natgillin/translations-raw huggingface dataset:
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)].
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 do 1,79)], bolnikih z nemerljivo boleznijo [razmerje ogroženosti 1,78 (95-% interval zaupanja 0,87 do 3,66)] in bolnikih z lokalno napredovalo boleznijo [razmerje ogroženosti 1,20 (95-% interval zaupanja 0,29 do 4,97)].
A vial of KANJINTI aseptically reconstituted with sterile water for injections (not supplied) is chemically and physically stable for 48 hours at 2ºC - 8ºC after reconstitution and must not be frozen.
Po aseptični rekonstituciji vsebine viale zdravila KANJINTI s sterilno vodo za injekcije (ni dodana) je pripravljena raztopina kemijsko in fizikalno stabilna 48 ur pri temperaturi 2 °C - 8 °C.
Patients experiencing dyspnoea at rest due to complications of advanced malignancy and comorbidities may be at increased risk of pulmonary events.
Pri bolnikih, ki imajo dispnejo v mirovanju zaradi komplikacij napredovale maligne bolezni in soobolenj, obstaja večje tveganje pljučnih zapletov.
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 na farmakokinetiko cisplatina ni vplivala.
The recommended starting dose is 8 mg/kg body weight.
Priporočeni začetni odmerek je 8 mg/kg telesne mase.
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 70 mesecev.
Talk to your doctor, pharmacist or nurse before you are given KANJINTI if:
Preden boste prejeli zdravilo KANJINTI zdravniku, farmacevtu ali medicinski sestri povejte, če:
*defined as absence of any invasive cancer both in the breast and axillary nodes An absolute benefit of 13 percentage points in favour of the trastuzumab arm was estimated in terms of 3 year event-free survival rate (65% versus 52%).
Absolutna korist 13 odstotnih točk v prid skupini, ki je prejemala trastuzumab, je bila ocenjena v smislu 3-letnega preživetja brez bolezni (65 % proti 52 %).
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 se lahko uporablja le natančna in validirana metoda.
What KANJINTI contains
Kaj vsebuje zdravilo KANJINTI
• abnormal or impaired blood clotting
• nenormalno ali okrnjeno strjevanje krvi
Neoplasms benign, malignant and unspecified (incl.
Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi)
The efficacy results from the joint analysis of the NSABP B-31 and NCCTG N9831 trials at the time of the definitive analysis of DFS* are summarised in Table 7.
Rezultati učinkovitosti iz skupne analize preskušanj NSABP B-31 in NCCTG N9831 v času končne analize preživetja brez bolezni* so povzeti v preglednici 7.
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. 5-FU).
As a three-weekly regimen the recommended initial loading dose of KANJINTI is 8 mg/kg body weight.
Pri 3-tedenskem režimu je priporočen polnitveni odmerek zdravila KANJINTI 8 mg/kg telesne mase.
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).
MARKETING AUTHORISATION NUMBER(S) EU/1/18/1281/001
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/18/1281/001
Table 11 Post-hoc exploratory analysis results from the joint analysis NSABP B-31/NCCTG N9831* and BCIRG 006 clinical studies combining DFS events and symptomatic cardiac events
Post-hoc eksplorativna analiza podatkov iz skupne analize kliničnih študij NSABP B-31/NCCTG N9831* in BCIRG 006, ki vključujejo dogodke preživetja brez bolezni in simptomatske srčne dogodke
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 trastuzumab dajali v kombinaciji s paklitakselom, po kemoterapiji z doksorubicinom in ciklofosfamidom (kemoterapiji AC).
Patients with MBC or MGC should be treated with KANJINTI until progression of disease.
Bolnike z metastatskim rakom dojk ali metastatskim rakom želodca je treba z zdravilom KANJINTI zdraviti do napredovanja bolezni.
MARKETING AUTHORISATION NUMBER(S) EU/1/18/1281/002
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/18/1281/002
Each 420mg vial of KANJINTI is reconstituted with 20 mL of sterile water for injections (not supplied).
Eno 420 mg vialo zdravila KANJINTI rekonstituirajte s 20 ml sterilne vode za injekcije (ni dodana).
Primary efficacy analysis DFS Hazard ratios (95% CI) p-value p < 0.0001
Primarna analiza učinkovitosti Razmerje ogroženosti za preživetje brez bolezni (95-% IZ) p-vrednost p < 0,0001
+Anaphylactic reaction
+anafilaktična reakcija neznano
Musculoskeletal and connective tissue disorders
Bolezni mišično-skeletnega sistema in vezivnega tkiva artralgija zelo pogosto
+Anaphylactic shock
+anafilaktični šok neznano
8 mg/kg + 6 mg/kg q3w
8 mg/kg + 6 mg/kg na 3 tedne
Death (OS event) No. patients with event p = 0.0182
Smrt (dogodek celokupnega preživetja): število bolnikov z dogodkom p = 0,0182
*Co-primary endpoint of DFS of 1 year versus observation met the pre-defined statistical boundary **Final analysis (including cross-over 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 randomised 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 mediano 12-mesečnem spremljanju.
Strong complete, basolateral or lateral membranous reactivity in ≥ 10% of tumour cells
Močno obarvane celotne, bazolateralne ali lateralne membrane pri ≥ 10 % tumorskih celic.
Cardiomyopathy
Srčne bolezni
QUALITATIVE AND QUANTITATIVE COMPOSITION KANJINTI 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.
KANJINTI 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.
Three-weekly dosing in metastatic breast cancer The efficacy results from the non-comparative monotherapy and combination therapy studies are summarised in table 5:
Odmerjanje enkrat na 3 tedne pri metastatskem raku dojk Preglednica 5 navaja rezultate učinkovitosti monoterapije in kombiniranega zdravljenja iz študij brez primerjalne skupine.
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 povišanje 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.
Table 4 Efficacy results from the monotherapy and combination therapy studies
Rezultati učinkovitosti iz študij monoterapije in kombiniranega zdravljenja Parameter
Formal cardiological assessment should be considered in patients in whom there are cardiovascular concerns following baseline screening.
Pri bolnikih, pri katerih so po osnovnem pregledu odkrili kardiovaskularne težave, je treba razmisliti o celovitem kardiološkem pregledu.
Overall survival, median months Progression-free survival, Median months
Preživetje brez napredovanja bolezni, mediana (meseci)
30-60 minutes repeated every 3 weeks for a total of six cycles
vsake 3 tedne, skupaj 6 ciklov.
• inflammation or scarring of the lungs
• vneta ali zabrazgotinjena pljuča
Women of childbearing potential
Ženske v rodnem obdobju
• slow heart rate
• upočasnjeno bitje srca
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, piskanjem, hipertenzijo, bronhospazmom, supraventrikularno tahiaritmijo, zmanjšano saturacijo arterijske krvi s kisikom, anafilaksijo, dihalno stisko, urtikarijo in angioedemom (glejte poglavje 4.8).
• acute narrowing of the airways
• akutna zožitev dihalnih poti
Breast inflammation/mastitis
Motnje reprodukcije in dojk vnetje dojk/mastitis pogosto
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
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
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING VIAL LABEL
PODATKI NA PRIMARNI OVOJNINI NALEPKA NA VIALI
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 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 %).
Trastuzumab1 N = 172
Kombinirano zdravljenje trastuzumab1 n = 172
These include, but are not limited to, pulmonary infiltrates, acute respiratory distress syndrome, pneumonia, pneumonitis, pleural effusion, respiratory distress, acute pulmonary oedema and respiratory insufficiency (see section 4.4).
Ti med drugim vključujejo pljučne infiltrate, akutni respiratorni distresni sindrom (ARDS), pljučnico, pnevmonitis, plevralni izliv, dihalno stisko, akutni pljučni edem in respiratorno insuficienco (glejte poglavje 4.4).
Response rate (95%CI)
Delež odgovora (95-% IZ)
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 je bil opisan z dvoprostornim modelom z vzporednim linearnim in nelinearnim izločanjem iz centralnega prostora.
Median Survival (months) (95%CI)
Mediana preživetja (meseci) (95-% IZ)
2 mg trastuzumab/kg body weight:
2 mg trastuzumaba/kg telesne mase s pomočjo formule:
STATEMENT OF ACTIVE SUBSTANCE(S) The vial contains 420 mg trastuzumab.
NAVEDBA ENE ALI VEČ UČINKOVIN Viala vsebuje 420 mg trastuzumaba.
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
AC → D = doksorubicin in ciklofosfamid, ki jima sledi docetaksel; AC → DH = doksorubicin in ciklofosfamid, ki jima sledita docetaksel in trastuzumab; IZ = interval zaupanja Preglednica 10.
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, piskanje, bronhospazem, tahikardijo, zmanjšano nasičenost s kisikom, dihalno stisko, izpuščaj, navzeo, bruhanje in glavobol (glejte poglavje 4.4).
• jaundice
• zlatenica
KANJINTI 150 mg powder for concentrate for solution for infusion 20 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film and aluminium seal flip-off dust cover containing 150 mg of trastuzumab.
KANJINTI 150 mg prašek za koncentrat za raztopino za infundiranje 20 ml viala iz prozornega stekla tipa I z butilnim gumijastim zamaškom, laminiranim s fluorirano smolo in snemno zaporko za prah iz aluminija, ki vsebuje 150 mg trastuzumaba.
The final OS results from the joint analysis of studies NSABP B-31 and NCCTG N9831 are summarised in table 8:
Končni rezultati za celokupno preživetje iz skupne analize študij NSABP B-31 in NCCTG N9831 so povzeti v preglednici 8.
In addition a post-hoc exploratory analysis was performed on the data sets from the joint analysis (JA) NSABP B-31/NCCTG N9831* and BCIRG 006 clinical studies combining DFS events and symptomatic cardiac events and summarised in table 11:
Dodatno so izvedli post-hoc eksplorativno analizo podatkov iz skupne analize kliničnih študij NSABP B-31/NCCTG N9831* in BCIRG 006, ki vključujejo dogodke preživetja brez bolezni in simptomatske srčne dogodke.
Distant recurrence No. patients with event p = 0.0008
Pojav oddaljenih metastaz: število bolnikov z dogodkom p = 0,0008
Patients are eligible for KANJINTI 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 KANJINTI so primerni bolniki, katerih rezultat čezmernega izražanja HER2 po metodi IHC znaša 3+ ali bolniki, katerih rezultat metod FISH ali CISH je pozitiven.
Tumour cell cluster with a faint/barely perceptible membranous reactivity irrespective of percentage of tumour cells stained
Klaster tumorskih celic ima bledo, komaj zaznavno obarvanje membrane, neglede na odstotek obarvanih tumorskih celic.
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).
- intravenous cyclophosphamide, at 600 mg/m2 over 30 minutes, given every 3 weeks for
- ciklofosfamid intravensko - 600 mg/m2 v 30 minutah, vsake 3 tedne, 4 cikle.
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 neoadjuvantno-adjuvantnega zdravljenja, zasnovano za proučevanje klinične učinkovitosti sočasnega dajanja trastuzumaba, in neoadjuvantne kemoterapije, ki je vsebovala antraciklin in taksan.
Dry eye
• solzne oči
Death (OS event) No. patients with event p = 0.0024
Smrt (dogodek celokupnega preživetja): število bolnikov z dogodkom p = 0,0024
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 pojavijo motnje v delovanju srca.
KANJINTI 420 mg powder for concentrate for solution for infusion 50 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film and aluminium seal flip-off dust cover containing 420 mg of trastuzumab.
KANJINTI 420 mg prašek za koncentrat za raztopino za infundiranje 50 ml viala iz prozornega stekla tipa I z butilnim gumijastim zamaškom, laminiranim s fluorirano smolo in snemno zaporko za prah iz aluminija, ki vsebuje 420 mg trastuzumaba.
Very common side effects (may affect more than 1 in 10 people):
Zelo pogosti neželeni učinki (lahko se pojavijo pri več kot 1 od 10 bolnikov):
If you get any side effects, talk to your doctor, pharmacist or nurse.
Če se pri vas pojavi kateri koli neželen učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
+Cardiac failure (congestive)
+(kongestivno) srčno popuščanje pogosto
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.
Ponavadi se pojavijo v zgodnejših fazah zdravljenja, torej med prvo, drugo in tretjo infuzijo, ter so manj pogoste pri naslednjih infuzijah.
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;
Median duration of response (months) (95%CI)
Mediana časa odgovora (meseci) (95-% IZ)
Primary tumour type
Vrsta primarnega tumorja n
Tumour cell cluster with a strong complete, basolateral or lateral membranous reactivity irrespective of percentage of tumour cells stained
Klaster tumorskih celic ima močno obarvane celotne, bazolateralne ali lateralne membrane, neglede na odstotek obarvanih tumorskih celic.
STATEMENT OF ACTIVE SUBSTANCE(S) The vial contains 150 mg trastuzumab.
NAVEDBA ENE ALI VEČ UČINKOVIN Viala vsebuje 150 mg trastuzumaba.
Cardiac dysfunction
Motnje v delovanju srca
1+ 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.
This yields a 7.4 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab, at a pH of approximately 6.1.
Rekonstitucija da 7,4 ml raztopine za enkratno uporabo, ki vsebuje približno 21 mg/ml trastuzumaba, s pH približno 6,1.
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
This yields a 21 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab, at a pH of approximately 6.1.
Rekonstitucija da 21 ml raztopine za enkratno uporabo, ki vsebuje približno 21 mg/ml trastuzumaba, s pH približno 6,1.
Glomerulonephritis membranous Not known Glomerulonephropathy
Bolezni sečil motnje delovanja ledvic pogosto membranski glomerulonefritis neznano glomerulonefropatija neznano ledvična odpoved neznano
The infusion may be resumed when symptoms abate.
Ko simptomi izginejo, lahko z infuzijo nadaljujemo.
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 pozne gestacijske toksičnosti/placentnega prehoda, ki so trajale do šest mesecev, niso ugotovili akutne ali z večkratnim odmerjanjem povezane toksičnosti.
This can lead to symptoms such as breathlessness (including breathlessness at night), cough, fluid retention (swelling) in the legs or arms, palpitations (heart fluttering or irregular heart beat) (see 2.
To lahko privede do simptomov, kot so težave z dihanjem (vključno s težavami z dihanjem ponoči), kašelj, zadrževanje tekočine
Weak to moderate complete, basolateral or lateral membranous reactivity in ≥ 10% of tumour cells
Šibko do srednje močno obarvane celotne, bazolateralne ali lateralne membrane pri ≥ 10 % tumorskih celic.
• difficulty in breathing when lying flat
• oteženo dihanje v ležečem položaju
1Palpitation
1palpitacije zelo pogosto
Disease-free survival No. patients with event p = 0.0003
Preživetje brez bolezni: število bolnikov z dogodkom p = 0,0003
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)
po operaciji so sledili: - dodatni cikli trastuzumaba, danega adjuvantno (do zaključitve prvega leta zdravljenja).
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.
LIST OF EXCIPIENTS Excipients: histidine, histidine monohydrochloride, trehalose dihydrate, polysorbate 20.
SEZNAM POMOŽNIH SNOVI Pomožne snovi: histidin, histidinijev klorid monohidrat, trehaloza dihidrat, polisorbat 20.
- 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, sta bili zasnovani za proučevanje klinične koristi kombinacije zdravljenja s trastuzumabom in paklitakselom po kemoterapiji z doksorubicinom in ciklofosfamidom (kemoterapiji AC).
LIST OF EXCIPIENTS Histidine, histidine monohydrochloride, trehalose dihydrate, polysorbate 20.
SEZNAM POMOŽNIH SNOVI Histidin, histidinijev klorid monohidrat, trehaloza dihidrat, polisorbat 20.
KANJINTI 420 mg powder for concentrate for solution for infusion
KANJINTI 420 mg prašek za koncentrat za raztopino za infundiranje
Patients with HER2+ tumours were randomised to receive either neoadjuvant chemotherapy concurrently with neoadjuvant-adjuvant trastuzumab, or neoadjuvant chemotherapy alone.
Bolniki s HER2-pozitivnimi tumorji so bili randomizirani v skupino, ki je prejemala neoadjuvantno kemoterapijo sočasno z neoadjuvantnim trastuzumabom najprej, nato pa še adjuvantno, ali v skupino, ki je prejemala le neoadjuvantno kemoterapijo.
• tremor
• tresenje (tremor)
Tumour cell cluster with a weak to moderate complete, basolateral or lateral membranous reactivity irrespective of percentage of tumour cells stained
Klaster tumorskih celic ima šibko do srednje močno obarvane celotne, bazolateralne ali lateralne membrane, neglede na odstotek obarvanih tumorskih celic.