natgillin/translations-raw huggingface dataset:
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
V času primarne analize so bile koristi zdravila Perjeta bolj očitne pri bolnikih iz določenih skupin z visokim tveganjem, zlasti pri bolnikih, ki so imeli bolezen s pozitivnimi bezgavkami ali negativnimi hormonskimi receptorji (glejte preglednico 6).
Perjeta in combination with trastuzumab and docetaxel CLEOPATRA (WO20698) is a multicentre, randomised, double-blind, placebo-controlled phase III clinical trial conducted in 808 patients with HER2-positive metastatic or locally recurrent unresectable breast cancer.
Zdravilo Perjeta v kombinaciji s trastuzumabom in docetakselom CLEOPATRA (WO20698) je multicentrična, randomizirana, dvojno slepa, s placebom kontrolirana klinična študija faze III, v katero je bilo vključenih 808 bolnikov s HER2 pozitivnim metastatskim rakom dojk ali z lokalno neoperabilno ponovitvijo raka dojk.
Treatment with Perjeta and trastuzumab resulted in a response rate of 24.2%, with a further 25.8% of patients experiencing stabilisation of disease lasting at least 6 months, indicating that Perjeta is active following progression on trastuzumab.
Zdravljenje z zdravilom Perjeta in trastuzumabom je dalo 24,2-% delež odgovora, pri nadaljnjih 25,8 % bolnikov je prišlo do stabilizacije bolezni, ki je trajala vsaj 6 mesecev.
No definitive conclusion on adverse effects can be drawn on the male reproductive organs in cynomolgus monkey repeated dose toxicity study.
Končnih zaključkov glede neželenih učinkov na reproduktivne organe samcev na podlagi študij toksičnosti ponavljajočih se odmerkov pri opicah cynomolgus, ni mogoče podati.
The safety of Perjeta was generally consistent across studies, although the incidence and most common adverse drug reactions (ADRs) varied depending on whether Perjeta was administered as monotherapy or with concomitant anti-neoplastic agents.
Varnost zdravila Perjeta je bila na splošno med študijami skladna, čeprav so se incidenca in najpogostejši neželeni učinki razlikovali glede na to, ali je bilo zdravilo Perjeta uporabljeno v monoterapiji ali sočasno z drugimi antineoplastičnimi zdravili.
Hypersensitivity reactions/anaphylaxis
Preobčutljivostne reakcije/anafilaksija
As in the CLEOPATRA, TRYPHAENA, and NEOSPHERE trials, a higher incidence of febrile neutropenia was observed among Perjeta-treated Asian patients compared with other races in the APHINITY trial (15.9% of Perjeta-treated patients and 9.9% of placebo-treated patients).
CLEOPATRA, TRYPHAENA in NEOSPHERE so tudi v preskušanju APHINITY opažali večjo pojavnost febrilne nevtropenije pri bolnikih azijskega porekla, ki so prejemali zdravilo Perjeta, kot pri bolnikih drugih ras (pri 15,9 % bolnikov, ki so prejemali zdravilo Perjeta, in 9,9 % bolnikov, ki so prejemali placebo).
For details regarding trastuzumab, please refer to the summary of product characteristics (SmPC).
Za podrobnosti glede trastuzumaba glejte povzetek glavnih značilnosti zdravila.
The maximum tolerated dose of pertuzumab has not been determined.
Največji prenosljivi odmerek pertuzumaba ni znan.
Perjeta is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.
Zdravilo Perjeta je v kombinaciji s trastuzumabom in docetakselom indicirano za zdravljenje odraslih bolnikov z metastatskim HER2-pozitivnim rakom dojk ali z lokalno, neoperabilno ponovitvijo raka dojk, ki pred tem še niso prejeli anti-HER2 terapije ali kemoterapije za metastatsko bolezen.
The incidence of symptomatic LVD was also lower in the Perjeta-treated group (1.8% in the placebo-treated group vs. 1.5% in the Perjeta-treated group) (see section 4.4).
Incidenca simptomatske LVD je bila prav tako manjša v skupini, zdravljeni z zdravilom Perjeta (1,8 % v skupini, ki je prejemala placebo v primerjavi z 1,5 % v skupini, ki je prejemala zdravilo Perjeta) (glejte poglavje 4.4).
There were too few patients with inflammatory breast cancer to draw any firm conclusions but the pCR rate was higher in patients who received Perjeta plus trastuzumab and docetaxel.
Bolnic z vnetnim rakom dojk je bilo premalo za trdne zaključke, razen tega, da je bil delež pCR višji pri bolnicah, ki so prejemale zdravilo Perjeta, trastuzumab in docetaksel.
Placebo + trastuzumab + chemotherapy
Placebo + trastuzumab + kemoterapija
Demographics were well balanced between arms (median age was 49-50 years, the majority were
Vsi vključeni bolniki so bili ženskega spola, demografska struktura je bila dobro uravnotežena med skupinami (mediana starost je bila 49-50 let, večina bolnic je bila belk [77 %]).
Keep the vial in the outer carton in order to protect from light
Shranjujte vialo v zunanji ovojnini za zagotovitev zaščite pred svetlobo
Patients' physical function, global health status and diarrhoea scores showed a clinically meaningful change during chemotherapy in both treatment arms.
Ocene telesne zmožnosti, splošnega zdravstvenega stanja in driske so se v obeh terapevtskih skupinah med kemoterapijo klinično pomembno spremenile.
Nervous system disorders Neuropathy peripheral Headache
Bolezni živčevja periferna nevropatija glavobol dizgevzija periferna senzorična nevropatija omotica parestezija
Inhibition of these signalling pathways can result in cell growth arrest and apoptosis, respectively.
Zavrtje teh signalnih poti lahko ustavi rast celic (zavrtje prve) in apoptozo (zavrtje druge).
** Final analysis of overall survival, cutoff date 11
** Končna analiza celokupnega preživetja, podatki zajeti do 11. februarja 2014.
pCR rates were similar in patients with operable versus locally advanced disease.
Deleži pCR so bili podobni pri bolnicah z operabilno obliko in pri tistih z lokalno napredovalo boleznijo.
No dose recommendations can be made for patients with severe renal impairment because of the limited pharmacokinetic data available (see section 5.2).
Za bolnike s hudo okvaro ledvic je na voljo le malo farmakokinetičnih podatkov, zato priporočil o odmerjanju ni mogoče dati (glejte poglavje 5.2).
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 %).