FrancophonIA/ELRC3.0 huggingface dataset:
English: International non-proprietary name (INN): telavancin
Estonian: Rahvusvaheline mittekaubanduslik nimetus (INN): telavantsiin
English: The antibiotics were given for up to 14 days.
Estonian: Antibiootikume manustati kuni 14 päeva.
English: The main measure of effectiveness was the number of patients whose infection had been cured after the end of treatment.
Estonian: Efektiivsuse peamine näitaja oli patsientide arv, kellel nakkus oli pärast ravi lõppu paranenud.
English: giving an opinion, ask any remaining questions at day 180.
Estonian: enne otsuse tegemist esitada 180. päeval täiendavaid küsimusi.
English: Ref. EMEA/586612/2008
Estonian: London, 20. november 2008 Viide: EMEA/650798/2008
English: The application was at day 201 when the company withdrew.
Estonian: Taotluse menetlemine oli kestnud 201 päeva, kui ettevõte võttis taotluse tagasi.
English: The Committee was also concerned that Vibativ may cause ‘QTc prolongation' (an alteration of the electrical activity of the heart).
Estonian: Komitee leidis ka, et Vibativ võib põhjustada QTc-intervalli pikenemist (südame elektrilise aktiivsuse muutus).
English: ‘Complicated' means that the infection is difficult to treat, because it has spread to the deep tissues below the skin, treatment with surgery might be needed, or the patient has other conditions that might affect the response to treatment.
Estonian: „Tüsistunud” tähendab, et nakkust on raske ravida, sest see on kas levinud sügavale nahaalustesse kudedesse, vaja võib olla kirurgilist ravi või patsiendil on muu haigus, mis võib ravivastust mõjutada.
English: The studies were carried out at sites where infection with MRSA is common.
Estonian: Uuringud tehti kohtades, kus MRSA-nakkus on sage.
English: Hence, the CHMP recommended that Vibativ be refused marketing authorisation.
Estonian: Komitee soovitas seepärast Vibativi müügiloa andmisest keelduda.
English: On 20 October 2008, Astellas Pharma Europe B. V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Vibativ, for the treatment of complicated skin and soft tissue infections in adults.
Estonian: 20. oktoobril 2008 teatas Astellas Pharma Europe B. V. ametilikult inimravimite komiteele oma soovist võtta tagasi naha ja pehmekudede tüsistunud nakkuste raviks täiskasvanutel kasutada kavatsetud ravimi Vibativ müügiloa taotlus.
English: The CHMP also had concerns regarding the production of the medicine, its stability and the possible presence of impurities.
Estonian: Inimravimite komitee ei olnud rahul ka ravimi tootmise, stabiilsuse ja võimalike sisalduvate ebapuhtuste tõttu.
English: Vibativ was compared with vancomycin (another antibiotic) in two main studies involving a total of 2,079 adults with complicated skin and soft tissue infections due to Gram-positive bacteria.
Estonian: Vibativi võrreldi vankomütsiiniga (samuti antibiootikum) kahes põhiuuringus, milles osales kokku 2079 grampositiivsete bakterite põhjustatud naha ja pehmekudede tüsistunud nakkusega täiskasvanud patsienti.
English: Together, the cell wall and membrane form a barrier between the bacterial cell contents and the external environment.
Estonian: Koos moodustavad rakusein ja -membraan barjääri bakteriraku sisemuse ja väliskeskkonna vahel.
English: What are the consequences of the refusal for patients in clinical trials or compassionate use programmes using Vibativ?
Estonian: Kuidas mõjutab keeldumine praegu Vibativi kliinilistes uuringutes või eriloaga kasutamise programmides osalevaid patsiente?
English: The active substance in Vibativ, telavancin, is an antibiotic that belongs to the group ‘glycopeptides'.
Estonian: Vibativi toimeaine telavantsiin on glükopeptiidide rühma kuuluv antibiootikum.
English: Vibativ is a powder to be made up into a solution for infusion (drip into a vein).
Estonian: Vibativ on pulber, millest valmistatakse infusioonilahus (veeni tilgutatav lahus).
English: The company informed the CHMP that there are currently no clinical trials or compassionate use programmes ongoing with Vibativ.
Estonian: Ettevõte teatas inimravimite komiteele, et Vibativi kliinilisi uuringuid ega ravimi eriloaga kasutamise programme praegu ei toimu.
English: Based on the review of the data and the company's responses to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Vibativ could not have been approved for the treatment of complicated skin and soft tissue infections in adults.
Estonian: Tuginedes esitatud andmete analüüsile ja ettevõtte vastustele inimravimite komitee esitatud küsimustele, nägi komitee tagasivõtmise ajal põhjuseid ettevaatlikkuseks ning oli esialgsel seisukohal, et Vibativile ei või anda naha ja pehmekudede tüsistunud nakkuste raviks täiskasvanutel kasutamiseks müügiluba.
English: Once the company has supplied responses to the questions, the CHMP reviews them and may, before
Estonian: Kui ettevõte on küsimustele vastanud, vaatab inimravimite komitee vastused läbi ja võib
English: It contains the active substance telavancin.
Estonian: Ravim sisaldab toimeainena telavantsiini.
English: How is Vibativ expected to work?
Estonian: Milline on Vibativi eeldatav toime?
English: At that point in time, the CHMP was of the opinion that the benefits of Vibativ in the treatment of complicated skin and soft tissue infections in adults did not outweigh its risks.
Estonian: Inimravimite komitee oli tagasivõtmise ajal seepärast arvamusel, et Vibativi kasulikkus naha ja pehmekudede tüsistunud nakkuste ravis täiskasvanutel ei ületa ravimiga kaasnevaid riske.
English: The effects of Vibativ were first tested in experimental models before being studied in humans.
Estonian: Enne inimuuringuid kontrolliti Vibativi toimet muudet katsetega.
English: The CHMP was concerned that there was no additional benefit of Vibativ over vancomycin, and could cause more kidney damage than vancomycin.
Estonian: Inimravimite komitee arvas, et Vibativil puudub täiendav kasulik toime võrreldes vankomütsiiniga ja see võib kahjustada neere rohkem kui vankomütsiin.
English: It is expected to work in two ways, both by stopping the bacteria making their cell walls and by disrupting their cell membranes.
Estonian: Eeldatavasti toimib see antibiootikum kahel viisil - takistades nii bakterirakkude seina sünteesi kui ka lagundades bakterite rakumembraane.
English: By disrupting this barrier, telavancin is expected to kill the bacteria that are causing the infection.
Estonian: Telavantsiin eeldatavasti lõhub selle barjääri ja hävitab nii nakkust põhjustavad bakterid.
English: Questions and answers on the withdrawal of the marketing application for Vibativ
Estonian: Teave müügiloa taotluse tagasivõtmise kohta Vibativ
English: These include Staphylococcus aureus (including ‘methicillin-resistant' forms known as ‘MRSA') and Streptococcus pyogenes.
Estonian: Vibativi kavatseti kasutada ainult juhul, kui on teada või oletatakse, et nakkuse põhjustavad grampositiivsed bakterid: eelkõige bakter Staphylococcus aureus (sealhulgas metitsilliiniresistentne Staphylococcus aureus, MRSA) ja Streptococcus pyogenes.
English: What was Vibativ expected to be used for?
Estonian: Milleks kavatseti Vibativi kasutada?
English: Vibativ was expected to be used to treat adults with complicated infections of the skin and the ‘soft tissues' below the skin.
Estonian: Vibativi kavatseti kasutada naha- või nahaaluste pehmekudede tüsistunud nakkuste raviks täiskasvanutel.
English: The applicant Geiser Pharma S.L.
Estonian: Taotleja Geiser Pharma S.L.
English: • The Committee considered (Co-)Rapporteur's assessment report;
Estonian: • komitee võttis arvesse (kaas-)hindaja hindamisaruannet;
English: The benefit-risk balance of the applied medicinal product is considered positive.
Estonian: Taotletava ravimi kasulikkuse ja riski tasakaalu peetakse positiivseks.
English: • The Committee was of the view that the submitted in-vitro studies and bibliographical data demonstrate sufficiently the safety and efficacy of the medicinal product.
Estonian: • komitee oli arvamusel, et esitatud in vitro uuringud ja bibliograafilised andmed tõendavad piisavalt ravimi ohutust ja efektiivsust.
English: First, the lower amount of cyclodextrins is preferable from a safety point of view.
Estonian: Esiteks on tsüklodekstriinide väiksem kogus ohutuse aspektist eelistatav.
English: This minor difference in concentration (5.93%) is expected to be reduced even more by the available saliva in the mouth.
Estonian: Eeldatavalt vähendab suus olev sülg seda väikest kontsentratsioonierinevust (5,93%) veelgi.
English: • The Committee considered the totality of the data submitted by the applicant in relation to the objections raised as potential serious risk to public health and the questions asked by the CHMP;
Estonian: • komitee võttis arvesse kõiki taotleja esitatud andmeid seoses potentsiaalselt suurest rahvaterviseriskist tulenevate vastuväidetega ja inimravimite komitee küsimustega;
English: The therapeutic equivalence has been claimed to be demonstrated based on in-vitro data only.
Estonian: Terapeutiline ekvivalentsus on väidetavalt tõestatud ainult in vitro andmete põhjal.
English: No clinical studies have been contacted and instead the applicant requested a biowaiver.
Estonian: Kliinilisi uuringuid ei ole tehtud ja selle asemel taotles taotleja bioekvivalentsusuuringu nõudest loobumist.
English: This justification was accepted by the CHMP.
Estonian: Inimravimite komitee kiitis selle põhjenduse heaks.
English: However, there are some quantitative and qualitative differences among the products which concern:
Estonian: Siiski on asjaomastel ravimitel teatavaid kvantitatiivseid ja kvalitatiivseid erinevusi:
English: The applicant has requested a waiver of the need to conduct clinical studies.
Estonian: Taotleja taotles kliiniliste uuringute tegemisest loobumist.
English: The proposed indication is short-term symptomatic relief of sore throat.
Estonian: Kavandatud näidustus on kurguvalu lühiajaline sümptomaatiline leevendus.
English: The product information remains as per the final version achieved during the Coordination group procedure as mentioned in Annex III of the CHMP opinion.
Estonian: Ravimiteave jääb selliseks nagu koordineerimisrühma menetluses kokkulepitud lõplikus versioonis, kooskõlas inimravimite komitee arvamuse III lisaga.
English: Therefore, this difference in concentration is considered insignificant and clinically irrelevant, taking into consideration that eventually the same dose is administered locally.
Estonian: Seetõttu peetakse sellist kontsentratsioonierinevust tühiseks ja kliiniliselt ebaoluliseks, sest paikselt manustatakse kokkuvõttes sama annus.
English: The drug inhibits the synthesis of prostaglandins by mixed inhibition of the enzymes COX-1/COX-2 with some selectivity towards COX-1.
Estonian: Ravim pärsib prostaglandiinide sünteesi, inhibeerides nii COX-1 kui COX-2 ensüüme, olles mõnevõrra selektiivsem COX-1 suhtes.
English: On the top of that, flurbiprofen is a highly permeable and passively absorbed drug of which the permeability is not altered by a difference in concentration.
Estonian: Lisaks on flurbiprofeen väga suure permeaablusega ja passiivselt absorbeeritav ravim, mille permeaablus ei sõltu kontsentratsioonierinevusest.
English: Literature data (Radkova et al., 2017, Imai et al., 1988) demonstrate that different formulations of flurbiprofen (spray and lozenges) displayed comparable efficacy and safety profiles, despite the lack of cycloextrins from lozenges, and were also taken into consideration.
Estonian: Kirjandusandmed (Radkova et al., 2017, Imai et al., 1988) näitavad, et flurbiprofeeni eri ravimvormidel (sprei ja losengid) on võrreldavad efektiivsus- ja ohutusprofiilid vaatamata sellele, et losengides tsüklodekstriinid puuduvad, ning seda väidet võeti arvesse.
English: The proposed indication is ‘pain relief of mild to moderate symptoms of acute sore throat'.
Estonian: Kavandatud näidustus on „valu leevendamine ägeda kurguvalu kergete kuni mõõdukate sümptomite korral“.
English: The Committee, as a consequence, considers that the benefit-risk balance of Flurbiprofen Geiser 8,75 mg oromucosal spray, solution and associated names is favourable and therefore recommends the granting of the marketing authorisation(s) for the medicinal products referred to in Annex I of the CHMP opinion.
Estonian: Seetõttu on komitee arvamusel, et ravimi Flurbiprofen Geiser 8,75 mg suuõõnesprei lahuse ja seotud nimetuste kasulikkuse ja riski tasakaal on soodne, ning soovitab seega anda inimravimite komitee arvamuse I lisas viidatud ravimite müügiloa(d).
English: The originator product is Strepflam 8.75 Lozenges by Crookes Healthcare/Reckitt Benckiser Healthcare, which has been registered since June 2001.
Estonian: Originaalravim on ettevõtte Crookes Healthcare/Reckitt Benckiser Healthcare poolt 2001. aasta juunist alates registreeritud Strepflam 8,75 losengid.
English: The CHMP also considered that the different amount of cyclodextrins is not of concern.
Estonian: Inimravimite komitee oli arvamusel, et tsüklodekstriinide erinev kogus ei tekita probleeme.
English: Second, flurbiprofen is moderately bound to the cyclodextrins and the release of the active substance is immediate when it comes in contact with the buccal membrane.
Estonian: Teiseks seondub flurbiprofeen tsüklodekstriinidega mõõdukalt ja põselimaskestaga kokkupuutel vabaneb toimeaine kohe.
English: If bioequivalence has been established among such different formulations, the minor differences in the present case will not affect the pharmacokinetic and clinical profile of the test product.
Estonian: Kui on tõestatud selliste erinevate preparaatide bioekvivalentsus, ei mõjuta käesoleva juhtumi korral esinevad väikesed erinevused uuritava ravimi farmakokineetikat ega kliinilist profiili.
English: The application for Strefen Direct 8,75 mg Oromucosal spray was made under Article 8(3) of Directive 2001/83/EC.
Estonian: Strefen Direct 8,75 mg suuõõnesprei taotlus oli esitatud direktiivi 2001/83/EÜ artikli 10 lõike 3 kohaselt.
English: Moreover, it was emphasised that the originator has demonstrated bioequivalence between the oromucosal spray (Strefen Direct 8,75 mg Oromucosal spray) and lozenges (Strepflam 8,75 mg Lozenges), for which more significant formulation differences exist.
Estonian: Peale selle rõhutati, et originaalravimi tootja on tõendanud suuõõnesprei (Strefen Direct 8,75 mg suuõõnesprei) ja losengide (Strepflam 8,75 mg losengid) bioekvivalentsust ning just nende ravimvormide erinevused on kõige olulisemad.
English: The reference medicinal product was Strefen Direct 8,75 mg Oromucosal spray (UK/H/5072/001).
Estonian: Võrdlusravim oli Strefen Direct 8,75 mg suuõõnesprei (UK/H/5072/001).
English: ii) the amount of cyclodextrins: the amount of cyclodextrins is lower in the test product compared to this of the reference medicinal product;
Estonian: 2) tsüklodekstriinide kogus: tsüklodekstriini kogus on uuritavas ravimis väiksem kui võrdlusravimis;
English: The assessment was performed having in mind that this was this is a hybrid application under Article 10(3) of Directive 2001/83/EC.
Estonian: Hindamisel võeti arvesse seda, et tegemist oli direktiivi 2001/83/EÜ artikli 10 lõike 3 kohase hübriidtaotlusega.
English: The CHMP considered that the noted differences between the reference and test product are minor and the applicant has sufficiently demonstrated why these differences do not affect the local efficacy, safety or the systemic absorption of the product.
Estonian: Inimravimite komitee oli arvamusel, et võrdlusravimi ja uuritava ravimi vahel täheldatud erinevused on väikesed ning taotleja on piisaval määral tõendanud, et need erinevused ei mõjuta ravimi paikset efektiivsust, ohutust ega süsteemset imendumist.
English: • The Committee considered the referral under Article 29(4) of Directive 2001/83/EC;
Estonian: • komitee arutas direktiivi 2001/83/EÜ artikli 29 lõike 4 kohast esildist;
English: Flurbiprofen belongs to the non-steroidal anti-inflammatory class of medicines (NSAID) which have analgesic, antipyretic, and anti-inflammatory properties.
Estonian: Flurbiprofeen kuulub mittesteroidsete põletikuvastaste ravimite (NSAID) rühma, millel on analgeetilised, antipüreetilised ja põletikuvastased omadused.
English: So in the hypothetical scenario of a difference in the amount of produced saliva this would not impact on the absorbed amount of the active substance.
Estonian: Kui hüpoteetiliselt esineks süljeerituse erinevus, ei mõjutaks see toimeaine imendunud kogust.
English: Results from the in-vitro tests performed by the applicant have shown equivalence in the critical quality attributes that were tested (single actuation content, droplet size distribution, drug small particles, spray pattern, plum geometry and priming), suggesting that the quantitative and qualitative differences between the reference and the test medicinal products do not affect the deposition of the spray in the site of action (the buccal cavity).
Estonian: Taotleja tehtud in vitro uuringud tõendasid ekvivalentsust uuritud kriitiliste kvaliteediomaduste osas (ühe manustamisega manustatav kogus, tilkade suuruse jaotuvus, ravimi väikesed osakesed, pihustusmuster, sulekujuline pihustusgeomeetria ja eeltäitmine), mis näitab, et võrdlusravimi ja uuritava ravimi kvantitatiivsed ja kvalitatiivsed erinevused ei mõjuta sprei sadestumist toimekohas (põses).
English: With regards to the different concentration (17.16 mg/ml vs. 16.20 mg/ml), it was noted that that due to the different sprayed volumes (0.17 mL vs. 0.18 mL), the delivered dose is eventually the same.
Estonian: Kontsentratsioonierinevusega (17,16 mg/ml vs 16,20 mg/ml) seoses märgiti, et erineva pihustatava mahu (0,17 ml vs 0,18 ml) tõttu on manustatud annus kokkuvõttes sama.
English: submitted an application under the decentralised procedure for Flurbiprofen Geiser 8,75 mg oromucosal spray, solution and associated names (ES/H/0552/001/DC).
Estonian: esitas detsentraliseeritud menetluse kohase taotluse Flurbiprofen Geiser 8,75 mg suuõõnesprei lahuse ja sarnaste nimetuste kohta (ES/H/0552/001/DC).
English: The test product has some quantitative and qualitative differences with the reference product, namely;
Estonian: Uuritaval ravimil on võrdlusravimiga võrreldes teatavad kvantitatiivsed ja kvalitatiivsed erinevused, nimelt:
English: Based on the in-vitro tests, equivalence has been shown between the reference and the test products with respect to the following quality attributes: amount of active substance in each dose, the particle size, the plume geometry and the spray pattern.
Estonian: In vitro analüüsides tõestati võrdlusravimi ja uuritava ravimi ekvivalentsus seoses järgmiste kvaliteediomadustega: toimeaine kogus ühes annuses, osakeste suurus, sulekujuline pihustusgeomeetria ja pihustusmuster.
English: The present referral was triggered on the grounds that the waiver for clinical studies is not in line with the “Guideline on equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract” (CPMP/EWP/239/95 Rev.1) and that the differences may impact on the clinical performance of the test product.
Estonian: Käesolev esildis algatati põhjusel, et kliinilistest uuringutest loobumine ei ole kooskõlas suunisega „Seedetraktis paikselt kasutatavate ja paikselt toimivate ravimite terapeutilise ekvivalentsuse tõestamise ekvivalentsusuuringute suunis“ (CPMP/EWP/239/95, versioon 1) ja erinevused võivad mõjutada uuritava ravimi kliinilist toimet.
English: During the decentralised procedure (DCP) and the CMDh procedure, the RMS (ES) considered that the above mentioned differences were minor and without a clinical impact on the efficacy and safety of the test product.
Estonian: Detsentraliseeritud menetluse ning inimravimite vastastikuse tunnustamise ja detsentraliseeritud menetluste koordineerimisrühma menetluse käigus oli referentliikmesriik (Hispaania) arvamusel, et eespool nimetatud erinevused on väikesed ning neil ei ole kliinilist mõju uuritava ravimi efektiivsusele ja ohutusele.
English: The application was submitted under Article 10(3) of Directive 2001/83/EC.
Estonian: Taotlus esitati direktiivi 2001/83/EÜ artikli 10 lõike 3 alusel.
English: The saliva secretion does not play a relevant contribution in the in-vivo performance of the buccal spray since most of the content of the spray is swallowed as a consequence of gag the reflex caused by the impact of the spray in the throat, without any time to be affected by the secretion of saliva.
Estonian: Süljeeritus ei mõjuta eriti suuõõnesprei in vivo toimivust, sest enamik spreist neelatakse kurku manustamisest tingitud okserefleksi tagajärjel nii kiiresti alla, et see ei jõua süljeeritust mõjutada.
English: Grounds for the CHMP opinion
Estonian: Inimravimite komitee arvamuse alused
English: i) the concentration: 17.16 mg/ml in the test medicinal product versus 16.20 mg/ml in the reference product;
Estonian: 1) kontsentratsioon: 17,16 mg/ml uuritavas ravimis vs 16,20 mg/ml võrdlusravimis;
English: Acknowledging that deviations from the guideline on equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract (CPMP/EWP/239/95 Rev.1) could be accepted if they are justified appropriately and having reviewed all the data submitted and the responses submitted by the applicant, the CHMP considered that the waiver of the clinical trials to demonstrate therapeutic equivalence has been adequately substantiated.
Estonian: Võttes arvesse, et kõrvalekaldeid seedetraktis paikselt kasutatavate ja paikselt toimivate ravimite terapeutilise ekvivalentsuse tõestamise ekvivalentsusuuringute suunistest (CPMP/EWP/239/95, versioon 1) võib aktsepteerida, kui see on asjakohaselt põhjendatud, ning olles läbi vaadanud taotleja esitatud andmed ja vastused, oli inimravimite komitee arvamusel, et terapeutilist ekvivalentsust tõestavatest kliinilistest uuringutest loobumine on piisavalt põhjendatud.
English: i) different concentration: 17.16 mg/ml in the test product versus 16.20 mg/ml in the reference product (0.096% difference of content of drug substance in weight/volume)
Estonian: 1) erinev kontsentratsioon: 17,16 mg/ml uuritavas ravimis vs 16,20 mg/ml võrdlusravimis (toimeaine kontsentratsioonierinevus 0,096 massi-/mahuprotsenti);
English: Differences with respect to the reference medicinal product are possible, as long as it is demonstrated that these differences do not affect the therapeutic equivalence between the reference and the test product.
Estonian: Erinevused võrdlusravimiga on võimalikud tingimusel, et on tõestatud, et need erinevused ei mõjuta võrdlusravimi ja uuritava ravimi terapeutilist ekvivalentsust.
English: Overall summary of the scientific evaluation by the CHMP Flurbiprofen Geiser 8,75 mg oromucosal spray, is a non-steroidal anti-inflammatory (NSAID) with analgesic, antipyretic, and anti-inflammatory properties.
Estonian: Flurbiprofen Geiser 8,75 mg suuõõnesprei on analgeetiliste, antipüreetiliste ja põletikuvastaste omadustega mittesteroidne põletikuvastane ravim (NSAID).
English: Differences with respect to the reference medicinal product are possible in the context of a hybrid application, as long as these differences do not affect the therapeutic equivalence between the reference and the test products.
Estonian: Erinevused võrdlusravimiga on võimalikud hübriidmanustamise kontekstis, kui need erinevused ei mõjuta võrdlusravimi ja uuritava ravimi terapeutilist ekvivalentsust.
English: The CHMP considered that the removal of the mint flavour is considered clinically irrelevant in this specific case.
Estonian: Inimravimite komitee oli arvamusel, et konkreetsel juhul on piparmündi maitse ja lõhna eemaldamine kliiniliselt ebaoluline.