FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP assessed the dossier and the available data, including the issues raised by the objecting CMS.
Estonian: Inimravimite komitee hindas toimikut ja olemasolevaid andmeid, sh küsimusi, mille oli tõstatanud asjaomane vastuseisev liikmesriik.
English: Hence a premix development using a suitable vehicle was considered.
Estonian: Seetõttu kaaluti eelsegu valmistamist, kasutades sobivat kandjat.
English: In the bioequivalence study, a total of 19 adverse events were reported by 13 subjects.
Estonian: Bioekvivalentsuse uuringus täheldati 13 katsealusel kokku 19 kõrvalnähtu.
English: Out of 19 adverse events observed, 14 were for the reference product and 5 were for the test product.
Estonian: 19st täheldatud kõrvalnähust esines 14 võrdlusravimi ja 5 uuritava ravimi kasutamisel.
English: Furthermore the objecting CHMP members pointed out that in both guidelines, it is also stated that antioxidants should not be used to disguise poorly formulated products.
Estonian: Lisaks märkisid vastuseisvad inimravimite komitee liikmed, et mõlemas suunises on ka öeldud, et antioksüdante ei tohi kasutada toodete ebapiisava koostise varjamiseks.
English: The chosen clopidogrel base necessitated the use of an antioxidant which was not considered to be optimal.
Estonian: Valitud klopidogreelialus tingis vajaduse kasutada antioksüdanti , mida ei peetud optimaalseks.
English: are stable in comparison to clopidogrel bisulphate, which is sensitive to hydrolytic degradation.
Estonian: on stabiilsed võrreldes klopidogreelbisulfaadiga, mis on hüdrolüütilise lagunemise suhtes tundlik;
English: - in the view of the CHMP, do not differ with regard to safety relevant properties.
Estonian: - inimravimite komitee arvates ei erine võrdlusravimist oluliste ohutusomaduste poolest.
English: This was not considered to be acceptable by the objecting Concerned Member State (CMS) as there are stable salts available, and the use of the clopidogrel base was considered to result in an unnecessary exposure of patients to an antioxidant.
Estonian: Seda ei pidanud vastuseisev asjaomane liikmesriik vastuvõetavaks, sest on olemas ka stabiilseid sooli ja klopidogreelialuse kasutamine põhjustab liikmesriigi arvates patsientide tarbetu kokkupuute antioksüdandiga.
English: In addition, the CHMP was also concerned that it had not been demonstrated that the proposed production and quality control methods could guarantee that a major deficiency in the quality of the product would not occur.
Estonian: Lisaks tekitas inimravimite komitees ettevaatlikkust ka see, et ei olnud tõendatud, kas väljapakutud tootmisja kvaliteedikontrolli meetodid tagavad, et ravimi kvaliteedis ei esine suuri puudusi.
English: The drug substance and the drug product manufacturer have been shown to be capable of producing a, stable product essentially similar in efficacy and safety to the reference product.
Estonian: Toimeaine ja ravimi tootja on tõendanud, et ta suudab toota stabiilset ravimit, mille efektiivsus ja ohutus on võrdlusravimi efektiivsuse ja ohutusega olulisel määral sarnane.
English: Since the nature of the base made it unsuitable to incorporate appropriate in-process quality checks for the clopidogrel base, the Applicant has attempted to control the quality of the base produced by ensuring the quality of the intermediate.
Estonian: Et aluse olemuse tõttu oli võimatu sobivalt kontrollida klopidogreelialuse kvaliteeti protsessi sees, on taotleja püüdnud juhtida toodetud aluse kvaliteeti vaheaine kvaliteedi tagamisega.
English: Although the clopidogrel free base posed the challenges of converting an unstable, gummy and sticky nature into a granular, free flowing and stable material for use in formulations, the Applicant chose the clopidogrel free base as the suitable candidate for product development.
Estonian: Kuigi klopidogreeli vaba alus tekitas probleeme ebastabiilse, viskoosse ja kleepuva aine muutmisel granulaarseks, vabalt voolavaks ja stabiilseks materjaliks, mida võiks kasutada ravimvormides, pidas taotleja klopidogreeli vaba alust ravimi väljatöötamiseks sobivaks.
English: The Applicant addressed the long-term safety of BHA at the oral explanation before the CHMP on 17 February 2010, by making reference to the Acceptable Daily Intake (ADI), an estimate of the amount of BHA that can be ingested on a daily basis over a lifetime without appreciable risk to health.
Estonian: Taotleja käsitles butüülitud hüdroksüanisooli pikaajalist ohutust suuliste selgituste andmisel inimravimite komitees 17. veebruari 2010 koosolekul, viidates aktsepteeritavale ööpäevasele kogusele (ADI) ehk hinnangule, kui suur on ööpäevas manustatav butüülitud hüdroksüanisooli kogus, mida võib elu jooksul neelata, ilma et tekiks märkimisväärne terviserisk.
English: In conclusion, the CHMP agreed that although the choice of the clopidogrel base was not considered to be optimal, the use of BHA and the production process did not pose a potentially serious risk to public health.
Estonian: Kokkuvõttes nõustus inimravimite komitee, et kuigi klopidogreelialuse valikut ei peetud optimaalseks, ei ohusta butüülitud hüdroksüanisool ja vastavate tootmisprotsesside kasutamine rahvatervist.
English: In order to circumvene the challenges of using the clopidogrel base, it was essential to convert it into a granular and free flowable material.
Estonian: Klopidogreeli vaba alusega seotud probleemide vältimiseks oli väga oluline muuta see granulaarseks ja vabalt voolavaks materjaliks.
English: The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Estonian: Kehtivateks versioonideks ravimi omaduste kokkuvõttest, pakendi märgistusest ja infolehest saavad lõplikud, koordinatsioonigrupi töö käigus kindlaks määratud versioonid.
English: In contrast to the reference product that contains the hydrogen sulphate salt, the generic product contains a clopidogrel base.
Estonian: Erinevalt vesiniksulfaatsoola sisaldavast võrdlusravimist sisaldab geneeriline ravim klopidogreelialust.
English: However in view of the fact that no major concerns were found in relation to quality of the product and that the use of antioxidant did not pose a safety concern, the CHMP accepted the choice of the clopidogrel base.
Estonian: Kuid võttes arvesse, et ravimi kvaliteet ei tekitanud suuri küsitavusi ja antioksüdant ei põhjusta ohutusprobleemi, nõustus inimravimite komitee klopidogreelialuse kasutamisega.
English: Clopidogrel is indicated for the prevention of atherothrombotic events in patients suffering from myocardial infarction or acute coronary syndrome.
Estonian: Klopidogreel on näidustatud aterotrombootiliste nähtude ennetamiseks müokardiinfarkti või ägeda koronaarsündroomiga patsientidel.
English: Therefore the chosen antioxidant BHA and the concentration in which it is used, was considered to be acceptable by the CHMP, from a safety point of view.
Estonian: Seetõttu olid valitud antioksüdant butüülitud hüdroksüanisool ja selle kontsentratsioon inimravimite komitee arvates ohutuse seisukohalt vastuvõetavad.
English: The product developed with clopidogrel premix was found to be non-hygroscopic.
Estonian: Leiti, et klopidogreeli eelseguga väljatöötatud preparaat ei olnud hügroskoopne.
English: When clopidogrel bisulfate (as in Reference product) and clopidogrel base (as in Test product) were administered as a single dose to healthy volunteers in this study, the drug products were well tolerated with no serious adverse events for either, and no relevant difference in the safety profiles of the test and reference formulation was observed with regard to the number and pattern of adverse events.
Estonian: Kui uuringus manustati klopidogreelbisulfaati (võrdlusravim) ja klopidogreelialust (uuritav ravim) tervetele vabatahtlikele ühekordse annusena, taluti ravimeid hästi ning kumbki ravim ei tekitanud raskeid kõrvalnähte, samuti puudus oluline erinevus uuritava ravimi ja võrdlusravimi ohutusprofiilis seoses kõrvalnähtude arvu ja esinemisviisiga.
English: The adenylate cyclase-coupled ADP receptor P2Y12 is the main target of clopidogrel and leads to inhibition of platelet activation, aggregation, and Gp IIb/IIIa receptor activation.
Estonian: Klopidogreeli peamine sihtmärk on adenülaattsüklaasiga seondunud ADP retseptor P2Y12, ning selle toimel aine inhibeerib trombotsüütide aktivatsiooni, agregatsiooni ja GPIIb/IIIa retseptori aktivatsiooni.
English: Taking into consideration the literature survey, the taurocholate, hydrochloride, hydrobromide and hydrogen sulphate salts and free base of clopidogrel were considered.
Estonian: Teaduskirjanduse uurimise järel kaaluti taurokolaat-, vesinikkloriid-, vesinikbromiid- ja vesiniksulfaatsoolade ning klopidogreeli vaba aluse kasutamist.
English: Clopidogrel is a non-competitive inhibitor of adenosine diphosphate (ADP) at the platelet receptors.
Estonian: Klopidogreel on adenosiindifosfaadi (ADP) mittekonkureeriv inhibiitor ADP seondumisel trombotsüütide retseptoritega.
English: The Applicant explained that to make it feasible for better handling, it was decided to add the excipient BHA, which in turn resulted in a stable clopidogrel premix.
Estonian: Taotleja selgitas, et parema käsitsemise võimaldamiseks otsustati lisada abiainet butüülitud hüdroksüanisooli, mille tulemusel saadi stabiilne klopidogreeli eelsegu.
English: BHA is present in amounts less than the ADI, which is generally deduced from the No Effect Level of the substance; therefore a biological action or effect on the patients is not expected.
Estonian: Butüülitud hüdroksüanisooli leidub ravimis väiksemas koguses kui aktsepteeritav ööpäevane kogus, mis enamasti tuletatakse aine toimet mitteavaldava kontsentratsiooni põhjal; seetõttu ei ole bioloogiline toime ega mõju patsientidele tõenäoline.
English: It is also argued that in view of the above, the selection of the clopidogrel base and the development of the clopidogrel premix had been justified for its use in generic formulation.
Estonian: Sel põhjusel väideti ka, et klopidogreelialuse valimine ja klopidogreeli eelsegu väljatöötamine on selle geneerilise ravimi korral põhjendatud.
English: The Applicant explained that the amount of BHA from clopidogrel tablets was no more than 0.75% of its ADI, which was argued to be a negligible.
Estonian: Taotleja selgitas, et klopidogreelitablettidega manustatud butüülitud hüdroksüanisooli kogus ei ole suurem kui 0,75% aktsepteeritavast ööpäevasest kogusest ja seda võib seega väita tühiseks.
English: are bioequivalent to the reference medicinal product clopidogrel bisulphate
Estonian: on võrdlusravimi klopidogreelbisulfaadiga bioekvivalentsed;
English: The Applicant attended the CHMP meeting for an oral explanation on 17 February 2010 to present their position with regard to the choice of clopidogrel base as the active substance compared to the more stable clopidogrel salts, and also to discuss the safety of the long-term use of BHA.
Estonian: Taotleja andis inimravimite komitee 17. veebruari 2010 koosolekul suulisi selgitusi selle kohta, miks valiti stabiilsemate klopidogreeli soolade asemel toimeaineks klopidogreelialus, ning arutas butüülitud hüdroksüanisooli pikaajalise kasutamise ohutust.
English: Based on the information presented, taurocholate, hydrochloride, hydrobromide and hydrogen sulphate salts of clopidogrel were found to be unsuitable for product development for various reasons.
Estonian: Esitatud andmete alusel peeti klopidogreeli taurokolaat-, vesinikkloriid-, vesinikbromiid- ja vesiniksulfaatsooli ravimi väljatöötamiseks eri põhjustel ebasobivaiks.
English: The Applicant also claimed that the test product when compared with the reference product Plavix, met the bioequivalence criteria with respect to the rate and extent of absorption of clopidogrel.
Estonian: Taotleja väitis ka, et võrreldes võrdlusravimiga Plavix vastas uuritava ravimi klopidogreeli imendumise kiirus ja ulatus bioekvivalentsuse kriteeriumidele.
English: As the clopidogrel base corresponds to an unstable, viscous mass, the drug substance is stabilized by means of a premix, which contains the antioxidant butylated hydroxy anisol (BHA).
Estonian: Et klopidogreelialus on ebastabiilne viskoosne mass, stabiliseeritakse toimeaine eelseguga, mis sisaldab antioksüdanti butüülitud hüdroksüanisooli (BHA).
English: The Clopidogrel Orion 75 mg Film coated Tablets:
Estonian: Clopidogrel Orion 75 mg õhukese polümeerkattega tabletid:
English: From the data provided the Applicant claimed that clopidogrel tablets 75 mg are stable when compared to Plavix 75 mg (Clopidogrel Bisulphate Tablets 75 mg).
Estonian: Taotleja esitatud andmetes väidetakse, et klopidogreeli 75 mg tabletid on võrreldes Plavixi 75 mg tablettidega (klopidogreelbisulfaadi 75 mg tabletid) stabiilsed.
English: The overall control strategy to ensure suitable and reproducible quality of the product has been justified with regard to the handling of the viscous mass of the clopidogrel base, and the proposed specifications for the clopidogrel base are considered to be acceptable by the CHMP.
Estonian: Üldine kvaliteedijuhtimisstrateegia, millega tagatakse ravimi sobiv ja reprodutseeritav kvaliteet, on klopidogreelialuse viskoosse massi käsitsemise seisukohast põhjendatud ja inimravimite komitee pidas klopidogreelialuse väljapakutud tehnilisi andmeid vastuvõetavateks.
English: Overall, it is claimed by the Applicant that their clopidogrel tablets 75 mg has adequate quality and benefit/risk ratio and is comparable to the reference product.
Estonian: - taotleja klopidogreelialuse 75 mg tablettidel on piisav kvaliteedi ning kasulikkuse ja riski suhe ning need on võrreldavad võrdlusravimiga,
English: It was argued that at that time, the potential to develop a salt with suitable pharmaceutical and pharmacological properties, and free from any FTO (freedom-to-operate) issues later, was thoroughly literature researched.
Estonian: Ta väitis, et teaduskirjanduse alusel oli põhjalikult uuritud võimalusi töötada välja sobivate farmatseutiliste ja farmakoloogiliste omadustega sool, mille korral ei tekiks hiljem tegutsemisvabadust piiravaid asjaolusid.
English: The use of the unstable clopidogrel base as active substance necessitated the use of the antioxidant butylated hydroxyl anisol (BHA) for stabilisation.
Estonian: Ebastabiilse klopidogreelialuse toimeainena kasutamine muutis vajalikuks kasutada stabiliseerimise eesmärgil antioksüdandi butüülitud hüdroksüanisooli.
English: The CHMP agreed that the Applicant's choice of the clopidogrel base and consequently the use of BHA had been sufficiently explained.
Estonian: Inimravimite komitee oli nõus, et taotleja on klopidogreelialuse valikut ja sellest tulenevat butüülitud hüdroksüanisooli kasutamist piisavalt selgitanud.
English: Clopidogrel is known to hydrolyse and to form a hydrolytic impurity i.e an acetic acid impurity, which is a major degradant.
Estonian: On teada, et klopidogreel hüdrolüüsub ja moodustab hüdrolüütilise lisandi, s.o äädikhappe lisandi, millel on tugevad lagundavad omadused.
English: The premix approach was thought to help in the flow property of clopidogrel base.
Estonian: Loodeti, et eelsegu kasutamine aitab parandada klopidogreelialuse voolavust.
English: The reference medicinal product for this generic application is Plavix (Clopidogrel Hydrogen sulphate) 75 mg film-coated tablets.
Estonian: Selle geneerilise ravimi taotluse võrdlusravim on Plavix (klopidogreelvesiniksulfaat) 75 mg õhukese polümeerkattega tabletid.
English: The product is formulated as immediate release tablets containing 75 mg clopidogrel.
Estonian: Preparaadi ravimvorm on toimeainet kiiresti vabastavad tabletid, mis sisaldavad 75 mg klopidogreeli.
English: The CHMP noted that the primary purpose for the addition of BHA was to prevent the initiation of free radicals, by blocking the oxidative pathway, and was assured by the Applicant that the lowest level possible had been used.
Estonian: Inimravimite komitee märkis, et butüülitud hüdroksüanisooli lisamise esmane põhjus oli ennetada oksüdatiivse raja blokeerimise kaudu vabade radikaalide moodustumist.
English: - the Applicant's choice of the clopidogrel base and consequently the use of BHA has been sufficiently explained
Estonian: - taotleja on klopidogreelialuse valikut ja sellest tulenevat butüülitud hüdroksüanisooli kasutamist piisavalt selgitanud;
English: The acetic acid impurity (a major degradant) was found to be controlled in the Applicant's clopidogrel Tablets 75 mg as compared to Plavix 75 mg (Clopidogrel Bisulphate Tablet 75 mg).
Estonian: Taotleja toodetud klopidogreeli 75 mg tablettides leiti olevat äädikhappe lisandi (tugev lagundav toime) sisaldus võrreldes Plavixi 75 mg tablettidega (klopidogreelbisulfaadi 75 mg tabletid) piiratud.
English: - the Applicant's Clopidogrel Base Tablets 75 mg has adequate quality and benefit/risk ratio and is comparable to the reference product the CHMP has recommended the granting of the Marketing Authorisation 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: soovitas inimravimite komitee anda müügiloa, mille jaoks lepiti koordineerimisrühma menetluses kokku ravimi omaduste kokkuvõtte, märgistuse ja pakendi infolehe lõplikud versioonid, nagu on märgitud selle arvamuse III lisas.
English: Therefore justification that the overall control strategy ensured suitable and reproducible quality of the product with regard to the handling of the viscous mass of clopidogrel base was requested from the Applicant and justification also for the absence of specifications for the clopidogrel base.
Estonian: Seetõttu paluti taotlejal põhjendada, kuidas üldine kontrollimisstrateegia tagab ravimi stabiilse ja reprodutseeritava kvaliteedi, arvestades klopidogreelialuse viskoosse massi käsitsemist.
English: Lithuania
Estonian: Leedu
English: - the overall control strategy to ensure suitable and reproducible quality of the product has been justified with regard to the handling of the viscous mass of the clopidogrel base
Estonian: - arvestades klopidogreelialuse kui viskoosse massi käsitsemist, on üldine kvaliteedijuhtimisstrateegia sobiva ja reprodutseeritava kvaliteedi tagamiseks põhjendatud;
English: STORING X
Estonian: X SÄILITAMINE
English: ENGLISH
Estonian: ESTONIAN
English: <This medicinal product does not require any special storage conditions>
Estonian: <See ravimpreparaat ei vaja säilitamisel eritingimusi>
English: <Store in a refrigerator (2(C - 8(C)>
Estonian: <Hoida külmkapis (2(C...8(C)>
English: <This medicinal product does not require any special temperature storage conditions>*****
Estonian: <See ravimpreparaat ei vaja säilitamisel temperatuuri eritingimusi>*****
English: <Store in a refrigerator>
Estonian: <Hoida külmkapis>
English: <Store and transport refrigerated (2(C - 8(C)>*
Estonian: <Hoida ja transportida külmas (2(C...8(C)>*
English: <Store and transport frozen {temperature range}>**
Estonian: <Hoida ja transportida sügavkülmas {temperatuuri vahemik}>**
English: <Store and transport refrigerated>*
Estonian: <Hoida ja transportida külmas>*
English: <Store in a freezer {temperature range}>
Estonian: <Hoida sügavkülmas {temperatuuri vahemik}>
English: <Store and transport frozen>**
Estonian: <Hoida ja transportida sügavkülmas>**
English: White homogeneous emulsion.
Estonian: Valge homogeenne emulsioon.
English: Ask your veterinary surgeon how to dispose of medicines no longer required.
Estonian: Küsige palun oma veterinaararstilt, kuidas hävitatakse ravimeid, mida enam ei vajata.
English: ATC-vet code: QI01AA23.
Estonian: ATCvet kood: QI01AA23
English: SPECIAL STORAGE CONDITIONS Store and transport refrigerated.
Estonian: SÄILITAMISE ERITINGIMUSED Hoida ja transportida külmas.
English: This product contains mineral oil.
Estonian: Ravim sisaldab mineraalõli.
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Estonian: Toimeaine, mis on bioloogilist päritolu ja ette nähtud aktiivse immuunsuse esilekutsumiseks, ei kuulu määruse (EÜ) number 470/2009 reguleerimisalasse.
English: The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Estonian: Müügiloa hoidja peab teavitama Euroopa Komisjoni käesoleva otsusega kinnitatud ravimi turustamise plaanidest.
English: If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Estonian: Kui täheldate tõsiseid kõrvaltoimeid või muid toimeid, mida pole käesolevas pakendi infolehes mainitud, palun teavitage sellest oma veterinaararsti.
English: MARKETING AUTHORISATION NUMBER EU/2/06/061/001-004
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/2/06/061/001-004
English: 4.8 Interactions with other medicinal products and other forms of interaction
Estonian: 4.8 Koostoimed teiste ravimitega ja muud koostoimed
English: SPECIAL WARNING(S), IF NECESSARY Accidental self-injection is dangerous.
Estonian: ERIHOIATUS(ED), KUI VAJALIK Juhuslik vaktsiini enesele süstimine on ohtlik.
English: This vaccine has been tested for safety in chickens.
Estonian: Selle vaktsiini ohutust on testitud kanadel.
English: Glass vials: 1 year.
Estonian: Klaasviaalid: 1 aasta
English: DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION Date of first authorisation: 01/09/2006
Estonian: ESMASE MÜÜGILOA VÄLJASTAMISE / MÜÜGILOA UUENDAMISE KUUPÄEV Esmase müügiloa väljastamise kuupäev: 01.09.2006
English: MANUFACTURER'S BATCH NUMBER Lot {number}
Estonian: TOOTJAPOOLNE PARTII NUMBER Partii {number}
English: If pain persists for more than 12 hours after medical examination, seek medical advice again.
Estonian: Juhul kui valu püsib rohkem kui 12 tundi pärast arstlikku kontrolli, pöörduda uuesti arsti poole.
English: It is recommended to use a closed multiject vaccination system.
Estonian: Soovitatakse kasutada mitut järjestikust süstimist võimaldavat suletud vaktsineerimissüsteemi.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibitthe manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Estonian: Vastavalt Euroopa Parlamendi ja nõukogu direktiivi nr 2001/82/EÜ artiklile 71 võivad liikmesriigid kooskõlas siseriiklike õigusaktidega keelustada immunoloogilise veterinaarravimi tootmise, impordi, omamise, müügi, tarnimise ja/või kasutamise oma territooriumil või osal oma territooriumist, kui on tuvastatud, et:
English: The bottles are closed with a nitryl rubber stopper and sealed with a coded aluminium cap.
Estonian: Pudelid on suletud nitriilkummist korgiga ja on kaetud kodeeritud alumiiniumkaanega.
English: Serum antibodies could be expected to persist for at least 12 months after administration of two doses of vaccine.
Estonian: Seerumi antikehad peaksid püsima vähemalt 12 kuud pärast kahe annuse vaktsiini manustamist.
English: a) the administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Estonian: a) veterinaarravimi manustamine loomadele takistab looma haiguste diagnoosimise, kontrolli ja haigustõrje riiklike programmide rakendamist, või komplitseerib nakkuste puudumise tõendamist elusloomadel või toiduainetes või muudes toodetes, mis on saadud loomadelt, kellele on manustatud ravimit;
English: No information is available on vaccination in the presence of maternally derived antibodies.
Estonian: Puuduvad andmed vaktsineerimise kohta maternaalsete antikehade olemasolu korral.
English: Use sterile syringes and needles.
Estonian: Kasutada steriilseid süstlaid ja nõelu.