FrancophonIA/ELRC3.0 huggingface dataset:
English: [EMA/MB/146523/2011] The Management Board noted the report on performance of national competent authorities with respect to a subset of KPIs, which had been agreed by the Board in June 2010.
Slovenian: [EMA/MB/146523/2011] Upravni odbor se je seznanil s poročilom o uspešnosti delovanja pristojnih nacionalnih organov v zvezi s podskupino glavnih kazalnikov uspešnosti, ki jih je odbor potrdil junija 2010.
English: Andrzej Ryś
Slovenian: Andrzej Rýs
English: [EMA/MB/757388/2011] The Board adopted the amendments to the implementing rules on the Agency's fees.
Slovenian: [EMA/MB/757388/2011] Upravni odbor je sprejel spremembe izvedbenih pravil o pristojbinah, ki se plačujejo agenciji.
English: • impact of health-technology assessment on the work of regulators, presented by Kent Woods, of the Medicines and Healthcare products Regulatory Agency (MHRA).
Slovenian: • predstavitev Kenta Woodsa iz Regulativne agencije za zdravila in zdravstvene izdelke (Medicines and Healthcare products Regulatory Agency, MHRA) o vplivu ocenjevanja zdravstvene tehnologije na delo regulativnih organov.
English: • implementation of the new pharmacovigilance legislation, presented by Noël Wathion, of the EMA;
Slovenian: • predstavitev Noëla Wathiona iz agencije EMA o izvajanju nove zakonodaje o farmakovigilanci;
English: [EMA/MB/105478/2011] The Board adopted the revised consultation procedure and the revised CV template.
Slovenian: [EMA/MB/105478/2011] Odbor je sprejel spremenjen postopek posvetovanja in spremenjeno predlogo za življenjepis.
English: • [EMA/786515/2010] Annual report 2010 of the Agency's Audit Advisory Committee.
Slovenian: • [EMA/786515/2010] Letno poročilo Odbora za presojo in svetovanje pri agenciji za leto 2010.
English: EMA/MB/232704/2011 Management Board
Slovenian: EMA/MB/728597/2011 Upravni odbor
English: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX XXXXXXXXXX
Slovenian: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
English: Minutes from the 69th meeting, held on 7 October 2010
Slovenian: Zapisnik 69. seje, ki je potekala 7. oktobra 2010
English: The Management Board has its representative at the AAC.
Slovenian: Upravni odbor ima v Odboru za presojo in svetovanje svojega predstavnika.
English: • No 03/2011 - the appointment of Zanda AUCE as CVMP member, proposed by Latvia, finalised on
Slovenian: • Št. 03/2011 - imenovanje Zande AUCE kot članice odbora CVMP na predlog Latvije, zaključeno 4. februarja 2011.
English: • No 33/2010 - the appointment of Dalibor VALÍK as CHMP member, proposed by the Czech
Slovenian: • Št. 33/2010 - imenovanje Daliborja VALÍKA kot člana odbora CHMP na predlog Češke, zaključeno 3. januarja 2011.
English: • No 32/2010 - the appointment of Dana Gabriela MARIN as CHMP alternate, proposed by Romania,
Slovenian: • Št. 32/2010 - imenovanje Dane Gabriele MARIN kot nadomestne članice v odboru CHMP na predlog Romunije, zaključeno 20. decembra 2010.
English: • Preparation for the revision of the Fee Regulation, which will be carried out in two steps: first,
Slovenian: • priprava za pregled uredbe o pristojbinah, ki bo potekal v dveh korakih: najprej se bo spremenila Uredba o pristojbinah, kar bo agenciji EMA omogočilo zaračunavanje farmakovigilančnih dejavnosti (kadar bo nujno), temu pa bo sledil celovit pregled celotne uredbe o pristojbinah;
English: • No 01/2011 - the appointment of Helen JUKES as CVMP member, proposed by the United
Slovenian: • Št. 01/2011 - imenovanje Helen JUKES kot članice odbora CVMP na predlog Združenega kraljestva, zaključeno 11. januarja 2011.
English: • No 04/2011 - the appointment of Lyubina TODOROVA as CHMP alternate, proposed by Bulgaria,
Slovenian: • Št. 04/2010 - imenovanje Lyubine TODOROVE kot nadomestne članice v odboru CHMP na predlog Bolgarije, zaključeno 22. februarja 2011.
English: • outcome and recommendations from the Agency's evaluation and the stakeholder conference
Slovenian: • predstavitev Nerimantasa Steikūnasa iz agencije EMA o izidu postopka ocenjevanja in priporočilih agencije ter o konferenci zainteresiranih strani (poročilo družbe Ernst & Young);
English: Representative of healthcare professionals' organisations
Slovenian: Predstavnik zdravniških organizacij
English: • No 02/2011 - the appointment of Miloslav SALAVEC as CHMP alternate, proposed by the Czech
Slovenian: • Št. 02/2010 - imenovanje Miloslava SALAVECA kot nadomestnega člana v odboru CHMP na predlog Češke, zaključeno 4. februarja 2011.
English: For the other three patients, this information was lacking.
Slovenian: Za ostale tri bolnike teh podatkov ni bilo.
English: Methadone is a synthetic opioid.
Slovenian: Metadon je sintetični opioid.
English: Most of the patients were currently or previously included in OST programs.
Slovenian: Večina bolnikov je bila takrat ali v preteklosti vključena v programe NZO.
English: The cases concerned former or current injecting drug abusers, aged 24 to 53 years old.
Slovenian: Primeri so bili povezani z nekdanjimi ali trenutnimi injicirajočimi uporabniki drog, starimi od 24 do 53 let.
English: Fourteen (14) cases of renal failure were reported.
Slovenian: Poročali so o štirinajstih (14) primerih odpovedi ledvic.
English: This leads to ‘povidone storage disease' that may cause serious harm.
Slovenian: To privede do „bolezni kopičenja povidona“, ki lahko povzroči resne okvare.
English: The review took into account 15 cases of serious adverse reactions reported in Norway.
Slovenian: Med pregledom je upošteval 15 primerov resnih neželenih učinkov, o katerih so poročali na Norveškem.
English: The condition for lifting the suspension of these marketing authorisations is set out in Annex IV.
Slovenian: Pogoj za preklic začasnega umika teh dovoljenj za promet z zdravili je opredeljen v Prilogi IV.
English: The overall effectiveness of methadone maintenance treatment is established in the literature and has been reviewed in several articles.
Slovenian: Splošna učinkovitost vzdrževalnega zdravljenja z metadonom je dokazana v literaturi in je bila pregledana v več člankih.
English: Therefore, the PRAC recommends the suspension of this product.
Slovenian: Odbor PRAC je zato priporočil začasen umik tega zdravila.
English: For 12 of the 15 patients, evidence that they had been prescribed or used methadone (urine sample or patient's statement) was available.
Slovenian: Za 12 od 15 bolnikov so bili na voljo dokazi o tem, da jim je bil predpisan ali da so uporabljali metadon (vzorec urina ali izjava bolnika).
English: However, available data do not demonstrate the effectiveness of povidone in mitigating this risk.
Slovenian: Vendar pa razpoložljivi podatki ne kažejo, da bi bil povidon učinkovit pri zmanjševanju tega tveganja.
English: • The PRAC considered the proportionate response to the evidence of harm.
Slovenian: • odbor je proučil sorazmeren odziv na dokaze o povzročanju okvar.
English: Additional warnings in the label were further considered, but a direct information to the patients is challenging and according to the experts, such measures are unlikely to further minimise the risk of injection.
Slovenian: Obravnavana so bila tudi dodatna opozorila na nalepki, vendar so neposredne informacije za bolnike težavne, prav tako pa strokovnjaki menijo, da tovrstni ukrepi verjetno ne bi dodatno zmanjšali tveganja za injiciranje.
English: The review of oral methadone medicines containing povidone started on 10 April 2014 under Article 107i of Directive 2001/83/EC.
Slovenian: Pregled zdravil za peroralno uporabo, ki vsebujejo metadon in povidon, se je začel dne 10. aprila 2014 v skladu s členom 107i Direktive 2001/83/ES.
English: Supervised administration of every dose was also discussed but this would be difficult to consistently incorporate into daily OST practice and would lead to serious non-compliance.
Slovenian: Obravnavana je bila tudi možnost nadzorovanega dajanja vsakega odmerka, vendar bi bilo to težko dosledno vključevati v vsakodnevne dejavnosti v okviru NZO in bi povzročilo resno nevodljivost.
English: Should this oral solution be repeatedly injected, povidone would be permanently retained and accumulate within organs and tissues, leading to potential serious harm.
Slovenian: Če bi se ta peroralna raztopina večkrat injicirala, bi se povidon trajno ohranil in se nakopičil v organih in tkivih, s čimer bi lahko povzročil resne okvare.
English: In all cases, staining of biological samples supports the conclusion that povidone accumulated in the affected organs.
Slovenian: V vseh primerih je barvanje bioloških vzorcev potrdilo zaključek, da se je povidon kopičil v prizadetih organih.
English: The efficacy of methadone in OST was acknowledged in this referral procedure.
Slovenian: Učinkovitost metadona pri NZO je bila v tem napotitvenem postopku potrjena.
English: The PRAC noted that all these 15 cases reported “intentional drug misuse”, “product deposit” and “drug administered via inappropriate route” and were assessed by the regional pharmacovigilance centre in Norway as possibly or probably related to the injection of povidone.
Slovenian: Odbor PRAC je upošteval, da so v vseh teh 15 primerih poročali o „namerni napačni uporabi zdravila“, „kopičenju zdravila“ ter „dajanju zdravila po napačni poti“ in da je regionalni center za farmakovigilanco na Norveškem ocenil, da so bili ti primeri morda ali verjetno povezani z injiciranjem povidona.
English: Available data from the scientific literature suggests that an association between deposits of povidone and renal impairment has not been well established.
Slovenian: Razpoložljivi podatki iz znanstvene literature kažejo, da povezava med kopičenjem povidona in okvaro ledvic ni povsem dokazana.
English: For one of the five patients the bone marrow biopsy showed about 90% histiocytic infiltration characteristic for povidone deposit and only about 5% of bone marrow available for erythropoiesis.
Slovenian: Pri enem od petih bolnikov je biopsija kostnega mozga pokazala, da je pri kopičenju povidona prišlo do približno 90-odstotne infiltracije s histiociti, samo približno 5 % kostnega mozga pa je bilo na voljo za eritropoezo.
English: In nine cases a history of drug abuse with substances that have been injected was specified and in eight of these nine cases a history of injecting methadone intended for oral use was reported.
Slovenian: Pri devetih bolnikih je bilo navedeno, da so v preteklosti zlorabljali droge, pri čemer so uporabljali snovi za injiciranje, in v osmih od teh devetih primerov so že poročali o injiciranju metadona, namenjenega za peroralno uporabo.
English: The product information of this methadone oral solution already contains clear advice that it should not be injected.
Slovenian: Informacije o zdravilu za to peroralno raztopino, ki vsebuje metadon, že vsebujejo jasno opozorilo, da se raztopina ne sme injicirati.
English: Overall summary of the scientific evaluation of methadone products for oral use containing povidone
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravil za peroralno uporabo, ki vsebujejo metadon in povidon
English: In most cases, prescription or use of methadone can be confirmed, while some of them also have admitted injecting oral methadone.
Slovenian: V večini primerov je mogoče potrditi, da je bil predpisan ali uporabljen metadon, nekateri bolniki pa so tudi priznali, da so si injicirali metadon za peroralno uporabo;
English: Treatment with methadone should be given in the context of a wider rehabilitation program, opioid substitution therapy (OST).
Slovenian: Zdravljenje z metadonom se mora uvesti v okviru širšega programa za zdravljenje odvisnosti, imenovanega nadomestno zdravljenje z opioidi (NZO).
English: • The PRAC reviewed all available data from published literature, pre-clinical and clinical studies and post-marketing experience on the safety of methadone medicinal products for oral use containing povidone, responses submitted by the marketing authorisation holders (MAHs) in writing and during the oral explanations, the outcome of the ad-hoc expert advisory group meeting as well as stakeholders' submissions in particular with regards to the risks associated with the misuse of the products by injection which is a well-known risk in the target population;
Slovenian: • odbor PRAC je pregledal vse razpoložljive podatke iz objavljene literature, predkliničnih in kliničnih študij ter izkušenj iz obdobja trženja v zvezi z varnostjo zdravil za peroralno uporabo, ki vsebujejo metadon in povidon, odgovore, ki so jih v obliki pisne dokumentacije in ustnih pojasnil podali imetniki dovoljenja za promet z zdravilom, ugotovitve s sestanka ad hoc strokovne svetovalne skupine ter tudi podatke, ki so jih predložile zainteresirane strani, zlasti v zvezi s tveganji, povezanimi z napačno uporabo zdravil z injiciranjem, ki je dobro znano tveganje pri ciljni populaciji;
English: Flexible-dose methadone maintenance therapy is more clinically effective than no drug therapy in dependent opioid users.
Slovenian: Vzdrževalno zdravljenje s prilagodljivimi odmerki metadona je pri odvisnih uporabnikih opioidov klinično učinkovitejše od zdravljenja brez zdravil.
English: For the other eight cases, renal biopsies were lacking, but povidone deposits were detected in biopsies from other tissues.
Slovenian: Za ostalih osem primerov biopsije ledvic niso bile na voljo, so pa nalaganje povidona odkrili v biopsijskih vzorcih, odvzetih iz drugih tkiv.
English: The distribution and elimination of povidone when administered intravenously has been well investigated and studies using radioactive labelled povidone of different molecular weight have demonstrated that clearance of polymers after intravenous administration is dependent on molecular weight.
Slovenian: Porazdelitev in izločanje povidona po intravenskem dajanju sta dobro raziskana, pri čemer so študije, v katerih so uporabili radioaktivno označeni povidon z različnimi relativnimi molekulskimi masami, pokazale, da je očistek polimerov po intravenskem dajanju odvisen od relativne molekulske mase.
English: On 2nd April 2014, the Norwegian Medicines Agency, NOMA, triggered a referral under Article 107i of Directive 2001/83/EC concerning methadone-containing medicines for oral use containing povidone asking the PRAC to review the benefit-risk balance of all oral methadone medicines containing polyvinylpyrrolidone (more commonly known as povidone or PVP) authorised in the EU and to make a recommendation to the Human Co-ordination Group for Mutual Recognition and Decentralised Procedures (CMDh) on any measures necessary to ensure the safe and effective use, and on whether the marketing authorisation for these products should be maintained, varied, suspended or withdrawn.
Slovenian: Norveška agencija za zdravila, NOMA, je dne 2. aprila 2014 sprožila napotitveni postopek v skladu s členom 107i Direktive 2001/83/ES za zdravila za peroralno uporabo, ki vsebujejo metadon in povidon, ter zaprosila odbor PRAC, da pregleda razmerje med tveganji in koristmi vseh v EU odobrenih zdravil za peroralno uporabo, ki vsebujejo metadon in polivinilpirolidon (bolje znan kot povidon ali PVP), ter Usklajevalni skupini za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh) posreduje priporočila glede morebitnih ukrepov, potrebnih za zagotovitev varne in učinkovite uporabe, ter glede tega, ali bi bilo treba dovoljenje za promet s temi zdravili ohraniti, spremeniti, začasno umakniti ali preklicati.
English: To lift the suspension, this product should be appropriately reformulated taking into account its misuse potential.
Slovenian: Za preklic začasnega umika je treba zdravilo ustrezno reformulirati ob upoštevanju možnosti za napačno uporabo.
English: Following parenteral administration, it is generally accepted that low molecular weight povidone (Mw <25 000) is readily excreted by the kidney: the glomerulus can excrete within a few days all povidone of Mw 40 000 or below; the normal glomerulus of healthy human subjects is relatively impermeable to povidone Mw >70 000 (while in humans with nephrotic disease, the permeability for larger molecules was increased); the reticuloendothelial system (RES) retains molecules with a Mw >110,000 (Ravin et al. 1952; Hulme and Hardwicke 1968).
Slovenian: Na splošno velja, da se po parenteralnem dajanju povidon z majhno relativno molekulsko maso (Mr < 25.000) zlahka izloči skozi ledvice: glomerul lahko v nekaj dneh izloči ves povidon z Mr 40.000 ali manj; normalen glomerul pri zdravih osebah je relativno nepropusten za povidon z Mr > 70.000 (pri ljudeh z nefrotskim sindromom pa je bila propustnost za večje molekule večja); retikuloendotelijski sistem (RES) zadrži molekule z Mr > 110.000 (Ravin in sod., 1952; Hulme in Hardwicke, 1968).
English: • The PRAC was of the opinion that available pre-clinical and clinical data provide evidence that high molecular weight povidone (>110,000) when injected is likely to be permanently retained in the body, in particular in the bone marrow and bone tissue.
Slovenian: • odbor PRAC je menil, da razpoložljivi predklinični in klinični podatki dokazujejo, da je verjetno, da se bo povidon z veliko relativno molekulsko maso (> 110.000) v primeru injiciranja trajno ohranil v telesu, zlasti v kostnem mozgu in kostnem tkivu.
English: High Mw povidone (>110,000) will not be excreted by the kidney and therefore will be retained in the body if repeatedly injected and may lead to serious harm;
Slovenian: Povidon z veliko Mr (> 110.000) se ne izloči skozi ledvice, zaradi česar se v primeru večkratnega injiciranja ohrani v telesu in lahko povzroči resne okvare;
English: For five patients, bone destruction and/or bone marrow affection (including anaemia) were reported and findings from biopsies showed accumulation of povidone in the bone marrow.
Slovenian: Pri petih bolnikih so poročali o razgradnji kosti in/ali okvari kostnega mozga (vključno z anemijo), pri čemer so rezultati biopsije pokazali, da se je povidon kopičil v kostnem mozgu.
English: Methadone tablets containing low Mw povidone (K25 or K30)
Slovenian: Tablete metadona, ki vsebujejo povidon z majhno Mr (K25 ali K30)
English: The inclusion of povidone K90 in oral methadone solutions was initially intended to enhance viscosity and reduce the risk of misuse by injection.
Slovenian: Povidon K90 je bil peroralnim raztopinam, ki vsebujejo metadon, prvotno dodan z namenom, da bi izboljšal viskoznost in zmanjšal tveganje za napačno uporabo z injiciranjem.
English: There is evidence that lower molecular weight povidone (<25,000) is readily excreted but that higher Mw povidone (>110,000) is not, or (>70,000) only partially excreted;
Slovenian: Dokazi kažejo, da se povidon z manjšo relativno molekulsko maso (< 25.000) zlahka izloči, medtem ko se povidon z večjo Mr (> 110.000) ne izloči ali se izloči samo delno (> 70.000);
English: Methadone is used in the treatment of moderate to severe pain and is also used as maintenance/substitution medication in the management of opioid dependence.
Slovenian: Uporablja se za zdravljenje zmerne do hude bolečine ter tudi kot zdravilo za vzdrževalno/nadomestno zdravljenje odvisnosti od opioidov.
English: It was also noted that misuse by injection of methadone product is an inherent risk in the target population with evidence showing an occurrence of injection of methadone for oral use among injecting drug users varying from 5.0% to 79.5% (Winstock et al. 2010, Guichard et al. 2003, Waldvogel et al 2005, Judson G et al. 2010, and Vlahov D et al. 2007) and an underreporting considered to be likely.
Slovenian: Ugotovljeno je bilo tudi, da je napačna uporaba zdravila, ki vsebuje metadon, z injiciranjem inherentno tveganje pri ciljni populaciji, saj dokazi kažejo, da je primerov injiciranja metadona za peroralno uporabo med injicirajočimi uporabniki drog od 5,0 do 79,5 % (Winstock in sod., 2010; Guichard in sod., 2003; Waldvogel in sod., 2005; Judson G. in sod., 2010; in Vlahov D. in sod., 2007), pri čemer je verjetno, da vsi primeri niso prijavljeni.
English: Although the brand of methadone cannot be confirmed with certainty it is suspected, based on the availability of the product and pattern of usage in Western Norway that the observed serious adverse reactions (e.g. anaemia and bone marrow disorder) were caused by povidone deposition in drug abusers who have misused methadone oral solutions containing povidone K90.
Slovenian: Čeprav blagovne znamke metadona ni mogoče z gotovostjo potrditi, se na podlagi razpoložljivosti zdravila in vzorca uporabe v zahodnem delu Norveške domneva, da so bili opaženi resni neželeni učinki (npr. anemija in bolezen kostnega mozga) posledica nalaganja povidona pri uporabnikih drog, ki so napačno uporabljali peroralne raztopine, ki vsebujejo metadon in povidon K90.
English: • The PRAC considered case reports, including fatal cases, in former or current injecting drug users, and noted the serious adverse reactions, the nature of which (including bone marrow adverse effects and pathological fractures) was consistent with the accumulation of povidone and also noted that povidone deposition in organs and tissues had been seen on biopsies.
Slovenian: • odbor PRAC je proučil poročila o primerih, vključno s primeri s smrtnim izidom, pri nekdanjih ali trenutnih injicirajočih uporabnikih drog in opazil resne neželene učinke, katerih značilnosti (vključno z neželenimi učinki na kostni mozeg in patološkimi zlomi) so se ujemale s kopičenjem povidona, prav tako pa je upošteval, da so nalaganje povidona v organih in tkivih pokazale tudi biopsije.
English: Other methadone products containing povidone concerned by the review are tablets and have lower Mw povidone (e.g. K25, K30, also in lower amount), which is known to be excreted from the kidney and therefore is expected not to be retained in the body.
Slovenian: Druga zdravila, ki vsebujejo metadon in povidon ter so bila vključena v pregled, so tablete, ki vsebujejo povidon z manjšo Mr (npr. K25, K30 ter tudi manjše količine), za katerega je znano, da se izloči skozi ledvice, zato ni pričakovati, da bi se ohranil v telesu.
English: The PRAC reviewed all available safety data, in particular with regards to the risks associated with the misuse by injection of methadone products for oral use containing povidone.
Slovenian: Odbor PRAC je pregledal vse razpoložljive podatke o varnosti, zlasti v povezavi s tveganji, povezanimi z napačno uporabo zdravil za peroralno uporabo, ki vsebujejo metadon in povidon, z injiciranjem.
English: Povidone is an excipient available in a variety of different molecular sizes from K12 (low molecular weight (Mw), average Mw ~ 2000) to K90 (high Mw, average Mw 1,100,000).
Slovenian: Povidon je pomožna snov, ki je na voljo v obliki molekul zelo različnih velikosti, in sicer od K12 (majhna relativna molekulska masa (Mr), povprečna Mr ~ 2000) do K90 (velika Mr, povprečna Mr 1.100.000).
English: Six kidney biopsies were presented and all demonstrated deposits of povidone in the tubular-interstitial area.
Slovenian: Predloženi so bili rezultati šestih biopsij ledvic, ki so vsi pokazali, da se je povidon nalagal v tubulointersticijskem predelu.
English: The CMDh also reached an agreement on the variation to the terms of the Marketing Authorisations for methadone tablets containing low molecular weight povidone (K25 or K30) for which the amendments to be introduced to the Summary of Product Characteristics and package leaflet are set out in Annex III.
Slovenian: Skupina CMDh se je prav tako sporazumela glede spremembe pogojev dovoljenj za promet s tabletami metadona, ki vsebujejo povidon z majhno relativno molekulsko maso (K25 ali K30) in za katere so spremembe, ki se bodo vključile v povzetek glavnih značilnosti zdravila ter navodilo za uporabo, opredeljene v Prilogi III.
English: It is mainly used in oral solutions (K90) as a viscosity-increasing agent, or as a binding agent (e.g. K25, K30) in tablets.
Slovenian: Večinoma se uporablja v peroralnih raztopinah (K90) kot sredstvo za izboljšanje viskoznosti ali kot vezivno sredstvo (npr. K25 in K30) v tabletah.