FrancophonIA/ELRC3.0 huggingface dataset:
English: METHOD AND ROUTE(S) OF ADMINISTRATION Reconstitute and dilute before use.
Estonian: Enne kasutamist lahustada ja lahjendada.
English: One vial contains pixantrone dimaleate equivalent to 29 mg pixantrone
Estonian: Üks viaal sisaldab piksantroondimaleaati koguses, mis vastab 29 mg piksantroonile.
English: Uncommon Dizziness, lethargy
Estonian: Pearinglus, letargia
English: Very common Nausea, vomiting
Estonian: Väga sage Iiveldus, oksendamine Sage
English: Using sterile procedures, reconstitute each 29 mg vial with 5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Estonian: Lahuse valmistamiseks lisage igasse 29 mg viaali 5 ml naatriumkloriidi 9 mg/ml (0,9%) süstelahust, kasutades steriilseid protseduure.
English: It appears as a dark blue powder which comes in vials containing 29 mg of pixantrone.
Estonian: Pulber on tumesinine, seda tarnitakse 29 mg piksantrooni sisaldavates viaalides.
English: Pixuvri is for intravenous use only.
Estonian: Manustamisviis Pixuvri on ainult intravenoosseks kasutamiseks.
English: PHARMACEUTICAL FORM Powder for concentrate for solution for infusion.
Estonian: Pixuvri on infusioonilahuse kontsentraadi pulber.
English: Pixuvri contains sodium
Estonian: Pixuvri sisaldab naatriumi
English: Aseptically reconstitute each 29 mg vial with 5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Estonian: Lahuse valmistamiseks lisage igasse 29 mg viaali 5 ml naatriumkloriidi 9 mg/ml (0,9%) süstelahust aseptilistes tingimustes.
English: Repeated MUGA scan or ECHO determinations of LVEF should be considered in patients with risk factors such as high cumulative exposure to prior anthracyclines or significant pre-existing cardiac disease.
Estonian: Riskifaktoritega (näiteks kõrge kumulatiivne ekspositsioon eelneva antratsükliinravi tõttu või raske eelnev südamehaigus) patsientidel peaks kaaluma korduvaid LVEF-uuringuid MUGA-skaneeringu või ehhokardiograafia abil.
English: Common Stomatitis, diarrhoea, constipation, abdominal pain,
Estonian: Stomatiit, diarröa, kõhukinnisus, kõhuvalu, suu kuivus, düspepsia
English: log rank p-value = 0.005 HR = 0.60 (95% CI 0.42, 0.86)
Estonian: log rank p = 0,005
English: Marketing Authorisation Holder Les Laboratoires Servier 50, rue Carnot
Estonian: Müügiloa hoidja ja tootja Les Laboratoires Servier 50, rue Carnot 92284 Suresnes cedex Prantsusmaa
English: Special precautions for disposal
Estonian: Erihoiatused ravimpreparaadi hävitamiseks
English: If on day 1 of any cycle the Absolute Neutrophil Count (ANC) is < 1.0 x 109/l or platelet count is
Estonian: Kui tsükli 1. päeval on neutrofiilide üldarv (Absolute Neutrophil Count, ANC) < 1,0 x 109/l või trombotsüütide arv < 75 x·109/l, on soovitatav ravi edasi lükata, kuni ANC väärtuseni ≥ 1,0 x 109/l ja trombotsüütide arvuni ≥ 75 x 109/l.
English: Common Dyspnoea, cough Uncommon Pleural effusion, pneumonitis, rhinorrhoea
Estonian: Pleuraefusioon, pneumoniit, ninavoolus
English: Table 3 Adverse drug reactions reported related to Pixuvri in completed Pixuvri single agent studies by frequency System Organ Class
Estonian: Tabel 3 Pixuvri kohta teatatud ravimi kõrvaltoimed üksikravimiga läbiviidud uuringutes (kõrvaltoimete esinemissagedus)
English: Common Pallor, vein discolouration, hypotension Uncommon Vein disorder
Estonian: Kahvatus, veenide värvi muutus, hüpotensioon
English: somnolence
Estonian: Imendumine
English: Method of administration
Estonian: Organsüsteemi klass
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains pixantrone dimaleate equivalent to 29 mg pixantrone.
Estonian: Iga viaal sisaldab piksantroondimaleaati koguses, mis vastab 29 mg piksantroonile.
English: Neutropenia, leukopenia, lymphopenia, anaemia, thrombocytopenia Common Febrile neutropenia, blood disorder Uncommon Bone marrow failure, eosinophilia
Estonian: Väga sage Neutropeenia, leukopeenia, lümfopeenia, aneemia, trombotsütopeenia
English: End-of-Study
Estonian: Uuringu lõpp
English: Common Proteinuria, haematuria Uncommon Oliguria
Estonian: Proteinuuria, hematuuria
English: oedema
Estonian: Oliguuria
English: Reconstituted and diluted solution
Estonian: Manustamiskõlblikuks muudetud lahus
English: Uncommon Hypersensitivity to the medicinal product
Estonian: Ülitundlikkus ravimi suhtes
English: dry mouth, dyspepsia,
Estonian: Erüteem, küünte haigused, kihelus
English: 120 capsules
Estonian: 120 kapslit
English: Invented name Strength Pharmaceutical Form Route of Administration Packaging Content
Estonian: Müügiloa nr Euroopa Liidus Ravimi väljamõeldud nimetusTugevus Ravimvorm ManustamisteePakendi iseloomustus Pakendi sisu Pakendi suurus EU/1/05/315/001
English: Capsule, soft bottle (HDPE)
Estonian: Pudel (HDPE)
English: 250 mg
Estonian: 250 mg Pehmekapsel
English: 100 mg/ml
Estonian: 100 mg/ml Suukaudne lahus Suukaudne
English: Oral solution bottle (glass)
Estonian: Pudel (klaas)
English: EU Number
Estonian: Suukaudne
English: It is available as tablets (5, 7.5 10, 15 and 20 mg).
Estonian: Seda turustatakse tablettidena (5, 7,5, 10, 15 ja 20 mg).
English: Olazax olanzapine
Estonian: Olazax olansapiin
English: The full EPAR for Olazax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Olazaxi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Patients over 65 years of age and patients who have reduced liver or kidney function may need a lower starting dose of 5 mg per day.
Estonian: Üle 65-aastased patsiendid ning neeru- ja maksapuudulikkusega patsiendid võivad vajada väiksemat algannust (5 mg ööpäevas).
English: The usual dose range is between 5 and 20 mg per day.
Estonian: Tavaline annusevahemik on 520 mg ööpäevas.
English: The recommended starting dose of Olazax depends on the disease being treated: 10 mg per day is used in schizophrenia and in the prevention of manic episodes, and 15 mg per day in the treatment of manic episodes, unless it is used with other medicines, in which case the starting dose can be 10 mg per day.
Estonian: Olazaxi soovituslik algannus sõltub ravitavast haigusest: skisofreenia korral ja maaniaepisoodide ennetamiseks kasutatakse annust 10 mg ööpäevas ning maaniaepisoodide raviks 15 mg ööpäevas, välja arvatud kasutamisel koos teiste ravimitega, mil algannus võib olla 10 mg ööpäevas.
English: The European Commission granted a marketing authorisation valid throughout the EU for Olazax on 11 December 2009.
Estonian: Euroopa Komisjon andis Olazaxi müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 11. detsembril
English: The Committee recommended that Olazax be given marketing authorisation.
Estonian: Komitee soovitas anda Olazaxile müügiloa.
English: For more information about treatment with Olazax, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.This summary was last updated in 07-2014.
Estonian: Kui vajate Olazaxiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.Kokkuvõtte viimane uuendus: 07-2014.
English: Other information about Olazax
Estonian: Muu teave Olazaxi kohta
English: Therefore, the CHMP's view was that, as for Zyprexa, the benefit outweighs the identified risk.
Estonian: Seetõttu on inimravimite komitee arvamusel, et nagu ka Zyprexa korral, ületab ravimi kasulikkus sellega kaasnevad riskid.
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 Olazax.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: Because Olazax is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine.
Estonian: Et Olazax on geneeriline ravim ja bioekvivalentne võrdlusravimitega, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimitel.
English: Olazax is used to treat adults with schizophrenia.
Estonian: Olazaxi kasutatakse täiskasvanud patsientidel skisofreenia ravimiseks.
English: What is Olazax?
Estonian: Mis on Olazax?
English: Olazax is also effective in maintaining improvement in patients who have responded to an initial course of treatment.
Estonian: Olazaxi saab kasutada ka esialgse ravivastusega patsientide paranemistulemuse efektiivseks säilitamiseks.
English: This means that Olazax is similar to a ‘reference medicine' already authorised in the European Union (EU) called Zyprexa.
Estonian: See tähendab, et Olazax on sarnane võrdlusravimiga Zyprexa, millel juba on Euroopa Liidus müügiluba.
English: The CHMP concluded that, in accordance with EU requirements, Olazax has been shown to have comparable quality and to be bioequivalent to Zyprexa.
Estonian: Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Olazax võrdväärne kvaliteet ja bioekvivalentsus ravimiga Zyprexa.
English: Olazax is a medicine containing the active substance olanzapine.
Estonian: Olazax on ravim, mis sisaldab toimeainena olansapiini.
English: Olazax is also used to treat moderate to severe manic episodes (extremely high mood) in adults.
Estonian: Samuti kasutatakse Olazaxi mõõdukate ja raskete maaniaepisoodide (meeleolu äärmuslik tõus) raviks täiskasvanud patsientidel.
English: Why has Olazax been approved?
Estonian: Miks Olazax heaks kiideti?
English: Olazax is a ‘generic medicine'.
Estonian: Olazax on geneeriline ravim.
English: The dose is adjusted according to how well the patient responds to and tolerates the treatment.
Estonian: kohandatakse olenevalt patsiendi ravivastusest ja ravimitaluvusest.
English: Because Olazax is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Zyprexa.
Estonian: Et Olazax on geneeriline ravim, piirdusid patsiendiuuringud katsetega, milles näidati Olazaxi bioekvivalentsust võrdlusravimiga Zyprexa.
English: This is a summary of the European public assessment report (EPAR) for Olazax.
Estonian: See on ravimi Olazax Euroopa avaliku hindamisaruande kokkuvõte.
English: The active substance in Olazax, olanzapine, is an antipsychotic medicine.
Estonian: Olazaxi toimeaine olansapiin on antipsühhootikum (psühhoosivastane ravim).
English: What are the benefits and risks of Olazax shown during the studies?
Estonian: Milles seisneb Olazaxi kasulikkus ja mis riskid ravimiga kaasnevad?
English: How has Olazax been studied?
Estonian: Kuidas Olazaxi uuriti?
English: How is Olazax used?
Estonian: Kuidas Olazaxi kasutatakse?
English: What is Olazax used for?
Estonian: Milleks Olazaxi kasutatakse?
English: How does Olazax work?
Estonian: Kuidas Olazax toimib?
English: The doctor will calculate the number of 150 and 500 mg tablets the patient needs to take.
Estonian: Arst arvutab 150 ja 500 mg tablettide arvu, mille patsient peab võtma.
English: The full EPAR for Capecitabine Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Capecitabine Teva kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: For other types of cancer, treatment is stopped if the disease gets worse or the patient cannot tolerate the treatment.
Estonian: Teiste vähi liikide korral ravi peatatakse, kui haigus süveneb või patsient ei talu ravi.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Capecitabine Teva on 20 April 2012.
Estonian: Euroopa Komisjon andis Capecitabine Teva müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 20. aprillil 2012.
English: It is available as tablets (150 and 500 mg).
Estonian: Seda turustatakse tablettidena (150 mg ja 500 mg).
English: Capecitabine Teva tablets should be swallowed with water within the 30 minutes after a meal.
Estonian: Capecitabine Teva tabletid neelatakse veega 30 minuti jooksul pärast sööki.
English: Capecitabine Teva is taken twice a day at doses between 625 and 1,250 mg per square metre body surface area (calculated using the patient's height and weight).
Estonian: Capecitabine Tevat võetakse kaks korda ööpäevas annustes 625-1250 mg kehapinna ruutmeetri kohta (arvutatakse patsiendi pikkuse ja kaalu põhjal).
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 Capecitabine Teva.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: As a result, it inhibits the growth of tumour cells and eventually kills them.
Estonian: Selle tulemusena pärsib 5-FU kasvajarakkude kasvu ja lõpuks hävitab need.
English: For more information about treatment with Capecitabine Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Capecitabine Tevaga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: The Committee recommended that Capecitabine Teva be given marketing authorisation.
Estonian: Komitee soovitas anda Capecitabine Teva müügiloa.
English: This is a summary of the European public assessment report (EPAR) for Capecitabine Teva.
Estonian: See on ravimi Capecitabine Teva Euroopa avaliku hindamisaruande kokkuvõte.
English: Other information about Capecitabine Teva
Estonian: Muu teave Capecitabine Teva kohta
English: Because Capecitabine Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Estonian: Et Capecitabine Teva on geneeriline ravim ja võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: The CHMP concluded that, in accordance with EU requirements, Capecitabine Teva has been shown to have comparable quality and to be bioequivalent to Xeloda.
Estonian: Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Capecitabine Teva võrdväärne kvaliteet ja bioekvivalentsus ravimiga Xeloda.
English: Capecitabine Teva is used with or without other anticancer medicines in patients who have had surgery for ‘stage III' or ‘Dukes' stage C' colon cancer;
Estonian: Capecitabine Tevat kasutatakse koos teiste vähiravimitega või ilma nendeta, et ravida käärsoolevähki patsientidel, kellele on tehtud III staadiumi ehk Dukes'i skaala C-staadiumi käärsoolevähi operatsioon;
English: Therefore, the CHMP's view was that, as for Xeloda, the benefit outweighs the identified risk.
Estonian: Seetõttu arvas inimravimite komitee, et nagu ka Xeloda korral, ületab Capecitabine Teva kasulikkus sellega kaasnevad riskid.
English: Capecitabine Teva is used with or without other anticancer medicines;
Estonian: Capecitabine Tevat kasutatakse koos teiste vähiravimitega või ilma nendeta;
English: This means that Capecitabine Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Xeloda.
Estonian: See tähendab, et Capecitabine Teva on sarnane võrdlusravimiga Xeloda, millel juba on Euroopa Liidus müügiluba.
English: Because Capecitabine Teva is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Xeloda.
Estonian: Et Capecitabine Teva on geneeriline ravim, piirdusid patsiendiuuringud katsetega, milles näidati ravimi bioekvivalentsust võrdlusravimiga Xeloda.
English: Capecitabine Teva is a medicine that contains the active substance capecitabine.
Estonian: Capecitabine Teva on ravim, mis sisaldab toimeainena kapetsitabiini.
English: Why has Capecitabine Teva been approved?
Estonian: Miks Capecitabine Teva heaks kiideti?
English: It can also be used on its own when treatment with both anthracyclines and taxanes (another type of anticancer medicine) has failed or when repeat treatment with anthracyclines is not suitable for the patient.
Estonian: Capecitabine Tevat tohib kasutada ka ainsa ravimina, kui ravi antratsükliinide ja taksaanidega (teist liiki vähiravimid) ei ole andnud tulemust või kui kordusravi antratsükliinidega patsiendile ei sobi.
English: Capecitabine Teva should only be prescribed by a doctor who is qualified in the use of anticancer medicines.
Estonian: Capecitabine Tevat tohib määrata üksnes vähiravimite pädevusega arst.
English: What is Capecitabine Teva?
Estonian: Mis on Capecitabine Teva?
English: Capecitabine Teva is a ‘generic medicine'.
Estonian: Capecitabine Teva on geneeriline ravim.
English: Capecitabine Teva is used with docetaxel (another anticancer medicine) after treatment with anthracyclines (another type of anticancer medicine) has failed.
Estonian: Capecitabine Tevat kasutatakse koos dotsetakseeliga (samuti vähiravim) pärast tulemusteta ravi antratsükliinidega (teist liiki vähiravimid).
English: Capecitabine Teva is used with other anticancer medicines, including a platinum-containing anticancer medicine such as cisplatin;
Estonian: Capecitabine Tevat kasutatakse koos teiste vähiravimitega, sealhulgas plaatinat sisaldava vähiravimiga (näiteks tsisplatiiniga);
English: The active substance in Capecitabine Teva, capecitabine, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the group ‘anti-metabolites'.
Estonian: Capecitabine Teva toimeaine kapetsitabiin on antimetaboliitide (raku normaalset ainevahetust pärssivad ained) hulka kuuluv tsütotoksiline ravim (poolduvaid rakke, näiteks vähirakke hävitav ravim).
English: What are the benefits and risks of Capecitabine Teva?
Estonian: Milles seisneb CapecitabineTeva kasulikkus ja mis riskid ravimiga kaasnevad?
English: How has Capecitabine Teva been studied?
Estonian: Kuidas Capecitabine Tevat uuriti?
English: Capecitabine Teva is an anticancer medicine.
Estonian: Capecitabine Teva on retseptiravim.
English: How is Capecitabine Teva used?
Estonian: Kuidas Capecitabine Tevat kasutatakse?
English: What is Capecitabine Teva used for?
Estonian: Milleks Capecitabine Tevat kasutatakse?
English: How does Capecitabine Teva work?
Estonian: Kuidas Capecitabine Teva toimib?
English: • colon (large bowel) cancer.
Estonian: • käärsoole- ehk jämesoolevähk.
English: No time-dependency was observed.
Estonian: Sõltuvust ajast ei täheldatud.
English: Via della Chimica, 9 36100 Vicenza Italy
Estonian: Via della Chimica, 9 36100 Vicenza Itaalia
English: Ask your doctor for advice prior to driving or using machines.
Estonian: Küsige oma arstilt nõu enne autojuhtimist või masinatega töötamist.
English: Date of first authorisation: 24 February 2015 Date of latest renewal:
Estonian: Müügiloa esmase väljastamise kuupäev: 24. veebruar 2015 Müügiloa viimase uuendamise kuupäev:
English: None of these metabolites are pharmacologically active.
Estonian: Ükski neist metaboliitidest ei ole farmakoloogiliselt aktiivne.
English: Email: info.zambonspa@zambongroup.com
Estonian: E-post: info.zambonspa@zambongroup.com
English: Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
Estonian: Teatage oma arstile, kui te võtate või olete hiljuti võtnud või kavatsete võtta mis tahes muid ravimeid.
English: (2 years)
Estonian: (2 aastat)
English: Social circumstances
Estonian: Sotsiaalsed tingimused
English: Experience of use of safinamide in patients over 75 years of age is limited.
Estonian: Safinamiidi kasutamise kogemused üle 75-aastastel patsientidel on piiratud.
English: If you suffer from moderately reduced liver function, you should not take more than 50 mg a day; your doctor will advise if this applies to you.
Estonian: Kui teil on mõõdukalt vähenenud maksafunktsioon, siis ärge võtke rohkem kui 50 mg ööpäevas; kui see kehtib teie kohta, annab teie arst sellest teile teada.
English: Other medicines and Xadago
Estonian: Muud ravimid ja Xadago
English: The terminal elimination half-life of total radioactivity was approximately 80 hours.
Estonian: Radioaktiivsuse terminaalne eliminatsiooni poolväärtusaeg oli ligikaudu 80 tundi.
English: Safinamide should be taken with water.
Estonian: Safinamiidi tuleb võtta koos veega.
English: Contact your doctor immediately and take the Xadago pack with you.
Estonian: Võtke kohe ühendust oma arstiga ja võtke Xadago karp kaasa.
English: (24 weeks)
Estonian: (24 nädalat)
English: If necessary, the concomitant use of these medicinal products should be at the lowest effective dose.
Estonian: Vajadusel peab neid ravimeid kasutama väikseima toimiva annusena.
English: A risk for the breast-fed child cannot be excluded.
Estonian: Ohtu imikule ei saa välistada.
English: This daily dose may be increased to 100 mg/day on the basis of individual clinical need.
Estonian: Päevast annust võib suurendada 100 mg-ni ööpäevas vastavalt individuaalsele kliinilisele vajadusele.
English: - Uncontrollable jerky movements may occur or worsen when Xadago is used together with levodopa.
Estonian: - Kontrollimatud imelikud liigutused võivad tekkida või süveneda, kui Xadago't kasutatakse koos levodopaga.
English: If a dose is missed the next dose should be taken at the usual time the next day.
Estonian: Kui ravimi annus jääb võtmata, siis tuleb järgmine annus manustada tavalisel ajal järgmisel päeval.
English: Xadago is used for the treatment of Parkinson's disease in adults.
Estonian: Xadago't kasutatakse Parkinsoni tõve raviks täiskasvanutel.
English: Safinamide's metabolism is not dependent on Cytochrome P450 (CYP) based enzymes.
Estonian: Safinamiidi metabolism ei sõltu tsütokroom P450-l (CYP) põhinevatel ensüümidel.
English: Dyskinesia occurred early in treatment, was rated “severe”, led to discontinuation in very few patients (approx. 1.5%), and did not require reduction of dose in any patient.
Estonian: Düskineesiat esines ravi varajases faasis, seda hinnati “tõsiseks” ning viis väga väheste patsientide (ligikaudu 1,5%) ravimi manustamise lõpetamiseni ning ei vajanud annuse vähendamist ühegi patsiendi puhul.
English: Xadago is not recommended for use in children and adolescents, below 18 years old due to the lack of data on safety and efficacy in this population.
Estonian: Xadago't ei soovitata kasutada lastel ja noorukitel vanuses alla 18 aasta seoses ohutuse ja efektiivsuse andmete puudumisega selles patsientide rühmas.
English: C-safinamide accounted for approximately 30% of the total radioactivity AUC0-24h, indicative of an extensive metabolism.
Estonian: C-safinamiidi plasma AUC0-24h moodustas ligikaudu 30% koguradioaktiivsusest AUC0-24h, mis viitab ulatuslikule metabolismile.
English: Impulse control disorders (ICDs)
Estonian: Impulsi kontrolli häired (IKH)
English: The volume of distribution (Vss) is approximately 165 L which is 2.5-fold of body volume indicating extensive extravascular distribution of safinamide.
Estonian: Jaotusruumala (Vss) on ligikaudu 165 l, mis on 2,5 korda suurem keha ruumalast, mis viitab safinamiidi ulatuslikule jaotumisele väljaspool vereringet.
English: The safety and efficacy of safinamide in children and adolescents under 18 years of age have not been established.
Estonian: Safinamiidi ohutus ja efektiivsus lastel ja noorukitel vanuses alla 18 aasta ei ole veel tõestatud.
English: - Pethidine (a strong pain killer).
Estonian: - petidiini (tugev valuvaigisti).
English: Studies were not stratified for co-medication, and no randomized interaction studies were performed for these medicinal products.
Estonian: Uuringuid ei stratifitseeritud kaasravimite seisukohalt ning nende ravimite kohta ei viidud läbi koostoime randomiseerituid uuringuid.