FrancophonIA/ELRC3.0 huggingface dataset:
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 4 mg topotecan (as hydrochloride).
Estonian: TOIMEAINE(TE) SISALDUS Iga viaal sisaldab 4 mg topotekaani (vesinikkloriidina).
English: Small cell lung cancer The usual dose is 1.5 mg per m of body surface area once daily for 5 days.
Estonian: Tavaline annus on 1,5 mg ruutmeetri kehapinna kohta üks kord ööpäevas, 5 päeva jooksul.
English: Further dilution of the appropriate volume of the reconstituted solution with either sodium chloride 9 mg/ml (0.9 %) solution for injection or 50 mg/ml (5 %) glucose solution for infusion is required to a final concentration of between 25 and 50 microgram/ml.
Estonian: Vastava koguse lahustatud aine edasiseks lahjendamiseks tuleb kasutada kas 9 mg/ml (0,9%) naatriumkloriidi- või 5 mg/ml (5%) glükoosilahust kuni lõpliku kontsentratsioonini 25…50 μg/ml.
English: In patients (n = 39) with recurrence within 180 days after chemoradiotherapy with cisplatin, the median survival in the topotecan plus cisplatin arm was 4.6 months (95 % C.I.
Estonian: Patsientide seas (n = 39), kellel tekkis retsidiiv 180 päeva jooksul pärast kemoradioteraapiat tsisplatiiniga, oli elulemuse mediaan topotekaani pluss tsisplatiini grupis 4,6 kuud (95% usaldusvahemik: 2,6, 6,1) ja tsisplatiini grupis 4,5 kuud (95% usaldusvahemik: 2,9, 9,6); riskimäär 1,15 (0,59, 2,23).
English: hypersensitivity reaction including rash
Estonian: ülitundlikkusreaktsioonid, sh lööve
English: 18.3, 31.6) compared to 13.9 weeks (95 % C.I.
Estonian: Topotekaani + BSC patsientidel oli elulemuse mediaan 25,9 nädalat (95% CI 18,3, 31,6) võrreldes 13,9 nädalaga (95% CI 11,1, 18,6) ainult BSC puhul (p = 0,0104).
English: No effects on male or female fertility have been observed in reproductive toxicity studies in rats (see section 5.3).
Estonian: Reproduktsioonitoksilisuse uuringutes rottidel ei täheldatud mõju isaste või emaste loomade viljakusele.
English: Dosage in renally impaired patients
Estonian: Annustamine neerukahjustusega patsientidele
English: Small Cell Lung Carcinoma
Estonian: Väikerakk kopsuvähk
English: NAME OF THE MEDICINAL PRODUCT Topotecan Actavis 1 mg powder for concentrate for solution for infusion topotecan
Estonian: RAVIMPREPARAADI NIMETUS Topotecan Actavis, 1 mg infusioonilahuse kontsentraadi pulber
English: NAME OF THE MEDICINAL PRODUCT Topotecan Actavis 4 mg powder for concentrate for solution for infusion topotecan
Estonian: RAVIMPREPARAADI NIMETUS Topotecan Actavis, 4 mg infusioonilahuse kontsentraadi pulber
English: Patients with prior cisplatin chemoradiotherapy Cisplatin
Estonian: Eelnevalt tsiplatiini kemoteraapiat saanud patsiendid Topotekaan/Tsisplatiin
English: Guidelines for the safe handling and disposal of antineoplastic agents Reconstitution and dilution of the medicinal product must be performed by trained personnel.
Estonian: Antineoplastiliste ainete lahustamise, säilitamise ja hävitamise juhised
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Topotecan Actavis 4 mg powder for concentrate for solution for infusion topotecan
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE Topotecan Actavis 4 mg infusioonilahuse kontsentraadi pulber topotecanum
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Topotecan Actavis 1 mg powder for concentrate for solution for infusion topotecan
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE Topotecan Actavis 1 mg infusioonilahuse kontsentraadi pulber topotecanum
English: In those (n = 102) with recurrence after 180 days, the median survival in the topotecan plus cisplatin arm was 9.9 months (95 % C.I.
Estonian: Pärast 180 päeva tekkinud retsidiiviga patsientide seas (n = 102) oli elulemuse mediaan topotekaani pluss tsisplatiini grupis 9,9 kuud (95% usaldusvahemik: 7, 12,6) ja tsisplatiini grupis 6,3 kuud (95% usaldusvahemik: 4,9, 9,5); riskimäär 0,75 (0,49, 1,16).
English: Paediatrics
Estonian: Viaalid
English: 9/l, and the haemoglobin level is ≥ 9 g/dl (after transfusion if necessary).
Estonian: Topotekaani ei tohi uuesti manustada, kui neutrofiilide arv ei ole ≥ 1 x 109/l ja trombotsüütide arv ≥ 100 x 109/l ning hemoglobiini tase ei ole ≥ 9 g/dl (vajadusel pärast vereülekannet).
English: The prescribing information for cisplatin should be consulted for a full list of adverse events associated cisplatin use.
Estonian: Tsisplatiiniga seotud kõrvaltoimete täieliku loetelu leiate tsisplatiini ravimi omaduste kokkuvõttest.
English: What measures are being taken to ensure the safe and effective use of Orkambi?
Estonian: Mis meetmed võetakse, et tagada Orkambi ohutu ja efektiivne kasutamine?
English: Further information on Orkambi can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Orkambi.
Estonian: Lisateave Orkambi kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/Orkambi.
English: Other information about Orkambi
Estonian: Muu teave Orkambi kohta
English: Orkambi received a marketing authorisation valid throughout the EU on 19 November 2015.
Estonian: Orkambi on saanud müügiloa, mis kehtib kogu ELis, 19. novembril 2015.
English: All children were treated with Orkambi.
Estonian: Kõiki lapsi raviti Orkambiga.
English: The tablets or granules are taken every 12 hours with fat-containing foods.
Estonian: Tablette või graanuleid võetakse iga 12 tunni järel koos rasva sisaldava toiduga.
English: The European Medicines Agency decided that Orkambi's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et Orkambi kasulikkus on suurem kui sellega kaasnevad riskid ja et ravimi kasutamise võib ELis heaks kiita.
English: The study is to evaluate how the disease progresses in the two groups of children.
Estonian: Uuringu eesmärk on hinnata haiguse süvenemist kummaski lasterühmas.
English: What is Orkambi and what is it used for?
Estonian: Mis on Orkambi ja milleks seda kasutatakse?
English: Orkambi's side effects mainly affected the gut and breathing and were generally considered mild to moderate and manageable.
Estonian: Orkambi kõrvalnähud mõjutasid peamiselt soolestikku ja hingamist neid peeti üldiselt kergeks kuni mõõdukaks ning hallatavaks.
English: The beneficial effects of Orkambi were smaller than expected for a medicine that treats the mechanism of the disease rather than its symptoms.
Estonian: Orkambi kasulik toime oli väiksem, kui võib eeldada ravimilt, mis ravib haiguse mehhanismi, mitte sümptomeid.
English: The recommended dose depends on the age and weight of the patient.
Estonian: Soovitatav annus sõltub patsiendi vanusest ja kehamassist.
English: As for all medicines, data on the use of Orkambi are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse Orkambi kasutamise kohta pidevat järelevalvet.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Orkambi have also been included in the summary of product characteristics and the package leaflet.
Estonian: Orkambi ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Orkambi (lumacaftor / ivacaftor)
Estonian: Orkambi (lumakaftoor/ivakaftoor)
English: The effects of Orkambi in children aged 2 to 5 years were considered to be similar to those in older children and a long-term study will be carried out to confirm this.
Estonian: Orkambi toimet 2-5-aastastel lastel peeti sarnaseks selle toimega vanematel lastel ning selle kinnitamiseks tehakse pikaajaline uuring.
English: In the studies, Orkambi was compared with placebo (a dummy treatment), both added to patients' usual therapy.
Estonian: Nendes uuringutes võrreldi Orkambit platseeboga (näiv ravim), kumbagi lisati patsientide tavapärasele ravile.
English: What are the risks associated with Orkambi?
Estonian: Mis riskid Orkambiga kaasnevad?
English: Build-up of thick and sticky secretions in the lungs causes inflammation and long-term infection.
Estonian: Viskoosse ja kleepja eritise kogunemine kopsudesse põhjustab põletikku ja pikaajalist infektsiooni.
English: For more information about using Orkambi, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Orkambi kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
English: Stopping treatment with Orkambi caused chloride levels to rise again.
Estonian: Orkambiga toimuva ravi peatamisel suurenes kloriidisisaldus uuesti.
English: However, as cystic fibrosis caused by F508del mutation is particularly severe, the observed effects were considered clinically relevant for patients with no other option.
Estonian: Et aga mutatsiooni F508del põhjustatud tsüstiline fibroos on eriti raske, peeti täheldatud toimet kliiniliselt oluliseks patsientidele, kellel puuduvad muud ravivõimalused.
English: Side effects reported with Orkambi are carefully evaluated and any necessary action taken to protect patients.
Estonian: Orkambi kõrvaltoimeid hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
English: In total, these serious side effects occurred in more than 1 in 200 people during the clinical studies.
Estonian: Kokku esinesid rasked kõrvalnähud kliinilistes uuringutes enam kui 1 inimesel 200st.
English: Serious side effects include liver problems such as raised liver enzymes, cholestatic hepatitis (build-up of bile leading to inflammation of the liver) and hepatic encephalopathy (a brain disease caused by liver problems).
Estonian: Rasked kõrvalnähud on muu hulgas maksaprobleemid, näiteks maksaensüümide sisalduse suurenemine, kolestaatiline hepatiit (sapipeetus, mis põhjustab maksapõletikku) ja hepaatiline entsefalopaatia (ajuhaigus, mille põhjustavad maksaprobleemid).
English: The most common side effects with Orkambi (which may affect more than 1 in 10 people) are dyspnoea (shortness of breath), diarrhoea and nausea (feeling sick).
Estonian: Orkambi kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on düspnoe (hingeldus), kõhulahtisus ja iiveldus.
English: Overall the number of exacerbations was reduced by 39% when compared with placebo.
Estonian: Võrreldes platseeboga vähenes ägenemiste üldarv 39% võrra.
English: Orkambi is available as tablets and granules.
Estonian: Orkambit turustatakse tablettidena ja graanulitena.
English: In the study in children aged 6 to 11 years, the main measure of effectiveness was a decrease in the lung clearance index (LCI2.5), which indicates an improvement in lung ventilation.
Estonian: 6-11-aastaste laste uuringus oli efektiivsuse põhinäitaja kopsukliirensi indeksi (LCI2,5) vähenemine, mis näitab kopsuventilatsiooni paranemist.
English: How does Orkambi work?
Estonian: Kuidas Orkambi toimib?
English: There was improvement in CFTR protein activity as measured by a decrease in the amount of chloride in sweat after 24 weeks of treatment.
Estonian: CFTR-valgu aktiivsus suurenes, mõõdetuna higi kloriidisisalduse vähenemisega pärast 24 ravinädalat.
English: Results from the first study showed that after 24 weeks of treatment patients who took Orkambi had an average improvement in FEV1 of 2.41 percentage points more than those who took placebo; this figure was 2.65 in the second study.
Estonian: Esimese uuringu tulemused tõendasid, et pärast 24-nädalast ravi paranes Orkambi uuringurühma patsientide FEV1 keskmiselt 2,41% võrra rohkem kui platseeborühma patsientidel ning teises uuringus 2,65% võrra.
English: Cystic fibrosis is an inherited disease that has severe effects on the lungs and the digestive system.
Estonian: Tsüstiline fibroos on pärilik haigus, mis kahjustab raskelt kopse ja seedesüsteemi.
English: In cystic fibrosis, the secretions become thick and cause blockage.
Estonian: Tsüstilise fibroosi korral muutuvad need eritised viskoosseks ja põhjustavad ummistusi.
English: Orkambi is used in patients who have inherited the mutation from both parents.
Estonian: Orkambit kasutatakse patsientidel, kes on pärinud mutatsiooni mõlemalt vanemalt.
English: For the full list of all side effects and restrictions with Orkambi, see the package leaflet.
Estonian: Orkambi kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: What benefits of Orkambi have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Orkambi kasulikkus?
English: How is Orkambi used?
Estonian: Kuidas Orkambit kasutatakse?
English: After 24 weeks of treatment, LCI2.5 decreased by 1.01 in patients treated with Orkambi compared with an increase of 0.08 in patients treated with placebo.
Estonian: Pärast 24 ravinädalat vähenes Orkambiga ravitud patsientide LCI2.5 1,01 võrra ja platseeborühmas suurenes 0,08 võrra.
English: The company that markets Orkambi is required to conduct a 5-year study in patients with cystic fibrosis to evaluate the long-term effects of the medicine.
Estonian: Orkambi turustaja peab tegema tsüstilise fibroosiga patsientidel 5-aastase uuringu, milles hinnatakse ravimi pikaajalisi toimeid.
English: The children's growth (measured in terms of the body mass index, weight and height) also improved.
Estonian: Paranes ka laste kasvamine (mõõdetuna kehamassiindeksi, kehamassi ja pikkuse järgi).
English: A further long-term study in children aged 2 to 5 years with cystic fibrosis is also required to compare those who have the F508del mutation in the CFTR gene and are treated with Orkambi with those who have not been treated with Orkambi.
Estonian: Vaja on ka täiendavat pikaajalist uuringut 2-5-aastastel tsüstilise fibroosiga lastel, et võrrelda toimet Orkambiga ravitavate ning CFTR-geeni mutatsiooniga F508del lastel ja lastel, keda Orkambiga ei ravita.
English: Orkambi can only be prescribed by a doctor with experience in the treatment of cystic fibrosis.
Estonian: Orkambiga toimuvat ravi tohib määrata ainult tsüstilise fibroosi ravis kogenud arst.
English: One of the active substances in Orkambi, lumacaftor, increases the amount of CFTR protein on the cell and the other, ivacaftor, increases the activity of the defective CFTR protein.
Estonian: Orkambi toimeaine lumakaftoor suurendab CFTR-valgu kogust raku pinnal ja ravimi teine toimeaine ivakaftoor suurendab defektse CFTR-valgu aktiivsust.
English: Cystic fibrosis is caused by mutations in the CFTR gene.
Estonian: Tsüstilist fibroosi põhjustavad CFTR-geeni mutatsioonid.
English: In the two studies in patients aged 12 years and above, the main measure of effectiveness was based on improvement in patients' predicted FEV1 which is a measure of how well the lungs work.
Estonian: Mõlemas vähemalt 12-aastaste patsientide uuringus põhines efektiivsuse põhinäitaja patsientide prognoositava FEV1-väärtuse paranemisel.
English: Treatment with Orkambi also reduced the number of exacerbations (flares-up) requiring hospital admission or antibiotic therapy.
Estonian: Samuti vähendas Orkambi haiglaravi või antibiootikumravi vajavate ägenemiste arvu.
English: A further study involved 60 children aged 2 to 5 years with cystic fibrosis who had the F508del mutation in the CFTR gene.
Estonian: Veel ühes uuringus osales tsüstilise fibroosiga 60 last vanuses 2-5 a, kellel oli CFTR-geenis mutatsioon F508del.
English: It should be prescribed only to patients confirmed to have the F508del mutation in both copies of the CFTR gene.
Estonian: Seda tohib määrata ainult patsientidele, kellel on tõendatud mutatsiooni F508del esinemine CFTR-geeni mõlemas koopias.
English: Orkambi is a medicine used to treat cystic fibrosis in patients aged 2 years and above.
Estonian: Orkambi on ravim, mida kasutatakse tsüstilise fibroosi raviks vähemalt 2-aastastel patsientidel.
English: An overview of Orkambi and why it is authorised in the EU
Estonian: Ülevaade ravimist Orkambi ja ELis müügiloa väljastamise põhjendus
English: Patients with cystic fibrosis have high levels of chloride in sweat due to CFTR not working properly.
Estonian: Tsüstilise fibroosiga patsientidel on CFTR-valgu ebanormaalse toime tõttu higi kloriidisisaldus suur.
English: The mutations reduce the amount of CFTR protein on the cell surface or affect the way the protein works.
Estonian: Mutatsioonid vähendavad CFTR-valgu kogust rakupinnal või häirivad valgu toimimist.
English: It affects the cells that produce mucus and digestive juices.
Estonian: See kahjustab rakke, milles tekivad lima või seedemahlad.
English: Orkambi has been shown to improve lung function and lung ventilation in patients with cystic fibrosis from 6 years of age.
Estonian: Orkambi kasutamisel on tõendatud kopsutalitlust ja kopsuventilatsiooni parandav toime vähemalt 6aastastel tsüstilise fibroosiga patsientidel.
English: Orkambi is used in patients who have a genetic mutation (change) called the F508del mutation.
Estonian: Orkambit kasutatakse patsientidel, kel on geneetiline mutatsioon F508del.
English: In the gut, blockage of the tubes from the pancreas slows down the digestion of food and causes poor growth.
Estonian: Soolestikus aeglustab kõhunäärmejuhade ummistus toidu seedimist ja põhjustab seetõttu kasvupeetust.
English: All patients had the F508del mutation in the CFTR gene.
Estonian: Kõigil patsientidel oli mutatsioon F508del CFTR-geeni mõlemas koopias.
English: This mutation affects the gene for a protein called cystic fibrosis transmembrane conductance regulator (CFTR) which is involved in regulating the production of mucus and digestive juices.
Estonian: See mutatsioon mõjutab geeni, mis juhib tsüstilise fibroosi transmembraanse juhtivuse regulaatorvalku (CFTR).
English: These actions make mucus and digestive juices less thick.
Estonian: Need toimed vähendavad lima ja seedemahlade viskoossust.
English: Orkambi improved lung function in two main studies involving 1,108 cystic fibrosis patients aged 12 years and above, and one study involving 204 children aged from 6 to 11 years.
Estonian: Kahes põhiuuringus, milles osales 1108 vähemalt 12-aastast tsüstilise fibroosiga patsienti, ja ühes uuringus, milles osales 204 last vanuses 6-11 a, oli Orkambi kopsutalitluse parandamisel efektiivne.
English: Orkambi contains the active substances lumacaftor and ivacaftor.
Estonian: Orkambi sisaldab toimeainetena lumakaftoori ja ivakaftoori.
English: This gene makes the CFTR protein, which is involved in regulating the production of mucus and digestive juices.
Estonian: See geen juhib CFTR-valgu teket, mis reguleerib lima ja seedemahlade teket.
English: Why is Orkambi authorised in the EU?
Estonian: ELis Orkambile väljastatud müügiloa põhjendus
English: 22 March 2013 EMA/402540/2013
Estonian: 22. märts 2013 EMA/402540/2013
English: Patients were followed for a median of 3.9 years.
Estonian: Patsiente jälgiti keskmiselt 3,9 aastat.
English: Tel. +44 (0)20 7418 8427 E-mail: press@ema.europa.eu
Estonian: Telefon: +44 (0)20 7418 8427 E-posti aadress: press@ema.europa.eu
English: • If you have any questions, you should contact your doctor or pharmacist.
Estonian: • Kui teil on küsimusi, võtke ühendust oma arsti või apteekriga.
English: Contact our press officers Monika Benstetter or Martin Harvey Allchurch
Estonian: Pressiesindajate kontaktandmed Monika Benstetter või Martin Harvey Allchurch
English: Of those enrolled, 14,741 were from Europe and 10,932 were from China.
Estonian: Uuringusse registreeritud patsientidest 14 741 olid Euroopast ja 10 932 Hiinast.
English: In higher doses, it reduces the levels of fat in the blood via a mechanism that is not fully understood.
Estonian: Suuremates annustes vähendab see veres sisalduvaid rasvu mehhanismi abil, mida täielikult ei mõisteta.
English: • The review of Tredaptive, Pelzont and Trevaclyn was initiated at the request of the European Commission on 19 December 2012, under Article 20 of Regulation (EC) No 726/2004 following the procedural steps laid out in Article 107j and 107k of Directive 2001/83/EC.
Estonian: • Ravimite Tredaptive, Pelzont ja Trevaclyn läbivaatus algatati Euroopa Komisjoni palvel 19. detsembril 2012 määruse (EÜ) nr 726/2004 artikli 20 alusel, järgides direktiivi 2001/83/EÜ artiklites 107j ja 107k sätestatud menetlustoiminguid.
English: The medicine has been marketed under one of these trade names by Merck Sharp & Dohme Ltd in all EU Member States, except Bulgaria, France and Romania.
Estonian: Ltd on turustanud ravimit, kasutades üht neist kaubanduslikest nimetustest, kõigis Euroopa Liidu liikmesriikides, välja arvatud Bulgaarias, Prantsusmaal ja Rumeenias.
English: Healthcare professionals should follow these recommendations:
Estonian: Tervishoiutöötajatel palutakse järgida alljärgnevaid soovitusi.
English: The European Commission asked the Agency to assess the impact of the new data from the HPS2-THRIVE study, and to issue an opinion on whether the marketing authorisation for these medicines should be maintained, varied, suspended or withdrawn across the EU.
Estonian: Euroopa Komisjon palus Euroopa Ravimiametil hinnata uuringust HPS2-THRIVE saadud uute andmete mõju ning anda arvamus selle kohta, kas nimetatud ravimite müügiload tuleks kogu Euroopa Liidus säilitada, muuta, peatada või tagasi võtta.
English: • A review of these data was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC).
Estonian: • Need andmed vaatas esmalt üle ravimiohutuse järelevalve riskihindamiskomitee.
English: The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for all questions concerning medicines for human use, which adopted the Agency's final opinion.
Estonian: Komitee soovitused saadeti inimravimite kõigi küsimuste eest vastutavale inimravimite komiteele, kes võttis vastu Euroopa Ravimiameti lõpliku arvamuse.
English: • The HPS2-THRIVE study was a large, long-term study involving 25,673 patients considered to be at high risk for cardiovascular events due to a history of occlusive vascular disease.
Estonian: • Ulatuslikku pikaajalisse uuringusse HPS2-THRIVE oli kaasatud 25 673 patsienti, kellel peeti varasema oklusiivse vaskulaarse haiguse tõttu kardiovaskulaarsete juhtude riski suureks.
English: More information on the HPS2-THRIVE study is available below.
Estonian: Uuringu HPS2-THRIVE lisateave on allpool.
English: • An increase in the incidence of non-fatal but serious adverse events was seen.
Estonian: • Täheldati mittefataalsete, kuid raskete kõrvalnähtude esinemissageduse suurenemist.
English: • Tredaptive, Pelzont and Trevaclyn contain two active substances: nicotinic acid (1,000 mg) and laropiprant (20 mg).
Estonian: • Tredaptive, Pelzont ja Trevaclyn sisaldavad kahte toimeainet: nikotiinhapet (1000 mg) ja laropipranti (20 mg).
English: Such treatment is ultimately aimed to reduce the risk of heart attacks, strokes and other conditions affecting the heart and blood vessels.
Estonian: Sellise ravi lõppeesmärk on vähendada südameinfarkti, insuldi ning teiste südant ja veresooni mõjutavate haigusseisundite riski.
English: • The two active substances, nicotinic acid and laropiprant, have different functions.
Estonian: • Kahel toimeainel, nikotiinhappel ja laropiprandil, on eri funktsioonid.
English: • The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision on 22 March 2013.
Estonian: • Inimravimite komitee arvamus edastati Euroopa Komisjonile, kes võttis 22. märtsil 2013 vastu õiguslikult siduva lõpliku otsuse.
English: Patients were treated with simvastatin 40 mg or simvastatin 40 mg plus ezetimibe 10 mg to achieve a total cholesterol level of less than 3.5 mmol/l, and were then randomised to nicotinic acid / laropiprant or placebo.
Estonian: Patsiente raviti 40 mg simvastatiini või 40 mg simvastatiini ja 10 mg esetimiibiga, et vähendada kogukolesterooli sisaldus allapoole 3,5 mmol/l.
English: The review of Tredaptive, Pelzont and Trevaclyn was initiated in December 2012 after new data from a large, long-term study called HPS2-THRIVE became available.
Estonian: Ravimite Tredaptive, Pelzont ja Trevaclyn läbivaatus algatati 2012. aasta detsembris ulatusliku pikaajalise uuringuga HPS2-THRIVE kogutud uute andmete avalikustamise järel.
English: They were available as modified release tablets (meaning that the two active substances are released at different rates over a few hours).
Estonian: Ravimeid turustati toimeainet modifitseeritult vabastavate tablettidena (toimeained vabanevad tabletist mõne tunni jooksul eri kiirusega).