FrancophonIA/ELRC3.0 huggingface dataset:
English: The network is supported by a pool of thousands of experts drawn from across Europe, allowing it to source the best possible scientific expertise for the regulation of medicines in the EU and to provide scientific advice of the highest quality.
Slovenian: Mreža ima dostop do na tisoče strokovnjakov iz vse Evrope, kar ji omogoča razpolaganje z najboljšim možnim strokovnim znanjem za regulacijo zdravil v EU in strokovno svetovanje najvišje kakovosti.
English: EMA has a committee dedicated to the safety of medicines for human use - the Pharmacovigilance Risk Assessment Committee, or PRAC.
Slovenian: Agencija EMA ima poseben odbor, namenjen varnosti zdravil za uporabo v humani medicini - Odbor za ocenjevanje tveganja na področju farmakovigilance (PRAC).
English: EMA enables one application, one assessment, one market authorisation for the whole of the EU.
Slovenian: Agencija EMA omogoča eno prošnjo, eno oceno in eno dovoljenje za promet za celotno EU.
English: Transparency about how the system works and how it reaches its decisions is an important feature of the EU regulatory system for medicines.
Slovenian: Preglednost v zvezi z načinom dela in sprejemanjem odločitev je pomembna lastnost evropskega regulativnega sistema za zdravila.
English: Medicines regulatory authorities:
Slovenian: Organi za regulacijo zdravil:
English: The EU regulatory system for medicines
Slovenian: Regulativni sistem EU za zdravila
English: • the mutual-recognition procedure where companies that have a medicine authorised in one EU Member States can apply for this authorisation to be recognised in other EU countries.
Slovenian: • postopek z medsebojnim priznavanjem, pri čemer lahko podjetja, ki so za zdravilo pridobila dovoljenje za promet v eni državi članici EU, zaprosijo za priznanje dovoljenja v drugih državah EU.
English: Safety monitoring of medicines
Slovenian: Spremljanje varnosti zdravil
English: Manufacturers, importers and distributors of medicines in the EU must be licensed before they can carry out those activities.
Slovenian: Proizvajalci, uvozniki in distributerji zdravil v EU pot rebujejo licenco, preden lahko opravljajo svoje dejav nosti.
English: In addition to its role in risk assessment, the committee provides advice and recommendations to the European medicines regulatory network on risk management planning and benefit-risk assessment for medicines after marketing.
Slovenian: Poleg ocenjevanja tveganja odbor evropski regulativni mreži za zdravila zagotavlja nasvete in priporočila v zvezi z načrtovanjem obvladovanja tveganja in oceno razmerja med tveganji in koristmi po začetku trženja zdravil.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) or Committee for Medicinal Products for Veterinary Use (CVMP) then carries out a scientific assessment of the application and gives a recommendation to the European Commission on whether or not to grant a marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji oziroma Odbor za zdravila za uporabo v veterinarski medicini (CVMP) nato opravi znanstveno oceno vloge in poda priporočilo Evropski komisiji, ali naj se dovoljenje za promet izda ali ne.
English: The European Clinical Trials Database (EudraCT) tracks which clinical trials have been authorised in the EU.
Slovenian: Evropska zbirka podatkov o kliničnih preskušanjih spremlja klinična preskušanja, ki so bila odobrena v EU.
English: The PRAC has a broad remit covering all aspects of pharmacovigilance.
Slovenian: Odbor za ocenjevanje tveganja na področju farmakovigilance (PRAC) ima širok obseg pristojnosti, ki pokrivajo vse vidike farmakovigilance.
English: EMA and the Member States cooperate and share expertise in the assessment of new medicines and of new safety information.
Slovenian: Evropska agencija za zdravila in države članice sodelujejo in si izmenjujejo strokovno znanje pri ocenjevanju novih zdravil in novih informacij o varnosti.
English: The majority of medicines authorised in the EU do not fall within the scope of the centralised procedure but are authorised by national competent authorities (NCAs) in the Member
Slovenian: Večina zdravil, za katera se izda dovoljenje za promet v EU, ne spada na področje uporabe centraliziranega postopka, temveč jih odobrijo nacionalni pristojni organi v državah članicah.
English: The CHMP can carry out scientific assessments and give opinions, in cooperation with WHO, on medicines for use exclusively outside the EU.
Slovenian: Odbor CHMP lahko v sodelovanju s SZO izvaja znanstvena ocenjevanja in podaja mnenja o zdravilih za uporabo izključno izven EU.
English: The HMA meets four times per year to address key strategic issues for the network, such as the exchange of information, IT developments and sharing of best practices, and to streamline mutual recognition and decentralised procedures.
Slovenian: Forum vodij agencij za zdravila se sreča štirikrat letno, da bi razpravljal o ključnih strateških vprašanjih, ki zadevajo mrežo, kot so izmenjava informacij, razvoj na področju IT in izmenjava najboljših praks, in poenostavil postopke medsebojnega priznavanja in decentralizirane postopke.
English: It describes how medicines are authorised and monitored in the European Union (EU) and how the European medicines regulatory network - a partnership between the European Commission, the medicines regulatory authorities in EU Member States and the European Economic Area (EEA), and the European Medicines Agency (EMA) - works to ensure that patients in the
Slovenian: Pojasnjeno je, kako so v Evropski uniji (EU) odobrena in nadzorovana zdravila1 in kako evropska regulativna mreža za zdravila - partnerstvo med Evropsko komisijo, regulativni organi za zdravila v državah članicah EU in v Evropskem gospodarskem prostoru (EGP) in Evropsko agencijo za zdravila (EMA) - bolnikom v EU zagotavlja dostop do visokokakovostnih, učinkovitih in varnih zdravil.
English: It is used by NCAs and clinical-trial sponsors to enter information protocols and results of clinical trials.
Slovenian: Uporabljajo jo pristojni nacionalni organi in naročniki kliničnih preskušanj za vnašanje informacijskih protokolov in rezultatov kliničnih preskušanj.
English: ICH is dedicated to harmonisation in safety, quality and efficacy as the main criteria for approving and authorising new medicines.
Slovenian: Svet ICH se posveča predvsem usklajevanju na področjih varnosti, kakovosti in učinkovitosti, kar so glavna merila za odobritev novih zdravil.
English: • the decentralised procedure where companies can apply for the simultaneous authorisation of a medicine in more than one EU Member State if it has not yet been authorised in any EU country and does not fall within the scope of the centralised procedure;
Slovenian: • decentralizirani postopek, pri čemer podjetje istočasno predloži vlogo za dovoljenje za promet z zdravilom v več kot eni državi članici EU, pod pogojem, da to zdravilo še ni prejelo dovoljenja za promet v nobeni državi EU in ne sodi v okvir centraliziranega postopka;
English: IT systems which connect all parties in the network facilitate the exchange of information on aspects such as safety monitoring of medicines, authorisation and supervision of clinical trials or compliance with good manufacturing and distribution practices.
Slovenian: IT sistemi, ki povezujejo vse člane mreže, olajšujejo izmenjavo informacij na področjih, kot so spremljanje varnost zdravili, odobritev in nadziranje kliničnega preskušanja ali skladnost z dobro proizvodno in distribucijsko prakso.
English: The centralised procedure allows the marketing of a medicine on the basis of a single EU-wide assessment and marketing authorisation which is valid throughout the EU.
Slovenian: Centralizirani postopek dovoljuje promet z zdravilom na podlagi enega ovrednotenja, ki velja za celotno EU, in dovoljenja za promet, ki velja za celotno EU.
English: For a medicine that is authorised by a Member State, details on the assessment of the medicine are also available in a Public Assessment Report.
Slovenian: Podrobnosti glede zdravil, ki so dovoljenje prejela s strani držav članic, so prav tako na voljo v javnem poročilu o oceni zdravila.
English: This network is what makes the EU regulatory system unique.
Slovenian: Regulativni sistem EU je zaradi te mreže edinstven.
English: 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
Slovenian: European Medicines Agency 30 Churchill Place Canary Wharf
English: Scientific advice can also be given by NCAs.
Slovenian: Tudi pristojni nacionalni organi lahko dajejo znanstvene nasvete.
English: • Paediatric Committee (PDCO)
Slovenian: • Odbor za pediatrijo (PDCO)
English: On the basis of scientific assessments carried out by EMA, it grants or refuses, changes or suspends marketing authorisations for medicines that have been submitted via the centralised procedure.
Slovenian: Komisija na podlagi strokovne ocene agencije EMA odobri, zavrne, spremeni ali začasno odvzame dovoljenje za promet z zdravilom, za katerega je bila vloga predložena v okviru centraliziranega postopka.
English: The European Economic Area (EEA) is formed of the 28 EU Member States plus:
Slovenian: Evropski gospodarski prostor (EGP) = 28 držav članic +
English: EMA provides public access to reports of suspected side effects for centrally-authorised medicines in the European database of suspected drug-reaction reports.
Slovenian: Agencija EMA zagotavlja javno dostopnost poročil o morebitnih neželenih učinkih centralno odobrenih zdravil v evropski bazi podatkov, ki vsebuje poročila o morebitnih učinkih zdravil.
English: The same rules and harmonised procedures apply to all the 28 Member States regarding the authorisation of medicines and the supervision of the safety medicines.
Slovenian: Ista pravila in usklajeni postopki veljajo za vse države članice tudi v zvezi z izdajanjem dovoljenj za promet z zdravili in spremljanjem varnosti zdravil.
English: They also rely on each other for exchange of information in the regulation of medicine, for example regarding the reporting of side effects of medicines, the oversight of clinical trials and the conduct of inspections of medicines' manufacturers and compliance with good clinical practice (GCP), good manufacturing practice (GMP), good distribution practice (GDP), and good pharmacovigilance practice (GVP).
Slovenian: Prav tako si medsebojno izmenjujejo informacije o regulaciji zdravila, na primer v zvezi s poročanjem o neželenih učinkih zdravil, nadzoru kliničnega preskušanja in izvajanja pregledov proizvajalcev zdravil ter o skladnosti glede dobre klinične prakse, dobre proizvodne prakse, dobre distribucijske prakse in dobre farmakovigilančne prakse.
English: A European Public Assessment Report, or EPAR, is published for every human or veterinary medicine that has been granted or refused a marketing authorisation following an assessment by EMA.
Slovenian: Evropsko javno poročilo o oceni zdravila ali EPAR se izda za vsako zdravilo za uporabo v humani ali veterinarski medicini, ki je na podlagi ocene agencije EMA prejelo dovoljenje za promet oziroma je bilo zanj dovoljenje za promet zavrnjeno.
English: Every batch of medicines must be certified as having been manufactured and tested in accordance with GMP and in conformance with the marketing authorisation before it can be released onto the market in the EU.
Slovenian: Za vsako serijo zdravil mora biti potrjeno, da je bila proizvedena in preskušena v skladu z dobro proizvodno prakso in da ima dovoljenje za promet, preden se lahko da na trg EU.
English: EMA prepares scientific guidelines in cooperation with experts from its scientific committees and working groups.
Slovenian: Agencija EMA v sodelovanju s strokovnjaki iz svojih znan stvenih odborov in delovnih skupin pripravlja znanstvene smernice.
English: This website allows users to view all suspected side effect reports submitted to EudraVigilance
Slovenian: Na tej spletni strani si uporabniki lahko ogledajo poročila o morebitnih neželenih učinkih, ki so bila vnesena v sistem EudraVigilance.
English: When assessing these medicines, the CHMP applies the same rigorous standards as for medicines intended for use inside the EU.
Slovenian: Pri ocenjevanju teh zdravil upošteva enake standarde kot pri zdravilih za uporabo v EU.
English: A waiver applies for some countries which have applied to have their regulatory systems for the supervision of manufacturers of active pharmaceutical ingredients assessed by the EU and have been found to be equivalent to the EU.
Slovenian: Iz te obveznosti so izvzete nekatere države, ki so podale vlogo, da EU oceni njihov regulativni sistem za nadzor nad proizvajalci zdravilnih učinkovin, EU pa je ugotovila, da je ta enakovreden evropskemu.
English: In order to be imported into the EU, an active pharmaceutical ingredient needs to be accompanied by a Written Confirmation issued by the competent authority of the country where it is produced, confirming that the good manufacturing practice (GMP) applied is at least equivalent to the recognised EU GMP standards.
Slovenian: Za uvoz v EU se mora zdravilni učinkovini priložiti pisno potrdilo s strani pristojnega organa države proizvodnje, ki potrjuje, da je upoštevana dobra proizvodna praksa vsaj enakovredna sprejetim standardom EU glede dobre proizvodne prakse.
English: encourages the exchange of knowledge, ideas and best practice between scientists striving for the highest standards for medicines'
Slovenian: vključenimi v regulacijo zdravil v EU, se spodbuja izmenjava znanja, zamisli in dobrih praks med znanstveniki v prizadevanju, da bi dosegli najvišje standarde za regulacijo zdravil.
English: It can also take EU-wide action when a safety issue has been identified for a nationally authorised product and when harmonised regulatory measures in all MSs are considered necessary following assessment by EMA's PRAC.
Slovenian: Prav tako lahko Komisija ukrepa na ravni EU v primeru odkrite varnostne grožnje v zvezi z nacionalno odobrenim zdravilom ali v primeru, da odbor agencije EMA za ocenjevanje tveganja na področju farmakovigilance oceni, da je potrebno uskladiti regulativne ukrepe v vseh državah članicah.
English: The heads of the NCAs work closely with EMA and the European Commission to maximise cooperation and ensure the European medicines regulatory network functions efficiently.
Slovenian: Vodje pristojnih nacionalnih organov so tesno povezani z agencijo EMA in Evropsko komisijo, da bi zagotovili učinkovito in uspešno sodelovanje znotraj evropske regulativne mreže za zdravila ter njeno delovanje.
English: • Pharmacovigilance Risk Assessment Committee (PRAC)
Slovenian: • Odbor za ocenjevanje tveganja na področju farmakovigilance (PRAC)
English: • Committee for Orphan Medicinal Products (COMP)
Slovenian: • Odbor za zdravila sirote (COMP)
English: EMA and many NCAs are also involved in the Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Co-operation Scheme (jointly referred to as PIC/S), a close international cooperation between pharmaceutical inspection authorities in the field of GMP.
Slovenian: Agencija EMA in številni pristojni nacionalni organi so prav tako vključeni v Konvencijo za farmacevtski nadzor in Načrt za sodelovanje pri farmacevtskem nadzoru (s skupnim poimenovanjem PIC/S).
English: A subset of this information is made publicly available by EMA via the EU clinical trials register.
Slovenian: Agencija EMA javnosti omogoči dostop do dela teh informacij prek registra kliničnih preskusov zdravil.
English: In addition, the EU's pharmacovigilance legislation enables the PRAC to hold public hearings during safety reviews of medicines if deemed useful.
Slovenian: omogoča organizacijo javnih predstavitev v obdobju varnostnih pregledov zdravil, če se presodi, da bi bilo to koristno.
English: Pharmaceutical companies submit a single authorisation application to EMA.
Slovenian: Farmacevtska podjetja predložijo eno vlogo za pridobitev dovoljenja pri Evropski agenciji za zdravila.
English: If there is a safety issue with a medicine that is authorised in more than one Member State, the same regulatory action is taken across the EU and patients and healthcare professionals in all Member States are provided with the same guidance.
Slovenian: V primeru varnostne težave z zdravilom, ki ima dovoljenje za promet v več kot eni državi članici, obvelja enak regulativni postopek po vsej EU.
English: • Committee for Medicinal Products for Human Use (CHMP)
Slovenian: • Odbor za zdravila za uporabo v humani medicini (CHMP)
English: • Committee for Medicinal Products for Veterinary Use (CMVP)
Slovenian: • Odbor za zdravila za uporabo v veterinarski medicini
English: They are available to guide the development programmes of all medicine developers who wish to submit an application for a marketing authorisation in the EU, and to ensure that medicines are developed consistently and to the highest quality.
Slovenian: Na ta način jih vodijo skozi njihove razvojne programe ter zagotavljajo, da se zdravila po vsej EU razvijajo dosledno in na najvišji kakovostni ravni.
English: • Committee on Herbal Medicinal Products (HMPC)
Slovenian: • Odbor za zdravila rastlinskega izvora (HMPC)
English: This includes manufacturers located outside the EU unless a mutual recognition agreement (MRA) is in place between the European Union and the country of manufacture.
Slovenian: Proizvajalce, ki so našteti v dokumentaciji vloge za dovoljenje za promet z zdravilom v EU, preveri pristojen organ EU, vključno s tistimi, ki se nahajajo izven EU, razen v primeru obstoječega sporazuma o vzajemnem priznavanju med Evropsko unijo in državo proizvodnje.
English: Marketing authorisations
Slovenian: Dovoljenja za promet z zdravilom
English: 18 months.
Slovenian: 18 mesecev.
English: You can hold it in either your right or left hand.
Slovenian: Držite ga lahko v desni ali levi roki.
English: - Breathe out slowly.
Slovenian: - Počasi izdihnite.
English: Special patient groups:
Slovenian: Posebne skupine bolnikov:
English: The Reference and Concerned Member States rejected the variation to extend the indication on 3 August 2005.
Slovenian: Referenčna in zadevne države članice so 3. avgusta 2005 zavrnile spremembo za razširitev indikacij.
English: The overall study results showed:
Slovenian: V celoti so rezultati študije pokazali:
English: Plasma protein binding is 91%.
Slovenian: Vezava na beljakovine v plazmi je 91 %.
English: In the MRP Sweden is the Reference Member State and Austria, Belgium, Denmark, Finland, France, Greece, Germany, Italy, Ireland, Luxembourg, The Netherlands, Portugal, Spain and the UK are Concerned Member States.
Slovenian: V postopku medsebojnega priznavanja je Švedska referenčna država članica, medtem ko so Avstrija, Belgija, Danska, Finska, Francija, Grčija, Nemčija, Italija, Irska, Luksemburg, Nizozemska, Portugalska, Španija in Združeno kraljestvo zadevne države članice.
English: When you need to use it, follow these steps:
Slovenian: Ko ga morate uporabiti, ravnajte po naslednjih točkah:
English: - Hold your breath for about 10 seconds or for as long as is comfortable.
Slovenian: - Zadržite dih za približno 10 sekund oz. kolikor dolgo vam ni neprijetno.
English: - Remove the Diskus from your mouth.
Slovenian: - Odmaknite Diskus od ust.
English: The doctor will assess whether you can take Seretide during this time.
Slovenian: Zdravnik bo ocenil, ali lahko v tem obdobju uporabljate Seretide.
English: Instructions for proper use Your doctor, nurse or pharmacist should instruct you in the proper use of your inhaler.
Slovenian: Navodila za pravilno uporabo Zdravnik, medicinska sestra ali farmacevt vas morajo naučiti pravilne uporabe inhalatorja.
English: Treatment was stepped up every 12 weeks until **Total control was achieved or the highest dose of study drug was reached.
Slovenian: Zdravljenje so vsakih 12 tednov stopnjevali navzgor, dokler **ni bilo doseženo popolno obvladanje ali pa najvišji odmerek proučevanega zdravila.
English: Therefore, Annex III may not necessarily represent the current text.
Slovenian: Zaradi tega je možno, da ta zapis ne predstavlja trenutno veljavnega besedila.
English: The incidence in placebo was not taken into account.
Slovenian: Incidenca pri placebu ni upoštevana.
English: Once the counter shows 0, your inhaler is empty.
Slovenian: Ko števec pokaže 0, je inhalator prazen.
English: The respective mechanisms of action of both drugs are discussed below:
Slovenian: Mehanizma delovanja obeh zdravil sta obravnavana spodaj:
English: Adults and adolescents 12 years and older:
Slovenian: Odrasli in mladostniki, stari 12 let in več:
English: <Detailed information on this medicine is available on the web site of {MA/Agency}>
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani {MA/agencija}
English: A recommendation in section 4.2 “Posology and method of administration” was considered acceptable.
Slovenian: Priporočilo v poglavju 4.2 “Odmerjanje in način uporabe”, je bilo opredeljeno kot sprejemljivo.
English: Germany atmadisc Diskus
Slovenian: Nemčija atmadisc Diskus
English: When you first take Seretide Diskus out of the box, it will be in the closed position.
Slovenian: Ko Seretide Diskus prvič vzamete iz škatle, je v zaprtem položaju.
English: SAFETY
Slovenian: VARNOST
English: If you forget to take your medicine, take your next dose when it is due.
Slovenian: Če ste pozabili vzeti zdravilo, vzemite naslednji odmerek, ko je čas zanj.
English: Please tell your doctor if you are taking or have recently taken any other medicines, including those for asthma or any medicines obtained without a prescription.
Slovenian: Obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi za astmo, ali katerokoli zdravilo, ki ste ga dobili brez recepta.
English: Your Diskus is now ready for you to use.
Slovenian: Diskus je zdaj pripravljen za uporabo.
English: Recommended Doses:
Slovenian: Priporočeni odmerki:
English: The lever will return to its original position and is reset.
Slovenian: Vzvod se vrne v izhodiščni položaj in je tako znova nastavljen.
English: - When you close the Diskus, it clicks shut.
Slovenian: Ko se Diskus zapre, klikne.
English: Each single dose of Seretide provides:
Slovenian: En posamični odmerek zdravila Seretide vsebuje:
English: Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), and very rare (<1/10,000) including isolated reports.
Slovenian: Opredelitev pogostnosti je: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 in < 1/10), občasni (≥ 1/1000 in < 1/100) in zelo redki (< 1/10.000) vključno s posameznimi primeri.
English: R03AK06
Slovenian: Oznaka ATC: R03AK06
English: *Reported commonly in placebo
Slovenian: *Pogosto opisani pri placebu
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF SERETIDE DISKUS AND ASSOCIATED NAMES (SEE ANNEX I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA SERETIDE DISKUS IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
English: On 12 August 2005, the MAHs presented to the EMEA a referral under Article 6(13) of Commission Regulation (EC) No 1084/2003.
Slovenian: Imetniki dovoljenja za promet z zdravilom so 12. avgusta 2005 Evropski agenciji za zdravila predložili napotitev v skladu s členom 6(13) Uredbe Komisije (ES) št. 1084/2003.
English: See your doctor immediately so they can review your condition and assess the medication you need to take.
Slovenian: Takoj obiščite zdravnika, da bo presodil vaše stanje in ocenil, katera zdravila morate jemati.
English: WHAT SERETIDE IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE ZDRAVILO SERETIDE IN ZA KAJ GA UPORABLJAMO
English: Caution is recommended and long-term treatment with such drugs should if possible be avoided.
Slovenian: Potrebna je previdnost; če je mogoče, se je dolgotrajnemu zdravljenju s takšnimi zdravili treba izogniti.
English: A dose indicator on the Diskus indicates the number of doses left.
Slovenian: Kazalnik odmerkov na Diskusu kaže število preostalih odmerkov.
English: Less than 5% of the dose is excreted in urine, mainly as metabolites.
Slovenian: Manj kot 5 % odmerka se izloči v urinu, v glavnem v obliki presnovkov.