FrancophonIA/ELRC3.0 huggingface dataset:
English: 95% CI for one sample binomial using Pearson-Clopper method.
Croatian: 1. 95% CI za binomni test na jednom uzorku primjenom Pearson-Clopperove metode.
English: Interruption of treatment with pertuzumab should be considered if no improvement in the patient's condition is achieved.
Croatian: Treba razmotriti privremen prekid liječenja pertuzumabom ako se bolesnikovo stanje ne poboljša.
English: Perjeta contains the active substance pertuzumab and is used to treat adult patients with breast cancer when:
Croatian: Perjeta sadrži djelatnu tvar pertuzumab, a koristi se za liječenje odraslih bolesnika s rakom dojke:
English: Glucose (5%) solution should not be used to dilute Perjeta since it is chemically and physically unstable in such solutions.
Croatian: Za razrjeđivanje lijeka Perjeta ne smije se koristiti otopina glukoze (5%) jer je Perjeta u takvim otopinama kemijski i fizikalno nestabilna.
English: Perjeta will be stored by the health professionals at the hospital or clinic.
Croatian: Lijek Perjeta čuvaju zdravstveni radnici u bolnici ili klinici.
English: Perjeta recognises and attaches to a target called “human epidermal growth factor receptor 2” (HER2).
Croatian: Perjeta prepoznaje i veže se za ciljnu molekulu koja se zove “receptor humanog epidermalnog faktora rasta 2” (HER2).
English: Very rarely, patients have died due to anaphylactic reactions during Perjeta infusion.
Croatian: U vrlo rijetkim slučajevima bolesnici su umrli zbog anafilaktičkih reakcija tijekom infuzije lijeka Perjeta.
English: The final analysis of OS was performed when 389 patients had died (221 in the placebo-treated group and 168 in the Perjeta-treated group).
Croatian: Završna analiza ukupnog preživljenja provedena je kada je umrlo 389 bolesnika (221 u skupini koja je primala placebo i 168 u skupini liječenoj lijekom Perjeta).
English: Treatment should include standard anthracycline- and/or taxane-based chemotherapy.
Croatian: Liječenje treba uključivati standardnu kemoterapiju utemeljenu na antraciklinu i/ili taksanu.
English: Perjeta is a type of medicine called a “monoclonal antibody” which attaches itself to specific targets in your body and on the cancer cells.
Croatian: Perjeta je vrsta lijeka koji se zove “monoklonsko protutijelo”, a veže se za specifične ciljne molekule u tijelu te za stanice raka.
English: Some of the side effects which you get may be due to your breast cancer.
Croatian: Neke od nuspojava koje se kod Vas mogu javiti mogu biti uzrokovane samim rakom dojke.
English: 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).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Perjeta u svim podskupinama pedijatrijske populacije za karcinom dojke (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: It is given by a drip into a vein (intravenous infusion) once every three weeks.
Croatian: • Lijek se primjenjuje sporom infuzijom u venu (intravenskom infuzijom) jednom svaka tri tjedna.
English: Difference in pCR rates
Croatian: Razlika u stopama pCR-a
English: If you have ever had heart problems during previous treatment with trastuzumab.
Croatian: • ako ste imali srčanih tegoba tijekom prethodnog liječenja trastuzumabom.
English: Patients should have a pre-treatment LVEF of ≥ 55% (≥ 50% after completion of the anthracycline component of chemotherapy, if given).
Croatian: Ejekcijska frakcija lijeve klijetke prije liječenja mora biti ≥ 55% (≥ 50% nakon završetka liječenja antraciklinskom sastavnicom kemoterapije, ako se ona primjenjuje).
English: The addition of Perjeta to trastuzumab plus chemotherapy did not affect patients' overall role function over the course of the study.
Croatian: Dodavanje lijeka Perjeta trastuzumabu plus kemoterapiji nije utjecalo na sveukupno društveno funkcioniranje bolesnika tijekom ispitivanja.
English: Most events were Grade 1 or 2 in severity, occurred in the first two cycles, and responded to standard therapies, such as topical or oral treatment for acne.
Croatian: Ti su događaji većinom bili stupnja težine 1 ili 2, javljali su se tijekom prva 2 ciklusa i odgovarali su na standardno liječenje poput topikalne ili peroralne terapije za liječenje akni.
English: Ask your doctor about whether you can breast-feed during or after treatment with Perjeta.
Croatian: • Pitajte liječnika smijete li dojiti tijekom ili nakon liječenja lijekom Perjeta.
English: However sensitivity analyses performed at the recommended dose and schedule of Perjeta showed that at the extreme values of these two covariates, there was no significant impact on the ability to achieve target steady-state concentrations identified in preclinical tumour xenograft models.
Croatian: Međutim, analize osjetljivosti provedene pri preporučenoj dozi i rasporedu primjene lijeka Perjeta pokazale su da ekstremne vrijednosti tih dviju kovarijanti ne utječu značajno na sposobnost postizanja ciljnih koncentracija u stanju dinamičke ravnoteže određenih u nekliničkim ksenotransplantacijskim modelima tumora.
English: Elderly patients (> 65 years) may have a higher risk of diarrhoea compared with younger patients (< 65 years).
Croatian: Rizik od proljeva može biti veći u starijih (> 65 godina) nego u mlađih bolesnika (< 65 godina).
English: Swollen ankles or other body parts due to your body retaining too much water Not being able to sleep
Croatian: • oticanje gležnjeva ili drugih dijelova tijela zbog prekomjernog zadržavanja vode u tijelu
English: Simes corr. for CMH test)
Croatian: CMH test)
English: Other medicines and Perjeta Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili medicinsku sestru ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Based on modifications made to the study treatment, most reactions were assessed as secondary to docetaxel infusions.
Croatian: Na temelju prilagodbi ispitivanog liječenja za većinu je reakcija ocijenjeno da su posljedica infuzija docetaksela.
English: Positive
Croatian: Pozitivan
English: These dose levels resulted in clinically relevant exposures of 2.5 to 20-fold greater than the recommended human dose, based on Cmax.
Croatian: Navedene su doze dovele do klinički značajnih izloženosti koje su bile 2,5 do 20 puta veće od onih koje se postižu primjenom preporučene doze u ljudi, izračunato temeljem Cmax.
English: Perjeta and trastuzumab should start on Day 1 of the first taxane-containing cycle and should continue even if chemotherapy is discontinued.
Croatian: Liječenje lijekom Perjeta i trastuzumabom treba započeti 1. dan prvog ciklusa kemoterapije koja sadrži taksan, a treba ga nastaviti čak i ako se kemoterapija prekine.
English: In both treatment groups, the proportion of patients experiencing febrile neutropenia was highest in the first cycle of therapy and declined steadily thereafter.
Croatian: U obje terapijske skupine je udio bolesnika u kojih se javila febrilna neutropenija bio najveći tijekom prvog ciklusa liječenja, nakon čega se stalno smanjivao.
English: Medical review of these 15 reports showed that in 8/15 cases, the reported events were not indicative of IRR/hypersensitivity/anaphylaxis.
Croatian: Medicinska ocjena tih 15 prijavljenih slučajeva pokazala je da u 8/15 slučajeva prijavljeni događaji nisu ukazivali na reakciju na infuziju/preosjetljivost/anafilaksiju.
English: Only chemotherapy-naive patients were treated and they received low cumulative doses of epirubicin (up to 300 mg/m2).
Croatian: Liječile su se samo bolesnice koje prethodno nisu primale kemoterapiju i primile su niske kumulativne doze epirubicina (do 300 mg/m2).
English: Perjeta and trastuzumab should be withheld for at least 3 weeks for any signs and symptoms suggestive of congestive heart failure.
Croatian: Liječenje lijekom Perjeta i trastuzumabom mora se prekinuti na najmanje 3 tjedna ako se pojave bilo kakvi znakovi i simptomi koji ukazuju na kongestivno zatajenje srca.
English: If you forget to have Perjeta
Croatian: Ako ste zaboravili primiti lijek Perjeta
English: The statistically significant OS benefit in favour of the Perjetatreated group, previously observed at an interim analysis of OS (performed one year after the primary analysis), was maintained (HR 0.68, p = 0.0002 log-rank test).
Croatian: Statistički značajan koristan učinak na ukupno preživljenje u skupini liječenoj lijekom Perjeta, prethodno opažen prilikom privremene analize ukupnog preživljenja (proveden godinu dana nakon primarne analize), bio je održan (HR 0,68; p = 0,0002 log-rang test).
English: However, only limited safety data are available on concurrent use of Perjeta and an anthracycline.
Croatian: Međutim, dostupni su samo ograničeni podaci o sigurnosti kod istodobne primjene lijeka Perjeta i antraciklina.
English: Perjeta should be discontinued if symptomatic heart failure is confirmed (see section 4.4 for more details).
Croatian: Perjeta se mora trajno obustaviti ako se potvrdi simptomatsko zatajenje srca (vidjeti dio 4.4 za više informacija).
English: On the basis of reported adverse reactions, Perjeta has no or negligible influence on the ability to drive or use machines.
Croatian: S obzirom na prijavljene nuspojave, Perjeta ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: This clinical assessment should be based on the severity of the preceding reaction and response to administered treatment for the adverse reaction (see section 4.2).
Croatian: Ova se klinička procjena mora temeljiti na težini prethodne reakcije i odgovoru na primijenjeno liječenje nuspojava (vidjeti dio 4.2).
English: In patients receiving a taxane, Perjeta and trastuzumab should be administered prior to the taxane.
Croatian: U bolesnika koji primaju taksan, lijek Perjeta i trastuzumab treba primijeniti prije taksana.
English: The most common NCI-CTCAE Grade 3-4 ADRs (≥10%) were neutropenia and febrile neutropenia.
Croatian: Najčešće nuspojave lijeka stupnja 3-4 prema NCI-CTCAE klasifikaciji (≥ 10%) bile su neutropenija i febrilna neutropenija.
English: If you stop having Perjeta
Croatian: Ako prestanete primati lijek Perjeta
English: No dose adjustment is necessary in the elderly population ≥ 65 years of age.
Croatian: Nije potrebno prilagođavati dozu u starijih bolesnika u dobi od ≥ 65 godina.
English: Approximately half the patients in each treatment group had ER-positive and/or PgR-positive disease.
Croatian: Približno polovica bolesnica u svakoj liječenoj skupini imala je ER-pozitivnu i/ili PgR-pozitivnu bolest.
English: Compared with published data for similar regimens without pertuzumab, high pCR rates were observed in all 3 treatment arms (see Table 4).
Croatian: U usporedbi s podacima objavljenima za slične protokole bez pertuzumaba, u sve su 3 liječene skupine primijećene visoke stope pCR-a (vidjeti Tablicu 4).
English: 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.
Croatian: Liječenje lijekom Perjeta i trastuzumabom rezultiralo je stopom odgovora od 24,2%, a u dodatnih 25,8% bolesnika došlo je do stabilizacije bolesti koja je potrajala najmanje 6 mjeseci, što ukazuje na to da Perjeta djeluje i nakon progresije bolesti na trastuzumab.
English: Women of childbearing potential should use effective contraception while receiving Perjeta and for 6 months following the last dose of pertuzumab.
Croatian: Žene reproduktivne dobi moraju primjenjivati djelotvornu kontracepciju dok primaju lijek Perjeta i još 6 mjeseci nakon posljednje doze pertuzumaba.
English: When Perjeta attaches to the HER2 cancer cells, it may slow or stop the cancer cells from growing, or may kill them.
Croatian: Kada se Perjeta veže za stanice raka koje sadrže HER2, ona može usporiti ili zaustaviti rast tih stanica ili ih može uništiti.
English: If you are given Perjeta with trastuzumab and chemotherapy at the same time, some side effects may also be due to these other medicines.
Croatian: Ako s lijekom Perjeta istodobno primate trastuzumab i kemoterapiju, neke od nuspojava mogu biti posljedica primjene tih drugih lijekova.
English: Once the infusion is prepared it should be administered immediately (see section 6.3).
Croatian: Infuziju treba primijeniti odmah nakon pripreme (vidjeti dio 6.3).
English: If a significant infusion reaction occurs, the infusion should be slowed down or interrupted and appropriate medical therapies should be administered.
Croatian: Ako dođe do značajne reakcije na infuziju, infuziju treba usporiti ili privremeno prekinuti te uvesti odgovarajuće liječenje.
English: This absence of drug-drug interaction was confirmed by pharmacokinetic data from the NEOSPHERE and APHINITY studies.
Croatian: Taj izostanak interakcija između lijekova potvrdili su farmakokinetički podaci iz ispitivanja NEOPSHERE i APHINITY.
English: Infusion reactions occurred in 18.6% - 25.0% of patients on the first day of Perjeta administration (in combination with trastuzumab and chemotherapy).
Croatian: 18,6% - 25,0% bolesnika prvog dana primjene lijeka Perjeta (u kombinaciji s trastuzumabom i kemoterapijom).
English: Table 6 Efficacy results in subgroups by nodal status and hormone receptor status1 Population
Croatian: Tablica 6 Rezultati djelotvornosti u podskupinama prema statusu zahvaćenosti limfnih čvorova i statusu hormonskih receptora1
English: The breast cancer has been identified to be of the “HER2-positive” form - your doctor will test you for this.
Croatian: • kada je utvrđeno da je rak dojke “HER2 pozitivan” - Vaš će liječnik to utvrditi pretragama
English: When the diarrhoea is under control treatment with pertuzumab may be reinstated.
Croatian: Kad se proljev stavi pod kontrolu, liječenje pertuzumabom može se ponovno započeti.
English: Pertuzumab is a recombinant humanised monoclonal antibody that specifically targets the extracellular dimerization domain (subdomain II) of the human epidermal growth factor receptor 2 protein (HER2), and thereby, blocks ligand-dependent heterodimerisation of HER2 with other HER family members, including EGFR, HER3 and HER4.
Croatian: Pertuzumab je rekombinantno humanizirano monoklonsko protutijelo koje ciljano djeluje na izvanstaničnu dimerizacijsku domenu (poddomenu II) proteina receptora humanog epidermalnog faktora rasta 2 (HER2) i tako blokira heterodimerizaciju receptora HER2 ovisnu o ligandu s drugim članovima obitelji HER receptora, uključujući EGFR, HER3 i HER4.
English: The 420 mg dose of pertuzumab should be administered as soon as possible.
Croatian: Dozu od 420 mg pertuzumaba treba primijeniti što je prije moguće.
English: Dose reductions are not recommended for Perjeta or trastuzumab.
Croatian: Ne preporučuje se smanjivati dozu lijeka Perjeta ni trastuzumaba.
English: Most events were mild to moderate in severity and occurred in the first few cycles of treatment.
Croatian: Većina događaja bili su po težini blagi do umjereni, a javili su se tijekom prvih nekoliko ciklusa liječenja.
English: For further information on dosing of trastuzumab and chemotherapy (which can cause side effects as well), please refer to the package leaflet for these products.
Croatian: Za dodatne informacije o doziranju trastuzumaba i kemoterapije (koji također mogu izazvati nuspojave) pročitajte uputu o lijeku za navedene lijekove.
English: Based on the population pharmacokinetic analysis, no significant difference was observed in the pharmacokinetics of pertuzumab between patients < 65 years (n=306) and patients ≥ 65 years (n=175).
Croatian: U populacijskoj farmakokinetičkoj analizi nije opažena značajna razlika u farmakokinetici pertuzumaba između bolesnika mlađih od 65 godina (n=306) i bolesnika u dobi od ≥ 65 godina (n=175).
English: In this study, cardiac safety was similar to that observed in patients given the same regimen but with Perjeta administered sequentially (following FEC chemotherapy).
Croatian: U tom je ispitivanju sigurnost za srce bila slična onoj opaženoj u bolesnika koji su primali isti protokol, ali uz sekvencijsku primjenu lijeka Perjeta (nakon kemoterapije FEC).
English: HR= hazard ratio; CI= confidence interval; Pla= placebo; Ptz= pertuzumab (Perjeta); T= trastuzumab (Herceptin); D= docetaxel.
Croatian: HR= omjer hazarda; CI= interval pouzdanosti; Pla= placebo; Ptz= pertuzumab (Perjeta); T= trastuzumab (Herceptin); D=docetaksel.
English: Due to the exclusion of patients with brain metastases no data are available on Perjeta activity on brain metastases.
Croatian: S obzirom da u ispitivanje nisu uključivani bolesnici s metastazama u mozgu, nema podataka o djelovanju lijeka Perjeta na moždane metastaze.
English: If the LVEF has declined as indicated in section 4.2 and has not improved, or has declined further at the subsequent assessment, discontinuation of Perjeta and trastuzumab should be strongly considered, unless the benefits for the individual patient are deemed to outweigh the risks.
Croatian: Ako se ejekcijska frakcija lijeve klijetke smanji kako je opisano u dijelu 4.2 te se ne poboljša ili se dodatno pogorša pri sljedećoj ocjeni, neophodno je ozbiljno razmotriti obustavu liječenja lijekom Perjeta i trastuzumabom, osim ako se smatra da su koristi liječenja za pojedinog bolesnika veće od rizika.
English: • a fixed subcutaneous dose of trastuzumab by injection (600 mg) every 3 weeks irrespective of the patient's body weight.
Croatian: • fiksne supkutane doze trastuzumaba injekcijom (600 mg) svaka 3 tjedna, neovisno o bolesnikovoj tjelesnoj težini.
English: In neoadjuvant and adjuvant trials, Perjeta was administered on the same day as other study treatments in all cycles.
Croatian: U ispitivanjima neoadjuvantnog i adjuvantnog liječenja Perjeta se u svim ciklusima primjenjivala istoga dana kad i druge ispitivane terapije.
English: Secondary endpoints included the assessment of patient-reported global health status, role and physical function, and treatment symptoms using the EORTC QLQ-C30 and EORTC QLQ-BR23 questionnaires.
Croatian: Sekundarne mjere ishoda uključivale su bolesnikovu ocjenu općeg zdravstvenog stanja, društvene i tjelesne funkcije te liječenja simptoma uz pomoć upitnika EORTC QLQ-C30 i EORTC QLQ-BR23.
English: As a result, pertuzumab inhibits ligand-initiated intracellular signalling through two major signal pathways, mitogen-activated protein (MAP) kinase and phosphoinositide 3-kinase (PI3K).
Croatian: Time pertuzumab inhibira ligandom potaknutu unutarstaničnu signalizaciju dvama glavnim signalnim putovima: putom mitogenom-aktivirane proteinske (MAP) kinaze i putom fosfoinozitid-3-kinaze (PI3K).
English: The bag should be gently inverted to mix the solution in order to avoid foaming.
Croatian: Za miješanje otopine vrećicu treba nježno preokrenuti kako bi se izbjeglo pjenjenje.
English: 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.
Croatian: • ako ste ikada imali srčanih tegoba (poput zatajenja srca, liječenja zbog ozbiljnih nepravilnosti srčanog ritma, nekontroliranog krvnog tlaka, nedavnog srčanog udara), srčana funkcija će se kontrolirati prije i za vrijeme liječenja lijekom Perjeta, a liječnik će provesti pretrage kako bi provjerio radi li Vam srce ispravno.
English: On the basis of the scientific conclusions for pertuzumab the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing pertuzumab is unchanged subject to the proposed changes to the product information
Croatian: Na temelju znanstvenih zaključaka za pertuzumab, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) pertuzumab nepromijenjen, uz predložene izmjene informacija o lijeku.
English: Do not use this medicine if you notice any particles in the liquid or it is the wrong colour (please see section 6).
Croatian: • Ovaj lijek se ne smije upotrijebiti ako su u tekućini vidljive čestice ili ako je neodgovarajuće boje (pogledajte dio 6.).
English: For full instructions on assay performance and interpretation please refer to the package leaflets of validated HER2 testing assays.
Croatian: Za cjelovite upute o izvođenju testova i interpretaciji nalaza, vidjeti upute priložene u pakiranju validiranih testova na HER2.
English: Cardiac failure congestive**
Croatian: kongestivno zatajenje srca**
English: The indication in the neoadjuvant treatment of breast cancer is based on demonstration of an improvement in pathological complete response rate, and trends to improvement in disease-free survival that nevertheless do not establish or precisely measure a benefit with regard to long-term outcomes, such as overall survival or disease-free survival.
Croatian: Indikacija za primjenu u neoadjuvantnom liječenju raka dojke temelji se na dokazanom poboljšanju stope patološkog potpunog odgovora i trendovima prema poboljšanju preživljenja bez simptoma bolesti, koji ipak ne potvrđuju ili ne omogućuju precizno određivanje koristi s obzirom na dugoročne ishode kao što su ukupno preživljenje ili preživljenje bez simptoma bolesti.
English: Tell your doctor straight away, if you get pregnant during treatment with Perjeta or during the 6 months after stopping treatment.
Croatian: • Odmah obavijestite liječnika ako zatrudnite tijekom liječenja lijekom Perjeta ili unutar 6 mjeseci nakon prestanka liječenja.
English: pCR rates were similar in patients with operable and locally advanced disease.
Croatian: Stope pCR-a bile su slične u bolesnica s operabilnom i onih s lokalno uznapredovalom bolešću.
English: 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.
Croatian: Sveukupno nisu primijećene razlike u djelotvornosti i sigurnosti lijeka Perjeta između bolesnika u dobi od ≥ 65 godina i onih mlađih od 65 godina, uz izuzetak proljeva, čija je incidencija bila povišena u bolesnika u dobi od ≥ 65 godina.
English: Disease Free Survival (DFS)
Croatian: Preživljenje bez simptoma bolesti (DFS)
English: 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).
Croatian: Medijan vremena do smrti bio je 40,8 mjeseci u skupini koja je primala placebo, a 56,5 mjeseci u skupini liječenoj lijekom Perjeta (vidjeti Tablicu 3, Sliku 2).
English: The PK results of pertuzumab in the NEOSPHERE and APHINITY studies were consistent with the predictions from the previous population PK model.
Croatian: Farmakokinetički rezultati pertuzumaba u ispitivanjima NEOSPHERE i APHINITY bili su u skladu s predviđanjima iz prethodnog populacijskog farmakokinetičkog modela.
English: 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.
Croatian: Bilo je premalo bolesnica s upalnim rakom dojke da bi se mogli donijeti bilo kakvi čvrsti zaključci, ali je stopa pCR-a bila viša u bolesnica koje su primale lijek Perjeta plus trastuzumab i docetaksel.
English: A feeling of numbness, prickling or tingling in feet or hands; sharp jabbing, throbbing, freezing or burning pain; feeling pain from something which should not be painful such as a light touch; less able to feel changes in heat or cold; loss of balance or coordination
Croatian: • utrnulost ili trnci u stopalima ili šakama; oštra probadajuća, pulsirajuća, žareća bol; bol uzrokovana nečime što ne bi trebalo biti bolno, kao što je lagan dodir; smanjena sposobnost osjećanja temperaturnih promjena; gubitak ravnoteže ili koordinacije
English: Figure 3 Kaplan-Meier Curve of Invasive Disease Free Survival
Croatian: Slika 3 Kaplan-Meierova krivulja preživljenja bez invazivne bolesti