natgillin/translations-raw huggingface dataset:
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, ki so se zdravili samo z docetakselom.
If LVEF has not improved, or has declined further, or if symptomatic congestive heart failure (CHF) has developed, discontinuation of Trazimera should be strongly considered, unless the benefits for the individual patient are deemed to outweigh the risks. 
Če se LVEF ne izboljša, se dodatno zmanjša ali se razvije simptomatsko kongestivno srčno popuščanje, je treba resno razmisliti o prekinitvi zdravljenja z zdravilom Trazimera, razen če je korist za posameznega bolnika večja od tveganja.
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 v intravenski obliki trastuzumaba pri ljudeh (2 mg/kg), so pokazali, da se trastuzumab izloča v mleko.
Trastuzumab plus docetaxel N=110 
trastuzumab in docetaksel n = 110
An overfill of 5% ensures that the labelled dose of 420 mg can be withdrawn from each vial. 
Petodstotni presežek omogoča, da iz viale dejansko odvzamemo na nalepki naveden odmerek 420 mg.
• numbness or tingling of the fingers and toes 
• odrevenelost ali zbadanje v prstih na nogah in rokah
Only patients with a large amount of HER2 will be treated with Trazimera. 
Z zdravilom Trazimera zdravimo samo bolnike z veliko količino HER2.
It must not be diluted with glucose solutions. 
Ne redčite z raztopinami glukoze.
A: doxorubicin; C: cyclophosphamide; P: paclitaxel; H: trastuzumab At median duration of follow up of 1.8 years for the patients in the AC→P arm and 2.0 years for patients in the AC→PH arm p value for OS did not cross the pre-specified statistical boundary for comparison of AC→PH vs. AC→P 
A = doksorubicin; C = ciklofosfamid; P = paklitaksel; H = trastuzumab; IZ = interval zaupanja Po medianem spremljanju 1,8 leta za bolnike v skupini AC → P in 2,0 leta za bolnike v skupini AC → PH.
In patients with EBC eligible for neoadjuvant-adjuvant treatment, Trazimera 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 
Pri bolnikih z zgodnjim rakom dojk, ki so primerni za neoadjuvantno-adjuvantno zdravljenje, se zdravilo Trazimera uporablja sočasno z antraciklini le pri bolnikih, ki se še niso zdravili s kemoterapijo, in to samo pri shemah z majhnimi odmerki antraciklinov (največji kumulativni odmerek doksorubicina 180 mg/m 2 ali epirubicina 360 mg/m
Trazimera contains the active substance trastuzumab, which is a monoclonal antibody. 
Zdravilo Trazimera vsebuje učinkovino trastuzumab, ki je monoklonsko protitelo.
Table 12 Efficacy Results from MO16432 Parameter 
Rezultati učinkovitosti iz preskušanja MO16432
As a three-weekly regimen the recommended initial loading dose of Trazimera is 8 mg/kg body weight. 
Pri 3-tedenskem režimu je priporočen začetni polnilni odmerek zdravila Trazimera 8 mg/kg telesne mase.
Trastuzumab plus docetaxel N=92 
trastuzumab in docetaksel n = 92
See section 5.1 for chemotherapy combination dosing. 
Za odmerjanje v kombinaciji s kemoterapijo glejte poglavje 5.1.
A careful risk-benefit assessment should be made before deciding to treat with Trazimera. 
Pred odločitvijo za zdravljenje z zdravilom Trazimera je treba skrbno pretehtati razmerje med koristjo in tveganjem.
The appropriate amount of solution should be withdrawn from the vial and added to a polyvinylchloride, polyethylene, polypropylene or ethylene vinyl acetate infusion bag, or a glass infusion bottle containing 250 mL of sodium chloride 9 mg/mL (0.9%) solution. 
Primerno količino raztopine je potrebno odvzeti iz viale in dodati v polivinilkloridno, polietilensko, polipropilensko ali etilenvinilacetatno infuzijski vrečko ali infuzijsko stekleničko, ki vsebuje 250 ml 0,9-odstotne (9 mg/ml) raztopine natrijevega klorida.
The recommended initial loading dose is 8 mg/kg body weight. 
Priporočeni začetni polnilni odmerek je 8 mg/kg telesne mase.
Observation N=1693 
Parameter opazovanje n = 1.693
Trazimera intravenous formulation is not for subcutaneous use and should be given as an intravenous infusion only. 
Intravenska oblika zdravila Trazimera ni namenjena subkutani aplikaciji in jo lahko dajemo le z intravensko infuzijo.
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 prejemala le anastrozol (2,4 meseca).
Overall survival (death) - No. patients with event - No. patients without event P-value versus Observation Hazard Ratio versus Observation 
Celokupno preživetje (smrt) - št. bolnikov z dogodkom - št. bolnikov brez dogodka P-vrednost v primerjavi z Opazovanjem
AC→DH (vs. AC→D) (BCIRG 006) 
AC  DH (v primerjavi z AC  D) (BCIRG 006)
The median duration of follow up was 1.8 years for the patients in the AC→P arm and 2.0 years for patients in the AC→PH arm. 
Mediana spremljanja je bila 1,8 leta za bolnike v skupini AC → P in 2,0 leta za bolnike v skupini AC → PH.
A vial of Trazimera reconstituted with water for injections (not supplied) is stable for 48 hours at 2ºC - 8ºC after reconstitution and must not be frozen. 
Po rekonstituciji vsebine viale zdravila Trazimera z vodo za injekcije (ni priložena) je pripravljena raztopina stabilna 48 ur pri temperaturi 2 °C-8 °C.
Trazimera is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer: (MBC): 
Zdravilo Trazimera je indicirano za zdravljenje odraslih bolnikov s HER2-pozitivno metastatsko obliko raka dojk:
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 pokazali, da sočasna uporaba cisplatina ali sočasna uporaba cisplatina in trastuzumaba ni vplivala na izpostavljenost biološko aktivnim metabolitom kapecitabina (npr. 5-FU).
An updated RMP should be submitted: • At the request of the European Medicines Agency. 
Posodobljen RMP je treba predložiti:
Severe pulmonary events have been reported with the use of trastuzumab in the post-marketing setting (see section 4.8). 
V obdobju trženja zdravila so pri uporabi trastuzumaba poročali o hudih pljučnih zapletih (glejte poglavje 4.8).
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, in sicer po kemoterapiji AC.
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 raziskovalni analizi podskupin, ki so jo opravili v preskušanju TOGA (BO18255), pri dodatku trastuzumaba ni bilo opazne koristi v celokupnem preživetju pri bolnikih z oceno splošnega stanja zmogljivosti po ECOG (Eastern Cooperative Oncology Group) 2 pred začetkom zdravljenja [razmerje ogroženosti 0,96 (95 % IZ: 0,51-1,79)], bolnikih z nemerljivo boleznijo [razmerje ogroženosti 1,78 (95 % IZ: 0,87-3,66)] in bolnikih z lokalno napredovalo boleznijo [razmerje ogroženosti 1,20 (95 % IZ: 0,29-4,97)].
The highest rate of cardiac dysfunction was seen in patients receiving trastuzumab concurrently with anthracycline/cyclophosphamide (27%), and was significantly higher than for anthracycline/cyclophosphamide alone (7% - 10%). 
Najvišji delež motenj v delovanju srca so opazili pri bolnikih, ki so trastuzumab prejemali sočasno z antraciklinom/ciklofosfamidom (27 %).
At 8 years, the diseasefree 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 so delež preživetja brez ponovitve bolezni v skupini AC→PH ocenili na 77,2 % (95 % IZ: 75,4; 79,1), kar predstavlja absolutno korist 11,8 % v primerjavi s skupino AC→P.
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 pokazali, da doksorubicin in paklitaksel ne vplivata na farmakokinetiko trastuzumaba.
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 preskušanju BCIRG 006 se razmerje ogroženosti za primarni opazovani dogodek, preživetje brez ponovitve bolezni, izraža kot absolutna korist v smislu 3-letnega preživetja brez ponovitve bolezni za 5,8 odstotne točke v prid skupini AC → DH (trastuzumab) (86,7 % v primerjavi z 80,9 %) ter za 4,6 odstotne točke v prid skupini DCarbH (trastuzumab) v primerjavi s skupino AC → D (85,5 % v primerjavi z 80,9 %).
MBC 805 0.183 - 0.302 EBC 390 0.158 - 0.253 AGC 274 0.189 - 0.337 
EBC 390 0,158-0,253 AGC 274 0,189-0,337
AC→D = doxorubicin plus cyclophosphamide, followed by docetaxel; AC→DH = doxorubicin plus cyclophosphamide, followed by docetaxel plus trastuzumab; CI = confidence interval 
AC → D = doksorubicin in ciklofosfamid, ki jima sledi docetaksel; AC → DH = doksorubicin in ciklofosfamid, ki jima sledita docetaksel in trastuzumab; IZ = interval zaupanja
Patients with MBC or MGC should be treated with Trazimera until progression of disease. 
Bolnike z metastatskim rakom dojk ali metastatskim rakom želodca je treba zdraviti z zdravilom Trazimera do napredovanja bolezni.
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-odstotnim zmanjšanjem tveganja v primerjavi s samo opazovanjem (razmerje ogroženosti = 0,76; 95 % IZ: 0,67; 0,86).
The resulting solution contains approximately 21 mg/mL trastuzumab. 
Pripravljena raztopina vsebuje približno 21 mg/ml trastuzumaba.
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 zapletov napredovale maligne bolezni in sočasna obolenja, obstaja večje tveganje infuzijske reakcije s smrtnim izidom.
Docetaxel was administered as follows: intravenous docetaxel - 100 mg/m 2 as an intravenous infusion over 1 hour, given every 3 weeks for 4 cycles (day 2 of first docetaxel cycle, then day 1 of each subsequent cycle) 
Odmerjanje docetaksela je bilo naslednje: - docetaksel intravensko - 100 mg/m 2 v obliki intravenske infuzije v 1 uri, vsake 3 tedne, skupaj 4 cikle (na 2. dan prvega cikla in nato na 1. dan vsakega nadaljnjega cikla)
An overfill of 4% ensures that the labelled dose of 150 mg can be withdrawn from each vial. 
Štiriodstotni presežek omogoča, da iz viale dejansko odvzamemo na nalepki naveden odmerek 150 mg.
or - intravenous 5-fluorouracil - 800 mg/m 2/day as a continuous intravenous infusion over 5 days, given every 3 weeks for 6 cycles (days 1 to 5 of each cycle) 
- 5-fluorouracil intravensko - 800 mg/m2/dan v obliki kontinuirane intravenske infuzije 5 dni, vsake 3 tedne, skupaj 6 ciklov (na 1. do 5. dan vsakega cikla).
L-histidine hydrochloride monohydrate L-histidine sucrose polysorbate 20 
L-histidinijev klorid monohidrat L-histidin saharoza polisorbat 20
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. 
Ugotavljanje čezmernega izražanja HER2 ali amplifikacije gena HER2 pri raku dojk Trastuzumab se uporablja le pri bolnikih, pri katerih tumorji čezmerno izražajo HER2 ali imajo amplifikacijo gena HER2, določeno s točnim in validiranim preskusom.
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 glejte navodila za uporabo, ki so priložena metodam za določanje HER2.
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 tej podskupini niso opazili koristi v preživetju brez ponovitve bolezni (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).
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 povezani tudi s smrtnim izidom.
AUC0-21days (µg.day/mL) 
AUC 0 - 21. dan (µg.dan/ml)
• Doxorubicin 60 mg/m 2 and paclitaxel 150 mg/m 2, administered 3-weekly for 3 cycles, 
- doksorubicin 60 mg/m 2 in paklitaksel 150 mg/m 2, enkrat na 3 tedne, 3 cikle;
The reconstituted Trazimera results in a colourless to pale brownishyellow transparent solution and should be essentially free of visible particulates. 
Raztopljeno zdravilo Trazimera je brezbarvna do rahlo rjavorumena prozorna tekočina, ki mora biti brez vidnih delcev.
• sleepiness (somnolence) 
• bolečina v vratu bolezenska zaspanost (somnolenca)
Trastuzumab may persist in the circulation for up to 7 months after stopping treatment based on population pharmacokinetic analysis of all available data (see section 5.2). 
Glede na populacijsko farmakokinetično analizo vseh razpoložljivih podatkov je lahko trastuzumab prisoten v krvnem obtoku do 7 mesecev po prenehanju zdravljenja (glejte poglavje 5.2).
Each 150 mg vial of Trazimera is reconstituted with 7.2 mL of sterile water for injections (not supplied). 
Vsebino 150 mg viale zdravila Trazimera rekonstituiramo v 7,2 ml sterilne vode za injekcije (ni priložena).
- 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 so zasnovali za proučevanje kombinacije zdravljenja s trastuzumabom in docetakselom, bodisi po kemoterapiji AC bodisi v kombinaciji z docetakselom in karboplatinom pri bolnikih z zgodnjo obliko HER2-pozitivnega raka dojk po operaciji.
Each 420 mg vial of Trazimera is reconstituted with 20 mL of sterile water for injections (not supplied). 
Vsebino 420 mg viale zdravila Trazimera rekonstituiramo v 20 ml sterilne vode za injekcije (ni priložena).
However, trastuzumab plus docetaxel was efficacious in patients whether or not they had received prior adjuvant anthracyclines. 
Trastuzumab je bil skupaj z docetakselom učinkovit, ne glede na to, ali so bolniki predhodno prejeli adjuvantno zdravljenje z antraciklini ali ne.
- 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;
• pain in the arms and/or legs 
• motnje delovanja pljuč bolečine v rokah in/ali nogah
Solutions of Trazimera for intravenous infusion are physically and chemically stable in polyvinylchloride, polyethylene, polypropylene or ethylene vinyl acetate bags, or glass intravenous bottles, containing sodium chloride 9 mg/mL (0.9%) solution for injection for 24 hours at temperatures not exceeding 30°C. 
Raztopine zdravila Trazimera za infundiranje so v polivinilkloridnih, polietilenskih, polipropilenskih ali etilenvinilacetatnih vrečkah ali v stekleničkah za intravensko uporabo, ki vsebujejo 0,9-odstotno (9 mg/ml) raztopino natrijevega klorida za injiciranje, fizikalno in kemično stabilne 24 ur pri temperaturah do 30 °C.
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
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 v smislu 3-letnega preživetja brez ponovitve bolezni za 11,8 odstotne točke v prid skupini, ki je prejemala AC → PH (trastuzumab) (87,2 % v primerjavi s 75,4 %).
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 so izkušnje z dajanjem trastuzumaba sočasno s shemami, ki vsebujejo majhne odmerke antraciklinov, omejene (glejte poglavje 4.4).
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. 
Primerjava simuliranih serumskih koncentracij trastuzumaba po monoterapiji s trastuzumabom (polnilni 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) ne dokazuje farmakokinetičnega vpliva sočasne uporabe docetaksela na farmakokinetiko trastuzumaba.
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 so korist ugotovili pri bolnikih, ki so imeli najvišjo stopnjo čezmernega izražanja beljakovine HER2, kar pomeni rezultat po metodi IHC 3+ ali 2+ ter istočasno pozitiven rezultat po metodi FISH.
Response rate (95% CI) 
Delež odgovora (95 % IZ)
• dry eyes 
• solzenje oči
Table 4 Efficacy Results from the Monotherapy and Combination Therapy Studies Parameter Monotherapy 
Rezultati učinkovitosti iz študij monoterapije in kombiniranega zdravljenja Parameter
Disease-free survival No. patients with event (%) 
Preživetje brez ponovitve bolezni: število bolnikov z dogodkom (%)
• Severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy. 
• Pri bolnikih, ki imajo hudo dispnejo v mirovanju zaradi zapletov napredovale maligne bolezni, ali pri tistih, ki potrebujejo zdravljenje s kisikom.
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.
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, pri katerih so tumorji čezmerno izražali HER2 in pri katerih je prišlo do napredovanja bolezni po 1 ali več zdravljenjih njihove metastatske bolezni s kemoterapijo (le trastuzumab).
Overall Survival, Median months Progression-Free Survival, Median months 
Preživetje brez napredovanja bolezni, mediana (meseci)
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 opazovani dogodek, preživetje brez ponovitve bolezni, je dodatek trastuzumaba kemoterapiji s paklitakselom zmanjšal tveganje za ponovitev bolezni za 52 %.
HER2 overexpression should be detected using an immunohistochemistry (IHC)-based assessment of fixed tumour blocks (see section 4.4). 
ugotavljamo z imunohistokemijsko (IHC) metodo na fiksiranih blokih tumorskega tkiva (glejte poglavje 4.4).
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.
• bladder and skin infections 
• znojenje okužbe mehurja in kože
Data from study JP16003, a single-arm study of trastuzumab (4 mg/kg intravenous loading dose and 2 mg/kg intravenous dose weekly) and docetaxel (60 mg/m2 intravenous dose) 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 (intravenski polnilni odmerek 4 mg/kg in 2 mg/kg enkrat na teden) in docetaksel (intravenski odmerek 60 mg/m2) so pokazali, da sočasna uporaba trastuzumaba ni imela vpliva na farmakokinetiko enkratnega odmerka docetaksela.
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 zapletov napredovale maligne bolezni in sočasnih obolenj, obstaja večje tveganje pljučnih zapletov.
The addition of trastuzumab to paclitaxel chemotherapy also resulted in a 37% decrease in the risk of death. 
Hkrati je zmanjšal tudi tveganje za smrt za 37 %.
The efficacy results from the interim efficacy analysis crossed the protocol pre-specified statistical boundary for the comparison of 1-year of trastuzumab versus observation. 
Pri primerjavi 1-letnega zdravljenja s trastuzumabom z opazovanjem so rezultati učinkovitosti iz vmesne analize učinkovitosti presegli statistično mejo, ki so jo določili vnaprej s protokolom.