FrancophonIA/ELRC3.0 huggingface dataset:
English: This protein suppresses the body's immune (defense) system, thereby protecting cancer cells from being attacked by the immune cells.
Croatian: Taj protein potiskuje imunosni (obrambeni) sustav tijela i tako štiti stanice raka od napada imunosnih stanica.
English: The MAH shall ensure that in each Member State where Tecentriq is marketed, all healthcare professionals and patients/carers who are expected to prescribe and use Tecentriq have access to/are provided with the following educational package:
Croatian: Nositelj odobrenja osigurat će da u svakoj zemlji članici gdje je Tecentriq stavljen u promet svi zdravstveni radnici i bolesnici/skrbnici za koje se očekuje da će propisivati i primjenjivati Tecentriq imaju pristup/dobiju sljedeći edukacijski paket:
English: What Tecentriq is and what it is used for What you need to know before you are given Tecentriq How Tecentriq is given
Croatian: Što je Tecentriq i za što se koristi Što morate znati prije nego počnete primati Tecentriq Kako se Tecentriq primjenjuje Moguće nuspojave
English: Other medicines and Tecentriq
Croatian: Drugi lijekovi i Tecentriq
English: Antibodies are cleared principally by catabolism.
Croatian: Protutijela se iz tijela uklanjaju prvenstveno katabolizmom.
English: If you notice any of the symptoms above, tell your doctor straight away.
Croatian: Ako primijetite bilo koji od gore navedenih simptoma, odmah obavijestite svog liječnika.
English: The following categories of frequency have been used: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to
Croatian: Koriste se sljedeće kategorije učestalosti: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000).
English: • performed under aseptic conditions by trained personnel in accordance with good practice rules especially with respect to the aseptic preparation of parenteral products.
Croatian: • Pripremu treba provoditi obučeno osoblje u aseptičnim uvjetima i u skladu s pravilima dobre prakse, osobito onima koja se odnose na aseptičnu pripremu lijekova za parenteralnu primjenu.
English: Reduce infusion rate or interrupt.
Croatian: Smanjiti brzinu infuzije ili privremeno prekinuti njezinu primjenu.
English: The bag should be gently inverted to mix the solution in order to avoid foaming.
Croatian: Vrećicu treba nježno preokrenuti kako bi se otopina pomiješala, a izbjeglo pjenjenje.
English: Isolated hypothyroidism may be managed with replacement therapy and without corticosteroids.
Croatian: Izolirana hipotireoza može se liječiti nadomjesnom terapijom i bez kortikosteroida.
English: A monoclonal antibody is a type of protein designed to recognise and attach to a specific target in the body.
Croatian: Monoklonska protutijela su vrsta proteina oblikovana tako da prepoznaju specifičnu ciljnu tvar u tijelu i pričvrste se za nju.
English: What you need to know before you are given Tecentriq
Croatian: Što morate znati prije nego počnete primati Tecentriq
English: * The primary analysis population consists of the first 850 randomised patients
Croatian: *Populaciju za primarnu analizu čini prvih 850 randomiziranih bolesnika
English: OS results for each of steps 2 and 3 could be formally tested for statistical significance only if the result in the preceding step was statistically significant.
Croatian: Statistička značajnost rezultata za OS u 2. koraku i 3. koraku mogla se formalno ispitati samo ako su rezultati u prethodnom koraku bili statistički značajni.
English: Tecentriq will be stored by the healthcare professionals at the hospital or clinic.
Croatian: Tecentriq će čuvati zdravstveni radnici u bolnici ili klinici.
English: 12.3 (6.0, NE)
Croatian: 12,3 (6,0; NP)
English: • allergic reaction (infusion-related reaction, hypersensitivity or anaphylaxis)
Croatian: • alergijska reakcija (reakcija na infuziju, preosjetljivost ili anafilaksija)
English: The initial dose of Tecentriq must be administered over 60 minutes.
Croatian: Početna doza lijeka Tecentriq mora se primijeniti tijekom razdoblja od 60 minuta.
English: No dose reduction was allowed.
Croatian: Nije bilo dopušteno smanjivati dozu.
English: • numbness or paralysis, which may be signs of Guillain-Barré syndrome
Croatian: • utrnulost ili paraliza, što mogu biti znakovi “Guillain-Barréova sindroma“
English: The management guidelines for these adverse reactions are described in sections 4.2 and 4.4.
Croatian: Smjernice za zbrinjavanje tih nuspojava opisane su u dijelovima 4.2 i 4.4.
English: • nerve damage resulting in possible numbness, pain, and/or loss of motor function (peripheral neuropathy)
Croatian: • oštećenje živaca koje može dovesti do utrnulosti, boli i/ili gubitka motoričke funkcije (periferna neuropatija)
English: Dose modifications during treatment
Croatian: Prilagodbe doze tijekom liječenja
English: Among 107 Arm B patients who had a response status of stable disease, partial response, or complete response after induction therapy, 40 received pemetrexed switch maintenance therapy.
Croatian: Među 107 bolesnika iz skupine B koji su nakon uvodnog liječenja imali stabilnu bolest, djelomičan odgovor ili potpun odgovor, njih 40 prešlo je na terapiju održavanja pemetreksedom.
English: The effect of age on the pharmacokinetics of atezolizumab was assessed in a population pharmacokinetic analysis.
Croatian: Učinak dobi na farmakokinetiku atezolizumaba ocjenjivao se u populacijskoj farmakokinetičkoj analizi.
English: • myasthenia gravis, an illness that can cause muscle weakness
Croatian: • miastenija gravis - bolest koja može uzrokovati slabost mišića
English: The key results from this analysis as well as from the updated PFS analysis in the ITT population are summarised in Tables 6 and 7.
Croatian: Ključni rezultati te analize, kao i analize ažuriranih podataka za PFS u ITT populaciji, sažeto su prikazani u Tablicama 6 i 7.
English: Polska Roche Polska Sp.z o.o.
Croatian: Roche Polska Sp.z o.o.
English: You must not be given Tecentriq if:
Croatian: Ne smijete primiti Tecentriq:
English: How long treatment lasts
Croatian: Koliko dugo traje liječenje
English: In order to improve the traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded in the patient file.
Croatian: Kako bi se poboljšala sljedivost bioloških lijekova, naziv i broj serije primijenjenog lijeka potrebno je jasno evidentirati u zdravstvenom kartonu bolesnika.
English: Seven (0.2%) patients required the use of corticosteroids.
Croatian: U sedam (0,2%) bolesnika bila je potrebna primjena kortikosteroida.
English: * An analysis of OS in the all comer population was performed based on the stratified log-rank test and the result is provided for descriptive purposes only (p = 0.0378); according to the pre-specified analysis hierarchy, the p-value for the OS analysis in the all comer population cannot be considered statistically significant.
Croatian: *Analiza OS-a u populaciji svih uključenih bolesnika provedena je na temelju stratificiranog log-rang testa, a rezultat se navodi samo za ilustraciju (p=0,0378); prema unaprijed specificiranoj hijerarhijskoj analizi, p-vrijednost za analizu OS-a u populaciji svih uključenih bolesnika ne može se smatrati statistički značajnom.
English: Treatment with atezolizumab until loss of clinical benefit was permitted as defined by the following criteria:
Croatian: Liječenje atezolizumabom bilo je dopušteno do gubitka kliničke koristi, koju definiraju sljedeći kriteriji:
English: Description of the signs and symptoms of immune-related adverse reactions.
Croatian: Opis znakova i simptoma imunološki uzrokovanih nuspojava.
English: • elevated liver enzymes (shown in tests), which may be a sign of an inflamed liver
Croatian: • povišene vrijednosti jetrenih enzima (vide se u nalazima pretraga), koje mogu biti znak upale jetre
English: It belongs to a group of medicines called monoclonal antibodies.
Croatian: Pripada skupini lijekova pod nazivom monoklonska protutijela.
English: Tecentriq has minor influence on your ability to drive and use machines.
Croatian: Tecentriq malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Talk to your doctor or nurse before you are given Tecentriq if you:
Croatian: Obratite se svom liječniku ili medicinskoj sestri prije nego što primite Tecentriq:
English: All prescribers of Tecentriq must be familiar with the Physician Information and Management Guidelines.
Croatian: Svi liječnici koji propisuju Tecentriq moraju biti upoznati s informacijama za liječnike i smjernicama za liječenje.
English: Permanently discontinue Tecentriq (except endocrinopathies controlled with replacement hormones)
Croatian: Trajno prekinuti liječenje lijekom Tecentriq (osim u slučaju endokrinopatija kontroliranih hormonskom nadomjesnom terapijom)
English: Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with systemic corticosteroid use, administration of other systemic immunosuppressants may be considered.
Croatian: Temeljem ograničenih podataka iz kliničkih ispitivanja u bolesnika u kojih se imunološki uzrokovane nuspojave nisu mogle kontrolirati sistemskim kortikosteroidima, može se razmotriti i primjena drugih sistemskih imunosupresiva.
English: Tecentriq must be initiated and supervised by physicians experienced in the treatment of cancer.
Croatian: Liječenje lijekom Tecentriq moraju započeti i nadzirati liječnici koji imaju iskustva s liječenjem raka.
English: Treatment may be resumed when the event is resolved
Croatian: Liječenje se može nastaviti nakon što se reakcija povuče
English: What Tecentriq is and what it is used for
Croatian: Što je Tecentriq i za što se koristi
English: Rare hypophysitisk
Croatian: Rijetko hipofizitisk
English: By attaching to the protein, Tecentriq helps your immune system to fight your cancer.
Croatian: Pričvršćivanjem za taj protein Tecentriq pomaže imunosnom sustavu da se bori protiv raka.
English: Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and bilirubin should be monitored prior to initiation of treatment, periodically during treatment with atezolizumab and as indicated based on clinical evaluation.
Croatian: Vrijednosti aspartat aminotransferaze (AST), alanin aminotransferaze (ALT) i bilirubina treba kontrolirati prije početka liječenja atezolizumabom, periodički tijekom liječenja i kada je indicirano na temelju kliničke procjene.
English: Approximately half the patients had received a taxane (51%) or anthracycline (54%) in the (neo)adjuvant setting.
Croatian: Približno je polovica bolesnika prethodno primala taksan (51%) ili antraciklin (54%) za (neo)adjuvantno liječenje.
English: A population pharmacokinetic analysis indicates that the clearance of atezolizumab is 0.200 L/day and the typical terminal elimination half-life is 27 days.
Croatian: Populacijska farmakokinetička analiza ukazuje na to da klirens atezolizumaba iznosi 0,200 l/dan, a tipično terminalno poluvrijeme eliminacije je 27 dana.
English: Patients with Grade 1 or 2 infusion-related reactions may continue to receive atezolizumab with close monitoring; premedication with antipyretic and antihistamines may be considered.
Croatian: Bolesnici s reakcijama na infuziju 1. ili 2. stupnja mogu nastaviti primati atezolizumab pod strogim nadzorom, a može se razmotriti i premedikacija antipiretikom i antihistaminicima.
English: România Roche România S.R.L.
Croatian: Roche România S.R.L.
English: Due to increased haematologic toxicities observed in Asian patients in IMpower150, it is recommended that the starting dose of paclitaxel should be 175 mg/m2 every three weeks.
Croatian: S obzirom na povećanu hematološku toksičnost opaženu u bolesnika azijskog podrijetla u ispitivanju IMpower150, preporučuje se početna doza paklitaksela od 175 mg/m2 svaka tri tjedna.
English: From a microbiological point of view, the prepared solution for infusion should be used immediately.
Croatian: S mikrobiološkog stanovišta, pripremljenu otopinu za infuziju treba odmah primijeniti.
English: • If you become pregnant while you are being treated with Tecentriq tell your doctor.
Croatian: • Ako zatrudnite tijekom liječenja lijekom Tecentriq, obavijestite o tome svog liječnika.
English: • The card should also prompt to enter contact details of the physician and include a warning message for healthcare professionals treating the patient at any time, including in conditions of emergency, that the patient is using Tecentriq.
Croatian: • Na kartici treba istaknuti i da treba navesti kontaktne podatke liječnika, a kartica mora uključivati i upozorenje za zdravstvene radnike koji će u bilo kojem trenutku liječiti bolesnika (uključujući u hitnim slučajevima) da se kod bolesnika primjenjuje Tecentriq.
English: (10.0, NE)
Croatian: (10,0; NP)
English: • protein in urine (proteinuria)
Croatian: • proteini u mokraći (proteinurija)
English: • have had serious side effects because of other antibody therapies that help your immune system to fight cancer
Croatian: • ako ste nekada imali ozbiljne nuspojave uzrokovane liječenjem drugim protutijelima koja pomažu imunosnom sustavu u borbi protiv raka
English: Treatment with atezolizumab could be continued when nab-paclitaxel was stopped due to unacceptable toxicity.
Croatian: Liječenje atezolizumabom moglo se nastaviti kada je primjena nab-paklitaksela prekinuta zbog neprihvatljive toksičnosti.
English: A total of 1,225 patients were enrolled and per the analysis plan the first 850 randomised patients were included in the primary efficacy analysis.
Croatian: Ukupno je bilo uključeno 1225 bolesnika, a prvih 850 randomiziranih bolesnika uključeno je u primarnu analizu djelotvornosti, prema planu analiza.
English: OS was not mature with an event patient ratio of approximately 40%.
Croatian: Podaci za OS nisu bili zreli, a omjer događaja i bolesnika iznosio je približno 40%.
English: • Evidence of clinical benefit as assessed by the investigator
Croatian: • dokazi kliničke koristi prema ocjeni ispitivača
English: Based on exploratory analysis and acknowledging the small sample size, the presence of BRCA1/2 mutation does not seem to impact the PFS clinical benefit of atezolizumab and nab-paclitaxel.
Croatian: Sudeći prema eksploracijskoj analizi i uzimajući u obzir malu veličinu uzorka, čini se da prisutnost mutacije BRCA1/2 ne utječe na kliničku korist atezolizumaba i nab-paklitaksela u smislu PFS-a.
English: Triple-negative breast cancer
Croatian: Trostruko negativan rak dojke
English: The schedule of administration must be adjusted to maintain the appropriate interval between doses.
Croatian: Raspored primjene mora se prilagoditi tako da se održi odgovarajući interval između doza.
English: Patients experiencing fatigue should be advised not to drive and use machines until symptoms abate (see section 4.8).
Croatian: Bolesnicima koji osjećaju umor treba savjetovati da ne upravljaju vozilima i da ne rade sa strojevima dok im se simptomi ne povuku (vidjeti dio 4.8).
English: • have human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome
Croatian: • ako imate infekciju virusom humane imunodeficijencije (HIV) ili sindrom stečene imunodeficijencije (AIDS)
English: The majority of patients had a baseline ECOG performance status of 1 (59%) and PDL1 expression <1% (approximately 52%).
Croatian: Većina bolesnika imala je početni funkcionalni ECOG status 1 (59%) i ekspresiju PD-L1 < 1% (približno 52%).
English: In the IMpassion130 study, of the 614 patients tested, 89 (15%) carried pathogenic BRCA1/2 mutations.
Croatian: Od 614 bolesnika testiranih u sklopu ispitivanja IMpassion130, njih 89 (15%) bili su nositelji patogenih mutacija BRCA1/2.
English: 6.6 Special precautions for disposal and other handling Tecentriq does not contain any antimicrobial preservative or bacteriostatic agents and should be prepared by a healthcare professional using aseptic technique to ensure the sterility of prepared solutions.
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Tecentriq ne sadrži antimikrobne konzervanse ni bakteriostatska sredstva i treba ga pripremiti zdravstveni radnik primjenom aseptične tehnike kako bi se osigurala sterilnost pripremljenih otopina.
English: There were 24.2% of patients who received only prior platinum-containing adjuvant or neoadjuvant therapy and progressed within 12 months.
Croatian: Bilo je 24,2% bolesnika koji su prethodno primali samo adjuvantnu ili neoadjuvantnu terapiju koja je sadržavala platinu i doživjeli progresiju unutar 12 mjeseci.
English: Deutschland Roche Pharma AG
Croatian: Roche Pharma AG
English: Body weight, gender, positive ADA status, albumin levels and tumour burden have a statistically significant, but not clinically relevant effect on atezolizumab pharmacokinetics.
Croatian: Tjelesna težina, spol, pozitivan nalaz na protutijela na lijek, vrijednosti albumina i tumorsko opterećenje imaju statistički značajan, ali ne i klinički važan učinak na farmakokinetiku atezolizumaba.
English: For instructions on dilution and handling of the medicinal product before administration, see section 6.6.
Croatian: Za upute o razrjeđivanju i rukovanju lijekom prije primjene vidjeti dio 6.6.
English: For suspected immune-related adverse reactions, thorough evaluation to confirm aetiology or exclude other causes should be performed.
Croatian: Ako se sumnja na imunološki uzrokovane nuspojave, potrebno je provesti detaljnu procjenu kako bi se potvrdila etiologija ili isključili drugi uzroci.
English: There was no effect on the male reproductive organs.
Croatian: Nije bilo učinaka na reproduktivne organe mužjaka.
English: The time to onset was 1.2 months.
Croatian: Vrijeme do nastupa iznosilo je 1,2 mjeseca.
English: No studies have been conducted to investigate the pharmacokinetics of atezolizumab in children or adolescents.
Croatian: Nisu provedena ispitivanja kojima bi se istražila farmakokinetika atezolizumaba u djece ili adolescenata.
English: Atezolizumab is a monoclonal antibody and is expected to be present in the first milk and at low levels afterwards.
Croatian: Budući da je atezolizumab monoklonsko protutijelo, očekuje se da će biti prisutan u prvom mlijeku, a u niskim koncentracijama i nakon toga.
English: Women of childbearing potential have to use effective contraception during and for 5 months after treatment with atezolizumab.
Croatian: Žene reproduktivne dobi moraju koristiti učinkovitu metodu kontracepcije tijekom liječenja i još 5 mjeseci nakon liječenja atezolizumabom.
English: Atezolizumab should not be used during pregnancy unless the clinical condition of the woman requires treatment with atezolizumab.
Croatian: Atezolizumab se ne smije primjenjivati tijekom trudnoće, osim u slučajevima kada kliničko stanje žene zahtijeva liječenje atezolizumabom.
English: Asian patients
Croatian: Bolesnici azijskog podrijetla
English: • pain in the muscles and bones
Croatian: • bol u mišićima i kostima
English: In the absence of data, atezolizumab should be used with caution in these populations after careful evaluation of the balance of benefits and risks for the patient.
Croatian: Zbog nedostatka podataka, atezolizumab u tim populacijama treba primjenjivati uz oprez nakon pažljive procjene omjera koristi i rizika za bolesnika.
English: Since atezolizumab is cleared from the circulation through catabolism, no metabolic drug-drug interactions are expected.
Croatian: Budući da se atezolizumab eliminira iz cirkulacije katabolizmom, ne očekuju se metaboličke interakcije s drugim lijekovima.
English: However, systemic corticosteroids or other immunosuppressants can be used to treat immune-related adverse reactions after starting atezolizumab (see section 4.4).
Croatian: Međutim, sistemski kortikosteroidi ili drugi imunosupresivi mogu se primjenjivati za liječenje imunološki uzrokovanih nuspojava nakon uvođenja atezolizumaba (vidjeti dio 4.4).
English: Tecentriq is used to treat adults with:
Croatian: Tecentriq se koristi za liječenje odraslih bolesnika koji imaju:
English: If you stop receiving Tecentriq
Croatian: Ako prestanete primati Tecentriq
English: This means the lung cancer has: spread to other parts of the body come back after previous treatment.
Croatian: To znači da se rak pluća: proširio u druge dijelove tijela vratio nakon prethodnog liječenja
English: Most patients were women (99.6%), 67.5% were white and 17.8% Asian.
Croatian: Većina bolesnika bila je ženskog spola (99,6%), 67,5% njih bili su bijelci, a 17,8% azijskog podrijetla.
English: If a planned dose of Tecentriq is missed, it should be administered as soon as possible.
Croatian: Ako bolesnik propusti primiti planiranu dozu lijeka Tecentriq, treba je primijeniti što je prije moguće.
English: ‡ Stratified by presence of liver metastases, and by prior taxane treatment.
Croatian: Stratifikacija prema prisutnosti jetrenih metastaza i prethodnom liječenju taksanima.
English: Treatment beyond disease progression was permitted at the discretion of the physician.
Croatian: Nastavak liječenja nakon progresije bolesti bio je dopušten sukladno odluci liječnika.
English: These results indicate a potential risk, based on its mechanism of action, that administration of atezolizumab during pregnancy could cause foetal harm, including increased rates of abortion or stillbirth.
Croatian: Ovi rezultati upućuju na mogući rizik da bi zbog mehanizma djelovanja atezolizumaba njegova primjena u trudnoći mogla naškoditi plodu te tako dovesti do povećanih stopa pobačaja ili mrtvorođenja.
English: • prepared in a laminar flow hood or biological safety cabinet using standard precautions for the safe handling of intravenous agents.
Croatian: • Pripremu treba provoditi u komori s laminarnim protokom zraka ili u biološki sigurnom kabinetu primjenjujući standardne mjere opreza za sigurno rukovanje lijekovima za intravensku primjenu.
English: Treatment beyond disease progression may be considered at the discretion of the physician (see section 5.1).
Croatian: Nastavak liječenja nakon progresije bolesti može se razmotriti sukladno odluci liječnika (vidjeti dio 5.1).
English: Tecentriq works by attaching to a specific protein in your body called programmed death-ligand 1 (PD-L1).
Croatian: Tecentriq djeluje tako da se pričvrsti za specifičan protein u Vašem tijelu, koji se zove ligand receptora programirane stanične smrti 1 (PD-L1).
English: Median duration of treatment was 15.0 weeks and median duration of survival follow-up was 8.5 months in all comers.
Croatian: Medijan trajanja liječenja iznosio je 15,0 tjedana, dok je medijan praćenja preživljenja iznosio 8,5 mjeseci u svih uključenih bolesnika.
English: • Do not use this medicine after the expiry date which is stated on the carton and the vial label after EXP.
Croatian: • Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici bočice iza oznake “Rok valjanosti“ ili “EXP“.
English: Etoposide is also administered by intravenous infusion on days 2 and 3.
Croatian: Etopozid se uz to primjenjuje i intravenskom infuzijom 2. i 3. dana.
English: You will be given Tecentriq by a doctor experienced in cancer treatment in a hospital or clinic.
Croatian: Tecentriq će Vam dati Vam liječnik koji ima iskustva s liječenjem raka, u bolnici ili klinici.
English: Includes reports of encephalitis, meningitis, photophobia.
Croatian: Uključuje prijavljene slučajeve encefalitisa, meningitisa, fotofobije.
English: Atezolizumab must be permanently discontinued for any Grade 3 immune-related adverse reaction that recurs and for any Grade 4 immune-related adverse reactions, except for endocrinopathies that are controlled with replacement hormones (see sections 4.2 and 4.8).
Croatian: Liječenje atezolizumabom mora se trajno prekinuti u slučaju bilo koje imunološki uzrokovane nuspojave 3. stupnja koja se ponovno javi ili u slučaju bilo koje imunološki uzrokovane nuspojave 4. stupnja, izuzev endokrinopatija kontroliranih hormonskom nadomjesnom terapijom (vidjeti dijelove 4.2 i 4.8).
English: The recommended dose is 1,200 milligrams (mg) every three weeks.
Croatian: Preporučena doza je 1200 miligrama (mg) svaka tri tjedna.
English: The time to onset was 18 and 33 days.
Croatian: Vrijeme do nastupa kretalo se u rasponu od 18 do 33 dana.