FrancophonIA/ELRC3.0 huggingface dataset:
English: For information concerning the use of Yttrium (90Y)-labelled medicinal products in pregnancy and lactation refer to the Summary of Product Characteristics/package leaflet of the medicinal product to be radiolabelled.
Estonian: Teavet ütriumiga (90Y) märgistatud ravimpreparaatide kasutamise kohta raseduse ja imetamise ajal vt vastava radiomärgistatava ravimpreparaadi omaduste kokkuvõttest ja/või pakendi infolehelt.
English: Possible side effects following the intravenous administration of Yttrium (90Y)-labelled medicinal products prepared by radiolabelling with YTRACIS, will be dependent on the specific medicinal product being used.
Estonian: YTRACIS'e abil ütriumiga (90Y) radiomärgistatud ravimpreparaatide veenisisese manustamisega kaasnevad võimalikud kõrvaltoimed sõltuvad kasutatavast ravimist.
English: Effects on ability to drive or use machines following treatment by Yttrium (90Y)-labelled medicinal products will be specified in the Summary of Product Characteristics/package leaflet of the particular medicinal product to be radiolabelled.
Estonian: Raviga ütriumiga (90Y) märgistatud ravimpreparaatidega kaasnev mõju autojuhtimisele ja masinate käsitsemise võimele täpsustatakse vastava radiomärgistatava ravimpreparaadi omaduste kokkuvõttes ja/või pakendi infolehel.
English: Breast-feeding: Ask your doctor or pharmacist for advice before taking any medicine.
Estonian: Enne ravimi kasutamist pidage nõu arsti või apteekriga.
English: BATCH NUMBER
Estonian: PARTII NUMBER Partii nr: {XXXXX}
English: Method of Administration
Estonian: Manustamisviis
English: Refer to the Summary of Product Characteristics/package leaflet of the particular medicinal product to be radiolabelled.
Estonian: Vaata konkreetse radiomärgistatava ravimpreparaadi omaduste kokkuvõtet ja/või pakendi infolehte.
English: Such information will be supplied in the Summary of Product Characteristics/package leaflet of the medicinal product to be radiolabelled.
Estonian: Neid kirjeldatakse radiomärgistatava ravimpreparaadi omaduste kokkuvõttes ja/või pakendi infolehel.
English: For more information, refer to the package leaflet of the particular medicinal product to be radiolabelled.
Estonian: Lugege lisainfot vastava radiomärgistatava ravimpreparaadi pakendi infolehelt.
English: For information concerning interactions associated with the use of Yttrium (90Y)-labelled medicinal products refer to the Summary of Product Characteristics/package leaflet of the medicinal product to be radiolabelled.
Estonian: Ütriumiga (90Y) märgistatud ravimpreparaatide kasutamisega seotud koostoimete kohta vt vastava radiomärgistatava ravimpreparaadi omaduste kokkuvõtet ja/või pakendi infolehte.
English: For information on contraindications to particular Yttrium (90Y)-labelled medicinal products prepared by radiolabelling with YTRACIS, refer to the Summary of Product Characteristics/package leaflet of the particular medicinal product to be radiolabelled.
Estonian: Vastunäidustuste kohta YTRACIS'e abil ütriumiga (90Y) märgistatud ravimpreparaatide suhtes vt vastava ravimpreparaadi omaduste kokkuvõtet ja/või pakendi infolehte.
English: The pharmacokinetic properties of Yttrium (90Y)-labelled medicinal products prepared by radiolabelling with YTRACIS, prior to administration, will be dependent on the nature of the medicinal product to be radiolabelled.
Estonian: YTRACIS'e abil ütriumiga (90Y) märgistatud ravimpreparaatide farmakodünaamilised omadused sõltuvad konkreetse radiomärgistatava ravimi iseloomust.
English: 91192 GIF-SUR-YVETTE Cedex France
Estonian: 91192 GIF-SUR-YVETTE Cedex
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION YTRACIS Yttrium (90Y) chloride
Estonian: YTRACIS radiofarmatseutiline prekursor, lahus Ütrium (90Y) kloriid
English: Absorbed dose per unit activity administered (mGy/MBq)
Estonian: (mGy/MBq)
English: F-91192 Gif-sur-Yvette Cedex FRANCE
Estonian: F-91192 GIF-SUR-YVETTE CEDEX PRANTSUSMAA
English: F-91192 GIF-SUR-YVETTE Cedex France
Estonian: F-91192 Gif-sur-Yvette Cedex PRANTSUSMAA
English: This summary was last updated in 10-2015.
Estonian: Kokkuvõtte viimane uuendus: 10-2015.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Sycrest on 1 September 2010.
Estonian: Euroopa Komisjon andis Sycresti müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 1. septembril
English: Sycrest tablets should not be chewed or swallowed.
Estonian: Sycresti tablette ei tohi närida ega alla neelata.
English: A risk management plan has been developed to ensure that Sycrest is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Sycresti võimalikult ohutu kasutamine.
English: The patient should avoid eating or drinking for 10 minutes after taking the medicine.
Estonian: Patsient ei tohi manustamisele järgneva 10 minuti jooksul süüa ega juua.
English: What measures are being taken to ensure the safe and effective use of Sycrest?
Estonian: Mis meetmed võetakse, et tagada Sycresti ohutu ja efektiivne kasutamine?
English: Sublingual tablets are tablets that are placed under the tongue, where they dissolve.
Estonian: Keelealused tabletid on tabletid, mis asetatakse manustamiseks keele alla, kus need lahustuvad.
English: It is available as sublingual tablets (5 and 10 mg).
Estonian: Seda turustatakse keelealuste tablettidena (5 mg ja 10 mg).
English: The recommended starting dose of Sycrest is 5 mg twice a day, one dose in the morning and one in the evening.
Estonian: Sycresti soovituslik algannus on 5 mg kaks korda ööpäevas, üks annus hommikul ja teine õhtul.
English: Sycrest asenapine
Estonian: Sycrest asenapiin
English: The studies on schizophrenia were not considered to have shown sufficient evidence of the effectiveness in treating this disease.
Estonian: Skisofreeniapatsientide uuringutest ei saadud piisavalt tõendeid ravimi efektiivsuse kohta selle haiguse ravis.
English: When taken in combination with other medicines, Sycrest should be taken last.
Estonian: Koos teiste ravimitega kasutamisel tuleb Sycresti võtta kõige viimasena.
English: The full EPAR for Sycrest can be found on the Agency's website under EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Sycresti kohta on Euroopa Ravimiameti veebilehel EMA website/Find medicine/Human medicines/European Public Assessment Reports..
English: Since these neurotransmitters are involved in bipolar disorder, Sycrest helps to normalise the activity of the brain, reducing the symptoms of the disease.
Estonian: Et need neurotransmitterid on seotud bipolaarse häirega, aitab Sycrest ajutalitlust normaliseerida ja haiguse sümptomeid vähendada.
English: The most common side effects with Sycrest (seen in more than 1 patient in 10) are anxiety and somnolence (sleepiness).
Estonian: Sycresti kõige sagedamad kõrvalnähud (esinenud enam kui 1 patsiendil 10st) on ärevus ja unisus.
English: Sycrest is a medicine that contains the active substance asenapine.
Estonian: Sycrest on ravim, mis sisaldab toimeainena asenapiini.
English: The Y-MRS rates the severity of symptoms of manic episodes on a scale from 0 to 60.
Estonian: Y-MRS-skaala hindab maaniaepisoodide sümptomite raskust 0-60-punktisel skaalal.
English: Sycrest is used to treat moderate to severe manic episodes (extremely high mood) in adults (aged 18 years or over) with bipolar disorder, a mental illness in which patients have periods of abnormally high mood alternating with periods of normal or depressed mood.
Estonian: Sycresti kasutatakse mõõdukate kuni raskete maaniaepisoodide (meeleolu äärmuslik tõus) raviks täiskasvanutel (vähemalt 18-aastastel), kellel on bipolaarne meeleoluhäire - vaimuhaigus, mille korral patsientide maaniaepisoodid vahelduvad normaalse meeleolu või depressiooniperioodidega.
English: This dose can be increased to 10 mg twice a day depending on how the patient responds.
Estonian: Annust tohib suurendada 10 mg-ni, mida võetakse olenevalt patsiendi ravivastusest kaks korda ööpäevas.
English: This is a summary of the European public assessment report (EPAR) for Sycrest.
Estonian: See on ravimi Sycrest Euroopa avaliku hindamisaruande kokkuvõte.
English: Other information about Sycrest:
Estonian: Muu teave Sycresti kohta
English: Sycrest was also studied in patients with schizophrenia.
Estonian: Sycresti uuriti ka skisofreeniaga patsientidel.
English: It is thought that Sycrest works by blocking receptors for the neurotransmitters 5-hydroxytrypamine (also called serotonin) and dopamine.
Estonian: Arvatakse, et Sycresti toime seisneb neurotransmitterite 5-hüdroksütrüptamiini (serotoniini) ja dopamiini retseptorite blokeerimises.
English: For more information about treatment with Sycrest, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Sycrestiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: What is Sycrest?
Estonian: Mis on Sycrest?
English: The studies included short- and long-term studies in patients receiving Sycrest, other medicines for schizophrenia (olanzapine, risperidone or haloperidol) or placebo.
Estonian: Uuringud hõlmasid lühi- ja pikaajalisi uuringuid patsientidel, kellele manustati Sycresti, teisi skisofreeniaravimeid (olansapiini, risperidooni või haloperidooli) või platseebot.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Sycrest, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati Sycresti omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
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 Sycrest.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: The main measure of effectiveness was the change in the patients' ‘Young mania rating scale' (Y-MRS) score.
Estonian: Efektiivsuse põhinäitaja oli muutus patsientide sümptomites Y-MRS-skaala põhjal.
English: The other two studies lasted longer: one compared Sycrest with olanzapine over nine weeks in patients who had come from the short-term studies; and the other was a 12-week ‘add on' study, in which 326 patients who were already being treated with another medicine (lithium or valproic acid) were also given either Sycrest or placebo.
Estonian: Kaks teist uuringut kestsid kauem: ühes võrreldi Sycresti olansapiiniga 9 nädala jooksul patsientidel, kellel oli lõpetatud lühiajalised uuringud, ja teine oli 12-nädalane senisele ravile täiendava ravimi lisamise uuring, milles muu ravimiga (liitiumi või valproehappega) ravitavale 326 patsiendile manustati Sycresti või platseebot.
English: What is the risk associated with Sycrest?
Estonian: Mis riskid Sycrestiga kaasnevad?
English: Why has Sycrest been approved?
Estonian: Miks Sycrest heaks kiideti?
English: In two of these studies, a total of 977 adult patients were given Sycrest, olanzapine (another antipsychotic medicine) or placebo (a dummy treatment) over three weeks.
Estonian: Kahes uuringus manustati 977 täiskasvanud patsiendile kolme nädala jooksul Sycresti, olansapiini (samuti antipsühhootikum) või platseebot (näivat ravimit).
English: Sycrest was effective at treating manic episodes in patients with bipolar disorder.
Estonian: Sycrest oli bipolaarse meeleoluhäirega patsientide maaniaepisoodide ravis efektiivne.
English: The CHMP, however, did not recommend that the medicine be authorised to treat schizophrenia because of the lack of effectiveness shown in this illness.
Estonian: Samas ei soovita inimravimite komitee ravimit heaks kiita kasutamiseks skisofreenia ravis, sest puuduvad tõendid, et ravim oleks skisofreenia ravis efektiivne.
English: The active substance in Sycrest, asenapine, is an antipsychotic medicine.
Estonian: Sycresti toimeaine asenapiin on antipsühhootikum (psühhoosivastane ravim).
English: In the second long-term study, the reductions in Y-MRS score were 10.3 and 7.9 for Sycrest and placebo, respectively, after three weeks and 12.7 and 9.3 after 12 weeks.
Estonian: Teises pikaajalises uuringus vähenes Y-MRSskaala punktisumma pärast 3-nädalast Sycresti ja platseebo manustamist vastavalt 10,3 ja 7,9 ning 12 nädala pärast vastavalt 12,7 ja 9,3 punkti.
English: In the first long-term study, a reduction in Y-MRS score of 12.9 was seen in patients taking Sycrest compared with 16.2 in patients taking olanzapine.
Estonian: Esimeses pikaajalises uuringus vähenes Y-MRS-skaala punktisumma Sycrestiga ravitud patsientidel 12,9 ja olansapiiniga ravitud patsientidel 16,2 punkti.
English: What is Sycrest used for?
Estonian: Milleks Sycresti kasutatakse?
English: In the first shortterm study, the reductions in Y-MRS score after three weeks were 11.5 and 14.6 points for Sycrest and olanzapine, respectively, compared with 7.8 points for placebo.
Estonian: Esimeses lühiajalises uuringus vähenes Y-MRS-skaala punktisumma 3 nädala järel Sycresti ja olansapiini kasutamisel vastavalt 11,5 ja 14,6 ning platseebo korral 7,8 punkti.
English: What benefit has Sycrest shown during the studies?
Estonian: Milles seisneb uuringute põhjal Sycresti kasulikkus?
English: How is Sycrest used?
Estonian: Kuidas Sycresti kasutatakse?
English: The CHMP decided that Sycrest's benefits are greater than its risks and recommended that it be given marketing authorisation for the treatment of moderate to severe manic episodes in patients with bipolar disorder.
Estonian: Inimravimite komitee otsustas, et Sycresti kasulikkus mõõdukate kuni raskete maaniaepisoodide ravis bipolaarse meeleoluhäirega patsientidel on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: How does Sycrest work?
Estonian: Kuidas Sycrest toimib?
English: The reductions for the second shortterm study were 10.8 and 12.6 points for Sycrest and olanzapine, respectively, and 5.5 for placebo.
Estonian: Teises lühiajalises uuringus vähenes punktisumma Sycrestiga 10,8, olansapiiniga 12,6 ja platseeboga 5,5 punkti.
English: How has Sycrest been studied?
Estonian: Kuidas Sycresti uuriti?
English: Four main studies looked at the use of Sycrest for manic episodes in bipolar disorder.
Estonian: Sycresti kasutamist bipolaarse häire maaniaepisoodide korral uuriti neljas põhiuuringus.
English: The medicine can only be obtained with a prescription.
Estonian: Sycrest on retseptiravim.
English: You may need medical treatment.
Estonian: Võimalik, et teil on vaja meditsiinilist abi.
English: - You do not take the medicine every day.
Estonian: • Ärge võtke ravimit iga päev.
English: The remainders are metabolites.
Estonian: Ülejäänud on metaboliidid.
English: Your doctor will monitor your condition to see if the treatment is working.
Estonian: Teie arst jälgib teie seisundit, et näha, kas ravi toimib.
English: - Swallow the capsules whole with a glass of water.
Estonian: - Neelake kapslid tervelt koos klaasitäie veega.
English: Cycle:Day
Estonian: Tsükkel:Päev
English: This includes patients:
Estonian: Nende patsientide hulka kuuluvad:
English: PVC/PCTFE/Alu blister containing 6 capsules.
Estonian: PVC/PCTFE/Alu blister, mis sisaldab 6 kapslit.
English: Hazard Ratio= 0.47
Estonian: Riskisuhe= 0,47
English: - Do not take Farydak in Week 3.
Estonian: • Ärge võtke Farydak'i 3. nädalal.
English: Follow all your doctor's instructions carefully.
Estonian: Järgige hoolikalt arsti ettekirjutusi.
English: The days of the cycle are numbered on the blister.
Estonian: Tsükli päevad on blistril nummerdatud.
English: One Farydak blister = 3 weeks = 1 cycle
Estonian: Üks Farydak'i blister = 3 nädalat = 1 tsükkel
English: Tell your doctor about all the doses that you have missed during any 21-day cycle of treatment.
Estonian: Rääkige oma arstile kõikidest annustest, mis teil 21-päevase tsükli ajal jäid võtmata.
English: Farydak is not to be used in children or adolescents under 18 years of age.
Estonian: Farydak'i ei tohi kasutada lastel ja noorukitel alla 18 aasta.
English: The majority of patients had received prior transplant (63.6%).
Estonian: Enamus patsientidest olid eelnevalt transplanteeritud (63,6%).
English: A total of 53.0% of patients were male.
Estonian: Kokku 53,0% patsientidest olid meessoost.
English: Your doctor will tell you exactly how many capsules of Farydak you need to take.
Estonian: Teie arst ütleb teile täpselt, mitu Farydak'i kapslit peate võtma.
English: - Do not chew or crush the capsules.
Estonian: - Ärge närige ega purustage kapsleid.
English: Therefore, starting dose adjustments are not necessary.
Estonian: Seetõttu ei ole algannuse kohandamine vajalik.
English: - After Week 3 you start a new cycle again as shown in Tables 1 and 2 below.
Estonian: • Pärast 3. nädalat alustage uut tsüklit nagu näidatud tabelites 1 ja 2.
English: If you feel dizzy while taking this medicine, do not drive a vehicle or use any tools or machines.
Estonian: Kui te tunnete selle ravimi võtmise ajal pearinglust, ärge juhtige autot ega kasutage mis tahes tööriistu või masinaid.
English: Do not change the dose without talking to your doctor.
Estonian: Ärge muutke annust arstiga konsulteerimata.
English: Your heart rate will also be checked using a machine that measures the electrical activity of the heart (called an ECG).
Estonian: Samuti kontrollitakse teie südametööd aparaadiga, mis mõõdab südame elektrilist aktiivsust (kutsutakse EKG-ks).
English: Other medicines and Farydak
Estonian: Muud ravimid ja Farydak
English: - The medicine can be taken with or without food.
Estonian: - Seda ravimit võib võtta koos toiduga ja ilma.
English: The educational programme is aimed to address the risk of medication error.
Estonian: Teavitusprogrammi eesmärk on juhtida tähelepanu ravivigade riskile.
English: The capsules should be swallowed whole with water, with or without food (see section 5.2), and they should not be opened, crushed or chewed.
Estonian: Kapslid tuleb alla neelata tervelt koos veega, toiduga koos või ilma (vt lõik 5.2) ning kapsleid ei tohi avada, purustada ega närida.
English: - if you are allergic to panobinostat or any of the other ingredients of this medicine (listed in section 6).
Estonian: - kui olete panobinostaadi või selle ravimi mis tahes koostisosade (loetletud lõigus 6) suhtes allergiline.
English: Panobinostat is a P-gp substrate.
Estonian: Panobinostaat on P-gp substraat.
English: Monitoring recommendations
Estonian: Soovitused jälgimiseks
English: Patients should be advised to contact their physician to discuss the use of any laxative product.
Estonian: Patsientidele tuleb soovitada oma arstiga arutada mis tahes laksatiivsete ravimite kasutamist.
English: Metabolism via CYP2D6 and 2C19 was minor.
Estonian: Metabolism CYP2D6 ja 2C19 kaudu oli vähene.
English: Demographics and baseline disease characteristics were balanced and comparable between the study arms.
Estonian: Demograafilised andmed ja ravieelsed haiguse tunnused olid tasakaalustatud ning uuringurühmade vahel võrreldavad.
English: Pharmacotherapeutic group: Other antineoplastic agents, ATC code: L01XX42
Estonian: Farmakoterapeutiline rühm: Teised kasvajavastased ained, ATC-kood: L01XX42
English: The list of associated symptoms is provided in section 4, Possible side effects.
Estonian: Seostatavate sümptomite nimekiri on toodud lõigus 4 „Võimalikud kõrvaltoimed“.
English: Treatment was administered for a maximum of 16 cycles (see Tables 1 and 2).
Estonian: Ravi manustati maksimaalselt 16 tsükli jooksul (vt tabelid 1 ja 2).
English: The dose should not be reduced below 10 mg and the same treatment schedule (3-week treatment cycle) should be kept.
Estonian: Annust ei tohi vähendada alla 10 mg ja säilitada tuleb sama annustamisskeem (3-nädalane ravitsükkel).
English: Hard capsule 6 capsules 12 capsules 24 capsules
Estonian: Kõvakapsel 6 kapslit 12 kapslit 24 kapslit
English: If a dose is missed, it can be taken up to 12 hours after the specified dose time.
Estonian: Kui annus jääb võtmata, võib seda võtta kuni 12 tunni jooksul pärast määratud manustamisaega.
English: Electrocardiographic changes
Estonian: Elektrokardiograafilised muutused
English: The patient information pack should contain:
Estonian: Patsiendi teabematerjalide hulgas peavad olema:
English: Time (months)
Estonian: Aeg (kuudes)
English: Modification of the treatment dose and/or schedule may be required based on individual tolerability.
Estonian: Raviannuse ja/või annustamisskeemi muutmine võib olla vajalik vastavalt individuaalsele taluvusele.
English: Its fraction in the erythrocyte is 0.60 in vitro, independent of the concentration.
Estonian: Selle fraktsioon erütrotsüütides on in vitro 0,60, sõltumata kontsentratsioonist.
English: Panobinostat represented 6 to 9% of the drug-related exposure in plasma.
Estonian: Panobinostaat moodustas 6 kuni 9% ravimiga seotud ekspositsioonist plasmas.
English: If you accidentally take more capsules than you should, or if someone else accidentally takes your medicine, talk to a doctor or go to a hospital straight away.
Estonian: Kui võtate kogemata rohkem kapsleid kui ette nähtud või kui keegi teine võtab kogemata teie ravimit, rääkige sellest otsekohe oma arstile või minge haiglasse.
English: Contents of the pack and other information What Farydak contains
Estonian: Pakendi sisu ja muu teave Mida Farydak sisaldab
English: - if you notice any signs of an infection.
Estonian: - kui te märkate infektsiooni nähte.
English: - Farydak is taken over 21 days (2 weeks on and 1 week off) - this is called a treatment cycle.
Estonian: • Farydak'i võetakse 21-päevaste tsüklitena (2 nädalat ravi ja 1 nädal ilma ravita) - seda kutsutakse ravitsükliks.
English: Panobinostat is moderately (approximately 90%) bound to human plasma proteins.
Estonian: Panobinostaat seondub mõõdukalt (umbes 90% ulatuses) inimese plasmavalkudega.
English: Response rates are summarised in Table 9.
Estonian: Ravivastuse määrad on kokku võetud tabelis 9.
English: It is recommended that patients with clinical benefit continue the treatment for eight additional cycles.
Estonian: Patsientidel, kes on saanud ravist kliinilist kasu, on soovitatav jätkata ravi täiendava 8 ravitsükliga.
English: Day 10 Day 11 Day 12 Day 13 Day 14 Day 15 Day 16 Day 17 Day 18 Day 19 Day 20 Day 21
Estonian: 8. päev 9. päev 10. päev 11. päev 12. päev 13. päev 14. päev 15. päev 16. päev 17. päev 18. päev 19. päev 20. päev 21. päev
English: • uncontrolled shaking of the body
Estonian: • kontrollimatu keha värisemine
English: If you have to vomit after you swallow the Farydak capsules, do not take any more capsules until your next scheduled dose.
Estonian: Kui te oksendate pärast Farydak'i kapslite allaneelamist, ärge võtke rohkem kapsleid enne järgmist ettenähtud annustamiskorda.
English: OS was not statistically significantly different between the two treatment groups.
Estonian: Kahes ravirühmas ei olnud statistiliselt olulist erinevust üldises elulemuses.
English: If you use a hormonal contraceptive you must also use a barrier method of contraception (such as condom or diaphragm) in addition.
Estonian: Kui te kasutate hormonaalset rasestumisvastast vahendit, peate täiendavalt kasutama ka barjäärmeetodit (nagu kondoom või diafragma).
English: Additional analysis suggests that the risk of QTc prolongation does not increase over time (see section 4.2).
Estonian: Täiendav analüüs annab alust arvata, et QTc pikenemise risk ei suurene aja jooksul (vt lõik 4.2).
English: In the phase III clinical study 162 out of 387 patients were aged 65 years or over.
Estonian: III faasi kliinilises uuringus olid 162 patsienti 387-st 65-aastased või vanemad.
English: These could be signs of a low level of red blood cells.
Estonian: Need võivad olla vere punaliblede sisalduse vähenemise nähud.