FrancophonIA/ELRC3.0 huggingface dataset:
English: Mepact, used with other anticancer medicines, increased how long patients survived without their disease coming back: 68% of the patients receiving Mepact (231 out of 338) survived without the disease coming back, compared with 61% of the patients who did not receive it (207 out of 340).
Estonian: Koos muude vähiravimitega kasutatud Mepact suurendas patsientide elulemust ilma haiguse taastumiseta: patsientide osakaal, kes jäid ellu ilma haiguse taastumiseta, oli Mepacti korral 68% (231 patsienti 338st) ja nendel, kes Mepacti ei saanud, 61% (207 patsienti 340st).
English: After surgery to remove the cancer, all of the patients were given various combinations of anticancer medicines.
Estonian: Pärast vähi kirurgilist eemaldamist manustati kõigile patsientidele vähiravimite mitmesuguseid kombinatsioone.
English: Mepact is given as a slow infusion lasting an hour.
Estonian: Mepacti manustatakse üks tund kestva aeglase infusioonina.
English: The dose of Mepact depends on the patient's height and weight.
Estonian: Mepacti annus sõltub patsiendi pikkusest ja kehamassist.
English: It works by activating macrophages and monocytes (types of white blood cell that form part of the immune system).
Estonian: See toimib makrofaagide ja monotsüütide (vere teatud valgelibled, mis moodustavad osa immuunsüsteemist) aktiveerimise kaudu.
English: Mepact has been studied in one main study involving 678 patients aged between one and 31 years with high-grade non-metastatic osteosarcoma.
Estonian: Mepacti uuriti ühes põhiuuringus, milles osales 678 kõrgmaliigse mittemetastaatilise osteosarkoomiga patsienti vanuses 1-31 aastat.
English: Mepact is used with other anticancer medicines after the cancer has been removed by surgery.
Estonian: Mepacti kasutatakse koos muude vähiravimitega pärast vähkkasvaja kirurgilist eemaldamist.
English: Because the number of patients with osteosarcoma is low, the disease is considered ‘rare', and Mepact was designated an ‘orphan medicine' (a medicine used in rare diseases) on 21 June 2004.
Estonian: Et osteosarkoomiga patsientide arv on väike ja see haigus esineb harva, nimetati Mepact 21. juunil 2004 harvikravimiks.
English: The study compared patients who were given Mepact with those who were not.
Estonian: Uuringus võrreldi Mepacti saanud patsiente nendega, kes seda ravimit ei saanud.
English: For more information about treatment with Mepact, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Mepacti-ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: What is Mepact?
Estonian: Mis on Mepact?
English: It must not be used at the same time as ciclosporin or other calcineurin inhibitors (medicines that reduce the activity of the immune system), or high doses of non-steroidal anti-inflammatory drugs (NSAIDs; used to treat pain and inflammation).
Estonian: Ravimit ei tohi kasutada samal ajal koos tsüklosporiini või muude kaltsineuriiniinhibiitoritega (immuunsüsteemi aktiivsust vähendavad ravimid) ega suures annuses manustatavate mittesteroidsete põletikuvastaste ravimitega (NSAID-ravimid; kasutatakse valu ja põletiku raviks).
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 Mepact.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: The precise way that mifamurtide works in osteosarcoma is not fully understood, but it is thought to cause the white blood cells to release chemicals that kill the cancerous cells.
Estonian: Mifamurtiidi täpne toimemehhanism osteorsarkoomi korral ei ole veel täielikult teada, kuid arvatakse, et mifamurtiidi toimel vabaneb valgelibledest aineid, mis hävitavad vähirakke.
English: Mepact is a powder that is made up into a suspension for infusion (drip into a vein).
Estonian: Mepact on pulber, millest valmistatakse infusioonisuspensioon (veeni tilgutatav suspensioon).
English: Why has Mepact been approved?
Estonian: Miks Mepact heaks kiideti?
English: Mepact should not be used in people who may be hypersensitive (allergic) to mifamurtide or any of the other ingredients.
Estonian: Mepacti ei tohi kasutada patsiendid, kes võivad olla mifamurtiidi või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
English: Mepact is used to treat high-grade non-metastatic osteosarcoma (a type of bone cancer) in patients aged between two and 30 years.
Estonian: Mepacti kasutatakse kõrgmaliigse mittemetastaatilise osteosarkoomi (luuvähi liik) raviks 2-30aastastel patsientidel.
English: Half of the patients were also given Mepact.
Estonian: Pooltele patsientidele manustati ka Mepacti.
English: The CHMP decided that Mepact's benefits are greater than its risks when used with other anticancer medicines and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et kasutamisel koos muude vähiravimitega on Mepacti kasulikkus suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: Other information about Mepact:
Estonian: Muu teave Mepacti kohta
English: This document is a summary of the European public assessment report (EPAR) for Mepact.
Estonian: Käesolev dokument on ravimi Mepact Euroopa avaliku hindamisaruande kokkuvõte.
English: It must not be given as a bolus injection (all at once).
Estonian: Ravimit ei tohi manustada boolussüstina (kogu annus korraga).
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Mepact is available here.
Estonian: Harvikravimite komitee arvamuse kokkuvõte Mepacti kohta on siin.
English: It contains the active substance mifamurtide.
Estonian: Ravim sisaldab toimeainena mifamurtiidi.
English: What is the risk associated with Mepact?
Estonian: Mis riskid Mepactiga kaasnevad?
English: How does Mepact work?
Estonian: Kuidas Mepact toimib?
English: What benefit has Mepact shown during the studies?
Estonian: Milles seisneb uuringute põhjal Mepacti kasulikkus?
English: Mepact treatment should be started and supervised by a specialised doctor who has experience in diagnosing and treating osteosarcoma.
Estonian: Ravi Mepactiga tohib alustada üksnes osteosarkoomi diagnoosimises ja ravis kogenud eriarst ning see peab toimuma tema järelevalve all.
English: The active substance in Mepact, mifamurtide, is an immunomodulator.
Estonian: Mepacti toimeaine mifamurtiid on immuunmodulaator.
English: For the full list of all side effects reported with Mepact, see the package leaflet.
Estonian: Mepacti kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: How has Mepact been studied?
Estonian: Kuidas Mepacti uuriti?
English: The full EPAR for Mepact can be found here.
Estonian: Euroopa avaliku hindamisaruande täistekst Mepacti kohta on siin.
English: The medicine can only be obtained with a prescription.
Estonian: Mepact on retseptiravim.
English: How is Mepact used?
Estonian: Kuidas Mepacti kasutatakse?
English: What is Mepact used for?
Estonian: Milleks Mepacti kasutatakse?
English: 4 implants + 1 applicator
Estonian: 4 implantaati + 1 aplikaator
English: 74.2 mg Implant
Estonian: 74,2 mg
English: Subcutaneous use sachet (PET/LDPE/alu)
Estonian: Kotike (PET/LDPE/Al)
English: Strength Pharmaceutical Form Route of Administration
Estonian: Ravimvorm Manustamisviis Sisepakendi iseloomustus
English: Studies lasted for six months or one year.
Estonian: Uuringud kestsid 6 kuud kuni 1 aasta.
English: After 26 weeks of treatment, patients had the option to either stop treatment or continue with it for up to a year.
Estonian: 26-nädalase ravi järel oli patsientidel võimalus ravi lõpetada või jätkata veel kuni aasta.
English: Tresiba is injected once a day, preferably at the same time every day.
Estonian: Tresibat süstitakse üks kord ööpäevas, eelistatavalt iga päev samal kellaajal.
English: The correct dose is determined individually for each patient.
Estonian: Ravimi annus määratakse igale patsiendile individuaalselt.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tresiba on 21 January 2013.
Estonian: Euroopa Komisjon andis Tresiba müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 21. jaanuaril
English: What measures are being taken to ensure the safe and effective use of Tresiba?
Estonian: Mis meetmed võetakse, et tagada Tresiba ohutu ja efektiivne kasutamine?
English: The full EPAR for Tresiba can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Tresiba kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: A risk management plan has been developed to ensure that Tresiba is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Tresiba võimalikult ohutu kasutamine.
English: Other information about Tresiba
Estonian: Muu teave Tresiba kohta
English: This means that Tresiba has a long duration of action.
Estonian: See tähendab, et Tresiba toimeaeg on pikk.
English: This is a summary of the European public assessment report (EPAR) for Tresiba.
Estonian: See on ravimi Tresiba Euroopa avaliku hindamisaruande kokkuvõte.
English: Regarding its safety, the Committee concluded that Tresiba is generally safe and its side effects are comparable to those of other insulin analogues with no unexpected side effects reported.
Estonian: Ohutuse osas järeldas inimravimite komitee, et Tresiba on üldiselt ohutu, selle kõrvalnähud on võrreldavad teiste insuliini analoogide kõrvalnähtudega ja ootamatutest kõrvalnähtudest ei ole teatatud.
English: After 26 weeks of treatment with Tresiba, the average reduction in HbA1c was 0.2 percentage points (HbA1c decreased from 8.2% to 8.0%) compared with a reduction of 0.3 percentage points with insulin detemir (HbA1c decreased from 8.0% to 7.7%).
Estonian: 26nädalase Tresibaga toimunud ravi järel vähenes HbA1c sisaldus keskmiselt 0,2% võrra (HbA1c sisaldus vähenes 8,2%-lt 8,0%-ni) ja detemiirinsuliiniga toimunud ravi järel 0,3% võrra (HbA1c sisaldus vähenes 8,0%-lt 7,7%-ni).
English: Tresiba insulin degludec
Estonian: Tresiba degludekinsuliin
English: Tresiba is a replacement insulin that is very similar to the natural insulin with a difference that it is absorbed more slowly in the body and takes longer to reach its target.
Estonian: Tresiba on asendusinsuliin, mis on väga sarnane looduslikult tekkiva insuliiniga, kuid see imendub organismis aeglasemalt ja seetõttu kestab selle toimimiskohta jõudmine kauem.
English: The CHMP decided that Tresiba's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et Tresiba kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: For more information about treatment with Tresiba, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Tresibaga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: The place within the chosen area should be changed with each injection to reduce the risk of lipodystrophy (changes in the distribution of body fat) under the skin that can affect the amount of insulin absorbed.
Estonian: Iga päev tuleb süstimiseks kasutada eri piirkonda, et vähendada nahaaluse lipodüstroofia (muutused keharasva jaotumises) tekkeriski, mis võib mõjutada imenduvat insuliini kogust.
English: Patients in these studies could also be given other diabetes medicines or rapid-acting insulin at mealtimes if needed.
Estonian: Nende uuringute patsiendid said vajaduse korral ka muid diabeediravimeid või kiiretoimelist insuliini söögikorra ajal.
English: For the full list of side effects and restrictions with Tresiba, see the package leaflet.
Estonian: Tresiba kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: It is available as a solution for injection in a cartridge (100 units/ml) and in a pre-filled pen (100 units/ml and 200 units/ml).
Estonian: Tresibat turustatakse süstelahusena kolbampullis (100 U/ml) ja eeltäidetud pensüstlas (100 U/ml ja 200 U/ml).
English: The most frequently reported side effect during treatment with Tresiba (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose levels).
Estonian: Tresiba kõige sagedam kõrvalnäht (võib esineda enam kui 1 patsiendil 10st) on hüpoglükeemia (vere väike glükoosisisaldus).
English: Tresiba acts in the same way as naturally produced insulin and helps glucose enter cells from the blood.
Estonian: Tresiba toimib samal viisil kui organismis looduslikult tekkiv insuliin, aidates glükoosil siseneda verest rakkudesse.
English: What is Tresiba?
Estonian: Mis on Tresiba?
English: The CHMP noted that the higher strength formulation of Tresiba met a medical need for patients requiring higher dose insulin (such as overweight patients), which would allow these patients to take their daily dose in a single injection rather than two injections.
Estonian: Komitee märkis samuti, et Tresiba suurema tugevusega ravimvorm vastab nende patsientide meditsiinilisele vajadusele, kes vajavad suuremat insuliiniannust (näiteks ülekaaluga patsiendid), mis võimaldab nendel patsientidel manustada vajaliku ööpäevase annuse ühe süstimiskorraga.
English: In addition Tresiba was compared with insulin detemir in one main study involving 350 children aged 1 to 18 years of age with type 1 diabetes.
Estonian: Lisaks võrreldi Tresibat detemiirinsuliiniga ühes põhiuuringus, milles osales 350 1-18-aastast I tüüpi diabeediga last.
English: Why has Tresiba been approved?
Estonian: Miks Tresiba heaks kiideti?
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 Tresiba.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: Tresiba is used to treat type 1 and type 2 diabetes in adults and children aged 1 to 18 years of age.
Estonian: Tresibat kasutatakse I ja II tüüpi diabeedi raviks täiskasvanutel ja 1-18-aastastel lastel.
English: Tresiba is a medicine that contains the active substance insulin degludec.
Estonian: Tresiba on ravim, mis sisaldab toimeainena degludekinsuliini.
English: What is the risk associated with Tresiba?
Estonian: Mis riskid Tresibaga kaasnevad?
English: Another main study involving 177 adults with type 2 diabetes investigated the effectiveness of combining Tresiba and liraglutide (a GLP-1 receptor agonist).
Estonian: Ühes põhiuuringus, milles osales 177 II tüüpi diabeediga täiskasvanut, uuriti Tresiba ja liraglutiidi (GLP-1-retseptori agonist) kombinatsiooni efektiivsust.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Tresiba, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati Tresiba omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: Patients were also given rapid-acting insulin at mealtimes.
Estonian: Patsientidele manustati ka söögikordade ajal kiiretoimelist insuliini.
English: The company that markets Tresiba will provide educational materials to healthcare professionals expected to treat or dispense medicines to patients with diabetes, aimed particularly at raising awareness of the higher strength formulation of Tresiba in order to ensure that the patient is prescribed the correct strength.
Estonian: Tresiba turustaja varustab kõik diabeediga patsiente ravivad ja neile ravimeid määravad arstid teabematerjaliga, mille põhieesmärk on anda teavet Tresiba tugevama ravimvormi kohta, et tagada õige tugevuse määramine patsientidele.
English: All of the studies measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which is the percentage of haemoglobin in the blood attached to glucose.
Estonian: Kõigis uuringutes mõõdeti glükohemoglobiini (HbA1c) sisaldust veres, mis näitab, kui suur osa hemoglobiinist on seondunud glükoosiga.
English: Across the studies, the average reduction in HbA1c levels with Tresiba treatment was 0.6 percentage points in adults with type 1 diabetes and 1.2 points in adults with type 2 diabetes.
Estonian: Kõigis uuringutes kokku vähenes HbA1c sisaldus Tresibaga toimunud ravi järel I tüüpi diabeediga täiskasvanutel keskmiselt 0,6% võrra ning II tüüpi diabeediga täiskasvanutel keskmiselt 1,2% võrra.
English: In type 2 diabetes, Tresiba can be used alone or in combination with diabetes medicines given by mouth, GLP-1 receptor agonist medicines and rapid acting mealtime insulin.
Estonian: II tüüpi diabeedi korral tohib Tresibat kasutada ainsa ravimina või kombinatsioonis suukaudsete diabeediravimite, GLP-1-retseptori agonisti sisaldava ravimiga või koos söögikordade ajal manustatava kiiretoimelise insuliiniga.
English: Tresiba has been studied in three main studies involving 1,578 adults with type 1 diabetes, where Tresiba (in combination with rapid acting mealtime insulin) was compared with insulin glargine or insulin detemir (other long acting insulins).
Estonian: Tresibat uuriti kolmes põhiuuringus, milles osales kokku 1578 I tüüpi diabeediga täiskasvanut ja milles Tresibat (koos söögikordade ajal manustatava kiiretoimelise insuliiniga) võrreldi glargiininsuliini või detemiirinsuliiniga (samuti pikatoimelised insuliinid).
English: For adolescents with type 2 diabetes, the CHMP concluded that although safety and effectiveness had only been shown for type 1 diabetes, the results of studies carried out in adolescents with type 1 and other studies in adults with type 2 diabetes could be applied to adolescents with type 2.
Estonian: Kuigi ohutus ja efektiivsus tõestati üksnes I tüüpi diabeedi korral, järeldas inimravimite komitee II tüüpi diabeediga noorukite kohta, et I tüüpi diabeediga noorukite ja II tüüpi diabeediga täiskasvanute uuringute tulemusi võib kohandada II tüüpi diabeediga noorukitele.
English: In type 1 diabetes, Tresiba must always be used in combination with rapid acting insulin, which is injected at mealtimes.
Estonian: I tüüpi diabeedi korral kasutatakse Tresibat alati koos kiiretoimelise insuliiniga, mida süstitakse söögikordade ajal.
English: The studies showed that Tresiba was at least as effective as other long acting insulins in controlling blood glucose levels in adults with type 1 and type 2 diabetes, and more effective than sitagliptin in adults with type 2 diabetes.
Estonian: Uuringud näitasid, et Tresiba oli vere glükoosisisalduse reguleerimisel I ja II tüüpi diabeediga täiskasvanutel vähemalt sama efektiivne kui muud pikatoimelised insuliinid ning II tüüpi diabeediga täiskasvanutel efektiivsem kui sitagliptiin.
English: Six other main studies involving 4,076 adults with type 2 diabetes compared Tresiba with insulin glargine, insulin detemir or sitagliptin (a medicine taken by mouth for type 2 diabetes).
Estonian: Kuues muus põhiuuringus, milles osales kokku 4076 II tüüpi diabeediga täiskasvanut, võrreldi Tresibat glargiininsuliini, detemiirinsuliini või sitagliptiiniga (II tüüpi diabeedi suukaudne ravim).
English: The CHMP concluded that Tresiba is effective in controlling blood glucose levels in patients with type 1 and type 2 diabetes.
Estonian: Inimravimite komitee järeldas, et Tresiba on efektiivne vere glükoosisisalduse reguleerimisel I ja II tüüpi diabeediga patsientidel.
English: In children, the effects of Tresiba on blood glucose control were similar to those of insulin detemir.
Estonian: Lastel oli vere glükoosisisalduse reguleerimisel Tresiba toime sarnane detemiirinsuliini toimega.
English: It also noted that Tresiba reduces the risk of hypoglycaemia during the night in patients with type 1 and type 2 diabetes.
Estonian: Komitee märkis ka, et Tresiba vähendab I ja II tüüpi diabeediga patsientidel öise hüpoglükeemia riski.
English: What benefit has Tresiba shown during the studies?
Estonian: Milles seisneb uuringute põhjal Tresiba kasulikkus?
English: How is Tresiba used?
Estonian: Kuidas Tresibat kasutatakse?
English: How does Tresiba work?
Estonian: Kuidas Tresiba toimib?
English: How has Tresiba been studied?
Estonian: Kuidas Tresibat uuriti?
English: What is Tresiba used for?
Estonian: Milleks Tresibat kasutatakse?
English: It is given as an injection under the skin in the thigh, upper arm or abdominal wall (at the front of the waist).
Estonian: Ravimit manustatakse nahaaluse süstina reie, õlavarre või kõhuseina piirkonda.
English: It will also produce educational materials for patients on how to use Tresiba correctly, which they should receive through their doctor together with suitable training.
Estonian: Ettevõte koostab Tresiba õigesti kasutamise teabematerjali ka patsientidele.
English: The full EPAR for Sabervel can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Saberveli kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Sabervel
Estonian: Muu teave Saberveli kohta
English: The usual recommended dose of Sabervel is 150 mg once a day.
Estonian: Saberveli tavaline soovituslik annus on 150 mg üks kord ööpäevas.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Sabervel on 13 April 2012.
Estonian: Euroopa Komisjon andis Saberveli müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 13. aprillil
English: For more information about treatment with Sabervel, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Saberveliga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
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 Sabervel.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: Therefore, the CHMP's view was that, as for Aprovel, the benefit outweighs the identified risk.
Estonian: Seetõttu arvas inimravimite komitee, et nagu ka Aproveli korral, ületab ravimi kasulikkus sellega kaasnevad riskid.
English: The Committee recommended that Sabervel be given marketing authorisation.
Estonian: Komitee soovitas anda Saberveli müügiloa.
English: Sabervel is used in adults who have essential hypertension (high blood pressure).
Estonian: Saberveli kasutatakse täiskasvanud patsientidel, kellel on essentsiaalne hüpertensioon (kõrgvererõhutõbi).
English: The active substance in Sabervel, irbesartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Estonian: Saberveli toimeaine irbesartaan on angiotensiin II retseptori antagonist, mis blokeerib organismis hormooni angiotensiin II toime.
English: This means that Sabervel is similar to a ‘reference medicine' already authorised in the European Union (EU) called Aprovel.
Estonian: See tähendab, et Sabervel on sarnane võrdlusravimiga Aprovel, millel juba on Euroopa Liidus müügiluba.