FrancophonIA/ELRC3.0 huggingface dataset:
English: Further doses of 1,000 mg are then given on days 8 and 15 of the first cycle.
Croatian: Potom se daljnje doze od 1 000 mg daju 8. i 15. dana prvog ciklusa.
English: What is Gazyvaro and what is it used for?
Croatian: Što je Gazyvaro i za što se koristi?
English: A dose of 100 mg of Gazyvaro is given on day one of the first cycle under close supervision of an experienced doctor who should monitor the patient for infusion-related reactions.
Croatian: Doza lijeka Gazyvaro od 100 mg daje se prvog dana prvog ciklusa pod strogim nadzorom iskusnog liječnika koji mora nadzirati bolesnika u slučaju reakcija povezanih s infuzijom.
English: • previously untreated chronic lymphocytic leukaemia (CLL).
Croatian: • prethodno neliječene kronične limfocitne leukemije (KLL).
English: The European Medicines Agency decided that Gazyvaro's benefits are greater than its risks and recommended that it be approved for use in the European Union (EU).
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Gazyvaro nadmašuju s njim povezane rizike te je preporučila njegovo odobrenje za primjenu u Europskoj uniji.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Gazyvaro have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Gazyvaro nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: The summaries of the opinion of the Committee for Orphan Medicinal Products for Gazyvaro can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation (CLL and FL).
Croatian: Sažetak mišljenja Odbora za lijekove za rijetke bolesti o lijeku Gazyvaro možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation (CLL and FL).
English: Patients may also be given other medicines to prevent infusion-related reactions and other side effects.
Croatian: Bolesnici mogu primiti i druge lijekove kako bi se smanjio rizik od pojave reakcija povezanih s infuzijom i drugih nuspojava.
English: In CLL and FL, cancerous B-lymphocytes multiply too quickly and replace the normal cells in the bone marrow (where blood cells are made) and in lymph nodes.
Croatian: U slučaju KLL-a i FL-a, kancerogeni B-limfociti umnožavaju se prebrzo i zamjenjuju normalne stanice u koštanoj srži (gdje nastaju krvne stanice) i u limfnim čvorovima.
English: It is also used with the medicine bendamustine in patients whose disease has not responded to treatment involving the medicine rituximab or whose cancer has progressed during or up to 6 months after such treatment.
Croatian: Također se primjenjuje uz lijek bendamustin u bolesnika čija bolest nije odgovorila na terapiju koja je uključivala lijek rituksimab ili u kojih je rak uznapredovao tijekom te terapije ili do 6 mjeseci nakon terapije.
English: It is not intended to provide practical advice on how to use Gazyvaro.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Gazyvaro.
English: For the remaining 5 cycles, Gazyvaro 1,000 mg is given on day one only.
Croatian: Tijekom preostalih 5 ciklusa lijek Gazyvaro od 1 000 mg daje se samo prvoga dana.
English: CLL is a cancer of B-lymphocytes, a type of white blood cell.
Croatian: KLL je rak B-limfocita, vrste bijelih krvnih stanica.
English: • follicular lymphoma (FL), another type of cancer of B-lymphocytes.
Croatian: • folikularnog limfoma (FL), još jedne vrste raka B-limfocita.
English: For the remaining cycles, the dose is given on day one only.
Croatian: Tijekom preostalih ciklusa doza se daje samo prvoga dana.
English: Gazyvaro is available as a concentrate that is made up into a solution for infusion (drip) into a vein and given over several hours.
Croatian: Lijek Gazyvaro dostupan je kao koncentrat za otopinu za infuziju (drip) u venu i daje se tijekom nekoliko sati.
English: Gazyvaro is a cancer medicine used to treat adult patients with:
Croatian: Gazyvaro je lijek protiv raka koji se koristi za liječenje odraslih osoba oboljelih od:
English: Gazyvaro can only be obtained with a prescription and treatment should be given under the close supervision of an experienced doctor.
Croatian: Gazyvaro se izdaje samo na liječnički recept, a liječenje se mora primjenjivati pod strogim nadzorom iskusnog liječnika.
English: What are the risks associated with Gazyvaro?
Croatian: Koji su rizici povezani s lijekom Gazyvaro?
English: For more information about treatment with Gazyvaro, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Gazyvaro pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: By attaching to CD20 on Blymphocytes, obinutuzumab makes the B-lymphocytes a target for the body's immune (defence) system, which kills the B-lymphocytes.
Croatian: Vezivanjem na protein CD20 na površini B-limfocita obinutuzumab B-limfocite čini ciljem imunosnog (obrambenog) sustava tijela koji uništava B-limfocite.
English: The active substance in Gazyvaro, obinutuzumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to the protein CD20, which is found on the surface of Blymphocytes.
Croatian: Djelatna tvar u lijeku Gazyvaro, obinutuzumab, monoklonalno je protutijelo (vrsta proteina) koje je namijenjeno prepoznavanju i vezivanju na protein CD20 koji je prisutan na površini B-limfocita.
English: The Agency considered that the benefit of Gazyvaro in prolonging the survival of CLL and FL patients before their disease worsened was clearly demonstrated.
Croatian: Agencija je zaključila da su jasno dokazane koristi lijeka Gazyvaro u produljivanju preživljenja u bolesnika oboljelih od KLL-a i FL-a prije pogoršanja bolesti.
English: Why is Gazyvaro approved?
Croatian: Zašto je lijek Gazyvaro odobren?
English: Gazyvaro was shown to be of benefit in one main study involving 1,202 patients with previously untreated FL.
Croatian: Korist od lijeka Gazyvaro utvrđena je u jednom glavnom ispitivanju kojim je obuhvaćeno 1 202 bolesnika s prethodno neliječenim FL-om.
English: Gazyvaro has also been investigated in a study involving 321 patients with FL in whom treatment with rituximab had either not worked or had stopped working.
Croatian: Lijek Gazyvaro ispitan je i u ispitivanju koje je obuhvatilo 321 bolesnika s FL-om u kojih terapija rituksimabom nije djelovala ili je prestala djelovati.
English: Once the disease has responded to treatment, Gazyvaro is then used on its own for the maintenance treatment of FL.
Croatian: Ako bolest reagira na liječenje, lijek Gazyvaro se tada koristi kao monoterapija za terapiju održavanja folikularnog limfoma (FL).
English: For practical information about using Gazyvaro, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Gazyvaro bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svojem liječniku ili ljekarniku.
English: For FL, Gazyvaro is given at a dose of 1,000 mg on day 1, 8 and 15 of the first 21 or 28-day treatment cycle.
Croatian: Kod folikularnog limfoma lijek Gazyvaro daje se u dozi od 1 000 mg 1., 8. i 15. dana prvog terapijskog ciklusa od 21 dana ili od 28 dana.
English: The study compared Gazyvaro plus other chemotherapy medicines with rituximab plus other chemotherapy medicines, and over a follow-up period of about three years on average, 17% (101 of 601 patients) given Gazyvaro died or their disease got worse, whereas 24% (144 of 601 patients) given rituximab died or their disease got worse.
Croatian: Tijekom razdoblja praćenja koje je trajalo u prosjeku tri godine, 17 % (101 od 601) bolesnika koji su primali lijek Gazyvaro preminulo je ili se njihova bolest pogoršala, u usporedbi s 24 % (144 od 601) onih koji su preminuli ili im se bolest pogoršala, a primali su rituximab.
English: What benefits of Gazyvaro have been shown in studies?
Croatian: Koje su koristi od lijeka Gazyvaro utvrđene u ispitivanjima?
English: In CLL, Gazyvaro has been shown to significantly delay the disease getting worse in previously untreated patients who had other medical conditions and were therefore ineligible for fludarabinebased therapy.
Croatian: Utvrđeno je da lijek Gazyvaro značajno odgađa pogoršavanje KLL-a u bolesnika koji nisu prethodno liječeni i koji su imali druga zdravstvena stanja te stoga nisu ispunjavali uvjete za terapiju koja se temelji na fludarabinu.
English: Patients treated with Gazyvaro and bendamustine lived significantly longer on average without their disease getting worse than patients treated with bendamustine alone (29.2 months versus 13.7 months).
Croatian: Bolesnici liječeni lijekom Gazyvaro i bendamustinom živjeli su u prosjeku značajno dulje bez pogoršanja bolesti od bolesnika liječenih bendamustinom kao monoterapijom (29,2 mjeseca u odnosu na 13,7 mjeseci).
English: Gazyvaro is used together with chemotherapy (other cancer medicines) in patients who have not had previous treatment for advanced FL.
Croatian: Gazyvaro se primjenjuje zajedno s kemoterapijom (drugim lijekom za liječenje raka) u bolesnika koji prethodno nisu primili terapiju za uznapredovali FL.
English: Gazyvaro is used together with chlorambucil (another cancer medicine) in patients for whom the cancer medicine fludarabine is not recommended;
Croatian: Gazyvaro se primjenjuje zajedno s klorambucilom (drugim lijekom za liječenje raka) u bolesnika kod kojih se ne preporučuje citostatik fludarabin;
English: Similarly, patients treated with Gazyvaro and chlorambucil lived significantly longer on average without their disease getting worse than patients treated with rituximab and chlorambucil (26.7 months versus 15.2 months).
Croatian: Slično tome, bolesnici liječeni lijekom Gazyvaro i klorambucilom u prosjeku su živjeli značajno dulje bez pogoršanja bolesti u odnosu na bolesnike liječene rituksimabom i klorambucilom (26,7 mjeseci u odnosu na 15,2 mjeseca).
English: How does Gazyvaro work?
Croatian: Kako djeluje Gazyvaro?
English: How is Gazyvaro used?
Croatian: Kako se Gazyvaro koristi?
English: In one main study involving 781 patients, those treated with Gazyvaro and chlorambucil lived significantly longer on average without their disease getting worse than patients treated with chlorambucil alone (26.7 months versus 11.1 months).
Croatian: U jednom glavnom ispitivanju koje je obuhvatilo 781 bolesnika, bolesnici liječeni lijekom Gazyvaro i klorambucilom u prosjeku su živjeli značajno dulje bez pogoršanja bolesti od bolesnika liječenih klorambucilom kao monoterapijom (26,7 mjeseci u odnosu na 11,1 mjesec).
English: For CLL, 28-day cycles are used.
Croatian: Za liječenje kronične limfocitne leukemije primjenjuje se 28-dnevni ciklus.
English: Gazyvaro contains the active substance obinutuzumab.
Croatian: Lijek Gazyvaro sadržava djelatnu tvar obinutuzumab.
English: Monday Tuesday Wednesday Thursday Friday Saturday Sunday
Croatian: ponedjeljak utorak srijeda četvrtak petak subota nedjelja
English: December 2023
Croatian: prosinac 2023
English: The median duration of treatment was 9.3 months.
Croatian: Srednje trajanje liječenja bilo je 9,3 mjeseca.
English: January 2020
Croatian: siječanj 2020
English: (See also section 4 ‘Possible side effects').
Croatian: (Također vidjeti dio 4 'Moguće nuspojave').
English: You need to know the names of the medicines you take.
Croatian: Morate znati imena lijekova koje uzimate.
English: 2333 BE Leiden The Netherlands
Croatian: 2333 BE Leiden Nizozemska
English: Always take this medicine exactly as your doctor has told you.
Croatian: Uvijek uzimajte ovaj lijek točno onako kako Vam je rekao Vaš liječnik.
English: Date of first authorisation: 21 June 2013
Croatian: Datum prvog odobrenja: 21. lipnja 2013.
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu ovu uputu prije nego počnete uzimati ovaj lijek jer sadrži Vama važne podatke.
English: Xtandi is indicated for:
Croatian: Xtandi je indiciran za:
English: Theoretically, induction of these transporters is also possible, and the net effect is presently unknown.
Croatian: Teoretski je također moguća i indukcija tih transportera, ali je neto učinak trenutno nepoznat.
English: This includes rare cases of seizure with complications leading to death.
Croatian: To uključuje i rijetke slučajeve napadaja s komplikacijama koji su imali smrtni ishod.
English: This medicine is not for use in children and adolescents.
Croatian: Ovaj lijek nije za primjenu u djece i adolescenata.
English: No overall differences in safety or effectiveness were observed between these elderly patients and younger patients.
Croatian: Nije primijećena sveukupna razlika u sigurnosti primjene ili učinkovitosti između ovih bolesnika starije dobi i mlađih bolesnika.
English: Other medicines and Xtandi
Croatian: Drugi lijekovi i Xtandi
English: Other possible side effects include:
Croatian: Druge moguće nuspojave uključuju:
English: Results from this analysis were consistent with those from the interim analysis (Table 3, Figure 4).
Croatian: Rezultati ove analize bili su konzistentni s onima iz interim analize (Tablica 3, Slika 4).
English: ECOG: Eastern Cooperative Oncology Group; BPI-SF: Brief Pain Inventory-Short Form; PSA: Prostate Specific Antigen
Croatian: ECOG: Eastern Cooperative Oncology Group; BPI-SF: Brief Pain Inventory-Short Form; PSA: prostata specifični antigen
English: - If you are pregnant or may become pregnant (see ‘Pregnancy, breast-feeding and fertility')
Croatian: - ako ste trudni ili možete zatrudnjeti (vidjeti ‘Trudnoća, dojenje i plodnost').
English: An updated survival analysis was conducted when 784 deaths were observed.
Croatian: Ažurirana analiza podataka o preživljenju provedena je nakon 784 smrti.
English: At the time of the primary analysis there were 1,633 patients randomised.
Croatian: U vrijeme primarne analize randomizirano je 1633 bolesnika.
English: 9 mm) with “ENZ” written on one side.
Croatian: 9 mm) s oznakom “ENZ” otisnutom na jednoj strani.
English: This should be taken into account if Xtandi is prescribed in these patients.
Croatian: Ovo treba uzeti u obzir ako je Xtandi propisan takvim bolesnicima.
English: - Xtandi can be taken with or without food.
Croatian: - Xtandi se može uzimati s hranom ili bez nje.
English: The reduction in plasma concentrations can be substantial, and lead to lost or reduced clinical effect.
Croatian: Smanjenje koncentracije u plazmi može biti značajno i može dovesti do gubitka ili smanjenog kliničkog učinka.
English: Interactions with certain medicinal products that are eliminated through metabolism or active transport are expected.
Croatian: Interakcije s određenim lijekovima koji se eliminiraju putem metabolizma ili aktivnog transporta su očekivane.
English: Enzalutamide is 97% to 98% bound to plasma proteins, primarily albumin.
Croatian: Enzalutamid je 97% do 98% vezan za proteine plazme, prvenstveno albumin.
English: These medicines may influence the effect of Xtandi, or Xtandi may influence the effect of these medicines.
Croatian: Ti lijekovi mogu utjecati na učinak lijeka Xtandi ili Xtandi može utjecati na učinak tih lijekova.
English: No major deviations from dose proportionality are observed over the dose range 40 to 160 mg.
Croatian: Nisu opažena nikakva velika odstupanja od proporcionalnosti dozi u rasponu doza od 40 do 160 mg.
English: Your doctor may decide that you should stop taking Xtandi.
Croatian: Vaš liječnik može odlučiti da je potrebno da prestanete uzimati lijek Xtandi.
English: If you are allergic to enzalutamide, this may result in a rash or swelling of the face, tongue, lip or throat.
Croatian: Ako ste alergični na enzalutamid, to može dovesti do osipa ili oticanja lica, jezika, usana ili grla.
English: Patients with serum creatinine > 177 μmol/L (2 mg/dL) were excluded from clinical trials.
Croatian: Bolesnici sa serumskim kreatininom > 177 μmol/l (2 mg/dl) bili su isključeni iz kliničkih ispitivanja.
English: What Xtandi is and what it is used for
Croatian: Što je Xtandi i za što se koristi
English: Medicinal products which prolong the QT interval
Croatian: Lijekovi koji mogu produljiti QT interval
English: The median was not reached in either treatment group and neither analysis showed a statistically significant difference between treatment arms.
Croatian: Niti kod jedne ispitivane skupine nije dosegnut medijan, niti je analiza pokazala statistički značajnu razliku između liječenih skupina.
English: Patients with rare hereditary problems of fructose intolerance should not take this medicinal product.
Croatian: Bolesnici s rijetkim nasljednim poremećajima nepodnošenja fruktoze ne smiju uzimati ovaj lijek.
English: You should not start or stop taking any medicine before you talk with the doctor that prescribed Xtandi.
Croatian: Ne smijete početi ili prestati uzimati neki lijek prije nego što o tome razgovarate s liječnikom koji je propisao Xtandi.
English: What Xtandi looks like and contents of the pack
Croatian: Kako Xtandi izgleda i sadržaj pakiranja
English: Date of latest renewal: 8 February 2018
Croatian: Datum posljednje obnove odobrenja: 08. veljače 2018.
English: Analysis of rPFS utilised centrally-reviewed radiographic assessment of progression.
Croatian: U analizi rPFS koristio se centralni pregled radiografske procjene progresije.
English: Do not stop taking this medicine unless your doctor tells you to.
Croatian: Nemojte prestati uzimati ovaj lijek osim ako Vam tako kaže liječnik.
English: When taken at the same time as Xtandi, these medicines may increase the risk of a seizure:
Croatian: Kad se uzimaju istovremeno s lijekom Xtandi, ovi lijekovi mogu povećati rizik od napadaja:
English: Changes in PSA serum concentration independently do not always predict clinical benefit.
Croatian: Promjene serumske koncentracije PSA same po sebi ne predskazuju uvijek i kliničku korist od liječenja.
English: The radioactivity in the fetus decreased to 0.08 times the maximum concentration at 72 hours after administration.
Croatian: Radioaktivnost u fetusa se smanjila na 0,08 puta maksimalne koncentracije nakon 72 sata od primjene.
English: Although there was a limited response in some patients from treatment with enzalutamide after abiraterone, the reason for this finding is currently unknown.
Croatian: Iako je u nekih bolesnika odgovor na liječenje enzalutamidom nakon abiraterona bio ograničen, razlog tome trenutno je nepoznat.
English: There is no antidote for enzalutamide.
Croatian: Ne postoji antidot za enzalutamid.
English: Keep a list of them with you to show to your doctor when you are prescribed a new medicine.
Croatian: Imajte sa sobom popis tih lijekova kako biste ga mogli pokazati liječniku kad Vam propisuje novi lijek.
English: What Xtandi is and what it is used for What you need to know before you take Xtandi How to take Xtandi
Croatian: Što je Xtandi i za što se koristi Što morate znati prije nego počnete uzimati Xtandi
English: The active metabolite is 95% bound to plasma proteins.
Croatian: Djelatni metabolit je 95% vezan za proteine plazme.
English: The volume of distribution of enzalutamide is greater than the volume of total body water, indicative of extensive extravascular distribution.
Croatian: Volumen distribucije enzalutamida veći je od volumena ukupne vode u tijelu, što ukazuje na opsežnu ekstravaskularnu distribuciju.
English: Seizures are more likely if you take more than the recommended dose of this medicine, if you take certain other medicines, or if you are at higher than usual risk of seizure.
Croatian: Vjerojatnost nastanka napadaja je veća ako ovaj lijek uzmete u dozi višoj od preporučene, ako uzimate određene druge lijekove ili ako Vam je rizik za napadaje veći od uobičajenog.
English: The other ingredients of the film-coated tablets are:
Croatian: Drugi sastojci filmom obloženih tableta su:
English: The study design could neither identify the patients who are likely to benefit, nor the order in which enzalutamide and abiraterone should be optimally sequenced.
Croatian: Dizajn ispitivanja nije mogao prepoznati bolesnike koji će vjerojatno imati koristi, kao niti redoslijed kojim bi enzalutamid i abirateron trebali biti optimalno primijenjeni.
English: Xtandi is a medicine that works by blocking the activity of hormones called androgens (such as testosterone).
Croatian: Xtandi je lijek koji djeluje blokiranjem djelovanja hormona koji se zovu androgeni (kao što je testosteron).
English: Based on pharmacokinetic data from studies in Japanese and Chinese patients with prostate cancer, there were no clinically relevant differences in exposure among the populations.
Croatian: Na temelju farmakokinetičkih podataka dobivenih tijekom ispitivanja na japanskim i kineskim bolesnicima s rakom prostate, nije bilo klinički značajne razlike u izloženosti među tim populacijama.
English: Recent cardiovascular disease
Croatian: Nedavna kardiovaskularna bolest
English: Most patients in the controlled clinical trials (> 74%) were Caucasian.
Croatian: Većina bolesnika u kontroliranim kliničkim ispitivanjima (> 74%) bili su bijelci.
English: - This medicine could possibly have an effect on male fertility.
Croatian: - Ovaj bi lijek mogao utjecati na plodnost u muškarca.
English: There are insufficient data to evaluate potential differences in the pharmacokinetics of enzalutamide in other races.
Croatian: Nema dovoljno podataka za procjenu mogućih razlika u farmakokinetici enzalutamida u drugih rasa.
English: If you have a seizure, worsening headache, confusion, blindness or other vision problems, please contact your doctor as soon as possible.
Croatian: Ako imate napadaj, glavobolju koja se pojačava, smetenost, sljepoću ili druge probleme s vidom, obratite se što prije Vašem liječniku.
English: Median OS was not reached.
Croatian: Medijan OS nije postignut.
English: There were no other important changes in clinical pathology or histopathology in any other organ system, including the liver, in either species.
Croatian: Nije bilo drugih važnih promjena u kliničkoj patologiji ili patohistologiji drugih organskih sustava, uključujući jetru, niti u jedne od ove dvije životinjske vrste.
English: If any of the above applies to you or you are not sure, talk to your doctor before taking this medicine.
Croatian: Ako se nešto od gore navedenog odnosi na Vas ili niste sigurni, obratite se svom liječniku prije nego uzmete ovaj lijek.
English: Therefore, in the three studies it was recommended that patients be maintained on their study treatments until discontinuation criteria were met as specified below for each study.
Croatian: Stoga je u svim trima ispitivanjima bilo preporučeno da bolesnici nastave uzimati ispitivani lijek sve dok se ne zadovolje kriteriji za prekid liječenja, kako je specificirano u nastavku za svako ispitivanje.
English: See results below (Table 2).
Croatian: Vidjeti rezultate u nastavku (Tablica 2).
English: - Do not take a double dose to make up for the dose you forgot.
Croatian: - Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: Patients should be advised of the potential risk of experiencing a psychiatric or neurological event while driving or operating machines.
Croatian: Bolesnike je potrebno obavijestiti o mogućem riziku od nastupa psihijatrijskog ili neurološkog događaja tijekom upravljanja vozilima ili rada sa strojevima.
English: Concomitant use with other medicinal products
Croatian: Istovremena primjena s drugim lijekovima
English: If you take more Xtandi than you should
Croatian: Ako uzmete više lijeka Xtandi nego što trebate
English: In addition to the co-primary efficacy endpoints, statistically significant improvements were also demonstrated in the following prospectively defined endpoints.
Croatian: Osim mjera koprimarnih ishoda djelotvornosti, statistički značajna poboljšanja također su pokazana u sljedećim prospektivno definiranim mjerama ishoda.