FrancophonIA/ELRC3.0 huggingface dataset:
English: The PRAC reviewed all the available data submitted with regards to the clinical efficacy and safety of fusafungine-containing products.
Estonian: Ravimiohutuse riskihindamise komitee vaatas üle kõik esitatud andmed fusafungiini sisaldavate ravimite kliinilise efektiivsuse ja ohutuse kohta.
English: Fusafungine , used in the form of a spray, is indicated in the local antibacterial and anti-inflammatory treatment of diseases in the upper respiratory airways (sinusitis, rhinitis, rhinopharyngitis, angina, laryngitis), inhaled in usual doses of 500 micrograms every 4 hours into each nostril or via the mouth.
Estonian: Spreina kasutatav fusafungiin on näidustatud ülemiste hingamisteede haiguste (sinusiit, riniit, rinofarüngiit, angiin, larüngiit) paikseks antibakteriaalseks ja põletikuvastaseks raviks.
English: The PRAC reviewed all the available data submitted with regards to the clinical safety of fusafunginecontaining products.
Estonian: Ravimiohutuse riskihindamise komitee vaatas üle kõik esitatud andmed fusafungiini sisaldavate ravimite kliinilise ohutuse kohta.
English: Fusafungine is currently indicated in the local antibacterial and anti-inflammatory treatment of diseases in the upper respiratory airways (sinusitis, rhinitis, rhinopharyngitis, angina, laryngitis), inhaled in usual doses of 500 micrograms every 4 hours into each nostril or via the mouth.
Estonian: Fusafungiin on praegu näidustatud ülemiste hingamisteede haiguste (sinusiit, riniit, rinofarüngiit, angiin, larüngiit) paikseks antibakteriaalseks ja põletikuvastaseks raviks.
English: 7 Bouter K. 7-day treatment of acute infectious rhinopharyngitis with fusafungine (1.0 mg x 4 daily): a double-blind placebo-controlled parallel-group study.
Estonian: 2000, Study report [NP07760] 7 Bouter K. 7-day treatment of acute infectious rhinopharyngitis with fusafungine (1.0 mg x 4 daily): a double-blind placebo-controlled parallel-group study.
English: The PRAC reviewed all the available data submitted with regards to the clinical efficacy of fusafunginecontaining products.
Estonian: Ravimiohutuse riskihindamise komitee vaatas üle kõik esitatud andmed fusafungiini sisaldavate ravimite kliinilise efektiivsuse kohta.
English: Fusafungine was shown to be superior to placebo in the acute rhinopharyngitis indication regarding evolution of nasal symptom score after 4 days of treatment in adults in three pivotal studies Chabolle, 19995, Eccles 20006 and Bouter, 20027) and the pooled analysis of them (Grouin 20038).
Estonian: Kolmest põhiuuringust (Chabolle, 19995, Eccles 20006 ja Bouter, 20027) ja nende koondanalüüsist
English: 10 sprayers
Estonian: 10 spreiprits
English: Reassortant influenza virus* (live attenuated) of the following strains**: A/California/7/2009 (H1N1)pdm09-like strain (A/California/7/2009, MEDI 228029) 10
Estonian: Järgmiste tüvede** reassortantne gripiviirus* (nõrgestatud elusvaktsiin): A/California/7/2009 (H1N1)pdm09 sarnane tüvi (A/California/7/2009, MEDI 228029) 10
English: *** fluorescent focus units
Estonian: *** fluorestseeruva kolde ühik (FFU).
English: Packaging
Estonian: Nasaalne
English: Medicinal product no longer authorised
Estonian: Ravim il on müügiluba lõppenud
English: Nasal use sprayer (glass/PE) 0.2ml
Estonian: Spreiprits (klaas/polüetüleen)
English: FFU*** ................................................................................................................................................per 0.2 ml dose
Estonian: FKÜ*** ................................................................................................................................................0,2 ml annuse kohta
English: Adopted at the 4-8 July 2016 PRAC
Estonian: Vastu võetud PRACi poolt 4.-8. juulil 2016
English: The frequency of these reactions is considered not known (cannot be estimated from the available data).
Estonian: Nende kõrvaltoimete esinemissagedus ei ole teada (ei saa hinnata olemasolevate andmete alusel).
English: To avoid this interference, [Product name] treatment should be stopped for at least 5 days before CgA measurements (see section 5.1).
Estonian: Selle häire vältimiseks tuleb ravi [ravimi nimetus] lõpetada vähemalt 5 päeva enne CgA määramist (vt lõik 5.1).
English: • You are due to have a specific blood test (Chromogranin A)
Estonian: • teil planeeritakse spetsiifilist vereanalüüsi (kromograniin A)
English: Ferrous sulfate - Mouth ulceration (EPITT no 18623)
Estonian: Raudsulfaat - suu haavandumine (EPITT nr 18623)
English: If you cannot follow this instruction or have difficulty swallowing, please contact your doctor.
Estonian: Kui te ei suuda seda juhist täita või teil on neelamisraskused, siis võtke ühendust oma arstiga.
English: Tablets should be taken before meals or during meals, depending on gastrointestinal tolerance.
Estonian: Tabletid tuleb sisse võtta enne sööki või söögi ajal, sõltuvalt seedetraktipoolsest taluvusest.
English: Post-marketing: The following ADRs have been reported during post-marketing surveillance.
Estonian: Turuletulekujärgne jälgimine: turuletulekujärgse jälgimise perioodil on teatatud järgmistest kõrvaltoimetest.
English: Proton pump inhibitors (PPIs): dexlansoprazole; esomeprazole; lansoprazole; omeprazole; pantoprazole; rabeprazole - Elevated circulating levels of Chromogranin A (EPITT no 18614)
Estonian: Prootonpumba inhibiitorid (PPI): dekslansoprasool, esomeprasool, lansoprasool, omeprasool, pantoprasool, rabeprasool - tsirkuleeriva kromograniin A sisalduse suurenemine (EPITT nr 18614)
English: 3 - How to take [Product name] Swallow the tablet whole with water.
Estonian: 3 - Kuidas [ravimi nimetus] võtta Neelake tablett koos veega tervena alla.
English: Not known (frequency cannot be estimated from the available data) Mouth ulceration (in case of incorrect use, when tablets are chewed, sucked or left in the mouth) Elderly patients and patients with difficulty swallowing may also be at risk of ulceration of the throat, oesophagus (the tube that connects your mouth with your stomach) or bronchus (the major air passages of the lungs) if the tablet enters the airways.
Estonian: Teadmata (esinemissagedust ei saa hinnata olemasolevate andmete alusel) Suu haavandumine (ebaõige kasutamise korral, kui tablette näritakse, imetakse või hoitakse suus) Eakatel patsientidel ja neelamisraskustega patsientidel on risk kurgu, söögitoru (suud maoga ühendav toru) või, kui tablett satub hingamisteedesse, bronhide (kopsude suured õhukanalid) haavandite tekkeks.
English: Do not suck, chew or keep the tablet in your mouth.
Estonian: Ärge imege ega närige tabletti ega hoidke tabletti suus.
English: Elderly patients and patients with deglutition disorders may also be at risk of oesophageal lesions or of bronchial necrosis, in case of false route.
Estonian: Eakatel ja neelamishäiretega patsientidel on risk söögitorukahjustuste tekkeks või tableti ebaõige liikumistee korral ka bronhinekroosi tekkeks.
English: Interference with laboratory tests
Estonian: Erihoiatused ja ettevaatusabinõud kasutamisel Häired laboratoorsete uuringute tegemisel
English: Tell your doctor before taking this medicine, if:
Estonian: 2 - Mida on vaja teada enne [ravimi nimetus] võtmist Hoiatused ja ettevaatusabinõud Enne ravimi võtmist rääkige oma arstile, kui:
English: The tablets should not be sucked, chewed or kept in the mouth, but swallowed whole with water.
Estonian: Tablette ei tohi imeda, närida ega hoida suus, vaid tuleb koos veega tervena alla neelata.
English: Due to the risk of mouth ulceration and tooth discolouration, tablets should not be sucked, chewed or kept in the mouth but swallowed whole with water.
Estonian: Suu haavandumise ja hammaste värvuse muutuse riski tõttu ei tohi tablette imeda, närida ega hoida suus, vaid tuleb koos veega tervena alla neelata.
English: Gastrointestinal disorders: mouth ulceration* * in the context of incorrect administration, when the tablets are chewed, sucked or kept in mouth.
Estonian: * Ebaõige manustamise kontekstis, kui tablette näritakse, imetakse või hoitakse suus.
English: This was then compared with results reported in the scientific literature.
Estonian: Seda võrreldi teaduslikus kirjanduses esitatud tulemustega.
English: What is Epostim?
Estonian: Mis on Epostim?
English: Withdrawal of the marketing authorisation application for Epostim (epoetin alfa) EMA/287731/2011
Estonian: Müügiloa taotluse tagasivõtmise teave: Epostim (alfaepoetiin) EMA/287731/2011
English: This means that Epostim was intended to be similar to a biological medicine that is already authorised in the European Union (also known as the ‘reference medicine') and contains the same active substance.
Estonian: See tähendab, et Epostim pidi olema sarnane bioloogilise ravimiga (võrdlusravimiga), millel juba on Euroopa Liidus müügiluba ning mis sisaldab sama toimeainet.
English: Epostim was expected to be used in the following situations:
Estonian: Epostimit kavatseti kasutada järgmistel eesmärkidel:
English: A second main study in 188 kidney patients compared Epostim with the reference medicine Eprex.
Estonian: Teises põhiuuringus, kus osales 188 neeruprobleemidega patsienti, võrreldi Epostimi võrdlusravim Eprexiga.
English: What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Estonian: Kuidas mõjutab müügiloa taotluse tagasivõtmine praegu kliinilistes uuringutes või eriloaga kasutamise programmides osalevaid patsiente?
English: This study is still ongoing and aims to show that Epostim has the same effect on maintaining haemoglobin levels as Eprex.
Estonian: See uuring alles käib ja selle eesmärk on näidata, et Epostim säilitab hemoglobiini sisaldust sama efektiivselt kui Eprex.
English: On 15 March 2011, Reliance GeneMedix Plc officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Epostim to be used to treat anaemia and stimulate red blood cell production.
Estonian: 15. märtsil 2011 teatas Reliance GeneMedix Plc ametlikult inimravimite komiteele oma otsusest võtta tagasi ravimi Epostim müügiloa taotlus.
English: In patients receiving chemotherapy or with kidney problems, anaemia can be caused by a lack of erythropoietin, or by the body not responding enough to the erythropoietin.
Estonian: Keemiaravi saavatel või neeruprobleemidega patsientidel võib aneemiat põhjustada erütropoetiini vähesus või organismi ebapiisav reageerimine erütropoetiinile.
English: In a main study in 75 adults with anaemia caused by kidney problems, patients were treated with Epostim and their blood levels of haemoglobin (a protein in red blood cells) measured to see how much their anaemia improved.
Estonian: Põhiuuringus, kus osales 75 neeruprobleemidest põhjustatud aneemiaga täiskasvanut, said patsiendid Epostimi ravi ja mõõdeti hemoglobiini (punaliblede valk) sisaldust nende veres, et näha, kui palju aneemia paranes.
English: The epoetin alfa in Epostim is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce it.
Estonian: Epostimis sisalduvat alfaepoetiini valmistatakse rekombinant-DNA-tehnika abil: seda toodab rakk, millele on lisatud alfaepoetiini teket võimaldav geen (DNA).
English: • to increase the amount of blood that can be taken from patients who are going to need the blood after surgery (autologous blood transfusion);
Estonian: • operatsioonieelselt võetava vere hulga suurendamiseks patsientidel, kes vajavad verd pärast operatsiooni (autoloogne vereülekanne);
English: The company informed the CHMP that here are no consequences for patients currently in clinical trials using Epostim.
Estonian: Ettevõte teatas inimravimite komiteele, et taotluse tagasivõtmine ei mõjuta praegu Epostimi kliinilistes uuringutes osalevaid patsiente.
English: The active substance in Epostim, epoetin alfa, is a copy of human erythropoietin and was expected to work in exactly the same way as the natural hormone to stimulate red blood cell production.
Estonian: Epostimi toimeaine alfaepoetiin on inimese erütropoetiini koopia ja pidi toimima täpselt samamoodi kui looduslik hormoon, stimuleerides punaliblede teket.
English: The reference medicine for Epostim is Eprex.
Estonian: Epostimi võrdlusravim on Eprex.
English: Erythropoietin is also used before surgery to increase the number of red blood cells and help minimise the consequences of blood loss.
Estonian: Erütropoetiini kasutatakse ka enne operatsiooni vere punaliblede sisalduse suurendamiseks ja verekaotuse tagajärgede minimeerimiseks.
English: • to treat anaemia in adults receiving chemotherapy for certain types of cancer and to reduce their need for blood transfusions;
Estonian: • aneemia ravi teatud vähivormide keemiaravi saavatel täiskasvanutel, et vähendada vereülekannete vajadust;
English: Epostim is a solution for injection that contains the active substance epoetin alfa.
Estonian: Epostim on süstelahus, mis sisaldab toimeainena alfaepoetiini.
English: Withdrawal of the marketing authorisation application for Epostim (epoetin alfa)
Estonian: Müügiloa taotluse tagasivõtmise teave: Epostim (alfaepoetiin)
English: Epostim was developed as a ‘biosimilar' medicine.
Estonian: Epostim töötati välja bioloogiliselt sarnase ravimina.
English: How is Epostim expected to work?
Estonian: Milline on Epostimi eeldatav toime?
English: The effects of Epostim were first tested in experimental models before being studied in humans.
Estonian: Enne inimuuringuid kontrolliti Epostimi toimet muude katsetega.
English: • to treat anaemia (low red blood cell counts) that is causing symptoms in adults and children with ‘chronic renal failure' (long-term, progressive decrease in the ability of the kidneys to work properly);
Estonian: • kroonilise neerupuudulikkusega (neerutalitluse pikaajaline süvenev halvenemine) täiskasvanutel ja lastel sümptomeid põhjustava aneemia (vere punaliblede vähesus) ravi;
English: • to reduce the need for blood transfusions in non-iron deficient patients who are about to undergo major orthopaedic (bone) surgery.
Estonian: • vereülekannete vajaduse vähendamiseks vere normaalse rauasisaldusega patsientidel enne ulatuslikku ortopeedilist (luu)operatsiooni.
English: A hormone called erythropoietin stimulates the production of red blood cells from the bone marrow.
Estonian: Hormoon erütropoetiin stimuleerib punaliblede teket luuüdis.
English: What was Epostim expected to be used for?
Estonian: Milleks kavatseti Epostimit kasutada?
English: Pharmaceutical Form Route of Administration
Estonian: Ravimvorm Manustamistee Pakendi iseloomustusPakendi sisu Pakendi suurus
English: 10 vials + 10 pre-filled syringes with attached needle
Estonian: 10 viaali + 10 kinnitatud nõelaga süstelit
English: 1 vial + 1 pre-filled syringe + 2 separate needles
Estonian: 1 viaal + 1 süstel + 2 nõela eraldi
English: 1 vial + 1 pre-filled syringe + 1 separate needle
Estonian: 1 viaal + 1 süstel + 1 nõel eraldi
English: 1 vial + 1 pre-filled syringe with attached needle
Estonian: 1 viaal + 1 kinnitatud nõelaga süstel
English: 06 March 2012
Estonian: 6. märts 2012
English: Outcome of a procedure under Article 13 of Regulation (EC) 1234/2008
Estonian: Määruse (EÜ) nr 1234/2008 artikli 13 kohase esildismenetluse tulemused
English: The European Commission issued a decision on 06 March 2012.
Estonian: Euroopa Komisjon tegi otsuse 6. märtsil 2012.
English: What is Norditropin?
Estonian: Mis on Norditropin?
English: EMA/CHMP/966954/2011 Rev. 1 EMEA/H/A-13/1304
Estonian: EMA/211566/20121 Rev. 1 EMEA/H/A-13/1304
English: Why was Norditropin reviewed?
Estonian: Miks Norditropini taotlus uuesti läbi vaadati?
English: Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom1.
Estonian: Madalmaad, Poola, Portugal, Rumeenia, Slovakkia, Sloveenia, Hispaania ja Ühendkuningriik1.
English: In May 2010, the company applied for an additional indication in Denmark and in the following Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Estonian: 2010. aasta mais esitas ettevõte näidustuse lisamise taotluse Taanis ja järgmistes asjaomastes liikmesriikides: Austria, Belgia, Bulgaaria, Küpros, Tšehhi Vabariik, Eesti, Soome, Prantsusmaa, Saksamaa, Kreeka, Ungari, Iirimaa, Itaalia, Läti, Leedu, Luksemburg, Malta,
English: The Committee concluded that the change to the marketing authorisation cannot be granted.
Estonian: Komitee järeldas, et ravimite müügiluba ei saa muuta.
English: 1 In May 2011 the marketing authorisations of the concerned products were withdrawn in Estonia, and in June 2011 the marketing authorisations of the concerned products were withdrawn in Latvia.
Estonian: 2011. aasta mais võeti asjaomaste ravimite müügiload tagasi Eestis ja 2011. aasta juunis Lätis.
English: The Committee looked at the study presented by the company to support the new indication.
Estonian: Inimravimite komitee vaatas üle uuringu, mille ettevõtte oli esitanud uue näidustuse toetuseks.
English: The Member States cited methodological weaknesses in the study presented, the wide range of doses used and insufficient data (e.g. missing data on body composition measurements).
Estonian: Need liikmesriigid viitasid esitatud uuringu metodoloogilistele puudustele, uuringus kasutatud annuste suurele varieeruvusele ja ebapiisavatele andmetele (näiteks puudusid kehaehituse mõõtmise andmed).
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP agreed that the data were insufficient and that the study presented, which was an observational study, did not meet required methodological standards.
Estonian: Tuginedes olemasolevate andmete hindamisele ja komiteesisesele teaduslikule arutelule, leidis inimravimite komitee, et esitatud andmed olid ebapiisavad ja esitatud vaatlusuuring ei vastanud vajalikele metodoloogilistele nõuetele.
English: Norditropin is authorised under a mutual recognition procedure based on an initial authorisation granted by Denmark.
Estonian: Norditropin on saanud müügiloa vastastikuse tunnustamise menetluse kaudu, mis põhineb Taanis antud esmasel müügiloal.
English: The European Medicines Agency has completed an arbitration procedure for Norditropin and associated names.
Estonian: Euroopa Ravimiamet on lõpetanud Norditropini ja sarnaste nimetuste vahekohtumenetluse.
English: Growth hormone promotes growth during childhood and adolescence, and also affects the way the body handles proteins, fat and carbohydrates.
Estonian: Kasvuhormoon soodustab lapse- ja noorukieas kasvu ning mõjutab ka valkude, rasvade ja süsivesikute ainevahetust organismis.
English: Norditropin is a medicine that contains somatropin, which is a copy of naturally occurring human growth hormone.
Estonian: Norditropin on ravim, mis sisaldab somatropiini, mis on inimese loodusliku kasvuhormooni koopia.
English: On 20 April 2011, Denmark referred the matter to the CHMP for arbitration.
Estonian: Seetõttu tegi Taani 20. aprillil 2011 inimravimite komiteele vahekohtumenetluse esildise.
English: The CHMP therefore recommended that the new indication for Norditropin and associated names should not be granted in Denmark or in the concerned Member States.
Estonian: Inimravimite komitee soovitas seetõttu mitte kiita heaks Taanis ja asjaomastes riikides Norditropini ja sarnaste nimetuste uut näidustust.
English: The grounds for the referral were the concerns of some Member States that the data on Norditropin submitted in the application were not sufficient to demonstrate its effectiveness in Prader-Willi syndrome.
Estonian: Vahekohtumenetluse algatamise põhjus oli mõne liikmesriigi ettevaatlikkus, et näidustuse toetuseks taotluses Norditropini kohta esitatud andmetest ei piisanud efektiivsuse tõestamiseks Praderi-Willi sündroomi korral.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) had been asked to arbitrate on a requested change to the marketing authorisation for these medicines to include a new indication for use in children with Prader-Willi syndrome.
Estonian: Ravimiameti inimravimite komiteel paluti olla vahekohtunikuks nende ravimite müügiloa muutmise küsimuses, kas lisada uue näidustusena Praderi-Willi sündroom lastel.
English: Although somatropin medicines are already approved in EU Member States for use in Prader-Willi syndrome, the Member States were unable to reach agreement on whether to accept this indication for Norditropin.
Estonian: Kuigi somatropiini sisaldavatel ravimitel on Euroopa Liidus juba Praderi-Willi sündroomiga laste näidustusel müügiluba, ei jõudnud liikmesriigid menetluse käigus kokkuleppele, kas kiita see näidustus heaks ka Norditropini puhul või mitte.
English: It is also used to correct short height in girls who have the genetic disease called Turner syndrome, in children who have long-standing kidney problems, and in children born small for their gestational age and who have not caught up by the age of four.
Estonian: Seda kasutatakse ka lühikese kasvu korrigeerimiseks Turneri sündroomiga (teatud geneetiline haigus) tüdrukutel, krooniliste neeruprobleemidega lastel ning üsasisese kasvupeetusega lastel, kes ei ole 4aastasena saavutanud eakohast normaalpikkust.
English: The new indication was for the use of Norditropin in children with Prader-Willi syndrome, a rare genetic disease that affects children's growth and development.
Estonian: Uus taotletav näidustus oli Norditropini kasutamine lastel, kellel on Praderi-Willi sündroom (laste kasvu ja arengut pärssiv harvaesinev geneetiline haigus).
English: The company that makes the medicine is NovoNordisk.
Estonian: Neid ravimeid toodab NovoNordisk.
English: Norditropin is used as replacement therapy in children and adults who have a growth hormone deficiency.
Estonian: Norditropini kasutatakse asendusravina kasvuhormooni vaegusega lastel ja täiskasvanutel.
English: The somatropin in Norditropin is produced by a method known as ‘recombinant DNA technology': it is made by an organism that has received a gene (DNA), which makes the organism able to produce it. Norditropin is marketed in the EU Member States under the names Norditropin FlexPro, Norditropin NordiFlex, Norditropin SimpleXx and associated names.
Estonian: Norditropini turustatakse Euroopa Liidu liikmesriikides järgmiste nimetuste all: Norditropin FlexPro, Norditropin NordiFlex, Norditropin SimpleXx ja sarnased nimetused.
English: The Reference Member State (RMS) for the decentralised procedure for Pantoprazole Olinka application was UK and the Concerned Member States (CMS) were: Germany and Poland.
Estonian: Pantoprazole Olinka taotluse detsentraliseeritud menetluses oli viiteliikmesriigiks Ühendkuningriik ning asjaomased liikmesriigid olid Tšehhi Vabariik, Saksamaa, Poola ja Slovakkia.
English: Other concerns LoOI-Q1: The Applicant was requested to clarify the origin and name of the reference product used in the new bioequivalence study.
Estonian: Muud probleemid (lahendamata küsimused-1.küsimus): taotlejalt nõuti selgitust uues bioekvivalentsuse uuringus kasutatud võrdlusravimi algupära ja nimetuse kohta.
English: Pantoprazole 20 mg Volkspharma Gastroresistant tablets
Estonian: Pantoprazole 20 mg Volkspharma
English: Pantoprazole 40 mg Volkspharma Gastroresistant tablets
Estonian: Pantoprazole 40 mg Volkspharma
English: It is only used in patients who have responded well to their current HIV treatment and who do not have an HIV infection that is resistant to treatment or not likely to respond to any of the active substances in the medicine.
Estonian: Seda kasutatakse üksnes patsientidel, kellel olemasolev HIV-ravi toimib hästi ning kelle HIV-nakkus ei ole ravile resistentne või selline, mis tõenäoliselt ei allu mõnele ravimi toimeainele.
English: The company also carried out a study that showed that the medicine is ‘bioequivalent' to the reference medicine.
Estonian: Ettevõte tegi ka uuringu, mis tõendas ravimi bioekvivalentsust võrdlusravimiga.