FrancophonIA/ELRC3.0 huggingface dataset:
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TRANSPARENT SEALED PLASTIC CASING LABEL (2 vial pack)
Slovenian: PROZOREN, ZATESNJEN PLASTIČEN OVOJ (pakiranje z 2 vialama)
English: After you have been given Glybera, you may notice that your legs have a yellow colour; this might occur in case iodine was used to clean (sterilise) your legs before you received the medicine.
Slovenian: Ko boste prejeli zdravilo Glybera, boste morda opazili, da so vaše noge rumenkaste.
English: uniQure biopharma B.V. Meibergdreef 61
Slovenian: uniQure biopharma B.V.
English: Clinical trial CT-AMT-11-05
Slovenian: Klinično preskušanje CT-AMT-11-05
English: Name and address of the manufacturer(s) responsible for batch release uniQure biopharma B.V. Meibergdreef 61
Slovenian: Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij uniQure biopharma B.V.
English: AAV1-LPLS447X was administered to 8 LPLD patients in a 12-week, open label dose escalating study (1 x 1011 gc to 3 x 1011 gc per kg body weight i.m.).
Slovenian: Klinično preskušanje CT-AMT-010-01 V 12-tedenski odprti študiji s povečevanjem odmerka so AAV1-LPLS447X dali 8 bolnikom z LPLD (1
English: • difficulty breathing, chest pain on breathing in and palpitations which may be caused by blockage of the main blood vessel of the lung
Slovenian: • mišične bolečine in bolečine ter togost v sklepih • težave z dihanjem, bolečina v prsnem košu pri vdihu in palpitacije, ki jih lahko povzroča
English: including the need for injections to be administered under ultrasound or electrophysiological guidance
Slovenian: • Smernice o preprečevanju tveganj, povezanih z intramuskularnim injiciranjem zdravila Glybera, vključno s potrebo, da se injiciranje izvede pod ultrazvočnim ali elektrofiziološkim nadzorom • Podrobna navodila o odmerku, številu in lokalizaciji injiciranja
English: Five eligible subjects were included in the study with all subjects receiving alipogene tiparvovec.
Slovenian: od katerih so vsi prejemali alipogentiparvovek.
English: Chiesi Pharmaceuticals B.V. Tel: +31 0 70 413 20 80
Slovenian: Tel: +31 0 70 413 20 80
English: Clinical trial CT-AMT-11-03
Slovenian: Klinično preskušanje CT-AMT-11-03
English: In addition methylprednisolone might be administered half an hour prior to the Glybera administration.
Slovenian: Poleg tega lahko pol ure pred injiciranjem zdravila Glybera prejmete metilprednizolon.
English: Clinical trial CT-AMT-011-02
Slovenian: Klinično preskušanje CT-AMT-011-02
English: Clinical trial CT-AMT-011-01
Slovenian: Klinično preskušanje CT-AMT-011-01
English: Sodium content and potassium content
Slovenian: Vsebnost natrija in kalija
English: After the amount of Glybera to be administered has been calculated (see section 4.2) remove the correct number of single use vials from the freezer to thaw at room temperature (15oC to 25oC), approximately 30-45 minutes in advance of syringe filling.
Slovenian: Priprava zdravila Glybera za injiciranje Ko se izračuna količina zdravila Glybera, ki jo je treba injicirati (glejte poglavje 4.2), vzemite ustrezno število vial za enkratno uporabo iz zamrzovalnika in počakajte, da se odtajajo na sobni temperaturi (15
English: Doctors shall be encouraged also to enrol patients with familial LPLD who are not treated with Glybera.
Slovenian: LPLD, ki se niso zdravili z zdravilom Glybera.
English: 1) Educational material for Pharmacists including the following key safety elements: • Detailed guidelines for product receipt and storage, procedure for the preparation, handling
Slovenian: • Podrobne smernice za sprejem in shranjevanje zdravila, postopek priprave, ravnanje in • Smernice za zagotavljanje, da bolniki prejmejo kartico z opozorili za bolnika, priloženo
English: Breast-feeding
Slovenian: presinkopa
English: Injection site discomfort, Injection site oedema, Injection site pruritus
Slovenian: Poškodbe in zastrupitve in zapleti pri posegih neugodje na mestu injiciranja, edem na mestu injiciranja, pruritus na mestu
English: Abdominal pain.Nausea, Constipation
Slovenian: Bolezni prebavil bolečina v trebuhu, navzea, obstipacija
English: The treatment should be monitored by measuring neutralising antibodies and T-Cell response against AAV1 and LPLS447X and T-Cell response at baseline as well as 6 and 12 months after treatment.
Slovenian: LPLS447X in merjenjem odziva limfocitov T ob izhodišču ter 6 in 12 mesecev po zdravljenju.
English: Doctor Phone:
Slovenian: Datum zdravljenja:
English: No vector DNA could be detected in the foetuses after treatment of either the females or the males prior to mating.
Slovenian: Po zdravljenju samcev ali samic pred parjenjem pri plodih niso zaznali DNK vektorja.
English: Side effects from your immunosuppressants
Slovenian: Razpredelnica z neželenimi učinki
English: Glybera should be administered to you in one treatment session only.
Slovenian: Zdravilo Glybera morate prejeti v obliki enkratne terapije.
English: Each vial of alipogene tiparvovec contains 1 extractable ml of solution, containing 3 x 1012 genome copies (gc).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka viala vsebuje 1 ml raztopine, ki ga je mogoče ekstrahirati, in vsebuje 3 x 1012 genomskih kopij
English: • injection site discomfort, swelling, rash and pain
Slovenian: • nelagodje na mestu injiciranja, oteklina, izpuščaj in bolečina Neželeni učinki imunosupresivnih sredstev
English: Chiesi Farmaceutici S.p.A. Tηλ: + 39 0521 2791
Slovenian: Tηλ: + 39 0521 2791
English: Store and transport vial frozen -25oC to -15oC.
Slovenian: Viale shranjujte in prevažajte zamrznjene pri temperaturi -25 °C do -15 °C.
English: Clear, to slightly opalescent, colourless solution.
Slovenian: raztopina za injiciranje Bistra do rahlo opalescentna brezbarvna raztopina
English: Dizziness was commonly observed after Glybera administration.
Slovenian: LPLD, ki so se zdravili z zdravilom Glybera.
English: 12 mg Concentrate for solution for infusion
Slovenian: 12 mg Koncentrat za raztopino za infundiranje
English: 1.2 ml (10 mg/ml) 1 vial
Slovenian: Intravenska uporaba viala (steklena) 1,2 ml (10 mg/ml) 1 viala
English: Official languages:
Slovenian: Uradni jeziki:
English: The European Union - key facts
Slovenian: Evropska unija - ključna dejstva
English: Guidelines and scientific advice
Slovenian: Smernice in znanstveni nasveti
English: Supporting regulatory science outside the EU - the Article 58 procedure
Slovenian: Spodbujanje regulativne znanosti izven EU - postopek iz člena 58
English: • Right of initiative - it can propose new or amended legislation for the pharmaceutical sector;
Slovenian: • Pravica do pobude - lahko predlaga novo ali spremenjeno zakonodajo za farmacevtski sektor;
English: National Competent Authorities
Slovenian: Pristojni nacionalni organi
English: International cooperation
Slovenian: Mednarodno sodelovanje
English: The European Commission can also take action concerning other aspects of medicine regulation:
Slovenian: Evropska komisija lahko ukrepa tudi v zvezi z drugimi vidiki regulacije zdravil:
English: Different authorisation routes: one set of common rules.
Slovenian: Različni načini pridobitve dovoljenja: enoten sklop skupnih pravil.
English: These guidelines reflect the latest thinking on developments in biomedical science.
Slovenian: Te smernice odražajo najnovejša dognanja glede razvoja v biomedicinski znanosti.
English: Pricing and reimbursement
Slovenian: Oblikovanje cen in povračilo
English: The European system offers different routes for such an authorisation.
Slovenian: Evropski sistem ponuja več načinov za pridobitev takšnega dovoljenja.
English: This process allows Member States to rely on each other's scientific assessments.
Slovenian: Ta postopek dopušča državam članicam, da se zanašajo na znanstvene ocene drugih držav članic.
English: primarily of innovative and high-technology medicines developed by pharmaceutical companies for use in the EU.
Slovenian: predvsem inovativnih in visokotehnoloških zdravil, ki jih razvijejo farmacevtska podjetja za uporabo v EU.
English: The role of the European Commission
Slovenian: Vloga Evropske komisije
English: Authorisation and supervision of manufacturers
Slovenian: Dovoljenja za proizvajalce in nadzor nad njimi
English: The regulatory authorities of each Member State are responsible for granting licences for such activities taking place within their respective territories.
Slovenian: Regulativni organi posamezne države članice so odgovorni za izdajanje licenc za dejavnosti, ki se odvijajo na njihovem ozemlju.
English: • Global outreach - it ensures appropriate collaboration with relevant international partners and promotes the EU regulatory system globally.
Slovenian: • Globalno delovanje - zagotavlja ustrezno sodelovanje z zadevnimi mednarodnimi partnerji in promovira regulativni sistem EU po svetu.
English: The European Commission plays an important role in the regulation of medicines in the EU.
Slovenian: Evropska komisija igra pomembno vlogo pri regulaciji zdravil v EU.
English: Clinical trials
Slovenian: Klinična preskušanja
English: The use of the centrally authorised procedure is compulsory for most innovative medicines, including medicines for rare diseases.
Slovenian: Uporaba centraliziranega postopka je obvezna pri večini inovativnih zdravil, vključno z zdravili za redke bolezni.
English: When a company wants to authorise a medicine in several Member States, it can use one of the following procedures:
Slovenian: Ko podjetje želi pridobiti dovoljenje za promet z zdravilom v več državah članicah, lahko uporabi enega od naslednjih postopkov:
English: EMA is responsible for the scientific evaluation,
Slovenian: Agencija EMA je odgovorna za znanstveno vrednotenje,
English: A strategic forum at the level of global agencies has recently been established - the International Coalition of Medicines Regulatory Authorities (ICMRA).
Slovenian: Nedavno je bil ustanovljen strateški forum na ravni svetovnih agencij - Mednarodna koalicija regulativnih organov za zdravila (ICMRA).
English: Population: >500m
Slovenian: Število prebivalcev: več kot 500 milijonov
English: GDP: € 12.9tn
Slovenian: BDP: 12,9 trilijona evrov
English: The European regulatory system for medicines monitors the safety of all medicines that are available on the European market throughout their life span.
Slovenian: Evropski regulativni sistem za zdravila spremlja varnost vseh zdravil, ki so na voljo na evropskem trgu, skozi njihovo celotno življenjsko dobo.
English: Medicines eligible for this procedure, which is derived from Article 58 of the regulation founding the Agency, are used to prevent or treat diseases that impact global public health.
Slovenian: Zdravila, ki so upravičena do tega postopka, ki izhaja iz člena 58 ustanovitvene uredbe agencije, so namenjena preprečevanju ali zdravljenju bolezni, ki vplivajo na globalno javno zdravje.
English: The role of EMA
Slovenian: Vloga agencije EMA
English: There are also a number of bilateral cooperation agreements in place that facilitate the exchange of important information on medicines between regulators inside and outside the EU.
Slovenian: Obstajajo še številni dvostranski sporazumi o sodelovanju, ki olajšujejo izmenjavo pomembnih informacij glede zdravil med regulativnimi organi znotraj in izven EU.
English: • Implementation - it can adopt implementing measures as well as oversee the correct application of EU law on pharmaceuticals;
Slovenian: • Izvajanje - lahko sprejme izvedbene ukrepe in nadzoruje pravilno uporabo prava EU na področju zdravil;
English: Regulatory cooperation and exchange of information with international regulators is also assured through the International Pharmaceutical Regulators' Forum (IPRF).
Slovenian: Regulativno sodelovanje in izmenjava informacij z mednarodnimi regulativnimi organi se zagotavlja tudi prek Mednarodnega farmacevtskega regulativnega foruma (IPRF).
English: The EMA has seven scientific committees that carry out its scientific assessments:
Slovenian: Agencija EMA ima sedem znanstvenih odborov, ki opravljajo znanstvene ocene:
English: ICMRA is a voluntary, executive level entity of medicines regulatory authorities worldwide providing strategic coordination, advocacy and leadership.
Slovenian: ICMRA je prostovoljna svetovna organizacija regulativnih organov za zdravila na izvršilni ravni, ki nudi strateško usklajevanje, zagovorništvo in vodstvo.
English: EMA was established in 1995 to ensure the best use of scientific resources across Europe for the evaluation, supervision and pharmacovigilance of medicines.
Slovenian: Agencija EMA je bila ustanovljena leta 1995 z namenom, da zagotavlja najboljšo uporabo znanstvenih virov po vsej Evropi za vrednotenje, nadzor in farmakovigilanco zdravil.
English: Experts participate in the work of EMA as members of its scientific committees, working parties, scientific advisory groups and other ad hoc advisory groups, or as members of the national assessment teams that evaluate medicines.
Slovenian: Strokovnjaki z agencijo EMA sodelujejo kot člani znanstvenih odborov, delovnih skupin, znanstvenih svetovalnih skupin in drugih ad hoc svetovalnih skupin ali kot člani nacionalnih ocenjevalnih skupin, ki ocenjujejo zdravila.
English: These activities aim to foster the timely exchange of regulatory and scientific expertise and the development of best practices in the regulatory field across the world.
Slovenian: Namen teh dejavnosti je spodbujati pravočasno izmenjavo regulativnega in strokovnega znanja ter razvijati najboljše prakse na področju regulacije po vsem svetu.
English: EMA's scientific committees
Slovenian: Znanstveni odbori agencije EMA
English: To protect public health and ensure the availability of high quality, safe and effective medicines for European citizens, all medicines must be authorised before they can be placed on the market in the EU.
Slovenian: Da bi zaščitili javno zdravje in zagotovili dostop do visokokakovostnih, varnih in učinkovitih zdravil za vse evropske državljane, morajo v EU vsa zdravila prejeti dovoljenje, preden se lahko dajo na trg.
English: The European Commission and EMA, in close cooperation with Member States, work to forge close ties with partner organisations around the world.
Slovenian: Evropska komisija in agencija EMA tesno sodelujeta z državami članicami in skušata vzpostaviti trdne vezi s partnerskimi organizacijami po vsem svetu.
English: By working closely together, Member States reduce duplication, share the workload and ensure the efficient and effective regulation of medicines across the EU.
Slovenian: S tesnim sodelovanjem države članice zmanjšujejo možnost podvajanja, si porazdelijo delovno obremenitev in zagotavljajo učinkovito in uspešno regulacijo zdravil po vsej EU.
English: The EU has developed a single market through a standardised system of laws that apply to all its Member States.
Slovenian: Evropska unija (EU) je razvila enotni trg s pomočjo standardiziranega sistema zakonov, ki veljajo za vse države članice.
English: These data are continuously monitored by EMA and the Member States in order to identify any new safety information.
Slovenian: Agencija EMA in države članice nenehno spremljajo te podatke, da bi odkrile morebitne nove informacije o varnosti.
English: Public hearings are intended to support the committee's decision-making by providing perspectives, knowledge and insights into the way medicines are used in clinical practice.
Slovenian: Namen javnih predstavitev je podpreti odločitve odbora z zagotavljanjem perspektive, znanja in vpogleda v način, kako se zdravila uporabljajo v klinični praksi.
English: Once granted by the European Commission, the centralised marketing authorisation is valid in all EU Member States.
Slovenian: Ko ga odobri Evropska komisija, je centralizirano dovoljenje za promet veljavno v vseh državah članicah EU.
English: EU Member States: 28
Slovenian: Evropska unija= 28 držav članic
English: The European Commission and EMA work with the World Health Organization (WHO) on a range of issues, including medicines intended for markets outside the EU (medicines reviewed under EMA's so-called ‘Article 58 procedure'), the quality of medicines and the development of international nonproprietary names.
Slovenian: Evropska komisija in agencija EMA sodelujeta s Svetovno zdravstveno organizacijo (SZO) pri številnih vprašanjih, kot so zdravila, namenjena trgom izven EU (zdravila, pregledana v skladu s EMA t.i. ‘postopkom iz člena 58'), kakovost zdravil in razvoj mednarodnih nelastniških imen.
English: Increasingly, patients and healthcare professionals are involved in the work of the Agency including in the evaluation of medicines.
Slovenian: V dejavnost agencije je vključenih vse več bolnikov in zdravstvenih delavcev, tudi pri ocenjevanju zdravil.
English: This is an important tool to help develop and make available high-quality, effective and safe medicines, for the benefit of patients.
Slovenian: To je pomemben način, kako olajšati razvoj in dostopnost visokokakovostnih, učinkovitih in varnih zdravil v korist bolnikov.
English: Once a marketing authorisation has been granted, decisions about price and reimbursement take place at the level of each Member State considering the potential role and use of the medicine in the context of the national health system of that country.
Slovenian: Po dodelitvi dovoljenja za promet se cena in povračilo določita na ravni posameznih držav članic, ob upoštevanju morebitne vloge in uporabe zdravila v nacionalnem zdravstvenem sistemu zadevne države.
English: This works because EU legislation requires that each Member State operates to the same rules and requirements regarding the authorisation and monitoring of medicines.
Slovenian: Tak sistem je učinkovit, ker zakonodaja EU od vsake države članice zahteva, da ta deluje v skladu z istimi pravili in zahtevami, kar zadeva odobritev in nadzor zdravil.
English: The regulation of medical devices does not fall within the scope of the European regulatory system for medicines.
Slovenian: Regulacija medicinskih pripomočkov ne spada med pristojnosti evropskega regulativnega sistema za zdravila.
English: Accession to the EU means a commitment to apply the “acquis communautaire” (the body of EU legislation and guidance) to ensure that all EU Member States operate to the same standards.
Slovenian: S pristopom k EU se država zaveže k izvajanju pravnega reda Skupnosti (zakonodaja in smernice EU), kar zagotavlja, da vse države članice EU upoštevajo iste standarde.
English: All manufacturing and importing licenses are entered into EudraGMDP, the publiclyavailable European database operated by EMA.
Slovenian: Vse proizvodne in uvozne licence so vnesene v EudraGMDP, javno dostopno evropsko bazo podatkov, ki jo upravlja agencija EMA.
English: This includes vaccines used in the WHO Expanded Programme on Immunization, or for protection against a public health priority disease, as well as medicines for WHO target diseases such as HIV/AIDS, malaria or tuberculosis.
Slovenian: Sem spadajo cepiva, ki se uporabljajo v razširjenem programu cepljenja SZO ali za zaščito pred boleznimi, ki imajo prednost pri obravnavi, kot tudi zdravila, s katerimi SZO ciljno obravnava bolezni, kot so HIV/aids, malarija in tuberkuloza.
English: Equivalence between Member States' inspectorates is ensured and maintained in a variety of ways, including common legislation, common good manufacturing practice (GMP), common procedures for inspectorates, technical support, meetings, trainings, and internal and external audits.
Slovenian: Enakovrednost inšpektoratov držav članic se zagotavlja in ohranja na več načinov, vključno s skupno zakonodajo, skupno dobro proizvodno prakso, skupnimi postopki za inšpektorate, tehnično podporo, srečanji, usposabljanji ter notranjimi in zunanjimi revizijami.
English: The national competent authorities (NCAs), responsible for the regulation of human and veterinary medicines in the EU, coordinate their work in a forum called Heads of Medicines Agencies (HMA).
Slovenian: Pristojni nacionalni organi, ki so odgovorni za regulacijo zdravil za uporabo v humani in veterinarski medicini v EU, usklajujejo svoje delo v okviru foruma z imenom Vodje agencij za zdravila (HMA).
English: Inspection outcomes can be accessed by all Member States and are made publicly available across the EU through EudraGMDP.
Slovenian: Vse države članice lahko dostopajo do rezultatov pregleda, ki so javno dostopni v vsej EU prek baze podatkov EudraGMDP.
English: The experts are chosen on the basis of their scientific expertise and many of them are made available to EMA by the NCAs in Member States.
Slovenian: Strokovnjaki so izbrani na podlagi svojega strokovnega znanja, večinoma pa jih na voljo agenciji EMA dajejo pristojni nacionalni organi v državah članicah.
English: Telephone +44 (0)20 3660 6000 Send a question via our website www.ema.europa.eu/contact www.ema.europa.eu
Slovenian: Send a question via our website www.ema.europa.eu/contact www.ema.europa.eu
English: EMA also gives product-specific scientific advice to companies for the development of medicines.
Slovenian: Agencija EMA prav tako podjetjem pri razvoju zdravil ponuja znanstvene nasvete za posamezne proizvode.
English: Public hearings
Slovenian: Javne predstavitve
English: This booklet explains how the European regulatory system for medicines operates.
Slovenian: V tej brošuri je opisano, kako deluje evropski regulativni sistem za zdravila.
English: The authorisation and oversight of a clinical trial is the responsibility of the Member State in which the trial is taking place.
Slovenian: Za odobritev in nadzor kliničnega preskušanja je od govorna država članica, v kateri preskušanje poteka.
English: All suspected side effects that are reported by patients and healthcare professionals must be entered into EudraVigilance, the EU web-based information system operated by EMA that collects, manages and analyses reports of suspected side effects of medicines.
Slovenian: Vsi morebitni neželeni učinki, o katerih poročajo bolniki in zdravstveni delavci, morajo biti vneseni v sistem EudraVigilance, to je spletni informacijski sistem EU, ki ga upravlja agencija EMA in ki zbira, upravlja in analizira poročila o možnih neželenih učinkih zdravil.
English: The Veterinary International Conference on Harmonisation (VICH) is the equivalent forum for veterinary medicines.
Slovenian: Mednarodna veterinarska konferenca za usklajevanje (VICH) je forum za zdravila za uporabo v veterinarski medicini z enako vlogo.
English: For the EU, one of the main forums for multilateral international cooperation is the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), which brings together medicines regulatory authorities and pharmaceutical industry from around the world.
Slovenian: Za EU je eden najpomembnejših forumov za večstransko mednarodno sodelovanje Mednarodni svet za usklajevanje tehničnih zahtev glede zdravil za uporabo v humani medicini (ICH), ki združuje regulativne organe za zdravila in farmacevtsko industrijo iz Evrope, Japonske in Združenih držav.
English: The European medicines regulatory system is based on a network of around 50 regulatory authorities from the 31 EEA countries (28 EU Member States plus Iceland, Liechtenstein and Norway), the European Commission and EMA.
Slovenian: ki jo sestavlja približno 50 regulativnih organov za zdra vila iz 31 držav Evropskega gospodarskega prostora (28 držav članic EU ter Islandija, Lihtenštajn in Norveška), Evropska komisija in Evropska agencija za zdravila.
English: If the product is manufactured outside the EU and has been imported, it needs to undergo full analytical testing in the EU, unless a mutual recognition agreement (MRA) is in place between the EU and the exporting country.
Slovenian: V kolikor je bil izdelek proizveden izven EU in je bil uvožen, ga mora EU v popolnosti analitično preskusiti, razen v primeru obstoječega sporazuma o vzajemnem priznavanju med EU in državo izvoznico.
English: Rules and requirements applicable to pharmaceuticals in the EU are the same, irrespective of the authorisation route for a medicine.
Slovenian: Pravila in zahteve, ki veljajo za zdravila v EU, so enaki ne glede na način pridobitve dovoljenja za promet z zdravilom.
English: • Committee for Advanced Therapies (CAT)
Slovenian: • Odbor za napredno zdravljenje (CAT)