FrancophonIA/ELRC3.0 huggingface dataset:
English: No studies have been conducted to evaluate the pharmacokinetics of macimorelin in paediatric patients or in patients with renal or hepatic impairment.
Estonian: Lastel ja neeru- või maksakahjustusega patsientidel ei ole tehtud matsimoreliini farmakokineetikat hindavaid uuringuid.
English: 6.1 List of excipients
Estonian: FARMATSEUTILISED ANDMED 6.1 Abiainete loetelu Laktoosmonohüdraat
English: Tremor
Estonian: Treemor
English: Macimorelin Aeterna Zentaris is indicated as a single-dose diagnostic test. No information is available on the safety and effects of macimorelin during long-term use.
Estonian: Macimorelin Aeterna Zentarise ühekordne annus on näidustatud kui diagnostiline test.
English: Macimorelin induced GH release was lower in patients with higher BMI.
Estonian: Matsimoreliini toimel eritus suurema KMI-ga patsientidel vähem kasvuhormooni.
English: What Macimorelin Aeterna Zentaris is and what it is used for 2.
Estonian: 1. Mis ravim on Macimorelin Aeterna Zentaris ja milleks seda kasutatakse 2. Mida on vaja teada enne ravimi Macimorelin Aeterna Zentaris kasutamist 3.
English: Gastrointestinal disorders
Estonian: Naatriumstearüülfumaraat
English: Aminocaproic acid
Estonian: Aminokaproonhape
English: These concerns echoed those of a few published observational studies.
Estonian: Need küsimused olid sarnased mõnes varem avaldatud vaatlusuuringus tõstatatud küsimustega.
English: The product information was modified to ensure that the information to healthcare professionals and patients is up to date.
Estonian: Ravimiteavet uuendati, et tagada ajakohastatud teabe jõudmine tervishoiutöötajate ning patsientideni.
English: The latest quality review of documents templates were taken into account during this review.
Estonian: Käesoleva ülevaate ajal võeti arvesse ka viimaseid dokumentide kvaliteedi läbivaatamise malle.
English: • The Committee considered that the product information should be updated.
Estonian: • inimravimite komitee leidis, et ravimiteavet tuleb uuendada.
English: A CHMP scientific advisory group (SAG) meeting was held in October 2011 and its views were considered by the CHMP in the framework of this review.
Estonian: Oktoobris 2011 toimus inimravimite komitee teadusnõuanderühma koosolek, kus avaldatud seisukohti võttis inimravimite komitee käesoleva läbivaatamise raames ka arvesse.
English: It has a broad action on proteolytic enzymes such as plasmin, trypsin, and kallikrein.
Estonian: Sellel on laiaulatuslik toime sellistele proteolüütilistele ensüümidele nagu plasmiin, trüpsiin ja kallikreiin.
English: The safety profile of EACA has evolved since its authorisation, and safety data has accumulated over the years.
Estonian: Aminokaproonhappe ohutusprofiil on alates müügiloa väljastamisest täienenud ja ohutusalased andmed on kogunenud aastate jooksul.
English: The marketing authorisations for aprotinin were suspended when concerns over its safety were raised in a previous review in 2007.
Estonian: Aprotiniini müügiload peatati, kui varasema, 2007. aasta menetluse käigus tõstatati ravimi ohutuse küsimus.
English: Aminocaproic acid is a lysine analogue authorised for several indications since 1963.
Estonian: Aminokaproonhape on lüsiini analoog, millel on erinevatel näidustustel müügiluba aastast 1963.
English: For some indications modifications to the wording were proposed, in order to bring them in line with current scientific knowledge on the use of EACA.
Estonian: Mõnede näidustuste puhul soovitati sõnastust muuta, et viia need kooskõlla tänapäevaste teadusandmetega aminokaproonhappe kasutamise kohta.
English: The results of the BART trial did not have a negative impact on the benefit risk profile of EACA.
Estonian: Kliinilise uuringu BART tulemused ei mõjutanud negatiivselt aminokaproonhappe kasulikkuse ja riski profiili.
English: EACA had not previously been associated with an increased risk of mortality and this has remained unchanged postpublication of the BART study.
Estonian: Aminokaproonhappe ja suremusriski suurenemise vahel varasem seos puudus ja see jäi samaks ka uuringu BART avaldamise järel.
English: Therefore the CHMP concluded that the balance of risks and benefits for aminocaproic acid is positive under normal conditions of use subject to the revision of the indications as follows:
Estonian: Seetõttu järeldas inimravimite komitee, et aminokaproonhappe kasulikkuse ja riski tasakaal on normaalsete kasutustingimuste korral positiivne järgmistel läbivaadatud näidustusel.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC, for aprotinin, aminocaproic acid and tranexamic acid (see Annex I).
Estonian: • inimravimite komitee vaatas läbi direktiivi nr 2001/83/EÜ artikli 31 kohase esildise aprotiniini, aminokaproonhappe ja traneksaamhappe kohta (vt I lisa);
English: This document presents the conclusions on EACA.
Estonian: Selles dokumendis esitatakse järeldused aminokaproonhappe kohta.
English: In March 2010 Germany triggered an article 31 referral to assess the benefits and risks of the antifibrinolytic drugs aprotinin, EACA and TXA in all their approved indications.
Estonian: 2010. aasta märtsis algatas Saksamaa artikli 31 kohase esildismenetluse antifibrinolüütilise toimega ravimite aprotiniini, aminokaproonhappe ning traneksaamhappe kasulikkuse ja riskide hindamiseks kõikide olemasolevate näidustuste piires.
English: Aprotinin, a naturally occurring polypeptide, is an inhibitor of proteolytic enzymes.
Estonian: Aprotiniin on looduslik polüpeptiid, mis pärsib proteolüütilisi ensüüme.
English: The preliminary results of a randomised controlled clinical trial, the ‘Blood conservation using antifibrinolytics: a randomised trial in a cardiac surgery population' (BART) study, had shown that although the use of aprotinin was associated with less serious bleeding than either of the comparator drugs, an increase in 30 day all-cause mortality had been observed among patients receiving aprotinin compared to patients taking other medicines.
Estonian: Randomiseeritud ja kontrollitud kliinilise uuringu „Blood conservation using antifibrinolytics: a randomised trial in a cardiac surgery population˝ (Vere konserveerimine antifibrinolüütikumidega: südamekirurgia patsientidel läbi viidud randomiseeritud kliiniline uuring, BART) esmased tulemused näitasid, et kuigi aprotiniini seostati kergema veritsusega kui kummagi võrdlusravimi korral, täheldati aprotiniini kasutanud patsientidel teisi ravimeid saanud patsientidega võrreldes üldsuremuse suurenemist 30 päeva lõikes.
English: Overall summary of the scientific evaluation of referral on antifibrinolytics Aminocaproic acid containing medicinal products (see Annex I)
Estonian: Antifibrinolüütilise toimega ravimite esildise teadusliku hindamise üldkokkuvõte Aminokaproonhapet sisaldavad ravimid (vt I lisa)
English: Aminocaproic acid has also been associated with hypotension, nasal and conjunctival congestion, gastrointestinal disturbances (diarrhoea, nausea, vomiting, abdominal pain), dizziness, headache, tinnitus and ejaculation disorders; blood disorders (agranulocytosis, coagulation disorders), muscular damage, convulsions, anaphylactic reactions, renal impairment, and thrombotic complications.
Estonian: Aminokaproonhapet on seostatud ka hüpotensiooni, nina ja konjunktiivi kongestiooni, seedetrakti häirete (kõhulahtisus, iiveldus, oksendamine, kõhuvalu), peapöörituse, peavalu, tinnituse ja ejakulatsioonihäiretega; vere häirete (agranulotsütoos, hüübimishäired), lihaskahjustuse, krampide, anafülaktiliste reaktsioonide, neerukahjustuse ja trombootiliste tüsistustega.
English: Taking into account all the available information on safety and efficacy, the Committee agreed on the variation of the marketing authorisation with the balance of the risks and benefits considered positive in the following revised indications for EACA:
Estonian: Võttes arvesse kogu olemasolevat ohutus- ja efektiivsusteavet, otsustas komitee kinnitada müügiloa tingimuste muutmise ja leidis, et aminokaproonhappe kasulikkuse ja riski tasakaal on positiivne järgmistel läbivaadatud näidustustel.
English: • The Committee considered the available scientific data, including evidence from new studies, on the efficacy of EACA.
Estonian: • inimravimite komitee arvestas saadaolevate teaduslike andmetega, sealhulgas tõenditega uutest uuringutest aminokaproonhappe efektiivsuse kohta.
English: • The Committee considered that evidence from randomised clinical trials and observational studies support the use of aminocaproic acid in patients undergoing dental or surgical procedures or at risk of complications from bleeding.
Estonian: • inimravimite komitee leidis, et randomiseeritud kliinilistest uuringutest ja vaatlusuuringutest pärit tõendusmaterjal toetab aminokaproonhappe kasutamist patsientidel, kellele tehakse stomatoloogilisi või kirurgilisi protseduure või keda ohustavad verejooksu tüsistused;
English: Antifibrinolytics (e.g. aprotinin, aminocaproic acid and tranexamic acid), are a class of haemostatic agents used to prevent excessive blood loss.
Estonian: Antifibrinolüütikumid (nt aprotiniin, aminokaproonhape ja traneksaamhape) on hemostaatilise toimega ainete klass, mida kasutatakse liigse verekaotuse vältimiseks.
English: Data available from randomised clinical trials and observational studies, including meta-analysis were considered.
Estonian: Arvesse võeti randomiseeritud kliiniliste ja vaatlusuuringute kättesaadavaid andmeid, samuti metaanalüüsi tulemusi.
English: The CHMP considered also the adverse reactions profile, including new adverse events (some of which serious) associated with the use of EACA.
Estonian: Inimravimite komitee arvestas ka kõrvaltoimete profiiliga, sealhulgas uute kõrvalnähtudega (millest mõned olid tõsised), mida seostati aminokaproonhappe kasutamisega;
English: Several data sources informed the opinion of the Committee, including available data from clinical studies, published literature, spontaneous reports and other data submitted by marketing authorisation holders (MAHs) of medicinal products containing aprotinin, EACA or TXA.
Estonian: Komitee arvamust toetasid mitmed andmeallikad, sh kättesaadavad andmed, mis pärinesid kliinilistest uuringutest, spontaansetest teadetest ja avaldatud kirjandusest, ning muud aprotiniini, aminokaproonhapet või traneksaamhapet sisaldavate ravimite müügilubade hoidjate esitatud asjakohased andmed.
English: • In view of the identified serious limitations of the efficacy data, the available new evidence and/or current medical knowledge on the use of EACA, and considering the adverse reactions profile (some of which serious) associated with the use of EACA, the CHMP considered that for some of the therapeutic indications the benefits no longer outweigh the risks and therefore they should be removed.
Estonian: • efektiivsusandmetes leitud tõsiste puuduste, saadaolevate uute tõendite ja/või praeguste meditsiiniliste teadmiste valguses aminokaproonhappe kasutamise kohta ning arvestades kõrvaltoimeid (millest mõned olid tõsised), mida seostati aminokaproonhappe kasutamisega, leidis inimravimite komitee, et mõnedel nendest terapeutilistest näidustustest ei kaalu kasulikud toimed enam riske üles ja seetõttu tuleb need kõrvale jätta;
English: • The Committee considered all data provided by the MAHs in writing, including data available from literature reviews.
Estonian: • inimravimite komitee võttis arvesse kõiki müügilubade hoidjate esitatud kirjalikke andmeid, sealhulgas avaldatud kirjandusest pärit andmeid;
English: A list of indications for which the CHMP considered that the benefit risk balance remains positive is presented below.
Estonian: Allpool on esitatud näidustuste loetelu, mille korral inimravimite komitee leidis, et kasulikkuse ja riski suhe jääb positiivseks.
English: Separate opinions and conclusions were issued by the CHMP for the three antifibrinolytics (aprotinin, EACA and TXA).
Estonian: Inimravimite komitee esitas kolme antifibrinolüütilise toimega ravimi (aprotiniini, aminokaproonhappe ja traneksaamhappe) kohta erinevad arvamused ja järeldused.
English: In addition to cardiac surgery, the CHMP considered that sufficient evidence is available on the safety and efficacy of EACA in other indications, including in patients undergoing dental or surgical procedures or at risk of complications from bleeding.
Estonian: Inimravimite komitee leidis, et aminokaproonhappe ohutus ja efektiivsus on lisaks südamekirurgiale piisavalt tõendatud ka teiste näidustuste korral, sh patsientidel, kellele tehakse stomatoloogilisi või kirurgilisi protseduure või keda ohustavad verejooksu tüsistused.
English: In view of the identified serious limitations of the efficacy data, the available new evidence and/or current medical knowledge on the use of EACA, and considering the adverse reactions profile (some of which serious) associated with the use of EACA, the CHMP considered that some of these indications should be removed.
Estonian: Efektiivsusandmetes leitud suurte puuduste, saadaolevate uute tõendite ja/või tänapäevaste meditsiiniliste teadmiste valguses aminokaproonhappe kasutamise kohta ning arvestades kõrvaltoimeid (millest mõned olid rasked), mida seostati aminokaproonhappe kasutamisega, leidis inimravimite komitee, et mõned nendest näidustustest tuleb tühistada.
English: The lysine analogues epsilon aminocaproic acid (EACA, also referred as aminocaproic acid) and tranexamic acid (TXA) inhibit more specifically the conversion of plasminogen to plasmin.
Estonian: Plasminogeeni muutmist plasmiiniks pärsivad spetsiifiliselt lüsiini analoogid ε-aminokaproonhape (EACA, kasutatakse ka nimetust aminokaproonhape) ja traneksaamhape (TXA).
English: In particular the therapeutic indications were updated to reflect current scientific knowledge on the use of EACA; other changes to the product information were inclusion of information on leukopenia, thrombocytopenia, blood urea nitrogen increased and renal failure as warnings and recommendations.
Estonian: Eelkõige uuendati terapeutilisi näidustusi, et need kajastaksid ajakohaseid teadusandmeid aminokaproonhappe kasutamise kohta; teised muutused ravimiteabes kujutasid endast hoiatuste ja soovituste näol andmete lisamist leukopeenia, trombotsütopeenia, vere uurealämmastiku sisalduse suurenemise ja neerupuudulikkuse kohta.
English: The marketing authorisations of EACA and TXA were not affected by the initial 2007 review.
Estonian: Algne 2007. aasta menetlus ei mõjutanud siiski aminokaproonhappe ja traneksaamhappe müügilubasid.
English: On the basis of the above, the Committee recommended the variation to the terms of the marketing authorisation for the medicinal products containing aminocaproic acid referred to in Annex I for which the amendments to the product information are set out in annex III of the opinion.
Estonian: Eeltoodu alusel soovitab inimravimite komitee muuta I lisas nimetatud aminokaproonhapet sisaldavate ravimite müügilubade tingimusi.
English: Grounds for amendment of the marketing authorisations of aminocaproic acid containing medicinal products listed in Annex I
Estonian: I lisas loetletud aminokaproonhapet sisaldavate ravimite müügilubade muutmise alused
English: Scientific conclusions and grounds for variation to the terms of the marketing authorisations for aminocaproic acid containing medicinal products presented by the EMA
Estonian: Euroopa Ravimiameti esitatud teaduslikud järeldused ja aminokaproonhapet sisaldavate ravimite müügilubade tingimuste muutmise alused
English: patients of all ages in haemorrhage caused by local or general fibrinolysis, including in Postsurgical haemorrhages in: - urology (surgery of the bladder and prostate) - gynaecology (cervical surgery), in patients where tranexamic acid is not available or not tolerated - obstetrics (post-partum and post-miscarriage haemorrhages) after correction of the coagulation defect - heart surgery (with or without bypass placement)
Estonian: Aminokaproonhape on näidustatud kasutamiseks igas vanuses patsientidel, kellel esineb lokaalsest või süsteemsest fibrinolüüsist põhjustatud verejooks, sealhulgas operatsioonijärgsed verejooksud järgmistel juhtudel: - uroloogia (põie- ja eesnäärmeoperatsioonid); - günekoloogia (emakakaela operatsioonid) patsientidel, kellel puudub ligipääs
English: Leukopenia, thrombocytopenia, BUN (blood urea nitrogen) increased and renal failure are adverse events which can be serious and have been reported, but these risks had not been considered in the current authorised product information.
Estonian: Leukopeenia, trombotsütopeenia, vere uurealämmastiku sisalduse suurenemine ja neerupuudulikkus on kõrvalnähud, mis võivad osutuda rasketeks.
English: The CHMP recommended that information on leukopenia, thrombocytopenia, BUN increased and renal failure should be appropriately reflected through warnings and recommendations in the product information.
Estonian: Inimravimite komitee soovitas ravimiteabes hoiatuste ja soovituste kaudu adekvaatselt kajastada infot leukopeenia, trombotsütopeenia, vere uurealämmastiku sisalduse suurenemise ja neerupuudulikkuse kohta.
English: - gastroenterology - odonto-stomatology (dental extractions in haemophiliacs, patients undergoing anticoagulant therapy)
Estonian: - günekoloogia (emakakaela operatsioonid) patsientidel, kellel puudub ligipääs
English: These member states were not able to reach an agreement.
Estonian: Liikmesriigid ei suutnud jõuda kokkuleppele.
English: The European Commission issued a decision on 6 February 2009.
Estonian: Euroopa Komisjon tegi otsuse 6. veebruaril 2009.
English: What is Implanon?
Estonian: Mis on Implanon?
English: This changes the body's hormonal balance and help to prevent ovulation.
Estonian: See muudab organismi hormonaalset tasakaalu ja aitab ennetada ovulatsiooni teket.
English: Why was Implanon reviewed?
Estonian: Miks Implanoni taotlus uuesti läbi vaadati?
English: Additionally, the data on effectiveness in obese women in particular in the third year of use was considered insufficient.
Estonian: Samuti peeti efektiivsuse andmeid rasvunud naiste korral, eelkõige kolmadal kasutusaastal, ebapiisavateks.
English: The company wanted the renewal of authorisation to be recognised in all the EU Member States, as well as Norway and Iceland where the product is already authorised.
Estonian: Ettevõte soovis müügiloa tunnustamist kõigis Euroopa Liidu liikmesriikides ning Norras ja Islandil, kus ravim on juba heaks kiidetud.
English: Implanon can protect for up to three years; at the end of this period the implant must be removed.
Estonian: Implanon võib rasestumise eest kaitsta kuni kolm aastat, mille järel tuleb implantaat naha alt eemaldada.
English: The CHMP also endorsed the changes to the product information for the medicine as agreed by the Coordination Group for the Mutual and Decentralised Procedures.
Estonian: Inimravimite komitee kinnitas ka ravimi omaduste kokkuvõtte muudatused, mille oli teinud vastastikuse tunnustamise ja detsentraliseeritud menetluse koordinatsioonirühm.
English: Article 29 of Directive 2001/83/EC as amended, referral on the grounds of potential serious risk to public health
Estonian: 1 Muudetud direktiivi 2001/83/EÜ artikkel 29 - esildis juhul, kui müügiluba võib ohustada rahvatervist.
English: The grounds for the referral were concerns regarding the side effects related to insertion and removal of the implant, the risk of breast cancer, the incidence of irregular bleedings leading to premature removal of the implant.
Estonian: Esildise aluseks olid probleemid seoses implantaadi sisestamise ja eemaldamise kõrvalnähtudega, rinnanäärmevähi riskiga ja ebaregulaarsete veritsuste esinemisega, mille tõttu on vaja implantaat enneaegselt eemaldada.
English: The European Medicines Agency (EMEA) has completed an arbitration procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Implanon.
Estonian: Euroopa Ravimiamet (EMEA) on lõpetanud vahekohtumenetluse, mis algatati pärast seda, kui Euroopa Liidu liikmesriigid ei jõudnud kokkuleppele ravimi Implanon heakskiitmises.
English: Implanon is a female contraceptive.
Estonian: Implanon on rasestumisvastane vahend naistele.
English: Once implanted, the rod releases a small amount of etonogestrel continuously into the bloodstream.
Estonian: Pärast implanteerimist vabaneb vardast pidevalt väike kogus etonogestreeli vereringesse.
English: Ref. EMEA/124262/2009
Estonian: London, 9. veebruar 2009 Viide: EMEA/122002/2009
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Implanon outweigh its risks, and therefore the renewal of the marketing authorisation for Implanon should be granted in all concerned member states.
Estonian: Tuginedes olemasolevate andmete hindamisele ja komiteesisesele teaduslikule arutelule, otsustas inimravimite komitee, et Implanoni kasulikkus ületab ravimiga kaasnevad riskid ja seega tuleb Implanoni müügiluba pikendada kõigis asjaomastes liikmesriikides.
English: N.V. Organon submitted Implanon for a second renewal of the marketing authorisation through mutual recognition on the basis of the initial authorisation granted by the Netherlands on 25 August 1998.
Estonian: Organon esitas avalduse Implanoni müügiloa teiseks pikendamiseks vastastikuse tunnustamise menetluse alusel, tuginedes Madalmaades 1998. aastal antud esmasele müügiloale.
English: It is presented as a small rod that is implanted by a doctor or a nurse using a special applicator just under the skin of the upper arm.
Estonian: Ravimit turustatakse väikese vardana, mille arst või õde implanteerib spetsiaalse paigaldusvahendi abil õlavarre naha alla.
English: On 6 October 2008, the Dutch regulatory agency referred the matter to the CHMP.
Estonian: 6. oktoobril 2008 tegi Madalmaade pädev astutus erimeelsuste lahendamiseks inimravimite komiteele esildise.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Implanon outweigh its risks, and that the marketing authorisation granted in the Netherlands can be recognised in other Member States of the European Union.
Estonian: EMEA inimravimite komitee otsustas, et Implanoni kasulikkus on suurem kui sellega kaasnevad riskid ja seega võib Madalmaades antud müügiluba tunnustada ka Euroopa Liidu teistes liikmesriikides.
English: Referral start date:
Estonian: Esildismenetluse alguse kuupäev:
English: The active substance in Implanon, etonogestrel, is a synthetic female hormone resembling progesterone.
Estonian: Implanoni toimeaine etonogestreel on naissuguhormooni progesterooni meenutav tehishormoon.
English: Implanon subdermal implant etonogestrel 68 mg
Estonian: Teave Implanoni subdermaalse implantaadi
English: Pharmaceutical form Route of administration Immediate Packaging Content Pack size EU/1/13/873/001 Xofigo 1100 kBq/mL Solution for injection Intravenous use
Estonian: EU/1/13/873/001 Xofigo
English: Name Strength
Estonian: Müügiloa nr Euroopa Liidus nimetus Tugevus
English: Package size l t o r
Estonian: Pakendi suurus l n a
English: Strength Pharmaceutical Form Route of Administration
Estonian: Ravimvorm Manustamistee Pakendi iseloomustus
English: Action is needed in the following circumstances:
Estonian: Meetmeid tuleb rakendada järgmistel juhtudel:
English: Date of first authorisation: 23 june 2017
Estonian: Müügiloa esmase väljastamise kuupäev: 23. juuni 2017
English: No specific antidote is known.
Estonian: Spetsiifilist antidooti ei ole teada.
English: PML is probably caused by a combination of factors.
Estonian: PML tuleneb tõenäoliselt mitme teguri kombinatsioonist.
English: A risk to newborns or infants cannot be excluded.
Estonian: Riski vastsündinutele või imikutele ei saa välistada.
English: Most patients (91%) were <65 years of age.
Estonian: Enamik patsiente (91%) olid < 65 aasta vanused.
English: 9/L, then treatment must be stopped immediately.
Estonian: 9/l, tuleb ravi kohe lõpetada.
English: The demographic and baseline characteristics were well balanced between the treatment groups.
Estonian: Demograafilised ja algandmed olid hästi ravirühmade vahel tasakaalustatud.
English: For symptoms see below.
Estonian: Sümptomeid vt altpoolt.
English: Other medicines and Skilarence
Estonian: Muud ravimid ja Skilarence