natgillin/translations-raw huggingface dataset:
The majority of the events were reported in anthracycline-treated patients.
Večina dogodkov je bila zabeležena pri bolnikih, zdravljenih z antraciklinom.
Perjeta and trastuzumab should start on Day 1 of the first taxane-containing cycle and should continue even if chemotherapy is discontinued.
Zdravilo Perjeta in trastuzumab naj se začneta uporabljati 1. dan prvega cikla, ki vsebuje taksan, in ju je treba uporabljati še naprej, tudi če se kemoterapija ukine.
When Perjeta attaches to the HER2 cancer cells, it may slow or stop the cancer cells from growing, or may kill them.
Ko se zdravilo Perjeta veže na HER2 rakave celice, lahko upočasni ali ustavi njihovo rast ali pa jih celo uniči.
No overall differences in efficacy and safety of Perjeta were observed in patients ≥65 and <65 years of age with the exception of diarrhoea, which had an increased incidence in patients ≥65 years of age.
V celoti niso opažali razlik v učinkovitosti in varnosti zdravila Perjeta med bolniki, starimi ≥ 65 let, in bolniki, starimi < 65 let; izjema je bila driska, ki je bila pogostejša pri bolnikih, starih ≥ 65 let.
Perjeta recognises and attaches to a target called “human epidermal growth factor receptor 2” (HER2).
Zdravilo Perjeta prepozna in se veže na tarčno mesto, imenovano “receptor za humani epidermalni rastni dejavnik tipa 2” (HER2).
The median time to death was 40.8 months in the placebo-treated group and 56.5 months in the Perjeta-treated group (see Table 3, Figure 2).
Mediana časa do smrti je bila 40,8 meseca v skupini, ki je prejemala placebo, in 56,5 meseca v skupini, ki je prejemala zdravilo Perjeta (glejte preglednico 3, sliko 2).
Perjeta should be discontinued if symptomatic heart failure is confirmed (see section 4.4 for more details).
Zdravilo Perjeta je treba ukiniti, če je simptomatsko srčno popuščanje potrjeno (za več podrobnosti glejte poglavje 4.4).
Difference in pCR rates
Delež pCR
BO17929 - single-arm trial in metastatic breast cancer
BO17929 - preskušanje z enim krakom pri metastatskem raku dojk
The observation period should be completed prior to any subsequent infusion of trastuzumab or chemotherapy (see section 4.4).
To obdobje opazovanja mora biti končano pred poznejšim infundiranjem trastuzumaba ali kemoterapije (glejte poglavje 4.4).
The median duration of the longest episode was 18 days in Perjeta-treated patients and 8 days in placebotreated patients.
Mediana trajanja najdaljše epizode je bila 18 dni v skupini bolnikov, ki je prejemala zdravilo Perjeta, in 8 dni v skupini bolnikov, ki je prejemala placebo.
Table 6 Efficacy results in subgroups by nodal status and hormone receptor status1 Population
Rezultati učinkovitosti po podskupinah glede na stanje bezgavk in stanje hormonskih receptorjev1
If particulates or discoloration are observed, the solution should not be used.
Če opazite delce ali razbarvanje, raztopine ne smete uporabiti.
The primary endpoint of the study was pathological complete response (pCR) rate in the breast (ypT0/is).
Primarni končni cilj študije je bil delež patološkega popolnega odgovora (pCR) v dojki (ypT0/is).
The results for investigator-assessed PFS were similar to those observed for IRF-assessed PFS.
Rezultati PFS po raziskovalčevi oceni so bili podobni oceni PFS s strani IRF.
In the TRYPHAENA study, Perjeta was given concurrently with epirubicin, as part of the FEC (5-fluorouracil, epirubicin, cyclophosphamide) regimen (see sections 4.8 and 5.1).
V študiji TRYPHAENA so zdravilo Perjeta uporabljali sočasno z epirubicinom kot del sheme FEC (5-fluorouracil, epirubicin, ciklofosfamid) (glejte poglavji 4.8 in 5.1).
A consistent pattern of results was observed regardless of pCR definition.
Rezultati so bili dosledni neodvisno od definicije pCR.
If you stop having Perjeta
Če ste prenehali prejemati zdravilo Perjeta
If you get any serious reaction, your doctor may stop treatment with Perjeta.
Če se bo pri vas pojavila resna reakcija, lahko zdravnik prekine zdravljenje z zdravilom Perjeta.
Glucose (5%) solution should not be used to dilute Perjeta since it is chemically and physically unstable in such solutions.
6.2 Inkompatibilnosti Za redčenje zdravila Perjeta se ne sme uporabljati raztopina glukoze (5-%), ker je zdravilo v njej kemijsko in fizikalno nestabilno.
Across all clinical studies, the volume of distribution of the central (Vc) and the peripheral (Vp) compartment in the typical patient, was 3.11 litres and 2.46 litres, respectively.
V vseh kliničnih študijah je pri tipičnem bolniku znašal volumen porazdelitve centralnega prostora (Vc) 3,11 litra, volumen porazdelitve perifernega prostora (Vp) pa 2,46 litra.
Women of childbearing potential should use effective contraception while receiving Perjeta and for 6 months following the last dose of pertuzumab.
Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem z zdravilom Perjeta in še 6 mesecev po prejemu zadnjega odmerka pertuzumaba.
Very rarely, patients have died due to anaphylactic reactions during Perjeta infusion.
V zelo redkih primerih so bolniki zaradi anafilaktičnih reakcij med infundiranjem zdravila Perjeta umrli.
The primary endpoint of this study was cardiac safety during the neoadjuvant treatment period of the study.
Primarni končni cilj študije je bila srčna varnost med neoadjuvantnim obdobjem zdravljenja v študiji.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Čas shranjevanja običajno ne sme presegati 24 ur pri temperaturi od 2 °C do 8 °C, razen če se razredčenje izvaja v kontroliranih in validiranih aseptičnih pogojih.
If trastuzumab treatment is discontinued, treatment with Perjeta should be discontinued.
Če se ukine zdravljenje s trastuzumabom, je treba ukiniti tudi zdravljenje z zdravilom Perjeta.
A consistent pattern of results was observed regardless of pCR definition used.
Rezultati so bili dosledni neodvisno od uporabljene definicije pCR.
Overall, the majority of hypersensitivity reactions were mild or moderate in severity and resolved upon treatment.
Skupno je bila večina preobčutljivostnih reakcij blagih ali zmernih in so med zdravljenjem izginile.
In repeated dose toxicity studies in cynomolgus monkeys, no definitive conclusions could be drawn on the adverse effect on male reproductive organs.
Iz študij toksičnosti pri ponavljajočih odmerkih pri opicah cynomolgus dokončni zaključki o neželenih učinkih na moške reproduktivne organe niso mogoči.
Swollen ankles or other body parts due to your body retaining too much water Not being able to sleep
• oteklost gležnjev ali drugih delov telesa zaradi čezmernega zadrževanja vode v telesu
The efficacy results are presented in Table 4.
Rezultati o učinkovitosti so prikazani v preglednici 4.
If you have ever had a chemotherapy medicine from the class called anthracyclines, e.g. doxorubicin or epirubicin - these medicines can damage heart muscle and increase the risk of heart problems with Perjeta.
• če ste predhodno prejemali kemoterapevtike iz skupine, imenovane antraciklini - npr. doksorubicin ali epirubicin - to so zdravila, ki lahko poškodujejo srčno mišico in povečajo tveganje za nastanek težav s srcem ob zdravljenju z zdravilom Perjeta.
Only chemotherapy-naive patients were treated and they received low cumulative doses of epirubicin (up to 300 mg/m2).
Zdravljenje so prejemali le bolniki, ki se predhodno še niso zdravili s kemoterapijo, in prejeli so majhne kumulativne odmerke epirubicina (do 300 mg/m2).
Patients with metastases, bilateral breast cancer, clinically important cardiac risk factors (see section 4.4) or LVEF < 55% were not included.
Bolnice z metastazami, bilateralnim rakom dojk, klinično pomembnimi dejavniki tveganja za srčno bolezen (glejte poglavje 4.4) ali LVEF < 55 % niso bile vključene.
Perjeta and trastuzumab should be withheld for at least 3 weeks for any signs and symptoms suggestive of congestive heart failure.
Zdravljenje z zdravilom Perjeta in trastuzumabom je treba prekiniti za vsaj 3 tedne v primeru znakov in simptomov, ki kažejo na kongestivno srčno popuščanje.
What Perjeta is and what it is used for What you need to know before you are given Perjeta How you are given Perjeta Possible side effects
Kaj je zdravilo Perjeta in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Perjeta Kako boste prejeli zdravilo Perjeta
Sequential use of Perjeta (in combination with trastuzumab and a taxane) has been evaluated following the epirubicin or doxorubicin component of many anthracycline-based regimens in the APHINITY and BERENICE studies.
Zaporedno uporabo zdravila Perjeta (v kombinaciji s trastuzumabom in taksanom) po epirubicinski ali doksorubicinski komponenti številnih shem na osnovi antraciklina so ocenili v študijah APHINITY in
There were too few patients with inflammatory breast cancer to draw any firm conclusions.
Bolnic z vnetnim rakom dojk je bilo premalo za trdne zaključke.
Patients should have a pre-treatment left ventricular ejection fraction (LVEF) of ≥ 50%.
Bolniki morajo imeti iztisni delež levega prekata (LVEF) pred zdravljenjem ≥ 50 %.
The efficacy results from the CLEOPATRA study are summarised in Table 3.
Rezultati učinkovitosti študije CLEOPATRA so povzeti v preglednici 3.
† Evaluated in patients with Best Overall Response of CR or PR. ^ Objective response rate and duration of response are based on IRF-assessed tumour assessments.
† Ocenjeno pri bolnikih z najboljšim celokupnim odgovorom CR ali PR. ^ Delež objektivnega odgovora in trajanje odgovora temeljita na oceni tumorja po IRF.
Approximately half the patients in each treatment group had hormone receptor-positive disease (defined as oestrogen receptor (ER) positive and/or progesterone receptor (PgR) positive) and approximately half of the patients in each treatment group had received prior adjuvant or neoadjuvant therapy.
Približno polovica bolnikov v vsaki od obeh terapevtskih skupin je imela hormonsko odvisen karcinom (opredeljen s pozitivnimi estrogenskimi receptorji (ER) in/ali progesteronskimi receptorji (PR)) in približno polovica bolnikov v vsaki od obeh terapevtskih skupin je predhodno prejemala adjuvantno ali neoadjuvantno zdravljenje.
In addition, consistent with foetal growth restrictions, secondary to oligohydramnios, lung hypoplasia (1 of 6 in 30 mg/kg and 1 of 2 in100 mg/kg groups), ventricular septal defects (1 of 6 in 30 mg/kg group), thin ventricular wall (1 of 2 in 100 mg/kg group) and minor skeletal defects (external - 3 of 6 in 30 mg/kg group) were also noted.
Dodatno so skladno z motnjami v rasti zarodka, sekundarno oligohidramniju, opazili tudi pljučno hipoplazijo (1 od 6 pri skupini z 30 mg/kg in 1 od 2 pri skupini z 100 mg/kg), okvaro ventrikularnega septuma (1 od 6 pri skupini z 30 mg/kg), tanko steno prekata (1 od 2 pri skupini z 100 mg/kg) in manjše skeletne okvare (eksterne 3 od 6 pri 30 mg/kg).
Patients were treated with Perjeta and trastuzumab until disease progression, withdrawal of consent or unmanageable toxicity.
Bolniki so zdravilo Perjeta in trastuzumab prejemali do napredovanja bolezni, umika soglasja ali pojava neobvladljivih toksičnih učinkov.
When the diarrhoea is under control treatment with pertuzumab may be reinstated.
Ko je driska uravnana, lahko zdravljenje s pertuzumabom ponovno uvedemo.
In the adjuvant setting, Perjeta should be administered in combination with trastuzumab for a total of one year (up to 18 cycles or until disease recurrence, or unmanageable toxicity, whichever occurs first) as part of a complete regimen for early breast cancer and regardless of the timing of surgery.
V okviru adjuvantnega zdravljenja je treba zdravilo Perjeta uporabljati v kombinaciji s trastuzumabom v skupnem trajanju eno leto (do 18 ciklov ali do ponovitve bolezni ali neobvladljivih toksičnih učinkov, kar od tega se pojavi prej), ki predstavlja del celostnega zdravljenja zgodnjega raka dojk in ne glede na čas operacije.
For recommendations on delayed or missed doses, please refer to Table 1 below.
Zamujeni ali izpuščeni odmerki Za priporočila glede zamujenih ali izpuščenih odmerkov glejte spodnjo preglednico 1.
Patients who have received prior anthracyclines or prior radiotherapy to the chest area may be at higher risk of LVEF declines.
Bolniki, predhodno zdravljeni z antraciklini ali obsevanjem v predelu prsnega koša, imajo lahko večje tveganje za zmanjšanje LVEF.
95% CI for one sample binomial using Pearson-Clopper method.
1 95-% interval zaupanja za binomsko porazdelitev z enim vzorcem po Pearson-Clopperjevi metodi.
You will be given 420 mg of Perjeta over 30 to 60 minutes.
• Dobili boste 420 mg zdravila Perjeta v 30 do 60 minutah.
The CHMP recommends that the terms of the marketing authorisation(s) should be varied.
Odbor CHMP zato priporoča spremembo pogojev dovoljenja za promet z zdravilom.
Tumour lysis syndrome (a condition which may happen when cancer cells die quickly, causing changes in blood levels of minerals and metabolites shown in a blood test).
• sindrom razpada tumorja (stanje, ki se lahko pojavi, ko rakave celice hitro propadejo; to povzroči spremembe vrednosti mineralov in presnovkov v krvi, kar pokaže preiskava krvi).
Patients were then randomised to receive Perjeta or placebo, in combination with adjuvant trastuzumab and chemotherapy.
Bolnike so nato randomizirali na prejemanje zdravila Perjeta ali placeba v kombinaciji s trastuzumabom, danim adjuvantno, in kemoterapijo.
Patients in the pivotal trial CLEOPATRA were tested at multiple time-points for anti-drug antibodies (ADA) to Perjeta.
Bolnikom v ključnem preskušanju CLEOPATRA so ob različnih časih večkrat določali protitelesa proti zdravilu (ADA - anti-drug antibodies) Perjeta.
Treatment with Perjeta and trastuzumab may continue until disease progression or unmanageable toxicity even if treatment with docetaxel is discontinued.
Zdravljenje z zdravilom Perjeta in trastuzumabom se lahko nadaljuje do napredovanja bolezni ali pojava neobvladljivih toksičnih učinkov tudi v primeru ukinitve zdravljenja z docetakselom.
Symptoms may include kidney problems (weakness, shortness of breath, fatigue and confusion), heart problems (fluttering of the heart of a faster or slower heartbeat), seizures, vomiting or diarrhoea and tingling in the mouth, hands or feet
Simptomi lahko vključujejo težave z ledvicami (oslabelost, kratko sapo, utrujenost in zmedenost), težave s srcem (trepetanje srca s hitrejšim ali počasnejšim bitjem), krče, bruhanje ali drisko in mravljinčenje v ustih, dlaneh ali stopalih.
Patients with clinically important cardiac risk factors were not included (see section 4.4).
Bolniki s klinično pomembnimi tveganji za razvoj srčnega obolenja niso bili vključeni (glejte poglavje 4.4).
No specific fertility studies in animals have been performed to evaluate the effect of pertuzumab.
Pri živalih niso izvedli specifičnih študij za oceno vpliva pertuzumaba na plodnost.
In case of overdose, patients must be closely monitored for signs or symptoms of adverse reactions and appropriate symptomatic treatment instituted.
Pri prevelikem odmerjanju je treba skrbno nadzorovati bolnikove znake in simptome neželenih učinkov in uvesti ustrezno simptomatsko zdravljenje.
Tell a doctor or nurse straight away, if you notice any of the side effects above.
Zdravniku ali medicinski sestri morate takoj povedati, če opazite katerega od zgoraj naštetih neželenih učinkov.
Perjeta and trastuzumab were given at standard doses in a 3-weekly regimen.
Zdravilo Perjeta in trastuzumab so dajali v standardnih odmerkih po 3-tedenski shemi.
• CLEOPATRA, in which Perjeta was given in combination with docetaxel and trastuzumab to patients with metastatic breast cancer (n=453)
• CLEOPATRA, v katerem so zdravilo Perjeta dajali v kombinaciji z docetakselom in trastuzumabom bolnikom z metastatskim rakom dojk (n = 453);
Intravenous administration of pertuzumab from GD19 through GD50 (period of organogenesis) was embryotoxic, with dose-dependent increases in embryo-foetal death between GD25 to GD70.
Intravenska uporaba pertuzumaba od 19. do 50. gestacijskega dne (GD, obdobje organogeneze) je bila embriotoksična; embriofetalne smrti so se povečevale od odmerka odvisno od GD 25 do GD 70.
Patients' median LVEF at baseline was 65.0% (range 50% - 88%) in both groups.
Mediana LVEF bolnikov pred začetkom zdravljenja je bila 65 (razpon 50−88 % v obeh skupinah).
Alternatively, docetaxel can be given at 100 mg/m2 on a 3 weekly schedule from the start, again depending on the chosen regimen.
Druga možnost je odmerek docetaksela 100 mg/m2 po 3-tednskem razporedu že od začetka, ponovno glede na izbrano shemo.
You will be given 840 mg of Perjeta over 60 minutes.
• Dobili boste 840 mg zdravila Perjeta v 60 minutah.
Consistent results were observed across pre-specified patient subgroups including the subgroups based on stratification factors of geographic region and prior adjuvant/neoadjuvant therapy or de novo metastatic breast cancer (see Figure 1).
Ugotovili so skladnost rezultatov po vnaprej opredeljenih podskupinah bolnikov, vključno s podskupinami glede na stratifikacijske dejavnike: geografsko območje, predhodno adjuvantno/neoadjuvantno zdravljenje ali de novo metastatski rak dojk (glejte sliko 1).
In the remaining 7 cases the events reported were indeed suggestive of IRR/ hypersensitivity/ anaphylaxis and in 3/7 of them, a causal relationship between the administration of pertuzumab and the fatal event could not be excluded.
V preostalih 7 primerih so poročani dogodki nakazovali na infuzijsko reakcijo/preobčutljivost/anafilaksijo, v 3/7 primerov pa vzročne povezanosti med dajanjem pertuzumaba in smrtnim dogodkom ni bilo mogoče izključiti.
While pertuzumab alone inhibited the proliferation of human tumour cells, the combination of pertuzumab and trastuzumab significantly augmented antitumour activity in HER2-overexpressing xenograft models.
Sam pertuzumab je sicer zavrl razmnoževanje humanih tumorskih celic, toda kombinacija pertuzumaba s trastuzumabom je bistveno povečala protitumorsko delovanje v ksenotransplantatnih modelih s čezmerno izraženim HER2.
Treatment Perjeta+Trastuzumab+Docetaxel and Perjeta+Trastuzumab are compared to Trastuzumab+ Docetaxel while Perjeta+Docetaxel is compared to Perjeta+Trastuzumab+Docetaxel.
Zdravljenji Perjeta + trastuzumab + docetaksel in Perjeta + trastuzumab sta primerjani s trastuzumab + docetaksel, medtem ko je zdravljenje Perjeta + docetaksel primerjano s Perjeta + trastuzumab + docetaksel.
An infusion reaction was defined in the pivotal trials as any event reported as hypersensitivity, anaphylactic reaction, acute infusion reaction or cytokine release syndrome occurring during an infusion or on the same day as the infusion.
Infuzijske reakcije Infuzijska reakcija je bila v ključnih preskušanjih opredeljena kot vsak dogodek, poročan kot preobčutljivost, anafilaktična reakcija, akutna infuzijska reakcija ali sindrom sproščanja citokinov, ki se je pojavil med infuzijo ali na dan infuzije.
Data available for Infusion Related Reactions (IRR) and anaphylaxis/hypersensitivity with fatal outcome for patients treated with Perjeta in clinical trials, data from published literature, and relevant data from the Roche global safety database showed that there were no cases of confirmed IRRs or anaphylaxis/hypersensitivity with a fatal outcome in pivotal clinical trials in patients treated with pertuzumab.
Razpoložljivi podatki za infuzijske reakcije in anafilakso/preobčutljivost s smrtnim izidom za bolnike, zdravljene z zdravilom Perjeta v kliničnih preskušanjih, podatki iz objavljene literature in ustrezni podatki iz globalne podatkovne zbirke o varnosti podjetja Roche so pokazali, da v ključnih kliničnih preskušanjih pri bolnikih, zdravljenih s pertuzumabom, ni bilo potrjenih primerov infuzijskih reakcij ali anafilaksije/preobčutljivosti s smrtnim izidom.
Loss of or altered taste
• izguba okusa ali spremenjen okus • zvišana telesna temperatura
After dilution, one ml of solution contains approximately 3.02 mg of pertuzumab for the initial dose and approximately 1.59 mg of pertuzumab for the maintenance dose (see section 6.6).
Po razredčitvi vsebuje en ml raztopine približno 3,02 mg pertuzumaba v začetnem odmerku in približno 1,59 mg pertuzumaba v vzdrževalnem odmerku (glejte poglavje 6.6).
After dilution, one ml of solution should contain approximately 3.02 mg of pertuzumab (840 mg/278 ml) for the initial dose where two vials are required and approximately 1.59 mg of pertuzumab (420 mg/264 ml) for the maintenance dose where one vial is required.
Po razredčitvi mora en ml raztopine vsebovati približno 3,02 mg pertuzumaba (840 mg/278 ml) za začetni odmerek, za katerega sta potrebni dve viali, in približno 1,59 mg (420 mg/264 ml) pertuzumaba za vzdrževalni odmerek, za katerega je potrebna ena viala.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsquent updates published on the European medicines web-portal.
• Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7)
Overall 6% of patients had inflammatory breast cancer, 25% had locally advanced breast cancer and 69% had operable breast cancer.
Skupno je imelo 6 % bolnic vnetni rak dojk, 25 % lokalno napredovali rak dojk in 69 % operabilni rak dojk.
If you are given Perjeta with trastuzumab and chemotherapy at the same time, some side effects may also be due to these other medicines.
Če hkrati z zdravilom Perjeta prejemate trastuzumab in kemoterapijo, so nekateri neželeni učinki lahko tudi posledica teh zdravil.
Perjeta has not been studied in patients with: a pre-treatment LVEF value of < 50%; a prior history of congestive heart failure (CHF); LVEF declines to < 50% during prior trastuzumab adjuvant therapy; or conditions that could impair left ventricular function such as uncontrolled hypertension, recent myocardial infarction, serious cardiac arrhythmia requiring treatment or a cumulative prior anthracycline exposure to > 360 mg/m2 of doxorubicin or its equivalent.
Zdravila Perjeta niso proučevali pri bolnikih: z vrednostjo LVEF pred zdravljenjem < 50 %; z anamnezo kongestivnega srčnega popuščanja; s padcem LVEF na < 50 % med predhodnim adjuvantnim zdravljenjem s trastuzumabom; s stanji, ki bi lahko okvarila delovanje levega prekata, kot so npr. neurejena hipertenzija, nedavni miokardni infarkt, resne motnje srčnega ritma, ki so zahtevale zdravljenje, predhodna kumulativna izpostavljenost antraciklinu do > 360 mg/m2 doksorubicina ali njegovega ekvivalenta.
In both studies most events were mild to moderate in severity.
obeh preskušanjih je bila po resnosti večina dogodkov blagih do zmernih.
Overall 7% of patients had inflammatory breast cancer, 32% had locally advanced breast cancer and 61% had operable breast cancer.
Skupno je imelo 7 % bolnic vnetni rak dojk, 32 % lokalno napredovali rak dojk in 61 % operabilni rak dojk.
However, in the group treated with Perjeta in combination with TCH, docetaxel was given intravenously at 75 mg/m2 (no escalation was permitted) and carboplatin (AUC 6) was given intravenously every three weeks.
V skupini, zdravljeni z zdravilom Perjeta v kombinaciji s shemo TCH, pa so docetaksel dali intravensko v odmerku 75 mg/m2 (povečanje ni bilo dovoljeno) in karboplatin (AUC 6) intravensko vsake tri tedne.
With doses of 15 mg/kg and higher, intermittent mild treatment-associated diarrhoea was noted.
Ob odmerkih 15 mg/kg in več so ugotovili intermitentno, blago z zdravilom povezano drisko.
Ask your doctor about whether you can breast-feed during or after treatment with Perjeta.
• Z zdravnikom se posvetujte, ali smete med zdravljenjem z zdravilom Perjeta ali po njem dojiti.