FrancophonIA/ELRC3.0 huggingface dataset:
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Norvir.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Treatment with Norvir should be given by a doctor who has experience in the treatment of HIV infection.
Slovenian: Zdravljenje z zdravilom Norvir mora uvesti zdravnik, ki ima izkušnje z zdravljenjem okužb z virusom HIV.
English: When the enzyme is blocked, the virus does not reproduce normally, slowing down its rate of multiplication.
Slovenian: Ko je encim zavrt, se virus ne razmnožuje več normalno, temveč upočasnjeno.
English: Norvir can be used as a ‘‘pharmacokinetic enhancer' (booster' to increase the blood levels of other antiviral medicines that belong to the same group as Norvir (protease inhibitors) called amprenavir, atazanavir, fosamprenavir, lopinavir, saquinavir, tipranavir and darunavir.
Slovenian: Zdravilo Norvir se uporablja kot „farmakokinetični stopnjevalec“, ki v krvi povečuje raven drugih protivirusnih zdravil iz iste skupine kot zdravilo Norvir (zaviralci proteaz), tj. amprenavir, atazanavir, fosamprenavir, lopinavir, sakvinavir, tipranavir in darunavir.
English: Norvir is a medicine that contains the active substance ritonavir.
Slovenian: Norvir je zdravilo, ki vsebuje zdravilno učinkovino ritonavir.
English: In the second study, patients taking Norvir had greater reductions in viral load and increases in CD4 cell counts than those taking zidovudine alone.
Slovenian: V drugi študiji je pri bolnikih, ki so prejemali zdravilo Norvir, prišlo do večjega znižanja virusnega bremena in povečanja števila celic CD4 kot pri tistih, ki so jemali le zidovudin.
English: What is the risk associated with Norvir?
Slovenian: Kakšna tveganja so povezana z zdravilom Norvir?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Norvir, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: CD4 T cells are white blood cells that are important in helping to fight infections, but which are killed by HIV.
Slovenian: T-celice CD4 so bele krvničke, ki imajo pomembno vlogo pri premagovanju okužb, vendarjih virus HIV uničuje.
English: Norvir, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Slovenian: Zdravilo Norvir v kombinaciji z drugimi protivirusnimi zdravili zniža količino virusa HIV v krvi in jo zadržuje na nizki ravni.
English: The effects of Norvir as an antiviral medicine in combination with other antiviral medicines were also studied in four studies of children.
Slovenian: Učinke zdravila Norvir kot protivirusnega zdravila v kombinaciji z drugimi protivirusnimi zdravili so raziskovali tudi v štirih študijah pri otrocih.
English: Norvir must not be used in patients who have severe problems with their liver or patients who are taking St John's wort (a herbal preparation used to treat depression) or medicines that are broken down in the same way as Norvir and are harmful at high levels in the blood.
Slovenian: Zdravila ne smejo uporabljati bolniki z resnim obolenjem jeter ali tisti, ki se zdravijo s šentjanževko (rastlinskim pripravkom za zdravljenje depresije) ali zdravili, ki se presnavljajo enako kot zdravilo Norvir in so pri visokih koncentracijah v krvi škodljiva.
English: The combination of Norvir and zidovudine was less effective than Norvir alone, although the reasons for this were unclear.
Slovenian: Kombinacija zdravil Norvir in zidovudin ni bila tako učinkovita kot zdravilo Norvir, uporabljeno kot samostojno zdravilo, čeprav razlogi za to niso jasni.
English: Information on these studies can be found in the EPAR summaries for the other medicines.
Slovenian: Informacije o teh študijah so na voljo v evropskih javnih poročilih o oceni zdravila (EPAR) za omenjena zdravila.
English: At higher doses, ritonavir acts as a ‘protease inhibitor'.
Slovenian: Ritonavir pri večjih odmerkih deluje kot „zaviralec proteaze“.
English: Norvir has been studied as a booster in clinical studies that were designed to assess the effects of the antiviral medicines that it is used to boost.
Slovenian: Delovanje zdravila Norvir kot stopnjevalca je bilo raziskano v kliničnih študijah, ki so bile zasnovane za oceno učinkov protivirusnih zdravil, katerih učinek se spodbuja z zdravilom Norvir.
English: Why has Norvir been approved?
Slovenian: Zakaj je bilo zdravilo Norvir odobreno?
English: Norvir can also be used as an HIV medicine, where it acts directly against the virus.
Slovenian: Zdravilo Norvir se lahko uporablja tudi za zdravljenje okužbe z virusom HIV, pri čemer deluje neposredno na viruse.
English: For the full list of all restrictions and side effects reported with Norvir, see the package leaflet.
Slovenian: Za celoten seznam omejitev in neželenih učinkov, o katerih so poročali pri uporabi zdravila Norvir, glejte navodilo za uporabo.
English: When the active substance, ritonavir, acts as a ‘booster' it does so by slowing down the rate at which certain antiviral medicines given in combination with ritonavir are broken down in the body.
Slovenian: Ko zdravilna učinkovina v zdravilu Norvir, ritonavir, deluje kot farmakokinetični stopnjevalec, v telesu upočasnjuje razgradnjo nekaterih protivirusnih zdravil, dajanih v kombinaciji z ritonavirjem.
English: The first compared Norvir with placebo (a dummy treatment) in 1,090 adults, as an add-on to the antiviral medicines the patients were already taking.
Slovenian: V prvi študiji so pri 1 090 odraslih zdravilo Norvir primerjali s placebom (zdravilom brez zdravilne učinkovine), dajali pa so ju kot dodatek drugim protivirusnim zdravilom, ki so jih bolniki že jemali.
English: Norvir, in combination with other antiviral medicines, also reduced viral loads in children.
Slovenian: Zdravilo Norvir lahko v kombinaciji z drugimi protivirusnimi zdravili zmanjša virusno breme tudi pri otrocih.
English: How does Norvir work?
Slovenian: Kako zdravilo Norvir deluje?
English: How has Norvir been studied?
Slovenian: Kako je bilo zdravilo Norvir raziskano?
English: What is Norvir used for?
Slovenian: Za kaj se zdravilo Norvir uporablja?
English: See the package leaflet provided with the other medicine for full details.
Slovenian: Za podrobne informacije glejte navodilo za uporabo, priloženo drugemu zdravilu.
English: The standard dose for adults is 100 or 200 mg, once or twice a day.
Slovenian: Običajni odmerek za odrasle je 100 ali 200 mg enkrat ali dvakrat na dan. Odmerek je odvisen od drugega zaviralca proteaz, ki ga bolnik jemlje.
English: When it is used as a booster, the side effects of Norvir depend on the other antiviral medicine being taken.
Slovenian: Če bolnik zdravilo Norvir uporablja kot stopnjevalec, so neželeni učinki odvisni od drugih protivirusnih zdravil, ki jih bolnik jemlje.
English: The second study compared Norvir taken alone, zidovudine (another antiviral medicine) taken alone and the combination of Norvir and zidovudine in 356 adults who had not taken treatment for HIV infection before.
Slovenian: V drugi študiji so pri 356 bolnikih, ki se pred tem zaradi okužbe z virusom HIV še niso zdravili, primerjali jemanje zgolj zdravila Norvir, jemanje zgolj zidovudina (drugega protivirusnega zdravila) in kombinacijo zdravila Norvir ter zidovudina.
English: What is Norvir?
Slovenian: Kaj je zdravilo Norvir?
English: How is Norvir used?
Slovenian: Kako se zdravilo Norvir uporablja?
English: Some medicines cannot be taken with Norvir when it is used in this way.
Slovenian: Kadar se zdravilo Norvir uporablja v ta namen, nekaterih drugih zdravil ni dovoljeno jemati.
English: 1.850 GBq/ml Radiopharmaceutical precursor
Slovenian: 1,850 GBq/ml
English: Vial (glass)
Slovenian: Viala (steklo) 2ml
English: Invented name Strength Pharmaceutical form
Slovenian: Farmacevtska oblika Pot uporabe Ovojnina Vsebina (koncentracija) Velikost pakiranje
English: MA (EU) number (Invented)
Slovenian: Številka MA (EU) (Izmišljeno) ime Jakost
English: The Board adopted the decision with two votes against.
Slovenian: Odbor je odločitev sprejel z dvema glasovoma proti.
English: The document should be agreed in two weeks' time.
Slovenian: Dokument naj bi bil dokončan v dveh tednih.
English: The European Parliament Budget Control Committee received the proposal to postpone the discharge for the financial year 2009 for the Agency, although both the European Parliament Committee on the Environment, Public Health and Food Safety and the European Court of Auditors recommended the discharge.
Slovenian: Odbor Evropskega parlamenta za proračunski nadzor je prejel predlog za odložitev podelitve razrešnice agenciji za finančno leto 2009, čeprav sta tako Odbor Evropskega parlamenta za okolje, javno zdravje in varnost hrane kot Evropsko računsko sodišče priporočila sprejetje razrešnice.
English: Therefore we cannot give our approval for current activities of Thomas Lönngren."
Slovenian: Zato ne moremo odobriti sedanjih dejavnosti Thomasa Lönngrena.“
English: During the period from 25 November 2010 to 15 March 2011, the Board finalised eight written procedures.
Slovenian: V obdobju od 25. novembra 2010 do 15. marca 2011 je odbor zaključil osem pisnih postopkov.
English: The provisional draft budget (PDB) 2012 amounts to EUR 238.4 million, representing an increase of EUR 29.5 million over the 2011 budget.
Slovenian: Začasni predlog proračuna za leto 2012 znaša 238,4 milijona EUR, kar v primerjavi s proračunom za leto 2011 pomeni povečanje za 29,5 milijona EUR.
English: Information on the Agency's cooperation with the World Organisation for Animal Health (OIE) will also be added.
Slovenian: Dodani bodo tudi podatki o sodelovanju agencije s Svetovno organizacijo za zdravje živali (OIE).
English: In the field of IT, a more strategic approach with clear prioritisation is called for.
Slovenian: Na področju IT pa je potreben bolj strateški pristop z jasno opredeljenimi prednostnimi nalogami.
English: The total staffing needed for the full implementation of the legislation (phased over five years) may be higher.
Slovenian: Skupno število zaposlenih, potrebnih za celovito izvajanje zakonodaje (postopno v naslednjih petih letih), je lahko večje.
English: The reason for the delays will need to be clarified over time.
Slovenian: Sčasoma bo treba te zamude pojasniti.
English: The Acting Executive Director met with Commissioner Dalli on 11 March 2011.
Slovenian: Vršilec dolžnosti izvršnega direktorja se je 11. marca 2011 sestal s komisarjem Dallijem.
English: The full annual report will be submitted to the Board in May 2011 for adoption at the June 2011 meeting.
Slovenian: Celotno letno poročilo bo upravnemu odboru predloženo maja 2011 za sprejetje na seji junija 2011.
English: • Presentation: Project 2014; Update to the Management Board.
Slovenian: • Predstavitev: Projekt 2014; posodobitev za upravni odbor.
English: However, the Agency expects that the Budgetary Authority will grant some posts later this year.
Slovenian: Vendar pa agencija pričakuje, da bo proračunski organ odobril nekatera delovna mesta kasneje v letošnjem letu.
English: The document follows the revised rules laid down by the European Commission.
Slovenian: Dokument je usklajen s spremenjenimi pravili, ki jih je določila Evropska komisija.
English: • Road map to 2015.
Slovenian: • Časovni načrt do leta 2015
English: The report identified areas where some delays occurred.
Slovenian: V poročilu so navedena tudi področja, na katerih je prišlo do zamud.
English: Declarations of conflicts of interests
Slovenian: Izjave o navzkrižju interesov
English: Meeting with Commissioner Dalli
Slovenian: Srečanje s komisionarjem Dallijem
English: They discussed a number of topics pertinent to the Agency.
Slovenian: Govorila sta o številnih temah v zvezi z agencijo.
English: 24 November 2010.
Slovenian: 24. novembra 2010.
English: 1 Committee for Medicinal Products for Human Use (CHMP) or Committee for Medicinal Products for Veterinary Use (CVMP).
Slovenian: 1 Odbor za zdravila za uporabo v humani medicini (CHMP) ali Odbor za zdravila za uporabo v veterinarski medicini (CVMP).
English: The Board stressed its role in protecting the public interest and the reputation of the Agency.
Slovenian: Odbor je poudaril svojo vlogo pri varovanju javnega interesa in ugleda agencije.
English: Members regretted the late notification by Mr Lönngren of details of his activities.
Slovenian: Člani so izrazili obžalovanje zaradi poznega obvestila Thomasa Lönngrena o podrobnostih njegovega delovanja.
English: • The task force on the availability of medicines, which has completed its mandate.
Slovenian: • delovna skupina za razpoložljivost zdravil, ki je zaključila mandat;
English: The European Commission has initiated a review of the Fee Regulation.
Slovenian: Evropska komisija je sprožila pregled uredbe o pristojbinah.
English: • Report from BNP Paribas Real Estate.
Slovenian: • Poročilo nepremičninske družbe BNP Paribas Real Estate.
English: Any budgetary requirements concerning the implementation of the pharmacovigilance legislation were only provisionally adopted, and need to be made fully plausible in the following months.
Slovenian: Vse proračunske zahteve v zvezi z izvajanjem zakonodaje o farmakovigilanci so bile sprejete samo začasno in morajo v naslednjih mesecih postati v celoti izvedljive.
English: • The legislative proposal on information to patients (the discussions will restart at the Council level).
Slovenian: • zakonodajni predlog o informiranju bolnikov (razprave se bodo ponovno začele na ravni Sveta);
English: With regard to the structural problems of the budget, Commissioner Dalli was of the opinion that the Agency should be allowed to retain the surplus revenue from fees.
Slovenian: Glede strukturnih težav s proračunom je komisar Dalli menil, da bi agenciji moralo biti dovoljeno, da zadrži presežek prihodkov od pristojbin.
English: The Acting Executive Director has also informed the Commissioner about 'project 2014'.
Slovenian: Vršilec dolžnosti izvršnega direktorja je komisarja obvestil tudi o „projektu 2014“.
English: There has been a significant increase in the numbers of paediatric procedures (around 20% higher than in 2009) and inspections (a 30% increase), and a very high increase in veterinary scientific advice applications (21 applications received, which is a 90% increase).
Slovenian: Do pomembnega povečanja delovanja je prišlo na področju pediatričnih postopkov (okoli 20 % več v primerjavi z letom 2009) in inšpekcijskih pregledov (30-odstotno povečanje), izrazito pa se je povečalo tudi število vlog za veterinarsko znanstveno svetovanje (prejetih je bilo 21 vlog oziroma 90 % več).
English: The Board was also informed that the Agency is reviewing the efficiency of its procedures and is introducing changes in other areas where savings can be made.
Slovenian: Odbor je bil tudi seznanjen, da agencija pregleduje učinkovitost svojih postopkov in uvaja nekatere spremembe na področjih, kjer so mogoči prihranki.
English: Mary G. Baker (morning session) Mike O'Donovan
Slovenian: Mary G. Baker (dopoldansko zasedanje) Mike O'Donovan
English: Discharge
Slovenian: Razrešnica
English: • The meeting with the European Commission to discuss principles of a future fee regulation (including the issue of non-remunerated tasks).
Slovenian: • srečanje z Evropsko komisijo za razpravo o načelih prihodnje uredbe o pristojbinah (vključno z vprašanjem o nalogah, ki se ne plačujejo);
English: The Board supported the proposed transitional measures for the pharmaceutical industry to comply with the 2 July 2011 deadline for the electronic submission of information on medicinal products for human use.
Slovenian: Odbor je podprl predlagane prehodne ukrepe za farmacevtsko industrijo, da bo delovala v skladu z rokom 2. julija 2011 za elektronsko predložitev informacij o zdravilih za uporabo v humani medicini.
English: The two-day meeting of the Management Board of the European Medicines Agency (EMA) started on 16 March 2011 with presentations and an exchange of views on the following topics:
Slovenian: Dvodnevna seja upravnega odbora Evropske agencije za zdravila (EMA) se je začela dne 16. marca 2011 s predstavitvijo in izmenjavo stališč o naslednjih temah:
English: It was also agreed that chairs may ask for the possibility to sit as observers in the meetings of the boards of other agencies.
Slovenian: Dogovorjeno je bilo tudi, da lahko predsedniki zaprosijo za možnost, da na sejah odborov drugih agencij sodelujejo kot opazovalci.
English: • Presentation: The EMA in 2010 - highlights.
Slovenian: • Predstavitev: EMA v letu 2010 - najpomembnejši dogodki.
English: [EMA/MB/19969/2011] The agenda was adopted.
Slovenian: [EMA/MB/19969/2011] Dnevni red je bil sprejet.
English: The Agency has not received new posts for 2011 and has difficulty recruiting scientific staff as contract agents, due to the short term of the contracts and lower remuneration level.
Slovenian: Agencija, ki ji za leto 2011 niso odobrili novih delovnih mest, se srečuje s težavami pri zaposlovanju znanstvenega osebja kot pogodbenih sodelavcev zaradi kratkoročnosti pogodb in nižje ravni nadomestil.
English: The Board noted the oral report on the activities of the Agency in 2010.
Slovenian: Upravni odbor se je seznanil z ustnim poročilom o dejavnostih agencije v letu 2010.
English: 22 March 2011
Slovenian: 22. marec 2011
English: The main set of new activities for the Agency derives from the implementation of the pharmacovigilance legislation, which comes into effect in July 2012.
Slovenian: Večji del novih dejavnosti agencije izhaja iz izvajanja zakonodaje o farmakovigilanci, ki bo začela veljati julija 2012.
English: The Agency will receive a list of questions to which the Agency will reply in order to receive the discharge in June.
Slovenian: Agencija bo prejela seznam vprašanj in odgovorila nanje ter bo razrešnico prejela v juniju.
English: • The public consultation on the Transparency Directive (a proposal for the review of the Directive may be made by the end of 2011).
Slovenian: • javno posvetovanje o direktivi o preglednosti (predlog za pregled direktive bo izdan do konca leta 2011).
English: The Agency will provide national competent authorities with individual line listings to enable them to review their own performance.
Slovenian: Agencija bo pristojnim nacionalnim organom posredovala posamezne sezname, s katerimi bodo lahko pregledali uspešnost svojega delovanja.
English: The Board adopted the establishment plan of 612 posts, which represents an increase of 45 posts required for the preparation and implementation of the pharmacovigilance legislation.
Slovenian: Odbor je sprejel načrt za 612 delovnih mest, kar pomeni 45 novih delovnih mest, potrebnih za pripravo in izvajanje zakonodaje o farmakovigilanci.
English: • The procedure for the appointment of the Executive Director (the 5 May 2011 meeting of the Board will be maintained as planned).
Slovenian: • postopek za imenovanje izvršnega direktorja (seja odbora bo potekala 5. maja 2011, kot je bilo načrtovano);
English: Work programme and preliminary draft budget 2012
Slovenian: Delovni program in predhodni predlog proračuna za leto 2012
English: Update from the meeting of Chairs of the EU agencies
Slovenian: Posodobljene informacije s seje predsednikov agencij EU
English: Revision of 'Charter of tasks and responsibilities of the Agency's accounting officer'
Slovenian: Revizija „Listine nalog in odgovornosti računovodij agencije“
English: Annual report 2010
Slovenian: Letno poročilo za leto 2010
English: This may be due to the decrease in the number of applications and to fluctuations in submission of applications during the year.
Slovenian: To je morda posledica manjšega števila vlog in nihanj v številu predloženih vlog med letom.
English: Request of the former Executive Director for authorisation of external activities after leaving the service
Slovenian: Prošnja nekdanjega izvršnega direktorja za odobritev zunanjih dejavnosti po odhodu s položaja
English: Report on the performance of the Agency's scientific procedures: key performance indicators (KPIs) for medicinal products for human and veterinary use
Slovenian: Poročilo o uspešnosti znanstvenih postopkov agencije: glavni kazalniki uspešnosti za zdravila za humano in veterinarsko uporabo
English: A smaller number of generic medicines in the centralised procedure comes as a result of the European Commission's policy on multiple applications for centrally authorised products.
Slovenian: Manjše število generičnih zdravil v centraliziranih postopkih je posledica politike Evropske komisije o več vlogah za zdravila, odobrena po centraliziranem postopku.
English: • The progress on the five calls within the process on corporate responsibility in the field of pharmaceuticals: coordinated access to orphan medicinal products, capacity building on contractual agreements for innovative medicines, market access for biosimilars, facilitating supply in small markets and promoting a good governance for non-prescription medicines.
Slovenian: • napredek v zvezi s petimi pozivi v okviru postopka za družbeno odgovornost na področju farmacevtskih izdelkov: usklajen dostop do zdravil sirot, povečevanje zmogljivosti na podlagi pogodbenih sporazumov za inovativna zdravila, vstop biološko podobnih zdravil na tržišče, zagotavljanje oskrbe majhnih trgov in spodbujanje dobrega upravljanja na področju zdravil brez recepta;
English: The Board noted the paper providing more detail about the ICT projects and budget for 2012.
Slovenian: Odbor se je seznanil z dokumentom, ki vsebuje podrobnosti o projektih IKT in proračun za leto 2012.
English: These comprised six consultations on new membership in the CHMP and CVMP, the adoption of the non-automatic carryover of appropriations from 2010 to 2011, and the adoption of the minutes of the 69th meeting of the Management Board from 16 December, as indicated below:
Slovenian: To vključuje šest posvetovanj o novem članstvu v odborih CHMP in CVMP, potrditev nesamodejnega prenosa proračunskih sredstev iz leta 2010 v leto 2011 ter potrditev zapisnika 69. seje upravnega odbora z dne 16. decembra, kot je navedeno v nadaljevanju:
English: The Board asked for information on the management of procurement and recruitment procedures, and on its work in the area of the management of conflicts of interests, to be included in the final work programme.
Slovenian: Odbor je zaprosil za informacije o vodenju postopkov naročanja in zaposlovanja ter o njegovem delu na področju obvladovanja navzkrižja interesov, kar naj bi bilo vključeno v končni delovni program.
English: Two new agencies joined the meeting.
Slovenian: Seje sta se udeležili dve novi agenciji.
English: Currently, the Agency provides annual reports drawn up by the internal audit capability and by the Audit Advisory Committee (AAC), as well as final reports from the European Court of Auditors, with the Agency's replies.
Slovenian: Trenutno agencija posreduje letna poročila, ki so bila pripravljena na službi za notranjo revizijo in v Odboru za presojo in svetovanje, ter končna poročila Evropskega računskega sodišča z odgovori agencije.
English: The Board stressed that the increase in pharmacovigilance and other activities at the Agency's level will mean a higher workload for the national authorities.
Slovenian: Odbor je poudaril, da se bo zaradi večjega obsega dejavnosti na področju farmakovigilance in drugih dejavnosti na ravni agencije povečala delovna obremenitev nacionalnih organov.