natgillin/translations-raw huggingface dataset:
In the studies of seasonal allergic rhinitis in patients aged 12 years or over, Avamys reduced symptom scores from around 9 points at the start of the study by between 3.6 and 5.4 points over two weeks, compared with a reduction of 2.3 to 3.7 points with placebo.
V študijah sezonskega alergijskega rinitisa pri bolnikih, starejših od 12 let, je zdravilo Avamys v dveh tednih za 3,6 do 5,4 točke zmanjšalo izhodiščno vrednost simptomov, ki je znašala približno 9 točk, v primerjavi z zmanjšanjem za 2,3 do 3,7 točke pri placebu.
In the study of perennial allergic rhinitis, Avamys had reduced scores by 3.6 points after four weeks, compared with a reduction of 2.8 points with placebo.
V študiji celoletnega alergijskega rinitisa je zdravilo Avamys po štirih tednih zmanjšalo vrednosti za 3,6 točke v primerjavi z zmanjšanjem za 2,8 točke pri placebu.
Avamys is for use in patients aged six years and over.
Zdravilo Avamys se uporablja pri bolnikih, starih šest let in več.
The Committee for Medicinal Products for Human Use (CHMP) decided that Avamys's benefits are greater than its risks for the treatment of the symptoms of allergic rhinitis in patients aged six years or over.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Avamys pri zdravljenju simptomov alergijskega rinitisa pri bolnikih, starih šest let in več, večje od z njim povezanih tveganj.
Why has Avamys been approved?
Zakaj je bilo zdravilo Avamys odobreno?
Avamys is a nasal spray that contains the active substance fluticasone furoate.
Avamys je pršilo za nos, ki vsebuje zdravilno učinkovino flutikazon furoat.
The full EPAR for Avamys can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Avamys je na voljo tukaj.
The first four studies looked at Avamys used in patients aged 12 years or over: three were short-term studies lasting two weeks and involved a total of 886 patients with seasonal allergic rhinitis
Prve štiri študije so proučevale uporabo zdravila Avamys pri bolnikih, starih 12 let in več: tri študije so bile kratkotrajne, trajale so dva tedna in vključevale 886 bolnikov s sezonskim alergijskim rinitisom (senenim nahodom), medtem ko je četrta trajala štiri tedne in vključevala 302 bolnika s celoletnimi (nesezonskimi alergijami), kot so alergije na živali.
In all of the studies, the main measure of effectiveness was the change in four symptoms of allergy affecting the nose.
V vseh študijah je bilo glavno merilo učinkovitosti sprememba štirih simptomov alergije, ki prizadenejo nos. Vsak simptom so merili na lestvici od 0 do 3, pri čemer je najvišji skupni rezultat znašal 12 točk.
Avamys was more effective than placebo at reducing symptoms of allergic rhinitis in patients aged six years and over.
Zdravilo Avamys je bilo pri zmanjševanju simptomov alergijskega rinitisa pri bolnikih, starih šest let in več, učinkovitejše od placeba.
What is Avamys used for?
Za kaj se zdravilo Avamys uporablja?
This can be reduced to one spray in each nostril once symptoms are controlled.
Ko vzpostavimo nadzor nad simptomi, lahko ta odmerek zmanjšamo na en vpih v vsako nosnico.
How has Avamys been studied?
Kako je bilo zdravilo Avamys raziskano?
What is Avamys?
Kaj je zdravilo Avamys?
How is Avamys used?
Kako se zdravilo Avamys uporablja?
How does Avamys work?
Kako zdravilo Avamys deluje?
• cooperating with international partners and contributing to international activities;
• sodelovanju z mednarodnimi partnerji in prispevanju k mednarodnim dejavnostim;
• successfully implementing tasks vested by new legislation;
• uspešnemu izvajanju nalog, ki jih zagotavlja nova zakonodaja;
Therefore, the volume of activities, as well as their complexity, is growing from year to year, and has to be accommodated by the Agency and its network of partners.
Zato se obseg dejavnosti, kakor tudi njihova kompleksnost, iz leta v leto povečujeta, čemur se morata prilagoditi agencija in njena mreža partnerjev.
The work programme for 2010 is set against a dynamic background of changes in the Agency's legislative and business environment.
Delovni program za leto 2010 temelji na dinamičnem ozadju sprememb v zakonodajnem in poslovnem okolju agencije.
As in previous years, significant attention will be given to further work in the field of safety-monitoring of medicines.
Kot prejšnja leta bo posebna pozornost posvečena nadaljnjemu delu na področju spremljanja varnosti zdravil.
Following the recent legislation on advanced therapy medicinal products, a number of additional legislative changes have already come into effect, or will soon.
Zaradi najnovejše zakonodaje o zdravilih za napredno zdravljenje so že ali bodo kmalu začele veljati številne dodatne zakonodajne spremembe.
• strengthening the European medicines network;
• okrepitvi Evropske mreže zdravil;
Implementation of the new remuneration system may take place in 2010, following the pilot project completed in 2009.
Izvajanje novega sistema nadomestil bi se lahko začelo leta 2010 na podlagi pilotnega projekta, zaključenega leta 2009.
• contributing to an environment that stimulates innovation and improved availability of medicines.
• prispevanju k okolju, v katerem se spodbujajo inovacije in boljša razpoložljivost zdravil.
The global nature of drug development and research, coupled with the high regard of the Agency in the international arena, mean that the Agency's international commitments will not only remain high on its agenda, but will also grow in importance and volume.
Svetovna narava razvoja in raziskav zdravil skupaj z visokim ugledom agencije na mednarodnem prizorišču pomeni, da mednarodna zavezanost agencije ne bo samo ostala pomembna prednostna naloga njenega programa, ampak bo pridobila na njenem pomenu in obsegu.
This year completes the implementation of the Agency's longterm strategy (Road Map to 2010) adopted by the Management Board in December 2004, and lays the ground for the new strategy document, which will span to 2015.
Letos se zaključuje izvajanje dolgoročne strategije agencije (Strateškega načrta do leta 2010), ki ga je upravni odbor sprejel decembra 2004, pripravlja pa se tudi podlaga za nov strateški dokument, ki bo zajemal obdobje do leta 2015.
• conducting the Agency's core activities to the highest quality standards, amid the increasing volume and complexity of activities;
• izvajanju osnovnih dejavnosti agencije v skladu z najvišjimi standardi kakovosti, ob povečanju obsega in kompleksnosti dejavnosti;
• fostering communication, provision of information and increasing transparency;
• spodbujanju obveščanja, zagotavljanja informacij in povečanju preglednosti;
The Agency will also commence preparations for possible future legislative changes in the areas of pharmacovigilance and counterfeit medicines.
Agencija bo prav tako začela priprave na morebitne prihodnje zakonodajne spremembe na področju farmakovigilance in ponarejanja zdravil.
The same challenges that affect the Agency also affect the network, amid growing pressure on scientific resources of the national competent authorities.
Enaki izzivi, ki bodo vplivali na agencijo, bodo vplivali tudi na mrežo, pri čemer bodo nacionalni pristojni organi izvajali vedno večji pritisk na znanstvene vire.
Work programme 2010 of the European Medicines Agency
Delovni program Evropske agencije za zdravila za leto
• continuing to improve the safety-monitoring of medicines;
• nadaljnjemu izboljšanju spremljanja varnosti zdravil;
The Agency will start implementing its Transparency Policy, developed in 2009, and will continue discussions within the EU regulatory network to have, as far as possible, a common approach in the field of transparency.
Prav tako bo agencija začela izvajati politiko preglednosti, ki jo je pripravila leta 2009, in bo nadaljevala razprave znotraj regulativne mreže EU, da bi čim prej razvili skupni pristop na področju preglednosti.
As part of this contribution, the Agency leads a fiveyear collaborative European project with the goal of developing innovative methods in pharmacoepidemiology and pharmacovigilance.
Agencija kot del tega prispevka vodi petletni, skupni evropski projekt, katerega cilj je razvoj inovativnih metod v farmakoepidemiologiji in farmakovigilanci.
Taking into account the achievements to date, the trends and changes in the Agency's environment, the following areas of focus are identified for this year's work programme:
Ob upoštevanju dosedanjih dosežkov, teženj in sprememb v okolju agencije, bo v letošnjem delovnem programu največja pozornost namenjena naslednjim področjem:
This work will result in the provision of better and more useful information to interested parties, including the health-technologyassessment bodies.
S tem bomo lahko zainteresiranim strankam zagotovili boljše in koristnejše informacije, vključno z organi za ocenjevanje zdravstvene tehnologije.
At the same time, the Agency's experts contribute to the Innovative Medicines Initiative (IMI) - the panEuropean work aimed at supporting innovation.
Hkrati bodo izvedenci agencije prispevali k pobudi za inovativna zdravila (IMI), to je vseevropsko sodelovanje za zagotavljanje podpore inovacijam.
For veterinary medicines, the Agency provides input to the European Technology Platform for Global Animal Health and the Action Plan for the Community Animal Health Strategy.
V zvezi z zdravili za uporabo v veterinarski medicini agencija sodeluje z evropsko tehnološko platformo za zdravje živali na svetovni ravni in prispeva k akcijskemu načrtu za strategijo Skupnosti za zdravstveno varstvo živali.
Further initiatives relating to provision of more information on benefit-risk assessment and rationale for decision-making will be implemented.
Izvedene bodo dodatne pobude v zvezi z zagotavljanjem več informacij o oceni razmerja med tveganji in koristmi ter utemeljitvijo postopka sprejemanja odločitev.
The focus in 2010 will include further implementation of the European risk-management strategy (ERMS), data-quality improvement in EudraVigilance, and support to the European Network of Centres for Pharmacovigilance and Pharmacoepidemiology.
Leta 2010 bomo poseben poudarek namenili nadaljnjemu izvajanju Evropske strategije za obvladovanje tveganja (ERMS), izboljšanju kakovosti podatkov v zbirki EudraVigilance ter podpori Evropske mreže centrov za farmakovigilanco in farmakoepidemiologijo.
Some of these areas that will influence the Agency's resource distribution in 2010 include complex interactions between the six scientific committees of the Agency, increases in post-authorisation, referral, safety-of-medicines-related activities, and provision of information.
Nekatera od teh področij, ki bodo vplivala na razporeditev sredstev agencije v letu 2010, zajemajo zapleteno medsebojno delovanje šestih znanstvenih odborov agencije, povečanje obsega dejavnosti po izdaji dovoljenja za promet z zdravilom, napotitvenih postopkov, dejavnosti, povezanih z varnostjo zdravil, in zagotavljanje informacij.
This trend is strengthened by the increasing number and complexity of applications across most of the Agency's activities, not least those relating to the recent legislation on advanced therapy medicinal products and paediatric medicines.
To težnjo povečujeta vedno večje število in zapletenost prijav v zvezi z večino dejavnosti agencije, pri čemer imajo pomembno vlogo tiste, ki se nanašajo na najnovejšo zakonodajo o zdravilih za napredno zdravljenje in pediatričnih zdravilih.
The Agency will launch its redesigned public website, which will provide easier access to information for patients, healthcare professionals and enterprises.
Agencija bo objavila prenovljeno spletno stran, na kateri bodo lažje dostopne informacije za bolnike, zdravstvene delavce in podjetja.
The Agency's activities in the field of communication and transparency will see further significant development.
Dejavnosti agencije na področju obveščanja in preglednosti bomo še dodatno izboljšali.
These include the revision of the Variations Regulation, which brings new ways of handing variations, but also has implications for the Agency's financing, and the revised Maximum Residue Limits (MRL) Regulation, which promotes MRL extrapolation and extends the scope to cover biocidal products, as well as products used under the prescribing ‘cascade'.
Te so popravek uredbe o spremembah, ki uvaja nove načine za obravnavanje zahtevkov za spremembe, a ima tudi posledice za financiranje agencije, ter revidirana uredba o mejnih vrednostih ostankov (MRL), ki spodbuja ekstrapolacijo mejnih vrednosti ostankov in razširja obseg uredbe tako, da ta vključuje tudi biocidne pripravke in zdravila, ki se uporabljajo v okviru „hierarhije“ predpisovanja.
This transition will be managed with care, in order to ensure that any changes ensure strong participation of Member State national competent authorities in the work of the Agency.
Ta prehod na nov sistem bomo izvedli previdno, saj želimo zagotoviti, da bodo lahko nacionalni pristojni organi držav članic v zvezi z vsemi spremembami dejavno sodelovali pri delu agencije.
The Agency will continue its contribution to an environment that stimulates innovation and availability of medicines through its core activities, such as provision of scientific advice to companies developing new medicines and implementation of the various policies supporting development of medicines.
Agencija si bo s svojimi osnovnimi dejavnostmi še naprej prizadevala, da bi ustvarila okolje, ki spodbuja inovacije in razpoložljivost zdravil, kot sta znanstveno svetovanje farmacevtskim družbam, ki razvijajo nova zdravila, in izvajanje različnih politik, ki podpirajo razvoj zdravil.
Fields of activity include: the implementation of initiatives relating to clinical trials and manufacturing of active ingredients in China and India, and to international work-sharing activities in the field of GMP and GCP inspections; further collaboration with non-EU regulators in the context of confidentiality arrangements and mutual-recognition agreements; and contribution to international standardisation activities.
Ta področja dejavnosti so: udejanjanje pobud v zvezi s kliničnimi preskušanji in proizvodnjo zdravilnih učinkovin na Kitajskem in v Indiji ter mednarodnimi dejavnostmi delitve dela na področju inšpekcijskih pregledov na področjih dobre proizvodne in klinične prakse; nadaljnje sodelovanje z zakonodajnimi organi v državah zunaj EU v okviru dogovorov o zaupnosti ter prispevanje k mednarodnim dejavnostim za standardizacijo.
Due to the nature of the work of the Agency, following the authorisation of new medicinal products, there is a cumulative increase in the work needed to supervise those products, carry out pharmacovigilance activities and conduct other post-authorisation tasks.
Zaradi narave dela agencije in odobritve novih zdravil se je povečal obseg dela, ki ga zahtevajo nadzorovanje teh zdravil, izvajanje farmakovigilančnih dejavnosti in izpolnjevanje drugih nalog po tem, ko zdravila že pridobijo dovoljenje za promet.
The European Commission issued a decision on this opinion on 22-09-2016.
Evropska komisija je o tem mnenju izdala odločbo dne 22-09-2016.
This is a procedure where one Member State (the ‘reference Member State', in this instance the UK) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Czech Republic, France and Slovakia).
To je postopek, pri katerem ena država članica („referenčna država članica“, v tem primeru Združeno kraljestvo) oceni zdravilo z namenom odobritve dovoljenja za promet z njim, ki bo veljavno v tej državi in v drugih državah članicah (v „zadevnih državah članicah“, v tem primeru na Češkem, v Franciji in na Slovaškem).
A review of scientific literature showed variable reductions in the uptake of different forms of diclofenac when taken with food.
Pregled znanstvene literature je pokazal spremenljiva zmanjšanja privzema različnih oblik diklofenaka, kadar se jemlje s hrano.
This is because it is recommended that this product is preferably taken with food, and food can have a big effect on the way the medicine is taken up into the body.
Priporoča se namreč, da je to zdravilo bolje jemati s hrano, hrana pa ima lahko velik vpliv na način privzema zdravila v telo.
However, the Member States were not able to reach an agreement and the UK medicines regulatory agency referred the matter to the CHMP for arbitration on 5 February 2016.
Ker pa države članice niso dosegle soglasja, je britanska regulativna agencija za zdravila dne 5. februarja 2016 zadevo napotila na CHMP v arbitražo.
The French and Slovakian medicines regulatory agencies considered that a bioequivalence study of the medicine taken with food was also required because it is recommended to be preferably taken with food.
Francoska in slovaška regulativna agencija za zdravila sta menili, da je potrebna tudi bioekvivalenčna študija jemanja zdravila s hrano, saj ga je po priporočilu bolje jemati s hrano.
Based on the evaluation of currently available data and the scientific discussion within the Committee, the CHMP concluded that bioequivalence to the reference medicine when taken with food has not been shown.
Na podlagi ocene trenutno razpoložljivih podatkov in znanstvene razprave v odboru je odbor CHMP zaključil, da biološka enakovrednost z referenčnim zdravilom pri jemanju s hrano ni bila dokazana.
Questions and answers on diclofenac epolamine 50 mg tablets EMA/490203/2016 Rev. 1
Vprašanja in odgovori o diklofenak epolaminu 50 mg tablete EMA/490203/2016 Rev. 1
On 21 July 2016, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine diclofenac epolamine (50 mg tablets).
21. julija 2016 je Evropska agencija za zdravila končala postopek arbitraže, do katerega je prišlo po nesoglasju med državami članicami Evropske unije (EU) glede odobritve zdravila diklofenak epolamin (50 mg tablete).
Since some prostaglandins are involved in causing pain and inflammation at sites of injury or damage in the body, reduced prostaglandin production reduces pain and inflammation.
Ker so nekateri prostaglandini vključeni v povzročanje bolečine in vnetja na mestih telesne poškodbe, se z zmanjšano tvorbo prostaglandinov bolečina in vnetje zmanjšata.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of this product do not outweigh its risks, and the marketing authorisation cannot be granted in the United Kingdom (UK) or in the following Member States of the EU: Czech Republic, France and Slovakia.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da koristi tega zdravila niso večje od z njim povezanih tveganj ter da se dovoljenje za promet v Združenem kraljestvu in v naslednjih državah članicah EU ne more izdati: Češka, Francija in Slovaška.
The active substance in this medicine, diclofenac, is used for relief of pain and inflammation.
Zdravilna učinkovina v tem zdravilu, diklofenak, se uporablja za lajšanje bolečine in vnetja.
The medicine was to be marketed as Diclofenac.
Zdravilo naj bi se tržilo pod imenom Diclofenac.
The CHMP therefore considered that the study of the medicine taken on an empty stomach only was not sufficient to show that this product is as effective as the reference medicine.
CHMP je zato presodil, da samo študija jemanja zdravila na prazen želodec ne zadošča za dokaz, da je zdravilo tako učinkovito kot referenčno zdravilo.
Diclofenac is a ‘non-steroidal anti-inflammatory drug' (NSAID) which reduces the body's production of substances called prostaglandins.
Diklofenak je nesteroidno protivnetno zdravilo (NSAID), ki v telesu zmanjšuje proizvodnjo snovi, imenovanih prostaglandini.
The CHMP concluded that the benefits of these diclofenac epolamine 50 mg tablets do not outweigh their risks and recommended that marketing authorisation should not be granted in the UK or in the concerned Member States.
CHMP je zaključil, da koristi diklofenak epolamina 50 mg tablete niso večje od tveganj, in je priporočil, da se dovoljenje za promet z zdravilom v Združenem kraljestvu in zadevnih državah članicah ne izda.
The grounds for the referral were that the study performed had only shown the medicine was bioequivalent to the reference medicine when taken on an empty stomach.
Podlaga za napotitev je bila, da je opravljena študija dokazala samo, da je zdravilo biološko enakovredno referenčnemu zdravilu, kadar se jemlje na prazen želodec.
Altergon Italia srl submitted diclofenac epolamine (50 mg tablets) to the UK medicines regulatory agency for a decentralised procedure.
Družba Altergon Italia srl je predložila diklofenak epolamin (50 mg tablete) britanski regulativni agenciji za zdravila v decentralizirani postopek.
Questions and answers on diclofenac epolamine 50 mg tablets
Vprašanja in odgovori o diklofenak epolaminu 50 mg tablete
Diclofenac epolamine (50 mg tablets) is a generic medicine based on a ‘reference medicine', Flector, which is authorised in France.
Diklofenak epolamin (50 mg tablete) je generično zdravilo, proizvedeno na podlagi referenčnega zdravila Flector, ki je odobreno v Franciji.
Because diclofenac epolamine (50 mg tablets) is a generic medicine, a study has been carried out to show that it is bioequivalent to the reference medicine, Flector, which is available as diclofenac
Ker je diklofenak epolamin (50 mg tablete) generično zdravilo, je bila opravljena študija za dokazovanje, da je biološko enakovredno referenčnemu zdravilu Flector, ki je na voljo kot diklofenak epolamin zrnca za pripravo raztopine za pitje.
Why is diclofenac epolamine (50 mg tablets) reviewed?
Zakaj se zdravilo diklofenak epolamin (50 mg tablete) pregleduje?
What is diclofenac epolamine (50 mg tablets)?
Kaj je zdravilo diklofenak epolamin (50 mg tablete)?
2132 HK Hoofddorp Netherlands
2132 HK Hoofddorp Nizozemska
102 53 Stockholm Sweden
102 53 Stockholm Švedska
4000 Roskilde
4000 Roskilde Danska
Al. Jerozolimskie 146A 02-305 Warsaw Poland
Al. Jerozolimskie 146A 02-305 Warsaw Poljska
Quinta da Fonte Edificio Gil Eanes Paço D´Arcos 2770-192 Paço D` Arcos Portugal
Quinta da Fonte Edificio Gil Eanes Paço D´Arcos 2770-192 Paço D` Arcos Portugalska
176 74 Kallithea Greece
176 74 Kallithea Grčija
Laboratórios Delta, Lda.
Portugalska Laboratórios Delta, Lda.
Nycomed France 13, rue Watt 75013 Paris France
Nycomed France 13, rue Watt 75013 Paris Francija
Almirall S.p.A via Messina, 38 Torre C 20154 Milan Italy
Almirall S.p.A via Messina, 38 Torre C 20154 Milan Italija
Nycomed Pharma GmbH Euro Plaza Gebäude F Technologiestrasse 5 1120 Vienna Austria
Nycomed Pharma GmbH Euro Plaza Gebäude F Technologiestrasse 5 1120 Vienna Avstrija
Via Temolo 4 20126 Milan Italy
Via Temolo 4 20126 Milan Italija
Netherlands Nycomed bv Jupiterstraat 250
Nizozemska Nycomed bv Jupiterstraas 250
Nycomed Portugal Produtos Farmaceuticos, Lda.
Portugalska Nycomed Portugal Produtos Farmaceuticos, Lda.
Nycomed Italia S.r.l via Libero Temolo 4 20126 Milan Italy
Nycomed Italia S.r.l via Libero Temolo 4 20126 Milan Italija
Nycomed Portugal - Produtos Farmacêuticos, Lda.
Portugalska Nycomed Portugal - Produtos Farmacêuticos, Lda.
Luxembourg Nycomed Belgium SCA/CVA
Luksemburg Nycomed Belgium SCA/CVA
78467 Konstance Germany
78467 Constance Nemčija
Luxembourg Nycomed Belgium SCA/CVA Gentsesteenweg 615
Luksemburg Nycomed Belgium SCA/CVA Gentsesteenweg 615
Hungary Nycomed GmbH Byk-Gulden-Str.2
Madžarska Nycomed GmbH Byk-Gulden-Str.2
Nycomed GmbH Byk-Gulden-Str.2 78467 Konstance Germany
Nycomed GmbH Byk-Gulden-Str.2 78467 Konstance Nemčija
Nycomed GmbH Byk-Gulden-Str.2 78467 Konstanz Germany
Nycomed GmbH Byk-Gulden-Str.2 78467 Konstanz Nemčija
Somac 40 mg enterotabletti 40 mg Gastro-resistant tablet
Somac 40 mg enterotabletti40 mg gastrorezistentna tableta peroralna uporaba
Somac 20 mg enterotabletti 20 mg Gastro-resistant tablet
Somac 20 mg enterotabletti20 mg gastrorezistentna tableta peroralna uporaba
Pantoprazol NYC 20 mg 20 mg Gastro-resistant tablet
Pantoprazol NYC 20 mg 20 mg gastrorezistentna tableta peroralna uporaba
Pantoprazol NYC 40 mg 40 mg Gastro-resistant tablet
Pantoprazol NYC 40 mg 40 mg gastrorezistentna tableta peroralna uporaba