FrancophonIA/ELRC3.0 huggingface dataset:
English: The exploratory analyses of covariates with information in only a subset of patients suggested that patients with greater shed HER2-ECD level had faster nonlinear clearance (lower Km) (P < 0.001).
Croatian: Eksploracijske analize kovarijanti na temelju podataka prikupljenih samo u jednoj podskupini bolesnika pokazali su da su bolesnici s višom razinom odcjepljivanja HER2-ECD-a imali brži nelinearni klirens (niži Km) (P<0,001).
English: Other side effects can occur at any time during treatment with Trazimera, not just related to an infusion.
Croatian: Ostale nuspojave mogu se pojaviti bilo kada tijekom liječenja lijekom Trazimera, a ne samo u svezi s infuzijom.
English: Cardiac failure (congestive)
Croatian: zatajenje srca (kongestivno)
English: Trastuzumab was administered weekly with chemotherapy and 3 weekly thereafter for a total of 52 weeks.
Croatian: Trastuzumab je primjenjivan tjedno uz kemoterapiju i svaka 3 tjedna nakon toga, ukupno 52 tjedna.
English: 5.2 Pharmacokineticproperties
Croatian: 5.2 Farmakokinetička svojstva
English: In patients who receive anthracycline-containing chemotherapy further monitoring is recommended, and should occur yearly up to 5 years from the last administration of Trazimera, or longer if a continuous decrease of LVEF is observed.
Croatian: U bolesnika koji primaju kemoterapiju koja sadrži antracikline, preporučuje se daljnje praćenje jednom godišnje do 5 godina od posljednje primjene lijeka Trazimera ili dulje ako je uočeno daljnje smanjenje LVEF-a.
English: When Trazimera binds to HER2 it stops the growth of such cells and causes them to die.
Croatian: Kada se Trazimera veže na HER2, zaustavlja rast tih stanica i uzrokuje njihovo odumiranje.
English: Study H0649g: IHC3+ patient subset
Croatian: Ispitivanje H0649g: IHC3+ podskupina bolesnica
English: For intravenous use only
Croatian: Samo za intravensku primjenu
English: DO NOT SHAKE!
Croatian: NE TRESITE BOČICU!
English: which was followed by • CMF on day 1 and 8 every 4 weeks for 3 cycles which was followed after surgery by • additional cycles of adjuvant trastuzumab (to complete 1 year of treatment)
Croatian: a zatim • CMF 1. i 8. dana svaka 4 tjedna u 3 ciklusa a zatim nakon kirurškog zahvata • dodatni ciklusi adjuvantnog trastuzumaba (do dovršetka 1 godine liječenja).
English: At the time of the analysis a total of 349 randomized patients had died: 182 patients (62.8%) in the control arm and 167 patients (56.8%) in the treatment arm.
Croatian: U vrijeme analize umrlo je 349 od ukupnog broja randomiziranih bolesnika: 182 bolesnika (62,8 %) u kontrolnoj skupini i 167 bolesnika (56,8 %) u ispitivanoj skupini.
English: Patients treated with Trazimera are at increased risk for developing CHF (New York Heart Association [NYHA] Class II-IV) or asymptomatic cardiac dysfunction.
Croatian: U bolesnika liječenih lijekom Trazimera postoji povećan rizik od razvoja kongestivnog zatajenja srca (CHF) (klase II-IV prema New York Heart Association [NYHA]) ili asimptomatske disfunkcije srca.
English: They include weakening of the heart muscle possibly leading to heart failure, inflammation of the lining around the heart and heart rhythm disturbances.
Croatian: Oni uključuju slabljenje srčanog mišića, što može uzrokovati zatajenje srca, upalu srčane ovojnice i poremećaje srčanog ritma.
English: These symptoms can be treated with an analgesic/antipyretic such as meperidine or paracetamol, or an antihistamine such as diphenhydramine.
Croatian: Ovi se simptomi mogu liječiti analgeticima/antipireticima, poput meperidina ili paracetamola, ili antihistaminicima, poput difenhidramina.
English: Reversibility of severe CHF (defined as a sequence of at least two consecutive LVEF values ≥50% after the event) was evident for 71.4% of trastuzumab-treated patients.
Croatian: Reverzibilnost teškog kongestivnog zatajenja srca (definirana kao slijed od najmanje dviju uzastopnih vrijednosti LVEF > 50% nakon događaja) bila je primjetna u 71,4% bolesnika liječenih trastuzumabom.
English: Time to steadystate (week)
Croatian: Vrijeme do stanja dinamičke ravnoteže (tjedni)
English: Severe anaphylactic reactions requiring immediate additional intervention can occur usually during either the first or second infusion of trastuzumab(see section 4.4) and have been associated with a fatal outcome.
Croatian: Teške anafilaktičke reakcije koje zahtijevaju dodatnu hitnu intervenciju obično se javljaju tijekom 1. ili 2. infuzije trastuzumaba (vidjeti dio 4.4) i mogu imati smrtni ishod.
English: Talk to your doctor, pharmacist or nurse before you are given Trazimera if:
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primite lijek Trazimera:
English: Table 13 Efficacy Results from BO18225 Parameter
Croatian: Tablica 13 Rezultati djelotvornosti iz ispitivanja BO18225 Parametar
English: At the time of a safety update after a median of 3.5-3.8 years follow up, an analysis of DFS reconfirms the magnitude of the benefit shown in the definitive analysis of DFS.
Croatian: U vrijeme kontrole sigurnosti primjene nakon medijana praćenja od 3,5-3,8 godina, analiza preživljenja bez bolesti ponovno je potvrdila značajnu korist prikazanu u konačnoj analizi preživljenja bez bolesti.
English: The presence of anti-trastuzumab antibodies had no impact on the pharmacokinetics, efficacy (determined by pathological Complete Response [pCR] and event free survival [EFS]) and safety determined by occurrence of administration related reactions (ARRs) of trastuzumab intravenous.
Croatian: Prisutnost protutijela na trastuzumab nije utjecala na farmakokinetiku, djelotvornost (određenu potpunim patološkim odgovorom [engl. pathological complete response, pCR]) i preživljenjem bez događaja [engl. event-free survival, EFS]) niti sigurnost određenu na temelju nastupa reakcija povezanih s primjenom trastuzumaba za intravensku primjenu.
English: Trastuzumab 1 Year N=1693
Croatian: Trastuzumab tijekom1 godine N=1693
English: If you experience any of the above symptoms when your treatment with Trazimera has finished, you should see your doctor and tell them that you have previously been treated with Trazimera.
Croatian: Ako se neki od gore navedenih simptoma jave nakon prestanka liječenja lijekom Trazimera, javite se svom liječniku i recite mu da ste prethodno bili liječeni lijekom Trazimera.
English: A careful risk-benefit assessment should be made before deciding to treat with Trazimera.
Croatian: Potrebna je pomna procjena rizika i koristi liječenja prije donošenja odluke o liječenju lijekom Trazimera.
English: The addition of trastuzumab to paclitaxel chemotherapy also resulted in a 37% decrease in the risk of death.
Croatian: Dodavanje trastuzumaba kemoterapiji paklitakselom rezultiralo je i smanjenjem rizika od smrti za 37 %.
English: Very rarely, patients with severe breathing difficulties before treatment have died when they were given Trazimera.
Croatian: Vrlo rijetko su bolesnici koji su i prije liječenja imali znatne poteškoće s disanjem preminuli nakon primjene lijeka Trazimera.
English: IHC is recommended as the first testing modality and in cases where HER2 gene amplification status is also required, either a silver-enhanced in situ hybridization (SISH) or a FISH technique must be applied.
Croatian: IHC se preporučuje kao prvi način testiranja, a u slučajevima kod kojih je potreban i status HER2 genske amplifikacije treba primijeniti ili srebrom povećanu in situ hibridizaciju (SISH) ili FISH metodu.
English: Some of the side-effects you experience may be due to your underlying cancer.
Croatian: Neke nuspojave koje primijetite mogu biti posljedica samog raka.
English: If you stop using Trazimera
Croatian: Ako prestanete primati lijek Trazimera
English: Details of risk minimisation measures that are consistent with the EU Risk Management Plan are presented in (section 4.4) Warnings and Precautions.
Croatian: Pojedinosti o mjerama za smanjenje rizika u skladu s europskim planom upravljanja rizicima navedene su u dijelu Posebna upozorenja i mjere opreza pri uporabi (dio 4.4).
English: If diluted aseptically, it may be stored for 24 hours (do not store above 30°C).
Croatian: Ako je otopina za infuziju pripravljana u aseptičkim uvjetima, može se čuvati 24 sata (ne čuvati na temperaturi iznad 30°C).
English: A vial of Trazimera reconstituted with water for injections (not supplied) is stable for 48 hours at 2ºC - 8ºC after reconstitution and must not be frozen.
Croatian: Sadržaj bočice lijeka Trazimera rekonstituiran s vodom za injekcije (nije priložena u pakiranju) stabilan je 48 sati na temperaturi od 2°C do 8°C nakon rekonstitucije i ne smije se zamrzavati.
English: If the initial loading dose was well tolerated, the subsequent doses can be administered as a 30minute infusion.
Croatian: Ako je bolesnik dobro podnio početnu udarnu dozu, sljedeće se doze mogu primjenjivati u 30minutnoj infuziji.
English: which was followed by
Croatian: nakon čega je slijedio:
English: The rate of asymptomatic cardiac dysfunction was increased in the 2-year treatment arm (8.1% versus 4.6% in the 1-year treatment arm).
Croatian: Stopa asimptomatske disfunkcije srca bila je povećana u skupini liječenoj tijekom 2 godine (8,1 % naspram 4,6 % u skupini liječenoj tijekom 1 godine).
English: Trazimera treatment should only be initiated by a physician experienced in the administration of cytotoxic chemotherapy (see section 4.4), and should be administered by a healthcare professional only.
Croatian: Liječenje lijekom Trazimera smije započeti samo liječnik s iskustvom u primjeni citotoksične kemoterapije (vidjeti dio 4.4), a lijek smije primijeniti samo zdravstveni radnik.
English: Either of which was administered with:
Croatian: Bilo koja od navedenih terapija primjenjivana je uz:
English: Trazimera contains the active substance trastuzumab, which is a monoclonal antibody.
Croatian: Trazimera sadrži djelatnu tvar trastuzumab, koji je monoklonsko protutijelo.
English: Chemotherapy was administered as follows:
Croatian: Kemoterapija je primjenjivana na sljedeći način:
English: For overall survival, the HR was 0.75 (95% CI 0.51-1.11) in the IHC 2+/FISH+ group and the HR was 0.58 (95% CI 0.41-0.81) in the IHC 3+/FISH+ group.
Croatian: Za ukupno preživljenje HR je iznosio 0,75 (95 % CI 0,51-1,11) u skupini IHC 2+/FISH+ i 0,58 (95 % CI 0,41-0,81) u skupini IHC 3+/FISH+.
English: In order to prevent medication errors it is important to check the vial labels to ensure that the medicine being prepared and given is Trazimera (trastuzumab) and not trastuzumab emtansine.
Croatian: U svrhu sprečavanja medikacijskih pogrešaka, važno je provjeriti naljepnice na bočicama kako biste bili sigurni da je lijek koji se priprema i primjenjuje Trazimera (trastuzumab), a ne trastuzumab emtanzin.
English: Post-hoc exploratory analysis with DFS and symptomatic cardiac events Long term follow-up Hazard ratios (95% CI)
Croatian: Post-hoc eksplorativna analiza s preživljenjem bez bolesti i simptomatskim srčanim događajima Dugoročno praćenje Omjeri hazarda (95% CI)
English: An overfill of 4% ensures that the labelled dose of 150 mg can be withdrawn from each vial.
Croatian: Višak od 4 % osigurava da se naznačena doza od 150 mg može izvući iz svake bočice.
English: Observed with combination therapy following anthracyclines and combined with taxanes
Croatian: Opaženo u kombiniranoj terapiji nakon antraciklina i u kombinaciji s taksanima.
English: The highest rate of cardiac dysfunction was seen in patients receiving trastuzumab concurrently with anthracycline/cyclophosphamide (27%), and was significantly higher than for anthracycline/cyclophosphamide alone (7% - 10%).
Croatian: Najviša stopa srčane disfunkcije zabilježena je u bolesnica koje su primale trastuzumab istodobno s antraciklinom/ciklofosfamidom (27%), što je bilo značajno više nego kod primjene samo antraciklina/ciklofosfamida (7% - 10%).
English: Table 12 Efficacy Results from MO16432 Parameter
Croatian: Tablica 12 Rezultati djelotvornosti iz ispitivanja MO16432 Parametar
English: In this trial, 87% of patients entered had disease that was IHC3+, and 95% of patients entered had disease that was IHC3+ and/or FISH-positive.
Croatian: U tom je ispitivanju 87 % bolesnica bilo IHC3+, a 95 % njih je bilo IHC3+ i/ili FISH pozitivno.
English: Risk factors for a cardiac event identified in four large adjuvant studies included advanced age (>50 years), low LVEF (<55%) at baseline, prior to or following the initiation of paclitaxel treatment, decline in LVEF by 10-15 points, and prior or concurrent use of anti-hypertensive medicinal products.
Croatian: Faktori rizika za srčani događaj utvrđeni u četiri velika ispitivanja adjuvantnog liječenja uključivali su stariju dob (> 50 godina), nizak LVEF (< 55%) na početku liječenja, prije ili nakon početka liječenja paklitakselom, pad LVEF-a za 10-15 bodova te prethodnu ili istodobnu primjenu antihipertenziva.
English: If symptomatic cardiac failure develops during Trazimera therapy, it should be treated with standard medicinal products for CHF.
Croatian: Ako se tijekom liječenja lijekom Trazimera razvije simptomatsko zatajenje srca, potrebno je primijeniti standardne lijekove koji se propisuju za CHF.
English: It must not be diluted with glucose solutions.
Croatian: Ne smije se razrjeđivati otopinom glukoze.
English: In addition, caution should be exercised in treating patients with increased cardiac risk, e.g. hypertension, documented coronary artery disease, CHF, LVEF of <55%, older age.
Croatian: Osim toga, neophodan je oprez pri liječenju bolesnika u kojih postoji povećan srčani rizik, npr. hipertenzija, dokumentirana bolest koronarnih arterija, kongestivno zatajenje srca, ejekcijska frakcija lijeve klijetke (LVEF) < 55%, starija dob.
English: Do not use Trazimera if you notice any particulate matter or discoloration prior to administration.
Croatian: Trazimera se ne smije upotrijebiti ako primijetite bilo kakve čestice ili promjenu boje prije primjene.
English: - in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.
Croatian: - u kombinaciji s adjuvantnom kemoterapijom koja uključuje docetaksel i karboplatin.
English: Early breast cancer is defined as non-metastatic primary invasive carcinoma of the breast.
Croatian: Rani rak dojke definira se kao primarni invazivni karcinom dojke bez metastaza.
English: In the pivotal metastatic trials of intravenous trastuzumab, the incidence of cardiac dysfunction varied between 9% and 12% when it was combined with paclitaxel compared with 1% - 4% for paclitaxel alone.
Croatian: U pivotalnim ispitivanjima intravenske formulacije trastuzumaba u metastatskoj bolesti, incidencija srčane disfunkcije kretala se između 9% i 12% kod primjene u kombinaciji s paklitakselom, u usporedbi s 1% - 4% kod primjene samo paklitaksela.
English: However, the majority of infusion-related reactions are mild to moderate in intensity (NCI-CTC grading system) and tend to occur earlier in treatment, i.e. during infusions one, two and three and lessen in frequency in subsequent infusions.
Croatian: Međutim, većina infuzijskih reakcija je blagog do umjerenog intenziteta (prema NCI-CTC stupnjevanju) i uglavnom se javlja na početku liječenja, tj. za vrijeme 1., 2. i 3. infuzije te im se učestalost smanjuje sa svakom sljedećom infuzijom.
English: Amongst the most serious and/or common adverse reactions reported in trastuzumab usage (intravenous and subcutaneous formulations) to date are cardiac dysfunction, infusion-related reactions, haematotoxicity (in particular neutropenia), infections and pulmonary adverse reactions.
Croatian: Među najozbiljnije i/ili najčešće nuspojave dosad prijavljene pri primjeni trastuzumaba (u intravenskoj i supkutanoj formulaciji) ubrajaju se disfunkcija srca, reakcije povezane s infuzijom, hematotoksičnost (osobito neutropenija), infekcije i plućne nuspojave.
English: In general, FISH is considered positive if the ratio of the HER2 gene copy number per tumour cell to the chromosome 17 copy number is greater than or equal to 2, or if there are more than 4 copies of the HER2 gene per tumour cell if no chromosome 17 control is used.
Croatian: Općenito, FISH se smatra pozitivnim ako je omjer broja genskih kopija HER2 po tumorskoj stanici i broja kopija kromosoma 17 veći ili jednak 2, ili ako postoji više od 4 kopije HER2 gena po tumorskoj stanici ako se ne koristi kromosomom 17 kao kontrola.
English: An absolute benefit of 13 percentage points in favour of the trastuzumab arm was estimated in terms of 3-year event-free survival rate (65% versus 52%).
Croatian: Za skupinu koja je primala trastuzumab procijenjena je apsolutna korist od 13 postotnih bodova za stopu trogodišnjeg preživljenja bez štetnih događaja (65 % naspram 52 %).
English: In 3 pivotal clinical trials of adjuvant trastuzumab given in combination with chemotherapy, the incidence of grade 3/4 cardiac dysfunction (specifically symptomatic Congestive Heart Failure) was similar in patients who were administered chemotherapy alone (i.e., did not receive trastuzumab) and in patients who were administered trastuzumab sequentially after a taxane (0.3-0.4%).
Croatian: U 3 pivotalna klinička ispitivanja adjuvantne primjene trastuzumaba u kombinaciji s kemoterapijom, incidencija disfunkcije srca stupnja 3/4 (osobito simptomatsko kongestivno zatajenje srca) bila je slična u bolesnika koji su primili samo kemoterapiju (dakle, nisu primili trastuzumab) i u bolesnika koji su primili trastuzumab nakon taksana (0,3 - 0,4%).
English: - in combination with neoadjuvant chemotherapy followed by adjuvant Trazimera therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter (see sections 4.4 and 5.1).
Croatian: - u kombinaciji s neoadjuvantnom kemoterapijom nakon koje slijedi adjuvantna terapija lijekom Trazimera za lokalno uznapredovalu (uključujući upalnu) bolest ili tumore promjera > 2 cm (vidjeti dijelove 4.4 i 5.1).
English: t1/2 range from Cmax,ss to Cmin,ss (day)
Croatian: Raspon t1/2 od Cmax,ss do Cmin,ss (dani)
English: An overfill of 5% ensures that the labelled dose of 420 mg can be withdrawn from each vial.
Croatian: Višak od 5 % osigurava da se naznačena doza od 420 mg može izvući iz svake bočice.
English: Trazimera is for single-use only, as the product contains no preservatives.
Croatian: Lijek Trazimera namijenjen je samo za jednokratnu primjenu jer ne sadrži konzervanse.
English: More patients experienced at least one grade 3 or 4 adverse event in the 2-year treatment arm (20.4%) compared with the 1-year treatment arm (16.3%).
Croatian: Barem jedan štetan događaj stupnja 3 ili 4 pojavio se u više bolesnika u skupini liječenoj tijekom 2 godine (20,4 %) u usporedbi sa skupinom liječenom tijekom 1 godine (16,3 %).
English: • You have metastatic gastric cancer with high levels of HER2, when it is in combination with the other cancer medicines capecitabine or 5-flououracil and cisplatin.
Croatian: • bolujete od metastatskog raka želuca s visokom razinom proteina HER2, u kombinaciji s drugim lijekovima za liječenje raka, kapecitabinom ili 5-fluorouracilom i cisplatinom.
English: When trastuzumab was administered after completion of adjuvant chemotherapy NYHA Class III-IV heart failure was observed in 0.6% of patients in the one-year arm after a median follow-up of 12 months.
Croatian: Kada se trastuzumab primjenjivao nakon završetka adjuvantne kemoterapije, zatajenje srca NYHA klase III-IV primijećeno je u 0,6% bolesnika iz skupine liječene godinu dana nakon medijana od 12 mjeseci praćenja.
English: In a method comparison study (study D008548) a high degree of concordance (>95%) was observed for SISH and FISH techniques for the detection of HER2 gene amplification in gastric cancer patients.
Croatian: U ispitivanju uspoređivanja metoda (ispitivanje D008548) u bolesnika s rakom želuca ustanovljen je visok stupanj podudarnosti (> 95 %) za SISH i FISH metode utvrđivanja genske amplifikacije HER2.
English: Trazimera intravenous infusion should be administered by a health-care provider prepared to manage anaphylaxis and an emergency kit should be available.
Croatian: Intravensku infuziju lijeka Trazimera treba dati stručni zdravstveni radnik obučen za liječenje anafilaksije, a na raspolaganju treba biti oprema za hitne slučajeve.
English: Patients with EBC should be treated with Trazimera for 1 year or until disease recurrence, whichever occurs first; extending treatment in EBC beyond one year is not recommended (see section 5.1).
Croatian: U bolesnika s ranim rakom dojke liječenje lijekom Trazimera traje godinu dana ili do povrata bolesti, štogod nastupi ranije; ne preporučuje se produljiti liječenje ranog raka dojke dulje od jedne godine (vidjeti dio 5.1).
English: Do not use this medicine after the expiry date which is stated on the outer carton and on the vial label after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici bočice iza oznake „EXP“.
English: Total CL range from Cmax,ss to Cmin,ss (L/day)
Croatian: Raspon ukupnog klirensa od Cmax,ss do Cmin,ss (l/dan)
English: The efficacy results from the BO16348 trial following 12 months* and 8 years** median follow-up are summarized in Table 6:
Croatian: Rezultati djelotvornosti dobiveni ispitivanjem BO16348, nakon medijana praćenja od 12 mjeseci* i 8 godina**, sažeti su u Tablici 6:
English: Paclitaxel, in combination with trastuzumab, was administered as follows:
Croatian: Paklitaksel je u kombinaciji s trastuzumabom primjenjivan na sljedeći način:
English: The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
English: • swelling or bleeding at the back of the eyes
Croatian: • oticanje mozga oticanje ili krvarenje u pozadini oka šok
English: Table 6 Efficacy Results from Study BO16348 Median follow-up 12 months* Median follow-up 8 years**
Croatian: Tablica 6 Rezultati djelotvornosti iz ispitivanja BO16348 Medijan praćenja 12 mjeseci*
English: In study BCIRG 006, 213/1075 patients in the DCarbH (TCH) arm, 221/1074 patients in the AC→DH (AC→TH) arm, and 217/1073 in the AC→D (AC→T) arm had a Karnofsky performance status ≤90 (either 80 or 90).
Croatian: U ispitivanju BCIRG 006 je 213/1075 bolesnica u skupini DCarbH (TCH), 221/1074 bolesnica u skupini AC→DH (AC→TH) i 217/1073 bolesnica u skupini AC→D (AC→T) imalo Karnofsky status <90 (bilo 80 ili 90).
English: Trastuzumab plus paclitaxel N=68
Croatian: Trastuzumab s paklitakselom N=68
English: Patients were recruited to the trial who were previously untreated for HER2-positive inoperable locally advanced or recurrent and/or metastatic adenocarcinoma of the stomach or gastrooesophageal junction not amenable to curative therapy.
Croatian: U ispitivanje su uključeni bolesnici koji prethodno nisu bili liječeni zbog HER2-pozitivnog inoperabilnog lokalno uznapredovalog ili rekurentnog i/ili metastatskog adenokarcinoma želuca ili gastroezofagealnog spoja nepogodnog za kurativno liječenje.