natgillin/translations-raw huggingface dataset:
• the climate of austerity, both for the Agency and the national competent authorities (NCAs).
• varčevalno ozračje za agencijo in nacionalne pristojne organe.
Opening up these resources to broader audiences could benefit drug development and improve patient care.
Zagotavljanje dostopa do teh virov širši javnosti bi lahko pripomoglo k razvoju zdravil in izboljšanju oskrbe bolnikov.
To this end, the Agency will accelerate the rollout of the Operational Excellence (OpEx@EMA) programme, which, among other objectives, will progressively review core business processes and ensure they are underpinned by efficient and effective IT systems.
Zato bo pospešila uvedbo programa operativne odličnosti (OpEx@EMA), kar bo, poleg drugih ciljev, omogočilo postopni pregled glavnih postopkov poslovanja in zagotovilo, da so podprti z učinkovitimi in uspešnimi informacijskimi sistemi.
It is important to stress that the scope of the new pharmacovigilance legislation goes far beyond the traditional scope of pharmacovigilance for human medicines.
Treba je poudariti, da področje uporabe nove zakonodaje o farmakovigilanci daleč presega tradicionalno področje uporabe farmakovigilance zdravil za uporabo v humani medicini.
Discussions on how to ensure patients' values are taken into account in benefit-risk assessments will start.
Začele se bodo razprave, kako zagotoviti, da se vrednote bolnikov upoštevajo pri oceni koristi in tveganja.
Emphasis will continue to be given to working within the 'one health' agenda, whereby promoting health in animals promotes health in man.
Še naprej bo posebna pozornost namenjena programu „skupnega zdravja“, pri čemer spodbujanje zdravja živali spodbuja zdravje ljudi.
The Agency will work with stakeholders and the regulatory network to ensure adequate and appropriate guidance is in place to facilitate the access to market of new technologies either in advance of, or as part of, the revision of veterinary legislation.
Agencija bo sodelovala z zainteresiranimi stranmi in regulativno mrežo za zagotovitev, da so vzpostavljene zadostne in ustrezne smernice, kar bo olajšalo dostop do trga novih tehnologij pred revizijo veterinarske zakonodaje ali v okviru nje.
The resources needed to implement the legislation on falsified medicines and on pharmacovigilance will need to be reconciled.
Uskladiti bo treba sredstva, ki so potrebna za izvajanje zakonodaje o ponarejenih zdravilih in zakonodaje o farmakovigilanci.
EMA/MB/554514/2011 Executive Director
EMA/468962/2012 Directorate
Another important issue for the Agency is assuring the continuity of its operations during the 2012 London Olympic Games.
Drugo pomembno vprašanje, ki zadeva agencijo, pa je zagotavljanje nemotenega poslovanja med olimpijskimi igrami v Londonu leta 2012.
Planned activities include identifying areas where additional medicines are needed, reflecting on the difficulties faced by SMEs in addressing unmet medical needs, and considering the merits and mechanics of an optional approach to the early authorisation of medicines in a restricted population.
Načrtovane dejavnosti vključujejo opredelitev področij, na katerih so potrebna dodatna zdravila, razmislek o težavah, s katerimi se mala in srednje velika podjetja srečujejo pri izpolnjevanju neizpolnjenih potreb zdravstva, ter preučitev prednosti in mehanizmov neobveznega pristopa k zgodnji odobritvi zdravil v omejeni skupini prebivalstva.
With respect to veterinary medicines, the European Commission is expected to finalise the legislative proposals arising from its consultation on better regulation in the veterinary sector and the impact assessment of the veterinary legislation that took place during 2010.
Evropska komisija naj bi v zvezi z zdravili za uporabo v veterinarski medicini dokončala zakonodajne predloge, ki so nastali pri posvetovanju o boljši ureditvi v veterinarskem sektorju, in oceno učinka veterinarske zakonodaje, ki je bila izvedena v letu 2010.
The implementation of the pharmacovigilance legislation is a main area of focus for the Agency and for the European medicines network as a whole, due to the significance of this legislation for public health, the amount of work that will have to be undertaken over the coming years by both the Agency and the network, and the significant amount of resources that will have to be found through internal reallocation and efficiency gains to finance this work.
Izvajanje zakonodaje o farmakovigilanci je glavno področje delovanja agencije in evropske mreže zdravil kot celote, in sicer zaradi pomena te zakonodaje za javno zdravje, količine dela, ki ga bosta morali agencija in evropska mreža zdravil opraviti v prihodnjih letih, in precejšnjih sredstev, ki jih bo treba poiskati z notranjo prerazporeditvijo in izboljšanjem učinkovitosti, da bi lahko financirali vse to.
Throughout 2012, focus will be placed on achieving efficiency gains and on reviewing and redesigning processes.
V letu 2012 bo posebna pozornost namenjena izboljšanju učinkovitosti ter pregledovanju in preoblikovanju.
As reflected in the road map and its implementation plan, the Agency and its Committee for Medicinal Products for Veterinary Use will continue to contribute on a wide range of topics related to veterinary medicines at European Union and international level, such as antimicrobial resistance, maximum residue limits, risk assessment, benefit-risk analysis methodology and harmonisation of standards and requirements.
Agencija in njen Odbor za zdravila za uporabo v veterinarski medicini bosta, kot kažeta časovni načrt in njegov izvedbeni načrt, še naprej prispevala k velikemu številu tem, ki se nanašajo na zdravila za uporabo v veterinarski medicini na ravni Evropske unije in mednarodni ravni, kot so protimikrobna odpornost, najvišje mejne vrednosti ostankov, ocena tveganja, metodologija analize koristi in tveganja ter usklajevanje standardov in zahtev.
In the meantime, the most notable deliverables in the area of transparency in 2012 will be granting access to EudraVigilance data for human and veterinary medicines, providing more information on clinical trials and starting the publication of scientific committee agendas and minutes.
Medtem pa bodo najpomembnejši dosežki na področju preglednosti v letu 2012 odobritev dostopa do podatkov o zdravilih za uporabo v humani in veterinarski medicini v sistemu EudraVigilance, zagotavljanje podrobnejših informacij o kliničnih preskušanjih ter začetek objavljanja dnevnih redov in zapisnikov znanstvenega odbora.
The Agency will step up its efforts to share primary data and information, provide secondary analyses of data and experiences, and proactively communicate its knowledge and grounds for regulatory opinions to the scientific community.
Agencija bo okrepila prizadevanja za izmenjavo glavnih podatkov in informacij, zagotavljanje sekundarnih analiz podatkov in izkušenj ter proaktivno sporočanje znanja in razlogov za regulativna mnenja znanstveni skupnosti.
The Agency will continue to strengthen and widen the scope of interactions with civil society by revising the framework for interaction with patients' organisations, and by gradually implementing the framework for interaction with healthcare professionals.
Še naprej bo spodbujala in širila medsebojno sodelovanje s civilno družbo, tako da bo pregledala okvir za medsebojno sodelovanje z organizacijami bolnikov in postopoma izvajala okvir za medsebojno sodelovanje z zdravstvenimi strokovnjaki.
An increase in scientific-advice and marketing-authorisation applications for novel veterinary therapies is expected and encouraged.
Pričakuje in spodbuja se obsežnejše znanstveno svetovanje in povečanje števila vlog za pridobitev dovoljenj za promet z zdravilom za nove oblike veterinarskega zdravljenja.
The new legislation in particular places requirements on the Agency to develop and manage certain databases, to cooperate in the coordination of inspections in third countries, to cooperate in assessment and verification of third countries' regulatory framework for active pharmaceutical ingredients (APIs) and a number of other new measures.
Zlasti nova zakonodaja agenciji nalaga zahteve v zvezi z razvojem in upravljanjem nekaterih podatkovnih zbirk, sodelovanjem in usklajevanjem inšpekcijskih pregledov v tretjih državah, sodelovanjem pri ocenjevanju in preverjanju regulativnega okvira tretjih držav za zdravilne učinkovine in številnimi drugimi novimi ukrepi.
The Agency will further develop processes and systems to make information of interest to the public available quicker and in a more efficient manner.
Agencija bo nadalje razvijala postopke in sisteme za hitrejši in učinkovitejši dostop do informacij, ki so zanimive za javnost.
In the area of availability of medicines, the Agency will implement a number of initiatives outlined in the road map implementation plan.
Agencija bo na področju razpoložljivosti zdravil izboljšala številne pobude, ki so opisane v izvedbenem načrtu za časovni načrt.
The project to improve the European public assessment reports will come to fruition, and the pilot provision of joint scientific advice with health technology assessment bodies and payers will continue.
Uresničila bo projekt za izboljšanje evropskih javnih poročil o oceni zdravila, nadaljevala pa bo tudi pilotni projekt skupnega znanstvenega svetovanja, ki ga bodo zagotavljali organi za oceno zdravstvene tehnologije in zavezanci.
While the new legislation significantly amends or adds to classic pharmacovigilance tasks, it also directly impacts many parts of the regulatory process related to patient safety that were not historically considered as pharmacovigilance.
Nova zakonodaja ne samo precej spreminja običajne naloge v zvezi s farmakovigilanco ali prispeva k njim, temveč tudi neposredno vpliva na številne dele regulativnega postopka, povezanega z varnostjo bolnikov, ki se v preteklosti niso šteli za farmakovigilanco.
The theme for 2012 in the veterinary field will be one of continuing to manage core activities against a backdrop of resource constraints.
Osrednja tema za leto 2012 na področju veterine bo nadaljevanje izvajanja glavnih dejavnosti kljub omejitvi sredstev.
By virtue of its unique position in the life sciences and healthcare environments, the Agency is a rich repository of data, information and knowledge.
Agencija je zaradi posebnega položaja, ki ga ima v bioloških vedah in zdravstvu, bogata zbirka podatkov, informacij in znanja.
The challenge for the Agency is that it is increasingly difficult to match the growing workload and new tasks with adequate resources.
Za agencijo postaja vedno težji izziv, kako za vse večji obseg dela in nove naloge zagotoviti zadostna sredstva.
• the new legislation on falsified medicines;
• nova zakonodaja o ponarejenih zdravilih;
The majority of the pharmacovigilance work currently undertaken by the Agency relates to approximately 600 centrally authorised products for human use.
Večina dela, ki ga agencija trenutno opravlja v zvezi s farmakovigilanco, se nanaša na približno 600 zdravil za uporabo v humani medicini, odobrenih po centraliziranem postopku.
Similarly, the Agency will continue its contribution to, and cooperation with, health technology assessment bodies.
Prav tako bo še naprej prispevala k delovanju organov za oceno zdravstvene tehnologije in sodelovala z njimi.
The most important change in the new legislation is the direct involvement of the Agency in pharmacovigilance of the nationally authorised products.
Najpomembnejša sprememba nove zakonodaje je neposredno sodelovanje agencije pri farmakovigilanci zdravil, ki so dovoljenja za promet pridobila po nacionalnih postopkih.
In addition to assessing applications to set quality standards and timelines, the Agency will implement measures to strengthen the quality, scientific and regulatory consistency of assessments and of the regulatory science underpinning the Agency's work, in line with the road map implementation plan.
Agencija bo poleg ocenjevanja vlog, s čimer bo določila standarde kakovosti in časovne okvire, izvajala tudi ukrepe za izboljšanje kakovosti ter znanstvene in regulativne skladnosti ocen ter znanstvenih osnov in načel za izvajanje regulativne politike, na kateri temelji delo agencije, v skladu z izvedbenim načrtom za časovni načrt.
The Agency will support the work of the Commission by providing technical advice, particularly with respect to how the proposals will impact on the availability of veterinary medicinal products in general and centrally authorised products in particular.
Agencija ji bo pomagala s tehničnimi nasveti, zlasti v zvezi s tem, kako bodo predlogi vplivali na razpoložljivost zdravil za uporabo v veterinarski medicini na splošno, natančneje na zdravila, odobrena po centraliziranem postopku.
The scope of the legislation covers centrally and nationally authorised products.
Področje uporabe zakonodaje vključuje zdravila, ki so dovoljenja za promet pridobila po centraliziranem ali nacionalnem postopku.
Pharmacovigilance legislation
Zakonodaja o farmakovigilanci
• the new pharmacovigilance legislation;
• nova zakonodaja o farmakovigilanci;
Governance of the Agency
Vodenje agencije
Anti-falsification legislation
Zakonodaja za preprečevanje ponarejanja zdravil
New applications for veterinary medicines
Zdravila za uporabo v veterinarski medicini
To make further progress in the area of communication and provision of information, the Agency will prepare a communications strategy.
Agencija bo pripravila komunikacijsko strategijo, da bi izboljšala komunikacijo in zagotavljanje informacij.
The European Medicines Agency in Europe and the world
Delovni program Evropske agencije za zdravila za leto
This requires that the Agency step up the implementation of its rationalisation programme, to generate internal resources for the conduct of new and existing responsibilities to the highest quality standards.
Da bi prihranila lastna sredstva za izpolnjevanje novih in sedanjih obveznosti v skladu z najvišjimi standardi kakovosti, se od nje zahteva učinkovitejše izvajanje programa racionalizacije.
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR POSITIVE OPINION PRESENTED BY THE EUROPEAN MEDICINES AGENCY
DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA POZITIVNO MNENJE, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
Applicant company name, address
Vlagatelj Ime podjetja, naslov
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF CLOPIDOGREL TEVA AND ASSOCIATED NAMES
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA CLOPIDOGREL TEVA IN Z NJIM POVEZANIH IMEN
BHA is present in amounts less than the ADI, which is generally deduced from the No Effect Level of the substance; therefore a biological action or effect on the patients is not expected.
BHA je vsebovana v količinah, ki so manjše od sprejemljivega dnevnega vnosa, ki je običajno izpeljan iz ravni brez učinka snovi; zato se ne pričakuje biološkega delovanja ali učinka na bolnike.
Based on the information presented, taurocholate, hydrochloride, hydrobromide and hydrogen sulphate salts of clopidogrel were found to be unsuitable for product development for various reasons.
Na podlagi predloženih informacij je bilo ugotovljeno, da so tavroholatna, hidrokloridna, hidrobromidna in hidrogensulfatna sol klopidogrela iz različnih razlogov neprimerne za razvoj zdravila.
The reference medicinal product for this generic application is Plavix (Clopidogrel Hydrogen sulphate) 75 mg film-coated tablets.
Referenčno zdravilo za to generično vlogo je Plavix (klopidogrel hidrogensulfat) v obliki 75-miligramskih filmsko obloženih tablete.
The product developed with clopidogrel premix was found to be nonhygroscopic.
Ugotovljeno je bilo, da je zdravilo, razvito s premiksom klopidogrela, nehigroskopsko.
The acetic acid impurity (a major degradant) was found to be controlled in the Applicant's clopidogrel Tablets 75 mg as compared to Plavix 75 mg (Clopidogrel Bisulphate Tablet 75 mg).
Ugotovljeno je bilo tudi, da je nečistota ocetne kisline (glavni razgradni produkt), nadzorovana v predlagateljevih 75-miligramskih tabletah klopidogrela v primerjavi z zdravilom Plavix 75 mg (75miligramska tableta klopidogrel bisulfata).
The issue was referred to the CMD(h) and an assessment was carried out by the Reference Member State (RMS).
Zadeva je bila napotena v proučitev skupini za usklajevanje postopka z medsebojnim priznavanjem in decentraliziranega postopka za zdravila za uporabo v humani medicini, referenčne države članice pa so izvedle oceno.
Whereas - the Applicant's choice of the clopidogrel base and consequently the use of BHA has been sufficiently explained - the overall control strategy to ensure suitable and reproducible quality of the product has been justified with regard to the handling of the viscous mass of the clopidogrel base - the Applicant's Clopidogrel Base Tablets 75 mg has adequate quality and benefit/risk ratio and is comparable to the reference product the CHMP has recommended the granting of the Marketing Authorisation for which the Summary of Product Characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III of this Opinion.
je Odbor za zdravila za uporabo v humani medicini priporočil odobritev dovoljenja za promet z zdravilom, za katerega ostajajo povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo v obliki zadnjih različic, dogovorjenih v postopku skupine za usklajevanje, kot je navedeno v Dodatku III tega mnenja.
You should take both tablets at the same time, one after the other.
Obe tableti vzemite ob istem času, eno za drugo.
The result of this is an improved ability to do physical activity.
Posledica je izboljšanje sposobnosti za telesno dejavnost.
(2) Most of the patients in whom these events have been reported had pre-existing cardiovascular risk factors.
(2) Večina bolnikov, pri katerih so poročali o teh dogodkih, je imela predhodno prisotne srčno-žilne dejavnike tveganja.
This effect lasts at least twelve hours and may be symptomatic, including syncope.
Ta učinek traja vsaj dvanajst ur in je lahko simptomatski, vključno s sinkopo.
- have low blood pressure.
- imate nizek krvni tlak,
A risk to the breastfed child cannot be excluded.
Tveganja za otroka, ki se doji, ni mogoče izključiti.
- sudden loss of vision (rarely reported).
• nenadna izguba vida (o tej so redko poročali).
Currently available data are described in section 5.1.
ki so trenutno na voljo, so opisani v poglavju 5.1.
For those patients for which there are data, the survival rate at 1 year is 96.4 %.
Pri bolnikih, pri katerih so bili podatki na voljo, je bilo preživetje po enem letu 96,4 %.
Date of latest renewal: 1 October 2013
Datum zadnjega podaljšanja dovoljenja za promet: 1. oktober 2013
It is not possible to determine whether these events were related directly to tadalafil.
Ni možno ugotoviti, ali so bili ti učinki neposredno povezani s tadalafilom.
Severe hypotension (<90/50 mm Hg).
Huda hipotenzija (< 90/50 mm Hg)
Patients should be informed not to take ADCIRCA with these medicinal products.
Bolnike je potrebno obvestiti, naj zdravila ADCIRCA ne jemljejo skupaj s temi zdravili.
Take your dose as soon as you remember if it is within 8 hours of when you should have taken your dose.
Odmerek vzemite čim prej, ko se spomnite, če je minilo manj kot 8 ur, odkar bi morali vzeti svoj odmerek.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 1 October 2008
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 1. oktober 2008
Acute myocardial infarction within the last 90 days.
Akutni miokardni infarkt v zadnjih 90 dneh.
Frequency estimate: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Ocene pogostnosti: zelo pogosti (≥ 1/10), pogosti (≥1/100 do < 1/10), občasni (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do <1/1000), zelo redki (< 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
More than half (53.3 %) of the patients in the study were receiving concomitant bosentan therapy.
Več kot polovica (53,3 %) bolnikov v študiji je sočasno prejemala zdravljenje s bosentanom.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Študije na živalih ne kažejo direktnih ali indirektnih škodljivih učinkov zvezi z nosečnostjo, embrio/fetalnega razvojem, porodom ali postnatalnim razvojem (glejte poglavje 5.3).
Therefore, this combination is not recommended (see section 4.4).
Omenjena kombinacija zato ni priporočljiva (glejte poglavje 4.4).
If you have such an erection, which lasts continuously for more than 4 hours you should contact a doctor immediately.
Če dobite takšno erekcijo, ki traja neprestano več kot 4 ure, takoj kontaktirajte zdravnika.
A reduction in sperm was seen in some men.
Zmanjšanje koncentracije sperme so opazili tudi pri nekaterih moških.
- chest pain - do not use nitrates, but seek immediate medical assistance (frequency common).
• bolečina v prsih - ne uporabljajte nitratov, ampak poiščite zdravniško pomoč (pojavi se pogosto).
Headache may occur at the beginning of therapy; and decreases over time even if treatment is continued.
Glavobol se lahko pojavi na začetku zdravljenja in se sčasoma zmanjša, če bolnik nadaljuje z zdravljenjem.
If you forget to take ADCIRCA
Če ste pozabili vzeti zdravilo ADCIRCA
This interaction lasted for more than 24 hours and was no longer detectable when 48 hours had elapsed after the last tadalafil dose.
Ta interakcija je trajala več kot 24 ur in je 48 ur po zadnjem odmerku tadalafila ni bilo več mogoče zaslediti.
The adverse reactions reported were transient, and generally mild or moderate.
Neželeni učinki, o katerih so poročali, so bili prehodni in večinoma blagi do zmerni.
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The overall frequency of discontinuation due to adverse events was low (ADCIRCA 11 %, placebo 16 %).
Skupna pogostnost prenehanja zaradi neželenih učinkov je bila nizka (ADCIRCA 11 %, placebo 16 %).
Stevens-Johnson Syndrome, Exfoliative dermatitis
StevensJohnsonov sindrom, eksofoliativni dermatitis
Children and adolescents ADCIRCA is not indicated for use by children and adolescents under the age of 18.
Zdravilo ADCIRCA ni namenjeno zdravljenju otrok in mladostnikov, mlajših od 18 let.
There were no clinically relevant differences in Cmax compared to healthy volunteers.
Pri vrednostih Cmax ni prišlo so klinično pomembnih razlik v primerjavi z zdravimi prostovoljci.
- are taking riociguat.
- jemljete riociguat.
Adverse reactions were similar to those seen at lower doses.
Neželeni učinki so bili podobni tistim, opaženim pri manjših odmerkih.
The clinical relevance of this finding is uncertain.
Klinična pomembnost tega je negotova.
As a precautionary measure, it is preferable to avoid the use of tadalafil during pregnancy.
Zaradi previdnosti je bolje, da se uporabi tadalafila med nosečnostjo izognemo.
Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH.
Zdravljenje sme uvesti in nadzorovati le zdravnik, ki ima izkušnje z zdravljenjem PAH.
Other medicines and ADCIRCA
Druga zdravila in zdravilo ADCIRCA
Therefore, the combination of tadalafil and doxazosin is not recommended.
Kombinacija tadalafila in doksazosina se zato ne priporoča.
See Section 4.
Glejte poglavje 4.
Two subsequent clinical studies suggest that this effect is unlikely in humans, although a decrease in sperm concentration was seen in some men (see sections 5.1 and 5.3).
Dve sledeči klinični študiji sta pokazali, da takšnega učinka pri ljudeh ni, čeprav so pri nekaterih moških opazili zmanjšanje koncentracije sperme (glejte poglavji 5.1 in 5.3).
Elderly patients Dose adjustments are not required in elderly patients.
Starejši bolniki Odmerka pri starejših bolnikih ni potrebno prilagajati.
They are in the shape of almonds and have "4467" marked on one side.
So v obliki mandlja in imajo na eni strani oznako "4467".