FrancophonIA/ELRC3.0 huggingface dataset:
English: It must not be used when sexual activity is inadvisable, such as in men with severe heart disease.
Slovenian: Ne smejo ga uporabljati osebe, ki jim je spolna dejavnost odsvetovana, na primer moški s hudimi obolenji srca.
English: The most common side effect with Vivanza (seen in more than 1 patient in 10) is headache.
Slovenian: Najpogostejši neželeni učinek zdravila Vivanza (opažen pri več kot 1 bolniku od 10) je glavobol.
English: Other information about Vivanza
Slovenian: Druge informacije o zdravilu Vivanza
English: What benefit has Vivanza shown during the studies?
Slovenian: Kakšne koristi je zdravilo Vivanza izkazalo med študijami?
English: For more information about treatment with Vivanza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Vivanza preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vivanza, 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: What is the risk associated with Vivanza?
Slovenian: Kakšna tveganja so povezana z zdravilom Vivanza?
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 Vivanza.
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: The recommended dose of Vivanza is 10 mg, taken by mouth with or without food, about 25 to 60 minutes before sexual activity; patients should not take more than one dose a day.
Slovenian: Priporočeni odmerek zdravila Vivanza je 10 mg, ki se vzame peroralno s hrano ali brez nje približno 25 do 60 minut pred spolnim odnosom, pri čemer bolniki ne smejo vzeti več kot en odmerek na dan. Orodisperzibilne tablete je treba vzeti brez tekočine.
English: • patients with unstable angina or hereditary eye problems known as ‘retinal degenerative disorders'.
Slovenian: • bolniki z nestabilno angino pektoris ali dednimi očesnimi težavami, znanimi kot „retinalna degenerativna obolenja“.
English: Two additional main studies compared orodispersible tablets with placebo in 701 men aged 21 to 84 years.
Slovenian: V dveh dodatnih študijah so orodisperzibilne tablete pri 701 moškem, starem od 21 do 84 let, primerjali s placebom.
English: Vivanza was significantly more effective than placebo for all measures in all studies.
Slovenian: Zdravilo Vivanza je bilo v vseh študijah in ob vseh uporabljenih merilih znatno učinkovitejše od placeba.
English: Vivanza is a medicine that contains the active substance vardenafil.
Slovenian: Vivanza je zdravilo, ki vsebuje zdravilno učinkovino vardenafil.
English: Vivanza is used to treat adult men with erectile dysfunction (sometimes called impotence), when they cannot get, or keep, a hard penis (erection) sufficient for satisfactory sexual activity.
Slovenian: Zdravilo Vivanza se uporablja za zdravljenje erektilne disfunkcije (imenovane tudi impotenca) pri odraslih moških, ki ne zmorejo doseči ali ohraniti dovolj čvrstega penisa (erekcije) za zadovoljiv spolni odnos.
English: Vivanza film-coated tablets have been compared with placebo (a dummy treatment) in four main studies including 2,431 men aged 20 to 83 years.
Slovenian: Filmsko obložene tablete zdravila Vivanza so primerjali s placebom (zdravilom brez zdravilne učinkovine) v štirih glavnih študijah, v katerih je sodelovalo 2 431 moških, starih od 20 do 83 let.
English: The active ingredient of Vivanza, vardenafil, belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Slovenian: Zdravilna učinkovina zdravila Vivanza, vardenafil, spada v skupino zdravil, imenovanih zaviralci fosfodiesteraze tipa 5 (PDE5).
English: The CHMP decided that Vivanza's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Vivanza večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: By blocking the breakdown of cGMP, Vivanza restores erectile function.
Slovenian: Z zaviranjem razgradnje cGMP zdravilo Vivanza ponovno vzpostavi erektilno funkcijo.
English: During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax.
Slovenian: Med običajnim spolnim vzburjenjem se cGMP tvori v penisu, v katerem povzroča, da se gobasto tkivo penisa (corpora cavernosa) sprosti.
English: It works by blocking the phosphodiesterase enzyme which normally breaks down a substance known as cyclic guanosine monophosphate (cGMP).
Slovenian: Deluje tako, da zavira encim fosfodiesterazo, ki običajno razgrajuje snov, znano kot ciklični gvanozin monofosfat (cGMP).
English: It must also not be taken by patients who have ever had loss of vision because of a problem with blood flow to the nerve in the eye (non arteritic anterior ischemic optic neuropathy or NAION).
Slovenian: Prav tako ga ne smejo jemati bolniki, pri katerih je že prišlo do izgube vida zaradi težav z dotokom krvi v očesni živec (nearteritična anteriorna ishemična optična nevropatija ali NAION).
English: Vivanza must not be taken with some medicines, such as ketoconazole and itraconazole (to treat fungal infections) in men over 75 years, or medicines called ‘HIV protease inhibitors' such as ritonavir or indinavir (to treat HIV infection).
Slovenian: Zdravilo Vivanza se ne sme jemati skupaj z nekaterimi zdravili, kot sta ketokonazol in itrakonazol (za zdravljenje glivičnih okužb), pri moških, starejših od 75 let, ali z zdravili, imenovanimi „zaviralci proteaze virusa HIV“, kot sta ritonavir ali indinavir (za zdravljenje okužbe z virusom HIV).
English: Vivanza must not be used in people who are hypersensitive (allergic) to vardenafil or any of the other ingredients.
Slovenian: Zdravila Vivanza ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) vardenafil ali katero koli drugo sestavino zdravila.
English: This allows blood to flow into the corpora, producing the erection.
Slovenian: To omogoči večji dotok krvi v gobasto tkivo, posledica česar je erekcija.
English: • patients with severe liver disease or end-stage kidney disease requiring dialysis;
Slovenian: • bolniki s hudim obolenjem jeter ali končno ledvično odpovedjo, pri katerih je potrebna dializa;
English: Why has Vivanza been approved?
Slovenian: Zakaj je bilo zdravilo Vivanza odobreno?
English: The dose may need to be adjusted in patients taking other medicines that block enzymes that break down Vivanza.
Slovenian: Pri bolnikih, ki jemljejo druga zdravila, ki zavirajo encime, ki razgrajujejo zdravilo Vivanza, bo odmerek morda treba prilagoditi.
English: In addition, Vivanza must not be taken with medicines known as guanylate cyclase stimulators, including riociguat (used to treat pulmonary hypertension [high blood pressure in the lungs]).
Slovenian: Poleg tega se ne jemati skupaj z zdravili, imenovanimi spodbujevalci gvanilat ciklaze, vključno z riocigvatom (zdravilom za zdravljenje pljučne hipertenzije, tj. visokega krvnega tlaka v pljučih).
English: One study was carried out in diabetic men and another in men who had had their prostate gland removed.
Slovenian: V eno študijo so bili vključeni moški s sladkorno boleznijo, v drugo pa bolniki, ki jim je bila odstranjena prostata.
English: For the full list of all side effects reported with Vivanza, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Vivanza, glejte navodilo za uporabo.
English: Vivanza must not be taken with nitrates (medicines used to treat angina).
Slovenian: Zdravilo Vivanza se ne sme jemati skupaj z nitrati (zdravili za zdravljenje angine pektoris).
English: Sexual stimulation is still needed to produce an erection.
Slovenian: Za samo erekcijo pa je vseeno potrebno spolno vzburjenje.
English: The dose may be increased to a maximum of 20 mg or decreased to 5 mg depending on the effectiveness and side effects.
Slovenian: Odmerek zdravila se lahko glede na učinkovitost in neželene učinke poveča na največ 20 mg ali zmanjša na 5 mg. Bolniki z jetrnimi obolenji ali resnimi motnjami v delovanju ledvic morajo začeti zdravljenje s 5-miligramskim odmerkom.
English: What is Vivanza used for?
Slovenian: Za kaj se zdravilo Vivanza uporablja?
English: How has Vivanza been studied?
Slovenian: Kako je bilo zdravilo Vivanza raziskano?
English: What is Vivanza?
Slovenian: Kaj je zdravilo Vivanza?
English: How does Vivanza work?
Slovenian: Kako zdravilo Vivanza deluje?
English: For Vivanza to be effective, sexual stimulation is required.
Slovenian: Zdravilo Vivanza je učinkovito le ob spolnem vzburjenju.
English: How is Vivanza used?
Slovenian: Kako se zdravilo Vivanza uporablja?
English: If Vivanza is taken with a high fat meal, the onset of activity may be delayed.
Slovenian: Zdravilo Vivanza lahko začne učinkovati pozneje, če se zaužije s hrano, ki vsebuje veliko maščob.
English: • Enhance cooperation within the Network, as well as with European and international partners.
Slovenian: • krepitev sodelovanja znotraj mreže ter z evropskimi in mednarodnimi partnerji;
English: Improving the quality and efficiency of our work
Slovenian: Izboljšanje kakovosti in učinkovitosti našega dela
English: This is exacerbated by the low number of new antimicrobials having been authorised over the past few years.
Slovenian: Težavo zaostruje majhno število novih protimikrobnih učinkovin, odobrenih v zadnjih nekaj letih.
English: The environment in which the Agency operates is constantly changing and evolving.
Slovenian: Okolje delovanja agencije se nenehno spreminja in razvija.
English: To account for this, the Agency will reinforce its support to these stakeholder groups as well.
Slovenian: V ta namen bo tudi okrepila svojo podporo tem interesnim skupinam.
English: Globalisation
Slovenian: Globalizacija
English: Antimicrobial resistance and other public health threats
Slovenian: Protimikrobna odpornost in druge grožnje za javno zdravje
English: Planning for changes within the Agency, which will arise as a result of the implementation of the revised legislation, will start in 2015.
Slovenian: Načrtovanje sprememb znotraj agencije, do katerih bo prišlo zaradi izvajanja revidirane zakonodaje, se bo začelo v letu 2015.
English: Structure of the work programme 2015
Slovenian: Uvod k delovnemu programu agencije za leto 2015
English: The implementation of the data-integration programme is the key activity for the Agency in this area.
Slovenian: Izvajanje programa povezovanja podatkov je ključna dejavnost agencije na tem področju.
English: The European medicines regulatory network (Network) is the cornerstone of the work and success of the European system.
Slovenian: Evropska regulativna mreža za zdravila (mreža) je osnova dela in uspešnosti evropskega sistema.
English: Information technology and social media
Slovenian: Informacijska tehnologija in družbeni mediji
English: In light of the above influences and other business environment factors, the Agency has set out the following priorities for 2015:
Slovenian: Agencija si je ob upoštevanju zgoraj predstavljenih vplivnih dejavnikov in drugih dejavnikov poslovnega okolja za leto 2015 zastavila naslednje prednostne naloge:
English: The process for evaluating medicines is constantly evolving.
Slovenian: Postopek vrednotenja zdravil se nenehno spreminja.
English: The network has access to thousands of experts from Member States across Europe, allowing it to source the best-possible expertise for the regulation of medicines in the European Union (EU).
Slovenian: Mreža ima dostop do na tisoče strokovnjakov iz vseh držav članic, kar ji omogoča razpolaganje z najboljšim možnim strokovnim znanjem za zakonsko ureditev zdravil v Evropski uniji (EU).
English: This means the environment trends, workload forecasts and implementation of a number of objectives and activities described in this work programme will impact the national authorities and their work as well.
Slovenian: To pomeni, da bodo okoljski trendi, napovedi delovne obremenitve ter uresničevanje oziroma izvajanje številnih ciljev in dejavnosti, ki so opisani v tem delovnem programu, vplivali tudi na nacionalne organe in njihovo delo.
English: Scientific advancement and managing complexity to facilitate patient access to medicines
Slovenian: Znanstveni napredek in obvladovanje kompleksnosti za lažji dostop bolnikov do zdravil
English: In 2015, the Agency will be capitalising on its recent programme to increase the effectiveness and efficiency of activities.
Slovenian: Agencija bo v letu 2015 izkoriščala svoj novi program za povečanje učinkovitosti in uspešnosti dejavnosti.
English: Antimicrobial resistance (AMR) is a growing problem for both humans and animals.
Slovenian: Protimikrobna odpornost je pri ljudeh in živalih vse večji problem.
English: Robust internal processes and expansion of the overall capabilities of the Network will be required.
Slovenian: Potrebni bodo zanesljivi notranji procesi ter razširitev celotnih zmogljivosti mreže.
English: • Further increase transparency and implement stakeholder and communication strategies.
Slovenian: • nadaljnje povečevanje preglednosti in izvajanje strategij za deležnike in komunikacijskih strategij;
English: • Improve quality, integration and accessibility of data held by the Agency.
Slovenian: • izboljšanje kakovosti, povezanosti in dostopnosti podatkov agencije.
English: The final elements of the EU's pharmacovigilance legislation will be implemented during 2015 and 2016.
Slovenian: Končni elementi zakonodaje EU o farmakovigilanci bodo uveljavljeni v letih 2015 in 2016.
English: The European medicines regulatory system is based on a network of around 50 human and veterinary medicines regulatory authorities ('national competent authorities', or NCAs) from the 31 European Economic Area countries and the European Medicines Agency.
Slovenian: Evropski regulativni sistem za zdravila temelji na mreži, ki jo tvori približno 50 regulativnih organov za zdravila za uporabo v humani in veterinarski medicini (pristojnih nacionalnih organov) iz 31 držav Evropskega gospodarskega prostora in Evropska agencija za zdravila.
English: The revised and improved processes, and the improved ways of working, will be embedded across the organisation as part of the transition into the continuous improvement phase.
Slovenian: V celotno organizacijo bodo vključeni spremenjeni in izboljšani procesi ter izboljšani načini dela kot del prehoda v fazo stalnega izboljševanja.
English: Priorities
Slovenian: Prednostne naloge
English: The Clinical Trials Regulation was published in May 2014, assigning the Agency the responsibility for developing the systems necessary to implement the Regulation.
Slovenian: V uredbi o kliničnem preskušanju, ki je bila objavljena maja 2014, je bila agenciji dodeljena odgovornost za razvoj sistemov, potrebnih za izvajanje uredbe.
English: The discussions are expected to continue in the next years, with the legislation expected to be adopted in 2016.
Slovenian: Razprave naj bi se nadaljevale v naslednjih letih, zakonodaja pa naj bi bila sprejeta leta 2016.
English: At the same time, there is increasing awareness of the need to avoid duplication of work done by regulators across the world and use global resources more effectively.
Slovenian: Istočasno se povečuje zavedanje, da je treba preprečiti podvajanje dela regulativnih organov po svetu in učinkoviteje uporabljati svetovne vire.
English: To manage this, and to improve pharmacovigilance activities and the safety of European patients, the Agency will be developing further data sources.
Slovenian: Da se bo agencija lahko spopadla s tem ter izboljšala dejavnosti farmakovigilance in varnost evropskih bolnikov, bo razvijala dodatne vire podatkov.
English: • Ensure efficient crisis management and responsiveness to public health threats, including addressing antimicrobial resistance and the availability of anti-infective treatments.
Slovenian: • zagotavljanje učinkovitega kriznega upravljanja in odzivnosti na grožnje za javno zdravje, vključno z bojem proti protimikrobni odpornosti in razpoložljivostjo zdravil za zdravljenje okužb;
English: The NCAs and the Agency will also need to prepare for the upcoming revision of the fee legislation, to ensure adequate financing and sustainability of the Network.
Slovenian: Pristojni nacionalni organi in agencija se bodo morali pripraviti tudi za prihodnjo revizijo zakonodaje o pristojbinah, da se zagotovita ustrezno financiranje in vzdržnost mreže.
English: Efficiency is key to the successful delivery of the Agency's activities and to coping with the growing number of responsibilities and increasing complexity of the regulatory procedures.
Slovenian: Učinkovitost je ključna za uspešno izvajanje dejavnosti agencije ter obvladovanje vse številnejših odgovornosti in vse večje zapletenosti regulativnih postopkov.
English: EMA/773839/2014 Rev. 1 Management Board
Slovenian: EMA/372777/2015
English: Key influences
Slovenian: Ključni vplivni dejavniki
English: The Agency will also be developing and improving its public health crisis response mechanisms, building on the past experience of pandemic influenza and the ongoing work on Ebola.
Slovenian: Poleg tega bo razvijala in izboljševala svoje mehanizme odzivanja na krizne razmere na področju javnega zdravja, pri čemer se bo opirala na pretekle izkušnje s pandemijo gripe in sedanje delo v zvezi z ebolo.
English: The Agency will also continue implementing the European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) project, which collects information on how antimicrobial medicines are used in animals across the EU, and thus allows for a better understanding of the risk factors that lead to the development and spread of antimicrobial resistance.
Slovenian: Agencija bo tudi še naprej izvajala projekt evropskega nadzora rabe protimikrobnih sredstev v veterini (ESVAC), ki zbira informacije o načinih uporabe protimikrobnih zdravil pri živalih po celotni EU in tako prispeva k boljšemu razumevanju dejavnikov tveganja, ki vodijo k razvoju in širjenju protimikrobne odpornosti.
English: As a result, development of the EU Clinical Trial Portal and Database, and other associated systems, will be one of the key focus areas of the Agency in the coming years.
Slovenian: Razvoj portala in podatkovne zbirke EU o kliničnih preskušanjih ter drugih s tem povezanih sistemov bo zato eno od prednostih področij njenega delovanja v prihodnjih letih.
English: At the same time, the ability to manage the increasing workload is on occasion limited by the current capacity of the Network, and finding sustainable solutions for maintaining and increasing the Network's capacity will be an important focus area.
Slovenian: Poleg tega zmožnost obvladovanja vse večje delovne obremenitve občasno omejuje tudi sedanja zmogljivost mreže, zato bo iskanje vzdržnih rešitev za ohranjanje in povečanje zmogljivosti mreže pomembna prednostna naloga.
English: Hence, the Agency will additionally support efforts to increase international worksharing in all areas, as well as support convergence of international practices and work within international coalitions to encourage better and more effective use of global regulatory resources.
Slovenian: Zato bo agencija dodatno podpirala prizadevanja za povečanje mednarodne delitve dela na vseh področjih ter konvergenco mednarodnih praks in dela znotraj mednarodnih koalicij, da bi spodbudila boljšo in učinkovitejšo uporabo svetovnih regulativnih virov.
English: Ensuring more prospective medicines reach their patients in such an environment requires adapting and simplifying our processes and approaches, making them more open, flexible and easier to navigate for the sponsors, especially the SMEs.
Slovenian: Da bi v takšnem okolju zagotovili, da bolnike doseže več potencialnih zdravil, moramo prilagoditi in poenostaviti naše postopke in pristope, da bi ti postali bolj odprti, prožni in enostavnejši za sponzorje, zlasti MSP.
English: This includes integrated support to early stages of medicines development, covering legally established scientific advice, orphan designation, paediatric procedures and support to SMEs.
Slovenian: To vključuje zagotavljanje celostne podpore v zgodnjih fazah razvoja zdravil, kar zajema pravno določeno znanstveno svetovanje, postopek določitve za zdravilo siroto, pediatrične postopke in podporo za MSP.
English: It will be an opportunity to look back at how much has been achieved in promoting public and animal health over 20 years and to plan for the future.
Slovenian: Ob tej priložnosti bomo lahko ocenili dosežke več kot dvajsetletnega spodbujanja javnega zdravja in zdravja živali ter pripravili načrt za prihodnost.
English: • Provide technical support to the European Commission during the co-decision process for the proposal on revision of the veterinary medicines legislation in the Council and the European
Slovenian: • zagotavljanje tehnične podpore Evropski komisiji med postopkom soodločanja v Evropskem parlamentu in Svetu o predlogu za revizijo zakonodaje o zdravilih za uporabo v veterinarski medicini;
English: Society wants to see the outcomes of clinical trials, pharmacovigilance and other stages of the medicines lifecycle.
Slovenian: Družba želi videti rezultate kliničnih preskušanj, farmakovigilance in drugih faz življenjskega cikla zdravil.
English: Increasing numbers of manufacturing sites located, and clinical trials conducted outside the EU will continue to be a trend.
Slovenian: Trend povečevanja števila proizvodnih obratov in opravljanja kliničnih preskušanj zunaj EU se bo nadaljeval.
English: As part of this change, the volume of data and information to be managed and the number of procedures to be run will increase significantly over the next years.
Slovenian: Kot del te spremembe se bo v naslednjih letih znatno povečal obseg podatkov in informacij, ki jih je treba upravljati, ter postopkov, ki jih je treba izvajati.
English: All aspects of the work of the Agency, from the initial evaluation through to postauthorisation monitoring, are thus becoming subject to more intense scrutiny by the stakeholders and the community as a whole, with impact on public trust in the Agency's work.
Slovenian: Vsi vidiki dela agencije, od začetnega ocenjevanja do spremljanja po pridobitvi dovoljenja za promet, so tako pod vedno bolj skrbnim drobnogledom deležnikov in skupnosti kot celote, kar vpliva na javno zaupanje v njeno delo.
English: 18 December 2014
Slovenian: 7 avgust 2015
English: In addition, the Agency is reviewing the available regulatory tools and their use, to allow patient access to medicines for conditions with unmet medical need, and exploring concepts such as adaptive pathways and specific mechanisms to support innovative medicines with high public-health potential.
Slovenian: Poleg tega agencija pregleduje razpoložljiva regulativna orodja in njihovo uporabo, da bi bolnikom omogočila dostop do zdravil za bolezenska stanja, za katera zdravstvene potrebe niso izpolnjene, ter raziskuje koncepte, kot so prilagodljivi postopki in posebni mehanizmi za podpiranje inovativnih zdravil z velikimi obeti za javno zdravje.
English: European medicines regulatory network
Slovenian: Evropska regulativna mreža za zdravila
English: To deliver on its responsibilities, the EMA works closely with the NCAs.
Slovenian: Da bi lahko izpolnjevala svoje dolžnosti, agencija tesno sodeluje z pristojnimi nacionalnimi organi.