FrancophonIA/ELRC3.0 huggingface dataset:
English: The marketing authorisation holder is Pfizer Limited.
Estonian: Müügiloa hoidja on Pfizer Limited.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Thelin on 10 August 2006.
Estonian: Euroopa Komisjon andis Thelini müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 10. augustil 2006.
English: Before treatment, the patients could walk around 366 metres in six minutes.
Estonian: Enne ravi suutsid patsiendid 6 minutiga kõndides läbida umbkaudu 366 meetrit.
English: If after 12 weeks the patient's condition is getting worse, then the doctor should review the treatment.
Estonian: Kui 12 nädala pärast patsiendi seisund halveneb, peab arst raviskeemi uuesti läbi vaatama.
English: It is taken as one tablet a day, preferably at the same time of the day.
Estonian: Ravimit võetakse üks tablett ööpäevas, soovitavalt samal kellaajal.
English: The ‘class' reflects the seriousness of the disease: ‘class III' involves marked limitation of physical activity.
Estonian: Klassifikatsioon väljendab haiguse raskusastet - III klass“ tähendab märkimisväärselt piiratud kehalist aktiivsust.
English: The patient's liver should be monitored before and during the treatment.
Estonian: Patsientide maksa tuleb nii enne ravi kui ka ravi kestel jälgida.
English: What measures are being taken to ensure the safe use of Thelin?
Estonian: Milliseid meetmeid võetakse, et tagada Thelini kasutamise ohutus?
English: The company will also set up a system to monitor Thelin's side effects, suspected interactions with other medicines and the outcome of any pregnancies that may happen in women using the medicine.
Estonian: Samuti loob ettevõte süsteemi jälgimaks kõrvalnähte, kahtlustatavaid koostoimeid muude ravimitega ning võimalikke rasestumisjuhtusid naistel, kes seda ravimit kasutavad.
English: The most common side effect with Thelin (seen in more than 1 patient in 10) is headache.
Estonian: Thelini kõige sagedam kõrvalnäht (esinenud enam kui 1 patsiendil 10st) on peavalu.
English: The study measured the improvement in exercise capacity by looking at the change in how far the patients could walk in six minutes after 12 to 18 weeks of treatment.
Estonian: Uuringutes hinnati kehalise võimekuse paranemist, võttes aluseks muutuse teepikkuses, mille patsient suutis pärast 12-18-nädalast ravi kõndides 6 minuti jooksul läbida.
English: It is available as yellow-toorange, capsule-shaped tablets (100 mg).
Estonian: Seda turustatakse kapslikujuliste kollakasoranžide tablettidena (100 mg).
English: Three doses of Thelin (50, 100 and 300 mg) have been compared with placebo (a dummy treatment) in three main studies involving a total of 523 patients with PAH, most of whom had class II or III disease.
Estonian: Thelini kolme annust (50 mg, 100 ja 300 mg) võrreldi platseeboga (näiv ravim) kolmes põhiuuringus, milles osales kokku 523 patsienti (enamikus II või III klassi pulmonaalse arteriaalse hüpertensiooniga patsiendid).
English: Thelin sitaxentan sodium
Estonian: Thelin naatriumsitaksentaan
English: Caution is needed when Thelin is taken at the same time as some other medicines.
Estonian: Ettevaatlik tuleb olla ravimi kasutamisel samaaegselt muude ravimitega.
English: The company that makes Thelin will provide doctors and patients with educational material about the medicine.
Estonian: Thelinit tootja tagab arstidele ja patsientidele ravimi kohta teabematerjalid.
English: What is Thelin?
Estonian: Mis on Thelin?
English: Because the number of patients with pulmonary arterial hypertension is low, the disease is considered ‘rare', and Thelin was designated an ‘orphan medicine' (a medicine used in rare diseases) on 21 October 2004.
Estonian: Et pulmonaalse arteriaalse hüpertensiooni patsientide arv on väike, ja see haigus esineb harva, nimetati Thelin 21. oktoobril 2004 harvikravimiks.
English: After 12 to 18 weeks, this distance had increased by 33 metres more in the patients taking 100 mg Thelin than in the patients taking placebo.
Estonian: Pärast 12-18-nädalast ravi suurenes see vahemaa Thelinit annuses 100 mg võtnud patsientidel võrreldes platseebot saanud patsientidega ligikaudu 33 meetri võrra.
English: Other information about Thelin:
Estonian: Muu teave Thelini kohta
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Thelin.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit, ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: However, the effectiveness was only considered sufficient in patients with class III disease.
Estonian: Ravimi efektiivsust peeti piisavaks aga üksnes III klassi pulmonaalse arteriaalse hüpertensiooniga patsientidel.
English: This document is a summary of the European public assessment report (EPAR) for Thelin.
Estonian: Käesolev dokument on ravimi Thelin Euroopa avaliku hindamisaruande kokkuvõte.
English: What is the risk associated with Thelin?
Estonian: Mis riskid Theliniga kaasnevad?
English: Thelin must not be taken with ciclosporin A (a medicine used to treat psoriasis and rheumatoid arthritis, and to prevent rejection of liver and kidney transplants).
Estonian: Thelinit ei tohi võtta koos A-tsüklosporiiniga (psoriaasi ja reumatoidartriidi raviks ning maksa- või neerusiiriku hülgamisreaktsiooni vältimiseks kasutatav ravim).
English: For more information about treatment with Thelin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Thelini kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge lisateabe saamiseks oma arsti või apteekri poole.
English: In the patients with class III disease, this was around 46 metres.
Estonian: III klassi pulmonaalse arteriaalse hüpertensiooniga patsientidel suurenes see ligikaudu 46 meetri võrra.
English: Thelin must not be used in women who are breastfeeding.
Estonian: Thelinit ei tohi kasutada rinnaga toitmise ajal.
English: The active substance in Thelin, sitaxentan sodium, blocks the receptors for a hormone called endothelin-1 (ET-1), which causes blood vessels to constrict.
Estonian: Thelini toimeaine naatriumsitaksentaan blokeerib veresoonte kokkutõmbumist põhjustava hormooni endoteliin-1 (ET-1) retseptorid.
English: See the package leaflet for full details.
Estonian: Üksikasjalik teave on pakendi infolehel.
English: Thelin should not be used in people who may be hypersensitive (allergic) to sitaxentan sodium or any of the other ingredients.
Estonian: Thelinit ei tohi kasutada patsiendid, kes võivad olla naatriumsitaksentaani või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
English: Thelin was more effective than placebo at improving exercise capacity.
Estonian: Thelin parandas kehalist võimekust efektiivsemini kui platseebo.
English: Why has Thelin been approved?
Estonian: Miks Thelin heaks kiideti?
English: The CHMP concluded that Thelin had shown an effectiveness that was as expected for this class of medicines.
Estonian: Inimravimite komitee jõudis järeldusele, et Thelini efektiivsus on tõestatud ning selle klassi ravimi korral ootuspärane.
English: By blocking the effect of ET-1, Thelin allows the vessels to dilate (expand), helping to lower the blood pressure and improving symptoms.
Estonian: Tõkestades ET-1 toime, soodustab Thelin veresoonte laienemist ning see aitab alandada vererõhku ja leevendada haigussümptomeid.
English: This pressure reduces the amount of oxygen that can get into the blood in the lungs, making physical activity more difficult.
Estonian: Kõrge vererõhk vähendab kopsudes verre imenduva hapniku kogust ja seetõttu raskendab kehalist tegevust.
English: For the full list of all side effects reported with Thelin, see the package leaflet.
Estonian: Thelini kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: Thelin is a medicine that contains the active substance sitaxentan sodium.
Estonian: Thelin on ravim, mille toimeaine on naatriumsitaksentaan.
English: It must not be used in patients who have mild to severe problems with their liver or raised levels of some liver enzymes.
Estonian: Seda ei tohi kasutada kerge kuni raske maksaprobleemiga või teatavate maksaensüümide kõrgenenud sisaldusega patsiendid.
English: Thelin has been shown to be effective in PAH with no identified cause and PAH caused by connective tissue disease.
Estonian: On tõestatud, et Thelin on efektiivne tuvastamata põhjusega pulmonaalse arteriaalse hüpertensiooni ning sidekoe haigusest põhjustatud pulmonaalse arteriaalse hüpertensiooni korral.
English: It causes high blood pressure in the vessels taking blood from the heart to the lungs.
Estonian: See põhjustab kõrget vererõhku südamest kopsu viivates veresoontes.
English: Thelin is used in patients with class III disease.
Estonian: Thelinit kasutatakse III klassi pulmonaalse arteriaalse hüpertensiooniga patsientidel.
English: PAH is abnormally high blood pressure in the arteries of the lungs.
Estonian: Pulmonaalse arteriaalse hüpertensiooni korral on vererõhk kopsuarterites ebanormaalselt kõrge.
English: Thelin is used to treat adults (aged 18 years or over) with pulmonary arterial hypertension (PAH) to improve exercise capacity (the ability to carry out physical activity).
Estonian: Thelinit kasutatakse pulmonaalse arteriaalse hüpertensiooni raviks vähemalt 18-aastastel täiskasvanud patsientidel, et tõsta nende kehalist võimekust.
English: Therefore, the Committee decided that Thelin's benefits are greater than its risks for patients with class III disease and recommended that it be given marketing authorisation.
Estonian: Seega otsustas komitee, et Thelini kasulikkus III klassi pulmonaalse arteriaalse hüpertensiooniga patsientidel on suurem kui sellega kaasnevad riskid.
English: How does Thelin work?
Estonian: Kuidas Thelin toimib?
English: What benefit has Thelin shown during the studies?
Estonian: Milles seisneb uuringute põhjal Thelini kasulikkus?
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Thelin is available here.
Estonian: Harvikravimite komitee arvamuse kokkuvõtte Thelini kohta leiate siit.
English: What is Thelin used for?
Estonian: Milleks Thelinit kasutatakse?
English: How has Thelin been studied?
Estonian: Kuidas Thelinit uuriti?
English: How is Thelin used?
Estonian: Kuidas Thelinit kasutatakse?
English: PAH is a debilitating disease where there is severe constriction (narrowing) of the blood vessels of the lungs.
Estonian: Pulmonaalne arteriaalne hüpertensioon on kurnav haigus, mille korral kopsude veresooned ahenevad tugevasti.
English: The full EPAR for Thelin can be found here.
Estonian: Euroopa avaliku hindamisaruande täistekst Thelini kohta on siin.
English: Thelin should only be started and monitored by a doctor who has experience in the treatment of PAH.
Estonian: Ravi Theliniga võib alustada üksnes pulmonaalse arteriaalse hüpertensiooni ravis kogenud arst ning see peab kulgema tema järelevalve all.
English: You may need to read it again.
Estonian: Teil võib tekkida vajadus seda uuesti lugeda.
English: This medicine is for long-term use.
Estonian: See ravim on mõeldud pikaajaliseks kasutamiseks.
English: MedDRA System Organ Class Preferred term
Estonian: MedDRA organsüsteemi klass Eelistatud mõiste
English: Elderly patients (≥ 65 years)
Estonian: Eakad patsiendid (≥ 65 aastat)
English: The suspension is stable for up to 7 days.
Estonian: Suspensioon püsib stabiilsena kuni 7 päeva.
English: - The other ingredients are:
Estonian: - Muud koostisosad on järgmised.
English: Date of first authorisation: 10/04/2017
Estonian: Müügiloa andmise kuupäev: 10/04/2017
English: Data exists only in the adult population.
Estonian: Andmed on olemas ainult täiskasvanute kohta.
English: A risk to the newborns/infants cannot be excluded.
Estonian: Riski vastsündinutele/väikelastele ei saa välistada.
English: The expiry date refers to the last day of that month.
Estonian: Kõlblikkusaeg viitab vastava kuu viimasele päevale.
English: Liver function should also be monitored.
Estonian: Jälgida tuleb ka maksafunktsiooni.
English: Efficacy and safety was studied in two retrospective trials in two centres in Europe.
Estonian: Efektiivsust ja ohutust uuriti Euroopa kahes uuringukeskuses kahe retrospektiivse uuringu raames.
English: *number of divided doses dependant on advice from doctor.
Estonian: *jagatud annuste arv oleneb arsti soovitustest.
English: The capsules can be taken with or without food.
Estonian: Kapslit võib võtta koos toiduga või ilma toiduta.
English: However, these patients should be carefully monitored and the dose titrated individually.
Estonian: Siiski tuleb selliseid patsiente tähelepanelikult jälgida ja nende annust individuaalselt tiitrida.
English: Telephone: +49 (0)89 5506675 - 0 Fax: +49 (0) 89 55 066 75 25 e-mail: info@leadiantbiosciences.com
Estonian: Telefon: +49 (0)89 5506675 - 0 Faks: +49 (0) 89 55 066 75 25 e-post:info@leadiantbiosciences.com
English: Germany e-mail: info@leadiantbiosciences.com
Estonian: Saksamaa e-post: info@leadiantbiosciences.com
English: Reabsorption is not complete.
Estonian: Uuesti imendumine ei ole täielik.
English: The suspension should be stored in a glass bottle.
Estonian: Suspensiooni tuleb hoida klaaspudelis.
English: Limited safety data are available (see section 4.8).
Estonian: Saadaval on piiratud ohutusandmed (vt lõik 4.8).
English: Your doctor will tell you how many capsules you need to take, and when you should take the capsules.
Estonian: Teie arst teavitab teid, kui mitu kapslit võtma peate ja millal kapsleid võtma peate.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Estonian: Teatage oma arstile või apteekrile, kui võtate, olete hiljuti võtnud või kavatsete võtta mis tahes teisi ravimeid.
English: This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Estonian: Erandlikel asjaoludel lubatud ja vastavalt EÜ määruse nr 726/2004 artiklile 14 (8) rakendab müügiloa hoidja ettenähtud aja jooksul järgmisi meetmeid::
English: Packs size: 100 capsules
Estonian: Pakendi suurus: 100 kapslit
English: Any unused product or waste material should be disposed of in accordance with national requirements.
Estonian: Kasutamata preparaat või jäätmematerjal tuleb hävitada kooskõlas kohalike nõuetega.
English: The three adverse reactions were all nonserious.
Estonian: Ükski kolmest kõrvaltoimest ei olnud tõsine.
English: This leaflet was last revised in <{MM/YYYY}>.
Estonian: Infolehte on viimati uuendatud <{KK/AAAA}>.
English: Your doctor or pharmacist will give you instructions on how much and how often your child needs to take the mixture.
Estonian: Teie arst või apteeker juhendab teid, kui palju ja kui tihti teie laps mikstuuri võtma peab.
English: Neonates less than one month of age
Estonian: Vastsündinud vanuses alla ühe kuu
English: The events were transitory and did not interfere with the therapy.
Estonian: Esinenud reaktsioonid olid ajutised ja need ei seganud ravi.
English: Study resultsPSUR and annual reassessments
Estonian: Uuringu tulemused - PSURid ja igaaastased ümberhindamised
English: Side effects of unknown frequency (cannot be estimated from the available data)
Estonian: Teadmata sagedusega (ei saa olemasolevate andmete alusel hinnata) esinevad kõrvaltoimed
English: Use in children (aged one month to 18 years)
Estonian: Kasutamine lastel (vanuses üks kuu kuni 18 aastat)
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Estonian: Nõuded asjaomase ravimi perioodiliste ohutusaruannete esitamiseks on sätestatud direktiivi 2001/83/EÜ artikli 107c punkti 7 kohaselt liidu kontrollpäevade loetelus (EURD loetelu) ja iga hilisem uuendus avaldatakse Euroopa ravimite veebiportaalis
English: In babies and children the dose will be calculated from the child's weight.
Estonian: Imikute ja laste puhul arvutatakse annus lähtuvalt lapse kaalust.
English: Take care to scrape any powder from the side of the bowl into the mixture and stir (for about 5 minutes) to make sure that there are no lumps.
Estonian: Kaapige anuma küljel olev kogu pulber hoolikalt mikstuuri sisse ja segage (umbes 5 minutit) ning veenduge, et ei esine tükke.
English: Adverse reactions are ranked according to system organ class, 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 (< 1/10,000), not known (cannot be estimated from the available data).
Estonian: Kõrvaltoimeid on järjestatud organsüsteemi klasside kaupa, kasutades järgmisi kriteeriume: 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), teadmata (ei saa olemasolevate andmete alusel hinnata).
English: If you stop taking this medicine your symptoms may worsen.
Estonian: Ravimi võtmise lõpetamisel võivad sümptomid süveneda.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Estonian: Piiratud tingimustel väljastatav retseptiravim (vt I lisa: Ravimi omaduste kokkuvõte, jaotis 4.2).
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Estonian: Enne ravimi kasutamist lugege infoleht tähelepanelikult läbi, kuna siin on teile vajalikku teavet.
English: UNIQUE IDENTIFIER - 2D BARCODE
Estonian: AINULAADNE IDENTIFIKAATOR - 2D RIBAKOOD
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Estonian: Loomuuringute raames on täheldatud reproduktiivtoksilisust (vt lõik 5.3).
English: Reproduction toxicity
Estonian: Reproduktiivtoksilisus
English: A pharmacy label should be placed on the bottle and include the patient's name, dosing instructions, use by date, name of medicinal product and any other required information to be in compliance with local pharmacy regulations.
Estonian: Pudelile tuleb kleepida apteegi silt, millel on kirjas patsiendi nimi, annustamisjuhised, kõlblikkusaeg, ravimi nimetus ja muud vajalikud andmed vastavalt kohalikele apteekidele kehtivatele juhistele.
English: The correct volumes should preferably be marked on the oral syringe.
Estonian: Eelistatavalt tuleb õige kogus märkida suusüstlale.
English: 80538 Munich
Estonian: 80538 München
English: Developmental toxicity studies in rats, hamsters and primates showed an absence of teratogenic effects.
Estonian: Rottidel, hamstritel ja primaatidel läbi viidud arengutoksilisuse uuringud on näidanud teratogeense efekti puudumist.
English: • phenobarbital (a medicine used for epilepsy)
Estonian: • fenobarbitaal (epilepsia puhul kasutatav ravim).
English: The hard capsules should be taken whole with sufficient water at approximately the same time each day.
Estonian: Kõvakapsleid tuleb võtta piisava koguse veega iga päev umbes samal ajal.
English: Women of childbearing potential should use an effective method of contraception.
Estonian: Rasestumisvõimelised naised peavad kasutama tõhusat rasestumisvastast vahendit.
English: This substance is normally produced by the liver from cholesterol.
Estonian: Tavaliselt toodetakse seda maksas kolesteroolist.
English: A similar effect on CYP27A1, albeit at higher doses, is also seen with sirolimus.
Estonian: Sarnast efekti CYP27A1 puhul, olenemata suuremast annusest, on täheldatud ka siroliimuse puhul.
English: The safety and efficacy in neonates less than one month of age has not been established.
Estonian: Alla ühe kuu vanuste vastsündinutega seoses ei ole ohutust ega efektiivsust määratud.
English: Do not use this medicine after the expiry date which is stated on the carton and blister pack after “EXP”.
Estonian: Ärge kasutage seda ravimit pärast kõlblikkusaega, mis on märgitud pappkarbile ja blisterpakendile pärast märget „KÕLBLIK KUNI“.
English: Reabsorption of chenodeoxycholic acid is variable (29 - 84%).
Estonian: Kenodeoksükoolhappe uuesti imendumise määr on varieeruv (29-84%).
English: • ciclosporin and sirolimus (medicines used to suppress the immune system)
Estonian: • tsüklosporiin ja siroliimus (immuunsüsteemi allasurumiseks kasutatavad ravimid);
English: 2D barcode carrying the unique identifier included.
Estonian: Lisatud on 2D-ribakood, mis sisaldab ainulaadset identifikaatorit.
English: 6.5 Nature and contents of container
Estonian: 6.5 Pakendi olemus ja sisaldus
English: Stir the mixture until all the powder is in suspension.
Estonian: Segage mikstuuri, kuni suspensioonis ei ole pulbrit.
English: Diarrhoea disappeared in 100% (23/23 patients) of the patients who had this symptom at baseline.
Estonian: Kõhulahtisust kadus 100% (23/23 patsienti) patsientidest, kellel see sümptom lähteolukorras esines.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER PACKS
Estonian: MINIMAALSED ANDMED, MIS PEAVAD OLEMA BLISTER- VÕI RIBAPAKENDIL BLISTERPAKENDID
English: - if you are allergic to chenodeoxycholic acid or any of the other ingredients of this medicine (listed in section 6)
Estonian: - kui olete kenodeoksükoolhappe või selle ravimi mis tahes koostisosade (loetletud lõigus 6) suhtes allergiline.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Estonian: Kui olete rase, imetate või arvate end olevat rase või kavatsete rasestuda, pidage enne selle ravimi kasutamist nõu oma arsti või apteekriga.
English: 22 80538 Munich Germany
Estonian: 22 80538 München Saksamaa
English: INFORMATION IN BRAILLE
Estonian: TEAVE BRAILLE'I KIRJAS(PUNKTKIRJAS)
English: Epilepsy resolved in 100% (3/3 patients) and polyneuropathy stabilised or improved in 100% (11/11).
Estonian: Epilepsia leevenes 100% (3/3) patsientidest ja polüneuropaatia stabiliseerus või leevenes 100% (11/11) patsientidest.
English: - Keep this leaflet.
Estonian: - Hoidke infoleht alles.
English: This can cause damage to the affected areas.
Estonian: See võib vastavaid kehaosi kahjustada.
English: The suspension is formed quite easily and is ready when there are no visible lumps or powder left.
Estonian: Suspensiooni valmistamine on suhteliselt lihtne ja suspensioon on valmis, kui selles ei ole näha tükke ega pulbrit.
English: Your doctor may decide to increase your dose depending on how your body responds to treatment.
Estonian: Teie arst võib otsustada annust suurendada vastavalt sellele, kuidas teie organism ravile reageerib.
English: It is a part of the bile, a fluid which helps in the digestion of fat and vitamins from food.
Estonian: See on osa sapist; tegemist on vedelikuga, mis aitab toidus sisalduvat rasva ja vitamiine seedida.
English: Please discuss suitable contraceptive methods with your doctor.
Estonian: Arutlege sobivate rasestumisvastaste vahendite teemal oma arstiga.
English: Disease signs and symptoms resolved, improved or stabilised in a majority of patients over the course of the study.
Estonian: Kogu uuringu ajal haigusnähud ja sümptomid kadusid, leevenesid või stabiliseerisid enamiku patsientide puhul.
English: Rankin and EDSS scores remained stable in 61.5% and 50% of patients respectively, however there was an overall worsening of the mean score from baseline.
Estonian: Rankini ja EDSSi skaala väärtused püsisid stabiilsed vastavalt 61,5% ja 50% patsientide puhul, kuigi lähtevisiidist alates üldine keskmine näitaja halvenes.
English: The suspension produced contains 22.9 mg of sodium per mL, which needs to be taken into consideration by patients on a controlled sodium diet.
Estonian: Valmistatud suspensioon sisaldab 22,9 mg naatriumit ml kohta; seda tuleb arvestada patsientide puhul, kes peavad naatriumi tarbimist jälgima.