FrancophonIA/ELRC3.0 huggingface dataset:
English: • Thick, whitish vaginal discharge and candidiasis (infection)
Slovenian: • gost, belkast izcedek iz nožnice in kandidiaza (glivična okužba nožnice)
English: What Faslodex contains - The active substance is fulvestrant.
Slovenian: Kaj vsebuje zdravilo Faslodex - Učinkovina je fulvestrant.
English: Increases in placental weight and post-implantation loss of foetuses were seen.
Slovenian: Opazili so povečanje mase placente in izgubo ploda po ugnezdenju.
English: All Patients -AE subgroup (n=423) -AI subgroup (n=313)
Slovenian: Vsi bolniki -AE podskupina (n = 423) -AI podskupina (n = 313)
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema zelo pogosti
English: Breast-feeding must be discontinued during treatment with Faslodex.
Slovenian: Med zdravljenjem z zdravilom Faslodex je potrebno opustiti dojenje.
English: Faslodex contains 500 mg benzyl alcohol per injection, equivalent to 100 mg/ml.
Slovenian: Zdravilo Faslodex vsebuje 500 mg benzilalkohola na injekcijo, kar je enako 100 mg/ml.
English: • Check that the needle is locked to the Luer connector before moving out of the vertical plane.
Slovenian: • Pred premikom iz navpične ravnine preverite, da je igla pričvrščena na nastavku Luer.
English: • in combination with palbociclib to treat women with a type of breast cancer called hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer, that is locally advanced or has spread to other parts of the body (metastatic).
Slovenian: • v kombinaciji s palbociklibom za zdravljenje žensk z rakom dojke, imenovanim rak dojke s pozitivnimi hormonskimi receptorji in negativnimi receptorji 2 za epidermalni rastni faktor, ki je lokalno napredoval ali se je razširil v druge dele telesa (je metastatski).
English: Faslodex contains 10% w/v ethanol (alcohol), i.e. up to 500 mg per injection, equivalent to 10 ml beer or 4 ml wine.
Slovenian: Zdravilo Faslodex vsebuje 10 % m/v etanola (alkohola), to je do 500 mg na injekcijo, kar ustreza 10 ml piva oziroma 4 ml vina.
English: Mechanism of action and pharmacodynamic effects Fulvestrant is a competitive estrogen receptor (ER) antagonist with an affinity comparable to estradiol.
Slovenian: Fulvestrant je kompetitivni antagonist estrogenskih receptorjev z afiniteto, primerljivo z afiniteto estradiola.
English: Two clear type 1 glass pre-filled syringes with polystyrene plunger rod, fitted with a tamper-evident closure, each containing 5 ml Faslodex solution for injection.
Slovenian: Dve napolnjeni injekcijski brizgi iz prozornega stekla tipa 1 s polistirenskim potisnim batom z zaporko, ki ščiti pred posegom, vsaka vsebuje 5 ml Faslodex raztopine za injekcije.
English: For user convenience, the needle bevel-up position is oriented to the lever arm (see Figure 4).
Slovenian: Zaradi praktičnosti pri uporabi je prirezani del igle na strani ročice (glejte sliko 4).
English: All Patients -AE subgroup (n=423) -AI subgroup (n=313) OS
Slovenian: Vsi bolniki -AE podskupina (n = 423) -AI podskupina (n = 313) OS
English: Faslodex 250 mg solution for injection.
Slovenian: Faslodex 250 mg raztopina za injiciranje
English: • Parenteral solutions must be inspected visually for particulate matter and discolouration prior to administration.
Slovenian: • Parenteralne raztopine je treba pred uporabo pregledati in se prepričati, da ne vsebujejo delcev in da niso spremenjene barve.
English: Faslodex contains 10% w/v ethanol (alcohol) as an excipient, i.e. up to 500 mg per injection, equivalent to 10 ml beer or 4 ml wine.
Slovenian: Zdravilo Faslodex vsebuje 10 % m/v etanola (alkohola) kot pomožno snov, to je do 500 mg na injekcijo, kar ustreza 10 ml piva oziroma 4 ml vina.
English: • Decreased levels of platelets (thrombocytopenia)
Slovenian: • zmanjšanje števila trombocitov (trombocitopenija)
English: See package leaflet for information on temperature excursions.
Slovenian: Za informacije o temperaturnih odklonih glejte navodilo za uporabo.
English: Elevated hepatic enzymes (ALT, AST, ALP)
Slovenian: Bolezni jeter, žolčnika in žolčevodov zelo pogosti zvišanje jetrnih encimov (ALT, AST, ALP)
English: • Transport filled syringe to point of administration.
Slovenian: • Prenesite napolnjeno brizgo na mesto, kjer bo zdravilo uporabljeno.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: No dose adjustments are recommended for patients with mild to moderate hepatic impairment.
Slovenian: Pri bolnicah z blago do zmerno okvaro jeter niso priporočljive prilagoditve odmerka.
English: 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.
Slovenian: 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.
English: No dose adjustments are recommended for patients with mild to moderate renal impairment (creatinine clearance 30 ml/min).
Slovenian: Pri bolnicah z blago do zmerno okvaro ledvic (kreatininski očistek ≥ 30 ml/min) niso priporočljive prilagoditve odmerka.
English: Progression-free survival was the primary endpoint.
Slovenian: Primarni končni cilj je bilo preživetje brez napredovanja bolezni.
English: Faslodex plus palbociclib (N=141)
Slovenian: Zdravilo Faslodex in palbociklib (N = 141)
English: Faslodex plus palbociclib (N=206)
Slovenian: Zdravilo Faslodex in palbociklib (N = 206)
English: ORR Odds Ratio (95% CI) and p-value
Slovenian: Razmerje obetov za ORR (95 % IZ) in vrednost p
English: Faslodex + Palbociclib (N=345)
Slovenian: Zdravilo Faslodex in palbociklib (N = 345)
English: There is no evidence of adverse endometrial effects in the breast cancer patients studied.
Slovenian: Pri preučenih bolnicah z rakom dojke ni znakov neželenih endometrijskih učinkov.
English: Patients with advanced/metastatic, symptomatic, visceral spread, that were at risk of life-threatening complications in the short term (including patients with
Slovenian: 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).
English: Faslodex plus placebo (N=105)
Slovenian: Zdravilo Faslodex in placebo (N = 105)
English: How to store Faslodex
Slovenian: Shranjevanje zdravila Faslodex
English: Comparison between groups (Faslodex 500 mg/Faslodex 250 mg) Hazard ratio 95% CI p-value
Slovenian: Primerjava med skupinami (Faslodex 500 mg/Faslodex 250 mg) razmerje ogroženosti
English: See the package leaflet for further information.
Slovenian: Za nadaljnja navodila glejte Navodilo za uporabo.
English: 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.
Slovenian: 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).
English: • Back pain*
Slovenian: • bolečine v križu*
English: Faslodex plus placebo (N=69)
Slovenian: Zdravilo Faslodex in placebo (N = 69)
English: Injection site related events including sciatica, neuralgia, neuropathic pain, and peripheral neuropathy have been reported with Faslodex injection.
Slovenian: Po injiciranju zdravila Faslodex so poročali o učinkih, povezanih z mestom injiciranja, med njimi o išiasu, nevralgiji, nevropatski bolečini in periferni nevropatiji.
English: Injection site haemorrhage f, injection site haematoma f, neuralgia c,f
Slovenian: hematom na mestu injiciranja f,
English: Faslodex + placebo (N=172)
Slovenian: Zdravilo Faslodex in placebo (N = 172)
English: Ethanol (96 per cent) Benzyl alcohol Benzyl benzoate Castor oil refined
Slovenian: 6.1 Seznam pomožnih snovi etanol (96 odstotni) benzilalkohol benzilbenzoat rafinirano ricinusovo olje
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja zelo pogosti izpuščaj
English: Faslodex plus placebo (N=174)
Slovenian: Zdravilo Faslodex in placebo (N = 174)
English: 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
Slovenian: Pri injiciranju zdravila Faslodex v dorzoglutealni predel je potrebna previdnost zaradi bližine spodaj potekajočega ishiadičnega živca (glejte poglavji 4.2 in 4.8).
English: Patients were well matched for baseline demographics and prognostic characteristics between the Faslodex plus palbociclib arm and the Faslodex plus placebo arm.
Slovenian: 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.
English: • Expel excess gas from the syringe.
Slovenian: • Iztisnite odvečni zrak iz brizge.
English: CBR Odds Ratio (95% CI) and p-value
Slovenian: Razmerje obetov za CBR (95 % IZ) in vrednost p
English: Faslodex has 2 pack presentations, either a pack containing 1 glass pre-filled syringe or a pack containing 2 glass pre-filled syringes.
Slovenian: V pakiranju je bodisi ena napolnjena injekcijska brizga iz prozornega stekla tipa 1, ali pa sta v pakiranju 2 napolnjeni injekcijski brizgi.
English: • Joint and musculoskeletal pain
Slovenian: • bolečine v sklepih in skeletnih mišicah
English: • Urinary tract infections
Slovenian: • okužbe sečil
English: Fulvestrant has been shown to cross the placenta after single intramuscular doses in rat and rabbit.
Slovenian: Znano je, da pri podganah in kuncih fulvestrant po enkratnih intramuskularnih odmerkih prehaja placento.
English: Progression-Free Survival Median [months (95% CI)] Hazard ratio (95% CI) and p-value
Slovenian: Mediana [meseci (95 % IZ)] Razmerje ogroženosti (95 % IZ) in vrednost p
English: • Hot flushes
Slovenian: • navali vročine
English: Thrombocytopenia includes the following PTs: Thrombocytopenia, Platelet count decreased.
Slovenian: Trombocitopenija vključuje naslednja PTs: trombocitopenija, zmanjšano število trombocitov.
English: Infections and infestations Very common Infections Blood and lymphatic system disorders Very common Neutropenia Leukopenia Anaemia Thrombocytopenia
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva zelo pogosti sklepna in mišično-skeletna bolečina pogosti bolečine v križu
English: Gastrointestinal disorders
Slovenian: estrogenskimi receptorji.
English: Metabolism and nutrition disorders
Slovenian: Mehanizem delovanja in farmakodinamični učinki
English: • Skin rash
Slovenian: • kožni izpuščaj
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Pri vožnji in upravljanju strojev morajo biti zato bolnice, pri katerih se ta neželeni učinek pojavi, previdne.
English: - Keep this leaflet.
Slovenian: Ne sukajte!
English: • Remove needle sheath.
Slovenian: • Odstranite ovojnico igle.
English: Vaginal moniliasis f, leukorrhea
Slovenian: pogosti zvišanje bilirubina občasni odpoved jeter c, f
English: Mexico plans to recognise unilaterally EU centralised authorisations.
Slovenian: iz Mehike namerava enostransko priznati centralizirana dovoljenja EU.
English: • Revised draft agenda version 4.0.
Slovenian: • Revidirani osnutek dnevnega reda, različica 4.0.
English: 7 June 2012
Slovenian: 7. junij 2012
English: The procedure concerns any incomplete and/or incorrect declarations of interests.
Slovenian: Postopek se nanaša na vsako nepopolno in/ali nepravilno izjavo o interesih.
English: The meeting this year focussed on the following:
Slovenian: Letošnja seja je bila osredotočena na:
English: The issue of language was raised.
Slovenian: Zastavljeno je bilo vprašanje jezika.
English: This is important to ensure that correct risk levels are generated by the system.
Slovenian: To je pomembno za zagotovitev, da se s sistemom ustvarjajo ustrezne ravni tveganja.
English: The Agency is stepping up its communications activities.
Slovenian: Agencija postopno krepi svoje komunikacijske dejavnosti.
English: This means that adopted minutes will be published irrespective of whether a procedure is finished or still ongoing.
Slovenian: To pomeni, da bodo sprejeti zapisniki objavljeni ne glede na to, ali je postopek končan ali še poteka.
English: As part of that work, the Agency had launched the ESVAC project in September 2009.
Slovenian: Agencija je v okviru teh prizadevanj septembra 2009 začela izvajati projekt ESVAC.
English: c.) Information and communications technology
Slovenian: c) Informacijska in komunikacijska tehnologija
English: This raised concern about the possible outcome of the discharge procedure even though considerable improvements had been made.
Slovenian: To je vzbudilo zaskrbljenost glede izida postopka razrešnice, čeprav so bile uvedene precejšnje izboljšave.
English: It was proposed to limit this impact by introducing the notion of 'department of an academic institution'.
Slovenian: Predlagano je bilo, naj se ta učinek omeji z uvedbo pojma „oddelek akademske institucije“.
English: Instead, policies adopted by the Agency should be used as a reference when developing national policies in this domain.
Slovenian: Namesto tega naj se politike, ki jih sprejme agencija, uporabljajo kot referenca pri razvoju nacionalnih politik na tem področju.
English: The European Parliament rapporteur for the discharge of EU agencies visited the Agency on 10 February.
Slovenian: Poročevalka Evropskega parlamenta za razrešnico agencij EU je 10. februarja obiskala agencijo.
English: This was the last meeting for those civil-society representatives who attended as observers today.
Slovenian: To je bila zadnja seja za tiste predstavnike civilne družbe, ki so se je udeležili kot opazovalci.
English: Replies to the Court are being prepared.
Slovenian: Odgovori za Računsko sodišče se pripravljajo.
English: This should be analysed separately.
Slovenian: To bi bilo treba obravnavati posebej.
English: Visit of Commissioner John Dalli
Slovenian: Obisk komisarja Johna Dallija
English: The hearings should see a 'real public participation'.
Slovenian: Obravnave bi morale temeljiti na „resnični udeležbi javnosti“.
English: Discharge for the budget 2010
Slovenian: Razrešnica za proračun za leto 2010
English: The rapporteur did not indicate whether or not she would recommend granting the discharge for the Agency.
Slovenian: Poročevalka ni povedala, ali bo priporočila podelitev razrešnice za agencijo ali ne.
English: • the definitions of ownership of a patent and (principal) investigator;
Slovenian: • opredelitev lastništva patenta in (glavnega) preiskovalca;
English: The analysis concluded that further amendments to the policy are warranted (as described in the next section).
Slovenian: Z analizo je bilo ugotovljeno, da so nadaljnje spremembe politike upravičene (kot je opisano v naslednjem oddelku).
English: These rules are applicable to temporary agents and contract agents, and are fully in place.
Slovenian: Ta pravila se uporabljajo za začasne in pogodbene uslužbence in veljajo v celoti.
English: Appointment of Michael Lenihan as the Agency's accounting officer
Slovenian: Imenovanje Michaela Lenihana za računovodjo agencije
English: Organisational changes
Slovenian: Organizacijske spremembe
English: European Surveillance of Veterinary Antimicrobial Consumption (ESVAC)
Slovenian: Evropski sistem za nadzor nad rabo veterinarskih protimikrobnih sredstev (ESVAC)
English: • The split of the amended proposal into two proposals: 'information to patients' and 'pharmacovigilance'.
Slovenian: • razdelitvijo spremenjenega predloga na dva predloga: „obveščanje bolnikov“ in „farmakovigilanco“.
English: This puts significant strain on the Agency and the national competent authorities.
Slovenian: To precej obremenjuje agencijo in pristojne nacionalne organe.
English: A second challenge for the Agency is to explain to the public the reason for the divergence and the impact this has.
Slovenian: Drugi izziv za agencijo je pojasniti javnosti razlog za razhajanje in njegov učinek.
English: The Executive Director stressed the Agency's commitment to contributing to combating antimicrobial resistance.
Slovenian: Izvršni direktor je poudaril zavezanost agencije, da prispeva k boju proti protimikrobni odpornosti.
English: The Commissioner addressed the staff of the Agency and responded to questions.
Slovenian: Komisar je nagovoril osebje agencije in odgovarjal na vprašanja.
English: Cooperation with the Mexican authorities
Slovenian: Sodelovanje z mehiškimi organi
English: The Board discussed significant constraints affecting the 2013 budget.
Slovenian: Upravni odbor je razpravljal o precejšnjih omejitvah, ki vplivajo na proračun za leto 2013.
English: John Dalli, Commissioner for Health, visited the Agency on 6 February 2012.
Slovenian: Komisar za zdravje John Dalli je 6. februarja 2012 obiskal agencijo.
English: List of written procedures during the period 15 September 2011 to 30 November 2011
Slovenian: Seznam pisnih postopkov v obdobju od 15. septembra do 30. novembra 2011
English: A number of national competent authorities will be visited as part of the study.
Slovenian: V okviru študije bo obiskanih več pristojnih nacionalnih organov.
English: The Board adopted the decision to hold its meetings in English only.
Slovenian: Upravni odbor je sprejel odločitev, da bodo njegove seje potekale samo v angleščini.
English: The policy takes into account comments made at the previous meeting and those received by correspondence.
Slovenian: Politika upošteva pripombe, dane na predhodni seji, in tiste, so prispele v korespondenci.
English: The draft report highlights a number of issues which the Agency believes are addressed through the developments mentioned earlier.
Slovenian: V osnutku poročila je poudarjenih več vprašanj, za katera agencija meni, da jih obravnavajo prej navedene izboljšave.
English: Public hearings should initially cover a limited number of aspects only, but may over time be expanded to cover more complex issues.
Slovenian: V javne obravnave bi bilo treba najprej vključiti samo omejeno število vidikov, sčasoma pa bi se lahko razširile na bolj zapletena vprašanja.
English: The Management Board decided to extend the pilot phase for one further year.
Slovenian: Upravni odbor je sklenil, da za eno leto podaljša pilotno fazo.
English: 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.
Slovenian: Udeleženci so poudarili, da je treba sistem farmakovigilance podpreti s pristojbinami, ki so predvidene v zakonodaji, vendar še nekaj let ne bodo začele veljati.
English: The final policy will be sent to the Board, together with a request for its members to complete a new declaration of interests.
Slovenian: Končna politika bo poslana upravnemu odboru, skupaj z zahtevo za njegove člane, naj izpolnijo novo izjavo o interesih.
English: • The finalisation of the eHealth Network with good representation from national authorities.
Slovenian: • dokončnim oblikovanjem mreže e-zdravja z ustreznim zastopstvom iz nacionalnih organov.
English: The use of case stories was suggested, as this is a useful tool to increase understanding of the matters raised.
Slovenian: Predlagana je bila uporaba študij primerov, saj je to uporabno orodje za boljše razumevanje obravnavanih vprašanj.
English: To be a communication tool, hearings should convey a clear and well-defined message.
Slovenian: Da so obravnave komunikacijsko orodje, morajo posredovati jasno in dobro opredeljeno sporočilo.
English: 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.
Slovenian: 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.
English: The EU contribution remains at the 2012 level of €38.8 million.
Slovenian: Prispevek EU ostaja na ravni iz leta 2012, in sicer 38,8 milijona EUR.
English: The final wording will be verified with the Legal Service of the Agency.
Slovenian: Končno besedilo bo preverila pravna služba agencije.
English: The formal process of reviewing nominations and identifying areas requiring reinforcement will take place at the June meeting.
Slovenian: Formalni postopek pregleda imenovanj in določitev področij, ki jih je treba okrepiti, bosta potekala na junijski seji.
English: 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.
Slovenian: Izrazil je tudi zaskrbljenost, da je bila zakonodaja EU sprejeta brez ustreznega upoštevanja stroškov, potrebnih za njeno izvajanje.
English: The additional posts reflect the increase in workload in the period 2010 to 2012.
Slovenian: Dodatna delovna mesta so posledica večje delovne obremenitve med letoma 2010 in 2012.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.