natgillin/translations-raw huggingface dataset:
The efficacy results from Study MO16432 are summarized in Table 12. 
Rezultati učinkovitosti iz študije MO16432 so povzeti v preglednici 12.
These are very common (may affect more than 1 in 10 people). 
Ti so zelo pogosti (lahko se pojavijo pri več kot 1 od 10 bolnikov).
(day) 
(dni)
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).
Docetaxel3 N=94 
Docetaksel3 N = 94
If you experience any of the above symptoms when your treatment with Ontruzant has finished, you should see your doctor and tell them that you have previously been treated with Ontruzant. 
Če se kateri koli od zgornjih simptomov pojavi po končanem zdravljenju z zdravilom Ontruzant, obiščite zdravnika in ga obvestite o tem, da ste se zdravili z zdravilom Ontruzant.
The efficacy results from study BO18225 are summarized in Table 13: 
Rezultati učinkovitosti iz študije BO18225 so povzeti v preglednici 13:
• insomnia (inability to sleep) 
• nespečnost (nezmožnost spati),
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. 
Da bodo zagotovljeni validacija postopkov testiranja in natančni in reproducibilni rezultati testiranja, mora testiranje HER2 opravljati laboratorij, v katerem je zaposleno kvalificirano osebje.
2) Swirl the vial gently to aid reconstitution. 
2) Nežno vrtite vialo, da pospešite rekonstitucijo.
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. 
Če prejemate zdravilo Ontruzant z drugimi zdravili za zdravljenje raka, kot so paklitaksel, docetaksel, zaviralec aromataze, kapecitabin, 5-fluorouracil ali cisplatin, preberite tudi navodila za uporabo, ki so priložena tem zdravilom.
Like all medicines, Ontruzant can cause side effects, although not everybody gets them. 
Kot vsa zdravila ima lahko tudi zdravilo Ontruzant neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Do not use Ontruzant if you notice any particulate matter or discoloration prior to administration. 
Ne uporabljajte zdravila Ontruzant, če pred uporabo opazite kakšne delce ali obarvanost.
Study H0649g: IHC3+ patient subset 
Študija H0649g: podskupina bolnikov z IHC3+
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 z napredovalim rakom želodca, v kateri so proučevali farmakokinetiko kapecitabina in cisplatina s trastuzumabom ali brez njega.
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). 
Končna analiza, ki so jo opravili po medianem spremljanju 8 let, je pokazala, da je enoletno zdravljenje s trastuzumabom povezano s 24-odstotnim zmanjšanjem tveganja v primerjavi samo z opazovanjem (HR = 0,76, 95 % IZ 0,67, 0,86).
In order to prevent medication errors it is important to check the vial labels to ensure that the medicine being prepared and given is Ontruzant (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 Ontruzant (trastuzumab) in ne trastuzumab emtanzin.
Study H0648g: IHC3+ patient subset 
Študija H0648g: podskupina bolnikov z IHC3+
• You have metastatic gastric cancer with high levels of HER2, when it is in combination with the other cancer medicines capecitabine or 5-flououracil and cisplatin. 
• imate metastatskega raka želodca, pri katerem so izražene velike količine HER2, v kombinaciji z drugimi zdravili za zdravljenje raka, kapecitabinom ali 5-flououracilom in cisplatinom.
If anthracyclines are used, the patient's cardiac function should be monitored carefully. 
Če bolnika zdravimo z antraciklini, je treba skrbno spremljati delovanje srca.
• blood infection 
• okužba krvi.
• Hypersensitivity to trastuzumab, murine proteins, or to any of the excipients listed in section 6.1 
• Preobčutljivost na trastuzumab, murine (mišje) beljakovine ali katero koli pomožno snov, navedeno v poglavju 6.1.
Although there are some limitations when using Cairo-Bishop criteria for diagnosis leading to underestimation of the number of cases, the update of the Product Information to include TLS with a frequency unknown is endorsed, because trastuzumab is a potent mediator of antibody-dependent cell-mediated cytotoxicity (ADCC). 
Čeprav so ob uporabi Cairo-Bishopovih meril za diagnozo prisotne nekatere omejitve, ki vodijo v podcenitev števila primerov, je smiselna posodobitev Informacij o zdravilu, v katere je treba vključiti sindrom razpada tumorja z neznano pogostnostjo, ker je trastuzumab močan mediator citotoksičnosti, povzročene s celicami, odvisnimi od protiteles (antibody-dependent cell-mediated cytotoxicity ADCC).
The reconstituted Ontruzant results in a colourless to pale yellow transparent solution and should be essentially free of visible particulates. 
Rekonstituirano zdravilo Ontruzant je brezbarvna do rahlo rumena prozorna tekočina in mora biti praviloma brez vidnih delcev.
Patients treated with trastuzumab are at increased risk for developing CHF (New York Heart Association [NYHA] Class II-IV) or asymptomatic cardiac dysfunction. 
Pri bolnikih, zdravljenih s trastuzumabom, obstaja večje tveganje za pojav kongestivnega srčnega popuščanja (New York Heart Association [NYHA], razred II-IV) ali asimptomatične motnje v delovanju srca.
During an Ontruzant infusion, chills, fever and other flu like symptoms may occur. 
Med infuzijo zdravila Ontruzant se lahko pojavijo mrzlica, zvišana telesna temperatura in drugi simptomi, podobni gripi.
FP +H N=294 HR (95% CI) 
FP +H N = 294 HR (95 % IZ) vrednost p
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. 
Študije pogostnosti pozitivnosti HER2 pri raku želodca (RŽ) z imunohistokemijo (immunohistochemistry - IHC) in fluorescenčno hibridizacijo in situ (fluorescence in situ hybridization - FISH) ali kromogeno hibridizacijo in situ (chromogenic in situ hybridization - CISH) so pokazale, da se pozitivnost HER2 razlikuje v širokem obsegu, ki sega od 6,8 % do 34,0 % pri IHC in 7,1 % do 42,6 % pri FISH.
Amongst the most serious and/or common adverse reactions reported in Ontruzant usage to date are cardiac dysfunction, infusion-related reactions, haematotoxicity (in particular neutropenia), infections and pulmonary adverse reactions. 
Med najresnejšimi in/ali pogostimi neželenimi učinki, o katerih so poročali pri uporabi zdravila Ontruzant, so motnje v delovanju srca, reakcije, povezane z infuzijo, hematotoksičnost (še posebno nevtropenija), okužbe in pljučni neželeni učinki.
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 večjim kumulativnim odmerkom antraciklina, ki so ga dajali pred uvedbo trastuzumaba, in velikim indeksom telesne mase (body mass index - BMI) > 25 kg/m2.
Duration of response, median months 
Trajanje odziva, mediano število mesecev
The risk of neutropenia may be slightly increased when trastuzumab is administered with docetaxel following anthracycline therapy. 
Tveganje za nevtropenijo se lahko rahlo zveča, kadar dajemo trastuzumab z docetakselom po antraciklinski terapiji.
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. 
Dejavniki tveganja, povezani z intersticijsko boleznijo pljuč, vključujejo predhodno ali sočasno zdravljenje z drugimi načini zdravljenja raka, za katere je znano, da so z njo povezani, na primer s taksani, gemcitabinom, vinorelbinom in zdravljenje z obsevanjem.
Overall response rate,% 
mediano število mesecev Celotna odzivnost, %
Other side effects can occur at any time during treatment with Ontruzant, not just related to an infusion. 
Drugi neželeni učinki lahko nastopijo kadar koli med zdravljenjem z zdravilom Ontruzant in niso povezani le z infuzijo.
The CHMP recommends that the terms of the Marketing Authorisation(s) should be varied. 
Odbor CHMP zato priporoča spremembo pogojev dovoljenja za promet z zdravilom.
in combination with neoadjuvant chemotherapy followed by adjuvant Ontruzant therapy, for locally advanced (including inflammatory) disease or tumours >2 cm in diameter (see sections 4.4 and 5.1). 
v kombinaciji z neoadjuvantno kemoterapijo, čemur sledi adjuvantno zdravljenje z zdravilom Ontruzant, za lokalno napredovalo (tudi vnetno) bolezen ali tumorje > 2 cm v premeru (glejte poglavji 4.4 in 5.1).
• altered taste 
• spremenjeno okušanje,
Only patients with a large amount of HER2 will be treated with Ontruzant. 
Z zdravilom Ontruzant bodo zdravili samo bolnike z veliko količino HER2.
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). 
Pogostnost asimptomatskih motenj v delovanju srca je bila večja v skupini z dveletnim zdravljenjem (8,1 % proti 4,6 % v skupini z enoletnim zdravljenjem).
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 kot bolniki, katerih tumorji HER2 ne izražajo čezmerno.
Patients who had previously received anthracycline-based adjuvant chemotherapy were treated with paclitaxel (175 mg/m2 infused over 3 hours) with or without trastuzumab. 
Bolnike, ki so predhodno prejemali adjuvantno kemoterapijo na podlagi antraciklinov, so zdravili s paklitakselom samim (175 mg/m2, infundiranih v času 3 ur) ali skupaj s trastuzumabom.
There are no immunogenicity data available for trastuzumab in gastric cancer. 
Za trastuzumab pri raku želodca ni na voljo podatkov o imunogenosti.
Trastuzumab plus docetaxel4 N=110 
Trastuzumab in docetaksel4 N = 110
Do not use this medicine after the expiry date which is stated on the outer carton and on the vial label after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in etiketi viale poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
The median overall survival was extended by 4.6 months for patients in the combination arm. 
Mediano celotno preživetje je bilo pri bolnicah, ki so jemale kombinacijo zdravil, daljše za 4,6 meseca.
MBC and EBC patients had similar PK parameters (e.g. clearance (CL), the central compartment volume (Vc)) and population-predicted steady-state exposures (Cmin, Cmax and AUC). 
Bolniki z MBC in EBC so imeli podobne farmakokinetične parametre (npr. očistek (CL), volumen centralnega prostora (Vc)) in izpostavljenosti v stanju dinamičnega ravnovesja (Cmin, Cmax in AUC), predvidene za populacijo.
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 v teh preskušanjih pojavile motnje v delovanju srca, je prišlo do izboljšanja po standardnem zdravljenju za kongestivno srčno popuščanje.
• swelling of the face, lips and throat 
• otekanje obraza, ustnic in žrela,
1Blood pressure decreased 
1znižan krvni tlak
• depression 
• depresija,
Ejection fraction decreased* 
1atrijska undulacija zmanjšan iztisni delež*
Treatment with AC→PH resulted in a statistically significant improvement in OS compared with AC→P (stratified HR=0.64; 95% CI [0.55, 0.74]; log-rank p-value <0.0001). 
Zdravljenje z AC→PH je statistično značilno izboljšalo OS v primerjavi z AC→P (stratificirano HR = 0,64; 95 % IZ [0,55, 0,74]; vrednost p log-rank < 0,0001).
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Samsung Bioepis NL B.V. 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Samsung Bioepis NL B.V.
Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC03 Ontruzant is a biosimilar medicinal product. 
Farmakoterapevtska skupina: Zdravila z delovanjem na novotvorbe (citostatiki), monoklonska protitelesa, oznaka ATC: L01XC03.
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. 
Če je bolnik izpustil/-a odmerek zdravila Ontruzant za več kot en teden, mu je treba čim prej dati ponoven polnilni odmerek zdravila Ontruzant v približno 90 minutah (tedenski režim: 4 mg/kg; 3-tedenski režim: 8 mg/kg).
All candidates for treatment with trastuzumab, but especially those with prior anthracycline and cyclophosphamide (AC) exposure, should undergo baseline cardiac assessment including history and physical examination, electrocardiogram (ECG), echocardiogram, and/or multigated acquisition (MUGA) scan or magnetic resonance imaging. 
Vsi kandidati za zdravljenje s trastuzumabom, posebno tisti, ki so se predhodno zdravili z antraciklini in ciklofosfamidom (AC), morajo opraviti osnovni pregled srca, vključno z anamnezo in fizikalnim pregledom, elektrokardiogramom (EKG), ehokardiogramom in/ali radioizotopsko ventrikulografijo (multigated acquisition scan - MUGA) ali magnetnoresonančnim slikanjem.
If LVEF percentage drops ≥10 points from baseline AND to below 50%, treatment should be suspended and a repeat LVEF assessment performed within approximately 3 weeks. 
Če odstotek LVEF pade za ≥ 10 točk od začetne vrednosti IN pod 50 %, zdravljenje prekinemo in ponovno opravimo meritev LVEF v približno treh tednih.
Trastuzumab is designed to bind selectively to an antigen called human epidermal growth factor receptor 2 (HER2). 
Trastuzumab je oblikovan tako, da se selektivno veže na antigen, ki se imenuje humani receptor za epidermalni rastni faktor 2 (HER2).
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. 
Mediano trajanje spremljanja je bilo 2,9 leta v skupini AC→D in 3,0 leta v vsaki od skupin AC→DH in DCarbH.
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 the 24.8% patients in the AC→P arm who crossed over to receive trastuzumab. 
Posodobljeni rezultati analize DFS (stratificirano HR = 0,61; 95 % IZ [0,54, 0,69]) so pokazali podobno korist za DFS kot končna primarna analiza DFS, kljub 24,8 % bolnikov v skupini AC→P, ki so prešli na prejemanje trastuzumaba.
No reactivity or membranous reactivity in any tumour cell 
Brez reaktivnosti ali membranska reaktivnost v kateri koli tumorski celici.
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%). 
V treh ključnih kliničnih preskušanjih pri adjuvantnem zdravljenju zgodnjega raka dojk s trastuzumabom v kombinaciji s kemoterapijo je bila incidenca motenj v delovanju srca stopnje 3/4 (še posebno simptomatskega kongestivnega srčnega popuščanja) podobna pri bolnikih, ki so prejeli le kemoterapijo (to je, niso prejeli trastuzumaba), in pri bolnikih, ki so prejeli trastuzumab zaporedno po taksanu (0,3 do 0,4 %).
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA
Pharmacokinetic data from Study H4613g/GO01305 suggested that carboplatin had no impact on the PK of trastuzumab. 
Farmakokinetični podatki iz študije H4613g/GO01305 so nakazali, da karboplatin ni vplival na farmakokinetiko trastuzumaba.
No incompatibilities between Ontruzant and polyvinylchloride, polyethylene or polypropylene bags have been observed. 
Inkompatibilnosti med zdravilom Ontruzant in vrečkami iz polivinilklorida, polietilena ali propilena niso ugotovili.
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). 
V študiji BCIRG 006 je imelo 213/1075 bolnikov v skupini DCarbH (TCH), 221/1074 bolnikov v skupini AC→DH (AC→TH) in 217/1073 bolnikov v skupini AC→D (AC→T) stanje zmogljivosti po Karnofskem ≤ 90 (bodisi 80 ali 90).
Observation N=1693 
Opazovanje N = 1693
Paediatric population There is no relevant use of Ontruzant in the paediatric population. 
Zdravilo Ontruzant ni namenjeno za uporabo pri pediatrični populaciji.
• abnormal thinking 
• nenormalno mišljenje,
• somnolence (sleepiness) 
• somnolenca (zaspanost),
Ontruzant may affect your ability to drive a car or operate machines. 
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Ontruzant lahko vpliva na vašo sposobnost za vožnjo ali upravljanje strojev.
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. 
Zdravilo Ontruzant vam zdravnik lahko predpiše skupaj s kemoterapevtskim zdravilom paklitakselom ali docetakselom kot zdravilo prve izbire za metastatskega raka dojk ali pa ga lahko predpiše samega, če so se druga zdravljenja izkazala za neuspešna.
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%). 
Najpogostejše so bile motnje v delovanju srca pri bolnikih, ki so prejemali trastuzumab sočasno z antraciklinom/ciklofosfamidom (27 %); ta je bila značilno večja kot pri jemanju samo antraciklina/ciklofosfamida (7 %-10 %).
It is also used in combination with medicines called aromatase inhibitors with patients with high levels of HER2 and hormone receptor-positive metastatic breast cancer (cancer that is sensitive to the presence of female sex hormones). 
Uporablja se tudi v kombinaciji z zdravili, ki se imenujejo zaviralci aromataze, za zdravljenje bolnikov z metastatsko obliko raka dojk z velikimi količinami HER2 in pozitivnimi hormonskimi receptorji (to pomeni, da je tumor občutljiv na prisotnost ženskih spolnih hormonov);
Some of the side effects you experience may be due to your underlying cancer. 
Nekatere od teh neželenih učinkov, ki jih opazite, lahko povzroča vaša bolezen - rak.
Neutralizing anti-trastuzumab antibodies were detected in post-baseline samples in 2 of 30 patients in the trastuzumab intravenous arm. 
Nevtralizirajoča protitelesa proti trastuzumabu so odkrili v 2 od 30 vzorcev, odvzetih po začetku zdravljenja pri bolnikih iz skupine, ki je prejemala intravenski trastuzumab.
In general, FISH is considered positive if the ratio of the HER2 gene copy number per tumour cell to the chromosome 17 copy number is greater than or equal to 2, or if there are more than 4 copies of the HER2 gene per tumour cell if no chromosome 17 control is used. 
V splošnem velja, da je rezultat metode FISH pozitiven, če je razmerje med številom kopij gena HER2 na tumorsko celico in številom kopij kromosoma 17 enako ali večje od 2, ali je število kopij gena HER2 na tumorsko celico večje od 4, če ne uporabimo preverjanja s kromosomom 17.
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. 
Med zdravljenjem z zdravilom Ontruzant in še 7 mesecev po zadnjem odmerku zdravila Ontruzant ne smete dojiti, ker lahko zdravilo Ontruzant z vašim mlekom prehaja v otroka.
Ontruzant intravenous infusion should be administered by a health-care provider prepared to manage anaphylaxis and an emergency kit should be available. 
Intravensko infuzijo zdravila Ontruzant mora dajati zdravstveno osebje, usposobljeno za ukrepanje ob anafilaksiji; na voljo mora biti oprema za urgentno ukrepanje.
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 se izraža kot absolutna korist enoletnega zdravljenja s trastuzumabom v smislu 8-letnega preživetja brez bolezni za 6,4 odstotne točke.
More patients experienced at least one grade 3 or 4 adverse event in the 2-year treatment arm (20.4%) compared with the 1-year treatment arm (16.3%). 
V skupini z dveletnim zdravljenjem je več bolnikov opazilo vsaj en neželeni učinek stopnje 3 ali 4 (20,4 %) kot v skupini z enoletnim zdravljenjem (16,3 %).
following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel. 
po adjuvantni kemoterapiji z doksorubicinom in ciklofosfamidom, v kombinaciji s paklitakselom ali docetakselom;
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). 
V združeni analizi študij NSABP B-31 in NCCTG N9831 je bil zgodnji rak dojk omejen na ženske z operabilnim rakom dojke z velikim tveganjem, opredeljenim kot HER2-pozitivna oblika s pozitivnimi aksilarnimi bezgavkami ali HER2-pozitivna oblika z negativnimi aksilarnimi bezgavkami z dejavniki velikega tveganja (velikost tumorja > 1 cm in ER negativni ali velikost tumorja > 2 cm, ne glede na hormonski status).
in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable. 
v kombinaciji s paklitakselom za zdravljenje tistih bolnikov, ki še niso prejemali kemoterapije za svojo metastatsko bolezen in za katere antraciklini niso primerni;
These events have occasionally been fatal. 
Ti dogodki so se včasih končali s smrtjo bolnika.
If the initial loading dose was well tolerated, the subsequent doses can be administered as a 30-minute infusion. 
Če je bolnik začetni polnilni odmerek dobro prenesel, lahko nadaljnje odmerke dajemo kot 30-minutne infuzije.
Table 9 Overview of efficacy analyses BCIRG 006 AC→D versus AC→DH 
Pregled analiz učinkovitosti BCIRG 006 AC→D proti AC→DH
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 Ontruzant. 
redkih primerih so pri nosečnicah, ki so prejemale zdravilo Ontrutant, opazili zmanjšanje količine amnijske tekočine (plodovnice), ki obdaja razvijajočega se otroka v maternici.