natgillin/translations-raw huggingface dataset:
It was to be used when the disease had relapsed (come back after previous treatment).
Uporabljalo naj bi se pri relapsu bolezni (ponovitvi po predhodnem zdravljenju).
The CHMP was concerned that the company had not provided sufficient evidence of the medicine's benefits, because the number of patients who responded to treatment was not dramatic and because response rates may not be a suitable measure of the medicine's effectiveness.
CHMP je bil zaskrbljen, da družba ni predložila zadostnih dokazov o koristi zdravila, saj število bolnikov, ki so se odzvali na zdravljenje, ni bilo dramatično, in ker stopnja odziva bolnikov morda ni primerno merilo za učinkovitost zdravila.
There are no consequences on the use of Avastin in its authorised indications, for which the balance of benefits and risks remains unchanged.
Umik nima nobenih posledic za uporabo zdravila Avastin za odobrene indikacije, pri katerih ostaja razmerje med koristmi in tveganji nespremenjeno.
Half of the patients received Avastin alone and the other half received Avastin together with irinotecan.
Polovica bolnikov je prejemala zdravilo Avastin samostojno, druga polovica pa v kombinaciji z irinotekanom.
Glioblastoma is a type of brain tumour that affects the ‘glial' cells (the cells that surround and support the nerve cells).
Glioblastom je vrsta možganskega tumorja, ki vpliva na nevroglijske celice (celice, ki obkrožajo in podpirajo živčne celice).
As a result, the cancer cells cannot develop their own blood supply and are starved of oxygen and nutrients, helping to slow down the growth of tumours.
Zaradi tega se rakave celice ne morejo oskrbovati s krvjo ter dobivajo premalo kisika in hranil, to pa pripomore k upočasnjeni rasti tumorjev.
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found in the body.
Monoklonsko protitelo je protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da prepozna posebno strukturo (imenovano antigen), ki se nahaja v telesu, in se veže nanjo.
What are the consequences of the refusal for patients in clinical trials using Avastin?
Kakšne so posledice zavrnitve za bolnike, ki sodelujejo v kliničnih preskušanjih zdravila Avastin?
Bevacizumab has been designed to attach to vascular endothelial growth factor (VEGF), a protein that circulates in the blood and makes blood vessels grow.
Bevacizumab je bil zasnovan tako, da se veže na endotelijski rastni faktor v žilah (VEGF), beljakovino, ki kroži po krvi in omogoča rast krvnih žil.
The active substance in Avastin, bevacizumab, is a monoclonal antibody.
Zdravilna učinkovina v zdravilu Avastin, bevacizumab, je monoklonsko protitelo.
On 19 November 2009, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of a change to the marketing authorisation for the medicinal product Avastin.
Odbor za zdravila za uporabo v humani medicini (CHMP) je v svojem negativnem mnenju z dne 19. novembra 2009 priporočil zavrnitev vloge za spremembo dovoljenja za promet z zdravilom Avastin.
The change concerned an extension of indication to add the treatment of glioblastoma after relapse.
Sprememba se je nanašala na razširitev indikacije z vključitvijo zdravljenja glioblastomov po ponovitvi bolezni.
Avastin was also expected to be used to treat another type of cancer called glioblastoma.
Zdravilo Avastin naj bi se uporabljalo tudi za zdravljenje druge vrste raka, imenovane glioblastom.
In addition, the CHMP could not interpret the findings on survival because the study did not compare Avastin directly with any other treatments.
Poleg tega si CHMP ni mogel razlagati ugotovitev glede preživetja, saj družba zdravila Avastin ni neposredno primerjala z drugimi zdravili.
Avastin was to be used in on its own or in combination with irinotecan (another anticancer medicine).
Zdravilo Avastin naj bi se uporabljalo samostojno ali v kombinaciji z irinotekanom (drugim zdravilom proti raku).
By attaching to VEGF, Avastin stops it having an effect.
Z vezavo na VEGF zdravilo Avastin zaustavi njegovo delovanje.
It is already used in combination with other medicines to treat cancer of the colon or rectum (large intestine), breast cancer, non-small cell lung cancer and kidney cancer.
Uporablja se v kombinaciji z drugimi zdravili za zdravljenje raka kolona ali danke (debelega črevesa), raka dojke, nedrobnoceličnega pljučnega raka in raka ledvic.
What is happening with Avastin for the treatment of colorectal, breast, lung and kidney cancer?
Kaj se dogaja z zdravilom Avastin za zdravljenje kolorektalnega raka, raka dojke, pljučnega raka in raka ledvic?
The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Avastin for glioblastoma.
Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Avastin za glioblastom.
In glioblastoma, Avastin is expected to work in the same way as it does in its existing indications.
Zdravilo Avastin naj bi pri glioblastomu delovalo na enak način kot pri drugih odobrenih indikacijah.
Therefore, at that point in time, the CHMP was of the opinion that the balance of benefits and risks of Avastin in the treatment of glioblastoma after relapse could not be established.
Zato je CHMP tokrat menil, da ni mogoče ugotoviti ravnotežja med koristmi in tveganji zdravila Avastin pri zdravljenju glioblastoma po ponovitvi.
Avastin is a concentrate that is made up into a solution for infusion (drip into a vein).
Zdravilo Avastin je koncentrat za pripravo raztopine za infundiranje (kapalne infuzije v veno).
It contains the active substance bevacizumab.
Vsebuje zdravilno učinkovino bevacizumab.
The European Commission granted a marketing authorisation valid throughout the European Union for Lixiana on 19 June 2015.
Evropska komisija je dovoljenje za promet z zdravilom Lixiana, veljavno po vsej Evropski uniji, izdala 19. junija 2015.
The full EPAR for Lixiana can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Lixiana je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What measures are being taken to ensure the safe and effective use of Lixiana?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Lixiana?
This is a summary of the European public assessment report (EPAR) for Lixiana.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Lixiana.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Lixiana's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Lixiana večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Lixiana is available as tablets (15, 30 and 60 mg) and can only be obtained with a prescription.
Zdravilo Lixiana je na voljo v obliki tablet (15, 30 in 60 mg), njegovo predpisovanje in izdaja pa je le na recept.
Although there was greater a risk of bleeding from the mucosa (tissues lining body cavities such as the nose, gut and vagina), the Committee considered that the risk could be managed with appropriate measures.
Čeprav so opazili večje tveganje krvavitve iz sluznice (tkiv, ki obdajajo telesne odprtine, kot so nos, črevo in nožnica), je odbor menil, da je tveganje mogoče obvladati z ustreznimi ukrepi.
It is used in patients who have one or more risk factors, such as having had a previous stroke, high blood pressure, diabetes, heart failure or being 75 years old or over;
Uporablja se pri bolnikih z enim ali več dejavniki tveganja, kot so možganska kap v preteklosti, visok krvni tlak, sladkorna bolezen, srčno popuščanje ali starost nad 75 let;
With respect to safety, overall the risk of serious bleeding such as bleeding into the brain was reduced compared with warfarin, although there may be less difference where warfarin treatment is well managed.
Kar zadeva varnost, je bilo splošno tveganje za resno krvavitev, kot je denimo krvavitev v možganih, manjše kot pri uporabi varfarina, čeprav so lahko razlike manjše, kadar je zdravljenje z varfarinom dobro vodeno.
It must also not be used in pregnant or breastfeeding women or in patients also being treated with another anticoagulant.
Prav tako se ne sme uporabljati pri nosečnicah in doječih materah ter pri bolnikih, ki se že zdravijo z drugim antikoagulantom.
Lixiana is an anticoagulant medicine (a medicine that prevents blood clotting) used in adults:
Zdravilo Lixiana je antikoagulant (zdravilo za preprečevanje strjevanja krvi), ki se uporablja pri odraslih:
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lixiana have also been included in the summary of product characteristics and the package leaflet.Other information about Lixiana
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Lixiana upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.Druge informacije o zdravilu Lixiana
What benefits of Lixiana have been shown in studies?
Kakšne koristi je zdravilo Lixiana izkazalo v študijah?
The company that markets Lixiana will provide educational materials for doctors prescribing the medicine and an alert card for patients, explaining the risks of bleeding with the medicine and how to manage them.
Družba, ki trži zdravilo Lixiana, bo zagotovila izobraževalno gradivo za zdravnike, ki bodo predpisovali zdravilo, in opozorilno kartico za bolnike, na kateri bodo pojasnjena tveganja krvavitve pri uporabi zdravila in navodila za njihovo obvladovanje.
What is Lixiana and what is it used for?
Kaj je zdravilo Lixiana in za kaj se uporablja?
Lixiana must not be used in patients who are actively bleeding, have liver diseases that affect blood clotting, have severe uncontrolled high blood pressure or who have a condition putting them at significant risk of major bleeding.
Zdravilo Lixiana se ne sme uporabljati pri bolnikih z aktivno krvavitvijo, boleznijo jeter, ki vpliva na strjevanje krvi, nenadzorovanim zelo visokim krvnim tlakom ali boleznijo, zaradi katere pri njih obstaja veliko tveganje za hude krvavitve.
For more information about treatment with Lixiana, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Lixiana preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
What are the risks associated with Lixiana?
Kakšna tveganja so povezana z zdravilom Lixiana?
The most common side effects with Lixiana (which may affect up to 1 in 10 people) are bleeding from skin and soft tissues, nose bleeds (epistaxis) and the vagina.
Najpogostejši neželeni učinki zdravila Lixiana (ki lahko prizadenejo največ 1 osebo od 10) so krvavitev iz kože in mehkih tkiv ter krvavitve iz nosu (epistaksa) in nožnice.
Other common side effects are anaemia (low levels of red blood cells), rash, itching, headache, dizziness, belly pain and abnormal results in tests of liver function.
Drugi pogosti neželeni učinki so anemija (nizke ravni rdečih krvnih celic), izpuščaji, srbenje, glavobol, omotica, bolečine v trebuhu in nenormalni izvidi preiskav delovanja jeter.
Why is Lixiana approved?
Zakaj je bilo zdravilo Lixiana odobreno?
When another recommended definition of the type of stroke was used, embolism or stroke due to blood clots was seen in 143 patients given Lixiana (0.9%) and 157 given warfarin (1%).
Ko so uporabili drugo priporočeno opredelitev vrste možganske kapi, so embolijo ali možgansko kap zaradi krvnih strdkov zabeležili pri 143 bolnikih, ki so prejemali zdravilo Lixiana (0,9 %), in 157 bolnikih, ki so prejemali varfarin (1 %).
It is not intended to provide practical advice on how to use Lixiana.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
For practical information about using Lixiana, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Lixiana naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
A first systemic embolism or stroke occurred in 182 patients given standard doses of Lixiana and in 232 of those given warfarin, corresponding to annual rates for these events of around 1.2% and 1.5% respectively.
Prvi pojav sistemske embolije ali možganske kapi so zabeležili pri 182 bolnikih, ki so prejemali standardne odmerke zdravila Lixiana, in 232 bolnikih, ki so prejemali varfarin, kar pomeni, da je bil letni delež teh dogodkov približno 1,2 % oziroma 1,5 %.
Dose adjustments may also need to be made in patients who are switched between Lixiana and other anticoagulant medicines.
Odmerek je včasih treba prilagoditi tudi pri bolnikih, ki preidejo na zdravilo Lixiana z drugih antikoagulantov in obratno.
By blocking factor Xa, the medicine reduces the levels of thrombin in the blood, which helps treat clots and reduce the risk of them forming in the arteries and veins and leading to DVT, pulmonary embolism, stroke or other organ damage.
Zdravilo Lixiana z zaviranjem faktorja Xa zniža ravni trombina v krvi, s čimer pomaga odpraviti strdke in zmanjša tveganje, da bi se ti tvorili v arterijah in venah ter povzročili globoko vensko trombozo, pljučno embolijo, možgansko kap ali poškodbo drugih organov.
For the full list of all side effects reported with Lixiana, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Lixiana, glejte navodilo za uporabo.
Doses should be halved in patients with moderately or severely reduced kidney function, or low body weight or in those who are also taking certain medicines (known as P-gp inhibitors) that can interfere with the removal of edoxaban from the body.
Bolniki z zmerno ali hudo okvaro delovanja ledvic, bolniki z nizko telesno maso ali tisti, ki sočasno jemljejo nekatera druga zdravila (imenovana zaviralci P-glikoproteina), ki lahko vplivajo na izločanje edoksabana iz telesa, morajo jemati polovične odmerke.
The main measure of effectiveness was the number of patients who had another episode of DVT or pulmonary embolism during the study period.
Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih sta se med trajanjem študije ponovno pojavili globoka venska tromboza ali pljučna embolija.
There was a trend for better results in patients with reduced kidney function than those whose kidney function was normal.
Izkazalo se je, da so bili rezultati boljši pri bolnikih z okvarjenim delovanjem ledvic kot pri tistih z normalnim delovanjem ledvic.
Lixiana contains the active substance edoxaban.
Zdravilo Lixiana vsebuje zdravilno učinkovino edoksaban.
The active substance in Lixiana, edoxaban, is a ‘factor Xa inhibitor'.
Zdravilna učinkovina v zdravilu Lixiana, edoksaban, je zaviralec faktorja Xa.
However, the trend for its benefits in preventing stroke in atrial fibrillation to be less clear in those patients with high creatinine clearance (good kidney function) was considered to require further study.
Vendar pa je treba dodatno proučiti opažanje, da so njegove koristi pri preprečevanju možganske kapi pri atrijski fibrilaciji manj očitne pri bolnikih z velikim očistkom kreatinina (dobrim delovanjem ledvic).
How does Lixiana work?
Kako zdravilo Lixiana deluje?
How is Lixiana used?
Kako se zdravilo Lixiana uporablja?
Lixiana has been shown to be as effective as the standard anticoagulant warfarin in preventing stroke and systemic embolism in patients with atrial fibrillation.
Izkazalo se je, da je zdravilo Lixiana pri preprečevanju možganske kapi in sistemske embolije pri bolnikih z atrijsko fibrilacijo enako učinkovito kot standardni antikoagulant varfarin.
In the treatment and prevention of blood clots in patients with DVT or pulmonary embolism, Lixiana was also found to be as effective as warfarin, in a study involving over 8,200 patients.
V študiji, v kateri je sodelovalo več kot 8 200 bolnikov, so ugotovili, da je zdravilo Lixiana enako učinkovito kot varfarin tudi pri zdravljenju in preprečevanju krvnih strdkov pri bolnikih z globoko vensko trombozo ali pljučno embolijo.
Ref.: EMEA/487740/2009 EMEA/H/C/1059
: EMEA/487737/2009 EMEA/H/C/1059
The standard dose of Grepid is one 75 mg tablet once a day, taken with or without food.
Običajni odmerek zdravila Grepid je ena 75-miligramska tableta enkrat na dan, ki se vzame s hrano ali brez nje.
Grepid can be given to the following groups of patients:
Zdravilo Grepid se lahko daje naslednjim skupinam bolnikov:
The European Commission granted a marketing authorisation valid throughout the EU for Grepid to Pharmathen S.A. on 28 July 2009.
Evropska komisija je dovoljenje za promet z zdravilom Grepid, veljavno po vsej EU, odobrila družbi Pharmathen S.A. dne 28. julija 2009.
What are the benefit and risk of Grepid?
Kakšne so koristi in tveganja, povezana z zdravilom Grepid?
This means that Grepid is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Plavix.
Other information about Grepid:
Druge informacije o zdravilu Grepid:
Grepid can be started between a few days and 35 days after the attack;
Zdravilo Grepid se lahko začne jemati od nekaj dni po napadu do 35 dni po njem;
Grepid clopidogrel EPAR summary for the public
Grepid klopidogrel Povzetek EPAR za javnost
The Committee recommended that Grepid be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Grepid odobri dovoljenje za promet.
Grepid is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Zdravilo Grepid se uporablja pri odraslih za preprečevanje aterotrombotičnih dogodkov (težav, ki jih povzročajo krvni strdki in otrdelost krvnih žil).
Grepid is a ‘generic medicine'.
Zdravilo Grepid je „generično zdravilo“.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Grepid has been shown to have comparable quality and to be bioequivalent to Plavix.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v s skladu z zahtevami EU dokazano, da ima zdravilo Grepid primerljivo raven kakovosti kot zdravilo Plavix ter je biološko enakovredno.
Grepid can be started between seven days and six months after the stroke;
Zdravilo Grepid se lahko začne jemati od sedem dni po napadu in do šest mesecev po njem;
Because Grepid is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Ker je zdravilo Grepid generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
Why has Grepid been approved?
Zakaj je bilo zdravilo Grepid odobreno?
Because Grepid is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Ker je zdravilo Grepid generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Plavix.
Grepid is a medicine that contains the active substance clopidogrel.
Grepid je zdravilo, ki vsebuje zdravilno učinkovino klopidogrel.
The active substance in Grepid, clopidogrel, is an inhibitor of platelet aggregation.
Zdravilna učinkovina v zdravilu Grepid, klopidogrel, je zaviralec agregacije trombocitov.
• patients who have had a recent ischaemic stroke (stroke caused by failure of the blood supply to part of the brain).
• bolnikom, ki so nedavno utrpeli ishemično kap (kap, ki jo povzroči neoskrba določenega dela možganov s krvjo).
The full EPAR for Grepid can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Grepid je na voljo tukaj.
How has Grepid been studied?
Kako je bilo zdravilo Grepid raziskano?
What is Grepid?
Kaj je zdravilo Grepid?
How is Grepid used?
Kako se zdravilo Grepid uporablja?
What is Grepid used for?
Za kaj se zdravilo Grepid uporablja?
How does Grepid work?
Kako zdravilo Grepid deluje?
It is given 21 to 49 days after transplantation, but only if the transplant has not already restored the patient's immune system and if the patient has not developed graft-versus-host disease (when transplanted cells attack the body).
Daje se 21 do 49 dni po presaditvi, a le, če presadek ni že sam obnovil bolnikovega imunskega sistema in če se pri bolniku ni pojavila reakcija presadka proti gostitelju (stanje, pri katerem presajene celice napadejo telo).
This is a summary of the European public assessment report (EPAR) for Zalmoxis.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Zalmoxis.
Although more data are needed to determine the size of the benefit, the Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Zalmoxis' benefits are greater than its risks and recommended that it be approved for use in the EU.
Čeprav je za določitev obsega koristi potrebnih več podatkov, je Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji zaključil, da so koristi zdravila Zalmoxis večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
What measures are being taken to ensure the safe and effective use of Zalmoxis?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Zalmoxis?
The number of patients who survived after one year was 51% for patients who received Zalmoxis compared with 34 to 40% for patients who did not receive Zalmoxis.
Delež bolnikov, ki so preživeli eno leto, je bil 51 % pri bolnikih, ki so prejeli zdravilo Zalmoxis, v primerjavi s 34 do 40 % pri bolnikih, ki niso prejeli zdravila Zalmoxis.
It must also not be used in patients who have already developed graft-versus-host disease that requires treatment.
Prav tako se ne sme uporabljati pri bolnikih, pri katerih se je že pojavila reakcija presadka proti gostitelju, zaradi katere je potrebno zdravljenje.
The safety profile of Zalmoxis is considered acceptable.
Varnostni profil zdravila Zalmoxis je ocenjen kot sprejemljiv.
In this study, Zalmoxis was not compared with any other treatment.
V tej študiji zdravila Zalmoxis niso primerjali z nobenim drugim zdravilom.
Zalmoxis is given as an infusion (drip) into a vein lasting 20 to 60 minutes, every month for up to four months until the circulating T cells reach a certain level.
Zdravilo Zalmoxis se daje z infundiranjem (kapalno infuzijo) v veno, ki traja od 20 do 60 minut, vsak mesec do največ štiri mesece, dokler celice T v obtoku ne dosežejo določene ravni.
The main measure of effectiveness was restoration of the immune system as measured by blood levels of T cells.
Glavno merilo učinkovitosti je bila obnova imunskega sistema, izmerjena s količino celic T v krvi.
These T cells are then genetically modified to include a ‘suicide gene'.
Te celice T se nato gensko spremenijo tako, da vključujejo „samomorilski gen“.
The summary of the opinion of the Committee for Orphan Medicinal Products for Zalmoxis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Zalmoxis je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
The company will also collect data from all patients treated with Zalmoxis through a registry and will monitor their progress after treatment to study long-term safety and effectiveness of the medicine.
Družba bo poleg tega v registru zbrala podatke o vseh bolnikih, zdravljenih z zdravilom Zalmoxis, in spremljala njihov napredek po zdravljenju, da bi preučila dolgoročno varnost in učinkovitost zdravila.
77% of the patients receiving Zalmoxis (23 out of 30) had their immune systems restored.
Pri 77 % bolnikov (23 od 30), ki so prejeli zdravilo Zalmoxis , se je imunski sistem obnovil.