FrancophonIA/ELRC3.0 huggingface dataset:
English: No adverse reactions were observed in healthy Beagle puppies over 8 weeks of age when treated with 5 times the maximum dose repeated 6 times at intervals of two to four weeks.
Estonian: Ravimpreparaadi ohutus on kindlaks tehtud ohutuskatsetes kuni 5 -kordse annusega tervetel Beagle kutsikatel vanuses üle 8 nädala, kellele manustati ravimit 6 korda kahe kuni neljanädalaste intervallidega.
English: Mild gastrointestinal effects (vomiting, diarrhoea), pruritus, lethargy, anorexia, and neurological signs (convulsions, ataxia and muscle tremors) have been reported very rarely.
Estonian: Väga harvadel juhtudel on raporteeritud kergeid gastrointestinaalnähte (oksendamine, kõhulahtisus), sügelust, letargiat, isutust ja neuroloogilisi nähte (krambid, ataksia, lihasvärinad).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED Pappkarp
English: Bodyweight of dog (kg)
Estonian: Koera kaal (kg)
English: Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis).
Estonian: Sarkoptoosi (tekitaja Sarcoptes scabiei var. canis) ravi.
English: The terminal plasma half-life is approximately 2 weeks in most dogs; however, half-life of afoxolaner can differ between dogs (e.g. in one study, t½ in Collies at 25 mg/kg bodyweight was up to 47.7 days) with no effect on safety.
Estonian: Lõplik poolestusaeg plasmas on koertel ligikaudu 2 nädalat, kuid afoksolaneeri poolestusaeg võib erineda tõugude lõikes (näit.
English: Dosage:
Estonian: Raviskeem:
English: Mottled red to reddish brown, circular shaped (tablets for dogs 2-4 kg), or rectangular shaped (tablets for dogs >4-10 kg, tablets for dogs >10-25 kg and tablets for dogs >25-50 kg).
Estonian: Kirjud punased kuni pruunikaspunased ümmargused (tabletid koertele 2-4 kg) või ristkülikukujulised tabletid (tabletid koertele >4-10 kg, tabletid koertele >10-25 kg ja tabletid koertele >25-50 kg).
English: Further monthly administration of the product may be required based on clinical assessment and skin scrapings.
Estonian: Kliinilise ülevaatuse ja nahakaabete analüüside põhjal võib osutuda vajalikuks ravimi edasine manustamine sagedusega üks kord kuus.
English: chewable tablets for dogs 2-4 kg chewable tablets for dogs >4-10 kg chewable tablets for dogs >10-25 kg chewable tablets for dogs >25-50 kg
Estonian: närimistabletid koertele kaaluga 2-4 kg närimistabletid koertele kaaluga >4-10 kg närimistabletid koertele kaaluga >10-25 kg närimistabletid koertele kaaluga >25-50 kg
English: 31000 Toulouse
Estonian: 4 Chemin du Calquet 31000 Toulouse
English: Maize starch
Estonian: Närimistabletid.
English: Afoxolaner MERIAL 11 mg dogs 2-4 kg Afoxolaner MERIAL 28 mg dogs >4-10 kg Afoxolaner MERIAL 68 mg dogs >10-25 kg Afoxolaner MERIAL 136 mg dogs >25-50 kg afoxolaner
Estonian: Afoxolaner MERIAL 11 mg koer 2-4 kg Afoxolaner MERIAL 28 mg koer >4-10 kg Afoxolaner MERIAL 68 mg koer >10-25 kg Afoxolaner MERIAL 136 mg koer >25-50 kg afoxolaner
English: Oral use
Estonian: KÕLBLIKKUSAEG
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
Estonian: PREPARAADI VÕI JÄÄTMETE HÄVITAMISEL, KUI NEED ON KEHTESTATUD
English: Afoxolaner MERIAL 11 mg chewable tablets for dogs (2-4 kg) Afoxolaner MERIAL 28 mg chewable tablets for dogs (>4-10 kg) Afoxolaner MERIAL 68 mg chewable tablets for dogs (>10-25 kg) Afoxolaner MERIAL 136 mg chewable tablets for dogs (>25-50 kg) afoxolaner
Estonian: Afoxolaner MERIAL 11 mg närimistabletid koertele kaaluga (2-4 kg) Afoxolaner MERIAL 28 mg närimistabletid koertele kaaluga (>4-10 kg) Afoxolaner MERIAL 68 mg närimistabletid koertele kaaluga (>10-25 kg) Afoxolaner MERIAL 136 mg närimistabletid koertele kaaluga (>25-50 kg) Afoksolaneer
English: Chewable tablets
Estonian: Keskmise ahelaga triglütseriidid
English: PACKAGE LEAFLET: Afoxolaner MERIAL 11 mg chewable tablets for dogs 2-4 kg Afoxolaner MERIAL 28 mg chewable tablets for dogs >4-10 kg Afoxolaner MERIAL 68 mg chewable tablets for dogs >10-25 kg Afoxolaner MERIAL 136 mg chewable tablets for dogs >25-50 kg
Estonian: PAKENDI INFOLEHT Afoxolaner MERIAL 11 mg närimistabletid koertele kaaluga 2-4 kg Afoxolaner MERIAL 28 mg närimistabletid koertele kaaluga >4-10 kg Afoxolaner MERIAL 68 mg närimistabletid koertele kaaluga >10-25 kg Afoxolaner MERIAL 136 mg närimistabletid koertele kaaluga >25-50 kg
English: • rare (more than 1 but less than 10 animals in 10,000 animals treated)
Estonian: Kõrvaltoimete esinemissagedus on defineeritud järgnevalt: - väga sage (kõrvaltoime(d) ilmnes(id) rohkem kui 1-l loomal 10-st ravitud loomast) - sage (rohkem kui 1-l, kuid vähem kui 10-l loomal 100-st ravitud loomast) - aeg-ajalt (rohkem kui 1-l, kuid vähem kui 10-l loomal 1000-st ravitud loomast) - harv (rohkem kui 1-l, kuid vähem kui 10-l loomal 10,000-st ravitud loomast) - väga harv (vähem kui 1-l loomal 10,000-st ravitud loomast, kaasaarvatud üksikjuhud).
English: 4.5 Special precautions for use
Estonian: ERINÕUDED ETTEVAATUSABINÕUDE OSAS KASUTAMATA JÄÄNUD
English: Afoxolaner MERIAL 11 mg chewable tablets for dogs 2-4 kg Afoxolaner MERIAL 28 mg chewable tablets for dogs >4-10 kg Afoxolaner MERIAL 68 mg chewable tablets for dogs >10-25 kg Afoxolaner MERIAL 136 mg chewable tablets for dogs >25-50 kg afoxolaner
Estonian: Afoxolaner MERIAL 11 mg närimistabletid koertele kaaluga 2-4 kg Afoxolaner MERIAL 28 mg närimistabletid koertele kaaluga >4-10 kg Afoxolaner MERIAL 68 mg närimistabletid koertele kaaluga >10-25 kg Afoxolaner MERIAL 136 mg närimistabletid koertele kaaluga >25-50 kg afoxolaner
English: Afoxolaner MERIAL 11 mg chewable tablets for dogs 2-4 kg Afoxolaner MERIAL 28 mg chewable tablets for dogs >4-10 kg Afoxolaner MERIAL 68 mg chewable tablets for dogs >10-25 kg Afoxolaner MERIAL 136 mg chewable tablets for dogs >25-50 kg
Estonian: Afoxolaner MERIAL 11 mg närimistabletid koertele kaaluga 2-4 kg Afoxolaner MERIAL 28 mg närimistabletid koertele kaaluga >4-10 kg Afoxolaner MERIAL 68 mg närimistabletid koertele kaaluga >10-25 kg Afoxolaner MERIAL 136 mg närimistabletid koertele kaaluga >25-50 kg
English: What is Istodax?
Estonian: Mis on Istodax?
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Istodax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Estonian: Harvikravimite komitee arvamuse kokkuvõte Istodaxi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Therefore it was not possible to conclude that the benefits of the medicine outweigh the risks and the CHMP confirmed its initial negative opinion.
Estonian: Seetõttu ei olnud võimalik järeldada, et ravimi kasulikkus ületab riske ja inimravimite komitee kinnitas oma algset negatiivset arvamust.
English: EMEA/H/C/product number
Estonian: EMEA/H/C/tootenumber
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 15 November 2012.
Estonian: Pärast taotluse põhjenduste kaalumist vaatas inimravimite komitee oma algse arvamuse uuesti läbi ja kinnitas müügiloa andmisest keeldumist 15. novembril 2012.
English: The company that applied for authorisation is Celgene Europe Ltd.
Estonian: Müügiluba taotles ettevõte Celgene Europe Ltd.
English: The main measure of effectiveness was based on the proportion of patients who had a complete response to treatment.
Estonian: Peamine tulemusnäitaja põhines ravile täielikult allunud patsientide suhtarvul.
English: Refusal of the marketing authorisation for Istodax (romidepsin) EMA/725439/2012
Estonian: Istodaxi (romidepsiin) müügiloa andmisest keeldumine EMA/725439/2012
English: In particular, the Committee could not conclude on the clinical benefit of the medicine.
Estonian: Komitee ei saanud teha järeldust ravimi kliinilise kasulikkuse kohta.
English: However, the fact that Istodax was not compared with any other treatment did not allow the Committee to conclude on the clinical benefit of the medicine in terms of overall survival (how long the patients lived) or progression-free survival (how long the patients lived without their disease getting worse).
Estonian: Kuid fakt, et Istodaxi ei võrreldud ühegi muu ravimiga, ei võimalda inimravimite komiteel teha järeldusi ravimi kliinilise kasulikkuse kohta üldise elulemuse (kui kaua patsiendid elasid) või progressioonivaba elulemuse (kui kaua patsiendid elasid, ilma et nende haigus süveneks) seisukohast.
English: Istodax is a medicine that contains the active substance romidepsin.
Estonian: Istodax on ravim, mis sisaldab toimeainena romidepsiini.
English: The CHMP also noted that, due to an oversight, the company failed to provide an adequate certificate of Good Manufacturing Practice for the site where the medicine is manufactured, which is legally required.
Estonian: Inimravimite komitee märkis ka, et hooletuse tõttu ei esitanud ettevõte sobivat hea tootmistava tõendit keskuse kohta, kus ravimit toodetakse.
English: Refusal of the marketing authorisation for Istodax (romidepsin)
Estonian: Istodaxi (romidepsiin) müügiloa andmisest keeldumine
English: The company presented the results from one main study with Istodax involving 131 patients with peripheral T-cell lymphoma who had received previous treatment.
Estonian: Ettevõte esitas ühe Istodaxi põhiuuringu tulemused, mis hõlmas 131 perifeerse T-rakulise lümfoomiga patsienti, kes olid saanud varem ravi.
English: Istodax was expected to be used for the treatment of adults with peripheral T-cell lymphoma that no longer responds to or has come back after at least two previous therapies.
Estonian: Istodaxi kavatseti kasutada täiskasvanute raviks, kellel esineb perifeerne T-rakuline lümfoom, mis ei allu enam ravile või on pärast vähemalt kaht varasemat ravikuuri taastekkinud.
English: In the study, Istodax was not compared with any other treatment.
Estonian: Selles uuringus ei võrreldud Istodaxi ühegi muu ravimiga.
English: Istodax was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 28 October 2005 for the treatment of peripheral T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated).
Estonian: Istodax nimetati 28. oktoobril 2005 harvikravimiks perifeerse T-rakulise lümfoomi (nodaalse, muu ekstranodaalse ja leukeemilise/dissemineerunud vormi) raviks.
English: In November 2012, following the re-examination, the CHMP removed its concern over the certificate of Good Manufacturing Practice, but retained its other concerns.
Estonian: 2012. aasta novembris, pärast taasläbivaatamist, leidis hea tootmistava tõendi probleem lahenduse, kuid teised probleemid jäid lahenduseta.
English: As it was not compared with any other treatment, it was not possible to establish whether the observed effects were due to the medicine or due to the disease characteristics of patients in the main study.
Estonian: Et Istodaxi ei võrreldud ühegi muu ravimiga, ei olnud võimalik kindlaks teha, kas täheldatud toimete põhjuseks oli ravim või põhiuuringus osalenud patsientide haiguse iseloom.
English: It was to be available as a powder and solvent to be made into a solution for infusion (drip into a vein).
Estonian: Seda kavatseti turustada pulbri ja lahustina, millest valmistatakse infusioonilahus (veeni tilgutatav lahus).
English: The exact way that romidepsin works in peripheral T-cell lymphoma is not known, but its effects on genes that regulate cell proliferation and cell death are expected to lead to a reduction in the rate of growth and division of the cancer cells.
Estonian: Romidepsiini toimimise täpne mehhanism perifeerses T-rakulises lümfoomis ei ole teada, kuid oletatavasti vähendab selle toime rakkude paljunemist ja rakusurma reguleerivatele geenidele vähirakkude kasvu ning jagunemise kiirust.
English: In July 2012, the CHMP noted that the main study showed that Istodax had anti-tumour activity in terms of patients' response to treatment.
Estonian: 2012. aasta juulis märkis inimravimite komitee, et põhiuuringu kohaselt toimis Istodax patsientide ravivastuse järgi kasvaja vastaselt.
English: Peripheral T-cell lymphoma is a cancer of a type of white blood cells called T-cells, which are part of the immune system.
Estonian: Perifeerne T-rakuline lümfoom on T-rakkude e vere valgeliblede (immuunsüsteemi osa) vähk.
English: On 19 July 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Istodax, intended for the treatment of peripheral T-cell lymphoma.
Estonian: 19. juulil 2012 andis inimravimite komitee negatiivse arvamuse, soovitades keelduda Istodaxi müügiloa andmisest.
English: The active substance in Istodax, romidepsin, is expected to work by blocking the activity of proteins called histone deacetylases, which are involved in turning genes ‘on' and ‘off' within cells.
Estonian: Eeldati, et Istodaxi toimeaine romidepsiin blokeerib valkude histoondeatsetülaaside (lülitavad rakkudes geene sisse ja välja) aktiivsuse.
English: How is Istodax expected to work?
Estonian: Milline on Istodaxi eeldatav toime?
English: The effects of Istodax were first tested in experimental models before being studied in humans.
Estonian: Enne inimuuringuid kontrolliti Istodaxi toimet muude katsetega.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with Istodax.
Estonian: Ettevõte teatas inimravimite komiteele, et müügiloa andmisest keeldumine ei mõjuta Istodaxi kliinilistes uuringutes või tasuta ravi programmides osalevaid patsiente.
English: What was Istodax expected to be used for?
Estonian: Milleks kavatseti Istodaxi kasutada?
English: What measures are being taken to ensure the safe and effective use of Dovato?
Estonian: Mis meetmed võetakse, et tagada Dovato ohutu ja efektiivne kasutamine?
English: The patient should take one tablet once a day.
Estonian: Soovitatav annus on üks tablett üks kord ööpäevas.
English: Other information about Dovato
Estonian: Muu teave Dovato kohta
English: Both active substances have already been authorised in the European Union as separate tablets: dolutegravir in 2014 and lamivudine in 1996.
Estonian: Mõlemad toimeained on Euroopa Liidus juba eraldi tablettidena heaks kiidetud: dolutegraviir 2014. aastal ja lamivudiin 1996. aastal.
English: As for all medicines, data on the use of Dovato are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse Dovato kasutamise kohta pidevat järelevalvet.
English: What is Dovato and what is it used for?
Estonian: Mis on Dovato ja milleks seda kasutatakse?
English: Dovato (dolutegravir / lamivudine)
Estonian: Dovato (dolutegraviir/lamivudiin)
English: Dovato is a medicine for treating infection with human immunodeficiency virus type 1 (HIV-1) in adults and adolescents over 12 years old who weigh at least 40 kg.
Estonian: Dovato on ravim, mida kasutatakse inimese 1. tüüpi immuunpuudulikkuse viiruse (HIV-1) infektsiooni raviks täiskasvanutel ja üle 12-aastastel noorukitel (kehamassiga vähemalt 40 kg).
English: In both studies there were no cases of resistance to treatment after 48 weeks.
Estonian: Kummaski uuringus ei täheldatud 48 ravinädala järel ravimiresistentsust.
English: Dovato is available as tablets containing 50 mg of dolutegravir and 300 mg of lamivudine.
Estonian: Dovatot turustatakse tablettidena, mis sisaldavad 50 mg dolutegraviiri ja 300 mg lamivudiini.
English: For more information about using Dovato, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Dovato kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dovato have been included in the summary of product characteristics and the package leaflet.
Estonian: Dovato ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Dovato (dolutegravir / lamivudine) EMA/276259/2019
Estonian: Dovato (dolutegraviir/lamivudiin) EMA/276259/2019
English: Side effects reported with Dovato are carefully evaluated and any necessary action taken to protect patients.
Estonian: Dovato kõrvaltoimeid hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
English: Dovato does not cure HIV infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Estonian: Dovato ei ravi HIV-nakkust ega AIDSi välja, kuid võib edasi lükata immuunsüsteemi kahjustumist ning AIDSiga kaasnevate infektsioonide ja haiguste teket.
English: What are the risks associated with Dovato?
Estonian: Mis riskid Dovatoga kaasnevad?
English: The most common serious side effects (which may affect up to 1 in 100 people) are allergic reactions, including rash and severe liver problems.
Estonian: Kõige raskemad kõrvalnähud (võivad esineda kuni 1 patsiendil 100st) on allergilised reaktsioonid, sealhulgas lööve ja rasked maksaprobleemid.
English: In two main studies, the Dovato combination was just as effective as a triple combination in patients with HIV-1, with no cases of resistance developing in these patients.
Estonian: Kahes põhiuuringus oli Dovato kombinatsioon HIV-1ga patsientidel sama efektiivne kui kolme toimeaine kombinatsioon ning nendel patsientidel ei tekkinud resistentsust.
English: Dovato received a marketing authorisation valid throughout the EU on 1 July 2019 Further information on Dovato can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/dovato This overview was last updated in 08-2019.
Estonian: Lisateave Dovato kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/dovato.
English: Dolutegravir stops the activity of an enzyme called integrase (and is known as an integrase inhibitor), while lamivudine stops the activity of reverse transcriptase (and is known as a nucleoside reverse transcriptase inhibitor or NRTI).
Estonian: Dolutegraviir blokeerib ensüümi integraasi (seepärast nimetatakse seda integraasiinhibiitoriks) ning lamivudiin blokeerib pöördtranskriptaasi (seda nimetatakse nukleosiidseks pöördtranskriptaasi inhibiitoriks, NRTI).
English: Two main studies, involving 1,441 patients, have shown that the combination of the two active substances in Dovato is as effective at lowering the amount of HIV in the blood as a triple combination therapy (dolutegravir plus tenofovir plus emtricitabine).
Estonian: Kahest põhiuuringust, milles osales 1433 patsienti, selgus, et Dovatos sisalduv kahe toimeaine kombinatsioon vähendas HIVi kogust veres sama efektiivselt kui kolme toimeaine kombinatsioon (dolutegraviir, tenofoviir ja emtritsitabiin).
English: This medicine contains the active substances dolutegravir and lamivudine and is used to treat infections that are not resistant to medicines of the same class as dolutegravir or to lamivudine.
Estonian: Ravim sisaldab toimeainetena dolutegraviiri ja lamivudiini ning sellega ravitakse infektsioone, mis ei ole dolutegraviiri ja lamivudiiniga samasse klassi kuuluvate ravimite suhtes resistentsed.
English: Dovato can only be obtained with a prescription and should be prescribed by a doctor who is experienced in managing HIV infection.
Estonian: Dovato on retseptiravim, mida tohib määrata ainult HIV-infektsiooni ravis kogenud arst.
English: The most common side effects with Dovato (which may affect up to 1 in 10 people) are headache, diarrhoea, nausea and difficulty sleeping.
Estonian: Dovato kõige sagedamad kõrvalnähud (võivad esineda kuni 1 patsiendil 10st) on peavalu, kõhulahtisus, iiveldus ja unetus.
English: Triple combination therapy is used for HIV treatment to reduce the chance of the virus becoming resistant to treatment.
Estonian: HIV-infektsiooni ravis kasutatakse kolme toimeaine kombinatsiooni selleks, et vähendada viiruse resistentseks muutumise tõenäosust.
English: What benefits of Dovato have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Dovato kasulikkus?
English: How does Dovato work?
Estonian: Kuidas Dovato toimib?
English: In these studies, 91% of patients with HIV-1 who took the Dovato combination no longer had detectable levels of HIV (below 50 copies per ml) after 48 week compared with 93% of those who were taking the triple combination.
Estonian: Nendes uuringutes oli HIV-1ga patsiente, kelle veres ei olnud 48 nädala järel HIVi võimalik tuvastada, Dovato kombinatsiooni kasutanutest 91% ja kolme toimeaine kombinatsiooni kasutanutest 93%.
English: An overview of Dovato and why it is authorised in the EU
Estonian: Ülevaade ravimist Dovato ja ELis müügiloa väljastamise põhjendus
English: The two active substances in Dovato, dolutegravir and lamivudine, block the activity of enzymes that the virus uses to make new copies of itself.
Estonian: Dovato mõlemad toimeained, dolutegraviir ja lamivudiin, blokeerivad ensüümide toime, mis aitavad HIV-il nakatunud rakkudes paljuneda.
English: Furthermore, both active substances are available in a single tablet and are acceptably safe.The European Medicines Agency therefore decided that Dovato's benefits are greater than its risks and that it can be authorised for use in the EU.
Estonian: Seepärast otsustas Euroopa Ravimiamet, et Dovato kasulikkus on suurem kui sellega kaasnevad riskid ja et ravimi kasutamise võib ELis heaks kiita.
English: How is Dovato used?
Estonian: Kuidas Dovatot kasutatakse?
English: 3 (3x1) inhalers (360(3x120) actuations) (multipack)
Estonian: 3 (3x1) inhalaatoriga (360(3x120) annust)
English: 1 inhaler (120 actuations)
Estonian: 1 inhalaator (120 annust)
English: Pack size
Estonian: multipakend
English: • Not known (frequency cannot be estimated from the available data)
Estonian: • Teadmata (esinemissagedust ei saa hinnata olemasolevate andmete alusel)
English: 597 678 01 Blansko Czech Republic
Estonian: 597 678 01 Blansko Tšehhi Vabariik
English: You should speak with your doctor about any suspicious skin changes.
Estonian: Te peaksite rääkima oma arstiga igasugusest kahtlasest naha muutusest.
English: Your doctor may need to adjust or stop your dose.
Estonian: Arst võib teie annust kohandada või ravi lõpetada.
English: Children and adolescents Rasagiline Mylan is not recommended for use under the age of 18.
Estonian: Lapsed ja noorukid Rasagiline Mylani ei soovitata kasutada alla 18-aastastel.
English: Rasagiline is not recommended for use in children and adolescents due to lack of data on safety and efficacy.
Estonian: Rasagiliini ei soovitata kasutada lastel ja noorukitel ohutuse ja efektiivsuse andmete puudumise tõttu.
English: The frequency of possible side effects listed below is defined using the following convention:
Estonian: Allpool loetletud võimalike kõrvaltoimete esinemissagedus on määratletud järgmiselt:
English: There was a significant and beneficial effect in quality of life (as assessed by PD-QUALIF scale).
Estonian: Oluline ning soodne toime avaldus elukvaliteedi osas (vastavalt PDQUALIF skaala hinnangule).
English: In case of overdose, patients should be monitored and the appropriate symptomatic and supportive therapy instituted.
Estonian: Üleannustamise korral tuleb patsiente jälgida ja alustada sobiva sümptomaatilise ja toetava raviga.
English: Do not use this medicine after the expiry date which is stated on the carton or blister after EXP.
Estonian: Ärge kasutage seda ravimit pärast kõlblikkusaega, mis on märgitud karbil või blisterpakendil pärast „EXP“.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without prescription or if you are smoking or intend to stop smoking.
Estonian: Teatage oma arstile või apteekrile, kui te kasutate või olete hiljuti kasutanud või kavatsete kasutada mistahes muid ravimeid, kaasa arvatud ilma retseptita ostetud ravimeid, või kui te suitsetate või kavatsete suitsetamisest loobuda.
English: Adverse events were mild or moderate and not related to rasagiline treatment.
Estonian: Kõrvaltoimed olid kerged või mõõdukad ja mitte seotud rasagiliinraviga.