FrancophonIA/ELRC3.0 huggingface dataset:
English: They are called ‘WHO level III scale' medicines as they are on the highest step of the World Health Organization's three-step pain relief ladder.
Estonian: Neid nimetatakse WHO skaala III astme ravimiteks, sest nad on Maailma Terviseorganisatsiooni kolmeastmelise valuravi skaala kõrgeimal, st kolmandal astmel.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of most of these medicines continue to outweigh their risks, but that warnings on the use of these medicines together with alcohol should be made consistent across the class.
Estonian: Ameti inimravimite komitee jõudis järeldusele, et enamiku asjaomaste ravimite kasulikkus on endiselt suurem kui riskid, kuid hoiatusi nende ravimite tarvitamise kohta koos alkoholiga tuleb ühtlustada.
English: These medicines were reviewed following concerns that alcohol might have an effect on the way they release the active substance in the body.
Estonian: Nende ravimite andmed vaadati läbi kahtluste tõttu, et alkohol võib mõjutada viisi, kuidas neist toimeaine organismis vabaneb.
English: However, for one of the controlled-release systems tested - once-daily capsules using a polymethacrylate-triethylcitrate coating to control the release of morphine - there was a significant interaction with alcohol.
Estonian: Ühe toimeaine vabanemist reguleeriva süsteemi korral - üks kord ööpäevas manustatavad kapslid, mis on morfiini vabanemise reguleerimiseks kaetud polümetakrülaat-trietüültsitraatkihiga - oli aga koostoime alkoholiga märkimisväärne.
English: They include morphine and the related medicines oxycodone and hydromorphone, all of which work by attaching to receptors in the brain and spinal cord to prevent pain.
Estonian: Nende hulka kuuluvad morfiin ja sellega seotud oksükodoon ja hüdromorfoon, mis vaigistavad valu aju ja seljaaju retseptoritega seondudes.
English: Because some of the chemicals used in the controlled-release systems dissolve in alcohol, there is a theoretical possibility that taking these medicines together with alcohol may cause the active substance to be released too quickly.
Estonian: Et toimeaine vabanemist reguleerivates süsteemides kasutatakse teatud keemilisi aineid, mis lahustuvad alkoholis, võib nende ravimite võtmine koos alkoholiga teoreetiliselt põhjustada toimeaine liiga kiiret vabanemist.
English: However, the CHMP noted that all medicines in this class have the potential to interact with alcohol, such as increasing the opioids' sedative effects.
Estonian: Samas märkis inimravimite komitee, et kõikidel selle klassi ravimitel võib olla koostoime alkoholiga, näiteks võib tugevneda opioidide rahustav toime.
English: The CHMP also took information from studies looking at the drinking habits of patients with severe pain into account.
Estonian: Samuti võttis inimravimite komitee arvesse tugeva valu all kannatavate patsientide alkoholitarbimise harjumusi vaadelnud uuringutest saadud teavet.
English: This is called ‘dose dumping' and could put patients at risk of exposure to large doses of the opioid, leading to side effects such as respiratory depression (an inhibition of breathing).
Estonian: Annuse äkilise vabanemise efekti tõttu võivad patsiendid saada opioide liiga suures koguses, mis võib põhjustada selliseid kõrvalnähtusid nagu respiratoorne depressioon (hingamistakistus).
English: There are over 500 different medicines belonging to the WHO level III scale group authorised in European Union (EU) Member States.
Estonian: WHO valuvaigistamise skaala III astmel on üle 500 eri ravimi, millel on Euroopa Liidu liikmesriikides müügiload.
English: Therefore, the Committee recommended that the marketing authorisations for these medicines should be suspended until the companies that make these medicines have reformulated the medicines so that they are more stable in alcohol.
Estonian: Seetõttu soovitas komitee asjaomaste ravimite müügiload peatada, kuni ravimitootjad on ravimite koostist muutnud, et ravimid oleksid alkoholis stabiilsemad.
English: ‘Modified-release' forms of these medicines release the active substance slowly, often over many hours.
Estonian: Toimeainet modifitseeritult vabastav ravimvorm tähendab, et toimeaine vabaneb aeglaselt, sageli mitme tunni jooksul, ja manustamiskordade arv ööpäevas väheneb.
English: The CHMP noted that the use of this medicine in combination with alcohol is already contra-indicated.
Estonian: Inimravimite komitee märkis, et selle ravimi kasutamisel on alkoholi tarbimine juba vastunäidustatud.
English: Therefore, the CHMP concluded that modified-release opioids using the polymethacrylate-triethylcitrate controlled-release system are highly sensitive to alcohol and that there is a risk of dose dumping if patients drink alcohol while taking them.
Estonian: Sellest tulenevalt leidis inimravimite komitee, et toimeainet polümetakrülaat-trietüültsitraadi abil modifitseeritult vabastavad opioidid on ülimalt tundlikud alkoholi suhtes ning kui patsiendid joovad nende tarvitamise ajal alkoholi, on neil annuse äkilise vabanemise risk.
English: The European Medicines Agency has completed a review of the safety and effectiveness of modifiedrelease oral opioid medicines of the WHO level III scale for the management of pain.
Estonian: Euroopa Ravimiamet on lõpetanud Maailma Terviseorganisatsiooni (WHO) valuvaigistamise skaala III astmel kasutatavate toimeainet modifitseeritult vabastavate suukaudsete opioidravimite ohutuse ja efektiivsuse läbivaatamise.
English: These suspensions will remain in force until the companies that make these medicines have reformulated them so that they are more stable in alcohol.
Estonian: Müügiload on peatatud seni, kuni tootjad on muutnud nende ravimite koostist, nii et need on alkoholis stabiilsemad.
English: The CHMP used the results of these studies to predict what would happen if these medicines were taken with alcohol.
Estonian: Uuringute tulemuste põhjal oletas inimravimite komitee, mis juhtuks nende ravimite võtmisel koos alkoholiga.
English: The CHMP concluded that around half of the controlled-release systems tested showed a slight increase in the amount of active substance they released when placed in an alcohol solution, but that this effect was mild and would only have a minor effect on the release of the active substance.
Estonian: Inimravimite komitee järeldas, et ligikaudu poolte uuritud süsteemide korral vabanes toimeainet alkoholilahusega kokku puutudes veidi rohkem kui tavaliselt, kuid erinevus ei olnud märkimisväärne ning selle mõju toimeaine vabastamisele oli tähtsusetu.
English: The CHMP reviewed the results of laboratory studies looking at the way that controlled-release systems act when they are placed in solutions containing alcohol.
Estonian: Inimravimite komitee vaatas läbi laboriuuringute tulemused toimeaine vabanemist reguleerivate süsteemide toimimise kohta alkoholi sisaldavates lahustes.
English: What are modified-release oral medicines of the WHO level III scale for the management of pain?
Estonian: Mis on WHO valuvaigistamise skaala III astmel kasutatavad toimeainet modifitseeritult vabastavad suukaudsed ravimid?
English: This ladder gives recommendations on the order in which painkillers of increasing strength should be used to control a patient's pain1.
Estonian: Skaalat kasutatakse valuvaigistite järjestamise soovitamiseks vastavalt nende toime tugevusele 1.
English: This means that almost a full day's dose of morphine would be released all at once if a patient were to take the capsule with large drink of neat strong liquor, such as whisky or vodka.
Estonian: See tähendab, et kui patsient võtaks kapsli koos suure klaasi lahjendamata kange alkoholiga, näiteks viski või viinaga, saaks ta korraga terve päeva morfiiniannuse.
English: break down slowly in the body or limit the active substance's release, such as cellulose-based substances and polymers.
Estonian: Toimeainet modifitseeritult vabastavate tablettide ja kapslite valmistamisel kombineeritakse toimeaine muude ainetega, mis lagunevad organismis aeglaselt või piiravad toimeaine vabanemist, näiteks tselluloosipõhised ained ja polümeerid.
English: Questions and answers on the review of modified-release oral opioid medicines of the WHO level III scale for the management of pain
Estonian: Teave WHO valuvaigistamise skaala III astmel kasutatavate toimeainet modifitseeritult vabastavate suukaudsete opioidravimite läbivaatamise kohta
English: A European Commission decision on this opinion will be issued in due course.
Estonian: Inimravimite komitee jäi nendele seisukohtadele ka pärast otsuse läbivaatamist.
English: Companies responses provided on: 25 January 2010, 4 May 2010 and 2 July 2010 Opinion date:
Estonian: Pärast soovituste läbivaatamist kinnitas komitee need 18. novembril 2010.
English: They should consider switching patients currently taking opioids containing the polymethacrylate-triethylcitrate controlled-release system to alternatives while the suspension is in force.
Estonian: Toimeaine vabanemist polümetakrülaat-trietüültsitraadiga reguleerivate süsteemide korral peavad nad kaaluma muude ravimite kasutamist ajal, kui asjaomaste ravimite müügiload on peatatud.
English: However, for modified-release medicines that contain a ‘polymethacrylate-triethylcitrate controlled release system', the Committee concluded that the marketing authorisations should be suspended.
Estonian: Komitee otsustas, et toimeainet polümetakrülaat-trietüültsitraadi abil modifitseeritult vabastavate ravimite müügiload tuleb peatada.
English: INN + Strength
Estonian: Väljamõeldud nimetus INN + tugevus
English: Marketing authorisaton holder
Estonian: Müügiloa hoidja
English: Member State in EEA
Estonian: Liikmesriik EL/EMP
English: Meda Pharma Gmbh & Co. Kg
Estonian: Meda Pharma Gmbh & Co.
English: Ratiopharm Gmbh Flupirtinmaleat Ratiopharm
Estonian: Flupirtinmaleat Ratiopharm
English: Farmacêuticos, S.A.
Estonian: Meda Pharma - Produtos Farmacêuticos, S.A.
English: Flupirtinmaleat Tamarang
Estonian: Flupirtinmaleat Tamarang Flupirtiinmaleaat, 100 mg kapsel
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for flupirtine-containing medicinal products
Estonian: I lisa Ravimite ja pakendi suuruste loetelu
English: Hormosan Pharma Gmbh
Estonian: Ratiopharm Gmbh
English: • An educational plan for patients which is aimed at risk minimisation and to support safe and effective use for the product.
Estonian: • Koolitusplaan patsientidele, mille eesmärgiks on riski vähendamine ning ravimi ohutu ja tõhusa kasutamise tagamine.
English: ¾ The Member States must ensure that the education plans for physicians, health care providers, and patients contain the measures a) to m) as detailed below, and are suitable for the purpose of minimising adverse events associated with the intravitreal injection procedure (e.g. endophthalmitis) prior to marketing.
Estonian: Euroopa Liidu liikmesriigid peavad tagama, et arstide, tervishoiuteenuse pakkujate ja patsientide koolitusplaanid hõlmavad meetmeid a) kuni m), nagu allpool üksikasjalikult kirjeldatud, ja sobima klaaskehasse süstimise protseduuriga (nt endoftalmiidi puhul) kaasnevate kõrvaltoimete minimeerimiseks enne turustamist.
English: This plan shall consist of measures aiming to minimise adverse events associated with the intravitreal injection procedure (e.g. endophthalmitis) through adequate education about: a) The intravitreal procedure as it was performed in the pivotal clinical studies b) Sterile techniques to minimize risk of infection c) Use of antibiotics d) Use of povidone iodine e) Performing lid scrubs f) Use of anesthetic to ensure patient comfort g) Techniques for the intravitreal injection h) Management of intraocular pressure (IOP) i) Management of endophthalmitis j) Understanding the risk factors involved in developing endophthalmitis k) Reporting of serious adverse events
Estonian: kaasnevate kõrvaltoimete vähendamisele vastava koolituse abil: a) klaaskehasse süstimise protseduur, nagu seda tehti olulise tähtsusega kliinilistes uuringutes, b) steriilsed meetodid nakkusohu minimeerimiseks, c) antibiootikumide kasutamine, d) polüvidoonjodiidi kasutamine, e) silmalau puhastamine, f) anesteetikumi kasutamine patsiendi mugavuse tagamiseks, g) klaaskehasse süstimise tehnika, h) silmasisese rõhu (IOP) kontrollimine, i) endoftalmiidi ravimine, j) endoftalmiidi tekkega seotud riskifaktorite mõistmine, k) tõsistest kõrvaltoimetest teatamine.
English: • An educational plan for physicians and health care providers which is aimed at risk minimisation and to support safe and effective use for the product.
Estonian: • Koolitusplaan arstidele ja tervishoiuteenuse pakkujatele, mille eesmärgiks on riski vähendamine ning ravimi ohutu ja tõhusa kasutamise tagamine.
English: This plan shall consist of measures to provide adequate education on: l) Key signs and symptoms of serious adverse events associated with the intravitreal injection procedure m) When to seek urgent attention from the health care provider
Estonian: See plaan koosneb allpool loetletud abinõudest piisavate teadmiste andmiseks: l) klaaskehasse süstimise protseduuriga kaasnevate tõsiste kõrvaltoimete tähtsaimad nähud ja sümptomid, m) millal otsida kiiresti abi tervishoiuteenuse pakkujalt?
English: EU/1/17/1176
Estonian: EU/1/17/1176/001 Yargesa
English: 84 x 1 capsules (unit dose)
Estonian: 84 x 1 kapslit (ühikuannus)
English: 100 mg Capsule, hard Oral use blister (PVC/ PCTFE/Alu)
Estonian: Blisterpakend (PVC/PCTFE/alu)
English: Yargesa
Estonian: Suukaudne
English: The marketing authorisation was renewed on 9 October 2003 and on 9 October 2008.
Estonian: Müügiluba pikendati 9. oktoobril 2003 ja 9. oktoobril 2008.
English: Similar results were seen after a year.
Estonian: Aasta möödudes olid tulemused sarnased.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Simulect to Novartis Europharm Limited on 9 October 1998.
Estonian: Euroopa Komisjon andis Simulecti müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, ettevõttele Novartis Europharm Limited 9. oktoobril 1998.
English: This summary was last updated in 10-2008.
Estonian: Kokkuvõtte viimane uuendus: 10-2008.
English: It should be given under qualified medical supervision.
Estonian: Seda tuleb manustada pädevate meditsiinitöötajate järelevalve all.
English: The Committee recommended that Simulect be given marketing authorisation.
Estonian: Komitee soovitas anda Simulectile müügiloa.
English: Simulect has been assessed in three main studies involving a total of 1,067 adults who were having a kidney transplant.
Estonian: Simulecti kasutamist hinnati kolmes põhiuuringus, milles osales kokku 1067 täiskasvanud neerusiirdamispatsienti.
English: Other information about Simulect:
Estonian: Muu teave Simulecti kohta
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) SIMULECT EPAR summary for the public
Estonian: EUROOPA AVALIK HINDAMISARUANNE SIMULECT Kokkuvõte üldsusele
English: Simulect must not be used during pregnancy or breast-feeding.
Estonian: Raseduse ega imetamise ajal Simulecti kasutada ei tohi.
English: The first injection should be given a maximum of two hours before transplantation surgery, and the second four days after the transplant, unless the patient has had a severe hypersensitivity (allergic) reaction or has complications after the operation, such as loss of the new kidney.
Estonian: Esimene süst tehakse kuni kaks tundi enne siirdamisoperatsiooni ja teine neli päeva pärast siirdamist, välja arvatud juhul, kui patsiendil on tekkinud raske ülitundlikkusreaktsioon (allergiline reaktsioon) või kui on tekkinud operatsioonijärgseid tüsistusi, näiteks siiratud neeru kaotus (toimimise lakkamine).
English: This reduces the number of activated T-lymphocytes, lowering the risk of the transplant being rejected.
Estonian: See kahandab aktiveeritud T-lümfotsüütide hulka ja vähendab äratõukereaktsiooni ohtu.
English: Simulect is given as two injections.
Estonian: Simulecti manustatakse kahe süstina.
English: In children weighing less than 35 kg, it is 20 mg, given as two 10 mg doses.
Estonian: Alla 35 kg kaaluvate laste annus on 20 mg, mis manustatakse kahe 10 mg annusena.
English: Simulect is given into a vein, either as a ‘bolus' injection (given all at once) or as an infusion over 20 to 30 minutes.
Estonian: Simulecti manustatakse veeni kas boolussüstina (kogu annus korraga) või infusioonina 20-30 minuti jooksul.
English: Simulect was more effective than placebo.
Estonian: Simulect oli platseebost efektiivsem.
English: The studies in children and adolescents showed that the lower dose of Simulect was appropriate for children, and that adolescents could use the adult dose.
Estonian: Laste ja noorukite uuringud näitasid, et lastele sobis paremini Simulecti väiksem annus ning noorukid võisid kasutada täiskasvanute annust.
English: Looking at the results of the first two studies taken together, 40% of the patients receiving Simulect in addition to dual therapy failed treatment over six months (145 out of 363), compared with 56% of the patients receiving placebo (201 out of 359).
Estonian: Kahe esimese uuringu koondtulemuste põhjal ebaõnnestus kuue kuu möödudes ravi 40%-l patsientidest (145 patsiendil 363-st), kellele manustati Simulecti lisaks kahe preparaadiga ravile, ent platseebo korral ebaõnnestus ravi 56%-l patsientidest (201 patsiendil 359-st).
English: In the first two studies, most of the 722 patients were also taking ciclosporin and corticosteroids (‘dual therapy'), with some patients also taking azathioprine or mycophenolate mofetil.
Estonian: Kahes esimeses uuringus kasutas enamik 722 patsiendist ka tsüklosporiini ja kortikosteroide (kahe preparaadiga ravi) ning mõni patsient kasutas ka asatiopriini või mükofenolaatmofetiili.
English: In adults, the most common side effects (seen in more than 20% of patients) were constipation, urinary tract infections (infection of the structures that carry urine), pain, nausea (feeling sick), peripheral oedema (swelling), hypertension (high blood pressure), anaemia (low red blood cell counts), headache, hyperkalaemia (high blood potassium levels), hypercholesterolaemia (high blood cholesterol levels), surgical wound complication, weight increase, increased serum creatinine (a marker of kidney problems), hypophosphataemia (low blood phosphate levels), diarrhoea and upper respiratory tract infection (colds).
Estonian: Täiskasvanutel olid kõige sagedamad kõrvalnähud (esinenud enam kui 20%-l patsientidest) kõhukinnisus, kuseteede nakkused, valu, iiveldus, perifeerne ödeem (turse), hüpertensioon (kõrge vererõhk), aneemia (punaliblede vähesus), peavalu, hüperkaleemia (vere liigne kaaliumisisaldus), hüperkolesteroleemia (vere liigne kolesteroolisisaldus), operatsioonihaava tüsistus, kehakaalu suurenemine, seerumi kreatiniinisisalduse (neeruprobleemide marker) suurenemine, hüpofosfateemia (vere väike fosfaadisisaldus), kõhulahtisus ja ülemiste hingamisteede nakkus (nohu).
English: Why has Simulect been approved?
Estonian: Miks Simulect heaks kiideti?
English: It contains the active substance basiliximab.
Estonian: See sisaldab toimeainena basiliksimabi.
English: In adults and children weighing more than 35 kg, the recommended total dose is 40 mg, given as two 20 mg doses.
Estonian: Soovituslik koguannus täiskasvanutele ja üle 35 kg kaaluvatele lastele on 40 mg, mis manustatakse kahe 20 mg annusena.
English: In the third study, all 345 adults were taking ciclosporin, steroids and azathioprine (‘triple therapy').
Estonian: Kolmanda uuringu kõik 345 täiskasvanut kasutasid tsüklosporiini, steroide ja asatiopriini (kolme preparaadiga ravi).
English: Simulect should only be prescribed and given by a doctor who has experience in the use of immunosuppressive treatment following an organ transplant.
Estonian: Simulecti võib määrata ja manustada ainult elundi siirdamise järgses immuunvastust vähendavas ravis kogenud arst.
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found on certain cells in the body.
Estonian: Monoklonaalne antikeha on antikeha (teatud valk), mis on ette nähtud ära tundma organismi teatud rakkudes leiduvat spetsiifilist struktuuri (antigeeni), ja sellega seonduma.
English: Simulect is used in combination with other medicines used to prevent organ rejection, such as ciclosporin, corticosteroids, azathioprine and mycophenolate mofetil.
Estonian: Simulecti kasutatakse koos teiste elundi äratõukereaktsiooni ennetamise ravimitega, näiteks koos tsüklosporiini, kortikosteroidide, asatiopriini ja mükofenolaatmofetiiliga.
English: Simulect is a powder and solvent that are made up into a solution for injection or infusion (drip into a vein).
Estonian: Simulect on pulber ja lahusti, millest valmistatakse süste- või infusioonilahus (veeni tilgutatav lahus).
English: What is the risk associated with Simulect?
Estonian: Mis riskid kaasnevad Simulectiga?
English: All three studies compared the effectiveness of Simulect with that of placebo (a dummy treatment).
Estonian: Kõigis kolmes uuringus võrreldi Simulecti efektiivsust platseeboga (näiv ravim).
English: Simulect is used in adults and children aged over one year, to prevent the body from rejecting a newly transplanted kidney.
Estonian: Simulecti kasutatakse täiskasvanutel ja vähemalt ühe aasta vanustel lastel äsja siiratud neeru äratõukereaktsiooni ennetamiseks.
English: In the third study, fewer patients receiving Simulect with triple therapy failed treatment (26%) than those receiving placebo (40%).
Estonian: Kolmandas uuringus oli patsiendirühmas, kus Simulecti manustati lisaks kolme preparaadiga ravile, ebaõnnestunud raviga patsiente vähem (26%) kui platseeborühmas (40%).
English: By binding to CD25, basiliximab blocks the activity of interleukin-2, reducing the rate at which the lymphocytes multiply.
Estonian: CD25-ga seondudes blokeerib basiliksimab interleukiin-2 toime, aeglustades lümfotsüütide paljunemist.
English: The active substance in Simulect, basiliximab, is a monoclonal antibody.
Estonian: Simulectis toimeainena sisalduv basiliksimab on monoklonaalne antikeha.
English: What is Simulect?
Estonian: Mis on Simulect?
English: For the full list of all side effects reported with Simulect, see the Package Leaflet.
Estonian: Simulecti kohta teatatud kõrvalnähtude täieliku loetelu leiate pakendi infolehelt.
English: In children, the side effects seen in more than 20% of patients were urinary tract infections, hypertrichosis (excess body hair), rhinitis (stuffy and runny nose), pyrexia (fever), hypertension, upper respiratory tract infection, viral infection, sepsis (blood infection) and constipation.
Estonian: Lastel esinenud kõrvalnähud (enam kui 20%-l patsientidest) olid kuseteede nakkused, hüpertrihhoos (liigkarvasus), riniit (ninakinnisus ja ninavoolus), püreksia (palavik), hüpertensioon, ülemiste hingamisteede nakkus, viirusnakkus, sepsis (nakkusveresus) ja kõhukinnisus.
English: Two additional studies looked at how Simulect is handled in the body when it is given to children aged over one year or to adolescents.
Estonian: Kahes täiendavas uuringus vaadeldi Simulecti toimet noorukite või vähemalt üheaastaste laste organismile
English: The main measure of effectiveness was the number of treatment failures (death, loss of the new kidney or signs of rejection) over the first year after the transplant.
Estonian: Efektiivsust mõõdeti põhiliselt nende patsientide arvu järgi, kellel siirdamise järgse aasta vältel ravi ebaõnnestus (surm, siiratud neeru kaotus või äratõukenähud).
English: In the studies, side effects were similar in patients taking Simulect and those receiving placebo, in combination with other medicines.
Estonian: Kõrvalnähud olid uuringutes kas Simulecti või platseebot lisaks teistele ravimitele kasutanud patsientidel sarnased.
English: What benefit has Simulect shown during the studies?
Estonian: Milles seisneb uuringute põhjal Simulecti kasulikkus?
English: CD25 is a receptor for the messenger interleukin-2, which stimulates the T-lymphocytes to divide.
Estonian: CD25 on T-lümfotsüütide jagunemist stimuleeriva virgatsaine interleukiin-2 retseptor.