natgillin/translations-raw huggingface dataset:
Members raised concern that the legislation does not provide for alternate members of the civil society representatives on the Management Board.
Člani so izrazili zaskrbljenost, da zakonodaja ne omogoča, da bi upravni odbor imel namestnike predstavnikov civilne družbe.
The Chair of the HMA management group provided an update on a number of items, including the following:
Predsednik upravne skupine vodij agencij za zdravila je predstavil posodobljene informacije o več temah, vključno z naslednjim:
• [EMA/876327/2011] EMA preparations for the impact of the Olympic Games 2012.
• [EMA/876327/2011] Priprave agencije EMA na vpliv olimpijskih iger leta 2012.
2011 EudraVigilance-Human mid-year report
Vmesno poročilo o stanju sistema EudraVigilance za zdravila za uporabo v humani medicini za leto 2011
The Management Board thanked the topic coordinators Aginus Kalis, Marcus Müllner, Pat O'Mahony and Kent Woods for their contribution in preparing the topics on the work programme and the budget for the discussion.
Upravni odbor se je zahvalil tematskim koordinatorjem Aginusu Kalisu, Marcusu Müllnerju, Patu O'Mahonyju in Kentu Woodsu za njihovo vlogo pri pripravi tem v zvezi z delovnim programom in proračunom za razpravo.
The Board took the opportunity to thank the topic coordinators (Xavier De Cuyper, Walter Schwerdtfeger and Lisette Tiddens) for preparing this topic for the discussion, and will look forward to a further discussion at the next meeting.
Upravni odbor se je tematskim koordinatorjem (Xavier De Cuyper, Walter Schwerdtfeger in Lisette Tiddens) ob tej priložnosti zahvalil za pripravo te teme za razpravo in povedal, da se veseli nadaljnje razprave na naslednji seji.
11bis Preparation for written procedures: Non-automatic carry-over 2011-2012
Priprava na pisne postopke: nesamodejni prenos v obdobje 2011-2012
The Board also decided to invite the current civil society representativesMary Baker, Mike O'Donovan and Lisette Tiddens - to participate at the next meeting as observers, to enable them to provide valuable input to the work of the Board.
Poleg tega se je odločil, da sedanje predstavnike civilne družbe - Mary Baker, Mika O'Donovana in Lisette Tiddens - povabi k sodelovanju na naslednji seji v vlogi opazovalcev, da lahko s svojimi dragocenimi izkušnjami prispevajo k delu upravnega odbora.
Mike O'Donovan gives his vote by proxy to Mary G Baker.
Mike O'Donovan za glasovanje pooblašča Mary G Baker.
The adopted framework focuses on the interaction in the area of human medicines.
Sprejet okvir namenja glavno pozornost sodelovanju na področju zdravil za uporabo v humani medicini.
Amendments to Management Board implementing rules on the Agency's fees
Spremembe izvedbenih pravil upravnega odbora o pristojbinah agencije
5 Denmark
5 Danska
In addition, members were asked to declare any specific interests that could be considered to be prejudicial to their independence with respect to the items on the agenda.
Člani odbora so bili poleg tega pozvani, naj se izrečejo o kakršnih koli posebnih interesih v zvezi s katero koli točko dnevnega reda, ki bi lahko vplivali na njihovo neodvisnost.
• [EMA/907269/2011] EU telematics projects report; [EMA/907270/2011] EU telematics operations report; [EMA/907383/2011] Minutes from the Management Board Telematics Committee meeting held on 22 September 2011.
• [EMA/907269/2011] Poročilo o telematskih projektih EU; [EMA/907270/2011] Poročilo o telematskih operacijah EU; [EMA/907383/2011] Zapisnik seje odbora upravnega odbora za telematiko, ki je potekala 22. septembra 2011.
• Progress on identifying commercially confidential information (a revised guidance document will be presented at the next HMA meeting in February 2012).
• napredek pri opredelitvi poslovno zaupnih informacij (na naslednji seji vodij agencij za zdravila februarja 2012 bodo predstavljene spremenjene smernice);
b.) Second update on the implementation of the conflicts of interests policy for staff
b) Druge novice o izvajanju politike o navzkrižju interesov za osebje
• Adoption of 73rd Management Board meeting minutes finalised on 25 November 2011.
• Sprejetje zapisnika 73. seje upravnega odbora je bilo končano 25. novembra 2011.
[EMA/MB/902165/2011] The mid-year report showed positive trends in the area of signal detection and management.
[EMA/MB/902165/2011] V vmesnem poročilu so bili ugotovljeni pozitivni trendi na področju odkrivanja in obvladovanja znakov.
George Antoniou (Cyprus) gives his vote by proxy to Patricia Vella Bonanno (Malta).
George Antoniou (Ciper) za glasovanje pooblašča Patricio Vella Bonanno (Malta).
Reflection paper on medicinal product supply shortages caused by manufacturing/GMP compliance problems
Študija o nezadostni oskrbi z zdravili, ki jo povzročijo proizvodne težave/težave v zvezi z zagotavljanjem skladnostji z dobro proizvodno prakso
[EMA/MB/826035/2011] The agenda was adopted.
[EMA/MB/826035/2011] Dnevni red je bil sprejet.
The amendments concern the following areas: inspections, plasma master files, certificates for medicinal products, type II variations to MUMS marketing authorisations for non-food-producing species, and core dossiers for medicinal products to be used in a human pandemic situation.
certifikate za zdravila, spremembe tipa II dovoljenj za promet z zdravili MUMS (manjša uporaba in manj pomembne živalske vrste) za vrste živali, ki niso živali za proizvodnjo živil, in temeljne dokumentacije za zdravila, ki se uporabljajo v razmerah pandemije med ljudmi.
This reflection paper focuses only on supply shortages in the area of human medicines.
Ta študija je osredotočena le na nezadostno oskrbo na področju zdravil za uporabo v humani medicini.
3 Belgium
3 Belgija
The Board wished to return to this topic at a future meeting.
Upravni odbor je izrazil željo, da se o tej temi razpravlja na eni od prihodnjih sej.
c.) The revised Management Board conflicts of interests policy
c) Spremenjena politika upravnega odbora o navzkrižjih interesov
a.) The work programme 2012
a) Delovni program za leto 2012
Claude Hemmer (Luxembourg) gives his vote by proxy to Aginus Kalis (Netherlands).
Claude Hemmer (Luksemburg) za glasovanje pooblašča Aginusa Kalisa (Nizozemska).
6 Estonia
6 Estonija
Changes in management
Spremembe v vodstvu agencije
[EMA/MB/924270/2011; EMA/914836/2011] This item (for information) was deferred to the next meeting.
[EMA/MB/924270/2011; EMA/914836/2011] Ta točka (v vednost) je bila preložena na naslednjo sejo.
List of participants at the 74th meeting of the Management Board, held in London on 15 December 2011
Seznam udeležencev 74. seje upravnega odbora v Londonu 15. decembra 2011
Ioannis Toutas (Greece) gives his vote by proxy to Pat O'Mahony (Ireland).
Ioannis Toutas (Grčija) za glasovanje pooblašča Pata O'Mahonyja (Irska).
Revised Management Board rules of procedure
Spremenjen poslovnik upravnega odbora
13 Lithuania 14 Malta
12 Latvija 13 Litva
7 Finland
7 Finska
European Commission Paola Testori Coggi Apologies from Pedro Ortum Silvan
Paola Testori Coggi Opravičilo Pedra Ortuma Silvana
With regard to the financing of the implementation of the pharmacovigilance legislation, the European Commission intends to present a 'bridging budget' for the year 2013.
Evropska komisija namerava v zvezi s financiranjem izvajanja zakonodaje o farmakovigilanci predstaviti „premostitveni proračun“ za leto 2013.
The meeting was cautious about the implementation of public hearings at an early stage.
Udeleženci seje so poudarili potrebo po previdnosti glede izvajanja javnih obravnav v zgodnji fazi.
Veterinarian organisations
Veterinarske organizacije
Planning 2012
Načrtovanje za leto 2012
• [EMA/MB/868582/2011] Outcome of written procedures during the period 15 September 2011 to
• [EMA/MB/868582/2011] Rezultat pisnih postopkov v obdobju od 15. septembra 2011 do 30. novembra 2011.
Vote on the adoption of agenda item 7c - MB conflicts of interests policy
Glasovanje o sprejetju točke 7c dnevnega reda - Politika upravnega odbora o navzkrižjih interesov
[EMA/MB/643417/2011] The Management Board noted the revised staff policy plan, in line with the reduced staffing and budget compared to the 2012 preliminary draft budget.
[EMA/MB/643417/2011] Upravni odbor se je seznanil s spremenjenim načrtom kadrovske politike v skladu z manjšim številom zaposlenih in manjšim proračunom v primerjavi s predhodnim predlogom proračuna za leto 2012.
Communication, transparency, future veterinary legislation, interactions with health technology assessment (HTA) bodies, process reengineering to increase efficiency of operations, and assuring functioning of the Agency during the busy Olympic period in London will be other areas of focus for
Druge teme, ki jim bo v letu 2012 posvečeno veliko pozornosti, so komuniciranje, preglednost, prihodnja veterinarska zakonodaja, sodelovanje z organi za ocenjevanje zdravstvene tehnologije, preoblikovanje postopkov za povečanje učinkovitosti operacij in zagotavljanje delovanja agencije v pestrem obdobju olimpijskih iger v Londonu.
[EMA/MB/899250/2011; EMA/INS/GMP/774201/2011] The Board discussed the issue of supply shortages, considering it to be of importance to public health.
[EMA/MB/899250/2011; EMA/INS/GMP/774201/2011] Upravni odbor je razpravljal o vprašanju nezadostne oskrbe in menil, da je to vprašanje pomembno za javno zdravje.
Czech Republic Bulgaria
Češka republika Bolgarija
[EMA/MB/880875/2011] The Management Board endorsed the adaptation of the fixed hourly cost to €41 for the year 2012 (the cost had been €40 since 2009).
[EMA/MB/880875/2011] Upravni odbor je potrdil prilagoditev fiksne urne postavke na 41 EUR za leto 2012 (od leta 2009 je ta postavka znašala 40 EUR).
Chair: Sir Kent Woods
Predsednik: Kent Woods
[EMA/MB/811207/2011] The Management Board endorsed the report on the Agency's procurement procedure and the proposed improvement action plan.
[EMA/MB/811207/2011] Upravni odbor je potrdil poročilo o postopku javnih naročil agencije in predlagani akcijski načrt za izboljšave.
Minutes of the 74th meeting of the Management Board
Zapisnik 74. seje upravnega odbora
[EMA/MB/554514/2011] The Management Board adopted the work programme 2012.
[EMA/MB/554514/2011] Upravni odbor je sprejel delovni program za leto 2012.
The Board also discussed the fact that management of supply shortages is equally complicated and involves various parties, such as the Agency, national competent authorities (NCAs), healthcare professionals, health ministries, companies and other bodies, all of which should work in a way that is efficient and responsive.
Upravni odbor je razpravljal tudi o dejstvu, da je obvladovanje nezadostne oskrbe enako zapleteno in vključuje različne vpletene strani, kot so agencija, nacionalni pristojni organi, zdravstveni delavci,
c.) Draft budget and establishment plan 2012
c) Predlog proračuna in kadrovski načrt za leto 2012
[EMA/MB/915206/2011; Ares(2011)992230 - 20/09/2011] The Management Board endorsed the IAS strategic audit plan for 2012-2014.
[EMA/MB/915206/2011; Ares(2011)992230 - 20/09/2011] Upravni odbor je potrdil strateški revizijski načrt službe IAS za obdobje 2012-2014.
[EMA/MB/834867/2011] The Management Board welcomed the proposed revisions to the Management Board policy on conflicts of interests.
[EMA/MB/834867/2011] Upravni odbor je pozdravil predlagane spremembe politike upravnega odbora o navzkrižjih interesov.
[EMA/MB/856505/2011] The Management Board noted the information on the ICT budget and the projects planned for 2012.
[EMA/MB/856505/2011] Upravni odbor se je seznanil z informacijami o proračunu in projektih IKT, načrtovanimi za leto 2012.
[EMA/MB/828587/2011] The Management Board noted the final minutes, adopted by written procedure on 23 November 2011.
[EMA/MB/828587/2011] Upravni odbor se je seznanil s končnim zapisnikom, ki je bil sprejet s pisnim postopkom 23. novembra 2011.
[EMA/MB/115339/2004/Rev.3] The Management Board adopted changes to the Management Board rules of procedure.
[EMA/MB/115339/2004/Rev.3] Upravni odbor je sprejel spremembe poslovnika upravnega odbora.
b.) MBTC chairmanship arrangements
b) Ureditev predsedovanja odboru MBTC
Pedro Ortun Silvan by proxy
Pedro Ortun Silvan po pooblaščencu
Pedro Ortun Silvan (DG Enter) gives his vote by proxy to Paola Testori-Coggi (DG Sanco).
Pedro Ortun Silvan (GD za podjetništvo in industrijo) za glasovanje pooblašča Paolo Testori-Coggi (GD za zdravje in varstvo potrošnikov).
• No 11/2011 - the appointment of Frederic Klein as CVMP alternate, proposed by Belgium, finalised on 19 October 2011.
• Št. 11/2011 - imenovanje Frederica Kleina za namestnika v odboru CVMP na predlog Belgije, ki je bilo končano 19. oktobra 2011.
[EMA/MB/882002/2011] The Management Board noted that a written procedure for non-automatic carry-forward will be launched for adoption no later than 15 February 2012.
[EMA/MB/882002/2011] Upravni odbor je bil seznanjen, da se bo najpozneje 15. februarja 2012 začel izvajati pisni postopek za sprejetje nesamodejnega prenosa.
A reflection paper on veterinary product supply shortages should be discussed.
Treba bi bilo torej razpravljati tudi o študiji o nezadostni oskrbi z zdravili za uporabo v veterinarski medicini.
[EMA/MB/901680/2011; EMA/901869/2011] The Management Board endorsed the implementing activities for 2012.
[EMA/MB/901680/2011; EMA/901869/2011] Upravni odbor je potrdil izvedbene dejavnosti za leto 2012.
[EMA/MB/239263/2011] The Management Board adopted amendments to the fee implementing rules.
[EMA/MB/239263/2011] Upravni odbor je sprejel spremembe izvedbenih pravil o pristojbinah.
• No 12/2011 - the appointment of Alia Michaelidou-Patsia as CVMP alternate, proposed by Cyprus, finalised on 28 November 2011.
• Št. 12/2011 - imenovanje Alie Michaelidou-Patsia za namestnico v odboru CVMP na predlog Cipra, ki je bilo končano 28. novembra 2011.
Proxies announced by the Chair
Pooblastila za zastopanje, ki jih je napovedal predsednik
e.) Staff policy plan 2012
e) Načrt kadrovske politike za leto 2012
• No 10/2011 - the appointment of Eva Persson as CVMP alternate, proposed by Sweden, finalised on 19 October 2011.
• Št. 10/2011 - imenovanje Eve Persson za namestnico v odboru CVMP na predlog Švedske, ki je bilo končano 19. oktobra 2011.
The Chair announced the proxies held by members present.
Predsednik je povedal, kateri prisotni člani imajo pooblastila za zastopanje.
Abstained
Vzdržani
Minutes from the 73rd meeting, held on 6 October 2011
Zapisnik 73. seje, ki je potekala 6. oktobra 2011
[EMA/MB/903626/2011; EMA/688885/2010; EMA/161137/2011] The Management Board endorsed the new framework for interaction with healthcare professionals (HCPs) and the criteria that apply to HCP organisations wishing to be involved in the Agency's activities.
[EMA/MB/903626/2011; EMA/688885/2010; EMA/161137/2011] Upravni odbor je potrdil nov okvir za sodelovanje z zdravstvenimi delavci in merila, ki se uporabljajo za organizacije zdravstvenih delavcev,
[EMA/MB/143451/2011] The Board adopted the Agency's budget and the establishment plan for 2012.
[EMA/MB/143451/2011] Upravni odbor je sprejel proračun in kadrovski načrt agencije za leto 2012.
[EMA/MB/886045/2011; EMA/121340/2011] The Management Board endorsed the reflection paper.
[EMA/MB/886045/2011; EMA/121340/2011] Upravni odbor je potrdil študijo.
[EMA/907384/2011] The Management Board adopted a change to the terms of reference of the Committee.
[EMA/907384/2011] Upravni odbor je sprejel spremembo pristojnosti in nalog odbora.
a.) Revised terms of reference
a) Spremenjene pristojnosti in naloge
EMA/MB/33634/2012 Adopted Management Board
EMA/511072/2012 Sprejet Upravni odbor
Representative of veterinarians' organisations
Predstavnik veterinarskih organizacij
4 Cyprus by proxy
4 Ciper po pooblaščencu
Report from the Heads of Medicines Agencies (HMA)
Poročilo vodij agencij za zdravila
The European Commission stated the importance of not raising expectations among the public in view of the resource constraints; the Commission will look at what can be addressed in the revision of the Clinical Trials Directive.
Evropska komisija je poudarila, da se zaradi omejenosti sredstev ne smejo povečati pričakovanja javnosti.
Luxembourg by proxy
Luksemburg po pooblaščencu
12 Latvia
11 Italija
7bis Personnel matter
Kadrovska zadeva
300 mg Concentrate for solution for infusion
300 mg koncentrat za raztopino za infundiranje intravenska uporaba viala (steklo)
Oral suspension Oral use bottle (glass)
40 mg/ml peroralna suspenzija peroralna uporaba steklenička (steklo)
Scientific conclusions and grounds for refusal presented by the European Medicines Agency
Znanstveni zaključki in podlaga za zavrnitev, ki jih je predstavila Evropska agencija za zdravila
• The Committee considered all the available data submitted from efficacy and safety.
• Odbor je upošteval vse predložene podatke, povezane z učinkovitostjo in varnostjo;
Acne affects more than 50% of teenagers but frequently continues into adulthood.
Akne prizadenejo več kot 50 % najstnikov in se pogosto nadaljujejo tudi v odrasli dobi.
b) the potential use of the product for women who are not comprised in the target population.
b) možnosti, da bi zdravilo uporabljale ženske, ki niso del ciljne populacije;
On 28 June 2011 and 29 June 2011 Italy and Sweden respectively, triggered a referral under Article 6(12) of Commission Regulation EC No 1084/2003.
Italija in Švedska sta 28. junija 2011 oziroma 29. junija 2011 sprožili napotitveni postopek v skladu s členom 6(12) Uredbe Komisije ES št. 1084/2003.
Therefore the Committee concluded that the variation application should be refused.
Zato je zaključil, da je vlogo za spremembo treba zavrniti.
The specific content of the proposed educational program was to be agreed with the national competent authorities following the authorisation of the combined indication.
O natančni vsebini predlaganega izobraževalnega programa naj bi se po odobritvi kombinirane indikacije dogovoril s pristojnimi nacionalnimi organi.
• The Committee considered the procedure under Article 6(12) of Commission Regulation (EC) no 1084/2003, for Ethinylestradiol-Drospirenone 24+4 and associated names initiated by Italy and Sweden.
• Odbor je obravnaval postopek v skladu s členom 6(12) Uredbe Komisije (ES) št. 1084/2003 za zdravilo Ethinylestradiol-Drospirenone 24+4 in povezana imena, ki sta ga sprožili Italija in Švedska.
Risk Minimisation Measures
Ukrepi za obvladovanje tveganja
Overall summary of the scientific evaluation of Ethinylestradiol-Drospirenone 24+4 and associated names (see annex I)
Splošni povzetek znanstvenega vrednotenja zdravila Ethinylestradiol-Drospirenone 24+4 in povezanih imen (glejte Prilogo I)
The mean age at presentation for treatment is 24 years, with 10% of treatment visits taking place when patients are between the ages of 35 and 44 years.
Povprečna starost pri prvem posvetovanju o zdravljenju je 24 let, medtem ko se 10 % bolnikov začne zdraviti med 35. in 44. letom starosti.
Overall benefit-risk assessment
Splošna ocena koristi in tveganja
Namely, the educational program and the drug utilization studies proposed to monitor the effectiveness of the measures.
V izobraževalnem programu in študijah uporabe zdravila je bilo namreč predlagano preverjanje učinkovitosti ukrepov.
This treatment does not exempt patients from specific acne treatment if necessary.” in section 4.1 “Therapeutic Indications” of the Summary of Product Characteristics (SmPC).
To zdravljenje ne izključuje zdravljenja bolnic s specifičnimi zdravili proti aknam, če je to potrebno.“ v poglavju 4.1 „Terapevtske indikacije“ povzetka glavnih značilnosti zdravila.
In addition, and in order to monitor the effectiveness of the educational program with the consequent monitoring of the EE/DRSP-COCs prescribing practices in Europe, two drug utilization studies were proposed.
Poleg tega je za namen preverjanja učinkovitosti izobraževalnega programa s posledičnim preverjanjem prakse predpisovanja kombiniranih peroralnih kontracepcijskih sredstev z etinilestradiolom/drospirenonom v Evropi predlagal dve študiji uporabe zdravila.
The social, psychological, and emotional impairment that can result from acne has been reported to be similar to that associated with epilepsy, asthma, diabetes, and arthritis.
Po poročilih je mogoče poslabšanje v socialnem, psihološkem in čustvenem smislu kot posledica aken primerljivo s tistim pri epilepsiji, astmi, sladkorni bolezni in artritisu.
These Member States considered the approval of the variation to constitute a serious risk for public health on the basis that the overall risk-benefit profile for Ethinylestradiol-Drospirenone 24+4 in the proposed indication was considered not acceptable in light of:
Ti državi članici sta menili, da bi odobritev spremembe pomenila resno tveganje za javno zdravje na podlagi tega, da je bil splošni profil med koristmi in tveganji zdravila Ethinylestradiol-Drospirenone 24+4 za predlagano indikacijo ocenjen kot nesprejemljiv ob upoštevanju:
The population included in the studies is considered representative of the respective target population for the treatment of moderate acne vulgaris.
Populacija, ki je sodelovala v teh študijah, velja za značilno glede na ciljno populacijo za zdravljenje zmernih vulgarnih aken.
Thus, the potential to restrict the duration of treatment by the proposed risk minimisation program is not considered realistic or sufficiently effective.
Potencial, da bi predlagani program za obvladovanje tveganja omejil trajanje zdravljenja, naj ne bi bil stvaren ali dovolj učinkovit.
The Marketing Authorisation Holder (MAH), Bayer B.V. submitted a type II variation via mutual recognition procedure for Ethinylestradiol-Drospirenone 24+4 and associated names (NL/H/1269, 1270/01/II/006) on 26 January 2009, to request an extension of the indication to include: “Oral contraception for women with moderate acne vulgaris.
Imetnik dovoljenja za promet z zdravilom, Bayer B.V., je 26. januarja 2009 po postopku z medsebojnim priznavanjem predložil vlogo za spremembo tipa II za zdravilo EthinylestradiolDrospirenone 24+4 in povezana imena (NL/H/1269, 1270/01/II/006), s katero je zahteval razširitev indikacije, tako da bi ta vključevala: „Peroralna kontracepcija za ženske z zmernimi vulgarnimi aknami.
Venous thromboembolic events (VTEs)
Venski trombembolični dogodki
Ethinylestradiol-Drospirenone 24+4 is a combined oral contraceptive (COC) and contains ethinylestradiol 20 µg and the progestogen drospirenone 3 mg (EE/DRSP).
Zdravilo Ethinylestradiol-Drospirenone 24+4 je kombinirano peroralno kontracepcijsko sredstvo, ki vsebuje 20 µg etinilestradiola in 3 mg progestagen drospirenona (EE/DRSP).
The classification of acne severity is from mild, moderate, moderately severe to severe depending on the presence of the lesions.
Akne po izrazitosti razvrščamo od blagih, zmernih in zmerno hudih do hudih, odvisno od prisotnosti lezij.
In addition, a higher percentage of subjects, 11.8% (18.6% versus 6.8%), showed a ‘clear' or ‘almost clear' rating on the Investigator's Static Global Assessment (ISGA) scale.
Poleg tega je večji delež bolnic, 11,8 % (18,6 % v primerjavi s 6,8 %), dobil oceno „čista koža“ ali „skoraj čista koža“ po lestvici (ISGA).
The CHMP recognised the efficacy in the overall lesion count reduction.
Prepoznal je učinkovitost pri zmanjšanju skupnega števila lezij;
• The Committee found merit on the concerns raised by the Member States regarding the continuation of use of EE/DRSP in the treatment of moderate acne when contraception is no longer needed for which the benefit/risk balance is not acceptable considering the risk of rare but serious adverse events balanced against the limited clinical benefits.
• Odbor je odobraval pomisleke, ki sta jih sporočili državi članici v zvezi z nadaljevanjem uporabe etinilestradiola/drospirenona za zdravljenje zmernih aken, ko kontracepcija ni več potrebna, pri čemer razmerje med koristmi in tveganji ni sprejemljivo glede na to, da je tveganje za redke, ampak hude neželene učinke združeno z omejeno klinično koristjo.