FrancophonIA/ELRC3.0 huggingface dataset:
English: Common: may affect up to 1 in 10 people
Croatian: Česte: mogu se javiti u manje od 1 na 10 osoba
English: In the BCIRG 006 study for the primary endpoint, DFS, the hazard ratio translates into an absolute benefit, in terms of 3-year disease-free survival rate estimates of 5.8 percentage points (86.7% versus 80.9%) in favour of the AC→DH (trastuzumab) arm and 4.6 percentage points (85.5% versus 80.9%) in favour of the DCarbH (trastuzumab) arm compared to AC→D.
Croatian: Za primarnu mjeru ishoda ispitivanja BCIRG 006, preživljenje bez bolesti, omjer hazarda apsolutno je povoljan u smislu trogodišnjeg preživljenja bez bolesti s razlikom od 5,8 postotnih bodova (86,7 % naspram 80,9 %) u korist AC→DH skupine (trastuzumab) i 4,6 postotnih bodova (85,5 % naspram 80,9 %) u korist DCarbH skupine (trastuzumab) u usporedbi s AC→D skupinom.
English: • Doxorubicin 60 mg/m 2 and paclitaxel 150 mg/m 2, administered 3-weekly for 3 cycles,
Croatian: • doksorubicin 60 mg/m 2 plus paklitaksel 150 mg/m 2, svaka 3 tjedna u 3 ciklusa,
English: - The other ingredient(s) are L-histidine hydrochloride monohydrate, L-histidine, sucrose, polysorbate 20.
Croatian: Drugi sastojci su L-histidinklorid hidrat, L-histidin, saharoza, polisorbat 20.
English: Other infusion-related symptoms are: feeling sick (nausea), vomiting, pain, increased muscle tension and shaking, headache, dizziness, breathing difficulties, wheezing, high or low blood pressure, heart rhythm disturbances (palpitations, heart fluttering or irregular heart beat), swelling of the face and lips, rash and feeling tired.
Croatian: mučnina, povraćanje, bol, povećana napetost mišića i drhtanje, glavobolja, omaglica, otežano disanje, piskanje, visok ili nizak krvni tlak, poremećaji srčanog ritma (osjećaj lupanja srca, lepršanje srca ili nepravilni otkucaji srca), oticanje lica i usana, osip i umor.
English: Trazimera should be carefully handled during reconstitution.
Croatian: Tijekom rekonstitucije, lijekom Trazimera treba rukovati oprezno.
English: Infusion reactions, allergic-like reactions and hypersensitivity It is estimated that approximately 40% of patients who are treated with trastuzumab will experience some form of infusion-related reaction.
Croatian: Procjenjuje se da će otprilike 40 % bolesnika u tijeku liječenja trastuzumabom razviti neki oblik infuzijske reakcije.
English: The median overall survival for the high HER2 expressing group was 11.8 months versus 16 months, HR 0.65 (95% CI 0.51-0.83) and the median progression free survival was 5.5 months versus 7.6 months, HR 0.64 (95% CI 0.510.79) for FP versus FP + H, respectively.
Croatian: Medijan ukupnog preživljenja u skupini s visokom ekspresijom proteina HER2 iznosio je 11,8 mjeseci naspram 16 mjeseci, omjer hazarda (HR) bio je 0,65 (95 % CI 0,51-0,83), dok je medijan preživljenja bez napredovanja bolesti iznosio 5,5 mjeseci naspram 7,6 mjeseci, HR 0,64 (95 % CI 0,51-0,79).
English: Strong complete, basolateral or lateral membranous reactivity in ≥10% of tumour cells
Croatian: Jaka, potpuna, bazolateralna ili lateralna membranska reaktivnost u ≥ 10% tumorskih stanica
English: Overall Survival, Median months Progression-Free Survival, Median months
Croatian: Ukupno preživljenje, medijan u mjesecima
English: If LVEF percentage drops ≥10 points from baseline AND to below 50%, treatment should be suspended and a repeat LVEF assessment performed within approximately 3 weeks.
Croatian: I TAKOĐER na manje od 50%, terapiju je potrebno prekinuti i ponoviti procjenu LVEF-a unutar otprilike 3 tjedna.
English: • failure of the lungs of the baby to develop in the womb
Croatian: • neuspjeli razvoj pluća djeteta u maternici
English: Ear and labyrinth disorders Deafness
Croatian: Poremećaji uha i labirinta gluhoća manje često
English: Solutions of Trazimera for intravenous infusion are physically and chemically stable in polyvinylchloride, polyethylene, polypropylene or ethylene vinyl acetate bags, or glass intravenous bottles, containing sodium chloride 9 mg/mL (0.9%) solution for injection for 24 hours at temperatures not exceeding 30°C.
Croatian: Otopina lijeka Trazimera za intravensku infuziju u polivinilkloridnoj, polietilenskoj, polipropilenskoj ili etilenvinilacetatnoj vrećici, odnosno staklenoj boci za infuziju, koja sadrži 0,9 %-tnu (9 mg/ml) otopinu natrijeva klorida za injekciju, fizički i kemijski je stabilna 24 sata na temperaturama ispod 30°C.
English: Table 8 Final Overall Survival Analysis from the joint analysis of trials NSABP B-31 and NCCTG N9831
Croatian: Tablica 8 Konačna analiza ukupnog preživljenja iz skupne analize ispitivanja NSABP B-31 i NCCTG N9831
English: The results of this substudy suggested that the exposure to the bioactive metabolites (e.g., 5-FU) of capecitabine was not affected by concurrent use of cisplatin or by concurrent use of cisplatin plus trastuzumab.
Croatian: Rezultati ovog podispitivanja ukazali su da istodobna primjena cisplatina ili istodobna primjena cisplatina i trastuzumaba ne utječe na izloženost bioaktivnim metabolitima (npr. 5-FU) kapecitabina.
English: In a subsequent trial with prospective monitoring of cardiac function, the incidence of symptomatic CHF was 2.2% in patients receiving trastuzumab and docetaxel, compared with 0% in patients receiving docetaxel alone.
Croatian: U kasnijem ispitivanju u kojem se prospektivno pratila srčana funkcija, incidencija simptomatskog kongestivnog zatajenja srca bila je 2,2% u bolesnica koje su primale trastuzumab i docetaksel, u usporedbi s 0% u bolesnica koje su primale samo docetaksel.
English: The hazard ratio translates into an absolute benefit, in terms of 3-year disease-free survival rate estimates of 11.8 percentage points (87.2% versus 75.4%) in favour of the AC→PH (trastuzumab) arm.
Croatian: Omjer hazarda apsolutno je povoljan u smislu trogodišnjeg preživljenja bez bolesti s razlikom od 11,8 postotnih bodova (87,2 % naspram 75,4 %) u korist skupine liječene AC→PH kemoterapijom (trastuzumabom).
English: Table 4 Efficacy Results from the Monotherapy and Combination Therapy Studies Parameter Monotherapy
Croatian: Tablica 4 Rezultati djelotvornosti iz ispitivanja monoterapije i kombinirane terapije Parametar
English: Discard at the end of this 3-month period or by the expiry date on the vial, whichever occurs first.
Croatian: Bacite lijek nakon isteka ovog tromjesečnog razdoblja ili roka valjanosti otisnutog na bočici, što god nastupi ranije.
English: Reproduction studies have been conducted in Cynomolgus monkeys at doses up to 25 times that of the weekly human maintenance dose of 2 mg/kg trastuzumab intravenous formulation and have revealed no evidence of impaired fertility or harm to the foetus.
Croatian: Ispitivanjima utjecaja na reprodukciju provedenim na makaki majmunima s dozama intravenske formulacije trastuzumaba do 25 puta većim od tjedne doze održavanja u ljudi od 2 mg/kg, nije dokazano smanjenje plodnosti niti opasnost za fetus.
English: Table 3 Recommended Scoring System to Evaluate the IHC Staining Patterns in Gastric Cancer Score Surgical specimen - staining pattern
Croatian: Tablica 3 Preporučena ljestvica vrednovanja rezultata bojanja preparata po IHC metodi u raku želuca Rezultat Kirurški uzorak karakteristika obojenja
English: Data from study JP16003, a single-arm study of trastuzumab (4 mg/kg intravenous loading dose and 2 mg/kg intravenous dose weekly) and docetaxel (60 mg/m2 intravenous dose) in Japanese women with HER2- positive MBC, suggested that concomitant administration of trastuzumab had no effect on the single-dose pharmacokinetics of docetaxel.
Croatian: Podaci iz ispitivanja JP16003, ispitivanja trastuzumaba (intravenska udarna doza od 4 mg/kg, nakon koje slijedi intravenska doza od 2 mg/kg jedanput tjedno) i docetaksela (60 mg/m2 intravenski) s jednom skupinom žena japanskog podrijetla s HER2-pozitivnim metastatskim rakom dojke, ukazali su da istodobna primjena trastuzumaba ne utječe na farmakokinetiku jednokratne doze docetaksela.
English: By comparison of simulated serum trastuzumab concentrations after trastuzumab monotherapy (4 mg/kg loading/2 mg/kg q1w intravenous) and observed serum concentrations in Japanese women with HER2- positive MBC (study JP16003) no evidence of a PK effect of concurrent administration of docetaxel on the pharmacokinetics of trastuzumab was found.
Croatian: Usporedbom simuliranih koncentracija trastuzumaba u serumu nakon monoterapije trastuzumabom (udarna doza od 4 mg/kg intravenski / 2 mg/kg intravenski jedanput tjedno) i opaženih koncentracija u serumu žena japanskog podrijetla s HER2-pozitivnim metastatskim rakom dojke (ispitivanje JP16003) nisu pronađeni dokazi farmakokinetičkog učinka istodobne primjene docetaksela na farmakokinetiku trastuzumaba.
English: Serious IRRs to trastuzumab infusion including dyspnoea, hypotension, wheezing, hypertension, bronchospasm, supraventricular tachyarrhythmia, reduced oxygen saturation, anaphylaxis, respiratory distress, urticaria and angioedema have been reported (see section 4.8).
Croatian: Zabilježene su ozbiljne reakcije povezane s infuzijom trastuzumaba uključujući dispneju, hipotenziju, piskanje, hipertenziju, bronhospazam, supraventrikularnu tahiaritmiju, smanjenu zasićenost kisikom, anafilaksiju, respiratorni distres, urtikariju i angioedem (vidjeti dio 4.8).
English: A study conducted in lactating Cynomolgus monkeys at doses 25 times that of the weekly human maintenance dose of 2 mg/kg trastuzumab intravenous formulation demonstrated that trastuzumab is secreted in the milk.
Croatian: Ispitivanja provedena na makaki majmunima u razdoblju laktacije, kojima su davane doze intravenske formulacije trastuzumaba 25 puta veće od tjednih doza održavanja u ljudi od 2 mg/kg, pokazala su da se trastuzumab izlučuje u mlijeko.
English: AC→PH (N=2031)
Croatian: AC→PII (N=2031)
English: As a three-weekly regimen the recommended initial loading dose of Trazimera is 8 mg/kg body weight.
Croatian: U trotjednim ciklusima preporučena početna udarna doza lijeka Trazimera iznosi 8 mg/kg tjelesne težine.
English: For the primary endpoint, DFS, the addition of trastuzumab to paclitaxel chemotherapy resulted in a 52% decrease in the risk of disease recurrence.
Croatian: Za primarnu mjeru ishoda, preživljenje bez bolesti, dodavanje trastuzumaba kemoterapiji paklitakselom rezultiralo je smanjenjem rizika od ponovne pojave bolesti za 52 %.
English: L-histidine hydrochloride monohydrate L-histidine sucrose polysorbate 20
Croatian: L-histidinklorid hidrat L-histidin saharoza polisorbat 20
English: The resulting solution contains approximately 21 mg/mL trastuzumab.
Croatian: Tako pripremljena otopina sadrži otprilike 21 mg/ml trastuzumaba.
English: A: doxorubicin; C: cyclophosphamide; P: paclitaxel; D: docetaxel; Carb: carboplatin; H: trastuzumab CI = confidence interval
Croatian: A: doksorubicin, C: ciklofosfamid, P: paklitaksel, D: docetaksel, Carb: karboplatin, H: trastuzumab CI = interval pouzdanosti
English: The reconstituted Trazimera solution contains 21 mg/mL of trastuzumab.
Croatian: Rekonstituirana otopina lijeka Trazimera sadrži 21 mg/ml trastuzumaba.
English: The median duration of follow up was 1.8 years for the patients in the AC→P arm and 2.0 years for patients in the AC→PH arm.
Croatian: Medijan trajanja praćenja iznosio je 1,8 godina za bolesnice u skupini koja je primila AC→P kemoterapiju i 2,0 godine za bolesnice u skupini koja je primala AC→PH kemoterapiju.
English: • blood infection
Croatian: • krvarenje iz nosa
English: Trazimera is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer: (MBC):
Croatian: Lijek Trazimera je indiciran u liječenju odraslih bolesnika s HER2 pozitivnim metastatskim rakom dojke:
English: Weak to moderate complete, basolateral or lateral membranous reactivity in ≥10% of tumour cells
Croatian: Slaba do umjereno potpuna, bazolateralna ili lateralna membranska reaktivnost u ≥ 10% tumorskih stanica
English: 15 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film containing 150 mg of trastuzumab.
Croatian: Staklena bočica od 15 ml (bezbojno staklo tipa I) s butilnim gumenim čepom presvučenim slojem fluorosmole sadrži 150 mg trastuzumaba.
English: For patients with EBC, cardiac assessments, as performed at baseline, should be repeated every 3 months during treatment and every 6 months following discontinuation of treatment until 24 months from the last administration of Trazimera.
Croatian: U bolesnika s ranim rakom dojke, kardiološki pregled istovjetan onom obavljenom u sklopu početne procjene, potrebno je ponavljati svaka 3 mjeseca tijekom liječenja te svakih 6 mjeseci nakon završetka liječenja do 24 mjeseca od posljednje primjene lijeka Trazimera.
English: • acute accumulation of fluid in the lungs
Croatian: • respiratorni distres zatajenje disanja akutno nakupljanje tekućine u plućima
English: The study recruited patients with newly diagnosed locally advanced (Stage III) or inflammatory EBC.
Croatian: U ispitivanje su uključivane bolesnice s novodijagnosticiranim, lokalno uznapredovalim rakom dojke (stadija III) ili upalnim ranim rakom dojke.
English: Long term follow-up efficacy analysis DFS Hazard rations (95% CI) p-value p<0.0001
Croatian: Analiza djelotvornosti tijekom dugoročnog praćenja** Omjeri hazarda za preživljenje bez bolesti (95% CI) p-vrijednost p<0,0001
English: *Co-primary endpoint of DFS of 1 year versus observation met the pre-defined statistical boundary **Final analysis (including crossover of 52% of patients from the observation arm to trastuzumab) ***There is a discrepancy in the overall sample size due to a small number of patients who were randomized after the cut-off date for the 12-month median follow-up analysis
Croatian: ***Postoji nesrazmjer u ukupnoj veličini uzorka zbog malog broja bolesnika koji su randomizirani nakon završnog datuma za analizu medijana praćenja od 12 mjeseci.
English: or - intravenous docetaxel - 75 mg/m 2 as an intravenous infusion over 1 hour, given every 3 weeks for 6 cycles (day 2 of cycle 1, then day 1 of each subsequent cycle)
Croatian: • intravenski docetaksel - 75 mg/m 2 u intravenskoj infuziji tijekom 1 sata, svaka 3 tjedna u 6 ciklusa (2. dan 1. ciklusa, a potom 1. dan svakog sljedećeg ciklusa)
English: Patients are eligible for Trazimera treatment if they show strong HER2 overexpression as described by a 3+ score by IHC or a positive FISH or CISH result.
Croatian: Liječenje lijekom Trazimera preporučuje se onim bolesnicima koji imaju izrazitu ekspresiju HER2 opisanu stupnjem 3+ na temelju IHC-a ili pak pozitivan FISH ili CISH rezultat.
English: Table 2 Recommended Scoring System to Evaluate the IHC Staining Patterns in Breast Cancer Score Staining pattern
Croatian: Tablica 2: Preporučena ljestvica vrednovanja rezultata bojanja preparata po IHC metodi kod raka dojke
English: Each 150 mg vial of Trazimera is reconstituted with 7.2 mL of sterile water for injections (not supplied).
Croatian: Sadržaj jedne bočice lijeka Trazimera od 150 mg rekonstituira se sa 7,2 ml sterilne vode za injekcije (nije priložena u pakiranju).
English: • Paclitaxel 175 mg/m2 administered 3-weekly for 4 cycles,
Croatian: • paklitaksel 175 mg/m2, svaka 3 tjedna u 4 ciklusa,
English: The recommended scoring system to evaluate the IHC staining patterns is as stated in Table 3:
Croatian: Preporučena ljestvica vrednovanja rezultata bojanja preparata po IHC metodi nalazi se u Tablici 3:
English: Primary efficacy analysis DFS Hazard ratios (95% CI) p-value p<0.0001
Croatian: Primarna analiza djelotvornosti Omjeri hazarda za preživljenje bez bolesti (95% CI) p-vrijednost p<0,0001
English: AC→PH (n=1672)
Croatian: AC→PII (n=1672)
English: The recommended scoring system to evaluate the IHC staining patterns is as stated in Table 2:
Croatian: Preporučena ljestvica vrednovanja rezultata bojanja preparata po IHC metodi nalazi se u Tablici 2:
English: • abnormally low levels of fluid around baby in womb
Croatian: • zatajenje bubrega abnormalno niska razina tekućine koja okružuje plod u maternici
English: - intravenous cyclophosphamide, at 600 mg/m 2 over 30 minutes, given every 3 weeks for
Croatian: - intravenski ciklofosfamid u dozi od 600 mg/m 2 kroz 30 minuta, svaka 3 tjedna u 4 ciklusa.
English: • skin rashes
Croatian: • osipi na koži
English: The final OS results from the joint analysis of studies NSABP B-31 and NCCTG N9831 are summarized in Table 8 below:
Croatian: Konačni rezultati ukupnog preživljenja iz skupne analize ispitivanja NSABP B-31 i NCCTG N9831 sažeto su prikazani u Tablici 8 u nastavku.
English: Trazimera should only be used in patients with metastatic gastric cancer (MGC) whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory SISH or FISH result, or by an IHC 3+ result.
Croatian: Lijek Trazimera treba davati samo onim bolesnicima s metastatskim rakom želuca čije tumorske stanice pokazuju povećanu ekspresiju HER2 određenu imunohistokemijski kao 2+ i potvrđenu SISHom ili FISH-om, ili određenu imunohistokemijski kao 3+.
English: 30 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film containing 420 mg of trastuzumab.
Croatian: Staklena bočica od 30 ml (bezbojno staklo tipa I) s butilnim gumenim čepom presvučenim slojem fluorosmole sadrži 420 mg trastuzumaba.
English: Each 420 mg vial of Trazimera is reconstituted with 20 mL of sterile water for injections (not supplied).
Croatian: Sadržaj jedne bočice lijeka Trazimera od 420 mg rekonstituira se sa 20 ml sterilne vode za injekcije (nije priložena u pakiranju).
English: - in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease.
Croatian: • u kombinaciji s docetakselom u liječenju bolesnika koji nisu prethodno primali kemoterapiju za metastatsku bolest
English: SUMMARY OF PRODUCT CHARACTERISTICS
Croatian: Rezultat Karakteristika obojenja
English: These include, but are not limited to, pulmonary infiltrates, acute respiratory distress syndrome, pneumonia, pneumonitis, pleural effusion, respiratory distress, acute pulmonary oedema and respiratory insufficiency (see section 4.4).
Croatian: Te nuspojave, između ostalog, uključuju plućne infiltrate, akutni respiratorni distres sindrom, upalu pluća, pneumonitis, pleuralni izljev, respiratorni distres, akutni plućni edem i respiratornu insuficijenciju (vidjeti dio 4.4).
English: • based on a loading dose of 4 mg trastuzumab/kg body weight, or a subsequent weekly dose of 2 mg trastuzumab/kg body weight:
Croatian: • za udarnu dozu trastuzumaba od 4 mg/kg tjelesne težine ili daljnje tjedne doze održavanja od 2 mg/kg tjelesne težine na sljedeći način:
English: In vitro, trastuzumabmediated ADCC has been shown to be preferentially exerted on HER2 overexpressing cancer cells compared with cancer cells that do not overexpress HER2.
Croatian: In vitro je pokazano da se trastuzumabom posredovana stanična citotoksičnost ovisna o protutijelima odvija s većim afinitetom na tumorskim stanicama koje imaju povećanu ekspresiju HER2 u usporedbi s tumorskim stanicama koje nemaju povećanu ekspresiju HER2.
English: Death (OS event): No. patients with event p=0.014
Croatian: Smrt (događaj ukupnog preživljenja): broj bolesnica s događajem p=0,014
English: Docetaxel was administered as follows: intravenous docetaxel - 100 mg/m 2 as an intravenous infusion over 1 hour, given every 3 weeks for 4 cycles (day 2 of first docetaxel cycle, then day 1 of each subsequent cycle)
Croatian: • intravenski docetaksel - 100 mg/m 2 u intravenskoj infuziji tijekom 1 sata, svaka 3 tjedna u 4 ciklusa (2. dan 1. ciklusa docetaksela, a potom 1. dan svakog sljedećeg ciklusa)
English: Severe pulmonary adverse reactions occur in association with the use of trastuzumab and have been associated with a fatal outcome.
Croatian: Pri primjeni trastuzumaba uočene su teške plućne nuspojave koje su povezane sa smrtni ishod.
English: Strong complete membrane staining is detected in >10% of the tumour cells.
Croatian: Jaka obojenost cijele membrane otkrivena u > 10 % tumorskih stanica.
English: Table 14 Population Predicted Cycle 1 PK Exposure Values (median with 5th - 95th Percentiles) for Trastuzumab Intravenous Dosing Regimens in MBC, EBC and AGC Patients Regimen
Croatian: Tablica 14 Vrijednosti farmakokinetičke izloženosti predviđene za populaciju u 1. ciklusu (medijan i 5. do 95. percentil) uz režime doziranja intravenske formulacije trastuzumaba u bolesnika s metastatskim rakom dojke, ranim rakom dojke i uznapredovalim rakom želuca
English: A faint/barely perceptible membrane staining is detected in >10% of the tumour cells.
Croatian: Blijeda, jedva uočljiva obojenost membrane u > 10 % tumorskih stanica.
English: 8mg/kg + 6mg/kg q3w
Croatian: metastatski 8 mg/kg + rak dojke 6 mg/kg jedanput svaka 3
English: This yields a 20.6 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab.
Croatian: Time se dobiva 20,6 ml otopine za jednokratnu primjenu, koja sadrži približno 21 mg/ml trastuzumaba.
English: Tumour cell cluster with a faint ⁄ barely perceptible membranous reactivity irrespective of percentage of tumour cells stained
Croatian: Nakupina tumorskih stanica s vrlo slabom/jedva primjetnom membranskom reaktivnošću bez obzira na postotak obojenih tumorskih stanica
English: Three -weekly dosing in metastatic breast cancer The efficacy results from the non-comparative monotherapy and combination therapy studies are summarised in Table 5:
Croatian: Trotjedni ciklusi u liječenju metastatskog raka dojke Rezultati djelotvornosti iz ispitivanja monoterapije i kombinirane terapije trastuzumabom bez kontrolnih skupina prikazani su u Tablici 5.
English: The efficacy results from the joint analysis of the NSABP B-31 and NCCTG 9831 trials at the time of the definitive analysis of DFS
Croatian: Rezultati djelotvornosti iz skupne analize ispitivanja NSABP B-31 i NCCTG 9831 u trenutku konačne analize preživljenja bez bolesti
English: Trazimera 150 mg powder for concentrate trastuzumab
Croatian: Trazimera 150 mg prašak za koncentrat trastuzumab
English: - intravenous push doxorubicin, at 60 mg/m 2, given every 3 weeks for 4 cycles.
Croatian: - brza intravenska injekcija doksorubicina u dozi od 60 mg/m 2, svaka 3 tjedna, u 4 ciklusa
English: Distant recurrence No. patients with event p=0.0008
Croatian: Pojava udaljenih metastaza: broj bolesnica s događajem p=0,0008
English: Respiratory distress
Croatian: Plućne reakcije
English: Trastuzumab may persist in the circulation for up to 7 months after stopping treatment based on population pharmacokinetic analysis of all available data (see section 5.2).
Croatian: Na temelju populacijske farmakokinetičke analize svih dostupnih podataka (vidjeti dio 5.2), trastuzumab može biti prisutan u cirkulaciji do 7 mjeseci nakon prestanka liječenja.
English: Median duration of follow up was 1.8 years in the AC→P arm and 2.0 years in the AC→PH arm
Croatian: Medijan trajanja praćenja iznosio je 1,8 godina u skupini koja je primala AC→P kemoterapiju i 2,0 godine u skupini koja je primala AC→PH kemoterapiju.
English: No staining is observed or membrane staining is observed in <10% of the tumour cells
Croatian: Nema vidljive obojenosti ili se obojenost membrane primjećuje u < 10 % tumorskih stanica.
English: Trazimera 150 mg powder for concentrate for solution for infusion Trazimera 420 mg powder for concentrate for solution for infusion
Croatian: Trazimera 150 mg prašak za koncentrat za otopinu za infuziju Trazimera 420 mg prašak za koncentrat za otopinu za infuziju
English: Table 15 Population Predicted Steady State PK Exposure Values (median with 5th - 95th Percentiles) for Trastuzumab Intravenous Dosing Regimens in MBC, EBC and AGC Patients
Croatian: Tablica 15 Vrijednosti farmakokinetičke izloženosti u stanju dinamičke ravnoteže predviđene za populaciju (medijan i 5. do 95. percentil) uz režime doziranja intravenske formulacije trastuzumaba u bolesnika s metastatskim rakom dojke, ranim rakom dojke i uznapredovalim rakom želuca