FrancophonIA/ELRC3.0 huggingface dataset:
English: Why was Extraneal reviewed?
Estonian: Mis oli Extraneali läbivaatamise põhjus?
English: Extraneal is a solution that contains icodextrin as the active substance, as well as sodium lactate, sodium chloride, calcium chloride and magnesium chloride.
Estonian: Extraneal on lahus, mis sisaldab toimeainena ikodekstriini, samuti naatriumlaktaati, naatriumkloriidi, kaltsiumkloriidi ja magneesiumkloriidi.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the variation to the marketing authorisation for Extraneal can be approved in all concerned Member States.
Estonian: Praeguseks kättesaadavate andmete hindamise ning komitees toimunud teadusliku arutelu põhjal jõudis inimravimite komitee järeldusele, et Extraneali müügiloa muudatuse võib kõigis asjaomastes liikmesriikides heaks kiita.
English: Extraneal is used in particular in patients who cannot be treated with solutions containing glucose.
Estonian: Extraneali kasutatakse eeskätt patsientidel, keda ei saa ravida glükoosi sisaldavate lahustega.
English: This is a blood clearance technique used in patients with long-term kidney failure, when a solution is pumped into the abdomen and an internal body membrane filters the blood.
Estonian: See on pikaajalise neerupuudulikkusega patsientidel kasutatav vere puhastamise meetod, mille käigus pumbatakse lahus kõhuõõnde, kus kehasisene membraan filtreerib verd.
English: The European Medicines Agency has completed an arbitration procedure for Extraneal 7.5% solution for peritoneal dialysis.
Estonian: Euroopa Ravimiamet on lõpetanud vahekohtumenetluse seoses Extraneali 7,5% peritoneaaldialüüsilahusega.
English: The grounds for the referral were that more sensitive tests than those proposed by the company could be used to detect peptidoglycans in the medicine, and that one of the currently approved manufacturers of the active substance should modify the manufacturing process of icodextrin to ensure that peptidoglycans are removed.
Estonian: Esildise aluseks oli väide, et peptiidoglükaanide määramiseks ravimis saab kasutada tundlikumaid teste kui ettevõtte väljapakutud variant ja et üks praegu heakskiidetud toimeaine tootjatest peaks muutma ikodekstriini tootmise protsessi, et tagada peptiidoglükaanide kõrvaldamine.
English: Peptidoglycans had been linked to cases of inflammation of the peritoneum (the lining of the abdomen) in some patients receiving Extraneal.
Estonian: Peptiidoglükaane on seostatud kõhukelme (peritoneumi) põletiku juhtudega mõnel Extraneali saaval patsiendil.
English: Icodextrin is a type of sugar that is used to keep blood glucose at the correct level.
Estonian: Ikodekstriin on vere glükoosisisalduse õige sisalduse säilitamiseks kasutatav suhkur.
English: Extraneal is a solution that is used in peritoneal dialysis.
Estonian: Extraneal on peritoneaaldialüüsiks kasutatav lahus.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the change to the marketing authorisation for Extraneal to include a peptidoglycan test can be granted, and that the use of the active substance icodextrin sourced from one of the currently approved manufacturers should cease.
Estonian: Ravimiameti inimravimite komitee on jõudnud otsusele, et Extraneali müügiluba võib peptiidoglükaani testi lisamiseks muuta ja et ühelt praegu heakskiidetud tootjalt tarnitava toimeaine ikodekstriini kasutamine tuleks lõpetada.
English: The company applied for a change (variation) to the marketing authorisation to include a test to measure the level of an impurity called peptidoglycan during the medicine's production process.
Estonian: Ettevõte taotles müügiloa muutmist, et lisada test, millega määrata peptiidoglükaani (lisand) sisaldust ravimi tootmise protsessi käigus.
English: Questions and answers on the referral for Extraneal icodextrin 7.5% solution for peritoneal dialysis
Estonian: Teave järgmise ravimi esildise kohta: Extraneal ikodekstriini 7,5% peritoneaaldialüüsilahus
English: Company responses provided on: 31 August 2009 Opinion date:
Estonian: Arvamuse esitamise kuupäev:
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size EU/1/15/1037/001 Pemetrexed Sandoz 100 mg Powder for concentrate for solution for infusion
Estonian: ML (EU) number Ravimpreparaadi nimetus
English: Steatosis
Estonian: Steatoos
English: However, the consequences of these findings are unclear.
Estonian: Siiski ei ole nende leidude tagajärjed selged.
English: The following issues were addressed by the applicant;
Estonian: Taotleja käsitles järgmisi küsimusi.
English: Additional data will be collected in on-going and proposed studies.
Estonian: Käimasolevates ja kavandatud uuringutes kogutakse lisaandmeid.
English: The quality of this product is considered to be acceptable.
Estonian: Ravimi kvaliteet on vastuvõetav.
English: The CHMP is of the opinion that the safety and efficacy of the above mentioned medicinal product is not properly or sufficiently demonstrated.
Estonian: on inimravimite komitee seisukohal, et eelnimetatud ravimi ohutus ja efektiivsus ei ole nõuetekohaselt või piisavalt tõestatud.
English: This view was also supported by the experts who considered the extrapolation as only hypothetical.
Estonian: Seda arvamust toetasid ka eksperdid, kes leidsid, et ekstrapoleerimine on ainult hüpoteetiline.
English: Such conditional Marketing Authorisation could therefore not be recommended.
Estonian: Seetõttu ei saa soovitada tingimusliku müügiloa andmist.
English: With respect to the Kynamro Patient Support programme, the CHMP considered that its usefulness, suitability and applicability in different EU countries are difficult to foresee.
Estonian: Kynamro patsientide tugiprogrammi osas leidis inimravimite komitee, et selle kasulikkust, sobivust ja rakendatavust erinevates EL riikides on raske ennustada.
English: In addition, complement activation was more pronounced in patients with antibody formation.
Estonian: Lisaks oli komplemendi aktiveerimine selgemalt väljendunud patsientidel, kellel olid tekkinud antikehad.
English: Scientific conclusions and grounds for refusal presented by the European Medicines Agency
Estonian: Lisa Euroopa Ravimiameti esitatud teaduslikud järeldused ja keeldumise alused
English: This is regarded by the CHMP as a major deficiency, and was also criticized by the expert advisory group.
Estonian: Inimravimite komitee peab seda oluliseks puudujäägiks ja seda kritiseeris ka ekspertide rühm.
English: Nevertheless, the relevance of the direct comparison to mipomersen within the two trials must not be disregarded.
Estonian: Sellest hoolimata ei tohi eirata otsest võrdlust mipomerseeniga nende kahe uuringu raames.
English: Furthermore, the guideline also states that “a new lipid-modifying agent is only acceptable for authorisation if there is no suggestion of a detrimental effect on morbidity and mortality.
Estonian: Peale selle sätestab juhend, et „uue, lipiide modifitseeriva ravimi müügiloa võib anda ainult juhul, kui ei ilmne negatiivset mõju haigestumusele ja suremusele.
English: Although most of the relevant risks are identified within the risk management plan, the risk management system is considered inadequate and the proposed risk minimization measures are deficient in a number of important areas.
Estonian: Ehkki enamik asjassepuutuvaid riske on riskijuhtimiskavas tuvastatud, peetakse riskijuhtimissüsteemi ebapiisavaks ja väljapakutud riskivähendusmeetmed ei ole mitmes olulises valdkonnas piisavad.
English: on 31 January 2013, the applicant submitted its detailed grounds for the request for re-examination of the CHMP opinion recommending the refusal of the granting of the marketing authorisation.
Estonian: 31. jaanuaril 2013 esitas taotleja üksikasjalikud põhjendused inimravimite komitee arvamuse taasläbivaatamiseks, milles soovitati müügiloa andmisest keelduda.
English: The CHMP assessed all the detailed grounds for re-examination and argumentations presented by the applicant and considered the views of the PRAC (PRAC meeting 4-7 February 2013) and the advisory expert group held on 12 March 2013.
Estonian: Inimravimite komitee hindas kõiki taotleja esitatud üksikasjalikke põhjendusi ja väiteid taasläbivaatamiseks ning võttis arvesse ravimiohutuse järelevalve riski hindamise komitee (PRAC istung 4.-7. veebruaril 2013) ja ekspertide rühma 12. märtsil 2013 peetud istungi arvamusi.
English: This is based on the consideration that in a high risk population a larger proportion of events could be expected also in the placebo group.
Estonian: See põhineb kaalutlusel, et suure riskiga populatsioonis on oodatavate juhtude osakaal suurem ka platseeborühmas.
English: Therefore, the CHMP concluded on 13 December 2012 that the benefit/risk ratio of mipomersen is negative.
Estonian: Seetõttu järeldas inimravimite komitee 13. detsembril 2012, et mipomerseeni kasulikkuse ja riski suhe on negatiivne.
English: Potential effect of LDL reduction
Estonian: LDL-kolesterooli vähenemise võimalik mõju
English: Therefore, pursuant to Article 12 of Regulation (EC) No 726/2004, the CHMP has recommended the refusal of the granting of the marketing authorisation for Kynamro.
Estonian: Seetõttu soovitab inimravimite komitee määruse (EÜ) nr 726/2004 artikli 12 alusel keelduda Kynamro müügiloa andmisest.
English: The experts felt, however, that potentially a restricted prescription programme in dedicated centres capable of providing support on individual patient basis might be helpful.
Estonian: Eksperdid leidsid siiski, et kasulikuks võib osutuda ravimi piiratud väljakirjutamise programm kindlaksmääratud keskustes, mis on suutelised pakkuma konkreetsetele patsientidele toetust.
English: The CHMP concluded that such data has not been presented by the applicant at this time point.
Estonian: Inimravimite komitee leidis, et seni ei ole taotleja selliseid andmeid esitanud.
English: The adopted Guideline on Clinical Investigation of Medicinal Products in the Treatment of Lipid Disorders (CPMP/EWP/3020/03/2004), states on the matter that the safety database should be large enough to reasonably rule out any suspicion of a detrimental effect of the new drug on mortality and that this requirement acquires special relevance in case of drugs belonging to a new therapeutic class.
Estonian: Vastuvõetud ravimite kliinilise uurimise juhend lipiidihäirete ravis (CPMP/EWP/3020/03/2004) sätestab, et ohutusandmebaas peab olema piisavalt suur, võimaldamaks põhjendatult välistada kahtlusi uue ravimi negatiivse mõju kohta suremusele, ja et see nõue on erilise tähtsusega uude ravimiklassi kuuluvate ravimite puhul.
English: Mipomersen may be immunogenic and antibodies were detected in 65% of subjects taking the product.
Estonian: Mipomerseen võib olla immunogeenne ja antikehi leiti 65%-l ravimit võtnud uuringus osalejatest.
English: The CHMP concluded that such type of Marketing Authorisation could not be recommended in the present case as it does not fulfil the requirements of Article 14(8) of Regulation (EC) No 726/2004, in particular, as the applicant would be able to provide comprehensive data on the efficacy and safety under normal condition of use of Kynamro.
Estonian: Inimravimite komitee leidis, et seda tüüpi müügiloa andmist ei saa praegusel juhul soovitada, sest see ei täida määruse (EÜ) nr 726/2004 artikli 14 lõike 8 nõudeid, eelkõige seetõttu, et taotleja saab esitada igakülgseid andmeid Kynamro efektiivsuse ja ohutuse kohta tavalistes kasutustingimustes.
English: Physicochemical and biological aspects relevant to the uniform clinical performance of the product have been investigated and are controlled in a satisfactory way.
Estonian: Ravimi ühtlase kliinilise toimega seotud füüsikalis-keemilisi ja bioloogilisi aspekte on uuritud ning nende kvaliteediohje on rahuldav.
English: The applicant has proposed a Patient Support Programme (a broad adherence support programme) to help address this concern.
Estonian: Selle probleemi lahendamiseks on taotleja välja pakkunud patsientide tugiprogrammi (laialdase ravijärgimuse tugiprogrammi).
English: This may not be the case for all patients and for patients with sustained increase of ALT or AST level the risk in terms of hepatic damage still remains unclear.
Estonian: See ei pruugi olla nii kõigil patsientidel ning püsivalt suurenenud ALT või AST sisaldusega patsientidel ei ole maksakahjustuse risk veel selge.
English: Withdrawal rate was similar in HoFH patients and in the full population of OLE CS6 (56%).
Estonian: Uuringu katkestamise sagedus oli HoFH-ga patsientidel ja kogu OLE CS6 populatsioonis ühesugune (56%).
English: Retrospectively analysed CVS risk
Estonian: Retrospektiivselt analüüsitud kardiovaskulaarne risk
English: The studies proposed are poorly defined and it is questioned that these can solve the concerns of particular interest like CVS events/hepatic toxicity.
Estonian: Väljapakutud uuringud on halvasti määratletud ja on küsitav, kas need suudavad lahendada erilist huvi pakkuvaid probleeme, nagu kardiovaskulaarsed juhud / maksatoksilisus.
English: Otherwise, additional studies to clarify the drug effect on these parameters are mandatory.” The issue of prospective planning for CVS safety outcome is even more specifically addressed in the recent Draft Guideline on Clinical Investigation of Medicinal Products in the Treatment of Lipid Disorders (EMA/CHMP/718840/2012).
Estonian: Kardiovaskulaarse ohutuse tulemusnäitajate prospektiivse plaanimise küsimust käsitletakse konkreetsemalt dokumendis „Draft Guideline on Clinical Investigation of Medicinal Products in the Treatment of Lipid Disorders” (lipiidihäirete ravimite kliinilise uurimise juhendi kavand) (EMA/CHMP/718840/2012).
English: At the time of opinion, there are no outstanding issues on the quality of the active substance or the medicinal product.
Estonian: Arvamuse vastuvõtmise ajal puudusid olulised lahendamata küsimused toimeaine ja ravimi kvaliteedi kohta
English: Finally, LDL reduction is only one mechanism affecting cardiovascular risk and as discussed above, no detrimental effect should be present that might counteract such improvements.
Estonian: Pealegi on LDL-kolesterooli vähenemine ainult üks kardiovaskulaarset riski mõjutav mehhanism ja (nagu eespool märgitud) ei tohi esineda negatiivset toimet, mis võiks selle paranemise neutraliseerida.
English: Indeed, an annual event rate of 6% has been described for a composite endpoint of non-fatal MI and cardiac death in a comparable population (Scandinavian-Simvastatin Survival Study Group, 1995, Lancet).
Estonian: Tõepoolest, juhtude 6% aastast esinemissagedust on kirjeldatud mittefataalse müokardiinfarkti ja kardiaalse surma kombineeritud tulemusnäitajana võrreldavas populatsioonis (Skandinaavia simvastatiini elulemuse uuringurühm, 1995, Lancet).
English: Furthermore, the CHMP considered the input from the expert group meeting and noted that there was an agreement amongst the experts that the tolerability of mipomersen treatment was poor.
Estonian: Peale selle kaalus inimravimite komitee ekspertide rühmalt saadud andmeid ja märkis, et eksperdid olid ühel meelel mipomerseenravi halva talutavuse osas.
English: Focusing on the targeted HoFH population, the CHMP noted that the withdrawal rate for HoFH patients who had been enrolled in the pivotal 6 months DB study CS5 and consented to further participate in the OL extension study CS6 (for one or two years, including the time in CS5), was approximately 60% (23/38) within the first two years.
Estonian: Keskendudes HoFH-ga sihtpopulatsioonile, märkis inimravimite komitee, et ravi katkestajate osakaal HoFH-ga patsientide hulgas, kes osalesid 6-kuulises DB põhiuuringus CS5 ja kes nõustusid osalema ka OL-i laiendusuuringus CS6 (üks või kaks aastat, sh uuringu CS5 aeg), oli esimese kahe aasta jooksul umbes 60% (23/38).
English: This was not considered applicable either, even if possible within the scope of Article 2 of Commission Regulation (EC) No. 507/2006, as the requirements as defined in Article 4 of the said Regulation were not met, in particular the demonstration by the applicant of a positive risk-benefit balance of the medicinal product and the likelihood to provide comprehensive clinical data by way of specific obligations.
Estonian: Ehkki see oleks komisjoni määruse (EÜ) nr 507/2006 artikli 2 kohaselt võimalik, ei peetud seda varianti samuti kohaldatavaks, sest nimetatud määruse artiklis 4 määratletud nõuded ei ole täidetud, eriti taotlejapoolne ravimi positiivse riski ja kasulikkuse suhte näitamine ja laiahaardeliste kliiniliste andmete esitamise tõenäosus konkreetsete kohustuste kaudu.
English: • A statistically significant mean reduction in LDL-C of approximately 25% (absolute change -2.92mmol/L) in patients with HoFH already receiving maximally tolerated lipid-lowering therapy is highly relevant for this small group of patients with a high unmet medical need;
Estonian: • Statistiliselt oluline LDL-kolesterooli keskmine vähenemine umbes 25% võrra (absoluutne muutus -2,92 mmol/l) HoFH-ga patsientidel, kes juba saavad maksimaalset talutavat lipiidisisaldust vähendavat ravi, on äärmiselt asjakohane selle väikese patsiendirühma jaoks, kus esineb suur vastamata meditsiiniline vajadus.
English: As part of their discussions, the CHMP discussed whether a Marketing Authorisation under exceptional circumstances for Kynamro in the restricted claimed indication as presented by the applicant during the oral explanation could be considered.
Estonian: Arutelude käigus kaalus inimravimite komitee, kas oleks võimalik anda eritingimustel Kynamro müügiluba taotletud piiratud näidustuseks, nagu taotleja seda suulise selgituse ajal esitas.
English: The applicant argues that the degree of LDL reduction observed with mipomersen treatment is expected to result in a potential reduction in coronary heart disease risk greater than 50%, which is based on meta-analyses of data from multiple studies (Baigent, 2010, the Lancet).
Estonian: Taotleja väidab, et mipomerseenravi korral täheldatav LDL-kolesterooli vähenemine põhjustab eeldatavalt südame koronaartõve riski vähenemist üle 50%, mis põhineb mitme uuringu andmete metaanalüüsil (Baigent, 2010, Lancet).
English: Kynamro is an apolipoprotein B (apo B) synthesis inhibitor indicated as an adjunct to maximally tolerated lipid-lowering medicines and diet to reduce low density lipoprotein-cholesterol (LDL-C) in adult patients with homozygous familial hypercholesterolaemia (HoFH).
Estonian: Kynamro on apolipoproteiin B (apo B) sünteesi inhibiitor, mis on näidustatud täienduseks maksimaalselt talutavatele lipiidisisaldust vähendavatele ravimitele ja dieedile LDL-kolesterooli (väikese tihedusega lipoproteiinide) sisalduse vähendamiseks homosügootse familiaalse hüperkolesteroleemiaga (HoFH) täiskasvanud patsientidel.
English: Thus, the CHMP concluded that with respect to mipomersen´s hepatotoxicity, no aspects other than the ones already assessed in the initial procedure, which could lead to different conclusions, were presented by the applicant.
Estonian: Seega leidis inimravimite komitee seoses mipomerseeni hepatotoksilisusega, et taotleja ei esitanud peale algse menetluse käigus hinnatute muid aspekte, mis võiksid viia erinevate järeldusteni.
English: With regard to ALT and AST elevations, results from the pooled phase 3 studies (mipomersen n=261, placebo n=129, including patients with HoFH and HeFH) are summarized.
Estonian: ALT ja AST suurenenud sisaldus on III faasi koonduuringute tulemustes (mipomerseen n=261, platseebo n=129, sealhulgas HoFH ja HeFH-ga patsiendid) summeeritud.
English: Exclusion criteria were also in place to ensure adequate hepatic function based on laboratory values (ALT, ALT > 1.5 x ULN).
Estonian: Väljaarvamise kriteeriumid olid vajalikud ka selleks, et olla kindel adekvaatses maksatalitluses laboratoorsete analüüside põhjal (ALT, ALT >1,5×ULN).
English: The mipomersen safety database from the conducted clinical programme is limited considering the original target population that intends to include patients with HeFH, even if it is limited to severe cases, and raises serious safety concerns for the both patient groups.
Estonian: Kliinilise programmi põhjal koostatud mipomerseeni ohutuse andmebaas on piiratud, arvestades algset sihtpopulatsiooni, mis hõlmab ka HeFH-ga patsiente (kuigi vaid raskeid juhte), ja tõstatab olulisi ohutusküsimusi mõlema patsiendirühma jaoks.
English: The CHMP also discussed whether a conditional Marketing Authorisation for the claimed restricted indication could be considered.
Estonian: Inimravimite komitee arutas ka, kas on võimalik kaaluda tingimusliku müügiloa andmist taotletud piiratud näidustusel.
English: A detrimental effect of mipomersen on CVS risk has not been shown but cannot be excluded since data are too limited.
Estonian: Mipomerseeni negatiivset mõju kardiovaskulaarsele riskile ei ole näidatud, kuid seda ei saa välistada, sest andmed on liiga piiratud.
English: To conclude on ground 2, the discussion provided by the applicant for the reexamination of Kynamro does not provide a new insight to the former CHMP assessment on mipomersen treatment and CVS risk.
Estonian: Kokkuvõttes võib 2. põhjenduse kohta märkida, et taotleja esitatud arutelu Kynamro taasläbivaatamiseks ei paku uut vaatenurka, mis muudaks inimravimite komitee poolt mipomerseenravi ja kardiovaskulaarse riskile antud varasemat hinnangut.
English: The CHMP considered the following:
Estonian: Inimravimite komitee võttis arvesse järgmist.
English: The CHMP also noted that the experts were not reassured that mipomersen is not conclusively linked to renal and CVS harm, and concluded that a >50% reduction in 5-year CHD risk as envisaged by the applicant for mipomersen treatment is purely hypothetical.
Estonian: Inimravimite komitee märkis samuti, et eksperdid ei ole veendunud, et mipomerseen ei ole seotud neeru- ja kardiovaskulaarkahjustustega, ning järeldas, et taotleja poolt mipomerseenravile omistatud koronaartõve riski 5-aastane vähenemine >50% on ainult hüpoteetiline.
English: The applicant claims that in the majority of patients ALT and AST levels stabilize or decrease even with continued treatment or they return to (near) baseline following discontinuation of mipomersen treatment.
Estonian: Taotleja väidab, et enamikul patsientidest ALT ja AST sisaldus stabiliseerub või isegi väheneb ravi jätkudes või taandub pärast mipomerseenravi lõpetamist (peaaegu) esialgsele tasemele.
English: Mipomersen is also associated with a high incidence of flu-like symptoms, effect on inflammatory markers and decrease on complement component C3.
Estonian: Mipomerseeni seostatakse ka gripilaadsete sümptomite suurema esinemissageduse, mõjuga põletikumarkeritele ja komplemendi komponendi C3 vähenemisega.
English: Within (maximal) 2 years of treatment almost 50% (18/38) of these HoFH patients withdrew from treatment due to AEs, mainly due to injection site reactions (ISRs), flu-like symptoms (FLS) and liver enzyme elevations.
Estonian: 2-aastase (maksimaalselt) ravi jooksul katkestas ravi kõrvalnähtude tõttu peaaegu 50% (18/38) HoFH-ga patsientidest, peamiselt süstekoha reaktsioonide (ISR), gripilaadsete sümptomite (FLS) ja maksaensüümide sisalduse suurenemise tõttu.
English: From the available data, it is also not clear whether patients´ ALT or AST levels reached a maximal effect (plateau).
Estonian: Samuti ei selgu olemasolevatest andemetest, kas patsientide ALT või AST sisaldus suurenes maksimaalseni (platootase).
English: Importantly, steatosis is plausibly correlated with the effect on cholesterol levels, which introduces an additional doubt on the long-term sustainability of this therapy, particularly in those patients where the beneficial effect in the lipid profile is more marked.
Estonian: Steatoos on eeldatavalt seotud ravi mõjuga kolesteroolisisaldusele, mis tekitab lisakahtlusi ravi pikaajalises jätkusuutlikkuses, eriti patsientidel, kellel soodne toime lipiidiprofiilile on enam väljendunud.