natgillin/translations-raw huggingface dataset:
Table 5 Laboratory abnormalities observed in patients treated with trastuzumab emtansine in study BO27938/KATHERINE
Preglednica 5: Laboratorijske nepravilnosti, zabeležene pri bolnikih, zdravljenih s trastuzumabom emtanzinom v študiji BO27938/KATHERINE
Based on population pharmacokinetic (PK) analysis, following intravenous administration of trastuzumab emtansine in patients with HER2-positive metastatic breast cancer, the clearance of trastuzumab emtansine was 0.68 L/day and the elimination half-life (t1/2) was approximately 4 days.
Izločanje Na podlagi populacijske farmakokinetične analize je bil očistek trastuzumaba emtanzina po njegovi intravenski uporabi pri bolnikih s HER2-pozitivnim razsejanim rakom dojk 0,68 l/dan in eliminacijski razpolovni čas (t1/2) približno 4 dni.
Conjugation of DM1 to trastuzumab confers selectivity of the cytotoxic agent for HER2-overexpressing tumour cells, thereby increasing intracellular delivery of DM1 directly to malignant cells.
Konjugiranje DM1 s trastuzumabom ustvari selektivnost citotoksične učinkovine za tumorske celice s čezmerno izraženim HER2 in tako poveča dostop DM1 neposredno v notranjost malignih celic.
Table 7 Summary of efficacy from study TDM4370g/BO21977 (EMILIA)
Preglednica 7: Povzetek o učinkovitosti iz študije TDM4370g/BO21977 (EMILIA)
In the EMILIA study (TDM4370g/BO21977), 5.2% (24/466) of patients tested positive for anti-trastuzumab emtansine antibodies, of which 13 were also positive for neutralizing antibodies.
V študiji EMILIA (TDM4370g/BO21977) je imelo 5,2 % (24/466) bolnikov pozitiven test za protitelesa proti trastuzumabu emtanzinu, od katerih jih je imelo 13
Volume (mL) = Total dose to be administered (body weight (kg) x dose (mg/kg)) 20 (mg/mL, concentration of reconstituted solution)
Količina (ml) = celotni odmerek za aplikacijo (telesna masa (kg) x odmerek (mg/kg)) 20 (mg/ml, koncentracija pripravljene raztopine)
Pharmacokinetic data in patients with severe renal impairment (CLcr 15 to 29 mL/min) are limited (n = 1), therefore no dosage recommendations can be made.
Farmakokinetičnih podatkov pri bolnikih s hudo ledvično okvaro (CLcr od 15 do 29 ml/min) je malo
Table 2 Dose Modification Guidelines Dose Modifications for Patients with EBC Adverse reaction Severity
Preglednica 2: Smernice za prilagoditev odmerka Prilagoditve odmerka pri bolnikih z EBC
Left ventricular ejection fraction (LVEF) < 40% has been observed in patients treated with trastuzumab emtansine, and therefore symptomatic congestive heart failure (CHF) is a potential risk (see section 4.8).
(LVEF) < 40 %, zato je možno simptomatsko kongestivno srčno popuščanje (glejte poglavje 4.8).
The pharmacokinetics of trastuzumab emtansine and DM1-containing catabolites were evaluated after the administration of 3.6 mg/kg of trastuzumab emtansine to metastatic HER2+ breast cancer patients with normal hepatic function (n=10), mild (Child-Pugh A; n=10) and moderate (Child-Pugh B; n=8) hepatic impairment.
Farmakokinetika trastuzumaba emtanzina in DM1 vsebujočih presnovkov je bila ocenjena po dajanju 3,6 mg trastuzumaba emtanzina na kg telesne mase bolnikom s HER2+ razsejanim rakom dojk z normalnim delovanjem jeter (n = 10), blago (razred A po Child-Pughovi lestvici; n = 10) in zmerno (razred B po Child-Pughovi lestvici, n = 8) jetrno okvaro.
Infusion-related reactions are characterised by one or more of the following symptoms: flushing, chills, pyrexia, dyspnoea, hypotension, wheezing, bronchospasm and tachycardia.
Značilnost z infundiranjem povezanih reakcij je eden ali več od naslednjih simptomov: rdečica, mrzlica, pireksija, dispneja, hipotenzija, piskajoče dihanje, bronhospazem in tahikardija.
Uncommon (may affect up to 1 in 100 people): · Inflammation of your lungs can cause breathing problems such as shortness of breath (either at rest or while performing any type of activity), coughing or coughing spells with a dry coughthese are signs of inflammation of your lung tissue.
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): · Vnetje pljuč lahko povzroči težave z dihanjem, na primer kratko sapo (lahko v mirovanju ali med izvajanjem kakršne koli dejavnosti), kašelj ali napade suhega kašlja - to so znaki vnetja pljučnega tkiva.
Important information about some of the ingredients of Kadcyla This medicine contains less than 1 mmol sodium (23 mg) per dose.
Pomembne informacije o nekaterih sestavinah zdravila Kadcyla To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
Treatment in patients with serum transaminases > 3 ´ ULN and concomitant total bilirubin > 2 ´ ULN should be permanently discontinued.
Pri bolnikih, ki imajo serumske transaminaze > 3´ ZNM in obenem celokupni bilirubin > 2´ ZNM, je treba zdravljenje s trastuzumabom emtanzinom dokončno ukiniti.
Volume (mL) = Total dose to be administered =(body weight (kg) x dose (mg/kg)) 20 (mg/mL, concentration of reconstituted solution)
Količina (ml) = celotni potrebni odmerek = (telesna masa (kg) x odmerek (mg/kg)) 20 (mg/ml, koncentracija pripravljene raztopine)
Nodular Regenerative Hyperplasia (NRH)
Nodularna regenerativna hiperplazija
This abnormality causes the structure of the liver to change.
Ta povzroči spreminjanje zgradbe jeter.
Randomization was stratified by clinical stage at presentation (operable vs. inoperable), hormone receptor status, preoperative HER2-directed therapy (trastuzumab, trastuzumab plus additional HER2-directed agent[s]), and pathological nodal status evaluated after preoperative therapy.
Randomizacija je bila stratificirana glede na klinični stadij ob postavitvi diagnoze (operabilen proti neoperabilen), stanje hormonskih receptorjev, predoperativno proti HER2 usmerjeno zdravljenje (trastuzumab, trastuzumab v kombinaciji z dodatnim proti HER2 usmerjenim zdravilom ali zdravili) in patološko stanje bezgavk, ocenjeno po predoperativnem zdravljenju.
In nonclinical studies, trastuzumab emtansine catabolites including DM1, Lys-MCC-DM1, and MCC-DM1 are mainly excreted in the bile with minimal elimination in urine.
V predkliničnih študijah so se kataboliti trastuzumaba emtanzina, vključno z DM1, Lys-MCC-DM1 in MCC-DM1, v glavnem izločali v žolču; izločanje v urinu je bilo minimalno.
No dose adjustment is required in patients aged ≥ 65 years.
Bolnikom, starim ≥ 65 let, odmerka ni treba prilagoditi.
The ADRs in 2,611 patients treated with trastuzumab emtansine are presented in Table 3.
Neželeni učinki pri 2611 bolnikih, zdravljenih s trastuzumabom emtanzinom, so prikazani v preglednici 3.
SPECIAL STORAGE CONDITIONS Store in a refrigerator (2ºC - 8ºC)
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku (2-8 °C)
Grade 4 (< 25,000/mm3)
4. stopnja (< 25.000/mm3)
When the heart muscle is weak, patients may develop symptoms such as shortness of breath at rest or when sleeping, chest pain, swollen legs or arms, and a sensation of rapid or irregular heartbeats.
Če je srčna mišica šibka, se pri bolniku lahko pojavijo simptomi, na primer kratka sapa v mirovanju ali med spanjem, bolečine v prsih, oteklost nog ali rok in občutek hitrega ali nerednega bitja srca.
Within each frequency grouping and SOC, adverse reactions are presented in order of decreasing seriousness.
V razvrstitvah pogostnosti in po organskih sistemih so neželeni učinki navedeni po padajoči resnosti.
· you are receiving treatment with blood thinning medicines (e.g. warfarin, heparin).
· če prejemate zdravila za redčenje krvi (npr. varfarin, heparin), · če ste v preteklosti imeli kakršne koli težave z jetri.
Figure 2 Kaplan-meier curve of IRC-assessed progression-free survival
Slika 2: Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni po oceni IRC
In the post-marketing setting, cases of oligohydramnios, some associated with fatal pulmonary hypoplasia, have been reported in pregnant women receiving trastuzumab.
V obdobju po odobritvi dovoljenja za promet so bili pri nosečnicah, ki so prejemale trastuzumab, opisani primeri oligohidramnija; nekateri so bili povezani s pljučno hipoplazijo, ki se konča s smrtjo.
Treatment must be permanently discontinued in the event of a life threatening infusionrelated reaction (see section 4.2).
Zdravljenje je treba dokončno ukiniti pri pojavu smrtno nevarnih reakcij, povezanih z infundiranjem (glejte poglavje 4.2).
Other medicines and Kadcyla Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
For dose modifications in the event of LVEF decrease, see Table 2 in section 4.2 and section 4.4.
Za prilagoditve odmerka v primeru zmanjšanja LVEF glejte preglednico 2 v poglavju 4.2 in poglavje 4.4.
Grade 4 (> 20 ´ ULN at any time)
4. stopnja (> 20´ ZNM kadar koli)
In the GLP toxicity studies, with the exception of irreversible peripheral axonal toxicity (observed only in monkeys at ³ 10 mg/kg) and reproductive organ toxicity (observed only in rats at 60 mg/kg), partially or completely reversible dose dependent toxicities were identified in both animal models.
V študijah toksičnosti v skladu z dobro laboratorijsko prakso so v obeh živalskih modelih ugotovili delno ali popolnoma reverzibilne od odmerka odvisne toksične učinke; izjema so bili ireverzibilni periferni aksonski toksični učinki (opaženi le pri opicah ob uporabi ³ 10 mg/kg) in ireverzibilni reproduktivni toksični učinki (opaženi le pri podganah ob uporabi 60 mg/kg).
TDM4370g/BO21977(EMILIA)
Razsejani rak dojk TDM4370g/BO21977 (EMILIA)
A treatment benefit was seen in the subgroup of patients who had relapsed within 6 months of completing adjuvant treatment and had not received any prior systemic anti-cancer therapy in the metastatic setting (n=118); hazard ratios for PFS and OS were 0.51 (95% CI: 0.30, 0.85) and 0.61 (95% CI: 0.32, 1.16), respectively.
Korist zdravljenja so ugotovili v podskupini bolnikov, pri katerih se je bolezen ponovila v 6 mesecih po dokončanju adjuvantnega zdravljenja in niso prejemali nobenega predhodnega sistemskega zdravljenja proti raku za razsejano bolezen (n = 118); razmerje ogroženosti za PFS je bilo 0,51 (95-% interval zaupanja: 0,30, 0,85) in za OS 0,61 (95-% interval zaupanja: 0,32, 1,16).
In the descriptive follow-up overall survival analysis, the hazard ratio was 0.75 (95% CI 0.64, 0.88).
V opisni analizi spremljanja celokupnega preživetja je bilo razmerje ogroženosti 0,75 (95-% interval zaupanja: 0,64 do 0,88).
Kadcyla must be reconstituted and diluted by a healthcare professional and administered as an intravenous infusion.
Zdravilo Kadcyla mora pripraviti in razredčiti zdravstveni delavec; zdravilo je treba dati kot intravensko infuzijo.
Table 3 Tabulated list of ADRs in patients treated with trastuzumab emtansine in clinical trials
Preglednica 3: Prikaz neželenih učinkov pri bolnikih, zdravljenih s trastuzumabom emtanzinom v kliničnih preskušanjih
Do not administer trastuzumab emtansine in combination with chemotherapy 5.
Trastuzumaba emtanzina ne uporabljajte sočasno s kemoterapijo.
Consider an alternate medicinal product with no or minimal potential to inhibit CYP3A4.
Razmisliti je treba o uporabi drugega zdravila, ki nima potenciala za zavrtje CYP3A4 ali pa je ta majhen.
Grade 3 or 4 increased AST and ALT were reported in 4.2% and 2.7% of patients with MBC respectively and usually occurred in the early treatment cycles (1-6).
3. ali 4. stopnje pa pri 2,7 % bolnikov z MBC; običajno se je pojavilo v zgodnjih ciklih zdravljenja
Upon binding to HER2, trastuzumab emtansine undergoes receptor-mediated internalization and subsequent lysosomal degradation, resulting in release of DM1-containing cytotoxic catabolites (primarily lysine-MCC-DM1).
Po vezavi na HER2 je trastuzumab emtanzin podvržen receptorsko posredovani internalizaciji in nato lizosomski razgradnji, ki sprosti citotoksične katabolite, ki vsebujejo DM1 (v prvi vrsti lizin-MCC
In order to prevent medicinal product errors it is important to review the Summary of Product Characteristics and to check the outer carton and vial labels to ensure that the medicinal product being prepared and administered is Kadcyla (trastuzumab emtansine) and not trastuzumab.
Z namenom preprečevanja napak pri uporabi zdravila je pomembno pregledati Povzetek glavnih značilnosti zdravila ter preveriti škatlo zdravila in nalepko na viali, da se zagotovi, da je pripravljeno in aplicirano zdravilo Kadcyla (trastuzumab emtanzin) in ne trastuzumab.
Increased Alanine Transaminase (ALT)
Zvišanje alanintransaminaze (ALT)
A clinically meaningful and statistically significant improvement in IDFS was observed in patients who received trastuzumab emtansine compared with trastuzumab (HR = 0.50, 95% CI [0.39, 0.64], p <0.0001.
Pri bolnikih, ki so prejemali trastuzumab emtanzin, so v primerjavi s prejemniki trastuzumaba opažali klinično pomembno in statistično značilno izboljšanje IDFS (HR = 0,50, 95-% IZ [0,39; 0,64],
Symptomatic CHF, Grade 3-4 LVSD or Grade 3-4 heart failure, or
Srčno popuščanje Simptomatsko kongestivno srčno popuščanje, 3.-4. stopnja LVSD ali 3.-4. stopnja srčnega popuščanja ali 2. stopnja srčnega popuščanja, ki ga spremlja LVEF < 45 %
If LVEF < 45% is confirmed, discontinue trastuzumab emtansine.
Če je potrjen LVEF < 45 %, prenehajte uporabljati trastuzumab emtanzin.
What Kadcyla looks like and contents of the pack · Kadcyla is a white to off-white lyophilised powder for concentrate for solution for infusion supplied in glass vials.
Izgled zdravila Kadcyla in vsebina pakiranja · Zdravilo Kadcyla je bel ali skoraj bel liofiliziran prašek za koncentrat za raztopino za infundiranje v steklenih vialah.
Thrombocytopenia, or decreased platelet counts, was commonly reported with trastuzumab emtansine and was the most common adverse reaction leading to treatment discontinuation, dose reduction, and dose interruption (see section 4.8).
Trombocitopenija Trombocitopenija ali zmanjšano število trombocitov je bila med uporabo trastuzumaba emtanzina opisana pogosto in je bila najpogostejši neželeni učinek, ki je povzročil prenehanje zdravljenja, zmanjšanje odmerka ali prekinitev odmerjanja (glejte poglavje 4.8).
If a strong CYP3A4 inhibitor is coadministered and trastuzumab emtansine treatment cannot be delayed, patients should be closely monitored for adverse reactions.
Če zdravljenja s trastuzumabom emtanzinom med sočasno uporabo močnega zaviralca CYP3A4 ni mogoče odložiti, je treba bolnike natančno kontrolirati zaradi možnih neželenih učinkov.
Rash, Pruritus, Alopecia, Nail disorder, Palmarplantar erythrodysaesthesia syndrome, Urticaria
alopecija, bolezni nohtov, sindrom palmarno-plantarne eritrodizestezije, urtikarija
Patients should receive treatment until disease progression or unmanageable toxicity.
Razsejani rak dojk (MBC) Bolniki naj prejemajo zdravljenje do napredovanja bolezni ali neobvladljive toksičnosti.
Patients with a history of congestive heart failure (CHF), serious cardiac arrhythmia requiring treatment, history of myocardial infarction or unstable angina within 6 months of randomization, or current dyspnoea at rest due to advanced malignancy were excluded from clinical studies.
V klinične študije niso bili vključeni bolniki z anamnezo kongestivnega srčnega popuščanja, resno motnjo srčnega ritma, ki je zahtevala zdravljenje, anamnezo miokardnega infarkta ali nestabilne angine pektoris v 6 mesecih pred randomizacijo ali s trenutno dispnejo v mirovanju zaradi napredovale maligne bolezni.
· Trastuzumab emtansine arm: trastuzumab emtansine 3.6 mg/kg intravenously over 30-90 minutes on Day 1 of a 21-day cycle · Control arm (lapatinib plus capecitabine): lapatinib 1250 mg/day orally once per day of a 21-day cycle plus capecitabine 1000 mg/m2 orally twice daily on Days 1-14 of a 21-day cycle
● kontrolna skupina (lapatinib in kapecitabin): lapatinib 1250 mg/dan peroralno enkrat na dan med 21-dnevnim ciklom ter kapecitabin 1000 mg/m2 peroralno dvakrat na dan od 1. do 14. dne
A total of 991 patients were randomised to trastuzumab emtansine or lapatinib plus capecitabine as follows:
V celoti je bilo 991 bolnikov randomiziranih v dve skupini - skupino s trastuzumabom emtanzinom in skupino s kombinacijo lapatiniba in kapecitabina:
· If you get any side effects, talk to your doctor, pharmacist or nurse.
· Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
What Kadcyla is used for
Za kaj uporabljamo zdravilo Kadcyla
Continue treatment with trastuzumab emtansine.
Nadaljujte zdravljenje s trastuzumabom emtanzinom.
Talk to your doctor before stopping your contraception.
Pred prenehanjem uporabe kontracepcije se posvetujte z zdravnikom.
Trastuzumab emtansine dose should not be re-escalated after a dose reduction is made.
Odmerka trastuzumaba emtanzina se po zmanjšanju ne sme več povečati.
The safety and efficacy in children and adolescents below 18 years of age have not been established as there is no relevant use in the paediatric population for the indication of breast cancer .
Varnost in učinkovitost pri otrocih in mladostnikih do 18. leta starosti nista ugotovljeni.
In vitro metabolism studies in human liver microsomes suggest that DM1, a component of trastuzumab emtansine, is metabolised mainly by CYP3A4 and, to a lesser extent, by CYP3A5.
Študije presnove in vitro v človeških jetrnih mikrosomih kažejo, da se DM1, malomolekulska sestavina trastuzumaba emtanzina, presnovi v glavnem s CYP3A4 in v manjši meri s CYP3A5.
Increase in serum transaminases (Grade 1-4) has been observed during treatment with trastuzumab emtansine in clinical studies (see section 4.4).
Med zdravljenjem s trastuzumabom emtanzinom so v kliničnih študijah opažali zvišanje serumskih transaminaz (1. do 4. stopnje) (glejte poglavje 4.4).
Kadcyla, as a single agent, is indicated for 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.
Zdravilo Kadcyla je kot monoterapija indicirano za adjuvantno zdravljenje 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.
Cases of overdose have been reported with trastuzumab emtansine treatment, most associated with thrombocytopenia, and there was one death.
Opisani so primeri prevelikega odmerjanja med zdravljenjem s trastuzumabom emtanzinom; večino je spremljala trombocitopenija in zabeležili so en smrtni primer.
Grade 2 (> 2.5 to ≤ 5´ the ULN)
2. stopnja (> 2,5 do ≤ 5´ ZNM)
· the cancer has spread to areas near the breast or to other parts of your body (metastasized) · the cancer has not spread to other parts of the body and treatment is going to be given after surgery
· če se rak ni razširil v druge dele telesa in bo zdravljenje potekalo po operaciji (zdravljenje po operaciji se imenuje adjuvantno zdravljenje).
Principal toxicities included liver (liver enzyme elevations) at ³ 20 mg/kg and ³ 10 mg/kg, bone marrow (reduced platelet and white blood cell count)/hematologic at ³ 20 mg/kg and ³ 10 mg/kg, and lymphoid organs at ³ 20 mg/kg and ³ 3 mg/kg, in rat and monkey, respectively.
(zvišanje jetrnih encimov) ob uporabi ³ 20 mg/kg oz. ³ 10 mg/kg, kostni mozeg (zmanjšanje števila trombocitov in belih krvnih celic)/hematološke vrednosti ob uporabi ³ 20 mg/kg oz. ³ 10 mg/kg ter limfatične organe ob uporabi ³ 20 mg/kg oz. ³ 3 mg/kg (vse prve vrednosti veljajo za podgane in vse druge za opice).
· Store in a refrigerator at (2°C - 8°C).
· Shranjujte v hladilniku (pri temperaturi 2-8 °C).
Dose Modifications for Patients with MBC Adverse reaction Severity
Prilagoditve odmerka pri bolnikih z MBC
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before you are given Kadcyla.
Če kaj od naštetega velja za vas (ali če niste prepričani), se posvetujte z zdravnikom ali farmacevtom,
This HCP educational pack shall consist of the following:
Informacije za zdravstvene delavce morajo vsebovati naslednje ključne poudarke:
· the most common serious ADRs (> 0.5% of patients) were haemorrhage, pyrexia, thrombocytopenia, dyspnoea, abdominal pain, musculoskeletal pain, and vomiting.
· najpogostejši resni neželeni učinki (> 0,5 % bolnikov): krvavitev, pireksija, trombocitopenija, dispneja, bolečine v trebuhu, mišično-skeletne bolečine in bruhanje.
No formal PK study has been conducted in patients with renal impairment.
Formalnih farmakokinetičnih študij pri bolnikih z ledvično okvaro niso izvedli.
What Kadcyla is and what it is used for
Kaj je zdravilo Kadcyla in za kaj ga uporabljamo Kaj je zdravilo Kadcyla
· Tingling, pain, numbness, itching, crawling sensation, pins and needles in your hands and feet.
· Mravljinčenje, bolečine, omrtvičenost, srbenje, občutek gomazenja ali zbadanja v dlaneh in stopalih.
Haemorrhage Haemorrhagic events were reported in 34.8% of patients in MBC clinical trials with trastuzumab emtansine and the incidence of severe haemorrhagic events (Grade ≥3) occurred in 2.2%.
O krvavitvah so poročali pri 34,8 % bolnikov v kliničnih preskušanjih MBC s trastuzumabom emtanzinom; incidenca hudih krvavitev (≥ 3. stopnje) je bila 2,2 %.
Very common (may affect more than 1 in 10 people): · Kadcyla may cause inflammation or damage to cells in the liver, resulting in elevated liver enzymes in blood tests.
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): · Zdravilo Kadcyla lahko povzroči vnetje ali okvaro jetrnih celic.
Succinic acid, sodium hydroxide, sucrose, polysorbate 20.
SEZNAM POMOŽNIH SNOVI Pomožne snovi: sukcinska kislina, natrijev hidroksid, saharoza, polisorbat 20.
Uncommon: · Another abnormality that can be caused by Kadcyla is a condition known as nodular regenerative hyperplasia of the liver.
Občasni: · Zdravilo Kadcyla lahko povzroči tudi stanje, imenovano nodularna regenerativna hiperplazija jeter.
The colour of the reconstituted solution should be colourless to pale brown.
Pripravljena raztopina mora biti brezbarvna do bledo rjave barve.
In addition, developmental toxicity of maytansine has been identified in non-clinical studies which suggests that DM1, the microtubule-inhibiting cytotoxic maytansinoid component of trastuzumab emtansine, will be similarly teratogenic and potentially embryotoxic.
Poleg tega so v predkliničnih študijah ugotovili razvojno toksičnost majtanzina, zaradi česar lahko predvidevamo, da bo DM1, citotoksična majtanzinoidna sestavina trastuzumaba emtanzina, ki zavira mikrotubule, podobno teratogen in potencialno embriotoksičen.
Tell your doctor or nurse straight away if you notice any of the following serious side effects while you are given Kadcyla:
Zdravniku ali medicinski sestri morate takoj povedati, če med prejemanjem zdravila Kadcyla opazite katerega od naslednjih resnih neželenih učinkov:
Very common: · decreased red blood cells (shown in a blood test) · being sick (vomiting) · diarrhoea · dry mouth
· zmanjšanje števila rdečih krvnih celic (pokaže se na preiskavi krvi)
Trastuzumab emtansine was given intravenously at 3.6 mg/kg on Day 1 of a 21-day cycle.
Trastuzumab emtanzin je bil dan intravensko v odmerku 3,6 mg/kg 1. dan 21-dnevnega cikla.
Since many medicinal products are excreted in human milk and because of the potential for serious adverse reactions in breast-feeding infants, women should discontinue breast-feeding prior to initiating treatment with trastuzumab emtansine.
Zaradi možnosti za resne neželene učinke pri dojenih dojenčkih morajo ženske prenehati dojiti pred uvedbo zdravljenja s trastuzumabom emtanzinom.
· the most common adverse drug reactions (ADRs) (≥25%) with trastuzumab emtansine were nausea, fatigue, musculoskeletal pain, haemorrhage, headache, transaminases increased, thrombocytopenia, and peripheral neuropathy.
· najpogostejši neželeni učinki (≥ 25 %) s trastuzumabom emtanzinom: navzea, utrujenost, mišičnoskeletne bolečine, krvavitev, glavobol, zvišanje transaminaz, trombocitopenija in periferna nevropatija.
Primary Endpoint
Primarni končni cilj
LVEF 40% to ≤ 45% and decrease is ≥ 10%
LVEF 40 % do ≤ 45 % in zmanjšanje za ≥ 10 % od izhodišča
Trastuzumab emtansine is administered intravenously.
Trastuzumab emtanzin se daje intravensko.