FrancophonIA/ELRC3.0 huggingface dataset:
English: The exact way Radicava works in patients with ALS is not known but it is thought to neutralise oxygencontaining molecules known as ‘free radicals', which have been linked to nerve damage in patients with ALS.
Estonian: Radicava täpne toimemehhanism ALSiga patsientidel ei ole teada, aga arvatavasti neutraliseerib see hapnikku sisaldavaid molekule ehk nn vabu radikaale, mida seostatakse ALSiga patsientidel esinevate närvikahjustustega.
English: The company informed the CHMP that the withdrawal does not have any impact on ongoing clinical trials.
Estonian: Ettevõte teatas inimravimite komiteele, et tagasivõtmine ei mõjuta pooleliolevaid kliinilisi uuringuid.
English: When patients in the placebo group were later switched to Radicava there was no noticeable effect.
Estonian: Kui platseebopatsiendid hiljem Radicavale üle viidi, ei ilmnenud olulist mõju.
English: The CHMP was also concerned about the duration of any benefits from Radicava, noting that 24 weeks (a cut-off point in the main study) was too short and that data from the extension phase of the study were difficult to interpret.
Estonian: Inimravimite komitee kahtles ka Radicava võimaliku kasuliku toime kestuses ning märkis, et 24 nädalat (põhiuuringu lõpp) oli liiga lühike ajavahemik ja et uuringu pikendusetapi andmeid oli keeruline tõlgendada.
English: During the evaluation, the CHMP consulted a group of experts in the field to obtain their views on the study results, the proposed registry and the patient population that could potentially benefit from treatment with Radicava.
Estonian: Hindamise käigus konsulteeris inimravimite komitee valdkonna ekspertidega ning küsis nende arvamusi uuringutulemuste, kavandatava registri ja patsiendirühmade kohta, kes võiksid saada Radicava-ravist kasu.
English: At the time of the withdrawal, the Committee was of the opinion that, because of lack of proven effectiveness, the benefits of Radicava did not outweigh its risks.
Estonian: Müügiloa taotluse tagasivõtmise ajal oli komitee arvamusel, et kuna ravimi efektiivsus ei ole tõendatud, ei ole Radicava kasulikkus suurem kui sellega kaasnevad riskid.
English: What was Radicava expected to be used for?
Estonian: Milleks kavatseti Radicavat kasutada?
English: Radicava was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 19 June 2015 for ALS.
Estonian: Radicava nimetati 19. juunil 2015 ALSi harvikravimiks (ravim, mida kasutatakse harvaesinevate haiguste korral).
English: The study looked at how much patients' symptoms changed over 24 weeks, using a standard rating scale known as ‘ALS functional rating scale revised'
Estonian: Uuringus analüüsiti patsientide sümptomite muutust 24 nädala jooksul, kasutades hindamise standardskaalat (ALSi muudetud funktsionaalskaala, ALSFRS-R).
English: How does Radicava work?
Estonian: Kuidas Radicava toimib?
English: The company proposed a registry study whereby patients treated with Radicava could be compared with patients who received other treatments for ALS in the past.
Estonian: Ettevõte pakkus välja registriuuringu, mis võimaldaks võrrelda Radicavaga ravitud patsiente varem muud ravi saanud ALSiga patsientidega.
English: The Committee noted that the main study did show significant improvements in ALSFRS-R scores in patients receiving Radicava compared with those receiving placebo.
Estonian: Komitee märkis, et põhiuuringus paranesid Radicavat saanud patsientide ALSFRS-R-i tulemused märkimisväärselt võrreldes platseebopatsientidega.
English: At the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Radicava could not have been approved.
Estonian: Inimravimite komitee nägi taotluse tagasivõtmise ajal põhjust ettevaatlikkuseks ja oli esialgsel seisukohal, et ravimit Radicava ei ole võimalik heaks kiita.
English: It was to be available as a solution for infusion (drip) into a vein.
Estonian: Ravimit kavatseti turustada infusioonilahusena (veeni tilgutatav lahus).
English: Radicava was expected to be used to treat patients with amyotrophic lateral sclerosis (ALS).
Estonian: Radicavat kavatseti kasutada amüotroofilise lateraalskleroosi (ALS) raviks.
English: The company presented results from a main study of 137 patients with ALS who received either Radicava or placebo (a dummy treatment).
Estonian: Patsiendid said kas Radicavat või platseebot (näiv ravim).
English: This testing should be provided free of charge.
Estonian: See analüüs peab olema tasuta.
English: The patients should receive a patient card that documents the negative result.
Estonian: Patsient peab saama patsiendikaardi, kus dokumenteeritakse negatiivne vastus.
English: The Member States must ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented in their national territory:
Estonian: Liikmesriigid peavad tagama kõikide järgmiste ravimi ohutu ja tõhusa kasutamise tingimuste ja piirangute täitmise oma territooriumil:
English: • The risk of formation of anti-C1INH antibodies and therefore the potential risk of formation of neutralising antibodies.
Estonian: • C1INH-vastaste antikehade moodustumise risk ja seetõttu võimalik risk neutraliseerivate antikehade moodustumiseks.
English: The patient card should contain the following key elements:
Estonian: Patsiendikaart sisaldab järgmisi võtmeelemente:
English: In addition, IgE testing should be repeated if symptoms of rabbit allergy develop.
Estonian: Lisaks tuleb IgE-testi korrata, kui tekivad küülikuallergia sümptomid.
English: • Prior to launch of the product in the Member State, the national competent authority shall agree the content and format of the educational material with the Marketing Authorisation Holder.
Estonian: • Enne toote turustamise algust liikmesriigis kooskõlastab müügiloa hoidja riikliku pädeva asutusega teabematerjali sisu ja vormi.
English: o IgE testing should be repeated once a year or after 10 treatments, whichever occurs first.
Estonian: o IgE-analüüsi tuleb korrata üks kord aastas või pärast iga 10. ravikorda olenevalt sellest, kumb on enne.
English: • The need to inform patients about the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis, and that they should alert their physician if these symptoms occur.
Estonian: • Vajadus teatada patsientidele ülitundlikkusreaktsioonide varajastest nähtudest, sh nõgestõbi, üldine urtikaaria, rõhumistunne rinnus, vilistav hingamine, hüpotensioon ja anafülaksia, ning et patsiendid peavad nende sümptomite ilmnemisest kohe teatama oma arstile.
English: • a reminder that IgE anti rabbit (dander) testing should be repeated once a year or after 10 treatments, whichever occurs first.
Estonian: • Meeldetuletus, et küüliku (kõõma) vastaste IgE-antikehade testi tuleb korrata üks kord aastas või pärast iga 10. ravikorda olenevalt sellest, kumb on enne.
English: • The patient card should include an area where patients can record the date and dose of every treatment by Ruconest (highlighting every tenth treatment)
Estonian: • Patsiendikaardil peab olema koht, kuhu patsient saab märkida iga manustatud Ruconesti annuse ja kuupäeva (tõstes esile iga 10. ravikorra).
English: • Educational material for the physician.
Estonian: • Arsti teabematerjal
English: • The importance of monitoring for clinical signs and symptoms of hypersensitivity and that patients should alert their doctor if they develop such symptoms during or after receiving Ruconest.
Estonian: • Ülitundlikkuse kliiniliste nähtude ja sümptomite jälgimise tähtsus ning see, et patsient peab arstile kohe teatama, kui need sümptomid tekivad Ruconesti manustamise ajal või järel.
English: • That patients with clinical evidence of cow's milk allergy may have antibodies cross reacting with the rabbit milk impurities in Ruconest.
Estonian: • Patsientidel, kellel esineb kliinilisi tõendeid lehmapiima suhtes tekkinud allergia kohta, võib esineda antikehi, mis ristreageerivad Ruconestis sisalduvate küülikupiima lisanditega.
English: • The fact that Ruconest is derived from milk of transgenic rabbits and contains trace of rabbit proteins (Host Related Impurities, HRI).
Estonian: • Asjaolu, et Ruconesti saadakse transgeensete küülikute piimast ja see sisaldab küülikuvalkude jälgi (peremeesorganismiga seotud lisandid, HRI).
English: The educational pack should contain the following:
Estonian: Teabematerjali pake sisaldab järgmist:
English: • The potential risk of an immune complex-mediated type III hypersensitivity reaction due to the formation of antibodies directed against Host Related Impurities (HRI).
Estonian: • Võimalik risk immuunkompleksi vahendatud III tüüpi ülitundlikkusreaktsiooni tekkeks antikehade moodustumise tõttu peremeesorganismiga seotud lisandite (HRI) vastu.
English: • That Ruconest is derived from milk of transgenic rabbits and contains trace of rabbit proteins
Estonian: • Ruconesti toodetakse transgeensete küülikute piimast ja see sisaldab küülikuvalkude jälgi.
English: o A protocol for performing a skin prick test (SPT) with Ruconest and an intravenous test dosing schedule in patients with a negative skin prick test, including criteria for interpreting results, for patients with clinical features of cow's milk allergy.
Estonian: o Protokoll nahatorketesti tegemiseks Ruconestiga ja analüüsimiseks kasutatav intravenoosne annustamisrežiim patsientidele, kelle nahatorketest on negatiivne, sh tulemuste tõlgendamise kriteeriumid patsientidele, kellel on kliinilised tõendid lehmapiima allergia suhtes.
English: • That they should be asked to carry the card and always show it to any health care professional treating them for acute attacks of hereditary angioedema.
Estonian: • Patsiendid peavad kaarti alati kaasas kandma ja näitama seda tervishoiutöötajale, kes ravib nende päriliku angioödeemi ägedat episoodi.
English: • The Marketing Authorisation Holder (MAH) should ensure that, at launch, all Healthcare Professionals who are expected to prescribe Ruconest are provided with an Educational pack.
Estonian: • Müügiloa hoidja tagab, et toote turustamise alguse ajal on kõigile tervishoiutöötajatele, kes võivad Ruconesti määrata, antud teabematerjali pake.
English: The educational material for the prescriber should include information on the following key elements:
Estonian: Teabematerjal ravi määrajale sisaldab järgmisi võtmeelemente:
English: o Before initiating treatment with Ruconest all patients should be tested for the presence of IgE antibodies against rabbit epithelium (dander).
Estonian: o Enne Ruconesti-ravi algust tuleb kõiki patsiente uurida küüliku epiteeli (kõõma) vastaste IgEantikehade olemasolu suhtes.
English: • The patient card should include an area where patients can record the results of their last IgE anti Rabbit (dander) and the date of the test
Estonian: • Patsiendikaardil peab olema koht, kuhu patsient saab märkida küüliku (kõõma) vastaste IgEantikehade viimase testi tulemuse ja kuupäeva.
English: • Copies of the patient card to be given to patients before they receive Ruconest
Estonian: • Patsiendile enne Ruconesti saamist antava teabekaardi näidised
English: Advice about the immunogenicity laboratory testing program for these antibodies provided by the company for following up suspected emergence of neutralising antibodies and information about the procedure to follow for the collection and shipment of a blood sample to the company's central laboratory.
Estonian: Nõuanded nende antikehade immunogeensuse laboratoorse analüüsi programmi kohta, mille annab ettevõte, et jälgida kahtlustatud neutraliseerivate antikehade tekkimist, ning teave protseduuri kohta, et jälgida vereproovide kogumist ja transporti ettevõtte kesklaborisse.
English: Advice about the immunogenicity laboratory testing program for detecting these antibodies for following up suspected immune complex-mediated disease, and about the procedure to follow for the collection and shipment of a blood sample to the company's central laboratory.
Estonian: Nõuanded immunogeensuse laboratoorse analüüsi programmi kohta, mis tuvastaks antikehi, et jälgida kahtlustatavat immuunkompleksi vahendatud haigust, ning protseduuri kohta, et jälgida vereproovide kogumist ja transporti ettevõtte kesklaborisse.
English: • That Ruconest should be initiated under the guidance and supervision of a physician experienced in the diagnosis and treatment of hereditary angioedema and should be administered by a health care professional.
Estonian: • Ravi Ruconestiga peab alustama päriliku angioödeemi diagnoosimisel ja ravis kogenud arsti juhtimisel ning tema järelevalve all ning ravimit peab manustama tervishoiutöötaja.
English: • That they are receiving Ruconest for treatment of acute attack of hereditary angioedema
Estonian: • Patsiendid saavad Ruconesti, et ravida päriliku angioödeemi ägedat episoodi.
English: o Information about the appropriate methodology to be used for laboratory testing of serum IgE antibodies against rabbit epithelium (dander)
Estonian: o Teave sobivate meetodite kohta, mida kasutatakse küüliku epiteeli (kõõma) vastaste IgEantikehade laboratoorseks määramiseks seerumist.
English: • That Ruconest is contra indicated in all patients with known or suspected rabbit allergy or with positive serum IgE antibodies against rabbit dander due to the risk of major allergic reactions, therefore:
Estonian: • Ruconest on raskete allergiliste reaktsioonide riski tõttu vastunäidustatud kõigile patsientidele, kellel on teadaolev või kahtlustatav allergia küülikute suhtes või kelle seerum annab positiivse reaktsiooni küüliku kõõma vastaste IgE-antikehade suhtes.
English: • That they have been tested negative for IgE anti rabbit (dander) within the last year.
Estonian: • Patsiente on viimase aasta jooksul uuritud küüliku (kõõma) vastaste IgE-antikehade suhtes ja vastus on olnud negatiivne.
English: • Summary of Product Characteristics and Patient Information Leaflet for Ruconest
Estonian: • Ruconesti ravimi omaduste kokkuvõte ja pakendi infoleht
English: Only patients who have been shown to have negative test results should be treated with Ruconest.
Estonian: Ruconestiga tohib ravida ainult patsiente, kellel annab see test negatiivse vastuse.
English: Similar results were seen in children.
Estonian: Lastega saadi sarnased tulemused.
English: This summary was last updated in 07-2011.
Estonian: Kokkuvõtte viimane uuendus: 07-2011.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Mycamine on 25 April 2008.
Estonian: Euroopa Komisjon andis Mycamine müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 25. Aprillil 2008.
English: There were three treatment studies and one prevention study.
Estonian: Neist kolm olid raviuuringud ja üks ennetusuuring.
English: Mycamine is used in babies, children and adults in the following situations:
Estonian: Mycaminet kasutatakse imikutel, lastel ja täiskasvanutel järgmistel juhtudel:
English: Most of the patients in these two studies were infected with human immunodeficiency virus (HIV).
Estonian: Enamik kummaski uuringus osalenud patsientidest oli nakatunud inimese immuunpuudulikkuse viirusega (HIV).
English: The full EPAR for Mycamine can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Mycamine kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Other information about Mycamine
Estonian: Muu teave Mycamine kohta
English: This checklist will remind prescribers how to use the medicine safely.
Estonian: See kontroll-loetelu aitab ravimi retseptiväljastajatel meeles pidada, kuidas ravimit ohutult kasutada.
English: What measures are being taken to ensure the safe use of Mycamine?
Estonian: Mis meetmeid võetakse, et tagada Mycamine kasutamise ohutus?
English: In all three studies, the main measure of effectiveness was the number of patients in whom treatment was successful, based on an improvement in symptoms and eradication of the fungus at the end of treatment.
Estonian: Kõigis kolmes uuringus oli efektiivsuse põhinäitaja nende patsientide arv, kellel ravi õnnestus, lähtudes sümptomite paranemisest ja seene kadumisest ravi lõpuks.
English: The main measure of effectiveness was the number of patients who did not develop a fungal infection during treatment or the following four weeks.
Estonian: Efektiivsuse põhinäitaja oli nende patsientide arv, kellel ravi ajal ega järgmise nelja nädala jooksul seennakkust ei tekkinud.
English: Mycamine is given once a day as an infusion lasting around one hour.
Estonian: Mycaminet manustatakse üks kord ööpäevas üks tund kestva infusioonina.
English: The company that makes Mycamine will ensure that prescribers in all Member States receive a checklist before the launch of the medicine.
Estonian: Mycamine tootja tagab, et ravimi retseptiväljastajad kõikides liikmesriikides varustatakse kontrollloeteluga, enne kui ravimit hakatakse turustama.
English: The effectiveness of Mycamine has been studied in four main studies, in which it was compared with other antifungal medicines.
Estonian: Mycamine efektiivsust uuriti neljas põhiuuringus, milles seda võrreldi teiste seeneravimitega.
English: It contains the active substance micafungin.
Estonian: See sisaldab toimeainena mikafungiini.
English: Mycamine should only be used after careful assessment of its risks and benefits, particularly in patients who have existing liver problems.
Estonian: Mycaminet tohib kasutada ainult pärast selle kasulikkuse ja kaasnevate riskide hoolikat hindamist, seda eriti maksahäiretega patsientide puhul.
English: Mycamine was more effective than fluconazole in preventing fungal infection in patients undergoing a bone marrow transplant: 80% of the patients (340 out of 425) receiving Mycamine did not develop a fungal infection, compared with 74% of the patients (336 out of 457) receiving fluconazole.
Estonian: Mycamine ennetas patsientidel, kellele siirati luuüdi, seennakkusi flukonasoolist efektiivsemalt: seennakkust ei tekkinud 80%-l patsientidest (340 patsiendil 425-st), kellele manustati Mycaminet, ja 74%-l patsientidest (336 patsiendil 457-st), kellele manustati flukonasooli.
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 Mycamine.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: Because of a possible risk of liver tumours, Mycamine is only to be used if other antifungal medicines are not appropriate.
Estonian: Maksakasvajate riski tõttu tohib Mycaminet kasutada üksnes juhul, kui muud seenevastased ravimid ei sobi.
English: For more information about treatment with Mycamine, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Mycaminega toimuva ravi kohta lisateavet, lugege pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Why has Mycamine been approved?
Estonian: Miks Mycamine heaks kiideti?
English: Mycamine is not recommended for use in patients who have severe problems with their liver, who have long-term liver disease or who are taking other medicines that could harm the liver or the DNA.
Estonian: Mycaminet ei ole soovitatav kasutada nende patsientide ravimisel, kellel on rasked maksahäired või pikaajaline maksahaigus või kes kasutavad muid ravimeid, mis võivad maksa või DNA-d kahjustada.
English: What is Mycamine?
Estonian: Mis on Mycamine?
English: The most common side effects with Mycamine (seen in between 1 and 10 patients in 100) are leucopenia (low levels of leucocytes, a type of white blood cell), neutropenia (low levels of neutrophils, a type of white blood cell), anaemia (low red blood cell counts), hypokalaemia (low blood potassium levels), hypomagnesaemia (low blood magnesium levels), hypocalcaemia (low blood calcium levels), headache, phlebitis (inflammation of a vein), nausea (feeling sick), vomiting, diarrhoea, abdominal (tummy) pain, signs of liver problems in the blood (increased levels of alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase or bilirubin), rash, pyrexia (fever) and rigors (shaking chills).
Estonian: Mycamine kõige sagedamad kõrvalnähud (esinenud 1-10 patsiendil 100st) on leukopeenia (leukotsüütide ehk vere valgeliblede vähesus), neutropeenia (neutrofiilide ehk teatud valgeliblede vähesus), aneemia (erütrotsüütide ehk vere punaliblede vähesus), hüpokaleemia (vere kaltsiumivaegus), peavalu, flebiit (veenipõletik), iiveldus, oksendamine, kõhulahtisus, kõhuvalu, maksaprobleemide markerite aluselise fosfataasi, aspartaataminotransferaasi, alaniinaminotransferaasi või bilirubiini suur sisaldus veres, lööve, püreksia (palavik) ja vappekülm.
English: EPAR summary for the public micafungin
Estonian: Kokkuvõte üldsusele mikafungiin
English: For the treatment of invasive candidiasis, Mycamine was compared with amphotericin B in a study involving 531 adults and 106 children, including newborns and premature babies.
Estonian: Kasutamisel invasiivse kandidiaasi ravis võrreldi Mycaminet amfoteritsiin B-ga uuringus, milles osales 531 täiskasvanut ja 106 last, sealhulgas vastsündinud ja enneaegsed imikud.
English: In the two studies of oesophageal candidiasis, around 90% of the patients were successfully treated with Mycamine, fluconazole or caspofungin.
Estonian: Kahes söögitoru kandidiaasi uuringus õnnestus ravi ligikaudu 90%-l patsientidest, kellele manustati Mycaminet, flukonasooli või kaspofungiini.
English: The dose depends on what it is being used for, the patient's weight, and the response to treatment.
Estonian: Annus sõltub näidustusest, patsiendi kehakaalust ja ravivastusest.
English: This is a summary of the European public assessment report (EPAR) for Mycamine.
Estonian: Käesolev dokument on ravimi Mycamine Euroopa avaliku hindamisaruande kokkuvõte.
English: Additional common side effects in children (seen in between 1 and 10 children in 100) are thrombocytopenia (low blood platelet counts), tachycardia (rapid heart rate), hypertension (high blood pressure), hypotension (low blood pressure), hepatomegaly (enlarged liver), acute renal failure (sudden kidney failure) and increased blood urea levels.
Estonian: Muud kõrvalnähud lastel (esinenud 1-10 lapsel 100st) on trombotsütopeenia (trombotsüütide ehk vereliistakute vähesus), tahhükardia (südamekloppimine), hüpertensioon (kõrge vererõhk), hüpotensioon (madal vererõhk), hepatomegaalia (maksa suurenemine), äge neerupuudulikkus ja vere uureasisalduse suurenemine.
English: Treatment with Mycamine should be initiated by a doctor who has experience managing fungal infections, and after considering official or national guidance on the use of antifungal medicines.
Estonian: Ravi Mycaminega peab alustama seennakkuste ravis kogenud arst, kes on tutvunud ametlike või riiklike juhistega seeneravimite kasutamise kohta.
English: • to prevent infection with Candida in patients who are having a bone marrow transplant or who are expected to have neutropenia (low levels of neutrophils, a type of white blood cell) for 10 days or more.
Estonian: • Candida infektsiooni profülaktikaks patsientidel, kellele siiratakse luuüdi või kellel on oodata neutropeenia (neutrofiilide ehk teatud valgeliblede vähesus) esinemist vähemalt 10 päeva vältel.
English: Fungal cells treated with Mycamine have incomplete or defective cell walls, making them fragile and unable to grow.
Estonian: Mycamine mõjul ei teki seenerakul täielikku või tervet membraani, mille tõttu on rakud haprad ja ei saa kasvada.
English: For the full list of all side effects reported with Mycamine, see the package leaflet.
Estonian: Mycamine kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.