FrancophonIA/ELRC3.0 huggingface dataset:
English: Pre-switching rates (Cycles 1-4) for serious adverse events, grade 3 adverse events and treatment discontinuations due to adverse events were low (< 5 %) and similar to post-switching rates (Cycles 58).
Slovenian: Pogostnost resnih neželenih učinkov, neželenih učinkov stopnje 3 in prekinitev zdravljenja zaradi neželenih učinkov je bila majhna (< 5 %) pred prehodom (1. do 4. cikel) in podobna kot po prehodu (5. do 8. cikel).
English: It may take up to 7 months for Ogivri to be removed from your body.
Slovenian: Da se zdravilo Ogivri popolnoma izloči iz vašega telesa, lahko traja tudi do 7 mesecev.
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 yea r= 0.99 (95 % CI: 0.87, 1.13), p-value = 0.90 and OS HR = 0.98 (0.83, 1.15); pvalue = 0.78].
Slovenian: Omenjena končna analiza ni pokazala dodatne koristi podaljšanja zdravljenja s trastuzumabom na dve leti v primerjavi z enoletnim zdravljenjem [razmerje ogroženosti za preživetje brez napredovanja bolezni v populaciji, ki so jo nameravali zdraviti pri dvoletnem zdravljenju v primerjavi z enoletnim zdravljenjem = 0,99 (95-% IZ: 0,87; 1,13), p-vrednost = 0,90 in razmerje ogroženosti za celokupno preživetje = 0,98 (0,83; 1,15), p-vrednost = 0,78].
English: Pharmacokinetic data from studies BO15935 and M77004 in women with HER2-positive MBC suggested that exposure to paclitaxel and doxorubicin (and their major metabolites 6-α hydroxylpaclitaxel, POH, and doxorubicinol, DOL) was not altered in the presence of trastuzumab (8 mg/kg or 4 mg/kg intravenous loading dose followed by 6 mg/kg q3w or 2 mg/kg q1w intravenous, respectively).
Slovenian: Učinek trastuzumaba na farmakokinetiko drugih zdravil z delovanjem na novotvorbe Farmakokinetični podatki iz študij BO15935 in M77004 pri bolnicah s HER2-pozitivnim metastatskim rakom dojk so nakazali, da izpostavljenost paklitakselu in doksorubicinu (in njunima glavnima metabolitoma 6-α hidroksil-paklitakselu, POH, in doksorubicinolu, DOL) ni bila spremenjena v prisotnosti trastuzumaba (uvajalni odmerek 8 mg/kg, ki mu je sledil odmerek 6 mg/kg intravensko vsake tri tedne ali uvajalni odmerek 4 mg/kg intravensko, ki mu je sledil odmerek 2 mg/kg intravensko enkrat na teden).
English: Ogivri should be carefully handled during reconstitution.
Slovenian: Med rekonstitucijo se mora z zdravilom Ogivri pazljivo ravnati.
English: MBC 805
Slovenian: MBC 805 EBC 390
English: In vitro, trastuzumab-mediated ADCC has been shown to be preferentially exerted on HER2 overexpressing cancer cells compared with cancer cells that do not overexpress HER2.
Slovenian: V in vitroštudijah je do s trastuzumabom posredovane ADCC preferenčno prihajalo na rakastih celicah, ki so čezmerno izražale HER2, v primerjavi s celicami, pri katerih se HER2 ni čezmerno izražal.
English: Ogivri intravenous formulation is not intended for subcutaneous administration and should be administered via an intravenous infusion only.
Slovenian: Intravenska oblika zdravila Ogivri ni namenjena subkutani aplikaciji in se lahko daje le z intravensko infuzijo.
English: Hazard Ratio (95 % CI) p = 0.0275
Slovenian: Razmerje ogroženosti (95-% IZ) p < 0,0275
English: Overall survival No. patients with event
Slovenian: Celokupno preživetje št. bolnikov z dogodkom
English: Patients with MBC or MGC should be treated with trastuzumab until progression of disease.
Slovenian: Bolnike z metastatskim rakom dojk ali metastatskim rakom želodca je treba s trastuzumabom zdraviti do napredovanja bolezni.
English: By comparison of simulated serum trastuzumab concentrations after trastuzumab monotherapy (4 mg/kg loading/2 mg/kg q1w intravenous) and observed serum concentrations in Japanese women with HER2- positive MBC (study JP16003) no evidence of a PK effect of concurrent administration of docetaxel on the pharmacokinetics of trastuzumab was found.
Slovenian: S primerjavo simuliranih serumskih koncentracij trastuzumaba po monoterapiji s trastuzumabom (uvajalni odmerek 4 mg/kg, 2 mg/kg enkrat na teden, intravensko) in opaženih serumskih koncentracijah pri japonskih bolnicah s HER2-pozitivnim metastatskim rakom dojk (študija JP16003) ni dokazov o farmakokinetičnem vplivu sočasne aplikacije docetaksela na farmakokinetiko trastuzumaba.
English: • abnormal kidney development in the womb
Slovenian: • nenormalen razvoj ledvic v maternici
English: 1 hour) with or without trastuzumab, 60 % of the patients had received prior anthracycline-based adjuvant chemotherapy.
Slovenian: V ključnem preskušanju docetaksela (100 mg/m², infundirano v 1 uri) s trastuzumabom ali brez njega je 60 % bolnikov predhodno prejelo adjuvantno kemoterapijo na osnovi antraciklinov.
English: Study MO16419
Slovenian: 3 Študija BO15935 4 Študija MO16419
English: • bladder and skin infections
Slovenian: • okužbe sečnega mehurja in kože
English: Trastuzumab plus docetaxel3 N = 92
Slovenian: Trastuzumab in docetaksel3 n = 92
English: • palpitations (heart fluttering or irregular heart beat).
Slovenian: • hitro ali močno utripanje srca (trepetanje srca ali nereden srčni utrip).
English: In a subsequent trial with prospective monitoring of cardiac function, the incidence of symptomatic CHF was 2.2 % in patients receiving trastuzumab and docetaxel, compared with 0 % in patients receiving docetaxel alone.
Slovenian: V naslednjem preskušanju, v katerem so prospektivno spremljali srčno delovanje, je bila incidenca simptomatičnega kongestivnega srčnega popuščanja pri bolnikih, ki so prejemali trastuzumab in docetaksel, 2,2-% v primerjavi z 0-% pri bolnikih, zdravljenih samo z docetakselom.
English: HER2 gene amplification should be detected using fluorescence in situ hybridisation (FISH) or chromogenic in situ hybridisation (CISH) of fixed tumour blocks.
Slovenian: Amplifikacijo gena HER2 določamo z metodo fluorescenčne hibridizacije in situ (FISH) metodo kromogene hibridizacije in situ (CISH) fiksiranih tumorskih blokov.
English: Ogivri 420 mg powder for concentrate for solution for infusion This medicine contains 322.6 mg sorbitol in each vial.
Slovenian: Ogivri 420 mg prašek za koncentrat za raztopino za infundiranje To zdravilo vsebuje 322,6 mg sorbitola v eni viali.
English: Ogivri 420 mg powder for concentrate for solution for infusion Each 420 mg vial of Ogivri is reconstituted with 20 mL of sterile water for injections (not supplied).
Slovenian: Ogivri 420 mg prašek za koncentrat za raztopino za infundiranje Vsebino 420-mg viale zdravila Ogivri se rekonstituira v 20 ml sterilne vode za injekcije (ni dodana).
English: Ogivri 420 mg powder for concentrate for solution for infusion One vial contains 420 mg of trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity and ion exchange chromatography including specific viral inactivation and removal procedures.
Slovenian: Ogivri 420 mg prašek za koncentrat za raztopino za infundiranje Ena viala vsebuje 420 mg trastuzumaba, humaniziranega monoklonskega protitelesa IgG1, pridobljenega iz suspenzijske celične kulture sesalcev (ovarijske celice kitajskega hrčka) in očiščenega z afinitetno ter ionsko izmenjevalno kromatografijo, ki vključuje specifično virusno inaktivacijo ter postopke odstranjevanja.
English: • conjunctivitis (discharge with itching of the eyes and crusty eyelids)
Slovenian: • konjunktivitis (izcedek iz oči in srbenje oči, zalepljene veke)
English: Acute respiratory distress syndrome
Slovenian: +akutni respiratorni distresni sindrom (ARDS)
English: - Doxorubicin 60 mg/m2 and paclitaxel 150 mg/m2, administered 3-weekly for 3 cycles,
Slovenian: - doksorubicin 60 mg/m² in paklitaksel 150 mg/m², dana enkrat na tri tedne, 3 cikle,
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Ogivri 150 mg powder for concentrate for solution for infusion One vial contains 150 mg of trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity and ion exchange chromatography including specific viral inactivation and removal procedures.
Slovenian: Ogivri 150 mg prašek za koncentrat za raztopino za infundiranje Ena viala vsebuje 150 mg trastuzumaba, humaniziranega monoklonskega protitelesa IgG1, pridobljenega iz suspenzijske celične kulture sesalcev (ovarijske celice kitajskega hrčka) in očiščenega z afinitetno ter ionsko izmenjevalno kromatografijo, ki vključuje specifično virusno inaktivacijo ter postopke odstranjevanja.
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:
Slovenian: • za uvajalni odmerek 8 mg trastuzumaba/kg telesne mase ali za nadaljnje tritedenske odmerke 6 mg trastuzumaba/kg telesne mase s pomočjo formule:
English: Each 150 mg vial of Ogivri is reconstituted with 7.2 mL of sterile water for injections (not supplied).
Slovenian: Vsebino 150-mg viale zdravila Ogivri se rekonstituira v 7,2 ml sterilne vode za injekcije (ni dodana).
English: • shock (a dangerous decrease of blood pressure causing symptoms like rapid, shallow breathing,
Slovenian: • šok (nevarno znižanje krvnega tlaka, ki povzroči simptome, kot so hitro in plitko dihanje, hladna in lepljiva koža, hiter in šibak pulz, vrtoglavica, oslabelost in omedlevica)
English: In the BCIRG 006 study for the primary endpoint, DFS, the hazard ratio translates into an absolute benefit, in terms of 3-year disease-free survival rate estimates of 5.8 percentage points (86.7 % versus 80.9 %) in favour of the AC→DH (trastuzumab) arm and 4.6 percentage points (85.5 % versus 80.9 %) in favour of the DCarbH (trastuzumab) arm compared to AC→D.
Slovenian: V študiji BCIRG 006 se razmerje ogroženosti za primarni cilj, preživetje brez bolezni, izraža kot absolutna korist skupine AC → DH (trastuzumab) v smislu 3-letnega preživetja brez bolezni za 5,8 odstotne točke (86,7 % v primerjavi z 80,9 %), korist skupine DCarbH (trastuzumab) pa za 4,6 odstotne točke v primerjavi s skupino AC → D (85,5 % v primerjavi z 80,9 %) v.
English: A final analysis was performed after a median follow-up of 8 years, which showed that 1 year trastuzumab treatment is associated with a 24 % risk reduction compared to observation only (HR = 0.76, 95 % CI 0.67, 0.86).
Slovenian: Pokazala je, da je 1-letno zdravljenje s trastuzumabom povezano s 24-% zmanjšanjem tveganja v primerjavi s samo opazovanjem (razmerje ogroženosti = 0,76; 95-% IZ: 0,67; 0,86).
English: Ogivri 150 mg powder for concentrate for solution for infusion Appropriate aseptic technique should be used.
Slovenian: Ogivri 150 mg prašek za koncentrat za raztopino za infundiranje Uporabiti je treba ustrezno aseptično tehniko.
English: Trastuzumab plus paclitaxel2 N = 68
Slovenian: Trastuzumab in paklitaksel2 n = 68
English: As a three-weekly regimen the recommended initial loading dose of trastuzumab is 8 mg/kg body weight.
Slovenian: Pri 3-tedenskem režimu je priporočen uvajalni odmerek trastuzumaba 8 mg/kg telesne mase.
English: • nausea (feeling sick)
Slovenian: • navzea (občutek slabosti)
English: Total CL range from Cmax,ss to Cmin,ss (L/day)
Slovenian: Vrsta primarnega tumorja n Obseg celokupnega očistka od max, ss do Cmin, ss (l/dan)
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
Slovenian: Preglednica 11 Post-hoc eksplorativna analiza podatkov iz skupne analize kliničnih študij NSABP B-31/NCCTG N9831 in BCIRG006, ki vključujejo dogodke preživetja brez bolezni in simptomatske srčne dogodke
English: Detection of HER2 overexpression or HER2 gene amplification in breast cancer Trastuzumab should only be used in patients whose tumours have HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.
Slovenian: Ugotavljanje čezmernega izražanja HER2 ali amplifikacije gena HER2 pri raku dojk Trastuzumab se uporablja le pri bolnikih, katerih tumorji čezmerno izražajo HER2 ali imajo amplifikacijo gena HER2, določeno s točno in validirano metodo.
English: The results of this sub study 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 metabolitom kapecitabina (npr. 5-FU).
English: Ogivri 420 mg powder for concentrate for solution for infusion Appropriate aseptic technique should be used.
Slovenian: Ogivri 420 mg prašek za koncentrat za raztopino za infundiranje Uporabiti je treba ustrezno aseptično tehniko.
English: 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.
Slovenian: 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).
English: Volume (mL) = Body weight (kg) x dose (8 mg/kg for loading or 6 mg/kg for maintenance) 21 (mg/mL, concentration of reconstituted solution)
Slovenian: telesna masa (kg) × odmerek (8 mg/kg za uvajanje ali 6 mg/kg za vzdrževanje) 21 (mg/ml, koncentracija pripravljene raztopine)
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)].
Slovenian: V eksplorativni analizi podskupin, ki so jo opravili v preskušanju TOGA (BO18255), ni bilo opazne koristi v celokupnem preživetju z dodatkom trastuzumaba pri bolnikih z oceno splošnega stanja zmogljivosti po ECOG (Eastern Cooperative Oncology Group) 2 pred začetkom zdravljenja [razmerje ogroženosti 0,96 (95-% interval zaupanja 0,51-1,79)], bolnikih z nemerljivo boleznijo [razmerje ogroženosti 1,78 (95-% interval zaupanja 0,87--3,66)] in bolnikih z lokalno napredovalo boleznijo [razmerje ogroženosti 1,20 (95-% interval zaupanja 0,29-4,97)].
English: - The resulting solution contains approximately 21 mg/mL trastuzumab.
Slovenian: - Pripravljena raztopina vsebuje približno 21 mg/ml trastuzumaba.
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).
Slovenian: - Študija BO16348 je bila zasnovana za primerjavo enoletnega in dvoletnega zdravljenja s trastuzumabom (odmerjanjem na 3 tedne) z opazovanjem bolnikov z zgodnjo obliko HER2
English: • failure of lungs to develop in the womb
Slovenian: • okvara pri razvoju pljuč v maternici
English: Table 4 Efficacy results from the monotherapy and combination therapy studies Parameter
Slovenian: Preglednica 4 Rezultati učinkovitosti iz študij monoterapije in kombiniranega zdravljenja
English: Trastuzumab 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 s trastuzumabom mora vpeljati zdravnik z izkušnjami s citotoksično kemoterapijo (glejte poglavje 4.4).
English: A vial of Ogivri reconstituted with water for injections (not supplied) is stable for 48 hours at 2ºC-8ºC after reconstitution and must not be frozen.
Slovenian: Po rekonstituciji vsebine viale zdravila Ogivri s sterilno vodo za injekcije (ni dodana) je pripravljena raztopina stabilna 48 ur pri temperaturi 2 °C - 8 °C.
English: Table 16 Population predicted PK parameter values at steady state for trastuzumab intravenous dosing regimens in MBC, EBC and AGC patients
Slovenian: Preglednica 16 Farmakokinetične vrednosti izpostavljenosti, predvidene za populacijo, v stanju dinamičnega ravnovesja za režima odmerjanja trastuzumaba v intravenski obliki pri bolnikih z MBC, EBC in AGC Režim
English: Death (OS event) No. patients with event p = 0.0182
Slovenian: Smrt (dogodek celokupnega preživetja) št. bolnikov z dogodkom p < 0,0182
English: In addition, comparison of two years of trastuzumab treatment versus one year of trastuzumab treatment was performed.
Slovenian: Temu je sledilo adjuvantno dajanje trastuzumaba do skupno enega leta zdravljenja.
English: However, trastuzumab plus docetaxel was efficacious in patients whether or not they had received prior adjuvant anthracyclines.
Slovenian: Trastuzumab pa je bil skupaj z docetakselom učinkovit ne glede na to, ali so bolniki prej prejeli adjuvantno terapijo z antraciklini ali ne.
English: Ogivri 150 mg powder for concentrate for solution for infusion This medicine contains 115.2 mg sorbitol in each vial.
Slovenian: Zdravilo Ogivri vsebuje sorbitol Ogivri 150 mg prašek za koncentrat za raztopino za infundiranje To zdravilo vsebuje 115,2 mg sorbitola v eni viali.
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: • za uvajalni odmerek 4 mg trastuzumaba/kg telesne mase ali za nadaljnje tedenske odmerke 2 mg trastuzumaba/kg telesne mase s pomočjo formule:
English: Hazard Ratio (95 % CI) p = 0.0555
Slovenian: Razmerje ogroženosti (95-% IZ) p < 0,0555
English: Table 5 Efficacy results from the non-comparative monotherapy and combination therapy studies Parameter
Slovenian: Preglednica 5 Rezultati učinkovitosti monoterapije in kombiniranega zdravljenja iz študij brez primerjalne skupine
English: which was followed by - Paclitaxel 175 mg/m2 administered 3-weekly for 4 cycles,
Slovenian: čemur je sledilo: - paklitaksel 175 mg/m², dan enkrat na tri tedne, 4 cikle,
English: Primary efficacy analysis DFS Hazard ratios (95 % CI) p-value p < 0.0001
Slovenian: Primarna analiza učinkovitosti Razmerje ogroženosti za preživetje brez bolezni (95-% IZ) p-vrednost p < 0,0001
English: - in combination with neoadjuvant chemotherapy followed by adjuvant Ogivri therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter (see sections 4.4 and
Slovenian: Ogivri, za lokalno napredovalo (tudi vnetno) bolezen ali tumorje > 2 cm v premeru (glejte poglavji 4.4 in 5.1).
English: Volume (mL) = Body weight (kg) x dose (8 mg/kg for loading or 6 mg/kg for maintenance)
Slovenian: telesna masa (kg) × odmerek (8 mg/kg za uvajanje ali 6 mg/kg za vzdrževanje)
English: Median follow-up 12 months*
Slovenian: 12 mesecev*
English: Table 14 Population predicted cycle 1 PK exposure values (median with 5th - 95th percentiles) fortrastuzumab intravenous dosing regimens in MBC, EBC and AGC patients
Slovenian: Preglednica 14 Farmakokinetične vrednosti izpostavljenosti, predvidene za populacijo, za cikel 1 (mediana s 5.-95. percentilom) za režima odmerjanja trastuzumaba v intravenski obliki pri bolnikih z MBC, EBC in AGC
English: A faint/barely perceptible membrane staining is detected in > 10 % of the tumour cells.
Slovenian: Bledo/komaj zaznavno obarvanje membrane je prisotno pri > 10 % tumorskih celic.
English: Each 420 mg vial of Ogivri is reconstituted with 20 mL of sterile water for injections (not supplied).
Slovenian: Vsebino 420-mg viale zdravila Ogivri rekonstituiramo v 20 ml sterilne vode za injekcije (ni dodana).
English: In addition, a post-hoc exploratory analysis was performed on the data sets from the joint analysis (JA) NSABP B-31/NCCTG N9831* and BCIRG006 clinical studies combining DFS events and symptomatic cardiac events and summarised in Table 11:
Slovenian: Dodatno so izvedli post-hoc eksplorativno analizo podatkov iz skupne analize kliničnih študij NSABP B-31/NCCTG N9831* in BCIRG006, ki vključujejo dogodke preživetja brez bolezni in simptomatske srčne dogodke.
English: 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.
Slovenian: Študija MO16432 je bila multicentrično randomizirano preskušanje na področju neoadjuvantnoadjuvantnega zdravljenja, zasnovano za proučevanje klinične učinkovitosti sočasnega dajanja trastuzumaba in neoadjuvantne kemoterapije, ki je vsebovala antraciklin in taksan.
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 ogroženosti 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 % v primerjavi s 75,4 %).
English: The addition of trastuzumab to paclitaxel chemotherapy also resulted in a 37 % decrease in the risk of death.
Slovenian: Hkrati je zmanjšal tudi tveganje za smrt za 37 %.
English: Anaphylactic reaction
Slovenian: +anafilaktična reakcija neznano
English: Talk to your doctor, pharmacist or nurse before you are given Ogivri if:
Slovenian: Preden boste prejeli zdravilo Ogivri, zdravniku, farmacevtu ali medicinski sestri povejte, če:
English: 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*
Slovenian: Preglednica 7 Povzetek rezultatov učinkovitosti iz skupne analize preskušanj NSABP B-31 in NCCTG N9831 v času končne analize preživetja brez bolezni*:
English: Rare side effects: may affect up to 1 in 1000 people
Slovenian: Redki neželeni učinki, ki se lahko pojavijo pri največ 1 od 1.000 bolnikov:
English: What Ogivri contains
Slovenian: Kaj vsebuje zdravilo Ogivri
English: Surgical specimen - staining pattern
Slovenian: Rezultat Kirurški vzorci - videz preparata po barvanju
English: Patients are eligible for Ogivri treatment if they show strong HER2 overexpression as described by a 3+ score by IHC or a positive FISH or CISH result.
Slovenian: Za zdravljenje z zdravilom Ogivri so primerni bolniki, katerih rezultat čezmernega izražanja HER2 po metodi IHC znaša 3+ ali bolniki, katerih rezultat metod FISH ali CISH je pozitiven.
English: Event-free survival No. patients with event
Slovenian: Preživetje brez bolezni št. bolnikov z dogodkom
English: Tumour cell cluster with a faint ⁄ barely perceptible membranous reactivity irrespective of percentage of tumour cells stained
Slovenian: Klaster tumorskih celic ima bledo, komaj zaznavno obarvanje membrane, neglede na odstotek obarvanih tumorskih celic.
English: Cardiac failure (congestive)
Slovenian: +(kongestivno) srčno popuščanje
English: Ogivri 150 mg powder for concentrate for solution for infusion 15 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film containing 150 mg of trastuzumab.
Slovenian: Ogivri 150 mg prašek za koncentrat za raztopino za infundiranje Ena 15-ml viala iz prozornega stekla tipa I z butilnim gumijastim zamaškom, laminiranim s fluorirano smolo, ki vsebuje 150 mg trastuzumaba.
English: Death (OS event) No. patients with event p = 0.0024
Slovenian: Smrt (dogodek celokupnega preživetja) št. bolnikov z dogodkom p < 0,0024
English: STATEMENT OF ACTIVE SUBSTANCE(S) The vial contains 420 mg trastuzumab.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena viala vsebuje 420 mg trastuzumaba.
English: 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
Slovenian: Preglednica 15 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
English: N Cmin,ss* (mcg/mL)
Slovenian: Režim Vrsta primarnega tumorja n Cmin, ss* (μg/ml) Cmax, ss** (μg/ml)