natgillin/translations-raw huggingface dataset:
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.
Konjugacija DM1 s trastuzumabom čini citotoksični lijek selektivnim za stanice tumora s prekomjernom ekspresijom HER2, čime se povećava unutarstanična isporuka DM1 izravno u zloćudne stanice.
· Tingling, pain, numbness, itching, crawling sensation, pins and needles in your hands and feet.
• trnci, bol, utrnulost, svrbež, mravinjanje, bockanje u šakama i stopalima.
· Store in a refrigerator at (2°C - 8°C).
• Čuvati u hladnjaku (2°C - 8°C).
No adjustment to the starting dose is needed in patients with mild or moderate renal impairment (see section 5.2).
U bolesnika s blagim ili umjerenim oštećenjem bubrežne funkcije nije potrebna prilagodba početne doze (vidjeti dio 5.2).
Rash, Pruritus, Alopecia, Nail disorder, Palmarplantar erythrodysaesthesia syndrome, Urticaria
Poremećaji kože i potkožnog tkiva osip, pruritus, alopecija, poremećaj noktiju, sindrom palmarno-plantarne eritrodizestezije,
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.
U klinička ispitivanja nisu bili uključeni bolesnici s kongestivnim zatajenjem srca u anamnezi, ozbiljnom srčanom aritmijom koja zahtijeva liječenje, infarktom miokarda u anamnezi ili nestabilnom anginom unutar 6 mjeseci prije randomizacije, kao ni bolesnici koji su u tom trenutku imali dispneju u mirovanju zbog uznapredovale zloćudne bolesti.
Very common: · decreased red blood cells (shown in a blood test) · being sick (vomiting) · diarrhoea · dry mouth
• smanjen broj crvenih krvnih stanica (vidljivo iz nalaza krvnih pretraga)
Within each frequency grouping and SOC, adverse reactions are presented in order of decreasing seriousness.
Unutar svake kategorije učestalosti i klase organskog sustava nuspojave su navedene u padajućem nizu prema ozbiljnosti.
Hepatic
Hepatotoksičnost
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.
Među bolesnicima s ranim rakom dojke događaji krvarenja prijavljeni su u 29% bolesnika, dok je incidencija događaja teškog krvarenja (stupnja ≥ 3) iznosila 0,4%, uključujući jedan događaj 5. stupnja.
There is no known antidote for trastuzumab emtansine overdose.
Nema poznatog protulijeka za predoziranje trastuzumab emtanzinom.
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.
10 mg/kg, koje kod obje vrste odgovaraju dozi od 2040 µg DM1/m2, što je približno jednako kliničkoj dozi trastuzumab emtanzina koja se primjenjuje u bolesnika.
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.
• Kadcyla je bijel do bjelkasti liofilizirani prašak za koncentrat za otopinu za infuziju koji dolazi u staklenoj bočici.
Trastuzumab was given intravenously at 6 mg/kg on Day 1 of a 21-day cycle.
Trastuzumab se primjenjivao intravenski u dozi od 6 mg/kg 1. dana 21-dnevnog ciklusa.
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.
• bilo koje lijekove za razrjeđivanje krvi, poput varfarina ili lijekove za smanjenje sposobnosti krvi da se zgruša, poput aspirina • lijekove za gljivične infekcije koji se zovu ketokonazol, itrakonazol ili vorikonazol
Infusion-related reactions (due to cytokine release), characterized by one or more of the following symptoms have been reported: flushing, chills, pyrexia, dyspnoea, hypotension, wheezing, bronchospasm, and tachycardia.
U kliničkim su ispitivanjima prijavljene reakcije povezane s infuzijom (uzrokovane otpuštanjem citokina), koje karakterizira jedan ili više sljedećih simptoma: navale crvenila, zimica, pireksija, dispneja, hipotenzija, piskanje pri disanju, bronhospazam i tahikardija.
Figure 2 Kaplan-meier curve of IRC-assessed progression-free survival
Slika 2 Kaplan-Meierova krivulja preživljenja bez progresije bolesti prema ocjeni neovisnog ocjenjivačkog povjerenstva
Determine the volume of the reconstituted solution required based on a dose of 3.6 mg trastuzumab emtansine/kg body weight:
Upute za razrjeđivanje Odredite potreban volumen rekonstituirane otopine na temelju doze od 3,6 mg trastuzumab emtanzina/kg tjelesne težine:
If a patient requires 2 delays due to thrombocytopenia, consider reducing dose by one level.
Ako bolesniku treba dvaput odgoditi primjenu doze zbog trombocitopenije,
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.
Prije stavljanja lijeka Kadcyla (trastuzumab emtanzin) na tržište u svakoj državi članici, nositelj odobrenja će s nacionalnim nadležnim tijelom pojedine države članice dogovoriti sadržaj i oblik edukacijskih materijala za lijek Kadcyla (trastuzumab emtanzin) te komunikacijski plan.
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.
• navale crvenila, napadaji drhtanja, vrućica, otežano disanje, nizak krvni tlak ili ubrzano kucanje srca tijekom infuzije ili unutar 24 sata nakon infuzije - to su takozvane reakcije povezane s infuzijom
Dyspepsia, Gingival
artralgija, mialgija
The appropriate amount of solution should be withdrawn from the vial and added to an infusion bag containing 250 mL of sodium chloride 4.5 mg/mL (0.45%) solution for infusion or sodium chloride 9 mg/mL (0.9%) solution for infusion.
Odgovarajuću količinu otopine treba izvući iz bočice i dodati u infuzijsku vrećicu koja sadrži 250 ml otopine natrijeva klorida za infuziju od 4,5 mg/ml (0,45%) ili otopine natrijeva klorida za infuziju od
No reproductive and developmental toxicology studies have been conducted with trastuzumab emtansine.
Nisu provedena ispitivanja reproduktivne i razvojne toksičnosti trastuzumab emtanzina.
Uncommon: · Another abnormality that can be caused by Kadcyla is a condition known as nodular regenerative hyperplasia of the liver.
• Još jedan poremećaj koji Kadcyla može izazvati je bolest koja se naziva nodularnom regenerativnom hiperplazijom jetre.
No accumulation of trastuzumab emtansine was observed after repeated dosing of intravenous infusion every 3 weeks.
Nakon ponovljenih doza primijenjenih intravenskom infuzijom svaka 3 tjedna nije primijećena kumulacija trastuzumab emtanzina.
(> 3.0 to ≤ 5´ ULN on day of scheduled treatment)
(> 3,0 do ≤ 5 × GGN na dan kada je predviđena primjena terapije)
Table 2 Dose Modification Guidelines Dose Modifications for Patients with EBC Adverse reaction Severity
Tablica 2 Smjernice za prilagodbu doze Prilagodbe doze u bolesnika s ranim rakom dojke
· Trastuzumab emtansine, like trastuzumab, binds to domain IV of the HER2 extracellular domain
• Kao i trastuzumab, trastuzumab emtanzin se veže za domenu IV izvanstanične domene receptora HER2 (ECD), ali i za receptore
Table 4 Laboratory abnormalities observed in patients treated with trastuzumab emtansine in study TDM4370g/BO21977/EMILIA
Tablica 4 Poremećaji laboratorijskih vrijednosti primijećeni u bolesnika liječenih trastuzumab emtanzinom u ispitivanju TDM4370g/BO21977/EMILIA
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.
Prije uključivanja u ispitivanje, trebalo je u centralnom laboratoriju potvrditi HER2-pozitivan status uzoraka raka dojke, koji se definirao kao imunohistokemijski rezultat 3+ ili amplifikacija gena utvrđena in situ hibridizacijom.
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.
U bolesnika koji su primali trastuzumab emtanzin opaženo je klinički važno i statistički značajno poboljšanje IDFS-a u usporedbi s bolesnicima koji su primali trastuzumab (HR = 0,50; 95% CI [0,39;
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.
Medijan trajanja ukupnog preživljenja bio je 29,9 mjeseci u skupini liječenoj trastuzumab emtanzinom u usporedbi s 25,9 mjeseci u skupini koja je primala lapatinib i kapecitabin.
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.
Ako se pojave simptomi, to mogu biti kašalj, nedostatak zraka u mirovanju ili pri spavanju na leđima, bolovi u prsima i oticanje gležnjeva ili ruku, osjećaj ubrzanog ili nepravilnog kucanja srca.
After reconstitution one vial of 5 mL solution contains 20 mg/mL of trastuzumab emtansine (see section 6.6).
Nakon rekonstitucije jedna bočica s 5 ml otopine sadrži 20 mg/ml trastuzumab emtanzina (vidjeti dio 6.6).
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.
Zbog moguće pojave nuspojava, liječnik ili medicinska sestra nadzirat će Vas za vrijeme primjene doze te još najmanje 30 minuta nakon toga.
Trastuzumab emtansine was given intravenously at 3.6 mg/kg on Day 1 of a 21-day cycle.
Trastuzumab emtanzin primjenjivao se intravenski u dozi od 3,6 mg/kg 1. dana 21-dnevnog ciklusa.
After reconstitution one vial of 8 mL solution contains 20 mg/mL of trastuzumab emtansine (see section 6.6).
Nakon rekonstitucije jedna bočica s 8 ml otopine sadrži 20 mg/ml trastuzumab emtanzina (vidjeti dio 6.6).
The ADRs are listed below by MedDRA system organ class (SOC) and categories of frequency.
Nuspojave lijeka u nastavku su navedene prema MedDRA klasifikaciji organskih sustava i kategorijama učestalosti.
MARKETING AUTHORISATION NUMBER(S) EU/1/13/885/001
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/885/001
Dedicated embryo-foetal development studies have not been conducted in animals with trastuzumab emtansine.
Nisu provedena posebna istraživanja embriofetalnog razvoja kod primjene trastuzumab emtanzina u životinja.
It is not known whether trastuzumab emtansine is excreted in human milk.
Nije poznato izlučuje li se trastuzumab emtanzin u majčino mlijeko.
· the most common adverse drug reactions (ADRs) (≥25%) with trastuzumab emtansine were nausea, fatigue, musculoskeletal pain, haemorrhage, headache, transaminases increased, thrombocytopenia, and peripheral neuropathy.
• najčešće nuspojave (≥ 25%) trastuzumab emtanzina bile su mučnina, umor, bol u mišićno-koštanom sustavu, krvarenje, glavobolja, povišene vrijednosti transaminaza, trombocitopenija i periferna neuropatija.
Tell your doctor or nurse straight away if you notice any of the following serious side effects while you are given Kadcyla:
Odmah obavijestite svog liječnika ili medicinsku sestru ako tijekom liječenja lijekom Kadcyla primijetite neku od sljedećih ozbiljnih nuspojava:
Kadcyla is used to treat breast cancer in adults when: · the cancer cells have many HER2 proteins on them - your doctor will test your cancer cells for this.
• kada stanice raka na sebi imaju mnogo HER2 proteina - liječnik će to utvrditi pretragama stanica raka
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.
Otopina natrijeva klorida za infuziju od 4,5 mg/ml (0,45%) može se koristiti bez polietersulfonskog (PES) ugrađenog filtra od 0,20 ili 0,22 μm.
Increased Aspartate Transaminase (AST)
Povišene vrijednosti aspartat transaminaze
Estimates of 3 years IDFS rates were 88.3% vs. 77.0% in trastuzumab emtansine vs. trastuzumab arms, respectively.
Procijenjene 3-godišnje stope IDFS-a iznosile su 88,3% u skupini koja je primala trastuzumab emtanzin te 77,0% u skupini koja je primala trastuzumab.
Contents of the pack and other information
Kako čuvati lijek Kadcyla Sadržaj pakiranja i druge informacije
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).
U kliničkim ispitivanjima trastuzumab emtanzina prijavljeni su slučajevi intersticijske bolesti pluća, uključujući pneumonitis, od kojih su neki doveli do sindroma akutnog respiratornog distresa ili smrti (vidjeti dio 4.8).
STATEMENT OF ACTIVE SUBSTANCE(S)
Trajanje objektivnog odgovora (mjeseci)
Hyperbilirubinemia TBILI
Hiperbilirubinemija
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).
Tijekom liječenja trastuzumab emtanzinom u kliničkim ispitivanjima opažena je hepatotoksičnost, prvenstveno u obliku asimptomatskog povećanja koncentracija serumskih transaminaza (transaminitis stupnja 1-4) (vidjeti dio 4.8).
In human plasma, trastuzumab emtansine catabolites MCC-DM1, Lys-MCC-DM1, and DM1 were detected at low levels.
U plazmi ljudi pronađene su male količine katabolita trastuzumab emtanzina MCC-DM1, Lys-MCC-DM1 i DM1.
Grade 3 (> 5 to ≤ 20´ the ULN)
Stupanj 3 (> 5 do ≤ 20 × GGN)
No formal pharmacokinetic study has been conducted and no population PK data was collected in patients with severe hepatic impairment (Child-Pugh class C).
U bolesnika s teškim oštećenjem jetrene funkcije (Child-Pugh stadij C) nisu provedena formalna farmakokinetička ispitivanja niti su prikupljeni populacijski farmakokinetički podaci.
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.
Zbog moguće pojave nuspojava, liječnik ili medicinska sestra nadzirat će Vas za vrijeme prve infuzije te još najmanje 90 minuta nakon toga.
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.
• upala pluća može uzrokovati probleme s disanjem poput nedostatka zraka (u mirovanju ili pri izvođenju bilo kakve vrste aktivnosti), kašlja ili napadaja suhog kašlja - to su znakovi upale plućnoga tkiva
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.
Preporučuje se trajno prekinuti liječenje trastuzumab emtanzinom u bolesnika u kojih se dijagnosticiraju intersticijska bolest pluća ili pneumonitis, uz izuzetak radijacijskog pneumonitisa kod adjuvantnog liječenja.
Trastuzumab emtansine is an antibody-drug conjugate that contains trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture, covalently linked to DM1, a microtubule inhibitor, via the stable thioether linker MCC (4-[N-maleimidomethyl] cyclohexane-1-carboxylate).
Trastuzumab emtanzin je konjugat protutijela i lijeka koji sadrži trastuzumab, humanizirano IgG1 monoklonsko protutijelo proizvedeno u kulturi stanica sisavaca (jajnika kineskog hrčka) u suspenziji, kovalentno povezano s DM1, inhibitorom mikrotubula, preko stabilne tioeterske poveznice MCC (4
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%.
U kliničkim ispitivanjima trastuzumab emtanzina kod metastatskog raka dojke slučajevi krvarenja prijavljeni su u 34,8% bolesnika, dok je incidencija slučajeva teškog krvarenja (stupnja ≥ 3) iznosila 2,2%.
If not used immediately, the reconstituted vials can be stored for up to 24 hours at 2°C to 8°C, provided it was reconstituted under controlled and validated aseptic conditions, and must be discarded thereafter.
2°C do 8°C, pod uvjetom da se postupak rekonstitucije proveo u kontroliranim i validiranim aseptičkim uvjetima, a nakon tog razdoblja lijek se mora baciti.
The ADRs in 2,611 patients treated with trastuzumab emtansine are presented in Table 3.
Nuspojave lijeka u 2611 bolesnika liječenih trastuzumab emtanzinom prikazane su u Tablici
Excipients:
Česte:
MARKETING AUTHORISATION NUMBER(S) EU/1/13/885/002
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/885/002
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 se nalazi u staklenoj bočici (staklo tipa 1) od 15 ml (100 mg), zatvorenoj sivim gumenim čepom (butilna guma obložena slojem fluorosmole) i zabrtvljenoj aluminijskim prstenom s plastičnim „flip-off“ poklopcem bijele boje.
Patients who discontinued trastuzumab emtansine could complete the duration of their intended study treatment up to 14 cycles of HER2-directed therapy with trastuzumab if appropriate based on toxicity considerations and investigator discretion.
Bolesnici koji su prekinuli liječenje trastuzumab emtanzinom mogli su tijekom preostalog planiranog liječenja u sklopu ispitivanja od najviše 14 ciklusa terapije koja ciljano djeluje na HER2
Trastuzumab emtansine is an antibody-drug conjugate containing humanized anti-HER2 IgG1 antibody trastuzumab and DM1, a microtubule-inhibitory maytansinoid.
Trastuzumab emtanzin je konjugat protutijela i lijeka koji sadrži trastuzumab, humanizirano IgG1 protutijelo za HER2, i DM1, maitanzinoid koji inhibira mikrotubule.
The dosing should be delayed, or treatment discontinued as necessary in cases of left ventricular dysfunction (see section 4.2).
U slučajevima disfunkcije lijeve klijetke treba odgoditi primjenu doze ili po potrebi prekinuti liječenje (vidjeti dio 4.2).
Increased transaminases were reported in 32.4% of patients with EBC.
Povišene vrijednosti transaminaza prijavljene su u 32,4% bolesnika s ranim rakom dojke.
· Tell your doctor before using Kadcyla if you are pregnant, think you may be pregnant or are planning to have a baby.
• Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku prije nego uzmete lijek Kadcyla.
For dose modifications in the event of increased transaminases, see sections 4.2 and 4.4.
Za prilagodbu doze u slučaju povišenih vrijednosti transaminaza vidjeti dijelove 4.2 i 4.4.
In the Phase I and Phase II studies, 6.4% (24/376) of patients tested positive for anti- trastuzumab emtansine antibodies.
6,4% (24/376) bolesnika imalo je pozitivan nalaz testa na protutijela na trastuzumab emtanzin.
In the descriptive follow-up overall survival analysis, the hazard ratio was 0.75 (95% CI 0.64, 0.88).
U deskriptivnoj naknadnoj analizi ukupnog preživljenja, omjer hazarda iznosio je 0,75 (95% CI:
How to store Kadcyla
Kako čuvati lijek Kadcyla
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.
U bolesnika liječenih trastuzumab emtanzinom primijećeni su ozbiljni poremećaji jetre i žuči, uključujući nodularnu regenerativnu hiperplaziju (NRH) jetre, u nekim slučajevima sa smrtnim ishodom zbog oštećenja jetre izazvanog primjenom lijeka.
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.
U bolesnika u dobi od 65 do 74 godine (n=113) omjer hazarda prema ocjeni neovisnog ocjenjivačkog povjerenstva iznosio je 0,88 za PFS (95% CI: 0,53; 1,45) i 0,74 za OS (95% CI: 0,37, 1,47).
Early Breast Cancer
Rani rak dojke
The population PK analysis showed that creatinine clearance does not affect the PK of trastuzumab emtansine.
Populacijska farmakokinetička analiza pokazala je da klirens kreatinina ne utječe na farmakokinetiku trastuzumab emtanzina.
Kadcyla is not recommended for anyone under the age of 18 years.
Kadcyla se ne preporučuje za osobe mlađe od 18 godina, jer nema podataka o tome kako lijek djeluje u toj dobnoj skupini.
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).
• trastuzumaba - monoklonskog protutijela koje se selektivno veže za antigen (ciljni protein) koji se zove receptor humanog epidermalnog faktora rasta 2 (HER2).
Hierarchical testing applied for IDFS and OS 2.
Za IDFS i OS primijenjeno je hijerarhijsko testiranje.
INFORMATION IN BRAILLE Justification for not including Braille accepted
15. UPUTE ZA UPORABU 16. PODACI NA BRAILLEOVOM PISMU Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma.
Standard cardiac function testing (echocardiogram or multigated acquisition (MUGA) scanning) should be performed prior to initiation of treatment and also at regular intervals (e.g. every three months) during treatment.
Prije početka liječenja i također u redovitim razmacima tijekom liječenja (npr. svaka tri mjeseca) treba provoditi standardne testove srčane funkcije (ehokardiogram ili ekvilibrijsku radionuklidnu ventrikulografiju (engl. multigated acquisition, MUGA)).
LVEF 45% to < 50% and decrease is < 10% points from baseline*
LVEF od 45% do < 50% i smanjenje za ≥ 10 postotnih bodova od početne vrijednosti*
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 se nalazi u staklenoj bočici (staklo tipa 1) od 20 ml (160 mg), zatvorenoj sivim gumenim čepom (butilna guma obložena slojem fluorosmole) i zabrtvljenoj aluminijskim prstenom s plastičnim „flip-off“ poklopcem ljubičaste boje.
Grade ≥ 2.
PRILOG II.
For dose modifications in the event of hypersensitivity reactions, see sections 4.2 and 4.4.
Za prilagodbu doze u slučaju reakcija preosjetljivosti vidjeti dijelove 4.2 i 4.4.
In the subgroup of patients with hormone receptor-negative disease (n=426), the hazard ratios for PFS and OS were 0.56 (95% CI: 0.44, 0.72) and 0.75 (95% CI: 0.54, 1.03), respectively.
U podskupini bolesnika s bolešću negativnom na hormonske receptore (n=426) omjer hazarda za PFS iznosio je 0,56 (95% CI: 0,44; 0,72), a za OS 0,75 (95% CI: 0,54, 1,03).
· 160 mg trastuzumab emtansine vial: Using a sterile syringe, slowly inject 8 mL of sterile water for injection into the vial.
• Bočica sa 160 mg trastuzumab emtanzina: Sterilnom štrcaljkom polako ubrizgajte 8 ml sterilne vode za injekcije u bočicu.