FrancophonIA/ELRC3.0 huggingface dataset:
English: • The Committee concluded that, in view of the above, it is justified to limit the contraindication for Cardioxane in children aged 0 to 18 years receiving low cumulative anthracycline doses (less than 300 mg/m2 of doxorubicin or equivalent)
Estonian: • komitee otsustas eelöeldut arvestades, et õigustatud on säilitada Cardioxane vastunäidustus 0-18aastastel lastel, kes kasutavad antratsükliinide väikesi kumulatiivseid annuseid (vähem kui 300 mg/m2 doksorubitsiini või ekvivalentne kogus antratsükliini);
English: The affected paediatric patients consequently treated are at high risk of acute anthracycline cardiotoxicity, as a consequence of the high doses of chemotherapy received; therefore, a treatment with a cardioprotective agent is needed in this very small number of patients.
Estonian: Nende haiguste tõttu suures annuses keemiaravi saavatel pediaatrilistel patsientidel on antratsükliinidest tingitud ägeda kardiotoksilisuse suur risk, mistõttu tuleb neid väheseid patsiente ravida kardioprotektiivse ainega.
English: Moreover, in the view of the presented data, the RMS considered not acceptable to fully remove the contra-indication in children, as requested by the MAH.
Estonian: Arvestades esitatud andmeid, ei pidanud referentliikmesriik vastuvõetavaks ka müügiloa hoidja taotletud lastel kasutamise vastunäidustuse täielikku eemaldamist.
English: However, the RMS considered acceptable to alleviate the contra-indication in children and proposed limiting it to children receiving low cumulative anthracycline doses (less than 300mg/m2 of doxorubicin or equivalent).
Estonian: Referentliikmesriik pidas siiski vastuvõetavaks kõnealuse vastunäidustuse leevendamist ja pakkus välja säilitada vastunäidustus lastel, kes kasutavad antratsükliini väikesi kumulatiivseid annuseid (vähem kui 300 mg/m2 doksorubitsiini või sellega ekvivalentne kogus antratsükliini).
English: • The Committee considered the data submitted by the MAH in relation to the objections raised on the lifting of the contraindication for Cardioxane in children and adolescents receiving high cumulative doses of anthracycline.
Estonian: • komitee vaatas läbi müügiloa hoidja esitatud andmed vastuväidete kohta, mis olid seotud Cardioxane vastunäidustuse kõrvaldamisega antratsükliinide suuri kumulatiivseid annuseid kasutavatelt lastelt ja noorukitelt;
English: Unravelling confounders for the cause of SPM would be difficult and overall the long term risk of SPM remains unknown at present.
Estonian: Muude sekundaarseid ja primaarseid pahaloomulisi kasvajaid põhjustavate tegurite eristamine on keerukas ning sekundaarsete ja primaarsete pahaloomuliste kasvajate pikaajaline risk ei ole praegu teada.
English: The assessment of this risk is confounded by concomitant chemotherapy treatments, small numbers of patients and the overall rarity of SPM events.
Estonian: Kõnealuse riski hindamise muudavad keerukaks samal ajal kasutatav keemiaravi, patsientide väike arv ning sekundaarsete ja primaarsete pahaloomuliste kasvajate üldine väike esinemissagedus.
English: High cumulative doses of anthracycline are rarely used in the paediatric population; however, they are requested for the treatment of some pathologies such as sarcomas and relapsed acute myeloid leukaemia.
Estonian: Lastel kasutatakse antratsükliinide suuri kumulatiivseid annuseid harva, kuid teatud patoloogiate, nagu sarkoomide ja ägeda müeloidleukeemia retsidiivi raviks on see vajalik.
English: The data assessed during the Art.31 referral procedure in 2011 regarded the carcinogenic potential of dexrazoxane due its cytotoxic activity and on the occurrence of second malignant neoplasms in the paediatric population; such data justified the introduction of a contraindication of the product in children aged 0 to 18 years.
Estonian: 2011. aastal artikli nr 31 kohase esildismenetluse ajal analüüsitud andmed olid seotud deksrasoksaani tsütotoksilisest toimest tingitud kantserogeense potentsiaali ja sekundaarsete pahaloomuliste kasvajate esinemisega pediaatrilistel patsientidel.
English: The evaluation of the data submitted as part of this procedure have allowed a better characterisation of the risk of the short term effects on SPM, myelosuppression and infections, following treatment with DRZ in children undergoing chemotherapy with anthracycline based regimens.
Estonian: Praeguse menetluse käigus esitatud andmete hindamine võimaldas paremini iseloomustada deksrasoksaanravist sekundaarsetele ja primaarsetele pahaloomulistele kasvajatele, müelosupressioonile ja infektsioonidele tuleneva lühiajalise toime riski antratsükliinipõhise keemiaraviskeemiga ravitavatel lastel.
English: DRZ efficacy as a cardioprotectant has not been demonstrated in children for cumulative anthracycline doses of less than 300 mg/m2.
Estonian: Antratsükliini alla 300 mg/m2 kumulatiivse annuse kasutamisel ei ole deksrasoksaani efektiivsus kardioprotektiivse ainena lastel tõestatud.
English: The studies may not have been sufficiently powered to observe a statistically confirmed increase of SPM.
Estonian: Uuringud ei pruukinud olla piisava prognoosiväärtusega sekundaarsete ja primaarsete pahaloomuliste kasvajate esinemissageduse suurenemise statistiliseks tõendamiseks.
English: Although studies suggest there is no safe dose of anthracycline, it is known that the risk of anthracycline induced cardiotoxicity increases with higher cumulative dosing; guidelines imply that above 250 mg/m2 there is sufficient cardiac risk to provide recommendations on lifelong surveillance1.
Estonian: Suuniste kohaselt on 250 mg/m2 ületavate annustega seotud kardiaalne risk, mis on küllaldane eluaegse jälgimise soovituste andmiseks1.
English: Day 60 of the CMDh procedure was on 30/01/2017 and as no agreement could be reached, the procedure and the objections raised by the UK to the lifting of the contraindication for a subset of anthracycline treated paediatric population were referred to the CHMP on 31/01/2017 by the RMS.
Estonian: Kokkuleppe puudumise tõttu suunas referentliikmesriik menetluse ja Ühendkuningriigi tõstatatud vastuväited, mis käsitlesid vastunäidustuse eemaldamist teatud osalt antratsükliinidega ravitavatelt pediaatrilistelt patsientidelt, 31. jaanuaril 2017 edasiseks menetlemiseks inimravimite komiteele.
English: Data are reassuring as regard to occurrence of SPMs in children after being exposed to DRZ, up to 12 years post treatment.
Estonian: Sekundaarsete ja primaarsete pahaloomuliste kasvajate esinemissageduse andmed deksrasoksaanile eksponeeritud lastel kuni 12 aasta jooksul pärast ravi on julgustavad.
English: Furthermore, in the short (up to 5 years post treatment) to medium term (up to 12 years post treatment) anthracycline's anti-tumour efficacy was not compromised by DRZ use.
Estonian: Deksrasoksaani kasutamine ei mõjutanud antratsükliini kasvajavastast toimet lühiajalises (kuni 5 aastat pärast ravi) ja keskmises (kuni 12 aastat pärast ravi) perspektiivis.
English: However, data assessed are still insufficient to provide reassurance concerning the occurrence of long-term risk of SPM particularly solid SPMs.
Estonian: Hinnatud andmed on siiski ebapiisavad sekundaarsete ja primaarsete pahaloomuliste kasvajate, eriti sekundaarsete ja primaarsete pahaloomuliste soliidtuumorite tekke pikaajalise riskiga seotud kartuste hajutamiseks.
English: However there are still remaining uncertainties with regard to long term effects for DRZ in children.
Estonian: Deksrasoksaani pikaajalised toimed lastel ei ole endiselt täpselt teada.
English: The infusion is given over two hours, three times daily.
Estonian: Infusioon manustatakse kahe tunni jooksul kolm korda ööpäevas.
English: Treatment usually lasts between 5 and 14 days, depending on the type of infection.
Estonian: Ravi kestab tavaliselt 5-14 päeva sõltuvalt nakkuse tüübist.
English: What measures are being taken to ensure the safe and effective use of Zavicefta?
Estonian: Mis meetmed võetakse, et tagada Zavicefta ohutu ja efektiivne kasutamine?
English: The full EPAR for Zavicefta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Zavicefta kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: One of the main measures of effectiveness was based on eliminating the disease-causing bacteria.
Estonian: Üks efektiivsuse põhinäitajaid oli haigust põhjustavate bakterite elimineerimine.
English: • infections caused by Gram-negative bacteria (types of bacteria) when other treatments might not work.
Estonian: • Gram-negatiivsete bakterite (teatud tüüpi bakterid) põhjustatud nakkused, kui teised ravimid ei pruugi mõjuda.
English: Other information about Zavicefta
Estonian: Muu teave Zavicefta kohta
English: The benefits of Zavicefta have been shown in four main studies.
Estonian: Zavicefta kasulikkust näidati neljas põhiuuringus.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Zavicefta's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Inimravimite komitee otsustas, et Zavicefta kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: Due to the design of this study, this evidence of Zavicefta's benefits is not as strong as for the other studies; however these results support Zavicefta's activity when combined with the other studies.
Estonian: Uuringu ülesehituse tõttu ei ole need Zavicefta kasulikkuse tõendid sama tugevad kui teistes uuringutes, ent koos teiste uuringutega toetavad siiski Zavicefta toimet.
English: A study of Zavicefta in patients with hospital-acquired pneumonia has not yet been completed.
Estonian: Zavicefta uuring haiglatekkese pneumooniaga patsientidel ei ole veel lõppenud.
English: Zavicefta ceftazidime / avibactam
Estonian: Zavicefta tseftasidiim / avibaktaam
English: Zavicefta is an antibiotic used in adults to treat the following infections:
Estonian: Zavicefta on antibiootikum, mida kasutatakse täiskasvanutel järgmiste nakkuste raviks:
English: What is Zavicefta and what is it used for?
Estonian: Mis on Zavicefta ja milleks seda kasutatakse?
English: Zavicefta must not be used in patients who are hypersensitive (allergic) to the active substances in Zavicefta or any of the other ingredients, or in those who are hypersensitive to other cephalosporin antibiotics or have ever had a severe allergic reaction to another beta-lactam antibiotic.
Estonian: Zaviceftat ei tohi kasutada patsiendid, kes on Zavicefta toimeainete või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised), ega isikud, kes on ülitundlikud muude tsefalosporiinantibiootikumide suhtes või kellel on kunagi tekkinud mõne muu beetalaktaamantibiootikumi suhtes raske allergiline reaktsioon.
English: This is a summary of the European public assessment report (EPAR) for Zavicefta.
Estonian: See on ravimi Zavicefta Euroopa avaliku hindamisaruande kokkuvõte.
English: Why is Zavicefta approved?
Estonian: Miks Zavicefta heaks kiideti?
English: It is not intended to provide practical advice on how to use Zavicefta.
Estonian: Hindamisaruandes ei anta Zavicefta kasutamise praktilisi nõuandeid.
English: Zavicefta can only be obtained with a prescription, and prescribers should take into account official guidance on the use of antibiotics.
Estonian: Zavicefta on retseptiravim ja selle väljakirjutajad peavad arvestama antibiootikumide kasutamise ametlikke juhiseid.
English: However, the CHMP considered that the data already available supported Zavicefta's activity in hospital-acquired pneumonia and for the treatment of infections due to aerobic Gram-negative organisms in adult patients when other treatments might not work.
Estonian: Siiski leidis inimravimite komitee, et juba olemasolevad andmed toetavad Zavicefta toimet haiglatekkese pneumoonia ja Gramnegatiivsete aeroobsete organismide põhjustatud nakkuste ravis täiskasvanud patsientidel, kui teised ravimid ei pruugi toimida.
English: What are the risks associated with Zavicefta?
Estonian: Mis riskid Zaviceftaga kaasnevad?
English: The company that makes Zavicefta is carrying out a study to compare the effectiveness and safety of Zavicefta with meropenem (another antibiotic) for the treatment of hospital-acquired pneumonia.
Estonian: Zaviceftat tootev ettevõte viib läbi uuringu, milles võrreldakse Zavicefta ja meropeneemi (teine antibiootikum) efektiivsust ja ohutust haiglatekkese pneumoonia ravis.
English: Both studies showed that Zavicefta in combination with metronidazole was at least as effective as meropenem at curing the infection.
Estonian: Mõlemad uuringud näitasid, et Zavicefta kombinatsioonis metronidasooliga oli nakkuse ravis vähemalt sama efektiivne kui meropeneem.
English: The most common side effects with Zavicefta (which affected more than 5 in 100 people) are nausea (feeling sick), diarrhoea and a positive result in a Coombs test (a sign of the development of antibodies that attack red blood cells).
Estonian: Zavicefta kõige sagedamad kõrvalnähud (võivad esineda enam kui 5 patsiendil 100st) on iiveldus, kõhulahtisus ja Coombsi testi positiivne tulemus (punaseid vereliblesid ründavate antikehade tekkimise näitaja).
English: By blocking the action of these enzymes, avibactam allows ceftazidime to act against bacteria that would otherwise be resistant.
Estonian: Neid ensüüme blokeerides võimaldab avibaktaam tseftasidiimil toimida bakterite vastu, mis muidu oleksid resistentsed.
English: These enzymes enable bacteria to break down beta-lactam antibiotics such as ceftazidime, making them resistant to the antibiotic's action.
Estonian: Need ensüümid võimaldavad bakteritel lagundada beetalaktaamantibiootikume, nagu tseftasidiim, muutes bakterid antibiootikumi toimele resistentseks.
English: Doses may need to be reduced and/or given less often in patients with severely reduced kidney function.
Estonian: Tugevalt vähenenud neerutalitlusega patsientidel võib olla vaja vähendada annuseid ja/või nende manustamise sagedust.
English: Regarding Zavicefta's safety profile, side effects were those that can be expected for ceftazidime and a betalactamase inhibitor.
Estonian: Seoses Zavicefta ohutusprofiiliga olid kõrvalnähud sellised, mida võib tseftasidiimi ja beetalaktamaasi inhibiitori korral oodata.
English: For practical information about using Zavicefta, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Zavicefta kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: • infections of the lungs that are caught in hospital (hospital-acquired pneumonia), including ventilator-associated pneumonia (pneumonia caught from a ventilator, which is a machine that helps a patient to breathe);
Estonian: • haiglatekkene pneumoonia, sh ventilaatorraviga seotud pneumoonia (hingamisaparaadi kasutamisest tingitud pneumoonia);
English: For more information about treatment with Zavicefta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Zaviceftaga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: In two studies, the effects of the combination of Zavicefta and metronidazole (another antibiotic) were compared with those of the antibiotic meropenem in 1490 patients with complicated intra-abdominal infection.
Estonian: Kahes uuringus võrreldi Zavicefta ja metronidasooli (teine antibiootikum) kombinatsiooni toimeid teise antibiootikumi meropeneemi toimetega 1490 tüsistunud kõhuõõnenakkusega patsiendil.
English: Zavicefta was at least as effective as doripenem: 77% of patients (304 out of 393) treated with Zavicefta showed a response compared with 71% of patients (296 out of 417) treated with doripenem.
Estonian: Zavicefta oli vähemalt sama efektiivne kui doripeneem: Zaviceftaga ravitud patsientidest 77% (304 patsienti 393st) reageeris ravile, doripeneemiga ravitud patsiendirühmas oli ravivastus 71%-l (296 patsiendil 417st).
English: In a fourth study, 1,020 patients with complicated urinary tract infections (including pyelonephritis) caused by Gram-negative bacteria were treated with Zavicefta or the antibiotic doripenem.
Estonian: Neljandas uuringus raviti 1020 patsienti, kellel esinesid Gram-negatiivsete bakterite põhjustatud tüsistunud kuseteede nakkused (sealhulgas püelonefriit), Zaviceftaga või antibiootikumi doripeneemiga.
English: Zavicefta alone (for urinary tract infection) or in combination with metronidazole (for intra-abdominal infection) provided similar results to a number of alternative antibiotics in curing the infection: 91% of patients (140 out of 154) were cured after treatment with Zavicefta compared with 91% (135 out of 148) after treatment with the best alternative antibiotic.
Estonian: Zavicefta üksi (kuseteede nakkuse ravis) või kombinatsioonis metronidasooliga (kõhuõõnenakkuste ravis) andis samasugused tulemused kui ravi mitme alternatiivse antibiootikumidega: Zavicefta ravi järel paranes 91% patsientidest (140 patsienti 154st) ning parima alternatiivse antibiootikumi ravi järel paranes 91% patsientidest (135 patsienti 148st).
English: How is Zavicefta used?
Estonian: Kuidas Zaviceftat kasutatakse?
English: The active substances in Zavicefta are ceftazidime and avibactam.
Estonian: Zavicefta toimeained on tseftasidiim ja avibaktaam.
English: For the full list of all side effects with Zavicefta, see the package leaflet.
Estonian: Zavicefta kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zavicefta have also been included in the summary of product characteristics and the package leaflet.
Estonian: Zavicefta omaduste kokkuvõttesse ja pakendi infolehele lisati ravimi ohutu ja tõhusa kasutamise teave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: The CHMP considered that the studies on Zavicefta show that is effective at treating complicated intra-abdominal and urinary tract infections.
Estonian: Inimravimite komitee leidis, et Zavicefta uuringud näitavad, et see on tüsistunud kõhuõõne- ja kuseteede nakkuste ravis efektiivne.
English: A third study looked at 332 patients with complicated intra-abdominal or urinary tract infections caused by Gram-negative bacteria that were resistant to ceftazidime (could not be killed by ceftazidime).
Estonian: Kolmandas uuringus osales 332 patsienti, kellel oli tseftasidiimi suhtes resistentsete Gram-negatiivsete bakterite põhjustatud tüsistunud kõhuõõne- või kuseteede nakkused.
English: In addition, disease-causing bacteria were eliminated in 82% (126 out of 154) of patients after treatment with Zavicefta compared with 63% (94 out of 148) after treatment with the best alternative antibiotic.
Estonian: Lisaks olid pärast ravi Zaviceftaga haigust põhjustavad bakterid elimineeritud 82%-l patsientidest (126 patsiendil 154st) ning parima alternatiivse antibiootikumi ravi järel 63%-l patsientidest (94 patsiendil 148st).
English: This causes weakness in the bacterial cell walls which then become prone to collapse, ultimately leading to the death of the bacteria.
Estonian: See nõrgendab bakteri rakumembraani, mille tagajärjel rakk langeb kokku ja hävib.
English: In the second study, 94% of patients (166 out of 177) treated with Zavicefta and metronidazole were cured, compared with 94% (173 out of 184) of patients treated with meropenem.
Estonian: Teises uuringus paranes Zavicefta ja metronidasooliga ravitud patsientidest 94% (166 patsienti 177st) ning meropeneemiga ravitud patsientidest 94% (173 patsienti 184st).
English: • complicated (difficult to treat) infections of the urinary tract (structures that carry urine), including pyelonephritis (kidney infection);
Estonian: • tüsistunud (raskelt ravitavad) kuseteede nakkused, sealhulgas püelonefriit (neeruinfektsioon);
English: Zavicefta contains the active substances ceftazidime and avibactam.
Estonian: Zavicefta sisaldab toimeainetena tseftasidiimi ja avibaktaami.
English: In the first study, one of the patient groups studied showed 92% of patients (376 out of 410) treated with Zavicefta and metronidazole were cured, compared with 93% (385 out of 416) of patients treated with meropenem.
Estonian: Esimeses uuringus paranes Zavicefta ja metronidasooliga ravitud patsientidest 92% (376 patsienti 410st) ning meropeneemiga ravitud patsientidest 93% (385 patsienti 416st).
English: How does Zavicefta work?
Estonian: Kuidas Zavicefta toimib?
English: Zavicefta is available as a powder to be made up into a solution for infusion (drip) into a vein.
Estonian: Zaviceftat turustatakse infusioonilahuse (veeni tilgutatava lahuse) pulbrina.
English: What benefits of Zavicefta have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Zavicefta kasulikkus?
English: • complicated (difficult to treat) infections of the tissues and organs within the belly (intra-abdominal infections);
Estonian: • tüsistunud (raskelt ravitavad) kõhuõõne kudede ja elundite infektsioonid (kõhuõõnenakkused);
English: Ceftazidime is an antibiotic called a cephalosporin, which belongs to the wider group ‘beta-lactams'.
Estonian: Tseftasidiim on beetalaktaamide rühma kuuluv antibiootikum tsefalosporiin, mis takistab bakteri rakumembraani oluliste komponentmolekulide teket.
English: Avibactam blocks the action of bacterial enzymes called beta-lactamases.
Estonian: Avibaktaam blokeerib bakteriensüümide beetalaktamaaside toime.
English: International non-proprietary name (INN): abetimus
Estonian: Rahvusvaheline mittekaubanduslik nimetus (INN): abetiimus
English: What is Riquent?
Estonian: Mis on Riquent?
English: Following the CHMP's opinion, it usually takes around 2 months for the European Commission to grant a licence.
Estonian: kasutatavate ravimite komitee arvamuse järel kulub tavaliselt ligikaudu 2 kuud, enne kui Euroopa Komisjon müügiloa väljastab.
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Estonian: Kui te osalete kliinilises uuringus ja vajate ravi kohta lisateavet, võtke ühendust arstiga, kes teile ravi määras.
English: The application was at day 114 when the company withdrew.
Estonian: Taotlust oli menetletud 114 päeva, kui ettevõte taotluse tagasi võttis.
English: The letter from the company notifying the EMEA of the withdrawal of the application is available here.
Estonian: Ettevõtte taotluse tagasivõtmise avaldus EMEA-le on kättesaadav siin.
English: A compassionate use programme is a programme through which doctors can request a medicine for a specific disease for one of their patients before the medicine is fully authorised.
Estonian: Eriloaga kasutamise programm on programm, mille kaudu arstid võivad taotleda ravimi kasutamist mõnel patsiendil teatava haiguse ravimiseks enne ravimile täieliku müügiloa andmist.
English: Riquent is a solution for injection that contains 50 mg/ml of the active substance abetimus.
Estonian: Riquent on süstelahus, mis sisaldab toimeainena 50 mg/ml abetiimust.
English: The CHMP was evaluating the initial documentation provided by the Company and had not yet made any recommendations.
Estonian: Inimtervishoius kasutatavate ravimite komitee hindas ettevõtte esitatud esmaseid dokumente ega olnud veel soovitusi andnud.
English: Abetimus is a small piece of double-stranded DNA that has been designed to reduce circulating levels of these antibodies.
Estonian: Abetiimus on väike kaksikahelalise DNA lõik, mille eesmärk on vähendada nende antikehade taset vereringes.
English: Abetimus, the active substance in Riquent, is a selective immunosuppressive agent (a compound that selectively dampens down the immune system).
Estonian: Riquenti toimeaine abetiimus on selektiivne immunosupressant (selektiivselt immuunsüsteemi pärssiv ühend).