FrancophonIA/ELRC3.0 huggingface dataset:
English: • Data on stability, as well as in vitro and non-clinical studies, show that linear gadolinium agents release gadolinium from the ligand molecules to a greater extent than macrocyclic agents.
Croatian: • Podatci o stabilnosti, kao i podatci iz in vitro i nekliničkih ispitivanja pokazuju da linearna gadolinijska sredstva oslobađaju gadolinij iz molekula liganda u većoj mjeri od makrocikličkih sredstava.
English: The final stage of the review procedure was the adoption by the European Commission of a legally binding decision applicable in all EU Member States.
Croatian: U završnoj fazi postupka ocjene, Europska komisija donijela je pravno obvezujuće odluke koje se primjenjuju u svim državama članicama EU-a.
English: Gadolinium contrast agents are used as contrast enhancers to improve image quality with magnetic resonance scans.
Croatian: Gadolinijska kontrastna sredstva primjenjuju se kao pojačivači kontrasta kako bi se poboljšala kvaliteta prikaza magnetskom rezonancijom.
English: • If you need a scan with a gadolinium contrast agent to help in your treatment, your doctor will use the lowest dose required for a clear image.
Croatian: • Ako vam je potrebno snimanje s pomoću gadolinijskog kontrastnog sredstva kao pomoć u liječenju, vaš će liječnik primijeniti najnižu dozu koja je potrebna za dobivanje jasnog prikaza.
English: This review covers agents containing the following active substances: gadobenic acid, gadobutrol, gadodiamide, gadopentetic acid, gadoteric acid, gadoteridol, gadoversetamide and gadoxetic acid.
Croatian: Ocjenjivanje je obuhvatilo sredstva koja sadrže sljedeće djelatne tvari: gadobenatnu kiselinu, gadobutrol, gadodiamid, gadopentetatnu kiselinu, gadoteratnu kiselinu, gadoteridol, gadoversetamid i gadoksetatnu kiselinu.
English: • Gadolinium contrast agents are essential for diagnosing a wide range of life-threatening and debilitating diseases.
Croatian: • Gadolinijska kontrastna sredstva ključna su za dijagnosticiranje širokog raspona bolesti koje su opasne po život i onesposobljavajuće.
English: Most gadolinium-containing contrast agents have been authorised nationally in the EU.
Croatian: Većina kontrastnih sredstava koja sadrže gadolinij odobrena su u EU-u na nacionalnoj razini.
English: All other intravenous linear products (gadodiamide, gadopentetic acid and gadoversetamide) should be suspended in the EU.
Croatian: Sve druge linearne lijekove za intravensku primjenu (gadodiamid, gadopentetatna kiselina i gadoversetamid) treba obustaviti u EU-u.
English: • Gadolinium contrast agents are given to patients during body scans to help obtain a clear image of the inside of the body.
Croatian: • Gadolinijska kontrastna sredstva daju se bolesnicima prilikom snimanja tijela kako bi pomogla u dobivanju jasnog prikaza unutrašnjosti tijela.
English: • The marketing authorisations for the intravenous linear agents gadodiamide and gadoversetamide, as well as the intravenous formulation of the linear agent gadopentetic acid, are now suspended in the EU.
Croatian: • Odobrenja za stavljanje u promet intravenskih linearnih sredstava gadodiamida i gadoversetamida, kao i intravenske formulacije linearnog kontrastnog sredstva gadopentetatne kiseline, sada su obustavljena u EU-u.
English: • Healthcare professionals should use gadolinium contrast agents only when essential diagnostic information cannot be obtained with unenhanced scans.
Croatian: • Zdravstveni radnici trebaju primjenjivati gadolinijska kontrastna sredstva samo ako se snimanjem bez pojačanja ne mogu dobiti ključne dijagnostičke informacije.
English: The recommendations - confirmed by EMA's Committee for Medicinal Products for Human Use (CHMP) - followed a review that found that gadolinium deposition occurs in brain tissues following use of gadolinium contrast agents.
Croatian: Preporuke, koje je potvrdio Odbor za lijekove za humanu uporabu (CHMP) EMA-e, slijedile su ocjenjivanje kojim je utvrđeno da nakon primjene gadolinijskih kontrastnih sredstava dolazi do taloženja gadolinija u moždanom tkivu.
English: On 20 July 2017, the European Medicines Agency (EMA) concluded its review of gadolinium contrast agents, confirming recommendations to restrict the use of some linear gadolinium agents used in MRI body scans and to suspend the authorisations of others.
Croatian: Europska agencija za lijekove (EMA) zaključila je 20. srpnja 2017. svoje ocjenjivanje kontrastnih sredstava koja sadrže gadolinij te je potvrdila preporuke za ograničenje primjene nekih linearnih gadolinijskih sredstava koja se primjenjuju prilikom snimanja tijela magnetskom rezonancijom i obustavu odobrenja za druga linearna gadolinijska sredstva.
English: Another class of gadolinium agents known as macrocyclic agents (gadobutrol, gadoteric acid and gadoteridol) are more stable and have a lower propensity to release gadolinium than linear agents.
Croatian: Druga skupina gadolinijskih sredstva, poznata pod nazivom makrociklička kontrastna sredstva (gadobutrol, gadoteratna kiselina i gadoteridol), stabilnija su i manje sklona otpuštanju gadolinija od linearnih sredstava.
English: (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's final opinion.
Croatian: Konačne preporuke PRAC-a poslane su Odboru za lijekove za humanu uporabu (CHMP), odgovornom za pitanja koja se odnose na lijekove za humanu uporabu, koji je usvojio konačno mišljenje Agencije.
English: • The product information for gadolinium contrast agents remaining on the EU market is being updated accordingly.
Croatian: • Sukladno tome, provodi se ažuriranje informacija o lijeku za gadolinijska kontrastna sredstva koja ostaju na tržištu EU-a.
English: The intravenous linear agents gadoxetic acid and gadobenic acid can continue to be used for liver scans because they are taken up in the liver and meet an important diagnostic need.
Croatian: Intravenska linearna sredstva gadoksetatna kiselina i gadobenatna kiselina smiju se i dalje primjenjivati za snimanje jetre jer se apsorbiraju u jetri i zadovoljavaju važne dijagnostičke potrebe.
English: linear (intra-articular)
Croatian: linearni (intraartikularna primjena)
English: • All macrocyclic agents reviewed - gadobutrol, gadoteric acid and gadoteridol - also remain available.
Croatian: • Također ostaju dostupna sva makrociklička sredstva koja su ocijenjena - gadobutrol, gadoteratna kiselina i gadoteridol.
English: • Two intravenous linear agents - gadoxetic acid and gadobenic acid - remain available as these agents undergo hepatic uptake, and can be used for imaging poorly vascularised hepatic lesions, especially in delayed phase imaging, that cannot be adequately studied with other agents.
Croatian: • Dva intravenska linearna sredstva, gadoksetatna kiselina i gadobenatna kiselina, i dalje su dostupna jer se apsorbiraju u jetri, a mogu se upotrebljavati za oslikavanje slabije prokrvljenih lezija na jetri koje se ne mogu na odgovarajući način ispitati drugim sredstvima, osobito prilikom oslikavanja u zakašnjeloj fazi.
English: EMA's scientific review of gadolinium deposition in brain and other tissues is now concluded.
Croatian: Znanstvena ocjena EMA-e u pogledu taloženja gadolinija u mozgu i drugim tkivima zaključena je.
English: • Intra-articular formulations of the linear agent gadopentetic acid will continue to be available because the dose of gadolinium that is required for these scans is very low.
Croatian: • Intraartikularne formulacije linearnog kontrastnog sredstva gadopentetatne kiseline i dalje će biti dostupne zbog vrlo niske doze gadolinija koja je potrebna za takva oslikavanja.
English: Recommendations conclude EMA's scientific review of gadolinium deposition in brain and other tissues
Croatian: U preporukama se navodi zaključak znanstvene ocjene EMA-e u pogledu taloženja gadolinija u mozgu i drugim tkivima
English: Optimark (gadoversetamide)
Croatian: Optimark (gadoversetamid)
English: In addition, gadopentetic acid given intra-articularly (into the joint) can continue to be used for joint scans because the dose of gadolinium used for joint injections is very low.
Croatian: Nadalje, intraartikularna primjena (u zglob) gadopentetatne kiseline može se i dalje koristiti za snimanje zglobova zbog vrlo niske doze gadolinija koja se primjenjuje u injekcijama u zglob.
English: Omniscan (gadodiamide)
Croatian: Omniscan (gadodiamid)
English: There is currently no evidence that gadolinium deposition in the brain has caused any harm to patients; however EMA has recommended restrictions and suspensions for some intravenous linear agents in order to prevent any risks that could potentially be associated with gadolinium brain deposition.
Croatian: Međutim, EMA je preporučila ograničenja i obustave za neka intravenska linearna sredstva kako bi se spriječili svi rizici koji bi mogli biti povezani s taloženjem gadolinija u mozgu.
English: • No adverse neurological effects, such as cognitive or movement disorders, have been attributed to gadolinium deposition in the brain with any gadolinium agents.
Croatian: • Nije utvrđena veza između taloženja gadolinija u mozgu pri primjeni bilo kojeg gadolinijskog sredstva i štetnih neuroloških učinaka, na primjer kognitivnih poremećaja ili poremećaja kretanja.
English: Multihance (gadobenic acid)
Croatian: Multihance (gadobenatna kiselina) linearni (intravenska primjena)
English: Primovist (gadoxetic acid)
Croatian: Primovist (gadoksetatna kiselina) linearni (intravenska primjena)
English: Artirem / Dotarem (gadoteric acid) macrocyclic (intra-articular) maintain Gadovist (gadobutrol)
Croatian: Preporuka makrociklički (intraartikularna primjena)
English: The full EPAR for Bortezomib Hospira can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Bortezomib Hospira nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It blocks proteasome, which is a system in cells that breaks down proteins that are no longer needed.
Croatian: On onemogućuje djelovanje proteazoma, sustava u stanicama koji razgrađuje proteine koji više nisu potrebni.
English: The full EPAR for the reference medicine can also be found on the Agency's website.
Croatian: Cjeloviti EPAR za referentni lijek također se nalazi internetskim stranicama Agencije.
English: At least 72 hours must pass between two doses of Bortezomib Hospira.
Croatian: Mora proći najmanje 72 sata između dvije doze lijeka Bortezomib Hospira.
English: This means that Bortezomib Hospira is similar to a ‘reference medicine' already authorised in the European Union (EU) called Velcade.
Croatian: To znači da je Bortezomib Hospira sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Velcade.
English: Bortezomib Hospira must not be given by other routes.
Croatian: Lijek Bortezomib Hospira ne smije se davati drugim putovima.
English: • adults whose disease is getting worse after at least one other treatment and who have already had, or cannot undergo, blood stem-cell transplantation.
Croatian: • odraslih osoba čija se bolest pogoršava nakon najmanje jednog liječenja i koje su već bile podvrgnute, ili se ne mogu podvrgnuti, transplantaciji hematopoetskih matičnih stanica.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Bortezomib Hospira have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza koje zdravstveni radnici i bolesnici trebaju poštovati u cilju sigurne i učinkovite upotrebe lijeka Bortezomib Hospira nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Bortezomib Hospira has been shown to be comparable to Velcade.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je kako, u skladu sa zahtjevima EU-a, lijek Bortezomib Hospira posjeduje usporedivu kakvoću s lijekom Velcade.
English: No additional studies were needed as Bortezomib Hospira is a generic medicine that is given by injection and contains the same active substance as the reference medicine, Velcade.
Croatian: Dodatna ispitivanja nisu bila potrebna jer je lijek Bortezomib Hospira generički lijek koji se daje injekcijom i koji sadrži istu djelatnu tvar kao i referentni lijek, Velcade.
English: Therefore, the CHMP's view was that, as for Velcade, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a da, kao i kod lijeka Velcade, koristi nadmašuju utvrđeni rizik.
English: Doses of Bortezomib Hospira are given with rest periods between doses, in treatment cycles of three to six weeks depending on whether Bortezomib Hospira is given alone or in combination with other medicines.
Croatian: Doze lijeka Bortezomib Hospira daju se u razmacima s razdobljima odmora između dvije doze, i to u ciklusima liječenja od tri do šest tjedna ovisno o tome primjenjuje li se lijek Bortezomib Hospira kao monoterapija ili u kombinaciji s drugim lijekovima.
English: Because Bortezomib Hospira is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je loijek Bortezomib Hospira generički lijek, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: This is a summary of the European public assessment report (EPAR) for Bortezomib Hospira.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Bortezomib Hospira.
English: What measures are being taken to ensure the safe and effective use of Bortezomib Hospira?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Bortezomib Hospira?
English: Bortezomib Hospira is available in vials as a 3.5 mg powder to be made up into a solution for injection into a vein or under the skin.
Croatian: Lijek Bortezomib Hospira dostupan je u bočicama od 3,5 mg kao prašak za pripremu otopine za injekciju u venu ili pod kožu.
English: Bortezomib Hospira is a cancer medicine used to treat multiple myeloma, a blood cancer, in the following groups of patients:
Croatian: Lijek Bortezomib Hospira koristi se za liječenje multipla mijeloma, raka krvi, u sljedećih skupina bolesnika:
English: The company that markets Bortezomib Hospira will supply educational material to healthcare professionals on making up and giving the injection, calculating the dose, and prescribing and giving the correct treatment for patients receiving blood stem-cell transplantation.
Croatian: Tvrtka koja lijek Bortezomib Hospira stavlja u promet mora zdravstvenim radnicima dostaviti edukativne materijale u kojima se objašnjava način pripreme i primjene injekcije, izračunavanja doze i propisivanja i primjene odgovarajućeg liječenja u primatelja transplantacije hematopoetskih matičnih stanica.
English: Other information about Bortezomib Hospira
Croatian: Ostale informacije o lijeku Bortezomib Hospira
English: The active substance in Bortezomib Hospira, bortezomib, is a proteasome inhibitor.
Croatian: Djelatna tvar u lijeku Bortezomib Hospira, bortezomib, inhibitor je proteazoma.
English: What is Bortezomib Hospira and what is it used for?
Croatian: Što je Bortezomib Hospira i za što se koristi?
English: The Committee recommended that Bortezomib Hospira be approved for use in the EU.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje u promet lijeka Bortezomib Hospira u EU-u.
English: What are the benefits and risks of Bortezomib Hospira?
Croatian: Koje su koristi i rizici od lijeka Bortezomib Hospira?
English: It is not intended to provide practical advice on how to use Bortezomib Hospira.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Bortezomib Hospira.
English: The company provided data from the published literature on bortezomib.
Croatian: Tvrtka je dostavila podatke o bortezomibu iz objavljene literature.
English: Bortezomib Hospira is a ‘generic medicine'.
Croatian: Hospira je „generički lijek”.
English: For more information on the use of Bortezomib Hospira see the summary of product characteristics (also part of the EPAR).
Croatian: Za dodatne informacije o korištenju lijeka Bortezomib Hospira pogledajte sažetak opisa svojstava lijeka (također dio EPAR-a).
English: Why is Bortezomib Hospira approved?
Croatian: Zašto je Bortezomib Hospira odobren?
English: Bortezomib Hospira is also used to treat mantle cell lymphoma, another blood cancer, in untreated adults who cannot have blood stem-cell transplantation.
Croatian: Lijek Bortezomib Hospira također se koristi za liječenje limfoma plaštenih stanica, drugog oblika raka krvi, u odraslih osoba koje nisu primile terapiju, a za koje nije prikladna transplantacija hematopoetskih matičnih stanica.
English: • previously untreated adults who cannot have high-dose chemotherapy with blood stem-cell transplantation.
Croatian: • odraslih osoba koje nisu prethodno liječene i za koje nije prikladna kemoterapija u visokim dozama s transplantacijom hematopoetskih matičnih stanica.
English: For practical information about using Bortezomib Hospira, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Bortezomib Hospira bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: For more information about treatment with Bortezomib Hospira, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Bortezomib Hospira pročitajte u uputi o lijeku (također dio EPAR-a) odnosno obratite se svom liječniku ili ljekarniku.
English: In these patients, Bortezomib Hospira is used in combination with melphalan and prednisone;
Croatian: U tih bolesnika, lijek Bortezomib Hospira koristi se u kombinaciji s melfalanom i prednizonom;
English: For mantle cell lymphoma, Bortezomib Hospira is used in combination with rituximab, cyclophosphamide, doxorubicin and prednisone.
Croatian: U slučaju limfoma plaštenih stanica, lijek Bortezomib Hospira koristi se u kombinaciji s rituksimabom, ciklofosfamidom, doksorubicinom i prednizonom.
English: • previously untreated adults who are going to receive high-dose chemotherapy followed by blood stem-cell transplantation.
Croatian: • bolesnika koji nisu prethodno liječeni i koji trebaju primiti kemoterapiju u visokim dozama i potom biti podvrgnuti transplantaciji hematopoetskih matičnih stanica.
English: Bortezomib Hospira is either used on its own in these patients or in combination with pegylated liposomal doxorubicin or dexamethasone;
Croatian: Lijek Bortezomib Hospira koristi se kao monoterapija ili u kombinaciji s pegiliranim liposomalnim doksorubicinom ili deksametazonom;
English: In this group of patients, Bortezomib Hospira is used in combination with dexamethasone, or with dexamethasone plus thalidomide.
Croatian: U ovoj skupini bolesnika, lijek Bortezomib Hospira koristi se u kombinaciji s deksametazonom ili s deksametazonom i talidomidom.
English: Bortezomib Hospira contains the active substance bortezomib.
Croatian: Lijek Bortezomib Hospira sadrži djelatnu tvar bortezomib.
English: How is Bortezomib Hospira used?
Croatian: Kako se Bortezomib Hospira koristi?
English: How has Bortezomib Hospira been studied?
Croatian: Kako je Bortezomib Hospira ispitivan?
English: How does Bortezomib Hospira work?
Croatian: Kako djeluje Bortezomib Hospira?
English: Before you start you will need:
Croatian: Prije nego što počnete, trebat će Vam:
English: The median follow-up duration was 33 months.
Croatian: Medijan trajanja praćenja bio je 33 mjeseca.
English: • You will hear a click.
Croatian: • Čut ćete 'klik'.
English: Your injection has now started.
Croatian: Injekcija je sada započela.
English: The primary cause of death in the majority of these patients was CV events.
Croatian: Primarni uzrok smrti u većine tih bolesnika bili su KV događaji.
English: A total of 99.5% of patients were followed for survival until the end of the trial.
Croatian: Kod ukupno 99,5% bolesnika praćeno je preživljavanje do kraja ispitivanja.
English: • You may see an air bubble.
Croatian: • Možda ćete vidjeti mjehurić zraka.
English: (See picture).
Croatian: (Pogledajte sliku).
English: This will keep you on the original schedule.
Croatian: Na taj ćete se način nastaviti pridržavati prvotnog rasporeda.
English: • You can inject into your:
Croatian: • Lijek možete injicirati u:
English: • If the window does not turn completely yellow, call sanofi-aventis for help.
Croatian: • Ako prozorčić ne postane posve žut, nazovite sanofi-aventis za pomoć.
English: • Wash your hands with soap and water and dry with a towel.
Croatian: • Operite ruke sapunom i vodom i osušite ih ručnikom.
English: Praluent is not recommended for children and adolescents under 18 years old.
Croatian: Praluent se ne preporučuje za djecu i adolescente mlađe od 18 godina.
English: Press the yellow safety cover on your skin at roughly a 90° angle.
Croatian: Pritisnite žuti sigurnosni pokrov u kožu pod kutom od približno 90°.
English: (See section 6.6)
Croatian: (Vidjeti dio 6.6).
English: With long-term treatment, efficacy was sustained over the duration of the studies (up to 2 years).
Croatian: Kod dugoročnog se liječenja djelotvornost održala tijekom čitavog trajanja ispitivanja (do 2 godine).
English: Number of events
Croatian: Broj događaja
English:  Look at the window.
Croatian: Pogledajte prozorčić
English: No difference was seen in the incidence of pruritus.
Croatian: Nije zapažena razlika u incidenciji pruritusa.
English: Release the button immediately
Croatian: Odmah otpustite dugme
English: STEP B: How to inject
Croatian: KORAK B: Kako injicirati
English: The safety and efficacy of Praluent in children and adolescents less than 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost lijeka Praluent u djece i adolescenata mlađih od 18 godina nisu ustanovljene.
English: General allergic reactions
Croatian: Opće alergijske reakcije
English: • Check that the syringe is not open or damaged.
Croatian: • Provjerite da štrcaljka nije otvorena ili oštećena.
English: What Praluent is and what it is used for 2.
Croatian: Što je Praluent i za što se koristi 2.
English: There were no significant differences observed in safety and efficacy with increasing age.
Croatian: Nisu primijećene značajne razlike u sigurnosti i djelotvornosti koje bi se povezivale s povećanjem dobi.
English: Non-clinical data reveal no special hazard for humans based on evaluations of safety pharmacology, and repeated dose toxicity.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju ispitivanja sigurnosne farmakologije i toksičnosti ponovljenih doza.
English: If you stop using Praluent, your cholesterol levels can increase.
Croatian: Ako prestanete primjenjivati Praluent, vrijednosti kolesterola mogle bi Vam porasti.
English: • Your injection is complete, when the window has turned completely yellow, you may hear a second click.
Croatian: • Injekcija je gotova kada prozorčić postane posve žut; možda ćete čuti 'klik' po drugi put.
English: • Do not use skin that is tender, hard, red or hot.
Croatian: • Nemojte injicirati lijek u kožu koja je osjetljiva, tvrda, crvena ili vruća.
English: Consequently, the frequency of these adverse events is qualified as "not known".
Croatian: Posljedično, učestalost tih nuspojava određena je kao ''nepoznato''.
English: Clinical efficacy and safety in prevention of cardiovascular events
Croatian: Klinička djelotvornost i sigurnost u prevenciji kardiovaskularnih događaja
English:  Prepare the injection site.
Croatian: Pripremite mjesto injiciranja.
English: Hold the Praluent pen like this.
Croatian: Držite Praluent brizgalicu ovako
English: MONO study
Croatian: Ispitivanje MONO
English: There are no data on adverse effects on fertility in humans.
Croatian: Nema podataka o štetnim učincima na plodnost u ljudi.
English: • If needed, pinch the skin to make sure the injection site is firm.
Croatian: • Ako je potrebno, uhvatite nabor kože kako biste bili sigurni da je mjesto injiciranja čvrsto.