FrancophonIA/ELRC3.0 huggingface dataset:
English: Most of the literature provided by the Applicant concerned the administration of an oral solid dosage form, i.e. tablet.
Estonian: Enamik taotleja esitatud kirjandusandmetest käsitles suukaudse tahke ravimvormi, st tableti manustamist.
English: Although the “Guideline on the investigation of bioequivalence (CPMP/PWP/EWP/1401/98 Rev 1/Corr)” states: “In those cases where the test product is an oral solution which is intended to be bioequivalent to another immediate release oral dosage form, bioequivalence studies are required”, the application of a BCS-based biowaiver to bridge data from different pharmaceutical forms was considered to have been adequately justified from a scientific point of view, by provision of parallel artificial membrane permeability assay (PAMPA) data, literature and dissolution data, demonstrating that Dexamethasone drug substance has biopharmaceutical characteristics of BCS Class I/III, and that the excipients have no adverse affects on bioavailability.
Estonian: Ehkki bioekvivalentsuse uurimise suunistes (CPMP/PWP/EWP/1401/98 Rev 1/Corr) on märgitud, et „juhtudel, kui uuritav ravim on suukaudne lahus, mis on peab olema bioekvivalentne teise toimeainet kiiresti vabastava suukaudse ravimvormiga, on vaja bioekvivalentsuse uuringuid”, peeti BCSloobumise taotlust eri ravimvormide andmete ühendamiseks teaduslikult põhjendatuks, arvestades paralleelsete tehismembraanide läbilaskvuse meetodi (PAMPA) andmeid, kirjandusandmeid ja lahustuvusandmeid, mis näitasid, et deksametasoonil on biofarmatseutikumina BCS I/III klassi omadused ja et abiained ei mõjuta biosaadavust.
English: The CHMP therefore agreed that the bibliographic data provided in support of the application demonstrates the well-established use of dexamethasone sodium phosphate used in the oral solution and that a bioequivalence study was not necessary to show the relevance of the literature used in support of the pharmaceutical form concerned.
Estonian: Seetõttu nõustus inimravimite komitee, et taotluse toetuseks esitatud kirjandusandmed näitavad deksametasoonnaatriumfosfaadi hästi tõestatud meditsiinilist kasutust suukaudses lahuses ja et asjaomase ravimvormi toetuseks kasutatud kirjandusandmete asjakohasuse näitamiseks ei ole vaja bioekvivalentsuse uuringut.
English: The strength and quality of evidence gathered from the above information was considered adequate for a medicinal product with a well established and broad therapeutic index as dexamethasone.
Estonian: Ülalkirjeldatud andmetest kogutud tõendusmaterjali mõju ja kvaliteeti peeti sobivaks ravimile, millel on hästi tõestatud meditsiiniline kasutus ja suur terapeutiline vahemik nagu deksametasoonil.
English: The objecting Concerned Member State raised a potential serious risk to public health as it considered that the literature data on dexamethasone tablets that had been submitted could not be extrapolated to dexamethasone oral solution without adequate bridging data and therefore the efficacy and safety of Dexamethasone Alapis could not be demonstrated in the application.
Estonian: Vastuseisev asjaomane liikmesriik tõstatas küsimuse, et müügiluba võib ohustada rahvatervist, väites, et esitatud kirjandusandmeid deksametasooni tablettide kohta ei saa ilma asjakohaste ühendavate andmeteta ekstrapoleerida deksametasooni suukaudsele lahusele, mille tõttu ei ole ravimi Dexamethasone Alapis efektiivsus ja ohutus taotluses tõendatud.
English: Whereas, - the Applicant has provided sufficient literature data to demonstrate well-established use of dexamethasone, - efficacy and safety of dexamethasone has been adequately shown in the indications applied for - adequate bridging data between the tablet formulation and the oral solution formulation have been provided by the Applicant, the CHMP has recommended the granting of the marketing authorisation(s) for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III of this Opinion.
Estonian: Arvestades, et - taotleja esitas piisavalt kirjandusandmeid, et tõendada deksametasooni hästi tõestatud meditsiinilist kasutust, - deksametasooni efektiivsus ja ohutus on taotletavate näidustuste osas piisavalt tõendatud, - taotleja on esitanud asjakohased andmed, mis võimaldavad ühendada tablettide ja suukaudse lahuse andmeid, soovitas inimravimite komitee anda müügiloa (müügiload), mille jaoks lepiti koordineerimisrühma menetluses kokku ravimi omaduste kokkuvõtte, märgistuse ja pakendi infolehe lõplikud versioonid, nagu on märgitud selle arvamuse III lisas.
English: Dexamethasone is a highly potent and long-acting glucocorticoid with negligible sodium retaining properties.
Estonian: Deksametasoon on väga tugev ja pikatoimeline glükokortikoid, mille naatriumi ainevahetust takistav toime on tühine.
English: According to the Appendix II of the “Guideline on the investigation of bioequivalence (CPMP/PWP/EWP/1401/98 Rev 1/Corr)”, applying for a BCS-based biowaiver is restricted to highly soluble drug substances with known human absorption and considered not to have a narrow therapeutic index.
Estonian: Bioekvivalentsuse uurimise suuniste (CPMP/PWP/EWP/1401/98 Rev 1/Corr) II lisa järgi tohib BCSloobumist taotleda ainult hästi lahustuvate toimeainete korral, mille imendumine inimesel on teada ja mille terapeutilist vahemikku ei peeta väikeseks.
English: In vivo bioequivalence studies may be exempted if an assumption of equivalence in in vivo performance can be justified by satisfactory in vitro data.
Estonian: BCS-loobumise eesmärk on vähendada in vivo bioekvivalentsuse uuringuid, mille võib ära jätta, kui in vivo toime ekvivalentsuse oletust saab põhjendada rahuldavate in vitro andmetega.
English: However, as information on the composition of the dexamethasone syrup, elixir or oral solution investigated in the provided studies was missing in all articles, some concerns were raised on whether those data could be considered as sufficient to allow bridging of the data between the tablets and the oral formulation applied for.
Estonian: Samas puudus kõikides artiklites esitatud uuringutes uuritud deksametasooni siirupi, eliksiiri või suukaudse lahuse koostise teave ja seetõttu tekkis küsimusi selle kohta, kas neid andmeid saab lugeda piisavaks, et saaks ühendada tablettide ja taotletava suukaudset ravimvormi andmeid.
English: The majority of data submitted supporting efficacy and safety with dexamethasone in the indications being sought have been obtained with tablet formulations.
Estonian: Enamik esitatud andmetest, mis toetasid deksametasooni efektiivsust ja ohutust taotletavatel näidustustel, olid saadud tablettide kasutamisel.
English: Data on the solubility and on the absorption and permeability of dexamethasone were provided by the Applicant during the decentralised and the CMD(h) referral procedure to show that Dexamethasone Alapis met all criteria for a BCS-based biowaiver.
Estonian: Detsentraliseeritud ja CMD(h) esildismenetluse ajal esitas taotleja deksametasooni lahustuvuse, imendumise ja läbivuse andmed tõendamaks, et Dexamethasone Alapis vastab kõikidele BCSloobumisloa kriteeriumidele.
English: Literature data available on the various routes of administration for the same treatment show that dexamethasone is equally effective via any administration route.
Estonian: Olemasolevad kirjandusandmed sama ravi eri manustamisteede kohta näitavad, et deksametasooni efektiivsus on manustamisteest olenemata sama.
English: Therefore, from a pharmaceutical perspective, elixirs are a type of oral solutions and are expected to behave in vivo as such.
Estonian: Seega on eliksiir farmatseutilisest aspektist suukaudsete lahuste tüüp ja eeldatavasti toimib sellena ka in vivo.
English: In order to extrapolate efficacy and safety data from these studies to the oral solution formulation applied for, the Applicant provided data that showed that irrespective of immediate release oral dosage formulation (tablet or solution), the bioavailability of dexamethasone in terms of extent and rate of absorption, was similar.
Estonian: Nende uuringute efektiivsus- ja ohutusandmete ekstrapoleerimiseks taotletavale suukaudsele lahusele esitas taotleja andmed, mis näitasid, et sõltumata toimeainet kiiresti vabastavast suukaudsest ravimvormist (tablett või lahus) on deksametasooni biosaadavus imendumise ulatuse ja kiiruse osas sarnane.
English: This corresponds to over 180 literature reports (Randomized Clinical Trials (RCTs); Reviews, Monographs (Martindale etc.).
Estonian: See vastab enam kui 180 publikatsioonile (randomiseeritud kliinilised uuringud, ülevaated, monograafiad (Martindale jt)), mis tähendab, et toimeaine deksametasooni efektiivsuse ja ohutuse kohta on olemas väga palju andmeid.
English: In addition, a few literature reports (CTs) on the efficacy and safety of dexamethasone in oral solution/syrup have been submitted in the following indications applied for:
Estonian: Samuti esitati mõni publikatsioon (kliiniliste uuringute andmed) deksametasooni suukaudse lahuse/siirupi efektiivsuse ja ohutuse kohta järgmiste taotletavate näidustuste korral:
English: As a justification for not providing bioequivalence study to bridge the data submitted on the tablet formulation and the oral solution formulation applied for, the Applicant applied for a BCS (Biopharmaceutics Classification System)-based biowaiver.
Estonian: Et põhjendada tablettide ja taotletava suukaudse lahuse andmeid ühendava bioekvivalentsuse uuringute esitamata jätmist, taotles taotleja biofarmatseutikumide klassifikatsiooni süsteemil (BCS) põhinevat loobumist.
English: The bibliography provided was considered sufficient to support the well established use of dexamethasone substance in different tablet formulations.
Estonian: Esitatud kirjandusandmeid peeti piisavaks, et toetada deksametasooni kasutamist tablettidena.
English: From the literature data provided by the Applicant, it was shown that there were no significant differences between the bioavailabilities of immediate release tablet formulations and elixir formulations of dexamethasone (irrespective of the elixir formulation used).
Estonian: Taotleja esitatud kirjandusandmetest selgus, et deksametasooni toimeainet kiirelt vabastavate tablettide ja eliksiiride biosaadavuse vahel ei olnud olulist erinevust (olenemata eliksiiri koostisest).
English: It was therefore concluded by the CHMP that efficacy and safety of dexamethasone active substance in the therapeutic indications applied for had been sufficiently demonstrated by the provided literature.
Estonian: Sel põhjusel järeldas inimravimite komitee, et deksametasooni efektiivsust ja ohutust taotletavatel näidustustel on piisavalt tõestatud esitatud kirjandusandmeteega.
English: A referral was thus triggered at the CMD(h) and the Applicant was asked to provide detailed literature and critical assessment of the efficacy and safety of dexamethasone oral solution in the indications applied for.
Estonian: Inimravimite vastastikuse tunnustamise ja detsentraliseeritud menetluste kooskõlastusrühm (CMD(h)) tegi seepärast esildise ning taotlejal paluti esitada taotletavatel näidustustel deksametasooni suukaudse lahuse efektiivsuse ja ohutuse üksikasjalik kirjandusülevaade ning kriitiline hinnang.
English: In addition, the limited number of published studies that used a solution formulation used a similar posology to the tablet formulation.
Estonian: Samuti kasutati vähestes lahuse ravivormi käsitlevates avaldatud uuringutes samasugust annustamist kui tablettide korral.
English: The CHMP assessed the dossier and the available data, including the issues raised by the objecting CMS.
Estonian: Et kokkuleppele ei jõutud, tegi CMD(h) menetluse 60. päeval esildise inimravimite komiteele, kes hindas toimikut ja olemasolevaid andmeid, sealhulgas vastuseisva asjaomase liikmesriigi tõstatatud küsimusi.
English: Additional bridging data (or its absence fully justified) between the bibliographic data and the proposed pharmaceutical product were therefore requested to the Applicant during the decentralised and the CMD(h) referral procedures.
Estonian: Seetõttu nõuti detsentraliseeritud ja CMD(h) esildismenetluse ajal taotlejalt kirjanduseandmeid ja taotluse ravimvormi andmeid ühendavaid täiendavaid andmeid (või nende puudumise täielikku põhjendamist).
English: It also showed that dexamethasone had a broad therapeutic index.
Estonian: Kirjandusandmete järgi on deksametasoonil ka suur terapeutiline vahemik.
English: The National Competent Authorities of Member States, coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the MAH:
Estonian: Pädevad riiklikud asutused, kelle tegevust koordineerib viiteliikmesriik, tagavad, et müügiloa hoidja täidab järgmised tingimused.
English: This difference was considered to be too small to be relevant.
Estonian: Leitud erinevust peeti olulisena olemiseks liiga väikeseks.
English: ‘Primary' means that the insomnia does not have any identified cause, including other medical, mental or environmental causes.
Estonian: „Primaarne” tähendab, et unetusel ei ole kindlaksmääratud põhjust, sealhulgas muud meditsiinilist, vaimset ega keskkonnaga seotud põhjust.
English: International non-proprietary name (INN): ramelteon
Estonian: Rahvusvaheline mittekaubanduslik nimetus (INN): ramelteon
English: The company had requested a re-examination of the negative opinion, but this had not yet finished when the company withdrew.
Estonian: Ettevõte oli taotlenud negatiivse arvamuse ülevaatamist, kuid see ei olnud ajaks, mil ettevõte taotluse tagasi võttis, veel lõppenud.
English: Most of the studies were carried out in sleep laboratories, but the three main studies were carried out in the ‘natural setting' (at home) in a total of 2,807 patients.
Estonian: Enamik uuringutest viidi läbi unelaborites, kuid kolm põhiuuringut viidi läbi loomulikes tingimustes kodus (kokku 2807 patsiendil).
English: All of the studies but one were short-term, lasting five weeks or less.
Estonian: Kõik uuringud peale ühe olid lühiajalised kestusega kuni viis nädalat.
English: What is Ramelteon?
Estonian: Mis on Ramelteon?
English: Ref. EMEA/CHMP/502946/2008
Estonian: London, 25. september 2008 Viide: EMEA/549003/2008
English: The main measure of effectiveness was the time taken for the patients to fall asleep.
Estonian: Peamiseks efektiivsuse näitajaks oli patsiendil uinumiseks kulunud aeg.
English: On 19 September 2008, Takeda Global Research & Development Centre (Europe) Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ramelteon, for the treatment of primary insomnia in adult patients.
Estonian: 19. septembril 2008 teatas Takeda Global Research & Development Centre (Europe) Ltd ametlikult inimravimite komiteele oma soovist võtta tagasi täiskasvanud patsientidel primaarse unetuse raviks kasutada kavatsetud ravimi Ramelteon müügiloa taotlus .
English: The Committee was also concerned that the company had not demonstrated the long-term effectiveness of Ramelteon.
Estonian: Komitee leidis, et ettevõtte ei olnud tõendanud Rameltoni pikaajalist efektiivsust.
English: The one long-term study lasted six months, during which patients spent some nights in a sleep laboratory.
Estonian: Ühe pikaajalise uuringu jooksul, mis kestis kuus kuud, magasid patsiendid mõne öö unelaboris.
English: The letter from the company notifying the EMEA of the withdrawal of the application is available here.
Estonian: Ettevõtte kiri, milles ta teatab Euroopa Ravimiametile oma taotluse tagasivõtmisest, on avaldatud siin .
English: Ramelteon was expected to be used to treat primary insomnia (difficulty falling and staying asleep, and poor quality of sleep) in patients aged 18 years or over.
Estonian: Ramelteoni kavatseti kasutada primaarse unetuse (uinumis- ja unehäired ning une halb kvaliteet) raviks vähemalt 18-aastastel patsientidel.
English: The effectiveness of Ramelteon was compared with that of placebo (a dummy treatment) in a total of about 5,400 patients.
Estonian: Ramelteoni efektiivsust võrreldi platseebo (näiva ravimi) efektiivsusega kokku ligikaudu 5400 patsiendil.
English: Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Ramelteon had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Estonian: Inimravimite komitee oli tagasivõtmise ajal seepärast arvamusel, et Ramelteoni kasulikkus ei ole küllaldaselt tõendatud ega ületa tuvastatud riske.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had given a negative opinion and did not recommend a marketing authorisation for Ramelteon for the treatment of primary insomnia in adult patients.
Estonian: Tuginedes esitatud andmete analüüsile ja ettevõtte vastusele inimravimite komitee küsimustele, oli komitee andnud taotluse tagasivõtmise ajal negatiivse arvamuse ega soovitanud anda Ramelteonile primaarse unetusega täiskasvanud patsientide raviks müügiluba.
English: Questions and answers on the withdrawal of the marketing application for Ramelteon
Estonian: Teave müügiloa taotluse tagasivõtmise kohta Ramelteon
English: In addition, in
Estonian: Ainult ühes kolmest
English: The CHMP was concerned that the company had not demonstrated the effectiveness of Ramelteon, which was measured by looking at only one aspect of insomnia, the time to fall asleep.
Estonian: Inimravimite komitee leidis, et ettevõte ei olnud Ramelteoni efektiivsust tõendanud, sest ravimi efektiivsust mõõdeti ainult ühe unetuse aspekti uinumiseks kulunud aja järgi.
English: only one of the three studies carried out in the natural setting was there a difference in the time taken to fall asleep between patients taking Ramelteon and those taking placebo.
Estonian: loomulikes tingimustes läbiviidud uuringust esines erinevus uinumiseks kulunud ajas Ramelteoni ja platseebot kasutanud patsientide vahel.
English: The company informed the CHMP that there are no ongoing clinical trials or compassionate use programs with Ramelteon in the European Union.
Estonian: Ettevõte teatas inimravimite komiteele, et Ramelteoni kliinilisi uuringuid ega ravimi eriloaga kasutamise programme praegu Euroopa Liidus ei toimu.
English: What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Ramelteon?
Estonian: Kuidas mõjutab tagasivõtmine praegu Ramelteoni kliinilistes uuringutes või eriloaga kasutamise programmides osalevaid patsiente?
English: This means that it works by attaching itself to the receptors that melatonin normally attaches to. Melatonin is a naturally occurring hormone that is involved in co-ordinating the body's sleep cycle by acting on receptors in specific areas of the brain.
Estonian: Melatoniin on looduslikult esinev hormoon, mis osaleb organismi unetsükli koordineerimises, avaldades toimet aju teatavates piirkondades asuvatele retseptoritele.
English: The active substance in Ramelteon, ramelteon, is a melatonin-receptor agonist.
Estonian: Ramelteon sisaldab toimeainena ramelteooni, mis on melatoniini retseptori agonist.
English: When other aspects of sleep were considered, Ramelteon did not have any effect.
Estonian: Muude uneaspektide osas Ramelteonil toime puudus.
English: The effects of Ramelteon were first tested in experimental models before being studied in humans.
Estonian: Enne inimuuringuid kontrolliti Ramelteoni toimet muude katsetega.
English: How is Ramelteon expected to work?
Estonian: Milline on Ramelteoni eeldatav toime?
English: What was Ramelteon expected to be used for?
Estonian: Milleks kavatseti Ramelteoni kasutada?
English: Ramelteon was expected to work in the same way as melatonin in promoting sleep.
Estonian: Ramelteoni eeldatav toime on sarnane melatoniinigasoodustada und.
English: Ramelteon is a medicine that contains the active substance ramelteon.
Estonian: Ramelteon on ravim, mis sisaldab toimeainena ramelteooni.. Seda kavatseti turustada tablettidena.
English: You may also be given other medicines if needed.
Estonian: Teile võidakse vajadusel ka teisi ravimeid anda.
English: It should not be given to children or adolescents under the age of 18 years.
Estonian: Seda ei tohi manustada lastele ega alla 18-aastastele noorukitele.
English: Abbreviations: CI = confidence interval.
Estonian: Lühendid: CI = usaldusintervall.
English: This may be due to a number of reasons, for example, if there is:
Estonian: Selleks võib olla mitmeid põhjuseid, nt
English: It is very important that you arrive on time for your appointments.
Estonian: On väga tähtis, et te oma vastuvõtuaegadest kinni peate.
English: Your doctor may decide that Provenge is not suitable for you due to one or more of these conditions.
Estonian: Teie arst võib otsustada, et Provenge kasutamine ei ole teile ühe või mitme sellise seisundi tõttu sobiv.
English: To provide data from the observational US-based registry (PROCEED, Study P10-3)
Estonian: Andmete hankimine USA-põhisest vaatlusregistrist (PROCEED, uuring P10-3)
English: A small number of these patients discontinued treatment as a result.
Estonian: Vähesed nimetatud patsientidest katkestasid seetõttu ravi.
English: Fax: (0)20 7554 2201 dendreonuk@dendreon.com
Estonian: Faks: (0)20 7554 2201 dendreonuk@dendreon.com
English: The clinical significance is uncertain.
Estonian: Selle leiu kliiniline tähtsus on ebaselge.
English: Overall survival was not a study endpoint but a pre-specified analysis.
Estonian: Üldine elulemus ei olnud uuringu tulemusnäitaja, vaid eeldefineeritud analüüs.
English: This procedure usually takes 3-4 hours.
Estonian: See protseduur võtab 3...4 tundi.
English: In the insulated container 18 hours.
Estonian: Isoleeritud anumas 18 tundi.
English: If this happens, do not drive or use any tools or machines until you feel better.
Estonian: Sel juhul ärge juhtige autot ega kasutage tööriistu või masinaid enne, kui teie enesetunne paraneb.
English: NL-6229 EV, Maastricht The Netherlands
Estonian: NL-6229 EV, Maastricht Holland
English: Microbiological testing
Estonian: Mikrobioloogilised analüüsid
English: No data are available for these patients.
Estonian: Nende patsientide kohta andmed puuduvad.
English: It is recommended that the minimum interval between leukapheresis procedures should not be less than 2 weeks.
Estonian: Soovitatav minimaalne intervall leukafereesi protseduuride vahel ei tohiks olla lühem kui 2 nädalat.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/867/001
Estonian: MÜÜGILOA NUMBER(NUMBRID) EU/1/13/867/001
English: * Primarily associated with the leukapheresis procedure
Estonian: * Seotud peamiselt leukafereesi protseduuriga
English: Pharmacotherapeutic group: Immunostimulants, other immunostimulants, ATC code: L03AX17.
Estonian: Farmakoterapeutiline rühm: immunostimulaatorid, muud immunostimulaatorid, ATC-kood: L03AX17.
English: This will be added to your Patient Alert Card that you should bring to each appointment.
Estonian: See lisatakse teie patsiendi hoiatuskaardile, mille peate igale vastuvõtule kaasa võtma.
English: • The expiration date and time have passed.
Estonian: • kõlblikkuskuupäev ja -kellaaeg on möödas;
English: On the first day of the infusion, Provenge may cause infusion-related reactions such as:
Estonian: Infundeerimise esimesel päeval võib Provenge põhjustada infundeerimisega seotud reaktsioone nagu
English: The median age was 71, 90% of the patients were Caucasian, and all had a life expectancy of at least 6 months.
Estonian: Keskmine vanus oli 71 aastat, 90% patsientidest olid valged eurooplased ja kõigi eeldatav eluiga oli vähemalt 6 kuud.
English: The medicinal product should be used immediately.
Estonian: See ravimpreparaat tuleb kohe ära kasutada.
English: Table 2 Summary of overall survival (all patients as randomized) IMPACT
Estonian: Tabel 2 Üldise elulemuse kokkuvõte (kõik patsiendid vastavalt randomiseerimisele) IMPACT
English: The physician should monitor and/or treat the patient as appropriate.
Estonian: Arst peab patsienti asjakohaselt jälgima ja/või ravima.
English: Other medicines and Provenge
Estonian: Muud ravimid ja Provenge