FrancophonIA/ELRC3.0 huggingface dataset:
English: L-histidine hydrochloride monohydrate L-histidine α,α-trehalose dihydrate polysorbate 20
Croatian: L-histidinklorid hidrat L-histidin α,α-trehaloza dihidrat polisorbat 20
English: The frequency of progression in the liver was significantly reduced in patients treated with the combination of trastuzumab and paclitaxel, compared to paclitaxel alone (21.8% versus 45.7%;
Croatian: Učestalost pojave metastaza u jetri bila je znatno smanjena u bolesnica liječenih kombinacijom trastuzumaba i paklitaksela u usporedbi sa samim paklitakselom (21,8% naspram 45,7%; p=0,004).
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* are summarized in Table 7.
Croatian: Rezultati djelotvornosti iz skupne analize ispitivanja NSABP B-31 i NCCTG 9831 u trenutku konačne analize preživljenja bez bolesti* prikazani su sažeto u tablici 7.
English: Linear clearance was 0.136 L/day for MBC, 0.112 L/day for EBC and 0.176 L/day for AGC.
Croatian: Linearni klirens iznosio je 0,136 l na dan za metastatski rak dojke, 0,112 l na dan za rani rak dojke i 0,176 l na dan za uznapredovali rak želuca.
English: In patients receiving trastuzumab after completion of adjuvant chemotherapy, the risk of cardiac dysfunction was associated with a higher cumulative dose of anthracycline given prior to initiation of trastuzumab and a body mass index (BMI) >25 kg/m2.
Croatian: rizik od disfunkcije srca povezivao se s većom kumulativnom dozom antraciklina primijenjenoga prije početka liječenja trastuzumabom te indeksom tjelesne mase (ITM) većim od >25 kg/m2.
English: Disease-free survival No. patients with event (%)
Croatian: broj bolesnica s događajem (%)
English: Hazard ratio (95% CI)
Croatian: Omjeri hazarda (95% CI)
English: You will be observed by a health care professional during the infusion and for at least six hours after the start of the first infusion and for two hours after the start of other infusions.
Croatian: Za vrijeme infuzije i najmanje šest sati nakon početka prve infuzije te dva sata nakon početka sljedećih infuzija bit ćete pod nadzorom zdravstvenog radnika.
English: • dry mouth and skin
Croatian: • suhoća usta i kože • suhe oči
English: Neutralizing anti-trastuzumab antibodies were detected in post-baseline samples in 2 of 30 patients in the trastuzumab intravenous arm.
Croatian: Neutralizirajuća protutijela na trastuzumab pronađena su u uzorcima prikupljenima nakon početka ispitivanja u 2 od 30
English: • somnolence (sleepiness)
Croatian: • izrazita pospanost (pospanost)
English: Patients are eligible for trastuzumab treatment if they show strong HER2 overexpression as described by a 3+ score by IHC or a positive FISH or CISH result.
Croatian: Za liječenje trastuzumabom pogodni su oni bolesnici koji imaju izrazitu ekspresiju HER2 opisanu stupnjem 3+ na temelju IHC-a ili pak pozitivan FISH ili CISH rezultat.
English: 1) Using a sterile syringe, slowly inject the appropriate volume (as noted above) of sterile water for injection in the vial containing the lyophilised Ontruzant, directing the stream into the lyophilised cake.
Croatian: Upute za rekonstituciju 1) Sterilnom štrcaljkom polagano ubrizgajte odgovarajući volumen (kao što je gore navedeno) sterilne vode za injekcije u bočicu koja sadrži liofilizirani Ontruzant, usmjeravajući mlaz u liofilizirani kolačić.
English: The study recruited patients with newly diagnosed locally advanced (Stage III) or inflammatory EBC.
Croatian: U ispitivanje su uključeni bolesnici s novodijagnosticiranim, lokalno uznapredovalim rakom dojke (stadija III) ili upalnim ranim rakom dojke.
English: Median TTP (months) (95%CI)
Croatian: Medijan TTP (mjeseci) (95%CI)
English: At 8 years, the survival rate was estimated to be 86.9% in the AC→PH arm and 79.4% in the AC→P arm, an absolute benefit of 7.4% (95% CI 4.9%, 10.0%).
Croatian: 79,4% u skupini koja je primala AC→P kemoterapiju, što ukazuje na apsolutnu korist od 7,4% (95% CI 4,9%; 10,0%).
English: In one of the 3 pivotal studies conducted in which a median follow-up of 5.5 years was available (BCIRG006) a continuous increase in the cumulative rate of symptomatic cardiac or LVEF events was observed in patients who were administered trastuzumab concurrently with a taxane following anthracycline therapy up to 2.37% compared to approximately 1% in the two comparator arms (anthracycline plus cyclophosphamide followed by taxane and taxane, carboplatin and trastuzumab).
Croatian: U jednom od 3 provedena ključna ispitivanja s medijanom vremena praćenja od 5,5 godina (BCIRG006), u bolesnika koji su nakon anatraciklinske terapije primali trastuzumab istodobno s taksanom, zabilježen je kontinuirani porast kumulativne stope simptomatskih srčanih događaja ili događaja povezanih s LVEF-om i do
English: Severe pulmonary events have been reported with the use of trastuzumab in the post-marketing setting (see section 4.8).
Croatian: U razdoblju nakon stavljanja lijeka u promet, pri primjeni trastuzumaba zabilježeni su teški plućni događaji (vidjeti dio 4.8).
English: No. patients with event p=0.0555
Croatian: Broj bolesnika s događajem p=0,0555
English: Death (OS event) No. patients with event p=0.0182
Croatian: Smrt (događaj ukupnog preživljenja): broj bolesnika s događajem p=0,0182
English: These symptoms can be treated with an analgesic/antipyretic such as meperidine or paracetamol, or an antihistamine such as diphenhydramine.
Croatian: Ti se simptomi mogu liječiti analgeticima/antipireticima, poput meperidina ili paracetamola, ili antihistaminicima, poput difenhidramina.U većine bolesnika dolazi do povlačenja simptoma, nakon čega se nastavlja s daljnjim infuzijama trastuzumaba.
English: Median TTP (months) (95%CI) Median survival (months) (95%CI)
Croatian: Medijan TTP (mjeseci) (95%CI) Medijan preživljenja (mjeseci) (95%CI)
English: Pharmacokinetic data from studies BO15935 and M77004 in women with HER2-positive MBC suggested that exposure to paclitaxel and doxorubicin (and their major metabolites 6-α hydroxyl-paclitaxel, POH, and doxorubicinol, DOL) was not altered in the presence of trastuzumab (8 mg/kg or 4 mg/kg loading dose as an intravenous infusion followed by 6 mg/kg q3w or 2 mg/kg q1w infusion, respectively).
Croatian: Učinak trastuzumaba na farmakokinetiku drugih antineoplastika Farmakokinetički podaci iz ispitivanja BO15935 i M77004 u žena s HER2-pozitivnim metastatskim rakom dojke ukazali su na to da prisutnost trastuzumaba (udarna doza od 8 mg/kg odnosno 4 mg/kg u obliku intravenske infuzije, nakon koje slijedi doza od 6 mg/kg u infuziji svaka 3 tjedna odnosno od 2 mg/kg jedanput tjedno) nije promijenila izloženost paklitakselu i doksorubicinu (i njihovim glavnim metabolitima 6-α hidroksil-paklitakselu, POH, i doksorubicinolu, DOL).
English: Ontruzant is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC).
Croatian: Ontruzant je indiciran u liječenju odraslih bolesnika s HER2-pozitivnim ranim rakom dojke:
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 na to da istodobna primjena cisplatina ili istodobna primjena cisplatina i trastuzumaba nije utjecala na izloženost bioaktivnim metabolitima (npr. 5-FU)
English: HER2 over expression should be detected using an immunohistochemistry (IHC)-based assessment of fixed tumour blocks; HER2 gene amplification should be detected using in situ hybridisation using either SISH or FISH on fixed tumour blocks.
Croatian: Povećana ekspresija HER2 utvrđuje se imunohistokemijskom (IHC) metodom procjene fiksiranih blokova tumorskog tkiva; HER2 genska amplifikacija utvrđuje se hibridizacijom in situ, npr. SISH ili
English: A: doxorubicin; C: cyclophosphamide; P: paclitaxel; H: trastuzumab * At median duration of follow up of 1.8 years for the patients in the AC→P arm and 2.0 years for patients in the AC→PH arm ** p value for OS did not cross the pre-specified statistical boundary for comparison of AC→PH vs.
Croatian: A: doksorubicin, C: ciklofosfamid, P: paklitaksel, H: trastuzumab * Uz medijan trajanja praćenja od 1,8 godina za bolesnice u skupini koja je primala AC→P
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: Very common side effects of Ontruzant (may affect more than 1 in 10 people):
Croatian: Vrlo česte nuspojave lijeka Ontruzant (mogu se javiti u više od 1 na 10 osoba):
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: 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
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: nakon čega su poslije kirurškog zahvata slijedili • dodatni ciklusi adjuvantnog trastuzumaba (do dovršetka 1 godine liječenja).
English: Ontruzant 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 IHC3+ result.
Croatian: Ontruzant se smije davati samo onim bolesnicima s metastatskim rakom želuca čije tumorske stanice pokazuju povećanu ekspresiju HER2 određenu imunohistokemijski kao 2+ i potvrđenu srebrom povećanom in situ hibridizacijom (SISH) ili fluorescentnom in situ hibridizacijom (FISH), ili određenu imunohistokemijski kao 3+.
English: Each 150 mg vial of Ontruzant is reconstituted with 7.2 mL of sterile water for injection (not supplied).
Croatian: 150 mg rekonstituira se sa 7,2 ml sterilne vode za injekcije (nije priložena u pakiranju).
English: The recommended initial loading dose of Ontruzant is 4 mg/kg body weight.
Croatian: Preporučena početna udarna doza lijeka Ontruzant iznosi 4 mg/kg tjelesne težine.
English: Patients with MBC who have previously received anthracyclines are also at risk of cardiac dysfunction with trastuzumab treatment, although the risk is lower than with concurrent use of trastuzumab and anthracyclines.
Croatian: Pri liječenju trastuzumabom rizik od disfunkcije srca povećan je i u bolesnika s metastatskim rakom dojke koji su prije primali antracikline, premda je on manji od rizika koji postoji kod istodobne primjene trastuzumaba i antraciklina.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1241/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1241/001
English: 1Heart beat irregular
Croatian: 1nepravilni otkucaji srca
English: Median duration of response (months) (95%CI)
Croatian: Medijan trajanja odgovora (mjeseci) (95%CI)
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji mišićno koštanog sustava i vezivnog tkiva artralgija
English: • Doxorubicin 60 mg/m2 and paclitaxel 150 mg/m2, administered 3-weekly for 3 cycles, which was followed by Paclitaxel 175 mg/m2 administered 3-weekly for 4 cycles,
Croatian: • doksorubicin 60 mg/m2 plus paklitaksel 150 mg/m2, svaka 3 tjedna u 3 ciklusa, nakon čega je slijedio
English: Each 420 mg vial of Ontruzant is reconstituted with 20 mL of sterile water for injection (not supplied).
Croatian: 420 mg rekonstituira se s 20 ml sterilne vode za injekcije (nije priložena u pakiranju).
English: Ontruzant contains the active substance trastuzumab, which is a monoclonal antibody.
Croatian: Što je Ontruzant i za što se koristi Ontruzant sadrži djelatnu tvar trastuzumab koji je monoklonsko protutijelo.
English: No. patients with event p=0.0275
Croatian: Broj bolesnika s događajem p=0,0275
English: • swelling of the face, lips and throat
Croatian: • oticanje lica, usana i grla • zatajenje bubrega
English: In addition a post-hoc exploratory analysis was performed on the data sets from the joint analysis (JA) NSABP B-31/NCCTG N9831* and BCIRG006 clinical studies combining DFS events and symptomatic cardiac events and summarised in Table 11:
Croatian: Dodatno je provedena post hoc eksplorativna analiza podataka dobivenih iz skupne analize kliničkih ispitivanja NSABP B-31/NCCTG N9831* i BCIRG006, koja uključuje preživljenje bez bolesti i simptomatske srčane događaje.
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 tjedne doze održavanja od 2 mg/kg tjelesne težine:
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ontruzant 150 mg powder for concentrate trastuzumab
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Ontruzant 150 mg prašak za koncentrat trastuzumab
English: Hazard ratio vs AC→D (95% CI)
Croatian: Omjer hazarda naspram AC→D (95% CI)
English: The pre-planned final analysis of OS from the joint analysis of studies NSABP B-31 and NCCTG N9831 was performed when 707 deaths had occurred (median follow-up 8.3 years in the AC→PH group).
Croatian: NCCTG N9831 provedena je nakon 707 smrtnih slučajeva (medijan praćenja od 8,3 godine u skupini koja je primala AC→PH kemoterapiju).
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: klase III-IV primijećeno je u 0,6% bolesnika iz skupine liječene godinu dana nakon medijana od 12 mjeseci praćenja.
English: • jaundice (yellowish discoloration of the skin or eyes)
Croatian: • žutica (žućkasta promjena boje kože ili očiju) • upala ili ožiljci na plućima
English: Death (OS event) No. patients with event p=0.0024
Croatian: Smrt (događaj ukupnog preživljenja): broj bolesnika s događajem p=0,0024
English: Table 16 Population predicted PK parameter values at steady state for trastuzumab intravenous infusion dosing regimens in MBC, EBC and AGC patients
Croatian: Tablica 16: Vrijednosti farmakokinetičkih parametara u stanju dinamičke ravnoteže predviđene za populaciju uz režime doziranja intravenske infuzije trastuzumaba u bolesnika s metastatskim rakom dojke (MBC), ranim rakom dojke (EBC) i uznapredovalim rakom želuca (AGC)
English: Chemo only (n=116)
Croatian: Samo kemoterapija (n=116)
English: MBC 805
Croatian: MBC 805 EBC
English: The reconstituted Ontruzant solution contains 21 mg/mL of trastuzumab.
Croatian: Rekonstituirana otopina lijeka Ontruzant sadrži 21 mg/ml trastuzumaba.
English: Ontruzant 150 mg powder for concentrate for solution for infusion Ontruzant 420 mg powder for concentrate for solution for infusion
Croatian: Ontruzant 150 mg prašak za koncentrat za otopinu za infuziju Ontruzant 420 mg prašak za koncentrat za otopinu za infuziju
English: 8mg/kg + 6mg/kg q3w
Croatian: 8mg/kg + 6mg/kg jedanput svaka tri tjedna
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1241/002
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1241/002
English: The main test method used to determine HER2 positivity in the pivotal trial of docetaxel, with or without trastuzumab, was immunohistochemistry.
Croatian: Glavna metoda određivanja povećane ekspresije HER2 primijenjena u ključnom kliničkom ispitivanju docetaksela u monoterapiji ili kombinaciji s trastuzumabom bila je imunohistokemija.
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: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ontruzant 420 mg powder for concentrate for solution for infusion trastuzumab
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Ontruzant 420 mg prašak za koncentrat za otopinu za infuziju trastuzumab
English: Strong complete membrane staining is detected in >10% of the tumour cells.
Croatian: Jaka obojenost cijele membrane otkrivena u >10% tumorskih stanica.
English: Tumour cell cluster with a weak to moderate complete, basolateral or lateral membranous reactivity irrespective of percentage of tumour cells stained
Croatian: Nakupina tumorskih stanica sa slabom do umjereno potpunom, bazolateralnom ili lateralnom membranskom reaktivnošću bez obzira na postotak obojenih tumorskih stanica
English: The following list of side effects can occur at any time during treatment with Ontruzant, not just related to an infusion.
Croatian: Nuspojave sa sljedećeg popisa mogu nastati u bilo koje vrijeme tijekom liječenja lijekom Ontruzant,
English: Table 14 Population predicted cycle 1 PK exposure values (median with 5th - 95th percentiles) for trastuzumab intravenous infusion dosing regimens in MBC, EBC and AGC patients
Croatian: Tablica 14: Vrijednosti farmakokinetičke izloženosti predviđene za populaciju u 1. ciklusu (medijan s rasponom od 5. do 95. percentila) uz režime doziranja intravenske formulacije trastuzumaba u bolesnika s metastatskim rakom dojke (MBC), ranim rakom dojke (EBC) i uznapredovalim rakom želuca (AGC)
English: Table 11 Post-hoc exploratory analysis results from the joint analysis NSABP B-31/NCCTG N9831* and BCIRG006 clinical studies combining DFS events and symptomatic cardiac events AC→PH (vs. AC→P) (NSABP B-31 and NCCTG N9831)*
Croatian: Tablica 11: Rezultati post hoc eksplorativne analize podataka dobivenih iz skupne analize kliničkih ispitivanja NSABP B-31/NCCTG N9831* i BCIRG006, koja uključuje događaje preživljenja bez simptoma bolesti i simptomatske srčane događaje
English: Ontruzant 420 mg powder for concentrate for solution for infusion
Croatian: Ontruzant 420 mg prašak za koncentrat za otopinu za infuziju
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: Table 3 Recommended scoring system to evaluate the IHC staining patterns in gastric cancer
Croatian: Tablica 3: Preporučena ljestvica vrednovanja rezultata imunohistokemijskog bojenja preparata u raku želuca
English: As a three-weekly regimen the recommended initial loading dose of Ontruzant is 8 mg/kg body weight.
Croatian: U trotjednim ciklusima preporučena početna udarna doza lijeka Ontruzant iznosi 8 mg/kg tjelesne težine.
English: Median Survival (months) (95%CI)
Croatian: Medijan preživljenja (mjeseci) (95%CI)
English: Detection of HER2 overexpression or HER2 gene amplification in gastric cancer Only an accurate and validated assay should be used to detect HER2 overexpression or HER2 gene amplification.
Croatian: Za otkrivanje povećane ekspresije HER2 ili HER2 genske amplifikacije potrebno je primjenjivati samo precizne i validirane metode.
English: Each 150 mg vial of Ontruzant is reconstituted with 7.2 mL of water for injections (not supplied).
Croatian: Sadržaj jedne bočice lijeka Ontruzant od 150 mg rekonstituira se sa 7,2 ml vode za injekcije (nije priložena u pakiranju).
English: DFS analysis was also performed at the final analysis of OS from the joint analysis of studies NSABP B-31 and NCCTG N9831.
Croatian: Analiza preživljenja bez bolesti također je provedena prilikom konačne analize ukupnog preživljenja iz skupne analize ispitivanja NSABP B--31 i NCCTG N9831.
English: Each 420 mg vial of Ontruzant is reconstituted with 20 mL of water for injections (not supplied).
Croatian: Sadržaj jedne bočice lijeka Ontruzant od 420 mg rekonstituira se s 20 ml vode za injekcije (nije priložena u pakiranju).
English: Treatment with AC→PH resulted in a statistically significant improvement in OS compared with AC→P (stratified HR=0.64; 95% CI [0.55, 0.74]; log-rank p-value <0.0001).
Croatian: (stratificirani omjer hazarda = 0,64; 95% CI [0,55; 0,74]; log-rang p-vrijednost <0,0001).
English: Formal cardiological assessment should be considered in patients in whom there are cardiovascular concerns following baseline screening.
Croatian: U bolesnika u kojih nakon početne procjene postoji sumnja na kardiovaskularnu bolest, potrebno je razmotriti formalnu kardiološku procjenu.
English: Ontruzant 150 mg powder for concentrate for solution for infusion
Croatian: Ontruzant 150 mg prašak za koncentrat za otopinu za infuziju
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: STATEMENT OF ACTIVE SUBSTANCE(S) The vial contains 420 mg trastuzumab.
Croatian: Bočica sadrži 420 mg trastuzumaba.
English: Ontruzant should be carefully handled during reconstitution.
Croatian: Tijekom rekonstitucije, lijekom Ontruzant treba rukovati oprezno.
English: In rare cases, a reduction in the amount of (amniotic) fluid that surrounds the developing baby within the womb has been observed in pregnant women receiving Ontruzant.
Croatian: U rijetkim je slučajevima u trudnica koje primaju Ontruzant primijećeno smanjenje količine
English: The recommended scoring system to evaluate the IHC staining patterns is as stated in Table 3:
Croatian: Preporučena ljestvica vrednovanja rezultata imunohistokemijskog bojenja preparata nalazi se u tablici 3:
English: The data also suggested that the pharmacokinetics of cisplatin were not affected by concurrent use of capecitabine or by concurrent use of capecitabine plus trastuzumab.
Croatian: Podaci su također ukazali na to da istodobna primjena kapecitabina ili istodobna primjena kapecitabina i trastuzumaba ne utječe na farmakokinetiku cisplatina.
English: in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.
Croatian: AC kemoterapije (AC→DH) ili u kombinaciji s docetakselom i karboplatinom (DCarbH).
English: A weak to moderate complete membrane staining is detected in >10% of the tumour cells.
Croatian: Slaba do umjerena obojenost cijele membrane u >10% tumorskih stanica.
English: The recommended maintenance dose at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose.
Croatian: Preporučena doza održavanja koja se primjenjuje u trotjednim intervalima iznosi 6 mg/kg tjelesne težine, a počinje se primjenjivati tri tjedna nakon udarne doze.
English: - intravenous 5-fluorouracil - 800 mg/m2/day as a continuous intravenous infusion over 5 days, given every 3 weeks for 6 cycles (days 1 to 5 of each cycle) Either of which was administered with: - cisplatin - 80 mg/m2 every 3 weeks for 6 cycles on day 1 of each cycle.
Croatian: - intravenski 5-fluorouracil - 800 mg/m² na dan u kontinuiranoj intravenskoj infuziji tijekom 5 dana, svaka 3 tjedna u 6 ciklusa (od 1. do 5. dana svakog ciklusa).
English: - Study BO16348 was designed to compare one and two years of three-weekly trastuzumab treatment versus observation in patients with HER2 positive EBC following surgery, established chemotherapy and radiotherapy (if applicable).
Croatian: U adjuvantnom je liječenju trastuzumab ispitivan u 4 velika multicentrična, randomizirana ispitivanja: - Ispitivanje BO16348 s ciljem usporedbe liječenja trastuzumabom u trotjednim ciklusima tijekom jedne i dvije godine i opservacije u bolesnika s HER2-pozitivnim tumorom dojke u ranom stadiju nakon kirurškog zahvata, završene kemoterapije i radioterapije (ako su provedeni).
English: • based on a loading dose of 8 mg trastuzumab/kg body weight, or a subsequent 3-weekly dose of 6 mg trastuzumab/kg body weight: Volume (mL) =
Croatian: • za udarnu dozu trastuzumaba od 8 mg/kg tjelesne težine ili daljnje trotjedne doze održavanja od 6 mg/kg tjelesne težine: