FrancophonIA/ELRC3.0 huggingface dataset:
English: Black iron oxide (E172) Propylene glycol
Estonian: must raudoksiid (E172), polüetüleenglükool.
English: Pregabalin Zentiva 300 mg hard capsules Pregabalin
Estonian: Pregabalin Zentiva 300 mg kõvakapslid Pregabalinum
English: 25 mg capsules Light grey cap and light grey body; approx. 15,9 mm in length, hard gelatin capsule with imprinting “25”, containing almost white powder.
Estonian: Želatiinist kõvakapsel, millel on helehall kaas ja helehall keha märgistusega “25”, sisaldab peaaegu valget pulbrit ning kapsli pikkus on ligikaudu 15,9 mm.
English: Pregabalin Zentiva 50 mg hard capsules Capsule cap and body Black iron oxide (E172) Titanium dioxide (E171) Gelatin
Estonian: Pregabalin Zentiva 50 mg kõvakapslid Kapsli kaas ja keha: must raudoksiid (E172), titaandioksiid (E171),
English: Pregabalin Zentiva 150 mg hard capsules Capsule cap and body Black iron oxide (E172) Titanium dioxide (E171) Gelatin
Estonian: Pregabalin Zentiva 150 mg kõvakapslid Kapsli kaas ja keha: must raudoksiid (E172), titaandioksiid (E171),
English: 75 mg capsules Red cap and light grey body; approx. 14,3 mm in length, hard gelatin capsule with imprinting “75”, containing almost white powder.
Estonian: Želatiinist kõvakapsel, millel on helehall kaas ja helehall keha märgistusega “75”, sisaldab peaaegu valget pulbrit ning kapsli pikkus on ligikaudu 14,3 mm.
English: Pregabalin Zentiva 225 mg hard capsules
Estonian: Pregabalin Zentiva 225 mg kõvakapslid
English: Pregabalin Zentiva 200 mg hard capsules Pregabalin
Estonian: Pregabalin Zentiva 200 mg kõvakapslid Pregabalinum
English: 200 mg capsules Flesh opaque cap and Flesh opaque body; approx. 19,4 mm in length, hard gelatin capsule with imprinting “200”, containing almost white powder.
Estonian: Želatiinist kõvakapsel, millel on helehall kaas ja helehall keha märgistusega “200”, sisaldab peaaegu valget pulbrit ning kapsli pikkus on ligikaudu 19,4 mm.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED KARTONGKARP
English: Pregabalin Zentiva 50 mg hard capsules
Estonian: Pregabalin Zentiva 50 mg kõvakapslid
English: 50 mg capsules Light grey cap and light grey body; approx. 14,3 mm in length, hard gelatin capsule with imprinting “50”, containing almost white powder.
Estonian: Želatiinist kõvakapsel, millel on helehall kaas ja helehall keha märgistusega “50”, sisaldab peaaegu valget pulbrit ning kapsli pikkus on ligikaudu 14,3 mm.
English: Light grey cap and light grey body; approx. 18,0 mm in length, hard gelatin capsule with imprinting “150”, containing almost white powder.
Estonian: Želatiinist kõvakapsel, millel on helehall kaas ja helehall keha märgistusega “150”, sisaldab peaaegu valget pulbrit ning kapsli pikkus on ligikaudu 18,0 mm.
English: 100 mg capsules Red cap and red body; approx. 15,9 mm in length, hard gelatin capsule with imprinting “100”, containing almost white powder.
Estonian: Želatiinist kõvakapsel, millel on helehall kaas ja helehall keha märgistusega “100”, sisaldab peaaegu valget pulbrit ning kapsli pikkus on ligikaudu 15,9 mm.
English: Pregabalin Zentiva 300 mg hard capsules
Estonian: Pregabalin Zentiva 300 mg kõvakapslid
English: Pregabalin Zentiva 100 mg hard capsules Pregabalin
Estonian: Pregabalin Zentiva 100 mg kõvakapslid Pregabalinum
English: Capsules content Lactose monohydrate, Pregelatinized maize starch, Talc.
Estonian: Kapsli sisu: laktoosmonohüdraat,
English: Pregabalin Zentiva 25 mg hard capsules
Estonian: Pregabalin Zentiva 25 mg kõvakapslid
English: Pregabalin Zentiva 200 mg hard capsules
Estonian: Pregabalin Zentiva 200 mg kõvakapslid
English: Pregabalin Zentiva 100 mg hard capsules
Estonian: Pregabalin Zentiva 100 mg kõvakapslid
English: You may feel sleepy, confused, agitated, or restless as a result of taking more Pregabalin Zentiva than you should.
Estonian: Kui te olete võtnud Pregabalin Zentivat rohkem kui ette nähtud, võite tunda end unisena, segaduses, erutununa või rahutuna.
English: Pregabalin Zentiva 150 mg hard capsules Pregabalin
Estonian: Pregabalin Zentiva 150 mg kõvakapslid Pregabalinum
English: Pregabalin Zentiva 225 mg hard capsules Pregabalin
Estonian: Pregabalin Zentiva 225 mg kõvakapslid Pregabalinum
English: Flesh opaque cap and light grey body; approx. 19,4 mm in length, hard gelatin capsule with imprinting “225”, containing almost white powder.
Estonian: Želatiinist kõvakapsel, millel on ihuvärvi läbipaistmatu kaas ja helehall keha märgistusega “225”, sisaldab peaaegu valget pulbrit ning kapsli pikkus on ligikaudu 19,4 mm.
English: Pregabalin Zentiva 75 mg hard capsules Pregabalin
Estonian: Pregabalin Zentiva 75 mg kõvakapslid Pregabalinum
English: Pregabalin Zentiva 25 mg hard capsules Pregabalin
Estonian: Pregabalin Zentiva 25 mg kõvakapslid Pregabalinum
English: Pregabalin treatment has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall) in the elderly population.
Estonian: Peapööritustunne, unisus, teadvusekadu, segasus ja vaimsed häired Pregabaliinravi on seostatud peapööritustunde ja unisusega, mis võib suurendada juhuslike vigastuste (kukkumiste) esinemissagedust eakatel.
English: The physician information should contain the following key messages:
Estonian: Arstidele mõeldud informatsioon peab sisaldama järgmist põhiteavet:
English: • The possibility to include patients in the registry study to facilitate the collection of long term efficacy and safety data;
Estonian: • Võimalus kaasata patsiendid registriuuringusse, et kergendada pikaajaliste efektiivsus- ja ohutusandmete kogumist;
English: • The identified or potential risk of immunogenicity that might lead to immune-mediated symptoms;
Estonian: • Immunogeensuse kindlakstehtud või võimalik risk, mis võib viia immuunvahendatud sümptomite tekkeni;
English: • The role and use of patient alert card.
Estonian: • Patsiendi hoiatuskaardi roll ja kasutamine.
English: The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all physicians who are expected to prescribe/use Ilaris are provided with a physician information pack containing the following:
Estonian: Müügiloa hoidja tagab, et enne ravimi turule toomist on kõikidele arstidele, kes hakkavad Ilaris't välja kirjutama/kasutama, antud arsti teabepakett, mis sisaldab järgmist:
English: • The need to instruct patients on proper techniques for self-administration when the patient is willing and capable to do so, and guidance for Health Care Professionals on how to report administration errors;
Estonian: • Vajadus õpetada patsientidele ravimi õiget manustamistehnikat, kui patsient on nõus ja võimeline ravimit ise manustama, ning juhised tervishoiutöötajatele, kuidas teatada manustamisvigadest;
English: • The risk of serious infections, including opportunistic bacterial, viral and fungal infections in patients treated with Ilaris;
Estonian: • Tõsiste infektsioonide, kaasa arvatud oportunistlike bakteriaalsete, viirus- ja seennakkuste risk Ilaris-ravi saavatel patsientidel;
English: • The unknown safety of Ilaris in pregnant and lactating women, thus the need for physicians to discuss this risk with patients if they become or plan to become pregnant;
Estonian: • Ilaris'e teadmata ohutus rasedatel ja rinnaga toitvatel naistel, mistõttu peavad arstid seda riski arutama patsientidega, kes rasestuvad või planeerivad rasedust;
English: • The proper patient management as regards the interaction with vaccination;
Estonian: • Patsientide õige käsitlus, mis puudutab koostoimet vaktsineerimisega;
English: • The need to measure neutrophil counts prior to initiating treatment, after 1 to 2 months and periodically thereafter while receiving Ilaris as treatment with Ilaris should not be initiated in patients with neutropenia;
Estonian: • Vajadus määrata neutrofiilide arvu enne ravi alustamist, 1...2 kuu möödudes ning seejärel perioodiliselt Ilaris'e saamise ajal, sest neutropeeniaga patsientidel ei tohi alustada ravi Ilaris'ega;
English: • The need for Health Care Professionals to perform an annual clinical assessment of patients regarding a potential increased risk for the development of malignancies;
Estonian: • Vajadus viia tervishoiutöötajate poolt läbi patsientide iga-aastane kliiniline hindamine pahaloomuliste kasvajate potentsiaalselt suurenenud tekkeriski suhtes;
English: • The need to monitor patients for changes in their lipid profiles;
Estonian: • Vajadus jälgida patsiente lipiidide sisalduse muutuste suhtes;
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Estonian: TINGIMUSED VÕI PIIRANGUD, MIS PUUDUTAVAD RAVIMI OHUTUT JA TÕHUSAT KASUTAMIST LIIKMESRIIKIDE POOLT RAKENDAMISEKS
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Estonian: Liikmesriigid peavad tagama, et järgitakse kõiki allpool kirjeldatud tingimusi või piiranguid, mis puudutavad ravimi ohutut ja tõhusat kasutamist:
English: • The risk of acute injection-related reactions;
Estonian: • Ägedate süstimisega seotud reaktsioonide risk;
English: ANNEX CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Estonian: LISA TINGIMUSED VÕI PIIRANGUD, MIS PUUDUTAVAD RAVIMI OHUTUT JA TÕHUSAT KASUTAMIST LIIKMESRIIKIDE POOLT RAKENDAMISEKS
English: Key elements to be included in the educational material
Estonian: Olulised osad, mis peavad sisalduma õppematerjalis
English: Therefore, it should not be used in these indications outside the context of a clinical trial.
Estonian: Seetõttu ei tohi seda kasutada nendel näidustustel väljaspool kliinilist uuringut.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Estonian: RAVIMI OHUTUT JA TÕHUSAT KASUTAMIST PUUDUTAVAD TINGIMUSED VÕI PIIRANGUD, MIDA TULEB RAKENDADA LIIKMESRIIGIS
English: • Obligations of the health care professional in relation to the prescribing of romiplostim and the need to provide comprehensive advice on risk-benefit to patients.
Estonian: • Meditsiinitöötaja kohustused seoses romiplostiimi väljakirjutamisega ning vajadus patsiendi kõikehõlmavaks nõustamiseks riski-kasu suhte kohta.
English: The MAH shall agree the details of an educational programme with the National Competent Authorities and must implement such programme nationally to ensure that, prior to prescribing, all physicians are provided with a healthcare professional information pack containing the following:
Estonian: Müügiloa hoidja kooskõlastab õppeprogrammi rahvusliku Ravimiametiga ja peab selle programmi riiklikult juurutama, kindlustamaks, et enne ravimi väljakirjutamist varustatakse kõik arstid meditsiinitöötajale mõeldud infopaketiga, mis sisaldab alljärgnevat:
English: The Member States must ensure that all conditions with regard to the safe and effective use of the medicinal products described below are implemented:
Estonian: Liikmesriik peab kindlustama kõikide allpool kirjeldatud ravimi ohutut ja tõhusat kasutamist puudutavate tingimuste ja piirangute rakendamise.
English: Provision of dosing calculator to simplify the calculation of the correct dose and guide in correct reconstitution and administration.
Estonian: Annuse kalkulaatorite kasutamine õige annuse arvutamise lihtsustamiseks ja õige lahustamise ning manustamise juhend.
English: Background information on reticulin in the bone marrow.
Estonian: Taustinformatsioon retikuliini kohta luuüdis.
English: Warning that, whilst no data exists, an outcome of reticulin deposition in response to romiplostim may be bone marrow fibrosis.
Estonian: Hoiatus, et kuna andmed puuduvad, võib romiplostiimist tingitud retikuliini ladestumise tulemuseks luuüdis olla luuüdi fibroos.
English: Advice on when further investigations and a bone marrow biopsy might be appropriate.
Estonian: Nõuanne, et vajalikuks võivad osutuda täiendavad uuringud ja luuüdi biopsia.
English: If use of romiplostim is deemed necessary, platelet count should be closely monitored to minimise the risk of thromboembolic complications.
Estonian: Kui romiplostiimi kasutamine on vajalik, peab hoolikalt jälgima trombotsüütide arvu, et minimeerida trombemboolsete tüsistuste ohtu.
English: Romiplostim may induce the progression of existing haematological malignancies and myelodysplastic syndrome (MDS).
Estonian: Romiplostiim võib esile kutsuda olemasoleva hematoloogilise pahaloomulise kasvaja ja müelodüsplastilise sündroomi (MDS) progressiooni.
English: • The documents will discuss the following identified and potential risks: The incidence in clinical trials and likelihood of reoccurrence of thrombocytopenia after cessation of treatment.
Estonian: • Dokumendid käsitlevad alljärgnevaid teadaolevaid ja potentsiaalseid riske: Ravi lõpetamisjärgse trombotsütopeenia esinemissagedus kliinilistes uuringutes ja taastekke tõenäosus.
English: Romiplostim should not be used in patients with moderate to severe hepatic impairment unless the expected benefit outweighs the identified risk of portal venous thrombosis.
Estonian: Romiplostiimi ei tohi kasutada mõõduka kuni tõsise maksakahjustusega patsientide raviks, välja arvatud juhul, kui oodatav kasu kaalub üles portaalveeni tromboosi tuvastatud ohu.
English: • Summary of Product Characteristics (SPC) and Package Leaflet and Labelling
Estonian: • Ravimi omaduste kokkuvõte ja pakendi infoleht
English: The potential for thromboembolic events in patients with chronic ITP and those known risk factors for thromboembolic events (e.g., Factor V Leiden, ATIII deficiency, antiphospholipid syndrome).
Estonian: Trombembooliajuhtude tekkevõimalus kroonilise ITP-ga ning teadaolevate ohuteguritega (nt Leiden'i V faktor, ATIII puudulikkus, antifosfolipiidsündroom) patsientidel.
English: Background rates of reticulin in the bone marrow in ITP patients and the observed incidence and potential mechanism of action of reticulin deposition in response to romiplostim.
Estonian: Taustinfo retikuliini esinemissageduse kohta luuüdis ITP-ga patsientidel ning retikuliini ladestumise võimalik tekkemehhanism ja täheldatud esinemissagedus vastusena romiplostiimile.
English: Advice to follow dose adjustment guidelines to avoid platelet counts above the normal range.
Estonian: Nõuanne järgida annuse kohandamise juhendit vältimaks trombotsüütide arvu tõusu üle normi.
English: Clarification that risk-benefit for the treatment of paediatric ITP has not been established.
Estonian: Selgitus, et riski/kasu suhe ITP-ga pediaatrilise populatsiooni jaoks ei ole kindlaks tehtud.
English: Reiteration that the risk-benefit for the treatment of thrombocytopenia in non ITP patient populations has not been established.
Estonian: Fakti kordamine, et trombotsütopeenia ravi riski/kasu suhe mitte-ITP haigete populatsioonis ei ole kindlaks tehtud.
English: Data from clinical trials in MDS on the incidence of blast cell increases and progression to AML.
Estonian: Blastide hulga suurenemine MDS kliiniliste uuringute andmete põhjal ja progressioon AML-iks.
English: The incidence of neutralising antibodies to romiplostim in clinical trials.
Estonian: Romiplostiimi neutraliseerivate antikehade esinemissagedus kliinilistes uuringutes.
English: The incidence in clinical trials of thrombotic/thromboembolic complications.
Estonian: Trombootiliste/trombemboolsete tüsistuste esinemissagedus kliinilistes uuringutes.
English: The incidence of medication errors in clinical trials.
Estonian: Ravivigade esinemissagedus kliinilistes uuringutes.
English: The implications of romiplostim-neutralising antibodies cross-reacting with endogenous thrombopoietin (TPO).
Estonian: Tulenevalt romiplostiimi neutraliseerivate antikehade ristrektsioonist endogeense trombopoetiiniga (TPO), on antikehade määramine võimalik arsti nõudel, kontaktandmed antikehade määramise kohta.
English: United Kingdom Alkem Pharma GmbH
Estonian: Ühendkuningriik Alkem Pharma GmbH
English: Annex IA: Medicinal products recommended for maintenance and marketing authorisation applications for which bioequivalence vis-à-vis the EU reference medicinal product has been established
Estonian: IA lisa: Müügiloa säilitamiseks ja müügiloa taotluse jaoks soovitatud ravimid, mille bioekvivalentsus ELi võrdlusravimiga on kindlaks tehtud
English: SIA Ingen Pharma Cefuroxime Ingen Pharma
Estonian: Cefuroxime Ingen Pharma
English: Marketing Authorisatio n Holder
Estonian: Müügiloa hoidja
English: Cefuroxime 250 mg Tablet
Estonian: Tsefuroksiim 250 mg Tablett
English: Cefuroxime 500 mg Tablet
Estonian: Tsefuroksiim 500 mg Tablett
English: 14 October 2016 EMA/659373/2016 EMEA/H/C/004306
Estonian: 14. oktoober 2016 EMA/659373/2016 EMEA/H/C/004306
English: active form happens more readily in cancer cells than in normal cells.
Estonian: Muundumine aktiivseks vormiks toimub kergemini vähirakkudes kui normaalsetes rakkudes.
English: This prevents the cancer cells from growing and dividing, while normal cells are only slightly affected.
Estonian: See takistab vähirakkude kasvu ja jagunemist ning normaalsed rakud kahjustuvad vähe.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it was withdrawing its application because of a change in commercial strategy.
Estonian: Ettevõtte kirjas, milles ta teatab Euroopa Ravimiametile oma taotluse tagasivõtmisest, märgib ettevõte, et võtab taotluse tagasi muutunud äristrateegia tõttu.
English: The active substance in both medicines, pemetrexed, is changed in the body into an active form that blocks enzymes needed to make genetic material (DNA and RNA).
Estonian: Mõlemas ravimis sisalduv toimeaine pemetrekseed muundub organismis aine aktiivseks vormiks, mis blokeerib geenimaterjali (DNA ja RNA) tekkes osalevaid ensüüme.
English: The company informed the CHMP that there are no ongoing clinical trials or compassionate-use programmes for this product.
Estonian: Ettevõte teatas inimravimite komiteele, et ravimiga ei toimu praegu kliinilisi uuringuid ega eriloaga kasutamise programme.
English: Based on the review of the data at the time of the withdrawal, the CHMP had asked the company to provide clarification on some aspects of manufacturing, storage and plans to monitor safety and effectiveness of the medicine after authorisation.
Estonian: Tuginedes esitatud andmete analüüsile, oli komitee taotluse tagasivõtmise ajal palunud ettevõttel selgitada tootmise, hoiustamise ning müügiloajärgsete ohutuse ja toime jälgimise kavade teatud aspekte.
English: Pemetrexed (as ditromethamine) Hospira was expected to be used to treat two types of lung cancer: malignant pleural mesothelioma (a cancer of the lining of the lungs usually caused by exposure to asbestos) and advanced non-small-cell lung cancer of the kind known as ‘non-squamous'.
Estonian: Pemetrexed (ditrometamiin) Hospirat kavatseti kasutada kaht tüüpi kopsuvähi, pleura maliigse mesotelioomi (teatud kopsukelmevähk, mida tavaliselt põhjustab kokkupuude asbestiga) ja kaugelearenenud mitteväikerakk-kopsuvähi muu kui lamerakulise vormi raviks.
English: On 22 September 2016, Hospira UK Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Pemetrexed (as ditromethamine) Hospira, for the treatment of malignant pleural mesothelioma and non-small-cell lung cancer.
Estonian: Müügiloa taotleja Hospira UK Limited teatas 22. septembril 2016 inimravimite komiteele oma soovist võtta tagasi ravimi Pemetrexed (ditrometamiin) Hospira müügiloa taotlus.
English: The CHMP thought that the company could have addressed these questions and was of the provisional opinion that Pemetrexed (as ditromethamine) Hospira could have been approved for the treatment of malignant pleural mesothelioma and nonsmall-cell lung cancer.
Estonian: Inimravimite komitee oli arvamusel, et ettevõte oleks saanud nendele küsimustele vastata, ning oli esialgsel seisukohal, et ravimit Pemetrexed (ditrometamiin) Hospira oleks olnud võimalik heaks kiita pleura maliigse mesotelioomi ja kaugelearenenud mitteväikerakk-kopsuvähi raviks.
English: No further studies were carried out because Pemetrexed (as ditromethamine) Hospira is a generic medicine that is given by infusion into a vein and contains the same active substance as the reference medicine, Alimta.
Estonian: Lisauuringuid ei olnud vaja, sest Pemetrexed (ditrometamiin) Hospira on geneeriline infusiooniravim, mis sisaldab sama toimeainet kui võrdlusravim Alimta.
English: Because Pemetrexed (as ditromethamine) Hospira was developed as a generic medicine, the company presented the results of studies to show the quality of the medicine.
Estonian: Et Pemetrexed (ditrometamiin) Hospira töötati välja geneerilise ravimina, esitas ettevõte ravimi kvaliteeti tõendavate uuringute tulemused.
English: Pemetrexed (as ditromethamine) Hospira is a cancer medicine that contains the active substance pemetrexed.
Estonian: Pemetrexed (ditrometamiin) Hospira on vähiravim, mis sisaldab toimeainena pemetrekseedi.
English: This means that it was intended to be similar to a ‘reference medicine' already authorised in the European Union called Alimta.
Estonian: See tähendab, et Pemetrexed (ditrometamiin) Hospira pidi olema sarnane võrdlusravimiga Alimta, millel juba on Euroopa Liidus müügiluba.
English: EMA/659373/2016
Estonian: Müügiloa taotluse tagasivõtmise teave: Pemetrexed (ditrometamiin) Hospira EMA/659373/2016
English: It was to be available as a powder to be made up into a solution for infusion (drip) into a vein.
Estonian: Seda kavatseti turustada infusioonilahuse (veeni tilgutatava lahuse) pulbrina.
English: Pemetrexed (as ditromethamine) Hospira is expected to work in the same way as the reference medicine, Alimta.
Estonian: Pemetrexed (ditrometamiin) Hospira eeldatav toime on sama kui võrdlusravimi Alimta toime.
English: Pemetrexed (as ditromethamine) Hospira was developed as a ‘generic medicine'.
Estonian: Pemetrexed (ditrometamiin) Hospira töötati välja geneerilise ravimina.
English: What is Pemetrexed (as ditromethamine) Hospira?
Estonian: Mis on Pemetrexed (ditrometamiin) Hospira?
English: How does Pemetrexed (as ditromethamine) Hospira work?
Estonian: Kuidas Pemetrexed (ditrometamiin) Hospira toimib?
English: What was Pemetrexed (as ditromethamine) Hospira expected to be used for?
Estonian: Milleks kavatseti Pemetrexed (ditrometamiin) Hospirat kasutada?
English: Further information on Enurev Breezhaler can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Lisateave ravimi Enurev Breezhaler kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The Agency also noted that the fact that the medicine is used once a day may help patients to adhere to their treatment.
Estonian: Amet märkis ka, et ravimi kasutamine üks kord ööpäevas võib aidata patsientidel paremini järgida ravirežiimi.
English: Enurev Breezhaler received a marketing authorisation valid throughout the EU on 28 September 2012.
Estonian: Enurev Breezhaler on saanud müügiloa, mis kehtib kogu ELis, 28. septembril 2012.
English: Enurev Breezhaler (glycopyrronium bromide) EMA/326865/2018
Estonian: Enurev Breezhaler (glükopürrooniumbromiid) EMA/326865/2018
English: What measures are being taken to ensure the safe and effective use of Enurev Breezhaler?
Estonian: Mis meetmed võetakse, et tagada ravimi Enurev Breezhaler ohutu ja efektiivne kasutamine?
English: After 12 weeks of treatment, Enurev Breezhaler increased FEV1 by 97 ml more than with placebo in the first study, and by 108 ml more in the second study.
Estonian: 12-nädalase ravi järel suurendas Enurev Breezhaler patsientide forsseeritud ekspiratoorset mahtu esimeses uuringus 97 ml ja teises uuringus 108 ml võrra rohkem kui platseebo.
English: the main measure of effectiveness was improvement in patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second).
Estonian: patsientide forsseeritud ekspiratoorne maht (FEV1, suurim õhukogus, mida inimene suudab 1 s jooksul välja hingata).