natgillin/translations-raw huggingface dataset:
Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 55 micrograms of glycopyrronium bromide equivalent to 44 micrograms of glycopyrronium.
En odmerek glikopironijevega bromida, ki pride skozi ustnik inhalatorja, vsebuje 55 mikrogramov glikopironijevega bromida, kar ustreza 44 mikrogramom glikopironija.
Metabolism and nutrition disorders Hyperglycaemia
Presnovne in prehranske motnje hiperglikemija občasni
Each inhaler should be disposed of after all capsules have been used.
Vsak inhalator je treba zavreči, ko porabite vse kapsule.
Breezhaler inhaler).
Tovanor Breezhaler).
A pooled analysis of the 6- and 12-month pivotal studies found a statistically significantly higher percentage of patients receiving Tovanor Breezhaler responded with a 4 point or greater improvement in SGRQ compared to placebo at week 26 (57.8% and 47.6% respectively, p<0.001).
Po rezultatih analize združenih podatkov iz ključnih študij (6-mesečne in 12-mesečne) je bil po 26 tednih delež bolnikov, ki so dosegli izboljšanje ocene SGRQ za 4 točke ali več, statistično značilno večji med bolniki, ki so prejemali zdravilo Tovanor Breezhaler, v primerjavi s tistimi, ki so prejemali placebo (57,8 % v primerjavi s 47,6 %, p<0,001).
Tovanor Breezhaler 44 mcg inhalation powder glycopyrronium
Tovanor Breezhaler 44 μg prašek za inhaliranje glikopironij
Inhalation use only
samo za inhalacijo
Multipack comprising 3 packs (30 capsules + 1 inhaler)
Skupno pakiranje obsega 3 pakiranja (30 kapsul + 1 inhalator)
Psychiatric disorders Insomnia
Psihiatrične motnje nespečnost pogosti
In a pooled analysis of the 6and 12-month pivotal studies a statistically significantly higher percentage of patients receiving Tovanor Breezhaler responded with a 1 point or greater improvement in the TDI focal score at week 26 compared to placebo (58.4% and 46.4% respectively, p<0.001).
Po rezultatih analize združenih podatkov iz ključnih študij (6-mesečne in 12-mesečne) je bil po 26 tednih delež bolnikov, ki so dosegli izboljšanje skupne ocene indeksa TDI za 1 točko ali več, statistično značilno večji med bolniki, ki so prejemali zdravilo Tovanor Breezhaler, v primerjavi s tistimi, ki so prejemali placebo (58,4 % v primerjavi s 46,4 %, p<0,001).
Multipack: 90 (3 packs of 30 x 1) capsules + 3 inhalers.
Skupno pakiranje: 90 kapsul (3 pakiranja po 30 x 1) in 3 inhalatorji.
• Rash
• srbež
However, paradoxical bronchospasm has been observed with other inhalation therapy and can be life-threatening.
Paradoksni bronhospazem je lahko življenjsko nevaren.
• One or more blister cards, each containing either 6 or 10 Seebri Breezhaler capsules to be used in the inhaler
• en ali več pretisnih omotov, vsak vsebuje 6 ali
Immune system disorders Hypersensitivity
Bolezni imunskega sistema preobčutljivost občasni angioedem občasni
• Numbness
• navzea
Do not remove from the blister until immediately before use.
Iz pretisnega omota jih vzemite šele tik pred uporabo.
How to use Tovanor Breezhaler
Kako uporabljati zdravilo Tovanor Breezhaler
Multipacks containing 90 (3 packs of 30x1) hard capsules and 3 inhalers.
Skupno pakiranje vsebuje 90 trdih kapsul (3 pakiranja po 30x1) in 3 inhalatorje.
The inhaler in each pack should be disposed of after all capsules in that pack have been used.
Uporabno do Inhalator vsakega pakiranja je treba zavreči, ko porabite vse kapsule tega pakiranja.
Each capsule contains 63 micrograms of glycopyrronium bromide equivalent to 50 micrograms of glycopyrronium.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena kapsula vsebuje 63 mikrogramov glikopironijevega bromida, kar ustreza 50 mikrogramom glikopironija.
Skin and subcutaneous tissue disorders Rash
Bolezni kože in podkožja izpuščaj občasni pruritus občasni
• Cough with sputum
• kašelj z izmečkom
PA/Alu/PVC - Alu perforated unit-dose blister Packs containing 6x1, 10x1, 12x1 or 30x1 hard capsules, together with one inhaler.
Pakiranja vsebujejo 6x1, 10x1, 12x1 ali 30x1 trdo kapsulo in en inhalator.
Peak plasma levels and total systemic exposure following intravenous administration of 150 micrograms glycopyrronium bromide (equivalent to 120 micrograms glycopyrronium) in healthy volunteers were respectively about 50-fold and 6-fold higher than the peak and total exposure at steady-state achieved with the recommended dose (44 micrograms once daily) of Tovanor Breezhaler and were well tolerated.
Zdravi prostovoljci so dobro prenašali najvišjo koncentracijo učinkovine v plazmi in celotno sistemsko izpostavljenost po intravenski aplikaciji 150 mikrogramov glikopironijevega bromida (kar ustreza 120 mikrogramom glikopironija).
Tovanor Breezhaler can be used at the recommended dose in patients with mild to moderate renal impairment.
Bolniki z blago do zmerno okvaro ledvic lahko uporabljajo zdravilo Tovanor Breezhaler v priporočenem odmerku.
In the 6-month study, the percentage of patients experiencing a moderate or severe exacerbation was 17.5% for Tovanor Breezhaler and 24.2% for placebo (Hazard ratio: 0.69, p=0.023), and in the 12-month study it was 32.8% for Tovanor Breezhaler and 40.2% for placebo (Hazard ratio: 0.66, p=0.001).
(razmerje ogroženosti: 0,69, p=0,023), medtem ko je bil v 12-mesečni študiji odstotek takih bolnikov pri uporabi zdravila Tovanor Breezhaler 32,8 %, pri uporabi placeba pa
What Tovanor Breezhaler is
Kaj je zdravilo Tovanor Breezhaler
Other medicines and Tovanor Breezhaler
Shranjevanje zdravila Tovanor Breezhaler
Nervous system disorders Headache
Bolezni živčevja glavobol pogosti hipestezija občasni
Gastrointestinal disorders Dry mouth
Bolezni prebavil suha usta pogosti gastroenteritis pogosti navzea2)
Inhale deeply Check capsule is empty
vstavite predrite in izpustite globoko vdihnite preverite preverite, da je kapsula prazna
Your Seebri Breezhaler Inhaler pack contains: • One Seebri Breezhaler inhaler
Vaše pakiranje zdravila Tovanor Breezhaler vsebuje:
This will be done within the context of the 7th Framework Programme.
To se bo dogajalo v okviru 7. okvirnega programa.
NATIONAL COMPETENT AUTHORITIES 4,000 EUROPEAN EXPERTS
NACIONALNI PRISTOJNI ORGANI 4000 EVROPSKIH STROKOVNJAKOV
Contribute to the creation of an environment that stimulates innovation
Prispevati k nastanku okolja, ki spodbuja inovacije
The Agency's website will be at the forefront of this initiative.
Spletna stran Agencije bo v ospredju te pobude.
Participate in international standardisation activities.
Sodelovati pri mednarodnih standardizacijskih dejavnostih.
The SME Office has been set up within the Agency to address the particular needs of smaller companies.
Urad za mala in srednje velika podjetja je bil ustanovljen znotraj Agencije, da bi obravnaval posebne potrebe manjših družb.
Further interaction will develop in the areas specified by the European Commission.
Nadaljnji stiki bodo razviti na področjih, ki jih opredeljuje Evropska komisija.
The provision of understandable and clear information about medicines is an important goal for the Agency.
Zagotavljanje razumljivih in jasnih informacij o zdravilih je pomemben cilj Agencije.
1.6. International cooperation
1.6 Mednarodno sodelovanje
The documents will be improved in the light of stakeholders' expectations.
Te dokumente bo izboljšala glede na pričakovanja svojih zainteresiranih strani.
This document is a summary of the Agency's work programme for 2008.
Ta dokument je povzetek delovnega programa Agencije za leto 2008.
This trend is mirrored by the increased number of delegates from Member States attending meetings at the Agency.
Ta trend se odraža v povečanem številu delegatov iz držav članic, ki se udeležujejo srečanj na Agenciji.
Head: David Mackay
Vodja: David Mackay
Collaboration with patients will continue, building on the success achieved in previous years.
Sodelovanje z bolniki se bo nadaljevalo in gradilo na uspehih iz prejšnjih let.
Necessary changes in the assessment process have been made over the last year to meet this goal.
Za dosego tega cilja so bile lani izvedene potrebne spremembe procesa ocenjevanja.
Please note that figures for 2008 are estimates only.
Opozarjamo, da so številke za leto 2008 le ocene.
The Agency also plans to finalise the remaining work arising from the 2004 legislative review.
Hkrati namerava Agencija dokončati preostalo delo, ki izvira iz zakonodajnega pregleda iz leta 2004.
The constantly evolving environment in which the Agency operates will shape its priorities and work in 2008.
Stalno razvijajoče se okolje, v katerem deluje Agencija, bo narekovalo njene prednostne naloge in delo v letu 2008.
This will be done in collaboration with the national competent authorities.
To dejavnost bo izvajala v sodelovanju s pristojnimi nacionalnimi organi
Steps will be taken to prepare for its implementation.
Potekale bodo pripravo na njeno izvajanje.
The number of variations is growing every year.
Število sprememb se iz leta v leto povečuje.
Staff 11 Staff in active employment 13 Mission expenses 14 Socio-medical infrastructure 15 Exchange of civil servants and experts 16 Social welfare 17 Entertainment and representation expenses 18 Staff insurances Total Title 1 Building/equipment 20 Investment in immovable property, renting of building and associated costs 21 Expenditure on data processing 22 Movable property and associated costs 23 Other administrative expenditure 24 Postage and communications 25 Expenditure on formal and other meetings Total Title 2 Operational expenditure 300 Meetings 301 Evaluations 302 Translation 303 Studies and consultants 304 Publications 305 Community programmes Total Title 3
Osebje 11 Aktivno zaposleno osebje 13 Stroški službenih potovanj 14 Socialno-zdravstvena infrastruktura 15 Izmenjava javnih uslužbencev in strokovnjakov 16 Socialno varstvo 17 Stroški dodatkov za razvedrilo in reprezentanco 18 Zavarovanje osebja Naslov 1 skupaj Objekti/oprema 20 Naložbe v nepremičnine, najemi objektov in s tem povezani stroški 21 Odhodki za obdelavo podatkov 22 Premično premoženje in s tem povezani stroški 23 Drugi upravni odhodki 24 Poštnine in obveščanje 25 Izdatki za uradna in druga srečanja Naslov 2 skupaj Odhodki za poslovanje 300 Sestanki 301 Ocenjevanje 302 Prevajanje 303 Študije in svetovalci 304 Objavljanje 305 Programi Skupnosti Naslov 3 skupaj
Preparations for future enlargement
1.5 Priprave na prihodnjo širitev
Regulatory affairs and organisational support
Regulativne zadeve in organizacijska podpora
This would help to further promote exchange of information within the European medicines network.
To bi prispevalo k nadaljnjemu spodbujanju izmenjave informacij znotraj Evropske mreže zdravil.
The Agency is responsible for operational aspects of mutual-recognition agreements (MRA) between the European Community and partner (third) countries.
Agencija je odgovorna za operativne vidike sporazumov o vzajemnem priznavanju med Evropsko skupnostjo in partnerskimi (tretjimi) državami.
The number of applications for initial marketing authorisation has doubled over the last four years.
Število vlog za začetno dovoljenje za promet z zdravilom se je v zadnjih štirih letih podvojilo.
These agreements are in operation with Australia, New Zealand, Switzerland, Canada and Japan, and allow the conclusions of inspections of manufacturers carried out by respective inspection services to be mutually recognised.
Dogovori veljajo z Avstralijo, Novo Zelandijo, Švico, Kanado in Japonsko ter omogočajo vzajemno priznavanje sklepov inšpekcijskih pregledov proizvajalcev, ki jih opravijo posamezne inšpekcijske službe.
Annex 3 Revenue and expenditure overview 2006-2008
Priloga 3 Pregled prihodkov in odhodkov za obdobje 2006-2008
The Agency's integrated quality policy has been in operation for ten years, and its robust, integrated quality-management system is subject to continuous improvement.
Politika Agencije o integrirani kakovosti se odvija že 10 let in njen trden sistem integriranega upravljanja kakovosti neprestano izboljšujejo.
The legislation on access to documents has put significant pressure on the Agency's resources.
Zakonodaja o dostopu do dokumentov je močno obremenila sredstva Agencije.
Meanwhile, requests for other types of information are forecast to increase by a further 29%, to some 4,500 requests.
Zahtevki za druge vrste informacij pa bodo verjetno narasli za nadaljnjih 29 %, na okoli 4.500 zahtevkov.
The EMEA receives, creates and manages a large amount of documents.
EMEA prejme, proizvede ter upravlja z velikim številom dokumentov.
Parallel distribution
Vzporedna distribucija
The Agency's role in the international arena has grown substantially in recent years.
Vloga Agencije v mednarodnem prostoru se je v zadnjih letih močno povečala.
The European Commission published in 2007 a report on the status of the implementation of the legislation on traditional herbal medicinal products.
Evropska komisija je leta 2007 objavila poročilo o statusu izvajanja zakonodaje o tradicionalnih zdravilih rastlinskega izvora.
Increase the Agency's contribution to international regulatory activities
Povečati doprinos Agencije k mednarodnim regulativnim dejavnostim
The new legislation on advanced-therapy medicinal products will enter into force by the end of 2008.
Nova zakonodaja o zdravilih za napredne terapije bo začela veljati proti koncu leta 2008.
The HMPC plans to establish 20 monographs and 10 list entries this year.
Letos namerava HMPC pripraviti 20 monografij in dodati 10 vnosov na seznam.
Continue to support the European Commission in implementing its ‘Better Regulation' initiative in the field of pharmaceutical legislation.
Še naprej podpirati Evropsko komisiji pri izvajanju njene pobude „bolje oblikovanih predpisov“ na področju farmacevtske zakonodaje;
This may contribute to a higher number of applications for such products.
To bo morda prispevalo k večjemu številu vlog za taka zdravila.
The Agency hopes that these discussions will result in reduced duplication of international inspections and contribute to the efficient use of inspection resources.
Agencija upa, da bodo te razprave pripeljale do manjšega podvojevanja mednarodnih inšpekcijskih pregledov in s tem prispevale k učinkoviti izrabi inšpekcijskih sredstev.
A number of activities are underway with this goal in mind.
Za spoštovanje tega cilja se odvijajo številne dejavnosti.
As seen in the graph below, the level of generic medicines is expected to increase gradually.
Kot je razvidno s spodnjega grafa, se pričakuje postopna rast ravni generičnih zdravil.
This will provide much-needed regulatory tools for improving the availability of innovative medicines in Europe.
To bo omogočilo nujno potrebno regulativno orodje za izboljšavo dostopnosti inovativnih zdravil v Evropi.
The Agency and the Member States will continue their collaboration on the implementation of the European Surveillance Strategy.
Agencija in države članice bodo še naprej sodelovale pri izvajanju evropske strategije nadzora (European Surveillance Strategy).
Excluding the six additional posts for paediatrics legislation as per decision of the Management Board (EMEA/MB/244582/2007).
1 Brez šestih dodatnih mest za zakonodajo o pediatriji po odločitvi upravnega odbora (EMEA/MB/244582/2007).
The Agency forecasts that the number of requests for access will increase by around 68% to 155 requests (a single request may encompass hundreds of documents).
Agencija predvideva, da se bo število zahtevkov za dostop povečalo za približno 68 % na 155 zahtevkov (posamezni zahtevek lahko vsebuje več sto dokumentov).
This situation is expected to continue for 2008.
Pričakuje se, da se bodo leta 2008 enake razmere nadaljevale.
The Agency will implement further changes in its internal control system in order to make the system more efficient and effective.
Agencija bo uvedla nadaljnje spremembe v svojem sistemu notranjega nadzora, da bi postal bolj smotrn in učinkovit.
In this context, the remaining evaluation work in Bulgaria and Romania is expected to be completed as part of the MRA between the European Commission and Canada.
Na podlagi tega se pričakuje, da bo preostalo ocenjevalno delo v Bolgariji in Romuniji dokončano kot del sporazuma o vzajemnem priznavanju med Evropsko komisijo in Kanado.
The Agency's full work programme for 2008, which was adopted by the Management Board on 13 December 2007, can be found on the Agency's website: www.emea.europa.eu
Celoten delovni program Agencije za leto 2008, ki ga je upravni odbor sprejel 13. decembra 2007, je na voljo na spletni strani Agencije www.emea.europa.eu.
Another area of the Agency's international work will relate to clinical trials and inspections.
Drugo področje mednarodnega dela Agencije se bo nanašalo na klinična preskušanja in inšpekcijske preglede.
A detailed graph showing the number of applications split into product types can be found in the full version of the work programme, section 2.3.
Podroben graf, ki prikazuje število vlog, razdeljenih na vrste izdelkov, je na voljo v poglavju 2.3 celotne različice delovnega programa.
In 2008, the Agency will continue its existing international activities and will aim to expand international collaboration.
V letu 2008 bo Agencija nadaljevala svoje sedanje mednarodne dejavnosti s ciljem, da mednarodno sodelovanje še razširi.
Head: Hans-Georg Wagner
Vodja: Hans-Georg Wagner
In order to ensure that the Agency is able to operate key processes in case of a disaster or an unforeseen event of any kind, the Agency has developed a business-continuity plan.
Za zagotovitev, da bo lahko Agencija opravljala ključne procese v primeru naravne nesreče ali kakršnega koli nepredvidenega dogodka, je razvila načrt neprekinjenega poslovanja.
This provides the information necessary for the Agency to introduce needed improvements.
To bo Agenciji zagotovilo potrebne informacije za uvedbo potrebnih izboljšav.
This ensures that the products actually on the market continue to meet public- and animal-health requirements.
To zagotavlja, da zdravila, ki so že na trgu, še naprej izpolnjujejo zahteve glede javnega zdravja in zdravja živali.
PRIORITIES AND KEY OBJECTIVES FOR 2008
Prednostne naloge in glavni cilji za leto 2008 so:
The Agency anticipates that the number of delegates coming to the Agency in 2008 will increase by 8% (to 8,400) and the number of meetings by 12% compared to 2007.
Agencija pričakuje, da se bo število delegatov, ki bodo leta 2008 prišli v Agencijo, povečalo za 8 % (na 8,.400), število sej pa za 12 % v primerjavi z letom 2007.
Work is progressing in this area and additional proposals on how to tackle this issue will be considered in the revised Road Map which the EMEA will develop to steer the Agency's course from 2010 to 2013.
Na tem področju delo napreduje, dodatni predlogi, kako se lotiti te zadeve, pa bodo podani v revidiranem usmeritvenem načrtu, ki ga bo EMEA razvila, da usmeri svojo pot od leta 2010 do 2013.
Some of the challenges posed by the environment in which the Agency and its partners - the national competent authorities - operate relate to the increasing demand on scientific resources.
Nekateri izzivi, ki izvirajo iz okolja, v katerem delujejo Agencija in njeni partnerji (nacionalni odgovorni organi), zadevajo povečano povpraševanje po znanstvenih virih.
Increasing globalisation of the regulatory environment for medicines means that the EMEA needs to extend its activities in the international arena.
Vedno večja globalizacija regulativnega okolja za zdravila pomeni, da mora EMEA razširiti svoje dejavnosti ne mednarodnem področju.
Significant attention will be given to microbicides and to tropical, neglected, communicable and new emerging diseases.
Posebno pozornost bo Agencija posvetila mikrobicidom ter tropskim, zapostavljenim, nalezljivim in novim nastajajočim boleznim.
Maintain ongoing international cooperation in human and veterinary fields and explore possibilities for extending cooperation to other non-EU countries on important public-health matters.
Vzdrževati stalno mednarodno sodelovanje na področju humane in veterinarske medicine ter raziskati možnosti širitve sodelovanja na druge države zunaj EU glede pomembnih zadev na področju javnega zdravja;
Implementation of the plan will allow the Agency, the Member States and the veterinary pharmaceutical industry to improve and streamline the electronic exchange of pharmacovigilance information.
Izvajanje načrta bo omogočilo Agenciji, državam članicam in veterinarski farmacevtski industriji izboljšanje in racionaliziranje elektronske izmenjave informacij o farmakovigilanci.
This area of activity has experienced strong growth over the years, but it remains difficult to forecast the volume of arbitrations and referrals.
To področje dejavnosti se je v zadnjih letih zelo povečalo, vendar je še vedno težko napovedati število arbitraž in napotitev.
On top of this, there is the increasing complexity of activities stemming from advances in pharmaceutical research and development techniques.
Poleg tega pa se povečuje kompleksnost dejavnosti, kar izvira iz napredka v farmacevtskih tehnikah raziskav in razvoja.
The list of these European experts is available for examination on request at the EMEA offices.
Seznam teh evropskih strokovnjakov je na zahtevo na voljo v uradih agencije EMEA.
Head: Andreas Pott
Vodja: Andreas Pott
In 2008, the Agency expects that standards for the quality of the network will be agreed and that the Coordinating Group for the network of existing networks will be set up.
Agencija pričakuje, da bodo v letu 2008 uvedeni dogovorjeni standardi za kakovost mreže in da bo ustanovljena usklajevalna skupina za mrežo obstoječih mrež.
As a response to this requirement, the Agency is developing the EudraVigilance Access Policy, which it plans to finalise in 2008.
Kot odgovor na to zahtevo Agencija razvija politiko dostopa do sistema EudraVigilance in jo namerava v letu 2008 tudi dokončati.
The workload of the Agency continues to increase steadily, as a result of new regulatory initiatives and increasing activity in existing core areas of responsibility.
Delovna obremenitev Agencije se stalno povečuje zaradi novih regulativnih pobud ter povečanja dejavnosti na obstoječih glavnih področjih odgovornosti.
Orphan medicinal products are intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions affecting a small number of patients in the European Union.
Zdravila sirote so namenjena diagnosticiranju, preprečevanju ali zdravljenju smrtno nevarnih ali kronično izčrpavajočih bolezni, ki prizadenejo majhno število bolnikov v Evropski uniji.
The European Union has launched a number of initiatives that aim to help researchers overcome certain bottlenecks in the development of medicines.
Evropska unija je sprožila številne pobude, da bi znanstvenikom pomagala premostiti določene ovire pri razvoju zdravil.
EUROPEAN UNION INSTITUTIONS
INSTITUCIJE EVROPSKE UNIJE
The Agency's Road Map contains a number of strategic objectives in the field of transparency and provision of information.
Usmeritveni načrt Agencije vsebuje številne strateške cilje na področju preglednosti in zagotavljanja informacij.
As part of its corporate governance, the Agency seeks feedback from its stakeholders about their experience with the Agency and its procedures.
Agencija si kot del upravljanja želi povratne informacije svojih zainteresiranih strani o njihovih izkušnjah z Agencijo in njenimi postopki.
The Agency will step up its interactions with international organisations and increase its contribution to scientific and regulatory discussions at the international level.
Agencija bo okrepila svoje odnose z mednarodnimi organizacijami in povečala svoj doprinos k znanstvenim in zakonodajnim razpravam na mednarodni ravni.
The Agency is continuing its consolidation of existing practices and implementation of additional ones.
Agencija nadaljuje združevanje svojih obstoječih postopkov in izvajanje dodatnih.
Advanced therapies and other emerging therapies and new technologies
3.3 Napredne terapije in druge nastajajoče terapije ter nove tehnologije
The Agency will also contribute to the implementation of the Clinical Trials Directive.
Agencija bo prispevala tudi k izvajanju direktive o kliničnih preskušanjih.
The number of initial notifications received in 2008 is expected to be comparable to that for 2007.
Pričakuje se, da bo število začetnih obvestil, prejetih v letu 2008, primerljivo s številom v letu 2007.