FrancophonIA/ELRC3.0 huggingface dataset:
English: Attenuated live rabies vaccine virus, strain SPBN GASGAS: 106.8 FFU* - 108.1 FFU* (* Focus Forming Units)
Estonian: 106.8 FFU* - 108.1 FFU*
English: The thawed vaccine may be stored for up to 7 days at 2 °C - 8 °C before use; however baits for which the cooling chain was disrupted, because they were not stored in a refrigerator, should be destroyed.
Estonian: Katkenud jahutusahelaga peibutussöödad (söödad, mida ei hoitud külmkapis) tuleb aga hävitada.
English: Oral use blister (PCTFE/PVC/alu) 28 capsules
Estonian: Blister (PCTFE/PVC/alumiinium) 28 kapslit
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size EU/1/08/443/001 Thalidomide Celgene 50 mg Capsule, hard
Estonian: EU/1/08/443/001 Thalidomide Celgene 50 mg Kõvakapsel
English: The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel Sandoz to Acino Pharma GmbH on 21 september 2009.
Estonian: Euroopa Komisjon andis Clopidogrel Sandozi müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, ettevõttele Acino Pharma GmbH 21. septembril 2009.
English: The standard dose of Clopidogrel Sandoz is one 75 mg tablet once a day, taken with or without food.
Estonian: Clopidogrel Sandozi tavaannus on üks 75 mg tablett üks kord ööpäevas koos toiduga või ilma.
English: The Committee recommended that Clopidogrel Sandoz be given marketing authorisation.
Estonian: Komitee soovitas anda Clopidogrel Sandozile müügiloa.
English: Clopidogrel Sandoz can be started between seven days and six months after the
Estonian: Clopidogrel Sandozi manustamist võib alustada seitsme päeva kuni kuue kuu jooksul
English: Clopidogrel Sandoz clopidogrel EPAR summary for the public
Estonian: Clopidogrel Sandoz klopidogreel Kokkuvõte üldsusele
English: Clopidogrel Sandoz can be given to the following groups of patients:
Estonian: Clopidogrel Sandozit võib kasutada järgmiste patsiendirühmade korral:
English: Clopidogrel Sandoz can be started between a few days and 35 days after the attack;
Estonian: Clopidogrel Sandozi manustamist võib alustada mõne kuni 35 päeva jooksul pärast infarkti;
English: Because Clopidogrel Sandoz is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Estonian: Et Clopidogrel Sandoz on geneeriline ravim ja võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: This means that Clopidogrel Sandoz is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Estonian: See tähendab, et Clopidogrel Sandoz on sarnane võrdlusravimiga Plavix, millel juba on Euroopa Liidus müügiluba.
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel Sandoz has been shown to have comparable quality and to be bioequivalent to Plavix.
Estonian: Inimravimite komitee otsustas, et vastavalt Euroopa Liidu nõuetele on tõendatud Clopidogrel Sandozi võrdväärne kvaliteet ja bioekvivalentsus ravimiga Plavix.
English: Clopidogrel Sandoz is a ‘generic medicine'.
Estonian: Clopidogrel Sandoz on geneeriline ravim.
English: Clopidogrel Sandoz is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Estonian: Clopidogrel Sandozit kasutatakse aterotrombootiliste nähtude (trombide ehk soonesiseste verehüüvete moodustumisest ja arterite lubjastumisest põhjustatud probleemide) ennetamiseks täiskasvanutel.
English: The full EPAR for Clopidogrel Sandoz can be found here.
Estonian: Euroopa avaliku hindamisaruande täisteksti Clopidogrel Sandozi kohta leiate siit.
English: Because Clopidogrel Sandoz is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Estonian: Et Clopidogrel Sandoz on geneeriline ravim, piirdusid uuringud katsetega, milles näidati Clopidogrel Sandozi bioekvivalentsust võrdlusravimiga Plavix.
English: Clopidogrel Sandoz is a medicine that contains the active substance clopidogrel.
Estonian: Clopidogrel Sandoz on ravim, mis sisaldab toimeainena klopidogreeli.
English: Therefore, the CHMP's view was that, as for Plavix, the benefit outweighs the identified risk.
Estonian: Seetõttu arvas inimravimite komitee, et nagu ka Plavixi korral, ületab Clopidogrel Sandozi kasulikkus sellega kaasnevad riskid.
English: Other information about Clopidogrel Sandoz:
Estonian: Muu teave Clopidogrel Sandozi kohta
English: Why has Clopidogrel Sandoz been approved?
Estonian: Miks Clopidogrel Sandoz heaks kiideti?
English: What is Clopidogrel Sandoz?
Estonian: Mis on Clopidogrel Sandoz?
English: How does Clopidogrel Sandoz work?
Estonian: Kuidas Clopidogrel Sandoz toimib?
English: How is Clopidogrel Sandoz used?
Estonian: Kuidas Clopidogrel Sandozit kasutatakse?
English: What are the benefit and risk of Clopidogrel Sandoz?
Estonian: Milles seisneb Clopidogrel Sandozi kasulikkus ja mis riskid ravimiga kaasnevad?
English: What is Clopidogrel Sandoz used for?
Estonian: Milleks Clopidogrel Sandozit kasutatakse?
English: How has Clopidogrel Sandoz been studied?
Estonian: Kuidas Clopidogrel Sandozit uuriti?
English: The active substance in Clopidogrel Sandoz, clopidogrel, is an inhibitor of platelet aggregation.
Estonian: Clopidogrel Sandozi toimeaine klopidogreel on trombotsüütide agregatsiooni (vereliistakute kokkukleepumise) inhibiitor, mis aitab ennetada organismis trombide tekkimist.
English: 5 were from Canada and 5 from the USA, with no reports coming from Europe.
Estonian: Viis teadet pärinesid Kanadast ja viis USA-st, samas kui Euroopast teateid ei olnud.
English: Annex II Scientific conclusions and grounds for suspension of the marketing authorisations
Estonian: II LISA Teaduslikud järeldused ja müügilubade peatamise alused
English: All three facilities became part of Cetero Research.
Estonian: Kõik kolm keskust on nüüd Cetero Researchi osad.
English: In all 4 studies, the 90% confidence intervals for AUC0-72 and Cmax were within the 80% to 125% limits.
Estonian: Kõigis neljas uuringus olid 90% usaldusintervallid AUC0-72 ja Cmax puhul 80-125% piirides.
English: Based on the available safety data, the CHMP was therefore of the view that no signal of lack of efficacy was identified.
Estonian: Kättesaadavate ohutusandmete alusel oli inimravimite komitee seetõttu arvamusel, et efektiivsuse puudumist ei tuvastatud.
English: The dissolution testing data submitted was not considered complete as it was performed with a surfactant and only done in water and was therefore considered to be only of limited value.
Estonian: Esitatud lahustuvuse kontrollimise andmeid ei peetud täielikuks, sest katse oli läbi viidud surfaktandiga ja ainult vees, mistõttu leiti, et andmete väärtus on piiratud.
English: The conditions for the lifting of the suspension of the Marketing Authorisations are set out in Annex III of the CHMP opinion.
Estonian: Müügiloa peatamise lõpetamise tingimused on inimravimite komitee arvamuse III lisas.
English: The studies had a cross-over design with 2 weeks wash-out in between the study periods.
Estonian: Tegemist oli ristuuringuga, kus uuringuperioodide vahel oli kahenädalane väljauhtmisaeg.
English: The clinical phase of the study was performed in January and February 2006 at Gateway Medical Research Inc. in St. Charles (USA) while the analytical phase was performed at BA Research International LP in Houston (USA) and the statistical phase was performed at BA Research International LP in Austin (USA) in February and March 2006.
Estonian: Uuringu kliiniline faas viidi läbi 2006. aasta jaanuaris ja veebruaris St. Charlesis (USA) asuvas ettevõttes Gateway Medical Research Inc., samas kui analüütiline faas viidi läbi BA Research International LP keskuses Houstonis (USA) ning statistiline faas BA Research International LP keskuses Austinis (USA) veebruaris ja märtsis 2006.
English: The studies with the US and Canadian products were performed by Apotex Research Inc., Toronto, Canada.
Estonian: Uuringud USA ja Kanada ravimitega korraldas Apotex Research Inc. (Toronto, Kanada).
English: The MAH stated that plasma samples are no longer available and that there is therefore no possibility to reanalyse the data.
Estonian: Müügiloa hoidja teatas, et plasmaproovid ei ole enam kättesaadavad ja seetõttu ei ole võimalik andmeid uuesti analüüsida.
English: The Committee, as a consequence, recommended the suspension of the marketing authorisations for Leflunomide Apotex and associated names, pursuant to Article 116 of Directive 2001/83/EC; as a. the risk-benefit balance cannot be considered favourable and b. the particulars supporting the application as provided in Article 10 of Directive 2001/83/EC cannot be considered correct
Estonian: Selle tulemusena soovitas inimravimite komitee Leflunomide Apotexi ja sarnaste nimetuste müügiload direktiivi 2001/83/EÜ artikli 116 alusel peatada, sest a. kasulikkuse ja riski suhet ei saa pidada soodsaks ja b. direktiivi 2001/83/EÜ artikli 10 kohaselt taotlust toetavaid andmeid ei saa pidada korrektseks.
English: Overall summary of the scientific evaluation of Leflunomide Apotex (see Annex I)
Estonian: Leflunomide Apotexi (vt I lisa) teadusliku hindamise üldkokkuvõte
English: The CHMP agreed that the generic formulation is qualitative and quantitatively the same for the markets referred to and that the products are manufactured in the same manufacturing site, via the same manufacturing process.
Estonian: Inimravimite komitee nõustus, et geneeriline ravimvorm on viidatud turgude puhul kvalitatiivselt ja kvantitatiivselt sama ja et ravimid on toodetud samas tootmiskohas sama tootmisprotsessi käigus.
English: The fact that the qualitative compositions of the EU and non-EU Leflunomide Apotex products are fully identical and that the products are manufactured at the same manufacturing facility via the same manufacturing process can only be considered as supportive evidence.
Estonian: Tõsiasju, et ELi ja mitte-ELi Leflunomide Apotexi ravimite kvalitatiivne koostis on täielikult identne ning et ravimeid toodetakse samas tootmiskohas sama tootmisprotsessi käigus, saab pidada ainult toetavateks tõenditeks.
English: It is used in the treatment of adults with active moderate to severe rheumatoid arthritis and psoriatic arthritis.
Estonian: Ravimit kasutatakse aktiivse mõõduka kuni raske reumatoidartriidi ja psoriaatilise artriidiga täiskasvanute raviks.
English: The CHMP noted that such dissolution results were not provided.
Estonian: Inimravimite komitee märkis, et selliseid lahustuvustulemusi ei esitatud.
English: Leflunomide Apotex is available as 10 mg and 20 mg tablets.
Estonian: Leflunomide Apotexi turustatakse 10 mg ja 20 mg tablettidena.
English: Of the four remaining cases potentially attributable to Leflunomide Apotex, two involved arthralgia and swollen joints not related to rheumatoid arthritis (RA) while one was confounded by the concomitant use of other drugs while the last suggested concomitant use of TNF-alpha inhibitors.
Estonian: Ülejäänud neljast potentsiaalselt Leflunomide Apotexiga seostatavast juhust kaks hõlmasid artralgiat ja turses liigeseid, mis ei olnud seotud reumatoidartriidiga (RA), samas kui ühel juhul kasutati samal ajal muid ravimeid ning teisel juhul TNF-alfa inhibiitoreid.
English: In addition, all Leflunomide Apotex products for these markets are manufactured at the same manufacturing site, Apotex Inc., Toronto (Canada), according to the same manufacturing process.
Estonian: Kõiki Leflunomide Apotexi ravimvorme toodetakse nende turgude jaoks samas tootmiskohas ettevõttes Apotex Inc. Torontos (Kanada) sama tootmisprotsessi käigus.
English: However, according to the new bioequivalence guideline, such studies should be performed without the addition of surfactants and in media pH 1.2, 4.5, 6.8 and with the quality control method.
Estonian: Siiski tuleb uute bioekvivalentsuse juhiste kohaselt sellised uuringud läbi viia kvaliteedikontrolli meetodiga ja surfaktantide lisamiseta keskkonnas, mille pH on 1,2; 4,5; 6,6.
English: 102 case reports related to leflunomide were identified, out of which 10 could be identified as lack of effect /drug ineffective case reports, all related to Leflunomide Apotex.
Estonian: Tuvastati 102 juhtumi teadet seoses leflunomiidiga, millest 10 olid toime puudumise / ravimi ebaefektiivsuse teated, kõik seoses Leflunomide Apotexiga.
English: The CHMP also noted the safety assessment carried out by the MAH but carried out a separate search of EudraVigilance, identifying 14 cases of lack of efficacy specifically for generic products.
Estonian: Inimravimite komitee võttis samuti arvesse müügiloa hoidja tehtud ohutushindamist, kuid korraldas eraldi EudraVigilance'i otsingu, mis tuvastas 14 geneeriliste ravimite efektiivsuse puudumise juhtu.
English: Although the company did not discuss any other potential safety signals, the CHMP acknowledged that there are no signals of increased adverse events when compared to the reference product, based on the data in the last PSUR (reporting period 28-10-2010 until 27-10-2011).
Estonian: Kuigi ettevõte ei uurinud muid võimalikke ohutussignaale, võttis inimravimite komitee arvesse, et viimase perioodilise ohutusaruande (aruandeperiood 28.10.2010-27.10.2011) andmete alusel puuduvad viited kõrvaltoimete sagenemisele võrreldes võrdlusravimiga.
English: It is therefore plausible that the same quality active substance and excipients are used, although these bioequivalence studies were conducted using different sources of the reference product and no evidence was presented to confirm whether the reference product is indeed the same in all the studies.
Estonian: Seetõttu on usutav, et kasutatakse sama kvaliteediga toimeainet ja abiaineid, kuigi bioekvivalentsuse uuringud tehti võrdlusravimi erinevate allikatega ega esitatud tõendeid, et võrdlusravim on tõepoolest kõigis uuringutes sama.
English: The AUC, Cmax and Tmax of the US and Canadian fasting studies were comparable to the values obtained in the European study, which was also performed in fasting state.
Estonian: USAs ja Kanadas paastumise tingimustes korraldatud uuringute AUC, Cmax ja Tmax olid võrreldavad samuti paastumise tingimustes tehtud Euroopa uuringus saadud väärtustega.
English: The annual PSUR (data lock point 27 October 2011) submitted to the European authorities did not identify any lack of efficacy cases reported globally and the MAH therefore concluded that there was no change to the benefit risk ratio of Leflunomide Apotex.
Estonian: Euroopa ametiasutustele esitatud igaaastases perioodilises ohutusaruandes (andmete lukustus 27. oktoober 2011) ei tuvastatud kogu maailmas ühtki efektiivsuse puudumise juhtu ja seetõttu leidis müügiloa hoidja, et Leflunomide Apotexi kasulikkuse ja riski suhe ei ole muutunud.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for Leflunomide Apotex and associated names.
Estonian: • inimravimite komitee kaalus Leflunomide Apotexi ja sarnaste nimetuste kohta direktiivi 2001/83/EÜ artikli 31 alusel algatatud menetlust;
English: One case report reported lack of efficacy, where the product was used for lupus mixed connective tissue disease, which is not an approved indication.
Estonian: Üks juhtumi teade teatas efektiivsuse puudumisest, kui ravimit kasutati luupuse nähtudega segatüüpi sidekoehaiguse korral, mis ei ole lubatud näidustus.
English: The CHMP noted the data from the bioequivalence studies performed with the US and Canadian product and identified some minor protocol violations.
Estonian: Inimravimite komitee võttis arvesse USA ja Kanada võrdlusravimitega korraldatud bioekvivalentsuse uuringute andmeid ja tuvastas mõned väiksemad protokolli rikkumised.
English: Leflunomide Apotex contains leflunomide, a pyrimidine synthesis inhibitor belonging to the DMARD (disease-modifying antirheumatic drug) class of drugs, which are chemically and pharmacologically very heterogeneous.
Estonian: Leflunomide Apotex sisaldab leflunomiidi, mis on DMARDide (haigust modifitseerivad reumaravimid) rühma kuuluv pürimidiini sünteesi inhibiitor.
English: Regarding the safety profile of Leflunomide Apotex, the MAH performed a search for lack of effect / drug ineffectiveness in all case reports for leflunomide in the MAH's global pharmacovigilance database, from the date of first authorization of Leflunomide Apotex (08 September 2004) to 08
Estonian: Seoses Leflunomide Apotexi ohutusprofiiliga tegi müügiloa hoidja ülemaailmses ravimiohutuse järelevalve andmebaasis otsingu leflunomiidi toime puudumise / ebaefektiivsuse kohta kõigi juhtumi teadete hulgas alates esmasest Leflunomide Apotexi müügiloa andmisest (8. september 2004) kuni 8. augustini 2012.
English: For ten of these cases, the potential involvement of Leflunomide Apotex was ruled out.
Estonian: Leflunomide Apotexi võimalik kaasatus välistati kümnel juhul.
English: The CHMP also noted the PSUR data, which did not indicate any safety concerns; however this is insufficient to confirm the bioequivalence of the product.
Estonian: Inimravimite komitee märkis ära ka perioodilise ohutusaruande andmed, mis ei viidanud ohutusprobleemidele, aga sellest ei piisa ravimi bioekvivalentsuse kinnitamiseks.
English: The CHMP also noted that due to the lack of availability of samples, it was not possible to reanalyse the samples from the clinical study in order to check the validity of the original findings.
Estonian: Inimravimite komitee märkis samuti, et proovide puudumise tõttu ei olnud algsete leidude kehtivuse kontrollimiseks võimalik kliinilise uuringu proove uuesti analüüsida.
English: According to the bioequivalence guideline, dissolution studies to compare the proposed product with the reference product can be submitted as supportive of the results of bioequivalence studies, to evaluate whether there may still be differences between the formulations that might be relevant for efficacy and safety.
Estonian: Bioekvivalentsuse juhiste kohaselt võib bioekvivalentsuse uuringute toetamiseks esitada väljapakutud ravimit võrdlusravimiga võrdlevaid lahustuvusuuringuid, et hinnata, kas ravimvormide vahel võib esineda erinevusi, mis võivad olla tähtsad efektiivsuse ja ohutuse seisukohalt.
English: As the results from the bioequivalence study for the European product are in line with the results for US and Canadian products, in particular with regard to the blood plasma level results, the MAH considered the US and Canadian bio-equivalence data to support the data from the questioned EU bio-equivalence study.
Estonian: Et ravimi bioekvivalentsuse Euroopa uuringu tulemused vastavad USA ja Kanada ravimite uuringute tulemustele, eriti sisaldus vereplasmas, leidis müügiloa hoidja, et USA ja Kanada bioekvivalentsuse andmed toetavad ELi bioekvivalentsuse uuringu andmeid.
English: The results of the pivotal bioequivalence study showed that the 90% confidence intervals were within the 80% to 125% limits for AUC0-72 and Cmax and the pharmacokinetic data was therefore considered to demonstrate that the Leflunomide Apotex 20 mg tablets and the reference product 20 mg tablets were bioequivalent under fasting conditions.
Estonian: Olulise bioekvivalentsuse uuringu tulemused näitasid, et 90% usaldusintervallid olid AUC0-72 ja Cmax puhul 80-125% piirides ning seetõttu tõestavad farmakokineetilised andmed Leflunomide Apotex 20 mg tablettide ja võrdlusravimi 20 mg tablettide bioekvivalentsust paastumise tingimustes.
English: The CHMP noted that although f2 calculations were not provided, the MAH conclusion was supported based on the studies in the two media.
Estonian: Inimravimite komitee märkis, et kuigi f2 väärtusi ei esitatud, toetasid kahes keskkonnas läbiviidud uuringud müügiloa hoidja järeldusi.
English: Therefore, given the serious doubts regarding the reliability and the correctness of the data from the critical pivotal bioequivalence study B050309, submitted in support of the marketing authorisation, and in the absence of a reliable bioequivalence study specifically designed to establish the bioequivalence of Leflunomide Apotex to its EU reference product, the CHMP was unable to conclude on the bioequivalence of Leflunomide Apotex.
Estonian: Arvestades tõsiseid kahtlusi seoses müügiloa toetuseks esitatud kriitilise tähtsusega bioekvivalentsuse uuringu B050309 andmete usaldusväärsuse ja õigsusega ning usaldusväärse bioekvivalentsuse uuringu puudumist, mis oleks spetsiaalselt ette nähtud Leflunomide Apotexi ja ELi võrdlusravimi bioekvivalentsuse kindlakstegemiseks, ei saanud inimravimite komitee järeldada Leflunomide Apotexi bioekvivalentsust.
English: The single pivotal bioequivalence study B050309 conducted to support the marketing authorization application was a comparative, parallel, three arm study to compare the relative bioavailability of Leflunomide Apotex 20 mg tablets with that of the EU reference product Arava 20 mg tablets in healthy, adult volunteers under fasting conditions.
Estonian: Müügiloa taotluse toetamiseks tehtud ainus oluline bioekvivalentsuse uuring B050309 oli võrdlev paralleelne kolme rühmaga uuring, milles võrreldi Leflunomide Apotex 20 mg tablettide suhtelist biosaadavust ELi võrdlusravimi Arava 20 mg tablettidega tervetel täiskasvanud vabatahtlikel paastumise tingimustes.
English: Regarding the comparative dissolution testing, the CHMP was of the view that bioequivalence studies are pivotal to demonstrate bioequivalence for oral tablets.
Estonian: Seoses suhtelise lahustuvuse kontrollimisega oli inimravimite komitee arvamusel, et bioekvivalentsuse uuringud on suukaudsete tablettide bioekvivalentsuse näitamiseks olulised.
English: Therefore, and in the absence of a reliable bioequivalence study specifically designed to establish the bioequivalence of Leflunomide Apotex to its EU reference product, the benefit-risk balance of Leflunomide Apotex cannot be considered to be favourable.
Estonian: Sel põhjusel ja et puudub usaldusväärne bioekvivalentsuse uuring, mis oleks spetsiaalselt ette nähtud Leflunomide Apotexi ja ELi võrdlusravimi bioekvivalentsuse kindlakstegemiseks, ei saa Leflunomide Apotexi kasulikkuse ja riski suhet soodsaks pidada.
English: • The Committee considered that the available data gave rise to serious doubts as to the evidence of the bioequivalence of Leflunomide Apotex and associated names with the EU reference product in view of concerns on the reliability of the data, due to the findings of the inspection of the Cetero Research facilities.
Estonian: • inimravimite komitee leidis, et olemasolevad andmed tekitavad tõsiseid kahtlusi seoses Leflunomide Apotexi ja sarnaste nimetuste ning ELi võrdlusravimi bioekvivalentsuse andmete usaldusväärsusega, arvestades Cetero Researchi keskuses tehtud kontrolli tulemusi;
English: As further evidence of the bioequivalence of Leflunomide Apotex with the reference product, the MAH provided an overview of the qualitative and quantitative composition of its 10 and 20 mg tablets intended for the US, Canadian and European market, considering them to be identical.
Estonian: Leflunomide Apotexi ja võrdlusravimi bioekvivalentsuse lisatõendina esitas müügiloa hoidja USA, Kanada ja Euroopa turule ettenähtud 10 ja 20 mg tablettide kvantitatiivse ja kvalitatiivse koostise ülevaate, pidades neid identseks.
English: Finally, the CHMP noted that the MAH did not plan to perform a new bioequivalence study, as it considered the provided additional data sufficient to confirm the validity of the studies for the EU applications in which Cetero Research was involved.
Estonian: Lõpuks märkis inimravimite komitee, et müügiloa hoidja ei kavanda uue bioekvivalentsuse uuringu läbiviimist, sest ta peab esitatud lisaandmeid piisavaks, et kinnitada Cetero Researchi uuringute kehtivust ELis kasutamiseks.