natgillin/translations-raw huggingface dataset:
In the pivotal trial MO16432, trastuzumab was administered concurrently with neoadjuvant chemotherapy containing three cycles of doxorubicin (cumulative dose 180 mg/m2). 
V ključnem preskušanju MO16432 so trastuzumab dajali sočasno z neoadjuvantno kemoterapijo, ki je vključevala tri cikle doksorubicina (kumulativni odmerek 180 mg/m2).
• swelling of the lining of the heart 
• otekanje mrene, ki obdaja srce
In the post-marketing setting, cases of foetal renal growth and/or function impairment in association with oligohydramnios, some associated with fatal pulmonary hypoplasia of the foetus, have been reported in pregnant women receiving trastuzumab. 
V obdobju po prihodu zdravila na trg so pri nosečnicah, ki so prejemale trastuzumab, poročali o primerih motenj v rasti plodovih ledvic in/ali njihovem delovanju, v povezavi z oligohidramnijem, od katerih so bili nekateri povezani s smrtno hipoplazijo pljuč pri plodu.
KANJINTI is for single-use only, as the product contains no preservatives. 
Zdravilo KANJINTI je le za enkratno uporabo in ne vsebuje konzervansov.
In a population pharmacokinetic analysis, age and renal impairment were not shown to affect trastuzumab disposition. 
Farmakokinetična analiza skupin ni pokazala vplivov starosti in ledvične okvare na razpoložljivost trastuzumaba.
• based on a loading dose of 4 mg trastuzumab/kg body weight, or a subsequent weekly dose of 
• za polnitveni odmerek 4 mg trastuzumaba/kg telesne mase ali za nadaljnje tedenske odmerke
• The resulting solution contains approximately 21 mg/mL trastuzumab. 
• Pripravljena raztopina vsebuje približno 21 mg/ml trastuzumaba.
PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion 1 vial 
FARMACEVTSKA OBLIKA IN VSEBINA prašek za koncentrat za raztopino za infundiranje 1 viala
The appropriate amount of solution should be withdrawn from the vial and added to a polyvinylchloride, polyethylene or polypropylene infusion bag containing 250 mL of sodium chloride 9 mg/mL (0.9%) solution for injection. 
Primerno količino raztopine je potrebno odvzeti iz viale in dodati polivinilkloridni, polietilenski ali polipropilenski infuzijski vrečki, ki vsebuje 250 ml 9 mg/ml (0,9 %) natrijevega klorida raztopine za injiciranje.
Post-hoc subgroup analyses indicate that positive treatment effects are limited to targeting tumours with higher levels of HER2 protein (IHC 2+/FISH+ or IHC 3+). 
Rezultati post-hoc analiz podskupin kažejo, da zdravljenje tumorjev z višjimi koncentracijami HER2 proteina (IHC 2+/FISH+ ali IHC 3+) daje boljše rezultate.
In the BCIRG 006 study trastuzumab was administered either in combination with docetaxel, following AC chemotherapy (AC→DH) or in combination with docetaxel and carboplatin (DCarbH). 
V študiji BCIRG 006 so trastuzumab dajali v kombinaciji z docetakselom po kemoterapiji z doksorubicinom in ciklofosfamidom (AC → DH) ali v kombinaciji z docetakselom in karboplatinom (DCarbH).
What KANJINTI looks like and contents of the pack KANJINTI is a powder for concentrate for solution for intravenous infusion, which is supplied in a glass vial with a rubber stopper containing either 150 mg or 420 mg of trastuzumab. 
Izgled zdravila KANJINTI in vsebina pakiranja Zdravilo KANJINTI je prašek za koncentrat za raztopino za intravensko infundiranje, ki je na voljo v stekleni viali z gumijastim zamaškom, ki vsebuje ali 150 mg ali 420 mg trastuzumaba.
As a weekly regimen (initial loading dose of 4 mg/kg followed by 2 mg/kg every week) concomitantly with paclitaxel following chemotherapy with doxorubicin and cyclophosphamide. 
Pri tedenskem režimu (polnitveni odmerek 4 mg/kg telesne mase, nato 2 mg/kg telesne mase vsak teden) se zdravilo KANJINTI daje sočasno s paklitakselom po kemoterapiji z doksorubicinom in ciklofosfamidom.
- in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin. 
- v kombinaciji z adjuvantno kemoterapijo z docetakselom in karboplatinom;
Determine the volume of the solution required: 
Volumen raztopine, ki jo potrebujete, izračunate:
Breast cancer and gastric cancer 
Rak dojk in rak želodca
KANJINTI may also be given once a week for metastatic breast cancer 
Pri metastatskem raku dojk lahko zdravilo KANJINTI dajemo tudi enkrat na teden.
For patients with EBC, cardiac assessments, as performed at baseline, should be repeated every 3 months during treatment and every 6 months following discontinuation of treatment until 24 months from the last administration of KANJINTI. 
Pri bolnikih z zgodnjim rakom dojk je treba pregled srca, kot je bil opravljen pred zdravljenjem, ponoviti vsake 3 mesece med zdravljenjem in vsakih 6 mesecev po končanem zdravljenju do 24 mesecev po zadnjem dajanju zdravila KANJINTI.
At 8 years, the disease-free survival rate was estimated to be 77.2% (95% CI: 75.4, 79.1) in the AC→PH arm, an absolute benefit of 11.8% compared with the AC→P arm. 
Po 8 letih je bil delež preživetja brez bolezni ocenjen na 77,2 % (95-% IZ: 75,4; 79,1) v skupini AC → PH, kar predstavlja absolutno korist 11,8 % v primerjavi s skupino AC → P.
Injury, poisoning and procedural complications 
Poškodbe in zastrupitve in zapleti pri posegih kontuzija pogosto
Administration in combination with paclitaxel or docetaxel In the pivotal trials (H0648g, M77001), paclitaxel or docetaxel was administered the day following the first dose of trastuzumab (for dose, see the Summary of Product Characteristics (SmPC) for paclitaxel or docetaxel) and immediately after the subsequent doses of trastuzumab if the preceding dose of trastuzumab was well tolerated. 
Odmerjanje v kombinaciji s paklitakselom ali docetakselom V ključnih študijah (H0648g, M77001) so paklitaksel ali docetaksel dali en dan po polnitvenem odmerku trastuzumaba (za odmerek glejte Povzetek glavnih značilnosti zdravila za paklitaksel ali docetaksel) in takoj po nadaljnjih odmerkih trastuzumaba, če je bolnik predhoden odmerek trastuzumaba dobro prenašal.
In patients with EBC eligible for neoadjuvant-adjuvant treatment, KANJINTI should be used concurrently with anthracyclines only in chemotherapy-naive patients and only with low-dose anthracycline regimens i.e. maximum cumulative doses of doxorubicin 180 mg/m2 or epirubicin 360 mg/m2. 
Pri bolnikih z zgodnjim rakom dojk, ki so primerni za neoadjuvantno-adjuvantno zdravljenje, se zdravilo KANJINTI uporablja sočasno z antraciklini le pri bolnikih, ki še niso bili zdravljeni s kemoterapijo, in to samo pri shemah z majhnimi odmerki antraciklinov (največji kumulativni odmerek doksorubicina 180 mg/m2 ali epirubicina 360 mg/m2).
The population predicted PK exposure values (median with 5th - 95th Percentiles) and PK parameter values at clinically relevant concentrations (Cmax and Cmin) for MBC, EBC and AGC patients treated with the approved q1w and q3w dosing regimens are shown in table 14 (cycle 1), table 15 (steadystate), and table 16 (PK parameters). 
Farmakokinetične vrednosti izpostavljenosti, predvidene za populacijo (mediana s 5.-95. percentilom), in vrednosti farmakokinetičnih parametrov pri klinično pomembnih koncentracijah (Cmax in Cmin) za bolnike z MBC, EBC in AGC, zdravljene z odobrenim tedenskim in 3-tedenskim režimom odmerjanja, so prikazane v preglednici 14 (cikel 1), preglednici 15 (stanje dinamičnega ravnovesja) in preglednici 16 (farmakokinetični parametri).
For overall survival, the HR was 0.75 (95% CI 0.51-1.11) in the IHC 2+/FISH+ group and the HR was 0.58 (95% CI 0.41-0.81) in the IHC 3+/FISH+ group. 
Razmerje ogroženosti za celokupno preživetje je bilo 0,75 (95-% interval zaupanja 0,51 do 1,11) v IHC 2+/FISH+ skupini, v IHC 3+/FISH+ skupini pa je razmerje ogroženosti bilo 0,58 (95-% interval zaupanja 0,41 do 0,81).
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. 
Primerjava farmakokinetičnih rezultatov iz dveh študij faze II (BO15935 in M77004) in ene študije faze III (H0648g), v kateri so bolnike sočasno zdravili s trastuzumabom in paklitakselom, ter dveh študij faze II, v katerih so dajali trastuzumab v monoterapiji (W016229 in MO16982) bolnicam s HER2-pozitivnim metastatskim rakom dojk, nakazuje, da so se posamezne in povprečne najnižje serumske koncentracije trastuzumaba razlikovalo znotraj študij in med njimi, jasnega vpliva sočasne aplikacije paklitaksela na farmakokinetiko trastuzumaba pa ni bilo.
Patients with MBC who have previously received anthracyclines are also at risk of cardiac dysfunction with KANJINTI treatment, although the risk is lower than with concurrent use of KANJINTI and anthracyclines. 
Pri bolnikih z metastatskim rakom dojk, ki so se predhodno zdravili z antraciklini, pri zdravljenju z zdravilom KANJINTI tveganje za motnje v delovanju srca še vedno obstaja, le da je manjše kot pri sočasni uporabi zdravila KANJINTI in antraciklinov.
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). 
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 presnovkoma 6-α hidroksil-paklitakselu, POH, in doksorubicinolu, DOL) ni bila spremenjena v prisotnosti trastuzumaba (polnitveni odmerek 8 mg/kg intravensko, ki mu je sledil odmerek 6 mg/kg intravensko vsake tri tedne ali polnitveni odmerek 4 mg/kg intravensko, ki mu je sledil odmerek 2 mg/kg intravensko enkrat na teden).
In addition, cases of interstitial lung disease including lung infiltrates, acute respiratory distress syndrome, pneumonia, pneumonitis, pleural effusion, respiratory distress, acute pulmonary oedema and respiratory insufficiency have been reported. 
Poleg tega so poročali tudi o primerih intersticijske bolezni pljuč, vključno s pljučnimi infiltrati, akutnem respiratornem distresnem sindromu (ARDS), pljučnici, pnevmonitisu, plevralnem izlivu, dihalni stiski, akutnem pljučnem edemu in respiratorni insuficienci.
Disease-free survival No. patients with event (%) 
Preživetje brez bolezni: število bolnikov z dogodkom (%)
• abnormally low levels of fluid around baby in womb 
• nenormalno malo tekočine, ki obkroža plod v maternici
Table 12 Efficacy results from MO16432 
Rezultati učinkovitosti preskušanja MO16432
If LVEF has not improved, or has declined further, or symptomatic congestive heart failure (CHF) has developed, discontinuation of KANJINTI should be strongly considered, unless the benefits for the individual patient are deemed to outweigh the risks. 
Če se LVEF ne izboljša ali pride do nadaljnjega zmanjšanja ali se razvije simptomatsko kongestivno srčno popuščanje, je potreben resen razmislek o prekinitvi zdravljenja z zdravilom KANJINTI, razen če je korist za posameznega bolnika večja od tveganja.
If LVEF has not improved, or declined further, or symptomatic CHF has developed, discontinuation of KANJINTI should be strongly considered, unless the benefits for the individual patient are deemed to outweigh the risks. 
Če se LVEF ne izboljša ali pride do nadaljnjega zmanjšanja ali se razvije simptomatsko srčno popuščanje, je potreben resen razmislek o prekinitvi zdravljenja z zdravilom KANJINTI, razen če je korist za posameznega bolnika večja od tveganja.
Trastuzumab1 N = 105 
Kombinirano zdravljenje trastuzumab1 n = 105
Trastuzumab plus paclitaxel3 N = 32 
trastuzumab in paklitaksel3 n = 32
Other infusion-related symptoms are: feeling sick (nausea), vomiting, pain, increased muscle tension and shaking, headache, dizziness, breathing difficulties, wheezing, high or low blood pressure, heart rhythm disturbances (palpitations, heart fluttering or irregular heart beat), swelling of the face and lips, rash and feeling tired. 
Drugi z infuzijo povezani simptomi so lahko še siljenje na bruhanje (navzea), bruhanje, bolečina, povečana napetost mišic in tresenje, glavobol, omotica, težave z dihanjem, piskanje pri dihanju, visok ali nizek krvni tlak, motnje srčnega ritma (hitro ali močno utripanje srca, trepetanje srca ali nereden srčni utrip), otekanje obraza in ustnic, izpuščaj in občutek utrujenosti.
+Lung infiltration 
+pljučni infiltrati neznano
Full instructions on assay performance and results interpretation should be taken from the product information leaflet provided with the HER2 testing assays used. 
Za popolna navodila o učinkovitosti metod in interpretaciji rezultatov prosimo glejte navodila za uporabo, ki so priložena testnim metodam za določanje HER2.
Table 9 Overview of efficacy analyses BCIRG 006 AC→D versus AC→DH Parameter 
Pregled analiz učinkovitosti za preskušanje BCIRG 006; AC → D v primerjavi z AC → DH
No disease-free survival (DFS) benefit was noticed in this subgroup of patients (hazard ratio = 1.16, 95% CI [0.73, 1.83] for DCarbH (TCH) versus AC→D (AC→T); hazard ratio 0.97, 95% CI [0.60, 1.55] for AC→DH (AC→TH) versus AC→D). 
V preživetju brez bolezni v tej podskupini ni bilo opaziti koristi (razmerje ogroženosti = 1,16; 95-% IZ [0,73; 1,83] za DCarbH (TCH) v primerjavi z AC → D (AC → T); razmerje ogroženosti 0,97; 95-% IZ [0,60; 1,55] za AC → DH (AC → TH) v primerjavi z AC → D).
A study conducted in lactating cynomolgus monkeys at doses 25 times that of the weekly human maintenance dose of 2 mg/kg trastuzumab intravenous formulation demonstrated that trastuzumab is secreted in the milk. 
Izsledki študije, opravljene pri doječih opicah Cynomolgus z odmerki, 25-krat večjimi od tedenskega vzdrževalnega odmerka intravenske oblike trastuzumaba pri ljudeh (2 mg/kg), so pokazali, da se trastuzumab izloča v mleko.
p-value versus AC→P 
p-vrednost v primerjavi z
AC→D = doxorubicin plus cyclophosphamide, followed by docetaxel; DCarbH = docetaxel, carboplatin and trastuzumab; CI = confidence interval 
AC → D = doksorubicin in ciklofosfamid, ki jima sledi docetaksel; DCarbH = docetaksel, karboplatin in trastuzumab; IZ = interval zaupanja
Baseline levels of the shed HER2-ECD observed in MGC patients were comparable to those in MBC and EBC patients and no apparent impact on trastuzumab clearance was observed. 
Izhodiščne vrednosti odcepljene HER2-ECD, ki so jih opazili pri bolnikih z metastatskim rakom želodca, so bile primerljive s tistimi pri bolnikih z metastatskim rakom dojk in zgodnjim rakom dojk; očitnega vpliva na očistek trastuzumaba niso opazili.
HER2 gene amplification should be detected using fluorescence in situ hybridisation (FISH) or chromogenic in situ hybridisation (CISH) of fixed tumour blocks. 
Amplifikacijo gena HER2 določamo z metodo fluorescenčne hibridizacije in situ (FISH) ali metodo kromogene hibridizacije in situ (CISH) fiksiranih tumorskih blokov.
Trastuzumab plus docetaxel3 N = 92 
trastuzumab in docetaksel3 n = 92
Effect of trastuzumab on the pharmacokinetics of other antineoplastic agents 
Učinek trastuzumaba na farmakokinetiko drugih zdravil z delovanjem na novotvorbe
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 year = 0.99 (95% CI 0.87, 1.13), p-value = 0.90 and OS HR = 0.98 (0.83, 1.15); p-value = 0.78]. 
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].
The updated DFS analysis results (stratified HR = 0.61; 95% CI [0.54, 0.69]) showed a similar DFS benefit compared to the definitive primary DFS analysis, despite 24.8% patients in the AC→P arm who crossed over to receive trastuzumab. 
Posodobljeni rezultati analize preživetja brez bolezni (stratificirano razmerje ogroženosti 0,61; 95-% IZ [0,54; 0,69] so pokazali podobno korist v preživetju brez bolezni v primerjavi s končno primarno analizo preživetja brez bolezni, ne glede na to, da je 24,8 % bolnikov v skupini AC → P prešlo na zdravljenje s trastuzumabom.
Study WO16229: loading dose 8 mg/kg, followed by 6 mg/kg 3-weekly schedule 2. 
Študija WO16229: polnitveni odmerek 8 mg/kg, sledil je odmerek 6 mg/kg po 3-tedenskem režimu.
This will then be reduced to a maintenance dose of 6 mg/kg body weight every three weeks, beginning three weeks after your first dose. 
To se nato zmanjša na vzdrževalni odmerek 6 mg/kg telesne mase na vsake tri tedne, ki se začne uporabljati tri tedne po prvem odmerku.
If left ventricular ejection fraction (LVEF) percentage drops ≥ 10 points from baseline AND to below 50%, treatment should be suspended and a repeat LVEF assessment performed within approximately 
Če odstotek iztisnega deleža levega prekata (LVEF) pade za ≥ 10 točk od začetne vrednosti IN pod 50 %, zdravljenje prekinemo in ponovno opravimo meritev LVEF v približno treh tednih.
KANJINTI should be carefully handled during reconstitution. 
Med rekonstitucijo moramo z zdravilom KANJINTI pazljivo ravnati.
For time to response and duration of response no difference could be recorded between the arms. 
Med skupinama ni bilo razlik v času do odgovora na zdravljenje in trajanju odgovora.
There was a correlation between shed antigen and SGOT/AST levels; part of the impact of shed antigen on clearance may have been explained by SGOT/AST levels. 
Del vpliva odcepljenega antigena na očistek bi bilo mogoče pojasniti z vrednostmi SGOT/AST.
• heartburn (dyspepsia) 
• zgaga (dispepsija)
- Doxorubicin 60 mg/m2 and paclitaxel 150 mg/m2, administered 3-weekly for 3 cycles, 
- doksorubicin 60 mg/m2 in paklitaksel 150 mg/m2, dana enkrat na tri tedne, 3 cikle;
N Cmin,ss* 
Cmin, ss
which was followed by - Paclitaxel 175 mg/m2 administered 3-weekly for 4 cycles, 
temu je sledil - paklitaksel 175 mg/m2, dan enkrat na tri tedne, 4 cikle;
KANJINTI should only be used in patients with metastatic gastric cancer (MGC) whose tumours have HER2 overexpression as defined by IHC 2+ and a confirmatory SISH or FISH result, or by an IHC 3+ result. 
Zdravilo KANJINTI se uporablja le za bolnike z metastatskim rakom želodca, katerih tumorji imajo čezmerno izražen HER2, definiran kot IHC2+ z nadaljnjim potrditvenim SISH ali FISH rezultatom ali kot IHC3+.
+Pulmonary fibrosis 
+pljučna fibroza neznano
• numbness or tingling of the fingers and toes 
• otrplost ali zbadanje v prstih rok in nog
given every 3 weeks for 6 cycles (days 1 to 5 of each cycle) Either of which was administered with: 
dano vsake 3 tedne, skupaj 6 ciklov (dnevi 1 do 5 vsakega cikla).
Patients experiencing dyspnoea at rest due to complications of advanced malignancy and comorbidities may be at increased risk of a fatal infusion reaction. 
Pri bolnikih, ki imajo dispnejo v mirovanju zaradi komplikacij napredovale maligne bolezni in soobolenja, obstaja večje tveganje infuzijske reakcije s smrtnim izidom.
Progression free survival was doubled in the trastuzumab plus anastrozole arm compared to anastrozole (4.8 months versus 2.4 months). 
Preživetje brez napredovanja bolezni je bilo v skupini, ki je prejemala trastuzumab in anastrozol, dvakrat daljše (4,8 meseca) kot v skupini, ki je jemala le anastrozol (2,4 meseca).
A: doxorubicin; C: cyclophosphamide; P: paclitaxel; H: trastuzumab 
A: doksorubicin; C: ciklofosfamid; P: paklitaksel; H: trastuzumab; IZ: interval zaupanja
• liver damage/failure 
• poškodba/odpoved jeter
For the primary endpoint, DFS, the addition of trastuzumab to paclitaxel chemotherapy resulted in a 52% decrease in the risk of disease recurrence. 
Kar zadeva primarni cilj, preživetje brez bolezni, je dodatek trastuzumaba kemoterapiji s paklitakselom zmanjšal tveganje za ponovitev bolezni za 52 %.
• redness, swelling or sores in your mouth and/or throat 
• rdečina, oteklina ali ranice v ustih in/ali žrelu
Trastuzumab plus paclitaxel2 N = 68 
trastuzumab in paklitaksel2 n = 68
Severe pulmonary adverse reactions occur in association with the use of trastuzumab and have been associated with a fatal outcome. 
V povezavi z uporabo trastuzumaba se pojavljajo hudi pljučni neželeni učinki, ki so bili povezani tudi s smrtnim izidom.
The efficacy results from study BO18225 are summarised in table 13: Table 13 Efficacy results from BO18225 
Rezultati učinkovitosti za preskušanje BO18225 so povzeti v preglednici 13.
- in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease. 
- v kombinaciji z docetakselom za zdravljenje tistih bolnikov, ki še niso prejemali kemoterapije za metastatsko bolezen;
It may take up to 7 months for KANJINTI to be removed from your body. 
Izločanje zdravila KANJINTI iz vašega telesa lahko traja do 7 mesecev.
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. 
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.
+Bronchospasm 
+bronhospazem neznano
Each 150 mg vial of KANJINTI is reconstituted with 7.2 mL of sterile water for injections (not supplied). 
Eno 150 mg vialo zdravila KANJINTI rekonstituirajte s 7,2 ml sterilne vode za injekcije (ni dodana).
Comparison of trastuzumab PK data from Study M77004 in which women with HER2-positive MBC were treated concomitantly with trastuzumab, paclitaxel and doxorubicin to trastuzumab PK data in studies where trastuzumab was administered as monotherapy (H0649g) or in combination with anthracycline plus cyclophosphamide or paclitaxel (Study H0648g), suggested no effect of doxorubicin and paclitaxel on the pharmacokinetics of trastuzumab. 
Primerjava med farmakokinetičnimi podatki trastuzumaba iz študije M77004, v kateri so bolnice s HER2-pozitivnim metastatskim rakom dojk sočasno zdravili s trastuzumabom, paklitakselom in doksorubicinom in študij, v katerih so trastuzumab dajali v monoterapiji (H0649g) ali v kombinaciji z antraciklinom in ciklofosfamidom ali paklitakselom (študija H0648g), so nakazali, da učinka doksorubicina in paklitaksela na farmakokinetiko trastuzumaba ni.
The infusion may be continued after the symptoms improve. 
Po izboljšanju simptomov boste lahko z infuzijo nadaljevali.
• The recommended starting dose for the three-weekly cycle is 8 mg/kg body weight. 
• Priporočeni začetni odmerek za tri-tedensko shemo odmerjanja je 8 mg/kg telesne mase.
- The BCIRG 006 study was designed to investigate combining trastuzumab treatment with docetaxel either following AC chemotherapy or in combination with docetaxel and carboplatin in patients with HER2 positive EBC following surgery. 
- Preskušanje BCIRG 006 je bilo zasnovano za proučevanje kombinacije zdravljenja s trastuzumabom in docetakselom, bodisi po kemoterapiji z doksorubicinom in ciklofosfamidom (kemoterapiji AC) bodisi v kombinaciji z docetakselom in karboplatinom pri bolnikih z zgodnjo obliko HER2-pozitivnega raka dojk po operaciji.
Early breast cancer (neoadjuvant-adjuvant setting) 
Zgodnji rak dojk (neoadjuvantno-adjuvantno zdravljenje)