FrancophonIA/ELRC3.0 huggingface dataset:
English: The infusion should be given once every four weeks, for as long as the patient is considered to benefit, and doctors should re-assess at least once a year whether treatment should be continued.
Estonian: Cinqaerot manustatakse infusioonina kord iga nelja nädala tagant senikaua, kuni patsient saab sellest kasu, kusjuures vähemalt kord aastas peab arst hindama ravi jätkamise vajadust.
English: Cinqaero was compared with placebo (a dummy infusion), both given every 4 weeks for a year.
Estonian: Cinqaerot võrreldi platseeboga (näiva ravimi infusioon) ja mõlemat manustati iga nelja nädala tagant ühe aasta jooksul.
English: What is Cinqaero and what is it used for?
Estonian: Mis on Cinqaero ja milleks seda kasutatakse?
English: Why is Cinqaero approved?
Estonian: Miks Cinqaero heaks kiideti?
English: It is not intended to provide practical advice on how to use Cinqaero.
Estonian: Hindamisaruandes ei anta Cinqaero kasutamise praktilisi nõuandeid.
English: The medicine contains the active substance reslizumab.
Estonian: Ravim sisaldab toimeainena reslisumaabi.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cinqaero have been included in the summary of product characteristics and the package leaflet.
Estonian: Cinqaero ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: The most common side effect with Cinqaero (which may affect about 2 people in 100) is an increase in levels of the enzyme creatine phosphokinase in the blood (a measure of possible damage to muscles).
Estonian: Cinqaero kõige sagedam kõrvalnäht (võib esineda enam kui 2 patsiendil 100st) on vere kreatiinfosfokinaasi (teatud ensüümi) sisalduse suurenemine (näitab võimalikku lihaskahjustust).
English: The main measure of effectiveness was based on the number of flare-ups (exacerbations) of asthma during treatment.
Estonian: Efektiivsuse põhinäitaja oli astma ägenemiste arv ravi jooksul.
English: For practical information about using Cinqaero, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Cinqaero kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: By attaching to interleukin-5 and blocking its activity, Cinquaero reduces the number of eosinophils in the blood and lungs.
Estonian: Interleukiin-5-ga seondudes ja selle toimet blokeerides vähendab Cinqaero eosinofiilide sisaldust veres
English: This is a summary of the European public assessment report (EPAR) for Cinqaero.
Estonian: See on ravimi Cinqaero Euroopa avaliku hindamisaruande kokkuvõte.
English: The benefits of Cinqaero have been shown in two main studies involving 953 patients with eosinophilic asthma that was not well controlled by inhaled corticosteroids and other asthma medication used for the prevention of the disease.
Estonian: Cinqaero kasulikkust näidati kahes põhiuuringus, kus osales 953 eosinofiilse astmaga patsienti, kelle haigus ei allunud piisavalt ravile inhaleeritavate kortikosteroidide ja muu astmaravimiga.
English: For more information about treatment with Cinqaero, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Cinqaeroga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: For the full list of all side effects and restrictions with Cinqaero, see the package leaflet.
Estonian: Cinqaero kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: How does Cinqaero work?
Estonian: Kuidas Cinqaero toimib?
English: Anaphylactic (severe allergic) reactions may affect less than 1 person in 100.
Estonian: Vähem kui 1 patsiendil 100st võib esineda anafülaktilisi (raskeid allergilisi) reaktsioone.
English: Cinqaero is an asthma medicine that is used to treat adults with a particular type of asthma called eosinophilic asthma.
Estonian: Cinqaero on astmaravim, mida kasutatakse selliste täiskasvanute raviks, kellel esineb eosinofiilseks astmaks nimetatav astma liik.
English: How is Cinqaero used?
Estonian: Kuidas Cinqaerot kasutatakse?
English: It is available as a concentrate for making a solution for infusion (drip) into a vein.
Estonian: Seda turustatakse infusioonilahuse (veeni tilgutatava lahuse) kontsentraadina.
English: What are the risks associated with Cinqaero?
Estonian: Mis riskid Cinqaeroga kaasnevad?
English: In eosinophilic asthma, symptoms are associated with having too many of a type of white blood cell called eosinophils in the blood and in phlegm in the lungs.
Estonian: Eosinofiilse astma korral tulenevad sümptomid eosinofiilide ehk teatud valgevereliblede liigsest sisaldusest veres ja kopsudes olevas rögas.
English: What benefits of Cinqaero have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Cinqaero kasulikkus?
English: The reduction in flare-ups and improvement in lung function seen with Cinqaero were considered clinically relevant, particularly for patients who cannot be adequately controlled with high doses of inhaled corticosteroids and another medicine used for the prevention of asthma.
Estonian: Cinqaeroga toimuva ravi ajal täheldatud ägenemiste arvu vähenemine ja kopsutalitluse paranemine loeti kliiniliselt oluliseks, eelkõige patsientidel, kelle haigus ei allunud piisavalt ravile suures annuses inhaleeritavate kortikosteroidide ja muu astmaravimiga.
English: Cinqaero can only be obtained with a prescription and should be prescribed by doctors with experience in the treatment of eosinophilic asthma.
Estonian: Cinqaero on retseptiravim ja selle peab välja kirjutama eosinofiilse astma ravis kogenud arst.
English: The active substance in Cinqaero, reslizumab, is a monoclonal antibody designed to attach to a substance called interleukin-5, which
Estonian: Cinqaero toimeaine reslisumaab on monoklonaalne antikeha, mis seondub interleukiin-5-ga (eosinofiilide arengut ja aktiivsust soodustav aine).
English: It is used as an additional treatment in adults with severe asthma that is not properly controlled by a combination of high-dose corticosteroids taken by inhalation plus another medicine used for the prevention of asthma.
Estonian: Seda kasutatakse täiendava ravina raske astmaga täiskasvanud patsientidel, kelle haigus ei allu piisavalt ravile suures annuses inhaleeritavate kortikosteroidide ja muu astmaravimi kombinatsiooniga.
English: Additionally there was evidence of an improvement in lung function and asthma symptoms, and a decrease in number of eosinophils in the blood in patients given Cinqaero.
Estonian: Lisaks täheldati Cinqaerot võtnud patsientidel kopsutalitluse ja astmasümptomite paranemist ning eosinofiilide sisalduse vähenemist veres.
English: Cinqaero reslizumab
Estonian: Cinqaero reslisumaab
English: The result of the test was negative.
Estonian: Katse tulemused olid negatiivsed.
English: The response was submitted to the EMEA on 23 March 2006.
Estonian: Vastused esitati Euroopa Ravimiametile 23. märtsil 2006.
English: An appropriate positive control was used.
Estonian: Kasutati kohast positiivset kontrolli.
English: The reason for this was that the United Kingdom national competent authority, Veterinary Medicines Directorate (VMD) considered that this medicinal product could present a potential serious risk to public health on the following grounds:
Estonian: Edasisuunamise põhjusena nimetas Suurbritannia vastutav amet, veterinaarravimite direktoraat, et antud ravim võib osutuda rahvatervisele suureks ohuks järgmistel põhjustel:
English: Germany Intervet Deutschland GmbH
Estonian: Saksamaa Intervet Deutschland GmbH
English: ANNEX I NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER
Estonian: LISA I RAVIMI NIMETUS, RAVIMVORM, TUGEVUS, LOOMALIIGID, MANUSTAMISVIISID JA MÜÜGILOA HOIDJA
English: One positive result on chromosome aberration was reported.
Estonian: Kirjeldati ühte positiivset kromosoomi aberratsiooni tulemust.
English: Therefore, the Committee considered that no further mutagenicity study is required for the assessment of the substance.
Estonian: Seepärast otsustas komitee, et täiendavaid mutageensuse uuringuid ei ole aine hindamiseks vajalik teostada.
English: Pursuant to Article 33(4) of Directive 2001/82/EC, as amended, the matter has been referred to the CVMP.
Estonian: Vastavalt direktiivi 2001/82/EÜ täiendatud versiooni artikli 33 lõikele 4, suunati küsimus edasiseks arutamiseks veterinaarravimite komiteele.
English: The Reference Member State for the Mutual Recognition Procedure regarding Cobactan IV 4.5%, Germany, notified the EMEA on 2 March 2006 that the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMD(v)) failed to reach an agreement regarding the product.
Estonian: Cobactan IV 4,5% vastastikuse tunnustamise protseduuri võrdlusliikmesriik Saksamaa teavitas 2. märtsil 2006. aastal Euroopa Ravimiametit (EMEA), et vastastikuse tunnustamise ja detsentraliseeritud veterinaarprotseduuride koordineerimise rühm ei jõudnud ravimi suhtes ühisele otsusele.
English: Despite the fact that there have also been negative results in two in vivo micronucleus assays, the positive in vitro results are not negated, as both in vivo studies involved the assessment of effects in bone marrow cells.
Estonian: Hoolimata asjaolust, et kaks in vivo mikrotuuma katset on olnud negatiivsed, ei saa eitada ka positiivseid in vitro tulemusi, sest mõlemas in vivo uuringus hinnati ka toimet luuüdi rakkudele.
English: The positive finding in vitro was further investigated in an in vivo micronucleus test.
Estonian: In vitro positiivset tulemust uuriti edasi in vivo mikrotuuma katses.
English: Marketing Authorisation Holder
Estonian: Liikmesriik Müügiloa hoidja Kandidaat
English: The CVMP during its meeting of 14-16 March 2006 initiated a referral procedure under Article 33(4) of Directive 2001/82/EC, as amended, for Cobactan IV 4.5% containing cefquinome.
Estonian: 14.-16. märts 2006. aastal toimunud kohtumisel algatas veterinaarravimite komitee muudetud direktiivi 2001/82/EÜ artikli 33 lõike 4 alusel tsefkinoomi sisaldava ravimi Cobactan IV 4,5% läbivaatamise.
English: Taking into account the intrinsic values and limitations of the tests and that only one out of eleven studies has shown positive results, it is concluded that there are no concerns that 2,3-cyclohexenopyridine may present a potential serious risk to public health.
Estonian: Arvestades katse omaväärtusi ja piiranguid ning asjaolu, et positiivseid tulemusi leiti vaid ühes uuringus üheteistkümnest, järeldatakse, et 2,3-tsükloheksenopüridiin ei ole rahvatervisele ohtlik.
English: Given (1) the high proliferation rate of bone marrow tissue, (2) the intravenous route of administration, and (3) the high doses employed, it is highly unlikely that a second in vivo test in another tissue would give a positive result.
Estonian: Arvestades 1) luuüdi koe intensiivset proliferatsiooni, 2) veenisisest manustamist ja 3) suuri kasutatud annuseid, on äärmiselt ebatõenäoline, et teine in vivo katse teises koes annab positiivse tulemuse.
English: The product is indicated to treat respiratory diseases in horses caused by Streptococcus equi subsp.
Estonian: Ravim on näidustatud bakteri Streptococcus equi subsp.
English: Cobactan Powder and solvent for solution for injection
Estonian: Cobactan Pulber ja lahusti süstelahuse valmistamiseks
English: Cobactan IV 4.5%, presented as a powder and solvent for solution for injection, contains 45 mg/ml cefquinome (as sulphate).
Estonian: Süstelahuse valmistamise pulbri ja lahustina turustatav Cobactan IV 4,5% sisaldab 45 mg/ml tsefkinoomi (sulfaadina).
English: The highest dose corresponded to the maximum tolerated in a dose range finding assay and also caused clear symptoms of toxicity but no lethality in all animals of the main study.
Estonian: Suurim annus vastab suurimale talutavale annusele vastavalt annusevahemiku leidmise katses leitule ning põhjustas selgeid mürgistusnähte, kuid ei põhjustanud põhiuuringu loomadel mitte ühtegi surmajuhtumit.
English: Strength Animal species Frequency and route of administration
Estonian: Ravimvorm TugevusLoomaliigid Manustamise sagedus ja viis
English: zooepidemicus and severe bacterial infections with a high risk of septicaemia in foals in which Escherichia coli is involved.
Estonian: zooepidemicus tekitatud hingamisteede haiguse raviks hobustel ja kõrge septitseemia riskiga raskete bakteriaalsete infektsioonide raviks varssadel, kui tekitajaks on Escherichia coli.
English: In conclusion, the CVMP agrees that it was sufficiently demonstrated that 2,3-cyclohexenopyridine has no clastogenic potential in vivo, and that further studies are not warranted.
Estonian: Veterinaarravimite komitee nõustub, et 2,3-tsükloheksenopüridiini klastogeense potentsiaali puudumine in vivo on piisavalt tõestatud ja et täiendavaid uuringuid ei ole vaja teostada.
English: The clastogenic potential in vitro was not demonstrated in vivo.
Estonian: In vitro leitud klastogeenset potentsiaali in vivo ei kirjeldatud.
English: The specifications of the active ingredient cefquinome sulphate sterile used in the manufacturing of Cobactan IV 4.5% and the specifications at release and at end of shelf-life for the powder of the finished product Cobactan IV 4.5% were provided.
Estonian: Esitati ravimi Cobactan IV 4,5% tootmisel steriilselt kasutatava toimeaine tsefkinoomsulfaadi täpsed omadused ning lõpliku ravimi Cobactan IV 4,5% pulbri täpsed omadused turustamisel ja säilivusaja lõpus.
English: Genotoxicity testing was carried out at the impurity concentration of 1% with cefquinome (8 tests) and in addition 3 tests have been carried out with 2,3-cyclohexenopyridine alone.
Estonian: Genotoksilisuse uuringud (8 katset) sooritati tsefkinoomiga, milles lähteaine jäägi kontsentratsioon oli 1%, ning lisaks tehti 3 uuringut üksnes 2,3-tsükloheksenopüridiiniga.
English: In Chinese hamster lung fibroblasts in vitro, 2,3-cyclohexenopyridine induced structural chromosomal aberrations at 600-700 µg/ml in a dose-dependent manner when including metabolic activation in the method.
Estonian: Hiina hamstri kopsu fibroblastides tekitas 2,3-tsükloheksenopüridiin in vitro struktuurilisi aberratsioone annussõltuval viisil annuse 600700 µg/ml korral, kui võtta arvesse ka meetodi metaboolne aktivatsioon.
English: The maximum cefquinome concentrations measured in plasma of treated target animals (e.g. 2 µg/ml after a dose of 1 mg/kg bw) compared with the 2,3-cyclohexenopyridine concentrations expected (e.g. 1% of this impurity in cefquinome leading to 0.02 µg 2,3-cyclohexenopyridine/ml plasma) demonstrates that the concentrations of several hundred µg/ml in the positive in vitro test by far exceed the concentrations relevant in vivo.
Estonian: Ravitud loomade plasmas mõõdetud tsefkinoomi suurimad kontsentratsioonid (nt 2 µg/ml pärast annust 1 mg kehakaalu kg kohta) olid võrreldavad 2,3-tsükloheksenopüridiini eeldatavate kontsentratsioonidega (nt 1% lähteaine jääkide sisaldusega tsefkinoomi manustamisel saavutatakse 2,3-tsükloheksenopüridiini kontsentratsioon 0,02 µg/ml plasmas), mis näitab, et positiivse in vitro katse tulemuste korral kasutatud mitmesaja µg/ml kontsentratsioonid ületavad ulatuslikult in vivo olukorras olulisi kontsentratsioone.
English: In this study 2,3-cyclohexenopyridine was administered in 0.9% NaCl twice intravenously at an interval of 24 h at doses of 7.5, 25, and 75 mg/kg bw to male and female mice.
Estonian: Selles uuringus manustati isastele ja emastele hiirtele 2,3-tsükloheksenopüridiini 0,9% NaCl lahuses kaks korda veenisiseselt 24-tunnise vahega annustes 7,5, 25 ja 75 mg kehakaalu kg kohta.
English: The CVMP concluded that the clastogenic potential in vitro was not demonstrated in vivo.
Estonian: Veterinaarravimite komitee otsustas, et in vitro kirjeldatud klastogeenne potentsiaal ei ole in vivo tõestatud.
English: In vivo results are most relevant for human exposure, as these results “overrule” the results from in vitro tests.
Estonian: Inimeste kokkupuute hindamiseks on kõige olulisemad in vivo tulemused, mistõttu need tulemused on in vitro katsete tulemustest tähtsamad.
English: In the direct method, 2,3-cyclohexenopyridine induced slight structural chromosomal aberrations at 350 µg/ml with 24 and 48 h treatments.
Estonian: Vahetul meetodil tekitas 2,3tsükloheksenopüridiin kergeid struktuurilisi kromosoomide aberratsioone annuse 350 µg/ml korral 24ja 48-tunnistes uuringutes.
English: The specific findings of a clastogenic potential of 2,3- cyclohexenopyridine in one in vitro test at high concentrations was not confirmed to be present at the highest intravenous dose tested (2000 mg/kg bw) in the in vivo micronucleus test.
Estonian: 2,3-tsükloheksenopüridiini klastogeense potentsiaali leid ühes in vitro katses suurtel kontsentratsioonidel ei saanud kinnitust suurima veenisiseselt kasutatava annuse (2000 mg/kehakaalu kg kohta) kontrollimisel in vivo mikrotuuma katses.
English: Specifications for cefquinome sulfate report a 2,3- cyclohexenopyridine content of <1%.
Estonian: Tsefkinoomsulfaadi omaduste aruanne nimetab 2,3-tsükloheksenopüridiini sisalduseks ≤ 1%.
English: • For the starting material 2,3 cyclohexenopyridine, which also occurs as an impurity in the active substance, cefquinome a positive in vitro mutagenicity assay has been reported.
Estonian: • Tsefkinoomi lähteainel 2,3-tsükloheksenopüridiinil, mida leidub jääkidena ka toimeaines, on kirjeldatud positiivset toimet in vitro mutageensuse katsetes.
English: The specifications at release and at end of shelf-life reports of contents of 2,3- cyclohexenopyridine of <1% and <1.5%, respectively.
Estonian: Ravimi turustamisel ja säilivusaja lõpus on 2,3-tsükloheksenopüridiini sisaldus vastavalt ≤ 1% ja
English: 2.3 Data concerning the mutagenicity and carcinogenicity of cefquinome and its starter material 2,3-cyclohexenopyridine.
Estonian: 2.3 Tsefkinoomi ja tema lähteaine 2,3-tsükloheksenopüridiini mutageensuse ja kartsinogeensuse andmed
English: 2.2 Data regarding the specification of cefquinome, in particular in relation the impurity 2,3-cyclohexenopyridine.
Estonian: 2.2 Tsefkinoomi omaduste, eelkõige seoses 2,3-tsükloheksenopüridiini jääksisalduse andmed
English: 2.1 Considerations of the safety concerns regarding the starting material 2,3-cyclohexenopyridine
Estonian: 2.1 Lähteaine 2,3-tsükloheksenopüridiini ohutus
English: It is considered that a negative result in a second in vivo study using a different tissue is required before the concerns about this impurity are allayed.
Estonian: Enne kõnealuse lähteaine jäägi teema lõpetamist on vaja teisest ja erinevat kude kasutavast in vivo uuringust saada negatiivseid tulemusi.
English: Out of the 11 genotoxicity studies available for 2,3-cyclohexenopyridine, either conducted with cefquinome containing the impurity 2,3-cyclohexenopyridine or with 2,3-cyclohexenopyridine on its own one test (chromosome aberration in vitro) resulted in a positive response and only at a high 2,3cyclohexenopyridine concentration whereas the subsequent mammalian in vivo micronucleus test resulted in a negative response.
Estonian: 2,3-tsükloheksenopüridiini kohta on andmeid 11 genotoksilisuse uuringust, mis viid läbi kas 2,3tsükloheksenopüridiini jääke sisaldava tsefkinoomiga või 2,3-tsükloheksenopüridiini endaga (kromosoomide aberratsioon in vitro).
English: Also, the 4 in vivo genotoxicity tests performed with cefquinome at low and high concentrations of 2,3-cyclohexenopyridine were negative.
Estonian: Negatiivsed olid ka 4 in vivo genotoksilisuse uuringut, mis sooritati tsefkinoomiga 2,3-tsükloheksenopüridiini väikese ja suure sisalduse juures, mistõttu võib järeldada, et in vitro kirjeldatud toime ei ole bioloogiliselt oluline.
English: Date of first authorisation: 08 May 2014 Date of latest renewal: 11 January 2019
Estonian: Müügiloa viimase uuendamise kuupäev: 11. jaanuar 2019
English: Don't use LAVENTAIR ELLIPTA if you already use these medicines.
Estonian: Ärge kasutage LAVENTAIR ELLIPTAt, kui te juba kasutate nimetatud ravimeid.
English: The first time you use LAVENTAIR ELLIPTA you do not need to check that the inhaler is working properly; it contains previously measured doses and is ready to use straight away.
Estonian: LAVENTAIR ELLIPTA esmakordsel kasutamisel ei ole vaja kontrollida, kas inhalaator töötab korralikult; see sisaldab doseeritud annuseid ja on kohe kasutamiseks valmis.
English: It is very important that you use LAVENTAIR ELLIPTA every day, as instructed by your doctor.
Estonian: Väga tähtis on LAVENTAIR ELLIPTAt kasutada iga päev vastavalt arstilt saadud juhistele.
English: Elderly patients No dose adjustment is required in patients over 65 years.
Estonian: Üle 65-aastastel patsientidel ei ole vaja annust kohandada.
English: The other ingredients are lactose monohydrate (see section 2 under ‘LAVENTAIR ELLIPTA contains lactose') and magnesium stearate.
Estonian: Teised koostisosad on laktoosmonohüdraat (vt lõik 2 „LAVENTAIR ELLIPTA sisaldab laktoosi“) ja magneesiumstearaat.
English: Talk to your doctor before using this medicine: - if you have asthma (Don't use LAVENTAIR ELLIPTA to treat asthma)
Estonian: Enne selle ravimi kasutamist pidage nõu oma arstiga: - kui teil on astma (ärge kasutage LAVENTAIR ELLIPTAt astma raviks).
English: Lung function, symptomatic and health related quality of life outcomes at Week 24 Treatment comparisons with LAVENTAIR
Estonian: Kopsufunktsioon, sümptomaatilised ja tervisega seotud elukvaliteedi tulemused 24. nädalal
English: EU/1/14/899/001 1 inhaler of 7 doses EU/1/14/899/002 1 inhaler of 30 doses
Estonian: EU/1/14/899/001 Üks 7 annusega inhalaator EU/1/14/899/002 Üks 30 annusega inhalaator
English: LAVENTAIR ELLIPTA should be administered at the same time of the day each day to maintain bronchodilation.
Estonian: LAVENTAIR ELLIPTAt tuleb manustada iga päev samal kellaajal, et säiliks bronhe lõõgastav toime.
English: If you have any of the following symptoms after taking LAVENTAIR ELLIPTA stop using this medicine and tell your doctor immediately.
Estonian: Kui teil tekib LAVENTAIR ELLIPTA manustamise järgselt ükskõik milline järgnevalt loetletud sümptomitest, lõpetage otsekohe selle ravimi kasutamine ja teavitage oma arsti.
English: The safety profile of LAVENTAIR ELLIPTA is based on safety experience with umeclidinium/vilanterol and the individual components from the clinical development program comprising of 6,855 patients with COPD and from spontaneous reporting.
Estonian: LAVENTAIR ELLIPTA ohutusandmed on saadud umeklidiiniumi/vilanterooli ja üksikkomponentide kasutamisel kliinilise arendusprogrammi käigus, kus osales 6855 KOKiga patsienti, ja spontaansete teadete põhjal.
English: BERLIN-CHEMIE AG Tel.: + 49 (0) 30 67070
Estonian: Deutschland BERLIN-CHEMIE AG Tel.: + 49 (0) 30 67070
English: Submission of the final clinical study report on a Post-Authorisation Safety (PAS) Observational Cohort Study to Quantify the Incidence and Comparative Safety of Selected Cardiovascular and Cerebrovascular Events in COPD Patients with Laventair Ellipta compared with tiotropium (study 201038), according to a protocol agreed by the PRAC.
Estonian: Esitada järgmise uuringu lõplik kliinilise uuringu aruanne: müügiloa saamise järgne ohutuse vaatlev kohortuuring, et kindlaks määrata valitud kardiovaskulaarsete ja tserebrovaskulaarsete sündmuste esinemissagedus ning võrdlev ohutus KOKiga patsientidel Laventair Ellipta kasutamisel võrreldes tiotroopiumiga (uuring 201038) vastavalt ravimite riskihindamise komitee (PRAC) poolt kooskõlastatud uuringuplaanile.
English: The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
Estonian: Kõrvaltoimete esinemissageduse määratlemisel kasutatakse järgmist konventsiooni: väga sage (≥ 1/10); sage (≥ 1/100 kuni < 1/10); aeg-ajalt (≥ 1/1000 kuni < 1/100); harv (≥ 1/10 000 kuni < 1/1000); väga harv (< 1/10 000) ja teadmata sagedusega (ei saa hinnata olemasolevate andmete alusel).