natgillin/translations-raw huggingface dataset:
Death (OS event) No. patients with event p=0.0182 
Smrt (dogodek OS) število bolnikov z dogodkom p = 0,0182
Ontruzant 150 mg powder for concentrate for solution for infusion Appropriate aseptic technique should be used. 
Ontruzant 150 mg prašek za koncentrat za raztopino za infundiranje Uporabljati morate ustrezno aseptično tehniko.
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, ženske plodnosti ali toksičnosti v pozni nosečnosti/prenosa skozi placento ni bilo znakov akutne ali z več odmerki povezane toksičnosti ali toksičnosti za razmnoževanje v študijah, ki so trajale do 6 mesecev.
Ontruzant is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC). 
Zdravilo Ontruzant je indicirano za zdravljenje odraslih bolnikov z zgodnjo obliko HER2-pozitivnega raka dojk:
• failure of the lungs of the baby to develop in the womb 
• okvara pri razvoju pljuč otroka v maternici,
The population predicted PK exposure values (median with 5th-95th Percentiles) and PK parameter values at clinically relevant concentrations (Cmax and Cmin) for MBC, EBC and AGC patients treated with the approved q1w and q3w dosing regimens are shown in Table 14 (Cycle 1), Table 15 (steady-state), and Table 16 (PK parameters). 
95. percentilom), in vrednosti farmakokinetičnih parametrov pri klinično pomembnih koncentracijah (Cmax in Cmin) pri bolnikih z MBC, EBC in AGC, zdravljenih z odobrenima shemama odmerjanja enkrat na teden in enkrat na tri tedne, kažejo preglednica 14 (1. cikel), preglednica 15 (stanje mirovanja) in preglednica 16 (farmakokinetični parametri).
Strong complete, basolateral or lateral membranous reactivity in ≥10% of tumour cells 
Močna popolna bazolateralna ali lateralna membranska reaktivnost v ≥ 10 % tumorskih celic.
- The BCIRG 006 study was designed to investigate combining trastuzumab treatment with docetaxel either following AC chemotherapy or in combination with docetaxel and carboplatin in patients with HER2 positive EBC following surgery. 
- Študija BCIRG 006 je bila zasnovana za proučevanje kombiniranja zdravljenja s trastuzumabom in docetakselom bodisi po kemoterapiji z antraciklinom in ciklofosfamidom (kemoterapiji AC), bodisi v kombinaciji z docetakselom in karboplatinom pri bolnikih z zgodnjo obliko HER2-pozitivnega raka dojk po operaciji.
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. 
Rezultati učinkovitosti iz združene analize preskušanj NSABP B-31 in NCCTG 9831 v času končne analize DFS* so povzeti v preglednici 7.
+1Wheezing 
+1sopenje
• pain, swelling, redness or tingling of hands and/or feet 
• bolečina, otekanje, rdečina ali mravljinčenje dlani in/ali stopal,
What Ontruzant is and what it is used for What you need to know before you are given Ontruzant How Ontruzant is given 
Kaj je zdravilo Ontruzant in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili zdravilo Ontruzant Kako boste dobili zdravilo Ontruzant
• redness, swelling or sores in your mouth and/or throat 
• rdečina, otekanje ali razjede v ustih in/ali žrelu,
Table 16 Population predicted PK parameter values at steady state for trastuzumab intravenous infusion dosing regimens in MBC, EBC and AGC patients 
Farmakokinetične vrednosti izpostavljenosti, predvidene za populacijo, v stanju dinamičnega ravnovesja za shemi odmerjanja trastuzumaba v intravenski infuziji pri bolnikih z MBC, EBC in AGC
The final OS results from the joint analysis of studies NSABP B-31 and NCCTG N9831 are summarized in Table 8 below: 
Končni rezultati OS iz združene analize študij NSABP B-31 in NCCTG N9831 so povzeti v preglednici 8 v nadaljevanju:
in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease. 
v kombinaciji z docetakselom za zdravljenje tistih bolnikov, ki še niso prejemali kemoterapije za svojo metastatsko bolezen;
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 dveh zaporednih vrednosti LVEF ≥ 50 % po dogodku).
+Bronchospasm 
+bronhospazem neznana
+Anaphylactic reaction 
+anafilaktična reakcija neznana
Infusion related reaction 
povezane z infuzijo.
METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use only after reconstitution and dilution. 
Samo za intravensko uporabo po rekonstituciji in razredčenju.
• Severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy. 
• Bolniki, ki imajo hudo dispnejo v mirovanju zaradi komplikacij napredovale maligne bolezni, ali tisti, ki potrebujejo zdravljenje s kisikom.
- capecitabine - 1000 mg/m2 orally twice daily for 14 days every 3 weeks for 6 cycles (evening of day 1 to morning of day 15 of each cycle) 
- kapecitabin - 1000 mg/m2 peroralno dvakrat na dan 14 dni vsake 3 tedne, skupaj 6 ciklov
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. 
Mediano trajanje spremljanja je bilo 1,8 leta v skupini AC→P in 2,0 leti v skupini AC→PH.
Each 420 mg vial of Ontruzant is reconstituted with 20 mL of sterile water for injection (not supplied). 
Eno 420 mg vialo zdravila Ontruzant rekonstituirajte s 20 ml sterilne vode za injekcije (ni priložena).
Patients experiencing dyspnoea at rest due to complications of advanced malignancy and comorbidities may be at increased risk of a fatal infusion reaction. 
Pri bolnikih, ki imajo dispnejo v mirovanju zaradi zapletov napredovale maligne bolezni in soobolenja, obstaja večje tveganje za reakcije, povezane z aplikacijo, s smrtnim izidom.
Details of risk minimisation measures that are consistent with the EU Risk Management Plan are presented in (section 4.4) Warnings and Precautions. 
Podrobnosti ukrepov za zmanjševanje tveganj, ki so skladni z načrtom za obvladovanje tveganj
The recommended weekly maintenance dose of Ontruzant is 2 mg/kg body weight, beginning one week after the loading dose. 
Priporočen tedenski vzdrževalni odmerek zdravila Ontruzant je 2 mg/kg telesne mase, s katerim začnemo en teden po polnilnem odmerku.
Hazard ratio versus 
Razmerje tveganja proti
• jaundice (yellowish discoloration of the skin or eyes) 
• zlatenica (rumenkasto obarvanje kože ali oči), • vnetje ali brazgotinjenje pljuč.
STATEMENT OF ACTIVE SUBSTANCE(S) The vial contains 420 mg trastuzumab. 
Viala vsebuje 420 mg trastuzumaba.
However, trastuzumab plus docetaxel was efficacious in patients whether or not they had received prior adjuvant anthracyclines. 
Je pa bil trastuzumab skupaj z docetakselom učinkovit ne glede na to, ali so bolniki prej prejeli adjuvantno terapijo z antraciklini ali ne.
8mg/kg + 6mg/kg q3w 
8 mg/kg + 6 mg/kg enkrat na 3 tedne
Ontruzant should be carefully handled during reconstitution. 
Navodila za rekonstitucijo: Z zdravilom Ontruzant je treba med rekonstitucijo previdno ravnati.
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) 
temu pa so po operaciji sledili • dodatni cikli trastuzumaba, danega adjuvantno (do dopolnjenega 1 leta zdravljenja).
+Pulmonary fibrosis 
+pljučna fibroza neznana
Overall survival, median months Progression-free survival, median months 
Celotno preživetje, mediano število mesecev
• based on a loading dose of 4 mg trastuzumab/kg body weight, or a subsequent weekly dose of 2 mg trastuzumab/kg body weight: 
• pri polnilnem odmerku 4 mg trastuzumaba/kg telesne mase ali pri nadaljnjih tedenskih odmerkih 2 mg trastuzumaba/kg telesne mase uporabite naslednjo formulo:
Comparison of PK results from two Phase II studies (BO15935 and M77004) and one Phase III study (H0648g) in which patients were treated concomitantly with trastuzumab and paclitaxel and two Phase II studies in which trastuzumab was administered as monotherapy (W016229 and MO16982), in women with HER2-positive MBC indicates that individual and mean trastuzumab trough serum concentrations varied within and across studies but there was no clear effect of the concomitant administration of paclitaxel on the pharmacokinetics of trastuzumab. 
3. faze (H0648g), v katerih so sočasno zdravili bolnike s trastuzumabom in paklitakselom, in dveh študij 2. faze, v katerih so dajali trastuzumab v monoterapiji (W016229 in MO16982) bolnikom s HER2-pozitivnim metastatskim rakom dojk, kaže, da so se posamezne in povprečne najnižje serumske koncentracije trastuzumaba razlikovale znotraj študij in med njimi, jasnega vpliva sočasnega dajanja paklitaksela na farmakokinetiko trastuzumaba pa ni bilo.
Death (OS event): No. patients with event (%) 
Smrt (dogodek OS): število bolnikov z dogodkom
Weak to moderate complete, basolateral or lateral membranous reactivity in ≥10% of tumour cells 
Šibka do zmerna popolna bazolateralna ali lateralna membranska reaktivnost v ≥ 10 % tumorskih celic.
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. 
Pri bolnikih z zgodnjim rakom dojk so opazili zvečanje incidence simptomatskih in asimptomatskih neželenih učinkov, povezanih s srcem, ko so trastuzumab dajali po kemoterapiji, ki je vsebovala antraciklin, v primerjavi s sočasnim dajanjem z neantraciklinskim režimom, ki je vseboval docetaksel in karboplatin.
Death (OS event) No. patients with event p=0.0024 
Smrt (dogodek OS) število bolnikov z dogodkom p = 0,0024
• 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) = 
• za polnilni odmerek 8 mg trastuzumaba/kg telesne mase ali za nadaljnje odmerke 6 mg trastuzumaba/kg telesne mase enkrat na 3 tedne z naslednjo formulo: Volumen (ml) =
As a three-weekly regimen the recommended initial loading dose of Ontruzant is 8 mg/kg body weight. 
Pri 3-tedenskem režimu je priporočen začetni polnilni odmerek zdravila Ontruzant 8 mg/kg telesne mase.
The recommended initial loading dose is 8 mg/kg body weight. 
Priporočen začetni polnilni odmerek je 8 mg/kg telesne mase.
The recommended initial loading dose of Ontruzant is 4 mg/kg body weight. 
Priporočen začetni polnilni odmerek zdravila Ontruzant je 4 mg/kg telesne mase.
It may take up to 7 months for Ontruzant to be removed from your body. 
Izločanje zdravila Ontruzant iz vašega telesa lahko traja do 7 mesecev.
• throat infections 
• okužbe žrela,
• infection of lungs 
• okužba pljuč, • pljučne bolezni,
HER2 overexpression should be detected using an immunohistochemistry (IHC)-based assessment of fixed tumour blocks (see section 4.4). 
ugotavljamo z imunohistokemično (IHC) metodo v fiksiranih tumorskih blokih (glejte poglavje 4.4).
Table 4 Efficacy results from the monotherapy and combination therapy studies Parameter 
Rezultati učinkovitosti iz študij monoterapije in kombiniranega zdravljenja
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. 
Razmerje tveganja se izraža kot absolutna korist skupine, ki je prejemala AC→PH (trastuzumab), v smislu 3-letnega preživetja brez bolezni za 11,8 odstotne točke (87,2 % proti 75,4 %).
Three-weekly dosing in metastatic breast cancer The efficacy results from the non-comparative monotherapy and combination therapy studies are summarised in Table 5: 
Rezultati učinkovitosti monoterapije in kombiniranega zdravljenja iz študij brez primerjalne skupine so povzeti v preglednici 5:
In patients who receive anthracycline-containing chemotherapy further monitoring is recommended, and should occur yearly up to 5 years from the last administration of trastuzumab, or longer if a continuous decrease of LVEF is observed. 
je priporočljivo nadaljnje spremljanje, ki ga je treba izvajati vsako leto do 5 let po zadnjem dajanju trastuzumaba ali dlje, če iztisni delež levega prekata (LVEF) stalno pada.
Ontruzant 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 Ontruzant mora vpeljati zdravnik z izkušnjami s citotoksično kemoterapijo (glejte poglavje 4.4).
In the neoadjuvant setting, the experience of concurrent administration of trastuzumab and low-dose anthracycline regimen is limited (see section 4.4). 
Pri neoadjuvantnem zdravljenju je izkušenj z dajanjem trastuzumaba sočasno s shemami, ki vsebujejo majhne odmerke antraciklinov, malo (glejte poglavje 4.4).
In the NSABP B-31 and NCCTG N9831 studies trastuzumab was administered in combination with paclitaxel, following AC chemotherapy. 
V študijah NSABP B-31 in NCCTG N9831 so dajali trastuzumab v kombinaciji s paklitakselom po kemoterapiji z doksorubicinom in ciklofosfamidom (kemoterapiji AC).
+Anaphylactic shock 
+anafilaktični šok neznana
Each 150 mg vial of Ontruzant is reconstituted with 7.2 mL of sterile water for injection (not supplied). 
Eno 150 mg vialo zdravila Ontruzant rekonstituirajte s 7,2 ml sterilne vode za injekcije (ni priložena).
A two-compartment model with parallel linear and non-linear elimination from the central compartment described the trastuzumab concentration-time profile. 
Profil koncentracija-čas trastuzumaba je opisoval dvoprostorski model z vzporednim linearnim in nelinearnim odstranjevanjem iz centralnega prostora.
Ontruzant intravenous formulation is not intended for subcutaneous administration and should be administered via an intravenous infusion only. 
Intravenska oblika zdravila Ontruzant ni namenjena subkutani aplikaciji in se lahko daje le z intravensko infuzijo.
• acute accumulation of fluid in the lungs 
• akutno kopičenje tekočine v pljučih, • akutna zožitev zračnih poti,
Each 150 mg vial of Ontruzant is reconstituted with 7.2 mL of water for injections (not supplied). 
Eno 150 mg vialo zdravila Ontruzant rekonstituirajte s 7,2 ml vode za injekcije (ni priložena).
How to store Ontruzant 
Kako boste dobili zdravilo Ontruzant
Retinal haemorrhage 
Spiranje trastuzumaba
Tumour cell cluster with a faint⁄barely perceptible membranous reactivity irrespective of percentage of tumour cells stained 
Skupina tumorskih celic s šibko/komaj opazno membransko reaktivnostjo ne glede na odstotni delež obarvanih tumorskih celic.
Overall survival (death) - No. patients with event - No. patients without event 
Celotno preživetje (smrt) - število bolnikov z dogodkom - število bolnikov brez dogodka 40 (2,4 %)
However, trastuzumab may elevate the overall exposure of one doxorubicin metabolite (7-deoxy-13 dihydro-doxorubicinone, D7D). 
Vendar pa lahko trastuzumab zveča celotno izpostavljenost enemu presnovku doksorubicina (7
For overall survival, the HR was 0.75 (95% CI 0.51-1.11) in the IHC2+/FISH+ group and the HR was 0.58 (95% CI 0.41-0.81) in the IHC3+/FISH+ group. 
Mediano preživetje brez napredovanja bolezni je bilo 5,5 meseca v skupini, ki ni prejemala trastuzumaba, v primerjavi s 7,6 meseca v skupini, ki je prejemala trastuzumab - HR 0,64 (95 % IZ 0,51-0,79) pri FP oziroma FP + H. HR za celotno preživetje je bilo 0,75 (95 % IZ 0,51-1,11) v skupini IHC2+/FISH+, v skupini IHC3+/FISH+ pa je bilo HR 0,58 (95 % IZ 0,41-0,81).
Patients with MBC or MGC should be treated with Ontruzant until progression of disease. 
Bolnike z metastatskim rakom dojk ali metastatskim rakom želodca je treba zdraviti z zdravilom Ontruzant do napredovanja bolezni.
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. 
V preskušanju ToGA (BO18255) so bili bolniki, katerih tumorji so bili bodisi IHC3+ ali FISH
Ontruzant 150 mg powder for concentrate for solution for infusion Ontruzant 420 mg powder for concentrate for solution for infusion 
Ontruzant 150 mg prašek za koncentrat za raztopino za infundiranje Ontruzant 420 mg prašek za koncentrat za raztopino za infundiranje
Weekly dosing in metastatic breast cancer The efficacy results from the monotherapy and combination therapy studies are summarised in Table 4: 
Rezultati učinkovitosti iz študij monoterapije in kombiniranega zdravljenja so povzeti v preglednici 4:
Distant recurrence No. patients with event p=0.0008 
Pojav oddaljenih metastaz število bolnikov z dogodkom p = 0,0008
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 tudi nakazali, da sočasna uporaba kapecitabina ali sočasna uporaba kapecitabina in trastuzumaba ni vplivala na farmakokinetiko cisplatina.
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. 
Izsledki te podštudije so nakazali, da sočasna uporaba cisplatina ali sočasna uporaba cisplatina in trastuzumaba ni vplivala na izpostavljenost biološko aktivnim presnovkom kapecitabina (npr.
Very common side effects of Ontruzant (may affect more than 1 in 10 people): 
Zelo pogosti neželeni učinki zdravila Ontruzant (lahko se pojavijo pri več kot 1 od 10 bolnikov):
Determine the volume of the solution required: 
Določitev potrebnega volumna raztopine:
+Acute respiratory distress syndrome 
+sindrom akutne dihalne stiske neznana
Rare side effects of Ontruzant (may affect up to 1 in 1000 people): 
Redki neželeni učinki zdravila Ontruzant (lahko se pojavijo pri največ 1 od 1000 bolnikov):
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. 
1) Uporabite sterilno injekcijsko brizgo, počasi injicirajte primerno količino (kot navedeno zgoraj)
Tumour cell cluster with a weak to moderate complete, basolateral or lateral membranous reactivity irrespective of percentage of tumour cells stained 
Skupina tumorskih celic s šibko do zmerno popolno bazolateralno ali lateralno membransko reaktivnostjo ne glede na odstotni delež obarvanih tumorskih celic.
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)* 
Rezultati post-hoc eksplorativne analize iz združene analize kliničnih študij NSABP B-31/NCCTG N9831* in BCIRG006, v kateri so združili dogodke DFS in simptomatske srčne dogodke
Ontruzant 420 mg powder for concentrate for solution for infusion 
Ontruzant 420 mg prašek za koncentrat za raztopino za infundiranje
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 prepoznati bolnike, pri katerih se pojavijo motnje v delovanju srca.
Effect of trastuzumab on the pharmacokinetics of other antineoplastic agents 
Vpliv trastuzumaba na farmakokinetiko drugih zdravil z delovanjem na novotvorbe (citostatikov)
• shock 
• bruhanje,
DFS analysis was also performed at the final analysis of OS from the joint analysis of studies NSABP B-31 and NCCTG N9831. 
Ob končni analizi OS iz združene analize študij NSABP B-31 in NCCTG N9831 so opravili tudi analizo DFS.
The appropriate amount of solution should be withdrawn from the vial and added to an infusion bag containing 250 mL of 0.9% sodium chloride solution. 
Ustrezno količino raztopine odvzemite iz viale in jo dodajte infuzijski vrečki, ki vsebuje 250 ml
Patients with EBC should be treated with Ontruzant 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 eno leto ni priporočljivo (glejte poglavje 5.1).
In the pivotal trial MO16432, trastuzumab was administered concurrently with neoadjuvant chemotherapy containing three cycles of doxorubicin (cumulative dose 180 mg/m2). 
ki je vključevala tri cikle doksorubicina (kumulativni odmerek 180 mg/m2).
Median TTP (months) (95%CI) Median survival (months) (95%CI) 
Odzivnost (95 % IZ) Mediano trajanje odziva (meseci) (95 % IZ) Mediani TTP (meseci) (95 % IZ) Mediano preživetje (meseci) (95 % IZ)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ontruzant 420 mg powder for concentrate for solution for infusion trastuzumab 
IME ZDRAVILA IN POT(I) UPORABE Ontruzant 420 mg prašek za koncentrat za raztopino za infundiranje trastuzumab samo za intravensko uporabo
Tumour cell cluster with a strong complete, basolateral or lateral membranous reactivity irrespective of percentage of tumour cells stained 
Skupina tumorskih celic z močno popolno bazolateralno ali lateralno membransko reaktivnostjo ne glede na odstotni delež obarvanih tumorskih celic.
Instructions for reconstitution: 
- Navodilo shranite.
Risk factors for a cardiac event identified in four large adjuvant studies included advanced age (>50 years), low LVEF (<55%) at baseline, prior to or following the initiation of paclitaxel treatment, decline in LVEF by 10-15 points, and prior or concurrent use of anti-hypertensive medicinal products. 
Dejavniki tveganja za pojav neželenega učinka, povezanega s srcem, ki so jih opazili v štirih velikih adjuvantnih študijah, so vključevali starost nad 50 let, majhno osnovno vrednost LVEF (< 55 %),
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 MO16982: polnilni odmerek 6 mg/kg na teden × 3; sledila mu je shema enkrat na 3 tedne po 6 mg/kg.
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 
- 95. percentilom) za shemi odmerjanja trastuzumaba v intravenski infuziji pri bolnikih z MBC, EBC in AGC
So far, no results are available which compare the efficacy of trastuzumab administered with chemotherapy in the adjuvant setting with that obtained in the neo-adjuvant/adjuvant setting. 
Rezultatov, ki bi primerjali učinkovitost trastuzumaba, danega skupaj s kemoterapijo pri adjuvantnem zdravljenju, z učinkovitostjo trastuzumaba pri neoadjuvantno-adjuvantnem zdravljenju, doslej ni na voljo.
Disease-free survival No. patients with event p=0.0003 
Preživetje brez bolezni število bolnikov z dogodkom p = 0,0003
• The other ingredient(s) are L-histidine hydrochloride monohydrate, L-histidine, α,α-trehalose dihydrate, polysorbate 20. 
• Pomožne snovi so L-histidinijev klorid monohidrat, L-histidin, α,α-trehaloza dihidrat in polisorbat
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ontruzant 150 mg powder for concentrate trastuzumab 
IME ZDRAVILA IN POT(I) UPORABE Ontruzant 150 mg prašek za koncentrat trastuzumab samo za intravensko uporabo
Hazard ratio versus observation *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 
*** Obstaja neskladje v celotni velikosti vzorca zaradi majhnega števila bolnikov, ki so jih randomizirali po datumu zaključka zbiranja podatkov za analizo medianega 12-mesečnega spremljanja.