natgillin/translations-raw huggingface dataset:
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user, and would not normally be longer than 24 hours at 2°C - 8°C, unless reconstitution and dilution have taken place under controlled and validated aseptic conditions. 
Če se zdravilo ne uporabi takoj, je za čas in pogoje shranjevanja pred uporabo odgovoren uporabnik; običajno ne presegajo 24 ur pri temperaturi od 2 °C do 8 °C, razen če sta rekonstitucija in redčenje potekala v kontroliranih in validiranih aseptičnih pogojih.
Treatment with KANJINTI alone or with a taxane may affect the heart, especially if you have ever used an anthracycline (taxanes and anthracyclines are two other kinds of medicine used to treat cancer). 
Samostojno zdravljenje z zdravilom KANJINTI ali v kombinaciji s taksanom lahko vpliva na srce, še posebno, če ste se kdaj zdravili z antraciklinom (taksani in antraciklini sta dve drugi vrsti zdravil, ki se uporabljata za zdravljenje raka).
At the time of the analysis a total of 349 randomised patients had died: 182 patients (62.8%) in the control arm and 167 patients (56.8%) in the treatment arm. 
Do časa analize je umrlo skupaj 349 randomiziranih bolnikov: 182 bolnikov (62,8 %) v kontrolni skupini in 167 bolnikov (56,8 %) v skupini, ki je prejemala tudi trastuzumab.
The clinical relevance of these antibodies is not known. 
Klinični pomen pojava protiteles ni znan.
Administration as an intravenous push or bolus is prohibited. 
Uporaba zdravila kot hitra intravenska infuzija ali bolus je prepovedana.
Three-weekly and weekly schedule 
3-tedenski in tedenski režim
At the time of a safety update after a median of 3.5-3.8 years follow-up, an analysis of DFS reconfirms the magnitude of the benefit shown in the definitive analysis of DFS. 
Ob pregledu varnosti po mediani spremljanja 3,5 do 3,8 leta je analiza preživetja brez bolezni ponovno potrdila velikost koristi, prikazane v končni analizi preživetja brez bolezni.
In general, CISH is considered positive if there are more than 5 copies of the HER2 gene per nucleus in greater than 50% of tumour cells. 
V splošnem velja, da je rezultat metode CISH pozitiven, če obstaja več kot 5 kopij gena HER2 na jedro v več kot 50 % tumorskih celic.
Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. 
Predhodna kemoterapija mora vsebovati vsaj en antraciklinski in taksanski derivat, razen če bolniki za takšno zdravljenje niso bili primerni.
Your doctor may prescribe KANJINTI for the treatment of breast and gastric cancer when: 
Vaš zdravnik vam lahko zdravilo KANJINTI predpiše za zdravljenje raka dojk in raka želodca, če:
The reconstituted solution should not be frozen. 
Pripravljene raztopine ne smemo zamrzniti.
(12.3-ne) 
(12,3-no)
In order to prevent medication errors it is important to check the vial labels to ensure that the medicine being prepared and given is KANJINTI (trastuzumab) and not trastuzumab emtansine. 
Za preprečitev napak pri dajanju zdravila je pomembno preveriti nalepke na vialah in tako zagotoviti, da je pripravljeno in uporabljeno zdravilo KANJINTI (trastuzumab) in ne trastuzumab emtanzin.
AC→PH (vs.AC→P) (NSABP B-31 and NCCTG N9831)* 
AC → PH (v primerjavi z AC → P) (NSABP B-31 in NCCTG N9831)*
• swelling of the face, lips and throat 
• otekanje obraza, ustnic in grla
*Cmin,ss - Cmin at steady-state **Cmax,ss = Cmax at steady-state *** time to 90% of steady-state 
*Cmin, ss - Cmin v stanju dinamičnega ravnovesja **Cmax, ss = Cmax v stanju dinamičnega ravnovesja *** čas do 90 % stanja dinamičnega ravnovesja
In the pivotal trial of docetaxel (100 mg/m2 infused over 1 hour) with or without trastuzumab, 60% of the patients had received prior anthracycline-based adjuvant chemotherapy. 
V ključnem preskušanju docetaksela (100 mg/m2, infudirano v 1 uri) s trastuzumabom ali brez njega je 60 % bolnikov predhodno prejelo adjuvantno kemoterapijo na osnovi antraciklinov.
Appropriate aseptic technique should be used for reconstitution and dilution procedures. 
Za postopek rekonstitucije in redčenja je treba uporabiti ustrezno aseptično tehniko.
In addition, caution should be exercised in treating patients with increased cardiac risk, e.g. hypertension, documented coronary artery disease, CHF, LVEF of < 55%, older age. 
Previdnost je potrebna tudi pri zdravljenju bolnikov s povečanim srčnim tveganjem, npr. hipertenzijo, dokumentirano koronarno arterijsko boleznijo, kongestivnim srčnim popuščanjem, LVEF < 55 %, starejših bolnikih.
• Hypersensitivity to trastuzumab, murine proteins, or to any of the excipients listed in section 6.1 
• Preobčutljivost za trastuzumab, murine beljakovine ali katero koli pomožno snov, navedeno v poglavju 6.1.
To ensure validation of testing procedures and the generation of accurate and reproducible results, HER2 testing must be performed in a laboratory staffed by trained personnel. 
Za zagotovitev validacije postopkov testiranja in pridobitev točnih in ponovljivih rezultatov mora biti testiranje HER2 opravljeno v laboratoriju z ustrezno usposobljenim osebjem.
KANJINTI is a biosimilar medicinal product. 
Zdravilo KANJINTI je podobno biološko zdravilo.
Trastuzumab 1 Year N = 1,693 
trastuzumab 1 leto n = 1.693
Table 6 Efficacy results from study BO16348 
Rezultati učinkovitosti študije BO16348
Study H0648g: IHC3+ patient subset 
Študija H0648g: IHC 3+ podskupina bolnikov
Details of risk minimisation measures that are consistent with the EU Risk Management Plan are presented in “Warnings and precautions” (see section 4.4). 
Podrobnosti o dejavnostih za zmanjšanje tveganja v skladu z evropskim načrtom za obvladovanje tveganja (RMP) so navedene v poglavju »Posebna opozorila in previdnostni ukrepi« (glejte poglavje
The non-linear elimination parameter values were 8.81 mg/day for the maximum elimination rate (Vmax) and 8.92 μg/mL for the Michaelis-Menten constant (Km) for the MBC, EBC, and AGC patients. 
Vrednosti parametrov nelinearnega izločanja so bile 8,81 mg/dan za največjo hitrost izločanja (Vmax) in 8,92 µg/ml za Michaelis-Mentenovo konstanto (Km) za bolnike z MBC, EBC in AGC.
Study H0649g: IHC3+ patient subset 
Študija H0649g: IHC 3+ podskupina bolnikov
Instructions for aseptic reconstitution 
Navodila za aseptično rekonstitucijo
During a KANJINTI infusion, chills, fever and other flu like symptoms may occur. 
Med infuzijo zdravila KANJINTI se lahko pojavijo mrzlica, zvišana telesna temperatura in drugi simptomi, podobni gripi.
These symptoms can be treated with an analgesic/antipyretic such as meperidine or paracetamol, or an antihistamine such as diphenhydramine. 
Lahko jih zdravimo z analgetikom/antipiretikom, kot je meperidin ali paracetamol, ali antihistaminikom, kot je difenhidramin.
If a pregnant woman is treated with KANJINTI, or if a patient becomes pregnant while receiving KANJINTI or within 7 months following the last dose of KANJINTI, close monitoring by a multidisciplinary team is desirable. 
Če se noseča ženska zdravi z zdravilom KANJINTI ali če bolnica zanosi med zdravljenjem z zdravilom KANJINTI ali v obdobju 7 mesecev po prejemu zadnjega odmerka zdravila KANJINTI, je zaželeno, da jo skrbno spremlja multidisciplinarna ekipa.
420 mg vial 
420 mg viala
Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC03 
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, monoklonska protitelesa; ATC oznaka: L01XC03
On very rare occasions, patients have experienced the onset of infusion symptoms and pulmonary symptoms more than six hours after the start of the trastuzumab infusion. 
V zelo redkih primerih so se infuzijski in pljučni simptomi pojavili več kot šest ur po začetku infuzije trastuzumaba.
Women of childbearing potential should be advised to use effective contraception during treatment with KANJINTI and for 7 months after treatment has concluded (see section 5.2). 
Ženskam v rodni dobi je treba svetovati, naj med zdravljenjem z zdravilom KANJINTI ter še 7 mesecev po zaključku zdravljenja uporabljajo učinkovito kontracepcijo (glejte poglavje 5.2).
Time to steadystate*** (week) 
Čas do stanja dinamičnega ravnovesja*** (tedni)
Patients treated with KANJINTI are at increased risk for developing CHF (New York Heart Association [NYHA] class II-IV) or asymptomatic cardiac dysfunction. 
Pri bolnikih, ki so se zdravili z zdravilom KANJINTI, obstaja večje tveganje za pojav kongestivnega srčnega popuščanja (New York Heart Association - NYHA, razred II-IV) ali asimptomatične motnje v delovanju srca.
If the initial loading dose was well tolerated, the subsequent doses can be administered as a 30-minute infusion. 
Če je bolnik polnitveni odmerek dobro prenašal, lahko nadaljnje odmerke dajemo kot 30-minutne infuzije.
Should an infusion reaction occur the infusion should be discontinued or the rate of infusion slowed and the patient should be monitored until resolution of all observed symptoms (see section 4.2). 
Če se pojavi infuzijska reakcija, je potrebno infundiranje zdravila KANJINTI prekiniti ali upočasniti njegovo hitrost in bolnika nadzorovati, dokler vsi simptomi ne izzvenijo (glejte poglavje 4.2).
KANJINTI should not be diluted with glucose solutions since these cause aggregation of the protein. 
Zdravila KANJINTI ne redčite z raztopinami glukoze, ker le-te povzročajo agregacijo beljakovin.
Dedicated pharmacokinetic studies in the elderly and those with renal or hepatic impairment have not been carried out. 
Podrobnejših farmakokinetičnih študij pri starejših bolnikih in tistih z ledvično ali jetrno okvaro niso opravili.
Some of these side effects may be serious and may lead to hospitalisation. 
Nekateri od teh neželenih učinkov so lahko resni in vas lahko zaradi njih zdravijo v bolnišnici.
Dose reduction 
Zmanjšanje odmerka
If you receive KANJINTI with any other medicine to treat cancer, such as paclitaxel, docetaxel, an aromatase inhibitor, capecitabine, 5-fluorouracil, or cisplatin you should also read the patient information leaflets for these products. 
Če prejemate zdravilo KANJINTI z drugimi zdravili za zdravljenje raka, kot so paklitaksel, docetaksel, zaviralec aromataze, kapecitabin, 5-fluorouracil ali cisplatin, preberite tudi navodila za uporabo teh zdravil.
The first dose of your treatment is given over 90 minutes and you will be observed by a health professional while it is being given in case you have any side effects. 
Prvi odmerek vašega zdravljenja se daje v 90 minutah; med dajanjem boste zaradi možnosti pojava neželenih učinkov pod nadzorom zdravstvenega osebja.
• followed by adequate storage of the prepared solution for intravenous infusion to ensure maintenance of the aseptic conditions. 
• Po pripravi je treba pripravljeno raztopino za intravensko infundiranje ustrezno shraniti, da je zagotovljeno vzdrževanje aseptičnih pogojev.
• infections 
• okužbe
The safety of continuation or resumption of trastuzumab in patients who experience cardiac dysfunction has not been prospectively studied. 
Varnosti nadaljevanja ali ponovnega dajanja trastuzumaba pri bolnikih, pri katerih se je pojavila motnja v delovanju srca, niso proučevali prospektivno.
• Tumour lysis syndrome (a group of metabolic complications occurring after cancer treatment characterised by high blood levels of potassium and phosphate, and low blood levels of calcium). 
• Sindrom razpada tumorja (skupina presnovnih zapletov, ki se pojavijo po zdravljenju raka, za katero so značilne visoke vrednosti kalija in fosfata ter nizke vrednosti kalcija v krvi).
The main test method used to determine HER2 positivity in the pivotal trial of docetaxel, with or without trastuzumab, was immunohistochemistry. 
Glavna testna metoda, ki so jo uporabili za določitev pozitivnosti HER2 v ključnem preskušanju docetaksela skupaj s trastuzumabom ali brez njega, je bila imunohistokemija.
In the neoadjuvant-adjuvant EBC study (BO22227), at a median follow-up exceeding 70 months, 10.1% (30/296) of patients treated with trastuzumab intravenous developed antibodies against trastuzumab. 
V študiji neoadjuvantnega-adjuvantnega zgodnjega raka dojk (BO22227) z mediano spremljanja, ki je presegla 70 mesecev, so se pri 10,1 % bolnikov (30/296), zdravljenih z intravensko obliko trastuzumaba, razvila protitelesa proti trastuzumabu.
Asthma 
astma
The exploratory analyses of covariates with information in only a subset of patients suggested that patients with greater shed HER2-ECD level had faster non-linear clearance (lower Km) (p < 0.001). 
Eksplorativne analize sospremenljivk, opravljene samo s podatki za podskupino bolnikov, kažejo, da so imeli bolniki z višjimi vrednostmi odcepljenega HER2-ECD antigena hitrejši nelinearni očistek (nižjo Km) (p < 0,001).
Other medicines and KANJINTI 
Druga zdravila in zdravilo KANJINTI
1 Denotes adverse reactions that are reported largely in association with Infusion-related reactions. 
1 Označuje neželene učinke, o katerih so večinoma poročali v zvezi z infuzijskimi reakcijami.
The data suggest that beneficial effects were greater among those patients with higher levels of overexpression of HER2 (3+). 
Podatki kažejo, da so bili koristni učinki pri bolnikih z višjo stopnjo čezmernega izražanja HER2 (3+) večji.
Amongst the most serious and/or common adverse reactions reported in trastuzumab usage to date are cardiac dysfunction, infusion-related reactions, haematotoxicity (in particular neutropenia), infections and pulmonary adverse reactions. 
Med najbolj resnimi in/ali pogostimi neželenimi učinki, o katerih so do zdaj poročali pri uporabi trastuzumaba, so motnje v delovanju srca, infuzijske reakcije, hematotoksičnost (še posebno nevtropenija), okužbe in pljučni neželeni učinki.
HER2 testing is mandatory prior to initiation of therapy (see sections 4.4 and 5.1). 
Pred začetkom zdravljenja je potrebno testiranje na HER2 (glejte poglavji 4.4 in 5.1).
Therefore, your heart function will be checked before, during (every three months) and after (up to two to five years) treatment with KANJINTI. 
Zato bo zdravnik preveril delovanje vašega srca pred zdravljenjem, med njim (vsake tri mesece) in po zdravljenju z zdravilom KANJINTI (od dve do pet let).
Studies indicate that breast cancer patients whose tumours overexpress HER2 have a shortened disease-free survival compared to patients whose tumours do not overexpress HER2. 
Študije kažejo, da imajo bolniki z rakom dojk, katerih tumorji čezmerno izražajo HER2, krajše preživetje brez bolezni v primerjavi z bolniki, katerih tumorji ne izražajo HER2.
• You have metastatic breast cancer (breast cancer that has spread beyond the original tumour) with high levels of HER2. 
• imate metastatskega raka dojk (raka dojk, ki se je razširil še na druga mesta zunaj prvotnega tumorja), pri katerem so izražene velike količine HER2.
For the other parameters the improvements seen for the combination were for overall response (16.5% versus 6.7%); clinical benefit rate (42.7% versus 27.9%); time to progression (4.8 months versus 2.4 months). 
Pri drugih parametrih so bila izboljšanja pri kombinaciji vidna pri celokupnem odgovoru (16,5 % v primerjavi s 6,7 %), deležu klinične koristi (42,7 % v primerjavi s 27,9 %) in času do napredovanja bolezni (4,8 meseca v primerjavi z 2,4 meseca).
Patients who develop asymptomatic cardiac dysfunction may benefit from more frequent monitoring (e.g. every 6 - 8 weeks). 
Za bolnike z asimptomatičnimi motnjami v delovanju srca je koristen pogostejši nadzor (npr. vsakih 6 do 8 tednov).
They include weakening of the heart muscle possibly leading to heart failure, inflammation of the lining around the heart and heart rhythm disturbances. 
Vključujejo slabenje srčne mišice z možnim prehodom v srčno popuščanje, vnetje osrčnika in motnje srčnega ritma.
The majority of patients with cardiac symptoms and evidence of a clinical benefit of trastuzumab treatment continued on therapy without additional clinical cardiac events. 
Pri večini bolnikov s srčnimi simptomi in znaki klinične koristi zdravljenja s trastuzumabom je nadaljevanje zdravljenja z njim potekalo brez dodatnih kliničnih zapletov v delovanju srca.
Administration in combination with an aromatase inhibitor In the pivotal trial (BO16216) trastuzumab and anastrozole were administered from day 1. 
Odmerjanje v kombinaciji z zaviralcem aromataze V ključni študiji (BO16216) so trastuzumab in anastrozol dajali od 1. dne dalje.
The median duration of follow-up was 2.9 years in the AC→D arm and 3.0 years in each of the AC→DH and DCarbH arms. 
Mediana spremljanja je bila 2,9 let v skupini AC → D in 3,0 let v skupinah AC → DH in DCarbH.
The efficacy of trastuzumab in combination with paclitaxel in patients who did not receive prior adjuvant anthracyclines has not been studied. 
Učinkovitost trastuzumaba v kombinaciji s paklitakselom pri bolnikih, ki niso prejeli predhodne kemoterapije z antraciklinom, ni bila proučevana.
The median overall survival was extended by 4.6 months for patients in the combination arm. 
Mediana celokupnega preživetja je bila v skupini, ki je jemala kombinacijo zdravil, daljša za 4,6 meseca.
• You should use effective contraception during treatment with KANJINTI and for at least 7 months after KANJINTI treatment has ended. 
• Med zdravljenjem z zdravilom KANJINTI in vsaj še 7 mesecev po zaključku zdravljenja morate uporabljati učinkovito kontracepcijo.
Always keep this medicine in the closed original pack at a temperature of 2ºC - 8ºC in a refrigerator. 
Zdravilo shranjujte v dobro zaprti originalni ovojnini pri temperaturi 2 °C - 8 °C, v hladilniku.
In patients who receive anthracycline-containing chemotherapy further monitoring is recommended, and should occur yearly up to 5 years from the last administration of KANJINTI, or longer if a continuous decrease of LVEF is observed. 
Pri bolnikih, ki prejemajo kemoterapijo z antraciklini, je priporočljivo nadaljnje spremljanje, ki ga je treba izvajati letno do 5 let po zadnjem dajanju zdravila KANJINTI ali dlje, če iztisni delež levega prekata (LVEF) stalno pada.
KANJINTI is for intravenous use only. 
Zdravilo KANJINTI je samo za intravensko uporabo.
• You have metastatic gastric cancer with high levels of HER2, when it is in combination with the other cancer medicines capecitabine or 5-fluorouracil and cisplatin. 
• imate metastatskega raka želodca, pri katerem so izražene velike količine HER2, v kombinaciji z drugimi zdravili za zdravljenje raka, kapecitabinom ali 5-fluorouracilom in cisplatinom.
Linear clearance was 0.136 L/day for MBC, 0.112 L/day for EBC and 0.176 L/day for 
Linearni očistek je bil 0,136 l/dan za bolnike z MBC, 0,112 l/dan za bolnike z EBC in 0,176 l/dan za bolnike z AGC.
Trastuzumab may have a minor influence on the ability to drive or use machines (see section 4.8). 
Trastuzumab ima lahko blag vpliv na sposobnost vožnje in upravljanje strojev (glejte poglavje 4.8).
6.6 Special precautions for disposal and other handling Appropriate aseptic technique should be used for reconstitution and dilution procedures. 
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Za postopek rekonstitucije in redčenja je treba uporabiti ustrezno aseptično tehniko.
This condition may be harmful to your baby in the womb and has been associated with the lungs not developing fully resulting in foetal death. 
Tako stanje lahko škodi otroku v maternici in je povezano z nedozorelostjo pljuč ter lahko privede do plodove smrti.
Trastuzumab has been investigated in one randomised, open-label phase III trial ToGA (BO18255) in combination with chemotherapy versus chemotherapy alone. 
Trastuzumab so proučevali v randomiziranem, odprtem preskušanju faze III ToGA (BO18255) v kombinaciji s kemoterapijo v primerjavi s samo kemoterapijo.
Study JP19959 was a substudy of BO18255 (ToGA) performed in male and female Japanese patients with advanced gastric cancer to study the pharmacokinetics of capecitabine and cisplatin when used with or without trastuzumab. 
Študija JP19959 je bila podštudija BO18255 (ToGA) pri japonskih bolnikih in bolnicah z napredovalim rakom želodca, v kateri so proučevali farmakokinetiko kapecitabina in cisplatina s trastuzumabom ali brez njega.
Trastuzumab may persist in the circulation for up to 7 months after stopping KANJINTI treatment based on population pharmacokinetic analysis of all available data (see section 5.2). 
Trastuzumab je lahko po prenehanju zdravljenja z zdravilom KANJINTI v krvnem obtoku prisoten do 7 mesecev glede na populacijsko farmakokinetično analizo vseh razpoložljivih podatkov (glejte poglavje 5.2).
Positive 
pozitivno
+ Denotes adverse reactions that have been reported in association with a fatal outcome. 
+ Označuje neželene učinke, o katerih so poročali v povezavi s smrtnim izidom.
In rare cases, a reduction in the amount of (amniotic) fluid that surrounds the developing baby within the womb has been observed in pregnant women receiving trastuzumab. 
V redkih primerih so pri nosečnicah, ki so prejemale trastuzumab, opazili zmanjšanje količine (amnijske) tekočine, ki obdaja razvijajočega se otroka v maternici.
METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use. 
POSTOPEK IN POT(I) UPORABE ZDRAVILA Za intravensko uporabo.
For early breast cancer, metastatic breast cancer and metastatic gastric cancer, KANJINTI is given every 3 weeks. 
Pri zgodnji obliki raka dojk, metastatskem raku dojk in metastatskem raku želodca se zdravilo KANJINTI daje vsake 3 tedne.
After aseptic dilution in polyvinylchloride, polyethylene or polypropylene bags containing sodium chloride 9 mg/mL (0.9%) solution for injection, chemical and physical stability of KANJINTI has been demonstrated for up to 30 days at 2°C - 8°C, and subsequently for 24 hours at temperatures not exceeding 30°C. 
Po aseptičnem redčenju v polivinilkloridnih, polietilenskih ali polipropilenskih vrečkah, ki vsebujejo raztopino 9 mg/ml (0,9 %) natrijevega klorida za injiciranje, je kemijska in fizikalna stabilnost zdravila KANJINTI dokazana do 30 dni pri temperaturi 2 °C-8 °C in kasneje 24 ur pri temperaturah, ki ne presežejo 30 °C.
The frequency of progression in the liver was significantly reduced in patients treated with the combination of trastuzumab and paclitaxel, compared to paclitaxel alone (21.8% versus 45.7%; p = 0.004). 
Pogostnost napredovanja v jetrih je bila signifikantno zmanjšana pri bolnikih, zdravljenih s kombinacijo trastuzumaba in paklitaksela, v primerjavi s samim paklitakselom (21,8 % v primerjavi s 45,7 %; p = 0,004).
Most of the patients (79%) who developed cardiac dysfunction in these trials experienced an improvement after receiving standard treatment for CHF. 
Pri večini bolnikov (79 %), pri katerih so se pojavile motnje v delovanju srca v teh preskušanjih, je prišlo do izboljšanja po standardnem zdravljenju za kongestivno srčno popuščanje.
The rate of asymptomatic cardiac dysfunction was increased in the 2-year treatment arm (8.1% versus 4.6% in the 1-year treatment arm). 
Delež asimptomatskih motenj v delovanju srca je bil večji v skupini z dvoletnim zdravljenjem (8,1 % v primerjavi s 4,6 % v skupini z enoletnim zdravljenjem).
In patients receiving trastuzumab after completion of adjuvant chemotherapy the risk of cardiac dysfunction was associated with a higher cumulative dose of anthracycline given prior to initiation of trastuzumab and a body mass index (BMI) > 25 kg/m2. 
Pri bolnikih, ki so prejemali trastuzumab po zaključku adjuvantne kemoterapije, je bilo tveganje za pojav motnje v delovanju srca povezano z višjim kumulativnim odmerkom antraciklina, ki so ga dajali pred uvedbo trastuzumaba in visokim indeksom telesne mase (body mass index - BMI) > 25 kg/m2.
In the ToGA (BO18255) trial, patients whose tumours were either IHC3+ or FISH positive were defined as HER2 positive and thus included in the trial. 
V preskušanju ToGA (BO18255) so bolnike, katerih tumorji so bili IHC3+ ali FISH pozitivni, definirali kot HER2 pozitivne in jih vključili v preskušanje.
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 je bil pri bolnikih, ki so trastuzumab prejemali sočasno z antraciklinom/ciklofosfamidom (27 %), bil je signifikantno višji kot pri jemanju samega antraciklina/ciklofosfamida (7 do 10 %).