FrancophonIA/ELRC3.0 huggingface dataset:
English: [EMA/MB/302460/2010] The Management Board had adopted revised contractual arrangements which contain a number of key performance indicators.
Slovenian: [EMA/MB/302460/2010] Upravni odbor je sprejel spremenjene pogodbene ureditve, ki vključujejo več ključnih kazalnikov uspešnosti.
English: [EMA/MB/298741/2010] The Management Board discussed two ongoing consultation procedures: one for the CVMP and one for the CHMP.
Slovenian: [EMA/MB/298741/2010] Upravni odbor je razpravljal o dveh trenutnih postopkih posvetovanja in sicer enem za odbor CVMP in enem za odbor CHMP.
English: [EMA/MB/297535/2010; EMA/MB/168222/2010] The Management Board adopted the analysis and assessment of the annual activity report 2009.
Slovenian: [EMA/MB/297535/2010; EMA/MB/168222/2010] Upravni odbor je potrdil analizo in oceno letnega poročila o dejavnostih za leto 2009.
English: [EMA/MB/311466/2010] The Management Board discussed the memorandum of understanding (MoU) which clarifies the responsibilities between the EMA and national competent authorities for monitoring of the scientific level and independence of evaluations.
Slovenian: [EMA/MB/311466/2010] Upravni odbor je razpravljal o memorandumu o soglasju, v katerem so pojasnjene obveznosti agencije EMA in nacionalnih pristojnih organov za spremljanje znanstvene ravni in neodvisnosti vrednotenja.
English: European Parliament
Slovenian: Evropski parlament
English: Documents for information
Slovenian: Dokumenti v vednost
English: Minutes of the 67th meeting of the Management Board
Slovenian: Zapisnik 67. seje upravnega odbora
English: [EMA/MB/338709/2010; EMA/712397/2009] The Management Board noted the draft reflection paper, which elaborates on four areas of action from the strategy paper 'Acceptance of clinical trials conducted in third countries for evaluation in Marketing Authorisation Applications'.
Slovenian: [EMA/MB/338709/2010; EMA/712397/2009] Upravni odbor se je seznanil z osnutkom študije, v kateri so podrobneje obravnavana štiri področja ukrepov iz strateškega dokumenta „Sprejemanje kliničnih preskušanj, izvedenih v tretjih državah, za ocenjevanje v vlogah za pridobitev dovoljenja za promet“.
English: Representatives of patients' organisations
Slovenian: Predstavniki organizacij bolnikov
English: Election of the Management Board Chair
Slovenian: Izvolitev predsednika upravnega odbora
English: [EMA/MB/354158/2010] The Management Board endorsed the appointment of an ad interim accounting officer until the return to office of the accounting officer.
Slovenian: [EMA/MB/354158/2010] Upravni odbor je potrdil imenovanje začasnega računovodje, dokler se ne bo računovodja vrnil na delo.
English: [EMA/MB/276960/2010; EMA/319831/2010] The Management Board noted the Agency's report to the European Commission providing the Agency's views on the experience with the Fee Regulation.
Slovenian: [EMA/MB/276960/2010; EMA/319831/2010] Upravni odbor se je seznanil s poročilom agencije Evropski komisiji, v katerem so navedena njena stališča glede izkušenj z uredbo o pristojbinah.
English: [EMA/MB/13787/2009] The Management Board noted the update report on the implementation of EudraVigilance for veterinary products.
Slovenian: [EMA/MB/13787/2009] Upravni odbor se je seznanil s posodobljenim poročilom o izvajanju sistema EudraVigilance za proizvode za uporabo v veterinarski medicini.
English: Report from the Heads of Medicines Agencies
Slovenian: Poročilo vodij agencij za zdravila
English: [EMA/MB/345587/2010] The Management Board discussed the new format of the EudraVigilance report.
Slovenian: [EMA/MB/345587/2010] Upravni odbor je razpravljal o novi obliki poročila o sistemu EudraVigilance.
English: Chair: Pat O'Mahony
Slovenian: Predsednik: Pat O'Mahony
English: The members noted the update report from the Heads of Medicines Agencies (HMA) on a number of topics, including:
Slovenian: Člani upravnega odbora so se seznanili s posodobljenim poročilom vodij agencij za zdravila o več temah, vključno s/z:
English: [EMA/MB/298674/2010] The Management Board adopted its meeting dates for 2011 and noted tentative meeting dates for 2012.
Slovenian: [EMA/MB/298674/2010] Upravni odbor je potrdil datume sej za leto 2011 in se seznanil z okvirnimi datumi sej za leto 2012.
English: [EMA/MB/311343/2010; EMA/255244/2010; EMA/MB/353273/2010] The Management Board discussed and agreed in principle on a way forward for introducing changes to the way the Agency handles potential conflicts of interests of experts involved in the evaluation of medicines.
Slovenian: [EMA/MB/311343/2010; EMA/255244/2010; EMA/MB/353273/2010] Upravni odbor je razpravljal o prihodnjih ukrepih za uvedbo sprememb načina, kako agencija obravnava mogoča navzkrižja interesov strokovnjakov, ki sodelujejo pri vrednotenju zdravil, in se načelno strinjal s prihodnjimi ukrepi.
English: [EMA/MB/282448/2010] The Management Board heard the report on arbitration and referral activities of the CVMP.
Slovenian: [EMA/MB/282448/2010] Upravni odbor se je seznanil s poročilom o dejavnostih arbitraže in napotitev odbora CVMP.
English: [EMA/MB/372194/2010, EMA/MB/400828/2010] The Management Board noted the decision of the European Commission to re-open the vacancy announcement following advice of the European Commission legal service with regard to a wider publication of the vacancy.
Slovenian: [EMA/MB/372194/2010, EMA/MB/400828/2010] Upravni odbor se je seznanil s sklepom Evropske komisije, da v skladu z nasvetom pravne službe Evropske komisije, da je treba poskrbeti za širšo objavo prostega delovnega mesta, znova objavi obvestilo o prostem delovnem mestu.
English: • The progress on the HMA strategy paper.
Slovenian: • napredkom pri strateškem dokumentu vodij agencij za zdravila.
English: The Board constituted a group of topic coordinators to work together with the Agency's staff: Chair, Vice-chair, Kent Woods, Giuseppe Nisticò, Guido Rasi.
Slovenian: V njej bodo predsednik, podpredsednica, Kent Woods, Giuseppe Nisticò in Guido Rasi.
English: Otherwise, the national competent authorities may have significant difficulties contributing to activities which are important for public health.
Slovenian: Treba je vzpostaviti povezavo med obsegom dela in razpoložljivimi viri za opravljanje potrebnega dela, drugače bodo nacionalni pristojni organi le težko prispevali k dejavnostim, ki so pomembne za javno zdravje.
English: Representative of veterinarians' organisations
Slovenian: Predstavniki veterinarskih organizacij
English: Veterinary medicinal products
Slovenian: Zdravila za uporabo v veterinarski medicini
English: Human medicinal products
Slovenian: Zdravila za uporabo v humani medicini
English: [EMA/MB/194352/2010] The Management Board noted the final minutes, adopted by written procedure on 26 April 2010.
Slovenian: Zapisnik 66. seje, ki je potekala 17. in 18. marca 2010 [EMA/MB/194352/2010] Upravni odbor se je seznanil s končnim zapisnikom, ki je bil s pisnim postopkom sprejet 26. aprila 2010.
English: Pending completion of these steps, the Board expressed a scrutiny reservation.
Slovenian: Upravni odbor je do dokončanja teh ukrepov podal proučitveni pridržek.
English: Representative of doctors' organisations
Slovenian: Predstavniki zdravniških organizacij
English: List of participants at the 67
Slovenian: Seznam udeležencev 67. seje upravnega odbora, ki je potekala v Londonu 10. junija 2010
English: Ref. EMEA/652773/2009 EMEA/H/C/1040
Slovenian: : EMEA/769850/2009 EMEA/H/C/1040
English: London, 22 October 2009 Doc.
Slovenian: London, 22. oktobra 2009 Sklic dok.
English: It was expected to be available as tablets (50 and 150 mg).
Slovenian: Na voljo naj bi bilo v obliki tablet (50 in 150 mg).
English: However that trial was being stopped.
Slovenian: Vendar so preskušanje ustavili.
English: If you are a patient in this trial and need more information about your treatment, contact the doctor who is treating you.
Slovenian: Če ste vključeni v to preskušanje ter potrebujete več informacij o zdravljenju, se obrnite na zdravnika, ki vam je predpisal zdravljenje.
English: Questions and answers on the withdrawal of the marketing authorisation application for Zunrisa casopitant
Slovenian: Vprašanja in odgovori v zvezi z umikom vloge za pridobitev dovoljenja za promet z zdravilom Zunrisa kasopitant
English: After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues.
Slovenian: Potem ko je CHMP ocenil odgovore družbe na seznam vprašanj, so nekatera tehtna vprašanja še vedno ostala nerešena.
English: The effects of Zunrisa were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Zunrisa so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Zunrisa?
Slovenian: Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Zunrisa?
English: It blocks a chemical in the body called substance P from attaching to the NK1 receptors.
Slovenian: V telesu preprečuje, da bi se kemikalija, ki jo imenujemo snov P, vezala na receptorje NK1.
English: The company presented data from large studies in cancer patients receiving chemotherapy.
Slovenian: Predlagatelj je predstavil podatke iz velikih študij, opravljenih pri bolnikih z rakom, ki so prejemali kemoterapijo.
English: When substance P attaches to these receptors, it can cause nausea and vomiting.
Slovenian: Če se snov P veže na omenjene receptorje, lahko povzroči slabost in bruhanje.
English: The company informed the CHMP that at the time of the withdrawal one clinical trial with Zunrisa was ongoing.
Slovenian: Družba je obvestila CHMP, da v času umika poteka eno klinično preskušanje zdravila Zunrisa.
English: The active substance in Zunrisa, casopitant, is a ‘neurokinin 1 (NK1) receptor antagonist'.
Slovenian: Zdravilna učinkovina v zdravilu Zunrisa je „antagonist receptorja za nevrokinin 1 (NK1)“.
English: The Committee also asked the company to reconsider the target population for patients having surgery to ensure it adequately reflected the kind of patients who were involved in the studies.
Slovenian: Odbor je prosil predlagatelja, da spremeni ciljno populacijo bolnikov po operativnem posegu tako, da bi primerno odražala bolnike, ki so sodelovali v študijah.
English: What is Zunrisa?
Slovenian: Kaj je zdravilo Zunrisa?
English: The main measure of effectiveness was the number of patients who did not vomit or needed to be given rescue medication for vomiting in the first five days following the start of a cycle of chemotherapy.
Slovenian: Glavno merilo učinkovitosti je bilo število bolnikov, ki niso bruhali ali niso potrebovali rešilnega zdravila za bruhanje v prvih petih dneh po začetku cikla kemoterapije.
English: Zunrisa is a medicine that contains the active substance casopitant.
Slovenian: Zdravilo Zunrisa vsebuje zdravilno učinkovino kasopitant.
English: The patients were given a combination of Zunrisa with two other medicines (dexamethasone and ondansetron) or the combination without Zunrisa.
Slovenian: Bolnikom so dali bodisi kombinacijo zdravila Zunrisa in še dveh zdravil (deksametazona in ondansetrona) bodisi kombinacijo brez zdravila Zunrisa.
English: On 25 September 2009, Glaxo Group Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Zunrisa, for the prevention of nausea and vomiting in patients undergoing surgery or receiving chemotherapy.
Slovenian: Družba Glaxo Group Ltd je dne 25. septembra 2009 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Zunrisa, namenjenim preprečevanju slabosti in bruhanja pri bolnikih po operativnih posegih ali med kemoterapijo.
English: What was Zunrisa expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Zunrisa uporabljalo?
English: The company also presented data from studies in patients at a high risk of having nausea and vomiting after surgery.
Slovenian: Predlagatelj je predstavil tudi podatke iz študij z bolniki, pri katerih je bilo tveganje slabosti in bruhanja po operativnem posegu zelo veliko.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Zunrisa could not have been approved for use with other medicines in the prevention of nausea and vomiting in patients receiving chemotherapy or in those undergoing surgery.
Slovenian: Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil določene zadržke in je začasno menil, da zdravila Zunrisa ni mogoče odobriti za uporabo z drugimi zdravili za preprečevanje slabosti in bruhanja pri bolnikih, ki prejemajo kemoterapijo, ali po operativnih posegih
English: The main measure of effectiveness for the study was the number of patients who did not vomit or needed to be given any rescue medication in the first 24 hours after surgery.
Slovenian: Glavno merilo učinkovitosti je bilo število bolnikov, ki niso bruhali ali niso potrebovali rešilnega zdravila za bruhanje v prvih štiriindvajsetih urah po operativnem posegu.
English: After looking at the results of the main studies, the CHMP noted that, while the studies showed that Zunrisa was effective in some cancer patients receiving chemotherapy, its use in patients receiving chemotherapy treatments that are moderate triggers of nausea and vomiting was not fully supported by the results.
Slovenian: Po pregledu rezultatov glavne študije je CHMP ugotovil, da študije sicer kažejo učinkovitost zdravila Zunrisa pri določenih bolnikih z rakom, ki prejemajo kemoterapijo, vendar rezultati ne podpirajo popolnoma uporabe tega zdravila pri bolnikih, ki prejemajo kemoterapevtike, ki so zmerni spodbujevalci slabosti in bruhanja.
English: Zunrisa was expected to be used in combination with other medicines to prevent nausea and vomiting in patients receiving chemotherapy treatments (medicines to treat cancer) that are moderate or strong triggers of nausea and vomiting.
Slovenian: Zdravilo Zunrisa naj bi se uporabljalo v kombinaciji z drugimi zdravili za preprečevanje slabosti in bruhanja pri bolnikih po zdravljenju s kemoterapevtiki (zdravili za zdravljenje raka), ki so zmerni do močni spodbujevalci slabosti in bruhanja.
English: The patients received Zunrisa with ondansetron or ondansetron alone.
Slovenian: Bolniki so prejeli zdravilo Zunrisa in ondansetron ali pa samo ondansetron.
English: How is Zunrisa expected to work?
Slovenian: Kako naj bi zdravilo Zunrisa delovalo?
English: By blocking the receptors, casopitant was expected to prevent nausea and vomiting which often happens during chemotherapy or as a complication of surgery.
Slovenian: Kasopitant naj bi z blokiranjem teh receptorjev preprečil slabost in bruhanje, ki sta pogosta med kemoterapijo ali kot zaplet po operativnih posegih.
English: Zunrisa was also expected to be used with other medicines to prevent nausea and vomiting in patients undergoing surgery.
Slovenian: Zdravilo Zunrisa naj bi se uporabljalo z drugimi zdravili za preprečevanje slabosti in bruhanja pri bolnikih po operativnih posegih.
English: The referral procedure started on 19 September 2005.
Slovenian: Napotitveni postopek se je pričel 19. septembra 2005.
English: Page 2/2 ©EMEA 2007
Slovenian: stran 2/2 ©EMEA 2007
English: The final opinion was converted into a Decision by the European Commission on 4 July 2006.
Slovenian: Končno mnenje je bilo spremenjeno v odločbo Evropske komisije dne 4. julija 2006.
English: International Non-Proprietary Name (INN): salmeterol / fluticasone
Slovenian: Mednarodno nelastniško ime (INN): salmeterol / flutikazon
English: The Rapporteur and Co-Rapporteur appointed were Dr D Lyons and Dr G Calvo Rojas, respectively.
Slovenian: Poročevalec je bil dr. D. Lyons, soporočevalec pa dr. G. Calvo Rojas.
English: In the MRP Sweden is the Reference Member State (RMS) and Austria, Belgium, Finland, France, Germany, Italy, Ireland, Luxembourg, Portugal, Spain and the United Kingdom are Concerned Member States (CMS).
Slovenian: V postopku medsebojnega priznavanja je bila Švedska referenčna država članica, medtem ko so bile Avstrija, Belgija, Finska, Francija, Nemčija, Italija, Irska, Luksemburg, Portugalska, Španija in Združeno kraljestvo zadevne države članice.
English: *Note: the information given in this document and Annexes reflect only the CHMP Opinion dated 27 April 2006.
Slovenian: *Opomba: informacije, podane v tem dokumentu in v dodatkih, odražajo zgolj mnenje CHMP z dne 27. aprila 2006.
English: VIANI DISKUS and associated names (See Annex I)
Slovenian: VIANI DISKUS in z njim povezana imena (glejte Dodatek I)
English: PERSUANT TO ARTICLE 6(13) OF COMMISSSION REGULATION (EC) No 1084/2003 FOR
Slovenian: PREDLOŽENO V SKLADU S ČLENOM 6(13) UREDBE KOMISIJE (ES) št. 1084/2003, ZA
English: In several EU Member States Viani Diskus and associated names are approved through the Mutual Recognition Procedure (MRP).
Slovenian: V številnih državah članicah EU je bilo zdravilo Viani Diskus in z njim povezana imena odobreno s postopkom medsebojnega priznavanja (MRP).
English: On 12 August 2005 the Marketing Authorisation Holders presented to the EMEA a referral under article 6(13) of Commission Regulation (EC) No 1084/2003.
Slovenian: Dne 12. avgusta 2005 so imetniki dovoljenja za promet z zdravilom zadevo napotili na agencijo EMEA v skladu s členom 6(13) Uredbe Komisije (ES) št. 1084/2003.
English: Supplementary information was provided by the Marketing Authorisation Holders on 3 February 2006 and written explanations were given on 30 March 2006.
Slovenian: Imetniki dovoljenja za promet z zdravilom so 3. februarja 2006 predložili dodatne informacije, 30. marca 2006 pa še pisna pojasnila.
English: SUMMARY INFORMATION ON REFERRAL OPINION
Slovenian: POVZETEK INFORMACIJ O MNENJU V ZVEZI Z NAPOTITVIJO,
English: Viani Diskus and associated names (see Annex I) contain salmeterol and fluticasone propionate, a fixed dose combination of the long acting β-agonist salmeterol and the inhaled corticosteroid fluticasone propionate and is indicated for the regular treatment of asthma where use of a combination product (long-acting beta-2-agonist and inhaled corticosteroid) is appropriate: - patients not adequately controlled with inhaled corticosteroids and ‘as needed' inhaled short acting beta-2-agonist or - patients already adequately controlled on both inhaled corticosteroid and long-acting beta-2-agonist.
Slovenian: Zdravilo Viani Diskus in z njim povezana imena (glejte Dodatek I), ki vsebuje salmeterol in flutikazon propionat, kombinacijo fiksnih odmerkov dolgo delujočega β-agonista (LABA) salmeterola in inhalacijskega kortikosteroida (ICS) flutikazon propionata (FP), je indicirano za običajno zdravljenje astme, kadar je uporaba kombiniranega zdravila (dolgo delujočega beta-2-agonista in inhalacijskega kortikosteroida) ustrezna: pri bolnikih, pri katerih z inhalacijskimi kortikosteroidi in »po potrebi« z inhalacijskim kratko delujočim beta-2-agonistom ni mogoče doseči zadostnega nadzora bolezni, ali pri bolnikih, pri katerih je bilo mogoče že z inhalacijskimi kortikosteroidi in dolgo delujočim beta-2agonistom vzpostaviti zadosten nadzor bolezni.
English: Based on evaluation of the available data and the Rapporteur's assessment reports, the CHMP adopted an opinion on 27 April 2006 recommending the variation to the terms of the Marketing Authorisations with amendments to the Summary of Product Characteristics, Labelling and Package leaflet .
Slovenian: Na podlagi ocene razpoložljivih podatkov in ocenjevalnih poročil poročevalca je CHMP dne 27. aprila 2006 sprejel mnenje, v katerem priporoča variacijo pogojev dovoljenj za promet z zdravilom ter spremembo Povzetka glavnih značilnosti zdravila, označevanja in Navodila za uporabo.
English: On the basis of the grounds for referral, the point considered by the CHMP was whether it is appropriate to introduce initial maintenance therapy with the fixed dose combination of salmeterol and fluticasone propionate in all patients with chronic persistent asthma.
Slovenian: V skladu z razlogi za napotitev je CHMP obravnaval vprašanje, ali je primerno uvesti začetno vzdrževalno zdravljenje s kombinacijo fiksnih odmerkov salmeterola in flutikazon propionata pri vseh bolnikih s kronično perzistentno astmo.
English: The list of product names concerned is given in the Annex I. The scientific conclusions are provided in the Annex II, together with the amended Summary of Product Characteristics, Labelling and Package Leaflet in the Annex III.
Slovenian: Seznam zadevnih imen zdravil je naveden v Dodatku I. Znanstveni zaključki so podani v Dodatku II, Dodatek III pa vsebuje spremenjeni Povzetek glavnih značilnosti zdravila, označevanje in Navodilo za uporabo.
English: The Marketing Authorisation Holders submitted a type II variation subject to the MRP in July 2004 to extend the indication to include initial maintenance therapy with the fixed dose combination in patients with chronic persistent asthma.
Slovenian: Imetniki dovoljenja za promet z zdravilom so predložili vlogo za variacijo tipa II, ki je bila obravnavana v postopku medsebojnega priznavanja julija 2004, z namenom razširiti indikacijo, tako da bo vključevala začetno vzdrževalno zdravljenje s kombinacijo fiksnih odmerkov pri bolnikih s kronično perzistentno astmo.
English: The RMS and CMSs rejected the type II variation based on the grounds that the overall risk/benefit was unfavourable for the initial maintenance therapy indication.
Slovenian: Referenčna država članica in zadevne države članice so zavrnile variacijo tipa II, ker je bilo splošno razmerje med tveganji in koristmi zdravila neugodno za indikacijo začetnega vzdrževalnega zdravljenja.
English: Further information on Nucala can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/nucala.
Slovenian: Nadaljnje informacije za zdravilo Nucala so na voljo na spletni strani agencije: ema.europa.eu/en/medicines/human/EPAR/nucala.
English: What measures are being taken to ensure the safe and effective use of Nucala?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Nucala?
English: The recommended dose is 100 mg in patients aged 12 years and above, and 40 mg in patients aged 6 to 11 years.
Slovenian: Priporočeni odmerek je 100 mg pri bolnikih, starejših od 12 let, in 40 mg pri bolnikih, starih od 6 do 11 let.
English: This helps to reduce inflammation, resulting in a reduction in asthma attacks and improvement of symptoms.
Slovenian: S tem pomaga ublažiti vnetje, kar zmanjša število napadov astme in izboljša simptome.
English: Nucala received a marketing authorisation valid throughout the EU on 2 December 2015.
Slovenian: Za zdravilo Nucala je bilo 2. decembra 2015 izdano dovoljenje za promet, veljavno po vsej EU.
English: The European Medicines Agency decided that Nucala's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Nucala večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: In addition, a reduction in corticosteroid dose was considered clinically relevant, given the potential complications of long-term corticosteroid treatment.
Slovenian: Poleg tega je bilo zmanjšanje odmerka kortikosteroidov ocenjeno za klinično pomembno glede na morebitne zaplete pri dolgotrajnem zdravljenju s kortikosteroidi.