FrancophonIA/ELRC3.0 huggingface dataset:
English: Of the patients treated with Alofisel, combined remission occurred in almost 50% of patients (53 out of 107); this compared with 34% of patients (36 out of 105) receiving placebo.
Estonian: Kombineeritud remissiooni saavutas peaaegu 50% Alofiseliga ravitud patsientidest (53 patsienti 107st) ja 34% platseebot saanud patsientidest (36 patsienti 105st).
English: Data on the safety of Alofisel are limited but they provide enough information on the pattern of side effects.
Estonian: Alofiseli ohutusandmed on piiratud, kuid annavad piisavalt teavet kõrvalnähtude kohta.
English: This encourages the fistula to heal and close.
Estonian: Selle tulemusena fistul paraneb ja sulgub.
English: What is Alofisel and what is it used for?
Estonian: Mis on Alofisel ja milleks seda kasutatakse?
English: To make this medicine, the cells are selected and cultivated in the laboratory to increase their number.
Estonian: Selle ravimi valmistamiseks valitakse välja rakud ja neid kultiveeritakse laboris, et suurendada rakkude hulka.
English: When injected into the walls of the fistula, these cells can help to reduce inflammation and support the growth of new tissue.
Estonian: Fistuli seintesse süstimisel võivad need rakud vähendada põletikku ja soodustada uue koe kasvu.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Alofisel can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Estonian: Harvikravimite komitee arvamuse kokkuvõte Alofiseli kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Alofisel must not be used in patients with hypersensitivity (allergy) to bovine serum (the clear liquid in blood from cattle) or to any of the ingredients of Alofisel.
Estonian: Alofiseli ei tohi kasutada patsientidel, kes on ülitundlikud (allergilised) veiseseerumi (selge vedelik veiste veres) või Alofiseli mis tahes muu koostisosa suhtes.
English: After preparing the fistulas for treatment in an operating room, the contents of two vials (each containing 30 million cells) are injected around the internal openings and two further vials through the external openings into the walls of the fistula.
Estonian: Pärast fistulite ettevalmistamist raviks operatsioonisaalis süstitakse kahe viaali sisu (ühes viaalis on 30 miljonit rakku) sisemiste avade ümbrusse ja seejärel süstitakse veel kahe viaali sisu läbi välimiste avade fistuli seintesse.
English: The main measure of effectiveness, called ‘combined remission', was the closing of abnormal external openings together with lack of fluid collections of more than 2 cm associated with internal passages (since these are likely to re-open the fistula).
Estonian: Efektiivsuse põhinäitaja - nn kombineeritud remissioon - oli ebanormaalsete välimiste avade sulgumine koos vedelikuga täitunud > 2 cm sisemiste kanalite puudumisega (kuna need võivad fistuli uuesti avada).
English: The full EPAR for Alofisel can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Alofiseli kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Treatment with conventional or biological medicines had not worked in these patients.
Estonian: Nendel patsientidel ei olnud tekkinud ravivastust tava- või bioloogilistele ravimitele.
English: The patient is given an anaesthetic (either to put the patient to sleep or to numb the treatment area).
Estonian: Patsiendile manustatakse anesteetikumi (patsiendi uinutamiseks või ravipiirkonna tuimastamiseks).
English: Why is Alofisel approved?
Estonian: Miks Alofisel heaks kiideti?
English: This is a type of medicine that contains cells or tissues that have been modified so that they can be used to cure, diagnose or prevent a disease.
Estonian: Somaatilise rakuteraapia ravim sisaldab rakke või kudesid, mida on töödeldud nii, et neid saab kasutada haiguse ravimiseks, diagnoosimiseks või ennetamiseks.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Alofisel have also been included in the summary of product characteristics and the package leaflet.
Estonian: Alofiseli ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: One main study, involving 212 patients with Crohn's disease and complex anal fistulas, found Alofisel more effective than placebo (a dummy treatment) 24 weeks after treatment.
Estonian: Ühes põhiuuringus, milles osales 212 komplekssete pärakufistulitega Crohni tõvega patsienti, oli Alofisel 24 nädalat pärast ravi efektiivsem kui platseebo (näiv ravim).
English: This is a summary of the European public assessment report (EPAR) for Alofisel.
Estonian: See on ravimi Alofisel Euroopa avaliku hindamisaruande kokkuvõte.
English: It is not intended to provide practical advice on how to use Alofisel.
Estonian: Hindamisaruandes ei anta Alofiseli kasutamise praktilisi nõuandeid.
English: Alofisel is of value in the treatment of complex anal fistulas that have not responded well to other treatments.
Estonian: Alofisel on kasulik selliste komplekssete pärakufistulite ravis, mis ei ole piisaval määral allunud muule ravile.
English: Because the number of patients with anal fistula is low, the disease is considered ‘rare', and Alofisel was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 October 2009.
Estonian: Et pärakufistuliga patsientide arv on väike ja see haigus esineb harva, nimetati Alofisel 8. oktoobril 2009 harvikravimiks.
English: Complex fistulas are those with several abnormal passages and openings, or with passages that go deep inside the body, or where there are other complications such as collection of pus.
Estonian: Komplekssed fistulid koosnevad mitmest ebanormaalsest kanalist ja avast, paiknevad sügavamal või kaasneb nendega muid tüsistusi, näiteks mäda kogunemine.
English: Alofisel is a medicine that is used to treat complex anal fistulas in adults with Crohn's disease (an inflammatory condition of the gut) when a conventional or biological medicine has not worked well enough.
Estonian: Alofisel on ravim, mida kasutatakse komplekssete pärakufistulite raviks Crohni tõvega (põletikuline soolehaigus) täiskasvanutel, kui tava- või bioloogilised ravimid ei ole andnud piisavat tulemust.
English: What are the risks associated with Alofisel?
Estonian: Mis riskid Alofiseliga kaasnevad?
English: The most common side effects with Alofisel (which may affect up to 1 in 10 people) are anal abscess (a swollen area with a collection of pus), proctalgia (anal pain), anal fistula and pain during treatment.
Estonian: Alofiseli kõige sagedamad kõrvalnähud (võivad esineda kuni 1 patsiendil 10st) on anaalabstsess (pärakumädanik), proktalgia (pärakuvalu), pärakufistul ja valu ravi ajal.
English: Alofisel contains the active substance darvadstrocel, which comprises stem cells removed from fat tissue of adult donors.
Estonian: Alofisel sisaldab toimeainena darvadstrotseeli, mis sisaldab täiskasvanud doonorite rasvkoest eraldatud tüvirakke.
English: How is Alofisel used?
Estonian: Kuidas Alofiseli kasutatakse?
English: For more information about treatment with Alofisel, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Alofiseliga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: The company that markets Alofisel will provide educational material for healthcare professionals on how to give the medicine correctly and on the possibility of passing on an infection to the patient.
Estonian: Alofiseli turustaja varustab tervishoiutöötajad teabematerjaliga, kus selgitab ravimi õiget kasutamist ja patsientide infektsiooniriski.
English: For practical information about using Alofisel, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Alofiseli kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: Alofisel should be given only by specialist doctors experienced in the diagnosis and treatment of the condition for which it is used.
Estonian: Alofiseli tohivad patsientidele manustada vaid eriarstid, kellel on asjaomase näidustatud haigusseisundi diagnoosimise ja ravi kogemus.
English: It is a type of advanced therapy medicine called a ‘somatic cell therapy product'.
Estonian: See on somaatilise rakuteraapia ravimite hulka kuuluv uudne ravim.
English: How does Alofisel work?
Estonian: Kuidas Alofisel toimib?
English: The medicine can only be obtained with a prescription.
Estonian: See on retseptiravim.
English: What benefits of Alofisel have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Alofiseli kasulikkus?
English: Fistulas are abnormal passages between the lower parts of the gut and the skin near the anus.
Estonian: Fistulid ehk uurised on ebanormaalsed ühenduskanalid soolestiku alumiste osade ja pärakuümbruse naha vahel.
English: Alofisel is made up of ‘mesenchymal stem cells' from the fat tissue of a donor.
Estonian: Alofisel sisaldab mesenhüümi tüvirakke, mis on eraldatud doonori rasvkoest.
English: 30 film-coated tablets in blisters
Estonian: 30 õhukese polümeerikattega tabletti blistrites
English: The marketing authorisation was renewed on 18 August 2003 and on 18 August 2008.
Estonian: Müügiluba pikendati 18. augustil 2003 ja 18. augustil 2008.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Prandin to Novo Nordisk A/S on 29 January 2001.
Estonian: Euroopa Komisjon andis Prandini müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, ettevõttele Novo Nordisk A/S 29.jaanuaril 2001.
English: This dose may need to be increased after one or two weeks.
Estonian: Nädala või kahe pärast võib osutuda vajalikuks seda annust suurendada.
English: Prandin is not recommended for patients below 18 years of age because of a lack of information on safety and effectiveness in this age group.
Estonian: Prandini ei soovitata kasutada alla 18-aastastel patsientidel, sest ohutuse ja efektiivsuse andmed selle vanuserühma kohta puuduvad.
English: It is available as round tablets (white: 0.5 mg; yellow: 1 mg; peach: 2 mg).
Estonian: Seda turustatakse ümmarguste tablettidena (valged: 0,5 mg, kollased: 1 mg või virsikuvärvi: 2 mg).
English: Prandin is a medicine that contains the active substance repaglinide.
Estonian: Prandin on ravim, mis sisaldab toimeainena repagliniidi.
English: A doctor should regularly test the patient's blood glucose to find the lowest effective dose.
Estonian: Arst peab patsiendi vere glükoosisisaldust regulaarselt kontrollima, et leida väikseim efektiivne annus.
English: The recommended starting dose is 0.5 mg.
Estonian: Soovitatav algannus on 0,5 mg.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PRANDIN EPAR summary for the public
Estonian: EUROOPA AVALIK HINDAMISARUANNE PRANDIN Kokkuvõte üldsusele
English: The Committee recommended that Prandin be given marketing authorisation.
Estonian: Komitee soovitas anda Prandinile müügiloa.
English: Why has Prandin been approved?
Estonian: Miks Prandin heaks kiideti?
English: The main studies compared Prandin with other medicines used in type 2 diabetes (glibenclamide, glipizide or gliclazide).
Estonian: Põhiuuringutes võrreldi Prandini muude II tüüpi suhkurtõve raviks kasutatavate ravimitega (glibenklamiid, glipitsiid või gliklatsiid).
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 suhkurtõbi on haigus, mille korral kõhunäärmes ei teki vereglükoosi sisalduse reguleerimiseks piisavalt insuliini või organism ei suuda insuliini tõhusalt kasutada.
English: The raised insulin levels returned to normal after the meal.
Estonian: Pärast söögikorda alanes kõrgenenud insuliinisisaldus taas normaalsele tasemele.
English: In the study where Prandin was added to metformin, the effects of the two medicines were at least additive (equivalent to the effects of the two medicines added together).
Estonian: Uuringus, kus Prandin lisati metformiinile, oli kahe ravimi kogutoime võrdne vähemalt nende ravimite üksiktoimete summaga.
English: If patients are transferred from another anti-diabetes medicine, the recommended starting dose is 1 mg.
Estonian: Juhul kui patsiendi raviks kasutati mõnda muud suhkurtõve ravimit, mis asendatakse Prandiniga, on soovitatavaks algannuseks 1 mg.
English: Other information about Prandin:
Estonian: Muu teave Prandini kohta
English: What is the risk associated with Prandin?
Estonian: Mis riskid Prandiniga kaasnevad?
English: Prandin is taken before meals, normally up to 15 minutes before each main meal.
Estonian: Prandini manustatakse kuni 15 minutit enne iga põhisöögikorda.
English: What is Prandin?
Estonian: Mis on Prandin?
English: The dose is adjusted to give the best control.
Estonian: Parima tulemuse saavutamiseks tuleb annust kohandada.
English: Prandin doses may also need to be adjusted when given with some medicines used in heart conditions, and to treat pain, asthma and other conditions.
Estonian: Samuti võib osutuda vajalikuks kohandada Prandini annust, kui seda manustatakse koos mõne teise ravimiga, mida kasutatakse valu vaigistamiseks või astma või mõne muu tervisehäire raviks.
English: In all studies, Prandin led to a decrease in the level of HbA1c, which showed that blood glucose levels had been controlled to a similar level to that seen with the comparator medicines.
Estonian: Prandin põhjustas kõikides uuringutes HbA1c taseme vähenemist, mis näitas, et glükoosi sisaldust veres suudeti mõjustada võrdlusravimitega samasel määral.
English: The studies measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c) which gives an indication of how well the blood glucose is controlled.
Estonian: Uuringutes mõõdeti teatud aine - glükohemoglobiini (HbA1c) - kontsentratsiooni veres, mis näitab, kui hästi organism reguleerib vereglükoosi sisaldust.
English: The full list is available in the Package Leaflet.
Estonian: Täieliku loetelu leiate pakendi infolehelt.
English: Another study looked at the effect of adding Prandin to metformin.
Estonian: Ühes uuringus vaadeldi Prandini lisamise mõju ravile metformiiniga.
English: How does Prandin work?
Estonian: Kuidas Prandin toimib?
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Prandin's benefits are greater than its risks for the treatment of type 2 diabetes.
Estonian: Inimravimite komitee jõudis otsusele, et Prandini kasulikkus II tüüpi suhkurtõve ravis on suurem kui sellega kaasnevad riskid.
English: The most common side effects with Prandin (seen in between 1 and 10 patients in 100) are hypoglycaemia (low blood glucose levels), abdominal (tummy) pain and diarrhoea.
Estonian: Prandini kõige sagedamad kõrvalnähud (esinenud ühel kuni kümnel patsiendil sajast) on hüpoglükeemia (vere vähene glükoosisisaldus), kõhuvalu ja kõhulahtisus.
English: It should also not be used in patients with diabetic ketoacidosis (high levels of ketones [acids] in the blood), in patients with severe liver problems or in patients also taking gemfibrozil (a medicine used to reduce blood fat levels).
Estonian: Samuti ei tohi ravimit kasutada patsiendid, kellel on diabeetiline ketoatsidoos (ketoonide ja hapete rohkus veres), raske maksahaigus või patsiendid, kes võtavad lisaks gemfribroziili (vere rasvasisaldust vähendav ravim).
English: Prandin should not be used in people who may be hypersensitive (allergic) to repaglinide or any of the other ingredients.
Estonian: Prandini ei tohi kasutada patsiendid, kes on repagliniidi või selle ravimi mõne muu koostisaine suhtes ülitundlikud (allergilised).
English: For the full list of all side effects seen with Prandin, see the Package Leaflet.
Estonian: Prandini kohta teatatud kõrvalnähtude täieliku nimekirja leiate pakendi infolehelt.
English: What benefit has Prandin shown during the studies?
Estonian: Milles seisnes uuringute põhjal Prandini kasulikkus?
English: A total of 2,156 patients received Prandin in all trials combined.
Estonian: Kõigis katsetes kokku manustati Prandini 2156 patsiendile.
English: Prandin can also be used for type 2 diabetes patients whose blood glucose levels are usually controlled well on diet, but are experiencing temporary loss of blood glucose control.
Estonian: Prandini võib kasutada ka nendel II tüüpi suhkurtõvega patsientidel, kelle veresuhkru sisaldus on ajutiselt kontrolli alt väljunud, kuid on tavaliselt reguleeritav dieediga.
English: It is used together with diet and exercise to lower blood glucose (sugar) levels in patients whose hyperglycaemia (high blood glucose levels) cannot be controlled by diet, weight reduction and exercise.
Estonian: Prandini kasutatakse koos dieedi ja kehaliste harjutustega vereglükoosi (-suhkru) sisalduse vähendamiseks patsientidel, kelle hüperglükeemiat (kõrget veresuhkrut) pole võimalik ainuüksi dieedi, kaalu alandamise ja kehaliste harjutustega kontrolli all hoida.
English: It should also not be used in patients with type 1 (insulin-dependent) diabetes who do not have any ‘C-peptide' in their blood (a marker of type 1 diabetes).
Estonian: Ravimit ei tohi kasutada I tüüpi (insuliinisõltuva) suhkurtõvega patsiendid, kelle veri ei sisalda C-peptiidi (I tüüpi suhkurtõve marker).
English: Prandin has been studied in 45 ‘clinical pharmacology' studies (looking at how the medicine works in the body) and 16 clinical trials (looking at its effects in treating type 2 diabetes patients).
Estonian: Prandini toimet organismis on uuritud 45 kliinilis-farmakoloogilises uuringus ja selle efektiivsust II tüüpi suhkurtõvega patsientide ravis 16 kliinilise katse käigus.
English: Prandin helps the pancreas to produce more insulin at mealtimes and is used to control type 2 diabetes.
Estonian: Prandin soodustab söögi ajal kõhunäärmes insuliini tekkimist ning seda kasutatakse II tüüpi suhkurtõve raviks.
English: Prandin produced a good insulin response to a meal within 30 minutes of being dosed in type 2 diabetes patients, leading to a blood glucose-lowering effect throughout the meal.
Estonian: Prandin tekitas väga hea insuliinireaktsiooni einele 30 minutit pärast selle manustamist II tüüpi suhkurtõvega patsientidele.
English: How is Prandin used?
Estonian: Kuidas Prandini kasutatakse?
English: Prandin is used in patients who have type 2 diabetes (non-insulin-dependent diabetes).
Estonian: Prandini kasutatakse II tüüpi suhkurtõvega (insuliinisõltumatu suhkurtõvega) patsientide raviks.
English: How has Prandin been studied?
Estonian: Kuidas Prandini uuriti?
English: The full EPAR for Prandin is available here.
Estonian: Euroopa avaliku hindamisaruande täisteksti Prandini kohta leiate siit.
English: What is Prandin used for?
Estonian: Milleks Prandini kasutatakse?
English: Prandin may also be used with metformin (another anti-diabetes medicine) in type 2 diabetes patients whose blood glucose levels are not satisfactorily controlled on metformin alone.
Estonian: II tüüpi suhkurtõvega patsientidel, kelle veresuhkru sisaldust ainult metformiiniga pole võimalik ohjata, võib Prandini kasutada koos metformiiniga (samuti suhkurtõve ravim).
English: Miglustat Dipharma received a marketing authorisation valid throughout the EU on 18 February 2019.
Estonian: Miglustat Dipharma on saanud müügiloa, mis kehtib kogu ELis, 18. veebruaril 2019.
English: Further information on Miglustat Dipharma can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/miglustat-dipharma.
Estonian: Lisateave Miglustat Dipharma kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/miglustat-dipharma.
English: This overview was last updated in 06-2019
Estonian: Kokkuvõtte viimane uuendus: 06.2019
English: For Niemann-Pick type-C disease, it is two capsules three times a day for patients aged 12 years and over; in younger patients, the dose depends on their weight and height.
Estonian: C-tüüpi Niemanni-Picki tõve korral on see 2 kapslit 3 korda ööpäevas vähemalt 12-aastastel patsientidel; noorematel patsientidel sõltub annus kehamassist ja pikkusest.
English: Miglustat Dipharma (miglustat)
Estonian: Miglustat Dipharma (miglustaat)
English: What measures are being taken to ensure the safe and effective use of Miglustat Dipharma?
Estonian: Mis meetmed võetakse, et tagada ravimi Miglustat Dipharma ohutu ja efektiivne kasutamine?
English: • patients of all ages with Niemann-Pick type-C disease, a potentially fatal disease in which glycosphingolipids build up within cells in the brain and elsewhere in the body.
Estonian: • Mis tahes vanuses patsiendid, kellel on C-tüüpi Niemanni-Picki tõbi, mis on potentsiaalselt surmav haigus, mille korral glükosfingolipiidid ladestuvad ajurakkudes ja mujal organismis.
English: These include loss of coordination, problems with ‘saccadic' (rapid) eye movements that can lead to impaired vision, delayed development, difficulty swallowing, decreased muscle tone, fits and learning difficulties.
Estonian: Need on näiteks koordinatsioonikadu, nägemisvaegust põhjustada võivate sakaadiliste (kiirete) silmaliigutustega seotud probleemid, arengupeetus, neelamisraskused, lihastoonuse vähenemine, epilepsiaepisoodid ja õppimisraskused.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Miglustat Dipharma has been shown to have comparable quality and to be bioequivalent to Zavesca.
Estonian: Euroopa Ravimiamet järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Miglustat Dipharma võrreldav kvaliteet ja bioekvivalentsus ravimiga Zavesca.
English: For more information about using Miglustat Dipharma, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Miglustat Dipharma kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
English: Side effects reported with Miglustat Dipharma are carefully evaluated and any necessary action taken to protect patients.
Estonian: Miglustat Dipharma kõrvaltoimeid hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
English: This means that Miglustat Dipharma contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Zavesca.
Estonian: See tähendab, et Miglustat Dipharma sisaldab sama toimeainet ja toimib samamoodi nagu võrdlusravim Zavesca, millel juba on ELis müügiluba.
English: The recommended starting dose for type-1 Gaucher disease is one capsule three times a day.
Estonian: Soovitatav algannus 1. tüübi Gaucher' tõve korral on 1 kapsel 3 korda ööpäevas.
English: Miglustat Dipharma is intended for long-term use.
Estonian: Miglustat Dipharma on ette nähtud pikaajaliseks kasutamiseks.
English: Because Miglustat Dipharma is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Estonian: Et Miglustat Dipharma on geneeriline ravim ja võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: Miglustat Dipharma is used to treat the neurological symptoms of the disease (symptoms affecting the brain and nerves).
Estonian: Miglustat Dipharmaga ravitakse haiguse neuroloogilisi sümptomeid (aju- ja närvisümptomid).
English: Patients with this disease lack an enzyme called glucocerebrosidase, which results in a glycosphingolipid called glucosylceramide building up in different parts of the body, such as the spleen, liver and bones.
Estonian: Selle haigusega patsientidel puudub ensüüm glükotserebrosidaas, mis põhjustab teatud glükosfingolipiidi - glükosüültseramiidi - ladestumist organismi eri osades, näiteks põrnas, maksas ja luudes.