FrancophonIA/ELRC3.0 huggingface dataset:
English: In case of signs or symptoms suggestive of such injury, treatment should be stopped.
Estonian: Selliste märkide ja sümptomite ilmnemisel tuleb ravi peatada.
English: • You should stop treatment and contact your doctor immediately if you develop symptoms of liver injury (such as tiredness, yellowing of the skin, darkening of the urine, nausea and vomiting).
Estonian: • Te peate ravimi võtmise kohe peatama ja arsti poole pöörduma, kui teil tekivad maksakahjustuste sümptomid (nt väsimus, naha kollasus, uriini tumenemine, iiveldus ja oksendamine).
English: Liver testing also to be performed again 2-4 weeks after stopping treatment.
Estonian: Lisaks tuleb maksaanalüüse korrata 2-4 nädala jooksul pärast ravi lõppu.
English: Although uncertainties around causality remain, the following measures to minimise a possible risk for liver injury will be introduced:
Estonian: Kuigi nende probleemide põhjused ei ole veel lõplikult teada, on maksakahjustuste riski minimeerimiseks võetud järgmised meetmed:
English: While the review was ongoing, the PRAC had issued temporary recommendations that no new patients should start treatment.
Estonian: Läbivaatamise ajaks oli komitee andnud ajutised soovitused, mille kohaselt ei tohi seda ravimit uutele patsientidele määrata.
English: • You will also have liver tests during treatment and after treatment has stopped.
Estonian: • Teile tehakse maksaanalüüsid ka ravi ajal ja pärast ravi lõppu.
English: Since progesterone may promote the growth of fibroids, by preventing the effects of progesterone ulipristal acetate reduces the size of the fibroids.
Estonian: Et progesteroon võib soodustada fibroidide kasvu, vähendab ulipristaalatsetaat progesterooni toimet pärssides fibroidide suurust.
English: • Healthcare professionals should advise their patients about the signs and symptoms of liver injury and the action to take should they occur.
Estonian: • Tervishoiutöötajad peavad paluma oma patsientidel teatada maksakahjustuste märkidest ja sümptomitest ning andma neile juhiseid, mida nende tekke korral teha.
English: − Liver function tests to be performed before starting each treatment course, monthly during the first 2 treatment courses, and thereafter as clinically indicated.
Estonian: − Maksafunktsiooni analüüsid tuleb teha enne iga ravikuuri algust, esimese 2 ravikuuri jooksul üks kord kuus ja pärast seda vastavalt kliinilistele näidustustele.
English: − Esmya should not be started if levels of alanine transaminase (ALT) or aspartate aminotransferase (AST) are more than 2 times the upper limit of normal (ULN).
Estonian: − Esmya-ravi ei tohi alustada siis, kui alaniintransaminaasi (ALT) või aspartaataminotransferaasi (AST) tase on normi ülapiirist enam kui 2 korda kõrgem.
English: The measures include: contraindication in women with known liver problems; liver tests before, during and after stopping treatment; a card for patients to inform them about the need for liver monitoring and to contact their doctor should they develop symptoms of liver injury.
Estonian: Need meetmed on: vastunäidustus teadaolevate maksaprobleemidega naistel; maksaanalüüsid enne ravi, ravi ajal ning pärast selle lõpetamist; infokaart patsientidele, et nende maksa seisundit tuleb jälgida ja et nad peavad pöörduma maksakahjustuste sümptomite tekke korral arsti poole.
English: In addition, use of the medicine for more than one treatment course has been restricted to women who are not eligible for surgery.
Estonian: Lisaks on ravimi kasutamine enam kui üheks ravikuuriks lubatud ainult naistel, kellele on kirurgiline ravi vastunäidustatud.
English: The medicine has been shown to be effective at reducing bleeding and anaemia associated with the condition, as well as the size of the fibroids.
Estonian: Ravim vähendab tõendatult emakafibroididega kaasnevat veritsemist ja aneemiat ning fibroidide suurust.
English: • Healthcare professionals prescribing Esmya in the EU will receive a letter with further details once a European Commission decision has been issued.
Estonian: • Esmyat Euroopa Liidus määravad tervishoiutöötajad on saanud üksikasjalikku teavet sisaldava kirja.
English: EMA concludes review of medicine for uterine fibroids
Estonian: EMA lõpetab emakafibroidide ravimi läbivaatamise
English: The PRAC's final recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted an opinion.
Estonian: Komitee lõplikud soovitused saadeti inimravimitega seotud küsimuste eest vastutavale inimravimikomiteele, kes võttis vastu arvamuse.
English: • A card will be included in the package of the medicine with information on the risk of liver injury and the need for liver monitoring.
Estonian: • Ravimi pakendis on kaart, mis sisaldab teavet maksakahjustuste riski kohta ja viitab vajadusele maksa seisundit jälgida.
English: (Esmya continues to be indicated for one course (lasting up to 3 months) of pre-operative treatment for moderate to severe symptoms of uterine fibroids in adult women of reproductive age.)
Estonian: (Esmya on jätkuvalt näidustatud ühekordseks emakafibroidide mõõdukate kuni raskete sümptomite operatsioonieelseks ravikuuriks (kestusega kuni 3 kuud) reproduktiivses eas täiskasvanud naistel.)
English: The active substance in Esmya, ulipristal acetate, works by attaching to the targets on cells (receptors) that the hormone progesterone normally attaches to, preventing progesterone from having its effect.
Estonian: Esmya toimeaine ulipristaalatsetaat seondub rakkudel sihtkohtadega (retseptoritega), millega tavaliselt seondub hormoon progesteroon, takistades progesterooni toimimist.
English: The European Medicines Agency (EMA) has recommended that several measures be put in place to minimise the risk of rare but serious liver injury with Esmya (ulipristal acetate).
Estonian: Euroopa Ravimiamet (EMA) andis 31. mail 2018 soovituse rakendada mitu meedet, et minimeerida Esmya-ravis (ulipristaalatsetaat) harva esinevate, kuid raskete maksakahjustuste riski.
English: The review was carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines.
Estonian: Teabe vaatas läbi inimravimite ohutusprobleemide hindamise eest vastutav ravimiohutuse riskihindamise komitee.
English: Certain women may start treatment with Esmya once the new measures are implemented.
Estonian: Pärast uute meetmete rakendamist võivad teatavad naised alustada ravi Esmyaga.
English: • Esmya will not be prescribed to you if you have liver problems.
Estonian: • Arst ei määra teile Esmyat, kui teil on maksaprobleeme.
English: − Restricted indication in the intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age: Esmya should only be used in women who are not eligible for surgical treatment.
Estonian: − Piiratud näidustus emakafibroidide mõõdukate kuni raskete sümptomite vahelduvaks raviks reproduktiivses eas täiskasvanud naistel: Esmyat tohivad võtta ainult naised, kellele kirurgiline ravi on vastunäidustatud.
English: It also recommended that studies should be performed to determine the effects of Esmya on the liver and whether the new measures are effective in minimising the risks.
Estonian: Samuti soovitas komitee uurida Esmya mõju maksale ja uute riskiminimeerimismeetmete tõhusust.
English: The CHMP opinion will now be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States in due course.
Estonian: Inimravimikomitee arvamus edastati Euroopa Komisjonile, kes võttis 26/07/2018 vastu õiguslikult siduva lõpliku otsuse, mis on kohaldatav kõigis Euroopa Liidu liikmesriikides.
English: Ulipristal acetate is also the active substance of a single-dose medicine authorised for emergency contraception, ellaOne.
Estonian: Ulipristaalatsetaat on ka üheannuselise ravimi ellaOne toimeaine, mis on heaks kiidetud erakorralise kontratseptsiooni näidustusel.
English: The PRAC's recommendations have now been endorsed by EMA's Committee for Medicinal Products for Human Use (CHMP) and will be sent to the European Commission for a final legal decision.
Estonian: Komitee soovitused kinnitas EMA inimravimikomitee, kes edastas need Euroopa Komisjonile lõpliku õiguslikult siduva otsuse tegemiseks.
English: The review of Esmya was carried out by EMA's Pharmacovigilance Risk Assessment Committee (PRAC) following reports of serious liver injury, including liver failure leading to transplantation.
Estonian: Esmya läbivaatamise tegi EMA ravimiohutuse riskihindamise komitee raskete maksakahjustuste, sh siirdamiseni viiva maksapuudulikkuse teadete põhjal.
English: The PRAC concluded that Esmya may have contributed to the development of some cases of serious liver injury.1
Estonian: Komitee järeldas, et Esmya võis mõnel juhul soodustada raskete maksakahjustuste teket.1
English: • A liver test will be performed before you start treatment and if the test is abnormal, treatment with Esmya will not be started.
Estonian: • Enne ravi algust tehakse teile maksaanalüüs ja kui see näitab maksafunktsiooni häireid, siis ei määrata teile ravi Esmyaga.
English: • The medicine Esmya, used to treat uterine fibroids, has been reviewed because cases of serious liver problems have occurred in women taking the medicine, including four cases that resulted in liver transplantation.
Estonian: • Emakafibroidide raviks kasutatav ravim Esmya on läbi vaadatud, sest seda kasutanud naistel on tekkinud raskeid maksaprobleeme, sealhulgas on neljal naisel ravimi tõttu tekkinud maksa siirdamise vajadus.
English: − Contraindication in patients with underlying liver disorders.
Estonian: − Vastunäidustus maksahäiretega patsientidele.
English: Esmya was authorised in the EU in 2012 for the treatment of moderate to severe symptoms of uterine fibroids, which are benign (non-cancerous) tumours of the womb, in women who have not reached the menopause.
Estonian: Esmya kiideti ELis heaks 2012. aastal mõõdukate kuni raskete sümptomitega emakafibroidide (healoomulised emakakasvajad) raviks menopausieelsetel naistel.
English: − Treatment should be stopped in patients with ALT or AST levels more than 3 times ULN.
Estonian: − Normi ülapiirist enam kui 3 korda kõrgema tasemega ALT-iga või AST-iga patsientidel tuleb ravi peatada.
English: A letter will be sent to doctors to inform them of the new conditions of use, which will become applicable after a Commission decision is issued.
Estonian: Arstidele saadeti kiri uute kasutustingimuste kohta.
English: In 8 cases of serious liver injury, a role of Esmya in contributing to these cases is possible.
Estonian: Kaheksal juhul on võimalik, et Esmya soodustas raskete maksakahjustuste teket.
English: • If no liver problems are detected, a single course of Esmya can be used in women who are about to have surgery for their fibroids; Esmya can be used for more than one course only in women who cannot have surgery.
Estonian: • Kui maksaprobleeme ei avastata, võib Esmyat kasutada üheks ravikuuriks fibroidide operatsiooniks valmistuvatel naistel.
English: • Four cases of serious liver injury leading to hepatic transplantation and additional cases of hepatic injury have been reported in patients treated with Esmya (ulipristal acetate).
Estonian: • Esmya-ravi (ulipristaalatsetaat) saanud patsientidest neljal on teadaolevalt tekkinud maksa siirdamiseni viinud rasked maksakahjustused ning neile lisanduvad teised maksakahjustuste juhtumid.
English: Esmya is used to treat moderate to severe symptoms of uterine fibroids (benign tumours of the womb).
Estonian: Esmyat kasutatakse mõõdukate kuni raskete sümptomitega emakafibroidide (healoomulised emakakasvajad) raviks.
English: Date of first authorisation: 06/03/2003 Date of last renewal: 06/03/2013
Estonian: Esmase müügiloa väljastamise kuupäev: 06/03/2003 Müügiloa viimase uuendamise kuupäev: 06/03/2013
English: EXP Use immediately after opening.
Estonian: EXP Kasutada koheselt pärast avamist.
English: 10x1 ml (10 doses).
Estonian: 10 x 1ml (10 doosi)
English: Carbomer ........................................................................................................................................... 4 mg.
Estonian: Karbomeer ......................................................................................................................................... 4 mg
English: Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but at different sites and not mixed with MERIAL's inactivated vaccine against rabies.
Estonian: Olemasolevad ohutuse ja efektiivsuse andmed, mis näitavad, et seda vaktsiini võib manustada samal päeval, aga erinevatesse süstekohtadesse ja mitte kokku segatuna MERIAL inaktiveeritud marutaudi vastase vaktsiiniga.
English: In exceptional circumstances a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment.
Estonian: Erandjuhtudel võib esineda ülitundlikkusreaktsiooni, mis vajab vastavat sümptomaatilist ravi.
English: Active immunisation of horses of 4 months of age or older against equine influenza to reduce clinical signs and virus excretion after infection.
Estonian: 4 kuu vanuste ja vanemate hobuste aktiivne immuniseerimine hobuste gripi vastu, et vähendada kliinilisi tunnuseid ja viiruse eritumist pärast nakatumist.
English: In very rare occasions, abcessation may be observed.
Estonian: Väga harvadel juhtudel on täheldatud abstsessi moodustumist.
English: In exceptional circumstances, apathy and reduced appetite may be observed the day after vaccination.
Estonian: Erandjuhtudel võib vaktsineerimisjärgsel päeva täheldada apaatiat ja isu vähenemist.
English: The excipients, including adjuvants, listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this product.
Estonian: Abiained , mis on loetletud ravimi omaduste kokkuvõtte lõigus 6.1 on kas lubatud ained millele Komisjoni määruse (EL) nr 37/2010 lisa tabelis 1 viidatakse kui ravimjääkide piirnorme mittenõudvatele või neid loetakse Määruse (EÜ) nr 470/2009 reguleerimisalasse mittekuuluvateks, kui neid kasutatakse nii nagu selles veterinaarravimis.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu).
Estonian: Üksikasjalikku teavet antud veterinaarravimi kohta leiab Euroopa Ravimiameti koduleheküljelt aadressil http://www.ema.europa.eu/
English: In rare occasions swelling can reach a diameter up to 15-20 cm, with duration up to 2-3 weeks, that may require symptomatic treatment.
Estonian: Harvadel juhtudel võib paistetuse läbimõõt olla kuni 15-20 cm ning kesta 2-3 nädalat ning nõuda sümptomaatilist ravi.
English: Following the administration of overdoses of vaccine, no side-effects other than those described under section 4.6 have been observed.
Estonian: Vaktsiini manustamisel üledoosis ei ole täheldatud mingeid muid kõrvalmõjusid kui need, mis on toodud punktis 4.6
English: The vaccine stimulates active immunity against equine influenza.
Estonian: Vaktsiin stimuleerib hobuste gripi vastase aktiivse immuunsuse tekkimist.
English: Duration of immunity induced by the vaccination scheme: 5 months after primary vaccination course and 1 year after the third vaccination.
Estonian: Immuunsuse kestus skeemi järgi vaktsineerimisel: 5 kuud pärast esimest vaktsineerimist ja 1 aasta pärast 3-ndat vaktsineerimist .
English: Pain, local hyperthermia and muscle stiffness can occur in rare cases.
Estonian: Harvadel juhtudel võib esineda valu, lokaalne hüpertermia ja lihaste jäikus.
English: 2nd scheme - vaccination against equine influenza and tetanus:
Estonian: Teine skeem - vaktsineerimine hobuste gripi ja teetanuse vastu:
English: Manufacturer responsible for the batch release: MERIAL
Estonian: Partii väljastamise eest vastutav tootja: MERIAL,
English: Use immediately after opening.
Estonian: Kasutada koheselt pärast lahustamist
English: Carbomer ........................................................................................................................................... 4 mg. For the full list of excipients, see section 6.1.
Estonian: Karbomeer ......................................................................................................................................... 4 mg Abiainete terviklik loetelu on esitatud punktis 6.1.
English: Type I glass vial.
Estonian: I tüüpi klaaspudel
English: A slight increase in temperature (max. 1.5 °C) may occur for 1 day, exceptionally 2 days.
Estonian: 1,5 °C) 1, erandjuhtudel 2 päeva jooksul.
English: - Revaccination: 5 months after primary vaccination course followed by annual booster injections.
Estonian: - Kordusvaktsineerimine: 5 kuud pärast esmast vaktsineerimiskuuri, millele järgnevad iga-aastased kordusvaktsineerimised.
English: * vCP content checked by global FAID50 (fluorescent assay infectious dose 50%) and qPCR ratio between vCP.
Estonian: ≥ 5.3 log10 FAID50* * vCP sisaldus, kontrollituna globaalse FAID50 (fluorestsentstesti infitseeriv doos 50%) ja qPCR suhe vCP-de vahel.
English: The vaccine strains vCP2242 and vCP3011 are recombinant canarypox viruses expressing the haemagglutinin HA gene from the equine influenza virus strains A/eq/Ohio/03 (American strain, Florida sublineage clade 1) and A/eq/Richmond/1/07 (American strain, Florida sublineage clade 2), respectively.
Estonian: Vaktsiini tüved vCP2242 ja vCP3011 on rekombinantsed canarypox viirused, mis esindavad hobuste gripi A/eq/Ohio/03 (Ameerika tüvi, Florida alamliini kliini 1) ja A/eq/Richmond/1/07 (Ameerika tüvi, Florida alamliini kliini 2)hemaglutiniin HA geeni.
English: o against equine influenza: injection of 1 dose every year, alternatively with ProteqFlu or ProteqFlu-Te, respecting an interval of maximum 2 years for the tetanus component.
Estonian: • Millele järgneb: o teetanuse vastu: 1 doos ProteqFlu-Te maksimaalselt 2 aastase intervalliga o hobuste gripi vastu: 1 doos igal aastal, kas ProteqFlu või ProteqFlu-Te vaktsiiniga, vastavalt teetanusekomponendi maksimaalselt 2-aastase intervallile.
English: Box of 10 vials of 1 dose.
Estonian: Karp 10 pudeliga, milles igaühes 1 doos
English: Influenza A/eq/Ohio/03 [H3N8] recombinant canarypox virus (vCP2242) .............. ≥ 5.3 log10 FAID50* Influenza A/eq/Richmond/1/07 [H3N8] recombinant canarypox virus (vCP3011).
Estonian: Influenza A/eq/Ohio/03 [H3N8] rekombinantne canarypox virus (vCP2242) .......... ≥ 5.3 log10 FAID50* Influenza A/eq/ Richmond/1/07 [H3N8] recombinant canarypox virus (vCP3011).
English: Name and address of the manufacturer responsible for batch release
Estonian: Ravimipartii kasutamiseks vabastamise eest vastutava tootja nimi ja aadress MERIAL
English: In case of increased infection risk or insufficient colostrum intake, an additional initial injection of ProteqFlu-Te can be given at the age of 4 months followed by the full vaccination programme (primary vaccination course at 5-6 months of age and 4-6 weeks later followed by revaccination).
Estonian: Suurenenud nakkusohu korral või ternespiima puuduliku saamise korral võib esimese vaktsineerimise teostada 4 kuu vanuses, millele järgneb täielik vaktsineerimisprogramm (Esmane vaktsineerimine 5-6 kuu vanuses ja kordusvaktsineerimine 4-6 nädalat hiljem)
English: A transient swelling which usually regresses within 4 days may appear at the injection site.
Estonian: Süstekohale võib tekkida mööduv paistetus , mis tavaliselt taandub 4 päeva jooksul.
English: Administer one dose (1 ml), by intramuscular injection, preferably in the neck region, according to the following schedule: - Primary vaccination course with ProteqFlu-Te: first injection from 5-6 months of age, second injection 4-6 weeks later.
Estonian: Manustada üks doos (1 ml) intramuskulaarselt süstides, eelistatavalt kaelapiirkonda, järgneva vaktsineerimisskeemi järgi: - Esmane vaktsineerimiskuur ProteqFlu-Te vaktsiiniga: esimene süst 5-6 kuu vanuses, teine süst 4-6 nädalat hiljem.
English: Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Estonian: Müügipakendis veterinaarravimi kõlblikkusaeg: 3 aastat.Kasutada koheselt pärast avamist.
English: PACKAGE LEAFLET FOR: ProteqFlu suspension for injection for horses
Estonian: PAKENDI INFOLEHT ProteqFlu süstesuspensioon hobustele
English: Butyl elastomer closure and aluminium cap.
Estonian: Butüül-elastomeersulgur alumiiniumkorgiga.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION 1st scheme - vaccination against equine influenza:
Estonian: ANNUSTAMINE LOOMALIIGITI, MANUSTAMISTEE(D) JA -MEETOD Esimene skeem - vaktsineerimine hobuste gripi vastu:Manustada üks doos (1 ml ProteqFlu)
English: ProteqFlu Suspension for injection for horses
Estonian: ProteqFlu süstesuspensioon hobustele.
English: ProteqFlu suspension for injection for horses
Estonian: ProteqFlu Süstesuspensioon hobustele.
English: 1st scheme - vaccination against equine influenza:
Estonian: Esimene skeem - vaktsineerimine hobuste gripi vastu:Manustada üks doos (1 ml ProteqFlu)
English: This needs point further discussion.
Estonian: See vajab täiendavat arutelu.
English: Bioavailability is 65 to 70 %.
Estonian: Biosaadavus on 65 kuni 70%.
English: Overall conclusion on benefit/risk
Estonian: Kokkuvõtlik järeldus kasulikkuse/riski kohta
English: Invented name
Estonian: Väljamõeldud nimi
English: ATC code: C09A A04
Estonian: ATC-kood: C09A A04
English: Evaluation of Clinical Efficacy
Estonian: Kliinilise tõhususe hindamine
English: This indication was endorsed by several CMS.
Estonian: Selle näidustuse kiitsid heaks mitmed CMSd.
English: This may occur at any time during therapy.
Estonian: See võib ravi käigus ilmneda ükskõik millisel ajal.
English: Efficacy and safety of use in children has not been established.
Estonian: Laste puhul ei ole kasutamise efektiivsust ja ohutust uuritud.
English: The treatment should be discontinued one day prior to the surgery.
Estonian: Ravimi võtmine tuleks lõpetada üks päev enne operatsiooni.
English: When a pregnancy is planned or confirmed, the switch to an alternative treatment should be initiated as soon as possible.
Estonian: Kui planeeritakse rasedust või rasedus on avastatud, tuleks niipea kui võimalik rakendada alternatiivset ravi.
English: PHARMACEUTICAL FORM Tablets.
Estonian: RAVIMIVORM Tabletid.
English: This effect is anticipated and is usually not a reason to discontinue treatment.
Estonian: Selline mõju on ettearvatav ja ei ole tavaliselt ravi katkestamise põhjus.
English: Discontinuation of treatment does not lead to a rebound effect.
Estonian: Ravi katkestamisega ei kaasne tagasilöögi efekt.
English: An official referral for arbitration was notified by the Netherlands to the CHMP on 17.03.2005.
Estonian: Inimtervishoius kasutatavate ravimite komiteele edastasid läbirääkimisteks ametlikult küsimuse Madalmaad 17.03.2005.
English: When driving vehicles or operating machines it should be taken into account that occasionally dizziness or weariness may occur.
Estonian: Autot juhtides või masinatega töötades tuleks arvestada, et vahetevahel võib esineda pearinglust või ebakindlust.
English: The applicant subsequently sent on 23.02.2005 a Position Paper to all MS stating that the indication proposed by the RMS was not acceptable, and that a broader indication reflecting the study population should be approved, namely:
Estonian: Seejärel saatis taotleja 23.02.2005 kõigile MSdele olukorda tutvustava teatise, kus ta väitis, et RMS poolt pakutav näidustus ei ole aktsepteeritav ning et heaks kiita tuleks uuringupopulatsiooni kirjeldav laiem näidustus, täpsemalt:
English: Therefore, use in children is not recommended.
Estonian: Seega ei soovitata seda ravimit lastel kasutada.
English: About 20 % of the total quantity of perindopril absorbed is converted into perindoprilat, the active metabolite.
Estonian: Umbes 20% kogu imendunud perindopriili kogusest muutub aktiivseks metaboliidiks perindoprilaadiks.