FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients with moderate hepatic dysfunction (Child-Pugh score 7-9), regardless of indication, the dose of 60 mg every other day should not be exceeded; administration of 30 mg once daily can also be considered.
Estonian: Keskmise raskusega maksapuudulikkuse korral (Child-Pugh skoor 7…9) on maksimaalne soovitatav annus 60 mg ülepäeviti.
English: Cardiovascular safety results:
Estonian: Kardiovaskulaarne teave.
English: It is not known if <Etoricoxib> is excreted in human milk.
Estonian: <VÄLJAMÕELDUD NIMETUS>'t manustatakse suu kaudu.
English: Therefore, France sent a notification that was received by the EMEA on 19 September 2007 and a referral under Article 31 of Directive 2001/83/EC, as amended was started on 20 September 2007.
Estonian: See kiireloomuline ohutuspiirang algatati 16. veebruaril 2005 ja vormistati lõplikult 17. veebruaril 2005.
English: What is ankylosing spondylitis?
Estonian: Suukaudsed antikoagulandid.
English: 6.6 Special precautions for disposal No special requirements.
Estonian: Erinõuded puuduvad.
English: List of the names, pharmaceutical form, strength of the medicinal product(s), route of administration, marketing authorisation holders in the member states
Estonian: I lisa Ravimite nimetuste, ravimvormide, tugevuste, manustamisviiside, müügiloa hoidjate loetelu liikmesriikides
English: Jenapharm GmbH & Co. KG Otto-Schott-Str. 15
Estonian: KG Otto-Schott-Str. 15
English: Strength Pharmaceutical form
Estonian: Tugevus Ravimvorm Loomaliigid Manustamisviis Pakend Pakendi sisu
English: European Medicines Agency will review any new information that becomes available and this summary will be updated as necessary.
Estonian: Euroopa Ravimiamet vaatab kogu uue teabe igal aastal läbi ja vajaduse korral uuendab käesolevat kokkuvõtet.
English: A risk management plan has been developed to ensure that Raxone is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Raxone võimalikult ohutu kasutamine.
English: What measures are being taken to ensure the safe and effective use of Raxone?
Estonian: Mis meetmed võetakse, et tagada Raxone ohutu ja efektiivne kasutamine?
English: Raxone idebenone
Estonian: Raxone idebenoon
English: Other information about Raxone
Estonian: Muu teave Raxone kohta
English: Raxone is available as 150 mg tablets, and the recommended dose is two tablets taken three times a day with food.
Estonian: Raxonet turustatakse 150 mg tablettidena ning soovitatav annus on kaks tabletti, mida võetakse kolm korda ööpäevas koos toiduga.
English: This is because it has not been possible to obtain complete information about Raxone due to the rarity of the disease.
Estonian: See tähendab, et harvaesineva haiguse tõttu ei olnud võimalik saada Raxone kohta täielikku teavet.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Raxone are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Inimravimite komitee otsustas, et Raxone kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: With regard to the safety of Raxone, the majority of side effects seen with the medicine were mild or moderate in intensity.
Estonian: Seoses Raxone ohutusega olid enamik selle ravimi kõrvalnähte kerge või mõõduka intensiivsusega.
English: The reference medicine for Raxone is Mnesis (45 mg tablets).
Estonian: Raxone võrdlusravim on Mnesis (45 mg tabletid).
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Raxone can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Estonian: Harvikravimite komitee arvamuse kokkuvõte Raxone kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The full EPAR and risk management plan summary for Raxone can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst ja riskijuhtimiskava kokkuvõte Raxone kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What is Raxone and what is it used for?
Estonian: Mis on Raxone ja milleks seda kasutatakse?
English: This means that it is similar to a ‘reference medicine' containing the same active substance, but Raxone contains idebenone at a different strength.
Estonian: See tähendab, et Raxone on sarnane võrdlusravimiga, mis sisaldab sama toimeainet, kuid Raxonet turustatakse teise tugevusega.
English: Furthermore, some patients who were classified as ‘off chart' (unable to read any letters on the chart) at the beginning of the study were able to read at least one line during the eye test after treatment, and this was also considered clinically important.
Estonian: Mõni patsient, kes uuringu alguses ei suutnud tabelilt tuvastada ühtki tähte, suutsid ravijärgses nägemiskontrollis lugeda vähemalt üht rida, mida peeti samuti kliiniliselt oluliseks.
English: The main measure of effectiveness was improvement in vision, mostly based on the numbers of letters patients were able to read on a standard eye test chart.
Estonian: Efektiivsuse põhinäitaja oli nägemise paranemine, peamiselt nende tähtede arvu alusel, mida patsiendid suutsid standardselt nägemiskontrolli tabelilt tuvastada.
English: Why is Raxone approved?
Estonian: Miks Raxone heaks kiideti?
English: This is a summary of the European public assessment report (EPAR) for Raxone.
Estonian: See on ravimi Raxone Euroopa avaliku hindamisaruande kokkuvõte.
English: The most common side effects with Raxone (which may affect more than 1 in 10 people) are nasopharyngitis and cough; mild to moderate diarrhoea and back pain are also common (affecting up to 1 in 10 people).
Estonian: Raxone kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on nasofarüngiit ja köha; sagedad on ka kerge kuni mõõdukas kõhulahtisus ja seljavalu (esinevad kuni 1 patsiendil 10st).
English: The results of the main study showed an improvement in vision in patients treated with Raxone, and this trend towards a beneficial effect was confirmed by additional data from an expanded access program and a case record survey.
Estonian: Põhiuuringu tulemustest nähtus, et Raxonega ravitud patsientide nägemine paranes, ning seda suundumust kasuliku mõju poole kinnitati laiendatud juurdepääsu programmist ja haigusjuhtude uuringust saadud täiendavate andmetega.
English: It is not intended to provide practical advice on how to use Raxone.
Estonian: Hindamisaruandes ei anta Raxone kasutamise praktilisi nõuandeid.
English: What information is still awaited for Raxone?
Estonian: Mis teavet Raxone kohta veel oodatakse?
English: By the end of the study, patients treated with Raxone were able to read on average 3 to 6 letters more compared with patients receiving placebo.
Estonian: Uuringu lõpus suutsid Raxone uuringurühma patsiendid tuvastada keskmiselt 3-6 tähte rohkem kui platseeborühma patsiendid.
English: Because the number of patients with Leber's hereditary optic neuropathy is low, the disease is considered ‘rare', and Raxone was designated an ‘orphan medicine' (a medicine used in rare diseases) on 15 February 2007.
Estonian: Et Leberi päriliku optilise neuropaatiaga patsientide arv on väike ja see haigus esineb harva, nimetati Raxone 15. veebruaril 2007 harvikravimiks.
English: This means that mitochondria do not work properly to generate energy, and produce toxic forms of oxygen (free radicals) that damage nerve cells in the eye that are needed for vision.
Estonian: See tähendab, et nendel patsientidel ei toimi mitokondrid energia tootmisel normaalselt ja tekitavad toksilisi hapnikuvorme (vabu radikaale), mis kahjustavad nägemiseks vajalikke silma närvirakke.
English: Raxone is a ‘hybrid medicine'.
Estonian: Raxone on hübriidravim.
English: For the full list of all side effects and restrictions with Raxone, see the package leaflet.
Estonian: Raxone kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: What are the risks associated with Raxone?
Estonian: Mis riskid Raxonega kaasnevad?
English: The active substance in Raxone, idebenone, is an anti-oxidant agent that acts on mitochondria (the structures inside cells that produce the energy necessary for cells to function).
Estonian: Raxone toimeaine idebenoon on antioksüdant, mis mõjub mitokondritele (rakusisesed struktuurid, mis toodavad rakutegevuse jaoks vajalikku energiat).
English: Since Raxone has been approved under exceptional circumstances, the company that markets Raxone will conduct additional studies on the long-term effects and safety of Raxone, and will establish and maintain a registry of LHON patients treated with Raxone.
Estonian: Et Raxone kiideti heaks erandkorras, esitab Raxonet turustav ettevõte täiendavaid uuringuid Raxone pikaajalise mõju ja ohutuse kohta ning koostab Raxonega ravitud Leberi päriliku optilise neuropaatiaga patsientide registri ja uuendab seda.
English: How does Raxone work?
Estonian: Kuidas Raxone toimib?
English: For practical information about using Raxone, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Raxone kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: Idebenone is thought to help improve production of energy by restoring mitochondrial function, thereby preventing the cellular damage and the loss of sight seen in LHON.
Estonian: Idebenoon aitab eeldatavasti soodustada energiatootmist, taastades mitokondrite talitluse, takistades sellega rakukahjustuste tekkimist ja Leberi päriliku optilise neuropaatia korral tekkivat nägemise halvenemist.
English: Additional supportive data on the benefits of Raxone came from an expanded access program through which Raxone was made available to individual patients not participating in a clinical study, and from a case record survey, which included data from patients with LHON who did not receive any treatment.
Estonian: Täiendavaid toetavaid andmeid Raxone kasulikkuse kohta saadi laiendatud juurdepääsu programmist, millega Raxone tehti kättesaadavaks uuringus mitteosalenud üksikpatsientidele, ning haigusjuhtude uuringust, mis sisaldas ravimata Leberi päriliku optilise neuropaatiaga patsientide andmeid.
English: Additionally, 30% of patients treated with Raxone (16 out of 53) had a clinically relevant recovery of vision in at least one eye, compared with 10% of patients (3 out of 29) in the placebo group.
Estonian: Lisaks oli patsiente, kellel vähemalt ühes silmas taastus nägemine kliiniliselt olulisel määral, Raxone uuringurühmas 30% (16 patsienti 53st) ja platseeborühmas 10% (3 patsienti 29st).
English: For more information about treatment with Raxone, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Raxonega toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Raxone has been investigated in one main study involving 85 patients with LHON, in which it was compared with placebo (a dummy treatment) over 24 weeks.
Estonian: Raxonet on uuritud ühes põhiuuringus, kus osales 85 Leberi päriliku optilise neuropaatiaga patsienti ja kus seda võrreldi platseeboga (näiva ravimiga) 24 nädala jooksul.
English: How is Raxone used?
Estonian: Kuidas Raxonet kasutatakse?
English: Analyses of all these data showed a consistent pattern whereby generally a larger proportion of patients treated with Raxone had vision improvement compared with untreated or placebo-treated patients.
Estonian: Kõigi nende andmete analüüsidest nähtus järjekindlalt, et paranenud nägemisega patsientide protsent oli Raxone uuringurühmas üldiselt suurem kui ravimata või platseeborühma patsientidel.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Raxone, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati Raxone omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: Raxone is a medicine used to treat visual impairment in adults and adolescents aged 12 years and over with Leber's hereditary optic neuropathy (LHON), an inherited disease characterised by progressive loss of sight.
Estonian: Raxone on ravim, mida kasutatakse nägemiskahjustuse raviks Leberi päriliku optilise neuropaatiaga (LHON) täiskasvanutel ja üle 12-aastastel noorukitel.
English: Raxone has been authorised under ‘exceptional circumstances'.
Estonian: Raxone müügiluba anti erandkorras.
English: What benefits of Raxone have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Raxone kasulikkus?
English: Raxone contains the active substance idebenone.
Estonian: Raxone toimeaine on idebenoon.
English: The Committee noted the lack of treatments for preventing or reversing the vision loss in patients with LHON.
Estonian: Komitee märkis, et ravi Leberi päriliku optilise neuropaatiaga patsientide nägemise halvenemise raviks või ennetamiseks puudub.
English: Patients affected by LHON have mutations (defects) in the genetic material of mitochondria.
Estonian: Leberi päriliku optilise neuropaatiaga patsientidel on mitokondrite geenimaterjal defektne.
English: 10 (2 x 5) pre-filled pens
Estonian: 10 (2 x 5) pen-süstlit
English: Content (concentration)
Estonian: Pakendi sisu (kontsentratioon)
English: Packaging Content
Estonian: Pakendi sisu Pakendi suurus
English: EU Procedure number Invented name Strength Pharmaceutical Form
Estonian: Tugevus Ravimvorm Manustamistee Pakendi iseloomustus
English: Package size
Estonian: Müügiloa nr Euroopa Liidus
English: Date of first authorisation: 20 September 2006 Date of latest renewal: 15 July 2016
Estonian: Esmase müügiloa väljastamise kuupäev: 20 september 2006 Müügiloa viimase uuendamise kuupäev: 15 juuli 2016
English: They will calculate the right dose for you.
Estonian: Tema arvutab välja teie jaoks õige annuse.
English: In the case of overdose the doctor will take appropriate action.
Estonian: Üleannuse korral rakendab arst asjakohaseid meetmeid.
English: No interaction studies have been performed and no other forms of interaction have been identified.
Estonian: Koostoimeid ei ole uuritud ja koostoime muid vorme ei ole leitud.
English: The total dose of perflutren should not exceed 1.6 ml.
Estonian: Perflutreeni koguannus ei tohi ületada 1,6 ml.
English: Contents of the pack and other information What Luminity contains
Estonian: Pakendi sisu ja muu teave Mida Luminity sisaldab
English: Treatment of an overdose should be directed towards the support of all vital functions and prompt institution of symptomatic therapy.
Estonian: Üleannuse ravi peab olema suunatud kõigi eluliselt tähtsate funktsioonide toetamisele ja sümptomaatilise ravi kohesele alustamisele.
English: Luminity should not be used in children and adolescents (under 18 years of age) as it has not been studied in these groups
Estonian: Luminity't ei tohi kasutada lastel ega noorukitel (nooremad kui 18 aastat), kuna seda preparaati ei ole neil vanuserühmadel uuritud.
English: These side effects usually go away quickly without any treatment.
Estonian: Tavaliselt need kõrvaltoimed taanduvad kiiresti ilma igasuguse ravita.
English: The rate of infusion should be initiated at 4 ml/minute, but titrated as necessary to achieve optimal image enhancement, not to exceed 10 ml/minute.
Estonian: Infusiooni tuleb alustada kiirusega 4 ml/minutis, kuid seda tuleb korrigeerida, nii et saavutataks optimaalne kuvamistäpsus, mitte kiiremini kui 10 ml/minutis.
English: CLlung was found to be significantly reduced (51%) in females compared to males (all subjects).
Estonian: Avastati, et CLlung oli naistel tunduvalt (51 %) väikesem kui meestel (kõigil uuritavatel).
English: The safety and efficacy of Luminity in children and adolescents below 18 years have not been established.
Estonian: Lapsed Luminity ohutus ja efektiivsus alla 18 aastastel lastel ei ole veel tõestatud.
English: The product should be used immediately after its withdrawal from the vial.
Estonian: Preparaati tuleb kasutada koheselt pärast tema viaalist väljatõmbamist.
English: Justification for not including Braille accepted.
Estonian: Informatsiooni Braille' kirjas mitteesitamise põhjendus heaks kiidetud.
English: Fertility Animal studies do not indicate direct or indirect harmful effects on fertility.
Estonian: Fertiilsus Loomkatsetest ei nähtu otsest ega kaudset kahjulikku mõju fertiilsusele.
English: There is however a risk that these allergic type reactions become severe and may include anaphylactic shock (a serious, potentially life-threatening allergic response).
Estonian: On olemas oht, et sellised allergilist tüüpi reaktsioonid võivad muutuda tõsiseks ning kaasa tuua anafülaktilise šoki (tõsine, potentsiaalselt eluohtlik allergiline reaktsioon).
English: Overdose is not likely to happen since the medicine is administered by a doctor.
Estonian: Üleannustamine on ebatõenäoline, sest ravimit manustab arst.
English: In some cases, your doctor may choose to use two injections to complete the ultrasound examination.
Estonian: Mõnel juhul võib arst otsustada teha ultraheliuuringu läbiviimiseks kaks süstet.
English: All lipids are metabolised to free fatty acids.
Estonian: Kõik lipiidid metaboliseeritakse vabadeks rasvhapeteks.
English: Intravenous use.
Estonian: Intravenoosne kasutamine.
English: What you need to know before you use Luminity Do not use Luminity
Estonian: Mida on vaja teada enne Luminity kasutamist Ärge kasutage Luminity't
English: It is essential to follow instructions for use and handling of Luminity and to adhere to strict aseptic procedures during preparation.
Estonian: Tähtis on järgida Luminity kasutamise ja käsitsemise juhendit ning protseduuri ettevalmistamisel rangelt pidada kinni aseptika reeglitest.
English: EU/1/06/361/001 4 single-dose vials EU/1/06/361/002 1 single-dose vial
Estonian: EU/1/06/361/001 4 üheannuselist viaali EU/1/06/361/002 1 üheannuseline viaal
English: Pack sizes of 1 or 4 vials.
Estonian: Pakendi suurused: 1 või 4 viaali.
English: The contents of the vial are intended for single use only.
Estonian: Viaali sisu on mõeldud ainult ühekordseks kasutamiseks.
English: These levels are substantially above the recommended maximal clinical dose.
Estonian: Need annused ületavad olulisel määral soovitusliku maksimaalse kliinilise annuse.
English: In clinical trials these reactions were reported rarely and for post-marketing reports the frequency is not known.
Estonian: Kliinilistes uuringutes esines neid reaktsioone harva ning ravimi turuletulekujärgne esinemissagedus ei ole teada.
English: • altered heart rate, palpitations (you feel your heart beats harder or in an irregular way),
Estonian: • südame löögisageduse muutus, südamepekslemine (tunnete, et süda lööb tugevamini või ebaregulaarselt),
English: This product must only be administered intravenously.
Estonian: Seda toodet tohib manustada ainult intravenoosselt.
English: Doppler signal intensity corresponded well with measured and extrapolated perflutren concentrations in blood.
Estonian: Doppleri signaali intensiivsus vastas hästi perflutreeni mõõdetud ja ekstrapoleeritud kontsentratsioonidele veres.
English: The observed 99% drop in Doppler signal intensity within 10 minutes (t1/2 approximately 2 minutes) was in agreement with the decline in measurable blood levels of perflutren.
Estonian: Tuvastatud 99%-line Doppleri signaali intensiivsuse langus 10 minuti jooksul (t1/2 ligikaudu 2 minutit) oli kooskõlas perflutreeni mõõdetava veretaseme langusega.
English: Higher doses of the product, typically ≥ 1 ml/kg, resulted in more severe signs including unresponsiveness and occasionally death.
Estonian: Preparaadi suuremad annused, mis olid tavaliselt ≥1 ml/kg, põhjustasid raskemaid sümptomeid, sh reaktsioonide puudumist ja vahel ka surma.
English: This ensures that the medicine is shaken in the correct way and for long enough to make up a ‘dispersion' of microspheres of perflutren gas of the right size to get a good quality image.
Estonian: Seeläbi tagatakse preparaadi õige ja piisavalt kaua kestev loksutamine, et tulemuseks oleks õige suurusega gaasilise perfultreeni mikrosfääride „dispersioon“, mis võimaldab saada hea kvaliteediga kujutise.
English: Tell your doctor if you are taking or have recently taken any other medicines.
Estonian: Muud ravimid ja LuminityTeatage oma arstile, kui te võtate või olete hiljuti võtnud mis tahes muid ravimeid.
English: These effects were observed at exposure levels in excess of the maximum human exposure indicating little relevance to clinical use.
Estonian: Neid toimeid täheldati selliste ekspositsioonide korral, mis ületavad maksimaalse inimesel kasutatava ekspositsiooni, mis viitab nende leidude vähesele tähtsusele kliinilises kasutamises.
English: These results suggest that overall perflutren systemic elimination is rapid and is not significantly reduced in COPD patients compared to healthy subjects.
Estonian: Need tulemused viitavad sellele, et perflutreeni üldine süsteemne eliminatsioon on kiire ning ei ole KOK patsientidel oluliselt väiksem kui tervetel.
English: The time to maximum Doppler signal intensity tmax was shown to be similar to the perflutren blood tmax (1.13 versus 1.77 minutes).
Estonian: Doppleri signaali maksimaalse intensiivsuseni kuluv aeg tmax osutus sarnaseks perflutreeni tmax saabumisega veres (1,13 versus 1,77 minutit).
English: The most frequently reported adverse reactions are: headache (2.0%), flushing (1.0%) and back pain (0.9%).
Estonian: Kõige sagedamini täheldatud kõrvaltoimeteks on peavalu (2,0%), näo punetus (1,0%) ja seljavalu (0,9%).
English: A strict dose/response relationship cannot be defined, although higher doses have been shown to produce a contrast effect of longer duration.
Estonian: Ranget annuse ja vastuse suhet ei ole kindlaks tehtud, ehkki on selgunud, et suuremad annused kutsuvad esile pikema kestusega kontrasteeriva toime.
English: What Luminity looks like and contents of the pack
Estonian: Kuidas Luminity välja näeb ja pakendi sisu
English: Some patients may experience allergic type reactions such as swelling of the face.
Estonian: Mõnel patsiendil võib esineda allergilist tüüpi reaktsioone, nagu näiteks näoturse.
English: Use in this patient group should be on the basis of a benefit risk assessment by the physician.
Estonian: Kasutamine selles patsiendirühmas peab põhinema kasu/riski hindamisel arsti poolt.
English: Luminity is for diagnostic use only.
Estonian: Luminity on mõeldud ainult diagnostiliseks kasutamiseks.
English: Luminity has no effect on the ability to drive and use machines.
Estonian: Luminity ei mõjuta autojuhtimise ega masinate käsitsemise võimet.
English: Administration and mechanical activation procedure Luminity should not be administered by methods not specified in section 4.2 (e.g. intra-arterial injection).
Estonian: Manustamine ja mehaanilise aktiveerimise protseduur Luminity'd ei tohi manustada viisil, mida pole loetletud lõigus 4.2 (nt intraarteriaalne süste).
English: Contrast-enhanced echocardiography should only be considered in such patients if the results are likely to produce a change in individual patient management.
Estonian: Kontrastainega ehhokardiograafiat tuleks kasutada vaid neil patsientidel, kellel selle tulemused võivad eeldatavasti muuta individuaalset ravikorraldust.
English: BATCH NUMBER<, DONATION AND PRODUCT CODES>
Estonian: PARTII NUMBER<, ANNETUSE KOOD(ID) JA TOOTEKOOD(ID)>
English: The reported adverse reactions following the use of Luminity in pivotal and supportive trials (total of 2,526 patients) occur within minutes after administration and usually resolve without therapeutic intervention within 15 minutes.
Estonian: Registreeritud kõrvaltoimed, mida on täheldatud pärast Luminity kasutamist nii kesksetes kui toetavates uuringutes (kokku 2526 patsienti), on alanud mõne minuti jooksul pärast manustamist ning on tavaliselt taandunud ilma terapeutilise sekkumiseta 15 minuti jooksul.