FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Kengrexal's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Inimravimite komitee otsustas, et Kengrexali kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: Kengrexal was shown to be more effective than clopidogrel taken by mouth at reducing the occurrence of these events: 4.7% of patients (257 out of 5,470 patients) given Kengrexal had an event or died compared with 5.9% (322 out of 5,469 patients) of patients given clopidogrel.
Estonian: Kengrexali saanud patsientide hulgas esines haigus- ja surmajuhtumeid 4,7%-l (257 patsienti 5470st) võrreldes 5,9%-ga klopidogreeli saanud patsientidest (322 patsienti 5469st).
English: Treatment starts with an injection into a vein at a dose of 30 micrograms per kilogram bodyweight, which should last less than a minute; this is followed immediately after by an infusion at a rate of 4 micrograms per kilogram each minute.
Estonian: Ravi algab intravenoosse süstiga annuses 30 µg kehakaalu kg kohta ja selle kestus peab olema alla minuti; sellele järgneb kohe infusioon kiirusega 4 µg kg kohta minutis.
English: Other information about Kengrexal
Estonian: Muu teave Kengrexali kohta
English: What is Kengrexal and what is it used for?
Estonian: Mis on Kengrexal ja milleks seda kasutatakse?
English: At the end of the infusion, patients should be switched to maintenance treatment by mouth with clopidogrel, ticagrelor or prasugrel.
Estonian: Infusiooni lõpus tuleb patsientidele anda säilitusravi suukaudse klopidogreeli, tikagreloori või prasugreeliga.
English: Kengrexal was also investigated in one study in which it was given before surgery to patients who had been previously treated with blood-thinning medicines taken by mouth.
Estonian: Kengrexali uuriti ka ühes uuringus, kus seda manustati enne operatsiooni patsientidele, keda oli varem ravitud suukaudsete verd vedeldavate ravimitega.
English: Kengrexal is given to patients who have not been treated before the procedure with other blood-thinning medicines called ‘P2Y12 inhibitors' (clopidogrel, ticagrelor or prasugrel) taken by mouth, and for whom treatment with these medicines is not possible or desirable.
Estonian: Kengrexali manustatakse patsientidele, keda ei ole enne protseduuri ravitud muude verd vedeldavate suukaudsete ravimitega, mida nimetatakse P2Y12 inhibiitoriteks (klopidogreel, tikagreloor või prasugreel), ja kelle ravi nende ravimitega ei ole võimalik või soovitatav.
English: Regarding Kengrexal's safety profile, the CHMP noted that the incidence of bleeding was higher for Kengrexal than for clopidogrel, but this was expected given the greater effectiveness of the medicine, and was offset by the fact that the activity of Kengrexal wore off quickly once the infusion was stopped.
Estonian: Seoses Kengrexali ohutusprofiiliga märkis inimravimite komitee, et verejooksujuhtude esinemissagedus oli suurem Kengrexali kui klopidogreeli korral, kuid ravimi suuremat efektiivsust arvestades oli see eeldatav, ning seda tasakaalustas asjaolu, et infusiooni peatamisel kadus Kengrexali toime kiiresti.
English: Why is Kengrexal approved?
Estonian: Miks Kengrexal heaks kiideti?
English: It must also not be used in patients who have had a stroke or mini stroke (transient ischaemic attack or TIA).
Estonian: Seda ei tohi kasutada ka patsiendid, kellel on olnud varem insult või mini-insult (transitoorne isheemiline atakk).
English: The fact that the medicine is given into a vein is considered useful in patients who cannot swallow and cannot take treatments by mouth.
Estonian: Asjaolu, et ravimit manustatakse veeni, peetakse kasulikuks patsientide jaoks, kes ei saa neelata ega võtta suukaudseid ravimeid.
English: It is used together with aspirin in adults with coronary artery disease (heart disease caused by the obstruction of the blood vessels that supply the heart) who are undergoing percutaneous coronary intervention (PCI - a surgical procedure used to unblock narrowed blood vessels that supply the heart).
Estonian: Seda kasutatakse koos aspiriiniga südame koronaartõvega (südamelihast verega varustavate veresoonte ummistusest põhjustatud südamehaigus) täiskasvanutel, kellele tehakse perkutaanne koronaarinterventsioon (kirurgiline protseduur südamelihast verega varustavate ahenenud veresoonte ummistuse kõrvaldamiseks).
English: It is not intended to provide practical advice on how to use Kengrexal.
Estonian: Hindamisaruandes ei anta Kengrexali kasutamise praktilisi nõuandeid.
English: This is a summary of the European public assessment report (EPAR) for Kengrexal.
Estonian: See on ravimi Kengrexal Euroopa avaliku hindamisaruande kokkuvõte.
English: What are the risks associated with Kengrexal?
Estonian: Mis riskid Kengrexaliga kaasnevad?
English: The most common side effects with Kengrexal (which may affect up to 1 in 10 people) include mild and moderate bleeding and dyspnoea (difficulty breathing).
Estonian: Kengrexali kõige sagedamad kõrvalnähud (võivad esineda kuni 1 patsiendil 10st) on kerge ja mõõdukas verejooks ja düspnoe (hingamisraskused).
English: The main measure of effectiveness was based on the number of patients having an ‘event' such as a heart attack or clots in the heart blood vessels requiring intervention, or dying from any cause, in the 48 hours following PCI.
Estonian: Efektiivsuse põhinäitaja oli nende patsientide arv, kellel tekkis interventsiooni nõudev haigusjuht, nt südameinfarkt või südame veresoonte verehüübed, või kes surid 48 tunni jooksul pärast perkutaanse koronaarinterventsiooni protseduuri mis tahes põhjusel.
English: The medicine has been shown to be beneficial at reducing problems caused by blood clots in patients undergoing PCI who have not received previous treatment with P2Y12 inhibitors.
Estonian: On tõendatud, et ravim on kasulik verehüüvetest põhjustatud probleemide vähendamisel patsientidel, kellele tehakse perkutaanse koronaarinterventsiooni protseduur ja keda ei ole varem ravitud P2Y12 inhibiitoritega.
English: The most serious side effects with Kengrexal include severe and life-threatening bleeding and hypersensitivity (allergic) reactions.
Estonian: Kengrexali kõige tõsisemad kõrvalnähud on raske ja eluohtlik verejooks ning ülitundlikkusreaktsioonid (allergia).
English: Kengrexal is a blood-thinning medicine used to reduce the occurrence of problems caused by blood clots, such as heart attack.
Estonian: Kengrexal on verd vedeldav ravim, mida kasutatakse verehüüvetest põhjustatud probleemide, nagu südameinfarkti esinemissageduse vähendamiseks.
English: Kengrexal cangrelor
Estonian: Kengrexal kangreloor
English: Kengrexal must not be used in patients who are actively bleeding or who are at an increased risk of bleeding because of a bleeding disorder, recent major surgery or trauma, or uncontrolled high blood pressure.
Estonian: Kengrexali ei tohi kasutada patsientidel, kellel on aktiivne verejooks või veritsushäirest või hiljutisest suurest operatsioonist või traumast tingitud suurenenud veritsemisrisk või ravile allumatu kõrge vererõhk.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Kengrexal, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati Kengrexali omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: Kengrexal was compared with clopidogrel taken by mouth in one main study involving over 11,000 adults with coronary artery disease who were undergoing PCI.
Estonian: Kengrexali võrreldi suukaudse klopidogreeliga ühes põhiuuringus, milles osales üle 11 000 südame koronaartõvega täiskasvanu, kellele tehti perkutaanse koronaarinterventsiooni protseduur.
English: This means that it helps to prevent blood cells called platelets from sticking together and forming blood clots, thus helping to prevent another heart attack.
Estonian: See tähendab, et see aitab ennetada trombotsüütideks nimetatavate vererakkude agregatsiooni ja verehüüvete teket ning hoida ära järgmist südameinfarkti.
English: Kengrexal contains the active substance cangrelor.
Estonian: Kengrexal sisaldab toimeainena kangreloori.
English: For more information about treatment with Kengrexal, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Kengrexaliga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: For practical information about using Kengrexal, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Kengrexali kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: How is Kengrexal used?
Estonian: Kuidas Kengrexali kasutatakse?
English: For the full list of all side effects reported with Kengrexal, see the package leaflet.
Estonian: Kengrexali kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: Cangrelor stops the platelets sticking together by blocking a substance called ADP from attaching to their surface.
Estonian: Kangreloor peatab trombotsüütide agregatsiooni, blokeerides adenosiindifosfaadi (ADP) kinnitumise trombotsüütide pinnale.
English: What benefits of Kengrexal have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Kengrexali kasulikkus?
English: Kengrexal should be given by a doctor who is experienced in the treatment of coronary disease or in PCI procedures.
Estonian: Kengrexali peab manustama südame koronaartõve ravis või perkutaanse koronaarinterventsiooni protseduurides kogenud arst.
English: How does Kengrexal work?
Estonian: Kuidas Kengrexal toimib?
English: Kengrexal is available as a powder to be made up into a solution for injection and infusion (drip) into a vein.
Estonian: Kengrexali turustatakse süste- ja infusioonilahuse (veeni tilgutatava lahuse) pulbrina.
English: The medicine can only be obtained with a prescription and should be given in a hospital setting.
Estonian: Kengrexal on retseptiravim ja seda tohib manustada ainult haiglaravi tingimustes.
English: The active substance in Kengrexal, cangrelor, is an antiplatelet medicine.
Estonian: Kengrexali toimeaine kangreloor on trombotsüütide agregatsiooni vastane ravim.
English: 27 May 2013
Estonian: 27. mai 2013
English: The European Commission issued a decision on 27 May 2013.
Estonian: Euroopa Komisjon tegi otsuse 27. mail 2013.
English: Why was Simvastatin Vale reviewed?
Estonian: Miks Simvastatin Vale uuesti läbi vaadati?
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Estonian: Kaks ravimit on bioekvivalentsed, kui nad tekitavad organismis sama toimeainesisalduse.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance the United Kingdom) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Austria, Denmark, Finland, France, Germany, Greece, Ireland, Italy, the Netherlands, Portugal, Spain and Sweden as well as Norway).
Estonian: See on menetlus, mille korral üks liikmesriik (viiteliikmesriik, antud juhul Ühendkuningriik) hindab ravimit, et otsustada, kas anda ravimi müügiluba, mis kehtib selles riigis ja teistes liikmesriikides (asjaomased liikmesriigid, antud juhul Austria, Hispaania, Iirimaa, Itaalia, Kreeka, Madalmaad, Portugal, Prantsusmaa, Rootsi, Saksamaa, Soome, Taani ja ka Norra).
English: What is Simvastatin Vale?
Estonian: Mis on Simvastatin Vale?
English: Simvastatin Vale is used to treat certain forms of hypercholesterolaemia (high blood cholesterol levels) and to reduce the risk of heart disease and death in patients with atherosclerotic cardiovascular disease (where the arteries become narrower due to fatty materials building up on their inside walls) or diabetes.
Estonian: Ravimit Simvastatin Vale kasutatakse hüperkolesteroleemia (vere suur kolesteroolisisaldus) teatud vormide raviks ning südamehaiguste ja surma riski vähendamiseks aterosklerootilise südamehaiguse (haigus, mille korral südamearterid ahenevad arterite seintele ladestuvate rasvaosakeste tõttu) või diabeediga patsientidel.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Simvastatin Vale outweigh its risks, and the marketing authorisation can be granted in the United Kingdom and in the following Member States of the EU: Austria, Denmark, Finland, France, Germany, Greece, Ireland, Italy, the Netherlands, Portugal, Spain and Sweden as well as Norway.
Estonian: Euroopa Ravimiameti inimravimite komitee järeldas, et ravimi Simvastatin Vale kasulikkus ületab sellega kaasnevad riskid ja et müügiloa võib anda Ühendkuningriigis ning järgmistes ELi liikmesriikides: Austria, Hispaania, Iirimaa, Itaalia, Kreeka, Madalmaad, Portugal, Prantsusmaa, Rootsi, Saksamaa, Soome, Taani ja ka Norra.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that additional data were not needed because, based on the data submitted, Simvastatin Vale is expected to produce comparable levels of the active substance in the body as the reference medicine at both strengths.
Estonian: Tuginedes olemasolevate andmete hindamisele ja komiteesisesele teaduslikule arutelule, järeldas inimravimite komitee, et täiendavaid andmeid ei ole vaja, sest esitatud andmete põhjal võib eeldada, et Simvastatin Vale tekitab mõlema tugevusega suspensiooni kasutamisel organismis võrdlusravimiga Zocor sarnase toimeainesisalduse.
English: On 25 March 2013, 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 Simvastatin Vale.
Estonian: Euroopa Ravimiamet lõpetas 25. märtsil 2013 vahekohtumenetluse Euroopa Liidu liikmesriikide erimeelsuse küsimuses, mis käsitles ravimi Simvastatin Vale müügiluba.
English: However, the Member States were not able to reach an agreement and the United Kingdom referred the matter to the CHMP for arbitration on 29 January 2013.
Estonian: Liikmesriigid ei jõudnud siiski küsimuses üksmeelele, mistõttu Ühendkuningriigi ravimiamet tegi 29. jaanuaril 2013 inimravimite komiteele vahekohtumenetluse alustamise esildise.
English: The CHMP therefore concluded that the benefits of Simvastatin Vale outweigh its risks and recommended that the marketing authorisation be granted in the concerned Member States.
Estonian: Seetõttu otsustas inimravimite komitee, et Simvastatin Vale kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda asjaomastes liikmesriikides ravimi müügiloa.
English: Vale Pharmaceuticals Ltd submitted Simvastatin Vale to the United Kingdom's Medicines and Healthcare products Regulatory Agency for a decentralised procedure.
Estonian: Vale Pharmaceuticals Ltd esitas ravimi Simvastatin Vale müügiloa taotluse Ühendkuningriigi ravimiametile detsentraliseeritud menetluse kaudu.
English: The bioequivalence study submitted in support of the application compared Simvastatin Vale 20mg/5ml with Zocor 20 mg tablets.
Estonian: Müügiloa taotluse toetuseks esitatud bioekvivalentsusuuringus võrreldi Simvastatin Vale 20 mg/5 ml suukaudset suspensiooni Zocori 20 mg tablettidega.
English: Simvastatin Vale is a generic medicine based on a ‘reference medicine' already authorised in the EU, called Zocor.
Estonian: Simvastatin Vale on geneeriline ravim, mis põhineb võrdlusravimil Zocor, millel juba on ELis müügiluba.
English: Simvastatin Vale is a medicine that contains the active substance simvastatin.
Estonian: Simvastatin Vale on ravim, mis sisaldab toimeainena simvastatiini.
English: It is available as an oral suspension (20mg/5ml and 40mg/5ml).
Estonian: Ravimit turustatakse suukaudse suspensioonina (20 mg/5 ml ja 40 mg/5 ml).
English: However, some Member States considered that the higher strength of 40mg/5ml should have been used, in line with the current guideline on the investigation of bioequivalence.
Estonian: Siiski leidsid mõned liikmesriigid, et kehtiva bioekvivalentsusuuringu juhendi järgi oleks tulnud kasutada suurema toimeainesisaldusega 40 mg/5 ml suukaudset suspensiooni.
English: The grounds for the referral were concerns about the data submitted to show that Simvastatin Vale is ‘bioequivalent' to the reference medicine, Zocor.
Estonian: Esildise põhjuseks oli kahtlused andmete suhtes, mis esitati Simvastatin Vale ja võrdlusravimi Zocor bioekvivalentsuse tõendamiseks.
English: The active substance in Simvastatin Vale, simvastatin, belongs to a group of medicines called statins, the standard type of medicine used to reduce cholesterol.
Estonian: Simvastatin Vale toimeaine simvastatiin kuulub ravimite klassi, mida nimetatakse satiinideks (kolesteroolisisalduse vähendamise ravimid).
English: The study period was defined as 1 October 2005 to 30 September 2010.
Estonian: Uuringuperiood kestis 1. oktoobrist 2005 kuni 30. septembrini 2010.
English: Any existing data is old and does not meet the current methodology requirements.
Estonian: Kõik olemasolevad andmed on vananenud ega vasta praegustele metodoloogilistele nõuetele.
English: During this period no new patients should be initiated on treatment with meprobamate.
Estonian: Selle perioodi vältel ei tohi alustada uute patsientide ravi meprobamaadiga.
English: As a consequence, they considered additional risk minimisation measures to be unnecessary.
Estonian: Seetõttu ei pidanud nad täiendavaid riskivähendamismeetmeid vajalikuks.
English: Risk minimisation measures
Estonian: Riskivähendamismeetmed
English: The study period was defined as covering the period July 2009 to March 2011 and the resulting data was compared to data from the May 2006 to July 2009 period.
Estonian: Uuringuperiood hõlmas andmeid ajavahemikust juuli 2009-märts 2011; uuringu tulemusi võrreldi ajavahemiku mai 2006-juuli 2009 andmetega.
English: Grounds for the suspension of the Marketing Authorisations
Estonian: Müügilubade peatamise põhjused
English: Overall summary of the scientific evaluation of meprobamate-containing medicinal products for oral use (see Annex I)
Estonian: Meprobamaati sisaldavate suukaudsete ravimite (vt I lisa) teadusliku hindamise üldkokkuvõte
English: By comparison, 308 serious and non-serious reports were recorded during the 2001 to 2006 period.
Estonian: Võrdluseks - perioodil 2001 kuni 2006 registreeriti 308 rasket ja muud juhtu.
English: The most frequently encountered serious adverse events were comas (75 cases).
Estonian: Kõige sagedamini esinenud raske kõrvalnäht oli kooma (75 juhtu).
English: Overall benefit-risk assessment
Estonian: Üldine kasulikkuse ja riski suhte hindamine
English: As a result, a procedure under article 107 of Directive 2011/83/EC was automatically initiated at European level for meprobamate-containing medicinal products for oral use.
Estonian: Selle tulemusena algatati direktiivi 2011/83/EÜ artikli 107 kohane meprobamaati sisaldavate suukaudsete ravimite üleeuroopaline hindamismenetlus.
English: For the suspension to be lifted, the Marketing Authorisation Holders should provide convincing data to identify a patient population in which the benefits of meprobamate clearly outweigh its identified risks (see Annex III of the Opinion).
Estonian: Müügiloa peatamise otsuse tühistamiseks peavad müügiloa hoidjad esitama veenvaid andmeid patsientide populatsiooni kohta, kellel meprobamaadi kasulikkus ületab selgelt sellega seoses kindlakstehtud riskid (vt arvamuse III lisa).
English: Some MAHs nonetheless proposed minor amendments to the product information, in particular with regard to treatment duration.
Estonian: Mõned müügiloa hoidjad pakkusid siiski välja väiksed muudatused toote infolehes, iseäranis ravi kestuse osas.
English: Afssaps therefore considered the benefit-risk of meprobamate-containing products to be unfavourable and notified the European Medicines Agency (EMA) and the Committee for Medicinal Products for Human Use (CHMP) on 25 July 2011 of its intention to suspend the French marketing authorisations of oral medicines containing meprobamate, effective as of January 2012.
Estonian: Afssaps pidas seetõttu meprobamaati sisaldavate ravimite kasulikkuse ja riski suhet ebasoodsaks ning teatas 25. juulil 2011 Euroopa Ravimiametile ja Euroopa Ravimiameti inimravimite komiteele oma kavatsusest peatada alates 2012. aasta jaanuarist meprobamaati sisaldavate suukaudsete ravimite müügiload Prantsusmaal.
English: Cases of accidental overdose (higher doses than recommended during several days) occurred in 9% of patients.
Estonian: Tahtmatu üleannustamise juhte (soovitatavast suuremate annuste sissevõtmine mitme päeva vältel) esines 9%-l patsientidest.
English: This is of particular concern in the elderly population.
Estonian: See on aga eriti murettekitav eakate patsientide puhul.
English: Regarding the meprobamate/aceprometazine combination products, the second Lille CPRV analysis identified 365 medically confirmed cases during the study period, of which 277 (76%) were recorded as serious (corresponding to 894 adverse events) while 88 were recorded as non-serious (corresponding to 153 adverse events).
Estonian: Meprobamaati/atseprometasiini sisaldavate kombinatsioonravimite osas tuvastas Lille'i CPRV teine analüüs uuringuperioodi vältel 365 meditsiiniliselt kinnitatud juhtu, millest 277 (76%) olid rasked (vastasid 894 kõrvalnähule) ja 88 kergemad (vastasid 153 kõrvalnähule).
English: Seven comas had a fatal outcome.
Estonian: Seitse koomajuhtu lõppes surmaga.
English: In addition, Afssaps was particularly concerned by adverse events in elderly patients.
Estonian: Afssaps oli iseäranis mures eakatel patsientidel esinevate kõrvalnähtude pärast.
English: 30 fatal cases were recorded during the study period, of which 27 were associated with the use of psychotropic drugs and 20 were recorded as overdoses.
Estonian: Uuringuperioodil registreeriti 30 surmajuhtu, millest 27 olid seotud psühhotroopsete ravimite kasutamisega ning 20 olid üleannustamise tulemus.
English: This was confirmed by the analysis, which identified 9 cases of addiction/withdrawal during the study period (3 serious cases and 6 non-serious cases).
Estonian: Seda kinnitas ka analüüs, mis tuvastas uuringuperioodi vältel 9 sõltuvus-/võõrutusjuhtu (neist 3 rasket ja 6 kergemat juhtu).
English: 6 cases of inhalation pneumopathy and 3 cases of addiction/withdrawal were reported.
Estonian: Teatati ka kuuest inhalatsioonipneumopaatia ja kolmest sõltuvus/võõrutusjuhust.
English: The CHMP noted that despite the 10% decrease in the proportion of elderly patient during the current study period, elderly patients remained the main affected age group (40% of patients over 65 years of age and 32% of patients over 75 years of age).
Estonian: Inimravimite komitee märkis, et hoolimata eakate patsientide osakaalu 10% vähenemisest uuringuperioodil olid eakad patsiendid põhiline earühm, kellel täheldati kõrvalnähte (40%-l üle 65 aasta vanustest ja 32%-l üle 75 aasta vanustest patsientidest).
English: The overall reports involved patients over the age of 65 in 22% of cases and patients aged 75 and over in 13% of cases.
Estonian: 22% juhtudest esines üle 65 aasta vanustel patsientidel ja 13% juhtudest üle 75 aasta vanustel patsientidel.
English: The most frequently encountered serious adverse events were comas (11 cases), consciousness disorders (16 cases), confusion states (15 cases) and intoxications (33 cases, including deliberate, accidental or nonspecified).
Estonian: Rasketest kõrvalnähtudest esinesid kõige sagedamini kooma (11 juhtu), teadvuse häired (16 juhtu), segasusseisundid (15 juhtu) ning mürgistused (33 juhtu, sealhulgas tahtlikud, tahtmatud ja täpsustamata juhud).