FrancophonIA/ELRC3.0 huggingface dataset:
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in a pre-filled pen 1 multidose pre-filled pen with 6 pen injection needles
Estonian: RAVIMVORM JA PAKENDI SUURUS Süstelahus pen-süstlis
English: It is available in packs of 1 cartridge and 3 pen injection needles.
Estonian: See on saadaval pakendites 1 kolbampulli ja 3 pen-süstli nõelaga.
English: What REKOVELLE looks like and contents of the pack
Estonian: Kuidas REKOVELLE välja näeb ja pakendi sisu REKOVELLE on selge värvitu süstelahus (süstevedelik).
English: Manufacturer Ferring GmbH Wittland 11
Estonian: Deutschland Ferring Arzneimittel GmbH
English: • Firmly replace the pen cap on the pen for protection between injections.
Estonian: • Süstete vahepeal, asetage pen'ile kaitsekork.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1150/002
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/16/1150/002
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1150/006
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/16/1150/006
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1150/003
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/16/1150/003
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1150/004
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/16/1150/004
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1150/005
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/16/1150/005
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1150/001
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/16/1150/001
English: Headache
Estonian: Subkutaanne
English: OHSS
Estonian: Lot
English: There have been reports of ovarian and other reproductive system tumours in women who had undergone infertility treatment.
Estonian: Viljatusravi saanud naistel on täheldatud munasarja ja teiste suguorganite kasvajaid.
English: • The injection button is firmly pushed in all the way until it stops.
Estonian: • Te vajutasite süstimisnupu lõpuni alla.
English: Gilenya received a marketing authorisation valid throughout the EU on 17 March 2011.
Estonian: Gilenya on saanud müügiloa, mis kehtib kogu ELis, 17. märtsil 2011.
English: Further information on Gilenya can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Gilenya.
Estonian: Lisateave Gilenya kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/Gilenya.
English: In addition, the Agency concluded that all patients should have their heart activity closely monitored after the first dose.
Estonian: Amet järeldas ka, et kõikidel patsientidel peab pärast esimest annust hoolikalt jälgima südametegevust.
English: Gilenya is available as capsules (0.25 mg and 0.5 mg).
Estonian: Gilenyat turustatakse kapslitena (0,25 mg ja 0,5 mg).
English: What measures are being taken to ensure the safe and effective use of Gilenya?
Estonian: Mis meetmed võetakse, et tagada Gilenya ohutu ja efektiivne kasutamine?
English: Gilenya (fingolimod)
Estonian: Gilenya (fingolimood)
English: ‘Relapsing-remitting' means that the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions).
Estonian: Relapseeruv-remiteeruv tähendab, et patsiendil esinevad sümptomite ägenemised (relapsid), millele järgnevad taastumisperioodid (remissioonid).
English: Other information about Gilenya
Estonian: Muu teave Gilenya kohta
English: Because Gilenya decreases the heart rate and can affect the heart's electrical activity and rhythm, the patient's blood pressure and heart activity is checked before starting treatment and during treatment, and also if Gilenya treatment is restarted after an interruption.
Estonian: Kuna Gilenya vähendab südame löögisagedust ning võib mõjutada südame elektrilist aktiivsust ja südamerütmi, kontrollitakse patsiendi vererõhku ja südametegevust enne ravi, selle ajal ja ka siis, kui Gilenya-ravi alustatakse pärast ravi katkestamist uuesti.
English: As for all medicines, data on the use of Gilenya are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse Gilenya kasutamise kohta pidevat järelevalvet.
English: The Agency decided that Gilenya's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Amet otsustas, et Gilenya kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: Gilenya contains the active substance fingolimod.
Estonian: Gilenya sisaldab toimeainena fingolimoodi.
English: What is Gilenya and what is it used for?
Estonian: Mis on Gilenya ja milleks seda kasutatakse?
English: Details on the recommendations for monitoring patients are found in the summary of product characteristics.
Estonian: Patsientide jälgimise soovituste üksikasjalik teave on ravimi omaduste kokkuvõttes.
English: Side effects reported with Gilenya are carefully evaluated and any necessary action taken to protect patients.
Estonian: Gilenya kõrvaltoimeid hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
English: The main measure of effectiveness in all the studies was based on the number of relapses the patients experienced each year.
Estonian: Efektiivsuse põhinäitaja mõlemas uuringus oli patsientidel esinenud relapside arv ühe aasta jooksul.
English: Women should not become pregnant while taking Gilenya and for two months after treatment has stopped.
Estonian: Naised peavad Gilenya kasutamise ajal ja kahe kuu vältel pärast ravi hoiduma rasestumisest.
English: The checklist includes information on the tests and monitoring in patients before and during treatment with Gilenya.
Estonian: Kontrollnimekirjas on teave patsientide analüüside ja jälgimise kohta enne ja pärast ravi alustamist Gilenyaga.
English: The recommended dose for adults is one 0.5 mg capsule taken once a day by mouth, the recommended dose for children depends on body weight.
Estonian: Täiskasvanute soovitatav annus on üks 0,5 mg kapsel ööpäevas suukaudselt manustatuna; laste soovitatav annus sõltub nende kehamassist.
English: However, because of possible side effects, the Agency concluded that Gilenya should only be used in patients who have a real need for the medicine either because their disease has not improved with at least one other disease-modifying therapy or because it is severe and getting worse rapidly.
Estonian: Ravimi võimalikke kõrvalnähte arvestades leidis amet siiski, et Gilenyat tohib kasutada üksnes patsientidel, kes seda tõesti vajavad kas seetõttu, et nende haigus ei ole paranenud vähemalt ühe muu haigust modifitseeriva ravimiga või et haigus on raske ja süveneb kiiresti.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Gilenya have also been included in the summary of product characteristics and the package leaflet.
Estonian: Gilenya ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Gilenya must not be used in patients at risk of infections due to a weakened immune system, patients with a severe infection or a long-term active infection such as hepatitis, and patients with cancer or severe liver problems.
Estonian: Gilenyat ei tohi kasutada nõrgenenud immuunsüsteemist tuleneva infektsiooniriskiga patsiendid, raskete või pikaajaliste aktiivsete infektsioonidega (näiteks hepatiidiga) patsiendid, vähkkasvajaga ning raskete maksaprobleemidega patsiendid.
English: For more information about using Gilenya, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Gilenya kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
English: It must also ensure that all doctors who prescribe Gilenya receive an information pack containing important safety information, including a checklist of the risks with Gilenya and the situations where its use is not recommended.
Estonian: Samuti peab turustaja kõik ravimit määravad arstid varustama teabepakmega, milles on oluline ohutusteave, sealhulgas kontrollnimekiri Gilenya riskide ja nende olukordade kirjeldusega, mil ravimi kasutamist ei soovitata.
English: Of patients given Gilenya, 14% (15 out of 107) experienced relapses compared with 54% (58 out of 107) of patients given interferon beta-1a.
Estonian: Patsiente, kellel esines relapse, oli Gilenyat kasutanute seas 14% (15 patsienti 107st) ning beeta-1a-interferooni kasutanute seas 54% (58 patsienti 107st).
English: What are the risks associated with Gilenya?
Estonian: Mis riskid Gilenyaga kaasnevad?
English: Gilenya is used when the disease remains active despite appropriate treatment with at least one other disease-modifying therapy, or is severe and getting worse rapidly.
Estonian: Gilenyat kasutatakse juhul, kui haigus püsib aktiivsena hoolimata asjakohasest ravist vähemalt ühe muu haigust modifitseeriva ravimiga või kui haigus on raske ja süveneb kiiresti.
English: The company that markets Gilenya will provide results from a study to assess the risk of side effects on the heart and circulation.
Estonian: Gilenya turustaja korraldab uuringu, et hinnata südametegevuse ja vereringega seotud kõrvalnähtude riski.
English: For the full list of side effects of Gilenya, see the package leaflet.
Estonian: Gilenya kõrvalnähtude täielik loetelu on pakendi infolehel.
English: The European Medicines Agency concluded that there is clear evidence of the benefit of Gilenya in relapsing-remitting multiple sclerosis in both adults and children and noted that it had the benefit of being taken by mouth while most other medicines for this disease are given by injection.
Estonian: Euroopa Ravimiamet järeldas, et Gilenya kasulikkus relapseeruva-remiteeruva hulgiskleroosi ravis nii täiskasvanutel kui ka lastel on selgelt tõendatud, ja märkis, et ravimi eelis on suukaudne manustamine, sest selle haiguse muid ravimeid manustatakse enamasti süstena.
English: The most serious side effects are infections, macular oedema (swelling in the central part of the retina at the back of the eye) and atrioventricular block (a type of heart rhythm disorder) at the start of treatment.
Estonian: Kõige raskemad kõrvalnähud on infektsioonid, makulaarne ödeem (silmapõhjas asuva võrkkesta keskosa ehk kollatähni turse) ja atrioventrikulaarblokaad (südame teatud rütmihäire) ravi alguses.
English: How does Gilenya work?
Estonian: Kuidas Gilenya toimib?
English: In multiple sclerosis, the immune system (the body's defences) incorrectly attacks the protective sheath around the nerves in the brain and spinal cord.
Estonian: Hulgiskleroosi korral ründab immuunsüsteem (organismi kaitsemehhanism) ekslikult kaitsekesta, mis ümbritseb pea- ja seljaaju närve.
English: The most common side effects with Gilenya (seen in more than 1 patient in 10) are flu, sinusitis (inflammation of the sinuses), headache, cough, diarrhoea, back pain and raised liver enzyme levels (a sign of liver problems).
Estonian: Gilenya kõige sagedamad kõrvalnähud (esinenud enam kui 1 patsiendil 10st) on gripp, sinusiit (ninakõrvalurgete põletik), peavalu, köha, kõhulahtisus, seljavalu ja maksaensüümide suurenenud sisaldus (viitab maksaprobleemidele).
English: In two studies involving a total of 2,355 patients, Gilenya was compared with placebo over two years.
Estonian: Kahes uuringus, milles osales kokku 2355 patsienti, võrreldi Gilenyat kahe aasta vältel platseeboga.
English: Three main studies in adults and one main study in children have found that Gilenya was more effective than placebo (a dummy treatment) or interferon beta-1a (another medicine for treating multiple sclerosis) in patients with relapsing-remitting multiple sclerosis.
Estonian: Kolmes täiskasvanute põhiuuringus ja ühes laste põhiuuringus tõendati, et Gilenya oli relapseeruvaremiteeruva hulgiskleroosiga patsientidel efektiivsem kui platseebo (näiv ravim) ja beeta-1ainterferoon (samuti hulgiskleroosi ravim).
English: Gilenya must also not be used in patients with certain diseases affecting the heart and blood vessels or in those who have had such diseases or problems with the blood supply to the brain.
Estonian: Samuti ei tohi Gilenyat kasutada teatud südame- ja veresoonkonna haigustega patsiendid ega patsiendid, kellel on varem olnud sellised haigused või aju verevarustushäired.
English: The pack will also include information on a registry to collect data on babies born to women treated with Gilenya, as well as a patient reminder card for patients or their carers with key safety information.
Estonian: Teabepakmes on ka teave registri kohta, kuhu kogutakse Gilenyat kasutanud naistel sündinud laste andmed, samuti patsiendi hoiatuskaart kõige olulisema ohutusteabega.
English: The active substance in Gilenya, fingolimod, prevents T cells (a type of white blood cell involved in the immune system) travelling from the lymph nodes towards the brain and spinal cord, thus limiting the damage they cause in multiple sclerosis.
Estonian: Gilenya toimeaine fingolimood takistab T-rakkude (teatud valgeverelibled, mis on osa immuunsüsteemist) liikumist lümfisõlmedest pea- ja seljaaju suunas, vähendades sel viisil kahjustusi, mida T-rakud hulgiskleroosi korral põhjustavad.
English: How is Gilenya used?
Estonian: Kuidas Gilenyat kasutatakse?
English: An overview of Gilenya and why it is authorised in the EU
Estonian: Ülevaade ravimist Gilenya ja ELis müügiloa väljastamise põhjendus
English: What benefits of Gilenya have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Gilenya kasulikkus?
English: In a third study involving 1,292 patients, Gilenya was compared with interferon beta-1a over one year.
Estonian: Kolmandas uuringus, milles osales 1292 patsienti, võrreldi Gilenyat ühe aasta jooksul beeta-1ainterferooniga.
English: In a study involving 215 children, Gilenya was compared with interferon beta-1a for up to 2 years.
Estonian: 215 lapse uuringus võrreldi Gilenyat kuni kaks aastat beeta-1a-interferooniga.
English: Gilenya can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in multiple sclerosis.
Estonian: Ravi peab alustama ja jälgima hulgiskleroosi ravis kogenud arst.
English: Patients treated with Gilenya had around half the number of relapses compared with patients given placebo.
Estonian: Gilenyat kasutanud patsientidel oli ligikaudu kaks korda vähem relapse kui platseebot kasutanud patsientidel.
English: It does this by blocking the action of a receptor (target) on the T cells called the sphingosine-1phosphate receptor, which is involved in controlling the movement of these cells in the body.
Estonian: Selleks blokeerib fingolimood T-rakkudel oleva sfingosiin-1-fosfaadi retseptori (mis aitab reguleerida T-rakkude liikumist organismis).
English: Patients receiving Gilenya had around half the number of relapses compared with patients given interferon beta-1a.
Estonian: Gilenyat kasutanud patsientidel oli ligikaudu kaks korda vähem relapse kui beeta-1ainterferooni kasutanud patsientidel.
English: Gilenya is a type of medicine known as a ‘disease-modifying therapy' that is used to treat adults and children over 10 years of age with highly active relapsing-remitting multiple sclerosis (MS), a disease of the nerves in which inflammation destroys the protective sheath surrounding the nerve cells.
Estonian: Gilenya on haigust modifitseeriv ravim, mida kasutatakse väga aktiivse relapseeruva-remiteeruva hulgiskleroosi raviks täiskasvanutel ja üle 10-aastastel lastel.
English: More information on Esmya can be found here.
Estonian: Lisateavet Esmya kohta leiate siit.
English: On 8 February 2018, while the review was ongoing, the PRAC issue temporary recommendations.
Estonian: 8. veebruaril 2018, kui läbivaatamismenetlus veel kestis, väljastas ravimiohutuse riskihindamise komitee ajutised soovitused.
English: • Advise your patients about the signs and symptoms of liver injury.
Estonian: • Nõustage patsienti maksakahjustuse tunnuste ja sümptomite osas.
English: If the tests indicate that you have a liver problem, your treatment will be stopped.
Estonian: Kui analüüsitulemused näitavad, et teil on maksaprobleeme, siis ravi peatatakse.
English: Healthcare professionals prescribing Esmya in the EU will receive a letter with further details.
Estonian: Esmyat Euroopa Liidus määravad tervishoiutöötajad saavad üksikasjalikumat teavet sisaldava kirja.
English: Since progesterone may promote the growth of fibroids, by preventing the effects of progesterone ulipristal acetate reduces the size of the fibroids.
Estonian: Kuna progesteroon võib soodustada fibroidide kasvu, siis vähendab ulipristaalatsetaat progesterooni toimet takistades fibroidide suurust.
English: These recommendations are temporary measures to protect patients' health, pending the conclusion of the review of Esmya which started on 30 November 2017.
Estonian: Need soovitused on ajutised abinõud patsientide tervise kaitseks ning kehtivad 30. novembril 2017 alanud Esmya läbivaatamismenetluse järelduste saamiseni.
English: • If you have nausea (feeling sick), vomiting, upper belly pain, lack of appetite, tiredness or yellowing of the eyes or skin, contact your doctor immediately as these could be signs of liver problems.
Estonian: • Kui teil esineb iiveldus, oksendamine, ülakõhuvalu, isutus, väsimus või silmade või naha kollasus, siis pöörduge viivitamatult oma arsti poole, sest need võivad olla maksaprobleemide tunnused.
English: It is used for up to 3 months before women undergo surgery to remove the fibroids and can also be used long-term but with treatment breaks in other women.
Estonian: Ravimit kasutatakse kuni 3 kuu jooksul enne fibroidide operatsiooni, kuid ravimit tohib kasutada ka pikaajaliseks vaheaegadega raviks teistel naistel.
English: • For any patient with signs or symptoms consistent with liver injury (such as nausea, vomiting, right hypochondrial pain, anorexia, asthenia, jaundice), check transaminase levels immediately.
Estonian: • Maksakahjustusele viitavate tunnuste või sümptomitega (nagu iiveldus, oksendamine, valu paremal roidekaare all, isutus, asteenia, ikterus) patsientidel kontrollige kohe transaminaaside sisaldust.
English: All women taking Esmya should have a liver function test at least once a month during treatment.
Estonian: Kõikidel Esmyat kasutavatel naistel peab ravi ajal vähemalt üks kord kuus tegema maksafunktsiooni analüüsi.
English: Esmya was authorised in the EU in 2012 for the treatment of moderate to severe symptoms of uterine fibroids, which are non-cancerous (benign) tumours of the womb, in women who have not reached the menopause.
Estonian: Esmya kiideti ELis heaks 2012. aastal mõõdukate kuni raskete sümptomitega emakafibroidide, mis on mittepahaloomulised (healoomulised) emakakasvajad, raviks menopausieelsetel naistel.
English: • If your treatment is stopped, your doctor will check how well your liver is working 2 to 4 weeks after you stop taking Esmya.
Estonian: • Kui teie ravi on peatatud, kontrollib arst teie maksa tööd 2-4 nädalat pärast Esmya-ravi peatamist.
English: • As a precaution, while taking Esmya you will be required to have blood tests to check that your liver is working well.
Estonian: • Ettevaatusabinõuna peate Esmya võtmise ajal tegema vereproove, et kontrollida, kas maks töötab normaalselt.
English: Ulipristal acetate is also the active substance of a single-dose medicine authorised for emergency contraception, ellaOne.
Estonian: Ulipristaalatsetaat on ka toimeaine üheannuselises ravimis ellaOne, mis on heaks kiidetud erakorralise kontratseptsiooni näidustusel.
English: Liver test should be repeated 2 to 4 weeks after stopping treatment.
Estonian: Maksaanalüüse peab kordama 2-4 nädalat pärast ravi peatamist.
English: A link between Esmya and cases of serious liver injury is under review.
Estonian: Seos Esmya ja raske maksakahjustuse juhtude vahel on uurimisel.
English: • Do not start new patients on Esmya or new treatment courses in patients who have already completed a previous one.
Estonian: • Ärge alustage uutel patsientidel Esmya-ravi ega määrake uut ravikuuri patsientidele, kes varem on ravi saanud.
English: EMA's Pharmacovigilance Risk Assessment Committee (PRAC) is currently reviewing the benefits and risks with Esmya, following reports of serious liver injury, including liver failure leading to transplantation.
Estonian: Euroopa Ravimiameti (EMA) ravimiohutuse riskihindamise komiteel on praegu pooleli Esmya kasulikkuse ja riskide läbivaatamine, mis algatati pärast teadete saamist raske maksakahjustuse, sealhulgas siirdamiseni viinud maksapuudulikkuse kohta.
English: The PRAC's final recommendations will be forwarded to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt an opinion.
Estonian: Ravimiohutuse riskihindamise komitee lõplikud soovitused saadetakse inimravimitega seotud küsimuste eest vastutavale inimravimite komiteele, kes võtab vastu arvamuse.
English: • If you were about to start treatment with Esmya or start a new course of treatment, your doctor will put your treatment on hold until EMA's review of the medicine is complete.
Estonian: • Kui teil oli plaanis alustada ravi Esmyaga või alustada uut ravikuuri, siis praegu arst neid ravimeid ei määra seni, kuni Euroopa Ravimiameti tehtav ravimi läbivaatamismenetlus on lõppenud.
English: The active substance in Esmya, ulipristal acetate, works by attaching to the targets on cells (receptors) that the hormone progesterone normally attaches to, preventing progesterone from having its effect.
Estonian: Esmya toimeaine ulipristaalatsetaat seondub rakkudel nende kohtadega (retseptoritega), millega tavaliselt seondub hormoon progesteroon, takistades progesterooni toimimist.
English: Following reports of liver injury and hepatic failure with Esmya, EMA has made the following temporary recommendations:
Estonian: Teave tervishoiutöötajatele Pärast teadete saamist maksakahjustuse ja maksapuudulikkuse kohta Esmya kasutamise ajal on EMA välja andnud järgmised ajutised soovitused.
English: • Esmya, used to treat uterine fibroids, is being reviewed because cases of serious liver problems have occurred in women taking the medicine.
Estonian: • Andmed emakafibroidide raviks kasutatava Esmya kohta vaadatakse läbi, sest ravimit võtnud naistel on esinenud raskeid maksaprobleeme.
English: • Perform liver function tests at least once a month for all patients taking Esmya.
Estonian: • Tehke kõigile Esmyat võtvatele patsientidele vähemalt üks kord kuus maksfunktsiooni analüüsid.
English: These recommendations are temporary measures, pending the conclusion of an ongoing EMA review of Esmya.
Estonian: Need soovitused on ajutised abinõud, mis kehtivad EMA Esmya läbivaatamismenetluse lõpuni.
English: No new patients should start treatment for the time being
Estonian: Praegu ei tohi ravi määrata ühelegi uuele patsiendile.
English: The PRAC is also recommending that no new patients should be started on Esmya and no patients who have completed a course of treatment should start another one for the time being.
Estonian: Ravimiohutuse riskihindamise komitee soovitab ka uutel patsientidel Esmyaga ravi praegu mitte alustada ning ravimit ei tohi praegu uuesti määrata patsientidele, kes on varem ravi juba saanud.
English: If transaminase levels are more than 2 times the upper limit of normal, stop treatment and closely monitor the patient.
Estonian: Kui transaminaaside sisaldus on rohkem kui 2 korda üle normi ülempiiri, siis lõpetage ravi ja jälgige patsienti hoolikalt.
English: If the test is abnormal (liver enzyme levels more than 2 times the upper limit of normal), the healthcare professional should stop treatment and closely monitor the patient.
Estonian: Kui analüüsitulemus on ebanormaalne (maksaensüümide sisaldus on rohkem kui 2 korda suurem normi ülempiirist), peab tervishoiutöötaja ravi katkestama ja patsienti hoolikalt jälgima.
English: If the patient develops transaminase levels more than 2 times the upper limit of normal, stop treatment and monitor the patient closely.
Estonian: Kui patsiendi transaminaaside sisaldus suureneb rohkem kui 2 korda üle normi ülempiiri, siis lõpetage ravi ja jälgige patsienti hoolikalt.