FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients may also be given a medicine to prevent fever.
Estonian: Patsientidele võib anda ka mõnda ravimit palaviku ennetamiseks.
English: The recommended dose is 1 mg per kilogram bodyweight.
Estonian: Soovitatav annus on 1 mg kehakaalu kilogrammi kohta.
English: Before each infusion, patients should be given an antihistamine to reduce the risk of an allergic reaction.
Estonian: Enne iga infusiooni tuleb patsientidele allergilise reaktsiooni vähendamiseks anda antihistamiini.
English: The company that makes Naglazyme is carrying out studies looking at the long-term safety and effectiveness of Naglazyme in pregnant and breast-feeding women and in children under the age of five years, to see if they develop antibodies (proteins that are produced in the body in response to Naglazyme that could affect the response to treatment) and to look at the medicine's side effects.
Estonian: Naglazyme tootja korraldab uuringud, et uurida Naglazyme pikaajalist ohutust ja efektiivsust rasedatel ja rinnaga toitvatel naistel ning alla viieaastastel lastel, et jõuda selgusele, kas neil tekivad antikehad (valgud, mis tekivad organismis reaktsioonina Naglazymele ja mis võivad mõjutada ravivastust), ning et uurida ravimi kõrvalnähte.
English: Patients can also have reactions to the infusion (such as fever, chills, rash and hives).
Estonian: Patsientidel võivad tekkida reaktsioonid infusioonile (nagu palavik, külmavärinad, lööve ja nahapõletik).
English: Naglazyme galsulfase
Estonian: Naglazyme galsulfaas
English: After 24 weeks, the average distance walked over 12 minutes increased by 109 metres in the patients treated with Naglazyme and by 18 metres in those receiving placebo.
Estonian: Pärast 24 nädalat kestnud ravi suurenes Naglazymega ravitud patsientidel 12 minuti jooksul läbitud vahemaa 109 meetri võrra ja platseebot saanud patsientidel 18 meetri võrra.
English: What is the risk associated with Naglazyme?
Estonian: Mis riskid Naglazymega kaasnevad?
English: What information is still awaited for Naglazyme?
Estonian: Mis teavet Naglazyme kohta veel oodatakse?
English: In studies, the most common side effects with Naglazyme (seen in more than 1 patient in 10) were ear pain, dyspnoea (difficulty breathing), abdominal pain and general pain.
Estonian: Uuringutes olid Naglazyme kõige sagedamad kõrvalnähud (esinenud enam kui 1 patsiendil 10st) kõrvavalu, düspnoe (hingamisraskused), kõhuvalu, üldine valu.
English: It should be given where resuscitation equipment is available in case of a medical emergency.
Estonian: Ravimit võib manustada juhul, kui võimalikuks hädaolukorraks on olemas elustamisvahendid.
English: Naglazyme has been compared with placebo (a dummy treatment) in one main study involving 39 patients with MPS VI aged between five and 29 years.
Estonian: Naglazymet võrreldi platseeboga (näiv ravim) ühes põhiuuringus, kus osales 39 MPS VI-ga patsienti vanuses 5-29 aastat.
English: If the enzyme is not present, GAGs cannot be broken down and they build up in the cells.
Estonian: Kui seda ensüümi ei ole, ei saa organism glükosaminoglükaane lõhustada ning need kogunevad rakkudesse.
English: The company is also carrying out studies to determine the best dose to give to patients on a regular longterm basis.
Estonian: Lisaks korraldab tootja uuringud, et teha kindlaks, milline on tõhusaim annus korrapärase ja pikaajalise kasutamise korral.
English: The CHMP decided that Naglazyme's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et Naglazyme kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Nagalzyme can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Estonian: Harvikravimite komitee arvamuse kokkuvõte Nagalzyme kohta on ameti veebilehel: website ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The full EPAR for Naglazyme can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Nagalzyme kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
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 Naglazyme.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: For more information about treatment with Naglazyme, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Nagalzymega toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Naglazyme is used to treat patients who have mucopolysaccharidosis VI (MPS VI or Maroteaux-Lamy syndrome).
Estonian: Naglazymet kasutatakse nende patsientide raviks, kellel on mukopolüsahharidoos VI (MPS VI ehk Maroteaux-Lamy sündroom).
English: Naglazyme should not be used in people who may be hypersensitive (allergic) to galsulfase or any of the other ingredients.
Estonian: Naglazymet ei tohi kasutada patsiendid, kes võivad olla galsulfaasi või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
English: For the full list of all side effects reported with Naglazyme, see the package leaflet.
Estonian: Naglazyme kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: Why has Naglazyme been approved?
Estonian: Miks Naglazyme heaks kiideti?
English: Because the number of patients with MPS VI is low, the disease is considered ‘rare', and Naglazyme was designated an ‘orphan medicine' (a medicine used in rare diseases) on 14 February 2001.
Estonian: Et MPS VI patsientide arv on väike ja haigus esineb harva, nimetati Naglazyme 14. veebruaril 2001 harvikravimiks.
English: The Committee noted that, although patients under five years of age were not included in the main study of Naglazyme, it is important that they are treated if they have a severe form of MPS VI. Naglazyme has been authorised under ‘exceptional circumstances'.
Estonian: Inimravimite komitee märkis, et kuigi alla viieaastased patsiendid Naglazyme põhiuuringus ei osalenud, on nende ravimine oluline, kui neil on raskekujuline MPS VI.
English: Naglazyme helps to break down the GAGs and stop them building up in the cells.
Estonian: Naglazyme aitab lõhustada glükosaminoglükaane ning peatab nende kuhjumise rakkudesse.
English: Galsulfase is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce the enzyme.
Estonian: Galsulfaasi valmistatakse rekombinant-DNA-tehnika abil: seda toodab rakk, millele on lisatud ensüümi teket võimaldav geen (DNA).
English: What is Naglazyme used for?
Estonian: Milleks Naglazymet kasutatakse?
English: Enzyme replacement therapy provides patients with the enzyme they are lacking.
Estonian: Ensüümasendusravi käigus manustatakse patsiendile puuduvat ensüümi.
English: Naglazyme treatment should be supervised by a doctor who has experience in the management of patients with MPS VI or similar diseases.
Estonian: Ravi Naglazymega võib toimuda üksnes MPS VI või sarnaste haigustega patsientide ravis kogenud arsti järelevalve all.
English: The active substance in Naglazyme, galsulfase, is a copy of the human enzyme N-acetylgalactosamine 4-sulfatase.
Estonian: Naglazyme toimeaine galsulfaas on inimese ensüümi N-atsetüülgalaktosamiin-4sulfataasi koopia.
English: How is Naglazyme used?
Estonian: Kuidas Naglazymet kasutatakse?
English: Naglazyme is an enzyme replacement therapy.
Estonian: Neglazymega tehakse ensüümasendusravi.
English: Naglazyme was more effective than placebo.
Estonian: Naglazyme oli platseebost efektiivsem.
English: Naglazyme is a solution for infusion (drip into a vein) that contains the active substance galsulfase (1 mg/ml).
Estonian: Naglazyme on infusioonilahus (veeni tilgutatav lahus), mis sisaldab toimeainena galsulfaasi.
English: This is a summary of the European public assessment report (EPAR) for Naglazyme.
Estonian: Käesolev dokument on ravimi Naglazyme Euroopa avaliku hindamisaruande kokkuvõte.
English: What benefit has Naglazyme shown during the studies?
Estonian: Milles seisnes uuringute põhjal Naglazyme kasulikkus?
English: This disease is caused by the lack of an enzyme called N-acetylgalactosamine 4-sulfatase, which is needed to break down substances in the body called glycosaminoglycans (GAGs).
Estonian: Seda ensüümi on vaja süsivesikute glükosaminoglükaanide (GAG) lõhustamiseks organismis.
English: The medicine can only be obtained with a prescription.
Estonian: Naglazyme on retseptiravim.
English: How does Naglazyme work?
Estonian: Kuidas Naglazyme toimib?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Dafiro HCT on 4 November 2009.
Estonian: Euroopa Komisjon andis Dafiro HCT müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 4. novembril 2009.
English: Dafiro HCT is taken by mouth as one tablet once a day, at the same time of the day and preferably in the morning.
Estonian: Dafiro HCT-d võetakse suu kaudu üks tablett üks kord ööpäevas alati samal ajal, soovitavalt hommikul.
English: The full EPAR for Dafiro HCT can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Dafiro HCT kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The CHMP therefore decided that Dafiro HCT's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et Dafiro HCT kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: For more information about treatment with Dafiro HCT, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Dafiro HCT-ga 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 Dafiro HCT.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: This is a summary of the European public assessment report (EPAR) for Dafiro HCT.
Estonian: See on ravimi Dafiro HCT Euroopa avaliku hindamisaruande kokkuvõte.
English: The CHMP noted that patients already taking the three active substances would be more likely to comply with their treatment if prescribed Dafiro HCT which combines the three substances in a single tablet.
Estonian: Inimravimite komitee märkis, et patsiendid, kes juba manustavad neid kolme toimeainet, järgivad raviskeemi tõenäoliselt paremini, kui neile anda Dafiro HCT-d, milles on kolm toimeainet ühes tabletis.
English: The main study showed the benefit of the highest strength of Dafiro HCT in lowering the blood pressure.
Estonian: Põhiuuring näitas Dafiro HCT suurima annuse mõju vererõhu alandamisel.
English: The daily dose of Dafiro HCT should not exceed 10 mg of amlodipine, 320 mg of valsartan and 25 mg of hydrochlorothiazide.
Estonian: Dafiro HCT ööpäevane annus ei tohi olla üle 10 mg amlodipiini, 320 mg valsartaani ja 25 mg hüdroklorotiasiidi.
English: The three active substances in Dafiro HCT are anti-hypertensive medicines that are already in use in the European Union (EU).
Estonian: Dafiro HCT kolm toimeainet on Euroopa Liidus juba kasutatavad kõrgvererõhuravimid.
English: Dafiro HCT is a medicine that contains three active substances, amlodipine, valsartan and hydrochlorothiazide.
Estonian: Dafiro HCT on ravim, mis sisaldab kolme toimeainet: amlodipiini, valsartaani ja hüdroklorotiasiidi.
English: In addition, one main study was carried out in 2,271 patients with moderate to severe hypertension with the highest strength of Dafiro HCT (320 mg valsartan, 10 mg amlodipine and 25 mg hydrochlorothiazide).
Estonian: Lisaks viidi läbi põhiuuring, milles osales 2271 mõõduka kuni raske kõrgvererõhutõvega patsienti, kellele anti Dafiro HCT-d suurimas annuses (320 mg valsartaani, 10 mg amlodipiini ja 25 mg hüdroklorotiasiidi).
English: The most common side effects with Dafiro HCT (seen in between 1 and 10 patients in 100) are hypokalaemia (low blood potassium levels), dizziness, headache, hypotension (low blood pressure), dyspepsia (heartburn), pollakiuria (abnormally frequent urination), fatigue (tiredness) and oedema (fluid retention).
Estonian: Dafiro HCT kõige sagedamad kõrvalnähud (esinenud 1-10 patsiendil 100st) on hüpokaleemia (vere kaaliumivaegus), peapööritus, peavalu, hüpotensioon (madal vererõhk), düspepsia (kõrvetised), pollakiuuria (ebanormaalselt sage urineerimine), väsimus ja ödeem (turse).
English: Dafiro HCT is used to treat essential hypertension (high blood pressure) in adults whose blood pressure is already adequately controlled with a combination of amlodipine, valsartan and hydrochlorothiazide.
Estonian: Dafiro HCT-d kasutatakse essentsiaalse hüpertensiooniga (kõrgvererõhutõvega) täiskasvanutel, kelle vererõhk allub piisavalt ravile amlodipiini, valsartaani ja hüdroklorotiasiidi kombinatsiooniga.
English: Other information about Dafiro HCT
Estonian: Muu teave Dafiro HCT kohta
English: The dose of Dafiro HCT to be used is the same as the doses of three individual active substances that the patient was taking before.
Estonian: Dafiro HCT-d tuleb anda samas annuses kui kolme toimeainet, mida patsient varem eraldi võttis.
English: Dafiro HCT must not be used in people who are hypersensitive (allergic) to the active substances, to other sulfonamides, to dihydropyridine derivatives or to any of the other ingredients in Dafiro HCT.
Estonian: Dafiro HCT-d ei tohi kasutada patsiendid, kes on selle toimeainete, teiste sulfoonamiidide, dihüdropüridiini derivaatide klassi kuuluvate toimeainete või Dafiro HCT mis tahes muude koostisainete suhtes ülitundlikud (allergilised).
English: The average reduction in blood pressure was around 39.7/24.7 mmHg in patients taking Dafiro HCT compared with 32/19.7 mmHg, 33.5/21.5 mmHg and 31.5/19.5 mmHg in patients taking valsartan/hydrochlorothiazide, valsartan/amlodipine and hydrochlorothiazide/amlodipine combinations, respectively.
Estonian: Dafiro HCT-d manustanud patsientidel alanes vererõhk keskmiselt 39,7/24,7 mmHg võrra, ent valsartaani-hüdroklorotiasiidi, valsartaani-amlodipiini või hüdroklorotiasiidiamlodipiini kombinatsiooni manustanud patsientidel vastavalt 32/19,7 mmHg, 33,5/21,5 mmHg ja 31,5/19,5 mmHg võrra.
English: For the full list of all side effects reported with Dafiro HCT, see the package leaflet.
Estonian: Dafiro HCT kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: Treatment with the highest strength of Dafiro HCT was more effective at treating hypertension than dual combinations containing any of the two active substances.
Estonian: Ravi Dafiro HCT suurima annusega oli vererõhu alandamisel efektiivsem kui ravi mis tahes kahe toimeaine kombinatsiooniga.
English: Patients received either Dafiro HCT or one of the three combinations containing only two of the active substances for eight weeks.
Estonian: Patsiendid manustasid kaheksa nädala jooksul kas Dafiro HCT-d või kahe toimeaine kolmest kombinatsioonist ühte kombinatsiooni.
English: What is Dafiro HCT?
Estonian: Mis on Dafiro HCT?
English: Finally, Dafiro HCT must not be used in patients with hypokalaemia (low blood potassium levels), hyponatraemia (low blood sodium levels) and hypercalcaemia (high blood calcium levels) that do not respond to treatment and in patients with hyperuricaemia (high blood levels of uric acid) that causes symptoms.
Estonian: Dafiro HCT-d ei tohi anda ka patsientidele, kellel on ravile allumatu hüpokaleemia (vere kaaliumivaegus), hüponatreemia (vere naatriumivaegus) või hüperkaltseemia (suur kaltsiumisisaldus veres), samuti patsientidele, kellel on hüperurikeemia (suur kusihappe sisaldus veres), mis põhjustab haigusnähte.
English: Why has Dafiro HCT been approved?
Estonian: Miks Dafiro HCT heaks kiideti?
English: What is the risk associated with Dafiro HCT?
Estonian: Mis riskid Dafiro HCT-ga kaasnevad?
English: For all doses, Dafiro HCT also met requirements to prove that it was comparable to the combinations of the individual active substances taken separately.
Estonian: Dafiro HCT kõigi annuste kohta tõendati, et nende mõju on sama mis kolmel toimeainel eraldi võetuna.
English: How does Dafiro HCT work?
Estonian: Kuidas Dafiro HCT toimib?
English: What benefit has Dafiro HCT shown during the studies?
Estonian: Milles seisneb uuringute põhjal Dafiro HCT kasulikkus?
English: How has Dafiro HCT been studied?
Estonian: Kuidas Dafiro HCT-d uuriti?
English: Dafiro HCT must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension) in patients with type 2 diabetes or in patients with moderate or severe kidney impairment.
Estonian: II tüüpi diabeediga või mõõduka või raske neerupuudulikkusega patsiendid ei tohi kasutada Dafiro HCT-d koos aliskireeni sisaldavate ravimitega (samuti essentsiaalse hüpertensiooni ravimid).
English: What is Dafiro HCT used for?
Estonian: Milleks Dafiro HCT-d kasutatakse?
English: How is Dafiro HCT used?
Estonian: Kuidas Dafiro HCT-d kasutatakse?
English: Hydrochlorothiazide is a diuretic.
Estonian: Dafiro HCT on retseptiravim.
English: The educational material for Healthcare Professionals should contain the following key elements:
Estonian: Koolitusmaterjal meditsiinitöötajatele peab sisaldama järgmisi võtmetähtsusega aspekte:
English: • Educational material for Healthcare Professionals
Estonian: • Koolitusmaterjal meditsiinitöötajatele;
English: • Patient Alert Cards (text as agreed by the CHMP)
Estonian: • Patsiendi teavituskaart (tekst kinnitatud CHMP poolt).
English: The educational pack should contain the following:
Estonian: Koolitusmaterjalid sisaldavad:
English: The Marketing Authorisation Holder (MAH) should ensure that, at launch and thereafter, all Healthcare Professionals who are expected to use and/or prescribe Caprelsa are provided with an Educational pack.
Estonian: Müügiloa hoidja (MLH) kindlustab, et turuletoomisel ning selle järel, on kõik eeldatavad Caprelsat kasutavad ja/või väljakirjutavad arstid varustatud koolitusmaterjalidega.
English: • That vandetanib may cause Posterior reversible encephalopathy syndrome (PRES) also known as Reversible posterior leukoencephalopathy syndrome (RPLS)
Estonian: • et vandetaniib võib põhjustada posterioorset reversiibelset entsefalopaatia sündroomi (PRES) ehk reversiibelset posterioorset leukoentsefalopaatia sündroomi (RPLS);
English: • The role and use of the Patient Alert Card
Estonian: • Patsiendi teavituskaardi otstarve ja kasutamine.
English: • The need to counsel patients about the risk of prolonged QTc and PRES and inform them of what symptoms and signs to be aware of and the actions to take
Estonian: • vajadus nõustada patsiente pikenenud QTc-intervalli ja PRES riski suhtes, informeerida neid, milliste sümptomide ja haigusnähtude suhtes tuleb valvel olla ning kuidas tegutseda;
English: • If QTc increases markedly but stays below 500 msec, the advice of a cardiologist should be sought.
Estonian: • kui QTc pikeneb oluliselt, kuid jääb alla 500 msek, tuleb pöörduda kardioloogi poole;
English: • Vandetanib prolongs the QTc interval and can cause Torsades de Pointes and sudden death
Estonian: • vandetaniib pikendab QTc-intervalli ning võib põhjustada torsade de pointes'i ja äkksurma;
English: • Summary of Product Characteristics and Package Leaflet
Estonian: • Ravimi omaduste kokkuvõte ja Pakendi infoleht;
English: Prior to launch of the product in each Member State, the Marketing Authorisation Holder shall agree the content and format of the educational material with the national competent authority.
Estonian: Müügiloa hoidja kooskõlastab enne toote turuletoomist koolitusmaterjalide sisu ja formaadi kohalike ravimiametitega igas liikmesriigis.
English: • PRES should be considered in any patient presenting with seizures, headache, visual disturbances, confusion or altered mental function.
Estonian: • PRES tekkeriski tuleb arvestada, kui patsiendil on tekkinud krambid, peavalu, nägemishäired, segasus või vaimse seisundi muutus.
English: Conditions or restrictions with regard to the safe and effective use of medicinal product to be implemented by the member states
Estonian: Liikmesriikide poolt juurutatavad ravimi ohutust ja efektiivset kasutamist käsitlevad tingimused või piirangud Liikmesriigid peavad tagama kõikide ravimi ohutust ja efektiivset kasutamist käsitlevate tingimuste või piirangute juurutamise.
English: • The need for an ECG, and serum levels of potassium, calcium and magnesium and thyroid stimulating hormone (TSH) and the times and situations when it should be performed
Estonian: • vajadus jälgida EKG-d, kaaliumi, kaltsiumi ja magneesiumi ning kilpnääret stimuleeriva hormooni (TSH) sisaldust seerumis ning aeg ja seisundid, mille korral neid analüüsida tuleb;
English: • Details of medicinal products where the co-administration of vandetanib is either contraindicated or not recommended.
Estonian: • ravimite nimekiri, mille koosmanustamine vandetaniibiga on vastunäidustatud või ei ole soovitav;
English: Brain MRI should be performed in any patient presenting with seizures, confusion or altered mental status.
Estonian: Aju-MRT uuring tuleb teostada kõikidel patsientidel, kellel on tekkinud krambid, segasus või vaimse seisundi muutus;
English: Dosing can be resumed at a reduced dose after return of the ECG QTc interval to pretreatment status has been confirmed and correction of possible electrolyte imbalance has been made.
Estonian: • vandetaniibravi tuleb katkestada patsiendil, kellel registreeritakse üksik QTc-intervalli pikenemine üle 500 msek EKG-s. Annustamist vähendatud annusega võib taasalustada, kui QTc-intervalli pikkus EKG-s on muutunud selliseks, nagu enne ravi ning võimalik elektrolüütide tasakaaluhäire on korrigeeritud;
English: • Patients who develop a single value of corrected ECG QTc interval of at least 500 msec should stop taking vandetanib.
Estonian: • vandetaniibravi ei tohi alustada patsientidel: ○ kelle QTc-intervall EKG-s on pikem kui 480 msek; ○ kellel on kaasasündinud pika QTc-sündroom; ○ kellel on anamneesis torsade de pointes, v.a. juhul kui kõik selle tekkele viivad riskitegurid on eemaldatud.
English: 28 April 2014 EMA/276477/2014
Estonian: 28. aprill 2014 EMA/276477/2014
English: The pharmaceutical forms and the approved indications, strengths and doses vary in different EU countries.
Estonian: Ravimvormid ja heakskiidetud näidustused, tugevused ning annused on Euroopa Liidu eri liikmesriikides erinevad.
English: Restrictions on the use of methysergide-containing medicines
Estonian: Metüsergiidi sisaldavate ravimite kasutamispiirangud
English: The CHMP opinion was sent to the European Commission, which endorsed it and issued a final legally binding decision on 28 April 2014.
Estonian: Inimravimite komitee arvamus saadeti Euroopa Komisjonile, kes kiitis selle heaks ja tegi 28. aprillil 2014 lõpliku õiguslikult siduva otsuse.
English: In the EU, medicines containing methysergide have been authorised by national procedures and have been marketed under various trade names.
Estonian: Euroopa Liidus on metüsergiidi sisaldavate ravimite müügiload antud riiklike menetlustega ja neid ravimeid on turustatud mitme kaubandusliku nimetuse all.