FrancophonIA/ELRC3.0 huggingface dataset:
English: • abnormal development of the kidneys of the baby in the womb
Croatian: • abnormalni djetetov razvoj bubrega u maternici
English: Cardiac dysfunction
Croatian: Disfunkcija srca
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: Unaprijed planirana konačna analiza ukupnog preživljenja iz skupne analize ispitivanja NSABP B-31 i NCCTG N9831 provedena je nakon 707 smrtnih slučajeva (medijan praćenja od 8,3 godine u skupini koja je primala AC→PH kemoterapiju).
English: In the post-marketing setting, cases of foetal renal growth and/or function impairment in association with oligohydramnios, some associated with fatal pulmonary hypoplasia of the foetus, have been reported in pregnant women receiving trastuzumab.
Croatian: U razdoblju nakon stavljanja lijeka u promet, u trudnica koje su primale trastuzumab prijavljeni su slučajevi narušenog rasta i/ili funkcije bubrega kod fetusa povezani s oligohidramnionom, od kojih su neki bili povezani s fatalnom pulmonalnom hipoplazijom fetusa.
English: In the pivotal trial BO22227, trastuzumab was administered concurrently with neoadjuvant chemotherapy that contained four cycles of epirubicin (cumulative dose 300 mg/m2); at a median follow-up exceeding 70 months, the incidence of cardiac failure/congestive cardiac failure was 0.3% in the trastuzumab intravenous arm.
Croatian: U pivotalnom ispitivanju BO22227, trastuzumab se primjenjivao istodobno s neoadjuvantnom kemoterapijom koja se sastojala od četiri ciklusa epirubicina (kumulativna doza: 300 mg/m2); nakon medijana praćenja od više od 70 mjeseci, incidencija zatajenja srca/kongestivnog zatajenja srca iznosila je 0,3% u skupini koja je primala trastuzumab za intravensku primjenu.
English: In this final analysis, extending trastuzumab treatment for a duration of two years did not show additional benefit over treatment for 1 year [DFS HR in the intent to treat (ITT) population of 2 years versus 1 year = 0.99 (95% CI 0.87, 1.13), p-value = 0.90 and OS HR = 0.98 (0.83, 1.15); p-value = 0.78].
Croatian: U toj završnoj analizi produljenje liječenja trastuzumabom na dvije godine nije pokazalo dodatne korisne učinke u odnosu na jednogodišnje liječenje [omjer hazarda za preživljenje bez simptoma bolesti (DFS HR) u populaciji koju se namjeravalo liječiti (ITT) tijekom 2 godine naspram 1 godine = 0,99 (95% CI: 0,87; 1,13), p-vrijednost = 0,90 i omjer hazarda za ukupno preživljenje (OS HR) = 0,98 (0,83; 1,15); p-vrijednost = 0,78].
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: - Ispitivanje BO16348 s ciljem usporedbe liječenja trastuzumabom u trotjednim ciklusima tijekom jedne i dvije godine i opservacije u bolesnica s HER2 pozitivnim tumorom dojke u ranom stadiju nakon kirurškog zahvata, završene kemoterapije i radioterapije (ako su provedeni).
English: In general, SISH or 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.
Croatian: SISH ili FISH se smatra pozitivnim ako je omjer broja genskih kopija HER2 po tumorskoj stanici i broja kopija kromosoma 17 veći ili jednak 2.
English: Patients assigned to receive trastuzumab were given an initial loading dose of 8 mg/kg, followed by 6 mg/kg every three weeks for either one or two years.
Croatian: Trastuzumab je u pogodnih bolesnica primjenjivan u početnoj udarnoj dozi od 8 mg/kg, a zatim u dozi od 6 mg/kg svaka tri tjedna u trajanju od jedne ili dvije godine.
English: This helps your medicine work as well as it can.
Croatian: Na taj se način omogućuje najbolje djelovanje lijeka.
English: Patients with MBC who have previously received anthracyclines are also at risk of cardiac dysfunction with KANJINTI treatment, although the risk is lower than with concurrent use of KANJINTI and anthracyclines.
Croatian: U bolesnika s metastatskim rakom dojke koji su prethodno primali antracikline je također povećan rizik od disfunkcije srca pri liječenju lijekom KANJINTI, premda je on manji od rizika u bolesnika koji istodobno primaju KANJINTI i antracikline.
English: • You have metastatic breast cancer (breast cancer that has spread beyond the original tumour) with high levels of HER2.
Croatian: • bolujete od metastatskog raka dojke (tumora dojke koji se proširio izvan dojke) s visokom razinom proteina HER2.
English: The powder is a white to pale yellow pellet.
Croatian: Prašak čine bijele do blijedožute pelete.
English: • anaphylactic reactions
Croatian: • anafilaktičke reakcije
English: Studies indicate that breast cancer patients whose tumours overexpress HER2 have a shortened disease-free survival compared to patients whose tumours do not overexpress HER2.
Croatian: Ispitivanja su pokazala da bolesnici s rakom dojke čije tumorske stanice pokazuju povećanu ekspresiju HER2 imaju kraće vrijeme preživljenja bez simptoma bolesti nego bolesnici s tumorom koji nemaju povećanu ekspresiju HER2.
English: All candidates for treatment with KANJINTI, but especially those with prior anthracycline and cyclophosphamide (AC) exposure, should undergo baseline cardiac assessment including history and physical examination, electrocardiogram (ECG), echocardiogram, and/or multigated acquisition (MUGA) scan or magnetic resonance imaging.
Croatian: Svi bolesnici koji su kandidati za liječenje lijekom KANJINTI, osobito oni prethodno liječeni antraciklinima i ciklofosfamidom (AC protokol), prije početka liječenja moraju obaviti osnovni kardiološki pregled koji uključuje uzimanje anamneze, fizikalni pregled, elektrokardiogram (EKG), ultrazvuk srca i/ili radionuklidnu ventrikulografiju (MUGA) ili magnetsku rezonanciju.
English: Patients classified as staining 2+ or 3+ were included, while those staining 0 or 1+ were excluded.
Croatian: Bolesnice s tumorima intenziteta obojenja od 2+ do 3+ uključene su u ispitivanje, a one s 0 do 1+ nisu.
English: - intravenous docetaxel - 100 mg/m2 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/m2 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: +Lung infiltration
Croatian: +plućni infiltrat nepoznato
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%; p = 0.004).
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 pharmacokinetics of trastuzumab were evaluated in a population pharmacokinetic model analysis using pooled data from 1,582 subjects, including patients with HER2 positive MBC, EBC, AGC or other tumour types, and healthy volunteers, in 18 Phase I, II and III trials receiving trastuzumab intravenously.
Croatian: Farmakokinetika trastuzumaba ocjenjivala se u analizi populacijskog farmakokinetičkog modela, u kojoj su se koristili objedinjeni podaci prikupljeni u 1582 ispitanika, uključujući bolesnike s HER2 pozitivnim metastatskim rakom dojke, ranim rakom dojke, uznapredovalim rakom želuca ili drugim vrstama tumora te zdrave dobrovoljce koji su primali intravensku formulaciju trastuzumaba u 18 ispitivanja faze I, II i III.
English: Linear clearance was 0.136 L/day for MBC, 0.112 L/day for EBC and 0.176 L/day for
Croatian: Linearni klirens iznosio je 0,136 l/dan za metastatski rak dojke, 0,112 l/dan za rani rak dojke i 0,176 l/dan za uznapredovali rak želuca.
English: +Pulmonary fibrosis
Croatian: +plućna fibroza nepoznato
English: MBC and EBC patients had similar PK parameters (e.g. clearance (CL), the central compartment volume (Vc)) and population-predicted steady-state exposures (Cmin, Cmax and AUC).
Croatian: Bolesnici s metastatskim rakom dojke i ranim rakom dojke imali su slične farmakokinetičke parametre (npr. klirens, volumen središnjeg odjeljka [Vc]) i razine izloženosti u stanju dinamičke ravnoteže (Cmin, Cmax i AUC) predviđene za tu populaciju.
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: Trastuzumab has also been used in combination with paclitaxel or docetaxel for the treatment of patients who have not received chemotherapy for their metastatic disease.
Croatian: Trastuzumab je također primjenjivan u kombinaciji s paklitakselom ili docetakselom u liječenju bolesnica koje nisu primale kemoterapiju za metastatsku bolest.
English: Dedicated pharmacokinetic studies in the elderly and those with renal or hepatic impairment have not been carried out.
Croatian: Posebna farmakokinetička ispitivanja nisu provedena u starijih osoba niti u bolesnika s oštećenjem funkcije bubrega ili jetre.
English: Additionally, trastuzumab is a potent mediator of antibody-dependent cell-mediated cytotoxicity (ADCC).
Croatian: Osim toga, trastuzumab je snažan posrednik stanične citotoksičnosti ovisne o protutijelima.
English: 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 KANJINTI.
Croatian: Kardiološke preglede, istovjetne 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 KANJINTI.
English: Trastuzumab plus paclitaxel2 N = 68
Croatian: Trastuzumab s paklitakselom2 N = 68
English: Table 1 Undesirable effects reported with intravenous trastuzumab monotherapy or in combination with chemotherapy in pivotal clinical trials (N = 8,386) and in post-marketing
Croatian: Nuspojave prijavljene kod primjene intravenske formulacije trastuzumaba u monoterapiji ili u kombinaciji s kemoterapijom u pivotalnim kliničkim ispitivanjima (N = 8 386) i nakon stavljanja lijeka u promet
English: Sites of progression
Croatian: Mjesta progresije bolesti
English: EBC in the HERA trial was limited to operable, primary, invasive adenocarcinoma of the breast, with axillary nodes positive or axillary nodes negative if tumours at least 1 cm in diameter.
Croatian: Rani rak dojke u ispitivanju HERA bio je ograničen isključivo na operabilni, primarni, invazivni adenokarcinom dojke, s pozitivnim ili negativnim aksilarnim čvorovima ako je promjer tumora iznosio najmanje 1 cm.
English: Breast cancer and gastric cancer
Croatian: Rak dojke i rak želuca
English: Total CL range from Cmax,ss to Cmin,ss
Croatian: Raspon ukupnog klirensa od Cmax,ss do
English: In patients with EBC an increase in the incidence of symptomatic and asymptomatic cardiac events was observed when trastuzumab was administered after anthracycline-containing chemotherapy compared to administration with a non-anthracycline regimen of docetaxel and carboplatin and was more marked when trastuzumab was administered concurrently with taxanes than when administered sequentially to taxanes.
Croatian: U bolesnika s ranim rakom dojke zabilježeno je povećanje incidencije simptomatskih i asimptomatskih srčanih događaja pri primjeni trastuzumaba nakon kemoterapije antraciklinima, u odnosu na njegovu primjenu nakon neantraciklinskog protokola s docetakselom i karboplatinom, a taj je porast incidencije bio izraženiji kada se trastuzumab primjenjivao istodobno s taksanima nego kada se primjenjivao nakon terapije taksanima.
English: The appropriate amount of solution should be withdrawn from the vial and added to an infusion bag containing 250 mL of sodium chloride 9 mg/mL (0.9%) solution for injection.
Croatian: Odgovarajuću količinu otopine potrebno je izvući iz bočice i dodati u infuzijsku vrećicu koja sadrži 250 ml otopine natrijevog klorida 9 mg/ml (0,9%-tnog) za injekciju.
English: In the NSABP B-31 and NCCTG N9831 studies trastuzumab was administered in combination with paclitaxel, following AC chemotherapy.
Croatian: U sklopu ispitivanja NSABP B-31 i NCCTG N9831 trastuzumab je primjenjivan u kombinaciji s paklitakselom nakon AC kemoterapije.
English: However, trastuzumab plus docetaxel was efficacious in patients whether or not they had received prior adjuvant anthracyclines.
Croatian: Kombinacija trastuzumaba i docetaksela bila je, međutim, učinkovita bez obzira na to jesu li bolesnice prethodno primale adjuvantnu antraciklinsku terapiju.
English: This can lead to symptoms such as breathlessness (including breathlessness at night), cough, fluid retention (swelling) in the legs or arms, palpitations (heart fluttering or irregular heart beat) (see 2.
Croatian: To može dovesti do simptoma kao što su nedostatak zraka (uključujući nedostatak zraka tijekom noći), kašalj, zadržavanje tekućine (oticanje) u nogama ili rukama te osjećaj lupanja srca (lepršanje srca ili nepravilni otkucaji srca) (pogledajte odlomak „Kontrole rada srca“ u dijelu 2.).
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: Ostale nuspojave povezane s infuzijom su: 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: After reconstitution 1 mL concentrate contains 21 mg of trastuzumab.
Croatian: Nakon rekonstitucije 1 ml koncentrata sadrži 21 mg trastuzumaba.
English: - Doxorubicin 60 mg/m2 and paclitaxel 150 mg/m2, administered 3-weekly for 3 cycles,
Croatian: - doksorubicin 60 mg/m2 plus paklitaksel 150 mg/m2, svaka 3 tjedna u 3 ciklusa,
English: HER2 gene amplification should be detected using fluorescence in situ hybridisation (FISH) or chromogenic in situ hybridisation (CISH) of fixed tumour blocks.
Croatian: Genska amplifikacija HER2 treba biti utvrđena fluorescentnom in situ hibridizacijom (FISH) ili kromogenom in situ hibridizacijom (CISH) fiksiranih blokova tumorskog tkiva.
English: • redness, swelling or sores in your mouth and/or throat
Croatian: • crvenilo, oticanje ili ranice u ustima i/ili grlu
English: Table 5 Efficacy results from the non-comparative monotherapy and combination therapy studies
Croatian: Tablica 5. Rezultati djelotvornosti iz nekomparativnih ispitivanja monoterapije i kombinirane terapije
English: If the patient has missed a dose of KANJINTI by one week or less, then the usual maintenance dose (weekly regimen: 2 mg/kg; three-weekly regimen: 6 mg/kg) should be administered as soon as possible.
Croatian: Ako je bolesnik propustio primiti dozu lijeka KANJINTI za tjedan dana ili manje, nužno je što prije primijeniti uobičajenu dozu održavanja (tjedni ciklusi: 2 mg/kg; trotjedni ciklusi: 6 mg/kg).
English: - The NSABP B-31 and NCCTG N9831 studies that comprise the joint analysis were designed to investigate the clinical utility of combining trastuzumab treatment with paclitaxel following AC chemotherapy, additionally the NCCTG N9831 study also investigated adding trastuzumab sequentially to AC→P chemotherapy in patients with HER2 positive EBC following surgery.
Croatian: - Ispitivanja NSABP B-31 i NCCTG N9831, koja su obuhvaćena zajedničkom analizom, s ciljem istraživanja kliničke koristi kombiniranog liječenja trastuzumabom i paklitakselom nakon kemoterapije doksorubicinom i ciklofosfamidom (AC protokol), a u ispitivanju NCCTG N9831 dodatno je istraživana sekvencijska terapija trastuzumabom nakon AC→P kemoterapije, u bolesnica s HER2 pozitivnim ranim rakom dojke nakon kirurškog zahvata.
English: Heart checks
Croatian: Kontrole rada srca
English: Doxorubicin and cyclophosphamide were administered concurrently as follows: - intravenous push doxorubicin, at 60 mg/m2, given every 3 weeks for 4 cycles.
Croatian: Doksorubicin i ciklofosfamid su primijenjeni istodobno na sljedeći način: - brza intravenska injekcija doksorubicina u dozi od 60 mg/m2, svaka 3 tjedna, u 4 ciklusa.
English: This investigative clinical trial assay performed in a central laboratory utilised a 0 to 3+ scale.
Croatian: Navedene analize provedene su u središnjem laboratoriju, a rezultat je procjenjivan ljestvicom od 0 do 3+.
English: 420 mg vial
Croatian: 420 mg bočica
English: KANJINTI should be carefully handled during reconstitution.
Croatian: Tijekom rekonstitucije, lijekom KANJINTI treba rukovati oprezno.
English: • inflammation or scarring of the lungs
Croatian: • upala ili ožiljci na plućima
English: In an exploratory subgroup analysis performed in the TOGA (BO18255) trial there was no apparent benefit on overall survival with the addition of trastuzumab in patients with ECOG PS 2 at baseline [HR 0.96 (95% CI 0.51-1.79)], non measurable [HR 1.78 (95% CI 0.87-3.66)] and locally advanced disease [HR 1.20 (95% CI 0.29-4.97)].
Croatian: U eksplorativnoj analizi podskupina provedenoj u ispitivanju ToGA (BO18255) nije bilo vidljive koristi u ukupnom preživljenju od uključivanja trastuzumaba u terapiju bolesnika s ECOG PS 2 statusom na početku liječenja [HR 0,96 (95% CI 0,51-1,79)], kod bolesnika s nemjerljivom [HR 1,78 (95% CI 0,87-3,66)] i lokalno uznapredovalom bolešću [HR 1,20 (95% CI 0,29-4,97)].
English: The test method for HER2 overexpression used to determine eligibility of patients in the pivotal trastuzumab monotherapy and trastuzumab plus paclitaxel clinical trials employed immunohistochemical staining for HER2 of fixed material from breast tumours using the murine monoclonal antibodies CB11 and 4D5.
Croatian: Metoda testiranja povećane ekspresije HER2, primijenjena u pivotalnim kliničkim ispitivanjima u svrhu odabira bolesnica pogodnih za monoterapiju trastuzumabom ili liječenje kombinacijom trastuzumaba i paklitaksela, uključivalo je imunohistokemijske metode određivanja HER2 u materijalu uzetom iz tumora dojke pomoću CB11 i 4D5 mišjih monoklonskih protutijela.
English: KANJINTI intravenous formulation is not for subcutaneous use and should be given as an intravenous infusion only.
Croatian: KANJINTI u intravenskoj formulaciji nije namijenjen za supkutanu primjenu i smije se primijeniti isključivo intravenskom infuzijom.
English: Patients experiencing dyspnoea at rest due to complications of advanced malignancy and comorbidities may be at increased risk of a fatal infusion reaction.
Croatian: Bolesnici s dispnejom u mirovanju uslijed komplikacija uznapredovale zloćudne bolesti i popratnih komorbiditeta, mogu imati povećan rizik od infuzijskih reakcija sa smrtnim ishodom.
English: Table 12 Efficacy results from MO16432
Croatian: Rezultati djelotvornosti iz ispitivanja MO16432
English: AC→D = doxorubicin plus cyclophosphamide, followed by docetaxel; DCarbH = docetaxel, carboplatin and trastuzumab; CI = confidence interval
Croatian: AC→D = doksorubicin i ciklofosfamid nakon kojih slijedi docetaksel; DcarbH = docetaksel, karboplatin i trastuzumab; CI = interval pouzdanosti
English: In patients with EBC eligible for neoadjuvant-adjuvant treatment, KANJINTI should be used concurrently with anthracyclines only in chemotherapy-naive patients and only with low-dose anthracycline regimens i.e. maximum cumulative doses of doxorubicin 180 mg/m2 or epirubicin 360 mg/m2.
Croatian: U bolesnika s ranim rakom dojke koji zadovoljavaju uvjete za neoadjuvantno-adjuvantno liječenje KANJINTI se smije davati istodobno s antraciklinima isključivo u bolesnika koji prije nisu primali kemoterapiju i samo uz protokole s niskim dozama antraciklina tj. onih s najvećom kumulativnom dozom doksorubicina od 180 mg/m2 ili epirubicina od 360 mg/m2.
English: In the ToGA (BO18255) trial, patients whose tumours were either IHC3+ or FISH positive were defined as HER2 positive and thus included in the trial.
Croatian: ToGA ispitivanje (BO18255) bili su uključeni bolesnici s tumorima čije su tumorske stanice bile ili IHC3+ ili FISH pozitivne te su ocijenjeni HER2 pozitivni.
English: STATEMENT OF ACTIVE SUBSTANCE(S) The vial contains 420 mg trastuzumab.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Bočica sadrži 420 mg trastuzumaba.
English: Infusion-related reactions (IRRs) and hypersensitivity
Croatian: Reakcije povezane s infuzijom i preosjetljivost
English: In addition, terms reported in the post marketing setting are included in Table 1.
Croatian: Dodatno, u Tablici 1 navedene su i nuspojave prijavljene nakon stavljanja lijeka u promet.
English: No disease-free survival (DFS) benefit was noticed in this subgroup of patients (hazard ratio = 1.16, 95% CI [0.73, 1.83] for DCarbH (TCH) versus AC→D (AC→T); hazard ratio 0.97, 95% CI [0.60, 1.55] for AC→DH (AC→TH) versus AC→D).
Croatian: Nije primijećena prednost u pogledu preživljenja bez bolesti u toj podskupini bolesnica (omjer hazarda = 1,16; 95% CI [0,73; 1,83] za skupinu DCarbH (TCH), naspram AC→D (AC→T); omjer hazarda od 0,97; 95% CI [0,60; 1,55] za AC→DH (AC→TH) naspram AC→D).
English: Symptoms may include kidney problems (weakness, shortness of breath, fatigue and confusion), heart problems (fluttering of the heart of a faster or slower heartbeat), seizures, vomiting or diarrhoea and tingling in the mouth, hands or feet.
Croatian: Simptomi mogu uključivati bubrežne tegobe (slabost, nedostatak zraka, umor i smetenost), srčane tegobe (lepršanje srca te ubrzani ili usporeni otkucaji srca), napadaje, povraćanje ili proljev te trnce u ustima, šakama ili stopalima.
English: The appropriate amount of solution should be withdrawn from the vial and added to a polyvinylchloride, polyethylene or polypropylene infusion bag containing 250 mL of sodium chloride 9 mg/mL (0.9%) solution for injection.
Croatian: Odgovarajuću količinu otopine potrebno je izvući iz bočice i dodati u polivinilkloridnu, polietilensku ili polipropilensku infuzijsku vrećicu koja sadrži 250 ml otopine natrijevog klorida 9 mg/ml (0,9%tnog) za injekcije.
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 se utvrđuje imunohistokemijskom (IHC) metodom procjene fiksiranih blokova tumorskog tkiva; HER2 genska amplifikacija utvrđuje se hibridizacijom in situ, npr. SISH ili FISH na fiksiranim blokovima tumorskog tkiva.
English: Administration in combination with paclitaxel or docetaxel In the pivotal trials (H0648g, M77001), paclitaxel or docetaxel was administered the day following the first dose of trastuzumab (for dose, see the Summary of Product Characteristics (SmPC) for paclitaxel or docetaxel) and immediately after the subsequent doses of trastuzumab if the preceding dose of trastuzumab was well tolerated.
Croatian: U pivotalnim kliničkim ispitivanjima (H0648g, M77001) paklitaksel ili docetaksel primjenjivan je dan nakon prve doze trastuzumaba (za dozu vidjeti Sažetak opisa svojstava lijeka za paklitaksel ili docetaksel) i neposredno nakon sljedećih doza trastuzumaba ako je bolesnik prethodnu dozu trastuzumaba dobro podnio.
English: Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Croatian: Detaljne informacije su dostupne na internetskoj stranici Europske medicinske agencije http://www.ema.europa.eu.