natgillin/translations-raw huggingface dataset:
Patients may continue therapy during periods of reversible chemotherapy-induced myelosuppression but they should be monitored carefully for complications of neutropenia during this time. 
Bolniki lahko med obdobji reverzibilne mielosupresije, povzročene s kemoterapijo, nadaljujejo z zdravljenjem, vendar jih je v tem času treba skrbno spremljati zaradi zapletov, ki jih lahko povzroči nevtropenija.
Treatment with Perjeta may affect the heart. 
Zdravljenje z zdravilom Perjeta lahko vpliva na srce.
In the analyses of patient-reported outcomes, a 10-point difference was considered clinically meaningful. 
V analizah rezultatov samoocene bolnikov je kot klinično pomembna veljala razlika 10 točk.
If it has been 6 weeks or more since your last visit a higher Perjeta dose of 840 mg will be given to you. 
Če je od vašega zadnjega obiska minilo 6 tednov ali več, boste prejeli večji odmerek
Duration of Response †^ n= 
Trajanje odgovora †^
Patients should be observed closely for hypersensitivity reactions. 
Bolnike je treba skrbno opazovati glede preobčutljivostnih reakcij.
Perjeta may harm the unborn baby. 
Zdravilo Perjeta lahko škoduje nerojenemu otroku.
It is supplied in a glass vial containing 14 ml concentrate. 
Na voljo je v stekleni viali, ki vsebuje 14 ml koncentrata.
Medical review of these 15 reports showed that in 8/15 cases, the reported events were not indicative of IRR/hypersensitivity/anaphylaxis. 
Medicinski pregled teh 15 poročil je pokazal, da v 8/15 primerov poročani dogodki niso nakazovali na infuzijsko reakcijo/preobčutljivost/anafilaksijo.
4. p-value from Cochran-Mantel-Haenszel test, with Simes multiplicity adjustment. 
Vrednost p iz Cochran-Mantel-Haenszelovega testa s Simesovo korekcijo za večkratne primerjave.
Perjeta will be given to you by a doctor or nurse in a hospital or clinic. 
Zdravilo Perjeta vam bo dal zdravnik ali medicinska sestra v bolnišnici ali ambulanti.
A decrease in the number or low amount of white blood cells (shown in a blood test), with or without fever, which may increase the risk of an infection. 
• zmanjšanje števila ali majhno količino belih krvnih celic (to pokaže preiskava krvi) z zvišano telesno temperaturo ali brez nje, kar lahko poveča tveganje za okužbo;
Demographics were well balanced between the two treatment arms. 
Demografske značilnosti so bile med terapevtskima skupinama dobro uravnotežene.
The incidence of left ventricular dysfunction and cardiac failure congestive reflect the MedDRA Preferred Terms reported in the individual studies. 
Incidenca disfunkcije levega ventrikla in kongestivnega srčnega popuščanja odraža preferenčne izraze po MedDRA, o katerih so poročali pri posameznih študijah.
The final analysis of OS was performed when 389 patients had died (221 in the placebo-treated group and 168 in the Perjeta-treated group). 
Končna analiza celokupnega preživetja je bila izvedena, ko je umrlo 389 bolnikov (221 v skupini, ki je prejemala placebo, in 168 v skupini, ki je prejemala zdravilo Perjeta).
The indication in the neoadjuvant treatment of breast cancer is based on demonstration of an improvement in pathological complete response rate, and trends to improvement in disease-free survival that nevertheless do not establish or precisely measure a benefit with regard to long-term outcomes, such as overall survival or disease-free survival. 
Indikacija za neoadjuvantno zdravljenje raka dojk temelji na dokazanem izboljšanju deleža patološkega popolnega odgovora in težnjah k izboljšanju preživetja brez bolezni, ki pa ne dokazujejo ali natančno merijo koristi glede na dolgoročne izide, kot sta celokupno preživetje ali preživetje brez bolezni.
If you are allergic to pertuzumab, or to any of the other ingredients of this medicine (listed in section 6). 
• če ste alergični na pertuzumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
For instructions on dilution of Perjeta prior to administration, see sections 6.2 and 6.6. 
Za navodila o razredčenju zdravila Perjeta pred uporabo glejte poglavji 6.2 in 6.6.
If a significant infusion reaction occurs, the infusion should be slowed down or interrupted and appropriate medical therapies should be administered. 
Če se pojavi pomembna infuzijska reakcija, je treba hitrost infuzije zmanjšati ali jo prekiniti in uporabiti ustrezna zdravila.
The diarrhoea was managed (with the exception of euthanasia of one animal, 50 mg/kg/dose) with supportive care including intravenous fluid replacement therapy. 
Drisko so obvladali (razen pri eni živali, ki je prejela evtanazijo, odmerek 50 mg/kg) s podpornimi zdravili, vključno z intravenskim nadomeščanjem tekočine.
Secondary efficacy endpoints were overall survival (OS), PFS (investigator-assessed), objective response rate (ORR), duration of response, and time to symptom progression according to the FACT B Quality of Life questionnaire. 
Sekundarni cilji učinkovitosti so bili celokupno preživetje (OS - overall survival), PFS (ocenjeno s strani raziskovalca), delež objektivnega odgovora (ORR - objective response rate), trajanje odgovora in čas do napredovanja simptomov glede na Vprašalnik o kakovosti življenja FACT B.
*** Patients with best overall response of confirmed CR or PR by RECIST. 
*** Bolniki z najboljšim celokupnim odgovorom ali potrjenim CR ali PR po RECIST.
Left ventricular dysfunction (including congestive heart failure) 
Disfunkcija levega prekata (vključno s kongestivnim srčnim popuščanjem)
* ADRs with a fatal outcome have been reported. 
* Poročali so o neželenih učinkih s smrtnim izidom.
All analyses stratified by nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen. 
Vse analize so bile stratificirane po stanju bezgavk, verziji protokola, stanju centralnih hormonskih receptorjev in shemi adjuvantne kemoterapije.
Because human IgG is secreted in human milk and the potential for absorption and harm to the infant is unknown, a decision should be made to discontinue breast-feeding or to discontinue treatment, taking into account the benefit of breast-feeding for the child and the benefit of Perjeta therapy for the woman (see section 5.2). 
Ker se protitelesa IgG pri ljudeh izločajo v materino mleko in možnost absorpcije ter škodljivih vplivov na dojene otroke ni znana, se je treba odločiti med prenehanjem dojenja ali prenehanjem zdravljenja, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja z zdravilom Perjeta za mater (glejte poglavje 5.2).
Do not use this medicine if you notice any particles in the liquid or it is the wrong colour (please see section 6). 
• Ne uporabljajte tega zdravila, če opazite v tekočini kakšne delce ali če je tekočina spremenjene barve (glejte poglavje 6).
The majority of the reported events were Grade 1 or 2 
Večina zabeleženih dogodkov je bila 1. ali 2. stopnje.
BO17929 was a phase II, non-randomised study in patients with metastatic breast cancer whose tumours had progressed during treatment with trastuzumab. 
Študija BO17929 je bila nerandomizirana študija faze II pri bolnikih z metastatskim rakom dojk, katerih tumorji so napredovali med zdravljenjem s trastuzumabom.
A statistically significant improvement in IRF-assessed PFS was demonstrated in the Perjeta-treated group compared with the placebo-treated group. 
Statistično značilno izboljšanje PFS po oceni IRF je bilo dokazano v skupini, zdravljeni z zdravilom Perjeta, v primerjavi s skupino, zdravljeno s placebom.
The majority of patients had node-positive (63%) and/or hormone receptor-positive disease (64%), and were Caucasian (71%). 
Večina bolnikov je imela bolezen s pozitivnimi bezgavkami (63 %) in/ali pozitivnimi hormonskimi receptorji (64 %) ter so bili belci (71 %).
Patients experiencing infusion reactions should be advised not to drive and use machines until symptoms abate. 
Bolnikom, pri katerih se pojavi infuzijska reakcija, je treba svetovati, naj ne vozijo ali upravljajo strojev, dokler simptomi infuzijske reakcije ne izzvenijo.
Adjuvant Treatment 
Adjuvantno zdravljenje
You will also be given trastuzumab and chemotherapy. 
• Dobili boste tudi trastuzumab in kemoterapijo.
Perjeta and trastuzumab should be administered sequentially and not mixed in the same infusion bag. 
Zdravilo Perjeta in trastuzumab je treba dati zaporedoma in se ju ne sme mešati v isti infuzijski vrečki.
If you experience any of the above symptoms after treatment with Perjeta has been stopped, you should consult your doctor immediately and inform him or her that you have previously been treated with Perjeta. 
Če se vam kateri od omenjenih simptomov pojavi po koncu zdravljenja z zdravilom Perjeta, se morate takoj posvetovati z zdravnikom in ga obvestiti, da ste pred tem dobivali zdravilo Perjeta.
Immune system disorders Infusion reaction°°, * Hypersensitivity°, * 
Bolezni imunskega sistema infuzijska reakcija°°, * preobčutljivost°, *
In neoadjuvant and adjuvant trials, Perjeta was administered on the same day as other study treatments in all cycles. 
V preskušanjih neoadjuvantnega in adjuvantnega zdravljenja so zdravilo Perjeta dajali isti dan kot druga študijska zdravljenja v vseh ciklih.
Infusion reactions occurred in 18.6% - 25.0% of patients on the first day of Perjeta administration (in combination with trastuzumab and chemotherapy). 
Infuzijske reakcije so se pojavile pri 18,6-25,0 % bolnikov prvi dan aplikacije zdravila Perjeta (v kombinaciji s trastuzumabom in kemoterapijo).
Prespecified subgroup analyses without adjusting for multiple comparisons, therefore, results are considered descriptive. 
Stanje hormonskih receptorjev negativno pozitivno Analize vnaprej opredeljenih podskupin brez prilagoditve za večkratne primerjave; rezultati se zato štejejo kot opisni.
Do not throw away any medicines via wastewater or household waste. 
• Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
As a result, pertuzumab inhibits ligand-initiated intracellular signalling through two major signal pathways, mitogen-activated protein (MAP) kinase and phosphoinositide 3-kinase (PI3K). 
Posledica je, da pertuzumab zavre z ligandom sproženo znotrajcelično signaliziranje po dveh pomembnih signalnih poteh, in sicer prek z mitogenom aktivirane protein (MAP) kinaze in fosfoinozitidne 3-kinaze (PI3K).
Table 4 NEOSPHERE (WO20697) and TRYPHAENA (BO22280): Overview of efficacy (Intent to Treat Population) 
NEOSPHERE (WO20697) in TRYPHAENA (BO22280): Pregled učinkovitosti (populacija z namenom zdravljenja)
A total of 43% of patients in both treatment groups had previously received radiotherapy. 
Skupno 43 % bolnikov iz obeh skupin je bilo predhodno zdravljenih z obsevanjem.
Common (≥ 1/100 to < 1/10) Uncommon( ≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (< 1/10,000) 
zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000), neznana pogostnost (ni je mogoče oceniti iz razpoložljivih podatkov).
If you forget or miss your appointment to receive Perjeta make another appointment as soon as possible. 
Če ste pozabili ali zgrešili termin, ob katerem bi morali prejeti zdravilo Perjeta, se čim prej dogovorite za obisk.
Figure 2 Kaplan-Meier Curve of Overall Survival 
Kaplan-Meierjeva krivulja celokupnega preživetja
Diarrhoea is most frequent during concurrent administration with taxane therapy. 
Driska je najpogostejša med sočasnim prejemanjem terapije s taksanom.
Perjeta is not recommended during pregnancy and in women of childbearing potential not using contraception. 
Uporaba zdravila Perjeta med nosečnostjo in pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije, ni priporočljiva.
This absence of drug-drug interaction was confirmed by pharmacokinetic data from the NEOSPHERE and APHINITY studies. 
Odsotnost medsebojnega delovanja med zdravili je bila potrjena s farmakokinetičnimi podatki študij NEOSPHERE in APHINITY.
The amount of medicine you are given and how long the infusion will last are different for the first dose and following doses. 
• Količina zdravila, ki jo boste dobili, in trajanje infuzije se pri prvem in naslednjih odmerkih razlikujeta.
There is very limited data available in patients with unresectable locally recurrent disease. 
Pri bolnikih z neoperabilno lokalno ponovitvijo bolezni je na voljo le zelo malo podatkov.
Perjeta is compatible with polyvinylchloride (PVC) or non-PVC polyolefin bags including polyethylene. 
Zdravilo Perjeta je kompatibilno s polivinilkloridnimi (PVC) ali ne-PVC poliolefinskimi vrečkami,
Patients should be evaluated and carefully monitored until complete resolution of signs and symptoms. 
Bolnike je treba pregledati in jih natančno nadzirati, dokler znaki in simptomi povsem ne izginejo.
Most events were mild to moderate in severity and occurred in the first few cycles of treatment. 
Večina dogodkov je bila blagih do zmernih in se je pojavila v prvih nekaj ciklih zdravljenja.
IDFS including second primary non-breast cancer 
IDFS vključno z drugim primarnim rakom, ki ni bil rak dojk
The efficacy results from the APHINITY trial are summarised in Table 5 and in Figure 3. 
Rezultati učinkovitosti iz preskušanja APHINITY so povzeti v preglednici 5 in na sliki 3.
Limited data are available in patients > 75 years of age. 
Za bolnike, starejše od 75 let, je na voljo le malo podatkov.
In addition, pertuzumab mediates antibody-dependent cell-mediated cytotoxicity (ADCC). 
Poleg tega pertuzumab posreduje od protiteles odvisno, celično posredovano citotoksičnost (ADCC - antibody-dependent cell-mediated cytotoxicity).
In this study, cardiac safety was similar to that observed in patients given the same regimen but with Perjeta administered sequentially (following FEC chemotherapy). 
V tej študiji je bila kardiološka varnost podobna kot pri bolnikih, ki so prejemali enako shemo, le da je bilo zdravilo Perjeta uporabljeno zaporedno (po kemoterapiji FEC).
The population PK analysis suggested no PK differences based on age, gender and ethnicity (Japanese versus non-Japanese). 
Populacijska farmakokinetična analiza ni pokazala farmakokinetičnih razlik glede na starost, spol ali etnično pripadnost (Japonci v primerjavi z nejaponci).
14 ml of Perjeta concentrate should be withdrawn from the vial and diluted into a 250 ml PVC or non-PVC polyolefin infusion bag of sodium chloride 9 mg/ml (0.9%) solution for infusion. 
14 ml koncentrata zdravila Perjeta je treba povleči iz viale in razredčiti v 250-ml PVC ali ne-PVC poliolefinsko infuzijsko vrečko, ki vsebuje 9 mg/ml (0,9-%) raztopino natrijevega klorida za infundiranje.
Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC13 
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe (citostatiki), monoklonska protitelesa, oznaka ATC: L01XC13.
The PK results of pertuzumab in the NEOSPHERE and APHINITY studies were consistent with the predictions from the previous population PK model. 
Farmakokinetični rezultati pertuzumaba v študijah NEOSPHERE in APHINITY so skladni z napovedmi prejšnjega populacijskega farmakokinetičnega modela.
These dose levels resulted in clinically relevant exposures of 2.5 to 20-fold greater than the recommended human dose, based on Cmax. 
S temi odmerki so dosegli klinično pomembno izpostavljenost, ki je bila 2,5 do 20-krat večja kot pri priporočenem odmerku za ljudi (na osnovi Cmax).
Secondary endpoints included the assessment of patient-reported global health status, role and physical function, and treatment symptoms using the EORTC QLQ-C30 and EORTC QLQ-BR23 questionnaires. 
Sekundarni opazovani dogodki so obsegali oceno splošnega zdravstvenega stanja, družbene in družinske vloge, telesne zmožnosti ter simptomov zdravljenja z uporabo vprašalnikov EORTC QLQ-C30 in EORTC QLQ-BR23, ki so jih izpolnjevali bolniki.
• a fixed subcutaneous dose of trastuzumab by injection (600 mg) every 3 weeks irrespective of the patient's body weight. 
• kot fiksni subkutani odmerek, apliciran z injekcijo trastuzumaba (600 mg) vsake 3 tedne ne glede na bolnikovo telesno maso.
The statistically significant OS benefit in favour of the Perjetatreated group, previously observed at an interim analysis of OS (performed one year after the primary analysis), was maintained (HR 0.68, p = 0.0002 log-rank test). 
Statistično signifikantna dobrobit za celokupno preživetje v korist skupine, ki je prejemala zdravilo Perjeta, predhodno opažena pri vmesni analizi celokupnega preživetja (izvedeni eno leto po primarni analizi), se je ohranila (razmerje ogroženosti 0,68; p = 0,0002, test log-rang).
A feeling of numbness, prickling or tingling in feet or hands; sharp jabbing, throbbing, freezing or burning pain; feeling pain from something which should not be painful such as a light touch; less able to feel changes in heat or cold; loss of balance or coordination 
• občutek otrplosti, žgečkanje ali mravljinčenje v stopalih ali dlaneh; ostro zbadajoča, utripajoča ali pekoča bolečina; občutek bolečine zaradi nečesa, kar ne bi smelo biti boleče, kot je rahel dotik; manjša zmožnost občutenja temperaturnih sprememb; izguba ravnotežja ali koordinacije
Progression-Free Survival (independent review) - primary endpoint* 
Preživetje brez napredovanja bolezni (neodvisen pregled)primarni končni cilj*
In patients receiving a taxane, Perjeta and trastuzumab should be administered prior to the taxane. 
Bolniki, ki prejemajo taksan, morajo zdravilo Perjeta in trastuzumab dobiti pred taksanom.
None of these patients experienced anaphylactic/hypersensitivity reactions that were clearly related to ADA. 
Pri nobenem od teh bolnikov se ni pojavila anafilaktična/preobčutljivostna reakcija, ki bi bila jasno povezana z ADA. Pediatrična populacija
The most common NCI-CTCAE Grade 3-4 ADRs (≥10%) were neutropenia and febrile neutropenia. 
Najpogostejša neželena učinka 3. do 4. stopnje po merilih NCI-CTCAE (≥ 10 %) sta bila nevtropenija in febrilna nevtropenija.
The majority of the events were reported in anthracycline-treated patients. 
Večina dogodkov je bila zabeležena pri bolnikih, zdravljenih z antraciklinom.
Perjeta and trastuzumab should start on Day 1 of the first taxane-containing cycle and should continue even if chemotherapy is discontinued. 
Zdravilo Perjeta in trastuzumab naj se začneta uporabljati 1. dan prvega cikla, ki vsebuje taksan, in ju je treba uporabljati še naprej, tudi če se kemoterapija ukine.
When Perjeta attaches to the HER2 cancer cells, it may slow or stop the cancer cells from growing, or may kill them. 
Ko se zdravilo Perjeta veže na HER2 rakave celice, lahko upočasni ali ustavi njihovo rast ali pa jih celo uniči.
No overall differences in efficacy and safety of Perjeta were observed in patients ≥65 and <65 years of age with the exception of diarrhoea, which had an increased incidence in patients ≥65 years of age. 
V celoti niso opažali razlik v učinkovitosti in varnosti zdravila Perjeta med bolniki, starimi ≥ 65 let, in bolniki, starimi < 65 let; izjema je bila driska, ki je bila pogostejša pri bolnikih, starih ≥ 65 let.
Perjeta recognises and attaches to a target called “human epidermal growth factor receptor 2” (HER2). 
Zdravilo Perjeta prepozna in se veže na tarčno mesto, imenovano “receptor za humani epidermalni rastni dejavnik tipa 2” (HER2).
The median time to death was 40.8 months in the placebo-treated group and 56.5 months in the Perjeta-treated group (see Table 3, Figure 2). 
Mediana časa do smrti je bila 40,8 meseca v skupini, ki je prejemala placebo, in 56,5 meseca v skupini, ki je prejemala zdravilo Perjeta (glejte preglednico 3, sliko 2).
Perjeta should be discontinued if symptomatic heart failure is confirmed (see section 4.4 for more details). 
Zdravilo Perjeta je treba ukiniti, če je simptomatsko srčno popuščanje potrjeno (za več podrobnosti glejte poglavje 4.4).
Difference in pCR rates 
Delež pCR
BO17929 - single-arm trial in metastatic breast cancer 
BO17929 - preskušanje z enim krakom pri metastatskem raku dojk
The observation period should be completed prior to any subsequent infusion of trastuzumab or chemotherapy (see section 4.4). 
To obdobje opazovanja mora biti končano pred poznejšim infundiranjem trastuzumaba ali kemoterapije (glejte poglavje 4.4).
The median duration of the longest episode was 18 days in Perjeta-treated patients and 8 days in placebotreated patients. 
Mediana trajanja najdaljše epizode je bila 18 dni v skupini bolnikov, ki je prejemala zdravilo Perjeta, in 8 dni v skupini bolnikov, ki je prejemala placebo.
Table 6 Efficacy results in subgroups by nodal status and hormone receptor status1 Population 
Rezultati učinkovitosti po podskupinah glede na stanje bezgavk in stanje hormonskih receptorjev1
If particulates or discoloration are observed, the solution should not be used. 
Če opazite delce ali razbarvanje, raztopine ne smete uporabiti.
The primary endpoint of the study was pathological complete response (pCR) rate in the breast (ypT0/is). 
Primarni končni cilj študije je bil delež patološkega popolnega odgovora (pCR) v dojki (ypT0/is).
The results for investigator-assessed PFS were similar to those observed for IRF-assessed PFS. 
Rezultati PFS po raziskovalčevi oceni so bili podobni oceni PFS s strani IRF.
In the TRYPHAENA study, Perjeta was given concurrently with epirubicin, as part of the FEC (5-fluorouracil, epirubicin, cyclophosphamide) regimen (see sections 4.8 and 5.1). 
V študiji TRYPHAENA so zdravilo Perjeta uporabljali sočasno z epirubicinom kot del sheme FEC (5-fluorouracil, epirubicin, ciklofosfamid) (glejte poglavji 4.8 in 5.1).
A consistent pattern of results was observed regardless of pCR definition. 
Rezultati so bili dosledni neodvisno od definicije pCR.
If you stop having Perjeta 
Če ste prenehali prejemati zdravilo Perjeta
If you get any serious reaction, your doctor may stop treatment with Perjeta. 
Če se bo pri vas pojavila resna reakcija, lahko zdravnik prekine zdravljenje z zdravilom Perjeta.
Glucose (5%) solution should not be used to dilute Perjeta since it is chemically and physically unstable in such solutions. 
6.2 Inkompatibilnosti Za redčenje zdravila Perjeta se ne sme uporabljati raztopina glukoze (5-%), ker je zdravilo v njej kemijsko in fizikalno nestabilno.
Across all clinical studies, the volume of distribution of the central (Vc) and the peripheral (Vp) compartment in the typical patient, was 3.11 litres and 2.46 litres, respectively. 
V vseh kliničnih študijah je pri tipičnem bolniku znašal volumen porazdelitve centralnega prostora (Vc) 3,11 litra, volumen porazdelitve perifernega prostora (Vp) pa 2,46 litra.
Women of childbearing potential should use effective contraception while receiving Perjeta and for 6 months following the last dose of pertuzumab. 
Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem z zdravilom Perjeta in še 6 mesecev po prejemu zadnjega odmerka pertuzumaba.
Very rarely, patients have died due to anaphylactic reactions during Perjeta infusion. 
V zelo redkih primerih so bolniki zaradi anafilaktičnih reakcij med infundiranjem zdravila Perjeta umrli.
The primary endpoint of this study was cardiac safety during the neoadjuvant treatment period of the study. 
Primarni končni cilj študije je bila srčna varnost med neoadjuvantnim obdobjem zdravljenja v študiji.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions. 
Čas shranjevanja običajno ne sme presegati 24 ur pri temperaturi od 2 °C do 8 °C, razen če se razredčenje izvaja v kontroliranih in validiranih aseptičnih pogojih.
If trastuzumab treatment is discontinued, treatment with Perjeta should be discontinued. 
Če se ukine zdravljenje s trastuzumabom, je treba ukiniti tudi zdravljenje z zdravilom Perjeta.
A consistent pattern of results was observed regardless of pCR definition used. 
Rezultati so bili dosledni neodvisno od uporabljene definicije pCR.
Overall, the majority of hypersensitivity reactions were mild or moderate in severity and resolved upon treatment. 
Skupno je bila večina preobčutljivostnih reakcij blagih ali zmernih in so med zdravljenjem izginile.