FrancophonIA/ELRC3.0 huggingface dataset:
English: Moreover, this model holds true only for target strains in plasma or tissue sites with equivalent paromomycin distribution, no predictability can be expected against the pathogen located in other tissues.
Estonian: Lisaks on see mudel tõene üksnes siis, kui plasmas on sihttüvesid või kudedes on paromomütsiini jaotuvus ekvivalentne; muudes kudedes olevate patogeenide suhtes ei ole võimalik tulemusi prognoosida.
English: Scientific conclusions and grounds for suspension of the marketing authorisations
Estonian: II lisa Teaduslikud järeldused ja müügilubade peatamise alused
English: The quantification of paromomycin in tissues was carried out by validated HPLC-MS/MS analytical methods.
Estonian: Paromomütsiini kogus kudedes määrati valideeritud HPLC-MS/MS-analüüsimeetoditega.
English: In the case of E. coli, the PK/PD analysis was only favourable for strains with MICs equal to or below 4.44 µg/ml.
Estonian: E. coli korral oli farmakokineetilise/farmakodünaamilise analüüsi tulemus soodne ainult tüvede korral, mille MIC oli ≤ 4,44 µg/ml.
English: Therefore, the indication against colibacillosis based on an overestimated success from a theoretical modelling, against E. coli strictly located in plasma, for an unjustified duration of treatment and not confirmed by clinical data, is not acceptable.
Estonian: Kolibatsilloosi vastane, kuid kliiniliste andmetega kinnitamata näidustus, mis tugines selgelt plasmas oleva E. coli kohta tehtud teoreetilise mudeli tulemuste ülehinnatud edukusele ja mille ravikestus oli põhjendamata, ei ole seega aktsepteeritav.
English: For antimicrobials like paromomycin, whose efficacy is concentration-dependent, high plasma concentration levels relative to the MIC of the pathogen (Cmax/MIC ratio, also known as the inhibitory quotient or IQ) are a major determinant of clinical efficacy; a Cmax/MIC ratio > 8-10 is suggested to achieve optimal efficacy.
Estonian: Selliste antimikroobsete ainete korral nagu paromomütsiin, mille efektiivsus sõltub kontsentratsioonist, on peamine kliinilist efektiivsust määrav tegur patogeeni MIC-iga võrreldes suur plasmakontsentratsioon (suhe Cmax/MIC ehk inhibitsioonikoefitsient); arvatakse, et optimaalse efektiivsuse tagab Cmax/MIC > 8…10.
English: The CVMP was requested to review all available pre-clinical, clinical and residue depletion data for veterinary medicinal products containing paromomycin to be administered parenterally to pigs and recommend appropriate indications, dosing recommendations and withdrawal periods.
Estonian: Veterinaarravimite komiteel paluti läbi vaadata sigade parenteraalsete paromomütsiini sisaldavate veterinaarravimite kõik olemasolevad prekliinilised, kliinilised ja ravimijääkide kadumise andmed ning soovitada sobivad näidustused, annustamissoovitused ja keeluajad.
English: However, there are no pre-clinical and clinical data supporting the indication for the treatment of MMA in sows.
Estonian: Puuduvad prekliinilised ja kliinilised andmed, mis tõendaksid MMA ravi näidustust emistel.
English: Samples of the target tissues were analysed by HPLC method coupled with MS/MS detection.
Estonian: Sihtkudede proove analüüsiti HPLC-meetodiga koos MS/MS-tuvastusmeetodiga.
English: However, the deficiencies noted in the study (absence of data on storage stability, the wide recovery rates in muscle samples and the absence of ring sample in the sampling of the injection site) cannot be covered by any safety span.
Estonian: Uuringus täheldatud puudusi (puudusid säilitusaegse stabiilsuse andmed, tulemuste suur varieeruvus lihaseproovides ja süstekoha proovi ümbritseva rõngakujulise kontrollproovi puudumine) ei ole ohutusvaruga siiski võimalik neutraliseerida.
English: Evaluation and conclusions on the benefit-risk balance Therefore, the Committee considers that in the absence of adequate pre-clinical, clinical and residue depletion data and because the use of these medicinal products could pose a potential risk to animal and human health, the benefit-risk balance for the concerned veterinary medicinal products containing paromomycin to be administered parenterally to pigs is not favourable.
Estonian: Kasulikkuse ja riski tasakaalu hinnang ja järeldused Seega on komitee arvamusel, et seoses prekliiniliste, kliiniliste ja ravimijääkide kadumise piisavate andmete puudumisega ning ravimpreparaatide kasutamise võimaliku riskiga looma- ja inimtervisele ei ole sigade parenteraalsete paromomütsiini sisaldavate asjaomaste veterinaarravimite kasulikkuse ja riski tasakaal soodne.
English: As no adequate data are available to support indications, posology and withdrawal periods, the CVMP is not able to recommend any appropriate indications, dosage and withdrawal periods for the concerned veterinary medicinal products.
Estonian: Arvestades, et puuduvad piisavad andmed näidustuste, annustamise ja keeluaegade toetuseks, ei saa veterinaarravimite komitee soovitada asjaomase veterinaarravimi kohta ühtki asjakohast näidustust, annustusamist ega keeluaega.
English: Muscle of injection site is not the most reliable tissue for withdrawal time calculation, as it is often characterised by a high variability in residues levels, confirmed also in this case by the limited number of samples with concentrations above limit of quantification (2/4 on Day 12).
Estonian: Kõige olulisemad koed paromomütsiini ravimijääkide suhtes olid süstekoha lihas ja neer. Süstekoha lihas ei ole kõige usaldusväärsem kude keeluaja arvutamiseks, sest sellele on sageli iseloomulik ravimijääkide kontsentratsiooni suur varieeruvus, mida tõendab ka praegusel juhul mitu määramispiiri ületava kontsentratsiooniga proovi (12. päeval 2 proovi 4st).
English: Regarding A. pleuropneumoniae, the PK/PD analysis based on the inhibitory quotient (Cmax/MIC >8 to 10) shows that only 10% of the target bacterial population would be sensitive to paromomycin administered at the recommended posology.
Estonian: A. pleuropneumoniae kohta inhibitsioonikoefitsiendi (Cmax/MIC > 8…10) põhjal tehtud farmakokineetika/farmakodünaamika analüüsil selgus, et ainult 10% sihtbakteripopulatsioonist oleks soovitud annustamist kasutades paromomütsiini suhtes tundlik.
English: However, a number of deficiencies in the study were noted related to the storage of the samples, the stability of the residues in storage conditions, the wide range of recovery in muscle and the absence of a ring-shaped control surrounding the excised injection site core sample.
Estonian: Märgiti uuringu mitu puudust, mis olid seotud proovide säilitamisega, ravimijääkide stabiilsusega säilitamistingimustel, tulemuste suure varieeruvusega lihases ja eemaldatud süstekoha proovi ümbritseva rõngakujulise kontrollproovi puudumisega.
English: Residue data
Estonian: Ravimijääkide andmed
English: • the CVMP considered that the use of veterinary medicinal products containing paromomycin to be administered parenterally to pigs is not supported by pre-clinical, clinical and residue depletion data and the currently recommended indications, dosing regimens and withdrawal period could pose a potential risk to animal and human health;
Estonian: • veterinaarravimite komitee oli arvamusel, et sigade parenteraalsete paromomütsiini sisaldavate veterinaarravimite kasutamine ei ole põhjendatud prekliiniliste, kliiniliste ja ravimijääkide kadumise andmetega ning praegu soovitatavad näidustused, annustamisskeemid ja keeluajad võivad olla seotud võimaliku riskiga inim- ja loomatervisele;
English: • the CVMP concluded that the benefit-risk assessment for veterinary medicinal products containing paromomycin to be administered parenterally to pigs is negative because there were inadequate data to support efficacy of these veterinary medicinal products for the proposed indications at the recommended treatment dose and that this deficiency poses a risk of ineffective treatment and antimicrobial resistance development; the CVMP has recommended the suspension of the marketing authorisations for veterinary medicinal products containing paromomycin to be administered parenterally to pigs as referred in Annex I. The conditions to lift the suspension of the marketing authorisations are set out in Annex III.
Estonian: • veterinaarravimite komitee järeldas, et sigade parenteraalsete paromomütsiini sisaldavate veterinaarravimite kasulikkuse ja riski tasakaal on negatiivne, sest puuduvad piisavad andmed nende veterinaarravimite efektiivsuse tõestamiseks kavandatud näidustustel ja soovitatavates annustes ning see puudus on seotud ravi ebaõnnestumise ja antibiootikumiresistentsuse tekkeriskiga, soovitas veterinaarravimite komitee peatada sigade parenteraalsete paromomütsiini sisaldavate veterinaarravimite (vt I lisa) müügiload.
English: This result, however is likely to overestimate the efficacy of paromomycin at the recommended dose since the % binding of paromomycin to plasma proteins was not determined, which would reduce the portion of paromomycin in plasma able to work against E. coli.
Estonian: See tulemus tõenäoliselt ülehindab paromomütsiini efektiivsust soovitatava annuse kasutamisel, sest paromomütsiini plasmavalkudega seonduvuse protsenti ei määratud, kuid see vähendab E. coli vastu toimiva paromomütsiini osa plasmas.
English: The same marketing authorisation holder provided data in order to justify the use of ‘Gabbrovet solution injectable' in pigs at a dose of 14 mg paromomycin base/kg bodyweight for 5 consecutive days.
Estonian: Sama müügiloa hoidja esitas andmed Gabbroveti süstelahuse kasutamise põhjendamiseks sigadel annuses 14 mg paromomütsiini alust kehamassi kilogrammi kohta (mg/kg) 5 järjestikuse päeva jooksul.
English: The currently authorised indications are unspecific and no specific pathogens are mentioned, i.e. for the treatment of bacterial infections caused by pathogens which are susceptible to paromomycin or for bacterial infections of the respiratory tract, uro-genital tract, mastitis, enteritis, abscess, wounds, canine leishmaniosis and surgery.
Estonian: Praegu heakskiidetud näidustused on mittespetsiifilised ning ei nimeta spetsiifilisi patogeene, näiteks paromomütsiinile tundlike patogeenide põhjustatud bakterinfektsioonide ravi või hingamisteede, urogenitaaltrakti bakterinfektsioonide, mastiidi, enteriidi, abstsesside, haavade, koerte leišmanioosi ravi ja kirurgia.
English: This already poor result is in addition likely to overestimate the efficacy of paromomycin at the recommended dose since the % binding of paromomycin to plasma proteins was not determined, which would reduce the portion of paromomycin in plasma able to work against A. pleuropneumoniae.
Estonian: See iseenesest puudulik tulemus tõenäoliselt ülehindab paromomütsiini efektiivsust soovitatava annuse kasutamisel, sest paromomütsiini plasmavalkudega seonduvuse protsenti ei määratud, kuid see vähendab A. pleuropneumoniae vastu toimiva paromomütsiini osa plasmas.
English: The residue depletion study was performed in pigs with the intramuscular administration of the maximum recommended dose of 14 mg paromomycin/kg bodyweight/day for 5 consecutive days.
Estonian: Ravimijääkide kadumise uuring tehti sigadel, kasutades intramuskulaarset maksimaalset soovitatavat annust 14 mg/kg/d paromomütsiini 5 järjestikuse päeva jooksul.
English: In the absence of adequate data to support indications and posology, there is a risk that product administration at the currently recommended dose and duration of treatment will lead to ineffective treatment and a potential unnecessary suffering in the treated animals.
Estonian: Näidustust ja annustamist põhjendavate piisavate andmete puudumisel esineb risk, et ravimi manustamine praegu soovitatavas annuses ja kestusega põhjustab ravi ebaõnnestumist ja võimalikke ebavajalikke kannatusi ravitavatele loomadele.
English: During the aforementioned decentralised procedure, it has been noted that there are different approved indications, posology and withdrawal periods for veterinary medicinal products containing paromomycin to be administered parenterally to pigs across the European Union (EU).
Estonian: Nimetatud detsentraliseeritud menetluse ajal märgiti, et Euroopa Liidus sigade parenteraalsetel paromomütsiini sisaldavatel müügiloaga veterinaarravimitel on eri heakskiidetud näidustused, annustamine ja keeluajad.
English: In the absence of adequate data to support indications and posology, there is a risk that product administration at the currently recommended dose will lead to ineffective treatment and a potential unnecessary suffering in the treated animals.
Estonian: Näidustust ja annustamist põhjendavate piisavate andmete puudumise korral esineb risk, et ravimi manustamine praegu soovitatavas annuses põhjustab ravi ebaõnnestumist ja potentsiaalselt ebavajalikke kannatusi ravitavatele loomadele.
English: A pharmacokinetic study was carried out in target animals at the recommended dose (14 mg/kg bodyweight of paromomycin).
Estonian: Loomaliikidel tehti soovitatava annusega (14 mg/kg) farmakokineetika uuring.
English: • To provide adequate clinical data in support of an indication against colibacillosis at the recommended dose and duration of treatment.
Estonian: • Esitama peab asjakohased ja piisavad kliinilised andmed kolibatsilloosi näidustuse toetuseks soovitatud annuse ja ravikestuse kasutamisel.
English: Conditions for lifting the suspension of the marketing authorisations
Estonian: III lisa Müügilubade peatamise lõpetamise tingimused
English: One of the marketing authorisation holders proposed a withdrawal time of 16 days based on a linear regression with kidney as limiting tissue, and 16 days with muscle of injection site by using the ‘alternative' method, in line with CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95).
Estonian: Üks müügiloa hoidja pakkus keeluajaks 16 päeva, kasutades neeru kui piirava koe kohta lineaarset regressiooni, ja 16 päeva, kasutades süstekoha lihase kohta alternatiivset meetodit, mis on kooskõlas veterinaarravimite komitee keeluaegade ühtlustamise suunisega (EMEA/CVMP/036/95).
English: Finally the PK/PD model does not allow justifying the duration of treatment.
Estonian: Farmakokineetika/farmakodünaamika mudeli põhjal võimalik põhjendada ka ravi kestust.
English: • To provide adequate clinical data (including GCP, randomised, blinded field study) in support of the treatment of pleuropneumonia caused by Actinobacillus pleuropneumoniae at the recommended dose and duration of treatment.
Estonian: • Actinobacillus pleuropneumoniae põhjustatud pleuropneumoonia ravi ning soovitatava annuse ja ravikestuse toetuseks peab esitama piisavad kliinilised andmed (sh headele kliinilistele tavadele vastav randomiseeritud pimemenetlusega väliuuringu) Vaja on põhjendada annust ja ravikestust.
English: Furthermore, neither dose determination, nor dose confirmation studies have been made available to confirm the results of the PK/PD analysis and no field trial was made available.
Estonian: Samuti ei ole farmakokineetika/farmakodünaamika analüüsi tulemuste kinnitamiseks avaldatud annuse määramise ega annuse kontrollimise uuringuid ega väliuuringuid.
English: Relevant clinical data (including GCP, randomised, blinded field study) are required for each claim related to a specific type of Escherichia coli.
Estonian: Konkreetse Escherichia coli tüübiga seotud iga väite kohta peab esitama asjakohased kliinilised andmed (sh headele kliinilistele tavadele vastav randomiseeritud pimemenetlusega väliuuringu).
English: The statistical evaluation to establish withdrawal period was carried out following the CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95)1.
Estonian: Keeluaja määramise statistiline analüüs lähtus veterinaarravimite komitee keeluaegade ühtlustamise suunisest (EMEA/CVMP/036/95)1.
English: Parofor 175 mg/ml
Estonian: Parofor 175 mg/ml paromomütsii n
English: • Treatment of E. coli involved in swine colibacillosis (neonatal diarrhoea, post-weaning diarrhoea, oedema disease) and against Actinobacillus pleuropneumoniae strains with a
Estonian: tursehaigus) tekkes osaleva E. coli ravi ja Actinobacillus pleuropneumoniae nende tüvede ravi, mille MIC (minimaalne inhibeeriv kontsentratsioon) on ≤ 4 mg/l.
English: Czech Republic Huvepharma NV Uitbreidingstraat 80
Estonian: Tšehhi Vabariik Huvepharma NV Uitbreidingstraat 80
English: For injection site, a rounded withdrawal period of 16 days was calculated using the ‘alternative' method, in line with CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95).
Estonian: Süstekohas määrati ümardatud keeluaeg 16 päeva, kasutades veterinaarravimite komitee keeluaegade ühtlustamise suunisega (EMEA/CVMP/036/95) kooskõlas alternatiivset meetodit.
English: For kidney, a withdrawal time rounded to 16 days was determined based on linear regression using the ‘statistical' method, in line with CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95).
Estonian: Kõige olulisemad koed paromomütsiini ravimijääkide suhtes olid süstekoha lihas ja neer. Neerudes määrati 16 päevani ümardatud keeluaeg lineaarse regressiooni põhjal, kasutades veterinaarravimite komitee keeluaegade ühtlustamise suunisega (EMEA/CVMP/036/95) kooskõlas statistilist meetodit.
English: United Kingdom Huvepharma NV Uitbreidingstraat 80
Estonian: Huvepharma NV Uitbreidingstraat 80
English: 28 June 2012
Estonian: 28. juuni 2012
English: The European Commission issued a decision on 28 June 2012.
Estonian: Euroopa Komisjon tegi otsuse 28. juunil 2012.
English: However, the Member States were not able to reach an agreement and the UK referred the matter to the CHMP for arbitration on 22 December 2011.
Estonian: Liikmesriigid ei jõudnud aga menetluse käigus üksmeelele ja Ühendkuningriik tegi 22. detsembril 2011 inimravimite komiteele esildise vahekohtumenetluse alustamiseks.
English: What are Flutiform and Iffeza?
Estonian: Mis on Flutiform ja Iffeza?
English: Why were Flutiform and Iffeza reviewed?
Estonian: Miks Flutiformi ja Iffeza andmed uuesti üle vaadati?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Flutiform and Iffeza outweigh the risks, and that the marketing authorisation can be granted in the United Kingdom and in the following Member States of the EU: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Iceland, Ireland, Italy, Luxembourg, The Netherlands, Norway, Poland, Portugal, Romania, Slovakia and Sweden.
Estonian: Euroopa Ravimiameti inimravimite komitee järeldas, et Flutiformi ja Iffeza kasulikkus on suurem kui kaasnevad riskid ja et müügiloa võib välja anda Ühendkuningriigis ning järgmistes ELi liikmesriikides: Austria, Belgia, Bulgaaria, Iirimaa, Island, Itaalia, Küpros, Luksemburg, Madalmaad, Poola, Portugal, Prantsusmaa, Rootsi, Rumeenia, Saksamaa, Slovakkia, Soome, Taani, Tšehhi Vabariik ning Norras.
English: The CHMP looked at all the available evidence on the benefits and risks of the medicine in the treatment of asthma and concluded that the questions raised over its long-term effectiveness had been adequately addressed.
Estonian: Inimravimite komitee vaatas läbi kõik kättesaadavad tõendusmaterjalid kõnealuste ravimite kasulikkuse ja riskide kohta astma ravis ning järeldas, et ravimite pikaajalise efektiivsuse küsimusele on nõuetekohaselt vastatud.
English: Flutiform will also be marketed as Flofera and Flutiformo.
Estonian: Flutiformi kavatsetakse turustada veel nimetuste Flofera ja Flutiformo all.
English: Therefore, the Committee concluded that the benefits of Flutiform and Iffeza outweigh the risks and that marketing authorisation should be granted in all concerned Member States.
Estonian: Seetõttu järeldas inimravimite komitee, et Flutiformi ja Iffeza kasulikkus on suurem kui nendega kaasnevad riskid ning et ravimitele tuleb anda müügiluba kõigis asjaomastes liikmesriikides.
English: In the light of this The Netherlands questioned the long-term efficacy of this product in respect of asthma control.
Estonian: Seetõttu seadsid Madalmaad kahtluse alla nende ravimite pikaaegse efektiivsuse astma ravis.
English: When inhaled, formoterol fumarate helps to keep the airways open allowing the patient to breathe more easily.
Estonian: Pärast inhaleerimist aitab formoteroolfumaraat hoida hingamisteid avatuna, mis võimaldab patsiendil kergemini hingata.
English: The grounds for the referral were concerns raised by The Netherlands over data showing that the levels of fluticasone propionate in the blood following dosing with Flutiform and Iffeza are lower than when fluticasone propionate is given alone, which may indicate a lower amount of fluticasone propionate being deposited in the lungs.
Estonian: Esildise tegemine oli tingitud Madalmaade osutatud andmetest, mis näitasid, et flutikasoonpropionaadi sisaldus veres oli pärast Flutiformi ja Iffeza manustamist väiksem kui pärast flutikasoonpropionaadi eraldi manustamist, mis võib tähendada, et ka kopsudesse jõuab väiksemas koguses flutikasoonpropionaati.
English: On 19 April 2012, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicines Flutiform and Iffeza and associated names.
Estonian: Euroopa Ravimiamet lõpetas 19. aprillil 2012 vahekohtumenetluse, mis algatati, kui Euroopa Liidu (EL) liikmesriigid ei jõudnud kokkuleppele ravimitele Flutiform ja Iffeza ja sarnased nimetused müügiloa väljastamise küsimuses.
English: Flutiform and Iffeza are asthma medicines containing two active substances, fluticasone propionate and formoterol fumarate.
Estonian: Flutiform ja Iffeza on astmaravimid, mis sisaldavad kahte toimeainet: flutikasoonpropionaati ja formoteroolfumaraati.
English: Napp Pharmaceuticals Ltd submitted marketing authorisation applications for Flutiform and Iffeza and associated names to the UK medicines regulatory agency under the decentralised procedure.
Estonian: Napp Pharmaceuticals Ltd. esitas Ühendkuningriigi ravimiametile ravimite Flutiform ja Iffeza ja sarnaste nimetuste müügiloa taotlused detsentraliseeritud menetluse vahendusel.
English: Fluticasone propionate is an inhaled corticosteroid with high local anti-inflammatory activity and has been shown to reduce symptoms of asthma and reduce exacerbations of asthma.
Estonian: Flutikasoonpropionaat on inhaleeritav kortikosteroid, millel on tugev lokaalne põletikuvastane toime ja mille kasutamisel on täheldatud, et see vähendab astma sümptomeid ning hoiab ära astma ägenemist.
English: They are to be used for the treatment of asthma in situations where the combination of an inhaled corticosteroid (such as fluticasone propionate) and a long-acting beta 2 agonist (such as formoterol fumarate) is appropriate.
Estonian: Need ravimid on ette nähtud astma raviks olukordades, kus on otstarbekas kombineerida inhaleeritavat kortikosteroidi (nt flutikasoonpropionaat) ja pikatoimelist beeta-2-agonisti (nt formoteroolfumaraat).
English: The selective long-acting beta 2 agonist formoterol fumarate exerts an effect on beta 2 receptors on the smooth muscle in the lung to produce relaxation of the airways and bronchodilatation.
Estonian: Selektiivne pikatoimeline beeta-2-agonist formoteroolfumaraat toimib beeta-2 retseptoritele kopsude silelihastes, lõõgastades hingamisteede lihaseid ja laiendades bronhe.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance the UK) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Iceland, Ireland, Italy, Luxembourg, The Netherlands, Norway, Poland, Portugal, Romania, Slovakia and Sweden).
Estonian: See on menetlus, mille käigus üks liikmesriik (nn viiteliikmesriik, praegusel juhul Ühendkuningriik) hindab ravimit, et otsustada, kas anda oma riigis ja teistes liikmesriikides (nn asjaomased liikmesriigid, praegusel juhul
English: The training should be repeated on regular basis.
Estonian: Väljaõpet tuleb regulaarselt korrata.
English: • the new additional risk minimisation measures.
Estonian: • uued täiendavad riskivähendusmeetmed;