FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effects with Thalidomide Celgene used together with melphalan and prednisone (seen in more than 1 patient in 10) are neutropenia (low levels of neutrophils, a type of white blood cell), leucopenia (low white blood cell counts), anaemia (low red blood cell counts), lymphopenia (low levels of lymphocytes, another type of white blood cell), thrombocytopenia (low levels of platelets in the blood), peripheral neuropathy (nerve damage causing tingling, pain and numbness in the hands and feet), tremor (shaking), dizziness, paraesthesia (unusual sensations like pins and needles), dysaesthesia (reduced sense of touch), sleepiness, constipation and peripheral oedema (swelling, usually in the legs).
Estonian: Ravimi Thalidomide Celgene kõige sagedamad kõrvalnähud kasutamisel koos melfalaani ja prednisooniga (võivad esineda enam kui 1 patsiendil 10st) on neutropeenia (neutrofiilide ehk teatud valgeliblede vähesus), leukopeenia (leukotsüütide ehk vere valgeliblede vähesus), aneemia (erütrotsüütide ehk vere punaliblede vähesus), lümfotsütopeenia (lümfotsüütide ehk teatud muud tüüpi valgeliblede vähesus), trombotsütopeenia (trombotsüütide ehk vereliistakute vähesus), perifeerne neuropaatia (käte ja jalgade närvikahjustus, mis põhjustab kirvendust, valu ja tuimust), treemor (värin), peapööritus, paresteesia (vääraistingud, näiteks torkiv valu), düsesteesia (nõrgenenud puutetundlikkus), unisus, kõhukinnisus ja perifeerne ödeem (turse, tavaliselt jalgadel).
English: The company that markets Thalidomide Celgene will set up a pregnancy prevention programme in each Member State.
Estonian: Ravimi Thalidomide Celgene turustaja alustab kõigis liikmesriikides raseduse ennetamise programmi.
English: The European Medicines Agency concluded that, provided that very strict measures are put in place to avoid exposure of unborn children to thalidomide, Thalidomide Celgene's benefits are greater than its risks and it can be authorised for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et kui loote talidomiidiga kokkupuute ennetamiseks on võetud väga ranged meetmed, on ravimi Thalidomide Celgene kasulikkus suurem kui sellega kaasnevad riskid ja et ravimi kasutamise võib ELis heaks kiita.
English: What measures are being taken to ensure the safe and effective use of Thalidomide Celgene?
Estonian: Mis meetmed võetakse, et tagada ravimi Thalidomide Celgene ohutu ja efektiivne kasutamine?
English: In patients over 75 years of age a starting dose of 100 mg (2 capsules) a day is recommended.
Estonian: Üle 75-aastastel patsientidel on soovituslik algannus 100 mg (2 kapslit) ööpäevas.
English: It will also supply cards for patients to ensure that all appropriate safety measures are taken by each patient.
Estonian: Turustaja annab ka patsiendikaardid, tagamaks, et kõik patsiendid võtavad kõik vajalikud ohutusmeetmed.
English: • women who could become pregnant, unless they take all of the necessary steps to ensure that they are not pregnant before treatment and that they do not become pregnant during or soon after treatment;
Estonian: • fertiilses eas naised, v.a kui naine võtab enne ravi alustamist kõik meetmed, tagamaks, et ta ei ole enne ravi algust rase, samuti rasestumise ennetamiseks ravi ajal ja vahetult pärast ravi;
English: Patients receiving melphalan and prednisone lived for an average of 33.2 months from the start of the study, compared with 51.6 months when the treatment also included Thalidomide Celgene.
Estonian: Patsiendid, kes kasutasid melfalaani ja prednisooni, elasid uuringu algusest alates keskmiselt 33,2 kuud, lisaks ka ravimit Thalidomide Celgene kasutanud patsiendid 51,6 kuud.
English: Previously known as Thalidomide Pharmion.
Estonian: Varasem nimetus Thalidomide Pharmion.
English: The study included patients over 65 years of age, as well as younger patients who could not be treated with high-dose chemotherapy.
Estonian: Uuringus osalesid üle 65-aastased patsiendid, samuti nooremad patsiendid, kellel ei saanud kasutada suurtes annustes keemiaravi.
English: Side effects reported with Thalidomide Celgene are carefully evaluated and any necessary action taken to protect patients.
Estonian: Ravimi Thalidomide Celgene kõrvaltoimeid hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
English: As for all medicines, data on the use of Thalidomide Celgene are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse ravimi Thalidomide Celgene kasutamise kohta pidevat järelevalvet.
English: Thalidomide Celgene thalidomide
Estonian: Thalidomide Celgene1
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Thalidomide Celgene have also been included in the summary of product characteristics and the package leaflet.
Estonian: Ravimi Thalidomide Celgene ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Thalidomide Celgene can be used for a maximum of 12 treatment cycles, with each cycle lasting 6 weeks.
Estonian: Ravimit Thalidomide Celgene võib kasutada kuni 12 ravitsükli jooksul, millest iga ravitsükkel kestab 6 nädalat.
English: Most patients taking thalidomide get side effects.
Estonian: Enamikul talidomiidi kasutavatest patsientidest tekivad kõrvalnähud.
English: Thalidomide Celgene must never be used by the following groups:
Estonian: Mitte mingil juhul ei tohi ravimit Thalidomide Celgene kasutada järgmised patsiendirühmad:
English: What is Thalidomide Celgene and what is it used for?
Estonian: Mis on Thalidomide Celgene ja milleks seda kasutatakse?
English: Thalidomide Celgene increased the time patients lived in one main study involving 447 patients with multiple myeloma.
Estonian: Thalidomide Celgene efektiivsust uuriti ühes põhiuuringus, milles osales 447 hulgimüeloomiga patsienti.
English: Each Member State will also ensure that educational materials and patient cards are provided as necessary to prescribers and patients.
Estonian: Samuti tagab iga liikmesriik, et ravimi määrajad ja patsiendid saavad vajadusel alati teabematerjalid ja patsiendikaardid.
English: Thalidomide is a powerful human ‘teratogen', meaning that it has harmful effect on the unborn child, causing severe and life-threatening birth defects.
Estonian: Talidomiid on inimese tugevatoimeline teratogeen, mis tähendab, et see kahjustab loodet, põhjustades raskeid ja eluohtlikke väärarenguid.
English: Thalidomide Celgene is available as capsules (50 mg).
Estonian: Ravimit Thalidomide Celgene turustatakse kapslitena (50 mg).
English: The study compared the effect of melphalan and prednisone, with or without Thalidomide Celgene.
Estonian: Uuringus võrreldi melfalaani ja prednisooni toimet, kui neid manustati koos ravimiga Thalidomide Celgene või ilma selleta.
English: Other information about Thalidomide Celgene
Estonian: Muu teave ravimi Thalidomide Celgene kohta
English: Thalidomide Celgene, in combination with melphalan and prednisone, has been shown to prolong the life of patients with multiple myeloma.
Estonian: Thalidomide Celgene koos melfalaani ja prednisooniga pikendab hulgimüeloomiga patsientide eluiga.
English: For more information about using Thalidomide Celgene, see the package leaflet or contact tour doctor or pharmacist.
Estonian: Lisateavet ravimi Thalidomide Celgene kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
English: The company will also collect information on whether the medicine is used outside its approved indication.
Estonian: Ettevõte kogub teavet ka ravimi väärkasutamise kohta.
English: The boxes containing Thalidomide Celgene capsules will include a warning that thalidomide is harmful to the unborn child.
Estonian: Ravimi Thalidomide Celgene kapslite karbile lisatakse hoiatus, et talidomiid kahjustab loodet.
English: Thalidomide Celgene must be prescribed and dispensed according to a special programme put in place to prevent the exposure of unborn children to the medicine.
Estonian: Ravimit Thalidomide Celgene peab määrama ja manustama vastavalt eriprogrammile, mille eesmärk on välistada loote kokkupuude ravimiga.
English: The company also presented the results of a study looking at the combination of Thalidomide Celgene and dexamethasone as ‘induction' treatment for multiple myeloma for use before high-dose chemotherapy.
Estonian: Ettevõte esitas ka uuringu tulemused, milles vaadeldi ravimi Thalidomide Celgene ja deksametasooni kombinatsiooni hulgimüeloomi induktsioonravina enne suureannuselist keemiaravi.
English: Thalidomide Celgene is used to treat multiple myeloma (a cancer of the bone marrow) in combination with the cancer medicines melphalan and prednisone in patients who have not been treated for multiple myeloma before.
Estonian: Ravimit Thalidomide Celgene kasutatakse hulgimüeloomi (luuüdivähk) raviks koos vähiravimite melfalaani ja prednisooniga patsientidel, kellel ei ole hulgimüeloomi varem ravitud.
English: Thalidomide Celgene can only be obtained with a prescription and treatment must be started and monitored under the supervision of a doctor skilled in using medicines that modulate the immune system or medicines to treat cancer.
Estonian: Thalidomide Celgene on retseptiravim ja ravi peab alustama ja jälgima immuunsüsteemi moduleerivate ravimite või vähiravimite kasutamises kogenud arst.
English: It is used in patients aged 65 years or over, and in younger patients if they cannot be treated with high-dose chemotherapy.
Estonian: Seda kasutatakse üle 65-aastastel ning ka noorematel patsientidel, kellel ei saa kasutada suurtes annustes keemiaravi (vähiravi).
English: The active substance in Thalidomide Celgene, thalidomide, is thought to work by blocking the development of cancer cells, and by stimulating some of the specialised cells of the immune system
Estonian: Arvatakse, et ravimis Thalidomide Celgene toimeainena sisalduv talidomiid toimib vähirakkude arengut blokeerides ning stimuleerides immuunsüsteemi (organismi kaitsemehhanismid) teatud rakke vähirakke ründama.
English: The doctor may delay, reduce or stop doses if the patient gets certain side effects, including blood clots, nerve damage, rash, low heart rate, fainting or sleepiness.
Estonian: Kui patsiendil tekivad teatud kõrvalnähud (nt trombid, närvikahjustus, lööve, südametegevuse aeglustumine, minestus või unisus), võib arst annuste manustamist edasi lükata, annuseid vähendada või ravi katkestada.
English: What are the risks associated with Thalidomide Celgene?
Estonian: Mis riskid ravimiga Thalidomide Celgene kaasnevad?
English: For the full list of side effects reported with Thalidomide Celgene, see the package leaflet.
Estonian: Ravimi Thalidomide Celgene kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: It contains the active substance thalidomide.
Estonian: Ravim sisaldab toimeainena talidomiidi.
English: How does Thalidomide Celgene work?
Estonian: Kuidas Thalidomide Celgene toimib?
English: How is Thalidomide Celgene used?
Estonian: Kuidas ravimit Thalidomide Celgene kasutatakse?
English: The strict conditions put in place to prevent pregnancy and the exposure of unborn children to thalidomide must be met by all men and women taking the medicine.
Estonian: Kõik seda ravimit kasutavad mehed ja naised peavad järgima rangeid tingimusi, mille eesmärk on ennetada rasestumist ja loote kokkupuudet talidomiidiga.
English: The recommended dose is 200 mg (4 capsules) a day, taken at the same time, preferably at bedtime.
Estonian: Ravimi Thalidomide Celgene soovituslik annus on 200 mg (4 kapslit) ööpäevas.
English: It will provide educational kits for healthcare workers and brochures for patients, detailing the steps that need to be taken for the medicine to be used safely.
Estonian: Ravimi turustaja koostab tervishoiutöötajatele kirjalikud teabematerjalid ning patsientidele voldikud,
English: What benefits of Thalidomide Celgene have been shown in studies?
Estonian: Milles seisneb uuringute põhjal ravimi Thalidomide Celgene kasulikkus?
English: The full EPAR and risk management plan summary for Eperzan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst ja riskijuhtimiskava kokkuvõte Eperzani kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What measures are being taken to ensure the safe and effective use of Eperzan?
Estonian: Mis meetmed võetakse, et tagada Eperzani ohutu ja efektiivne kasutamine?
English: A risk management plan has been developed to ensure that Eperzan is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Eperzani võimalikult ohutu kasutamine.
English: This was considered to be clinically meaningful and there were three-year data showing that this effect was maintained during long-term treatment.
Estonian: Seda peeti kliiniliselt oluliseks vähenemiseks ja kolmeaastase uuringu andmed näitasid, et see toime püsis ka pikaajalise ravi korral.
English: Eperzan albiglutide
Estonian: Eperzan albiglutiid
English: The European Commission granted a marketing authorisation valid throughout the European Union for Eperzan on 28 March 2014.
Estonian: Euroopa Komisjon andis Eperzani müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 21. Märtsil 2014.
English: Other information about Eperzan
Estonian: Muu teave Eperzani kohta
English: What is Eperzan and what is it used for?
Estonian: Mis on Eperzan ja milleks seda kasutatakse?
English: Overall, the effect of Eperzan in reducing HbA1c varied between 0.6 and 0.9%.
Estonian: Üldkokkuvõttes oli Eperzani toime HbA1c sisalduse vähendamisel vahemikus 0,6-0,9%.
English: HbA1c gives an indication of how well the blood glucose is controlled.
Estonian: HbA1c sisaldus näitab, kui hästi on vere glükoosisisaldus kontrolli all.
English: Why is Eperzan approved?
Estonian: Miks Eperzan heaks kiideti?
English: This is a summary of the European public assessment report (EPAR) for Eperzan.
Estonian: See on ravimi Eperzan Euroopa avaliku hindamisaruande kokkuvõte.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Eperzan's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Inimravimite komitee otsustas, et Eperzani kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: The risks seen with the medicine were similar to those of other medicines in its class and Eperzan has the advantage of being given only once a week.
Estonian: Ravimi kasutamisel täheldatud riskid olid sarnased teiste sama klassi ravimite riskidega, samas on Eperzani eeliseks manustamine ainult üks kord nädalas.
English: The recommended dose is 30 mg injected once a week, though this may be increased by their doctor to 50 mg depending on the effects on their blood sugar levels.
Estonian: Soovitatav annus on 30 mg süstituna üks kord nädalas, aga sõltuvalt ravimi toimest vere suhkrusisaldusele võib arst otsustada suurendada annust 50 mg-ni.
English: This causes the release of insulin and helps to reduce blood glucose levels and control type 2 diabetes.
Estonian: See kutsub esile insuliini vabanemise ja aitab vähendada vere glükoosisisaldust ning kontrollida II tüüpi diabeeti.
English: What are the risks associated with Eperzan?
Estonian: Mis riskid Eperzaniga kaasnevad?
English: Eperzan is a diabetes medicine that contains the active substance albiglutide.
Estonian: Eperzan on diabeediravim, mis sisaldab toimeainena albiglutiidi.
English: It is not intended to provide practical advice on how to use Eperzan.
Estonian: Hindamisaruandes ei anta Eperzani kasutamise praktilisi nõuandeid.
English: Patients inject the medicine themselves (after suitable training) under the skin in the abdomen, thigh or the upper arm.
Estonian: Patsiendid süstivad ravimit endale ise (pärast piisava väljaõppe saamist) nahaaluse süstina kõhupiirkonda, reide või õlavarde.
English: Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Estonian: II tüüpi diabeet on haigus, mille korral kõhunääre ei tooda vere glükoosisisalduse reguleerimiseks piisavalt insuliini või organism ei suuda insuliini efektiivselt kasutada.
English: When used in combination with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered to avoid hypoglycaemia (low blood sugar levels).
Estonian: Kui Eperzani kasutatakse kombinatsioonis sulfonüüluurea või insuliiniga, siis võib olla vajalik sulfonüüluurea või insuliini annuse vähendamine, et vältida hüpoglükeemia (vere väike glükoosisisaldus) tekkevõimalust.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Eperzan, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati Eperzani omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: It works by attaching to receptors for a substance called glucagon-like peptide 1 (GLP-1), which are found on the surface of the cells in the pancreas and stimulate them to release insulin.
Estonian: Eperzan seondub glükagoonilaadse peptiidi 1 (GLP-1) retseptoritega, mis paiknevad kõhunäärme rakkude pinnal ja stimuleerivad insuliini vabanemist.
English: Eperzan is available as prefilled pens that contain a powder (30 and 50 mg) and solvent for making a solution to be injected under the skin.
Estonian: Eperzani turustatakse eeltäidetud pensüstaldes, mis sisaldavad pulbrit (30 mg ja 50 mg) ja lahustit süstelahuse valmistamiseks, mida süstitakse naha alla.
English: The benefits of Eperzan were studied in over 5,000 patients with type 2 diabetes in which Eperzan was compared with placebo (a dummy treatment) or with other diabetes medicines when used as an addon to various combination treatments or when used alone.
Estonian: Eperzani kasulikkust uuriti enam kui 5000-l II tüüpi diabeediga patsiendil, kellel võrreldi Eperzani platseebo (näiv ravim) või teiste diabeediravimitega, kui seda kasutati täiendava ravimina peale erinevate kombinatsioonravide või ainsa ravimina.
English: The most common side effects with Eperzan, affecting more than 1 in 20 people, are diarrhoea, nausea (feeling sick) and reactions at the injection site including rash, redness, or itching.
Estonian: Eperzani kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 20st) on kõhulahtisus, iiveldus ja süstekoha reaktsioonid, nagu lööve, punetus või nahasügelus.
English: For practical information about using Eperzan, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Eperzani kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: The active substance in Eperzan, albiglutide, is a ‘GLP-1 receptor agonist'.
Estonian: Eperzani toimeaine albiglutiid on GLP-1 retseptori agonist.
English: What benefits of Eperzan have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Eperzani kasulikkus?
English: Two other medicines, pioglitazone and liraglutide, were found to be more effective as an add-on than Eperzan.
Estonian: Kaks ravimit, pioglitasoon ja liraglutiid, olid täiendava ravi korral efektiivsemad kui Eperzan.
English: How is Eperzan used?
Estonian: Kuidas Eperzani kasutatakse?
English: For more information about treatment with Eperzan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Eperzaniga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: The CHMP noted that the effects of Eperzan in controlling blood glucose were shown to be clinically meaningful when the medicine was used alone and when compared with other medicines in combination treatments.
Estonian: Inimravimite komitee märkis, et Eperzani toimed vere glükoosisisalduse kontrollimisel olid läbiviidud uuringutes kliiniliselt olulised nii Eperzani kasutamisel ainsa ravimina kui ka võrreldes teiste ravimitega kombinatsioonravide korral.
English: How does Eperzan work?
Estonian: Kuidas Eperzan toimib?
English: When Eperzan is injected, albiglutide reaches the receptors in the pancreas and activates them.
Estonian: Eperzani süstimise järel jõuab albilglutiid kõhunäärmes paiknevate retseptoriteni ja aktiveerib need.
English: For the full list of all side effects and restrictions, see the package leaflet.
Estonian: Eperzani kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: Eperzan can also be used as an ‘add-on' to other diabetes medicines, including insulin, when these medicines together with exercise and diet are not providing adequate control of blood glucose.
Estonian: Eperzani tohib kasutada lisaks muudele diabeediravimitele, sealhulgas insuliin, kui need ravimid koos dieedi ja kehalise koormusega ei reguleeri piisavalt vere glükoosisisaldust.
English: It is used in adults with type 2 diabetes to control their blood glucose (sugar) level.
Estonian: Seda kasutatakse II tüüpi diabeediga (suhkurtõvega) täiskasvanud patsientide raviks, et nende vere glükoosisisaldust paremini reguleerida.
English: Eperzan was more effective than placebo at reducing HbA1c levels when used alone, and was more effective than the diabetes medicines sitagliptin and glimepiride and comparable to insulin glargine and insulin lispro when used as add-on to other treatments.
Estonian: Samuti oli Eperzan efektiivsem kui diabeediravimid sitagliptiin ja glimepiriid ning efektiivsuse poolest võrreldav glargiininsuliini ja lisproinsuliiniga, kui seda kasutati täiendava ravina peale muude ravimite.
English: Eperzan can be used on its own in patients whose blood glucose levels are not satisfactorily controlled on diet and exercise alone and who cannot take metformin (another diabetes medicine).
Estonian: Eperzani tohib kasutada ainsa ravimina koos dieedi ja füüsilise koormusega patsientidel, kes ei talu metformiini (samuti diabeediravim) ja kelle vere glükoosisisaldus (nn veresuhkur) ei ole üksnes dieedi ja kehalise koormuse abil piisavalt reguleeritav.
English: The final content, format and distribution modalities of both documents should be agreed with the national competent authority in each Member State.
Estonian: Mõlema dokumendi sisu, vorm ja jagamine tuleb liikmesriigi pädeva asutusega kokku leppida.
English: The Marketing Authorisation Holder must implement this educational plan nationally, prior to marketing.
Estonian: Müügiloa hoidja peab selle tegevuskava enne turustamise alustamist riiklikult ellu viima.
English: Annex
Estonian: Artikli
English: Physician brochure Patient brochure
Estonian: arsti brošüüri patsiendi brošüüri.
English: • how to recognise the potential side effects (thrombosis and embolism)
Estonian: • kuidas ära tunda võimalikke kõrvaltoimeid (tromboosi ja embooliat)
English: • distribution and use of the patient brochure and the need to ensure that the patient has read and understood the brochure
Estonian: • patsiendi brošüüri jagamine ja kasutamine ning vajadus tagada, et patsient loeks brošüüri ja saaks sellest aru
English: • appropriate diagnostic procedures to confirm FXIII A-subunit deficiency
Estonian: • sobivad diagnostilised protseduurid, mis kinnitavad FXIII A-alaühiku puudulikkust
English: Both documents are to be used as part of an educational plan aiming to minimise risks of medication errors, risk of thromboembolic events due to increased levels of non-proteolytically activated rFXIII in connection with incorrect storage, and risk of off-label use for treatment of breakthrough bleeding.
Estonian: Mõlemat brošüüri tuleb kasutada osana koolituskavast, et vähendada ravivigade riski, vale säilitamisega kaasneva mitteproteolüütilise aktiveeritud rFXIII taseme tõusust põhjustatud trombemboolia riski ja läbimurdeveritsuste korral väljaspool kinnitatud näidustust kasutamise riski.