natgillin/translations-raw huggingface dataset:
A total of 335 patients in the Faslodex plus palbociclib arm and 166 patients in the Faslodex plus placebo arm completed the questionnaire at baseline and at least 1 post-baseline visit.
Vprašalnik je ob izhodišču in vsaj 1 obisku po izhodišču izpolnilo skupno 335 bolnic iz skupine z zdravilom Faslodex in palbociklibom ter 166 bolnic iz skupine z zdravilom Faslodex in placebom.
What Faslodex looks like and contents of the pack Faslodex is a clear, colourless to yellow, viscous solution in a pre-filled syringe fitted with a tamper-evident closure, containing 5 ml solution for injection.
Zdravilo Faslodex je bistra, brezbarvna do rumena, gosta raztopina v napolnjeni injekcijski brizgi z zaporko, ki ščiti pred posegom in vsebuje 5 ml raztopine za injiciranje.
No dose adjustments are recommended for patients with mild to moderate hepatic impairment.
Pri bolnicah z blago do zmerno okvaro jeter niso priporočljive prilagoditve odmerka.
One clear type 1 glass pre-filled syringe with polystyrene plunger rod, fitted with a tamper-evident closure, containing 5 ml Faslodex solution for injection.
Ena napolnjena injekcijska brizga iz prozornega stekla tipa 1 s polistirenskim potisnim batom z zaporko, ki ščiti pred posegom, vsebuje 5 ml Faslodex raztopine za injekcije.
No dose adjustments are recommended for patients with mild to moderate renal impairment (creatinine clearance 30 ml/min).
Pri bolnicah z blago do zmerno okvaro ledvic (kreatininski očistek ≥ 30 ml/min) niso priporočljive prilagoditve odmerka.
Progression-free survival was the primary endpoint.
Primarni končni cilj je bilo preživetje brez napredovanja bolezni.
Faslodex plus palbociclib (N=141)
Zdravilo Faslodex in palbociklib (N = 141)
Faslodex plus palbociclib (N=206)
Zdravilo Faslodex in palbociklib (N = 206)
ORR Odds Ratio (95% CI) and p-value
Razmerje obetov za ORR (95 % IZ) in vrednost p
Faslodex + Palbociclib (N=345)
Zdravilo Faslodex in palbociklib (N = 345)
There is no evidence of adverse endometrial effects in the breast cancer patients studied.
Pri preučenih bolnicah z rakom dojke ni znakov neželenih endometrijskih učinkov.
Patients with advanced/metastatic, symptomatic, visceral spread, that were at risk of life-threatening complications in the short term (including patients with
Za vključitev v študijo niso bile primerne bolnice z napredovalo/metastatsko, simptomatsko, visceralno razširjeno boleznijo, ki so imele tveganje za smrtno nevarne zaplete kratkoročno (vključno z bolnicami z masivnimi, neobvladanimi izlivi [plevralni, perikardialni, peritonealni], pljučnim limfangitisom in več kot 50-odstotno zajetostjo jeter).
Faslodex plus placebo (N=105)
Zdravilo Faslodex in placebo (N = 105)
How to store Faslodex
Shranjevanje zdravila Faslodex
Comparison between groups (Faslodex 500 mg/Faslodex 250 mg) Hazard ratio 95% CI p-value
Primerjava med skupinami (Faslodex 500 mg/Faslodex 250 mg) razmerje ogroženosti
See the package leaflet for further information.
Za nadaljnja navodila glejte Navodilo za uporabo.
For the subgroup of patients with disease limited to non-visceral metastasis (n=208), the HR was 0.592 (95% CI: 0.419, 0.837) for the Faslodex arm compared to the anastrozole arm. For the subgroup of patients with visceral metastasis (n=254), the HR was 0.993 (95% CI: 0.740, 1.331) for the Faslodex arm compared to the anastrozole arm.
V podskupini bolnic z boleznijo, omejeno na nevisceralne metastaze (n = 208), je bilo razmerje ogroženosti (HR) v skupini z zdravilom Faslodex v primerjavi s skupino z anastrozolom 0,592 (95 % IZ: 0,419; 0,837).
• Back pain*
• bolečine v križu*
Faslodex plus placebo (N=69)
Zdravilo Faslodex in placebo (N = 69)
Injection site related events including sciatica, neuralgia, neuropathic pain, and peripheral neuropathy have been reported with Faslodex injection.
Po injiciranju zdravila Faslodex so poročali o učinkih, povezanih z mestom injiciranja, med njimi o išiasu, nevralgiji, nevropatski bolečini in periferni nevropatiji.
Injection site haemorrhage f, injection site haematoma f, neuralgia c,f
hematom na mestu injiciranja f,
Faslodex + placebo (N=172)
Zdravilo Faslodex in placebo (N = 172)
Ethanol (96 per cent) Benzyl alcohol Benzyl benzoate Castor oil refined
6.1 Seznam pomožnih snovi etanol (96 odstotni) benzilalkohol benzilbenzoat rafinirano ricinusovo olje
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja zelo pogosti izpuščaj
Faslodex plus placebo (N=174)
Zdravilo Faslodex in placebo (N = 174)
Caution should be taken while administering Faslodex at the dorsogluteal injection site due to the proximity of the underlying sciatic nerve (see sections 4.2 and
Pri injiciranju zdravila Faslodex v dorzoglutealni predel je potrebna previdnost zaradi bližine spodaj potekajočega ishiadičnega živca (glejte poglavji 4.2 in 4.8).
Patients were well matched for baseline demographics and prognostic characteristics between the Faslodex plus palbociclib arm and the Faslodex plus placebo arm.
Bolnice v skupini, ki je prejemala zdravilo Faslodex in palbociklib, so bile po izhodiščnih demografskih značilnosti in značilnostih prognoze bolezni dobro usklajene z bolnicami v skupini, ki je prejemala zdravilo Faslodex in placebo.
• Expel excess gas from the syringe.
• Iztisnite odvečni zrak iz brizge.
CBR Odds Ratio (95% CI) and p-value
Razmerje obetov za CBR (95 % IZ) in vrednost p
Faslodex has 2 pack presentations, either a pack containing 1 glass pre-filled syringe or a pack containing 2 glass pre-filled syringes.
V pakiranju je bodisi ena napolnjena injekcijska brizga iz prozornega stekla tipa 1, ali pa sta v pakiranju 2 napolnjeni injekcijski brizgi.
• Joint and musculoskeletal pain
• bolečine v sklepih in skeletnih mišicah
• Urinary tract infections
• okužbe sečil
Fulvestrant has been shown to cross the placenta after single intramuscular doses in rat and rabbit.
Znano je, da pri podganah in kuncih fulvestrant po enkratnih intramuskularnih odmerkih prehaja placento.
Progression-Free Survival Median [months (95% CI)] Hazard ratio (95% CI) and p-value
Mediana [meseci (95 % IZ)] Razmerje ogroženosti (95 % IZ) in vrednost p
• Hot flushes
• navali vročine
Thrombocytopenia includes the following PTs: Thrombocytopenia, Platelet count decreased.
Trombocitopenija vključuje naslednja PTs: trombocitopenija, zmanjšano število trombocitov.
Infections and infestations Very common Infections Blood and lymphatic system disorders Very common Neutropenia Leukopenia Anaemia Thrombocytopenia
Bolezni mišično-skeletnega sistema in vezivnega tkiva zelo pogosti sklepna in mišično-skeletna bolečina pogosti bolečine v križu
Gastrointestinal disorders
estrogenskimi receptorji.
Metabolism and nutrition disorders
Mehanizem delovanja in farmakodinamični učinki
• Skin rash
• kožni izpuščaj
A Phase 3, international, randomised, double-blind, parallel-group, multicentre study of Faslodex 500 mg plus palbociclib 125 mg versus Faslodex 500 mg plus placebo was conducted in women with HR-positive, HER2-negative locally advanced breast cancer not amenable to resection or radiation therapy with curative intent or metastatic breast cancer, regardless of their menopausal status, whose disease progressed after prior endocrine therapy in the (neo) adjuvant or metastatic setting.
Študija je zajela ženske, ki so imele HR-pozitivnega, HER2-negativnega lokalno napredovalega raka dojke, neprimernega za resekcijo ali radioterapijo s kurativnim namenom, ali metastatskega raka dojke, ne glede na menopavzalni status, pri katerih je bolezen napredovala med predhodnim endokrinim zdravljenjem v okviru (neo)adjuvantnega ali metastatskega zdravljenja bolezni.
However, since asthenia has been reported very commonly with Faslodex, caution should be observed by those patients who experience this adverse reaction when driving or operating machinery.
Pri vožnji in upravljanju strojev morajo biti zato bolnice, pri katerih se ta neželeni učinek pojavi, previdne.
- Keep this leaflet.
Ne sukajte!
• Remove needle sheath.
• Odstranite ovojnico igle.
Vaginal moniliasis f, leukorrhea
pogosti zvišanje bilirubina občasni odpoved jeter c, f
Mexico plans to recognise unilaterally EU centralised authorisations.
iz Mehike namerava enostransko priznati centralizirana dovoljenja EU.
• Revised draft agenda version 4.0.
• Revidirani osnutek dnevnega reda, različica 4.0.
7 June 2012
7. junij 2012
The procedure concerns any incomplete and/or incorrect declarations of interests.
Postopek se nanaša na vsako nepopolno in/ali nepravilno izjavo o interesih.
The meeting this year focussed on the following:
Letošnja seja je bila osredotočena na:
The issue of language was raised.
Zastavljeno je bilo vprašanje jezika.
This is important to ensure that correct risk levels are generated by the system.
To je pomembno za zagotovitev, da se s sistemom ustvarjajo ustrezne ravni tveganja.
The Agency is stepping up its communications activities.
Agencija postopno krepi svoje komunikacijske dejavnosti.
This means that adopted minutes will be published irrespective of whether a procedure is finished or still ongoing.
To pomeni, da bodo sprejeti zapisniki objavljeni ne glede na to, ali je postopek končan ali še poteka.
As part of that work, the Agency had launched the ESVAC project in September 2009.
Agencija je v okviru teh prizadevanj septembra 2009 začela izvajati projekt ESVAC.
c.) Information and communications technology
c) Informacijska in komunikacijska tehnologija
This raised concern about the possible outcome of the discharge procedure even though considerable improvements had been made.
To je vzbudilo zaskrbljenost glede izida postopka razrešnice, čeprav so bile uvedene precejšnje izboljšave.
It was proposed to limit this impact by introducing the notion of 'department of an academic institution'.
Predlagano je bilo, naj se ta učinek omeji z uvedbo pojma „oddelek akademske institucije“.
Instead, policies adopted by the Agency should be used as a reference when developing national policies in this domain.
Namesto tega naj se politike, ki jih sprejme agencija, uporabljajo kot referenca pri razvoju nacionalnih politik na tem področju.
The European Parliament rapporteur for the discharge of EU agencies visited the Agency on 10 February.
Poročevalka Evropskega parlamenta za razrešnico agencij EU je 10. februarja obiskala agencijo.
This was the last meeting for those civil-society representatives who attended as observers today.
To je bila zadnja seja za tiste predstavnike civilne družbe, ki so se je udeležili kot opazovalci.
Replies to the Court are being prepared.
Odgovori za Računsko sodišče se pripravljajo.
This should be analysed separately.
To bi bilo treba obravnavati posebej.
Visit of Commissioner John Dalli
Obisk komisarja Johna Dallija
The hearings should see a 'real public participation'.
Obravnave bi morale temeljiti na „resnični udeležbi javnosti“.
Discharge for the budget 2010
Razrešnica za proračun za leto 2010
The rapporteur did not indicate whether or not she would recommend granting the discharge for the Agency.
Poročevalka ni povedala, ali bo priporočila podelitev razrešnice za agencijo ali ne.
• the definitions of ownership of a patent and (principal) investigator;
• opredelitev lastništva patenta in (glavnega) preiskovalca;
The analysis concluded that further amendments to the policy are warranted (as described in the next section).
Z analizo je bilo ugotovljeno, da so nadaljnje spremembe politike upravičene (kot je opisano v naslednjem oddelku).
These rules are applicable to temporary agents and contract agents, and are fully in place.
Ta pravila se uporabljajo za začasne in pogodbene uslužbence in veljajo v celoti.
Appointment of Michael Lenihan as the Agency's accounting officer
Imenovanje Michaela Lenihana za računovodjo agencije
Organisational changes
Organizacijske spremembe
European Surveillance of Veterinary Antimicrobial Consumption (ESVAC)
Evropski sistem za nadzor nad rabo veterinarskih protimikrobnih sredstev (ESVAC)
• The split of the amended proposal into two proposals: 'information to patients' and 'pharmacovigilance'.
• razdelitvijo spremenjenega predloga na dva predloga: „obveščanje bolnikov“ in „farmakovigilanco“.
This puts significant strain on the Agency and the national competent authorities.
To precej obremenjuje agencijo in pristojne nacionalne organe.
A second challenge for the Agency is to explain to the public the reason for the divergence and the impact this has.
Drugi izziv za agencijo je pojasniti javnosti razlog za razhajanje in njegov učinek.
The Executive Director stressed the Agency's commitment to contributing to combating antimicrobial resistance.
Izvršni direktor je poudaril zavezanost agencije, da prispeva k boju proti protimikrobni odpornosti.
The Commissioner addressed the staff of the Agency and responded to questions.
Komisar je nagovoril osebje agencije in odgovarjal na vprašanja.
Cooperation with the Mexican authorities
Sodelovanje z mehiškimi organi
The Board discussed significant constraints affecting the 2013 budget.
Upravni odbor je razpravljal o precejšnjih omejitvah, ki vplivajo na proračun za leto 2013.
John Dalli, Commissioner for Health, visited the Agency on 6 February 2012.
Komisar za zdravje John Dalli je 6. februarja 2012 obiskal agencijo.
List of written procedures during the period 15 September 2011 to 30 November 2011
Seznam pisnih postopkov v obdobju od 15. septembra do 30. novembra 2011
A number of national competent authorities will be visited as part of the study.
V okviru študije bo obiskanih več pristojnih nacionalnih organov.
The Board adopted the decision to hold its meetings in English only.
Upravni odbor je sprejel odločitev, da bodo njegove seje potekale samo v angleščini.
The policy takes into account comments made at the previous meeting and those received by correspondence.
Politika upošteva pripombe, dane na predhodni seji, in tiste, so prispele v korespondenci.
The draft report highlights a number of issues which the Agency believes are addressed through the developments mentioned earlier.
V osnutku poročila je poudarjenih več vprašanj, za katera agencija meni, da jih obravnavajo prej navedene izboljšave.
Public hearings should initially cover a limited number of aspects only, but may over time be expanded to cover more complex issues.
V javne obravnave bi bilo treba najprej vključiti samo omejeno število vidikov, sčasoma pa bi se lahko razširile na bolj zapletena vprašanja.
The Management Board decided to extend the pilot phase for one further year.
Upravni odbor je sklenil, da za eno leto podaljša pilotno fazo.
The participants stressed that the pharmacovigilance system should be supported by fees, which are foreseen in the legislation but will not come into force until after a few years.
Udeleženci so poudarili, da je treba sistem farmakovigilance podpreti s pristojbinami, ki so predvidene v zakonodaji, vendar še nekaj let ne bodo začele veljati.
The final policy will be sent to the Board, together with a request for its members to complete a new declaration of interests.
Končna politika bo poslana upravnemu odboru, skupaj z zahtevo za njegove člane, naj izpolnijo novo izjavo o interesih.
• The finalisation of the eHealth Network with good representation from national authorities.
• dokončnim oblikovanjem mreže e-zdravja z ustreznim zastopstvom iz nacionalnih organov.
The use of case stories was suggested, as this is a useful tool to increase understanding of the matters raised.
Predlagana je bila uporaba študij primerov, saj je to uporabno orodje za boljše razumevanje obravnavanih vprašanj.
To be a communication tool, hearings should convey a clear and well-defined message.
Da so obravnave komunikacijsko orodje, morajo posredovati jasno in dobro opredeljeno sporočilo.
The Commission representative stressed the importance of the Agency concentrating on its core tasks, especially because 2013 will be financially a critical year, and discussions are still ongoing in the Commission concerning the EU contribution.
Predstavnik Komisije je poudaril, da je pomembno, da se agencija osredotoči na svoje ključne naloge, zlasti ker bo leto 2013 v finančnem pogledu kritično leto, v Komisiji pa še vedno razpravljajo o prispevku EU.
The EU contribution remains at the 2012 level of €38.8 million.
Prispevek EU ostaja na ravni iz leta 2012, in sicer 38,8 milijona EUR.
The final wording will be verified with the Legal Service of the Agency.
Končno besedilo bo preverila pravna služba agencije.
The formal process of reviewing nominations and identifying areas requiring reinforcement will take place at the June meeting.
Formalni postopek pregleda imenovanj in določitev področij, ki jih je treba okrepiti, bosta potekala na junijski seji.
The Board also expressed continuing concern that the EU legislation was adopted without adequate consideration being given to the costs required to implement the legislation.
Izrazil je tudi zaskrbljenost, da je bila zakonodaja EU sprejeta brez ustreznega upoštevanja stroškov, potrebnih za njeno izvajanje.
The additional posts reflect the increase in workload in the period 2010 to 2012.
Dodatna delovna mesta so posledica večje delovne obremenitve med letoma 2010 in 2012.
The Dutch member asked the European Commission and the Parliament representatives to bring these concerns to the attention of the EU Parliament, and to make the Parliament aware that full implementation of the pharmacovigilance legislation in July will not be possible.
Nizozemski član je predstavnike Evropske komisije in Evropskega parlamenta zaprosil, naj na to opozorijo Parlament EU in ga obvestijo, da polno izvajanje zakonodaje o farmakovigilanci v juliju ne bo mogoče.
The Board also extended its invitation to the observers from civil society to participate at the next meeting, in June, if the nomination process for new representatives is not completed in time for the meeting.
Podaljšal je tudi svoje povabilo opazovalcem iz civilne družbe, naj se udeležijo naslednje seje v juniju, če postopek imenovanja novih predstavnikov ne bo pravočasno končan za sejo.
The Board noted the budgetary uncertainties and their impact on the work programme, as described below.
Upravni odbor se je seznanil s proračunskimi negotovostmi in njihovim učinkom na delovni program, kot je opisano v nadaljevanju.
The first meeting of the network is planned for May 2012.
Prvi sestanek mreže je predviden maja 2012;
Regarding the collection and use of evidence, participants were of the opinion that the use of data from electronic registries would become easier in future, which would significantly facilitate the application of the concept.
Glede zbiranja in uporabe dokazov so udeleženci menili, da bo uporaba podatkov iz elektronskih registrov v prihodnosti preprostejša, kar bo močno olajšalo uporabo tega koncepta.
After initial experience, the process needs to be evaluated, to verify if the expected results are being achieved.
Postopek je treba po pridobitvi prvih izkušenj oceniti, da se preveri, ali so bili doseženi pričakovani rezultati.
The Agency will consider the request and will respond to the proposal.
Agencija bo prošnjo proučila in odgovorila na predlog.
Adaptive licensing: a useful approach for drug licensing in the EU?
Prilagodljivo izdajanje dovoljenj: uporaben pristop za izdajanje dovoljenj za zdravila v EU?
During this interim discussion, members noted that more expertise may be needed in the areas of pregnancy and lactation.
Člani so med to vmesno razpravo opozorili, da bo morda potrebnega več strokovnega znanja na področjih nosečnosti in dojenja.
Although the appointment of a rapporteur from a different Member State could be seen as adding to the trust of the system, other members were convinced that this would unnecessarily increase the complexity and associated costs of the system.
Čeprav bi se na imenovanje poročevalca iz druge države članice lahko gledalo kot na okrepitev zaupanja v sistem, so bili drugi člani prepričani, da bi to po nepotrebnem povečalo zapletenost sistema in s tem povezane stroške.
The Management Board was informed of the ongoing evaluation of the European Medicines Agency and the European Aviation Safety Agency (EASA).
Upravni odbor je bil obveščen, da poteka ocenjevanje Evropske agencije za zdravila in Evropske agencije za varnost v letalstvu (EASA).
Members agreed that all parts of agendas and minutes should be published.
Člani so se strinjali, da je treba objaviti vse dele dnevnih redov in zapisnikov.
The rapporteur was of the opinion that the Agency has to do more in the area of conflicts of interests.
Menila je, da si mora agencija bolj prizadevati na področju navzkrižja interesov.
• The DIA EuroMeeting, where two sessions will be dedicated to the European medicines regulatory network.
• EuroMeetingom organizacije DIA, pri čemer bosta dve seji namenjeni evropski regulativni mreži za zdravila.
This step will be completed at the June Management Board meeting, once nominations from all Member States and the European Commission have been received.
To dejanje bo končano na junijski seji upravnega odbora, in sicer po prejemu imenovanj iz vseh držav članic in Evropske komisije.
In his presentation, François Houÿez, of the European Organisation for Rare Diseases, stressed that patients are looking for greater involvement, better understanding of already reached regulatory decisions and participation in decision making.
François Houÿez iz Evropske organizacije za redke bolezni je med svojo predstavitvijo poudaril, da bolniki pričakujejo večjo vključenost, boljše razumevanje že doseženih regulativnih odločitev in udeležbo pri odločanju.
Topic coordinators
Tematski koordinatorji
This included 62 applications for new medicines, an increase of 35% as compared to 2010.
To vključuje 62 vlog za nova zdravila, kar pomeni 35-odstotno povečanje v primerjavi z letom 2010.
Annually, the Management Board dedicates the first day of its March meeting to discussions on strategic topics.
Upravni odbor vsako leto nameni prvi dan svoje marčevske seje razpravam o strateških temah.
The European Commission provided an update on legislative and policy developments, including the following:
Evropska komisija je predstavila najnovejše informacije o razvoju zakonodaje in politike, vključno z :
The Agency wishes to launch a debate with all stakeholders on the appropriateness of introducing such a concept in the European Union (EU), including a consideration of appropriate incentives to support the development of new medicines.
Agencija želi z zainteresiranimi stranmi začeti razpravo o ustreznosti uvedbe takega koncepta v Evropski uniji (EU), vključno s proučitvijo ustreznih pobud za podporo razvoju novih zdravil.
Declaration of conflicts of interests related to current agenda
Izjava o navzkrižju interesov v zvezi s sedanjim dnevnim redom
• Presentation on proposal for a directive of the European Parliament and the Council relating to the transparency measures regulating the prices of medicinal products for human use and their inclusion in the scope of public health insurance systems.
• Predstavitev o predlogu direktive Evropskega parlamenta in Sveta o preglednosti ukrepov, ki urejajo cene zdravil za uporabo v humani medicini in njihovo vključitev v področje nacionalnih sistemov zdravstvenega zavarovanja.
Interpretation will be discontinued, starting from the June 2012 meeting, resulting in savings of around EUR 25,000 per year.
Od junijske seje 2012 tolmačenje ne bo več zagotovljeno, s čimer bo letno prihranjenih približno 25 000 EUR.
In this session, the Board reflected on the concept of 'staggered' approval (also known as adaptive or progressive licensing).
Upravni odbor je na tem zasedanju razpravljal o konceptu „postopne“ odobritve (znanem tudi kot prilagodljivo ali postopno izdajanje dovoljenj).
A further discussion on ICT projects is planned for the June meeting.
Nadaljnja razprava o projektih IKT je načrtovana za junijsko sejo.
This action would strengthen the credibility of the system, would facilitate the work of regulators and increase the transparency of the pharmaceutical industry.
Ta ukrep bi povečal verodostojnost sistema, olajšal delo regulatorjev in povečal preglednost farmacevtske industrije.
b.) Overview of nominations received
b) Pregled prejetih imenovanj