natgillin/translations-raw huggingface dataset:
See section 4 “Serious side effects” for more details about signs of heart problems to look out for. 
Za podrobnosti o znakih težav s srcem, na katere morate biti pozorni, glejte poglavje 4, “Resni neželeni učinki”.
Diarrhoea symptoms returned to baseline after HER2 therapy in the Perjetaarm. 
Simptomi driske so se v skupini z zdravilom Perjeta po antiHER2 zdravljenju vrnili na izhodiščne.
Perjeta is administered as an intravenous infusion. 
Absorpcija Zdravilo Perjeta dajemo v obliki intravenske infuzije.
Perjeta and trastuzumab may be resumed if the LVEF has recovered to ≥50% or to a difference of 
Zdravilo Perjeta in trastuzumab je mogoče znova uvesti, če se LVEF dvigne na ≥ 50 % ali se razlika od vrednosti pred zdravljenjem zmanjša na < 10 odstotnih točk.
Left ventricular dysfunction 
Disfunkcija levega prekata
If you experience severe diarrhoea while receiving your anti-cancer treatment, your doctor may start you on anti-diarrhoeal treatment and may stop your treatment with Perjeta until the diarrhoea is under control. 
V primeru pojava hude driske med prejemanjem zdravil proti raku vas bo zdravnik morda začel zdraviti s sredstvi proti driski.
D-79639 Grenzach-Whylen 
D-79639 Grenzach-Whylen Nemčija
declines in LVEF of at least 10% points from baseline and to <50% were reported in 2.7% of Perjetatreated patients and 2.8% of placebo-treated patients, of whom 79.7% of Perjeta-treated patients and 
LVEF (razred II po NYHA) za vsaj 10 odstotnih točk od izhodiščne vrednosti in na < 50 % so poročali pri 2,7 % bolnikov, ki so prejemali zdravilo Perjeta, in 2,8 % tistih, ki so prejemali placebo; do datuma zamejitve podatkov je med njimi okrevalo 79,7 % bolnikov, ki so prejemali zdravilo Perjeta, in 80,6 % bolnikov, ki so prejemali placebo.
Cytokine release syndrome°° 
anafilaktična reakcija°, * sindrom sproščanja citokinov°°
The cancer has not spread to other parts of the body and treatment is going to be given before surgery takes place (treatment before surgery is called neoadjuvant therapy) The cancer has not spread to other parts of the body and treatment is going to be given after surgery (treatment after surgery is called adjuvant therapy) 
• če se rak ni razširil v druge dele telesa in bo zdravljenje uporabljeno po operaciji (zdravljenje po operaciji se imenuje adjuvantno zdravljenje).
The other ingredients are glacial acetic acid, L-histidine, sucrose, polysorbate 20 and water for injections 
• Pomožne snovi so koncentrirana ocetna kislina, L-histidin, saharoza, polisorbat 20 in voda za injekcije.
Parenteral medicinal products should be inspected visually for particulates and discolouration prior to administration. 
Zdravila za parenteralno uporabo je treba pred uporabo vizualno pregledati glede prisotnosti delcev in spremembe barve.
GD100. 
Slika1.
BERENICE is a non-randomized, open-label, multicentre, multinational, Phase II trial conducted in 401 patients with HER2-positive locally advanced, inflammatory, or early-stage breast cancer (with primary tumours > 2cm in diameter or node-positive disease). 
BERENICE je nerandomizirano, odprto, multicentrično, mednarodno preskušanje faze II pri 401 bolniku s HER2-pozitivnim, lokalno napredovalim ali vnetnim rakom dojk v zgodnjem stadiju (s primarnimi tumorji > 2 cm v premeru ali pozitivnimi bezgavkami).
4.5 Interaction with other medicinal products and other forms of interaction 
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Pri 37 bolnikih, ki so bili vključeni v podštudijo ključnega randomiziranega preskušanja
Cardiac risk should be carefully considered and balanced against the medical need of the individual patient before use of Perjeta with an anthracycline. 
Pred uporabo zdravila Perjeta skupaj z antraciklinom je treba skrbno razmisliti o kardiološkem tveganju in ga pretehtati glede na zdravstvene potrebe posameznega bolnika.
Complete response (CR) Partial Response (PR) Stable disease (SD) Progressive disease (PD) 
Stabilna bolezen (SD)
The PK of pertuzumab in these studies was comparable to those observed in single-agent studies. 
Farmakokinetika pertuzumaba je bila v teh študijah primerljiva s farmakokinetiko, ki so jo opažali v študijah z monoterapijo.
Talk to your doctor or nurse before you are given Perjeta: If you have ever had heart problems (such as heart failure, treatment for serious irregular heartbeats, uncontrolled high blood pressure, recent heart attack), your heart function will be checked before and during treatment with Perjeta and your doctor will run tests to check if your heart is working properly. 
• če ste kdaj imeli težave s srcem (npr. srčno popuščanje, ste se zdravili zaradi resnih motenj ritma srca, imate neurejen visok krvni tlak, ste nedavno preboleli srčni infarkt).
One 14 ml vial of concentrate contains 420 mg of pertuzumab at a concentration of 30 mg/ml. 
Ena 14-ml viala koncentrata vsebuje 420 mg pertuzumaba s koncentracijo 30 mg/ml.
Lacrimation increased 
• močnejše solzenje
Dysgeusia 
• zgaga
No dose adjustment is necessary in the elderly population ≥ 65 years of age. 
Starejši populaciji (stari 65 let ali več) odmerka ni treba prilagoditi.
The incidence of NCI-CTCAE Grade 3-4 diarrhoea was 9.3% in Perjeta-treated patients vs 5.1% in placebo-treated patients. 
Incidenca driske 3. in 4. stopnje po merilih NCI-CTCAE je bila v skupini, ki je prejemala zdravilo Perjeta, 9,3 % in v skupini, ki je prejemala placebo, 5,1 %.
The most common ADRs (≥30%) from this pooled data were diarrhoea, alopecia, nausea, fatigue, 
Najpogostejši neželeni učinki (≥ 30 %) v teh kumulativnih podatkih so bili driska, alopecija, slabost, utrujenost, nevtropenija in bruhanje.
• a drop in LVEF to less than 50% associated with a fall of ≥ 10% points below pre-treatment values. 
• LVEF pade pod 50 % in je njegova vrednost glede na vrednost pred zdravljenjem padla za ≥ 10
Neoadjuvant Treatment 
Neoadjuvantno zdravljenje
Very common (may affect more than 1 in 10 people): 
Med drugimi neželenimi učinki so: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov):
In the pivotal trial CLEOPATRA in metastatic breast cancer, the overall frequency of investigator reported hypersensitivity/anaphylaxis events during the entire treatment period was 9.3% in the placebo-treated group and 11.3% in the Perjeta-treated group, of which 2.5% and 2.0% were NCI-CTCAE Grade 3-4, respectively. 
V ključnem preskušanju CLEOPATRA pri metastatskem raku dojk je bila skupna pogostnost preobčutljivostnih/anafilaktičnih dogodkov, o katerih so poročali raziskovalci, med celotnim obdobjem zdravljenja 9,3 % pri bolnikih, ki so prejemali placebo, in 11,3 % pri bolnikih, ki so prejemali zdravilo Perjeta; od tega je bilo primerov 3. ali 4. stopnje po merilih NCI-CTCAE med bolniki, ki so prejemali placebo, 2,5 % in med bolniki, ki so prejemali zdravilo Perjeta, 2,0 %.
For docetaxel and other chemotherapy dose modifications, see relevant SmPC. 
Za prilagajanje odmerkov docetaksela in druge kemoterapije glejte ustrezen povzetek glavnih značilnosti zdravila.
Early breast cancer Perjeta is indicated for use in combination with trastuzumab and chemotherapy in: 
Zdravilo Perjeta je v kombinaciji s trastuzumabom in kemoterapijo indicirano za:
During the second cycle when all medicinal products were administered on the same day, the most common infusion reactions in the Perjeta-treated group (≥ 1.0%) were fatigue, dysgeusia, drug hypersensitivity, myalgia and vomiting (see section 4.4). 
V drugem ciklu, ko so bila vsa zdravila uporabljena isti dan, so bile najpogostejše infuzijske reakcije (≥ 1,0 %) v skupini, ki je prejemala zdravilo Perjeta, utrujenost, sprememba okusa v ustih,
Perjeta + trastuzumab + Chemotherapy N=2400 
Zdravilo Perjeta + trastuzumab + kemoterapija n = 2400
Tell a doctor or nurse straight away, if you notice any of the following side effects: Very severe or persistent diarrhoea (7 or more stools per day). 
• zelo hudo ali dlje časa trajajočo drisko (7 iztrebljanj na dan ali več);
p-value (Log-Rank test, stratified1) 3 year event-free rate2 [95% CI] Overall Survival (OS)3 
3-letni delež brez dogodkov2 [95-% IZ] Celokupno preživetje (OS)4
APHINITY is a multicentre, randomised, double-blind, placebo-controlled Phase III trial conducted in 4804 patients with HER2-positive early breast cancer who had their primary tumour excised prior to randomisation. 
APHINITY (BO25126) APHINITY je multicentrično, randomizirano, dvojno slepo, s placebom kontrolirano preskušanje faze III pri 4804 bolnikih s HER2-pozitivnim zgodnjim rakom dojk, ki so jim primarni tumor kirurško odstranili pred randomizacijo.
NEOSPHERE is a phase II, multicentre, multinational randomised controlled trial with Perjeta and was conducted in 417 adult female patients with newly diagnosed, early, inflammatory or locally advanced HER2-positive breast cancer (T2-4d; primary tumour > 2cm in diameter) who had not received prior trastuzumab, chemotherapy or radiotherapy. 
NEOSPHERE je multicentrično, multinacionalno, randomizirano, kontrolirano preskušanje faze II zdravila Perjeta pri 417 odraslih bolnicah z novoodkritim, zgodnjim, vnetnim ali lokalno napredovalim HER2-pozitivnimi rakom dojk (T2-4d; primarni tumor > 2 cm v premeru), ki pred tem niso prejemale zdravljenja s trastuzumabom, kemoterapije ali radioterapije.
Objective Response Rate (ORR)^ - secondary endpoint no. of patients with measurable disease 
Mediana (meseci) Delež objektivnega odgovora (ORR)^ - sekundarni končni cilj
Your doctor or nurse will check for side effects during your infusion and for 30 to 60 minutes afterwards. 
Zdravnik ali medicinska sestra bosta spremljala morebitne neželene učinke med tem, ko boste prejemali infuzijo, in še 30 do 60 minut po zaključku infuzije.
• APHINITY, in which adjuvant Perjeta was given in combination with trastuzumab and anthracycline-based or non-anthracycline-based, taxane-containing chemotherapy to patients with early breast cancer (n=2364) 
• APHINITY, v katerem so zdravilo Perjeta kot adjuvantno zdravljenje uporabljali v kombinaciji s trastuzumabom in kemoterapijo pri bolnikih z zgodnjim rakom dojk (n = 2364).
A multicenter, open-label, single-arm study of pertuzumab in combination with trastuzumab and a taxane in first line treatment of patients with HER2- positive advanced (metastatic or locally recurrent) breast cancer 
MO28047 (PERUSE) Multicentrično, odprto, preskušanje pertuzumaba z enim krakom v kombinaciji s trastuzumabom in taksanom v prvi liniji zdravljenja bolnikov s HER2 pozitivnim napredovalim (metastatskim ali lokalno ponavljajočim se) rakom dojk
Placebo + trastuzumab + Chemotherapy N=2404 
Placebo + trastuzumab + kemoterapija n = 2404
Reduced appetite 
• slabši tek (apetit)
Treatment including oxygen, beta agonists, antihistamines, rapid i.v. 
Za blaženje simptomov lahko pomagajo zdravljenje s kisikom, agonisti beta, antihistaminiki, hitro nadomeščanje parenteralnih tekočin in zdravljenje z antipiretiki.
In the APHINITY trial, the incidence of NCI-CTCAE v.4 Grade 3-4 neutropenia was 40.6% in patients treated with Perjeta, trastuzumab and chemotherapy compared with 39.1% in patients treated with placebo, trastuzumab and chemotherapy, including 28.3% and 26.5% Grade 4 neutropenia, 
V preskušanju APHINITY je bila pojavnost nevtropenije 3. do 4. stopnje po merilih NCI-CTCAE 40,6 % pri bolnikih, zdravljenih z zdravilom Perjeta, trastuzumabom in kemoterapijo, in 39,1 % pri bolnikih, zdravljenih s placebom, trastuzumabom in kemoterapijo, vključno z nevtropenijo 4. stopnje pri 28,3 % bolnikov, zdravljenih z zdravilom Perjeta, trastuzumabom in kemoterapijo, in pri 26,5 % bolnikov, zdravljenih s placebom, trastuzumabom in kemoterapijo.
Perjeta may elicit severe diarrhoea. 
Zdravilo Perjeta lahko izzove hudo drisko.
Placebo+ trastuzumab + docetaxel n=406 
Placebo trastuzumab + docetaksel n = 406
Severe hypersensitivity, including anaphylaxis and events with a fatal outcome, has been observed with Perjeta (see section 4.8). 
Pri zdravilu Perjeta so opazili hudo preobčutljivost, vključno z anafilaksijo in dogodki s smrtnim izidom (glejte poglavje 4.8).
Your doctor or nurse will check for side effects during your infusion and for 60 minutes afterwards. 
Zdravnik ali medicinska sestra bosta spremljala morebiten pojav neželenih učinkov med infuzijo in še 60 minut po končani infuziji.
HR (95% CI) 
(95-% IZ)
In the APHINITY trial, the adverse event of rash occurred in 25.8% of patients in Perjeta arm vs. 20.3% of patients in placebo arm. 
V preskušanju APHINITY se je izpuščaj pojavil pri 25,8 % bolnikov v skupini z zdravilom Perjeta in pri 20,3 % bolnikov v skupini s placebom.
Symptomatic treatment for mucositis and diarrhoea should be considered. 
Smotrno je razmisliti o podpornem zdravljenju mukozitisa in driske.
Pertuzumab was given intravenously at an initial dose of 840 mg, followed by 420 mg every three weeks. 
Pertuzumab so dali intravensko v uvajalnem odmerku 840 mg, nato pa v odmerku 420 mg vsake tri tedne.
Grade ≥ 3 diarrhoea was reported in 9.8% of patients in the Perjeta arm vs. 3.7% in the placebo arm. 
O driski ≥ 3. stopnje so poročali pri 9,8 % bolnikov v skupini z zdravilom Perjeta in pri 3,7 % bolnikov v skupini s placebom.
Sore throat, red, sore or runny nose, flu-like symptoms and fever Producing more tears 
• vnetje žrela, pordel nos, vnetje nosne sluznice ali izcedek iz nosu, gripi podobni simptomi in zvišana telesna temperatura
There was one case of symptomatic LVD in the Perjeta and trastuzumab-treated group. 
V skupini, zdravljeni z zdravilom Perjeta in trastuzumabom, je bil opažen en primer simptomatske LVD.
Perjeta must be permanently discontinued in case of NCI-CTCAE Grade 4 hypersensitivity reactions (anaphylaxis), bronchospasm or acute respiratory distress syndrome (see section 4.2). 
NCI-CTCAE (anafilaksije), bronhospazma ali akutnega respiratornega distresnega sindroma (glejte poglavje 4.2).
Perjeta+ trastuzumab + docetaxel n=402 
Perjeta trastuzumab + docetaksel n = 402
Trastuzumab was given intravenously at an initial dose of 8 mg/kg, followed by 6 mg/kg every three weeks. 
Trastuzumab so dali intravensko v uvajalnem odmerku 8 mg/kg, nato pa po 6 mg/kg vsake tri tedne.
What you need to know before you are given Perjeta 
Kaj morate vedeti, preden boste prejeli zdravilo Perjeta Zdravila Perjeta ne smete dobiti:
Paronychia Upper respiratory tract infection 
Infekcijske in parazitske bolezni nazofaringitis paronihija okužba zgornjih dihal
How Perjeta works 
Kako deluje zdravilo Perjeta
Number (%) of patients with event HR [95% CI] 
Število (%) bolnikov z dogodkom
n (%) [95% CI] 
n (%)
Primary Endpoint Invasive Disease Free Survival (IDFS) 
Primarni opazovani dogodek Preživetje brez invazivne bolezni (IDFS) Število (%) bolnikov z dogodkom
In the TRYPHAENA trial, febrile neutropenia occurred in 17.1% of patients treated with neoadjuvant Perjeta + TCH, and 9.3% of patients treated with neoadjuvant Perjeta, trastuzumab and docetaxel following FEC. 
V preskušanju TRYPHAENA se je febrilna nevtropenija pojavila pri 17,1 % bolnic, ki so v neoadjuvantnem zdravljenju prejele zdravilo Perjeta skupaj s shemo TCH, in pri 9,3 % bolnic, ki so v neoadjuvantnem zdravljenju po shemi FEC prejele kombinacijo zdravila Perjeta, trastuzumaba in docetaksela.
Unopened vial 
NALEPKA NA VIALI
ypT0 N0 
[95-% IZ] ypT0 N0
In the TRYPHAENA trial, diarrhoea occurred in 72.3% of patients treated with neoadjuvant Perjeta+TCH and 61.4% of patients treated with neoadjuvant Perjeta, trastuzumab and docetaxel following FEC. 
V preskušanju TRYPHAENA se je driska pojavila pri 72,3 % bolnic, ki so se neoadjuvantno zdravile z zdravilom Perjeta in shemo TCH, ter pri 61,4 % bolnic, ki so se neoadjuvantno zdravile s kombinacijo zdravila Perjeta, trastuzumaba in docetaksela po shemi FEC.
In the NEOSPHERE trial, diarrhoea occurred in 45.8% of patients treated with neoadjuvant Perjeta, trastuzumab and docetaxel compared with 33.6% of patients treated with trastuzumab and docetaxel. 
V preskušanju NEOSPHERE se je driska pojavila pri 45,8 % bolnic, ki so se neoadjuvantno zdravile z zdravilom Perjeta, trastuzumabom in docetakselom, v primerjavi s 33,6 % bolnic, ki so se zdravile s trastuzumabom in docetakselom.
Perjeta + trastuzumab + chemotherapy 
zdravilo Perjeta + trastuzumab + kemoterapija
Inflammation of your digestive tract (e.g. sore mouth) Decrease in the number of red blood cells - shown in a blood test Joint or muscle pain, muscle weakness 
• zmanjšano število rdečih krvnih celic - to pokaže preiskava krvi
The active substance is pertuzumab. 
• Učinkovina je pertuzumab.
• a drop in LVEF to less than 40% • a LVEF of 40%-45% associated with a fall of ≥ 10% points below pre-treatment value. 
• je LVEF 40 % do 45 % in je njegova vrednost glede na vrednost pred zdravljenjem padla za
Docetaxel N=75 
trastuzumab docetaksel n = 75
Patients were randomised to receive one of three neoadjuvant regimens prior to surgery as follows: 
Bolnice so pred operacijo randomizirali v enega od naslednjih treh neoadjuvantnih shem:
(median number of cycles of Perjeta was 4, across all treatment arms) and TRYPHAENA (median number of cycles of Perjeta was 3 - 6 across treatment arms) and from the treatment period of APHINITY (median number of cycles of Perjeta was 18). 
^ Preglednica 2 prikazuje združene podatke celotnega obdobja zdravljenja v preskušanju CLEOPATRA (podatki, zbrani do 11. februarja 2014; mediano število ciklov zdravila Perjeta je bilo 24) in iz neoadjuvantnega obdobja zdravljenja v preskušanju NEOSPHERE (mediano število ciklov zdravila Perjeta je bilo 4 v vseh zdravljenih skupinah) in preskušanju TRYPHAENA (mediano število ciklov zdravila Perjeta je bilo 3-6 v vseh zdravljenih skupinah) in iz obdobja zdravljena v preskušanju APHINITY (mediano število ciklov zdravila Perjeta je bilo 18).
Blood and lymphatic system disorders 
Bolezni krvi in limfatičnega sistema febrilna nevtropenija* nevtropenija levkopenija anemija
of Perjeta-treated patients and 57.1% of placebo-treated patients had recovered (defined as 2 
46,7 % tistih, ki so prejemali zdravilo Perjeta, in 57,1 % tistih, ki so prejemali placebo; okrevanje je bilo opredeljeno kot 2 zaporedni meritvi LVEF več kot 50 %.
Nail disorder Pruritus Dry skin 
Bolezni kože in podkožja alopecija izpuščaj bolezni nohtov pruritus suha koža
In the NEOSPHERE trial, 8.4% of patients treated with neoadjuvant Perjeta, trastuzumab and docetaxel experienced febrile neutropenia compared with 7.5% of patients treated with trastuzumab and docetaxel. 
V preskušanju NEOSPHERE se je pri 8,4 % bolnic, ki so prejele neoadjuvantno zdravljenje z zdravilom Perjeta, trastuzumabom in docetakselom, pojavila febrilna nevtropenija, v primerjavi s 7,5 % bolnic, ki so se zdravile s trastuzumabom in docetakselom.
Dose adjustments of pertuzumab are not needed in patients with mild or moderate renal impairment. 
Pri bolnikih z blago do zmerno okvaro ledvic prilagajanje odmerka pertuzumaba ni potrebno.
No events of febrile neutropenia were reported after cessation of docetaxel. 
Po prenehanju dajanja docetaksela niso poročali o primerih febrilne nevtropenije.
In the neoadjuvant setting, Perjeta should be administered for 3 to 6 cycles in combination with trastuzumab and chemotherapy, as part of a complete treatment regimen for early breast cancer (see section 5.1). 
Pri neoadjuvantnem zdravljenju, ki predstavlja del celostnega zdravljenja zgodnjega raka dojk, je treba zdravilo Perjeta dajati 3 do 6 ciklov v kombinaciji s trastuzumabom in kemoterapijo (glejte poglavje
After a median follow-up of 45.4 months, the APHINITY study showed a 19% (hazard ratio [HR] = 
Po spremljanju, ki je mediano trajalo 45,4 meseca, je študija APHINITY pokazala 19-odstotno zmanjšanje (razmerje ogroženosti 0,81; 95-% interval zaupanja 0,66; 1,00; p-vrednost 0,0446)
The highest incidence of diarrhoea (all Grades) was reported during the targeted therapy+taxane chemotherapy period (61.4% of patients in the Perjeta arm vs. 33.8% of patients in the placebo arm).The incidence of diarrhoea was much lower after chemotherapy cessation, affecting 
O največji pojavnosti driske (vseh stopenj) so poročali med obdobjem ciljnega zdravljenja ob hkratni kemoterapiji s taksanom (61,4 % bolnikov v skupini z zdravilom Perjeta in
The infusion may be resumed when symptoms abate. 
Ko simptomi izzvenijo, lahko z infundiranjem nadaljujemo.
No patients in the group treated with Perjeta plus trastuzumab and FEC followed by Perjeta plus trastuzumab and docetaxel experienced symptomatic LVD. 
Pri nobeni bolnici iz skupine, zdravljene z zdravilom Perjeta, trastuzumabom in shemo FEC, ki mu je sledilo zdravljenje z zdravilom Perjeta, trastuzumabom in docetakselom, ni prišlo do pojava simptomatske LVD.
Within each frequency grouping and SOC, ADRs are presented in the order of decreasing seriousness. 
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
In NEOSPHERE, 8.3% of Asian patients treated with neoadjuvant Perjeta, trastuzumab and docetaxel experienced febrile neutropenia compared with 4.0% of Asian patients treated with neoadjuvant trastuzumab and docetaxel. 
V preskušanju NEOSPHERE se je pri 8,3 % azijskih bolnicah, ki so se neoadjuvantno zdravile z zdravilom Perjeta, trastuzumabom in docetakselom, pojavila febrilna nevtropenija, v primerjavi s 4,0 % azijskih bolnic, ki so se neoadjuvantno zdravile s trastuzumabom in docetakselom.
Secondary efficacy endpoints were clinical response rate, breast conserving surgery rate (T2-3 tumours only), disease-free survival (DFS), and PFS. Additional exploratory pCR rates included nodal status (ypT0/isN0 and ypT0N0). 
Sekundarni končni cilji učinkovitosti so bili delež kliničnega odgovora, delež operacij z ohranitvijo dojke (le T2-3 tumorji), preživetje brez bolezni (DFS - disease-free survival) in preživetje brez napredovanja bolezni (PFS - progression-free survival).
METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use after dilution Do not shake 
POSTOPEK IN POT(I) UPORABE ZDRAVILA Za intravensko uporabo po razredčenju
The loading dose of 8 mg/kg of trastuzumab IV should be readministered over approximately 90 minutes, followed by a maintenance dose of 6 mg/kg IV administered every 3 weeks thereafter. 
Ponovno je treba dati uvajalni odmerek trastuzumaba 8 mg/kg, apliciran intravensko v približno 90 minutah, ki mu sledi vzdrževalni odmerek 6 mg/kg,
Name and address of the manufacturer responsible for batch release Roche Pharma AG 
Ime in naslov izdelovalca, odgovornega za sproščanje serij
p-value (Log-Rank test, stratified1) 3 year event-free rate3 [95% CI] Secondary Endpoints1 
3-letni delež brez dogodkov3 [95-% IZ] Sekundarni opazovani dogodki1
was 8.3% in the group treated with Perjeta plus trastuzumab and FEC (5-fluorouracil, epirubicin, cyclophosphamide) followed by Perjeta plus trastuzumab and docetaxel; 9.3% in the group treated with Perjeta plus trastuzumab and docetaxel following FEC; and 6.6% in the group treated with 
V preskušanju neoadjuvantnega zdravljenja TRYPHAENA je bila incidenca LVD (tekom celotnega obdobja zdravljenja) 8,3 % v skupini, ki je po zdravljenju z zdravilom Perjeta, trastuzumabom in shemo FEC (5-fluorouracil, epirubicin, ciklofosfamid) prejela zdravilo Perjeta, trastuzumab in docetaksel; 9,3 % v skupini, ki je po zdravljenju s shemo FEC prejela zdravilo Perjeta, trastuzumab in docetaksel; in 6,6 % v skupini, zdravljeni z zdravilom Perjeta v kombinaciji s shemo TCH (docetaksel,
Being given this medicine 
NAČIN IZDAJANJA ZDRAVILA
Disease Free Survival (DFS) 
Napredovanje bolezni (PD)
• 3 cycles of FEC followed by 3 cycles of docetaxel, all given concurrently with Perjeta and trastuzumab 
• 3 cikli sheme FEC, ki so ji sledili 3 cikli zdravljenja z docetakselom, oboje sočasno z zdravilom Perjeta in trastuzumabom,
Perjeta is given with other cancer treatments (trastuzumab andchemotherapy). 
• Zdravilo Perjeta se daje skupaj s še dvema drugima zdraviloma proti raku (trastuzumabom in kemoterapijo).
Pertuzumab displayed linear pharmacokinetics within the recommended dose range. 
Linearnost/nelinearnost V priporočenem območju odmerjanja je pertuzumab pokazal linearno farmakokinetiko.
Docetaxel N=73 
trastuzumab docetaksel n = 73