FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Furosemide Vitabalans do not outweigh its risks, and the marketing authorisation cannot be granted in Estonia and in the following Member States of the EU: Czech Republic, Denmark, Finland, Hungary, Latvia, Lithuania, Poland, Slovakia, Slovenia and Sweden, as well as Norway.
Estonian: Ameti inimravimite komitee jõudis järeldusele, et Furosemide Vitabalansi kasulikkus ei ületa sellega kaasnevaid riske ja et müügiluba ei saa välja anda Eestis ja järgmistes ELi liikmesriikides: Leedu, Läti, Poola, Rootsi, Slovakkia, Sloveenia, Soome, Taani, Tšehhi Vabariik ja Ungari ning samuti Norra.
English: The application was supported by published literature rather than studies carried out with Furosemide Vitabalans, because furosemide has a history of well-established use in the EU for at least 10 years.
Estonian: Taotlus toetus pigem avaldatud kirjandusele kui Furosemide Vitabalansiga tehtud uuringutele, sest furosemiidil on ELis vähemalt 10-aastane hästi tõendatud kasutus.
English: On 18 October 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 medicine Furosemide Vitabalans.
Estonian: 18. oktoobril 2012. aastal lõpetas Euroopa Ravimiamet vahekohtumenetluse, mis algatati, sest Euroopa Liidu liikmesriigid ei jõudnud kokkuleppele ravimi Furosemide Vitabalans müügiloa andmises.
English: What is Furosemide Vitabalans?
Estonian: Mis on Furosemide Vitabalans?
English: Why was Furosemide Vitabalans reviewed?
Estonian: Miks Furosemide Vitabalansi taotlus uuesti läbi vaadati?
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the data submitted were not sufficient to show that Furosemide Vitabalans could be used safely and effectively based on the well established use of furosemide.
Estonian: Praegu kättesaadavate andmete hindamise ja komitees toimunud teadusliku arutelu põhjal järeldas inimravimite komitee, et esitatud andmed ei olnud piisavad näitamaks, et Furosemide Vitabalansi võiks kasutada ohutult ja tõhusalt furosemiidi hästi tõendatud kasutuse alusel.
English: • cirrhosis of the liver (a type of liver disease) and renal disease, including nephrotic syndrome;
Estonian: • maksatsirroos (maksahaiguse liik) ja neeruhaigus, sh nefrootiline sündroom;
English: The Polish and Lithuanian agencies were of the opinion that the data submitted to support the application did not provide sufficient evidence to demonstrate the safety and effectiveness of Furosemide Vitabalans.
Estonian: Poola ja Leedu ravimiamet olid seisukohal, et taotluse toetuseks esitatud andmed ei tõenda Furosemide Vitabalansi ohutust ja tõhusust piisavalt.
English: Vitabalans Oy submitted an application for Furosemide Vitabalans to the Estonian medicines regulatory agency for a decentralised procedure.
Estonian: Vitabalans Oy esitas Eesti ravimiametile Furosamide Vitabalansi müügiloa detsentraliseeritud menetluse taotluse .
English: Questions and answers on Furosemide Vitabalans (tablet, 40 mg) EMA/423459/2013
Estonian: Forosemide Vitabalansi teave (tablett, 40 mg) EMA/107842/2013
English: The CHMP concluded that the balance of the benefits and risks of Furosemide Vitabalans could not be established, and therefore the marketing authorisation for Furosemide Vitabalans should not be granted in all concerned Member States.
Estonian: Inimravimite komitee järeldas, et Furosemide Vitabalansi kasulikkuse ja riski suhet ei ole võimalik kindlaks teha ja seetõttu ei tohi anda Furosamide Vitabalansile üheski asjaomases riigis müügiluba.
English: Furosemide Vitabalans was intended to be used to treat the following conditions:
Estonian: Furosemide Vitabalansi kavatseti kasutada järgmiste haiguste raviks:
English: Furosemide Vitabalans is a medicine that contains the active substance furosemide.
Estonian: Furosemide Vitabalans on ravim, mis sisaldab toimeainena furosemiidi.
English: Questions and answers on Furosemide Vitabalans (tablet, 40 mg)
Estonian: Forosemide Vitabalansi teave (tablett, 40 mg)
English: This is a procedure where one Member State (the ‘reference Member State', in this instance Estonia) 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 Czech Republic, Denmark, Finland, Hungary, Latvia, Lithuania, Norway, Poland, Slovakia, Slovenia and Sweden).
Estonian: („asjaomastes liikmesriikides”, antud juhul Leedu, Läti, Norra, Poola, Rootsi, Slovakkia, Sloveenia, Soome, Taani, Tšehhi Vabariik ja Ungari).
English: The grounds for the referral were that the data from the literature submitted to support this application could not be applied to Furosemide Vitabalans and the bridging data provided were not considered adequate to conclude on the benefit-risk profile of Furosemide Vitabalans.
Estonian: Menetlust põhjendati sellega, et kõnealuse taotluse toetuseks esitatud kirjandusandmeid ei saanud kohaldada Furosemide Vitabalansi suhtes ja üldistavaid andmeid ei peetud Furosemide Vitabalansi kasulikkuse ja riski profiili üle otsustamiseks piisavaks.
English: • oedema (swelling) associated with congestive heart failure (a type of heart disease);
Estonian: • südame paispuudulikkusega (südamehaiguse liik) kaasnev turse (paistetus);
English: The active substance in Furosemide Vitabalans, furosemide, belongs to a group of medicines known as diuretics.
Estonian: Furosemide Vitabalansi toimeaine furosemiid kuulub diureetikumide ravimirühma.
English: The results of the three studies after 12 weeks of treatment are as follows:
Estonian: Kolme uuringu tulemused olid pärast 12 ravinädalat järgmised:
English: Olumiant must not be used during pregnancy.
Estonian: Olumianti ei tohi kasutada raseduse ajal.
English: What measures are being taken to ensure the safe and effective use of Olumiant?
Estonian: Mis meetmed võetakse, et tagada Olumianti ohutu ja efektiivne kasutamine?
English: Olumiant (baricitinib)
Estonian: Olumiant (baritsitiniib)
English: Olumiant received a marketing authorisation valid throughout the EU on 13 February 2017.
Estonian: Olumianti müügiluba, mis kehtib kogu Euroopa Liidus, anti 13. veebruaril 2017.
English: The usual dose is 4 mg once a day but this can be reduced to 2 mg once a day when the disease is under control.
Estonian: Tavapärane annus on 4 mg üks kord ööpäevas ja seda tohib vähendada annuseni 2 mg üks kord ööpäevas, kui haigus allub ravile.
English: What is Olumiant and what is it used for?
Estonian: Mis on Olumiant ja milleks seda kasutatakse?
English: Further information on Olumiant can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/olumiant.
Estonian: Lisateave Olumianti kohta on ameti veebilehel: ema.europa.eu/en/medicines/human/EPAR/olumiant.
English: The dose may also need to be reduced in patients who have impaired kidney function, who have an increased risk of infections and in those aged over 75 years or who are taking certain other medicines.
Estonian: Annust võib olla vaja vähendada ka neerutalitlushäirega patsientidel, kellel on suurem risk infektsioonide tekkeks, kelle vanus on üle 75 aasta või kes võtavad teatud teisi ravimeid.
English: The European Medicines Agency decided that Olumiant's benefits are greater than its risks and it can be authorised for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et Olumianti kasulikkus on suurem kui sellega kaasnevad riskid ja et ravimi kasutamise võib ELis heaks kiita.
English: What are the risks associated with Olumiant?
Estonian: Mis riskid Olumiantiga kaasnevad?
English: In one study involving 584 patients, Olumiant was more effective than methotrexate.
Estonian: Uuringus, milles osales 584 patsienti, osutus Olumiant efektiivsemaks kui metotreksaat.
English: It works by blocking the action of enzymes known as Janus kinases.
Estonian: See blokeerib Janus-kinaasideks nimetatavate ensüümide toime.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Olumiant have also been included in the summary of product characteristics and the package leaflet.
Estonian: Olumianti ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: As for all medicines, data on the use of Olumiant is continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse Olumianti kasutamise kohta pidevat järelevalvet.
English: Patients will be given a special alert card that summarises the safety information about the medicine.
Estonian: Olumianti saavatele patsientidele antakse ka spetsiaalne teabekaart, millel on ravimi kokkuvõtlik ohutusteave.
English: By blocking the enzymes, baricitinib reduces the inflammation and other symptoms of the disease.
Estonian: Nende ensüümide blokeerimisega vähendab baritsitiniib põletikku ja muid haigussümptomeid.
English: Overall, its side effects are considered manageable and several measures have been put in place to minimise the risks with this medicine, particularly infection.
Estonian: Üldiselt loetakse ravimi kõrvalnähte ohjatavaks ja riskide, eeskätt infektsiooniriski vähendamiseks on võetud mitmesuguseid meetmeid.
English: For more information about using Olumiant, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Olumianti kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
English: However, long-term safety data are missing and these results alone are therefore not sufficient to support Olumiant use in previously untreated patients.
Estonian: Et pikaajalised ohutusandmed puuduvad, ei piisa neist andmetest, et tõendada Olumianti kasutamist varem ravimata patsientidel.
English: The Agency also took into account the lack of treatment options for these patients and the fact that Olumiant can be given by mouth is convenient for patients.
Estonian: Ühtlasi võttis inimravimite komitee arvesse selliste patsientide ravivõimaluste puudumist ning asjaolu, et Olumianti suukaudne manustamine on patsientidele mugav.
English: Side effects reported with Olumiant are carefully evaluated and any necessary action taken to protect patients.
Estonian: Olumianti kõrvaltoimeid hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
English: The active substance in Olumiant, baricitinib, is an immunosuppressant (a medicine that reduces the activity of the immune system).
Estonian: Olumiantis toimeainena sisalduv baritsitiniib on immunosupressant (aine, mis pärsib immuunsüsteemi talitlust).
English: Other information about Olumiant
Estonian: Muu teave Olumianti kohta
English: Treatment with Olumiant must be started by a doctor who has experience in the diagnosis and treatment of rheumatoid arthritis.
Estonian: Ravi Olumiantiga peab alustama reumatoidartriidi diagnoosimise ja ravi kogemusega arst.
English: In terms of safety, being an oral treatment means that Olumiant does not have the same risks as other DMARDs given by injection such as allergic reactions related to the way the medicine is given.
Estonian: Kuna Olumianti manustatakse suukaudselt, ei kaasne sellega samu ohutusriske nagu süstitavate haigust modifitseerivate ravimitega, näiteks manustamisviisiga seotud allergilised reaktsioonid.
English: The company that markets Olumiant will ensure that doctors who are expected to prescribe the medicine receive an information pack on the risks with Olumiant, particularly the risk of infection, and the monitoring that should be carried out in patients.
Estonian: Olumianti turustaja saadab kõigile ravimit määravatele arstidele teabematerjali Olumiantiga kaasnevate riskide (eeskätt infektsiooniriski) ja patsientide jälgimise teabega.
English: These enzymes play an important role in the process of inflammation and damage of the joints that occurs in rheumatoid arthritis.
Estonian: Neil ensüümidel on tähtis osa reumatoidartriidiga kaasnevas liigesepõletikus ja -kahjustustes.
English: Olumiant contains the active substance baricitinib.
Estonian: Olumiant sisaldab toimeainena baritsitiniibi.
English: An overview of Olumiant and why it is authorised in the EU
Estonian: Ülevaade ravimist Olumiant ja ELis müügiloa väljastamise põhjendus
English: What benefits of Olumiant have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Olumianti kasulikkus?
English: The most common side effects with Olumiant used alone or in combination with methotrexate were increased blood cholesterol levels, nose and throat infections and nausea (which may affect 2 or more people in 100).
Estonian: Olumianti kõige sagedamad kõrvalnähud (võivad esineda enam kui 2 patsiendil 100st) manustamisel ainuravimina või koos metotreksaadiga olid vere kolesteroolisisalduse suurenemine, nina- ja kurguinfektsioonid ning iiveldus.
English: Infections reported with Olumiant treatment also included herpes zoster (shingles).
Estonian: Olumianti-raviga seoses teatati ka vöötohatise (herpes zoster) infektsioonist.
English: In these studies, Olumiant (alone or with the DMARD methotrexate) resulted in more patients achieving an improvement of 20% or more in a standard symptom score (ACR 20) than comparator medicines and placebo.
Estonian: Nendes uuringutes saavutas Olumianti (kas üksi või koos haigust modifitseeriva ravimi metotreksaadiga) kasutanud patsientide seas ACR 20 skoori (sümptomite standardskoor) vähemalt 20% paranemise rohkem patsiente kui võrdlusravimite ja platseebo rühmas.
English: Olumiant can be used either alone or in combination with the DMARD methotrexate.
Estonian: Olumianti tohib kasutada kas ainuravimina või koos haigust modifitseeriva ravimi metotreksaadiga.
English: Three studies in around 2,500 patients showed that Olumiant improves symptoms, such as tenderness and joint swelling, in patients whose previous DMARDs have not worked well enough.
Estonian: Kolmes uuringus, milles osales umbes 2500 patsienti, tõendati Olumianti efektiivsus sümptomite (näiteks tundlikkus ja liigeseturse) leevendamisel patsientidel, kellel haigust modifitseerivad ravimid ei andnud piisavat ravivastust.
English: The Agency considered that Olumiant was shown to be effective at improving symptoms of rheumatoid arthritis in patients when previous treatment with DMARDs has not worked well enough or if patients cannot tolerate them.
Estonian: Inimravimite komitee leidis, et Olumiant on efektiivne reumatoidartriidi sümptomite leevendamisel patsientidel, kelle varasem ravi haigust modifitseerivate ravimitega ei ole andnud piisavat ravivastust või kellele see ravi ei sobi.
English: Olumiant has also been studied in patients who had not received previous treatment.
Estonian: Olumianti uuriti ka varem ravimata patsientidel.
English: Olumiant is a medicine used for treating rheumatoid arthritis (a disease causing inflammation of the joints).
Estonian: Olumiant on ravim, mida kasutatakse reumatoidartriidi (liigesepõletikku põhjustav haigus) raviks.
English: How is Olumiant used?
Estonian: Kuidas Olumianti kasutatakse?
English: For the full list of side effects reported with Olumiant, see the package leaflet.
Estonian: Olumianti kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: It is used in patients with moderate to severe arthritis when standard treatment with disease-modifying anti-rheumatic drugs (also known as ‘DMARDs') has not worked well enough or if patients cannot tolerate them.
Estonian: Seda kasutatakse mõõduka kuni raske artriidi raviks patsientidel, kes ei ole haigust modifitseerivate antireumaatiliste ravimitega (DMARD-ravimitega) tehtava standardraviga saavutanud piisavat ravivastust või kes ei talu sellist ravi.
English: How does Olumiant work?
Estonian: Kuidas Olumiant toimib?
English: • In patients previously treated with a class of DMARDs called TNF-inhibitors, 55% of patients (98 out of 177) on Olumiant achieved at least a 20% improvement, compared with 27% of patients (48 out of 176) on placebo.
Estonian: • Varem TNFi inhibiitorite klassi kuuluvaid haigust modifitseerivaid ravimeid kasutanud patsientide seas paranes ACR 20 skoor vähemalt 20% võrra 55%-l Olumianti võtnud patsientidest (98 patsienti 177st) ning 27%-l platseeborühma patsientidest (48 patsienti 176st).
English: • In patients previously treated with methotrexate, 70% of patients (339 out of 487) on Olumiant achieved at least a 20% improvement in symptom scores, compared with 61% of patients (202 out of 330) on adalimumab (another DMARD) and 40% (196 out of 488 patients) on placebo.
Estonian: • Varem metotreksaati võtnud patsientide seas paranes ACR 20 skoor vähemalt 20% võrra 70%-l Olumianti võtnud patsientidest (339 patsienti 487st), samas kui adalimumaabirühmas (samuti haigust modifitseeriv ravim) oli see näitaja 61% (202 patsienti 330st) ja platseeborühmas 40% (196 patsienti 488st).
English: • In patients previously treated with conventional DMARDs, 62% of patients (140 out of 227) on Olumiant achieved at least a 20% improvement, compared with 40% of patients (90 out of 228) on placebo.
Estonian: • Varem tavapäraseid haigust modifitseerivaid ravimeid kasutanud patsientide seas paranes ACR 20 skoor vähemalt 20% võrra 62%-l Olumianti võtnud patsientidest (140 patsienti 227st) ning 40%-l platseeborühma patsientidest (90 patsienti 228st).
English: The medicine can only be obtained with a prescription.
Estonian: Olumiant on retseptiravim.
English: Why is Olumiant authorised in the EU?
Estonian: Olumianti Euroopa Liidus heakskiitmise põhjused
English: EMA/CHMP/138741/2015 EMEA/H/C/000563
Estonian: EMA/101950/2015 EMEA/H/C/000563
English: The European Commission granted a marketing authorisation valid throughout the European Union for Aloxi on 22 March 2005.
Estonian: Euroopa Komisjon andis Aloxi müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 22. märtsil 2005.
English: What measures are being taken to ensure the safe and effective use of Aloxi?
Estonian: Mis meetmed võetakse, et tagada Aloxi ohutu ja efektiivne kasutamine?
English: A risk management plan has been developed to ensure that Aloxi is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Aloxi võimalikult ohutu kasutamine.
English: Aloxi palonosetron
Estonian: Aloxi palonosetroon
English: This is a summary of the European public assessment report (EPAR) for Aloxi.
Estonian: See on ravimi Aloxi Euroopa avaliku hindamisaruande kokkuvõte.
English: All of the studies measured the number of patients who did not vomit after receiving chemotherapy.
Estonian: Kõikides uuringutes määrati kindlaks nende patsientide arv, kes ei oksendanud pärast keemiaravi.
English: Other information about Aloxi
Estonian: Muu teave Aloxi kohta
English: The most common side effect with Aloxi (seen in between 1 and 10 patients in 100) is headache.
Estonian: Aloxi kõige sagedam kõrvalnäht (esinenud 1-10 patsiendil 100st) on peavalu.
English: The CHMP decided that the benefits of Aloxi are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et Aloxi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: Aloxi is a medicine that contains the active substance palonosetron.
Estonian: Aloxi on ravim, mis sisaldab toimeainena palonosetrooni.
English: The active substance in Aloxi, palonosetron, is a ‘5HT3 antagonist'.
Estonian: Aloxi toimeaine palonosetroon on 5HT3 antagonist.
English: Aloxi, given at two different doses, was compared with ondansetron and dolasetron (other medicines of the same type).
Estonian: Aloxit, mida manustati kahes eri annuses, võrreldi ondansetrooni ja dolasetrooniga (muud sama tüüpi ravimid).
English: The solution for injection should be given by a healthcare professional about 30 minutes before the start of chemotherapy.
Estonian: Tervishoiutöötaja peab manustama süstelahuse umbes 30 minutit enne keemiaravi algust.
English: It is available as a solution for injection (250 micrograms in 5 ml) and as capsules (500 micrograms).
Estonian: Seda turustatakse süstelahusena (250 µg 5 ml kohta) ja kapslitena (500 µg).
English: In the study looking at Aloxi capsules, all three doses of Aloxi were as effective as the solution for injection over 24 hours, with around three-quarters of the patients not vomiting.
Estonian: Kapslite uuringus olid kõik kolm Aloxi annust sama efektiivsed kui süstelahus, kusjuures 24 tunni jooksul ei oksendanud ligikaudu kolm neljandikku patsientidest.
English: For the full list of all side effects and restrictions with Aloxi, see the package leaflet.
Estonian: Aloxi kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: By blocking these receptors, Aloxi prevents the nausea and vomiting that often happen after chemotherapy.
Estonian: Nende retseptorite blokeerimise abil ennetab Aloxi iiveldust ja oksendamist, mis sageli esinevad pärast keemiaravi.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Aloxi, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati Aloxi omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: It may be made more effective by the addition of a corticosteroid (a type of medicine that can be used to prevent nausea and vomiting).
Estonian: Aloxi efektiivsust saab suurendada kortikosteroidi (ravim, mida kasutatakse iivelduse ja oksendamise ennetamiseks) lisamisega.
English: However, only the 500 microgram dose remained as effective as the solution for injection over the first five days after chemotherapy: around 59% of the patients receiving the 500 microgram capsule or the injection did not vomit during this period.
Estonian: Siiski oli keemiaravile järgnenud viie päeva jooksul üksnes 500 µg annus sama efektiivne kui süstelahus: ligikaudu 59% patsientidest, kes said 500 µg kapsli või süsti, ei oksendanud selle ajavahemiku jooksul.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Aloxi.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: Aloxi solution for injection was as effective as the comparator medicines.
Estonian: Aloxi süstelahus oli sama efektiivne kui võrdlusravimid.
English: Aloxi should only be given before chemotherapy.
Estonian: Aloxit tohib manustada ainult enne keemiaravi.
English: The solution for injection is used in adults and children 1 month of age or older for chemotherapy with medicines that are either a strong trigger of nausea and vomiting (such as cisplatin) or a moderate trigger (such as cyclophosphamide, doxorubicin or carboplatin).
Estonian: Süstelahust kasutatakse täiskasvanutel ja vähemalt 1 kuu vanustel lastel kas tugevat iiveldust ja oksendamist põhjustavate keemiaravi ainete (nt tsisplatiin) või mõõdukat iiveldust ja oksendamist põhjustavate keemiaravi ainete (nt tsüklofosfamiid, doksorubitsiin või karboplatiin) korral.
English: In adults, if the capsules are used, the patient should take one capsule one hour before the start of chemotherapy.
Estonian: Teise võimalusena manustatakse täiskasvanud patsientidele üks kapsel üks tund enne keemiaravi algust.
English: A further study compared three doses of Aloxi capsules (250, 500 and 750 micrograms) with the solution for injection in 651 adults receiving chemotherapy that was a moderate trigger of nausea and vomiting.
Estonian: Täiendavas uuringus võrreldi kolme erineva annusega (250, 500 ja 750 µg) Aloxi kapsleid süstelahusega 651 täiskasvanul, kes said mõõdukat iiveldust ja oksendamist põhjustavat keemiaravi.