FrancophonIA/ELRC3.0 huggingface dataset:
English: • The Committee, based on the published literature, considered that a significant percentage of the patient population using these products does not abstain from alcohol consumption despite the existing warnings and contraindications, and that therefore the existing risk minimisation measures do not adequately address the concern,
Estonian: • komitee leidis avaldatud teaduskirjanduse alusel, et märkimisväärne osa neid ravimeid kasutavast patsiendipopulatsioonist tarvitab alkoholi hoiatustest ja vastunäidustustest hoolimata, mille tõttu ei lahenda hetkel kasutatavad riskiminimeerimismeetmed probleemi piisavalt;
English: More than confirming that the generic and originator are bioequivalent, in this review it is important to consider whether the observed in vitro effect constitutes an unacceptable risk for patients.
Estonian: Käesoleva hindamismenetluse ülesanne ei ole mitte geneeriliste ja originaalravimite bioekvivalentsuse kinnitamine, vaid otsustamine, kas in vitro uuringutes täheldatud toime võib kujutada endast vastuvõetamatut riski patsientidele.
English: Pain at baseline was a significant predictive factor for alcohol use in the 3-years follow-up period.
Estonian: Enne uuringut esinenud valu ennustas alkoholitarbimist 3-aastase jälgimisperioodi jooksul.
English: Considering that the proposed pharmacodynamic warning already advises against concomitant use with alcohol, considering also the limitations of the in vitro data and difficulties in its interpretation by prescribers, the majority of the Committee was of the opinion that the addition of a pharmacokinetic interaction warning based on a description of the in vitro data would not favour the clarity of the message to patients and prescribers regarding the need to avoid concomitant use with alcohol.
Estonian: Arvestades asjaolu, et väljapakutud farmakodünaamiline hoiatus juba soovitab antud ravimeid koos alkoholiga mitte kasutada, ning võttes arvesse ka in vitro andmete puudusi ja raskusi nende tõlgendamisel ravimit väljakirjutavate arstide poolt, arvas enamik inimravimite komitee liikmeid, et alkoholiga kasutamise vältimise sõnum ei muutu patsientidele ja ravimit määravatele arstidele selgemaks, kui lisatakse in vitro andmete kirjeldusel põhineva farmakokineetilise hoiatus.
English: The Committee is also of the opinion that further minimisations measures would not adequately address the concern.
Estonian: Komitee arvates ei piisa edasistest riskiminimeerimismeetmetest probleemi lahendamiseks.
English: Having assessed the detailed grounds for re-examination provided by the MAH, the rapporteurs assessment reports, the conclusions from the ad hoc expert meeting together with the MAH's expressed concerns on the conclusions of the ad hoc expert meeting and all the information submitted during the referral procedure, the CHMP discussed each one of the grounds submitted:
Estonian: Vaadanud läbi müügiloa hoidja detailsed põhjendused arvamuse ülevaatamiseks, hindajate hindamisaruanded, ajutise ekspertrühma koosoleku järeldused koos müügiloa hoidja vastuväidetega koosoleku järelduste kohta ja kogu esildismenetluse käigus esitatud teabe, käsitles inimravimite komitee eraldi iga esitatud põhjendust.
English: The results of the only study with a morphine product (ethylcellulose N-50, methacrylic acid copolymer type C, polyethylene glycol 6000 and diethyl phthalate formulation) indicate that a relatively high quantity of alcohol has almost no effect in vivo.
Estonian: Morfiini sisaldava ravimvormiga (koostises etüültselluloos N50, metakrüülhappe C-tüüpi kopolümeer, polüetüleenglükool-6000 ja dietüülftalaat) tehtud ainus uuring näitas, et in vivo puudus suhteliselt suures kontsentratsioonis alkoholil peaaegu igasugune toime.
English: The CHMP had not addressed the issue of the additional risk to patients posed by modified release formulations of opioids which exhibit a greater vulnerability to alcohol compared with the reference product, whilst conferring no additional patient benefit.
Estonian: Inimravimite komitee ei olnud arvesse võtnud täiendava riski võimalust patsientidele tulenevalt toimeainet modifitseeritult vabastavate opioidide ravimvormidest, mis on võrdlusravimiga võrreldes alkoholi suhtes tundlikumad, omamata samas täiendavat kasulikkust patsientidele
English: In addition, as the medicinal product based on this release-mechanism is intended for once a day dosing, the content of morphine is high and therefore the risk of adverse events following dose-dumping is also higher.
Estonian: Sellise vabastamismehhanismiga ravim on ette nähtud kasutamiseks üksnes üks kord ööpäevas, st morfiinisisaldus on suur ja seetõttu on suurem ka annuse äkilise vabanemise efektist tingitud kõrvalnähtude tekke risk.
English: This will be related to the specificities of each formulation, namely the physical characteristics of the excipients and the manufacturing process.
Estonian: Selle fenomeni täpne ulatus sõltub konkreetsest ravimvormist, täpsemalt ravimis kasutatud abiainete füüsikalistest omadustest ja ravimi tootmisprotsessist.
English: • The Committee considered that products without a polymethacrylate-triethylcitrate coating as modified-release mechanism do not suggest a significant interaction with alcohol considered to be harmful under normal conditions of use,
Estonian: • komitee arutas, et ravimvormidel, mille toimeaine modifitseeritult vabastamine ei põhine polümetakrülaat-trietüültsitraatkattel, ei ole põhjust eeldada märkimisväärset koostoimet alkoholiga, mis tavatingimustel kasutamisel võiks olla ohtlik;
English: The Opinion did not take account of the earlier advice of its own working parties, namely the EWP and QWP, which had been requested by the CMD(h); nor did it provide any proper reasons for discounting that advice.
Estonian: Inimravimite komitee arvamus ei olnud arvesse võtnud tema enda töörühmade (konkreetselt efektiivsuse ja kvaliteedi töörühma) varasemat soovitust, mida oli palunud inimravimite vastastikuse tunnustamise ja detsentraliseeritud menetluse koordineerimisrühm ega olnud esitanud mitte ühtegi nõuetekohast põhjendust nende soovituste arvestamata jätmise kohta.
English: In addition, the CHMP agreed on the inclusion for all other products in the European market of a pharmacodynamic warning.
Estonian: Lisaks sellele leppis inimravimite komitee kokku, et kõigi teiste Euroopas turustatavate sarnaste ravimite infolehtedesse lisatakse farmakodünaamilise koostoime hoiatus.
English: In its detailed grounds for re-examination, the MAH referred to a competitor product in which the release of oxycodone is accelerated in the presence of alcohol as an example of a potentially clinically meaningful interaction.
Estonian: Oma detailsetes põhjendustes arvamuse ülevaatamiseks viitas müügiloa hoidja ühe teise tootja ravimile, mille korral oksükodooni vabanemine alkoholi toimel kiireneb ja mis võib seega olla võimaliku kliiniliselt olulise koostoime näiteks.
English: In its detailed grounds for re-examination the MAH referred to statistical analysis confirming different behaviours in the presence of alcohol for a generic and its originator product.
Estonian: Oma detailsetes põhjendustes arvamuse ülevaatamiseks viitas müügiloa hoidja statistilisele analüüsile, mis näitab ettevõtte enda originaalravimi ja geneeriliste ravimite erinevat toimet manustamisel koos alkoholiga.
English: It follows from the above that data presented on the in vitro effects of alcohol on the dissolution profile of these products are not necessarily a reliable predictor of in vivo behaviour and therefore recommendations such as suspension and reformulation of products should only be adopted for products for which the in vitro interaction is of such magnitude that the products are considered to pose serious risks to the patients.
Estonian: Eelpool öeldust nähtub, et esitatud andmed alkoholi in vitro toime kohta antud ravimite lahustuvusprofiilile ning sellest tulenevad soovitused müügiloa peatamiseks ja ravimvormi muutmiseks kehtivad üksnes nende ravimite kohta, mille korral in vitro täheldatud koostoime võib endast kujutada tõsist ohtu patsientidele.
English: From the products tested, fifty percent of the formulations were found to be affected by alcohol solutions in vitro.
Estonian: Katsetatud ravimitest 50% korral leiti, et alkoholilahused mõjutavad ravimit in vitro.
English: The dissolution profile of this product (80% dissolved substance within 15 min in 20% alcohol) is beyond the limit of the Ph. Eur.
Estonian: Selle ravimi lahustuvusprofiil (20% alkoholi juuresolekul lahustus 15 minuti jooksul 80%) ületab Euroopa farmakopöa poolt toimeaine tavapärase vabastamisaja piirid (45 minuti jooksul lahustub vähemalt 75% toimeainest).
English: Overall summary of the scientific evaluation of modified-release oral opioid products in the level III of the WHO scale for the management of pain (intense sustained pain resistant to previous medications) (see Annex I)
Estonian: WHO III astme valuravis (intensiivne püsiv valu, mis varasematele ravimitele ei reageeri) kasutatavate toimeainet modifitseeritult vabastavate suukaudsete opioidide (vt I lisa) teadusliku hindamise üldkokkuvõte
English: It is clearly stated in the Opinion that 50% of the formulations were found to be affected by alcohol in vitro.
Estonian: Arvamuses on selgelt öeldud, et 50% ravimvormide korral täheldati in vitro koostoimet alkoholiga.
English: In vivo studies conducted with a hydromorphone formulation based on ammonio methacrylate copolymer type B (Eudragit RS) confirmed the existing in vitro data suggesting that alcohol affects the formulation.
Estonian: Ammooniummetakrülaadi B-tüüpi kopolümeeriga (Eudragit RS) kaetud hüdromorfooni sisaldavate ravimitega tehtud in vivo uuringud kinnitasid in vitro andmeid, mille kohaselt alkohol mõjutab seda ravimvormi.
English: This is justified on the basis that a pharmacodynamic interaction between opioid products and alcohol may occur irrespective of the formulation.
Estonian: See on põhjendatud, sest farmakodünaamiline koostoime opioidi sisaldavate ravimite ja alkoholi vahel esineb ravimvormist sõltumata.
English: For all other strong-opioid modified release oral products in the European market (formulations not containing polymethacrylate-triethylcitrate), no significant risk of dose-dumping due to alcohol use was identified.
Estonian: Muude Euroopas turustatavate tugevaid opioide toimeainena modifitseeritult vabastavate suukaudsete ravimite (ravimvormid, mis ei sisalda polümetakrülaat-trietüültsitraati) korral ei täheldatud alkoholist tingitud annuse äkilise vabanemise efekti.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC, as amended for modified-release oral opioid products in the level III of the WHO scale for the management of pain (intense sustained pain resistant to previous medications),
Estonian: • inimravimite komitee arutas parandatud direktiivi 2001/83/EÜ artikli 31 kohast menetlust, mis käsitles WHO III astme valuravis (intensiivne püsiv valu, mis varasematele ravimitele ei reageeri) kasutatavaid toimeainet modifitseeritult vabastavaid opioide sisaldavaid ravimeid;
English: A product containing hydromorphone and a prolonged release system consisting of ammonio methacrylate co-polymer type B (Eudragit RS) also suffered a significant effect of high concentrations of alcohol on in vitro dissolution.
Estonian: Hüdromorfooni sisaldaval ravimil, mille toimeainet pikaajaliselt vabastava ravimvormi aluseks on ammooniummetakrülaadi B-tüüpi kopolümeer (Eudragit RS), esines in vitro samuti oluline toime lahustuvusele alkoholi suure kontsentratsiooni korral.
English: A product with this dissolution profile cannot be considered to behave as an immediate release formulation.
Estonian: Sellise lahustuvusprofiiliga ravimi kohta ei saa öelda, et see käitub nagu toimeaine kiire vabanemisega ravimvorm.
English: It should be noted that, while the authors of the above mentioned paper go on to conclude that ‘in vitro dissolution may provide evidence regarding the ruggedness of formulations to ingested alcohol', no recommendations are issued to specific products given that ‘…further research is needed to understand the relationship between dosage form, product formulation and configuration and drug release in the presence of ethanol.'
Estonian: Seda on näha autorite järeldusest, et „seoste mõistmiseks annuse vormi, ravimvormi ja konfiguratsiooni ning ravimi vabanemise kohta etanooli olemasolul on vaja täiendavaid uuringuid“.
English: This is demonstrated by measurements of gastric-duodenal ethanol levels after consumption of alcohol in healthy volunteers.
Estonian: Seda on näidanud tervetel vabatahtlikel läbi viidud mao ja kaksteistsõrmiksoole alkoholisisalduse mõõtmine pärast alkoholi tarvitamist.
English: It is therefore concluded that the approach is not inconsistent, firstly because in the case of alcohol, a recommendation not to take the product with alcohol will always exist regardless of the formulation.
Estonian: Seetõttu leiab inimravimite komitee, et tema arvamus ei ole ebajärjekindel; esiteks seetõttu, et alkoholi korral kehtib soovitus mitte võtta antud ravimeid koos alkoholiga sõltumata ravimvormist, ja teiseks põhjusel, et erinevalt alkoholist kajastab ravimi omaduste kokkuvõttes toodud teave koostoimete kohta toiduga in vivo uuringute andmeid.
English: • The Committee noted that a pharmacodynamic interaction between opioid products and alcohol may occur irrespective of the formulation,
Estonian: • komitee märkis, et farmakodünaamiline koostoime opioide sisaldavate ravimite ja alkoholi vahel võib tekkida ravimvormist sõltumata;
English: The exception is one morphine formulation using polymethacrylate-triethylcitrate coating as modified-release mechanism, for which dose dumping might occur when taken together with alcohol.
Estonian: Erandiks on üks morfiini sisaldav ravimvorm, mille toimeaine modifitseeritud vabastamine põhineb polümetakrülaat-trietüültsitraadist kattel, mille korral võib alkoholiga koos tarbimisel esineda annuse äkilise vabanemise efekt.
English: The polymethacrylatetriethylcitrate based formulation is highly sensitive to alcohol with its modified release properties being destroyed shortly after exposure, making it resemble an immediate release formulation.
Estonian: Polümetakrülaat-trietüültsitraat on alkoholi suhtes väga tundlik - vahetult pärast kokkupuudet alkoholiga kaotab aine toimeaine modifitseeritult vabastamist tagavad omadused, mille tõttu meenutab ravim toimeainet kiiresti vabastavat ravimvormi.
English: Consequently, the CHMP has recommended the suspension of the marketing authorisation for modified-release oral opioid products in the level III of the WHO scale for the management of pain containing a polymethacrylate-triethylcitrate coating as modified-release mechanism (see annex I).
Estonian: soovitas inimravimite komitee seetõttu peatada nende WHO III astme valuravis (intensiivne püsiv valu, mis varasematele ravimitele ei reageeri) kasutatavate toimeainet modifitseeritult vabastavate suukaudsete opioidide müügiload, mille toimeaine modifitseeritud vabastamine põhineb polümetakrülaat-trietüültsitraatkattel (vt I lisa).
English: • The Committee considered that, based on the published literature, a significant percentage of the patient population using these products does not abstain from alcohol consumption despite the existing warnings and contraindications,
Estonian: • komitee võttis arvesse teavet, et kirjanduses avaldatud andmete kohaselt kasutab suur protsent antud ravimeid võtvatest patsientidest vastavatest hoiatustest ja vastunäidustustest hoolimata samal ajal alkoholi;
English: According to the data on a competitor product presented by the MAH requesting re-examination, this product starts to exhibit accelerated release of the active substance after approximately 30 min of exposition to alcohol, and is claimed to release 76.5% of the oxycodone dose within one hour of exposure to concentrations of alcohol around 24%.
Estonian: Väidetavalt vabaneb ravimi ühetunnise kokkupuutumise korral umbes 24%lise alkoholiga 76,5% selles olevast oksükodoooni annusest.
English: This morphine formulation with polymethacrylate- triethylcitrate coating as modified-release mechanism has been identified as a product where dose dumping might occur when taken together with alcohol.
Estonian: Selle morfiini sisaldava ravimvormi toimeaine modifitseeritud vabastamine põhineb polümetakrülaat-trietüültsitraatkattel ja see leiti olevat ravim, mille manustamisel koos alkoholiga võib esineda annuse äkilise vabanemise efekt.
English: The CHMP having assessed all the detailed grounds for re-examination and argumentation presented by the MAH and having considered the views of the Rapporteurs, the scientific discussion within the Committee and the conclusions of the ad hoc expert group as well as the concerns raised by the MAH in this respect, concluded that products with a polymethacrylate-triethylcitrate coating are harmful under the normal conditions of use and that, for the remaining products, the Product Information should be amended to include a warning and recommendation for avoiding concomitant use with alcohol.
Estonian: Võttes arvesse müügiloa hoidja detailseid põhjendusi arvamuse ülevaatamiseks ja esitatud argumente, ettekandjate järeldusi, inimravimite komitees aset leidnud teaduslikke arutelusid ning ajutise ekspertide koosoleku järeldusi koos müügiloa hoidja tõstatatud küsimustega, otsustas inimravimite komitee, et polümetakrülaat-trietüültsitraatkatet sisaldavad ravimid on tavatingimustel kasutamisel ohtlikud.
English: • The Committee considered that a pharmacodynamic interaction between opioid products and alcohol may occur irrespective of the formulation,
Estonian: • komitee leidis, et farmakodünaamiline koostoime opioidi sisaldavate ravimite ja alkoholi vahel võib tekkida sõltumata ravimvormist;
English: • In addition, the Committee considered that the dissolution profile of products containing a polymethacrylate-triethylcitrate coating as modified-release mechanism is significantly affected in the presence of alcohol, leading to an uncontrolled rapid release of the majority of the active substance, and therefore the product exhibits a significant interaction with alcohol with potentially significant clinical effects (e.g. respiratory depression and death),
Estonian: See põhjustab enamiku toimeaine kiire ja kontrollimatu vabanemise, mille tõttu on ravimil märkimisväärne koostoime alkoholiga, millega kaasnevad potentsiaalselt märkimisväärsed kliinilised tagajärjed (nt respiratoorne depressioon ja surm);
English: Further to that, the IVIV correlation is, at present time, uncertain for most products.
Estonian: Oluline on ka veel see, et nii in vitro kui ka in vivo toime vaheline seos ei ole enamiku ravimite korral kindel.
English: Level III of the WHO scale includes fentanyl, hydromorphone, morphine and oxycodone, however no oral modified-release products containing fentanyl are currently authorised in the EU, as due to a marked first pass effect, oral administration of fentanyl is not feasible.
Estonian: Euroopa Liidus siiski fentanüüli sisaldavatel toimeainet modifitseeritult vabastavatel suukaudsetel ravimitel müügilube ei ole, sest presüsteemse metabolismi märkimisväärse mõju tõttu ei ole fentanüüli suukaudne manustamine võimalik.
English: An important interaction following alcohol consumption becomes progressively less likely with time due to dilution effect by gastric secretions and saliva, and gastric emptying.
Estonian: Tõsise koostoime tekkimise võimalus pärast alkoholi tarvitamist muutub aja kulgedes üha vähemtõenäolisemaks.
English: What is Arikayce?
Estonian: Mis on Arikayce?
English: EMA/430267/2016 EMEA/H/C/003936
Estonian: juuni 2016 EMA/430267/2016 EMEA/H/C/003936
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24 June 2016
Estonian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24.
English: The withdrawal letter is available here.
Estonian: Taotluse tagasivõtmise kiri on siin.
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is treating you.
Estonian: Kui osalete ravimi kliinilises uuringus ja vajate oma ravi kohta lisateavet, pöörduge palun arsti poole, kes teile ravi määras.
English: It was to be used in patients whose infection has persisted despite previous treatment.
Estonian: Ravimit kavatseti kasutada patsientidel, kellel nakkus on säilinud hoolimata eelnevast ravist.
English: These liposomes help reduce the rate at which the active substance is broken down, allowing it to remain in the body for longer.
Estonian: Liposoomid aitavad vähendada toimeaine lagunemise kiirust, võimaldades sel kauem kehas püsida.
English: Withdrawal of the marketing authorisation application for Arikayce (amikacin) EMA/430267/2016
Estonian: Müügiloa taotluse tagasivõtmise teave: Arikayce (amikatsiin) EMA/430267/2016
English: Further information on the orphan designation can be found here.
Estonian: Lisateave harvikravimiks nimetamise kohta on siin.
English: What consequences does this withdrawal have for patients in clinical trials?
Estonian: Kuidas mõjutab tagasivõtmine praegu kliinilistes uuringutes osalevaid patsiente?
English: The Committee's main concern was that the study submitted in the application did not provide enough evidence that Arikayce can permanently clear the bacteria from patients' sputum.
Estonian: Komitee pidas põhiprobleemiks seda, et taotluses esitatud uuring ei pakkunud piisavalt tõendeid, et Arikayce on võimeline püsivalt eemaldama bakterid patsientide kopsulimast.
English: The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Estonian: Taotlus võeti tagasi, kui inimravimite komitee oli hinnanud ettevõtte esitatud dokumente ja koostanud ettevõttele vastamiseks küsimused.
English: It was to be available as a suspension for inhalation.
Estonian: Seda kavatseti turustada inhalatsioonisuspensioonina.
English: After the CHMP had assessed the company's responses to the last round of questions, there were still some unresolved issues.
Estonian: Inimravimite komitee oli ettevõttele esitatud viimaste küsimuste vastused läbi vaadanud, kuid mõni küsimus oli veel lahendamata.
English: Withdrawal of the marketing authorisation application for Arikayce (amikacin)
Estonian: Müügiloa taotluse tagasivõtmise teave: Arikayce (amikatsiin)
English: This study compared Arikayce with placebo (a dummy treatment) and looked mainly at how effectively the medicine cleared bacteria from patients' sputum (phlegm) after about 3 months of treatment.
Estonian: Uuringus võrreldi Arikaycet platseeboga (näiv ravim) ja vaadati peamiselt seda, kui efektiivselt eemaldas ravim umbes 3-kuulise ravi järel bakterid patsientide kopsulimast.
English: Because the medicine is breathed in, it also reaches the lungs more directly than amikacin given by injection.
Estonian: Et ravimit hingatakse sisse, jõuab see kopsudesse vahetumalt kui süstitud amikatsiin.
English: How is Arikayce expected to work?
Estonian: Milline on Arikayce eeldatav toime?
English: Arikayce is an antibiotic containing the active substance amikacin.
Estonian: Arikayce on antibiootikum, mis sisaldab toimeainena amikatsiini.
English: In its letter notifying the Agency of the withdrawal, the company stated that its decision is based on the understanding that CHMP was not going to recommend approval of the medicine on the basis of current data.
Estonian: Oma kirjas Euroopa Ravimiametile taotluse tagasivõtmise kohta teatas ettevõte, et otsus põhineb arusaamal, et inimravimite komitee ei soovita olemasolevate andmete põhjal ravimi müügiloa andmist.
English: The company submitted results of an early (phase 2) study in 89 adult patients with lung infections caused by MAC or similar bacteria.
Estonian: Ettevõte esitas tulemused varasemast 2. faasi uuringust, mis korraldati 89 Mycobacterium avium'i kompleksi või sarnaste bakterite põhjustatud kopsunakkusega täiskasvanud patsiendil.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Arikayce did not outweigh its risks.
Estonian: Seetõttu oli inimravimite komitee müügiloa taotluse tagasivõtmise ajal arvamusel, et ravimi Arikayce kasulikkus ei ole suurem kui sellega kaasnevad riskid.