FrancophonIA/ELRC3.0 huggingface dataset:
English: GlaxoSmithKline Export Ltd
Slovenian: GlaxoSmithKline GmbH & Co.
English: 500mg Granules for Oral Suspension
Slovenian: 500 mg zrnca za peroralno suspenzijo
English: Ref. EMA/562492/2010 Rev. EMEA/H/A-31/968
Slovenian: EMA/562492/2010 Rev. EMEA/H/A-31/968
English: 1 Article 31 of Directive 2001/83/EC as amended, referral under Community interest.
Slovenian: Člen 31 Direktive 2001/83/ES, kakor je bila spremenjena, napotitev v interesu Skupnosti.
English: London, 14 June 2010 Doc.
Slovenian: London, 14. junija 2010 Ref. dok.
English: Because of this, a number of Member States have carried out safety reviews of this combination, but these have led to different conclusions.
Slovenian: Posledično so številne države članice opravile varnostne preglede te kombinacije, vendar so prišle do različnih zaključkov.
English: The Committee recommended that the withdrawals and suspensions should be gradual in line with national recommendations.
Slovenian: Odbor je priporočil, da morajo biti umiki in zadržanja postopni in v skladu z nacionalnimi priporočili.
English: However, there were insufficient data on their effectiveness.
Slovenian: Vendar pa obstoječi podatki niso zadostovali za potrditev njegove učinkovitosti.
English: The review was carried out under an ‘Article 31' referral1.
Slovenian: Pregled je bil opravljen v skladu z napotitvenim postopkom1 iz člena 31.
English: Medicines containing dextropropoxyphene on its own are authorised in 10 Member States (Belgium, Denmark, Finland, France, Greece, Italy, Luxembourg, the Netherlands, Spain and Sweden) and medicines containing dextropropoxyphene combined with paracetamol (sometimes with caffeine) are authorised in six Member States (Belgium, Cyprus, France, Luxembourg, Malta and Portugal) as well as Norway.
Slovenian: Zdravila, ki vsebujejo dekstropropoksifen samostojno, so odobrena v 10 državah članicah (Belgija, Danska, Finska, Francija, Grčija, Italija, Luksemburg, Nizozemska, Španija in Švedska); zdravila, ki vsebujejo dekstropropoksifen v kombinaciji s paracetamolom (včasih s kofeinom), pa so odobrena v šestih državah članicah (Belgija, Ciper, Francija, Luksemburg, Malta in Portugalska) ter na Norveškem.
English: In the United Kingdom and Sweden, the marketing authorisations for these medicines were withdrawn from 2005.
Slovenian: V Združenem kraljestvu in na Švedskem so bila dovoljenja za promet s temi zdravili umaknjena leta 2005.
English: Proposed activities to reduce this risk, such as including further warnings or restrictions, or limiting the size of packs, were not considered to be adequate to protect public health.
Slovenian: O predlaganih aktivnostih za zmanjšanje tega tveganja, npr. uvedba dodatnih opozoril ali omejitev, ali omejitev velikosti pakiranja, pa meni, da niso ustrezne za zaščito javnega zdravja.
English: What happened during the re-examination?
Slovenian: Kaj se je dogajalo med ponovno presojo?
English: This means that the difference between the dose needed to treat the patient and the dose that could harm the patient is small.
Slovenian: To pomeni, da je razlika med odmerkom, potrebnim za zdravljenje bolnika, in odmerkom, ki lahko bolniku škoduje, majhna.
English: Quite often, the patients had taken medicines prescribed for someone else.
Slovenian: Zelo pogosto so bolniki jemali zdravila, ki so bila predpisana za drugega bolnika.
English: It will be the responsibility of each Member State to set the timeframe for this withdrawal and assess the need for other activities such as recommendations for prescribers and patients on safe and effective pain relief.
Slovenian: Posamezna država članica bo pristojna za določitev časovnega okvira za ta umik in za oceno potrebe po dodatnih ukrepih, kot so priporočila za zdravnike, ki predpisujejo zdravilo, in bolnike v zvezi z varnim in učinkovitim lajšanjem bolečin.
English: To ensure prescribers have enough time to determine the most appropriate treatments for individual patients, the Committee recommended that the withdrawal of the medicines from the market be carried out gradually.
Slovenian: Za zagotovitev, da imajo zdravniki, ki predpisujejo zdravilo, dovolj časa za določitev najustreznejših zdravil za posameznega bolnika, je Odbor priporočil postopen umik zdravil s trga.
English: Therefore, the Committee recommended that the marketing authorisations for these medicines be withdrawn across the EU.
Slovenian: Odbor je zato priporočil umik dovoljenj za promet s temi zdravili v EU.
English: The Committee also reviewed data from published literature including analyses comparing the results of different studies (meta-analyses) in short-term pain relief.
Slovenian: Odbor je pregledal tudi podatke iz objavljene literature, vključno z analizami primerjav rezultatov različnih študij (metaanalize) pri kratkotrajnem lajšanju bolečin.
English: On 25 June 2009, the European Medicines Agency completed a review of the safety and effectiveness of dextropropoxyphene-containing medicines.
Slovenian: Evropska agencija za zdravila je dne 25. junija 2009 zaključila pregled varnosti in učinkovitosti zdravil, ki vsebujejo dekstropropoksifen.
English: What were the conclusions of CHMP after the initial review?
Slovenian: Kakšni so bili zaključki CHMP po začetnem pregledu?
English: Dextropropoxyphene is a painkiller that is used to treat short- and long-term (chronic) pain.
Slovenian: Dekstropropoksifen je zdravilo proti bolečinam, ki se uporablja za zdravljenje kratkotrajnih in dolgotrajnih (kroničnih) bolečin.
English: The CHMP also considered the views received from patient organisations.
Slovenian: CHMP je upošteval tudi pobude, ki jih je prejel od bolniških organizacij.
English: Questions and answers on the withdrawal of the marketing authorisations for medicines containing dextropropoxyphene
Slovenian: Vprašanja in odgovori v zvezi z umikom vloge za dovoljenje za promet z zdravili, ki vsebujejo dekstropropoksifen
English: On 21 October 2009, the Committee confirmed its original recommendation that the marketing authorisations for the non-parenteral (tablets, capsules and suppositories) forms of dextropropoxyphene-containing medicines should be withdrawn.
Slovenian: Dne 21. oktobra 2009 je Odbor potrdil svoje prvotno priporočilo, da je treba umakniti dovoljenja za promet z neparenteralnimi oblikami (tablete, kapsule in svečke) zdravil, ki vsebujejo dekstropropoksifen.
English: The Committee acknowledged that it is important that patients continue to receive adequate pain relief, and that it is necessary to allow for those who currently take dextropropoxyphene-containing medicines to be transferred to alternative treatments.
Slovenian: Odbor priznava, da je pomembno, da bolniki še naprej prejemajo ustrezno zdravilo za lajšanje bolečin, in da je nujno potrebno, da se bolnikom, ki trenutno prejemajo zdravila, vsebujoča dekstropropoksifen, omogoči prehod na alternativna zdravila.
English: In November 2007, the European Commission asked the CHMP to carry out a full assessment of the benefit-risk balance of combination products containing dextropropoxyphene and paracetamol and to issue an opinion on whether the marketing authorisations for these medicines should be maintained, varied, suspended or withdrawn across the EU.
Slovenian: Novembra 2007 je Evropska komisija pozvala CHMP, naj izvede celotno oceno razmerja med koristmi in tveganji za zdravila, ki vsebujejo kombinacijo dekstropropoksifena in paracetamola, ter naj izda mnenje, ali se dovoljenja za promet s temi zdravili v EU ohranijo, spremenijo, zadržijo ali umaknejo.
English: It is a weak opioid (opioids are medicines related to morphine) that relieves pain by acting on receptors in the brain and spinal cord.
Slovenian: Je šibek opioid (opioidi so zdravila, podobna morfinu), ki lajša bolečine z delovanjem na receptorje v možganih in hrbtenjači.
English: However, for the parenteral form (solution for injection), the CHMP recommended that the marketing authorisations be suspended until further data are available.
Slovenian: Za parenteralno obliko (raztopina za injiciranje) je CHMP priporočil zadržanje dovoljenj za promet, dokler niso na voljo nadaljnji podatki.
English: Patients may easily take too much dextropropoxyphene and risk a fatal overdose, as dextropropoxyphene can be rapidly fatal.
Slovenian: Zelo lahko se zgodi, da bolniki vzamejo preveč dekstropropoksifena in tvegajo prekomeren odmerek s smrtnim izidom, saj lahko dekstropropoksifen hitro privede do smrti.
English: In light of differences between Member States in terms of the number of fatal overdoses reported, the Committee also sought data from other sources available in Member States, including case reports of fatal overdose, data from poison centres, data from coroners' services, hospital statistics, national mortality statistics, and toxicology data from forensic services, from both published and unpublished research.
Slovenian: Zaradi razlik med državami članicami v številu primerov prekomernega odmerjanja s smrtnim izidom, o katerih so poročali, je Odbor pridobil podatke tudi iz drugih razpoložljivih virov v državah članicah, vključno s poročili o posameznih primerih prekomernega odmerjanja s smrtnim izidom, podatki centrov za zastrupitve, podatki mrliškopreglednih služb, statistikami bolnišnic, nacionalnimi statistikami umrljivosti ter toksikološkimi podatki forenzičnih služb, tako iz objavljenih kot tudi iz neobjavljenih raziskav.
English: Because the Committee was also concerned about the safety of medicines containing only dextropropoxyphene, in March 2009, the assessment was widened, in agreement with the Commission, to include all dextropropoxyphene-containing medicines, either on its own or in combination.
Slovenian: Ker je imel Odbor pomisleke tudi glede varnosti zdravil, ki vsebujejo samo dekstropropoksifen, je bila marca 2009 ocena po dogovoru s Komisijo razširjena, tako da je vključevala vsa zdravila, vsebujoča dekstropropoksifen, bodisi samostojno bodisi v kombinaciji.
English: The CHMP noted that safety was less of a concern for the parenteral form, because these medicines are only given in a hospital setting where there is a lower risk of overdose.
Slovenian: CHMP je ugotovil, da varnost ne pomeni tolikšnega zadržka pri parenteralni obliki, saj se ta zdravila dajejo le v bolnišnicah, kjer je tveganje prekomernega odmerjanja manjše.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of all medicines containing dextropropoxyphene, either on its own or in combination, do not outweigh their risks.
Slovenian: Na osnovi ovrednotenja trenutno razpoložljivih podatkov in znanstvene razprave v Odboru je CHMP zaključil, da koristi vseh zdravil, vsebujočih dekstropropoksifen, dajanih samostojno ali v kombinaciji, ne odtehtajo z njimi povezanih tveganj.
English: It has been available as a prescription-only medicine for about 40 years, both on its own and in combination, as tablets, capsules, suppositories and solutions for injection.
Slovenian: Približno 40 let je na voljo kot zdravilo, ki se izdaja samo na recept, in sicer bodisi samostojno bodisi v kombinaciji kot tablete, kapsule, svečke in raztopine za injiciranje.
English: There have been concerns for some years over the risk of death from overdose - both intentional and accidental - in patients taking medicines containing dextropropoxyphene and paracetamol.
Slovenian: Pomisleki glede tveganja smrti zaradi prekomernega odmerka - namernega in nenamernega - pri bolnikih, ki jemljejo zdravila, vsebujoča dekstropropoksifen in paracetamol so prisotni že nekaj let.
English: For long-term pain, the Committee noted that there is no evidence that dextropropoxyphene and paracetamol is more effective than alternative painkillers.
Slovenian: Pri dolgotrajni bolečini je Odbor ugotovil, da ni dokazov za to, da sta dekstropropoksifen in paracetamol učinkovitejša od alternativnih zdravil proti bolečini.
English: Why was dextropropoxyphene reviewed?
Slovenian: Zakaj je bil dekstropropoksifen pregledan?
English: The full extent of the risks of dextropropoxyphene-containing medicine only became apparent when looking at complete forensic data and national mortality statistics, including toxicology data.
Slovenian: Celoten obseg tveganj z zdravili, ki vsebujejo dekstropropoksifen, je postal razviden šele ob pregledu vseh forenzičnih podatkov in nacionalnih statistik umrljivosti, vključno s toksikološkimi podatki.
English: In terms of safety, the major concern of the Committee was the ‘narrow therapeutic index' of dextropropoxyphene.
Slovenian: Z vidika varnosti je bil glavni pomislek Odbora ozek terapevtski indeks dekstropropoksifena.
English: Following the re-examination, the Committee confirmed that the benefits of non-parenteral forms of dextropropoxyphene-containing medicines do not outweigh their risks and recommended their withdrawal.
Slovenian: Po ponovni presoji je Odbor potrdil, da koristi neparenteralnih oblik zdravil, vsebujočih dekstropropoksifen, ne odtehtajo z njimi povezanih tveganj, zato je priporočil njihov umik.
English: • Prescribers should be aware that the availability of dextropropoxyphene-containing medicines will decrease as the withdrawal takes place according to national timeframes.
Slovenian: • Zdravniki, ki predpisujejo zdravila, se morajo zavedati, da se bo razpoložljivost zdravil, ki vsebujejo dekstropropoksifen, zmanjšala, ko bo prišlo do umika v skladu z nacionalnimi časovnimi okvirji.
English: The available evidence suggests that the combination of dextropropoxyphene and paracetamol is no more effective than paracetamol on its own, or ibuprofen, for short-term pain.
Slovenian: Razpoložljivi dokazi kažejo, da kombinacija dekstropropoksifena in paracetamola pri kratkotrajni bolečini ni nič bolj učinkovita kot paracetamol, dajan samostojno, ali ibuprofen.
English: What are the recommendations for prescribers?
Slovenian: Kakšna so priporočila za zdravnike, ki predpisujejo zdravila?
English: During the re-examination, the CHMP looked again at the data it had previously received, taking into consideration the different forms of dextropropoxyphene-containing medicines.
Slovenian: Med ponovno presojo je CHMP ponovno pregledal podatke, ki jih je prejel predhodno, in proučil različne oblike zdravil, vsebujočih dekstropropoksifen.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of dextropropoxyphene do not outweigh its risks, and recommended that all marketing authorisations for dextropropoxyphene-containing medicines should be withdrawn throughout the European Union (EU).
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da koristi dekstropropoksifena ne odtehtajo tveganj, zato je priporočil umik vseh dovoljenj za promet z zdravili, ki vsebujejo dekstropropoksifen, v Evropski uniji (EU).
English: What is dextropropoxyphene?
Slovenian: Kaj je dekstropropoksifen?
English: The CHMP also concluded that data from several Member States, specifically those from forensic centres and national mortality statistics, showed a significant number of deaths associated with overdose in patients taking dextropropoxyphene.
Slovenian: Odbor CHMP je zaključil tudi, da so podatki iz več držav članic, zlasti podatki iz forenzičnih centrov in nacionalnih statistik umrljivosti, pokazali, da je veliko število smrti povezanih s prekomernim odmerjanjem pri bolnikih, ki jemljejo dekstropropoksifen.
English: The CHMP concluded that the available data showed that dextropropoxyphene-containing medicines were weak painkillers, and only have limited effectiveness in the treatment of pain.
Slovenian: CHMP je na podlagi razpoložljivih podatkov zaključil, da so zdravila, ki vsebujejo dekstropropoksifen, šibka zdravila proti bolečinam ter da so zgolj omejeno učinkovita pri lajšanju bolečin.
English: The CHMP noted that data from case reports of fatal overdose and from national poison centres underestimate the number of deaths from overdose with dextropropoxyphene-containing medicines.
Slovenian: CHMP je ugotovil, da podatki iz poročil o posameznih primerih prekomernega odmerjanja s smrtnim izidom in nacionalnih centrov za zastrupitve podcenjujejo število smrti zaradi prekomernega odmerjanja zdravil, ki vsebujejo dekstropropoksifen.
English: • Prescribers should carefully consider the best alternative treatments for patients currently taking dextropropoxyphene-containing medicines in line with national recommendations.
Slovenian: • Zdravniki, ki predpisujejo zdravila, morajo skrbno izbrati najboljše alternativno zdravilo za bolnike, ki trenutno prejemajo zdravila, vsebujoča dekstropropoksifen, v skladu z nacionalnimi priporočili.
English: The CHMP initially reviewed data presented by the companies that market dextropropoxyphenecontaining medicines, providing information on the efficacy and the safety of their medicines.
Slovenian: CHMP je najprej pregledal podatke, predložene s strani družb, ki dajejo v promet zdravila, vsebujoča dekstropropoksifen, vključno z informacijami o učinkovitosti in varnosti zdravil, ki jih dajejo v promet.
English: In the meantime, it is recommended that no new patients are started on dextropropoxyphene-containing medicines.
Slovenian: Priporočljivo je, da medtem novi bolniki ne začenjajo jemati zdravil, ki vsebujejo dekstropropoksifen.
English: • Patients who have any dextropropoxyphene-containing medicines that they are no longer using are encouraged to take them to their pharmacist for safe disposal.
Slovenian: • Bolniki, ki imajo doma zdravila, vsebujoča dekstropropoksifen, in jih ne uporabljajo več, naj jih prinesejo k farmacevtu, da se zagotovi njihova varna odstranitev.
English: • Patients who are currently receiving dextropropoxyphene-containing medicines should speak to their doctor at their next appointment to review their treatment.
Slovenian: • Bolniki, ki trenutno prejemajo zdravila, ki vsebujejo dekstropropoksifen, se morajo ob naslednjem obisku o tem pogovoriti s svojim zdravnikom, da jim določi nadaljnji potek zdravljenja.
English: Data assessed by the Committee highlighted that many of the cases of fatal overdoses seen have been accidental.
Slovenian: Podatki, ki jih je Odbor ocenil, so pokazali, da so številni primeri prekomernega odmerjanja s smrtnim izidom, nenamerni.
English: The CHMP therefore recommended that the marketing authorisations for the parenteral form of dextropropoxyphene-containing medicines be suspended until further data are available to show that the benefits outweigh the risks.
Slovenian: CHMP je zato priporočil zadržanje dovoljenj za promet s parenteralno obliko zdravil, ki vsebujejo dekstropropoksifen, dokler nadaljnji podatki ne bodo pokazali, da koristi odtehtajo z njimi povezana tveganja.
English: At the request of the marketing authorisation holders, the CHMP re-examined its opinion.
Slovenian: CHMP je na zahtevo imetnikov dovoljenja za promet z zdravili ponovno pregledal svoje mnenje.
English: What were the conclusions of the CHMP following the re-examination?
Slovenian: Do kakšnih zaključkov je prišel CHMP po ponovni presoji?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Metalyse on 23 February 2001.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Metalyse, veljavno po vsej Evropski uniji, izdala 23. februarja 2001.
English: Metalyse tenecteplase
Slovenian: Metalyse tenekteplaza
English: The main measure of effectiveness was the number of patients who were alive 30 days after treatment.
Slovenian: Glavno merilo učinkovitosti je bilo število bolnikov, ki so 30 dni po prejemu zdravljenja še živeli.
English: The full EPAR for Metalyse can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Metalyse je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Other information about Metalyse:
Slovenian: Druge informacije o zdravilu Metalyse:
English: This document is a summary of the European Public Assessment Report (EPAR) for Metalyse.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Metalyse.
English: Around 94% of patients who received either medicine were alive 30 days after treatment.
Slovenian: Približno 94 % bolnikov, ki so prejeli katero koli od obeh zdravil so 30 dni po prejemu zdravila še živeli.
English: Based on this and all other available data, the Committee decided that Metalyse's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Na podlagi te ugotovitve in drugih razpoložljivih podatkov je zaključil, da so koristi zdravila Metalyse večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: Tenecteplase is made by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce it.
Slovenian: Tenekteplaza se proizvaja z metodo, znano kot „tehnologija rekombinantne DNK“: izdela jo celica, ki je prejela gen (DNK), s katerim jo lahko tvori.
English: Treatment with Metalyse should be started as soon as possible after the start of heart attack symptoms.
Slovenian: Zdravljenje z zdravilom Metalyse je treba začeti čim prej po pojavu simptomov srčnega napada.
English: For more information about treatment with Metalyse, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Metalyse preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The CHMP noted that while Metalyse was as effective as alteplase in preventing death, it caused less serious bleeding, which meant that fewer blood transfusions were required.
Slovenian: CHMP je ugotovil, da je zdravilo Metalyse enako učinkovito kot alteplaza pri preprečevanju smrti, a povzroča manj resne krvavitve, kar pomeni, da je potrebnih manj infuzij krvi.
English: What benefit has Metalyse shown during the studies?
Slovenian: Kakšne koristi je zdravilo Metalyse izkazalo med študijami?
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Metalyse.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: If treatment is necessary in these patients, facilities for resuscitating them must be readily available.
Slovenian: Če je uporaba zdravila vseeno potrebna, mora biti na voljo oprema za oživljanje.
English: With the blood clot broken down, blood can flow more easily into the heart muscle, allowing the heart to keep working and helping to save the patient's life.
Slovenian: Po razgraditvi strdka kri lažje steče v srčno mišico, kar srcu omogoča nadaljnje delovanje, bolniku pa možnost preživetja.
English: It is used to dissolve the blood clots that have formed inside the blood vessels supplying the heart.
Slovenian: Uporablja se za razgradnjo krvnih strdkov, nastalih znotraj krvnih žil, ki oskrbujejo srce.
English: In addition to Metalyse, the patient should also be treated with other medicines that are used to prevent blood clots such as aspirin and heparin.
Slovenian: Poleg zdravila Metalyse je treba pri bolniku uporabiti tudi druga zdravila, ki preprečujejo nastajanje krvnih strdkov, kot sta aspirin in heparin.
English: Metalyse was as effective as alteplase in keeping patients alive after a heart attack.
Slovenian: Zdravilo Metalyse je bilo enako učinkovito kot alteplaza pri preživetju bolnikov po srčnem napadu.
English: What is the risk associated with Metalyse?
Slovenian: Kakšna tveganja so povezana z zdravilom Metalyse?
English: Metalyse is a powder and a solvent that are made up into a solution for injection.
Slovenian: Zdravilo Metalyse je prašek in vehikel za pripravo raztopine za injiciranje.