natgillin/translations-raw huggingface dataset:
If patients have a continued decrease in left ventricular function, but remain asymptomatic, the physician should consider discontinuing therapy if no clinical benefit of trastuzumab therapy has been seen. 
Ako se u bolesnika primijeti kontinuirano smanjenje funkcije lijeve klijetke, ali ostaje asimptomatsko, liječnik treba razmotriti prekid terapije trastuzumabom ako ona nije polučila nikakvu kliničku korist.
A study of trehalose, a major formulation excipient, did not reveal any toxicities. 
Ispitivanja trehaloze, glavne pomoćne tvari u sastavu lijeka, nisu pokazala toksičan učinak.
Each vial contains either: 150 mg trastuzumab that has to be dissolved in 7.2 mL of water for injection, or 420 mg trastuzumab that has to be dissolved in 20 mL of water for injection. 
Jedna bočica sadrži ili: 150 mg trastuzumaba koji treba otopiti u 7,2 ml vode za injekcije, ili 420 mg trastuzumaba koji treba otopiti u 20 ml vode za injekcije.
MBC EBC AGC 
EBC AGC
Patients with history of myocardial infarction (MI), angina pectoris requiring medical treatment, history of or existing CHF (NYHA Class II-IV), LVEF of <55%, other cardiomyopathy, cardiac arrhythmia requiring medical treatment, clinically significant cardiac valvular disease, poorly controlled hypertension (hypertension controlled by standard medical treatment eligible), and haemodynamic effective pericardial effusion were excluded from adjuvant and neoadjuvant EBC pivotal trials with trastuzumab and therefore treatment cannot be recommended in such patients. 
Bolesnici koji su u anamnezi imali infarkt miokarda (IM), anginu pektoris koja je zahtijevala liječenje, ranije ili postojeće kongestivno zatajenje srca (NYHA klase II-IV), LVEF <55%, neku drugu kardiomiopatiju, srčanu aritmiju koja je zahtijevala liječenje, klinički značajnu bolest srčanih zalistaka, loše kontroliranu hipertenziju (hipertenzija kontrolirana standardnim liječenjem smatrala se pogodnom za ispitivanje) i hemodinamički učinkovit perikardijalni izljev bili su isključeni iz ključnih ispitivanja adjuvantnog i neoadjuvantnog liječenja ranog raka dojke trastuzumabom, pa se liječenje za te bolesnike ne može preporučiti.
The results of these simulations indicate that at least 95% of patients will reach concentrations that are <1 µg/mL (approximately 3% of the population predicted Cmin,ss, or about 97% washout) by 7 months. 
Rezultati tih simulacija ukazuju da će najmanje 95% bolesnika postići koncentracije <1 µg/ml (približno 3%
In a method comparison study (study D008548) a high degree of concordance (>95%) was observed for SISH and FISH techniques for the detection of HER2 gene amplification in gastric cancer patients. 
U ispitivanju uspoređivanja metoda (ispitivanje D008548) u bolesnika s rakom želuca ustanovljen je visok stupanj podudarnosti (>95%) SISH i FISH metoda za utvrđivanje genske amplifikacije HER2.
As a result, trastuzumab has been shown, in both in vitro assays and in animals, to inhibit the proliferation of human tumour cells that overexpress HER2. 
Kao rezultat toga, trastuzumab je i u pokusima in vitro i na životinjama inhibirao proliferaciju ljudskih tumorskih stanica koje imaju povećanu ekspresiju
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. 
Kako bi se osigurala primjena validiranih postupaka testiranja i dobivanje točnih i ponovljivih rezultata, ispitivanje HER2 mora provesti laboratorij s primjereno obučenim osobljem.
Do not breast-feed your baby during Ontruzant therapy and for 7 months after the last dose of Ontruzant as Ontruzant may pass to your baby through your breast milk. 
Nemojte dojiti dijete za vrijeme terapije lijekom Ontruzant ni 7 mjeseci nakon posljednje doze lijeka jer se Ontruzant preko mlijeka može prenijeti na dijete.
However, the majority of infusion-related reactions are mild to moderate in intensity (NCI-CTC grading system) and tend to occur earlier in treatment, i.e. during infusions one, two and three and lessen in frequency in subsequent infusions. 
Međutim, većina reakcija povezanih s infuzijom blagog je do umjerenog intenziteta (prema NCI-CTC stupnjevanju) i uglavnom se javlja na početku liječenja tj. za vrijeme prve, druge i treće infuzije te im se učestalost smanjuje sa svakom sljedećom infuzijom.
FP +H N=294 HR (95% CI) 
FP +H N=294 HR (95% CI) p-vrijednost
(increased muscle tone or tension) 
• hipertonija (povećani tonus ili napetost mišića)
Ontruzant intravenous infusion should be administered by a health-care provider prepared to manage anaphylaxis and an emergency kit should be available. 
Intravensku infuziju lijeka Ontruzant treba primijeniti zdravstveni radnik obučen za liječenje anafilaksije, a na raspolaganju treba biti oprema za hitne slučajeve.
In study BCIRG 006, 213/1075 patients in the DCarbH (TCH) arm, 221/1074 patients in the AC→DH (AC→TH) arm, and 217/1073 in the AC→D (AC→T) arm had a Karnofsky performance status ≤90 (either 80 or 90). 
U ispitivanju BCIRG 006 je 213/1075 bolesnika u skupini DCarbH (TCH), 221/1074 bolesnika u skupini AC→DH (AC→TH) i 217/1073 bolesnika u skupini AC→D (AC→T) imalo Karnofsky status ≤90 (bilo 80 ili 90).
Patients with EBC should be treated with Ontruzant for 1 year or until disease recurrence, whichever occurs first; extending treatment in EBC beyond one year is not recommended (see section 5.1). 
U bolesnika s ranim rakom dojke liječenje lijekom Ontruzant traje godinu dana ili do povrata bolesti, što god nastupi ranije; ne preporučuje se produljiti liječenje ranog raka dojke dulje od jedne godine (vidjeti dio 5.1).
The efficacy results from study BO18225 are summarized in Table 13: 
Rezultati djelotvornosti dobiveni ispitivanjem BO18225 sažeti su u tablici 13:
Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC03 Ontruzant is a biosimilar medicinal product. 
Farmakoterapijska skupina: antineoplastici, monoklonska protutijela, ATK oznaka: L01XC03
Initial improvement followed by clinical deterioration and delayed reactions with rapid clinical deterioration have also been reported. 
Zabilježeni su i slučajevi kliničkog pogoršanja i odgođenih reakcija s brzim kliničkim pogoršanjem koji su uslijedili nakon početnog poboljšanja.
If you receive Ontruzant 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. 
Ako primate Ontruzant u kombinaciji s nekim drugim lijekom za liječenje raka, poput paklitaksela, docetaksela, inhibitora aromataze, kapecitabina, 5-fluorouracila ili cisplatina, pročitajte upute o lijeku i za te lijekove.
METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use only after reconstitution and dilution. 
NAČIN I PUT(EVI) PRIMJENE LIJEKA Samo za intravensku primjenu nakon rekonstitucije i razrjeđivanja.
This intravenous formulation is not for subcutaneous use and should be given as an intravenous infusion only. 
Ta intravenska formulacija nije namijenjena za potkožnu primjenu i smije se primijeniti isključivo intravenskom infuzijom.
4.1 Therapeutic indications 
4.1 Terapijske indikacije Rak dojke
A minority of patients was tested using fluorescence in-situ hybridisation (FISH). 
Kod manjeg broja bolesnika korištena je metoda fluorescentne in situ hibridizacije (FISH).
In study BO16348, after a median follow-up of 8 years the incidence of severe CHF (NYHA Class III & IV) in the trastuzumab 1-year treatment arm was 0.8%, and the rate of mild symptomatic and asymptomatic left ventricular dysfunction was 4.6%. 
U ispitivanju BO16348, nakon medijana praćenja od 8 godina, incidencija teškog kongestivnog zatajenja srca (NYHA klase III i IV) u skupini liječenoj trastuzumabom 1 godinu iznosila je 0,8%, dok je stopa blage simptomatske i asimptomatske disfunkcije lijeve klijetke iznosila
This translates into an absolute benefit in terms of an 8-year disease free survival rate of 6.4 percentage points in favour of 1-year trastuzumab treatment. 
To ukazuje na apsolutnu povoljnost u smislu 8-godišnjeg preživljenja bez simptoma bolesti s razlikom od 6,4 postotnih bodova u korist skupine liječene 1 godinu trastuzumabom.
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. 
U ključnom ispitivanju docetaksela (100 mg/m2 u jednosatnoj infuziji) u kombinaciji s trastuzumabom ili bez njega, 60% bolesnika prethodno je liječeno antraciklinskom adjuvantnom kemoterapijom.
Pharmacokinetic data from Study H4613g/GO01305 suggested that carboplatin had no impact on the PK of trastuzumab. 
Farmakokinetički podaci iz ispitivanja H4613g/GO01305 ukazali su na to da karboplatin ne utječe na farmakokinetiku trastuzumaba.
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 (see section 2 under “Warnings and precautions”). 
Tijekom primjene prve doze, koju ćete primati u infuziji trajanja 90 minuta, zbog mogućnosti razvoja nuspojava bit ćete pod nadzorom stručne medicinske osobe (pogledajte dio 2 pod "Upozorenja i mjere opreza").
Ontruzant may be prescribed in combination with the chemotherapy medicine paclitaxel or docetaxel as first treatment for metastatic breast cancer or it may be prescribed alone if other treatments have proved unsuccessful. 
Ontruzant može biti propisan u kombinaciji s kemoterapijskim lijekovima paklitakselom ili docetakselom u prvoj liniji liječenja metastatskog raka dojke ili može biti propisan sam ako su se drugi oblici liječenja pokazali neuspješnima.
In the joint analysis of the NSABP B-31 and NCCTG N9831 studies, EBC was limited to women with operable breast cancer at high risk, defined as HER2-positive and axillary lymph node positive or HER2 positive and lymph node negative with high-risk features (tumour size >1 cm and ER negative or tumour size >2 cm, regardless of hormonal status). 
U skupnoj analizi ispitivanja NSABP B-31 i NCCTG N9831, rani rak dojke je bio ograničen isključivo na žene s operabilnim rakom dojke visokog rizika, definiranim kao HER2-pozitivan s pozitivnim aksilarnim limfnim čvorovima ili HER2-pozitivan s negativnim aksilarnim limfnim čvorovima sa značajkama visokog rizika (veličina tumora >1 cm i ER-negativan ili veličina tumora >2 cm, bez obzira na hormonski status).
Trastuzumab is designed to bind selectively to an antigen called human epidermal growth factor receptor 2 (HER2). 
Trastuzumab je napravljen da se selektivno veže na antigen koji se naziva receptor humanog epidermalnog faktora rasta 2 (HER2).
IHC is recommended as the first testing modality and in cases where HER2 gene amplification status is also required, either a silver-enhanced in situ hybridization (SISH) or a FISH technique must be applied. 
IHC se preporučuje kao prvi način testiranja, a u slučajevima kod kojih je potreban i status HER2 genske amplifikacije treba primijeniti ili in situ hibridizaciju srebrom
Risk factors associated with interstitial lung disease include prior or concomitant therapy with other anti-neoplastic therapies known to be associated with it such as taxanes, gemcitabine, vinorelbine and radiation therapy. 
Čimbenici rizika za intersticijsku bolest pluća uključuju prethodnu ili istodobnu terapiju drugim antineoplastičnim lijekovima koje se povezuje s intersticijskom bolesti pluća, kao što su to taksani, gemcitabin, vinorelbin i terapija zračenjem.
This condition may be harmful to your baby in the womb and has been associated with the lungs not developing fully resulting in fetal death. 
Vašem djetetu u maternici i povezuje se sa smrću ploda zbog nepotpunog razvoja pluća.
In the pivotal metastatic trials of intravenous trastuzumab, the incidence of cardiac dysfunction varied between 9% and 12% when it was combined with paclitaxel compared with 1%-4% for paclitaxel alone. 
U ključnim ispitivanjima intravenskog trastuzumaba u metastatskoj bolesti, incidencija disfunkcije srca kretala se između 9% i 12% kod primjene u kombinaciji s paklitakselom, u usporedbi s
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). 
Završna analiza provedena nakon medijana praćenja od 8 godina pokazala je smanjenje rizika od 24% u skupini liječenoj trastuzumabom tijekom 1 godine u usporedbi usporedbi sa samo opservacijom (HR=0,76, 95% CI 0,67; 0,86).
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]. 
U toj završnoj analizi, produljenje liječenja trastuzumabom na dvije godine nije pokazalo dodatne korisne učinke u odnosu na jednogodišnje liječenje [omjer hazarda za preživljenje bez simptoma bolesti (DFS HR) u populaciji koju se namjeravalo liječiti (ITT) tijekom 2 godine naspram 1 godine = 0,99 (95% CI: 0,87; 1,13), p-vrijednost = 0,90 i omjer hazarda za ukupno preživljenje (OS HR) = 0,98 (0,83; 1,15); p-vrijednost = 0,78].
(L/day) 
(l na dan)
Trastuzumab plus docetaxel4 N=110 
Trastuzumab s docetakselom4 N=110
Ontruzant 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. 
Ontruzant je prašak za koncentrat za otopinu za intravensku infuziju, dostupan u staklenoj bočici s gumenim čepom te sadrži ili 150 mg ili 420 mg trastuzumaba.
In the final population PK model, in addition to primary tumour type, body-weight, serum aspartate aminotransferase and albumin were identified as statistically significant covariates affecting the exposure of trastuzumab. 
U konačnom populacijskom farmakokinetičkom modelu, kao statistički značajne kovarijante koje utječu na izloženost trastuzumabu identificirane su, uz primarnu vrstu tumora, i tjelesna težina te razina aspartat aminotransferaze i albumina u serumu.
From a microbiological point of view, the reconstituted solution and Ontruzant infusion solution should be used immediately. 
S mikrobiološkog stajališta, rekonstituiranu otopinu i infuzijsku otopinu lijeka Ontruzant potrebno je odmah primijeniti.
The infusion may be resumed when symptoms abate. 
Infuziju se može nastaviti nakon povlačenja simptoma.
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 je također primjenjivan u kombinaciji s paklitakselom ili docetakselom u liječenju bolesnika koji nisu primali kemoterapiju za metastatsku bolest.
The data suggest that beneficial effects were greater among those patients with higher levels of overexpression of HER2 (3+). 
Podaci upućuju na to da je povoljan učinak bio izraženiji u bolesnika s većim stupnjem povećane ekspresije HER2 (3+).
• abnormally low oxygen levels in the blood 
• akutno sužavanje dišnih puteva • abnormalno niske razine kisika u krvi
1) Using a sterile syringe, slowly inject the appropriate volume (as noted above) of water for injections in the vial containing the lyophilised Ontruzant, directing the stream into the lyophilised cake. 
1) Sterilnom štrcaljkom polako ubrizgajte odgovarajući volumen (kao što je gore navedeno) vode za injekcije u bočicu koja sadrži liofilizirani Ontruzant, usmjeravajući mlaz u liofilizirani kolačić.
Faint ⁄ barely perceptible membranous reactivity in ≥10% of tumour cells; cells are reactive only in part of their membrane 
Vrlo slaba/jedva primjetna membranska reaktivnost u ≥10% tumorskih stanica; stanice su reaktivne samo u dijelu membrane
Mechanism of action Trastuzumab binds with high affinity and specificity to sub-domain IV, a juxta-membrane region of HER2's extracellular domain. 
Trastuzumab se visokim afinitetom i specifičnošću veže za poddomenu IV jukstamembranske regije ekstracelularne domene HER2.
Ontruzant in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease. 
Ontruzant je u kombinaciji s kapecitabinom ili 5-fluorouracilom i cisplatinom indiciran u liječenju odraslih bolesnika s HER2 pozitivnim metastatskim adenokarcinomom želuca ili gastroezofagealnog spoja, koji nisu prethodno primali kemoterapiju za metastatsku bolest.
If the patient has missed a dose of Ontruzant by more than one week, a re-loading dose of Ontruzant should be administered over approximately 90 minutes (weekly regimen: 4 mg/kg; three-weekly regimen: 8 mg/kg) as soon as possible. 
Ako je bolesnik propustio primiti dozu lijeka Ontruzant za više od tjedan dana, potrebno je što prije ponoviti udarnu dozu lijeka Ontruzant u infuziji trajanja približno 90 minuta (tjedni ciklusi: 4 mg/kg; trotjedni ciklusi: 8 mg/kg).
In 3 pivotal clinical trials of adjuvant trastuzumab given in combination with chemotherapy, the incidence of grade 3/4 cardiac dysfunction (specifically symptomatic Congestive Heart Failure) was similar in patients who were administered chemotherapy alone (i.e. did not receive trastuzumab) and in patients who were administered trastuzumab sequentially after a taxane (0.3-0.4%). 
incidencija disfunkcije srca stupnja 3/4 (osobito simptomatsko kongestivno zatajenje srca) bila je slična u bolesnika koji su primili samo kemoterapiju (tj. nisu primili trastuzumab) i u bolesnika koji su primili trastuzumab nakon taksana (0,3-0,4%).
Do not use with glucose-containing solutions. 
Ne smiju se koristiti otopine koje sadrže glukozu.
There were no restrictions on the relative timing of trastuzumab and anastrozole at administration (for dose, see the SmPC for anastrozole or other aromatase inhibitors). 
Nije bilo ograničenja u odnosu na vrijeme primjene trastuzumaba i anastrozola (za dozu vidjeti Sažetak opisa svojstava lijeka za anastrozol ili ostale inhibitore aromataze).
Ontruzant may have a minor influence on the ability to drive or use machines (see section 4.8). 
4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Ontruzant može imati manji utjecaj na sposobnost upravljanja vozilima i rada sa strojevima (vidjeti dio 4.8).
Only patients with a large amount of HER2 will be treated with Ontruzant. 
Lijekom Ontruzant će biti liječeni samo bolesnici s visokom razinom HER2.
The efficacy of trastuzumab in combination with paclitaxel in patients who did not receive prior adjuvant anthracyclines has not been studied. 
Nije ispitana djelotvornost trastuzumaba u kombinaciji s paklitakselom u bolesnika koji prethodno nisu primili adjuvantnu terapiju antraciklinima.
The extracellular domain of the receptor (ECD, p105) can be shed into the blood stream and measured in serum samples. 
p105) može se otpustiti u krvotok i mjeriti u uzorcima seruma.
More patients treated with trastuzumab and paclitaxel progressed in the central nervous system than those treated with paclitaxel alone (12.6% versus 6.5%; p=0.377). 
Pojava metastaza u središnjem živčanom sustavu bila je češća u bolesnica liječenih trastuzumabom i paklitakselom u odnosu na one liječene samo paklitakselom (12,6% naspram 6,5%; p=0,377).
Paclitaxel2 N=77 
Paklitaksel2 N=77
Patients who had previously received anthracycline-based adjuvant chemotherapy were treated with paclitaxel (175 mg/m2 infused over 3 hours) with or without trastuzumab. 
Bolesnici koji su prethodno primali antraciklinsku adjuvantnu kemoterapiju liječeni su paklitakselom (175 mg/m² u trosatnoj infuziji) u kombinaciji s trastuzumabom ili bez njega.
Patients classified as staining 2+ or 3+ were included, while those staining 0 or 1+ were excluded. 
Bolesnici s tumorima intenziteta obojenja od 2+ do 3+ uključeni su u ispitivanje, a oni s 0 do 1+ nisu.
If symptomatic cardiac failure develops during trastuzumab therapy, it should be treated with standard medicinal products for CHF. 
Ako se tijekom terapije trastuzumabom razvije simptomatsko zatajenje srca, potrebno je primijeniti standardne lijekove za kongestivno zatajenje srca.
Studies of HER2-positivity rates in gastric cancer (GC) using immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) or chromogenic in situ hybridization (CISH) have shown that there is a broad variation of HER2-positivity ranging from 6.8% to 34.0% for IHC and 7.1% to 42.6% for FISH. 
Ispitivanja stupnja ekspresije HER2 u bolesnika s rakom želuca uporabom imunohistokemije (IHC) i fluorescentne in situ hibridizacije (FISH) ili kromogene in situ hibridizacije (CISH) pokazala su veliku varijabilnost ekspresije HER2 u rasponu od 6,8% do 34,0% kod IHC-a i od
For instructions on reconstitution of Ontruzant intravenous formulation before administration, see section 6.6. 
Za upute o rekonstituciji intravenske formulacije lijeka Ontruzant prije primjene vidjeti dio 6.6. 4.3 Kontraindikacije
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. 
U tjednim ciklusima (početna udarna doza od 4 mg/kg nakon koje se nastavlja dozom od 2 mg/kg svakog tjedna) primjenjuje se istodobno s paklitakselom nakon kemoterapije doksorubicinom i ciklofosfamidom.
Most patients who developed CHF or asymptomatic cardiac dysfunction in pivotal trials improved with standard CHF treatment consisting of an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) and a beta-blocker. 
U većine bolesnika u ključnim kliničkim ispitivanjima u kojih se razvilo kongestivno zatajenje srca ili asimptomatska disfunkcija srca, stanje se poboljšalo primjenom standardnog liječenja kongestivnog zatajenja srca inhibitorom angiotenzin-konvertirajućeg enzima (ACE inhibitorom) ili blokatorom angiotenzinskih receptora i beta-blokatorom.
In the neoadjuvant setting, the experience of concurrent administration of trastuzumab and low-dose anthracycline regimen is limited (see section 4.4). 
U neoadjuvantnom liječenju, iskustvo s istodobnom primjenom trastuzumaba i niske doze antraciklina je ograničeno (vidjeti dio 4.4).
- capecitabine - 1000 mg/m2 orally twice daily for 14 days every 3 weeks for 6 cycles (evening of day 1 to morning of day 15 of each cycle) 
- kapecitabin - 1000 mg/m² peroralno, dvaput dnevno tijekom 14 dana, svaka 3 tjedna u 6 ciklusa (od večeri 1. dana do jutra 15. dana svakog ciklusa)
In the pivotal trial MO16432, trastuzumab was administered concurrently with neoadjuvant chemotherapy containing three cycles of doxorubicin (cumulative dose 180 mg/m2). 
U tom ključnom kliničkom ispitivanju MO16432, trastuzumab se primjenjivao istodobno s neoadjuvantnom kemoterapijom koja se sastojala od tri ciklusa doksorubicina (kumulativna doza 180 mg/m2).
Patients with HER2+ tumours were randomised to receive either neoadjuvant chemotherapy concurrently with neoadjuvant-adjuvant trastuzumab, or neoadjuvant chemotherapy alone. 
Bolesnici s HER2+ tumorima randomizirani su da primaju bilo neoadjuvantnu kemoterapiju istodobno s neoadjuvantnim-adjuvantnim trastuzumabom ili samo neoadjuvantnu kemoterapiju.
In the post-marketing setting, cases of fetal renal growth and/or function impairment in association with oligohydramnios, some associated with fatal pulmonary hypoplasia of the fetus, have been reported in pregnant women receiving trastuzumab. 
U razdoblju nakon stavljanja lijeka u promet, u trudnica koje su primale trastuzumab prijavljeni su slučajevi narušenog rasta i/ili funkcije bubrega kod fetusa povezani s oligohidramnionom, od kojih su neki bili povezani sa smrtonosnom plućnom hipoplazijom u fetusa.
Administration in combination with an aromatase inhibitor In the pivotal trial (BO16216) trastuzumab and anastrozole were administered from day 1. 
U ključnom kliničkom ispitivanju (BO16216) trastuzumab i anastrozol primjenjivani su od prvoga dana.