FrancophonIA/ELRC3.0 huggingface dataset:
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.
Estonian: Toimeainena ainult dekstropropoksüfeeni sisaldavatel ravimitel on praegu müügiluba kümnes Euroopa Liidu liikmesriigis (Belgia, Hispaania, Itaalia, Kreeka, Luksemburg, Madalmaad, Prantsusmaa, Rootsi, Soome ja Taani) ning dekstropropoksüfeeni ja paratsetamooli (vahel ka koos kofeiiniga) kombinatsioonravimil on müügiluba kuues liikmesriigis (Belgia, Küpros, Luksemburg, Malta, Portugal ja Prantsusmaa), samuti Norras.
English: The CHMP also considered the views received from patient organisations.
Estonian: Samuti võttis inimravimite komitee arvesse patsiendiorganisatsioonide seisukohti.
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.
Estonian: Riski vähendamiseks kavandatavaid meetmeid, nagu uued hoiatused või ravimi kasutamise piirangud või väiksemates pakendites turustamine, ei peetud rahvatervise kaitsmiseks piisavaiks.
English: The review was carried out under an ‘Article 31' referral1.
Estonian: Hindamine toimus artikli 31 kohase esildismenetluse korras1.
English: On 25 June 2009, the European Medicines Agency completed a review of the safety and effectiveness of dextropropoxyphene-containing medicines.
Estonian: 25. juunil 2009 lõpetas Euroopa Ravimiamet dekstropropoksüfeeni sisaldavate ravimite ohutuse ja efektiivsuse hindamise.
English: At the request of the marketing authorisation holders, the CHMP re-examined its opinion.
Estonian: Müügiloa hoidjate taotlusel vaatas inimravimite komitee oma arvamuse taas läbi.
English: What happened during the re-examination?
Estonian: Mis toimus arvamuse taasläbivaatamisel?
English: Dextropropoxyphene is a painkiller that is used to treat short- and long-term (chronic) pain.
Estonian: Dekstropropoksüfeen on valuvaigisti, mida kasutatakse lühi- ja pikaajalise (kroonilise) valu raviks.
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.
Estonian: Iga liikmesriik otsustab ise, millal müügiload lõplikult tagasi võetakse, ning hindab muude meetmete otstarbekust, näiteks ravimeid välja kirjutavatele meditsiinitöötajatele ja patsientidele ette nähtud soovitused ohutu ja efektiivse valuravi kohta.
English: What were the conclusions of CHMP after the initial review?
Estonian: Mis olid inimravimite komitee järeldused pärast esialgset läbivaatamist?
English: Therefore, the Committee recommended that the marketing authorisations for these medicines be withdrawn across the EU.
Estonian: Seetõttu soovitas inimravimite komitee nende ravimite müügiload kogu ELis tagasi võtta.
English: This means that the difference between the dose needed to treat the patient and the dose that could harm the patient is small.
Estonian: See tähendab, et patsiendi raviks vajaliku annuse ja võimaliku kahjuliku toimega annuse erinevus on väike.
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.
Estonian: Inimravimite komitee märkis, et ohutusprobleem oli parenteraalse ravimvormi puhul väiksem, kuna neid ravimeid manustatakse ainult haiglatingimustes, mille puhul on üleannustamisrisk väiksem.
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.
Estonian: 2007. aasta novembris palus Euroopa Komisjon inimravimite komiteel korraldada dekstropropoksüfeeni ja paratsetamooli sisaldavate kombinatsioonravimite kasulikkuse ja nendega kaasnevate riskide täieliku hindamise ning esitada oma arvamus selle kohta, kas kõnealuste ravimite müügiload tuleks kogu ELis säilitada, peatada, tagasi võtta või tuleks neid muuta.
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.
Estonian: Võttes arvesse liikmesriikide vahelisi erinevusi surmaga lõppenud üleannustamisjuhtude arvus, hankis inimravimite komitee andmeid ka liikmesriikide muudest allikatest: surmaga lõppenud üleannustamisjuhtude teated, mürgistusravikeskuste andmed, matusetalituste andmed, haiglastatistika, riiklik suremusstatistika ning kohtuekspertiisi toksikoloogiaandmed nii avaldatud kui ka avaldamata uuringutest.
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.
Estonian: Selleks et anda ravimeid välja kirjutavatele meditsiinitöötajatele piisavalt aega otsustada, milline ravim patsiendile kõige rohkem sobib, soovitab inimravimite komitee ravimite turustamise lõpetada järk-järgult.
English: What is dextropropoxyphene?
Estonian: Mis on dekstropropoksüfeen?
English: The Committee recommended that the withdrawals and suspensions should be gradual in line with national recommendations.
Estonian: Inimravimite komitee soovitas, et müügiload võetaks tagasi või peatataks järk-järgult kooskõlas riiklike soovitustega.
English: Patients may easily take too much dextropropoxyphene and risk a fatal overdose, as dextropropoxyphene can be rapidly fatal.
Estonian: Patsiendid võivad dekstropropoksüfeeni võtta kergesti liiga suures koguses ja riskida surmaga lõppeda võiva üleannustamisega, sest dekstropropoksüfeeni üleannustamine võib surmaga lõppeda väga kiiresti.
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.
Estonian: 21. oktoobril 2009 kinnitas inimravimite komitee oma esialgset soovitust kõikide dekstropropoksüfeeni sisaldavate ravimite mitteparenteraalsete ravimvormide (tabletid, kapslid ja ravimküünlad) müügilubade tagasivõtmise kohta.
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.
Estonian: Inimravimite komitee arvates on oluline, et patsiendid saaksid sobivat valuravi ning et praegu dekstropropoksüfeeni sisaldavaid ravimeid kasutavad patsiendid saaksid üle minna alternatiivsele ravile.
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.
Estonian: Taasläbivaatamisel tutvus inimravimite komitee veel kord varem kogutud andmetega, võttes arvesse dekstropropoksüfeeni sisaldavate ravimite eri ravimvorme.
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).
Estonian: Euroopa Ravimiameti inimravimite komitee jõudis järeldusele, et dekstropropoksüfeeni kasulikkus ei ole suurem kui sellega kaasnevad riskid, ning soovitas kõikide dekstropropoksüfeeni sisaldavate ravimite müügiload kogu Euroopa Liidus (EL) tagasi võtta.
English: Data assessed by the Committee highlighted that many of the cases of fatal overdoses seen have been accidental.
Estonian: Inimravimite komitee läbi vaadatud andmetes toonitatakse, et paljud surmaga lõppenud üleannustamisjuhud on olnud juhuslikud.
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.
Estonian: Samuti järeldas inimravimite komitee, et mitme liikmesriigi andmed, eelkõige kohtuekspertiisi keskustest ja riiklik suremusstatistika osutasid märkimisväärsele surmajuhtude arvule dekstropropoksüfeeni liiga suures koguses võtnud patsientide korral.
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.
Estonian: Seetõttu soovitas inimravimite komitee dekstropropoksüfeeni sisaldavate ravimite parenteraalse ravimvormi müügiload peatada, kuni saadakse lisaandmeid, mis näitaksid, et nende kasulikkus on suurem kui kaasnevad riskid.
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.
Estonian: Dekstropropoksüfeeni sisaldavate ravimite riskidest pakuvad tervikliku ettekujutuse vaid täielikud kohtumeditsiiniandmed ja riiklik suremusstatistika, sealhulgas toksikoloogia andmed.
English: • Prescribers should be aware that the availability of dextropropoxyphene-containing medicines will decrease as the withdrawal takes place according to national timeframes.
Estonian: • Ravimeid välja kirjutavad meditsiinitöötajad peavad arvestama, et dekstropropoksüfeeni sisaldavate ravimite kättesaadavus väheneb, sest ravimite müügilubade tagasivõtmine toimub riikide määratud ajakava järgi.
English: What are the recommendations for prescribers?
Estonian: Millised on soovitused ravimeid välja kirjutavatele meditsiinitöötajatele?
English: Questions and answers on the withdrawal of the marketing authorisations for medicines containing dextropropoxyphene
Estonian: Teave müügilubade tagasivõtmise kohta dekstropropoksüfeeni sisaldavad ravimid
English: What were the conclusions of the CHMP following the re-examination?
Estonian: Mis olid inimravimite komitee järeldused pärast taasläbivaatamist?
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.
Estonian: Dekstropropoksüfeen on nõrk opioid (opioidid on morfiinilaadsed ravimid), mis leevendab valu peaja seljaajus asuvatele retseptoritele toimides.
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.
Estonian: Olemasolevad tõendid näitavad, et dekstropropoksüfeeni ja paratsetamooli kombinatsioonravim ei ole lühiajalise valu ravis efektiivsem kui paratsetamool või ibuprofeen monoteraapiana.
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.
Estonian: Et inimravimite komitee kahtles ka ainult dekstropropoksüfeeni sisaldavate ravimite ohutuses, laiendati 2009. aasta märtsis kokkuleppel komisjoniga hindamist nii, et hõlmati kõik dekstropropoksüfeeni sisaldavad ravimid, sõltumata sellest, kas tegemist on toimeainena ainult dekstropropoksüfeeni sisaldava ravimi või kombinatsioonravimiga.
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.
Estonian: Praeguse olemasolevate andmete hinnangute ja inimravimite komitees toimunud teadusliku arutelu põhjal tegi inimravimite komitee järelduse, et dekstropropoksüfeeni sisaldavate ravimite (nii monoteraapiana kui ka kombinatsioonravimina) kasulikkus ei ole suurem kui nendega kaasnevad riskid.
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.
Estonian: Viimastel aastatel on tekitanud ettevaatlikkust nii tahtlikust kui ka juhuslikust üleannustamisest põhjustatud surmajuhtude risk patsientidel, kes manustavad dekstropropoksüfeeni ja paratsetamooli sisaldavaid ravimeid.
English: In terms of safety, the major concern of the Committee was the ‘narrow therapeutic index' of dextropropoxyphene.
Estonian: Ohutusega seoses oli inimravimite komiteel kahtlusi peamiselt dekstropropoksüfeeni kitsa terapeutilise indeksi pärast.
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.
Estonian: Taasläbivaatamise järel jäi inimravimite komitee arvamusele, et dekstropropoksüfeeni sisaldavate ravimite mitteparenteraalsete ravimvormide kasulikkus ei ole suurem kui nendega kaasnevad riskid ning soovitas nende ravimite müügiload tagasi võtta.
English: For long-term pain, the Committee noted that there is no evidence that dextropropoxyphene and paracetamol is more effective than alternative painkillers.
Estonian: Pikaajalise valu ravi kohta märkis inimravimite komitee, et dekstropropoksüfeeni ja paratsetamooli kombinatsioonravimi efektiivsust võrreldes alternatiivsete valuvaigistitega ei ole tõendatud.
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.
Estonian: Esialgu vaatas inimravimite komitee läbi dekstropropoksüfeeni sisaldavaid ravimeid turustavate ettevõtete esitatud andmed ravimite efektiivsuse ja ohutuse kohta.
English: Why was dextropropoxyphene reviewed?
Estonian: Miks dekstropropoksüfeeni sisaldavad ravimid läbi vaadati?
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.
Estonian: Dekstropropoksüfeeni on retseptiravimina turustatud juba enam kui 40 aastat nii monoteraapiana kui ka eri kombinatsioonides, nii tablettide, kapslite, ravimküünalde kui ka süstelahustena.
English: • Patients who are currently receiving dextropropoxyphene-containing medicines should speak to their doctor at their next appointment to review their treatment.
Estonian: • Patsientidel, kes kasutavad praegu dekstropropoksüfeeni sisaldavaid ravimeid, soovitatakse järgmisel visiidil arutada arstiga ravi muutmist.
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.
Estonian: Inimravimite komitee järeldas, et olemasolevate andmete alusel on dekstropropoksüfeeni sisaldavad ravimid nõrgatoimelised valuvaigistid ning nende efektiivsus valu ravis on piiratud.
English: However, for the parenteral form (solution for injection), the CHMP recommended that the marketing authorisations be suspended until further data are available.
Estonian: Parenteraalsete ravimvormide (süstelahus) kohta soovitas inimravimite komitee aga müügiload lisaandmete saamiseni peatada.
English: The Committee also reviewed data from published literature including analyses comparing the results of different studies (meta-analyses) in short-term pain relief.
Estonian: Samuti tutvus inimravimite komitee teaduskirjanduses avaldatud andmete, sealhulgas lühiajalise valu ravi uuringute tulemuste võrdlusanalüüsidega (metaanalüüsid).
English: • Prescribers should carefully consider the best alternative treatments for patients currently taking dextropropoxyphene-containing medicines in line with national recommendations.
Estonian: • Ravimeid välja kirjutavad meditsiinitöötajad peavad kooskõlas riiklike ravisoovitustega hoolikalt kaaluma, mis on parim võimalik alternatiivne ravim praegu dekstropropoksüfeeni sisaldavaid ravimeid kasutavatele patsientidele.
English: In the meantime, it is recommended that no new patients are started on dextropropoxyphene-containing medicines.
Estonian: Seetõttu on soovitatav, et ravi dekstropropoksüfeeni sisaldavate ravimitega ei alustataks vahepeal uutel patsientidel.
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.
Estonian: • Patsiendid, kellel on dekstropropoksüfeeni sisaldavaid ravimeid, mida nad enam ei kasuta,
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.
Estonian: Inimravimite komitee märkis, et surmaga lõppenud üleannustamisjuhtude ja mürgistusravikeskuste andmetes hinnati dekstropropoksüfeeni sisaldavate ravimite üleannustamisest põhjustatud surmajuhtumite arvu väiksemana kui tegelikkuses.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Metalyse on 23 February 2001.
Estonian: Euroopa Komisjon andis Metalyse müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 23. veebruaril 2001.
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.
Estonian: Euroopa avaliku hindamisaruande täistekst Metalyse kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Around 94% of patients who received either medicine were alive 30 days after treatment.
Estonian: Ligikaudu 94% kumbagi ravimit saanud patsientidest oli 30 päeva pärast ravi elus.
English: Metalyse tenecteplase
Estonian: Metalyse tenekteplaas
English: The main measure of effectiveness was the number of patients who were alive 30 days after treatment.
Estonian: Efektiivsuse põhinäitaja oli nende patsientide arv, kes olid 30 päeva pärast ravi elus.
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.
Estonian: Sellest ja olemasolevatest andmetest lähtudes otsustas komitee, et Metalyse kasulikkus on suurem kui sellega kaasnevad riskid, ning soovitas anda ravimi müügiloa.
English: Treatment with Metalyse should be started as soon as possible after the start of heart attack symptoms.
Estonian: Ravi Metalysega tuleb alustada võimalikult kiiresti pärast südameinfarkti sümptomite ilmnemist.
English: The dose to be given is adjusted according to the patient's weight (see the package leaflet).
Estonian: Ravimi annust kohandatakse vastavalt patsiendi kehakaalule (vt pakendi infoleht).
English: If treatment is necessary in these patients, facilities for resuscitating them must be readily available.
Estonian: Kui sellistele patsientidele tuleb siiski ravimit anda, peavad olema käepärast elustamisvahendid.
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.
Estonian: Inimravimite komitee märkis, et Metalyse oli surma ennetamisel sama efektiivne kui alteplaas, kuid põhjustas kergemat verejooksu, mistõttu vajadus vereülekande järele oli väiksem.
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.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
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.
Estonian: Verehüüvete lagundamine hõlbustab vere voolu südamelihasesse, parandades südame tööd ja päästes nii patsiendi elu.
English: For more information about treatment with Metalyse, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Metalysega toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: This document is a summary of the European Public Assessment Report (EPAR) for Metalyse.
Estonian: See on ravimi Metalyse Euroopa avaliku hindamisaruande kokkuvõte.
English: It works by converting a protein in the clots called plasminogen into its active form, plasmin, which breaks down the fibrous protein holding the clot together.
Estonian: See muundab verehüüvetes sisalduva proteiini plasminogeeni selle aktiivseks vormiks plasmiiniks, mis lagundab verehüübeid kooshoidvat fibriini.
English: Metalyse should not be used in patients who have or have had recent bleeding problems or major surgery, or have a disease which may cause bleeding (such as a past stroke or severe high blood pressure).
Estonian: Metalyset ei tohi kasutada ka patsiendid, kellel on hiljuti olnud probleeme verejooksuga või kes on teinud läbi suurema kirurgilise operatsiooni või kes põevad mõnd haigust, mis võib põhjustada verejooksu (nt eelnev insult või raskekujuliselt kõrge vererõhk).
English: The patients were given either medicine within six hours of their symptoms appearing in addition to either aspirin or heparin.
Estonian: Patsientidele anti kuue tunni jooksul pärast sümptomite ilmnemist ühte neist ravimitest (lisaks aspiriinile või hepariinile).
English: The most common bleedings (seen in between 1 and 10 patients in 100) are epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), ecchymosis (bleeding beneath the skin), urogenital haemorrhage (bleeding from the structures that carry urine or from the genital area), bleeding at the injection site, and bleeding at puncture site.
Estonian: Sagedamad verejooksud (esinenud 1-10 patsiendil 100st) on epistaksis (ninaverejooks), seedekulgla hemorraagia (verejooks maos või sooles), ekhümoos (verevalum), kuse-suguelundite verejooks ja süstekoha verejooks.
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.
Estonian: Tenekteplaasi valmistatakse rekombinant-DNA-tehnika abil: seda toodab rakk, millele on lisatud selle tekkimist võimaldav geen (DNA).
English: Metalyse was compared with alteplase (another medicine used to treat heart attacks) in one main study involving about 17,000 adults who were having a heart attack.
Estonian: Metalyset võrreldi alteplaasiga (samuti südameinfarktiravim) põhiuuringus, milles osales 17 000 südameinfarktiga täiskasvanut.
English: What is the risk associated with Metalyse?
Estonian: Mis riskid Metalysega kaasnevad?
English: Metalyse should not be used in people who have had an anaphylactic reaction (a severe, lifethreatening allergic reaction) to tenecteplase, gentamicin (an ingredient found in the medicine) or any of the other ingredients.
Estonian: Metalyset ei tohi kasutada patsiendid, kel on olnud anafülaktiline reaktsioon (eluohtlik allergiline reaktsioon) tenekteplaasi, gentamütsiini või ravimi mis tahes muu koostisaine suhtes.