FrancophonIA/ELRC3.0 huggingface dataset:
English: The effectiveness of NeoRecormon to treat or prevent anaemia has been studied in many studies including anaemia in chronic renal failure (1,663 patients, including some comparative studies against placebo (a dummy treatment)), autologous blood transfusion (419 patients, comparison with placebo), anaemia in premature babies (177 babies, comparison with no treatment), and in cancer patients (1,204 patients with different types of cancer, comparison with placebo).
Estonian: Muu hulgas on uuritud kroonilise neerupuudulikkusega kaasnevat aneemiat (1663 patsienti, sh mõned võrdlusuuringud platseebo ehk näiva ravimiga), autoloogset vereülekannet (419 patsienti, võrdlus platseeboga), enneaegsetel imikutel esinevat aneemiat (177 imikut, võrdlus ravi puudumisega) ja vähipatsientidel esinevat aneemiat (1204 mitmesuguste vähitüüpidega patsienti, võrdlus platseeboga).
English: • to increase the amount of blood that can be taken from adult patients with moderate anaemia who are going to have an operation and need to have a supply of their own blood before surgery (autologous blood transfusion).This is only done when blood storage procedures are not available or are insufficient because the surgery requires a large volume of blood.
Estonian: • enne operatsiooni võetava vere koguse suurendamine mõõduka aneemiaga täiskasvanud patsientidel, kellelt võetakse enne operatsiooni hilisemaks ülekandmiseks verd (autoloogne vereülekanne).Seda tehakse üksnes siis, kui verd ei ole võimalik säilitada või kui olemasolevad varud on ebapiisavad, sest operatsioonil on vaja suurt verekogust.
English: For more information about treatment with NeoRecormon, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate NeoRecormoniga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: The dose, the frequency of injection, and how long it is used for depend on why NeoRecormon is used, and are adjusted according to the patient's response to treatment.
Estonian: Annus, süstimissagedus ja kasutamise kestus sõltuvad näidustusest ning neid kohandatakse patsiendi ravivastuse järgi.
English: It also increased the amount of blood that could be taken from patients before surgery for autologous blood transfusion and reduced the need for transfusion in premature babies and in cancer patients receiving chemotherapy.
Estonian: Samuti suurendas ravim patsiendilt enne operatsiooni autoloogseks vereülekandest võetavat verekogust ning vähendas enneaegsetel imikutel ja keemiaravi saavatel vähipatsientidel vereülekande vajadust.
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 NeoRecormon.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for NeoRecormon, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati NeoRecormoni omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: In patients receiving chemotherapy or with chronic renal failure, anaemia can be caused by a lack of erythropoietin, or by the body not responding enough to the erythropoietin it has naturally.
Estonian: Keemiaravi saavatel või kroonilise neerupuudulikkusega patsientidel võib aneemiat põhjustada erütropoetiini vaegus või organismi ebapiisav reageerimine organismis looduslikult sisalduvale erütropoetiinile.
English: The types of side effects seen with NeoRecormon depend on the cause of the patient's anaemia.
Estonian: NeoRecormoni kasutamisel esinevad kõrvalnähud sõltuvad patsiendi aneemia põhjusest.
English: For the full list of all side effects reported with NeoRecormon, see the package leaflet.
Estonian: NeoRecormoni kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: In patients who are to undergo autologous blood transfusion, NeoRecormon must not be used if they have had a heart attack or stroke within the last month, if they have angina pectoris (a severe type of chest pain), or if they are at risk of deep venous thrombosis (DVT, formation of blood clots in the deep veins of the body, usually in the leg).
Estonian: NeoRecormonit ei tohi kasutada ka autoloogset vereülekannet vajavad patsiendid, kellel on viimase kuu jooksul olnud infarkt või insult, kellel on stenokardia (teatud tugev rindkerevalu) või kellel on süvaveenitromboosi risk (trombid süvaveenis, tavaliselt jalas).
English: NeoRecormon epoetin beta
Estonian: NeoRecormon beetaepoetiin
English: The active substance in NeoRecormon, epoetin beta, is a copy of a human hormone called erythropoietin.
Estonian: NeoRecormoni toimeaine beetaepoetiin on inimhormooni erütropoetiini koopia.
English: For patients with chronic renal failure, NeoRecormon can be injected into a vein or under the skin, but it must be injected under the skin in premature babies and patients receiving chemotherapy, and into a vein in patients who are going to have their blood extracted for their surgery.
Estonian: Kroonilise neerupuudulikkusega patsientidel süstitakse NeoRecormonit veeni või naha alla, kuid enneaegsetel imikutel ja keemiaravi patsientidel tuleb seda süstida naha alla.
English: It is also available as a pre-filled syringe.
Estonian: Samuti turustatakse seda eeltäidetud süstaldes.
English: NeoRecormon was more effective than placebo at increasing haemoglobin levels in patients with various types of anaemia, including those with chronic renal failure.
Estonian: NeoRecormon suurendas mitmesugust tüüpi aneemiaga patsientidel, seahulgas kroonilise neerupuudulikkusega patsientidel hemoglobiinisisaldust efektiivsemalt kui platseebo.
English: Why has NeoRecormon been approved?
Estonian: Miks NeoRecormon heaks kiideti?
English: It contains the active substance epoetin beta.
Estonian: Ravim sisaldab toimeainena beetaepoetiini.
English: • to treat anaemia (low red blood cell counts) that is causing symptoms in adults and children with chronic renal failure (long-term, progressive decrease in the ability of the kidneys to work properly);
Estonian: • sümptomaatilise aneemia (erütrotsüütide vähesuse) ravi kroonilise neerupuudulikkusega (neerutalitluse pikaajaline süvenev halvenemine) täiskasvanutel ja lastel;
English: Treatment with NeoRecormon should be initiated by a doctor who has experience in the care of patients with the types of anaemia that NeoRecormon is used to treat and prevent.
Estonian: Ravi NeoRecormoniga peab alustama NeoRecormoniga ravitavate ja ennetatavate aneemiatüüpide ravis kogenud arst.
English: NeoRecormon is a medicine that stimulates red-blood-cell growth.
Estonian: NeoRecormon on erütrotsüütide (vere punaliblede) teket stimuleeriv ravim.
English: What is NeoRecormon?
Estonian: Mis on NeoRecormon?
English: The epoetin beta in NeoRecormon works in the body in the same way as the natural hormone to stimulate red blood cell production.
Estonian: NeoRecormonis sisalduv beetaepoetiin stimuleerib organismis erütrotsüütide teket samamoodi nagu looduslik hormoon.
English: What is the risk associated with NeoRecormon?
Estonian: Mis riskid NeoRecormoniga kaasnevad?
English: For more details, see the package leaflet.
Estonian: Üksikasjalik teave on pakendi infolehel.
English: Erythropoietin is produced by the kidneys and stimulates the production of red blood cells from the bone marrow.
Estonian: Erütropoetiin tekib neerudes ja see stimuleerib erütrotsüütide teket luuüdis.
English: • to treat anaemia that is causing symptoms in adults who are receiving chemotherapy for ‘non-myeloid' cancer (cancer that does not affect the bone marrow);
Estonian: • sümptomaatilise aneemia ravi mittemüeloidsete (luuüdi mittemõjutavate) kasvajatega täiskasvanud patsientidel, kes saavad keemiaravi;
English: It is available as a powder and solvent in a multidose vial, to be made up into a solution for injection.
Estonian: Seda turustatakse süstelahuse pulbri ja lahustina mitmeannuselises viaalis.
English: How does NeoRecormon work?
Estonian: Kuidas NeoRecormon toimib?
English: What benefit has NeoRecormon shown during the studies?
Estonian: Milles seisneb uuringute põhjal NeoRecormoni kasulikkus?
English: How is NeoRecormon used?
Estonian: Kuidas NeoRecormonit kasutatakse?
English: How has NeoRecormon been studied?
Estonian: Kuidas NeoRecormonit uuriti?
English: NeoRecormon must not be used in patients who have poorly controlled high blood pressure.
Estonian: Ravimit ei tohi kasutada patsiendid, kelle hüpertensioon allub halvasti ravile.
English: What is NeoRecormon used for?
Estonian: Milleks NeoRecormonit kasutatakse?
English: In Norway most of these activities were implemented already in 1995 without any effect on the way the product was prescribed and used.
Estonian: Norras võeti enamik neist meetmetest juba 1995. aastal, ilma et see oleks mõjutanud ravimi määramist ja kasutamist.
English: GROUNDS FOR THE SUSPENSION OF THE MARKETING AUTHORISATIONS
Estonian: MÜÜGILUBADE PEATAMISE ALUSED
English: • Data demonstrating that the products can be used safely taking into account information on intoxications from poison centres in Europe.
Estonian: • andmed, mis näitavad, et ravimeid saab kasutada ohutult, võttes arvesse Euroopa mürgistuskeskustest mürgistuste kohta saadud andmeid;
English: • Detailed risk minimisation measures and ways to ensure that the impact of such measures could be adequately evaluated once in place.
Estonian: • üksikasjalikud meetmed riskide minimeerimiseks ja viisid selliste võetud meetmete mõju adekvaatse hindamise tagamiseks.
English: They include tablets and supositories available under prescription in 12 EU Member States.
Estonian: Nende hulgas on Euroopa Liidu 12 liikmesriigis retsepti alusel väljastatavad tabletid ja rektaalsuposiidid.
English: The Marketing Authorisation Holder decided on the voluntary withdrawal on the basis of the assessment performed by the Norwegian Competent Authority.
Estonian: Müügiloa hoidja otsustas need vabatahtlikult tühistada Norra pädeva asutuse läbiviidud hindamise tulemusena.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MEDICINAL PRODUCTS CONTAINING CARISOPRODOL (see Annex I)
Estonian: KARISOPRODOOLI SISALDAVATE RAVIMITE (vt I lisa) TEADUSLIKU HINNANGU ÜLDKOKKUVÕTE
English: Medicinal products containing carisoprodol have been available in Europe since 1959 and are authorised in a number of EU Member States (see Annex I for the list of carisoprodol containing medicinal products authorised in the EU).
Estonian: Karisoprodooli sisaldavaid ravimeid on turustatud Euroopas alates 1959. aastast ning neile on väljastatud müügiluba mitmes Euroopa Liidu liikmesriigis (Euroopa Liidu müügiloaga karisoprodooli sisaldavate ravimite loetelu on esitatud I lisas).
English: The pharmacokinetic part of the above mentioned study showed that the blood concentration curve of carisoprodol increases and falls rapidly.
Estonian: Eelmainitud uuringu farmakokineetika osa näitas, et karisoprodooli kontsentratsiooni veres näitav kõver tõuseb ja langeb kiiresti.
English: Several risk minimisation activities (such as restriction of the indication, recommendation of only short term treatment, supply of only small package and change of the prescription category to a more restrictive) have been proposed by the MAHs.
Estonian: Müügiloa hoidjad on kavandanud mitut meedet riskide minimeerimiseks (näiteks näidustuse piiramine, soovitamine ainult lühiajaliseks raviks, turustamine ainult väikestes pakendites ja retseptinõuete rangemaks muutmine).
English: For other indications authorised in some countries it must be concluded that the efficacy is not documented, but it is based on anecdotal reports on clinical effect.
Estonian: Seoses teiste näidustustega, mille kohta on teatavates riikides müügiluba väljastatud, tuleb järeldada, et efektiivsust ei ole dokumenteeritud, vaid see põhineb kliinilise toime ebamäärastel tõenditel.
English: On 20 April 2007, the Norwegian Competent Authority (NoMA) issued a Rapid Alert informing the Member States, the EMEA and the European Commission in accordance with Article 107 of Directive 2001/83/EC, as amended, of the decision by the Marketing Authorisation Holder Actavis to voluntarily withdraw as of 1 May 2008 the Marketing Authorisations for carisoprodol containing medicinal products in its Member State.
Estonian: Norra pädev asutus andis 20. aprillil 2007 kiirhoiatuse, milles teatas liikmesriikidele, Euroopa Ravimiametile ja Euroopa Komisjonile muudetud direktiivi 2001/83/EÜ artikli 107 kohaselt müügiloa hoidja Actavise otsusest tühistada oma liikmesriigis vabatahtlikult alates 1. maist 2008 kõikide karisoprodooli sisaldavate ravimite müügiload.
English: The CHMP discussed the matter at its September 2007 plenary meeting and the procedure in accordance with Article 107(2) of Directive 2001/83/EC, as amended was started at the September 2007 CHMP meeting.
Estonian: Inimtervishoius kasutatavate ravimite komitee arutas seda küsimust 2007. aasta septembris toimunud plenaaristungil ning menetlust muudetud direktiivi 2001/83/EÜ artikli 107 lõike 2 alusel alustati komitee 2007. aasta septembris toimunud koosolekul.
English: This means that adverse drug reactions related to high carisoprodol concentrations are easier to identify.
Estonian: See tähendab, et karisoprodooli suurte kontsentratsioonidega seotud kõrvalnähte on kergem tuvastada.
English: These symptoms are attributable to the low therapeutic index of carisoprodol.
Estonian: Need sümptomid tulenevad karisoprodooli väikesest terapeutilisest indeksist.
English: In one of these studies it was concluded that patients receiving carisoprodol seemed to have an increased risk of being involved in traffic accidents involving person injury.
Estonian: Ühes neist uuringutest jõuti järeldusele, et karisoprodooli kasutavatel patsientidel näis suurenevat vigastusi põhjustavatesse liiklusõnnetustesse sattumise oht.
English: In the recent observational studies the prescribing patterns continued to be distorted.
Estonian: Hiljutistes vaatlusuuringutes täheldati ravimi määramisviisi jätkuvat moonutamist.
English: The lack of recent safety studies comparing carisoprodol to other analgesic products with a better studied safety profile available for the same indication emphasizes the need for further systematic investigation.
Estonian: Et puuduvad uuemad ohutusuuringud, milles karisoprodooli on võrreldud muude valuvaigistitega, mille ohutusprofiili sama näidustuse korral on uuritud paremini, on vaja edasisi süstemaatilisi uuringuid.
English: The three observational studies published in Norway in 2007 gave evidence for the signals of abuse and impairment identified by the spontaneous reporting system in Norway.
Estonian: Kolm Norras 2007. aastal avaldatud vaatlusuuringut näitasid ravimi väärkasutust ja funktsioonide halvenemist, mille kohta oli varem saadud andmeid Norra spontaansete teadete süsteemist.
English: The MAHs of carisoprodol containing products have not provided any sound clinical data, which would demonstrate the efficacy of carisoprodol.
Estonian: Karisoprodooli sisaldavate ravimite müügilubade hoidjad ei ole esitanud usaldusväärseid kliinilisi andmeid, mis võiksid näidata karisoprodooli efektiivsust.
English: The Committee in light of the above findings concluded that the benefit/risk balance of carisoprodol containing medicinal products is no longer positive.
Estonian: jõudis komitee eelnimetatud tulemusi silmas pidades otsusele, et karisoprodooli sisaldavate ravimite kasulikkuse ja riski suhe ei ole enam soodne.
English: Therefore, in practice a safe pattern of use of carisoprodol containing products is difficult to achieve in many patients.
Estonian: Sel põhjusel on paljude patsientide korral praktikas raske saavutada karisoprodooli sisaldavate ravimite ohutut kasutamist;
English: All carisoprodol containing medicinal products in the EU are authorised according to national procedures.
Estonian: Kõikidele karisoprodooli sisaldavatele ravimitele on antud Euroopa Liidus müügiluba riigisisese menetluse tulemusena.
English: The Committee considered that carisoprodol is indicated primarily for acute low back pain, however, because of the nature of low back pain this has resulted in a tendency for more chronic use of the drug, increasing the risk of dependence.
Estonian: komitee leidis, et karisoprodool on näidustatud eelkõige ägeda alaseljavalu raviks, kuid et alaseljavalu iseloomu tõttu on kaldutud ravimit kasutama näidustusest kroonilisemalt, mis suurendab sõltuvuse riski.
English: Carisoprodol is a centrally acting drug mainly indicated for short-term treatment of acute lower back pain.
Estonian: Karisoprodool on kesknärvisüsteemile toimet avaldav ravim, mis on põhiliselt näidustatud ägeda alaseljavalu lühiajaliseks raviks.
English: In the results from the study which was submitted during this procedure sedation, psychomotor impairment and other impairments were observed about 1.5 hour after ingestion, indicating these are effects associated with carisoprodol itself and not its metabolites.
Estonian: Käesoleva menetluse käigus esitatud uuringu tulemuste kohaselt täheldati sedatsiooni, psühhomotoorsete funktsioonide halvenemist ja seisundi muud halvenemist ligikaudu 1,5 tundi pärast manustamist, mis näitas, et need toimed seondusid karisoprodooli enda ja mitte selle metaboliitidega.
English: The study gave support to earlier work published on the impairing effects of carisoprodol.
Estonian: Selle uuringuga toetati varasemaid publikatsioone karisoprodooli kahjuliku mõju kohta tervisele.
English: In this perspective it is considered that unless the risk minimisation measures can be monitored and their impact can be evaluated accurately they could not be a valuable point in the evaluation of the use of carisoprodol.
Estonian: Seda silmas pidades leitakse, et riskide minimeerimiseks võetud meetmetest võib olla karisoprodooli kasutamise hindamisel kasu vaid sel juhul, kui nende üle on võimalik teha järelevalvet ja nende mõju täpselt hinnata.
English: In addition there is information on spontaneous reports as well as reports from poison centers in Europe and in the US that there are problems related to intoxications.
Estonian: Peale selle viitavad mürgistustega seotud probleemidele andmed spontaansete teadete ning Euroopa ja USA mürgistuskeskustest saadud teadete kohta.
English: The serum concentrations for carisoprodol together with the pharmacodynamic results on somnolence found in this study clearly confirmed the Norwegian observational study results that there should be strong warnings against the use of motor vehicle due to somnolence when using carisoprodol medication.
Estonian: Karisoprodooli seerumikontsentratsioonid koos selle uuringu farmakodünaamika tulemustega unisuse kohta kinnitasid selgelt Norra vaatlusuuringu tulemusi, mille kohaselt karisoprodooli sisaldavaid ravimeid kasutavaid patsiente tuleb kindlalt hoiatada, et nad unisuse tekkimise ohu tõttu ei juhiks mootorsõidukit.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR SUSPENSION OF THE MARKETING AUTHORISATIONS PRESENTED BY THE EMEA
Estonian: LISA II EUROOPA RAVIMIAMETI ESITATUD TEADUSLIKUD JÄRELDUSED NING MÜÜGILUBADE PEATAMISE ALUSED
English: • Data demonstrating convincing efficacy and safety derived from appropriately designed clinical trials (including an active comparator) and data justifying the proposed dose.
Estonian: • sobiva ülesehitusega kliinilistest uuringutest (milles on kasutatud aktiivset võrdlusravimit) saadud andmeid, mis tõestavad veenvalt ravimi efektiivsust ja ohutust ning põhjendavad kavandatud annust;
English: As pharmacological studies with carisoprodol have been limited to single dose studies, there have been some uncertainties to the mechanism for the observed effects of carisoprodol and whether they are associated with carisoprodol itself or with its metabolites.
Estonian: Et karisoprodooli farmakoloogilistes uuringutes on piirdutud ühekordse annuse uurimisega, on olnud teataval määral ebaselge, milline on karisoprodooli täheldatud toimete mehhanism ja kas need on olnud seotud karisoprodooli enda või selle metaboliitidega.
English: Taking all these elements into account, the CHMP concluded that the benefit/risk ratio for carisoprodol is not considered favourable and recommended the suspension of the Marketing Authorisations for the medicinal products referred to in Annex I.
Estonian: Kõiki neid asjaolusid arvesse võttes jõudis inimtervishoius kasutatavate ravimite komitee otsusele, et karisoprodooli kasulikkuse ja riski suhet ei saa pidada soodsaks, ning soovitas I lisas loetletud ravimite müügiload peatada.
English: Furthermore the CHMP took note that there are other effective medications with a more favourable safety profile for the treatment of acute low back pain.
Estonian: Peale selle märkis komitee, et ägeda alaseljavalu raviks on ka muid efektiivseid soodsama ohutusprofiiliga ravimeid,
English: Alternative options are available in the EU for the concerned indications.
Estonian: Euroopa Liidus turustatakse nende näidustuste jaoks muid ravimeid.
English: In addition there is data from poison information centres confirming these concerns.
Estonian: Peale selle kinnitavad neid probleeme mürgistuskeskustest saadud andmed;
English: A number of articles describing its abuse potential, toxicity and dependence have been published.
Estonian: Ravimi võimalikku väärkasutamist, mürgistusi ja sõltuvust on kirjeldatud mitmes artiklis.
English: The Committee considered the procedure under Article 107 of Directive 2001/83/EC, as amended, for medicinal products containing carisoprodol;
Estonian: inimtervishoius kasutatavate ravimite komitee vaatas läbi muudetud direktiivi nr 2001/83/EÜ artikli 107 kohaselt esitatud esildise karisoprodooli sisaldavate ravimite kohta;
English: Acute lower back pain is the only indication that has been documented by three randomised, controlled clinical studies using carisoprodol 350mg performed in the 60's and 70's and which do not fulfill current stardard for the Phase III clinical trials.
Estonian: Kolmes 1960.-1970. aastatel tehtud randomiseeritud ja kontrollitud kliinilises uuringus, milles kasutati karisoprodooli 350 mg, ja mis praegustele III faasi kliiniliste uuringute nõuetele ei vasta, dokumenteeriti ainsa näidustusena äge alaseljavalu.
English: The proof of efficacy for different dosing of carisoprodol and for combination products is missing completely.
Estonian: Karisoprodooli eri annuste efektiivsus ja selle efektiivsus kasutamisel koos teiste ravimitega on täiesti tõestamata.
English: The Committee considered that the efficacy of carisoprodol containing products is poorly documented; only three relatively old studies are available to demonstrate efficacy in acute low back pain.
Estonian: Ravimi efektiivsus ägeda alaseljavalu korral on tõestatud ainult kolmes suhteliselt vanas uuringus.
English: The Committee concluded that there is increasing evidence for carisoprodol-associated risk of abuse, psychomotor impairment and intoxications.
Estonian: komitee leidis, et on üha rohkem andmeid karisoprodooliga seotud väärkasutuse, psühhomotoorsete funktsioonide halvenemise ja mürgistuse riski kohta.
English: Thus the CHMP recommended the suspension of the Marketing Authorisations for all carisoprodol containing medicinal products listed in Annex I. For the suspension to be lifted the Marketing Authorisation Holders would need to provide:
Estonian: Inimtervishoius kasutatavate ravimite komitee soovitas seepärast kõikide I lisas loetletud karisoprodooli sisaldavate ravimite müügiload peatada.
English: Carisoprodol is associated with a risk of abuse, psychomotor impairment and intoxication.
Estonian: Karisoprodooliga seondub väärkasutuse, psühhomotoorsete funktsioonide halvenemise ja mürgistuse oht.