FrancophonIA/ELRC3.0 huggingface dataset:
English: The dose of ibrutinib should be reduced to 140 mg once daily (one capsule) or withheld for up to 7 days when it is used concomitantly with strong CYP3A4 inhibitors.
Estonian: Kasutamisel koos tugevate CYP3A4 inhibiitoritega tuleb ibrutiniibi annust vähendada 140 mg-ni (üks kapsel) üks kord ööpäevas või katkestada ravi kuni 7 päevaks.
English: Progression free survival (PFS) as assessed by IRC indicated an 80% statistically significant reduction in the risk of death or progression in the IMBRUVICA arm. Efficacy results for Study PCYC-1127CA are shown in Table 11 and the Kaplan-Meier curve for PFS is shown in Figure 8.
Estonian: Uuringu PCYC-1127-CA efektiivsuse näitajad on esitatud Tabelis 11 ja PFS Kaplan-Meieri kõver on joonisel 8.
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 420 mg film-coated tablets ibrutinib
Estonian: IMBRUVICA 420 mg õhukese polümeerikattega tabletid ibrutinibum
English: Fourth discontinue IMBRUVICA
Estonian: Neljas kord lõpetada IMBRUVICA manustamine lõpetada IMBRUVICA manustamine
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 560 mg film-coated tablets ibrutinib
Estonian: IMBRUVICA 560 mg õhukese polümeerikattega tabletid ibrutinibum
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 140 mg film-coated tablets ibrutinib
Estonian: IMBRUVICA 140 mg õhukese polümeerikattega tabletid ibrutinibum
English: Nausea
Estonian: Imbruvica
English: Epistaxis Petechiae
Estonian: Ninaverejooks Petehhiad
English: Very common Diarrhoea Vomiting
Estonian: Palavik Perifeersed tursed
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER 560 MG TABLET
Estonian: BLISTER - 560 MG TABLETID
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 280 mg film-coated tablets ibrutinib
Estonian: IMBRUVICA 280 mg õhukese polümeerikattega tabletid ibrutinibum
English: MA (EU) number (Invented) name Strength Pharmaceutical form Route of administration Immediate Packaging Pack size EU/1/12/763/001 Ecansya
Estonian: Manustamistee Sisepakendi iseloomustus
English: 1 bottle + 1 oral syringe 10 ml
Estonian: 1 pudel + 1 suukaudne süstal 10 ml
English: This overview was last updated in 07-2018.
Estonian: Kokkuvõtte viimane uuendus: 07.2018.
English: Ceplene received a marketing authorisation valid throughout the EU on 7 October 2008.
Estonian: Ceplene on saanud müügiloa, mis kehtib kogu ELis, 7. oktoobril 2008.
English: Every year, the Agency will review any new information that may become available and this summary will be updated as necessary.
Estonian: Amet vaatab igal aastal läbi kogu uue teabe ja vajaduse korral uuendab käesolevat ülevaadet.
English: What measures are being taken to ensure the safe and effective use of Ceplene?
Estonian: Mis meetmed võetakse, et tagada Ceplene ohutu ja efektiivne kasutamine?
English: The European Medicines Agency decided that Ceplene's benefits are greater than its risks and it can be authorised for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et Ceplene kasulikkus on suurem kui sellega kaasnevad riskid ja et ravimi kasutamise võib ELis heaks kiita.
English: Histamine is a substance occurring naturally in the body that is involved in many processes.
Estonian: Histamiin on organismis looduslikult esinev aine, mis osaleb paljudes protsessides.
English: A cycle lasts 3 weeks.
Estonian: Ravitsükkel kestab 3 nädalat.
English: Other information about Ceplene
Estonian: Muu teave Ceplene kohta
English: This can increase the length of time the patient stays in remission.
Estonian: See võib pikendada patsiendi remissiooniaega.
English: It is used during the patients' first ‘remission' (a period without symptoms of the disease after the first course of treatment).
Estonian: Seda kasutatakse patsientide esimese remissiooni (sümptomiteta periood pärast esimest ravikuuri) ajal.
English: Depending on the patient's response to treatment and side effects, the treatment may have to be suspended or the dose adjusted.
Estonian: Sõltuvalt patsiendi ravivastusest ja kõrvalnähtudest võib olla vaja ravi peatada või kohandada annust.
English: This is because it has not been possible to obtain complete information about Ceplene due to the rarity of the disease.
Estonian: See tähendab, et harvaesineva haiguse tõttu ei olnud võimalik saada Ceplene kohta täielikku teavet.
English: What is Ceplene and what is it used for?
Estonian: Mis on Ceplene ja milleks seda kasutatakse?
English: Between each cycle there should be a treatment-free period of 3 weeks.
Estonian: Iga ravitsükli vahele peab jääma 3nädalane ravivaba periood.
English: As for all medicines, data on the use of Ceplene are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse Ceplene kasutamise kohta pidevat järelevalvet.
English: Further information on Ceplene can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Lisateave Ceplene kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Side effects reported with Ceplene are carefully evaluated and any necessary action taken to protect patients.
Estonian: Ceplene kõrvaltoimeid hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
English: Ceplene has been authorised under ‘exceptional circumstances'.
Estonian: Ceplene on saanud müügiloa erandlikel asjaoludel.
English: The effectiveness of Ceplene has been studied in one main study involving 320 adults with AML who were in remission following leukaemia treatment.
Estonian: Ceplene efektiivsust uuriti ühes põhiuuringus, milles osales 320 ägeda müeloidleukeemiaga täiskasvanut, kes olid pärast leukeemiaravi remissioonis.
English: When Ceplene is first given, the patient's blood pressure, heart rate and lung function must be checked.
Estonian: Ceplene esimesel süstimisel tuleb kontrollida patsiendi vererõhku, südame löögisagedust ja kopsufunktsiooni.
English: Ceplene (histamine dihydrochloride)
Estonian: Ceplene (histamiindihüdrokloriid)
English: For more information about using Ceplene, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Ceplene 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 Ceplene have been included in the summary of product characteristics and the package leaflet.
Estonian: Ceplene ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: What information is still awaited for Ceplene?
Estonian: Mis teavet Ceplene kohta veel oodatakse?
English: The recommended dose of Ceplene is one injection twice a day, one to three minutes after an interleukin-2 injection.
Estonian: Ceplene soovitatav annus on üks süst kaks korda ööpäevas üks kuni kolm minutit pärast interleukiin-2 süstimist.
English: For patients who were into their first remission the combination of Ceplene and interleukin-2 was more effective than no treatment in increasing the time until AML came back or the patient died from any cause: the average time without disease increased from 291 days with no treatment to 450 days after treatment with Ceplene and interleukin-2.
Estonian: Esimeses remissioonis patsientidel pikendas Ceplene ja interleukiin-2 kombinatsioon aega ägeda müeloidse leukeemia taastekkeni või patsiendi mis tahes põhjusel surmani efektiivsemalt kui ravi puudumine: keskmine haigusvaba aeg pikenes 291 päevalt (ilma ravita) Ceplene ja interleukiin-2 raviga 450 päevale.
English: What are the risks associated with Ceplene?
Estonian: Mis riskid Ceplenega kaasnevad?
English: It must also not be used in patients who have received a bone marrow transplant from a donor, or who are taking steroids (medicines used to reduce or prevent inflammation) given systemically (given by mouth or by injection), clonidine (used to reduce high blood pressure) or histamine H2 blockers (used to treat stomach ulcers, indigestion or heartburn).
Estonian: Samuti ei tohi seda kasutada patsiendid, kellele on siiratud doonori luuüdi või kes kasutavad süsteemseid (suukaudseid või süstitavaid) steroide (põletikku vähendavad või ennetavad ravimid), klonidiini (kõrgvererõhu ravim) või histamiini H2-retseptorite blokaatoreid (maohaavandite, seedehäirete või kõrvetiste ravimid).
English: The most common side effects with Ceplene (seen in more than 1 patient in 10) are flushing (reddening), headache, tiredness, fever and inflammation or redness at the injection site.
Estonian: Ceplene kõige sagedamad kõrvalnähud (esinenud enam kui 1 patsiendil 10st) on punastuvus, peavalu, väsimus, palavik ja süstekoha põletik või punetus.
English: How does Ceplene work?
Estonian: Kuidas Ceplene toimib?
English: When Ceplene is given with interleukin-2, it helps the immune system to kill the leukaemia cells that may remain in the body during remission.
Estonian: Kui Ceplenet kasutatakse koos interleukiin-2ga, aitab see immuunsüsteemil hävitada leukeemiarakud, mis võivad remissiooni ajal organismis säilida.
English: Each Ceplene injection must be given slowly over five to 15 minutes, in a different site from the interleukin-2 injection, and preferably in the thigh or abdomen (belly).
Estonian: Iga Ceplene süsteannus tuleb süstida aeglaselt 5-15 minuti vältel ning teise kohta kui interleukiin-2 süst, eelistatavalt reide või kõhupiirkonda.
English: Ceplene was given in combination with interleukin-2 and compared with no treatment.
Estonian: Ceplenet manustati koos interleukiin-2ga ning seda ei võrreldud ühegi muu raviga.
English: Ceplene and interleukin-2 are given for 10 cycles.
Estonian: Ceplenet ja interleukiin-2 manustatakse 10 ravitsükli vältel.
English: The company that markets Ceplene will provide yearly updates on the safety and effectiveness of Ceplene in combination with interleukin-2 in AML patients in first remission.
Estonian: Ceplene turustaja esitab igal aastal ülevaate Ceplene ja interleukiin-2 kombinatsiooni ohutuse ja efektiivsuse kohta esimeses remissioonis ägeda müeloidleukeemiaga patsientidel.
English: Patients can inject themselves once they have been trained appropriately.
Estonian: Pärast asjakohase väljaõppe saamist tohivad patsiendid süstida endale ravimit ise.
English: This improves the effectiveness of interleukin-2, a medicine that stimulates the immune system to attack cancerous cells.
Estonian: See parandab interleukiin-2 (ravim, mis aktiveerib immuunsüsteemi vähirakke ründama) efektiivsust.
English: AML is rare, and Ceplene was designated an ‘orphan medicine' (a medicine used in rare diseases) on 11 April 2005.
Estonian: Äge müeloidleukeemia esineb harva ja Ceplene nimetati 11. aprillil 2005 harvikravimiks.
English: Ceplene is a medicine used in combination with interleukin-2 (a cancer medicine) as maintenance treatment in adults with acute myeloid leukaemia (AML), a type of cancer affecting the white blood cells.
Estonian: Ceplene on ravim, mida kasutatakse koos vähiravimiga interleukiin-2 säilitusravina ägeda müeloidleukeemiaga (teatav leukotsüütide vähivorm) täiskasvanutel.
English: Ceplene contains the active substance histamine dihydrochloride.
Estonian: Ceplene sisaldab toimeainena histamiindihüdrokloriidi.
English: For the full list of side effects of Ceplene, see the package leaflet.
Estonian: Ceplene kõrvalnähtude täielik loetelu on pakendi infolehel.
English: What benefit of Ceplene have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Ceplene kasulikkus?
English: An overview of Ceplene and why it is authorised in the EU
Estonian: Ülevaade ravimist Ceplene ja ELis müügiloa väljastamise põhjendus
English: Ceplene must not be used in patients who have severe heart problems or in women who are pregnant or breastfeeding.
Estonian: Ceplenet ei tohi kasutada raskete südameprobleemidega patsiendid, rasedad ega imetavad naised.
English: In the treatment of AML, it is thought to work by protecting immune system cells from damage.
Estonian: Ägeda müeloidleukeemia ravis kaitseb see arvatavasti immuunsüsteemi rakke kahjustumise eest.
English: Ceplene can only be obtained with a prescription and should be given under the supervision of a doctor who has experience in the treatment of AML.
Estonian: Ravi tuleb manustada ägeda müeloidleukeemia ravis kogenud arsti järelevalve all.
English: How is Ceplene used?
Estonian: Kuidas Ceplenet kasutatakse?
English: No effect of Ceplene and interleukin-2 was seen in patients in second or later remission.
Estonian: Teise või hilisema remissiooniga patsientidel ei täheldatud Ceplene ja interleukiin2ga toimet.
English: It is available as a solution for injection under the skin.
Estonian: Seda turustatakse subkutaanse (nahaaluse) süste lahusena.
English: This means that it changes the activity of the immune system (the body's natural defences).
Estonian: Ceplene toimeaine histamiindihüdrokloriid on immunomodulaator, mis tähendab, et see muudab immuunsüsteemi (organismi looduslike kaitsemehhanismide) aktiivsust.
English: Hence no safety margin could be calculated.
Estonian: Seetõttu ei ole ka võimalik välja arvutada ohutusvaru.
English: Subsequent safety assessments focusing on genotoxic potential were issued in 20012 and 20033 .
Estonian: Sellele järgnevad genotoksilisele potentsiaalile keskendunud ohutuse hindamised on avaldatud aastatel 20012 ja 20033.
English: • four cases of spontaneous abortion,
Estonian: • neli spontaanse abordi juhtu;
English: Whereas
Estonian: Võttes arvesse, et:
English: Annex II Scientific conclusions and grounds for variation to the terms of the marketing authorisations
Estonian: II lisa Teaduslikud järeldused ja müügilubade tingimuste muutmise alused
English: However it is still controversial if aneuploidy is a contributing cause or merely a consequence of neoplastic transformation.
Estonian: Samas ei ole endiselt selge, kas aneuploidsus on kasvaja tekkele kaasaaitav põhjus või lihtsalt neoplastilise transformatsiooni tagajärg.
English: Carcinogenicity is an important potential risk.
Estonian: Kartsinogeensus on oluline võimalik risk.
English: Post marketing experience
Estonian: Turustamisjärgne kogemus
English: Clinical Safety
Estonian: Kliiniline ohutus
English: The corresponding product information sections were updated accordingly.
Estonian: Vastavalt ajakohastati ka asjakohaseid ravimiteabe lõike.
English: The CHMP was asked to give its opinion on whether the indication of TCC containing medicinal products should be restricted and/or other regulatory measures should be taken.
Estonian: Inimravimite komiteel paluti esitada oma arvamus, kas tiokolhikosiidi sisaldavate ravimite näidustust tuleb piirata ja/või võtta muid regulatiivseid meetmeid.
English: • Lastly, evidence for carcinogenicity of aneugens is limited.
Estonian: • Tõendid aneugeenilise toimega ainete kartsinogeensuse kohta on piiratud.
English: These measures are to be included in the RMP.
Estonian: Need meetmed peavad kajastuma riskijuhtimiskavas.
English: This DUS should be conducted over a three year period.
Estonian: Ravimikasutamisuuring tuleb läbi viia kolme aasta vältel.
English: In addition males and females showed only a slight gender difference in exposure.
Estonian: Peale selle leiti isas- ja emasloomadel üksnes vähene sooline erinevus ekspositsiooni osas.
English: Postmarketing spontaneous cases were collected based on the reports recorded in two MAHs' global pharmacovigilance databases (cut-off dates of 15 February 2013 and 29 April 2013 respectively).
Estonian: Turustamisjärgsed spontaansete juhtude teatised pärinesid kahe müügiloa hoidja ülemaailmsest ravimiohutuse andmebaasist (seisuga vastavalt 15. veebruar 2013 ja 29. aprill 2013).
English: • Teratogenicity is classified as an important identified risk.
Estonian: • Teratogeensust võib pidada ravimi oluliseks kindlakstehtud riskiks.
English: In addition, the lack of evidence for the correlation between the use of TCC and cancer could be due to the difficulty of establishing a causal relationship between the medicine and the effect, which may occur years after intake.
Estonian: Peale selle võib tõendite puudumine tiokolhikosiidi ja vähi vahelise seose kohta olla tingitud raskustest põhjusliku seose kindlakstegemisel ravimi ning toime vahel, mis pealegi võib ilmneda alles palju aastaid pärast ravimi kasutamist.
English: In view of the above, on 15 February 2013, Italy requested the CHMP, under Article 31 of Directive 2001/83/EC, to assess the above concerns regarding aneuploidy and its impact on the benefit-risk balance for TCC containing medicinal products for systemic use.
Estonian: Ülaltoodut arvesse võttes palus Itaalia 15. veebruaril 2013 inimravimite komiteel direktiivi 2001/83/EÜ artikli 31 kohaselt hinnata eelkirjeldatud aneuploidsuse riske ja selle mõju süsteemseks kasutamiseks ettenähtud tiokolhikosiidi sisaldavate ravimite kasulikkuse ja riski tasakaalule.
English: Overall summary of the scientific evaluation of thiocolchicoside containing medicinal products for systemic use (see Annex I)
Estonian: Süsteemseks kasutamiseks mõeldud tiokolhikosiidi sisaldavate ravimite (vt I lisa) teadusliku hindamise üldkokkuvõte
English: The CHMP also noted that the limited number of cases of malformations/embryo-foetal toxicities may be due to the fact that, in most of the Member States, the medicine is contraindicated in pregnancy.
Estonian: Inimravimite komitee märkis samuti, et väärarengute / embrüofetaalse toksilisuse juhtude väike arv võib olla seotud asjaoluga, et enamikus liikmesriikidest on ravimi kasutamine raseduse ajal vastunäidustatud.
English: A risk management plan (RMP) will be submitted to national competent authorities in accordance with agreed timelines and periodic safety update reports (PSURs) will be submitted every 3 years.
Estonian: Riiklikele pädevatele asutustele tuleb esitada riskijuhtimiskava kokkulepitud ajakava kohaselt ja perioodilised ohutusaruanded iga 3 aasta järel.
English: However a follow-up study (in vivo micronucleus test) defined a no-effect level of 39.6 mg/kg.
Estonian: Samas leiti järelkontrolli uuringus (in vivo mikronukleuse test), et toime puudus sisalduse 39,6 mg/kg korral.
English: For the purpose of the review of this risk, the MAHs provided an analysis of this genotoxic potential for each systemic route of administration, together with an analysis of possible risk factors, including relevant criteria such as dose and duration of treatment.
Estonian: Selle riski hindamise eesmärgil esitasid müügiloa hoidjad genotoksilise potentsiaali analüüsi iga süsteemse manustamistee kohta koos võimalike riskitegurite analüüsiga, sealhulgas sellised asjakohased kriteeriumid nagu annus ja ravi kestus.
English: • one case of threat of premature delivery.
Estonian: • üks enneaegse sünnituse ohu juht.
English: In most cases the treatment is for short-term use and not associated with the perception of increased cancer risk for both physicians and patients, therefore a causal relationship between cancer occurrence and treatment is difficult to establish.
Estonian: Enamikul juhtudest on ravi tiokolhikosiidiga lühiajaline ega ole seotud suurema tajutava vähiriskiga nii arstide kui ka patsientide silmis, mistõttu on põhjuslikku seost vähi tekke ja ravi vahel väga keeruline kindlaks teha.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for thiocolchicoside containing medicinal products for systemic use (see annex I).
Estonian: • inimravimite komitee arutas direktiivi 2001/83/EÜ artikli 31 kohast menetlust süsteemseks kasutamiseks mõeldud tiokolhikosiidi sisaldavate ravimite kohta (vt I lisa);
English: The CHMP also recommended further changes to the product information including information on fertility.
Estonian: Inimravimite komitee soovitas viia ravimiteabesse täiendavad muudatused, sealhulgas teabe viljatuse kohta;
English: Case review reports from 2004 up to 29 April 2013 from the second database reported 23 cases secondary to exposure during pregnancy and / or exposition in utero:
Estonian: Teise müügiloa hoidja andmebaasis ajavahemikus 2004 kuni 29. aprill 2013 registreeriti 23 juhtu, mis olid seotud ekspositsiooniga ravimile raseduse ajal ja/või loote ekspositsiooniga in utero:
English: Aneuploidy is a common characteristic of cancer cells.
Estonian: Aneuploidsus on sageli esinev vähirakkude iseloomulik tunnus.
English: Taking the totality of data into account, the CHMP considered that causality cannot be excluded and that aneuploidy should be considered as a cancer risk factor on theoretical grounds.
Estonian: Võttes arvesse kõiki olemasolevaid andmeid, otsustas inimravimite komitee, et põhjuslikku seost ei saa välistada ja et aneuploidsust võib teoreetilistel põhjustel pidada vähi riskiteguriks.
English: Genotoxic mechanisms, such as aneuploidy, involving cell division and non-DNA targets, are known to occur above a certain threshold of exposure.
Estonian: Genotoksiline toime, näiteks aneuploidsus, mis on seotud raku jagunemisega ega ole suunatud DNA-le, ilmneb teadaolevalt teatud ekspositsiooni künnisväärtuse ületamisel.
English: On 21 February 2013, the CHMP started a referral procedure for TCC containing medicinal products.
Estonian: 21. veebruaril 2013 algatas inimravimite komitee tiokolhikosiidi sisaldavate ravimite kohta esildismenetluse.
English: The package size should be adapted to new recommended treatment-days.
Estonian: Ravimite pakendite suurust tuleb vähendada, et need vastaksid uuele soovitatavale ravipäevade arvule;
English: Amendments to the warnings and pregnancy and lactation sections of the product information were also endorsed.
Estonian: Samuti kiideti heaks ravimiteabe hoiatuste ning raseduse ja imetamise alalõikude muudatused.
English: After parenteral use, the plasma concentration of M2 is expected to be much lower as the M2 transformation occurs after oral administration mainly by intestinal metabolism.
Estonian: Parenteraalse manustamise järel on M2 plasmakontsentratsioon eeldatavalt palju väiksem, sest tiokolhikosiidi transformatsioon M2-ks leiab suukaudse manustamise korral aset peamiselt sooles toimuva metabolismi teel.
English: These products should also be contraindicated in women of childbearing potential not using contraception and during lactation.
Estonian: Samuti peavad nimetatud ravimid olema vastunäidustatud rasestumisvõimelistele naistele, kes ei kasuta rasestumisvastaseid meetodeid, ja imetamise ajal.
English: Thiocolchicoside (TCC) is a semi-synthetic sulfurated colchicoside derivative with a muscle relaxant pharmacological activity.
Estonian: Tiokolhikosiid on poolsünteetiline sulfureeritud kolhikosiidi derivaat, millel on lihaseid lõõgastav farmakoloogiline toime.
English: However, whether the exposure to M2 would be below a threshold of aneugenicity (including a sufficient safety margin) is unknown since M2 has not been analysed in the available clinical kinetic studies.
Estonian: Samas ei ole teada, kas M2 ekspositsioon jääb allapoole aneugeenilisuse sisaldust (koos piisava ohutusvaruga), sest M2 sisaldust ei ole läbiviidud kliinilistes kineetika uuringutes analüüsitud.
English: The preclinical development of TCC was mainly performed during the 1980s, and then complemented in the 1990s to be compliant with the European guidelines on the non-clinical documentation for mixed marketing authorisation applications (CPMP/SWP/799/95) and to investigate a new active metabolite SL18.0740 (M1) identified at that time.
Estonian: Tiokolhikosiidi prekliinilised uuringud on enamikus läbi viidud 1980. aastatel ja seejärel on neid täiendatud 1990. aastatel, et tagada vastavus Euroopa Liidu juhistega segatüüpi müügilubade taotluse mittekliinilise dokumentatsiooni nõuete osas (CPMP/SWP/799/95) ning uurida sel ajal kindlaks tehtud uut aktiivset metaboliiti SL18.0740 (M1).