FrancophonIA/ELRC3.0 huggingface dataset:
English: Xenical and Alli are together estimated to have been used by over 53 million people worldwide, with over 20 million in the EU.
Estonian: Xenicali ja Allit on kogu maailmas manustanud kokku hinnanguliselt üle 53 miljoni inimese, sealhulgas ELis üle 20 miljoni inimese.
English: A number of generic orlistat-containing medicines have also been authorised via national procedures in Belgium, Bulgaria, Denmark, Estonia, Latvia, Lithuania, Norway, Portugal, Slovakia, the Netherlands, and the United Kingdom.
Estonian: Mitmetele orlistaati sisaldavatele ravimitele anti müügiluba riiklike menetluste kaudu Belgias, Bulgaarias, Taanis, Eestis, Lätis, Leedus, Norras, Portugalis, Slovakkias, Madalmaades ja Ühendkuningriigis.
English: Why was orlistat reviewed?
Estonian: Miks orlistaadi taotlus uuesti läbi vaadati?
English: • Patients who have any questions should speak to their doctor or pharmacist at a routine appointment.
Estonian: • Patsiendid, kellel on mis tahes küsimusi, peavad rääkima oma arsti või apteekriga tavalise visiidi käigus.
English: The body does not absorb this fat and this helps the patient reduce their weight.
Estonian: Keha ei omasta rasva ja see aitab patsiendil kaalu langetada.
English: Patients should stop taking orlistat and inform their doctor if they experience any of these symptoms.
Estonian: Patsiendid peavad lõpetama orlistaadi võtmise ja teatama oma arstile, kui neil tekib ükskõik milline neist haigunähtudest.
English: Two orlistat-containing medicines hold an EU-wide marketing authorisation.
Estonian: Kahel orlistaati sisaldaval ravimil on kogu ELi hõlmav müügiluba.
English: A pattern was not seen in the type of liver problems reported, and in most cases there were other factors which were likely to increase the risk of liver injury such as existing health problems or the use of other medicines.
Estonian: Teatatud maksaprobleemide tüübis ei ilmnenud mingit seaduspära ja enamikul juhtudest esinesid muud tegurid, mis tõenäoliselt suurendasid maksakahjustuse riski, näiteks olemasolevad terviseprobleemid või muud kasutatavad ravimid.
English: • Patients and prescribers are reminded that the benefits of orlistat-containing medicines continue to outweigh the risks.
Estonian: • Patsientidele ja arstidele tuleb meelde tuletada, et orlistaati sisaldavate ravimite kasulikkus ületab endiselt selle riskid.
English: Consequently, the European Commission asked the CHMP to issue an opinion on orlistat and on whether the marketing authorisation for orlistat-containing medicines should be maintained, varied, suspended or withdrawn across the EU.
Estonian: Sellest tulenevalt palus Euroopa Komisjon inimravimite komiteel anda oma arvamus orlistaadi kohta ja orlistaati sisaldavate ravimite müügiloa säilitamise, muutmise, peatamise või tühistamise kohta kogu ELis.
English: When these enzymes are blocked, they cannot digest some fats in the diet, and this allows about a quarter of the fat eaten in the meal to be passed out in the stools undigested.
Estonian: Kui need ensüümid blokeeritakse, siis ei saa nad mõningaid toidurasvu lõhustada, mistõttu kuni neljandik toiduga tarbitud rasvadest läbib soolestiku seedimatuna.
English: Which data has the CHMP reviewed?
Estonian: Mis andmed inimravimite komitee uuesti läbi vaatas?
English: This risk has been closely monitored by the CHMP and measures to manage the known risks were put in place.
Estonian: Inimravimite komitee jälgis seda riski väga hoolikalt ja teadaolevate riskide juhtimiseks võeti vajalikud meetmed.
English: • Patients should note that symptoms of hepatitis can include yellowing skin and eyes, itching, dark coloured urine, stomach pain and liver tenderness (indicated by pain under the front of the rib cage), sometimes with a loss of appetite.
Estonian: • Patsiendid peavad mõistma, et hepatiidi nähud võivad hõlmata naha ja silmade kollasust, sügelust, tumeda värvusega uriini, kõhuvalu ja maksa hellust (ilmneb valuna rinnakorvi eesosa allservas) ning mõnikord kaasneb isutus.
English: The current European public assessment report for Alli can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Alli kohta on Euroopa Ravimiameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The current European public assessment report for Xenical can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Xenicali kohta on Euroopa Ravimiameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Orlistat is an anti-obesity medicine, which does not affect appetite.
Estonian: Orlistaat on kehakaalu kontrolli all hoidev ravim, mis ei mõjuta söögiisu.
English: Since 2001 it has been recognised that some patients taking orlistat could experience very rare liverrelated side effects.
Estonian: Alates 2001. aastast on teada mõned patsiendid, kellel orlistaadi võtmine võis tekitada väga harva esinevaid maksaga seotud kõrvalnähtusid.
English: There were 9 reports of liver failure in people using Alli since it was marketed in May 2007 until January 2011, although in some cases there were other possible explanations and in some cases there was insufficient information to assess the cause.
Estonian: Alates Alli turustamisest mais 2007 kuni jaanuarini 2011 koostati ravimi kasutajate kohta 9 maksakahjustuse teadet , kuigi mõnel juhul esinesid muud võimalikud selgitused ja mõnel juhul ei olnud põhjuse hindamiseks piisavalt teavet.
English: Orlistat blocks the action of gastrointestinal lipases (enzymes that digest fat).
Estonian: Orlistaat blokeerib seedetrakti lipaaside (rasvu lõhustavad ensüümid) toimet.
English: Xenical was authorised in 1998 and is available as capsules (120 mg) which can only be obtained with a prescription.
Estonian: Xenicalile anti müügiluba 1998. aastal ja seda turustatakse ainult retseptiravimina kapslitena (120 mg).
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of orlistat continue to outweigh its risks, and therefore recommended that the marketing authorisations be maintained for orlistat-containing medicines.
Estonian: Praegu olemasolevate andmete hindamise ja komitees toimunud teadusliku arutelu alusel jõudis inimravimite komitee järeldusele, et orlistaadi kasulikkus ületab endiselt riskid ning soovitas seega orlistaati sisaldavate ravimite müügiload säilitada.
English: The Committee considered that while there may be very rare cases of serious liver injury for which orlistat cannot be excluded as a possible cause, the cases do not provide good evidence of a causal link.
Estonian: Kuigi mõnede väga harvade raskete maksakahjustuse juhtude puhul ei saa orlistaati võimaliku põhjusena välistada, ei anna need juhud häid tõendeid põhjuslike seoste loomiseks.
English: Therefore, the CHMP considered it necessary to assess whether the evidence gathered over time on the risk of severe liver problems had altered the benefit-risk balance of orlistat-containing medicines.
Estonian: Seega pidas inimravimite komitee vajalikuks hinnata, kas aja jooksul kogutud tõendid raskete maksaprobleemide kohta rikkusid orlistaati sisaldavate ravimite kasulikkuse ja riski tasakaalu.
English: Alli was authorised in 2007 and is available as capsules (60 mg) and chewable tablets (27 mg) which can be obtained without a prescription (‘over-the-counter').
Estonian: Allile anti müügiluba 2007. aastal ja seda turustatakse käsimüügiravimina kapslite (60 mg) ja närimistablettidena (27 mg).
English: There remains no clear evidence that orlistat causes these reactions.
Estonian: Kindlad teadmised orlistaadi kui nende reaktsioonide põhjustaja kohta puuduvad.
English: The Committee also agreed on minor amendments to the package leaflet for all orlistat-containing medicines to ensure they give the same information, including a description of the symptoms of hepatitis to alert patients to these symptoms.
Estonian: Samuti nõustus inimravimite komitee väiksemate muudatustega kõikides orlistaati sisaldavate ravimite pakendi infolehtedes, kindlustamaks nendes samasuguse teabe olemasolu, sealhulgas hepatiidi nähtude kirjeldused, et hoiatada patsiente haigusnähtude suhtes.
English: Overall, from 1997 to January 2011, 21 cases of severe liver toxicity were reported where Xenical was considered a possible cause, although other factors that could have caused the liver injury were present.
Estonian: Üldse esitati alates 1997. aastast kuni jaanuarini 2011 teateid raske maksakahjustuse 21 juhu kohta, milles Xenical oli arvatavasti võimalik põhjus, kuigi samas esinesid ka muud tegurid, mis võisid maksakahjustust põhjustada.
English: The CHMP reviewed the available data on the risk of liver injury and other side effects with orlistat, including post-marketing surveillance, data from the studies supporting the marketing authorisations and population-based studies in the published literature.
Estonian: Inimravimite komitee vaatas läbi olemasolevad andmed maksakahjustuse riski ja orlistaadi muude kõrvalnähtude kohta, sealhulgas turustamisjärgsed järelevalve andmed, müügilube toetavate uuringute andmed ja teaduskirjanduses avaldatud rahvastikupõhiste uuringute andmed.
English: The product information for Alli, which currently lists ‘hepatitis', will be updated accordingly.
Estonian: Samamoodi uuendatakse Alli ravimiteavet, mis praegu sisaldab loetelus hepatiiti.
English: The Committee concluded that the number of reported severe liver reactions in orlistat users was low and below the background rate expected in these people, given the large number of users.
Estonian: Inimravimite komitee järeldas, et raskete maksareaktsioonide kohta esitatud teadete arv oli orlistaadi kasutajatel väike ja arvestades kasutajate suurt koguarvu, allpool neil inimestel oodatavat taustmäära.
English: The Committee also reviewed information requested from the companies that market orlistat-containing medicines, including the estimated number of people using these medicines and an analysis of the observed number of reports of severe liver problems compared with the expected background rate of liver problems in these people.
Estonian: Samuti vaatas komitee läbi orlistaati sisaldavaid ravimeid turustavatelt ettevõtetelt küsitud andmed, sealhulgas neid ravimeid kasutavate inimeste hinnanguline koguarv ja vaadeldud raskete maksaprobleemide teadete arv, samuti neil inimestel oodatavate maksprobleemide taustmäärade võrdleva analüüsi andmed.
English: The CHMP also noted that published population-based studies suggest that obesity may be associated with a higher risk of liver disease.
Estonian: Inimravimite komitee märkis samuti, et avaldatud rahvastikupõhiste uuringute andmed viitavad rasvumuse seostele maksahaiguste suurenenud riskiga.
English: Recent safety monitoring showed that from August 2009 to January 2011 four cases of severe liver injury were reported in patients using Xenical where the role of orlistat could not be excluded, including one fatal case of liver failure and one case leading to liver transplantation.
Estonian: Ohutuse järelevalve hiljutised tulemused näitasid, et alates 2009. aasta augustist kuni 2011. aasta jaanuarini teatati neljast raske maksakahjustuse juhust Xenicali tarvitanud patsientidel, kelle puhul ei saanud orlistaadi toimet välistada.
English: Since authorisation, there have been some reports of severe liver problems in users of these medicines.
Estonian: Alates müügiloa andmisest on nende ravimite kasutajatel teatatud mõnest raske maksaprobleemi juhust.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of orlistat continue to outweigh its risks, and recommended that the marketing authorisations be maintained with minor amendments to the product information to ensure the same information on very rare liver-related side effects is provided for all orlistat-containing medicines.
Estonian: Inimravimite komitee järeldas, et orlistaadi kasulikkus kaalub endiselt üles selle riskid ja soovitas müügilubade säilitamist koos väheste parandustega ravimiteabes, et kindlustada väga harva esinevate maksa mõjutavate kõrvalnähtudega seotud ühesuguse teabe kasutamine kõigi orlistaati sisaldavate ravimite puhul.
English: It noted that the product information for Xenical already listed ‘hepatitis that may be serious' as a side effect of unknown frequency, and recommended that the product information for all orlistat-containing medicines should be harmonised to include this information.
Estonian: Inimravimite komitee märkis, et Xenicali ravimiteave loetles juba „hepatiiti, mis võib olla raske″ kui teadmata sagedusega kõrvalnäht ja soovitas ühtlustada kõikide orlistaati sisaldavate ravimite ravimiteabe.
English: The CHMP considered that there was no strong evidence that orlistat increased the risk of severe liver injury, and there was no known mechanism by which orlistat was expected to cause liver disorders.
Estonian: Inimravimite komitee arvates puudusid olulised tõendid, et orlistaat suurendaks raskete maksakahjustuste riski ja oodatavate maksahäirete tekitamise mehhanism ei ole teada.
English: The European Medicines Agency has completed a review of orlistat-containing medicines, following concerns about the possible risk of severe liver injury with these medicines.
Estonian: Euroopa Ravimiamet koostas ülevaate orlistaati sisaldavatest ravimitest, mille kasutamisel esines raske maksakahjustuse risk.
English: • Patients and prescribers should be aware that certain liver-related problems, including very rare serious reactions such as hepatitis, have been reported and are listed in the product information for orlistat-containing medicines as possible side effects.
Estonian: • Patsiendid ja arstid peavad olema teadlikud sellest, et teatatud on mõnedest maksaga seotud probleemidest, sealhulgas väga harva esinevad rasked reaktsioonid (nagu hepatiit).
English: The product information for orlistat-containing medicines lists hepatitis, cholelithiasis (gall stones) and a change in liver enzyme levels as potential liver-related side effects.
Estonian: Orlistaati sisaldavate ravimite ravimiteave sisaldas loetelu võimalikest maksaga seotud kõrvalnähtudest, sealhulgas hepatiit, sapikivitõbi (sapikivid) ja muutused maksaensüümide sisalduses.
English: Date of first authorisation: 28 September 2012 Date of latest renewal: 13 July 2017
Estonian: Müügiloa esmase väljastamise kuupäev: 28. september 2012 Müügiloa viimase uuendamise kuupäev: 13. juuli 2017
English: If you use more Enurev Breezhaler than you should If you have inhaled too much of this medicine or if someone else accidentally uses your capsules, you must immediately either tell your doctor or go to the nearest emergency unit.
Estonian: Kui te kasutate Enurev Breezhalerit rohkem kui ette nähtud Kui te olete sisse hinganud liiga palju seda ravimit või keegi teine kasutab kogemata teie kapsleid, peate otsekohe ühendust võtma oma arstiga või pöörduma lähima haigla erakorralise meditsiini osakonda.
English: - if you experience eye pain or discomfort, temporary blurring of vision, visual halos or coloured images in association with red eyes.
Estonian: - teil tekib silmavalu või ebamugavustunne silmas, mööduv ähmane nägemine, halode või värviliste kujutiste nägemine koos silmade punetusega.
English: • Enurev Breezhaler capsules must always be stored in the blister card and only removed immediately before use.
Estonian: • Enurev Breezhaleri kapsleid peab alati hoidma blisterpakendis ja eemaldama alles vahetult enne kasutamist.
English: How long to continue your treatment with Enurev Breezhaler - Keep using this medicine for as long as your doctor tells you.
Estonian: Kui kaua peab jätkama ravi Enurev Breezhaleriga - Jätkake selle ravimi kasutamist senikaua, kui arst soovitab.
English: • One or more blister cards, each containing either 6 or 10 Seebri Breezhaler capsules to be used in the inhaler
Estonian: • Ühte või mitut blisterpakendit, millest igaühes on kas 6 või 10 Enurev Breezhaleri kapslit inhalaatorisiseks kasutamiseks
English: Enurev Breezhaler 44 micrograms once daily can be safely used in all age and body weight groups.
Estonian: Enurev Breezhalerit annuses 44 mikrogrammi üks kord ööpäevas võib ohutult kasutada kõikides vanuse- ja kehakaalu rühmades.
English: What Enurev Breezhaler looks like and contents of the pack Enurev Breeyhaler 44 micrograms inhalation powder, hard capsules are transparent and orange and contain a white powder.
Estonian: Kuidas Enurev Breezhaler välja näeb ja pakendi sisu Enurev Breezhaler 44 mikrogrammi inhalatsioonipulbri kõvakapslid on oranžid ja läbipaistvad ning sisaldavad valget pulbrit.
English: How to store Enurev Breezhaler Contents of the pack and other information
Estonian: Kuidas Enurev Breezhalerit säilitada Pakendi sisu ja muu teave
English: During treatment with Enurev Breezhaler, stop taking this medicine and tell your doctor immediately: - if you experience tightness of the chest, coughing, wheezing or breathlessness immediately after using Enurev Breezhaler (signs of bronchospasm).
Estonian: Ravi ajal Enurev Breezhaleriga, lõpetage selle ravimi kasutamine ning teavitage otsekohe oma arsti sellest: - kui teil tekib vahetult pärast Enurev Breezhaleri kasutamist pingetunne rindkeres, köha, vilistav hingamine või hingeldus (bronhospasmi nähud).
English: The capsules must be administered only using the Enurev Breezhaler inhaler (see section 6.6).
Estonian: Kapslite manustamiseks tohib kasutada ainult Enurev Breezhaler inhalaatorit (vt lõik 6.6).
English: Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using Enurev Breezhaler and to contact their doctor immediately should any of these signs or symptoms develop.
Estonian: Patsiente tuleb teavitada ägeda kitsa nurga glaukoomi sümptomitest ning juhendada, et ükskõik millise nimetatud sümptomi tekkimisel tuleb otsekohe lõpetada Enurev Breezhaleri kasutamine ning võtta ühendust arstiga.
English: Enurev Breezhaler once daily has also shown a statistically significant effect on health-related quality of life measured using the St. George's Respiratory Questionnaire (SGRQ).
Estonian: Üks kord ööpäevas manustatava Enurev Breezhaleri puhul on näidatud ka statistiliselt olulist mõju tervisega seotud elukvaliteedile, mida hinnati SGRQ (St. George's Respiratory Questionnaire) küsimustiku põhjal.
English: In clinical studies with Enurev Breezhaler, paradoxical bronchospasm was not observed.
Estonian: Enurev Breezhaleri kliinilistes uuringutes ei täheldatud paradoksaalset bronhospasmi.
English: What Enurev Breezhaler is and what it is used for What you need to know before you use Enurev Breezhaler How to use Enurev Breezhaler Possible side effects
Estonian: Mis ravim on Enurev Breezhaler ja milleks seda kasutatakse Mida on vaja teada enne Enurev Breezhaleri kasutamist Kuidas Enurev Breezhalerit kasutada Võimalikud kõrvaltoimed
English: The absolute bioavailability of glycopyrromium inhaled via Enurev Breezhaler was estimated to be about 45% of the delivered dose.
Estonian: Enurev Breezhaleri kaudu inhaleeritud glükopürrooniumi absoluutne biosaadavus oli hinnanguliselt umbes 45%.
English: Glycopyrronium should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the foetus.
Estonian: Enurev Breezhalerit tohib raseduse ajal kasutada ainult juhul, kui oodatav kasu patsiendile õigustab võimalikku riski lootele.
English: 2) Reports have been received from post-approval marketing experience in association with the use of Enurev Breezhaler.
Estonian: 2) Teated on kogutud turuletulekujärgselt seoses Enurev Breezhaleri kasutamisega.
English: This includes medicines similar to Enurev Breezhaler used for your lung disease, such as ipratropium, oxitropium or tiotropium (so called anticholinergics).
Estonian: See kehtib ka Enurev Breezhaleriga sarnaste ravimite kohta, mida kasutatakse teie kopsuhaiguse raviks, nagu ipratroopium, oksitroopium või tiotroopium (niinimetatud antikolinergilised ravimid).
English: The long duration of action can be partly attributed to sustained concentrations of active substance in the lung as reflected by the prolonged terminal elimination half-life of glycopyrronium after inhalation via the Enurev Breezhaler inhaler in contrast to the half life after intravenous administration (see section 5.2).
Estonian: Pikk toime kestus on osaliselt tingitud toimeaine püsivast kontsentratsioonist kopsudes, mida näitab glükopürrooniumi pikk terminaalne eliminatsiooni poolväärtusaeg pärast inhalatsiooni Enurev Breezhaler inhalaatorist erinevalt veenisisese manustamise järgsest poolväärtusajast (vt lõik 5.2).
English: The recommended dose is the inhalation of the content of one capsule once daily using the Enurev Breezhaler inhaler.
Estonian: Annustamine Soovitatav annus on ühe kapsli sisu inhalatsioon üks kord päevas Enurev Breezhaler inhalaatorist.
English: How to inhale Enurev Breezhaler - In this pack, you will find an inhaler and capsules (in blisters) that contain the medicine as inhalation powder.
Estonian: Kuidas Enurev Breezhalerit sisse hingata - Sellest pakendist leiate inhalaatori ja kapslid (blistrites), mis sisaldavad ravimit inhaleeritava pulbrina.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Enurev Breezhaler in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric use).
Estonian: Euroopa Ravimiamet ei kohusta esitama Enurev Breezhaleriga läbi viidud uuringute tulemusi laste kõikide alarühmade kohta KOKi korral (teave lastel kasutamise kohta: vt lõik 4.2).
English: Enurev Breezhaler should be used with caution in patients with narrow-angle glaucoma or urinary retention.
Estonian: Enurev Breezhalerit peab ettevaatlikult kasutama patsientidel, kellel esineb kitsa nurga glaukoom või uriinipeetus.
English: Following oral inhalation using the Enurev Breezhaler inhaler, glycopyrronium was rapidly absorbed and reached peak plasma levels at 5 minutes post dose.
Estonian: Pärast suukaudset inhalatsiooni Enurev Breezhaler inhalaatorist imendus glükopürroonium kiiresti ja saavutas maksimaalse plasmakontsentratsiooni 5 minutit pärast annuse manustamist.
English: - When you start a new pack, use the new Enurev Breezhaler inhaler that is supplied in the pack.
Estonian: - Kui alustate uue pakendi kasutamist, kasutage pakendis olevat uut Enurev Breezhaler inhalaatorit.
English: Enurev Breezhaler 44 micrograms once daily provided consistently statistically significant improvement in lung function (forced expiratory volume in one second, FEV1, forced vital capacity, FVC, and inspiratory capacity, IC) in a number of clinical studies.
Estonian: Enurev Breezhaler 44 mikrogrammi üks kord ööpäevas viis mitmes kliinilises uuringus kopsufunktsiooni (ühe sekundi forsseeritud ekspiratoorne maht [FEV1], forsseeritud vitaalkapatsiteet [FVC] ja inspiratoorne kapatsiteet [IC]) püsivalt statistiliselt olulise paranemiseni.
English: Enurev Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Estonian: Enurev Breezhaler on näidustatud kasutamiseks bronhe lõõgastava säilitusravina sümptomite leevendamiseks kroonilise obstruktiivse kopsuhaigusega (KOK) täiskasvanud patsientidel.
English: Infections and infestations Nasopharyngitis1)
Estonian: Infektsioonid ja infestatsioonid Nasofarüngiit
English: In COPD patients with mild and moderate renal impairment (estimated glomerular filtration rate, eGFR ≥30 ml/min/1.73 m2) Enurev Breezhaler can be used at the recommended dose.
Estonian: Kerge ja keskmise raskusega neerukahjustusega (hinnanguline glomerulaarfiltratsiooni kiirus, eGFR ≥30 ml/min/1,73 m2) KOKi patsientidel võib Enurev Breezhalerit kasutada soovitatavas annuses.