natgillin/translations-raw huggingface dataset:
Kadcyla (trastuzumab emtansine) is NOT a generic version of Herceptin (trastuzumab) and has different properties, indications and dose.
NIE JE generikum Herceptinu (trastuzumab) a má odlišné vlastnosti, indikácie a dávku.
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 je dostupná v 15 ml (100 mg) injekčných liekovkách zo skla typu 1 uzatvorených sivou butylovou gumovou zátkou potiahnutou fluoro-živicovým laminátom a zapečatených hliníkovým tesnením s bielym odklápacím viečkom z plastickej hmoty.
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.
Zápal pľúc môže spôsobiť problémy s dýchaním, ako je dýchavičnosť (buď v pokoji alebo pri vykonávaní akéhokoľvek typu činnosti), kašeľ alebo záchvaty suchého kašľa - to sú prejavy zápalu pľúcneho tkaniva.
Particulates may be observed on storage if diluted in 0.9% sodium chloride (see section 6.6).
Počas uchovávania sa môžu pozorovať častice pri nariedení v roztoku chloridu sodného 0,9
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).
1 871; medián počtu cyklov liečby trastuzumab emtanzinom bol 10) a v štúdii KATHERINE
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 observačnej štúdii (BO39807) približne 22 % (7 z 32) pacientov s MBC, ktorí začali liečbu trastuzumab emtanzinom s východiskovými hodnotami LVEF 40 −
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).
Kadcyla, trastuzumab emtanzin, je konjugát HER2-cielenej protilátky a liečiva, ktorý obsahuje humanizovaný anti-HER2 IgG1, trastuzumab, kovalentne naviazaný na inhibítora mikrotubulov DM1 (derivát maytansínu) prostredníctvom stabilného tioéterového linkera MCC (4-[N-maleimidometyl] cyklohexán-1-karboxylát).
Cases of interstitial lung disease (ILD), including pneumonitis, some leading to acute respiratory distress syndrome or a fatal outcome, have been reported in clinical studies with trastuzumab emtansine (see section 4.8).
V klinických štúdiách s trastuzumab emtanzinom sa zaznamenali prípady intersticiálnej choroby pľúc (interstitial lung disease, ILD) vrátane pneumonitídy, ktoré niekedy vedli k syndrómu akútnej respiračnej tiesne alebo k fatálnemu následku (pozri časť 4.8).
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)).
j. je pripravený zvládnuť alergické/anafylaktické reakcie na infúziu, ktorá sa má podávať v prostredí, kde je okamžite k dispozícii úplné vybavenie na resuscitáciu (pozri časť 4.4)).
· Infusion-related reactions or allergic reactions: Kadcyla can cause flushing, shivering fits, fever, trouble breathing, low blood pressure, rapid heartbeat, sudden swelling of your face, tongue, or trouble swallowing during the infusion or after the infusion on the first day of treatment.
záchvaty zimnice, horúčku, ťažkosti s dýchaním, nízky krvný tlak, rýchly srdcový pulz, náhly opuch tváre, jazyka alebo ťažkosti s prehĺtaním počas infúzie alebo po infúzii počas prvého dňa liečby.
After reconstitution one vial of 8 mL solution contains 20 mg/mL of trastuzumab emtansine (see section 6.6).
Po rekonštitúcii obsahuje jedna liekovka s 8 ml roztoku 20 mg/ml trastuzumab emtanzinu (pozri časť 6.6).
After reconstitution one vial of 5 mL solution contains 20 mg/mL of trastuzumab emtansine (see section 6.6).
Po rekonštitúcii obsahuje jedna liekovka s 5 ml roztoku 20 mg/ml trastuzumab emtanzinu (pozri časť 6.6).
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 je dostupná v 20 ml (160 mg) injekčných liekovkách zo skla typu 1 uzatvorených sivou butylovou gumovou zátkou potiahnutou fluoro-živicovým laminátom a zapečatených hliníkovým tesnením s červenofialovým odklápacím viečkom z plastickej hmoty.
(ECD), as well as to Fcγ receptors and complement C1q.
Trastuzumab emtanzin, tak ako aj trastuzumab, sa viaže na doménu IV HER2 extracelulárnej domény (extracellular domain - ECD), ako aj na Fcγ receptory a komplement C1q.
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).
577), u pacientov vo veku 65-75 rokov (n =
Instructions for dilution
Pokyny na rekonštitúciu
· If you get any side effects, talk to your doctor, pharmacist or nurse.
Ak sa u vás vyskytne akýkoľvek vedľajší účinok, obráťte sa na svojho lekára, lekárnika alebo zdravotnú sestru.
Immune system disorders
Poruchy imunitného systému precitlivenosť na liek
Both the invented name Kadcyla and its full non-proprietary name (trastuzumab emtansine) should be used and confirmed when prescribing, preparing the infusion solution and administering Kadcyla (trastuzumab emtansine) to patients.
Pri predpisovaní, príprave infúzneho roztoku a podávaní Kadcyly (trastuzumab emtanzin) pacientom sa majú používať a potvrdiť obidva názvy Kadcyly, obchodný názov aj jeho úplný generický názov (trastuzumab emtanzin).
Continue treatment with trastuzumab emtansine.
Pokračujte v liečbe trastuzumab emtanzinom.
Increased Aspartate Transaminase (AST)
Zvýšená hladina aspartáttransaminázy
In a sensitivity analysis censoring patients at the time of cross-over, the hazard ratio was 0.69 (95% CI 0.59, 0.82).
V analýzach citlivosti vylučujúcich pacientov v čase prechodu bol pomer rizika 0,69 (95%
Grade 2
2. stupeň.
Talk to your doctor or nurse before you are given Kadcyla if: · you have ever had a serious infusion-related reaction from using trastuzumab characterised by symptoms such as flushing, chills, fever, shortness of breath, difficulty breathing, rapid heartbeat or a drop in blood pressure.
• ste niekedy mali závažné reakcie súvisiace s infúziou po použití trastuzumabu, ktoré sa vyznačujú príznakmi ako sčervenanie, zimnica, horúčka, dýchavičnosť, ťažkosti s dýchaním, rýchly tlkot srdca alebo pokles krvného tlaku.
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.
10 mg/kg, kostnú dreň (zníženie počtu krvných doštičiek a bielych krviniek)/hematologické toxicity pri dávke ≥ 20 mg/kg a ≥
The population PK analysis showed that creatinine clearance does not affect the PK of trastuzumab emtansine.
Populačná FK analýza preukázala, že klírens kreatinínu neovplyvňuje FK trastuzumab emtanzinu.
Left ventricular dysfunction
Dysfunkcia ľavej komory LVEF <
Trastuzumab emtansine must be reconstituted and diluted by a healthcare professional and administered as an intravenous infusion.
Trastuzumab emtanzin musí rozpustiť, riediť a podávať vo forme intravenóznej infúzie zdravotnícky pracovník.
Thrombocytopenia Grade 3 (25,000 to < 50,000/mm3)
3. stupeň (25 000 až < 50 000/mm
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.
Aby sa predišlo zámene liekov, je dôležité prečítať si Súhrn charakteristických vlastností lieku a skontrolovať vonkajší obal a etikety na injekčných liekovkách, aby sa zabezpečilo, že liek, ktorý sa pripravuje a podáva, je Kadcyla (trastuzumab emtanzin) a nie trastuzumab.
After reconstitution one vial of 8 mL solution contains 20 mg/mL of trastuzumab emtansine.
Po rekonštitúcii obsahuje jedna liekovka s 8 ml roztoku 20 mg/ml trastuzumab emtanzinu.
Kadcyla is not recommended for anyone under the age of 18 years.
Kadcyla sa neodporúča používať u osôb mladších ako 18 rokov a to z dôvodu chýbajúcich informácií o spôsobe účinku tohto lieku u tejto vekovej skupiny.
Reactions secondary to extravasation have been observed in clinical studies with trastuzumab emtansine.
V klinických štúdiách s trastuzumab emtanzinom sa pozorovali sekundárne reakcie po extravazácii.
After reconstitution one vial of 5 mL solution contains 20 mg/mL of trastuzumab emtansine.
Po rekonštitúcii obsahuje jedna liekovka s 5 ml roztoku 20 mg/ml trastuzumab emtanzinu.
The median duration of overall survival was 29.9 months in the trastuzumab emtansine arm compared with 25.9 months in the lapatinib plus capecitabine arm. At the time of the descriptive follow-up overall survival analysis, a total of 27.4% of the patients had crossed over from the lapatinib plus capecitabine arm to the trastuzumab emtansine arm.
Medián celkového prežívania bolo v ramene s trastuzumab emtanzinom 29,9 mesiacov, v porovnaní s 25,9 mesiacmi v ramene lapatinib plus kapecitabín.
Serious, anaphylactic reactions have been observed in clinical studies with trastuzumab emtansine.
V klinických štúdiách s trastuzumab emtanzinom sa pozorovali závažné anafylaktické reakcie.
The population PK analysis showed that age did not affect the PK of trastuzumab emtansine.
Populačná FK analýza ukázala, že vek neovplyvňuje FK trastuzumab emtanzinu.
For dose modifications for thrombocytopenia, see sections 4.2 and 4.4.
Pre úpravy dávok v prípade trombocytopénie, pozri časti 4.2 a 4.4.
No formal pharmacokinetic study has been conducted and no population PK data was collected in patients with severe hepatic impairment (Child-Pugh class C).
C podľa Childovej-Pughovej klasifikácie) sa neuskutočnila žiadna formálna farmakokinetická štúdia a neboli zaznamenané žiadne údaje z populačnej farmakokinetickej (FK) analýzy.
Increased Alanine Transaminase (ALT)
Zvýšená hladina alaníntransaminázy (ALT)
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).
• trastuzumab - monoklonálna protilátka, ktorá sa selektívne viaže na antigén (cieľovú bielkovinu) nazývaný receptor pre ľudský epidermálny rastový faktor 2 (HER2).
In the subgroup of patients with non-measurable disease (n=205), based on IRC assessments, the hazard ratios for PFS and OS were 0.91 (95% CI: 0.59, 1.42) and 0.96 (95% CI: 0.54, 1.68),
V podskupine pacientov s nemerateľným ochorením (n=205) bol pomer rizika, na základe hodnotenia IRC, pre PFS 0,91 (95 % IS: 0,59, 1,42) a pre OS 0,96 (95 % IS: 0,54, 1,68).
The population PK analysis showed that race did not appear to influence the PK of trastuzumab emtansine.
Populačná FK analýza preukázala, že rasa pravdepodobne neovplyvňuje FK trastuzumab emtanzinu.
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).
55 %), nízke hladiny LVEF pred alebo po použití paklitaxelu ako adjuvantnej liečby, predchádzajúce alebo súbežné podávanie antihypertenzív, predchádzajúca liečba antracyklínom a vysoké BMI (>
Do not administer trastuzumab emtansine until total bilirubin recovers to Grade ≤ 1 and then reduce one dose level.
Nepodávajte trastuzumab emtanzin, kým sa hladina celkového bilirubínu neupraví na ≤
3 weeks (n = 70).
90 ml/min, n = 361).
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.
Kadcyla môže spôsobiť zápal alebo poškodenie buniek v pečeni, čo má za následok zvýšené hladiny pečeňových enzýmov v krvných testoch.
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).
Farmakokinetika trastuzumab emtanzinu u pacientov s miernou (klírens kreatinínu CLcr 60 až 89 ml/min, n =
The primary endpoint was investigator assessed Progression-Free Survival (PFS).
Primárnym koncovým ukazovateľom účinnosti bolo prežívanie bez progresie ochorenia (PFS) hodnotené skúšajúcim.
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 % pacientov dostalo ďalšiu HER2-cielenú látku navyše k trastuzumabu ako súčasť neoadjuvantnej liečby.
In patients with EBC, the overall incidence was 32.3% and 10.3% for
2. stupňa bol 8,6 %. U pacientov s EBC bol celkový výskyt periférnej neuropatie 32,3
· Kadcyla 100mg: One vial of powder for concentrate for solution for infusion contains 100 mg of trastuzumab emtansine.
Kadcyla 100 mg: Jedna injekčná liekovka s práškom na infúzny koncentrát obsahuje 100 mg trastuzumab emtanzinu.
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. alebo 4. stupňa a zvyčajne sa vyskytovali počas úvodných liečebných cyklov (1. - 6.).
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.
Pacienti liečení trastuzumab emtanzinom majú mať HER2 pozitívny stav nádoru, definovaný ako skóre 3 + pomocou imunohistochémie (IHC) alebo pomer ≥
In the Phase I and Phase II studies, 6.4% (24/376) of patients tested positive for anti- trastuzumab emtansine antibodies.
% (24/376) pacientov zistila pozitivita protilátok proti trastuzumab emtanzinu.
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.
8,7 % u pacientov s MBC liečených trastuzumab emtanzinom a 5,7 % u pacientov s EBC.
· Kadcyla 160mg: using a sterile syringe, slowly inject 8 mL of sterile water for injection into the
Kadcyla 160 mg: pomocou sterilnej injekčnej striekačky pomaly vstreknite 8 ml sterilnej vody na injekciu do injekčnej liekovky so 160 mg trastuzumab emtanzinu.
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.
%), na infúziu sa má použiť in-line polyétersulfónový (PES) filter 0,20 alebo 0,22 mikrónu.
Peripheral neuropathy, mainly as Grade 1 and predominantly sensory, was reported in clinical trials of trastuzumab emtansine.
V klinických skúšaniach s trastuzumab emtanzinom bola hlásená periférna neuropatia, predovšetkým 1. stupňa a prevažne senzorická.
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.
Výnimkou je radiačná pneumonitída objavujúca sa počas adjuvantnej liečby, kedy sa má trastuzumab emtanzin natrvalo vysadiť, ak ide o radiačnú pneumonitídu ≥
For patients randomised to trastuzumab emtansine, the median age was 53 years, most patients were female (99.8%), the majority were Caucasian (72%), and 57% had oestrogen-receptor and/or progesterone-receptor positive disease.
U pacientov randomizovaných na trastuzumab emtanzin bol medián veku 53 rokov, pričom väčšina pacientov boli ženy (99,8
Based on population PK analysis, body weight, albumin, sum of longest diameter of target lesions by Response Evaluation Criteria In Solid Tumors (RECIST), HER2 shed extracellular domain (ECD), baseline trastuzumab concentrations, and aspartate aminotransferase (AST) were identified as statistically significant covariates for trastuzumab emtansine PK parameters.
Na základe populačnej FK analýzy boli telesná hmotnosť, albumín, súčet najdlhšieho priemeru cieľových lézií podľa kritérií pre hodnotenie odpovede u solídnych nádorov (Response Evaluation Criteria
Cases of nodular regenerative hyperplasia (NRH) of the liver have been identified from liver biopsies in patients treated with trastuzumab emtansine.
U pacientov liečených trastuzumab emtanzinom boli z biopsií pečene identifikované prípady nodulárnej regeneratívnej hyperplázie (NRH) pečene.
Excipients:
PAES:
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.
2,5-násobok ULN alebo s hladinou celkového bilirubínu > 1,5-násobok ULN pred začatím liečby.
6.6 Special precautions for disposal and other handling Appropriate aseptic technique should be used.
Špeciálne opatrenia na likvidáciu a iné zaobchádzanie s liekom
· Kadcyla 160mg: One vial of powder for concentrate for solution for infusion contains 160 mg of trastuzumab emtansine.
Kadcyla 160 mg: Jedna injekčná liekovka s práškom na infúzny koncentrát obsahuje 160 mg trastuzumab emtanzinu.
MARKETING AUTHORISATION NUMBER(S) EU/1/13/885/001
EU/1/13/885/001
2,% [95% CI]
Počet (%) pacientov s udalosťou HR [95
· 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
Kontrolná skupina (lapatinib v kombinácii s kapecitabínom): lapatinib 1 250 mg/denne perorálne jedenkrát denne v priebehu 21-dňového cyklu v kombinácii s kapecitabínom
One vial of powder for concentrate for solution for infusion contains 160 mg of trastuzumab emtansine.
Jedna injekčná liekovka prášku na infúzny koncentrát obsahuje 160 mg trastuzumab emtanzinu.
peripheral neuropathy until resolution to ≤ Grade 2.
2. stupňom periférnej neuropatie pri vstupe do štúdie.
Haemorrhagic events were reported in 29% of patients with EBC and the incidence of severe haemorrhagic events (Grade ≥3) was 0.4%, including one Grade 5 event.
%. Hemoragické príhody boli hlásené u 29 % pacientov s EBC a výskyt závažných hemoragických príhod (≥
Instructions for reconstitution · 100 mg trastuzumab emtansine vial: Using a sterile syringe, slowly inject 5 mL of sterile water for injection into the vial.
Kadcyla 100 mg: pomocou sterilnej injekčnej striekačky pomaly vstreknite 5 ml sterilnej vody na injekciu do injekčnej liekovky so 100 mg trastuzumab emtanzinu.
Grade 3
- 4. stupeň
Increased bilirubin Increased AST Increased ALT Haematologic Decreased platelet count Decreased haemoglobin Decreased neutrophils Potassium
Znížená hladina hemoglobínu Znížený počet neutrofilov
Primary endpoints IRC-assessed progression-free survival (PFS) Number (%) of patients with event Median duration of PFS (months) Hazard ratio (stratified*) 95% CI for Hazard ratio p-value (Log-rank test, stratified*) Overall Survival (OS)** Number (%) of patients who died Median duration of survival (months) Hazard ratio (stratified*) 95% CI for Hazard ratio p-value (Log-rank test*) Key secondary endpoints Investigator-assessed PFS Number (%) of patients with event Median duration of PFS (months) Hazard ratio (95% CI) p-value (Log-rank test*) Objective response rate (ORR) Patients with measurable disease Number of patients with OR (%) Difference (95% CI) p-value (Mantel-Haenszel chi-squared test*) Duration of objective response (months) Number of patients with OR Median 95% CI OS: overall survival; PFS: progression-free survival; ORR: objective response rate; OR: objective response; IRC: independent review committee; HR: hazard ratios; CI: confidence interval * Stratified by: world region (United States, Western Europe, other), number of prior chemotherapeutic regimens for locally advanced or metastatic disease (0-1 vs. > 1), and visceral vs. non-visceral disease.
OS (overall survival): celkové prežívanie; PFS (progression-free survival): prežívanie bez progresie; ORR (objective response rate): miera objektívnej odpovede; OR (objective response): objektívna odpoveď; IRC (independent review committee): nezávislá hodnotiaca komisia; HR (hazard ratio): pomer rizika; IS: interval spoľahlivosti
Kadcyla 160 mg powder for concentrate for solution for infusion.
Kadcyla 160 mg prášok na infúzny koncentrát
AST recovers to Grade ≤ 1, and then reduce one dose level
1. stupeň, a potom ho znovu začnite podávať v dávke zníženej o jednu úroveň.
· 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.
%) boli trombocytopénia, zvýšené hladiny transamináz, anémia, neutropénia, únava a hypokaliémia.
LVEF 40% to ≤ 45% and decrease is ≥ 10%
LVEF 40 % až ≤
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).
50 000/mm 3) nepodávajte trastuzumab emtanzin, kým sa počet krvných doštičiek neupraví na 1. stupeň (≥
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
Prežívanie bez invazívneho ochorenia (IDFS)3 Počet (%) pacientov s udalosťou HR [95 % IS] p-hodnota (Log-Rank test, nestratifikovaný) 3-ročné obdobie bez udalosti2, % [95 % IS]
Thrombocytopenia Grade 2-3 on day of scheduled treatment (25,000 to <
- 3. stupeň v deň plánovaného podania lieku (25 000 až < 75 000/mm
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).
Aby sa predišlo zámene liekov, je dôležité skontrolovať etikety na injekčných liekovkách, aby sa zabezpečilo, že liek, ktorý sa pripravuje a podáva, je Kadcyla (trastuzumab emtanzin) a nie Herceptin (trastuzumab).
Hepatotoxicity, predominantly in the form of asymptomatic increases in the concentrations of serum transaminases (Grade 1-4 transaminitis), has been observed during treatment with trastuzumab emtansine in clinical studies (see section 4.8).
1. - 4. stupňa), sa pozorovala počas liečby trastuzumab emtanzinom v klinických štúdiách (pozri časť 4.8).
Kadcyla 100 mg powder for concentrate for solution for infusion.
Kadcyla 100 mg prášok na infúzny koncentrát