FrancophonIA/ELRC3.0 huggingface dataset:
English: Plasma concentrations are approximately dose proportional over the therapeutic dose range.
Estonian: Terapeutilises annusevahemikus on saavutatavad plasmakontsentratsioonid proportsionaalsed manustatud annusega.
English: Special populations
Estonian: Patsientide erigrupid
English: INFORMATION IN BRAILLE avandamet 2 mg/1000 mg
Estonian: INFORMATSIOON BRAILLE' KIRJAS (PUNKTKIRJAS) avandamet 2 mg/1000 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL (WITH BLUE BOX) MULTIPACKS ONLY (3x112 TABLETS)
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED VÄLISETIKETT (SISALDAB BLUE BOX'I) AINULT MULTIPAKENDID (3x112 TABLETTI)
English: • reduction in blood count (anaemia)
Estonian: • punaste vereliblede arvu langus (aneemia)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/258/004-006
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/03/258/004-006
English: Rosiglitazone treatment is associated with a dose-related reduction of haemoglobin levels.
Estonian: Rosiglitasoonravi võib põhjustada annusega seotud hemoglobiinitaseme langust.
English: Erythema
Estonian: LISAINFO
English: Î Discuss with your doctor any concerns about your eyesight.
Estonian: Î Kui te olete mures nägemise pärast, arutage seda oma arstiga.
English: Renal insufficiency: There are no clinically significant differences in the pharmacokinetics of rosiglitazone in patients with renal impairment or end stage renal disease on chronic dialysis.
Estonian: Neerufunktsiooni häirega või lõppstaadiumis neerupuudulikkusega dialüüsi saavatel patsientidel ei ole rosiglitasooni farmakokineetika kliiniliselt olulisel määral muutunud.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON (WITHOUT BLUE BOX) MULTIPACKS ONLY (112 TABLETS)
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED VAHEPAKEND (ILMA BLUE BOX'ITA) AINULT MULTIPAKENDID (112 TABLETTI)
English: These may affect more than 1 in 10 people:
Estonian: Väga sageli esinevad kõrvaltoimed Need võivad tekkida rohkem kui ühel inimesel 10-st:
English: These strengths are supplied in blister packs containing 28, 56, 112, 3x112 or 360 film-coated tablets.
Estonian: Avandamet 2 mg/500 mg on kahvaturoosad tabletid, mille ühele poole on märgitud „gsk“ ja teisele Need tugevused on blisterpakendites, mis sisaldavad 28, 56, 112, 3x112 või 360 kaetud tabletti.
English: Post-marketing reports of new-onset or worsening diabetic macular oedema with decreased visual acuity have been reported with thiazolidinediones, including rosiglitazone.
Estonian: Müügiloa saamise järgselt on tiasolidiindioonide (sh rosiglitasooni) kasutamisel teatatud diabeetilise maakula turse esmakordsest tekkest või süvenemisest, millega kaasneb nägemisteravuse langus.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/258/001-003
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/03/258/001-003
English: The frequency of adverse reactions identified from clinical trial data with rosiglitazone Adverse reaction
Estonian: Kliinilistes uuringutes täheldatud rosiglitasooni kõrvaltoimete esinemissagedus Kõrvaltoime
English: Pink film-coated tablets marked "gsk" on one side and "4/1000" on the other.
Estonian: Roosad polümeerikattega tabletid, mille ühele poole on märgitud „gsk“ ja teisele „4/1000“.
English: Nervous system disorders dizziness*
Estonian: Närvisüsteemi häired pearinglus* peavalu*
English: Hepatobiliary disorders hepatic dysfunction, primarily evidenced by elevated hepatic enzymes5
Estonian: Maksa ja sapiteede häired maksafunktsiooni häire, mille tunnuseks on peamiselt maksaensüümide aktiivsuse suurenemine5
English: Yellow film-coated tablets marked "gsk" on one side and "1/500" on the other.
Estonian: Kollased polümeerikattega tabletid, mille ühele poole on märgitud „gsk“ ja teisele „1/500“.
English: Within each system organ class, adverse reactions are presented in the table by decreasing frequency for the rosiglitazone monotherapy treatment regimen.
Estonian: Iga organsüsteemi klassi rosiglitasooni monoteraapia puhul täheldatud kõrvaltoimed on toodud tabelis tõsiduse vähenemise järjekorras.
English: Yellow film-coated tablets marked "gsk" on one side and "2/1000" on the other.
Estonian: Kollased polümeerikattega tabletid, mille ühele poole on märgitud „gsk“ ja teisele „2/1000“.
English: EU/1/03/258/018, 56 tablets, component of a 168 tablet multipack.
Estonian: EU/1/03/258/018, 56 tabletti, 168 tabletiga multipakendi komponent.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 2 mg of rosiglitazone (as maleate) and 500 mg of metformin hydrochloride.
Estonian: TOIMEAINE(TE) SISALDUS Tablett sisaldab 2 mg rosiglitasooni (rosiglitasoonmaleaadina) ja 500 mg metformiinvesinikkloriidi.
English: NAME OF THE MEDICINAL PRODUCT AVANDAMET 1 mg/500 mg film-coated tablets
Estonian: RAVIMPREPARAADI NIMETUS AVANDAMET 1 mg/500 mg õhukese polümeerikattega tabletid
English: NAME OF THE MEDICINAL PRODUCT AVANDAMET 4 mg/1000 mg film-coated tablets
Estonian: RAVIMPREPARAADI NIMETUS AVANDAMET 4 mg/1000 mg õhukese polümeerikattega tabletid
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 4 mg of rosiglitazone (as maleate) and 1000 mg of metformin hydrochloride.
Estonian: TOIMEAINE(TE) SISALDUS Tablett sisaldab 4 mg rosiglitasooni (rosiglitasoonmaleaadina) ja 1000 mg metformiinvesinikkloriidi.
English: EU/1/03/258/017, 56 tablets, component of a 168 tablet multipack.
Estonian: EU/1/03/258/017, 56 tabletti, 168 tabletiga multipakendi komponent.
English: NAME OF THE MEDICINAL PRODUCT AVANDAMET 2 mg/500 mg film-coated tablets
Estonian: RAVIMPREPARAADI NIMETUS AVANDAMET 2 mg/500 mg õhukese polümeerikattega tabletid
English: • collapse.
Estonian: • nälg.
English: Take special care with Avandamet
Estonian: Eriline ettevaatus on vajalik ravimiga Avandamet
English: EU/1/03/258/010 14 tablets EU/1/03/258/011 28 tablets EU/1/03/258/012 56 tablets EU/1/03/258/022 180 tablets
Estonian: EU/1/03/258/010 14 tabletti EU/1/03/258/011 28 tabletti EU/1/03/258/012 56 tabletti EU/1/03/258/022 180 tabletti
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/258/016
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/03/258/016
English: Metabolism and nutrition disorders hypercholesterolaemia1 Common hypertriglyceridaemia Common Hyperlipaemia weight increase increased appetite
Estonian: Ainevahetus- ja toitumishäired hüperkolesteroleemia1 Sage
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/258/015
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/03/258/015
English: EU/1/03/258/014, 56 tablets, component of a 112 tablet multipack.
Estonian: EU/1/03/258/014, 56 tabletti, 112 tabletiga multipakendi komponent.
English: GlaxoSmithKline GmbH & Co. KG Tel.: + 49 (0)89 36044 8701 produkt.info@gsk.com
Estonian: KG Tel.: + 49 (0)89 36044 8701 produkt.info@gsk.com
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 1 mg of rosiglitazone (as maleate) and 500 mg of metformin hydrochloride.
Estonian: TOIMEAINE(TE) SISALDUS Tablett sisaldab 1 mg rosiglitasooni (rosiglitasoonmaleaadina) ja 500 mg metformiinvesinikkloriidi.
English: Gastrointestinal disorders Constipation
Estonian: Seedetrakti häired kõhukinnisus
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
Estonian: VAJADUSEL ERINÕUDED KASUTAMATA JÄÄNUD RAVIMI VÕI
English: EU/1/03/258/013, 56 tablets, component of a 112 tablet multipack.
Estonian: EU/1/03/258/013, 56 tabletti, 112 tabletiga multipakendi komponent.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 2 mg of rosiglitazone (as maleate) and 1000 mg of metformin hydrochloride.
Estonian: TOIMEAINE(TE) SISALDUS Tablett sisaldab 2 mg rosiglitasooni (rosiglitasoonmaleaadina) ja 1000 mg metformiinvesinikkloriidi.
English: EU/1/03/258/007 14 tablets EU/1/03/258/008 28 tablets EU/1/03/258/009 56 tablets EU/1/03/258/021 180 tablets
Estonian: EU/1/03/258/007 14 tabletti EU/1/03/258/008 28 tabletti EU/1/03/258/009 56 tabletti EU/1/03/258/021 180 tabletti
English: Metformin partitions into erythrocytes.
Estonian: Ravim tungib erütrotsüütidesse.
English: NAME OF THE MEDICINAL PRODUCT AVANDAMET 2 mg/1000 mg film-coated tablets
Estonian: RAVIMPREPARAADI NIMETUS AVANDAMET 2 mg/1000 mg õhukese polümeerikattega tabletid
English: EU/1/03/258/004 28 tablets EU/1/03/258/005 56 tablets EU/1/03/258/006 112 tablets EU/1/03/258/020 360 tablets
Estonian: EU/1/03/258/004 28 tabletti EU/1/03/258/005 56 tabletti EU/1/03/258/006 112 tabletti EU/1/03/258/020 360 tabletti
English: Pale pink film-coated tablets marked "gsk" on one side and "2/500" on the other.
Estonian: Kahvatupunased polümeerikattega tabletid, mille ühele poole on märgitud „gsk“ ja teisele „2/500“.
English: EU/1/03/258/001 28 tablets EU/1/03/258/002 56 tablets EU/1/03/258/003 112 tablets EU/1/03/258/019 360 tablets
Estonian: EU/1/03/258/001 28 tabletti EU/1/03/258/002 56 tabletti EU/1/03/258/003 112 tabletti EU/1/03/258/019 360 tabletti
English: Each tablet contains 1 mg of rosiglitazone (as rosiglitazone maleate) and 500 mg of metformin hydrochloride (corresponding to metformin free base 390 mg).
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS Tablett sisaldab 1 mg rosiglitasooni (rosiglitasoonmaleaadina) ja 500 mg metformiinvesinikkloriidi (vastab 390 mg metformiini vabale alusele).
English: • liver doesn't function as well as it should (increase in liver enzymes).
Estonian: • maksatalitluse häired (maksaensüümide aktiivsuse suurenemine).
English: Each tablet contains 2 mg of rosiglitazone (as rosiglitazone maleate) and 1000 mg of metformin hydrochloride (corresponding to metformin free base 780 mg).
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS Tablett sisaldab 2 mg rosiglitasooni (rosiglitasoonmaleaadina) ja 1000 mg metformiinvesinikkloriidi (vastab 780 mg metformiini vabale alusele).
English: AVANDAMET is contraindicated in patients with:
Estonian: AVANDAMET on vastunäidustatud järgmiste seisundite korral:
English: Very rare side effects
Estonian: Harva esinevad kõrvaltoimed
English: Component of a multipack comprising 3 packs, each containing 112 film-coated tablets.
Estonian: 3 pakendit (igas 112 kaetud tabletti) sisaldava multipakendi komponent.
English: PSURs
Estonian: BLISTERPAKENDID
English: NAME OF THE MEDICINAL PRODUCT AVANDAMET 4 mg/1000 mg tablets rosiglitazone/metformin HCl
Estonian: RAVIMPREPARAADI NIMETUS AVANDAMET 4 mg/1000 mg tabletid rosiglitasoon/metformiin HCl
English: NAME OF THE MEDICINAL PRODUCT AVANDAMET 1 mg/500 mg tablets rosiglitazone/metformin HCl
Estonian: RAVIMPREPARAADI NIMETUS AVANDAMET 1 mg/500 mg tabletid rosiglitasoon/metformiin HCl
English: NAME OF THE MEDICINAL PRODUCT AVANDAMET 2 mg/500 mg tablets rosiglitazone/metformin HCl
Estonian: RAVIMPREPARAADI NIMETUS AVANDAMET 2 mg/500 mg tabletid rosiglitasoon/metformiin HCl
English: NAME OF THE MEDICINAL PRODUCT AVANDAMET 2 mg/1000 mg tablets rosiglitazone/metformin HCl
Estonian: RAVIMPREPARAADI NIMETUS AVANDAMET 2 mg/1000 mg tabletid rosiglitasoon/metformiin HCl
English: Lot
Estonian: Sage
English: Î Tell a doctor or pharmacist if you are taking any of these.
Estonian: Î Kui te võtate mõnda loetletud ravimitest, rääkige sellest arstile või apteekrile.
English: AVANDAMET must be discontinued if any deterioration in cardiac status occurs.
Estonian: Südamefunktsiooni häirete tekkimisel tuleb AVANDAMET ära jätta.
English: Eye disorders macular oedema
Estonian: Silma kahjustused maakula turse
English: AVANDAMET combines two antihyperglycaemic agents with complimentary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: rosiglitazone maleate, a member of the thiazolidinedione class and metformin hydrochloride, a member of the biguanide class.
Estonian: Nendeks on tiasolidiindioonide rühma kuuluv rosiglitasoonmaleaat ja biguaniidide rühma kuuluv metformiinvesinikkloriid.
English: HOW TO STORE AVANDAMET Keep out of the reach and sight of children.
Estonian: Kuidas Avandamet välja näeb ja pakendi sisu
English: • stomach (abdominal) pain
Estonian: • rindkerevalu (stenokardia)
English: OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Estonian: JÄÄTMEMATERJALI HÄVITAMISEKS, VASTAVALT RAVIMPREPARAADILE ESITATUD NÕUETELE
English: The improved glycaemic control is associated with reductions in both fasting and postprandial glucose.
Estonian: Veresuhkru kontroli paranemine on seotud nii tühja kõhu kui einejärgse veresuhkru sisalduse vähenemisega.
English: Component of a multipack comprising 2 packs, each containing 56 film-coated tablets.
Estonian: RAVIMVORM JA PAKENDI SUURUS Multipakend, mis sisaldab 2 pakendit, kummaski 56 kaetud tabletti.
English: Hepatobiliary disorders liver function disorders
Estonian: Sage hüpertriglütserideemia Sage hüperlipideemia
English: Film coat:
Estonian: Kilekate:
English: GlaxoSmithKline S.p.A. Tel: + 39 (0)45 9218 111
Estonian: Tel: + 39 (0)45 9218 111
English: Multipack comprising 2 packs, each containing 56 film-coated tablets.
Estonian: 2 pakendit (igas 56 kaetud tabletti) sisaldava multipakendi komponent.
English: NAME OF THE MEDICINAL PRODUCT AVANDAMET 4 mg/1000 mg film-coated tablets rosiglitazone/metformin HCl
Estonian: RAVIMPREPARAADI NIMETUS AVANDAMET 4 mg/1000 mg õhukese polümeerikattega tabletid rosiglitasoon/metformiin HCl
English: NAME OF THE MEDICINAL PRODUCT AVANDAMET 2 mg/500 mg film-coated tablets rosiglitazone/metformin HCl
Estonian: RAVIMPREPARAADI NIMETUS AVANDAMET 2 mg/500 mg õhukese polümeerikattega tabletid rosiglitasoon/metformiin HCl
English: NAME OF THE MEDICINAL PRODUCT AVANDAMET 1 mg/500 mg film-coated tablets rosiglitazone/metformin HCl
Estonian: RAVIMPREPARAADI NIMETUS AVANDAMET 1 mg/500 mg õhukese polümeerikattega tabletid rosiglitasoon/metformiin HCl
English: NAME OF THE MEDICINAL PRODUCT AVANDAMET 2 mg/1000 mg film-coated tablets rosiglitazone/metformin HCl
Estonian: RAVIMPREPARAADI NIMETUS AVANDAMET 2 mg/1000 mg õhukese polümeerikattega tabletid rosiglitasoon/metformiin HCl
English: B. PACKAGE LEAFLET
Estonian: • luumurrud
English: BATCH NUMBER Lot
Estonian: PARTII NUBER Partii nr:
English: These strengths are supplied in blister packs containing 14, 28, 56, 2x56, 3x56 or 180 film-coated tablets.
Estonian: Avandamet 2 mg/1000 mg on kollased tabletid, mille ühele poole on märgitud „gsk“ ja teisele Avandamet 4 mg/1000 mg on roosad tabletid, mille ühele poole on märgitud „gsk“ ja teisele Need tugevused on blisterpakendites, mis sisaldavad 14, 28, 56, 2x56, 3x56 või 180 kaetud tabletti.
English: 1 vial + 1 syringe + 1 needle + 1 adaptor + 2 alcohol pads
Estonian: IDACIO 40 mg/0,8 ml Süstelahus Subkutaanne viaal (klaas) 0,8 ml (40 mg/0,8 ml) 1 viaal + 1 süstal + 1 nõel + 1 adapter + 2 alkoholipadjakest
English: Strength Pharmaceutical Form
Estonian: Ravimvorm Manustamistee Sisepakendi iseloomustus
English: MA (EU) number
Estonian: Müügiloa nr Euroopa Liidus
English: MA (EU) number (Invented) name
Estonian: (Väljamõeldud) nimetus
English: Route of Administration
Estonian: Müügiloa nr Euroopa Liidus
English: The medicine should be taken without food.
Estonian: Ravimit tuleb võtta ilma toiduta.
English: As a result, patients fall asleep and wake up at unusual times.
Estonian: Selle tulemusel uinuvad ja ärkavad patsiendid ebatavalistel aegadel.
English: Hetlioz is intended for long-term use.
Estonian: Hetlioz on ette nähtud pikaajaliseks kasutamiseks.
English: This summary was last updated in 07-2015.
Estonian: Kokkuvõte viimane uuendus: 07-2015.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Hetlioz on 3 July 2015.
Estonian: Euroopa Komisjon andis Hetliozi müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 3. juulil 2015.
English: A risk management plan has been developed to ensure that Hetlioz is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Hetliozi võimalikult ohutu kasutamine.
English: These are usually mild or moderate in severity and temporary.
Estonian: Need on raskusastmelt tavaliselt kerged või mõõdukad ja ajutised kõrvalnähud.
English: Hetlioz tasimelteon
Estonian: Hetlioz tasimelteoon
English: What measures are being taken to ensure the safe and effective use of Hetlioz?
Estonian: Mis meetmed võetakse, et tagada Hetliozi ohutu ja efektiivne kasutamine?
English: The recommended dose is one capsule per day, taken one hour before bedtime, at the same time every night.
Estonian: Soovitatav annus on 1 kapsel ööpäevas üks tund enne magamaminekut, igal õhtul samal ajal.
English: Other information about Hetlioz
Estonian: Muu teave Hetliozi kohta
English: By taking it at a suitable time each day it can help to reset the sleep-wake cycle to more standard timing.
Estonian: Kui võtta seda iga päev sobival ajal, võib see aidata muuta une-ärkveloleku tsükli tavalistele aegadele lähedasemaks.
English: Regarding safety, Hetlioz was shown to be well tolerated, causing only few mild side effects.
Estonian: Ohutusega seoses osutus Hetlioz hästi talutavaks ning põhjustas vaid väheseid kergeid kõrvalnähte.
English: However, continued treatment would be necessary to maintain the beneficial effects.
Estonian: Kasuliku toime säilitamiseks on aga vaja ravi pidevalt jätkata.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Hetlioz's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Inimravimite komitee otsustas, et Hetliozi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: In the second study, 57 patients first received Hetlioz for around 11 weeks.
Estonian: Teises uuringus sai 57 patsienti Hetliozi esialgu ligikaudu 11 nädalat.
English: Improved results were seen in a subset of patients after 7 months of treatment, which indicate that patients may take weeks or months to respond.
Estonian: Patsientide alamrühmas täheldati paranenud tulemusi 7 kuud pärast ravi algust, mis osutab sellele, et patsientide ravivastus võib tekkida nädalate või kuude pärast.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Hetlioz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Estonian: Harvikravimite komitee arvamuse kokkuvõte Hetliozi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The most common side effects with Hetlioz (which may affect more than 3 in 100 people) are headache, somnolence, nausea (feeling sick) and dizziness.
Estonian: Hetliozi kõige sagedamad kõrvalnähud (võivad esineda enam kui 3 patsiendil 100st) on peavalu, unisus, iiveldus ja peapööritus.
English: The full EPAR and risk management plan summary for Hetlioz 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 Hetliozi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What is Hetlioz and what is it used for?
Estonian: Mis on Hetlioz ja milleks seda kasutatakse?
English: The CHMP noted that only around 20% of patients would be able to benefit from treatment with Hetlioz, but in view of the lack of approved treatments for non-24-hour sleep-wake disorder, which is a debilitating condition, this modest response was still considered important.
Estonian: Inimravimite komitee märkis, et Hetlioziga ravimisest saab kasu vaid ligikaudu 20% patsientidest, aga arvestades asjaolu, et puuduvad heakskiidetud ravimid mitte-24-tunnise une- ja ärkveloleku häire ravimiseks, mis on invaliidistav seisund, peeti ka seda tagasihoidlikku ravivastust siiski oluliseks.
English: What are the risks associated with Hetlioz?
Estonian: Mis riskid Hetlioziga kaasnevad?
English: This is a summary of the European public assessment report (EPAR) for Hetlioz.
Estonian: See on ravimi Hetlioz Euroopa avaliku hindamisaruande kokkuvõte.
English: Why is Hetlioz approved?
Estonian: Miks Hetlioz heaks kiideti?
English: For the full list of all side effects and restrictions with Hetlioz, see the package leaflet.
Estonian: Hetliozi kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Hetlioz, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati Hetliozi omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: In people with normal perception of light and dark, melatonin is produced in hours of darkness and promotes sleep by acting on melatonin receptors in specific areas of the brain.
Estonian: Inimestel, kes tajuvad valgust ja pimedust normaalselt, toodetakse melatoniini pimedal ajal ning see aitab magada, mõjutades aju teatud piirkondades asuvaid melatoniiniretseptoreid.
English: The main measure of effectiveness was the percentage of patients who were able to adjust to the 24-hour clock, which was calculated by looking at how the amount of melatonin breakdown products changed in the patient's urine over time.
Estonian: Efektiivsuse põhinäitaja oli nende patsientide protsent, kes suutsid kohaneda 24-tunnise tsükliga; see arvutati vaadeldes, kuidas melatoniini metaboliitide kogus patsiendi uriinis aja jooksul muutus.
English: Non-24hour sleep-wake disorder is a condition that occurs almost exclusively in people who are completely blind, where patients have sleep patterns that are not synchronised with day and night and often follow a cycle that is longer than the standard 24-hour clock.
Estonian: Mitte-24-tunnine une- ja ärkveloleku häire on seisund, mis tekib peaaegu eranditult vaid täiesti pimedatel inimestel, mille puhul patsientide unerütm ei ole sünkroonitud päeva ja ööga ning seetõttu tekib pikem kui tavaline 24-tunnine tsükkel.
English: The active substance in Hetlioz, tasimelteon, acts on the same receptors as melatonin to promote sleep and regulate sleep patterns.
Estonian: Hetliozi toimeaine tasimelteoon mõjutab samu retseptoreid kui melatoniin, et aidata magada ja reguleerida unerütmi.
English: It is not intended to provide practical advice on how to use Hetlioz.
Estonian: Hindamisaruandes ei anta Hetliozi kasutamise praktilisi nõuandeid.
English: The first study, which involved a total of 84 totally blind patients with non-24-hour sleep-wake disorder, compared Hetlioz with placebo (a dummy treatment).
Estonian: Esimeses uuringus, kus osales kokku 84 täiesti pimedat mitte-24-tunnise une- ja ärkveloleku häirega patsienti, võrreldi Hetliozi platseeboga (näiva ravimiga).
English: Those patients who were able to adjust to the 24-hour clock (20 patients in total) were then given Hetlioz or placebo for a further 8 weeks to study how well the effect of Hetlioz was maintained.
Estonian: Neile patsientidele, kes suutsid kohaneda 24-tunnise tsükliga (kokku 20 patsienti) anti seejärel Hetliozi või platseebot veel 8 nädalat, et uurida, kui hästi Hetliozi toime säilis.
English: For practical information about using Hetlioz, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Hetliozi kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: Hetlioz is a medicine used to treat totally blind adults with non-24-hour sleep-wake disorder.
Estonian: Hetlioz on ravim, mida kasutatakse mitte-24-tunnise une- ja ärkveloleku häire raviks täiesti pimedatel täiskasvanutel.
English: For more information about treatment with Hetlioz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Hetlioziga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: 20% of patients who received Hetlioz (8 out of 40) were able to adjust to the 24-hour clock after 1 months of treatment, compared with around 3% of patients on placebo (1 out of 38).
Estonian: Hetliozi saanud patsientidest 20% (40-st 8) suutis 1 kuu pärast ravi algust kohaneda 24-tunnise tsükliga, võrreldes ligikaudu 3%-ga platseebot saanud patsientidest (38-st 1).