FrancophonIA/ELRC3.0 huggingface dataset:
English: Trastuzumab was given intravenously at an initial dose of 8 mg/kg, followed by 6 mg/kg every three weeks.
Croatian: Trastuzumab se primjenjivao intravenski u početnoj dozi od 8 mg/kg, a zatim u dozi od 6 mg/kg svaka tri tjedna.
English: Patients were randomised to receive one of the following neoadjuvant regimens for 4 cycles prior to surgery:
Croatian: Bolesnice su bile randomizirane za liječenje jednim od sljedećih neoadjuvantnih protokola tijekom 4 ciklusa prije kirurškog zahvata:
English: IDFS= invasive disease free survival; CI= confidence interval; Pla= placebo; Ptz= pertuzumab (Perjeta); T= trastuzumab.
Croatian: IDFS = preživljenje bez simptoma invazivne bolesti; CI = interval pouzdanosti; Pla = placebo; Ptz = pertuzumab (Perjeta); T = trastuzumab.
English: • 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
Croatian: • 3 ili 4 ciklusa protokola FEC ili 5-fluorouracila, doksorubicina i ciklofosfamida (FAC), nakon čega su uslijedila 3 ili 4 ciklusa docetaksela ili 12 ciklusa paklitaksela koji se primjenjivao svaki tjedan
English: Treatment including oxygen, beta agonists, antihistamines, rapid i.v.
Croatian: Ublažavanju simptoma može pridonijeti i liječenje kisikom, beta agonistima, antihistaminicima, brzom intravenskom nadoknadom tekućine te antipireticima.
English: 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)
Croatian: • kada se rak nije proširio u druge dijelove tijela, a liječenje će se primijeniti nakon kirurškog zahvata (liječenje nakon kirurškog zahvata naziva se adjuvantnom terapijom)
English: • Cohort A - 4 cycles of two weekly dose-dense doxorubicin and cyclophosphamide followed by 4 cycles of Perjeta in combination with trastuzumab and paclitaxel.
Croatian: • kohorta A - 4 ciklusa zgusnutih doza (engl. dose dense) doksorubicina i ciklofosfamida svaka dva tjedna, nakon čega su uslijedila 4 ciklusa lijeka Perjeta u kombinaciji s trastuzumabom i paklitakselom
English: There was one case of symptomatic LVD in the Perjeta and trastuzumab-treated group.
Croatian: Zabilježen je jedan slučaj simptomatske disfunkcije lijeve klijetke u skupini liječenoj lijekom Perjeta i trastuzumabom.
English: Patients' median LVEF at baseline was 65.0% (range 50% - 88%) in both groups.
Croatian: Medijan ejekcijske frakcije lijeve klijetke bolesnika na početku liječenja iznosio je 65,0% (raspon 50% - 88%) u obje skupine.
English: No differences in pertuzumab PK were observed in patients with early breast cancer compared to patients with metastatic breast cancer.
Croatian: Nisu opažene razlike u farmakokinetici pertuzumaba između bolesnika s ranim rakom dojke i bolesnika s metastatskim rakom dojke.
English: Dose modification
Croatian: Prilagođavanje doze
English: Febrile neutropenia occurred in 13.7% of Perjeta-treated patients and 7.6% of placebo-treated patients.
Croatian: Febrilna neutropenija javila se u 13,7% bolesnika liječenih lijekom Perjeta te u 7,6% bolesnika koji su primali placebo.
English: 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).
Croatian: Sekundarne mjere ishoda za djelotvornost bile su IDFS uključujući drugi primarni rak osim raka dojke, ukupno preživljenje (engl. overall survival, OS), preživljenje bez simptoma bolesti (engl. disease-free survival, DFS), razdoblje bez recidiva (engl. recurrence-free interval, RFI) te razdoblje bez recidiva bolesti na udaljenom mjestu
English: Weak, numb, tingling or prickling sensations mainly affecting the feet and legs Nose bleeds
Croatian: • slabost, utrnulost, trnci ili bockanje, uglavnom na području stopala i nogu
English: IDFS including second primary non-breast cancer
Croatian: IDFS uključujući drugi primarni rak izvan dojke Broj (%) bolesnika s događajem
English: Randomisation was stratified by breast cancer type (operable, locally advanced, or inflammatory) and ER or PgR positivity.
Croatian: Randomizacija je bila stratificirana prema vrsti raka dojke (operabilan, lokalno uznapredovao ili upalni) te prema tome jesu li bolesnice imale pozitivan ER ili PgR status.
English: 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
Croatian: Multicentrično, otvoreno ispitivanje s jednom skupinom u kojem se ispituje pertuzumab u kombinaciji s trastuzumabom i taksanom u prvoj liniji liječenja bolesnika s HER2 pozitivnim uznapredovalim (metastatskim ili lokalno recidivirajućim) rakom dojke rujan 2020.
English: No dose recommendations can be made for patients with severe renal impairment because of the limited pharmacokinetic data available (see section 5.2).
Croatian: Zbog ograničenih dostupnih farmakokinetičkih podataka ne mogu se dati preporuke za doziranje u bolesnika s teškim oštećenjem bubrežne funkcije (vidjeti dio 5.2).
English: Your doctor or nurse will check for side effects during your infusion and for 60 minutes afterwards.
Croatian: Liječnik ili medicinska sestra će Vas motriti tijekom infuzije te 60 minuta nakon nje kako bi uočili moguće nuspojave.
English: 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.
Croatian: APHINITY je multicentrično, randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje faze III, provedeno u 4804 bolesnika s HER2 pozitivnim ranim rakom dojke kojima je primarni tumor uklonjen ekscizijom prije randomizacije.
English: The most common ADRs (≥30%) from this pooled data were diarrhoea, alopecia, nausea, fatigue,
Croatian: Najčešće nuspojave lijeka (≥ 30%) prema tim objedinjenim podacima bile su proljev, alopecija, mučnina, umor, neutropenija i povraćanje.
English: Five studies evaluated the effects of pertuzumab on the PK of co-administered cytotoxic agents, docetaxel, paclitaxel, gemcitabine, capecitabine, carboplatin and erlotinib.
Croatian: U pet su ispitivanja ispitani učinci pertuzumaba na farmakokinetiku istodobno primijenjenih citotoksičnih lijekova: docetaksela, paklitaksela, gemcitabina, kapecitabina, karboplatina i erlotiniba.
English: In the neoadjuvant period of the BERENICE trial, the incidence of NYHA Class III/IV symptomatic LVD (congestive heart failure according to NCI-CTCAE v.4) was 1.5% in the group treated with dose dense doxorubicin and cyclophosphamide (AC) followed by Perjeta plus trastuzumab and paclitaxel and none of the patients (0%) experienced symptomatic LVD in the group treated with FEC followed by Perjeta in combination with trastuzumab and docetaxel.
Croatian: U neoadjuvantnom razdoblju ispitivanja BERENICE incidencija simptomatske disfunkcije lijeve klijetke NYHA stupnja III/IV (kongestivno zatajenje srca prema verziji 4 NCI-CTCAE kriterija) iznosila je 1,5% u skupini liječenoj zgusnutim dozama (engl. dose dense) doksorubicina i ciklofosfamida (AC protokol) nakon čega je uslijedila primjena lijeka Perjeta plus trastuzumab i paklitaksel te 0% (nije se javila ni u jednog bolesnika) u skupini liječenoj FEC protokolom nakon kojega je uslijedila primjena lijeka Perjeta u kombinaciji s trastuzumabom i docetakselom.
English: • 4 cycles of AC or epirubicin and cyclophosphamide (EC), followed by 3 or 4 cycles of docetaxel or 12 cycles of weekly paclitaxel
Croatian: • 4 ciklusa protokola AC ili epirubicina i ciklofosfamida (EC), nakon čega su uslijedila 3 ili 4 ciklusa docetaksela ili 12 ciklusa paklitaksela koji se primjenjivao svaki tjedan
English: Inhibition of these signalling pathways can result in cell growth arrest and apoptosis, respectively.
Croatian: Inhibicija puta MAP kinaze može dovesti do zaustavljanja rasta stanice, a inhibicija puta PI3K do apoptoze.
English: 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.
Croatian: Preporučena početna udarna doza pertuzumaba je 840 mg, primijenjeno u obliku 60-minutne intravenske infuzije, nakon čega se svaka 3 tjedna daje doza održavanja od 420 mg koja se primjenjuje tijekom razdoblja od 30 do 60 minuta.
English: 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.
Croatian: Nakon carskog reza provedenog 100. dana gestacije u svim skupinama koje su primale različite doze pertuzumaba zabilježeni su oligohidramnion, smanjena relativna težina pluća i bubrega te mikroskopski znakovi hipoplazije bubrega sukladni zastoju u razvoju bubrega.
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 420 mg/14 ml
Croatian: Koncentrat za otopinu za infuziju 420 mg/14 ml
English: In the APHINITY trial, febrile neutropenia occurred in 12.1% of Perjeta-treated patients and 11.1% of placebo-treated patients.
Croatian: U ispitivanju APHINITY, febrilna neutropenija javila se u 12,1% bolesnika liječenih lijekom Perjeta te 11,1% onih koji su primali placebo.
English: In BERENICE, 4.1% (16/392) of the patients treated with Perjeta tested positive for ADA.
Croatian: U ispitivanju BERENICE, 4,1% (16/392) bolesnika liječenih lijekom
English: TRYPHAENA is a multicentre, randomised phase II clinical trial conducted in 225 adult female patients with HER2-positive locally advanced, operable, or inflammatory breast cancer (T2-4d; primary tumour > 2cm in diameter) who had not received prior trastuzumab, chemotherapy or radiotherapy.
Croatian: TRYPHAENA je multicentrično randomizirano kliničko ispitivanje faze II provedeno u 225 odraslih bolesnica s HER2 pozitivnim lokalno uznapredovalim, operabilnim ili upalnim rakom dojke (T2-4d; primarni tumor promjera >2 cm) koje prethodno nisu primale trastuzumab, kemoterapiju ni radioterapiju.
English: Pertuzumab was given intravenously at an initial dose of 840 mg, followed by 420 mg every three weeks.
Croatian: Pertuzumab se primjenjivao intravenski u početnoj dozi od 840 mg, a zatim u dozi od 420 mg svaka tri tjedna.
English: What you need to know before you are given Perjeta
Croatian: Što morate znati prije nego počnete primati lijek Perjeta Nemojte primati lijek Perjeta
English: In addition, ADRs reported in the post-marketing setting are included in Table 2.
Croatian: Osim toga, u Tablicu 2 uključene su i nuspojave lijeka prijavljene nakon njegova stavljanja u promet.
English: In the pivotal trial CLEOPATRA in metastatic breast cancer, rash occurred in 51.7% of Perjeta-treated patients, compared with 38.9% of placebo-treated patients.
Croatian: U pivotalnom ispitivanju CLEOPATRA u metastatskom raku dojke, osip se javio u 51,7% bolesnika liječenih lijekom Perjeta te u 38,9% bolesnika koji su primali placebo.
English: Patients in the pivotal trial CLEOPATRA were tested at multiple time-points for anti-drug antibodies (ADA) to Perjeta.
Croatian: U pivotalnom ispitivanju CLEOPATRA bolesnici su u više vremenskih točaka testirani kako bi se utvrdila prisutnost protutijela na lijek Perjeta.
English: Following surgery all patients received trastuzumab to complete one year of therapy.
Croatian: Nakon kirurškog zahvata, sve su bolesnice primale trastuzumab do završetka 1-godišnjeg razdoblja liječenja.
English: Demographics were well balanced between arms (median age was 49-50 years, the majority were
Croatian: Demografske su značajke bile ujednačene među skupinama (medijan dobi iznosio je 49-50 godina, a većina ispitanica bile su bjelkinje [77%]) i sve su bolesnice bile ženskog spola.
English: 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).
Croatian: U pivotalnom ispitivanju CLEOPATRA u metastatskom raku dojke, proljev se javio u 68,4% bolesnika liječenih lijekom Perjeta te u 48,7% bolesnika koji su primali placebo (vidjeti dio 4.4).
English: Perjeta may elicit severe diarrhoea.
Croatian: Perjeta može izazvati težak proljev.
English: Cardiac risk should be carefully considered and balanced against the medical need of the individual patient before use of Perjeta with an anthracycline.
Croatian: Prije primjene lijeka Perjeta s antraciklinom potrebno je pažljivo razmotriti srčani rizik i balansirati ga s medicinskim potrebama pojedinog bolesnika.
English: n (%) [95% CI]
Croatian: n (%) [95% CI] ypT0 N0 n (%) [95% CI]
English: Figure 1 IRF-assessed PFS by patient subgroup
Croatian: Slika 1 Analiza preživljenja bez progresije bolesti prema procjeni neovisnog ocjenjivačkog povjerenstva po podskupinama bolesnika
English: Paronychia Upper respiratory tract infection
Croatian: Infekcije i infestacije nazofaringitis paronihija infekcije gornjih dišnih putova
English: 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).
Croatian: BERENICE je nerandomizirano, otvoreno, multicentrično, multinacionalno ispitivanje faze II provedeno u 401 bolesnika s HER2-pozitivnim lokalno uznapredovalim, upalnim ili rakom dojke u ranom stadiju (s primarnim tumorom promjera > 2 cm ili bolešću koja zahvaća limfne čvorove).
English: At the time of the primary analysis, the benefits of Perjeta were more apparent in subgroups of patients a high risk of recurrence: patients with node-positive or hormone receptor-negative disease (see table
Croatian: U trenutku provedbe primarne analize koristi lijeka Perjeta bile su izraženije u bolesnika iz određenih visokorizičnih skupina, osobito bolesnika s pozitivnim nalazom zahvaćenosti limfnih čvorova ili bolešću negativnom na hormonske receptore (vidjeti Tablicu 6).
English: Anaphylactic reaction°,
Croatian: anafilaktička reakcija°,*
English: (vs Perjeta+ Trastuzumab+ Docetaxel)
Croatian: (naspram trastuzumab + docetaksel)
English: Your doctor or nurse will check for side effects during your infusion and for 30 to 60 minutes afterwards.
Croatian: Liječnik ili medicinska sestra će Vas motriti tijekom infuzije te 30 do 60 minuta nakon nje kako bi uočili moguće nuspojave.
English: If you have questions about these medicines, please ask your doctor or nurse.
Croatian: Ako imate pitanja o navedenim lijekovima, obratite se svom liječniku ili medicinskoj sestri.
English: In the pivotal trial CLEOPATRA in metastatic breast cancer, the incidence of NCI-CTCAE v.3 Grade 3-4 neutropenia was balanced in the two treatment groups (86.3% of Perjeta-treated patients and 86.6% of placebo-treated patients, including 60.7% and 64.8% Grade 4 neutropenia, respectively).
Croatian: U pivotalnom ispitivanju CLEOPATRA u metastatskom raku dojke, incidencija neutropenije stupnja 3-4 prema NCI-CTCAE v.3 bila je podjednaka u obje terapijske skupine (u 86,3% bolesnika liječenih lijekom Perjeta i 86,6% bolesnika koji su primali placebo, uključujući neutropeniju stupnja 4 u 60,7% bolesnika liječenih lijekom Perjeta te u 64,8% bolesnika koji su primali placebo).
English: 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.
Croatian: Docetaksel se primjenjivao intravenskom infuzijom u početnoj dozi od 75 mg/m2 svaka tri tjedna, koja se prema odluci ispitivača mogla povećati do 100 mg/m2 ako je bolesnica dobro podnijela početnu dozu.
English: Cough Epistaxis Dyspnoea
Croatian: Tablični prikaz nuspojava
English: Dry, itchy or acne like skin
Croatian: • suhoća ili svrbež kože te promjene na koži nalik aknama
English: As well as Perjeta you will also receive trastuzumab and medicines called chemotherapy Information about these medicines is described in separate package leaflets.
Croatian: Uz lijek Perjeta primat ćete i trastuzumab te lijekove koji se zovu kemoterapija.
English: Complete response (CR) Partial Response (PR) Stable disease (SD) Progressive disease (PD)
Croatian: Stopa objektivnog odgovora (ORR)^ - sekundarna mjera ishoda broj bolesnika s mjerljivom bolešću bolesnici koji su ostvarili odgovor na liječenje*** 95% CI za ORR potpun odgovor (CR) djelomičan odgovor (PR) stabilna bolest (SD) progresivna bolest (PD)
English: The PK of pertuzumab in these studies was comparable to those observed in single-agent studies.
Croatian: U navedenim je ispitivanjima farmakokinetika pertuzumaba bila slična onoj opaženoj u ispitivanjima u kojima je primijenjen samostalno.
English: One 14 ml vial of concentrate contains 420 mg of pertuzumab at a concentration of 30 mg/ml.
Croatian: Jedna bočica od 14 ml sadrži 420 mg pertuzumaba u koncentraciji od 30 mg/ml.
English: Placebo+ trastuzumab + docetaxel n=406
Croatian: Placebo+ trastuzumab + docetaksel n=406
English: 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,
Croatian: U ispitivanju APHINITY, incidencija neutropenije stupnja 3-4 prema verziji 4 NCI-CTCAE kriterija iznosila je 40,6% u bolesnika liječenih lijekom Perjeta, trastuzumabom i kemoterapijom u odnosu na 39,1% u bolesnika koji su primali placebo, trastuzumab i kemoterapiju, uključujući neutropeniju stupnja 4 u 28,3% odnosno 26,5% slučajeva.
English: pCR rate in the breast (ypT0/is)
Croatian: Stopa pCR-a u dojci i limfnom čvoru (ypT0/is
English: • a drop in LVEF to less than 40% • a LVEF of 40%-45% associated with a fall of ≥ 10% points below pre-treatment value.
Croatian: • ejekcijske frakcije lijeve klijetke od 40-45% uz smanjenje za ≥ 10 postotnih bodova u odnosu na vrijednost prije liječenja.
English: The 840 mg loading dose of pertuzumab should be re-administered as a 60 minute infusion, followed by a maintenance dose of 420 mg IV administered every 3 weeks thereafter.
Croatian: Udarnu dozu od 840 mg pertuzumaba treba ponovno primijeniti u obliku 60-minutne infuzije, a nakon toga nastaviti liječenje intravenskom dozom održavanja od 420 mg, svaka 3 tjedna.
English: Each vial contains a total of 420 mg pertuzumab at a concentration of 30 mg/ml
Croatian: Jedna bočica sadrži ukupno 420 mg pertuzumaba u koncentraciji od 30 mg/ml.
English: In the CLEOPATRA trial in metastatic breast cancer, nadir neutrophil counts were similar in Perjeta-treated and placebo-treated patients.
Croatian: U ispitivanju u metastatskom raku dojke pod nazivom CLEOPATRA, nadir neutrofila bio je podjednak u bolesnika liječenih lijekom Perjeta i onih koji su primali placebo.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use after dilution Do not shake
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Za intravensku primjenu nakon razrjeđivanja
English: Nail disorder Pruritus Dry skin
Croatian: Poremećaji kože i potkožnog tkiva alopecija osip poremećaj noktiju pruritus suha koža
English: The infusion rate may be slowed or interrupted if the patient develops an infusion reaction (see section 4.8).
Croatian: Ako se u bolesnika javi reakcija na infuziju, može se smanjiti brzina infuzije ili privremeno prekinuti njezina primjena (vidjeti dio 4.8).
English: In cynomolgus monkeys, weekly intravenous administration of pertuzumab at doses up to 150 mg/kg/dose was generally well tolerated.
Croatian: Makaki majmuni su u načelu dobro podnosili intravenske infuzije pertuzumaba u dozama do 150 mg/kg tjedno.
English: Baseline albumin and lean body weight were the most significant covariates influencing CL. CL decreased in patients with higher baseline albumin concentrations and increased in patients with greater lean body weight.
Croatian: Klirens se smanjio u bolesnika s višim početnim koncentracijama albumina, a povećao se u bolesnika s većom tjelesnom težinom bez masnog tkiva.
English: Within each frequency grouping and SOC, ADRs are presented in the order of decreasing seriousness.
Croatian: Unutar iste kategorije učestalosti i organskog sustava nuspojave su navedene u padajućem nizu prema ozbiljnosti.
English: • Perjeta plus docetaxel.
Croatian: • Perjeta plus docetaksel
English: Inflammation of the nail bed where the nail and skin meet Condition in which the left ventricle of the heart is functionally impaired with or without symptoms
Croatian: • stanje kod kojega dolazi do narušavanja funkcije lijeve srčane klijetke, a koje može ili ne mora biti praćeno simptomima
English: Perjeta+ Trastuzuma b N=107
Croatian: Perjeta + trastuzumab N=107
English: PHARMACEUTICAL FORM Concentrate for solution for infusion.
Croatian: Perjeta je koncentrat za otopinu za infuziju.
English: Name and address of the manufacturer responsible for batch release Roche Pharma AG
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet
English: 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.
Croatian: U ispitivanju APHINITY, štetni događaj osipa javio se u 25,8% bolesnika u skupini liječenoj lijekom Perjeta naspram 20,3% bolesnika u skupini koja je primala placebo.
English: Neoadjuvant Treatment
Croatian: Neoadjuvantno liječenje
English: Fever associated with dangerously low levels of a type of white blood cell (neutrophils) Pain in the body, arms, legs, and belly
Croatian: • vrućica povezana s opasno niskim razinama jedne vrste bijelih krvnih stanica (neutrofila)
English: FEC Perjeta+ Trastuzumab
Croatian: Perjeta + trastuzumab
English: Perjeta+ trastuzumab + docetaxel n=402
Croatian: Perjeta+ trastuzumab + docetaksel n=402
English: Those studies included the pivotal trials CLEOPATRA (n=808), NEOSPHERE (n=417), TRYPHAENA (n=225), and APHINITY (n=4804) [pooled in Table 2].
Croatian: Ta su ispitivanja uključivala pivotalna ispitivanja CLEOPATRA (n=808), NEOSPHERE (n=417), TRYPHAENA (n=225) i APHINITY (n=4804) [objedinjeni podaci navedeni su u Tablici 2]. Sigurnost lijeka Perjeta načelno je bila dosljedna u svim ispitivanjima, iako su se incidencija i najčešće nuspojave lijeka razlikovale ovisno o tome je li se Perjeta primjenjivala u monoterapiji ili istodobno s antineoplasticima.
English: Patients who only received Perjeta plus trastuzumab prior to surgery subsequently received both FEC and docetaxel post surgery.
Croatian: Bolesnice koje su prije kirurškog zahvata primale samo lijek Perjeta plus trastuzumab naknadno su primale i FEC i docetaksel nakon kirurškog zahvata.
English: Glacial acetic acid, L-histidine, sucrose and polysorbate 20.
Croatian: POPIS POMOĆNIH TVARI ledena acetatna kiselina, L-histidin, saharoza i polisorbat 20 voda za injekcije
English: Severe hypersensitivity, including anaphylaxis and events with a fatal outcome, has been observed with Perjeta (see section 4.8).
Croatian: Kod primjene lijeka Perjeta primijećena je teška preosjetljivost, uključujući anafilaksiju i događaje sa smrtnim ishodom (vidjeti dio 4.8).