FrancophonIA/ELRC3.0 huggingface dataset:
English: • However, other findings4-7 do not provide evidence of an association between testosterone and cardiovascular events, and data from a multinational observational registry study (RHYME) looking at prostate health outcomes in men treated with testosterone for over 2 years also indicate cardiovascular events within the anticipated range.
Estonian: • Teised tulemused4-7 aga ei tõenda testosterooni ja kardiovaskulaarsete juhtude seost ning testosterooniga ravitud meeste eesnäärmega seotud tervisenäitajaid üle 2 aasta jälginud rahvusvahelisest vaatlusuuringust (RHYME) saadud andmed osutavad samuti, et kardiovaskulaarsete juhtude sagedus jääb eeldatud vahemikku.
English: • The product information will also be amended to make it clear that these medicines should only be given to men in whom both signs and symptoms and laboratory tests confirm abnormally low levels of testosterone.
Estonian: • Samuti muudetakse ravimiteavet, märkides selgelt, et neid ravimeid tohib anda ainult meestele, kellel tunnused ja sümptomid ning laborianalüüsid kinnitavad testosterooni ebanormaalselt vähest sisaldust.
English: The CMDh1, a regulatory body representing EU Member States, has agreed by consensus that there is no consistent evidence of an increased risk of heart problems with testosterone medicines in men who lack the hormone (a condition known as hypogonadism).
Estonian: ELi liikmesriike esindav ravimite reguleerimise organ inimravimite vastastikuse tunnustamise ja detsentraliseeritud menetluste kooskõlastusrühm1 jõudis üksmeelsele järeldusele, et puuduvad järjepidevad tõendid südameprobleemide suurenenud riski kohta testosterooni sisaldavate ravimite kasutamisel hormoonpuudulikkusega (seisund, mida nimetatakse hüpogonadismiks) meestel.
English: • There is limited experience on the safety and efficacy of the use of these medicines in patients over 65 years of age.
Estonian: • Nende ravimite kasutamise efektiivsus- ja ohutusandmed vanematel kui 65-aastastel patsientidel on piiratud.
English: Testosterone-containing medicines work by replacing the missing testosterone, helping to restore normal testosterone levels to ensure normal sexual development and function in men.
Estonian: Testosterooni sisaldavad ravimid toimivad, asendades puuduva testosterooni, aidates taastada testosterooni normaalse sisalduse ja tagada normaalse seksuaalse arengu ja seksuaalfunktsiooni meestel.
English: • Caution is also advised in patients with pre-existing hypertension, since testosterone may cause an increase in blood pressure.
Estonian: • Soovitatav on olla ettevaatlik ka hüpertensiooniga patsientide korral, sest testosteroon võib põhjustada vererõhu suurenemist.
English: They are available as various formulations such as oral capsules, implants to be injected under the skin and as patches, gels or solutions to be applied to the skin.
Estonian: Ravimeid turustatakse erinevates ravimvormides, nagu suukaudsed kapslid, naha alla süstitavad implantaadid, plaastrid, geelid või nahale kantavad lahused.
English: • There is not much information on the use of testosterone medicines in men over 65 years of age.
Estonian: • Testosterooni sisaldavate ravimite kasutamise kohta vanematel kui 65-aastastel meestel ei ole kuigi palju teavet.
English: The changes to the product information for testosterone medicines are based on a PRAC review of data available from clinical trials, observational studies, meta-analyses, post-marketing data and further published data on the cardiovascular risks associated with testosterone therapy.
Estonian: Testosterooni sisaldavate ravimite ravimiteabe muudatused põhinevad testosteroonraviga seotud kardiovaskulaarsete riskide andmetel, mis saadi kliinilistest uuringutest, vaatlusuuringutest, metaanalüüsidest, turustamisjärgsetest teadetest ja muust avaldatud kirjandusest ja mille vaatas läbi ravimiohutuse järelevalve riskihindamiskomitee.
English: The use of testosterone in healthy older men is not an authorised use in the EU.
Estonian: Testosterooni kasutamine tervetel eakamatel meestel ei ole ELis lubatud.
English: Testosterone is a hormone, known as an androgen, responsible for the development and maintenance of reproductive function and sexual characteristics in men.
Estonian: Testosteroon on hormoon, tuntud kui androgeen, mis tingib meeste reproduktiivfunktsiooni ja sugutunnuste väljaarenemise ja säilimise.
English: Medicines containing testosterone are licensed in the EU to treat men with abnormally low levels of the hormone (hypogonadism).
Estonian: Testosterooni sisaldavad ravimid on ELis litsentsitud nende meeste raviks, kellel on hormooni ebanormaalselt vähe (hüpogonadism).
English: In men with hypogonadism, testosterone levels are abnormally low, affecting normal sexual development and function.
Estonian: Hüpogonadismiga meestel on testosterooni sisaldus ebanormaalselt väike, mõjutades normaalset seksuaalset arengut ja seksuaalfunktsiooni.
English: Testosterone-containing medicines are used to replace testosterone in men with hypogonadism.
Estonian: Testosterooni sisaldavaid ravimeid kasutatakse testosterooni asendamiseks hüpogonadismiga meestel.
English: In particular, concerns were raised with regards to a potential increased risk of cardiovascular events, namely myocardial infarction, in men treated with testosterone and who have pre-existing heart disease.1-3
Estonian: On tekkinud probleeme seoses kardiovaskulaarsete juhtude, nimelt müokardiinfarkti riski võimaliku suurenemisega meestel, keda ravitakse testosterooniga ja kellel juba on südamehaigus.1-3
English: • Although some studies show an increased risk of cardiovascular events in men treated with testosterone, findings in the literature do not show this consistently.
Estonian: • Kuigi mõned uuringud näitavad testosterooniga ravitud meestel kardiovaskulaarsete juhtude suurenenud riski, ei ole teaduskirjanduse andmed järjepidevad.
English: • Testosterone is a hormone responsible for normal sexual development and function in men.
Estonian: • Testosteroon on hormoon, mis tingib meeste normaalse seksuaalse arengu ja seksuaalfunktsiooni.
English: The PRAC further considered that the risks of effects on the heart and circulation, and any potential mechanisms for such effects should continue to be monitored, and information from ongoing studies should be provided as part of the next regular safety review (to which these medicines, like all medicines in the EU, are subject).
Estonian: käimasolevate uuringute teave tuleb esitada järgmises perioodilise ohutusaruande ülevaates (mida nende ravimite, nagu kõigi ravimite suhtes ELis kohaldatakse).
English: The PRAC recommendations were sent to the CMDh, which adopted a final position.
Estonian: Komitee soovitused saadeti inimravimite vastastikuse tunnustamise ja detsentraliseeritud menetluste kooskõlastusrühmale, kes võttis vastu lõpliku seisukoha.
English: The benefit-risk balance of these medicines has been reviewed following recent published evidence pointing to an increased risk of cardiovascular events, particularly myocardial infarction, in men treated with testosterone.
Estonian: Nende ravimite kasulikkuse ja riski tasakaal vaadati läbi pärast testosterooniga ravitud meestel kardiovaskulaarsete juhtude suurenenud riskile, eriti müokardiinfarktile osutavate hiljutiste tõendite avaldamist.
English: It should be borne in mind that physiological testosterone levels decrease somewhat with age, though there is no current consensus on appropriate age-specific testosterone reference values, and use to boost these levels in healthy older men is not an authorised use in the EU.
Estonian: Meeles tuleb pidada, et testosterooni füsioloogiline sisaldus vanuse suurenedes mõnevõrra väheneb, kuid praegu puudub üksmeel testosterooni vanusepõhistes kontrollväärtustes ning ravimi kasutamine tervete eakamate meeste testosteroonisisalduse suurendamiseks ei ole ELis lubatud.
English: • Some recent studies have shown an increased risk of cardiovascular events in men treated with testosterone.
Estonian: • Mõnest uuringust nähtub kardiovaskulaarsete juhtude suurenenud risk testosterooniga ravitud meestel.
English: Testosterone levels should then be monitored regularly during treatment.
Estonian: Testosterooni sisaldust tuleb jälgida nii ravi alguses kui ka regulaarsete vaheaegade järel ravi ajal.
English: The CMDh position follows a review by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) which looked at the risk of serious problems affecting the heart and circulation, particularly heart attacks, in men treated with these medicines.
Estonian: Inimravimite vastastikuse tunnustamise ja detsentraliseeritud menetluste kooskõlastusrühma seisukoht toetub läbivaatamisele, mille viis läbi Euroopa Ravimiameti ravimiohutuse järelevalve riskihindamiskomitee, kes uuris südant ja vereringet mõjutavate raskete probleemide, eelkõige südameinfarkti riski kõnealuste ravimitega ravitud meestel.
English: The product information should make it clear that testosterone should only be used when an abnormally low level of the hormone has been confirmed by signs and symptoms and appropriate laboratory tests.
Estonian: Ravimiteabes tuleb selgelt märkida, et testosterooni tuleks kasutada ainult siis, kui tunnused ja sümptomid ning asjakohased laborianalüüsid on kinnitanud hormooni erakordselt madalat sisaldust.
English: Testosterone levels naturally fall somewhat with age, but restoration of these levels in healthy older men is not an authorised use of the medicine in the EU.
Estonian: Testosterooni sisaldus väheneb loomulikult mõnevõrra vanuse suurenedes, kuid testosterooni sisalduse taastamine tervetel eakamatel meestel ei ole selle ravimi lubatud kasutusviis Euroopa Liidus.
English: The level of testosterone falls naturally with age and testosterone-containing medicines are not approved in the EU for use to boost testosterone levels in healthy older men.
Estonian: Testosterooni sisaldus väheneb vananedes loomulikult ja testosterooni sisaldavad ravimid ei ole ELis heaks kiidetud testosterooni sisalduse suurendamiseks tervetel eakamatel meestel.
English: As the CMDh position was adopted by consensus, it will now be directly implemented according to an agreed timetable by the Member States where the medicines are authorised.
Estonian: Et inimravimite vastastikuse tunnustamise ja detsentraliseeritud menetluste töörühma seisukoht võeti vastu konsensuse alusel, rakendavad ravimi müügiloaga liikmesriigid selle otse.
English: Increased risk of non-fatal myocardial infarction following testosterone therapy prescription in men.
Estonian: Risk of myocardial infarction in older men receiving testosterone therapy.
English: Information to healthcare professionals Testosterone-containing medicines are licensed in the EU for the treatment of male hypogonadism.
Estonian: Testosterooni sisaldavad ravimid on litsentsitud ELis meeste hüpogonadismi raviks.
English: The CMDh has endorsed the PRAC recommendations by consensus and they will now be directly implemented according to an agreed timetable by the Member States where the medicines are authorised.
Estonian: Inimravimite vastastikuse tunnustamise ja detsentraliseeritud menetluste kooskõlastusrühm kinnitas konsensuse alusel ravimiohutuse järelevalve riskihindamiskomitee soovitused ja nüüd rakendavad müügiloaga liikmesriigid neid otse kokkulepitud ajakava kohaselt.
English: Finkle WD, Greenland S, Ridgeway GK, et al.
Estonian: Baillargeon J, Urban RJ, Kuo Y-F, et al.
English: Baillargeon J, Urban RJ, Kuo Y-F, et al. Risk of myocardial infarction in older men receiving testosterone therapy.
Estonian: Finkle WD, Greenland S, Ridgeway GK, et al. Increased risk of non-fatal myocardial infarction following testosterone therapy prescription in men.
English: Effects of testosterone and progressive resistance exercise in healthy, highly functioning older men with low-normal testosterone levels.
Estonian: Hildreth KL, Barry DW, Moreau KL, et al. Effects of testosterone and progressive resistance exercise in healthy, highly functioning older men with low-normal testosterone levels.
English: Ecansya tablets should be swallowed with water within the 30 minutes after a meal.
Estonian: Ecansya tabletid neelatakse alla veega 30 minuti jooksul pärast sööki.
English: The name of the medicine was changed to Ecansya on 16 November 2012.
Estonian: Ravimi nimetus muudeti Ecansyaks 16. novembril 2012.
English: The full EPAR for Ecansya can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Ecansya kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Capecitabine Krka on 20 April 2012.
Estonian: Euroopa Komisjon andis Capecitabine Krka müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 20. aprillil 2012.
English: Other information about Ecansya
Estonian: Muu teave Ecansya kohta
English: The Committee recommended that Ecansya be given marketing authorisation.
Estonian: Komitee soovitas anda Ecansya müügiloa.
English: Ecansya is taken twice a day at doses between 625 and 1,250 mg per square metre body surface area (calculated using the patient's height and weight).
Estonian: Ecansyat võetakse kaks korda ööpäevas annustes 625-1250 mg kehapindala ruutmeetri kohta (arvutatakse patsiendi pikkuse ja kaalu põhjal).
English: Previously known as Capecitabine Krka.
Estonian: Varasem nimetus Capecitabine Krka.
English: Ecansya capecitabine
Estonian: Ecansya kapetsitabiin
English: The company carried out a ‘bioequivalence' study to show that 500 mg Ecansya produces the same levels of capecitabine in the blood as 500 mg of the reference medicine.
Estonian: Ettevõte korraldas bioekvivalentsuse uuringu, millega tõendas, et 500 mg ravimit Ecansya tekitab veres sama kapetsitabiinisisalduse kui 500 mg võrdlusravimit.
English: For more information about treatment with Ecansya, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Ecansyaga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: This is a summary of the European public assessment report (EPAR) for Ecansya.
Estonian: See on ravimi Ecansya Euroopa avaliku hindamisaruande kokkuvõte.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Ecansya.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: Because Ecansya is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Estonian: Et Ecansya on võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: What is Ecansya?
Estonian: Mis on Ecansya?
English: Therefore, the CHMP's view was that, as for Xeloda, the benefit outweighs the identified risk.
Estonian: Seetõttu arvas inimravimite komitee, et nagu ka Xeloda korral, ületab Ecansya kasulikkus sellega kaasnevad riskid.
English: The CHMP concluded that, in accordance with EU requirements, Ecansya has been shown to have comparable quality and to be bioequivalent to Xeloda.
Estonian: Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Ecansya võrdväärne kvaliteet ja bioekvivalentsus ravimiga Xeloda.
English: Why has Ecansya been approved?
Estonian: Miks Ecansya heaks kiideti?
English: Ecansya is a ‘generic' and a ‘hybrid' medicine.
Estonian: Ecansya on geneeriline ja hübriidravim.
English: Ecansya is a medicine that contains the active substance capecitabine.
Estonian: Ecansya on ravim, mis sisaldab toimeainena kapetsitabiini.
English: It can also be used on its own when treatment with both anthracyclines and taxanes (another type of anticancer medicine) has failed or when repeat treatment with anthracyclines is not suitable for the patient.
Estonian: Ecansyat tohib kasutada ka ainsa ravimina, kui ravi antratsükliinide ja taksaanidega (teist liiki vähiravimid) ei ole andnud tulemust või kui kordusravi antratsükliinidega patsiendile ei sobi.
English: Ecansya should only be prescribed by a doctor who is qualified in the use of anticancer medicines.
Estonian: Ecansya tohib määrata üksnes vähiravimite pädevusega arst.
English: What are the benefits and risks of Ecansya?
Estonian: Milles seisneb Ecansya kasulikkus ja mis riskid ravimiga kaasnevad?
English: Ecansya is an anticancer medicine.
Estonian: Ecansya on vähiravim.
English: Ecansya is used with or without other anticancer medicines in patients who have had surgery for ‘stage III' or ‘Dukes' stage C' colon cancer;
Estonian: • käärsoole- ehk jämesoolevähk: Ecansyat kasutatakse koos teiste vähiravimitega või ilma nendeta, et ravida käärsoolevähki patsientidel, kellele on tehtud III staadiumi ehk Dukesi skaala Cstaadiumi käärsoolevähi operatsioon;
English: The active substance in Ecansya, capecitabine, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the group ‘anti-metabolites'.
Estonian: Ecansya toimeaine kapetsitabiin on antimetaboliitide (raku normaalset ainevahetust pärssivate ainete) hulka kuuluv tsütotoksiline aine (ravim, mis hävitab poolduvaid rakke, näiteks vähirakke).
English: How does Ecansya work?
Estonian: Kuidas Ecansya toimib?
English: This means that it is similar to a ‘reference medicine', but it contains capecitabine at a new strength in addition to existing strengths: while the reference medicine, Xeloda, is available as 150 and 500 mg tablets, Ecansya is also available as 300 mg tablets.
Estonian: Võrdlusravimit Xeloda turustatakse 150 ja 500 mg tablettidena, ravimit Ecansya aga ka 300 mg tablettidena.
English: What is Ecansya used for?
Estonian: Milleks Ecansyat kasutatakse?
English: How is Ecansya used?
Estonian: Kuidas Ecansyat kasutatakse?
English: Ecansya is used with other anticancer medicines, including a platinum-containing anticancer medicine such as cisplatin;
Estonian: • kaugelearenenud maovähk: Ecansyat kasutatakse koos teiste vähiravimitega, sealhulgas plaatinat sisaldava vähiravimiga (näiteks tsisplatiiniga);
English: • metastatic colorectal cancer (cancer of the large bowel that has spread to other parts of the body).
Estonian: • metastaatiline kolorektaalvähk (jämesoolevähk, mis on levinud organismis ka mujale): Ecansyat kasutatakse koos teiste vähiravimitega või ilma nendeta;
English: How has Ecansya been studied?
Estonian: Kuidas Ecansyat uuriti?
English: • locally advanced or metastatic breast cancer (breast cancer that has begun to spread to other parts of the body).
Estonian: • paikne kaugelearenenud või metastaatiline rinnanäärmevähk (rinnavähk, mis on hakanud levima organismis ka mujale): Ecansyat kasutatakse koos dotsetakseeliga (samuti vähiravim) pärast tulemusteta ravi antratsükliinidega (teist liiki vähiravimid).
English: The full EPAR for Docetaxel Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Docetaxel Teva kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Docetaxel Teva is given as a one-hour infusion every three weeks.
Estonian: Docetaxel Tevat manustatakse üks tund kestva infusioonina iga kolme nädala tagant.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Docetaxel Teva on 26 January 2010.
Estonian: Euroopa Komisjon andis Docetaxel Teva müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 26. jaanuaril 2010.
English: By keeping the skeleton intact the cells cannot divide and they eventually die.
Estonian: Kui raku sisetoes püsib, ei saa rakk jaguneda ning lõpuks hävib.
English: It is used in the following types of cancer:
Estonian: Seda kasutatakse järgmiste vähivormide raviks.
English: Docetaxel Teva is only used when the neutrophil count (the level of a type of white blood cell) is normal (at least 1,500 cells/mm3.)
Estonian: Docetaxel Tevat kasutatakse ainult juhul, kui neutrofiilide (valgeliblede liigi) sisaldus veres on normaalne (vähemalt 1500 rakku/mm3).
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Docetaxel Teva.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: This is a summary of the European public assessment report (EPAR) for Docetaxel Teva.
Estonian: See on Docetaxel Teva Euroopa avaliku hindamisaruande kokkuvõte.
English: For more information about treatment with Docetaxel Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Docetaxel Tevaga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Other information about Docetaxel Teva
Estonian: Muu teave Docetaxel Teva kohta
English: Docetaxel Teva should be used in wards specialised in chemotherapy (medicines to treat cancer) and it should only be given under the supervision of a doctor who is qualified in the use of cancer chemotherapy.
Estonian: Docetaxel Tevat tohib kasutada üksnes spetsialiseeritud keemiaraviosakonnas (vähiravi) ning seda tohib manustada vaid vähivastases keemiaravis kogenud arsti järelevalve all.
English: Because Docetaxel Teva is a generic medicine, the company has provided data from the published literature on docetaxel.
Estonian: Et Docetaxel Teva on geneeriline ravim, esitas ettevõte dotsetakseeli kohta avaldatud kirjandusest pärinevaid andmeid.
English: Because Docetaxel Teva is a generic medicine, its benefit and risk are taken as being the same as the reference medicine.
Estonian: Et Docetaxel Teva on geneeriline ravim, peetakse ravimi kasulikkust ja riske samadeks mis võrdlusravimil.
English: The Committee recommended that Docetaxel Teva be given marketing authorisation.
Estonian: Komitee soovitas anda Docetaxel Teva müügiloa.
English: This means that Docetaxel Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Taxotere.
Estonian: See tähendab, et Docetaxel Teva on sarnane võrdlusravimiga Taxotere, millel juba on Euroopa Liidus müügiluba.
English: No additional studies were needed as Docetaxel Teva is given by infusion and contains the same active substance as the reference medicine, Taxotere.
Estonian: Lisauuringuid ei olnud vaja, sest Docetaxel Teva on infusioonina manustatav geneeriline ravim, mis sisaldab sama toimeainet kui võrdlusravim Taxotere.
English: Docetaxel Teva is used with cisplatin and 5-fluorouracil.
Estonian: Docetaxel Tevat kasutatakse koos tsisplatiini või 5-fluorouratsiiliga.
English: In addition, the company presented studies to show that the Docetaxel Teva solution for infusion has comparable quality to that of Taxotere.
Estonian: Ettevõtja esitas ka selliste uuringute andmeid, mis näitasid, et Docetaxel Teva infusioonilahuse kvaliteet on võrreldav Taxotere kvaliteediga.
English: What is Docetaxel Teva?
Estonian: Mis on Docetaxel Teva?
English: Docetaxel Teva is used with prednisone or prednisolone (anti-inflammatory medicines);
Estonian: Docetaxel Tevat kasutatakse koos prednisooni või prednisolooniga (põletikuravimid).
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Docetaxel Teva has been shown to have comparable quality to Taxotere.
Estonian: Inimravimite komitee järeldas, et Docetaxel Teva võrreldav kvaliteet Taxoterega on Euroopa Liidu nõuete kohaselt tõendatud.
English: Why has Docetaxel Teva been approved?
Estonian: Miks Docetaxel Teva heaks kiideti?