FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, the Agency's view was that, as for Zavesca, the benefit of Miglustat Dipharma outweighs the identified risk and it can be authorised for use in the EU.
Estonian: Seetõttu on amet arvamusel, et nagu ka Zavesca korral, ületab Miglustat Dipharma kasulikkus sellega kaasnevad riskid ja et ravimi kasutamise võib ELis heaks kiita.
English: • adults (aged 18 years and above) with mild to moderate type-1 Gaucher disease.
Estonian: • Kerge kuni mõõduka 1. tüüpi Gaucher' tõvega täiskasvanud (vähemalt 18-aastased).
English: As for all medicines, data on the use of Miglustat Dipharma are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse ravimi Miglustat Dipharma kasutamise kohta pidevat järelevalvet.
English: By preventing the enzyme from working, miglustat can reduce the production of glucosylceramide in cells, thereby reducing the symptoms of type-1 Gaucher disease.
Estonian: Pärssides ensüümi toimet, vähendab miglustaat glükosüültseramiidi teket rakkudes, vähendades seega 1. tüüpi Gaucher' tõve sümptomeid.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Miglustat Dipharma have been included in the summary of product characteristics and the package leaflet.
Estonian: Ravimi Miglustat Dipharma ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Studies on the benefits and risks of the active substance in Gaucher disease have already been carried out with the reference medicine, Zavesca, and do not need to be repeated for Miglustat Dipharma.
Estonian: Võrdlusravimiga Zavesca on juba tehtud toimeaine kasulikkuse ja riski uuringud kasutamisel Gaucher' tõve ravis ning neid ei ole vaja ravimiga Miglustat Dipharma korrata.
English: What is Miglustat Dipharma and what is it used for?
Estonian: Mis on Miglustat Dipharma ja milleks seda kasutatakse?
English: Miglustat Dipharma is used in patients who cannot receive the standard treatment of enzymereplacement therapy (ERT);
Estonian: Miglustat Dipharmat kasutatakse patsientidel, kes ei saa kasutada standardset ensüümasendusravi.
English: This enzyme is involved in the first step of the production of glucosylceramide.
Estonian: See ensüüm osaleb glükosüültseramiidi tekke esimeses etapis.
English: Both diseases cause a build-up of fatty substances called glycosphingolipids in the body.
Estonian: Mõlemad haigused põhjustavad glükosfingolipiidide (teatud rasvained) ladestumist organismis.
English: As for every medicine, the company provided studies on the quality of Miglustat Dipharma.
Estonian: Nagu iga ravimi korral, esitas ettevõte Miglustat Dipharma kvaliteedi uuringud.
English: Miglustat Dipharma is used to treat two inherited diseases that affect the way the body handles fats.
Estonian: Miglustat Dipharmat kasutatakse organismi rasvaainevahetust mõjutava kahe päriliku haiguse raviks.
English: Miglustat Dipharma is a ‘generic medicine'.
Estonian: Miglustat Dipharma on geneeriline ravim.
English: Miglustat Dipharma is available as 100 mg capsules to be taken by mouth.
Estonian: Ravimit Miglustat Dipharma turustatakse 100 mg suukaudsete kapslitena.
English: Other information about Miglustat Dipharma
Estonian: Muu teave ravimi Miglustat Dipharma kohta
English: An overview of Miglustat Dipharma and why it is authorised in the EU
Estonian: Ülevaade ravimist Miglustat Dipharma ja ELis müügiloa väljastamise põhjendus
English: Miglustat Dipharma is used to treat the following patients:
Estonian: Miglustat Dipharmat kasutatakse järgmiste patsientide raviks.
English: The active substance in Miglustat Dipharma, miglustat, blocks an enzyme called glucosylceramide synthase.
Estonian: Miglustat Dipharma toimeaine miglustaat pärsib ensüümi glükosüültseramiidi süntaasi toimet.
English: The medicine can only be obtained with a prescription and treatment should be supervised by doctors who are experienced in the management of Gaucher disease.
Estonian: Ravi peab toimuma Gaucher' tõve ravis kogenud arsti järelevalve all.
English: How is Miglustat Dipharma used?
Estonian: Kuidas ravimit Miglustat Dipharma kasutatakse?
English: How has Miglustat Dipharma been studied?
Estonian: Kuidas ravimit Miglustat Dipharma uuriti?
English: How does Miglustat Dipharma work?
Estonian: Kuidas Miglustat Dipharma toimib?
English: What are the benefits and risks of Miglustat Dipharma?
Estonian: Milles seisneb ravimi Miglustat Dipharma kasulikkus ja mis riskid ravimiga kaasnevad?
English: [the below currently approved indications should be deleted (specific wording of the indication may vary from product to product)]
Estonian: 4.1 Näidustused allpool loetletud praegu heakskiidetud näidustused tuleks kustutada (konkreetse näidustuse sõnastus võib ravimitel erineda)]
English: • Symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia)
Estonian: • kroonilise patoloogilise kognitiivse ja neurosensoorse häire (välja arvatud Alzheimeri tõbi ja dementsuse teised vormid) sümptomaatiline ravi eakatel
English: Annex III Amendments to relevant sections of the summaries of product characteristics and package leaflets
Estonian: III lisa Parandused ravimi omaduste kokkuvõtte ja pakendi infolehe vastavates lõikudes
English: • Acute retinopathies of vascular origin
Estonian: • vaskulaarse päritoluga ägedad retinopaatiad
English: • Ancillary treatment of Raynaud's syndrome
Estonian: • Raynaud' sündroomi lisaravi
English: • Ancillary treatment of intermittent claudication in symptomatic peripheral arterial occlusive disease (PAOD Stage II)
Estonian: • vahelduva lonkamise lisaravi sümptomaatilise perifeersete arterite oklusiivse haiguse (Peripheral artery occlusive disease PAOD II aste) korral
English: All references to the above mentioned indications should be deleted from the relevant sections of the package leaflets.
Estonian: Pakendi infolehe vastavatest lõikudes tuleks kustutada kõik viited ülalmainitud näidustustele.
English: • Prophylaxis of migraine headache All references to the above mentioned indications should be deleted from the remaining relevant sections of the summaries of product characteristics.
Estonian: • migreeni peavalu ennetamine Ravimi omaduste kokkuvõtt vastavates lõikudes tuleks kustutada kõik viited ülalmainitud näidustustele.
English: • Ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin
Estonian: • eeldatavalt vaskulaarse päritoluga nägemisteravuse halvenemise ja nägemisvälja häirete lisaravi
English: Overall conclusion
Estonian: Üldjäreldus
English: This was reflected in the product information in order to adequately inform healthcare providers and patients.
Estonian: See teave lisati ravimiteabesse tervishoiutöötajate ja patsientide informeerimiseks.
English: Annex II Scientific conclusions and grounds for the variation to the terms of the marketing authorisations
Estonian: II lisa Teaduslikud järeldused ja müügilubade tingimuste muutmise alused
English: Grounds for PRAC recommendation
Estonian: Riskihindamiskomitee soovituse alused
English: Nevertheless, the PRAC considered that the efficacy of acipimox in lowering blood lipids in patients with some forms of hyperlipoproteinaemia is demonstrated.
Estonian: Riskihindamiskomitee märkis siiski, et atsipimoksi efektiivsus vere lipiidisisalduse vähendamisel teatud hüperlipoproteineemia vormidega patsientidel on tõestatud.
English: The PRAC considered that the clinical development data on acipimox was very limited and noted that no clinical outcome studies were conducted.
Estonian: Riskihindamiskomitee leidis, et atsipimoksi kliinilise väljatöötamise andmed on väga piiratud, ja märkis, et kliinilisi ravitulemusi hindavaid uuringuid ei ole korraldatud.
English: • The PRAC considered that the available safety data identified a potential risk of muscle toxicity, for which a warning was added to the product information.
Estonian: • riskihindamiskomitee leidis, et olemasolevad ohutusandmed viitavad lihastoksilisuse võimalikule riskile, mille hoiatus lisati ravimiteabesse.
English: • The PRAC reviewed the totality of the available data, including studies and publications on acipimox, the MAH responses as well as relevant data on nicotinic acid, including the AIM-HIGH and HPS2-THRIVE studies;
Estonian: • riskihindamiskomitee vaatas läbi kõik olemasolevad andmed, sealhulgas atsipimoksiga toimunud uuringud ja publikatsioonid, müügiloa hoidja vastused ning nikotiinhappe kohta olemasolevad asjakohased andmed, sh uuringud AIM-HIGH ja HPS2-THRIVE;
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data for nicotinic-acid and related substances initiated by Denmark and decided to restrict the scope of the procedure to products containing acipimox, the only high-dose nicotinic acid-related substance indicated in lipid disorders authorised in the EU;
Estonian: • riskihindamiskomitee arutas Taani algatatud direktiivi 2001/83/EÜ artikli 31 kohast menetlust, mis tulenes nikotiinhappe ja sarnaste ainete ravimiohutuse andmetest, ning otsustas piirata menetluse ulatust üksnes atsipimoksi sisaldavatele ravimitele, sest see on ainus nikotiinhappe sarnast ainet suures annuses sisaldav ravim, mis on näidustatud lipiidihäirete raviks ja millel on Euroopa Liidus müügiluba;
English: The safety data available for acipimox, including data on nicotinic acid obtained from HPS2-THRIVE, showed that the safety profile of acipimox is well characterised.
Estonian: Atsipimoksi ohutusandmed, sealhulgas uuringu HPS2-THRIVE andmed nikotiinhappe kohta näitasid, et atsipimoksi ohutusprofiil on hästi kirjeldatud.
English: • The PRAC considered that acipimox is efficacious in reducing triglyceride levels in patients with hypertriglyceridaemia (Fredrickson type IV hyperlipoproteinaemia) and with hypercholesterolaemia and hypertriglyceridaemia (Fredrickson type IIb hyperlipoproteinaemia) but only, on the basis of available evidence including current medical knowledge on the use of acipimox, as a second or third line agent in patients who have not responded adequately to other treatments such as statin or fibrate treatment;
Estonian: • riskihindamiskomitee järeldas, et atsipimoks on efektiivne vere triglütseriidisisalduse vähendamisel hüpertriglütserideemiaga patsientidel (Fredricksoni IV tüüpi hüperlipoproteineemia) ning hüperkolesteroleemia ja hüpertriglütserideemiaga patsientidel (Fredricksoni IIb tüüpi hüperlipoproteineemia), aga olemasolevate andmete, sealhulgas meditsiiniliste teadmiste alusel atsipimoksi kasutamise kohta üksnes teise või kolmanda valiku ravimina patsientidel, kes ei ole piisaval määral reageerinud muudele ravimitele, nagu statiinid või fibraadid;
English: The PRAC also noted that according to the experts, the current data available did not have any major impact on the safety profile of acipimox.
Estonian: Riskihindamiskomitee märkis ka, et spetsialistide arvates ei mõjutanud uued andmed oluliselt atsipimoksi ohutusprofiili.
English: However, taking into account the available data as well as the current use of the product and on the basis of expert advice, the PRAC was of the opinion that acipimox should only be used to reduce triglyceride levels in patients who either do not tolerate statin or fibrates or who do not achieve triglyceride goals with statin or fibrate therapy alone and should therefore be used as an alternative or adjunct treatment to reduce triglyceride levels in these patients.
Estonian: Arvestades olemasolevaid andmeid, atsipimoksi praegust kasutamist ja spetsialistide nõuannet, oli riskihindamiskomitee samas arvamusel, et atsipimoksi tohib vere triglütseriidisisalduse vähendamiseks kasutada üksnes patsientidel, kes ei talu statiine või fibraate või kellel ei saavutata ainult satiin- või fibraatraviga vere triglütseriidisisalduse sihtväärtusi, mistõttu atsipimoks on sellistel patsientidel vere triglütseriidisisalduse vähendamisel alternatiivne või täiendav ravim.
English: A review of all available data was undertaken by the Pharmacovigilance Risk Assessment Committee (PRAC) to assess the above safety concerns and their impact on the benefit-risk balance of the centrally authorised combination products Tredaptive, Trevaclyn and Pelzont.
Estonian: Riskihindamiskomitee vaatas läbi kõik olemasolevad andmed, et hinnata neid ohutusprobleeme ning nende mõju tsentraalse müügiloaga kombinatsioonravimite Tredaptive, Trevaclyni ning Pelzonti kasulikkuse ja riski tasakaalule.
English: The PRAC concluded that the benefit-risk balance of acipimox-containing products remains favourable under normal conditions of use, subject to the agreed changes to the product information.
Estonian: Riskihindamiskomitee järeldas, et atsipimoksi sisaldavate ravimite kasulikkuse ja riski tasakaal on tavatingimustel kasutamisel endiselt soodne, kui ravimiteabesse tehakse kokkulepitud muudatused.
English: Following the conclusion of these procedures, the PRAC was of the view that the concerns regarding the combination products may also be of relevance for the mono-component products and the Danish Health and Medicines Authority therefore initiated a review under Article 31 of Directive 2001/83/EC to assess the impact of the HPS2-THRIVE data on the benefitrisk balance of these products and to give its recommendation on whether their marketing authorisations should be maintained, varied, suspended or revoked and if the supply of the medicinal product should be prohibited.
Estonian: Sel põhjusel algatas Taani ravimiamet direktiivi 2001/83/EÜ artikli 31 kohase menetluse, et hinnata uuringu HPS2-THRIVE andmete mõju ravimite kasulikkuse ja riski tasakaalule, ning palus riskihindamiskomiteel esitada arvamus, kas ravimite müügiload tuleb säilitada, muuta, peatada või tühistada ning ravimite turustamine keelata.
English: Based on the available data, acipimox was considered to be efficacious in reducing triglyceride levels in patients with hypertriglyceridaemia (Fredrickson type IV hyperlipoproteinaemia) and significantly superior to placebo in patients with hypercholesterolaemia and hypertriglyceridaemia (Fredrickson type IIb hyperlipoproteinaemia).
Estonian: Olemasolevate andmete järgi oli atsipimoks efektiivne vere triglütseriidisisalduse vähendamisel hüpertriglütserideemiaga patsientidel (Fredricksoni IV tüüpi hüperlipoproteineemia) ning platseebost oluliselt parem hüperkolesteroleemia ja hüpertriglütserideemiaga patsientidel (Fredricksoni IIb tüüpi hüperlipoproteineemia).
English: The PRAC therefore revised the indication accordingly.
Estonian: Riskihindamiskomitee muutis seepärast atsipimoksi näidustust.
English: As a result of the review, the PRAC recommended the suspension of the marketing authorisations of these products.
Estonian: Hindamise tulemusel soovitas riskihindamiskomitee peatada ravimite müügiload.
English: It was noted that acipimox was of particular use in patients who either do not tolerate a statin or do not achieve triglyceride goals with statin therapy alone and could therefore be used as an alternative or adjunct treatment to reduce triglyceride levels in these patients.
Estonian: Riskihindamiskomitee märkis, et atsipimoksi kasutatakse eelkõige patsientidel, kes ei talu statiini või kellel ei saavutata ainult statiinraviga triglütseriidisisalduse sihtväärtusi ja kellele seetõttu manustatakse atsipimoksi vere triglütseriidisisalduse vähendamiseks alternatiivse või täiendava ravimina.
English: On 19 December 2012, the European Medicines Agency was made aware of preliminary results from a large randomised clinical study (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events - HPS2-THRIVE) designed to assess the incremental benefit of extended release nicotinic acid (ERN)/laropiprant (LRPT) versus placebo in over 25,673 high-risk patients.
Estonian: 19. detsembril 2012 teatati Euroopa Ravimiametile ulatusliku randomiseeritud kliinilise uuringu (HDLravi mõju südamele käsitlenud uuring Heart Protection Study 2 - Treatment of HDL to Reduce Incidence of Vascular Events, HPS2-THRIVE) esialgsetest tulemustest.
English: Having considered the matter, the PRAC therefore recommended the variation of the marketing authorisations for acipimox-containing medicinal products.
Estonian: Pärast teema arutamist soovitas riskihindamiskomitee muuta atsipimoksi sisaldavate ravimite müügilube.
English: Having reviewed the list of EU products containing nicotinic acid or related substances, the PRAC noted that acipimox is the only high-dose substance indicated in lipid disorders still authorised in the EU and the scope of the procedure was therefore restricted to acipimox-containing products.
Estonian: Pärast Euroopa Liidus müügiluba omavate nikotiinhapet või sarnaseid aineid sisaldavate ravimite loetelu ülevaatamist leidis riskihindamiskomitee, et ainus nikotiinhappega sarnast ainet suures annuses sisaldav ravim, mis on Euroopa Liidus endiselt näidustatud lipiidihäirete raviks, on atsipimoks.
English: The CMDh, having considered the PRAC recommendation pursuant to article 107k of Directive 2001/83/EC dated 7 November 2013, reached a position on the variation to the terms of the marketing authorisations of acipimox for which the relevant sections of the summary of product characteristics and package leaflets are set out in Annex III.
Estonian: Riskihindamiskomitee 7. novembri 2013 soovitusega direktiivi 2001/83/EÜ artikli 107k kohaselt tutvununa jõudis inimravimite vastastikuse tunnustamise ja detsentraliseeritud menetluse koordineerimisrühm seisukohale, et atsipimoksi müügilube tuleb muuta.
English: The PRAC, as a consequence, concluded that the benefit-risk balance of the medicinal products containing acipimox identified in Annex I remains favourable, subject to the agreed changes to the product information.
Estonian: Sel põhjusel järeldas riskihindamiskomitee, et atsipimoksi sisaldavate ravimite (vt I lisa) kasulikkuse ja riski tasakaal on endiselt soodne, kui ravimiteabesse tehakse kokkulepitud muudatused.
English: The PRAC also agreed that acipimox should not be indicated for increasing HDL-C or for cardiovascular prevention in line with the recent data casting doubts on the association between elevating HDL-C levels and reducing the risk of cardiovascular disease.
Estonian: Riskihindamiskomitee leidis, et hiljutiste andmete alusel, mis seavad kahtluse alla HDLkolesterooli sisalduse suurendamise ning südame-veresoonkonnahaiguste riski vähenemise seose, ei peaks atsipimoks olema näidustatud HDL-kolesterooli sisalduse suurendamiseks või südameveresoonkonnahaiguste ennetamiseks.
English: The preliminary results of the HPS2-THRIVE study showed that the study did not meet its primary endpoint (reduction of the risk of major vascular events such as heart attack and stroke) as well as a statistically significant increase in the incidence of non-fatal but serious adverse events in the nicotinic acid/laropiprant group compared to the placebo group.
Estonian: Uuringu HPS2-THRIVE esialgsete tulemuste järgi ei saavutatud uuringus esmast tulemusnäitajat (oluliste vaskulaarsete sündmuste, nt müokardiinfarkti ja ajuinsuldi riski vähenemine).
English: PRAC recommendation
Estonian: Ravimiohutuse järelevalve riskihindamiskomitee soovitus
English: Having reviewed all the available data, including studies and publications on acipimox as well as data on the related substance nicotinic acid, including the AIM-HIGH and HPS2-THRIVE studies, the PRAC considered the efficacy of acipimox in the treatment of certain well-defined lipid disorders to be demonstrated and that acipimox therefore remains a treatment alternative in the management of lipid disorders characterised by elevated plasma levels of triglycerides (Fredrickson type IV hyperlipoproteinaemia), or both triglycerides and cholesterol
Estonian: Olles tutvunud kõigi olemasolevate andmetega, sealhulgas atsipimoksi käsitlenud uuringute ja publikatsioonide ning atsipimoksiga sarnase aine nikotiinhappe teabega, sealhulgas uuringute AIMHIGH ja HPS2-THRIVE andmetega, järeldas riskihindamiskomitee, et atsipimoksi efektiivsus teatud lipiidihäirete ravis on tõendatud.
English: The CMDh considered the below PRAC recommendation dated 7 November 2013 with regard to substances related to nicotinic acid (acipimox) indicated for the treatment of lipid disorders.
Estonian: Inimravimite vastastikuse tunnustamise ja detsentraliseeritud menetluse koordineerimisrühm arutas ravimiohutuse järelevalve riskihindamise komitee alljärgmist 7. novembri 2013 soovitust, mis käsitles lipiidihäirete raviks näidustatud nikotiinhappega sarnaseid aineid (atsipimoks).
English: The PRAC also took into account the views of the European experts consulted in an Ad-Hoc expert meeting, according to which acipimox has a role as lipid-lowering therapy in well-defined settings and indications, such as the treatment of severe hypertriglyceridaemia but only as a second or third line agent.
Estonian: Nende arvates on atsipimoksil teatud kindlates olukordades ja näidustustel teatud roll vere lipiidisisaldust vähendavas ravis, näiteks raske hüpertriglütserideemia ravis, aga seda üksnes teise või kolmanda valiku ravimina.
English: Most identified adverse events are already reflected in the acipimox product information and the PRAC considered that the available data did not identify any new safety information which impacts the benefit-risk balance of acipimox, with the exception of a potential risk of muscle toxicity, which was addressed by adding a warning to the product information.
Estonian: mis võiks mõjutada atsipimoksi kasulikkuse ja riski tasakaalu, välja arvatud lihastoksilisuse võimalik risk, mis lisati uue hoiatusena ravimiteabesse.
English: This guide should be handed over to the patient.
Estonian: See juhend tuleb anda patsiendile.
English: No new significant information was identified regarding this risk.
Estonian: Riski kohta olulist uut teavet ei esitatud.
English: From these consultations it was evident that the specialists are aware of the risks discussed, but the information is not adequately reaching the patients timely and effectively.
Estonian: Nende konsultatsioonide põhjal oli ilmne, et spetsialistid on teadlikud arutatud riskidest, kuid see teave ei jõua piisavalt õigeaegselt ja efektiivselt patsientideni.
English: In the previous European review (2014)3, several educational measures for patients and healthcare professionals (HCPs) were recommended.
Estonian: Euroopa eelmises ülevaates (2014)3 soovitati mitmeid patsientide ja tervishoiutöötajate teavitusmeetmeid.
English: Several tests for chromosome damage were positive.
Estonian: Mitmed kromosoomikahjustuste analüüsid olid positiivsed.
English: In addition to the boxed text this may include a symbol/pictogram, with the details to be adapted at national level.
Estonian: Lisaks kastis olevale tekstile võib see sisaldada sümbolit/piktogrammi, mille üksikasjad otsustatakse riiklikul tasandil.
English: In addition all products should have in place a risk management plan.
Estonian: Peale selle peab kõigi ravimite jaoks olema kehtestatud riskijuhtimiskava.
English: The medicinal products will continue to be listed in the additional monitoring list.
Estonian: Asjaomased ravimid jäävad edasi täiendava järelevalve alla kuuluvate ravimite loetellu.
English: This resulted in a value which was more than 25,000 times lower than the AUC in a woman treated orally with an equal dose (single oral dose 500 mg).
Estonian: Saadud väärtus oli ligikaudu 25 000 korda väiksem kui AUC naisel, keda ennast ravitakse võrdse suukaudse annusega (ühekordne 500 mg suukaudne annus).
English: They also provided experience from clinical practice on the management of women who wish to become pregnant or are pregnant.
Estonian: Peale selle esitati nende naiste ravimise kliiniline kogemus, kes soovivad rasestuda või on rasedad.
English: However, tests for gene mutations were negative.
Estonian: Samas olid geenimutatsioonide uuringud negatiivsed.