FrancophonIA/ELRC3.0 huggingface dataset:
English: Diluent:
Croatian: Razrjeđivač:
English: The vaccine must be administered by subcutaneous route or by in ovo route.
Croatian: Cjepivo se mora primijeniti subkutano ili in ovo.
English: - (glass) ampoule of 2,000 doses of vaccine, 4-ampoule carrier.
Croatian: - (staklena) ampula od 2.000 doza cjepiva, nosač s 4 ampula.
English: One single injection of 0.05 ml per chicken egg at 18 days of embryonation, by in ovo route.
Croatian: Jedna injekcija od 0,05 ml po 18-dnevnom embrioniranom jajetu, in ovo.
English: PACKAGE LEAFLET FOR: Vaxxitek HVT+IBD suspension and solvent for suspension for injection
Croatian: UPUTA O VMP ZA: Vaxxitek HVT+IBD suspenzija i razrjeđivač za suspenziju za injekcije
English: Manufacturer responsible for batch release:
Croatian: Proizvođač odgovoran za puštanje proizvodne serije:
English: • Repeat the thawing, opening, transfer and rinsing operations for the appropriate number of ampoules to be reconstituted in the diluent; either 1 ampoule of 1,000 doses of vaccine per 200 ml of diluent (or 1 ampoule of 2,000 doses of vaccine per 400 ml of diluent) for subcutaneous administration, or 4 ampoules of 1,000 doses of vaccine per 200 ml of diluent (or 4 ampoules of 2,000 doses of vaccine per 400 ml of diluent) for in ovo administration.
Croatian: • Ponavljajte postupak otapanja, otvaranja, prijenosa i ispiranja za odgovarajući broj ampula koje treba rekonstituirati u razrjeđivaču, bilo da je u pitanju 1 ampula od 1.000 doza cjepiva na 200 ml diluenta (ili 1 ampula od 2.000 doza cjepiva na 400 ml razrjeđivača) za subkutanu primjenu, ili 4 ampule od 1.000 doza cjepiva na 200 ml razrjeđivača (ili 4 ampule od 2.000 doza cjepiva na 400 ml razrjeđivača) za primjenu in ovo.
English: Laboratory of Lyon Porte des Alpes Rue de l'Aviation, 69800 Saint-Priest France
Croatian: Laboratory od Lyon Porte des Alpes Rue de l'Aviation,
English: Store the diluent below 30°C.
Croatian: Razrjeđivač čuvati na temperaturi ispod 30° C.
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Croatian: POSEBNE MJERE OPREZA ZA ODLAGANJE NEUPOTREBLJENOG PROIZVODA ILI OTPADNIH MATERIJALA, AKO IH IMA
English: Do not use in breeding birds and birds in lay.
Croatian: Ne primjenjivati na nesilicama i pticama za rasplod u vrijeme proizvodnje.
English: Discard any ampoules that have been accidentally thawed.
Croatian: Odbaciti sve nehotično otopljene ampule.
English: PACKAGE LEAFLET FOR STERILE DILUENT
Croatian: PODACI NA UNUTARNJEM PAKOVANJU STERILNI RAZRJEĐIVAČ
English: Manufacturer responsible for batch release
Croatian: Proizvođač odgovoran za puštanje proizvodne serije
English: Read the package leaflet supplied with the vaccine vial.
Croatian: Pročitati uputu o VMP isporučenu s cjepivom u bočici.
English: Reconstitution of the vaccine
Croatian: Rekonstitucija cjepiva
English: Merial Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest France
Croatian: Merial, Laboratoire Porte des Alpes Rue de l'Aviation
English: SC or in ovo route
Croatian: SC ili in ovo.
English: Posology
Croatian: PRIMJENE
English: 1 bag of 200 ml 1 bag of 400 ml 1 bag of 600 ml.
Croatian: 1 vrećica od 200 ml 1 vrećica od 400 ml 1 vrećica od 600 ml 1 vrećica od 800 ml 1 vrećica od 1000 ml 1 vrećica od 1200 ml 1 vrećica od 1400 ml 1 vrećica od 1600 ml 1 vrećica od 1800 ml 1 vrećica od 2400 ml
English: For in ovo route:
Croatian: Za primjenu in ovo:
English: The full EPAR for Palonosetron Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Palonosetron Accord nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It may be given with a corticosteroid (another type of medicine that can be used to prevent nausea and vomiting) to increase the effect.
Croatian: Može se dati s kortikosteroidom (drugom vrstom lijeka koji se može upotrebljavati za sprečavanje mučnine i povraćanja) kako bi se pojačao učinak.
English: It is available as a solution for injection or infusion (drip) into a vein, which should be given by a healthcare professional about 30 minutes before the start of chemotherapy.
Croatian: Dostupan je kao otopina za injekciju ili intravensku infuziju (drip), koju treba dati zdravstveni djelatnik otprilike 30 minuta prije početka kemoterapije.
English: This means that Palonosetron Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Aloxi.
Croatian: To znači da je Palonosetron Accord sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Aloxi.
English: This means that it stops a chemical in the body called 5-hydroxytryptamine (5HT, also known as serotonin) from attaching to 5HT3 receptors in the gut.
Croatian: To znači da sprečava vezivanje kemikalije prisutne u tijelu koja se naziva 5-hidroksitriptamin (5HT, poznata također pod nazivom serotonin) na receptore 5HT3 u crijevima.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Palonosetron Accord has been shown to be comparable to Aloxi.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da je u skladu sa zahtjevima EU-a dokazano da je lijek Palonosetron Accord usporediv s lijekom Aloxi.
English: It is used in adults and children 1 month of age or older for chemotherapy with medicines that are either a strong trigger of nausea and vomiting (such as cisplatin) or a moderate trigger (such as cyclophosphamide, doxorubicin or carboplatin).
Croatian: Primjenjuje se u odraslih osoba i djece u dobi od jednog mjeseca i više za kemoterapiju s lijekovima koji su snažni aktivatori mučnine i povraćanja (poput cisplatina) ili umjereni aktivatori (poput ciklofosfamida, doksorubicina ili karboplatina).
English: Palonosetron Accord should only be given before chemotherapy.
Croatian: Lijek Palonosetron Accord smije se davati samo prije kemoterapije.
English: Because Palonosetron Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Palonosetron Accord generički lijek, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: In children, the solution should be given by infusion into a vein over 15 minutes at a dose of 20 micrograms per kilogram body weight.
Croatian: potrebno primjenjivati intravenskom infuzijom tijekom 15 minuta u dozi od 20 mikrograma po kilogramu tjelesne težine.
English: Palonosetron Accord is a medicine used to prevent nausea (feeling sick) and vomiting caused by chemotherapy (medicines to treat cancer).
Croatian: Palonosetron Accord je lijek koji se upotrebljava za sprečavanje mučnine (osjećaja slabosti) i povraćanja uzrokovanih kemoterapijom (lijekovima koji se koriste za liječenje raka).
English: By blocking these receptors, Palonosetron Accord prevents the nausea and vomiting that often happen after chemotherapy.
Croatian: Blokirajući te receptore, lijek Palonosetron Accord sprečava mučninu i povraćanje do kojih često dolazi nakon kemoterapije.
English: This is a summary of the European public assessment report (EPAR) for Palonosetron Accord.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Palonosetron Accord.
English: What measures are being taken to ensure the safe and effective use of Palonosetron Accord?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Palonosetron Accord?
English: Other information about Palonosetron Accord
Croatian: Ostale informacije o lijeku Palonosetron Accord
English: A risk management plan has been developed to ensure that Palonosetron Accord is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Palonosetron Accord.
English: No additional studies were needed as Palonosetron Accord is a generic medicine that is given by injection and contains the same active substance as the reference medicine, Aloxi.
Croatian: Nisu bila potrebna dodatna ispitivanja jer je Palonosetron Accord generički lijek koji se daje injekcijom i sadržava istu djelatnu tvar kao i referentni lijek Aloxi.
English: The active substance in Palonosetron Accord, palonosetron, is a ‘5HT3 antagonist'.
Croatian: Djelatna tvar u lijeku Palonosetron Accord, palonosetron, jest „antagonist receptora 5HT3”.
English: What is Palonosetron Accord and what is it used for?
Croatian: Što je Palonosetron Accord i za što se koristi?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Palonosetron Accord, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka, kao i u uputi za lijek Palonosetron Accord, nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: The Committee recommended that Palonosetron Accord be approved for use in the EU.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje u promet lijeka Palonosetron Accord u EU-u.
English: It is not intended to provide practical advice on how to use Palonosetron Accord.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Palonosetron Accord.
English: What are the benefits and risks of Palonosetron Accord?
Croatian: Koje su koristi i rizici lijeka Palonosetron Accord?
English: For more information about treatment with Palonosetron Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Palonosetron Accord pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Why is Palonosetron Accord approved?
Croatian: Zašto je Palonosetron Accord odobren?
English: For practical information about using Palonosetron Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Palonosetron Accord pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: Therefore, the CHMP's view was that, as for Aloxi, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a da koristi nadmašuju utvrđeni rizik, kao i za lijek Aloxi.
English: Palonosetron Accord contains the active substance palonosetron.
Croatian: Palonosetron Accord sadržava djelatnu tvar palonosetron.
English: How does Palonosetron Accord work?
Croatian: Kako djeluje Palonosetron Accord?
English: How is Palonosetron Accord used?
Croatian: Kako se Palonosetron Accord koristi?
English: How has Palonosetron Accord been studied?
Croatian: Kako je Palonosetron Accord ispitivan?
English: Γ.Α.Σταμάτης & Σια Λτδ.
Croatian: Κύπρος Γ.Α.Σταμάτης & Σια Λτδ.
English: • Your doctor will monitor you carefully during the first infusion.
Croatian: • Liječnik će Vas pažljivo nadzirati tijekom prve infuzije.
English: 31 July 2021
Croatian: 31. srpnja 2021.
English: Do not try to treat yourself with other medicines.
Croatian: Nemojte se pokušavati sami liječiti drugim lijekovima.
English: Your healthcare professional will throw away any medicines that are no longer being used.
Croatian: Vaš će zdravstveni radnik baciti sve lijekove koji se više ne koriste.
English: Unstratified HR for other exploratory subgroups.
Croatian: Nestratificirani HR za druge eksploracijske podskupine.
English: • Tell your doctor if you are pregnant, think you might be pregnant or are planning to become pregnant.
Croatian: • Obavijestite svog liječnika ako ste trudni, mislite da biste mogli biti trudni ili planirate trudnoću.
English: For the treatment to be fully effective, it is very important to keep having the infusions.
Croatian: Da bi liječenje bilo potpuno učinkovito, vrlo je važno da nastavite primati infuzije.
English: For all subgroup analyses, formal statistical testing was not planned.
Croatian: Ni za jednu analizu podskupina nije bilo planirano formalno statističko testiranje.
English: This medicine should not be given to children or adolescents below 18 years of age.
Croatian: Ovaj se lijek ne smije davati djeci ni adolescentima mlađima od 18 godina.
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator.
Croatian: POSEBNE MJERE ČUVANJA Čuvati u hladnjaku
English: They may happen weeks or months after your last dose.
Croatian: To se može dogoditi tjednima ili mjesecima nakon posljednje doze.
English: Your doctor will keep giving you Tecentriq until you no longer benefit from it.
Croatian: Liječnik će Vam nastaviti davati Tecentriq do trenutka kad od njega više ne budete imali koristi.
English: Median in months
Croatian: Medijan u mjesecima
English: Pack of one vial.
Croatian: Pakiranje od jedne bočice.
English: • Give you other medicines to prevent complications and reduce symptoms.
Croatian: • dati druge lijekove koji će spriječiti komplikacije i ublažiti simptome
English: This includes medicines obtained without a prescription, including herbal medicines.
Croatian: To uključuje i lijekove koje ste nabavili bez recepta, uključujući biljne lijekove.
English: A total of 931 patients were enrolled.
Croatian: U ispitivanje je bio uključen ukupno 931 bolesnik.
English: If you miss an appointment, make another one straight away.
Croatian: Ako propustite doći na termin, odmah dogovorite novi.
English: Efficacy in elderly patients
Croatian: Djelotvornost u starijih bolesnika
English: This is because the effect of Tecentriq in pregnant women is not known - it is possible that it could harm your unborn baby.
Croatian: Naime, nije poznato kako Tecentriq utječe na trudnice - moguće je da bi mogao naškoditi Vašem nerođenom djetetu.
English: • have been told that your cancer has spread to your brain
Croatian: • ako Vam je rečeno da se rak proširio na mozak
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying unique identifier included.
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD Sadrži 2D barkod s jedinstvenim identifikatorom
English: ATC code: L01XC32
Croatian: ATK oznaka: L01XC32
English: This is because stopping treatment may stop the effect of the medicine.
Croatian: Naime, prekid liječenja mogao bi zaustaviti učinak ovog lijeka.
English: This regimen is administered every three weeks for four cycles.
Croatian: Ovaj se protokol primjenjuje svaka tri tjedna tijekom četiri ciklusa.
English: Details on how to minimise the safety concerns through appropriate monitoring and management.
Croatian: Informacije o tome kako minimizirati sigurnosne probleme odgovarajućim praćenjem i liječenjem.
English: Median in months ***
Croatian: Medijan u mjesecima ***
English: The safety and efficacy of Tecentriq in children and adolescents aged below 18 years have not been established.
Croatian: Sigurnost i djelotvornost lijeka Tecentriq u djece i adolescenata mlađih od 18 godina nisu još ustanovljene.
English: Nederland Roche Nederland B.V.
Croatian: Roche Nederland B.V.
English: However, it may be stopped if the side effects become too much of a problem.
Croatian: Međutim, njegova će se primjena možda prekinuti ako nuspojave postanu prevelik problem.
English: • Brief introduction to atezolizumab (indication and purpose of this tool)
Croatian: • Kratak uvod u atezolizumab (indikacija za primjenu i svrha kartice)
English: OTHER SPECIAL WARNING(S), IF NECESSARY Do not shake the vial
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Bočica se ne smije tresti
English: Tecentriq is available in a pack containing 1 glass vial.
Croatian: Tecentriq je dostupan u pakiranju koje sadrži 1 staklenu bočicu.
English: The study enrolled a total of 438 patients and had two patient cohorts.
Croatian: U ispitivanje je bilo uključeno ukupno 438 bolesnika, a imalo je dvije kohorte.
English: Before your treatment, your doctor will check your general health.
Croatian: Liječnik će prije liječenja provjeriti Vaše opće zdravstveno stanje.
English: • If you could become pregnant, you must use effective contraception; while you are being treated with Tecentriq and for 5 months after the last dose.
Croatian: • Ako možete zatrudnjeti, morate koristiti učinkovitu kontracepciju: dok se liječite lijekom Tecentriq i još 5 mjeseci nakon posljednje doze.
English: • You will not be given Tecentriq if you are pregnant unless your doctor considers it necessary.
Croatian: • Nećete primiti Tecentriq ako ste trudni, osim ako liječnik ne zaključi da je to neophodno.
English: However, monoclonal antibodies are not expected to alter DNA or chromosomes.
Croatian: Međutim, ne očekuje se da će monoklonska protutijela izmijeniti DNK ili kromosome.
English: Tecentriq may cause some side effects that you must tell your doctor about straight away.
Croatian: Tecentriq može uzrokovati neke nuspojave o kojima odmah morate obavijestiti svog liječnika.
English: The primary analysis was performed when all patients had at least 24 weeks of follow-up.
Croatian: Primarna analiza provedena je kada su svi bolesnici imali najmanje 24 tjedna praćenja.
English: The recommended dose is either:
Croatian: Preporučena doza je:
English: • No decline in ECOG performance status
Croatian: • nema pogoršanja ECOG funkcionalnog statusa
English: The median survival follow-up is 17 months.
Croatian: Medijan praćenja preživljenja iznosio je 17 mjeseci.
English: • have or have had chronic viral infection of the liver, including hepatitis B (HBV) or hepatitis C
Croatian: • ako imate ili ste nekada imali kroničnu virusnu infekciju jetre, uključujući hepatitis B (HBV) ili hepatitis C (HCV)
English: • Absence of tumour progression at critical anatomical sites (e.g., leptomeningeal disease) that cannot be readily managed and stabilised by protocol-allowed medical interventions prior to repeat dosing
Croatian: • izostanak tumorske progresije na kritičnim anatomskim mjestima (npr. leptomeningealna bolest) koja se ne može jednostavno zbrinuti i stabilizirati medicinskim intervencijama dopuštenima prema protokolu prije ponovljenog doziranja
English: Tell your doctor straight away if you notice any of the symptoms below:
Croatian: Odmah obavijestite svog liječnika ako primijetite bilo koji od sljedećih simptoma:
English: Further details on serious adverse reactions are provided in Section 4.4 Warnings & Precautions.
Croatian: Više pojedinosti o ozbiljnim nuspojavama navedeno je u dijelu 4.4 Upozorenja i mjere opreza.
English: Overall, ADA status appeared to have no clinically relevant impact on safety.
Croatian: Sveukupno se čini da status protutijela na lijek nije imao klinički značajnog utjecaja na sigurnost.
English: • Absence of symptoms and signs (including worsening of laboratory values [e.g., new or worsening hypercalcaemia]) indicating unequivocal progression of disease
Croatian: • izostanak simptoma i znakova (uključujući pogoršanje laboratorijskih vrijednosti [npr. razvoj ili pogoršanje hiperkalcijemije]) koji ukazuju na neupitnu progresiju bolesti
English: Your doctor may:
Croatian: Liječnik će Vam možda:
English: The stratified log-rank p-value was 0.41 and therefore the results are considered not statistically significant in this population.
Croatian: Stratificirana log-rang p-vrijednost iznosila je 0,41, pa se rezultati u toj populaciji ne smatraju statistički značajnima.
English: The median age was 73 years.
Croatian: Medijan dobi iznosio je 73 godine.
English: The use of in-line filter membranes is optional.
Croatian: Uporaba ugrađenih filtarskih membrana nije obavezna.
English: • Warning message for patients on the importance of consulting their doctor immediately in case they develop any of the listed signs and symptoms and on the important not attempting to treat themselves.
Croatian: • Poruku upozorenja za bolesnike o tome koliko je važno da se odmah posavjetuju sa svojim liječnikom ako se pojavi bilo koji od navedenih znakova ili simptoma i o tome koliko je važno da se ne pokušavaju sami liječiti.
English: • have an auto-immune disease (a condition where the body attacks its own cells)
Croatian: • ako imate autoimunu bolest (bolest kod koje tijelo napada vlastite stanice)
English: Submission of study results: 31 December
Croatian: Podnošenje rezultata ispitivanja: 31. prosinca 2020.
English: Ask your doctor if you should stop breast-feeding or if you should stop treatment with Tecentriq.
Croatian: Pitajte svog liječnika trebate li prestati dojiti ili prekinuti liječenje lijekom Tecentriq.
English: No data are available to allow conclusions to be drawn on possible effects of neutralising antibodies.
Croatian: Nema dostupnih podataka na temelju kojih bi se mogli donijeti zaključci o mogućim učincima neutralizirajućih protutijela.
English: • Information that atezolizumab can cause serious side effects during or after treatment, that need to be treated right away
Croatian: • Informacije o tome da atezolizumab može uzrokovati ozbiljne nuspojave tijekom ili nakon liječenja, koje treba odmah liječiti
English: • you are allergic to atezolizumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na atezolizumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: As a consequence, no formal tests of statistical significance could be performed for OS in the IC1/2/3 or all comer populations, and results of those analyses would be considered exploratory.
Croatian: Zbog toga se nisu mogli provesti formalni testovi statističke značajnosti za OS u populaciji IC1/2/3 ni u populaciji svih uključenih bolesnika, a rezultati tih analiza smatrali bi se eksploracijskima.
English: Aseptic preparation, handling and storage
Croatian: Aseptična priprema, rukovanje i čuvanje
English: Primary efficacy endpoints n=185
Croatian: Primarne mjere ishoda za djelotvornost n=185
English: Date of first authorisation: 21 September 2017
Croatian: Datum prvog odobrenja: 21. rujan 2017.
English: 3 weeks until disease progression.
Croatian: 3-tjednog ciklusa do progresije bolesti.
English: Rare: may affect up to 1 in 1,000 people • inflammation of the heart muscle
Croatian: Rijetke: mogu se javiti u do 1 na 1000 osoba • upala srčanog mišića
English: The systemic accumulation in area under the curve, maximum concentration and trough concentration was 1.91, 1.46 and 2.75-fold, respectively.
Croatian: Sistemska akumulacija u području ispod krivulje, maksimalna koncentracija i najniža koncentracija povećale su se 1,91, 1,46 odnosno 2,75 puta.
English: Immune-related adverse reactions affecting more than one body system have been observed.
Croatian: Primijećene su imunološki uzrokovane nuspojave koje su zahvatile više od jednog tjelesnog sustava.
English: The recommended dose of Tecentriq is:
Croatian: Preporučena doza lijeka Tecentriq je:
English: The Marketing Authorisation Holder shall submit the first periodic safety update report for this product within 6 months following authorisation.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet će prvo periodičko izvješće o neškodljivosti za ovaj lijek dostaviti unutar 6 mjeseci nakon dobivanja odobrenja.
English: Your first infusion will be given over 60 minutes.
Croatian: Prvu ćete infuziju primati tijekom 60 minuta.
English: Ireland Roche Products (Ireland) Ltd.
Croatian: Roche Products (Ireland) Ltd.
English: Do not stop treatment with Tecentriq unless you have discussed this with your doctor.
Croatian: Nemojte prekinuti liječenje lijekom Tecentriq ako o tome prethodno niste razgovarali sa svojim liječnikom.
English: What Tecentriq looks like and contents of the pack
Croatian: Kako Tecentriq izgleda i sadržaj pakiranja
English: It is important that you also read the package leaflet for these medicines.
Croatian: Važno je da pročitate i uputu o lijeku za te lijekove.
English: No dose adjustments are recommended.
Croatian: Nisu preporučene nikakve druge promjene.
English: The primary efficacy outcome was overall survival.
Croatian: Primarna mjera ishoda za djelotvornost bilo je ukupno preživljenje.