FrancophonIA/ELRC3.0 huggingface dataset:
English: Allergic type hypersensitivity reactions are possible with Nonafact The product contains traces of mouse proteins.
Estonian: Preparaat sisaldab hiire valkude jälgi.
English: For reconstitution of Nonafact.
Estonian: Nonafact'i lahustamiseks.
English: Cardiovascular events
Estonian: Kirurgilised protseduurid
English: See your doctor immediately, if bleeding does not stop as expected.
Estonian: Kui verejooks ei lakka, võtke viivitamatult ühendust oma arstiga.
English: Nonafact contains 100 IU per ml after reconstitution with water for injection.
Estonian: Nonafact 100 RÜ/ml pulber süstelahuse valmistamiseks.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 500 IU (100 IU/ml after reconstitution) 1000 IU (100 IU/ml after reconstitution)
Estonian: 500 RÜ (100 RÜ/ml pärast lahustamist).
English: Major surgery
Estonian: Suuremad kirurgilised protseduurid
English: Remove the protective sheath from the other end of the transfer needle.
Estonian: Eemaldage kaitse ülekandenõela teiselt otsalt.
English: Solvent: Water for injections.
Estonian: Lahusti: Süstevesi.
English: Reconstitute with 10 ml of water for injections.
Estonian: 1 viaal süstevett 10 ml.
English: Reconstitute with 5 ml of water for injections.
Estonian: Lahustada 5 ml süstevees.
English: Content (concentration)
Estonian: Manustamistee Sisepakendi iseloomustus Pakendi sisu (kontsentratsioon)>
English: Two initial opinions were issued.
Estonian: Esitati kaks esialgset arvamust.
English: The corresponding decision from the Commission was issued on 13 July 2011.
Estonian: Komisjon tegi sellekohase otsuse 13. juulil 2011.
English: Care should be taken to ensure consistency.
Estonian: Tagada tuleb järjepidevus.
English: The Singaporean manufacturing plant was only used once and no longer considered as an alternative.
Estonian: Singapuri tootmisettevõtet kasutati vaid üks kord ja seda ei käsitata enam alternatiivse lahendusena.
English: A 12 month monitoring should also be undertaken upon qualification.
Estonian: Kvalifitseerimisele peab järgnema 12 kuud kestev järelevalve.
English: The CHMP agreed with the proposed studies.
Estonian: Inimravimite komitee nõustus väljapakutud uuringutega.
English: These dialysis solutions were thus imported from Canada, Singapore, Turkey and USA.
Estonian: Seetõttu imporditi neid dialüüsilahuseid Kanadast, Singapurist, Türgist ja USAst.
English: A second opinion was then issued in May 2011 to recommend the inclusion of the site located in USA as an additional manufacturing site.
Estonian: Seejärel esitati 2011. aasta mais teine arvamus, milles soovitati USAs asuva tootmiskeskuse lisamist täiendava tootmiskeskusena.
English: The investigation supports that a combination of factors have contributed to the findings.
Estonian: Uurimine toetab seisukohta, et leidude põhjuseks oli mitme teguri koosmõju;
English: Grounds for variation of the marketing authorisations
Estonian: Müügilubade muutmise alused
English: The CHMP requests that the inspection of the Castlebar site be performed by the end of December 2011 and that the outcome of the inspection be provided to national competent authorities.
Estonian: Inimravimite komitee nõuab, et Castlebari tootmiskeskuse ülevaatus toimuks 2011. aasta detsembri lõpuks ja et inspektsiooni tulemus edastataks riiklikele pädevatele asutustele.
English: Further to the replacement of the product from Castlebar, mostly completed in April 2011, a decline in the number of aseptic peritonitis cases reported was observed.
Estonian: Pärast Castlebarist pärit toodete asendamist, mis lõppes valdavalt aprilliks 2011, täheldati kirjeldatud aseptilise peritoniidi juhtude arvu vähenemist.
English: This should allow early detection of low levels of endotoxin and trend analysis which should provide an early safety warning.
Estonian: See võimaldab väikese endotoksiinisisalduse varajast tuvastamist ja trendianalüüsi, mis hoiatab varakult ohu eest.
English: Monosol and 0.9% sodium chloride for haemodialysis solutions were promptly recalled from the market as alternatives were available.
Estonian: Monosoli ja 0,9% NaCl hemodialüüsilahused kõrvaldati kohe turult, sest neile leidus alternatiive.
English: Other enhanced pharmacovigilance activities include the clinical audit that will collect data on the number of peritonitis events in the EU and an observational study to assess the severity of peritonitis episodes (including fatal outcomes) and the impact on longer term clinical outcome.
Estonian: Teised tõhustatud ravimiohutuse järelevalve toimingud on muu hulgas kliiniline audit, mille käigus kogutakse andmeid peritoniidijuhtude arvu kohta Euroopa Liidus, ja vaatlusuuring, et hinnata peritoniidijuhtude raskust (sh surmajuhtumeid) ja mõju pikemaajalistele kliinilistele tulemustele.
English: In addition to the programme of quality improvement, future assured supply steps were developed.
Estonian: Peale kvaliteedi parandamise programmi töötati välja tarnekindluse tagamise kava.
English: This heightened pharmacovigilance was applied to products from alternative sites supplying Europe.
Estonian: Sellist tugevdatud ravimiohutuse järelevalvet rakendati alternatiivsetest tootmiskeskustest Euroopasse tarnitud toodete korral.
English: Products manufactured at the affected lines in Castlebar included peritoneal dialysis (PD) solutions Dianeal, Extraneal and Nutrineal; and Monosol and 0.9% sodium chloride for haemodialysis.
Estonian: Castlebaris probleemsetel liinidel toodetud tooted olid muu hulgas peritoneaaldialüüsi (PD) lahused Dianeal, Extraneal ja Nutrineal ning Monosoli ja 0,9% NaCl lahus hemodialüüsiks.
English: Enhancements of the affected line were proposed in order to prevent the occurrence of future biofilm/microbial contamination problems.
Estonian: Tehti ettepanekuid probleemsete tootmisliinide täiustamiseks, et vältida tulevikus biokile või mikroobse saastumise probleemide esinemist.
English: New re-designed equipment was installed with the intention of minimising areas where pooling of water/solutions could occur.
Estonian: Paigaldati uus, ümberkonstrueeritud seadmestik, et vähendada kohti, kuhu võivad koguneda vesi või lahused.
English: • The Committee requires the MAH to perform the epidemiological studies agreed, the clinical audit and observational study, and other measures as detailed in the risk management plan.
Estonian: • komitee nõuab, et müügiloa hoidja korraldaks kokkulepitud epidemioloogilised uuringud, kliinilise auditi ja vaatlusuuringu ning võtaks teised riskijuhtimiskavas nimetatud meetmed;
English: • The Committee agreed with the change management plan for development of the global corrective and preventive actions (CAPA) at Castlebar.
Estonian: • inimravimite komitee nõustus muudatuste juhtimiskavaga ülemaailmse parandus- ja ennetusplaani väljatöötamiseks Castlebaris.
English: Dialysis solutions produced at the affected lines are not being released onto the market pending the outcome of this inspection.
Estonian: Kõnealustel tootmisliinidel toodetud dialüüsilahuseid ei lasta turule enne inspektsioonitulemuste selgumist.
English: • The Committee considers that the establishment of a 12 month monitoring period, upon qualification of the Castlebar plant by the IMB, is appropriate.
Estonian: • Inimravimite komitee otsustas, et 12-kuulise järelevalveperioodi kehtestamine pärast Castlebari tehase kvalifitseerimist järelevalveasutuse poolt vastab nõuetele.
English: The first on the inclusion of the sites located in Canada, Poland and Turkey as additional manufacturing sites to the marketing authorisations of the respective peritoneal dialysis solutions was issued by the Committee in April 2011, and the corresponding decision from the Commission was issued on 12 May 2011.
Estonian: Aprillis 2011 esitas inimravimite komitee esimese arvamuse Kanadas, Poolas ja Türgis asuvate keskuste lisamiseks täiendavate tootmiskeskusena vastavate peritoneaaldialüüsilahuste müügilubadesse; komisjon tegi sellekohase otsuse 12. mail 2011.
English: Considering the likelihood of prolonged use of large quantities of imported PD solutions on the EU market, and in order to ensure continued supply of licensed medicinal products to the European Union, the necessary data packages to support the inclusion of additional manufacturing sites were expedited within the article 31 referral procedure.
Estonian: Arvestades imporditud peritoneaaldialüüsilahuste pikaajalise ja suurtes kogustes kasutamise tõenäosust Euroopa Liidu turul ja vajadust tagada müügiloaga ravimite jätkuv tarnimine Euroopa Liitu, kiirendati vajalike tootmiskeskuste lisamist toetavate andmete menetlemist artikli 31 kohase esildismenetluse raames.
English: Although protein/biofilm were not found upon dismantling the line, Gram positive and Gram negative microorganisms were identified.
Estonian: Ehkki tootmisliini lahtivõtmisel ei leitud valku ega biokilet, tuvastati grampositiivseid ja gramnegatiivseid mikroorganisme.
English: • The Committee considers that the future supply programme submitted by the MAH adequate.
Estonian: • Inimravimite komitee tunnistas müügiloa hoidja esitatud tulevase tarnekava sobivaks.
English: Overall, a combination of factors may have played a role in the findings, such as inadequately designed equipment, mechanical failure of equipment (cracks having been detected in some tanks used in the affected lines), methods of microbial monitoring not applied routinely and not state of the art, including outdated methods for monitoring endotoxins, and an inadequate cleaning and sanitisation regimen.
Estonian: Kokkuvõttes võis nende leidude põhjuseks olla mitme teguri kombinatsioon, sealhulgas seadmestiku konstruktsiooniviga, seadmete mehhaaniline rike (mõne probleemse tootmisliini mahutitel täheldati pragusid), samuti olid mikrobioloogilise seire meetodid iganenud ja neid rakendati korrapäratult, iganenud olid ka endotoksiinide kontrollimise meetodid ning ebapiisavaks osutusid puhastamis- ja desinfitseerimisrežiim.
English: The MAH should use this to prevent endotoxin contamination at other sites producing dialysis solutions for Europe, and apply all lessons learned accordingly.
Estonian: Müügiloa hoidja peab seda kasutama endotoksiini kontaminatsiooni ennetamiseks teistes Euroopa dialüüsilahuste tootmiskeskustes ja seega kohaldama kõiki saadud kogemusi.
English: A plan for maintenance of existing manufacturing sites, registration of additional sites located in Italy and the UK, expansion of different sites to increase its capacity and contingency for sufficient alternative providers/stocks for raw materials was agreed.
Estonian: Lepiti kokku olemasolevate tootmiskeskuste hooldamise plaan, Itaalias ja Ühendkuningriigis paiknevate täiendavate tootmiskeskuste registreerimine, tootmiskeskuste laiendamine tootlikkuse suurendamiseks ning piisavad alternatiivsed toormaterjali tarnijad/varud, et tulla toime ootamatustega.
English: A more sensitive method for endotoxin testing should be implemented and its limit of detection will be tightened for both finished product and excipients.
Estonian: Tuleb võtta kasutusele tundlikum endotoksiinide katsetamismeetod ja endotoksiinide tuvastamispiir tuleb muuta rangemaks nii valmistoodete kui ka abiainete osas.
English: The contingency plan for sufficient/alternative providers/stocks for raw materials was agreed.
Estonian: Lepiti kokku piisavad ja alternatiivsed toormaterjali tarnijad/varud, et toime tulla ootamatustega.
English: • The Committee considered all data submitted by the MAH, in writing and at oral explanations, including the overall root cause investigation report, and concludes that the MAH has performed a comprehensive investigation of the root cause leading to the out-of-specifications for endotoxins in dialysis solutions produced at particular lines of manufacture in Castlebar.
Estonian: • inimravimite komitee võttis arvesse kõiki müügiloa hoidja kirjalikult ja suuliselt esitatud andmeid, sealhulgas ülevaatlikku algpõhjuse väljaselgitamise aruannet, ning otsustas, et müügiloa hoidja on korraldanud ulatusliku uurimise selgitamaks, mis põhjustas spetsifikatsioonidele mittevastava endotoksiinisisalduse Castlebari teatud tootmisliinidel toodetud dialüüsilahustes.
English: Considering the global implications of the findings at Castlebar, and proposed improvements at this manufacturing site, global corrective and preventive actions (CAPA) should be drawn up and used to audit other sites producing dialysis solutions, including those authorised in the framework of this procedure at the time of the first and second opinions.
Estonian: Arvestades Castlebari leidude globaalset tähendust ja tootmiskeskuses väljapakutud täiendusi, tuleb koostada ülemaailmne parandus- ja ennetusplaan ning kasutada seda teiste, sealhulgas käesoleva menetluse esimese ja teise arvamuse raames heakskiidetud dialüüsilahuste tootmiskeskuste kontrollimiseks.
English: During the article 31, several measures were put in place in order to monitor the risk of developing aseptic peritonitis, identified as the primary risk following the use of dialysis solutions manufactured at the affected manufacturing lines in Castlebar.
Estonian: Artikli 31 kohase menetluse ajal kehtestati mitu meedet, et jälgida aseptilise peritoniidi tekke riski, mis tuvastati Castlebari probleemsetel tootmisliinidel toodetud dialüüsilahuste kasutamise peamise riskina.
English: The MAH's plan for maintenance of existing manufacturing sites, registration of additional sites and expansion of production capacity of others is appropriate.
Estonian: Müügiloa hoidja plaan olemasolevate tootmiskeskuste hooldamiseks, täiendavate tootmiskeskuste registreerimiseks ja teiste tootmiskeskuste tootmisvõime suurendamiseks vastab nõuetele.
English: An article 31 referral procedure of Directive 2001/83/EC was initiated by the European Commission (EC) following receipt of information from Baxter indicating that their manufacturing problem related to outof-specifications results for endotoxins in dialysis solutions produced at Castlebar was not resolved and the root cause had not been identified.
Estonian: Euroopa Komisjon algatas direktiivi 2001/83/EÜ artikli 31 kohase esildismenetluse pärast teadete saamist Baxterilt, et Castlebaris toodetud dialüüsilahuste spetsifikatsioonidele mittevastava endotoksiinide sisalduse põhjustanud tootmisprobleemi ei ole lahendatud ja selle algpõhjust ei ole tuvastatud.
English: All changes to processes, frequencies or limits resulting from the evaluation should also be submitted to the national competent authorities through appropriate regulatory procedures.
Estonian: Kõik hindamistest tulenevad protsesside, tootmiskoormuse või piirmäärade muudatused tuleb esitada vastavate regulatiivmenetluste kaudu riiklikele pädevatele asutustele.
English: The CHMP is now in a position to issue a third and final opinion on the article 31 review procedure focusing on the issues at the Castelbar site.
Estonian: Inimravimite komitee esitab nüüd Castlebari tootmiskeskuse probleemidele keskendunud artikli 31 kohase läbivaatusmenetluse raames kolmanda ja viimase arvamuse.
English: Whilst all data to finalise the article 31 was not available, a stepwise approach was followed for the assessment, resulting in subsequent opinions being adopted by the CHMP.
Estonian: Et kõik artikli 31 kohase menetluse lõpuleviimiseks vajalikud andmed ei olnud kättesaadavad, otsustati kasutada etapiviisilist hindamist, mille käigus võtab inimravimite komitee vastu mitu järjestikust arvamust.
English: To meet supply demands, the unprecedented importation of PD solutions from Canada, Turkey and USA increased.
Estonian: Nõudluse rahuldamiseks suurendati peritoneaaldialüüsilahuste erakorralist importi Kanadast, Türgist ja USAst.
English: Focus should be given to the timeliness of communication of safety signals to healthcare professionals and competent authorities, and the accuracy and consistency of the systems in place to collect safety information and provide it to the regulatory networks.
Estonian: Keskenduda tuleb ohusignaalide õigeaegsele teatamisele tervishoiutöötajatele ja pädevatele asutustele ning ohutusandmete kogumise ja regulatiivvõrgustikele edastamise süsteemide korrektsele ning järjepidevale kasutamisele.
English: The outcome of global CAPA will be provided to the national competent authorities and any changes considered necessary should be addressed through the appropriate change management protocols and subsequent regulatory procedures at a national level, as applicable.
Estonian: Ülemaailmse parandus- ja ennetusplaani tulemused edastatakse riiklikele pädevatele asutustele ning vajalikke muudatusi tuleb rakendada riiklikul tasandil sobivate muudatuste juhtimise protokollide ja järgnevate regulatiivmenetluste kaudu.
English: For completeness, the CHMP considered that a pharmacovigilance inspection should be carried out.
Estonian: Inimravimite komitee otsustas, et terviklikkuse huvides tuleb läbi viia ravimiohutuse järelevalve inspektsioon.
English: Overall summary of the scientific evaluation of dialysis solutions from Baxter group of companies and associated companies produced at Castlebar (see Annex I)
Estonian: Baxteri kontserni ettevõtete ja nendega seotud ettevõtete Castlebaris toodetud dialüüsilahuste teadusliku hindamise üldkokkuvõte (vt I lisa)
English: This will be an intensive period of monitoring to establish that the site is performing to acceptable standards.
Estonian: Sellel intensiivse seire perioodil tehakse kindlaks, kas tootmiskeskus täidab vastuvõetavaid standardeid.
English: This period of intense monitoring will bring further reassurance that the site is performing to acceptable standards.
Estonian: See intensiivne seireperiood annab kindluse, et tootmiskeskus vastab standarditele.
English: In view of severe supply limitations for Dianeal, Extraneal and Nutrineal and the risk of switching patients to alternative PD solutions or therapies, the CHMP considered that the use of comparable products produced by Baxter at alternative manufacturing sites outside the EEA (European Economic Area) should be prioritised, as these products were assessed to be therapeutically equivalent to the EU products, and there was sufficient reassurance regarding their quality.
Estonian: Arvestades Dianeali, Extraneali ja Nutrineali rangeid tarnepiiranguid ning patsientide alternatiivsetele peritoneaaldialüüsilahustele või ravile üleviimise riski, leidis inimravimite komitee, et eelisjärjekorras tuleks kasutada väljaspool Euroopa Majanduspiirkonda asuvates Baxteri tootmiskeskustes toodetavaid võrreldavaid ravimeid.
English: • The Committee considers that critical enhancements have been introduced, including the re-design of the affected lines, introduction of modern rapid microbial methods on site to raw materials, excipients and finished product, and a more sensitive method for endotoxin testing, with tightened limit of detection for both finished product and excipients.
Estonian: • inimravimite komitee otsustas, et sisse on viidud otsustavaid täiendusi, näiteks on konstrueeritud ümber tootmisliinid, on juurutatud kaasaegsed kiired mikrobioloogilised meetodid toormaterjalide, abiainete ja valmistoodete kontrollimiseks ning nii valmistoodete kui ka abiainete puhul kasutatakse rangema tuvastuspiiriga tundlikumat endotoksiinide katsetamismeetodit.
English: Modern rapid microbial methods should be applied on site to raw materials, excipients and finished product, to reduce variability, improve turn around time and improve the quality of information.
Estonian: Toormaterjale, abiaineid ja valmistooteid tuleb kohapeal kontrollida kaasaegsete kiirete mikrobioloogiliste meetoditega, et vähendada tulemuste erinevust, kiirendada protsessi ja parandada andmete kvaliteeti.
English: Taking into account the crucial nature of these medicinal products, and the need for unaffected batches of dialysis solutions to be made available to patients across the EU in the shortest possible timeframe, alternatives were sought.
Estonian: Võttes arvesse nende ravimite tähtsust, oli vaja nii ruttu kui võimalik teha saastumata dialüüsilahuste partiid kõikjal Euroopa Liidus patsientidele kättesaadavaks.
English: Annex II
Estonian: II LISA
English: Scientific conclusions and grounds for the variation to the terms of the marketing authorisations presented by the EMA
Estonian: Euroopa Ravimiameti esitatud teaduslikud järeldused ja müügiloa tingimuste muutmise alused
English: Additional risk minimisation activities focus on reporting of batch numbers, communication via a direct healthcare professional communication and an adverse event questionnaire in addition to quality risk minimisation activities.
Estonian: Riski vähendamise lisameetmed peale kvaliteediriski vähendamise meetmete hõlmavad partiinumbrite teatamist, otsesuhtlust tervishoiutöötajatega ja kõrvalnähtude küsimustikku.
English: Following continued review until September 2011, the CHMP now considers that weekly reports can cease, and the MAH should promptly inform the appropriate national competent authorities of any data suggestive of a signal with the dialysis solutions on the market.
Estonian: Pärast septembrini 2011 jätkunud läbivaatamist otsustas inimravimite komitee, et iganädalased aruanded võib lõpetada ja et müügiloa hoidja peab müügilolevate dialüüsilahuste ohtlikkusele viitavatest andmetest kohe teatama asjakohastele riiklikele pädevatele asutustele.
English: As an additional measure, a consolidated risk management plan (RMP) specific for the re-launch of dialysis solutions manufactured at the Castlebar lines affected by the endotoxin issue has been submitted.
Estonian: Lisameetmena on esitatud konsolideeritud riskijuhtimiskava, mis käsitleb endotoksiini probleemidega Castlebari tootmisliinidel toodetavate dialüüsilahuste uuesti turule viimist.
English: On the basis of the proposed measures, the CHMP was reassured that corrective actions are being implemented and will be subject of further monitoring.
Estonian: Väljapakutud meetmed veensid inimravimite komiteed, et kasutusele võetakse paranduskava, mille rakendamist edaspidi jälgitakse.
English: The product information for dialysis solutions includes the risk of peritonitis.
Estonian: Dialüüsilahuste ravimiteabes on nimetatud peritoniidi riski.
English: In view of the above, the Committee considers that the benefit risk balance of dialysis solutions from Baxter group of companies and associated companies produced at Castlebar (see Annex I) is positive and therefore recommends the variation to the terms of the marketing authorisations, subject to the conditions set out in annex III.
Estonian: Ülaltoodut arvesse võttes otsustas inimravimite komitee, et Baxteri kontserni ettevõtete ja nendega seotud ettevõtete Castlebaris toodetud dialüüsilahuste (vt I lisa) kasulikkuse ja riski suhe on positiivne, ning seetõttu pooldab komitee müügilubade tingimuste muutmist III lisas esitatud tingimuste kohaselt.
English: Member states should ensure that measures are implemented in accordance with global CAPA during inspections of the sites located under their territories.
Estonian: Liikmesriigid peavad tagama, et nende territooriumil asuvate tootmiskeskuste kontrollimise ajal võetakse meetmeid kooskõlas ülemaailmse parandus- ja ennetusplaaniga.
English: • Finally, the Committee considers that a pharmacovigilance inspection should be carried out for completeness and to ensure that communication of safety signals to healthcare professionals and competent authorities is adequate, and the systems in place to collect safety information and provide it to the regulatory networks are accurately and consistently applied.
Estonian: • inimravimite komitee arvab, et terviklikkuse huvides ja et tagada ohusignaalide adekvaatne edastamine tervishoiutöötajatele ja pädevatele asutustele ning ohutusandmete kogumise ja regulatiivvõrgustikele edastamise süsteemide korrektne ning järjekindel kasutamine, tuleb korraldada ravimiohutuse järelevalve inspektsioon.