natgillin/translations-raw huggingface dataset:
The Board supported the development of a subset of functionalities required for the EudraVigilance audit that would meet predefined high-level requirements.
Odbor je podprl razvoj podskupin funkcionalnosti, ki so potrebne za revizijo sistema EudraVigilance in bi bile v skladu s predhodno določenimi zahtevami na visoki ravni.
Audit reports
Revizijska poročila
The Agency also anticipates that the adoption of the legislation on falsified medicines and the conclusion of the discussions on substances of human origin will also impact on activities in the near future.
Agencija pričakuje, da bosta na njeno delovanje v bližnji prihodnosti vplivala tudi sprejetje zakonodaje o ponarejenih zdravilih in zaključek razprave o snoveh človeškega izvora.
• [EMA/MB/111120/2011] Summary of transfers of appropriations in the budget 2010.
• [EMA/MB/111120/2011] Povzetek prenosov dodeljenih sredstev v proračunu za leto 2010.
Rannveig Gunnarsdóttir (Iceland)
Rannveig Gunnarsdóttir (Islandija)
The Board also noted the high level of activity in the area of variations.
Odbor se je seznanil tudi z velikim obsegom delovanja na področju sprememb.
• [EMA/MB/62985/2011] Information technology.
• [EMA/MB/62985/2011] Informacijska tehnologija.
• The enquiry by MEPs into off-label use of medicines in the EU (the MEPs' letters will be included on the April HMA agenda).
• poizvedba evropskih poslancev o nenamenski uporabi zdravil v EU (dopisi evropskih poslancev bodo vključeni na dnevni red vodij agencij za zdravila v aprilu).
The Board also discussed that the training programme for regulators is an important element to ensure that high-quality assessors are available.
Odbor je razpravljal tudi o pomenu programa usposabljanja regulativnih organov za zagotavljanje visokokakovostnih ocenjevalcev.
Amendments to the Management Board implementing rules on the Agency's fees
Spremembe izvedbenih pravil upravnega odbora o pristojbinah, ki se plačujejo agenciji
The Board asked, therefore, to be informed of further details on pharmacovigilance implementation, requirements for IT expenditure and staffing needs.
Zato je odbor zaprosil, da ga obveščajo o nadaljnjih podrobnostih izvajanja zakonodaje o farmakovigilanci, stroških IT ter potrebah po zaposlovanju.
[EMA/MB/149825/2011] The Board adopted the amendments to the delegate reimbursement rules which allow flight tickets to be changed if a meeting ends two hours earlier or later than planned.
[EMA/MB/149825/2011] Odbor je sprejel spremembe pravil o povračilu stroškov delegatom, ki omogočajo zamenjavo letalskih kart v primeru, da se srečanje konča dve uri prej ali kasneje, kot je bilo načrtovano.
In this context, reference was made to the joint HMA/EMA training strategy.
V okviru tega je bila omenjena skupna strategija usposabljanja vodij agencij za zdravila in agencije EMA.
The Board discussion focused on the implementation of the new legislative provisions in relation to EudraVigilance and EU Telematics Controlled Terms.
Razprava v odboru je poseben poudarek dala izvajanju določil nove zakonodaje v zvezi s sistemom EudraVigilance in telematsko nadzorovanimi izrazi EU.
• [EMA/MB/66833/2011] Performance of the Agency's scientific procedures: Survey 2010 for medicinal products for human use.
• [EMA/MB/66833/2011] Uspešnost znanstvenih postopkov agencije: raziskava zdravil za humano uporabo 2010.
• [EMA/MB/105462/2011] Outcome of written procedures during the period from 17 October 2010 to
• [EMA/MB/105462/2011] Izid pisnih postopkov v obdobju od 17. oktobra 2010 do
• 69th Management Board minutes from 16 December 2010, finalised on 11 February 2011.
• Zapisnik 69. seje upravnega odbora z dne 16. decembra 2010, zaključeno 11. februarja 2011.
Minutes of the 70th meeting of the Management Board
Zapisnik 70. seje upravnega odbora
The revised procedure now foresees that unless five or more members expressed their reservations with regards to the nomination, the candidate is considered accepted and the procedure is closed.
Spremenjeni postopek zdaj predvideva, da je kandidat potrjen in se postopek zaključi, razen če pet ali več članov izrazi zadržek glede imenovanja.
[EMA/MB/218686/2011] The Management Board adopted a decision giving its approval for the currently declared activities of Thomas Lönngren, who stepped down as Executive Director of the Agency on 31 December 2010.
[EMA/MB/218686/2011] Upravni odbor je sprejel odločitev, s katero je odobril trenutno prijavljene dejavnosti Thomasa Lönngrena, ki je dne 31. decembra 2010 odstopil s položaja izvršnega direktorja agencije.
[EMA/MB/808316/2010] The Management Board noted the minutes adopted by written procedure on 7 February 2011.
[EMA/MB/808316/2010] Upravni odbor se je seznanil z zapisnikom, ki je bil sprejet s pisnim postopkom dne 7. februarja 2011.
The members noted the update report from the Heads of Medicines Agencies on a range of topics, including the following:
Člani so se seznanili s posodobljenim poročilom vodij agencij za zdravila o različnih temah:
• The process for the implementation of the strategy paper (the HMA meetings will be reorganised to facilitate the implementation of the strategy paper).
• postopek izvajanja strateškega dokumenta (seje vodij agencij za zdravila se bodo preoblikovale, tako da bo mogoče izvajanje strateškega dokumenta);
• The new legislation on falsified medicines (the text of the legislation is likely to be published in the
• nova zakonodaja o ponarejenih zdravilih (besedilo zakona bo verjetno objavljeno v Uradnem listu maja 2011);
The Acting Executive Director updated the Board on the issue of products containing benfluorex, saying that the Agency had provided a platform for discussion but had not had a mandate to deal with national products.
Vršilec dolžnosti izvršnega direktorja je odbor obvestil o odprtem vprašanju glede zdravil, ki vsebujejo benfluoreks, pri čemer agencija sicer zagotavlja prostor za razpravo, ni pa pooblaščena za obravnavo nacionalnih zdravil.
"We believe that Thomas Lönngren's advisory role regarding strategic development of the companies, as well as business plans and investment opportunities are strictly connected with privileged information and confidential data that he gained during his mandate as EMA Executive Director.
Predstavniki Evropskega parlamenta v odboru so zahtevali, da se v zapisnik seje vnese naslednja izjava: „Menimo, da je svetovalna vloga Thomasa Lönngrena pri strateškem razvoju družb ter poslovnih načrtov in naložbenih priložnosti tesno povezana z zaščitenimi informacijami in zaupnimi podatki, ki jih je pridobil med opravljanjem funkcije izvršnega direktorja agencije EMA.
[EMA/MB/80540/2011] The Management Board adopted the revised charter of the accounting officer, which clarifies the accounting officer's obligations and responsibilities in line with the Financial Regulation.
[EMA/MB/80540/2011] Upravni odbor je sprejel spremenjeno listino za računovodje, ki pojasnjuje njihove dolžnosti in odgovornosti v skladu s finančno uredbo.
Accommodation of the Agency
Prostori agencije
• [EMA/MB/784841/2011] Preliminary draft budget.
• [EMA/MB/784841/2011] Predhodni predlog proračuna.
• [EMA/807799/2010] Annual report 2010 of the Agency's Internal Audit.
• [EMA/807799/2010] Letno poročilo službe za notranjo revizijo pri agenciji za leto 2010.
European Medicines Agency attendees
Sodelujoči iz Evropske agencije za zdravila
• [EMA/MB/805742/2011] Preliminary work programme.
• [EMA/MB/805742/2011] Predhodni delovni program.
A formal letter can be issued to the IMI board as part of the process to improve prospects of obtaining funding.
Kot del postopka za izboljšanje možnosti za pridobivanje sredstev se lahko odboru IMI izda uraden dopis.
• [EMA/634206/2010] Minutes from the latest Management Board Telematics Committee meeting
• [EMA/634206/2010] Zapisnik zadnje seje Odbora za telematiko pri upravnem odboru 2010-11
• [EMA/MB/78578/2011] Update report on the Agency's implementation of the EU telematics strategy.
• [EMA/78578/2011] Dopolnjeno poročilo o izvajanju strategije EU za telematske projekte s strani agencije.
[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.
[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.
[EMA/MB/757388/2011] The Board adopted the amendments to the implementing rules on the Agency's fees.
[EMA/MB/757388/2011] Upravni odbor je sprejel spremembe izvedbenih pravil o pristojbinah, ki se plačujejo agenciji.
• impact of health-technology assessment on the work of regulators, presented by Kent Woods, of the Medicines and Healthcare products Regulatory Agency (MHRA).
• 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.
• implementation of the new pharmacovigilance legislation, presented by Noël Wathion, of the EMA;
• predstavitev Noëla Wathiona iz agencije EMA o izvajanju nove zakonodaje o farmakovigilanci;
[EMA/MB/105478/2011] The Board adopted the revised consultation procedure and the revised CV template.
[EMA/MB/105478/2011] Odbor je sprejel spremenjen postopek posvetovanja in spremenjeno predlogo za življenjepis.
• [EMA/786515/2010] Annual report 2010 of the Agency's Audit Advisory Committee.
• [EMA/786515/2010] Letno poročilo Odbora za presojo in svetovanje pri agenciji za leto 2010.
EMA/MB/232704/2011 Management Board
EMA/MB/728597/2011 Upravni odbor
Minutes from the 69th meeting, held on 7 October 2010
Zapisnik 69. seje, ki je potekala 7. oktobra 2010
The Management Board has its representative at the AAC.
Upravni odbor ima v Odboru za presojo in svetovanje svojega predstavnika.
• No 03/2011 - the appointment of Zanda AUCE as CVMP member, proposed by Latvia, finalised on
• Št. 03/2011 - imenovanje Zande AUCE kot članice odbora CVMP na predlog Latvije, zaključeno 4. februarja 2011.
• No 33/2010 - the appointment of Dalibor VALÍK as CHMP member, proposed by the Czech
• Št. 33/2010 - imenovanje Daliborja VALÍKA kot člana odbora CHMP na predlog Češke, zaključeno 3. januarja 2011.
• No 32/2010 - the appointment of Dana Gabriela MARIN as CHMP alternate, proposed by Romania,
• Št. 32/2010 - imenovanje Dane Gabriele MARIN kot nadomestne članice v odboru CHMP na predlog Romunije, zaključeno 20. decembra 2010.
• Preparation for the revision of the Fee Regulation, which will be carried out in two steps: first,
• 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;
• No 01/2011 - the appointment of Helen JUKES as CVMP member, proposed by the United
• Št. 01/2011 - imenovanje Helen JUKES kot članice odbora CVMP na predlog Združenega kraljestva, zaključeno 11. januarja 2011.
• No 04/2011 - the appointment of Lyubina TODOROVA as CHMP alternate, proposed by Bulgaria,
• Št. 04/2010 - imenovanje Lyubine TODOROVE kot nadomestne članice v odboru CHMP na predlog Bolgarije, zaključeno 22. februarja 2011.
• outcome and recommendations from the Agency's evaluation and the stakeholder conference
• predstavitev Nerimantasa Steikūnasa iz agencije EMA o izidu postopka ocenjevanja in priporočilih agencije ter o konferenci zainteresiranih strani (poročilo družbe Ernst & Young);
Representative of healthcare professionals' organisations
Predstavnik zdravniških organizacij
• No 02/2011 - the appointment of Miloslav SALAVEC as CHMP alternate, proposed by the Czech
• Št. 02/2010 - imenovanje Miloslava SALAVECA kot nadomestnega člana v odboru CHMP na predlog Češke, zaključeno 4. februarja 2011.
For the other three patients, this information was lacking.
Za ostale tri bolnike teh podatkov ni bilo.
Methadone is a synthetic opioid.
Metadon je sintetični opioid.
Most of the patients were currently or previously included in OST programs.
Večina bolnikov je bila takrat ali v preteklosti vključena v programe NZO.
The cases concerned former or current injecting drug abusers, aged 24 to 53 years old.
Primeri so bili povezani z nekdanjimi ali trenutnimi injicirajočimi uporabniki drog, starimi od 24 do 53 let.
Fourteen (14) cases of renal failure were reported.
Poročali so o štirinajstih (14) primerih odpovedi ledvic.
This leads to ‘povidone storage disease' that may cause serious harm.
To privede do „bolezni kopičenja povidona“, ki lahko povzroči resne okvare.
The review took into account 15 cases of serious adverse reactions reported in Norway.
Med pregledom je upošteval 15 primerov resnih neželenih učinkov, o katerih so poročali na Norveškem.
The condition for lifting the suspension of these marketing authorisations is set out in Annex IV.
Pogoj za preklic začasnega umika teh dovoljenj za promet z zdravili je opredeljen v Prilogi IV.
The overall effectiveness of methadone maintenance treatment is established in the literature and has been reviewed in several articles.
Splošna učinkovitost vzdrževalnega zdravljenja z metadonom je dokazana v literaturi in je bila pregledana v več člankih.
Therefore, the PRAC recommends the suspension of this product.
Odbor PRAC je zato priporočil začasen umik tega zdravila.
For 12 of the 15 patients, evidence that they had been prescribed or used methadone (urine sample or patient's statement) was available.
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).
However, available data do not demonstrate the effectiveness of povidone in mitigating this risk.
Vendar pa razpoložljivi podatki ne kažejo, da bi bil povidon učinkovit pri zmanjševanju tega tveganja.
• The PRAC considered the proportionate response to the evidence of harm.
• odbor je proučil sorazmeren odziv na dokaze o povzročanju okvar.
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.
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.
The review of oral methadone medicines containing povidone started on 10 April 2014 under Article 107i of Directive 2001/83/EC.
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.
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.
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.
Should this oral solution be repeatedly injected, povidone would be permanently retained and accumulate within organs and tissues, leading to potential serious harm.
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.
In all cases, staining of biological samples supports the conclusion that povidone accumulated in the affected organs.
V vseh primerih je barvanje bioloških vzorcev potrdilo zaključek, da se je povidon kopičil v prizadetih organih.
The efficacy of methadone in OST was acknowledged in this referral procedure.
Učinkovitost metadona pri NZO je bila v tem napotitvenem postopku potrjena.
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.
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.
Available data from the scientific literature suggests that an association between deposits of povidone and renal impairment has not been well established.
Razpoložljivi podatki iz znanstvene literature kažejo, da povezava med kopičenjem povidona in okvaro ledvic ni povsem dokazana.
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.
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.
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.
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.
The product information of this methadone oral solution already contains clear advice that it should not be injected.
Informacije o zdravilu za to peroralno raztopino, ki vsebuje metadon, že vsebujejo jasno opozorilo, da se raztopina ne sme injicirati.
Overall summary of the scientific evaluation of methadone products for oral use containing povidone
Splošni povzetek znanstvenega vrednotenja zdravil za peroralno uporabo, ki vsebujejo metadon in povidon
In most cases, prescription or use of methadone can be confirmed, while some of them also have admitted injecting oral methadone.
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;
Treatment with methadone should be given in the context of a wider rehabilitation program, opioid substitution therapy (OST).
Zdravljenje z metadonom se mora uvesti v okviru širšega programa za zdravljenje odvisnosti, imenovanega nadomestno zdravljenje z opioidi (NZO).
• 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;
• 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;
Flexible-dose methadone maintenance therapy is more clinically effective than no drug therapy in dependent opioid users.
Vzdrževalno zdravljenje s prilagodljivimi odmerki metadona je pri odvisnih uporabnikih opioidov klinično učinkovitejše od zdravljenja brez zdravil.
For the other eight cases, renal biopsies were lacking, but povidone deposits were detected in biopsies from other tissues.
Za ostalih osem primerov biopsije ledvic niso bile na voljo, so pa nalaganje povidona odkrili v biopsijskih vzorcih, odvzetih iz drugih tkiv.
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.
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.
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.
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.
To lift the suspension, this product should be appropriately reformulated taking into account its misuse potential.
Za preklic začasnega umika je treba zdravilo ustrezno reformulirati ob upoštevanju možnosti za napačno uporabo.
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).
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).
• 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.
• 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.