FrancophonIA/ELRC3.0 huggingface dataset:
English: This review covers agents containing the following active substances: gadobenic acid, gadobutrol, gadodiamide, gadopentetic acid, gadoteric acid, gadoteridol, gadoversetamide and gadoxetic acid.
Slovenian: Ta pregled zajema kontrastna sredstva, ki vsebujejo naslednje zdravilne učinkovine: gadobensko kislino, gadobutrol, gadodiamid, gadopentetno kislino, gadoterno kislino, gadoteridol, gadoversetamid in gadoksetinsko kislino.
English: • It is known that small amounts of gadolinium may remain in the brain after a scan with these agents, although there is currently no evidence that these small amounts cause any harm.
Slovenian: • Znano je, da lahko po slikanju s temi kontrastnimi sredstvi v možganih ostane manjša količina gadolinija, vendar trenutno ni dokazov, da bi takšne majhne količine povzročile kakršno koli škodo.
English: restrict use to liver scans
Slovenian: omejitev uporabe na slikanje jeter
English: • Healthcare professionals in the EU will be sent a letter with information about EMA's review of gadolinium contrast agents.
Slovenian: • Zdravstveni delavci v EU bodo prejeli dopis z informacijami o pregledu kontrastnih sredstev z gadolinijem, ki ga je opravila agencija EMA.
English: OptiMARK (gadoversetamide) is the only gadolinium contrast agent that was authorised centrally via EMA in the EU.
Slovenian: Zdravilo OptiMARK (gadoversetamid) je edino kontrastno sredstvo z gadolinijem, ki je dovoljenje za promet v EU pridobilo po centraliziranem postopku prek agencije EMA.
English: • Healthcare professionals should use gadolinium contrast agents only when essential diagnostic information cannot be obtained with unenhanced scans.
Slovenian: • Zdravstveni delavci naj kontrastna sredstva z gadolinijem uporabljajo le, kadar s slikanjem brez kontrasta ni mogoče pridobiti bistvenih diagnostičnih informacij.
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.
Slovenian: Trenutno ni dokazov, da je odlaganje gadolinija v možganih povzročilo kakršno koli škodo bolnikom, vendar je agencija EMA priporočila omejitve in začasni umik dovoljenja za promet z nekaterimi linearnimi intravenskimi kontrastnimi sredstvi, da bi preprečili kakršna koli tveganja, ki bi lahko bila povezana z odlaganjem gadolinija v možganih.
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.
Slovenian: • Če boste kot pomoč pri zdravljenju potrebovali slikanje s kontrastnim sredstvom z gadolinijem, bo zdravnik uporabil najmanjši možni odmerek, potreben za jasno sliko.
English: The suspensions or restrictions on linear agents can be lifted if the companies concerned provide evidence of new benefits in an identified patient group that outweigh the risk of brain deposition or if the companies can modify their products so they do not release gadolinium significantly or cause its retention in tissues.
Slovenian: Začasni umik dovoljenja za promet oziroma omejitve uporabe linearnih kontrastnih sredstev se lahko odpravijo, če zadevne družbe predložijo dokaze o novih koristih pri določeni skupini bolnikov, ki odtehtajo tveganje za odlaganje gadolinija v možganih, ali če svoja kontrastna sredstva spremenijo tako, da se gadolinij ne bo več znatno sproščal ali ostajal v tkivih.
English: • The product information for gadolinium contrast agents remaining on the EU market is being updated accordingly.
Slovenian: • Informacije o zdravilu za kontrastna sredstva z gadolinijem, ki ostajajo na trgu EU, se ustrezno posodobijo.
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.
Slovenian: • Podatki o stabilnosti ter študije in vitro in neklinične študije dokazujejo, da linearna kontrastna sredstva z gadolinijem bolj sproščajo gadolinij iz molekul ligandov kot makrociklična sredstva.
English: • Gadolinium contrast agents are essential for diagnosing a wide range of life-threatening and debilitating diseases.
Slovenian: • Kontrastna sredstva z gadolinijem so zelo pomembna pri diagnostiki številnih smrtno nevarnih in izčrpavajočih bolezni.
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.
Slovenian: • Dovoljenja za promet z linearnima intravenskima kontrastnima sredstvoma gadodiamidom in gadoversetamidom ter z intravensko formulacijo linearnega kontrastnega sredstva gadopentetne kisline so zdaj v EU začasno umaknjena.
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.
Slovenian: Evropska agencija za zdravila (EMA) je 20. julija 2017 zaključila pregled kontrastnih sredstev z gadolinijem in potrdila priporočila za omejitev uporabe nekaterih linearnih kontrastnih sredstev z gadolinijem, ki se uporabljajo pri magnetnoresonančnem slikanju telesa, za druge pa začasni umik dovoljenja za promet z njimi.
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.
Slovenian: Kontrastna sredstva z gadolinijem iz drugega razreda, znana kot makrociklična kontrastna sredstva (gadobutrol, gadoterna kislina in gadoteridol), so stabilnejša in sproščajo manj gadolinija kot linearna kontrastna sredstva.
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.
Slovenian: Priporočila, ki jih je potrdil Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji EMA, so sledila pregledu, s katerim so ugotovili, da po uporabi kontrastnih sredstev z gadolinijem prihaja do odlaganja gadolinija v možganskih tkivih.
English: • Gadolinium contrast agents are given to patients during body scans to help obtain a clear image of the inside of the body.
Slovenian: • Kontrastna sredstva z gadolinijem se dajejo bolnikom med slikanjem telesa in omogočajo jasnejšo sliko notranjosti telesa.
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.
Slovenian: • Dve linearni intravenski kontrastni sredstvi (gadoksetinska in gadobenska kislina) ostajata na voljo, saj prehajata v jetra in se lahko uporabljata za slikanje slabo ožiljenih jetrnih lezij, zlasti pri slikanju z zakasnitvijo, ki jih z drugimi kontrastnimi sredstvi ni mogoče ustrezno proučiti.
English: linear (intra-articular)
Slovenian: linearna (intraartikularna uporaba)
English: (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's final opinion.
Slovenian: Končna priporočila odbora PRAC so bila poslana Odboru za zdravila za uporabo v humani medicini (CHMP), odgovornemu za vprašanja glede zdravil za uporabo v humani medicini, ki je sprejel končno mnenje agencije.
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.
Slovenian: • Intraartikularne formulacije linearnega kontrastnega sredstva gadopentetne kisline bodo še naprej na voljo, saj je odmerek gadolinija, potreben pri tovrstnem slikanju, zelo majhen.
English: Gadolinium contrast agents are used as contrast enhancers to improve image quality with magnetic resonance scans.
Slovenian: Kontrastna sredstva z gadolinijem se uporabljajo za izboljšanje kontrasta in kakovosti slike pri magnetnoresonančnem slikanju.
English: Most gadolinium-containing contrast agents have been authorised nationally in the EU.
Slovenian: Večina kontrastnih sredstev, ki vsebuje gadolinij, je dovoljenje za promet v EU pridobila po nacionalnih postopkih.
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.
Slovenian: Od linearnih intravenskih kontrastnih sredstev se še naprej lahko uporabljata gadoksetinska in gadobenska kislina, in sicer za slikanje jeter, ker prehajata v jetra in imata pomembno diagnostično vlogo.
English: • All macrocyclic agents reviewed - gadobutrol, gadoteric acid and gadoteridol - also remain available.
Slovenian: • Prav tako bodo še naprej na voljo vsa pregledana makrociklična kontrastna sredstva (gadobutrol, gadoterna kislina in gadoteridol).
English: All other intravenous linear products (gadodiamide, gadopentetic acid and gadoversetamide) should be suspended in the EU.
Slovenian: Za vsa druga linearna intravenska kontrastna sredstva (gadodiamid, gadopentetna kislina in gadoversetamid) se dovoljenje za promet v EU začasno umakne.
English: Optimark (gadoversetamide)
Slovenian: Optimark (gadoversetamid)
English: Multihance (gadobenic acid)
Slovenian: Multihance (gadobenska kislina)
English: • No adverse neurological effects, such as cognitive or movement disorders, have been attributed to gadolinium deposition in the brain with any gadolinium agents.
Slovenian: • Pri nobenem kontrastnem sredstvu z gadolinijem ne pripisujejo nobenih neželenih nevroloških učinkov, kot so kognitivne motnje ali motnje gibanja, kopičenju gadolinija v možganih.
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.
Slovenian: Za slikanje sklepov se prav tako še naprej lahko uporablja gadopentetna kislina, ki se daje intraartikularno (v sklepe), saj je odmerek gadolinija, uporabljen za injiciranje v sklep, zelo majhen.
English: Primovist (gadoxetic acid)
Slovenian: Primovist (gadoksetinska kislina)
English: Recommendations conclude EMA's scientific review of gadolinium deposition in brain and other tissues
Slovenian: Agencija EMA je s priporočili zaključila znanstveni pregled odlaganja gadolinija v možganih in drugih tkivih
English: EMA's scientific review of gadolinium deposition in brain and other tissues is now concluded.
Slovenian: Agencija EMA je zdaj zaključila znanstveni pregled odlaganja gadolinija v možganih in drugih tkivih.
English: Product
Slovenian: Kontrastno sredstvo
English: Omniscan (gadodiamide)
Slovenian: Omniscan (gadodiamid)
English: The medicine can only be obtained with a prescription and treatment should only be started and given under the supervision of a doctor who has experience in the use of cancer chemotherapy.
Slovenian: Predpisovanje in izdaja zdravila je le na recept, zdravljenje z njim pa se sme uvesti in izvajati samo pod nadzorom zdravnika, ki ima izkušnje z uporabo kemoterapije za zdravljenje raka.
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.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Bortezomib Hospira je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
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.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Bortezomib Hospira primerljivo z zdravilom Velcade.
English: This is a summary of the European public assessment report (EPAR) for Bortezomib Hospira.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Bortezomib Hospira.
English: What measures are being taken to ensure the safe and effective use of Bortezomib Hospira?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Bortezomib Hospira?
English: The Committee recommended that Bortezomib Hospira be approved for use in the EU.
Slovenian: Priporočil je, da se zdravilo Bortezomib Hospira odobri za uporabo v EU.
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.
Slovenian: Družba, ki trži zdravilo Bortezomib Hospira, bo za zdravstvene delavce zagotovila izobraževalno gradivo o postopku priprave in injiciranja, izračunavanju odmerka ter predpisovanju in izvajanju ustreznega zdravljenja za bolnike, pri katerih bo opravljena presaditev krvotvornih matičnih celic.
English: Because Bortezomib Hospira is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Bortezomib Hospira generično zdravilo, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: This means that Bortezomib Hospira is similar to a ‘reference medicine' already authorised in the European Union (EU) called Velcade.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Velcade.
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.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo tega zdravila upoštevati zdravstveni delavci in bolniki so prav tako vključeni v povzetek glavnih značilnosti zdravila Bortezomib Hospira in navodilo za njegovo uporabo.
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.
Slovenian: Odmerki zdravila Bortezomib Hospira se dajejo s premori med odmerki, v ciklih zdravljenja, ki trajajo od tri od šest tednov, kar je odvisno od tega, ali se zdravilo Bortezomib Hospira daje samostojno ali v kombinaciji z drugimi zdravili.
English: For more information on the use of Bortezomib Hospira see the summary of product characteristics (also part of the EPAR).
Slovenian: Za več informacij o uporabi zdravila Bortezomib Hospira glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
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.
Slovenian: Zdravilo Bortezomib Hospira je na voljo v vialah v obliki 3,5-miligramskega praška za pripravo raztopine za injiciranje v veno ali pod kožo.
English: What are the benefits and risks of Bortezomib Hospira?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Bortezomib Hospira?
English: Bortezomib Hospira is a cancer medicine used to treat multiple myeloma, a blood cancer, in the following groups of patients:
Slovenian: Bortezomib Hospira je zdravilo proti raku, ki se uporablja za zdravljenje multiplega mieloma, krvnega raka, pri naslednjih skupinah bolnikov:
English: Other information about Bortezomib Hospira
Slovenian: Druge informacije o zdravilu Bortezomib Hospira
English: Cancer cells are more sensitive than normal cells to the effects of proteasome inhibitors like bortezomib.
Slovenian: Rakave celice so na učinke zaviralcev proteasoma, kot je bortezomib, občutljivejše od normalnih celic.
English: Bortezomib Hospira is also used to treat mantle cell lymphoma, another blood cancer, in untreated adults who cannot have blood stem-cell transplantation.
Slovenian: Zdravilo Bortezomib Hospira se uporablja tudi za zdravljenje limfoma plaščnih celic, tj. še ene vrste krvnega raka, pri predhodno nezdravljenih odraslih, pri katerih presaditev krvotvornih matičnih celic ni mogoča.
English: For more information about treatment with Bortezomib Hospira, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Bortezomib Hospira preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: What is Bortezomib Hospira and what is it used for?
Slovenian: Kaj je zdravilo Bortezomib Hospira in za kaj se uporablja?
English: • previously untreated adults who are going to receive high-dose chemotherapy followed by blood stem-cell transplantation.
Slovenian: • predhodno nezdravljenih bolnikih, ki bodo prejeli kemoterapijo z velikimi odmerki, čemur bo sledila presaditev krvotvornih matičnih celic.
English: For practical information about using Bortezomib Hospira, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Bortezomib Hospira naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Bortezomib Hospira is a ‘generic medicine'.
Slovenian: Zdravilo Bortezomib Hospira je „generično zdravilo“.
English: At least 72 hours must pass between two doses of Bortezomib Hospira.
Slovenian: Med dvema odmerkoma zdravila Bortezomib Hospira mora miniti vsaj 72 ur.
English: The active substance in Bortezomib Hospira, bortezomib, is a proteasome inhibitor.
Slovenian: Zdravilna učinkovina zdravila Bortezomib Hospira, bortezomib, je zaviralec proteasoma.
English: Bortezomib Hospira must not be given by other routes.
Slovenian: Zdravilo Bortezomib Hospira se bolniku ne sme dati na noben drug način.
English: In these patients, Bortezomib Hospira is used in combination with melphalan and prednisone;
Slovenian: Pri teh bolnikih se zdravilo Bortezomib Hospira uporablja v kombinaciji z melfalanom in prednizonom;
English: For mantle cell lymphoma, Bortezomib Hospira is used in combination with rituximab, cyclophosphamide, doxorubicin and prednisone.
Slovenian: Za zdravljenje limfoma plaščnih celic se zdravilo Bortezomib Hospira uporablja v kombinaciji z rituksimabom, ciklofosfamidom, doksorubicinom in prednizonom.
English: Bortezomib Hospira is either used on its own in these patients or in combination with pegylated liposomal doxorubicin or dexamethasone;
Slovenian: Zdravilo Bortezomib Hospira se pri teh bolnikih uporablja samostojno ali v kombinaciji s pegiliranim liposomalnim doksorubicinom ali deksametazonom;
English: Why is Bortezomib Hospira approved?
Slovenian: Zakaj je bilo zdravilo Bortezomib Hospira odobreno?
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.
Slovenian: Ker je zdravilo Bortezomib Hospira generično zdravilo, ki se daje z injekcijo in vsebuje isto zdravilno učinkovino kot referenčno zdravilo Velcade, niso bile potrebne nobene dodatne študije.
English: In this group of patients, Bortezomib Hospira is used in combination with dexamethasone, or with dexamethasone plus thalidomide.
Slovenian: Pri tej skupini bolnikov se zdravilo Bortezomib Hospira uporablja v kombinaciji z deksametazonom ali pa z deksametazonom in talidomidom.
English: How has Bortezomib Hospira been studied?
Slovenian: Kako je bilo zdravilo Bortezomib Hospira raziskano?
English: How is Bortezomib Hospira used?
Slovenian: Kako se zdravilo Bortezomib Hospira uporablja?
English: Bortezomib Hospira contains the active substance bortezomib.
Slovenian: Zdravilo Bortezomib Hospira vsebuje zdravilno učinkovino bortezomib.
English: It is not intended to provide practical advice on how to use Bortezomib Hospira.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: How does Bortezomib Hospira work?
Slovenian: Kako zdravilo Bortezomib Hospira deluje?
English: Before you start you will need:
Slovenian: Preden začnete, boste potrebovali:
English:  Before you start.
Slovenian:  Preden začnete.
English: • You will hear a click.
Slovenian: • Slišali boste klik.
English: The median follow-up duration was 33 months.
Slovenian: Mediano trajanje spremljanja je bilo 33 mesecev.
English: (See picture).
Slovenian: (Glejte sliko).
English: The primary cause of death in the majority of these patients was CV events.
Slovenian: Primarni vzrok smrti pri večini teh bolnikov so bili KV dogodki.
English: This will keep you on the original schedule.
Slovenian: Tako boste ohranili originalni razpored uporabe.
English: Your injection has now started.
Slovenian: Injiciranje se je zdaj začelo.
English: • You may see an air bubble.
Slovenian: • Morda boste videli mehurček zraka.
English: With long-term treatment, efficacy was sustained over the duration of the studies (up to 2 years).
Slovenian: Med dolgotrajnim zdravljenjem se je učinkovitost ohranila med celotnim trajanjem študij (do 2 leti).
English: For the remaining duration of breast-feeding, exposure is expected to be low.
Slovenian: Za preostali čas trajanja dojenja se pričakuje, da bo izpostavljenost majhna.
English: All of the studies met their primary endpoint.
Slovenian: Vse študije so dosegle primarni opazovani dogodek.
English: A total of 99.5% of patients were followed for survival until the end of the trial.
Slovenian: Glede preživetja so do konca preskušanja spremljali 99,5 % bolnikov.
English: • Check that the syringe is not open or damaged.
Slovenian: • Preverite, da brizga ni odprta ali poškodovana.
English: • You can inject into your:
Slovenian: • Zdravilo lahko injicirate v:
English: • If the window does not turn completely yellow, call sanofi-aventis for help.
Slovenian: • Če okence ne postane povsem rumeno, za pomoč pokličite družbo sanofi-aventis.
English: Number of events
Slovenian: Število dogodkov
English: • Wash your hands with soap and water and dry with a towel.
Slovenian: • Roke si umijte z milom in vodo in jih osušite z brisačo.
English: LONG TERM study
Slovenian: Študija LONG TERM
English: ODYSSEY OUTCOMES study
Slovenian: Študija ODYSSEY OUTCOMES
English: Evaluation of Cardiovascular (CV) events
Slovenian: Ocenjevanje kardiovaskularnih (KV) dogodkov
English: STEP B: How to inject
Slovenian: KORAK B: Kako injicirati
English: Date of first authorisation: 23 September 2015
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 23. september 2015
English: LDL-C reduction was consistent regardless of concomitantly used statins and doses.
Slovenian: Znižanje h-LDL je bilo dosledno, ne glede na sočasno uporabljene statine in odmerke.
English: The safety and efficacy of Praluent in children and adolescents less than 18 years of age have not been established.
Slovenian: Varnost in učinkovitost zdravila Praluent pri otrocih in mladostnikih, mlajših od 18 let, nista ugotovljeni.
English: Immunogenicity data are highly dependent on the sensitivity and specificity of the ADA assay.
Slovenian: Podatki o imunogenosti so močno odvisni od senzitivnosti in specifičnosti preizkusa za ADA.
English: On-treatment analysis - analysis restricted to the time period that patients actually received treatment.
Slovenian: b Analiza med zdravljenjem - analiza, omejena na obdobje, med katerim so bolniki dejansko prejemali zdravljenje.
English: • Your injection is complete, when the window has turned completely yellow, you may hear a second click.
Slovenian: • Injiciranje je končano, ko je okence popolnoma rumeno; morda boste slišali še en klik.
English: Clinical efficacy and safety in prevention of cardiovascular events
Slovenian: Klinična učinkovitost in varnost pri preprečevanju srčno-žilnih dogodkov