FrancophonIA/ELRC3.0 huggingface dataset:
English: The hepatocellular adenomas were also seen in a 2-year carcinogenicity study in mice, which demonstrated a small increased incidence of this finding in male mice at the mid dose, and in both male and female mice at the highest dose.
Estonian: Ka kaheaastases uuringus hiirtel leiti hepatotsellulaarse adenoomi sageduse väikest tõusu isastel hiirtel keskmise annuse juures ning nii emastel kui ka isastel hiirtel kõrge annuse juures.
English: Gefitinib is excreted mainly as metabolites via the faeces, with renal elimination of gefitinib and metabolites accounting for less than 4% of the administered dose.
Estonian: Neerude kaudu eritub ravimit ja metaboliite vähem kui 4% manustatud annusest.
English: 8.9 m vs 6.1 m p=0.0124
Estonian: 8,9 k vs. 6,1 k p = 0,0124
English: HR 2.85 1.5 m vs 5.5 m p<0.0001
Estonian: HR 2,85 1,5 k vs. 5,5 k p < 0,0001
English: Very common Anorexia mild or moderate (CTC grade 1 or 2).
Estonian: Kerge või mõõdukas anoreksia (CTC 1. või 2. klass).
English: Table 3 - Efficacy outcomes for gefitinib versus carboplatin/paclitaxel from the IPASS study Population
Estonian: Gefitiniibi tõhususe tulemused võrreldes karboplatiini/paklitakseeliga IPASS-uuringus Populatsioon
English: Table 4 - Quality of life outcomes for gefitinib versus carboplatin/paclitaxel from the IPASS study
Estonian: Gefitiniibi elukvaliteedi tulemused võrreldes karboplatiini/paklitakseeliga uuringus IPASS
English: Gefitinib Mylan contains lactose.
Estonian: Gefitinib Mylan sisaldab laktoosi.
English: Elevations in total bilirubin, mainly mild to moderate.
Estonian: Üldbilirubiini tõus, peamiselt kerge kuni mõõdukas.
English: A reduction in female fertility was observed in the rat at a dose of 20 mg/kg/day.
Estonian: Emaste rottide viljakus vähenes annuse juures 20 mg/kg/ööpäevas.
English: This increase in exposure may be of clinical relevance since adverse experiences are related to dose and exposure to gefitinib.
Estonian: Ekspositsiooni tõus võib olla kliiniliselt tähtis, kuna kõrvaltoimed olenevad annusest ja ekspositsioonist gefitiniibile.
English: Tablet coating Polyvinyl alcohol (E1203) Macrogol 4000 (E1521) Talc (E553b) Titanium dioxide (E171) Red iron oxide (E172) Yellow iron oxide (E172)
Estonian: Polüvinüülalkohol (E1203) Makrogool 4000 (E1521) Talk (E553b)
English: 5.6 m vs 5.1 m p=0.0871
Estonian: 5,6 k vs. 5,1 k p = 0,0871
English: Table 5 - Efficacy outcomes for gefitinib versus docetaxel from the INTEREST study Population
Estonian: Gefitiniibi tõhususe tulemused võrreldes dotsetakseeliga uuringus INTEREST Populatsioon
English: 5.2 m vs 5.1 m p=0.2942
Estonian: 5,2 k vs. 5,1 k p = 0,2942
English: HR 0.74 5.7 m vs 5.8 m p<0.0001
Estonian: HR 0,74 5,7 k vs. 5,8 k p < 0,0001
English: PVC/PVDC/Aluminium perforated unit dose blister in cartons containing 30x1 film-coated tablets.
Estonian: PVC/PVDC/alumiiniumist perforeeritud üksikannuselised blistrid karpides, mis sisaldavad 30 × 1 õhukese polümeerikattega tabletti.
English: Concomitant medicinal products that induce CYP3A4 (e.g. phenytoin, carbamazepine, rifampicin, barbiturates or St John's wort, Hypericum perforatum) should be avoided.
Estonian: CYP3A4 indutseerijate (nt fenütoiin, karbamasepiin, rifampitsiin, barbituraadid või liht-naistepuna (Hypericum perforatum)) samaaegset manustamist tuleb võimaluse korral vältida.
English: • If it is less than 12 hours until your next dose: skip the missed tablet.
Estonian: • Kui järgmise annuseni jääb vähem kui 12 tundi, ärge unustatud tabletti enam võtke.
English: 2.0 m vs 2.6 m p=0.5771
Estonian: 2,0 k vs. 2,6 k p = 0,5771
English: HR 0.83 2.9 m vs 2.8 m p=0.1746
Estonian: HR 0,83 2,9 k vs. 2,8 k p = 0,1746
English: Vomiting, mainly mild or moderate (CTC grade 1 or 2).
Estonian: Oksendamine, peamiselt kerge või mõõdukas (CTC 1. või 2. klass).
English: a Values presented are for gefitinib versus docetaxel.
Estonian: Esitatud väärtused kehtivad gefitiniibi kohta võrreldes dotsetakseeliga.
English: An increased risk of cerebral haemorrhage in adult patients with NSCLC receiving gefitinib has not been established.
Estonian: Ajuhemorraagia kõrgemat riski gefitiniibi kasutavatel täiskasvanud mitteväikerakk-kopsuvähiga patsientidel ei ole täheldatud.
English: Substances that cause significant sustained elevation in gastric pH may reduce gefitinib plasma concentrations and thereby reduce the efficacy of gefitinib.
Estonian: Toimeained, mis põhjustavad mao pH-taseme olulise tõusu, võivad vähendada gefitiniibi plasmakontsentratsiooni ja sellega gefitiniibi toimet langetada.
English: 5.0 m vs 4.9 m p=0.2420
Estonian: 5,0 k vs. 4,9 k p = 0,2420
English: Each film-coated tablet contains 250 mg of gefitinib.
Estonian: Üks õhukese polümeerikattega tablett sisaldab 250 mg gefitiniibi.
English: 4.4 times higher in adenocarcinoma than in non-adenocarcinoma
Estonian: < 0,0001 4,4 korda kõrgem näitaja adenokartsinoomi puhul võrreldes mitteadenokartsinoomiga
English: HR 1.12 2.0 m vs 2.7 m p=0.1041
Estonian: HR 1,12 2,0 k vs. 2,7 k p = 0,1041
English: HR 1.24 1.7 m vs 2.6 m p=0.1353
Estonian: HR 1,24 1,7 k vs. 2,6 k p = 0,1353
English: HR 0.48 9.5 m vs 6.3 m p<0.0001
Estonian: HR 0,48 9,5 k vs. 6,3 k p < 0,0001
English: International normalised ratio (INR) elevations and/or bleeding events have been reported in some patients taking warfarin together with gefitinib (see section 4.5).
Estonian: Mõnedel gefitiniibi ja varfariini kasutavatel patsientidel on täheldatud INR-i (International Normalised Ratio s.o. rahvusvaheline normaliseeritud indeks) tõusu ja/või veritsust (vt lõik 4.5).
English: HR 1.02 6.4 m vs 6.0 m p=0.9131
Estonian: HR 1,02 6,4 k vs. 6,0 k p = 0,9131
English: Talk to your doctor or pharmacist before taking Gefitinib Mylan - if you have ever had any other lung problems.
Estonian: Enne Gefitinib Mylan'i kasutamist pidage nõu oma arsti või apteekriga, - kui te põete või olete põdenud teisi kopsuhaigusi.
English: • Severe skin reactions (rare) affecting large areas of your body.
Estonian: • Raskekujulised nahareaktsioonid laialdasel kehapinnal (harv).
English: Gefitinib Mylan contains lactose
Estonian: Gefitinib Mylan sisaldab laktoosi
English: Numbers in square brackets are 95%confidence intervals for HR. c Stratified log-rank test for overall; otherwise cox proportional hazards model.
Estonian: Stratifitseeritud üldine logaritmile astaktest; muul juhul Coxi proportsionaalsete ohtude mudel.
English: HR 0.16 7.0 m vs 4.1 m p=0.0012
Estonian: HR 0,16 7,0 k vs. 4,1 k p = 0,0012
English: - Proton-pump inhibitors, H2-antagonists and antacids (for ulcers, indigestion, heartburn and to reduce acids in the stomach).
Estonian: - liht-naistepuna (Hypericum perforatum) sisaldavad taimsed preparaadid (kasutatakse depressiooni ja ärevuse korral); - prootonpumba inhibiitorid, H2-antagonistid ja antatsiidid (haavandi, seedimishäirete ja kõrvetiste raviks ning maohappe vähendamiseks).
English: How to take Gefitinib Mylan
Estonian: Kuidas Gefitinib Mylan'it võtta
English: This side effect is uncommon; however, some patients have died from this.
Estonian: See kõrvaltoime esineb aeg-ajalt, kuid mõnedel juhtudel on see lõppenud surmaga
English: 4.4 m vs 2.2 m p=0.0084
Estonian: 4,4 k vs. 2,2 k p = 0,0084
English: 5.6 m vs 2.8 m p<0.0001
Estonian: 5,6 k vs. 2,8 k p < 0,0001
English: Haemorrhage, such as epistaxis and haematuria.
Estonian: Hemorraagia, nt ninaverejooks ja hematuuria.
English: • Vomiting.
Estonian: • oksendamine
English: How to store Gefitinib Mylan
Estonian: Kuidas Gefitinib Mylan'it säilitada
English: Table 6 Efficacy outcomes for gefitinib versus placebo from the ISEL study Population
Estonian: Gefitiniibi tõhususe tulemused võrreldes platseeboga uuringus ISEL Populatsioon
English: 3.0 m vs 2.6 m p=0.0006
Estonian: 3,0 k vs. 2,6 k p = 0,0006
English: • Increase of bilirubin and the other liver enzyme known as aspartate aminotransferase in a blood test; if too high, your doctor may tell you to stop taking Gefitinib Mylan.
Estonian: • bilirubiini ja aspartaadi aminotransferaasi nimelise maksaensüümi taseme tõus vereanalüüsil.
English: Primary endpoint Progression free survival (PFS) a,b
Estonian: Esmane tulemusnäitaja progressioonivaba elulemuse (PFS)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 250 mg of gefitinib.
Estonian: TOIMEAINE(TE) SISALDUS Üks õhukese polümeerikattega tablett sisaldab 250 mg gefitiniibi.
English: Very common Diarrhoea, mainly mild or moderate (CTC grade 1 or 2).
Estonian: Kõhulahtisus, peamiselt kerge või mõõdukas (CTC 1. või 2. klass).
English: Symptoms may include a general feeling of being unwell, with or without possible jaundice (yellowing of the skin and eyes).
Estonian: Tunnusteks on üldine halb enesetunne, võib esineda naha ja silmade kollasus
English: 2.7 m vs 2.6 m p=0.0707
Estonian: 2,7 k vs. 2,6 k p = 0,0707
English: Values presented are for gefitinib versus carboplatin/paclitaxel.
Estonian: Esitatud väärtused kehtivad gefitiniibi kohta võrreldes karboplatiini/paklitakseeliga.
English: Common (may affect up to 1 in 10 people):
Estonian: Sage (võib mõjutada kuni 1 inimest 10-st):
English: 1317 5.3% vs 1.6%
Estonian: Vähemalt korra suitsetanud 1317 5,3% vs. 1,6%
English: Gefitinib should be used cautiously in the presence of mild to moderate changes in liver function.
Estonian: Maksaanalüüside kerge kuni mõõduka kõrvalekalde korral tuleb gefitiniibi manustada ettevaatusega.
English: • Inflammation of the blood vessels in the skin.
Estonian: • naha veresoonte põletik.
English: Some lung problems may get worse during treatment with Gefitinib Mylan.
Estonian: Mõni kopsuhaigus võib Gefitinib Mylan'i ravi ajal süveneda; - kui teil on kunagi esinenud maksaprobleeme.
English: • Diarrhoea.
Estonian: • kõhulahtisus
English: • Cystitis (burning sensations during urination and frequent, urgent need to urinate).
Estonian: • tsüstiit (kõrvetustunne urineerimisel, sage tung urineerida)
English: 2.9 m vs 2.7 m p=0.0197
Estonian: 2,9 k vs. 2,7 k p = 0,0197
English: Adverse reactions associated with overdose should be treated symptomatically; in particular severe diarrhoea should be managed as clinically indicated.
Estonian: Üleannustamisest põhjustatud kõrvaltoimeid tuleb ravida sümptomaatiliselt.
English: INR elevations and/or bleeding events have been reported in some patients concomitantly taking warfarin (see section 4.4).
Estonian: Üksikutel varfariini samal ajal manustavatel patsientidel on tekkinud INR tõus ja/või veritsusepisood (vt lõik 4.4).
English: A further case of CNS haemorrhage has been reported in a child with an ependymoma from a trial with gefitinib alone.
Estonian: Gefitiniibi monoravi uuringus tekkis ühel ependümoomi diagnoosiga lapsel kesknärvisüsteemi hemorraagia.
English: During treatment with gefitinib, asthenia has been reported.
Estonian: Gefitiniibravi ajal on kirjeldatud asteeniat.
English: Stomatitis, predominantly mild in nature (CTC grade 1).
Estonian: Stomatiit, peamiselt kerge loomuga (CTC 1. klass).
English: smoking, CT scan evidence of reduced normal lung (≤ 50%), pre-existing ILD, older age (≥ 65 years old), and extensive areas adherent to pleura (≥ 50%).
Estonian: Mõlemal juhul oli suremuse risk tõusnud nendel interstitsiaalse kopsuhaigusega patsientidel, kellel lisandusid järgnevad riskitegurid: suitsetamine, CT-uuringul kinnitunud normaalse kopsukoe vähenemine (≤ 50%), varem põetud interstitsiaalne kopsuhaigus, vanus ≥ 65 aastat ja interstitsiaalne kopsuhaigus pleuraga laialdaselt külgnevatel kopsualadel (≥ 50%).
English: • Nausea.
Estonian: • maksapõletik.
English: • Red and sore eyelids.
Estonian: • punetavad ja kipitavad silmalaud
English: HR Hazard ratio (hazard ratios <1 favour gefitinib).
Estonian: HR Riskitiheduste suhe (riskitiheduste suhe <1 tähendavad gefitiniibi eelist).
English: • Protein in your urine (shown in a urine test).
Estonian: • valk uriinis (näitab uriinianalüüs)
English: Nausea, mainly mild (CTC grade 1).
Estonian: Asteenia, peamiselt kerge (CTC 1. klass).
English: Primary endpoint overall survivala,b
Estonian: Esmane lõplik üldine elulemusa, b
English: HR Hazard ratio (hazard ratios <1 favour gefitinib)
Estonian: HR Riskitiheduste suhe (riskitiheduste suhe <1 tähendab gefitiniibi eelist)
English: • Fever.
Estonian: • palavik
English: Uncommon Pancreatitis Gastrointestinal perforation
Estonian: Pankreatiit Mao-sooletrakti mulgustus
English: Cutaneous vasculitis
Estonian: • iiveldus
English: HR 1.04 2.2 m vs 2.7 m p=0.4658
Estonian: HR 1,020 7,6 k vs. 8,0 k p = 0,4658
English: Gefitinib Mylan 250 mg film-coated tablets gefitinib
Estonian: Gefitinib Mylan 250 mg õhukese polümeerikattega tabletid Gefitiniib (Gefitinibum)
English: NAME OF THE MEDICINAL PRODUCT Gefitinib Mylan 250 mg tablets gefitinib
Estonian: RAVIMPREPARAADI NIMETUS Gefitinib Mylan 250 mg tabletid Gefitinibum
English: How to take Gefitinib Mylan 4.
Estonian: Gefitinib Mylan'i võtmist.
English: Asiansd
Estonian: Imetamine
English: Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to the clinical exposure levels and with possible relevance to clinical use were as follows: - Corneal epithelia atrophy and corneal translucencies - Renal papillary necrosis - Hepatocellular necrosis and eosinophilic sinusoidal macrophage infiltration.
Estonian: - Sarvkesta epiteeli atroofia ja sarvkesta hõljum - Neerude papillaarne nekroos - Hepatotsellulaarne nekroos ja eosinofiilne sinusoidaalne makrofagaalne infiltratsioon.
English: Dry mouth*, predominantly mild (CTC grade 1).
Estonian: Suukuivus*, peamiselt kerge (CTC 1. klass).
English: Hepatotoxicity and liver impairment
Estonian: Hepatotoksilisus ja maksakahjustus
English: • Increase of a liver enzyme known as alanine aminotransferase in a blood test; if too high, your doctor may tell you to stop taking this medicine.
Estonian: • alaniinaminotransferaasi nimelise maksaensüümi taseme tõus vereanalüüsil.
English: There is no relevant use of gefitinib in the paediatric population in the indication of NSCLC.
Estonian: Puudub gefitiniibi asjakohane kasutus lastel mitteväikerakk-kopsuvähi näidustusel.
English: - Warfarin (a so-called oral anticoagulant, to prevent blood clots).
Estonian: Järgmised ravimid mõjutavad seda, kuidas ravim toimib: - varfariin (niinimetatud suukaudne ravim veretrombide ehk hüüvete tekke ennetamiseks).
English: PHARMACEUTICAL FORM AND CONTENTS Film-coated tablet
Estonian: Toimemehhanism ja farmakodünaamilised toimed
English: NAME OF THE MEDICINAL PRODUCT Gefitinib Mylan 250 mg film-coated tablets gefitinib
Estonian: RAVIMPREPARAADI NIMETUS Gefitinib Mylan 250 mg õhukese polümeerikattega tabletid Gefitinibum
English: NAME OF THE MEDICINAL PRODUCT Gefitinib Mylan 250 mg film-coated tablets
Estonian: RAVIMPREPARAADI NIMETUS Gefitinib Mylan 250 mg õhukese polümeerikattega tabletid
English: These medicines may affect the way this medicine works.
Estonian: Ravim võib olla neile kahjulik, isegi kui haigusnähud on sarnased.
English: Ever smoker
Estonian: Suitsetamise staatus
English: Gastrointestinal disorders
Estonian: Naatriumlaurüülsulfaat Magneesiumstearaat
English: It was to be available as 300 mg tablets.
Estonian: Seda kavatseti turustada 300 mg tablettidena.
English: Corluxin was not compared with any other medicine.
Estonian: Corluxini ei võrreldud teiste ravimitega.
English: What is Corluxin?
Estonian: Mis on Corluxin?
English: EMA/261739/2015 EMEA/H/C/002830
Estonian: 21. mai 2015 EMA/386104/2015 EMEA/H/C/002830
English: In its letter notifying the Agency of the withdrawal of application, the company stated that the withdrawal was due to strategic business reasons.
Estonian: Ettevõtte kirjas, milles ta teatab Euroopa Ravimiametile oma taotluse tagasivõtmisest, märgib ettevõte, et võttis taotluse tagasi äristrateegia tõttu.
English: The applicant submitted data from a main study involving 50 patients with Cushing's syndrome who had diabetes and/or high blood pressure, two common features of the condition.
Estonian: Taotleja esitas andmed ühest põhiuuringust, kus osales 50 Cushingi sündroomiga patsienti, kellel oli diabeet ja/või kõrge vererõhk, mis esinevad haiguse korral sageli.
English: On 23 March 2015, FGK Representative Service GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Corluxin, intended for the treatment of Cushing's syndrome.
Estonian: FGK Representative Service GmbH teatas 23. märtsil 2015 ametlikult inimravimite komiteele oma soovist võtta tagasi ravimi Corluxin müügiloa taotlus.
English: Corluxin is a medicine containing the active substance mifepristone.
Estonian: Corluxin on ravim, mis sisaldab toimeainena mifepristooni.
English: Withdrawal of the marketing authorisation application for Corluxin (mifepristone)
Estonian: Müügiloa taotluse tagasivõtmise teave: Corluxin (mifepristoon)
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21 May 2015
Estonian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555
English: Patients with Cushing's syndrome can have ‘central' weight gain (affecting the face and torso but not the limbs), growth of fat above the collar bone and the back of the neck, a roundish face, easy bruising, excessive growth of coarse hair on the face, weakening of the muscles and bones, depression, diabetes and high blood pressure.
Estonian: Cushingi sündroomiga patsientide sümptomid on kehakaalu suurenemine (näol ja kerel, kuid mitte jäsemetel), rasvkoe paksenemine rangluu kohal ja turjal, kuunägu, kergesti tekkivad verevalumid, liigne karvakasv näol, lihasnõrkus, nõrgad luud, depressioon, diabeet ja kõrge vererõhk.
English: The CHMP also had concerns about the main study, citing, among other things, the lack of a comparator medicine.
Estonian: Samuti nägi komitee põhjust ettevaatlikkuseks seoses põhiuuringuga, tuues näiteks muu hulgas võrdlusravimi puudumise.
English: On the whole, the evidence for effectiveness in the indication applied for was limited and there were some safety concerns with the medicine, including side effects caused by the reduced activity of circulating cortisol, fluid and mineral disturbances (particularly reduced potassium levels in blood and increased blood pressure in some patients) and thickening of the womb in some female patients.
Estonian: Kokkuvõttes olid tõendid ravimi efektiivsuse kohta taotletud näidustuse korral piiratud ja ravimiga esines ohutusprobleeme, sh vereringes oleva kortisooli vähendatud toimest tingitud kõrvalnähud, vedeliku ja mineraalainetega seotud häired (eelkõige vere kaaliumisisalduse vähenemine ja vererõhu tõus mõnel patsiendil) ning emaka limaskesta paksenemine mõnel naispatsiendil.
English: By blocking these receptors, mifepristone is expected to reduce the effects of the excess cortisol circulating in the body, thereby alleviating the symptoms of the disease.
Estonian: Eeldatakse, et retseptorite blokeerimisega vähendab mifepristoon vereringes oleva liigse kortisooli mõju ja leevendab sellega haiguse sümptomeid.
English: Corluxin was to be used to treat Cushing's syndrome in patients who cannot have surgery or for whom surgery has failed.
Estonian: Corluxini kavatseti kasutada Cushingi sündroomi raviks patsientidel, keda ei saanud opereerida või kelle operatsioon ei õnnestunud.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Corluxin in the proposed indication did not outweigh its risks.
Estonian: Seetõttu oli inimravimite komitee müügiloa taotluse tagasivõtmise ajal arvamusel, et Corluxini kasulikkus kavandatud näidustusel ei ületa kaasnevaid riske.
English: Withdrawal of the marketing authorisation application for Corluxin (mifepristone) EMA/261739/2015
Estonian: Müügiloa taotluse tagasivõtmise teave: Corluxin (mifepristoon) EMA/386104/2015
English: The company informed the CHMP that, at the time of the withdrawal, there were no ongoing clinical trials or compassionate use programmes for Corluxin.
Estonian: Ettevõte teatas inimravimite komiteele, et tagasivõtmise ajal ei toimunud Corluxini kliinilisi uuringuid ega eriloaga kasutamise programme.
English: The CHMP had concerns related to the manufacture of the medicine, including the control of impurities and the testing of the finished product.
Estonian: Inimravimite komitee nägi põhjust ettevaatlikkuseks seoses ravimi tootmisega, sh tootmisprotsessist tulenevate lisandite piiramise ja lõpptoote katsetamisega.
English: The study looked at improvements in blood sugar levels and blood pressure following 24 weeks of Corluxin treatment.
Estonian: glükoosisisalduse ja vererõhu näitajate paranemist 24-nädalase Corluxini-ravi järel.
English: The active substance in Corluxin, mifepristone, is known to block receptors for cortisol known as glucocorticoid (GR-II) receptors.
Estonian: Corluxini toimeaine mifepristoon blokeerib teatud kortisooliretseptorid, nimelt glükokortikoidide (GR-II) retseptorid.
English: At the time of the withdrawal, the CHMP was of the provisional opinion that Corluxin could not be approved for use in the broad indication the company applied for, which was the “treatment of adult patients with endogenous Cushing's syndrome for whom surgery is not an option or for whom surgery has failed.”
Estonian: Inimravimite komitee oli müügiloa taotluse tagasivõtmise ajal esialgsel arvamusel, et Corluxini kasutamist ettevõtte taotletud üldisel näidustusel „endogeense Cushingi sündroomiga täiskasvanud patsientide ravi, keda ei saanud opereerida või kelle operatsioon ei õnnestunud” ei ole võimalik heaks kiita.
English: How is Corluxin expected to work?
Estonian: Milline on Corluxini eeldatav toime?
English: What was Corluxin expected to be used for?
Estonian: Milleks kavatseti Corluxini kasutada?
English: Cushing's syndrome is a disease characterised by an excess production of the hormone cortisol by the adrenal glands, two glands situated above the kidneys.
Estonian: Cushingi sündroom on haigus, mille korral neerupealistes tekib liiga palju hormooni kortisooli.
English: Communication Plan
Estonian: Teavitamiskava
English: CONDITIONS OF THE MARKETING AUTHORISATIONS National Competent Authorities, coordinated by the Reference Member State where applicable, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Estonian: Riikide pädevad asutused, mida koordineerib viiteliikmesriik, kui see on asjakohane, tagavad, et müügiloa hoidjad täidavad järgmised tingimused:
English: The harmonised date for release of the letter is of 15 working days following the European Commission decision.
Estonian: Nimetatud kiri tuleb välja saata 15 päeva jooksul pärast Euroopa Komisjoni otsust.
English: The MAHs should inform healthcare professionals on the outcome of this review on nimesulide via a “Direct Healthcare Professional Communication” (DHPC) as agreed by the CHMP.
Estonian: Müügiloa hoidjad teatavad tervishoiutöötajaile nimesuliidi esildise läbivaatamise tulemused tervishoiutöötajate teatises, mille sisu lepitakse kokku inimravimite komiteega.
English: Immediate Packaging
Estonian: 5 kapsel
English: EMEA/457286/2008-EN
Estonian: EMEA/457286/2008-ET
English: The CVMP Opinion was adopted on 12 December 2007 and the subsequent Commission Decision on 11 March 2008.
Estonian: Veterinaarravimite komitee otsus võeti vastu 12. detsembril 2007 ja seejärel 11. märtsil 2008 võeti vastu komisjoni otsus.
English: The Marketing Authorisation Holders were requested in a list of questions to provide:
Estonian: Müügiloa hoidjatel paluti küsimuste loetelus esitada:
English: The established withdrawal periods are safe and can be retained.
Estonian: 5. kehtestatud keeluajad on ohutud ja need võib samaks jätta.
English: • Justification of the withdrawal period, in case the recommended dose should increase.
Estonian: • põhjendus keeluaja kohta, kui soovitatav annus peaks suurenema.
English: Neither the Periodic Safety Update Reports of the products nor the literature presented included reports of lack of efficacy in the field.
Estonian: Toodete perioodiliselt uuendatavad ohutusaruanded ja esitatud kirjandus ei sisaldanud teavet tõhususe puudumise kohta kõnealuses valdkonnas.