FrancophonIA/ELRC3.0 huggingface dataset:
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A
Estonian: INIMTERVISHOIUS KASUTATAVATE RAVIMITE KOMITEE ARVAMUS PÄRAST ARTIKLI 29 LÕIKE 41 KOHAST ESILDIST, MIS KÄSITLES RAVIMIT Xeomin Rahvusvaheline mittekaubanduslik nimetus (INN): bakteri Clostridium botulinum A-tüüpi neurotoksiin
English: During their 16-19 July 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Xeomin, that the objections raised by Finland, France and Italy, should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Estonian: 16.-19. juuli 2007 koosolekul leidis inimtervishoius kasutatavate ravimite komitee, tuginedes kõigile esitatud andmetele ja komiteesisesele teaduslikule arutelule, et Xeomini kasulikkuse ja riski suhe on soodne, et Soome, Prantsusmaa ja Itaalia tõstatatud küsimused ei saa olla müügiloa andmisel takistuseks ning et viiteliikmesriigi esitatud ravimi omaduste kokkuvõtet, märgistust ja pakendi infolehte tuleb muuta.
English: On the basis of the questions raised by the Member States, the points to be considered by the CHMP concerned the posology, the repeated administration and safety profile in two Phase III studies.
Estonian: Tuginedes liikmesriikide tõstatatud küsimustele, arutas inimtervishoius kasutatavate ravimite komitee ravimi annustamist, korduvat manustamist ja kahes III faasi uuringutes tekkinud ohutusküsimusi.
English: Merz Pharmaceuticals GmbH submitted applications for mutual recognition of Xeomin, 100 LD50 units powder for solution for injection, on the basis of the marketing authorisation granted by Germany on 31 May 2005.
Estonian: Merz Pharmaceuticals GmbH esitas taotlused Xeomini süstelahuse pulbri (100 LD50 ühikut) vastastikuseks tunnustamiseks Saksamaa poolt 31. mail 2005 antud müügiloa alusel.
English: Xeomin, 100 LD50 units powder for solution for injection, is indicated for the symptomatic management of blepharospasm and cervical dystonia of a predominantly rotational form (spasmodic torticollis) in adults.
Estonian: Xeomin, süstelahuse pulber (100 LD50 ühikut), on näidustatud laukrambi ja kaelalihaste toonusehäire valdavalt rotatsioonilise vormi (krambitaolise lihaskontraktsiooni tekitatud kõverkaelsus, torticollis spastica) sümptomaatiliseks raviks täiskasvanutel.
English: The tablets should be taken with food.
Estonian: Tablette tuleb võtta koos toiduga.
English: The recommended dose is 4 tablets once a day for the first 2 weeks and then 2 tablets taken 3 times a week for the next 22 weeks.
Estonian: Soovitatav annus on 4 tabletti üks kord ööpäevas esimese 2 nädala jooksul ja seejärel 2 tabletti kolm korda nädalas järgmise 22 nädala jooksul.
English: The medicine is available as 100 mg tablets.
Estonian: Ravimit turustatakse 100 mg tablettidena.
English: A risk management plan has been developed to ensure that Sirturo is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Sirturo võimalikult ohutu kasutamine.
English: The company will also provide longer term safety data on the medicine.
Estonian: Ettevõte esitab ka ravimi pikaajalise kasutuse ohutusandmed.
English: What measures are being taken to ensure the safe and effective use of Sirturo?
Estonian: Mis meetmed võetakse, et tagada Sirturo ohutu ja efektiivne kasutamine?
English: Sirturo bedaquiline
Estonian: Sirturo bedakviliin
English: Without the ability to generate energy, the bacteria die and the patient's condition can start to improve.
Estonian: Energiaallikata bakterid hävivad ja patsiendi seisund saab hakata paranema.
English: In addition, it is recommended that patients are directly observed by a healthcare professional as they take the medicine.
Estonian: Samuti on soovitatav, et tervishoiutöötaja jälgib patsiente vahetult ravimi võtmise ajal.
English: Tuberculosis is an infection caused by the bacterium Mycobacterium tuberculosis.
Estonian: Tuberkuloos on infektsioon (nakkus), mida põhjustab bakter Mycobacterium tuberculosis.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Sirturo's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Inimravimite komitee otsustas, et Sirturo kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Sirturo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Estonian: Harvikravimite komitee arvamuse kokkuvõte Sirturo kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The full EPAR and risk management plan summary for Sirturo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst ja riskijuhtimiskava kokkuvõte Sirturo kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The Committee highlighted the need for new medicines to treat multi-drug resistant tuberculosis and noted that Sirturo was the first of a new class of medicines for which cross-resistance with other medicines had not yet been seen.
Estonian: Komitee rõhutas multiresistentse tuberkuloosi uute ravimite vajadust ja märkis, et Sirturo on esimene uue ravimiklassi ravim, mille korral ei ole veel esinenud ristresistentsust teiste ravimitega.
English: What is Sirturo and what is it used for?
Estonian: Mis on Sirturo ja milleks seda kasutatakse?
English: Other information about Sirturo
Estonian: Muu teave Sirturo kohta
English: The most common side effects with Sirturo (which may affect more than 1 in 10 people) are headache, dizziness, nausea (feeling sick), vomiting, and arthralgia (joint pain).
Estonian: Sirturo kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on peavalu, peapööritus, iiveldus, oksendamine ja liigesevalu.
English: This is a summary of the European public assessment report (EPAR) for Sirturo.
Estonian: See on ravimi Sirturo Euroopa avaliku hindamisaruande kokkuvõte.
English: Because the number of patients with tuberculosis is low in the EU, the disease is considered ‘rare', and Sirturo was designated an ‘orphan medicine' (a medicine used in rare diseases) on 26 August 2005.
Estonian: Et tuberkuloosiga patsientide arv Euroopa Liidus on väike ja see haigus esineb harva, nimetati Sirturo 26. augustil 2005 harvikravimiks.
English: Why is Sirturo approved?
Estonian: Miks Sirturo heaks kiideti?
English: Although an analysis of these deaths did not support the conclusion that they were caused by Sirturo, the CHMP has required the company to provide more information from a long-term follow-up study to allay any concerns.
Estonian: Kuigi surmajuhtumite analüüs ei kinnitanud, et põhjuseks oli Sirturo, küsis inimravimite komitee ettevõttelt probleemi selgitamiseks lisateavet pikaajalisest järeluuringust.
English: Sirturo is a tuberculosis medicine that contains the active substance bedaquiline.
Estonian: Sirturo on tuberkuloosiravim, mis sisaldab toimeainena bedakviliini.
English: Since Sirturo has been granted a conditional approval, the company that markets Sirturo will provide additional data on the medicine's benefits and safety when used with different combinations of medicines.
Estonian: Et Sirturo kiideti heaks tingimuslikult, esitab Sirturot turustav ettevõte veel andmeid ravimi kasulikkuse ja ohutuse kohta kasutamisel koos teiste ravimitega.
English: Cross-resistance is when bacteria develop resistance to a medicine after being exposed to another one, which is often the case with multi-drug resistant tuberculosis.
Estonian: Ristresistentsus tähendab bakteri resistentsust ravimi suhtes pärast kokkupuudet muu ravimiga, mida sageli juhtub multiresistentse tuberkuloosi korral.
English: It is not intended to provide practical advice on how to use Sirturo.
Estonian: Hindamisaruandes ei anta Sirturo kasutamise praktilisi nõuandeid.
English: With regard to safety, the side effects reported in the Sirturo group in the main study were not markedly different from those in the placebo group, though there were higher levels of liver enzymes and some reports of alterations in the heart's electrical activity (known as prolonged QT interval).
Estonian: Ohutuse suhtes ei erinenud põhiuuringus Sirturo rühma patsientide kõrvalnähud oluliselt platseeborühma omadest, kuigi maksaensüümide aktiivsus suurenes ja mõnel juhul teatati südame elektrilise talitluse muutustest (pikenenud QT-intervall).
English: Sirturo is used in combination with other tuberculosis medicines in adults with tuberculosis that is affecting the lung and that is multi-drug resistant (resistant to at least isoniazid and rifampicin, two standard tuberculosis medicines).
Estonian: Sirturot kasutatakse koos teiste tuberkuloosiravimitega täiskasvanutel, kellel on multiresistentne kopsutuberkuloos (resistentne vähemalt isoniasiidi ja rifampitsiini suhtes; mõlemad on tavalised tuberkuloosiravimid).
English: What information is still awaited for Sirturo?
Estonian: Mis teavet Sirturo kohta veel oodatakse?
English: The active substance in Sirturo, bedaquiline, works by specifically blocking an enzyme inside the M. tuberculosis bacteria called ATP synthase, which the bacteria need to generate energy.
Estonian: Sirturo toimeaine bedakviliin blokeerib bakteri M. tuberculosis ensüümi ATP süntaasi, mida bakter vajab energia tootmiseks.
English: It is given when combinations without Sirturo cannot be used, either because the disease is resistant to them or because of their side effects.
Estonian: Sirturot kasutatakse, kui Sirturota ravimikombinatsioone ei saa kasutada haiguse resistentsuse või ravimite kõrvalnähtude tõttu.
English: What are the risks associated with Sirturo?
Estonian: Mis riskid Sirturoga kaasnevad?
English: The study showed that after 24 weeks, 79% of the patients given Sirturo (52 out of 66 patients) tested negative for the bacteria in the sputum (phlegm) compared with 58% of patients given placebo (38 out of 66 patients).
Estonian: Patsiente, kellel oli 24 nädala pärast bakterid rögas puudusid, oli Sirturo rühmas 79% (52 patsienti 66st) ja platseeborühmas 58% (38 patsienti 66st).
English: Sirturo increased the number of patients who tested negative for the tuberculosis bacteria and shortened the average time it took to clear the bacteria from the sputum.
Estonian: Sirturo kasutamisel suurenes tuberkuloosibakterite suhtes negatiivse analüüsiga patsientide arv ja vähenes bakteri rögast kadumise keskmine aeg.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Sirturo, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati Sirturo omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: For practical information about using Sirturo, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Sirturo kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: How does Sirturo work?
Estonian: Kuidas Sirturo toimib?
English: For more information about treatment with Sirturo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Sirturoga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Sirturo on 05/03/2014.
Estonian: Euroopa Komisjon andis Sirturo müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, <müügiloa andmise kuupäev>.
English: In a main study in adults with multi-drug resistant tuberculosis affecting the lung, Sirturo was compared with placebo (a dummy treatment) when added to combination treatment with other standard tuberculosis medicines.
Estonian: Põhiuuringus, kus osalesid multiresistentse kopsutuberkuloosiga täiskasvanud, võrreldi Sirturot platseeboga (näiva ravimiga) kasutamisel kombineeritud ravis tavaliste tuberkuloosiravimitega.
English: For the full list of all side effects and restrictions, see the package leaflet.
Estonian: Sirturo kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: The average time it took to clear the bacteria from the sputum was also shorter for patients in the Sirturo group than for those in the placebo group (83 days versus 125 days).
Estonian: Bakterid kadusid rögast Sirturo rühma patsientidel keskmiselt kiiremini (83 päevaga) kui platseeborühmas (125 päevaga).
English: How is Sirturo used?
Estonian: Kuidas Sirturot kasutatakse?
English: There was also a higher number of reported deaths in the Sirturo group.
Estonian: Sirturo rühmas oli suremus suurem.
English: What benefits of Sirturo have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Sirturo kasulikkus?
English: Treatment should be started and monitored by a doctor who is experienced in the treatment of multi-drug resistant tuberculosis.
Estonian: Ravi peab alustama multiresistentse tuberkuloosi ravis kogenud arst ja see peab toimuma tema järelevalve all.
English: Sirturo can only be obtained with a prescription.
Estonian: Sirturo on retseptiravim.
English: Sirturo has been given ‘conditional approval'.
Estonian: Situro müügiluba anti tingimuslikult.
English: List of the names, pharmaceutical form, strength of the medicinal products, route of administration, applicants /marketing authorisation holders in the Member States
Estonian: Loetelu ravimpreparaadi nimetustest, ravimvormidest, kontsentratsioonidest, manustamisteedest ja müügiloa taotlejatest/hoidjatest liikmesriikides
English: Member State EU/EEA
Estonian: EL/EEA liikmesriik
English: Pharmaceutical form
Estonian: Ravimvorm Manustamistee
English: Mifepristone Linepharma 200 mg tablet
Estonian: Mifepristone 200 mg tablet
English: Annex I
Estonian: Kontsentratsio on
English: Elocta received a marketing authorisation valid throughout the EU on 19 November 2015.
Estonian: Elocta on saanud müügiloa, mis kehtib kogu ELis, 19. novembril 2015.
English: Further information on Elocta can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Elocta.
Estonian: Lisateave Elocta kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/Elocta.
English: This summary was last updated in 10-2018.
Estonian: Kokkuvõtte viimane uuendus: 10.2018.
English: What measures are being taken to ensure the safe and effective use of Elocta?
Estonian: Mis meetmed võetakse, et tagada Elocta ohutu ja efektiivne kasutamine?
English: Other information about Elocta
Estonian: Muu teave Elocta kohta
English: The European Medicines Agency therefore decided that Elocta's benefits are greater than its risks and it can be authorised for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et Elocta kasulikkus on suurem kui sellega kaasnevad riskid ja et ravimi kasutamise võib ELis heaks kiita.
English: Elocta (efmoroctocog alfa) EMA/697822/2018
Estonian: Elocta (alfaefmoroktokog) EMA/697822/2018
English: As for all medicines, data on the use of Elocta are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse Elocta kasutamise kohta pidevat järelevalvet.
English: What is Elocta and what is it used for?
Estonian: Mis on Elocta ja milleks seda kasutatakse?
English: Hypersensitivity (allergic) reactions are seen rarely with Elocta and these include: swelling of the face, rash, hives, tightness of the chest and difficulty breathing, burning and stinging at the injection site, chills, flushing, itching over the whole body, headache, low blood pressure, lethargy, nausea, restlessness, and a fast heartbeat.
Estonian: Ülitundlikkusreaktsioonid (allergiareaktsioonid) esinevad Elocta manustamisel harva ja need on näiteks näoturse, lööve, nõgeslööve, rõhumistunne rinnus ja hingamisraskused, põletus- ja torkimistunne süstekohas, külmavärinad, õhetus, kogu keha sügelus, peavalu, madal vererõhk, letargia, iiveldus, rahutus ning kiirenenud südametegevus.
English: Two main studies of Elocta showed that the medicine is effective at both preventing and treating bleeding episodes.
Estonian: Kaks Elocta põhiuuringut tõendasid, et ravim on efektiivne nii verejooksuepisoodide ennetamisel kui ka ravis.
English: Elocta (efmoroctocog alfa)
Estonian: Elocta (alfaefmoroktokog)
English: Side effects reported with Elocta are carefully evaluated and any necessary action taken to protect patients.
Estonian: Elocta kõrvaltoimeid hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
English: In a study of 165 adult patients with haemophilia A, patients who were given Elocta as a tailored preventive treatment had around 3 bleeding episodes a year, which compares with 37 episodes a year in patients not given preventive treatment.
Estonian: Uuringus, milles osales 165 A-hemofiiliaga täiskasvanud patsienti, esines Eloctat kohandatud ennetava ravina saanud patsientidel ligikaudu 3 verejooksuepisoodi aastas võrreldes 37 episoodiga aastas patsientidel, kes ei saanud ennetavat ravi.
English: What are the risks associated with Elocta?
Estonian: Mis riskid Eloctaga kaasnevad?
English: For more information about using Elocta, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Elocta kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
English: In addition, when bleeding did occur, Elocta treatment was rated as ‘excellent' or ‘good' in more than 78% of cases, with 87% of bleeding episodes resolving with only one injection.
Estonian: Verejooksu esinemisel hinnati ravi Eloctaga suurepäraseks või heaks enam kui 78%-l juhtudest ja 87% verejooksuepisoodidest lahenes ainult ühe süstiga.
English: The dose and frequency of the injections depend on whether Elocta is used to treat or prevent bleeding, the severity of the patient's factor VIII deficiency, the extent and location of the bleeding and the patient's condition and bodyweight.
Estonian: Süstide annus ja sagedus sõltuvad sellest, kas Eloctat kasutatakse verejooksu raviks või ennetamiseks, patsiendi VIII hüübimisfaktori vaeguse raskusastmest, verejooksu ulatusest ja asukohast ning patsiendi seisundist ja kehamassist.
English: The active substance in Elocta, efmoroctocog alfa, works in the body in the same way as human factor VIII.
Estonian: Elocta toimeaine alfaefmoroktokog toimib organismis samamoodi nagu inimese VIII hüübimisfaktor.
English: In a study in 69 children, Elocta was similarly effective: 2 bleeding episodes occurred per year on average and 81% of bleeding episodes resolved with only one injection.
Estonian: Elocta efektiivsus 69 lapse uuringus oli sarnane: keskmiselt esines aastas 2 verejooksuepisoodi ja 81% episoodidest lahenes ainult ühe süstiga.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Elocta have been included in the summary of product characteristics and the package leaflet.
Estonian: Elocta ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: For the full list of side effects and restrictions of Elocta, see the package leaflet.
Estonian: Elocta kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: Studies show that Elocta is effective at preventing and treating bleeding episodes in patients with haemophilia A and its safety is in line with what is expected for medicines of its kind.
Estonian: Uuringud tõendavad, et Elocta on efektiivne verejooksude ennetamisel ja ravis A-hemofiiliaga patsientidel ning selle ohutus on võrreldav teiste sarnaste ravimite ohutusega.
English: How does Elocta work?
Estonian: Kuidas Elocta toimib?
English: How is Elocta used?
Estonian: Kuidas Eloctat kasutatakse?
English: What benefits of Elocta have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Elocta kasulikkus?
English: Elocta is a medicine used to treat and prevent bleeding in patients with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII).
Estonian: Elocta on ravim, mida kasutatakse verejooksude raviks ja ennetamiseks patsientidel, kellel on Ahemofiilia (VIII hüübimisfaktori vaegusest tingitud pärilik hüübimishäire).
English: It contains the active substance efmoroctocog alfa.
Estonian: Elocta sisaldab toimeainena alfaefmoroktokogi.
English: There is also a risk with factor VIII medicines that some patients will develop inhibitors (antibodies) against factor VIII, causing the medicine to stop working and resulting in a loss of bleeding control.
Estonian: Mõnel VIII hüübimisfaktorit sisaldavaid ravimeid kasutaval patsiendil võivad tekkida VIII hüübimisfaktori vastased inhibiitorid (antikehad), mis peatavad ravimi toime, nii et see ei peata enam verejooksu.
English: An overview of Elocta and why it is authorised in the EU
Estonian: Ülevaade ravimist Elocta ja ELis müügiloa väljastamise põhjendus
English: Elocta can only be obtained with a prescription and treatment should be started under the supervision of a doctor who has experience in the treatment of haemophilia.
Estonian: Ravi peab algama hemofiilia ravis kogenud arsti järelevalve all.
English: Elocta is available as a powder and solvent used to make a solution for injection.
Estonian: Eloctat turustatakse süstelahuse pulbri ja lahustina.
English: The Member States shall ensure that the Marketing Authorisation Holder complies with the following requirements in their Member State:
Estonian: Liikmesriigid peavad tagama, et müügiloa hoidja järgib nende liikmesriigis alljärgnevaid nõudmisi:
English: The MULTAQ Information Card should contain the following key safety messages:
Estonian: MULTAQ'i teabekaart peab sisaldama järgnevat olulist ohutusteavet:
English: o Class I or Class III antiarrhythmics.
Estonian: o I või III klassi antiarütmikumid.
English: • That plasma creatinine levels may rise initially due to inhibition of the renal tubular excretion of creatinine and are not necessarily indicative of a deterioration in renal function.
Estonian: • Kreatiniini sisaldus vereplasmas võib algselt tõusta kreatiniini eritumise pärssimise tõttu neerutorukestes ja see ei viita tingimata neerufunktsiooni halvenemisele.
English: • That patients should be counselled that: they should consult a physician if they develop or experience worsening signs or symptoms of heart failure; they should immediately report to a physician any symptoms of potential liver injury; MULTAQ interacts with a number of medicines; if they consult other doctors they should inform them that they are taking MULTAQ; they should not take St John's Wort with MULTAQ; they should avoid grapefruit juice.
Estonian: • Patsiente tuleb nõustada, et: nad konsulteeriks arstiga südamepuudulikkuse nähtude tekkimisel või süvenemisel või sümptomite tekkimisel; nad kohe teavitaksid arsti võimaliku maksakahjustuse mistahes sümptomite tekkest; MULTAQ'il on koostoimed mitmete ravimitega; kui nad pöörduvad teiste arstide poole, siis nad peavad neid teavitama, et võtavad MULTAQ'it; naistepuna ürti ei tohi võtta koos MULTAQ'iga; nad peavad vältima greipfruudi mahla.
English: • That the use of MULTAQ is not recommended in patients with recent (1-3 months) stable NYHA class III heart failure or with LVEF <35%.
Estonian: • MULTAQ'it ei soovitata kasutada patsientidel äsjase (1...3 kuud) stabiilse, NYHA III klassi südamepuudulikkusega või kui LVEF <35%.