FrancophonIA/ELRC3.0 huggingface dataset:
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)
Slovenian: temu pa so po operaciji sledili • dodatni cikli trastuzumaba, danega adjuvantno (do dopolnjenega 1 leta zdravljenja).
English: +Pulmonary fibrosis
Slovenian: +pljučna fibroza neznana
English: Overall survival, median months Progression-free survival, median months
Slovenian: Celotno preživetje, mediano število mesecev
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:
Slovenian: • pri polnilnem odmerku 4 mg trastuzumaba/kg telesne mase ali pri nadaljnjih tedenskih odmerkih 2 mg trastuzumaba/kg telesne mase uporabite naslednjo formulo:
English: 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.
Slovenian: 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.
English: Death (OS event): No. patients with event (%)
Slovenian: Smrt (dogodek OS): število bolnikov z dogodkom
English: Weak to moderate complete, basolateral or lateral membranous reactivity in ≥10% of tumour cells
Slovenian: Šibka do zmerna popolna bazolateralna ali lateralna membranska reaktivnost v ≥ 10 % tumorskih celic.
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.
Slovenian: 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.
English: Death (OS event) No. patients with event p=0.0024
Slovenian: Smrt (dogodek OS) število bolnikov z dogodkom p = 0,0024
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) =
Slovenian: • 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) =
English: As a three-weekly regimen the recommended initial loading dose of Ontruzant is 8 mg/kg body weight.
Slovenian: Pri 3-tedenskem režimu je priporočen začetni polnilni odmerek zdravila Ontruzant 8 mg/kg telesne mase.
English: The recommended initial loading dose is 8 mg/kg body weight.
Slovenian: Priporočen začetni polnilni odmerek je 8 mg/kg telesne mase.
English: The recommended initial loading dose of Ontruzant is 4 mg/kg body weight.
Slovenian: Priporočen začetni polnilni odmerek zdravila Ontruzant je 4 mg/kg telesne mase.
English: It may take up to 7 months for Ontruzant to be removed from your body.
Slovenian: Izločanje zdravila Ontruzant iz vašega telesa lahko traja do 7 mesecev.
English: • throat infections
Slovenian: • okužbe žrela,
English: • infection of lungs
Slovenian: • okužba pljuč, • pljučne bolezni,
English: HER2 overexpression should be detected using an immunohistochemistry (IHC)-based assessment of fixed tumour blocks (see section 4.4).
Slovenian: ugotavljamo z imunohistokemično (IHC) metodo v fiksiranih tumorskih blokih (glejte poglavje 4.4).
English: Table 4 Efficacy results from the monotherapy and combination therapy studies Parameter
Slovenian: Rezultati učinkovitosti iz študij monoterapije in kombiniranega zdravljenja
English: The hazard ratio translates into an absolute benefit, in terms of 3-year disease-free survival rate estimates of 11.8 percentage points (87.2% versus 75.4%) in favour of the AC→PH (trastuzumab) arm.
Slovenian: 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 %).
English: Three-weekly dosing in metastatic breast cancer The efficacy results from the non-comparative monotherapy and combination therapy studies are summarised in Table 5:
Slovenian: Rezultati učinkovitosti monoterapije in kombiniranega zdravljenja iz študij brez primerjalne skupine so povzeti v preglednici 5:
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Zdravljenje z zdravilom Ontruzant mora vpeljati zdravnik z izkušnjami s citotoksično kemoterapijo (glejte poglavje 4.4).
English: In the neoadjuvant setting, the experience of concurrent administration of trastuzumab and low-dose anthracycline regimen is limited (see section 4.4).
Slovenian: Pri neoadjuvantnem zdravljenju je izkušenj z dajanjem trastuzumaba sočasno s shemami, ki vsebujejo majhne odmerke antraciklinov, malo (glejte poglavje 4.4).
English: In the NSABP B-31 and NCCTG N9831 studies trastuzumab was administered in combination with paclitaxel, following AC chemotherapy.
Slovenian: V študijah NSABP B-31 in NCCTG N9831 so dajali trastuzumab v kombinaciji s paklitakselom po kemoterapiji z doksorubicinom in ciklofosfamidom (kemoterapiji AC).
English: +Anaphylactic shock
Slovenian: +anafilaktični šok neznana
English: Each 150 mg vial of Ontruzant is reconstituted with 7.2 mL of sterile water for injection (not supplied).
Slovenian: Eno 150 mg vialo zdravila Ontruzant rekonstituirajte s 7,2 ml sterilne vode za injekcije (ni priložena).
English: A two-compartment model with parallel linear and non-linear elimination from the central compartment described the trastuzumab concentration-time profile.
Slovenian: Profil koncentracija-čas trastuzumaba je opisoval dvoprostorski model z vzporednim linearnim in nelinearnim odstranjevanjem iz centralnega prostora.
English: Ontruzant intravenous formulation is not intended for subcutaneous administration and should be administered via an intravenous infusion only.
Slovenian: Intravenska oblika zdravila Ontruzant ni namenjena subkutani aplikaciji in se lahko daje le z intravensko infuzijo.
English: • acute accumulation of fluid in the lungs
Slovenian: • akutno kopičenje tekočine v pljučih, • akutna zožitev zračnih poti,
English: CI)
Slovenian: N
English: Each 150 mg vial of Ontruzant is reconstituted with 7.2 mL of water for injections (not supplied).
Slovenian: Eno 150 mg vialo zdravila Ontruzant rekonstituirajte s 7,2 ml vode za injekcije (ni priložena).
English: How to store Ontruzant
Slovenian: Kako boste dobili zdravilo Ontruzant
English: Retinal haemorrhage
Slovenian: Spiranje trastuzumaba
English: Tumour cell cluster with a faint⁄barely perceptible membranous reactivity irrespective of percentage of tumour cells stained
Slovenian: Skupina tumorskih celic s šibko/komaj opazno membransko reaktivnostjo ne glede na odstotni delež obarvanih tumorskih celic.
English: Overall survival (death) - No. patients with event - No. patients without event
Slovenian: Celotno preživetje (smrt) - število bolnikov z dogodkom - število bolnikov brez dogodka 40 (2,4 %)
English: However, trastuzumab may elevate the overall exposure of one doxorubicin metabolite (7-deoxy-13 dihydro-doxorubicinone, D7D).
Slovenian: Vendar pa lahko trastuzumab zveča celotno izpostavljenost enemu presnovku doksorubicina (7
English: 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.
Slovenian: 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).
English: Patients with MBC or MGC should be treated with Ontruzant until progression of disease.
Slovenian: Bolnike z metastatskim rakom dojk ali metastatskim rakom želodca je treba zdraviti z zdravilom Ontruzant do napredovanja bolezni.
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.
Slovenian: V preskušanju ToGA (BO18255) so bili bolniki, katerih tumorji so bili bodisi IHC3+ ali FISH
English: Ontruzant 150 mg powder for concentrate for solution for infusion Ontruzant 420 mg powder for concentrate for solution for infusion
Slovenian: Ontruzant 150 mg prašek za koncentrat za raztopino za infundiranje Ontruzant 420 mg prašek za koncentrat za raztopino za infundiranje
English: Weekly dosing in metastatic breast cancer The efficacy results from the monotherapy and combination therapy studies are summarised in Table 4:
Slovenian: Rezultati učinkovitosti iz študij monoterapije in kombiniranega zdravljenja so povzeti v preglednici 4:
English: Distant recurrence No. patients with event p=0.0008
Slovenian: Pojav oddaljenih metastaz število bolnikov z dogodkom p = 0,0008
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.
Slovenian: Podatki so tudi nakazali, da sočasna uporaba kapecitabina ali sočasna uporaba kapecitabina in trastuzumaba ni vplivala na farmakokinetiko cisplatina.
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.
Slovenian: Izsledki te podštudije so nakazali, da sočasna uporaba cisplatina ali sočasna uporaba cisplatina in trastuzumaba ni vplivala na izpostavljenost biološko aktivnim presnovkom kapecitabina (npr.
English: Very common side effects of Ontruzant (may affect more than 1 in 10 people):
Slovenian: Zelo pogosti neželeni učinki zdravila Ontruzant (lahko se pojavijo pri več kot 1 od 10 bolnikov):
English: Determine the volume of the solution required:
Slovenian: Določitev potrebnega volumna raztopine:
English: +Acute respiratory distress syndrome
Slovenian: +sindrom akutne dihalne stiske neznana
English: Rare side effects of Ontruzant (may affect up to 1 in 1000 people):
Slovenian: Redki neželeni učinki zdravila Ontruzant (lahko se pojavijo pri največ 1 od 1000 bolnikov):
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.
Slovenian: 1) Uporabite sterilno injekcijsko brizgo, počasi injicirajte primerno količino (kot navedeno zgoraj)
English: Tumour cell cluster with a weak to moderate complete, basolateral or lateral membranous reactivity irrespective of percentage of tumour cells stained
Slovenian: Skupina tumorskih celic s šibko do zmerno popolno bazolateralno ali lateralno membransko reaktivnostjo ne glede na odstotni delež obarvanih tumorskih celic.
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)*
Slovenian: 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
English: Ontruzant 420 mg powder for concentrate for solution for infusion
Slovenian: Ontruzant 420 mg prašek za koncentrat za raztopino za infundiranje
English: In all patients cardiac function should be monitored during treatment (e.g. every 12 weeks).
Slovenian: 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.
English: Effect of trastuzumab on the pharmacokinetics of other antineoplastic agents
Slovenian: Vpliv trastuzumaba na farmakokinetiko drugih zdravil z delovanjem na novotvorbe (citostatikov)
English: • shock
Slovenian: • bruhanje,
English: DFS analysis was also performed at the final analysis of OS from the joint analysis of studies NSABP B-31 and NCCTG N9831.
Slovenian: Ob končni analizi OS iz združene analize študij NSABP B-31 in NCCTG N9831 so opravili tudi analizo DFS.
English: 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.
Slovenian: Ustrezno količino raztopine odvzemite iz viale in jo dodajte infuzijski vrečki, ki vsebuje 250 ml
English: 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).
Slovenian: Podaljšanje zdravljenja zgodnjega raka dojk na več kot eno leto ni priporočljivo (glejte poglavje 5.1).
English: In the pivotal trial MO16432, trastuzumab was administered concurrently with neoadjuvant chemotherapy containing three cycles of doxorubicin (cumulative dose 180 mg/m2).
Slovenian: ki je vključevala tri cikle doksorubicina (kumulativni odmerek 180 mg/m2).
English: Median TTP (months) (95%CI) Median survival (months) (95%CI)
Slovenian: Odzivnost (95 % IZ) Mediano trajanje odziva (meseci) (95 % IZ) Mediani TTP (meseci) (95 % IZ) Mediano preživetje (meseci) (95 % IZ)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ontruzant 420 mg powder for concentrate for solution for infusion trastuzumab
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Ontruzant 420 mg prašek za koncentrat za raztopino za infundiranje trastuzumab samo za intravensko uporabo
English: Tumour cell cluster with a strong complete, basolateral or lateral membranous reactivity irrespective of percentage of tumour cells stained
Slovenian: Skupina tumorskih celic z močno popolno bazolateralno ali lateralno membransko reaktivnostjo ne glede na odstotni delež obarvanih tumorskih celic.
English: Instructions for reconstitution:
Slovenian: - Navodilo shranite.
English: 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.
Slovenian: 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 %),
English: 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
Slovenian: Študija MO16982: polnilni odmerek 6 mg/kg na teden × 3; sledila mu je shema enkrat na 3 tedne po 6 mg/kg.
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
Slovenian: - 95. percentilom) za shemi odmerjanja trastuzumaba v intravenski infuziji pri bolnikih z MBC, EBC in AGC
English: 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.
Slovenian: Rezultatov, ki bi primerjali učinkovitost trastuzumaba, danega skupaj s kemoterapijo pri adjuvantnem zdravljenju, z učinkovitostjo trastuzumaba pri neoadjuvantno-adjuvantnem zdravljenju, doslej ni na voljo.
English: Disease-free survival No. patients with event p=0.0003
Slovenian: Preživetje brez bolezni število bolnikov z dogodkom p = 0,0003
English: • acne
Slovenian: • akne.
English: • The other ingredient(s) are L-histidine hydrochloride monohydrate, L-histidine, α,α-trehalose dihydrate, polysorbate 20.
Slovenian: • Pomožne snovi so L-histidinijev klorid monohidrat, L-histidin, α,α-trehaloza dihidrat in polisorbat
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ontruzant 150 mg powder for concentrate trastuzumab
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Ontruzant 150 mg prašek za koncentrat trastuzumab samo za intravensko uporabo
English: 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
Slovenian: *** 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.
English: Pregnancy 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 fetus.
Slovenian: Študije vpliva na sposobnost za razmnoževanje so opravili pri opicah Cynomolgus z odmerki, ki so bili do 25-krat večji od tedenskega vzdrževalnega odmerka pri ljudeh, ki je 2 mg/kg trastuzumaba za intravensko uporabo.
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,
Slovenian: in sicer takole: • doksorubicin 60 mg/m2 in paklitaksel 150 mg/m2,vsake 3 tedne, 3 cikle, temu je sledil
English: • abnormal or impaired blood clotting
Slovenian: • nenormalno ali upočasnjeno strjevanje krvi,
English: • nausea
Slovenian: • nahod,
English: Time to steady-state
Slovenian: Čas do stanja ravnovesja*
English: Table 8 Final overall survival analysis from the joint analysis of trials NSABP B-31 and NCCTG N9831
Slovenian: Vnaprej načrtovana končna analiza OS iz združene analize študij NSABP B-31 in NCCTG N9831
English: The infusion may be continued after the symptoms improve.
Slovenian: Po ublažitvi simptomov boste lahko z infuzijo nadaljevali.
English: Hazard ratio vs AC→D (95% CI)
Slovenian: Razmerje tveganja proti AC→D (95 % IZ)
English: Ontruzant 150 mg powder for concentrate for solution for infusion
Slovenian: Ontruzant 150 mg prašek za koncentrat za raztopino za infundiranje
English: Trastuzumab and anthracyclines should not be given concurrently in combination in the adjuvant treatment setting.
Slovenian: Pri adjuvantnem zdravljenju trastuzumaba in antraciklinov ne smemo dajati sočasno.
English: The recommended maintenance dose at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose.
Slovenian: Priporočen vzdrževalni odmerek zdravila Ontruzant je 6 mg/kg telesne mase na 3 tedne, s katerim začnemo po 3 tednih od prejema polnilnega odmerka.
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.
Slovenian: - Študiji NSABP B-31 in NCCTG N9831, ki sta del združene analize, sta bili zasnovani za proučevanje klinične koristi kombiniranja zdravljenja s trastuzumabom in paklitakselom po kemoterapiji z antraciklinom in ciklofosfamidom (kemoterapiji AC).
English: AC→D = doxorubicin plus cyclophosphamide, followed by docetaxel; AC→DH = doxorubicin plus cyclophosphamide, followed by docetaxel plus trastuzumab; CI = confidence interval Table 10 Overview of efficacy analyses BCIRG 006 AC→D versus DCarbH
Slovenian: AC→D = doksorubicin in ciklofosfamid, ki jima je sledil docetaksel; AC→DH = doksorubicin in ciklofosfamid, ki sta jima sledila docetaksel in trastuzumab; IZ = interval zaupanja.
English: This yields a 7.4 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab, at a pH of approximately 6.0.
Slovenian: Rekonstitucija da 7,4 ml raztopine za enkratno uporabo, ki vsebuje približno 21 mg/ml trastuzumaba s pH približno 6,0.
English: Faint ⁄ barely perceptible membranous reactivity in ≥10% of tumour cells; cells are reactive only in part of their membrane
Slovenian: Šibka ⁄ komaj opazna membranska reaktivnost v ≥ 10 % tumorskih celic.
English: Congestive heart failure (NYHA Class II-IV) is a common adverse reaction associated with the use of trastuzumab and has been associated with a fatal outcome (see section 4.4).
Slovenian: Kongestivno srčno popuščanje ( NYHA razred II-IV) je pogost neželeni učinek trastuzumaba.
English: In the pivotal metastatic trials of intravenous trastuzumab, the incidence of cardiac dysfunction varied between 9% and 12% when it was combined with paclitaxel compared with 1%-4% for paclitaxel alone.
Slovenian: V ključnih preskušanjih z intravensko danim trastuzumabom pri metastatski bolezni je bila incidenca motenj v delovanju srca pri bolnikih, ki so zdravilo prejemali sočasno s paklitakselom, v razponu od 9
English: This yields a 7.4 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab.
Slovenian: Rekonstitucija da 7,4 ml raztopine za enkratno uporabo, ki vsebuje približno 21 mg/ml trastuzumaba.
English: This yields a 21 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab, at a pH of approximately 6.0.
Slovenian: Rekonstitucija da 21 ml raztopine za enkratno uporabo, ki vsebuje približno 21 mg/ml trastuzumaba s pH približno 6,0.
English: Distant recurrence No. patients with event p<0.0001
Slovenian: Pojav oddaljenih metastaz število bolnikov z dogodkom p < 0,0001
English: p-value versus
Slovenian: Vrednost p proti AC→P
English: Table 6 Efficacy results from Study BO16348 Median follow-up 12 months*
Slovenian: Rezultati učinkovitosti iz preskušanja BO16348
English: Table 3 Recommended scoring system to evaluate the IHC staining patterns in gastric cancer
Slovenian: Priporočeni način vrednotenja rezultatov obarvanja preparatov po metodi IHC pri raku želodca Ocena Kirurški vzorec - videz preparata po obarvanju