natgillin/translations-raw huggingface dataset:
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. 
Pri 71,4 % bolnikov, zdravljenih s trastuzumabom, je bilo hudo kongestivno srčno popuščanje reverzibilno (opredeljeno kot zaporedje najmanj 2 zaporednih vrednosti LVEF ≥ 50 % po dogodku).
Weak to moderate complete, basolateral or lateral membranous reactivity in ≥10% of tumour cells 
Šibko do zmerno obarvanje celotne, bazolateralne ali lateralne membrane pri ≥ 10 % tumorskih celic.
How to store Trazimera 
Kako uporabljati zdravilo Trazimera
Detection of HER2 over expression or HER2 gene amplification in gastric cancer Only an accurate and validated assay should be used to detect HER2 over expression or HER2 gene amplification. 
Ugotavljanje čezmernega izražanja HER2 ali amplifikacije gena HER2 pri raku želodca Za ugotavljanje čezmernega izražanja HER2 ali amplifikacije gena HER2 lahko uporabljamo le natančno in validirano metodo.
*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 
***V celokupni velikosti vzorca je neskladje zaradi majhnega števila bolnikov, ki so jih randomizirali po preteku datuma, do katerega so upoštevali podatke za analizo po medianem 12-mesečnem spremljanju.
The infusion may be resumed when symptoms abate. 
Ko simptomi izginejo, se lahko z infuzijo nadaljuje.
Death (OS event): No. patients with event (%) 
Št. bolnikov z dogodkom (%)
Death (OS event) No. patients with event p=0.0182 
Smrt (dogodek celokupnega preživetja): število bolnikov z dogodkom p = 0,0182
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. 
Za zdravljenje z zdravilom Trazimera so primerni bolniki, pri katerih rezultat čezmernega izražanja HER2 po metodi IHC znaša 3+, ali pri katerih je rezultat metod FISH ali CISH pozitiven.
Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration. 
Zdravila za parenteralno dajanje je treba pred uporabo vizualno pregledati, saj ne smejo vsebovati delcev ali biti obarvana.
• 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: 
• za polnilni odmerek 8 mg trastuzumaba/kg telesne mase ali za nadaljnje 3-tedenske odmerke 6 mg trastuzumaba/kg telesne mase s pomočjo formule:
The recommended scoring system to evaluate the IHC staining patterns is as stated in Table 2: 
Priporočeni način vrednotenja rezultatov obarvanja preparatov po metodi IHC je naveden v preglednici 2.
Strong complete, basolateral or lateral membranous reactivity in ≥10% of tumour cells 
Močno obarvanje celotne, bazolateralne ali lateralne membrane pri ≥ 10 % tumorskih celic.
L-histidine hydrochloride monohydrate, L-histidine, polysorbate 20, sucrose. 
L-histidinijev klorid monohidrat, L-histidin, polisorbat 20, saharoza.
15 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film containing 150 mg of trastuzumab. 
15 ml viala iz prozornega stekla tipa I z butilnim gumijastim zamaškom, laminiranim s fluorirano smolo, ki vsebuje 150 mg trastuzumaba.
In the neoadjuvant-adjuvant treatment setting, study MO16432, a multicentre randomised trial, was designed to investigate the clinical efficacy of concurrent administration of trastuzumab with neoadjuvant chemotherapy including both an anthracycline and a taxane, followed by adjuvant trastuzumab, up to a total treatment duration of 1 year. 
Študija MO16432 je bila multicentrično randomizirano preskušanje na področju neoadjuvantnoadjuvantnega zdravljenja, zasnovanega za proučevanje klinične učinkovitosti sočasnega dajanja trastuzumaba in neoadjuvantne kemoterapije, ki je vsebovala antraciklin in taksan.
White lyophilised powder or cake. 
bel liofiliziran prašek ali pogača
or - intravenous paclitaxel - 175 mg/m2 as a continuous intravenous infusion, given every 3 weeks for 4 cycles (day 1 of each cycle). 
- paklitaksel intravensko - 175 mg/m 2 v obliki kontinuirane intravenske infuzije, vsake 3 tedne, skupaj 4 cikle (na 1. dan vsakega cikla).
The recommended scoring system to evaluate the IHC staining patterns is as stated in Table 3: 
Priporočeni način vrednotenja rezultatov obarvanja preparatov po metodi IHC je naveden v preglednici 3.
Tumour cell cluster with a faint ⁄ barely perceptible membranous reactivity irrespective of percentage of tumour cells stained 
Skupek tumorskih celic ima bledo, komaj zaznavno obarvane membrane, ne glede na odstotek obarvanih tumorskih celic.
Patients with HER2+ tumours were randomised to receive either neoadjuvant chemotherapy concurrently with neoadjuvant-adjuvant trastuzumab, or neoadjuvant chemotherapy alone. 
Bolnike s HER2-pozitivnimi tumorji so randomizirali v skupino, ki je prejemala neoadjuvantno kemoterapijo sočasno z neoadjuvantnim-adjuvantnim trastuzumabom, ali v skupino, ki je prejemala le neoadjuvantno kemoterapijo.
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. 
Zdravljenje z zdravilom Trazimera mora uvesti zdravnik z izkušnjami s citotoksično kemoterapijo (glejte poglavje 4.4).
SISH technology is however, recommended to allow for the parallel evaluation of tumour histology and morphology. 
Za vzporedno oceno histologije in morfologije tumorja je priporočljiva tehnika SISH.
• based on a loading dose of 4 mg trastuzumab/kg body weight, or a subsequent weekly dose of 2 mg trastuzumab/kg body weight: 
• za polnilni odmerek 4 mg trastuzumaba/kg telesne mase ali za nadaljnje tedenske odmerke 2 mg trastuzumaba/kg telesne mase s pomočjo formule:
Trazimera vial 
Izpiranje trastuzumaba
and 7.1% to 42.6% for FISH. 
79,5 % bolnikov.
A minority of patients was tested using fluorescence in-situ hybridisation (FISH). 
Manjši del bolnikov so testirali z metodo FISH.
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. 
V ključnem preskušanju BO22227 so trastuzumab dajali sočasno z neoadjuvantno kemoterapijo, ki je vključevala štiri cikle epirubicina (kumulativni odmerek 300 mg/m2), mediana spremljanja je presegla
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). 
Poročali so o resnih reakcijah, povezanih z infuzijo trastuzumaba, vključno z dispnejo, hipotenzijo, piskajočim dihanjem, hipertenzijo, bronhospazmom, supraventrikularno tahiaritmijo, zmanjšano nasičenostjo arterijske krvi s kisikom, anafilaksijo, dihalno stisko, urtikarijo in angioedemom (glejte poglavje 4.8).
For intravenous use only after reconstitution and dilution. 
za intravensko uporabo, samo po rekonstituciji in redčenju Pred uporabo preberite priloženo navodilo!
• you are allergic to trastuzumab, to murine (mouse) proteins, or to any of the other ingredients of this medicine (listed in section 6). 
Ne uporabljajte zdravila Trazimera, če: • ste alergični na trastuzumab, murine (mišje) beljakovine ali katerokoli sestavino tega zdravila
30 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film containing 420 mg of trastuzumab. 
30 ml viala iz prozornega stekla tipa I z butilnim gumijastim zamaškom, laminiranim s fluorirano smolo, ki vsebuje 420 mg trastuzumaba.
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 
Farmakokinetične vrednosti izpostavljenosti, predvidene za populacijo, za 1. cikel (mediana s 5.-95. percentilom) za režima odmerjanja trastuzumaba v intravenski obliki pri bolnikih z MBC, EBC in AGC
A two-compartment model with parallel linear and non-linear elimination from the central compartment described the trastuzumab concentration-time profile. 
Časovno-koncentracijski profil trastuzumaba so opisali z dvoprostornim modelom z vzporednim linearnim in nelinearnim izločanjem iz centralnega prostora.
Breast inflammation/mastitis 
Motnje reprodukcije in dojk vnetje dojk/mastitis pogosti
The final OS results from the joint analysis of studies NSABP B-31 and NCCTG N9831 are summarized in Table 8 below: 
Končni rezultati za celokupno preživetje iz skupne analize preskušanj NSABP B-31 in NCCTG N9831 so povzeti v spodnji preglednici 8.
8mg/kg + 6mg/kg q3w 
8 mg/kg + 6mg/kg na 3 tedne
No. patients with event 
Število bolnikov z dogodkom 46
Weekly dosing in metastatic breast cancer The efficacy results from the monotherapy and combination therapy studies are summarised in Table 
Tedensko odmerjanje pri metastatskem raku dojk Preglednica 4 navaja rezultate učinkovitosti iz študij monoterapije in kombiniranega zdravljenja.
Reactions include chills, fever, dyspnoea, hypotension, wheezing, bronchospasm, tachycardia, reduced oxygen saturation, respiratory distress, rash, nausea, vomiting and headache (see section 4.4). 
Te reakcije vključujejo mrzlico, zvišano telesno temperaturo, dispnejo, hipotenzijo, piskajoče dihanje, bronhospazem, tahikardijo, zmanjšano nasičenost s kisikom, dihalno stisko, izpuščaj, navzeo, bruhanje in glavobol (glejte poglavje 4.4).
clearance (CL), the central compartment volume (Vc)) and population-predicted steady-state exposures (Cmin, Cmax and AUC). 
Bolniki z MBC in EBC so imeli podobne farmakokinetične parametre (npr. očistek, volumen centralnega prostora (Vc)) in izpostavljenosti v stanju dinamičnega ravnovesja (Cmin, Cmax in AUC), predvidene za populacijo.
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: 
Post-hoc raziskovalna analiza podatkov iz skupne analize kliničnih preskušanj NSABP B- 31/NCCTG N9831* in BCIRG 006, ki vključujejo dogodke preživetja brez ponovitve bolezni in simptomatske srčne dogodke.
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. 
Podatki so pokazali tudi, da sočasna uporaba kapecitabina ali sočasna uporaba kapecitabina in trastuzumaba ni vplivala na farmakokinetiko cisplatina.
- The other ingredient(s) are L-histidine hydrochloride monohydrate, L-histidine, sucrose, polysorbate 20. 
- Druge sestavine zdravila so L-histidinijev klorid monohidrat, L-histidin, saharoza in polisorbat
Distant recurrence No. patients with event p=0.0008 
Pojav oddaljenih metastaz: število bolnikov z dogodkom p = 0,0008
A faint/barely perceptible membrane staining is detected in >10% of the tumour cells. 
Bledo, komaj zaznavno obarvanje membrane je prisotno pri > 10 % tumorskih celic.
In all patients cardiac function should be monitored during treatment (e.g. every 12 weeks). 
Med zdravljenjem je treba nadzorovati delovanje srca pri vseh bolnikih (npr. vsakih 12 tednov), kar olajša razpoznavo bolnikov, pri katerih se pojavljajo motnje v delovanju srca.
Respiratory distress 
Pljučni zapleti
Signs and symptoms of cardiac dysfunction such as dyspnoea, orthopnoea, increased cough, pulmonary oedema, S3 gallop, or reduced ventricular ejection fraction, have been observed in patients treated with trastuzumab (see section 4.4). 
Pri bolnikih, ki so se zdravili s trastuzumabom, so opazili znake in simptome motenj v delovanju srca, kot so dispneja, ortopneja, povečan kašelj, pljučni edem, galop S3 ali zmanjšan ventrikularni srčni iztis (glejte poglavje 4.4).
• abnormal or impaired blood clotting 
• nenormalno ali slabše strjevanje krvi
Table 2 Recommended Scoring System to Evaluate the IHC Staining Patterns in Breast Cancer Score Staining pattern 
Priporočeno točkovanje za vrednotenje obarvanja preparatov po metodi IHC pri raku želodca
Trazimera intravenous formulation is not intended for subcutaneous administration and should be administered via an intravenous infusion only. 
Intravenska oblika zdravila Trazimera ni namenjena subkutanemu (podkožnemu) dajanju in se ga lahko daje le z intravensko infuzijo.
HER2 gene amplification should be detected using fluorescence in situ hybridisation (FISH) or chromogenic in situ hybridisation (CISH) of fixed tumour blocks. 
Amplifikacijo gena HER2 določamo z metodo hibridizacije in situ, torej z metodo SISH ali FISH na fiksiranih blokih tumorskega tkiva.
* are summarized in Table 7. 
Analiza je povzeta v preglednici 11.
Death (OS event) No. patients with event p=0.0024 
Smrt (dogodek celokupnega preživetja): število bolnikov z dogodkom p = 0,0024
Table 16 Population Predicted PK Parameter Values at Steady State for Trastuzumab Intravenous Dosing Regimens in MBC, EBC and AGC Patients 
Farmakokinetične vrednosti izpostavljenosti, predvidene za populacijo, v stanju dinamičnega ravnovesja za režima odmerjanja trastuzumaba v intravenski obliki pri bolnikih z MBC, EBC in AGC
Tumour cell cluster with a weak to moderate complete, basolateral or lateral membranous reactivity irrespective of percentage of tumour cells stained 
Skupek tumorskih celic ima šibko do zmerno obarvane celotne, bazolateralne ali lateralne membrane, ne glede na odstotek obarvanih tumorskih celic.
Tumour cell cluster with a strong complete, basolateral or lateral membranous reactivity irrespective of percentage of tumour cells stained 
Skupek tumorskih celic ima močno obarvane celotne, bazolateralne ali lateralne membrane, ne glede na odstotek obarvanih tumorskih celic.
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. 
Običajno se pojavijo v zgodnejših fazah zdravljenja, torej med prvo, drugo in tretjo infuzijo, ter so manj pogoste pri naslednjih infuzijah.
Primary efficacy analysis DFS Hazard ratios (95% CI) p-value p<0.0001 
Primarna analiza učinkovitosti Razmerje ogroženosti za preživetje brez ponovitve bolezni (95 % IZ) p-vrednost p < 0,0001
This yields a 20.6 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab, at a pH of approximately 6.0. 
Rekonstitucija da 20,6 ml raztopine za enkratno uporabo, ki vsebuje približno 21 mg/ml trastuzumaba, s pH vrednostjo približno 6,0.
Doxorubicin and cyclophosphamide were administered concurrently as follows: 
Odmerjanje doksorubicina in ciklofosfamida, ki so ju dajali sočasno, je bilo naslednje:
The reconstituted Trazimera solution contains 21 mg/mL of trastuzumab. 
Pripravljena raztopina zdravila Trazimera vsebuje 21 mg/ml trastuzumaba.
- intravenous cyclophosphamide, at 600 mg/m 2 over 30 minutes, given every 3 weeks for 
- ciklofosfamid intravensko - 600 mg/m 2 v 30 minutah, vsake 3 tedne, 4 cikle.
Biopsy specimen - staining pattern 
Vzorci biopsijevidez preparata po barvanju
Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments. 
Bolniki s hormonsko odvisnimi tumorji, pri katerih je bolezen napredovala po predhodnem hormonskem zdravljenju, razen če za takšno zdravljenje niso bili primerni;
Strong complete membrane staining is detected in >10% of the tumour cells. 
Močno obarvanje celotne membrane pri > 10 % tumorskih celic.
1) Using a sterile syringe, slowly inject the appropriate volume (as noted above) of sterile water for injections in the vial containing the lyophilised Trazimera. 
1) Uporabite sterilno injekcijsko brizgo in počasi injicirajte ustrezen volumen (naveden zgoraj)
This yields a 7.4 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab, at a pH of approximately 6.0. 
Rekonstitucija da 7,4 ml raztopine za enkratno uporabo, ki vsebuje približno 21 mg/ml trastuzumaba, s pH vrednostjo približno 6,0.
There was no evidence of acute or multiple dose-related toxicity in studies of up to 6 months, or reproductive toxicity in teratology, female fertility or late gestational toxicity/placental transfer studies. 
V študijah teratogenosti, plodnosti pri ženskah ali pozne gestacijske toksičnosti/placentnega prehoda, ki so trajale do 6 mesecev, niso ugotovili akutne ali z večkratnim odmerjanjem povezane toksičnosti.
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 
Farmakokinetične vrednosti izpostavljenosti, predvidene za populacijo, v stanju dinamičnega ravnovesja (mediana s 5.-95. percentilom) za režima odmerjanja trastuzumaba v intravenski obliki pri bolnikih z MBC, EBC in AGC
Anaphylactic reaction 
+anafilaktična reakcija neznana
• depression 
• slabost
Study WO16229: loading dose 8 mg/kg, followed by 6 mg/kg 3 weekly schedule Study MO16982: loading dose 6 mg/kg weekly x 3; followed by 6 mg/kg 3-weekly schedule Study BO15935 
Študija WO16229: polnilni odmerek 8 mg/kg, čemur je sledil odmerek 6 mg/kg po 3-tedenskem režimu.
This yields a 20.6 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab. 
Rekonstitucija da 20,6 ml raztopine za enkratno uporabo in vsebuje približno 21 mg/ml trastuzumaba.
• skin rashes 
• kožni izpuščaji
- intravenous push doxorubicin, at 60 mg/m 2, given every 3 weeks for 4 cycles. 
- doksorubicin v obliki intravenskega bolusa - 60 mg/m 2, vsake 3 tedne, 4 cikle;
A weak to moderate complete membrane staining is detected in >10% of the tumour cells. 
Šibko do zmerno obarvanje celotne membrane pri > 10 % tumorskih celic.
Trazimera 150 mg powder for concentrate for solution for infusion Trazimera 420 mg powder for concentrate for solution for infusion trastuzumab 
Trazimera 150 mg prašek za koncentrat za raztopino za infundiranje Trazimera 420 mg prašek za koncentrat za raztopino za infundiranje trastuzumab
Trazimera 150 mg powder for concentrate for solution for infusion Trazimera 420 mg powder for concentrate for solution for infusion 
Trazimera 150 mg prašek za koncentrat za raztopino za infundiranje Trazimera 420 mg prašek za koncentrat za raztopino za infundiranje
Disease-free survival No. patients with event p=0.0003 
Preživetje brez ponovitve bolezni: število bolnikov z dogodkom p = 0,0003
Trazimera 420 mg powder for concentrate for solution for infusion 
Trazimera 420 mg prašek za koncentrat za raztopino za infundiranje
• abnormal thinking 
• nenormalno razmišljanje bolezni ledvic
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. 
Mediana celokupnega preživetja v skupini, ki je imela visoko izražen HER2, je bila 11,8 meseca v primerjavi s 16 meseci; razmerje ogroženosti 0,65 (95 % IZ: 0,51-0,83).
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). 
Podaljšanje zdravljenja zgodnjega raka dojk na več kot 1 leto ni priporočljivo (glejte poglavje 5.1).
Reversibility of mild symptomatic and asymptomatic left ventricular dysfunction was demonstrated for 79.5% of patients. 
Reverzibilnost blage simptomatske in asimptomatske disfunkcije levega prekata so dokazali pri
• haemorrhoids 
• oglušelost
Anaphylactic shock 
+anafilaktični šok neznana
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. 
Srčno popuščanje razreda III-IV po NYHA se je po medianem času spremljanja 12 mesecev pojavilo pri 0,6 % bolnikov v skupini, ki se je s trastuzumabom po zaključku adjuvantne kemoterapije zdravila 1 leto.
Trazimera 420 mg powder for concentrate for solution for infusion trastuzumab 
Trazimera 420 mg prašek za koncentrat za raztopino za infundiranje trastuzumab
Talk to your doctor, pharmacist or nurse before you are given Trazimera if: 
Preden boste prejeli zdravilo Trazimera, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, če:
Instructions for Reconstitution: 
- Navodilo shranite.
Duration of Response, Median months 
Trajanje odgovora, mediana (meseci) 4,8
Median duration of response (months) (95% CI) Median TTP (months) (95% CI) 
Mediana TTP (meseci) (95 % IZ)
Table 7 Summary of Efficacy results from the joint analysis of the NSABP B-31 and NCCTG N9831 trials at the time of the definitive DFS analysis 
Povzetek rezultatov učinkovitosti iz skupne analize preskušanj NSABP B-31 in NCCTG N9831 v času končne analize preživetja brez ponovitve bolezni
- 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. 
Preskušanji NSABP B-31 in NCCTG N9831, ki imata skupno analizo, so zasnovali za proučevanje klinične koristi kombinacije zdravljenja s trastuzumabom in paklitakselom po kemoterapiji z antraciklinom (doksorubicinom) in ciklofosfamidom (kemoterapiji AC).
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. 
Študije o vplivu na sposobnost za razmnoževanje so opravili pri opicah Cynomolgus z odmerki, ki so bili do 25-krat večji od tedenskega vzdrževalnega odmerka intravenske oblike trastuzumaba pri ljudeh (2 mg/kg).
Retinal haemorrhage 
Rekonstituirana raztopina
• Paclitaxel 175 mg/m2 administered 3-weekly for 4 cycles, 
temu je sledil - paklitaksel 175 mg/m2, enkrat na 3 tedne, 4 cikle;
The recommended maintenance dose of Trazimera at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose. 
Priporočeni vzdrževalni odmerek zdravila Trazimera je 6 mg/kg telesne mase po 3 tednih od prejema polnilnega odmerka in nato v 3-tedenskih razmakih.
• jaundice 
• driska
Cardiac failure (congestive) 
• vnetje očesne veznice (konjunktivitis)
Hazard Ratio vs AC→P (95% CI) p-value 
Razmerje ogroženosti v primerjavi z AC → P (95 % IZ) p-vrednost
Hazard Ratio versus AC→P (95% CI) 
Razmerje ogroženosti v primerjavi z AC → P (95 % IZ)
Distant recurrence No. patients with event p<0.0001 
Pojav oddaljenih metastaz: število bolnikov z dogodkom p < 0,0001
Long term follow-up efficacy analysis DFS Hazard rations (95% CI) p-value p<0.0001 
Razmerje ogroženosti za preživetje brez ponovitve bolezni (95 % IZ) p-vrednost p < 0,0001
Trastuzumab washout period was assessed following q1w or q3w intravenous administration using the population PK model. 
Obdobje izpiranja trastuzumaba so ocenjevali po intravenski aplikaciji zdravila enkrat na teden ali enkrat na 3 tedne s pomočjo populacijskega farmakokinetičnega modela.
No staining is observed or membrane staining is observed in <10% of the tumour cells 
Obarvanje ni prisotno ali pa so obarvane membrane pri < 10 % vseh tumorskih celic v preparatu.
Do not administer as an intravenous push or bolus. 
Zdravila se ne sme dajati kot hitro intravensko infuzijo ali bolus.