulin polymerization, both DM1 and trastuzumab emtansine cause cells to arrest in the G2/M phase of the cell cycle, ultimately leading to apoptotic cell death.
Z zavrtjem polimerizacije tubulina DM1 in trastuzumab emtanzin ustavita celice v fazi celičnega cikla G2/M in navsezadnje povzročita apoptotično smrt celic.
MARKETING AUTHORISATION NUMBER(S) EU/1/13/885/002
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/885/002
In patients with MBC, the overall incidence of peripheral neuropathy was 29.0% and 8.6% for Grade ≥ 2.
Pri bolnikih z MBC je bila skupna incidenca perifernih nevropatij 29,0 % in perifernih nevropatij ³ 2. stopnje 8,6 %.
You will be observed by a doctor or nurse while it is being given and for at least 90 minutes following the initial dose, in case you have any side effects.
Zdravnik oziroma medicinska sestra vas bo opazovala med dajanjem zdravila in vsaj še 90 minut po prvem odmerku za primer, če bi se pojavil kateri koli neželeni učinek.
The safety of trastuzumab emtansine has been evaluated in 2,611 breast cancer patients in clinical studies.
Varnost trastuzumaba emtanzina so ocenili v kliničnih študijah pri 2611 bolnikih z rakom dojk.
You will be observed by a doctor or nurse while it is being given and for at least 30 minutes following the dose, in case you have any side effects.
Zdravnik oziroma medicinska sestra vas bo opazovala med dajanjem zdravila in vsaj še 30 minut po odmerku za primer, če bi se pojavil kateri koli neželeni učinek.
Increased Aspartate Transaminase (AST)
Zvišanje aspartattransaminaze (AST)
General risk factors for a cardiac event and those identified in adjuvant breast cancer studies with trastuzumab therapy include advancing age (> 50 years), low baseline LVEF values (< 55%), low LVEF levels prior to or following the use of paclitaxel in the adjuvant setting, prior or concomitant use of antihypertensive medicinal products, previous therapy with an anthracycline and high BMI (> 25 kg/m2).
Med splošnimi dejavniki tveganja za srčni dogodek in tistimi, ki so jih ugotovili v študijah adjuvantnega zdravljenja raka dojk s trastuzumabom, so višja starost (> 50 let), nizek izhodiščni LVEF (< 55 %), nizek LVEF pred uporabo paklitaksela ali po njej med adjuvantnim zdravljenjem, predhodna ali sočasna uporaba antihipertenzivnih zdravil, predhodno zdravljenje z antraciklinom in visok ITM
- Systemic exposures (AUC) of trastuzumab emtansine at Cycle 1 in patients with mild and moderate hepatic impairment were approximately 38% and 67% lower than that of patients with normal hepatic function, respectively.
- Sistemska izpostavljenost trastuzumabu emtanzinu (AUC) v 1. ciklu je bila pri bolnikih z blago jetrno okvaro približno 38 %, pri bolnikih z zmerno jetrno okvaro pa 67 % nižja kot pri bolnikih z normalnim delovanjem jeter.
· Do not use this medicine after the expiry date which is stated on the outer carton and vial after EXP.
· Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na zunanji ovojnini poleg oznake Uporabno do in na viali poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
Dedicated embryo-foetal development studies have not been conducted in animals with trastuzumab emtansine.
Namenskih študij embrio-fetalnega razvoja s trastuzumabom emtanzinom pri živalih niso izvedli.
· Bleeding problems: Kadcyla can lower the number of platelets in your blood.
· Težave s krvavitvami: Zaradi zdravila Kadcyla se vam lahko zmanjša število krvnih ploščic
Table 1 Dose reduction schedule
Preglednica 1: Shema zmanjševanja odmerka Shema zmanjševanja odmerka
Trastuzumab emtansine has not been studied in patients with serum transaminases > 2.5 ´ ULN or total bilirubin > 1.5 ´ ULN prior to initiation of treatment.
Trastuzumab emtanzin ni bil raziskan pri bolnikih, ki imajo pred uvedbo zdravljenja serumske transaminaze > 2,5´ ZNM ali celokupni bilirubin > 1,5´ ZNM.
· Trastuzumab emtansine, like trastuzumab, binds to domain IV of the HER2 extracellular domain
● Tako kot trastuzumab se tudi trastuzumab emtanzin veže na domeno IV zunajcelične domene
Patients should be observed during the infusion and for at least 90 minutes following the initial infusion for fever, chills, or other infusion-related reactions.
Bolnike je treba med infundiranjem in vsaj še 90 minut po prvem odmerku opazovati zaradi možnosti zvišanja telesne temperature, pojava mrzlice in drugih z infundiranjem povezanih reakcij.
Based on population PK analysis, following intravenous administration, the central volume of distribution of trastuzumab emtansine was (3.13 L) and approximated that of plasma volume.
Na podlagi populacijske farmakokinetične analize je bil po intravenski uporabi centralni volumen porazdelitve trastuzumaba emtanzina 3,13 l in je bil približno tolikšen kot volumen plazme.
Patient demographics and baseline tumor characteristics were balanced between treatment arms.
Demografski podatki bolnikov in izhodiščne značilnosti tumorja so bili med terapevtskima skupinama dobro uravnoteženi.
No adjustment to the starting dose is needed in patients with mild or moderate renal impairment (see section 5.2).
Bolnikom z blago ali zmerno ledvično okvaro začetnega odmerka ni treba prilagoditi (glejte poglavje 5.2).
· You should continue to take your contraception for at least 7 months after your last dose of
· Z uporabo kontracepcije nadaljujte vsaj še 7 mesecev po zadnjem odmerku zdravila Kadcyla.
Permanently discontinue trastuzumab emtansine in the absence of another likely cause for the elevation of liver enzymes and bilirubin, e.g. liver metastasis or concomitant medication
Dokončno prenehajte uporabljati trastuzumab emtanzin, če ni drugega verjetnega vzroka za zvišanje jetrnih encimov in bilirubina, npr. jetrnih zasevkov ali sočasnega zdravljenja.
The MAH shall ensure that in parallel to the launch of Kadcyla (trastuzumab emtansine), all health care professionals who may prescribe, dispense or administer Kadcyla (trastuzumab emtansine) and/or Herceptin (trastuzumab) are provided with a health care professional (HCP) educational pack.
Imetnik dovoljenja za promet mora zagotoviti, da ob prihodu zdravila Kadcyla (trastuzumaba emtanzina) na trg, vsi zdravstveni delavci, ki lahko predpišejo, izdajo ali aplicirajo zdravilo Kadcyla (trastuzumab emtanzin) in/ali zdravilo Herceptin (trastuzumab) prejemejo paket izobraževalnih gradiv za zdravstvene delavce, ki ga sestavljajo:
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodiumfree'.
Vsebnost natrija v pomožnih snoveh To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni ‘brez natrija'.
Use caution with these agents and consider additional monitoring when concomitant use is medically necessary.
Pri uporabi teh zdravil je potrebna previdnost in razmisliti je treba o dodatnem nadzoru,
Treat at the same dose level
Zdravljenje nadaljujte z enakim odmerkom.
Breast tumor samples were required to show HER2 overexpression defined as 3+ IHC or ISH amplification ratio ≥ 2.0 determined at a central laboratory.
Vzorci tumorja dojke so morali imeti čezmerno izražen HER2; to je bilo opredeljeno kot IHC 3+ ali razmerje amplifikacije pri ISH ≥ 2,0, določeno v centralnem laboratoriju.
In the event of decreased platelet count to Grade 3 or greater (< 50,000/mm3), do not administer trastuzumab emtansine until platelet counts recover to Grade 1 (≥ 75,000/mm3) (see section 4.2).
Če je zmanjšanje števila trombocitov 3. stopnje ali več (< 50.000/mm3), trastuzumaba emtanzina ne uporabite, dokler se število trombocitov ne vrne na 1. stopnjo (≥ 75.000/mm3) (glejte poglavje 4.2).
Always keep this medicine in the closed original pack at a temperature of 2ºC - 8 ºC in a refrigerator.
Zdravilo shranjujte v dobro zaprti originalni ovojnini v hladilniku pri temperaturi 2-8 °C.
The reconstituted Kadcyla solution diluted in infusion bags containing sodium chloride 9 mg/mL (0.9%) solution for infusion, or sodium chloride 4.5 mg/mL (0.45%) solution for infusion, is stable for up to 24 hours at 2°C to 8°C, provided it was prepared under controlled and validated aseptic conditions.
Pripravljena raztopina zdravila Kadcyla, razredčena v infuzijski vrečki z 0,9-% (9 mg/ml) raztopino natrijevega klorida za infundiranje ali 0,45-% (4,5 mg/ml) raztopino natrijevega klorida za infundiranje, je stabilna do 24 ur pri temperaturi od 2 do 8 °C, če je bila pripravljena v nadzorovanih in preverjenih aseptičnih pogojih.
Specific treatment for trastuzumab emtansine extravasation is unknown at this time.
Specifično zdravljenje ekstravazacije trastuzumaba emtanzina ta čas ni znano.
If the LVEF remains < 50% and has not recovered to < 10% points from baseline, discontinue trastuzumab emtansine.
Če LVEF ostane < 50 % in se ne popravi na vrednost, ki je znotraj 10 % od izhodiščne, prenehajte uporabljati trastuzumab emtanzin.
In particular, tell your doctor or pharmacist if you are taking: · any medicines to thin your blood such as warfarin or decrease the ability to form blood clot such as aspirin · medicines for fungal infections called ketoconazole, itraconazole or voriconazole · antibiotics for infections called clarithromycin or telithromycin · medicines for HIV called atazanavir, indinavir, nelfinavir, ritonavir or saquinavir.
· katero koli zdravilo za redčenje krvi, kot je varfarin, ali zdravilo, ki zmanjša sposobnost za tvorjenje krvnih strdkov, kot so zdravila z acetilsalicilno kislino, · zdravila proti glivičnim okužbam ketokonazol, itrakonazol ali vorikonazol, · antibiotik proti okužbam klaritromicin ali telitromicin, · zdravila proti HIV atazanavir, indinavir, nelfinavir, ritonavir ali sakvinavir, · zdravilo proti depresiji, imenovano nefazodon.
It is not known whether trastuzumab emtansine is excreted in human milk.
Ni znano, ali se trastuzumab emtanzin pri človeku izloča v materino mleko.
· the most common National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade ≥ 3 ADRs (> 2%) were thrombocytopenia, increased transaminases, anaemia, neutropenia, fatigue and hypokalaemia.
· najpogostejši neželeni učinki ≥ 3. stopnje po NCI-CTCAE (National Cancer Institute - Common Terminology Criteria for Adverse Events), (> 2 %): trombocitopenija, zvišanje transaminaz, anemija, nevtropenija, utrujenost in hipokaliemija.
No relationship was observed between trastuzumab emtansine exposure (AUC), trastuzumab emtansine maximum serum concentration (Cmax), total trastuzumab exposure (AUC), or Cmax of DM1 and increases in transaminase.
Povezave med zvišanjem transaminaz in izpostavljenostjo trastuzumabu emtanzinu (AUC), največjo koncentracijo trastuzumaba emtanzina (Cmax), celotno izpostavljenostjo trastuzumabu emtanzinu (AUC) ali Cmax DM1 niso ugotovili.
Particulates may be observed on storage if diluted in 0.9% sodium chloride (see section 6.6).
Če raztopino razredčimo z 0,9-% natrijevim kloridom se med shranjevanjem lahko pojavijo delci (glejte poglavje 6.6).
Patients in Study TDM4370g/BO21977 and Study BO29738 who received 3.6 mg/kg of trastuzumab emtansine intravenously every 3 weeks had a mean Cycle 1 maximum serum concentration (Cmax) of trastuzumab emtansine of 83.4 (± 16.5) mg/mL and 72.6 (± 24.3) mg/mL, respectively.
Bolniki v študiji TDM4370g/BO21977 in študiji BO29738, ki so prejemali 3,6 mg/kg trastuzumaba emtanzina intravensko na 3 tedne, so imeli povprečno v ciklu 1 največjo koncentracijo (Cmax) trastuzumaba emtanzina v serumu 83,4 (± 16,5) mg/ml (v študiji TDM4370g/BO21977) in 72,6
Administration of trastuzumab emtansine was well tolerated in rats and monkeys at doses up to 20 and 10 mg/kg, respectively, corresponding to 2040 mg DM1/m2 in both species, which is approximately equivalent to the clinical dose of trastuzumab emtansine in patients.
Podgane in opice so uporabo trastuzumaba emtanzina dobro prenašale v odmerkih do 20 mg/kg (podgane) in 10 mg/kg (opice); to pri obeh vrstah ustreza 2040 mg DM1/m2 in je približno enakovredno kliničnemu odmerku trastuzumaba emtanzina pri bolnikih.
PAES: In order to further investigate the efficacy of trastuzumab emtansine in the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy, the MAH should submit the final analysis of OS from the phase 3, randomised, open-label study KATHERINE (BO27938).
Študija učinkovitosti zdravila po pridobitvi dovoljenja za promet z zdravilom: Za nadaljnjo preučitev učinkovitosti trastuzumaba emtanzina pri adjuvantnem zdravljenju odraslih bolnikov s HER2-pozitivnim zgodnjim rakom dojk, ki imajo rezidualno invazivno bolezen v dojki in/ali bezgavkah, po neoadjuvantnem zdravljenju na osnovi taksanov in proti HER2 usmerjene terapije, mora imetnik dovoljenja za promet predložiti končno analizo celokupnega preživetja iz randomizirane, odprte študije faze III KATHERINE (BO27938).
Time to symptom progression, as defined by a 5-point decrease in the score derived from the Trials Outcome Index-Breast (TOI-B) subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life (FACT-B QoL) questionnaire was also assessed during the clinical study.
Med klinično študijo so ocenili tudi čas do napredovanja simptomov, kar je bilo opredeljeno kot zmanjšanje seštevka na podlestvici TOI-B (Trials Outcome Index-Breast) vprašalnika FACT-B QoL (Functional Assessment of Cancer Therapy-Breast Quality of Life) za 5 točk.
An average of 3.5 DM1 molecules are conjugated to each molecule of trastuzumab.
Na eno molekulo trastuzumaba so povprečno konjugirane 3,5 molekule DM1.
Grade 3-4
3.-4. stopnja
Patients were randomised to receive trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks (n = 67) or trastuzumab 8 mg/kg intravenous loading dose followed by 6 mg/kg intravenously every 3 weeks plus docetaxel 75-100 mg/m2 intravenously every
Bolnike so randomizirali v skupino, ki je prejemala trastuzumab emtanzin v odmerku 3,6 mg/kg intravensko na 3 tedne (n = 67) ali v skupino, ki je prejemala trastuzumab v uvajalnem intravenskem odmerku 8 mg/kg in nato 6 mg/kg intravensko na 3 tedne v kombinaciji z docetakselom 75-100 mg/m2
The median number of anti-cancer agents that patients had received in any setting was 8.5 (range, 5-19) and in the metastatic setting was 7.0 (range, 3-17), including all agents intended for the treatment of breast cancer.
Povprečno število zdravil proti raku, ki so jih bolniki prejemali v katerem koli zdravljenju, je bilo 8,5 (razpon: 5-19), za razsejano bolezen pa 7,0
Trastuzumab emtansine when administered intravenously every 3 weeks exhibited linear PK across doses ranging from 2.4 to 4.8 mg/kg; patients who received doses less than or equal to 1.2 mg/kg had faster clearance.
Na 3 tedne intravensko uporabljeni trastuzumab emtanzin je imel v razponu odmerkov od 2,4 do 4,8 mg/kg linearno farmakokinetiko; bolniki, ki so dobili odmerke, manjše ali enake 1,2 mg/kg, so imeli hitrejši očistek.
· Use effective contraception to avoid becoming pregnant while you are being treated with Kadcyla.
· Med zdravljenjem z zdravilom Kadcyla uporabljajte učinkovito kontracepcijsko zaščito, da ne boste zanosili.
In addition, exploratory analysis showed that the impact of covariates (i.e., renal function, race and age) on the pharmacokinetics of total trastuzumab and DM1 was limited and was not clinically relevant.
Poleg tega je eksplorativna analiza pokazala, da je bil vpliv sospremenljivk (tj. delovanja ledvic, rase in starosti) na farmakokinetiko celokupnega trastuzumaba in
Hypersensitivity was reported in 2.7% of patients with EBC, with Grade 3 or 4 in 0.4% of patients.
O preobčutljivosti so poročali pri 2,7 % bolnikov z EBC; pri 0,4 % bolnikov je bila 3. ali 4. stopnje.
All patients were previously treated with HER2-directed therapies (trastuzumab and lapatinib), and chemotherapy (anthracycline, taxane, and capecitabine) in the neoadjuvant, adjuvant, locally advanced, or metastatic setting.
Vsi bolniki so predhodno prejemali proti HER2 usmerjena zdravila (trastuzumab in lapatinib) in kemoterapijo (antraciklin, taksan in kapecitabin) v neoadjuvantnem, adjuvantnem zdravljenju ali zdravljenju lokalno napredovale ali razsejane bolezni.
Thrombocytopenia or decreased platelet counts were reported in 24.9% of patients in MBC clinical studies with trastuzumab emtansine and was the most common adverse reaction leading to treatment discontinuation (2.6%).
Trombocitopenijo ali zmanjšano število trombocitov so v kliničnih študijah MBC s trastuzumabom emtanzinom zabeležili pri 24,9 % bolnikov in to je bil najpogostejši neželeni učinek, zaradi katerega so z zdravljenjem prenehali (2,6 %).
Trastuzumab emtansine has not been studied in patients with platelet counts ≤ 100,000/mm3 prior to initiation of treatment.
Trastuzumab emtanzin ni raziskan pri bolnikih, ki so imeli pred uvedbo zdravljenja število trombocitov ≤ 100.000/mm3.
Treatment should be interrupted in patients with a severe IRR until signs and symptoms resolve.
Pri bolnikih s hudimi reakcijami, povezanimi z infundiranjem, je treba zdravljenje prekiniti, dokler znaki in simptomi ne minejo.
Over time, this may lead to symptoms such as a bloated sensation or swelling of the abdomen due to fluid accumulation or bleeding from abnormal blood vessels in the gullet or rectum.
Sčasoma to lahko povzroči simptome, na primer občutek napihnjenosti ali oteklost trebuha zaradi kopičenja tekočine ali krvavitev iz nenormalnih žil v požiralniku ali danki.
Left ventricular dysfunction occurred in 3.0% of patients with EBC, with Grade 3 or 4 in 0.5% of patients.
Disfunkcija levega prekata se je pojavila pri 3,0 % bolnikov z EBC: pri 0,5 % bolnikov je bila 3. ali 4. stopnje.