natgillin/translations-raw huggingface dataset:
Based on the clinical trial results, the beneficial effects were limited to patients with the highest level of HER2 protein overexpression, defined by a 3+ score by IHC, or a 2+ score by IHC and a positive FISH result. 
Na osnovi rezultatov kliničnega preskušanja je bila korist ugotovljena pri bolnikih, ki so imeli najvišjo stopnjo čezmernega izražanja proteina HER2, kar pomeni rezultat po IHC metodi 3+, ali pa 2+ ter istočasno pozitiven rezultat po metodi FISH.
PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. 
FARMACEVTSKA OBLIKA Prašek za koncentrat za raztopino za infundiranje.
KANJINTI intravenous formulation is not for subcutaneous use and should be given as an intravenous infusion only. 
Intravenska oblika zdravila KANJINTI ni namenjena subkutani aplikaciji in se lahko daje le z intravensko infuzijo.
Severe pulmonary events have been reported with the use of trastuzumab in the post-marketing setting (see section 4.8). 
V obdobju po prihodu zdravila na trg so pri uporabi trastuzumaba poročali o hudih pljučnih zapletih (glejte poglavje 4.8).
The recommended weekly maintenance dose of KANJINTI is 2 mg/kg body weight, beginning one week after the loading dose. 
Priporočen tedenski vzdrževalni odmerek zdravila KANJINTI je 2 mg/kg telesne mase, z začetkom en teden po polnitvenem odmerku.
• The recommended starting dose for the once weekly cycle is 4 mg/kg body weight. 
• Priporočeni začetni odmerek za shemo odmerjanja enkrat na teden je 4 mg/kg telesne mase.
PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion 
FARMACEVTSKA OBLIKA IN VSEBINA prašek za koncentrat za raztopino za infundiranje
Trastuzumab has also been used in combination with paclitaxel or docetaxel for the treatment of patients who have not received chemotherapy for their metastatic disease. 
Trastuzumab so uporabljali tudi v kombinaciji s paklitakselom ali docetakselom za zdravljenje bolnikov, ki predhodno niso prejeli kemoterapije za metastatsko bolezen.
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). 
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).
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. 
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 %).
• failure of the lungs of the baby to develop in the womb 
• okvara pri razvoju pljuč otroka v maternici
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. 
V in vitro študijah 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.
Three-weekly schedule 
3-tedenski režim
KANJINTI 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. 
KANJINTI 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.
Trastuzumab has been used in clinical trials as monotherapy for patients with MBC who have tumours that overexpress HER2 and who have failed one or more chemotherapy regimens for their metastatic disease (trastuzumab alone). 
Trastuzumab so v kliničnih preskušanjih uporabljali kot monoterapijo pri bolnikih z metastatsko obliko raka dojk, katerih tumorji so čezmerno izražali HER2 in pri katerih je prišlo do napredovanja bolezni po eni ali več kemoterapevtskih zdravljenjih njihove metastatske bolezni (le trastuzumab).
Detection of HER2 overexpression or HER2 gene amplification in breast cancer KANJINTI should only be used in patients whose tumours have HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay. 
Ugotavljanje čezmernega izražanja HER2 ali amplifikacije gena HER2 pri raku dojk Zdravilo KANJINTI se uporablja le pri bolnikih, katerih tumorji čezmerno izražajo HER2 ali imajo amplifikacijo gena HER2, določeno s točno in validirano metodo.
Median duration of response (months) (range) Median TTP (months) (95%CI) 
Mediana časa odgovora (meseci) (razpon) Mediana TTP (meseci) (95-% IZ)
A careful risk-benefit assessment should be made before deciding to treat with KANJINTI. 
Pred odločitvijo za zdravljenje z zdravilom KANJINTI je treba skrbno pretehtati razmerje med koristjo in tveganjem.
Table 8 Final overall survival analysis from the joint analysis of trials NSABP B-31 and NCCTG N9831 
Končna analiza celokupnega preživetja iz skupne analize preskušanj NSABP B-31 in NCCTG N9831
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. 
S primerjavo simuliranih serumskih koncentracij trastuzumaba po monoterapiji s trastuzumabom (polnitveni 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.
Study MO16982: loading dose 6 mg/kg weekly x 3; followed by 6 mg/kg 3-weekly schedule 3. 
Študija MO16982: polnitveni odmerek 6 mg/kg na teden 3 tedne; sledil je odmerek 6 mg/kg po 3-tedenskem režimu.
Weekly dosing in metastatic breast cancer The efficacy results from the monotherapy and combination therapy studies are summarised in table 4. 
Tedensko odmerjanje pri metastatskem raku dojk Preglednica 4 navaja rezultate učinkovitosti iz študij monoterapije in kombiniranega zdravljenja.
Rare side effects (may affect up to 1 in 1,000 people): 
Redki neželeni učinki (lahko se pojavijo pri največ 1 od 1.000 bolnikov):
Data from study JP16003, a single-arm study of trastuzumab (4 mg/kg intravenous loading dose and 2 mg/kg intravenous weekly) and docetaxel (60 mg/m2 intravenous) in Japanese women with HER2-positive MBC, suggested that concomitant administration of trastuzumab had no effect on the single dose pharmacokinetics of docetaxel. 
Podatki iz študije JP16003 z eno skupino, v kateri so japonske bolnice s HER2-pozitivnim metastatskim rakom dojk prejemale trastuzumab (polnitveni odmerek 4 mg/kg intravensko in 2 mg/kg intravensko enkrat na teden) in docetaksel (60 mg/m2 intravensko) so nakazali, da sočasna aplikacija trastuzumaba ni imela vpliva na farmakokinetiko enkratnega odmerka docetaksela.
Metastatic breast cancer 
Metastatski rak želodca
KANJINTI 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 KANJINTI mora vpeljati zdravnik z izkušnjami s citotoksično kemoterapijo (glejte poglavje 4.4).
The recommended initial loading dose of KANJINTI is 4 mg/kg body weight. 
Priporočen polnitveni odmerek zdravila KANJINTI je 4 mg/kg telesne mase.
Febrile neutropenia, leukopenia, anaemia, thrombocytopenia and neutropenia occurred very commonly. 
Febrilna nevtropenija in levkopenija sta se pojavljali zelo pogosto.
However, trastuzumab plus docetaxel was efficacious in patients whether or not they had received prior adjuvant anthracyclines. 
Trastuzumab pa je bilo skupaj z docetakselom učinkovit ne glede na to, ali so bolniki prej prejeli adjuvantno terapijo z antraciklini ali ne.
• Severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy. 
• Pri bolnikih, ki imajo hudo dispnejo v mirovanju zaradi komplikacij napredovale maligne bolezni, ali pri tistih, ki potrebujejo zdravljenje s kisikom.
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.