natgillin/translations-raw huggingface dataset:
Due to the exclusion of patients with brain metastases no data are available on Perjeta activity on brain metastases. 
Ker v preskušanje niso bili vključeni bolniki z zasevki v možganih, ni na voljo podatkov o tem, kako zdravilo Perjeta deluje nanje.
Taking into account the PRAC Assessment Report on the PSUR(s) for pertuzumab, the scientific conclusions of CHMP are as follows: 
Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za pertuzumab je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
Treatment with Perjeta may cause severe diarrhoea. 
Zdravljenje z zdravilom Perjeta lahko povzroči hudo drisko.
On the basis of reported adverse reactions, Perjeta has no or negligible influence on the ability to drive or use machines. 
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Na osnovi poročil o neželenih učinkih zdravilo Perjeta nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Table 2 Summary of ADRs in patients treated with Perjeta in clinical trials^, and in the Postmarketing setting† 
Povzetek neželenih učinkov pri bolnikih, zdravljenih z zdravilom Perjeta v kliničnih preskušanjih^ in v obdobju trženja zdravila††
Pertuzumab is a humanised IgG1 monoclonal antibody produced in mammalian (Chinese hamster ovary) cells by recombinant DNA technology. 
Pertuzumab je humanizirano monoklonsko protitelo IgG1, pridobljeno iz celične kulture sesalcev
Pertuzumab and trastuzumab were administered intravenously (see section 4.2) every 3 weeks starting on Day 1 of the first taxane-containing cycle, for a total of 52 weeks (up to 18 cycles) or until recurrence, withdrawal of consent or unmanageable toxicity. 
Pertuzumab in trastuzumab sta bila uporabljena intravensko (glejte poglavje 4.2) na 3 tedne z začetkom 1. dan prvega cikla, ki je vseboval taksan, in v skupnem trajanju 52 tednov (do 18 ciklov) ali do ponovitve bolezni, umika bolnikove privolitve ali neobvladljivih toksičnih učinkov.
METHOD OF ADMINISTRATION For intravenous use after dilution 
POSTOPEK UPORABE Za intravensko uporabo po razredčenju.
HER2 overexpression was determined at a central laboratory and defined as a score of 3+ by IHC or an ISH amplification ratio ≥2.0 in the trials outlined below. 
Čezmerno izraženost HER2 so ugotavljali v centralnem laboratoriju in je bila opredeljena kot ocena 3+ z imunohistokemijo (IHK) ali razmerje amplifikacije ≥ 2,0 pri in situ hibridizaciji (ISH) v preskušanjih, predstavljenih v nadaljevanju.
Following surgery all patients received Perjeta and trastuzumab intravenously every 3 weeks to complete 1 year of therapy. 
Po operaciji so za dokončanje 1-letnega zdravljenja vsi bolniki vsake 3 tedne intravensko prejemali zdravilo Perjeta in trastuzumab.
Perjeta should only be initiated under the supervision of a physician experienced in the administration of anti-cancer agents. 
Zdravljenje z zdravilom Perjeta lahko uvede le zdravnik, ki ima izkušnje z uporabo zdravil proti raku.
Early Breast Cancer 
Zgodnji rak dojk
Do not use this medicine after the expiry date which is stated on the outer carton after EXP. 
• Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na zunanji ovojnini poleg oznake Uporabno do. Datum izteka roka uporabnosti se izteče na zadnji dan navedenega meseca.
When administered with Perjeta the recommendation is to follow a 3 weekly schedule for trastuzumab administered as either: 
Za dajanje trastuzumaba ob zdravilu Perjeta se priporoča 3-tedenska shema dajanja trastuzumaba:
The primary endpoint of the study was invasive disease-free survival (IDFS), defined as the time from randomisation to first occurrence of ipsilateral local or regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, or death from any cause. 
Primarni opazovani dogodek v študiji je bilo preživetje brez invazivne bolezni (IDFS - invasive disease-free survival); IDFS je bilo opredeljeno kot čas od randomizacije do prvega pojava istostranske lokalne ali regionalne ponovitve invazivnega raka dojk, ponovitve v oddaljenih organih,
Permanent discontinuation should be considered in patients with severe infusion reactions. 
Pri bolnikih s hudo infuzijsko reakcijo je treba razmisliti o trajnem prenehanju uporabe zdravila.
Dose reductions are not recommended for Perjeta or trastuzumab. 
Prilagoditev odmerka Odmerkov zdravila Perjeta ali trastuzumaba ni priporočljivo zmanjševati.
IDFS= invasive disease free survival; CI= confidence interval; Pla= placebo; Ptz= pertuzumab (Perjeta); T= trastuzumab. 
IDFS = preživetje brez invazivne bolezni; IZ = interval zaupanja; Ptz= pertuzumab (zdravilo Perjeta); T= trastuzumab
The efficacy of Perjeta in HER2-positive breast cancer is supported by a randomised phase III trial and a single-arm phase II trial in metastatic breast cancer, two randomised neoadjuvant phase II trials in early breast cancer (one controlled), a non-randomised neoadjuvant phase II trial, and a randomised phase III trial in the adjuvant setting. 
Učinkovitost zdravila Perjeta pri HER2-pozitivnem raku dojk potrjujejo: randomizirano preskušanje faze III in preskušanje faze II z eno samo skupino pri metastatskem raku dojk, dve randomizirani preskušanji faze II neoadjuvantnega zdravljenja pri zgodnjem raku dojk (eno kontrolirano),
From the global safety database of the MAH a total of 15 case reports were retrieved inculding MedDRA PTs potentially indicative of an IRR or hypersensitivity/anaphylaxis which were associated with fatal outcome. 
Iz globalne podatkovne zbirke o varnosti zdravila imetnika dovoljenja za promet z zdravilom je bilo pridobljenih skupno 15 poročil o primerih, ki so vključevala prednostni izraz po MedDRA, ki bi lahko nakazoval na infuzijsko reakcijo ali preobčutljivost/anafilaksijo, povezano s smrtnim izidom.
At Caesarean section on GD100, oligohydramnios, decreased relative lung and kidney weights and microscopic evidence of renal hypoplasia consistent with delayed renal development were identified in all pertuzumab dose groups. 
Pri vseh skupinah odmerkov pertuzumaba so na GD 100 opravili carski rez in ugotovili oligohidramnij, zmanjšano relativno maso ledvic in pljuč ter mikroskopski dokaz ledvične hipoplazije, skladne z zapoznelim razvojem ledvic.
Dry, itchy or acne like skin 
• suha, srbeča ali aknasta koža
In the pivotal trial CLEOPATRA, the initial dose of Perjeta was given the day before trastuzumab and docetaxel to allow for the examination of Perjetaassociated reactions. 
V ključnem preskušanju CLEOPATRA je bil začetni odmerek zdravila Perjeta uporabljen 24 ur pred trastuzumabom in docetakselom; to je omogočilo ovrednotenje reakcij, povezanih z zdravilom Perjeta.
Early intervention with loperamide, fluids and electrolyte replacement should be considered, particularly in elderly patients, and in case of severe or prolonged diarrhoea. 
Zlasti pri starejših bolnikih in v primeru hude ali dolgotrajne driske je treba razmisliti o zgodnjem zdravljenju z loperamidom in nadomeščanju tekočin ter elektrolitov.
If you have inflammation of the digestive tract (e.g.sore mouth or diarrhoea) you may be more likely to develop this side effect. 
Če imate vnetje prebavnega trakta (npr. vnetje ustne sluznice ali drisko), potem je bolj verjetno, da se bo pri vas pojavil ta neželeni učinek.
In the APHINITY trial, febrile neutropenia occurred in 12.1% of Perjeta-treated patients and 11.1% of placebo-treated patients. 
V preskušanju APHINITY se je febrilna nevtropenija pojavila pri 12,1 % bolnikov, ki so prejemali zdravilo Perjeta, in pri 11,1 % bolnikov, ki so prejemali placebo.
Infusion reactions with symptoms that can either be mild or more severe and may include feeling sick (nausea), fever, chills, feeling tired, headache, loss of appetite, joint and muscle pains, and hot flushes. 
• infuzijske reakcije s simptomi, ki so lahko blagi ali hujši in se lahko kažejo kot slabost, zvišana telesna temperatura, mrzlica, utrujenost, glavobol, izguba apetita, bolečine v sklepih in mišicah ter oblivi vročine;
Standard doses of 5-fluorouracil, epirubicin, doxorubicin, cyclophosphamide, docetaxel, paclitaxel and carboplatin were administered. 
Uporabljeni so bili standardni odmerki 5-fluorouracila, epirubicina, doksorubicina, ciklofosfamida, docetaksela,
The incidence of rash was higher in patients who received six cycles of Perjeta compared with patients who received three cycles of Perjeta, independent of the chemotherapy given. 
Incidenca izpuščaja je bila večja pri bolnicah, ki so prejele 6 ciklov zdravila Perjeta, v primerjavi z bolnicami, ki so prejele tri cikle zdravila Perjeta, neodvisno od prejete kemoterapije.
The incidence of symptomatic left ventricular systolic dysfunction (LVD) [congestive heart failure] was higher in patients treated with Perjeta in combination with trastuzumab and chemotherapy compared with trastuzumab and chemotherapy . 
Pojavnost simptomatske sistolične disfunkcije levega prekata (kongestivno srčno popuščanje) je bila večja pri bolnikih, ki so prejemali zdravilo Perjeta v kombinaciji s trastuzumabom in kemoterapijo, kot pri tistih, ki so prejemali trastuzumab in kemoterapijo.
Perjeta is a type of medicine called a “monoclonal antibody” which attaches itself to specific targets in your body and on the cancer cells. 
Gre za zdravilo, ki deluje tako, da se veže na določena tarčna mesta v vašem telesu in na rakave celice.
Patients were randomised 1:1 to receive placebo + trastuzumab + docetaxel or Perjeta + trastuzumab + docetaxel. 
Bolnike so randomizirali v razmerju 1 : 1 v skupino, ki je prejemala kombinacijo placeba + trastuzumaba + docetaksela in skupino, ki je prejemala kombinacijo zdravil Perjeta + trastuzumab + docetaksel.
For full instructions on assay performance and interpretation please refer to the package leaflets of validated HER2 testing assays. 
Celotna navodila, vključno z izvedbo metode in interpretacijo rezultatov, so priložena validiranim testom HER2.
What Perjeta contains 
Kaj vsebuje navodilo
< 10% points below pre-treatment values. 
≥ 10 odstotnih točk.
In the pivotal trial CLEOPATRA, the majority of patients in both treatment groups experienced at least one leucopenic event (63.0% of patients in the Perjeta-treated group and 58.3% of patients in the placebo-treated group), of which the majority were neutropenic events (see section 4.4). 
V ključnem preskušanju CLEOPATRA je večina bolnikov v obeh zdravljenih skupinah vsaj enkrat doživela levkopenijo (63,0 % bolnikov v skupini, ki je prejemala zdravilo Perjeta, in 58,3 % bolnikov v skupini, ki je prejemala placebo); od tega največkrat nevtropenijo (glejte poglavje 4.4).
Other medicines and Perjeta Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. 
Obvestite zdravnika ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, tudi če ste ga dobili brez recepta.
The cancer has spread to other parts of the body such as the lungs or liver (metastasised) and has not previously been treated with anticancer medicines (chemotherapy) or other medicines designed to attach to HER2, or else the cancer has come back in the breast after previous treatment. 
• če se je rak razširil (so se pojavili zasevki) v druge dele telesa, kot so pljuča ali jetra, in ga še niso zdravili z zdravili za zdravljenje raka (kemoterapijo) ali drugimi zdravili, ki se vežejo na receptor HER2, ali se je rak v dojki pojavil ponovno po predhodnem zdravljenju;
The ADRs are listed below by MedDRA system organ class (SOC) and categories of frequency: 
Z zdravljenjem povezani neželeni učinki so navedeni spodaj po organskih sistemih MedDRA in naslednjih skupinah pogostnosti:
The type and severity of events were consistent with those observed in CLEOPATRA at the cycles when Perjeta was given on the same day as trastuzumab and docetaxel, with the majority of reactions being mild or moderate in severity. 
Vrsta in izrazitost dogodkov sta bili skladni z že opaženimi v preskušanju CLEOPATRA v vseh ciklih, ko so zdravilo Perjeta dajali isti dan kot trastuzumab in docetaksel.
Patients with metastatic breast cancer 
Bolniki z metastatskim rakom dojk
The European Medicines Agency has waived the obligation to submit the results of studies with Perjeta in all subsets of the paediatric population in breast cancer (see section 4.2 for information on paediatric use). 
Perjeta za vse podskupine pediatrične populacije pri raku dojk (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Patients with early breast cancer 
Bolniki z zgodnjim rakom dojk
A post hoc exploratory analysis revealed that for patients who had received prior trastuzumab (n = 88), the hazard ratio for IRF-assessed PFS was 0.62 (95% CI 0.35, 1.07), compared with 0.60 (95% CI 0.43, 0.83) for patients who had received prior therapy which did not include trastuzumab (n = 288). 
Post hoc eksplorativna analiza podatkov je pokazala, da je bilo razmerje ogroženosti za PFS po oceni IRF pri bolnikih, ki so predhodno prejeli trastuzumab (n = 88) 0,62 (95-% interval zaupanja 0,35; 1,07); pri bolnikih, ki so predhodno prejeli terapijo brez trastuzumaba (n = 288), pa je bilo razmerje ogroženosti
Perjeta and trastuzumab should be withheld for at least 3 weeks for: 
Zdravljenje z zdravilom Perjeta in trastuzumabom je treba prekiniti za vsaj 3 tedne, če:
Vial (Type I glass) with a stopper (butyl rubber) containing 14 ml of solution. 
Viala iz stekla tipa I z butilnim gumijastim zamaškom vsebuje 14 ml raztopine.
It is a clear to slightly pearly (opalescent), colourless to pale yellow liquid. 
koncentrat za raztopino za infundiranje Bistra do rahlo opalescentna, brezbarvna do bledo rumena tekočina.
3.3% (13/389 patients) of Perjeta-treated patients and 6.7% (25/372 patients) of placebo-treated patients tested positive for ADA. 
Pozitiven izvid testiranja ADA je imelo 3,3 % bolnikov (13/389 bolnikov) v skupini, zdravljeni z zdravilom Perjeta, in 6,7 % (25/372 bolnikov) v skupini, zdravljeni s placebom.
Perjeta +Docetaxel N=96 
+ docetaksel n = 96
no. of patients with an event Median months Overall Survival - secondary endpoint** 
Mediana (meseci) Celokupno preživetjesekundarni končni cilj**
Secondary efficacy endpoints were IDFS including second primary non-breast cancer, overall survival (OS), disease-free survival (DFS), recurrence-free interval (RFI) and distant recurrence-free interval (DRFI). 
celokupno preživetje (OS), preživetje brez bolezni (DFS), interval brez ponovitve (RFI) in interval brez ponovitve v oddaljenih organih (DRFI - distant recurrence-free interval).
Docetaxel was given intravenously at an initial dose of 75 mg/ m2 followed by 75 mg/ m2 or 100 mg/ m2 (if tolerated) every 3 weeks. 
Docetaksel so dali intravensko v uvajalnem odmerku 75 mg/m2, zatem pa 75 mg/m2 ali 100 mg/m2 (če ga je bolnica dobro prenašala) vsake 3 tedne.
• 6 cycles of TCH in combination with Perjeta. 
• 6 ciklov sheme TCH v kombinaciji z zdravilom Perjeta.
If the first infusion is well tolerated, subsequent infusions may be administered over a period of 30 minutes to 60 minutes (see section 4.4). 
lahko nadaljnje infuzije damo v 30 do 60 minutah (glejte poglavje 4.4).
Metastatic breast cancer 
Metastatski rak dojk
The pCR rates as well as the magnitude of benefit with Perjeta (Perjeta plus trastuzumab and docetaxel compared to patients receiving trastuzumab and docetaxel) were lower in the subgroup of patients with hormone receptor-positive tumours (difference of 6% in pCR in the breast) than in patients with hormone receptor-negative tumours (difference of 26.4% in pCR in the breast). 
Tako deleži pCR, kot korist zdravila Perjeta (zdravilo Perjeta in trastuzumab ter docetaksel v primerjavi z bolnicami, ki so prejemale trastuzumab in docetaksel) so bili nižji pri podskupini bolnic s hormonsko odvisnimi tumorji (razlika v pCR v dojki 6 %) v primerjavi z bolnicami s hormonsko neodvisnimi tumorji (razlika v pCR v dojki 26,4 %).
• 6 cycles of docetaxel in combination with carboplatin 
• 6 ciklov docetaksela v kombinaciji s karboplatinom.
The recommended initial loading dose of pertuzumab is 840 mg administered as a 60 minute intravenous infusion, followed every 3 weeks thereafter by a maintenance dose of 420 mg administered over a period of 30 to 60 minutes. 
Priporočen začetni uvajalni odmerek pertuzumaba je 840 mg v 60-minutni intravenski infuziji, ki mu sledi vzdrževalni odmerek 420 mg vsake 3 tedne, dan v 30 do 60 minutah.
Patients who only received Perjeta plus trastuzumab prior to surgery subsequently received both FEC and docetaxel post surgery. 
Bolnice, ki so pred operacijo prejemale le zdravilo Perjeta in trastuzumab, so po operaciji naknadno prejele tako terapijo s FEC, kot tudi docetaksel.
In the CLEOPATRA trial in metastatic breast cancer, nadir neutrophil counts were similar in Perjeta-treated and placebo-treated patients. 
V študiji CLEOPATRA pri metastatskem raku dojk je bilo najmanjše število nevtrofilcev podobno pri bolnikih, zdravljenih z zdravilom Perjeta, in bolnikih, ki so prejemali placebo.
No adverse reactions were observed in sexually mature female cynomolgus monkeys exposed to pertuzumab (see section 5.3). 
Pri spolno zrelih samicah opic cynomolgus, ki so bile izpostavljene pertuzumabu, niso ugotovili neželenih učinkov (glejte poglavje 5.3).
Perjeta should be administered in combination with trastuzumab and docetaxel . 
Zdravilo Perjeta je treba uporabjati v kombinaciji s trastuzumabom in docetakselom.
In the pivotal trial CLEOPATRA in metastatic breast cancer, the incidence of LVD during study treatment was higher in the placebo-treated group than in the Perjeta-treated group (8.6% and 6.6%, respectively). 
Disfunkcija levega prekata (LVD - left ventricular dysfunction) V ključnem preskušanju CLEOPATRA pri metastatskem raku dojk je bila incidenca LVD v času zdravljenja v študiji večja v skupini, ki je prejemala placebo (8,6 %), kot v skupini, ki je prejemala zdravilo Perjeta (6,6 %).
Demographics were well balanced (median age was 49-50 years, the majority were caucasian (71%)) 
(mediana starost je bila 49-50 let, večina bolnic je bila belk (71 %)).
Pertuzumab is a recombinant humanised monoclonal antibody that specifically targets the extracellular dimerization domain (subdomain II) of the human epidermal growth factor receptor 2 protein (HER2), and thereby, blocks ligand-dependent heterodimerisation of HER2 with other HER family members, including EGFR, HER3 and HER4. 
Pertuzumab je rekombinantno humanizirano monoklonsko protitelo, specifično usmerjeno na ekstracelularno dimerizacijsko domeno (poddomeno II) proteina, receptorja za humani epidermalni rastni faktor 2 (HER2).
• an IV infusion with an initial loading dose of trastuzumab 8 mg/kg body weight followed every 3 weeks thereafter by a maintenance dose of 6 mg/kg body weight or 
• v intravenski infuziji z začetnim uvajalnim odmerkom trastuzumaba 8 mg/kg telesne mase, ki mu sledi vzdrževalni odmerek trastuzumaba 6 mg/kg telesne mase vsake 3 tedne,
The incidences of embryo-foetal loss were 33, 50, and 85% for pregnant female monkeys treated with bi-weekly pertuzumab doses of 10, 30, and 100 mg/kg, respectively (2.5 to 20-fold greater than the recommended human dose, based on Cmax). 
Incidence izgube zarodka so bile 33 % pri brejih samicah, ki so na dva tedna dobivale odmerek pertuzumaba 10 mg/kg, 50 % pri brejih samicah, ki so na dva tedna dobivale odmerek pertuzumaba 30 mg/kg in 85 % pri brejih samicah, ki so na dva tedna dobivale odmerek pertuzumaba 100 mg/kg (2,5- do 20-krat večja kot pri priporočenem odmerku za ljudi, na osnovi Cmax).
In TRYPHAENA, the incidence of febrile neutropenia was higher in patients who received six cycles of Perjeta compared with patients who received three cycles of Perjeta, independent of the chemotherapy given. 
V preskušanju TRYPHAENA je bila incidenca febrilne nevtropenije večja pri bolnicah, ki so prejele 6 ciklov zdravila Perjeta, kot pri bolnicah, ki so prejele le 3 cikle zdravila Perjeta, neodvisno od vrste dane kemoterapije.
Decreases in LVEF have been reported with medicinal products that block HER2 activity, including Perjeta. 
Med uporabo zdravil, ki zavirajo aktivnost HER2, med katere spada tudi zdravilo Perjeta, so poročali o zmanjšanju LVEF.
• 3 or 4 cycles of FEC or 5-fluorouracil, doxorubicin and cyclophosphamide (FAC), followed by 3 or 4 cycles of docetaxel or 12 cycles of weekly paclitaxel 
• 3 ali 4 cikli FEC ali 5-fluorouracila, doksorubicina in ciklofosfamida (FAC) in nato 3 ali 4 cikli docetaksela ali 12 ciklov paklitaksela vsak teden,
As in the CLEOPATRA trial, a higher incidence of neutropenia and febrile neutropenia was observed among Asian patients compared with other patients in both neoadjuvant trials. 
Tako kot pri preskušanju CLEOPATRA je bila v obeh preskušanjih neoadjuvantnega zdravljenja opažena večja incidenca nevtropenije in febrilne nevtropenije med azijskimi bolnicami, v primerjavi z ostalimi.
If a carboplatin-based regimen is used, the recommended dose for docetaxel is 75 mg/m2 throughout (no dose escalation). 
Če se uporablja shemo, ki temelji na karboplatinu, je priporočeni odmerek docetaksela ves čas 75 mg/m2
• 4 cycles of AC or epirubicin and cyclophosphamide (EC), followed by 3 or 4 cycles of docetaxel or 12 cycles of weekly paclitaxel 
• 4 cikli AC ali epirubicina in ciklofosfamida (EC) in nato 3 ali 4 cikli docetaksela ali 12 ciklov paklitaksela vsak teden,
In the pivotal trial CLEOPATRA in metastatic breast cancer, diarrhoea occurred in 68.4% of Perjetatreated patients and 48.7% of placebo-treated patients (see section 4.4). 
V ključnem preskušanju CLEOPATRA pri metastatskem raku dojk se je driska pojavila pri 68,4 % bolnikov v skupini, ki je prejemala zdravilo Perjeta, in pri 48,7 % bolnikov v skupini, ki je prejemala placebo (glejte poglavje 4.4).
The estimate of IDFS at 4-years was 92.3% in the Perjeta-treated group versus 90.6% in the placebo treated group. 
Ocena IDFS je bila po 4-letih 92,3 % v skupini z zdravilom Perjeta in 90,6 % v skupini s placebom.
If you have questions about these medicines, please ask your doctor or nurse. 
Če imate vprašanja o teh zdravilih, se posvetujte z zdravnikom ali medicinsko sestro.
• Cohort A - 4 cycles of two weekly dose-dense doxorubicin and cyclophosphamide followed by 4 cycles of Perjeta in combination with trastuzumab and paclitaxel. 
• kohorta A: 4 cikli pogostih odmerkov doksorubicina in ciklofosfamida na dva tedna, ki so jim sledili 4 cikli zdravila Perjeta v kombinaciji s trastuzumabom in paklitakselom
Cardiac failure congestive** 
kongestivno s rčno popuščanje**
Approximately half the patients in each treatment group had hormone receptor-positive disease (defined as ER positive and/or PgR positive). 
Približno polovica bolnic v vsaki zdravljeni skupini je imela hormonsko odvisen karcinom (opredeljen s pozitivnimi ER
Docetaxel was given as an initial dose of 75 mg/m2 IV infusion every three weeks with the option to escalate to 100 mg/m2 at the investigator's discretion if the initial dose was well tolerated. 
Docetaksel so dali v uvajalnem odmerku 75 mg/m2 v obliki intravenske infuzije vsake tri tedne z možnostjo povečanja na 100 mg/m2 glede na mnenje raziskovalca, če je bolnica uvajalni odmerek dobro prenesla.
• Cohort B - 4 cycles of FEC followed by 4 cycles of Perjeta in combination with trastuzumab and docetaxel. 
• kohorta B: 4 cikli FEC, ki so jim sledili 4 cikli zdravila Perjeta v kombinaciji s trastuzumabom in docetakselom.
Approximately half the patients in each treatment group had ER-positive and/or PgR-positive disease. 
Približno polovica bolnic v vsaki zdravljeni skupini je imela prisotne ER in/ali PR v tumorjih.
Febrile neutropenia occurred in 13.7% of Perjeta-treated patients and 7.6% of placebo-treated patients. 
Febrilna nevtropenija se je pojavila pri 13,7 % bolnikov iz skupine, ki je prejemala zdravilo Perjeta, in pri 7,6 % bolnikov iz skupine, ki je prejemala placebo.
You will also be given trastuzumab and chemotherapyl. 
Poleg zdravila Perjeta boste prejeli tudi trastuzumab in kemoterapijo.
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 420 mg/14 ml 
koncentrat za raztopino za infundiranje 420 mg/14 ml