FrancophonIA/ELRC3.0 huggingface dataset:
English: Monotard is an insulin suspension for injection.
Estonian: Monotard on insuliini süstesuspensioon.
English: What is Monotard used for?
Estonian: Milleks Monotardi kasutatakse?
English: How does Monotard work?
Estonian: Kuidas Monotard toimib?
English: Fipronil 24.9 mg; (S)-methoprene 30 mg; eprinomectin 1.2 mg; praziquantel 24.9 mg Fipronil 74.7 mg; (S)-methoprene 90 mg; eprinomectin 3.6 mg; praziquantel 74.7 mg
Estonian: Fiproniil 24.9 mg; (S)-metopreen 30 mg; eprinomektiin 1.2 mg; prasikvanteel 24.9 mg Fiproniil 74.7 mg; (S)-metopreen 90 mg; eprinomektiin 3.6 mg; prasikvanteel 74.7 mg
English: (EU) MA Number Invented name
Estonian: EL (ML) number Väljamõ eldud
English: What measures are being taken to ensure the safe and effective use of Slenyto?
Estonian: Mis meetmed võetakse, et tagada Slenyto ohutu ja efektiivne kasutamine?
English: Further information on Slenyto can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Lisateave Slenyto kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The side effects seen with the medicine over 2 years appear mild or moderate but more data are needed on longer term safety.
Estonian: 2 aasta jooksul täheldatud ravimi kõrvalnähud tundusid olevat kerged või mõõdukad, kuid pikaajalise ohutuse kohta on vaja rohkem andmeid.
English: Slenyto (melatonin)
Estonian: Slenyto (melatoniin)
English: The European Medicines Agency decided that Slenyto's benefits are greater than its risks and it can be authorised for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et Slenyto kasulikkus on suurem kui sellega kaasnevad riskid ja et ravimi kasutamise võib ELis heaks kiita.
English: What is Slenyto and what is it used for?
Estonian: Mis on Slenyto ja milleks seda kasutatakse?
English: Slenyto is available as tablets (1 and 5 mg).
Estonian: Slenytot turustatakse tablettidena (1 ja 5 mg).
English: As for all medicines, data on the use of Slenyto are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse Slenyto kasutamise kohta pidevat järelevalvet.
English: Slenyto (melatonin) EMA/570422/2018
Estonian: Slenyto (melatoniin) EMA/570422/2018
English: Other information about Slenyto
Estonian: Muu teave Slenyto kohta
English: The most common side effects with Slenyto (which may affect up to 1 in 10 people) are sleepiness, tiredness, mood swings, headache, irritability, aggression and feeling hungover.
Estonian: Slenyto kõige sagedamad kõrvalnähud (võivad esineda kuni 1 patsiendil 10st) on unisus, väsimus, meeleolukõikumised, peavalu, ärrituvus, agressiivsus ja pohmelusetunne.
English: All patients had previously tried other measures, such as keeping to a regular sleeping routine, which did not work.
Estonian: Kõik patsiendid olid varem proovinud muid abinõusid, näiteks korrapärase unerežiimi hoidmist, kuid need ei toiminud.
English: • autism spectrum disorder (ASD), a range of conditions that affects the patient's social interactions;
Estonian: • autismispektri häire - rühm seisundeid, mis mõjutavad patsiendi sotsiaalset interaktsiooni;
English: The medicine contains the active substance melatonin.
Estonian: Ravim sisaldab toimeainena melatoniini.
English: The normal dose is 2 mg taken 30 minutes to one hour before bedtime.
Estonian: Tavaannus on 2 mg manustatuna 30 minutit kuni 1 tund enne magamaminekut.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Slenyto have been included in the summary of product characteristics and the package leaflet.
Estonian: Slenyto ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: For more information about using Slenyto, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Slenyto kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
English: Slenyto is a medicine for treating insomnia (difficulty sleeping) in children and adolescents (2 to 18 years old) who have:
Estonian: Slenyto on ravim, mida kasutatakse insomnia (unehäirete) raviks 2-18 aasta vanustel lastel ja noorukitel, kellel on:
English: • Smith-Magenis syndrome, a condition that can lead to learning difficulties.
Estonian: • Smithi-Magenise sündroom - arenguhäire, mis võib põhjustada õpiraskusi.
English: Melatonin is involved in coordinating the body's sleep cycle by acting on cells in specific areas of the brain and helping to bring about sleep.
Estonian: Melatoniin osaleb organismi unetsükli koordineerimisel, avaldades toimet rakkudele aju teatud piirkondades ning aidates kaasa uinumisele.
English: Because Slenyto releases melatonin slowly over a few hours, it mimics the natural production of melatonin in the body.
Estonian: Slenyto vabastab melatoniini aeglaselt mõne tunni vältel, imiteerides loodusliku melatoniini tootmist organismis.
English: What are the risks associated with Slenyto?
Estonian: Mis riskid Slenytoga kaasnevad?
English: Side effects reported with Slenyto are carefully evaluated and any necessary action taken to protect patients.
Estonian: Slenyto kõrvaltoimeid hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
English: Slenyto is used after other measures such as keeping to a regular sleeping routine have not worked.
Estonian: Slenytot kasutatakse pärast seda, kui muud abinõud, näiteks korrapärase unerežiimi hoidmine, ei ole toiminud.
English: The doctor should review treatment regularly, at least every 6 months, and only continue treatment if the patient is benefits from it.
Estonian: Kui ravimi toime ei ole piisav, tohib annust suurendada annuseni 10 mg. Arst peab ravi korrapäraselt, st vähemalt iga 6 kuu järel läbi vaatama ning ravi tohib jätkata üksnes juhul, kui see on patsiendile kasulik.
English: Patients with developmental conditions may produce less melatonin, leading to the development of insomnia.
Estonian: Arenguhäiretega patsientidel võib organismis tekkida vähem melatoniini ning see võib omakorda põhjustada insomniat.
English: The active substance in Slenyto, melatonin, is a naturally occurring hormone, which is normally produced by a gland in the brain called the pineal gland.
Estonian: Slenyto toimeaine melatoniin on looduslikult esinev hormoon, mida tavaliselt toodab ajus paiknev käbinääre.
English: In a main study of 125 patients, those given Slenyto over 13 weeks slept on average for 51 extra minutes of sleep a night compared with and 19 extra minutes for those given placebo (a dummy treatment).
Estonian: Põhiuuringus, milles osales 125 patsienti, magasid 13 nädala vältel Slenytot kasutanud patsiendid igal ööl keskmiselt 51 minutit kauem ning platseebot (näiv ravim) kasutanud patsiendid 19 minutit kauem.
English: Slenyto increases levels of melatonin in the blood, helping them to sleep.
Estonian: Slenyto suurendab melatoniini sisaldust veres ja aitab seeläbi patsiendil magada.
English: How is Slenyto used?
Estonian: Kuidas Slenytot kasutatakse?
English: How does Slenyto work?
Estonian: Kuidas Slenyto toimib?
English: In addition, children who took Slenyto fell asleep around 38 minutes earlier than normal while those taking placebo fell asleep 13 minutes earlier.
Estonian: Peale selle kulus Slenytot kasutanud lastel uinumiseks tavalisest ligikaudu 38 minutit vähem ning platseebot kasutanud patsientidel 13 minutit vähem.
English: Its levels in the blood normally increase after the onset of darkness and peak in the middle of the night.
Estonian: Pimeduse saabudes melatoniini sisaldus veres tavaliselt suureneb, saavutades maksimaalse taseme keskööl.
English: The proportion of children with neurological conditions, such as autism spectrum disorder (ASD) and Smith-Magenis syndrome, who also have insomnia is high and not many treatments are available.
Estonian: Insomniat esineb paljudel neuroloogiliste seisundite, näiteks autismispektri häirete ja Smithi-Magenise sündroomiga lastel ning ravivalikuid on vähe.
English: An overview of Slenyto and why it is authorised in the EU
Estonian: Ülevaade ravimist Slenyto ja ELis müügiloa väljastamise põhjendus
English: Slenyto has been shown to be effective at improving sleeping time in children and adolescents with neurological conditions, including autism spectrum disorder and Smith-Magenis syndrome.
Estonian: On tõendatud Slenyto efektiivsus neuroloogiliste seisunditega, sealhulgas autismispektri häire ja Smithi-Magenise sündroomiga laste ja noorukite uneaja pikendamisel.
English: What benefits of Slenyto have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Slenyto kasulikkus?
English: Slenyto has been shown to improve sleeping times in these patients, with patients taking Slenyto sleeping for an extra 51 minutes a night compared with an extra 19 minutes with placebo.
Estonian: On tõendatud, et Slenyto pikendab nende patsientide uneaega: Slenytot kasutanud patsiendid magasid igal ööl keskmiselt 51 minutit kauem ning platseebot kasutanud patsiendid 19 minutit kauem.
English: The medicine can only be obtained with a prescription.
Estonian: Slenyto on retseptiravim.
English: Why is Slenyto authorised in the EU?
Estonian: ELis Slenytole väljastatud müügiloa põhjendus
English: Strength Pharmaceutical Form
Estonian: Ravivorm
English: 16 December 2014 EMA/785229/2014 corr1
Estonian: 16. detsember 2014 EMA/785229/2014
English: Currently, products containing colistimethate sodium for use by injection or by inhalation as a solution or as a mist (nebulised) are approved under various trade names in Austria, Belgium, Bulgaria, Croatia, the Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, Malta, Netherlands Poland, Portugal, Romania, Slovakia, Spain, Sweden and United Kingdom.
Estonian: Praegu on naatriumkolistimetaati sisaldavad süstitavad või lahuse või nebuliseeritava vedelikuna inhaleeritavad ravimvormid mitme kaubandusliku nimetuse all heaks kiidetud Austrias, Belgias, Bulgaarias, Eestis, Hispaanias, Horvaatias, Iirimaal, Itaalias, Kreekas, Luksemburgis, Madalmaades, Maltas, Poolas, Portugalis, Prantsusmaal, Rootsis, Rumeenias, Saksamaal, Slovakkias, Taanis, Tšehhi Vabariigis, Ungaris ja Ühendkuningriigis.
English: The review of polymyxin-based medicines was initiated on 16 September 2013 at the request of the European Commission, under Article 31 of Directive 2001/83/EC.
Estonian: Polümüksiinil põhinevate ravimite läbivaatamine algas 16. septembril 2013 Euroopa Komisjoni taotlusel vastavalt direktiivi 2001/83/EÜ artiklile 31.
English: Information to healthcare professionals
Estonian: Tervishoiutöötajate teave
English: The CHMP opinion was forwarded to the European Commission, which issued a final decision valid throughout the EU on 16 December 2014.
Estonian: Inimravimite komitee arvamus edastati Euroopa Komisjonile ja komisjon tegi 16. detsembril 2014 kogu Euroopa Liidus kehtiva lõpliku otsuse.
English: • Patients who have any questions about their treatment should consult their doctor or pharmacist.
Estonian: • Küsimuste korral peavad patsiendid pidama nõu arsti või apteekriga.
English: Colistin-base activity (CBA) (mg)1
Estonian: Kolistiinbaasi aktiivsus (CBA) (mg)1
English: European Medicines Agency completes review of polymyxin-based medicines
Estonian: Euroopa Ravimiametil on valmis polümüksiinil põhinevate ravimite läbivaatamine
English: 1 Nominal potency of the drug substance = 12.500 IU/mg
Estonian: Toimeaine nominaalne tugevus: 12 500 IU/mg
English: However, it was considered that in the interim the product information should be updated throughout the EU to reflect what was currently known.
Estonian: Samas leiti, et seni tuleb ravimiteavet ajakohastada kogu Euroopa Liidus, kajastades praegu olemasolevat teavet.
English: Polymyxin-based products have been available since the 1960s, but their use quickly decreased due to the availability of antibiotics with fewer potential side effects.
Estonian: Polümüksiinil põhinevaid ravimeid on turustatud alates 1960. aastatest, kuid nende kasutamine on kiiresti vähenenud vähesemate võimalike kõrvalnähtudega antibiootikumide kättesaadavuse tõttu.
English: The Agency's recommendations are based on a review of the available clinical, pharmacological and pharmacokinetic data, although significant gaps still exist, particularly with regard to the pharmacokinetics in special populations such as children and patients with renal impairment.
Estonian: EMA soovitused põhinevad olemasolevate kliiniliste, farmakoloogiliste ja farmakokineetiliste andmete läbivaatamisel, kuigi endiselt on suuri lünki, eelkõige seoses farmakokineetikaga eripopulatsioonides, näiteks lastel ja neerupuudulikkusega patsientidel.
English: Critically ill patients should be given a higher starting dose (loading dose) to provide an effective level of the antibiotic in the body more quickly.
Estonian: Kriitilises seisundis patsientidele tuleb manustada suurem algannus (küllastusannus), et saavutada organismis antibiootikumi efektiivne tase kiiremini.
English: The European Commission therefore requested the EMA to review the available data and make recommendations on whether the marketing authorisations for these medicines should be changed and the product information amended appropriately.
Estonian: Seetõttu palus Euroopa Komisjon EMA-l läbi vaadata olemasolevad andmed ja soovitada, kas nende ravimite müügilube tuleb muuta ja selle järgi muuta ravimiteavet.
English: Recommendations issued for safe use in patients with serious infections resistant to standard antibiotics
Estonian: Antakse soovitused ohutu kasutamise kohta patsientidel, kellel on standardsele antibiootikumravile resistentne raske infektsioon
English: The medicine should be given with another suitable antibiotic where possible.
Estonian: Võimaluse korral tuleb ravimit kasutada koos muu sobiva antibiootikumiga.
English: Although data were very limited, the Committee recommended doses for use in patients with kidney problems and in children, and provided guidance on dosage in adults when given directly into fluid surrounding the brain or spinal cord (intrathecal or intraventricular injection).
Estonian: Kuigi andmed olid väga piiratud, tegi komitee neeruprobleemidega patsientide ja laste annused ning andis täiskasvanutele manustamise suunised, kui ravimit manustatakse otse pea- või seljaaju ümbritsevasse vedelikku (intratekaalne või intraventrikulaarne manustamine).
English: Based on the limited available evidence the recommended dose in adults is 9 million IU daily in 2 or 3 divided doses as a slow intravenous infusion; in critically ill patients a loading dose of 9 million IU should be given.
Estonian: Piiratud olemasolevate andmete põhjal on täiskasvanute soovitatav annus 9 000 000 IU ööpäevas jagatuna 2 või 3 annuseks aeglase intravenoosse infusioonina; kriitilises seisundis patsientidele tuleb manustada küllastusannus 9 000 000 IU.
English: (Products for inhalation as a dry powder have a different dosage and distribution in the body, and were not affected by the conclusions of the review.)
Estonian: (Kuiva inhalatsioonipulbri ravimvormi annused ja levik organismis on teistsugune ning neid läbivaatamise järeldused ei mõjuta.)
English: Where appropriate, adult doses of 125,000 IU for intraventricular administration and no more than this for intrathecal administration are recommended.
Estonian: Kui asjakohane, on soovitatav annus täiskasvanutele intraventrikulaarse manustamise korral 125 000 IU ja intratekaalse manustamise korral sellest mitte rohkem.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) reviewed the available data about the pharmacokinetics, effectiveness and safety of these medicines.
Estonian: Inimravimite komitee vaatas läbi nende ravimite farmakokineetika, efektiivsuse ja ohutuse olemasolevad andmed.
English: The review of these data was conducted by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which considered them and formulated the Agency's final opinion.
Estonian: Andmed vaatas läbi ja neid arutas inimravimite komitee, kes vastutab inimravimitega seotud küsimuste eest ja kes koostas Euroopa Ravimiameti lõpliku arvamuse.
English: On 23 October 2014 the European Medicines Agency (EMA) completed a review of the safety and effectiveness of products containing the antibiotics colistin or colistimethate sodium (known as polymyxins) and recommended changes to their product information to ensure safe use in the treatment of serious infections that are resistant to standard antibiotics.
Estonian: 23. oktoobril 2014 valmis Euroopa Ravimiametil (EMA) antibiootikume kolistiini ja naatriumkolistimetaati (polümüksiinid) sisaldavate ravimite ohutuse ja efektiivsuse läbivaatamine ning soovitati muuta nende ravimiteavet, et tagada ohutu kasutamine standardsele antibiootikumravile resistentsete raskete infektsioonide ravis.
English: Due in part to this limited use, colistimethate sodium has retained activity against a number of bacteria which have become resistant to commonly used antibiotics.
Estonian: Osaliselt tänu sellisele piiratud kasutamisele on säilinud naatriumkolistimetaadi toime mitme bakteri vastu, mis on muutunud standardse antibiootikumravi suhtes resistentseks.
English: • The product information for medicines containing colistimethate sodium will be updated as required to take these recommendations into account.
Estonian: • Naatriumkolistimetaati sisaldavate ravimite ravimiteavet uuendatakse vastavalt vajadusele, et neid soovitusi arvestada.
English: Information to patients
Estonian: Patsienditeave
English: • Dosage should be in line with relevant treatment guidelines.
Estonian: • Annustamine peab järgima asjakohaseid ravisuuniseid.
English: In addition, colistimethate sodium has been approved in the EU for inhalation as a dry powder under the trade name Colobreathe.
Estonian: Naatriumkolistimetaat on Euroopa Liidus heaks kiidetud ka kuiva inhalatsioonipulbrina kaubandusliku nimetuse Colobreathe all.
English: The Committee recommended that doses should always be expressed in international units (IU) but because doses of colistimethate sodium can be expressed in different ways a conversion table should be included in the product information.
Estonian: Inimravimite komitee soovitas, et annuseid tuleb alati väljendada rahvusvahelistes ühikutes (IU), aga kuivõrd naatriumkolistimetaadi annuseid saab väljendada mitmel viisil, tuleb ravimiteabesse lisada teisendustabel.
English: • Use of intravenous colistimethate sodium together with other medications that are potentially nephrotoxic or neurotoxic should be undertaken with great caution.
Estonian: • Naatriumkolistimetaadi intravenoossel manustamisel koos muude potentsiaalselt nefro- või neurotoksiliste ravimitega tuleb olla väga ettevaatlik.
English: This has led to a resurgence in recent years in the use of polymyxins in patients with few other options.
Estonian: Viimastel aastatel on selle tõttu sagenenud polümüksiinide kasutamine patsientidel, kellel on vähe teisi ravivõimalusi.
English: • The available information on colistimethate sodium has been reviewed and recommendations have been made on its safe use and appropriate dosage.
Estonian: • Naatriumkolistimetaadi kohta olemasolev teave on läbi vaadatud ning on tehtud selle ohutu kasutamise ja sobiva annustamise soovitused.
English: The recommended dose in adults is 1 to 2 million IU given 2 to 3 times a day, and in children 0.5 to 1 million IU twice daily, adjusted according to the severity of the condition and the response.
Estonian: Täiskasvanute soovitatav annus on 1 000 000…2 000 000 IU 2…3 korda ööpäevas ja lastel 500 000…1 000 000 IU 2 korda ööpäevas, kohandatuna seisundi raskuse ja ravivastusega.
English: Research currently underway may provide further information on pharmacodynamics and pharmacokinetics of these medicines to improve the evidence-base behind any dose recommendations.
Estonian: Praegustest uuringutest võib saada nende ravimite farmakodünaamika ja farmakokineetika kohta lisateavet, millega täiendada annustamissoovituste aluseks olevat tõenduspõhja.
English: • In children, the suggested dose is 75,000 to 150,000 IU/kg daily, in 3 divided doses.
Estonian: • Laste soovitatav annus on 75 000…150 000 IU/kg ööpäevas jagatuna 3 annuseks.
English: Products containing colistin are available for use by mouth or for external application but are not included in this review, as they are not considered to produce significant amounts of the active substance in the body.
Estonian: Kolistiini sisaldavaid ravimeid turustatakse suukaudsete või välispidiste ravimvormidena, kuid neid läbivaatamine ei käsitlenud, sest arvatakse, et nendest ei teki organismis olulises koguses toimeainet.
English: A parallel review under Article 5(3) of Regulation (EC) No 726/2004 is currently also under way, looking at the quality of the products and the way the potency of colistimethate sodium is measured and tested, and may result in further changes to the product information once complete.
Estonian: Praegu toimub määruse (EÜ) nr 726/2004 artikli 5 lõike 3 alusel paralleelne läbivaatamine, milles käsitletakse ravimite kvaliteeti ja naatriumkolistimetaadi toime tugevuse mõõtmise ja katsetamise meetodeid; selle läbivaatamise tulemuse põhjal võidakse teha ravimiteabes uusi muudatusi.
English: However, current experience has raised concerns that the existing product information, in particular relating to dosing and the way the medicine is handled in the body (pharmacokinetics), might need updating.
Estonian: Praegune kogemus on aga tekitanud küsimuse, kas tuleb ajakohastada kehtivat ravimiteavet, eelkõige annustamise ja farmakokineetika teavet (teavet selle kohta, mis toimub ravimiga organismis).
English: • Intravenous colistimethate sodium does not cross the blood-brain barrier to a significant extent.
Estonian: • Intravenoosne naatriumkolistimetaat ei läbi oluliselt hematoentsefaalbarjääri.
English: Colistimethate sodium (IU)
Estonian: Naatriumkolistimetaat (IU)
English: Colistin and its prodrug colistimethate sodium are the only polymyxins approved for clinical use in the EU, and the review was limited to products used by injection or inhalation (all formulated as colistimethate sodium).
Estonian: Kolistiin ja selle eelravim naatriumkolistimetaat on ainsad Euroopa Liidus kliiniliseks kasutamiseks heaks kiidetud polümüksiinid ning läbivaatamine piirdus süstitavate või inhaleeritavate ravimvormidega (kõik naatriumkolistimetaadina).
English: • Colistin and colistimethate sodium are older antibiotics (belonging to the class called polymyxins) that are sometimes used for infections that have become resistant to newer treatments.
Estonian: • Kolistiin ja naatriumkolistimetaat on vanemad antibiootikumid (kuuluvad polümüksiinide klassi), mida mõnikord kasutatakse uuemate ravivõimaluste suhtes resistentseks muutunud infektsioonide korral.
English: Consideration should be given to co-administration with another antibacterial agent whenever this is possible.
Estonian: Võimaluse korral tuleb kaaluda manustamist koos muu antibakteriaalse ravimiga.
English: Polymyxins are a group of antibiotics that includes colistin and colistimethate sodium (a ‘prodrug' that is converted to colistin in the body), which have been available in the EU since the 1960s for the treatment of susceptible infections.
Estonian: Polümüksiinid on kolistiini ja naatriumkolistimetaati (viimane on eelravim, mis muundub organismis kolistiiniks) sisaldavate antibiootikumide rühm, mida on Euroopa Liidus turustatud alates 1960. aastatest neile tundlike infektsioonide raviks.
English: Colistimethate sodium is given by injection or inhaled, and becomes colistin inside the body.
Estonian: Naatriumkolistimetaati süstitakse või inhaleeritakse ja see muutub organismis kolistiiniks.
English: • Injection or infusion (drip) of colistimethate sodium should only be used to treat serious infections in patients with few other treatment options, normally combined with another antibiotic.
Estonian: • Naatriumkolistimetaati tohib manustada süsti või infusiooniga ainult raskete infektsioonide ravis patsientidele, kelle jaoks on muid ravivõimalusi vähe, tavaliselt koos muu antibiootikumiga.