FrancophonIA/ELRC3.0 huggingface dataset:
English: For more information about using NeuroBloc, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet NeuroBloci kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
English: The active substance in NeuroBloc, botulinum toxin type B, is a well-known toxic substance produced by the bacterium Clostridium botulinum.
Estonian: NeuroBloci toimeaine B-tüübi botulismitoksiin on hästi tuntud toksiline aine, mida toodab bakter Clostridium botulinum.
English: The effect of an injection of NeuroBloc gradually wears off over time.
Estonian: NeuroBloci süstimise toime kaob aja jooksul järk-järgult.
English: Cervical dystonia, which is also known as torticollis, is a disorder when the neck muscles contract, causing abnormal movement and twisting of the neck and unusual positioning of the head.
Estonian: Kaelalihaste düstoonia, mida nimetatakse ka tortikolliseks (kõverkaelsus), on häire, mille korral kaelalihased tõmbuvad kokku, põhjustades kaela ebanormaalset liikumist ja kõverdumist ning pea ebaharilikku asendit.
English: Three of the studies included patients who had stopped responding to type A botulinum toxin (another type of botulinum toxin that may also be used to treat cervical dystonia), and the fourth only included patients who did respond to type A toxin.
Estonian: Kolmes uuringus osalesid patsiendid, kellel ei tekkinud enam A-tüübi botulismitoksiiniga (veel üks botulismitoksiini tüüp, mida võib kasutada kaela düstoonia raviks) ravivastust, ja neljandas osalesid ainult patsiendid, kellel tekkis A-tüübi botulismitoksiiniga ravivastus.
English: NeuroBloc treatment starts with 10,000 U, divided into equal doses and injected directly into the two to four muscles in the neck and shoulders that are most affected.
Estonian: Ravi NeuroBlociga alustatakse 10 000 U annusega, mis jagatakse võrdseteks osadeks ja süstitakse kahte kuni nelja enim mõjutatud kaela- ja õlavöötmelihasesse.
English: NeuroBloc is a medicine used to treat cervical dystonia in adults.
Estonian: NeuroBloc on ravim, mida kasutatakse kaelalihaste düstoonia raviks täiskasvanutel.
English: When injected directly into a muscle it reduces the release of acetylcholine and muscle contraction in the affected neck or shoulder muscles, thereby relieving the patient's symptoms.
Estonian: Otse lihasesse süstimisel vähendab ravim atsetüülkoliini vabanemist ja lihaste kokkutõmbumist kaela- või õlavöötmelihastes, millesse seda süstitakse, vähendades seeläbi patsiendi sümptomeid.
English: The most common side effects with NeuroBloc (which may affect more than 1 in 10 people) are dry mouth, headache (in patients new to treatment with botulinum toxins), dysphagia (difficulty swallowing) and pain at the site of the injection.
Estonian: NeuroBloci kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on suukuivus, peavalu (esmakordselt botulismitoksiinidega ravi saavatel patsientidel), düsfaagia (neelamisraskused) ja valu süstekohas.
English: Acetylcholine is needed to transfer electrical impulses from the nerves to the muscles in order for the muscles to contract.
Estonian: Atsetüülkoliin on vajalik elektriimpulsside ülekandeks närvidelt lihastele, mis põhjustavad lihaste kokkutõmbumise.
English: What are the risks associated with NeuroBloc?
Estonian: Mis riskid NeuroBlociga kaasnevad?
English: It is only used in hospitals, by a doctor who has experience in the treatment of cervical dystonia and in the use of botulinum toxins.
Estonian: Ravimit kasutatakse üksnes haiglas ning seda tohib manustada ainult kaela düstoonia ravis ja botulismitoksiinide kasutamises kogenud arst.
English: The toxin is the cause of a type of food poisoning called botulism, where patients suffer from muscle weakness and paralysis.
Estonian: Toksiin põhjustab teatud tüüpi toidumürgitust, botulismi, mille korral patsientidel tekib lihasnõrkus ja -halvatus.
English: NeuroBloc is available as a solution for injection (5,000 units [U] per millilitre) and it can only be obtained with a prescription.
Estonian: Neurobloci turustatakse süstelahusena (5000 ühikut [U] milliliitri kohta).
English: How does NeuroBloc work?
Estonian: Kuidas NeuroBloc toimib?
English: For the full list of side effects reported with NeuroBloc, see the package leaflet.
Estonian: NeuroBloci kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: The toxin reduces the release of acetylcholine from the nerve endings.
Estonian: Toksiin vähendab atsetüülkoliini vabanemist närvilõpmetest.
English: NeuroBloc (botulinum toxin type B)
Estonian: Neurobloc (B-tüübi botulismitoksiin)
English: How is NeuroBloc used?
Estonian: Kuidas NeuroBloci kasutatakse?
English: An overview of NeuroBloc and why it is authorised in the EU
Estonian: Ülevaade ravimist NeuroBloc ja ELis müügiloa väljastamise põhjendus
English: NeuroBloc contains the active substance botulinum toxin type B.
Estonian: NeuroBloc sisaldab toimeainena B-tüübi botulismitoksiini.
English: The medicine improved the TWSTRS score of the non-responders to type A botulinum toxin as well as the score of the responders.
Estonian: NeuroBloc parandas TWSTRSi skoori nii patsientidel, kellel ei tekkinud A-tüübi botulismitoksiiniga ravivastust, kui ka neil, kellel tekkis ravivastus.
English: In NeuroBloc, the toxin is used as a muscle relaxant.
Estonian: NeuroBlocis kasutatakse toksiini lihaslõõgastina.
English: NeuroBloc was more effective than placebo (a dummy treatment) at improving symptoms of cervical dystonia in four studies involving a total of 392 adults.
Estonian: Neljas uuringus, milles osales kokku 392 täiskasvanut, oli NeuroBloc kaela düstoonia sümptomite leevendamisel efektiivsem kui platseebo (näiv ravim).
English: What benefits of Neurobloc have been shown in studies?
Estonian: Milles seisneb uuringute põhjal NeuroBloci kasulikkus?
English: In the study, 27 children (aged 3 to 15 years) have been receiving IPLEX for up to one year.
Estonian: Uuringus osalevale 27 lapsele (3-15-aastased) on manustatud IPLEXi kuni ühe aasta jooksul.
English: Patients had also not been treated for long enough to show that the medicine's effect continues when used for longer than one year.
Estonian: Patsiente poldud ravitud ka piisavalt kaua tõendamaks, et ravimi toime püsib, kui seda kasutada kauem kui üks aasta.
English: ‘Primary' means that there is no known reason for the insensitivity.
Estonian: Primaarne tähendab, et insensitiivsuse põhjus ei ole teada;
English: International non-proprietary name (INN): mecasermin rinfabate
Estonian: Rahvusvaheline mittekaubanduslik nimetus (INN): mekasermiinrinfabaat
English: The main measure of effectiveness was based on the speed of growth during the study, compared to that in the year before the study began.
Estonian: Efektiivsust mõõdeti põhiliselt kasvu kiiruse järgi uuringu ajal, võrreldes kasvu kiirusega uuringu algusele eelnenud aastal.
English: The application was at day 120 when the company withdrew.
Estonian: Taotluse menetlemine oli 120. päeva seisus, kui ettevõte taotluse tagasi võttis.
English: If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Estonian: Juhul kui te osalete kliinilises uuringus või selle ravimi eriloaga kasutamise programmis ja soovite oma ravi kohta lisateavet, võtke palun ühendust arstiga, kes teile selle ravi määras.
English: What is IPLEX?
Estonian: Mis on IPLEX?
English: The CHMP had formulated a list of questions to be answered by the company, but the company had not yet responded to them.
Estonian: Inimtervishoius kasutatavate ravimite komitee oli ettevõttele vastamiseks koostanud küsimuste loetelu, kuid ettevõte ei olnud neile veel vastanud.
English: Its effectiveness has been studied in one clinical trial, which is still ongoing.
Estonian: Selle efektiivsust uuriti ühes kiinilises uuringus, mis ei ole veel lõpule viidud.
English: Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Estonian: Pärast seda, kui ettevõte on esitatud küsimustele vastanud, vaatab inimtervishoius kasutatavate ravimite komitee need läbi ning võib enne oma arvamuse väljendamist esitada ettevõttele 180. päeval veel täiendavaid küsimusi.
English: The letter from the company notifying the EMEA of the withdrawal of the application is available here.
Estonian: Ettevõtte taotluse tagasivõtmise avaldus on avaldatud EMEA veebilehel ja on kättesaadav siin.
English: They also had major concerns regarding the way in which the medicine's effectiveness had been assessed, especially regarding the type of patients that have been included in the clinical trial.
Estonian: Samuti nägi komitee olulist probleemi selles, kuidas ravimi efektiivsust oli hinnatud, eelkõige seoses kliinilisse uuringusse kaasatud patsientide valikuga.
English: This may allow IGF-I to circulate in the body at higher levels and for longer periods than unbound IGF-I.
Estonian: See võimaldab IGF-I-l ringelda kehas suuremas koguses ja kauem kui sidumata IGF-I-l.
English: IPLEX was to be used in children with short stature whose bodies have problems handling growth hormone because:
Estonian: IPLEXi kavatseti kasutada lühikest kasvu lastel, kelle kehal on kasvuhormooniga probleeme, sest:
English: • they have primary insensitivity to the hormone, so that injected growth hormone has no effect.
Estonian: • neil on hormooni suhtes primaarne insensitiivsus, mistõttu süstitav kasvuhormoon ei avalda toimet.
English: Because the number of patients with these diseases is low, they are considered ‘rare', and mecasermin rinfabate was designated an ‘orphan medicine' (a medicine used in rare diseases) on 20 June 2006.
Estonian: Kuna nimetatud haigustega patsiente on vähe ja need haigused haruldased, omistati mekasermiinrinfabaadile 20. juunil 2006 harva kasutatava ravimi nimetus.
English: Mecasermin rinfabate is produced by a method known as ‘recombinant DNA technology': it is made by bacteria that have received a gene (DNA), which makes them able to produce it.
Estonian: Mekasermiinrinfabaati toodetakse rekombinant-DNAtehnikaks nimetataval meetodil: seda toodavad bakterid, millesse on viidud selle produtseerimist võimaldav geen (DNA).
English: IPLEX is a solution for injection containing 60 mg/ml mecasermin rinfabate as the active substance.
Estonian: IPLEX on süstelahus, mis sisaldab toimeainena 60 mg/ml mekasermiinrinfabaati.
English: In IPLEX, IGF-I is bound to IGFBP-3 because this mimics the way in which IGF-1 is carried in the body.
Estonian: IGF-I on IPLEXis seondunud IGFBP-3-ga, kuna see matkib IGF-I kehas edasikandumise viisi.
English: In the body, natural growth hormone promotes growth in children by stimulating the body to produce IGF-I. IGF-I then stimulates the bones to grow.
Estonian: Looduslik kasvuhormoon edendab kehas lapse kasvu, stimuleerides keha IGF-I-i produtseerima.
English: Therefore, at the time of the withdrawal, the CHMP's view was that the benefit of IPLEX had not been sufficiently demonstrated and did not outweigh the identified risks.
Estonian: Seetõttu oli inimtervishoius kasutatavate ravimite komitee taotluse tagasivõtmise ajal arvamusel, et IPLEXi kasulikkus pole piisavalt tõestatud ja ei kaalu üles tuvastatud ohte.
English: What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with IPLEX?
Estonian: Millised on taotluse tagasivõtmise tagajärjed IPLEXi kliinilistes uuringutes või eriloaga kasutamise programmides osalevatele patsientidele?
English: On 26 March 2007, Insmed Europe Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for IPLEX, for the treatment of patients with primary growth hormone insensitivity and of patients with growth hormone gene deletion who have developed neutralising antibodies to growth hormone.
Estonian: 26. märtsil 2007 teavitas Insmed Europe Ltd ametlikult inimtervishoius kasutatavate ravimite komiteed oma soovist võtta tagasi taotlus IPLEXi müügiloa saamiseks kasvuhormooni suhtes primaarse insensitiivsusega patsientide raviks ja kasvuhormooni geeni deletsiooniga patsientide raviks, kellel on tekkinud neutraliseerivad antikehad kasvuhormoonile.
English: • they are not able to make growth hormone and have received growth hormone in the past, but have developed neutralising antibodies, special proteins than can prevent injected growth hormone from having an effect.
Estonian: • nad ei ole suutelised kasvuhormooni produtseerima ja on varem kasvuhormooni saanud, kuid neil on tekkinud neutraliseerivad antikehad - teatud valgud, mis võivad süstitud kasvuhormooni toime välistada.
English: IPLEX provides IGF-I directly, as part of the binary protein, and this allows bone growth while bypassing the need for growth hormone itself.
Estonian: IPLEXiga manustatakse vahetult IGF-I-d, osana binaarvalgust, ning see võimaldab kasvuhormooni enda vajadusest mööda minna.
English: The company informed the CHMP that the withdrawal will have no impact on the ongoing clinical study of the safety and efficacy of IPLEX in the treatment of Growth Hormone Insensitivity Syndrome.
Estonian: Ettevõte teavitas inimtervishoius kasutatavate ravimite komiteed, et tagasivõtmine ei mõjuta pooleliolevat kliinilist uuringut IPLEXi ohutuse ja efektiivsuse kohta kasvuhormooni suhtes insensitiivsuse sündroomi ravis.
English: The active substance in IPLEX, mecasermin rinfabate, is a binary protein made up of two proteins that are normally produced by the body: insulin-like growth factor I (IGF-I) and insulin-like growth factor binding protein 3 (IGFBP-3).
Estonian: IPLEXis toimeainena sisalduv mekasermiinrinfabaat on binaarvalk, mis koosneb kahest kehas tavapäraselt moodustuvast valgust: insuliinisarnasest kasvutegurist I (IGF-I) ja insuliinisarnase kasvuteguriga seonduvast valgust 3 (IGFBP-3).
English: The CHMP had major concerns regarding the way the medicine is manufactured, and they were unsure that the medicine that would have been marketed would have been comparable to the one used in the clinical trial.
Estonian: Inimtervishoius kasutatavate ravimite komitee nägi peamist probleemi ravimi tootmise viisis ning komitee ei saanud olla kindel, et turule toodav ravim on võrreldav kliinilises uuringus kasutatud ravimiga.
English: The effects of IPLEX were first tested in experimental models before being studied in humans.
Estonian: Enne inimuuringuid kontrolliti IPLEXi toimet muude katsetega.
English: London, 26 April 2007 Doc.
Estonian: London, 26. aprill 2007 Dokumendi nr EMEA/231337/2007
English: Based on the review of the data at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that IPLEX could not have been approved for the treatment of patients with primary growth hormone insensitivity and of patients with growth hormone gene deletion who have developed neutralising antibodies to growth hormone.
Estonian: Tuginedes läbivaadatud andmetele, nägi inimtervishoius kasutatavate komitee taotluse tagasivõtmise ajal mõningaid probleeme ning oli esialgsel arvamusel, et IPLEXi ei saa primaarse insensitiivsusega patsientide ega kasvuhormooni geeni deletsiooniga patsientide, kellel on tekkinud kasvuhormoonile neutraliseerivad antikehad, raviks heaks kiita.
English: How is IPLEX expected to work?
Estonian: Missugune on IPLEXi eeldatav toime?
English: What was IPLEX expected to be used for?
Estonian: Milleks kavatseti IPLEXi kasutada?
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING AUTHORISATION APPLICATION for IPLEX
Estonian: TEAVE MÜÜGILOA TAOTLUSE TAGASIVÕTMISE KOHTA
English: Tolperisone-containing products are currently approved in the following EU countries: Bulgaria, Cyprus, Czech Republic, Germany, Hungary, Latvia, Lithuania, Poland, Romania and Slovak Republic.
Estonian: Tolperisooni sisaldavad ravimid on praegu heaks kiidetud järgmistes Euroopa Liidu riikides: Bulgaaria, Küpros, Leedu, Läti, Poola, Rumeenia, Saksamaa, Slovakkia, Tšehhi Vabariik ja Ungari.
English: On 15 July 2011, Germany triggered a referral under Article 31 of Directive 2001/83/EC.
Estonian: 15. juulil 2011 tegi Saksamaa direktiivi 2001/83/EÜ artikli 31 kohase esildise.
English: Tolperisone exerts its action at 3 levels:
Estonian: Tolperisoon mõjub kolmel tasemel:
English: The precise mechanism of action is not fully known.
Estonian: Täpne toimemehhanism ei ole täielikult teada.
English: The divergent positions are appended to this opinion.
Estonian: Lahknevad seisukohad on lisatud arvamusele.
English: The following indications have been approved in at least one Member State (specific wording of the indication may vary from product to product):
Estonian: Järgmised näidustused on heaks kiidetud vähemalt ühes liikmesriigis (täpne sõnastus võib eri ravimitel olla erinev):
English: Therefore, in accordance with Article 32(4)(d) of Directive 2001/83/EC, the CHMP recommended:
Estonian: Sel põhjusel soovitas inimravimite komitee direktiivi 2001/83/EÜ artikli 32 lõike 4 punkti d kohaselt:
English: Overall summary of the scientific evaluation of tolperisone-containing products (see Annex I)
Estonian: Teaduslikud järeldused Tolperisooni sisaldavate ravimite (vt I lisa) teadusliku hindamise üldkokkuvõte
English: This indication is mainly supported by the Stamenova (2005) study, which is of acceptable quality.
Estonian: Näidustust toetab peamiselt uuring Stamenova (2005), mille kvaliteet on vastuvõetav.
English: It is therefore considered that efficacy in these indications has not been demonstrated.
Estonian: Sel põhjusel leitakse, et nendel näidustustel ei ole efektiivsust tõendatud.
English: Neurolahyrism affects predominantly young adult males at time of famine and generally does not occur in European countries, therefore generalisation of the study results to the existing indication is questionable.
Estonian: Neurolatürism esineb peamiselt noortel täiskasvanud meestel nälgimise korral ja seda ei esine tavaliselt Euroopa riikides, mistõttu uuringutulemuste üldistamine olemasoleva näidustuse jaoks on küsitav.
English: Tolperisone is a centrally acting muscle relaxant first synthesized in 1956, and used in clinical practice since the 1960's.
Estonian: Tolperisoon on tsentraalse toimega lihasrelaksant, mis sünteesiti esimest korda 1956. aastal ja mida kasutatakse kliinilises praktikas alates 1960. aastatest.
English: This effect is well demonstrated in several animal models.
Estonian: Toime on hästi tõendatud mitme loommudeliga.
English: The data available on this indication comes from two observational studies (1986 and 1989) with a total of 166 patients, where 450 mg tolperisone were given daily for a few weeks.
Estonian: Näidustuse olemasolevad andmed pärinevad kahest jälgimisuuringust (1986 ja 1989), milles osales kokku 166 patsienti, kellele manustati mõne nädala jooksul 450 mg/d tolperisooni.
English: The CHMP was therefore requested to give its opinion on whether the marketing authorisations for medicinal products containing tolperisone, and associated names should be maintained, varied, suspended or withdrawn.
Estonian: Inimravimite komiteel paluti seepärast anda arvamus, kas tolperisooni sisaldavate ravimite ja sarnaste nimetuste müügiload tuleb säilitada, muuta, peatada või tühistada.
English: The only studies that exist are of observational nature, were conducted in a heterogeneous population and contain extremely limited information.
Estonian: Ainsad olemasolevad uuringud on jälgimisuuringud, mis toimusid heterogeenses populatsioonis ja sisaldavad äärmiselt piiratud teavet.
English: The mechanism of tolperisone-related hypersensitivity is unknown.
Estonian: Tolperisooniga seotud ülitundlikkuse mehhanism ei ole teada.
English: Relevant studies also exist in the locomotor indication, the majority of which failed to demonstrate the efficacy of the product.
Estonian: Asjakohased uuringud on olemas ka lokomotoorse näidustuse korral, kuid neist enamik ei suutnud tõendada ravimi efektiivsust.
English: Finally, the Hodinka 2001 study also failed to demonstrate a relevant difference in the primary endpoint, and the only transient significant difference observed was in the Roland-Morris Disability Scale at day 7, having disappeared at day 14.
Estonian: Ka uuringus Hodinka (2001) ei tõendatud olulist erinevust esmases tulemusnäitajas ja ainus täheldatud ajutine oluline erinevus Roland-Morrise invaliidsuse skaalal tekkis 7. päeval ja kadus 14. päeval.
English: In particular, the CHMP re-assessed 4 pooled analyses (Alken-2005, Farkas-2011, Varga2011a and Varga-2011b) of randomised clinical trials (Pratzel 1995, Struck 2002 and Struck 2004) and requested the Biostatistics Working Party (BSWP) to give its view on the pooled analyses data.
Estonian: Eelkõige vaatas inimravimite komitee uuesti läbi 4 koondanalüüsi (Alken 2005, Farkas 2011, Varga 2011a ja Varga 2011b) ja randomiseeritud kliiniliste uuringute (Pratzel 1995, Struck 2002 ja Struck 2004) tulemused ning palus komitee biostatistika töörühmal esitada koondanalüüside kohta arvamus.
English: A causal relationship with tolperisone was assessed as at least possible in 90% of all hypersensitivity reactions.
Estonian: Põhjuslik suhe tolperisooniga hinnati vähemalt võimalikuks 90%-l kõigist ülitundlikkusreaktsioonidest.
English: It is also noted that the reporting rates in Germany appear to be significantly higher than those calculated through the MAH's database.
Estonian: Samuti märgiti, et teatamise sagedus Saksamaal näib olevat oluliselt suurem kui müügiloa hoidja andmebaasi alusel arvutatu.
English: In contrast, the prematurely terminated Avigen study AV650-018 (2007) failed to demonstrate any effect in the multiple sclerosis population.
Estonian: Erinevalt eelmisest ei suutnud Avigeni uuring AV650-018 (2007) näidata mingit toimet hulgiskleroosiga populatsioonis.
English: It can therefore be concluded that of the four main studies in this indication, which became available after the initial marketing authorisation was granted, one suffers from substantial deficiencies and the remaining 3 failed to demonstrate an effect on the efficacy outcome.
Estonian: Seetõttu võib järeldada, et näidustusega seotud neljast põhiuuringust, mis avaldati pärast esmase müügiloa andmist, on üks oluliste puudustega ja ülejäänud kolm ei tõendanud mingit mõju efektiivsusnäitajatele.
English: • The Committee considered that the risk of hypersensitivity reactions is more significant than previously identified.
Estonian: • komitee leidis, et ülitundlikkusreaktsioonide risk on olulisem, kui oli tuvastatud varem;
English: The actively controlled study was open label, used pentoxyphyllin as control and involved a total of 70 patients.
Estonian: Aktiivse kontrollrühmaga uuring oli avatud, kasutas kontrollina pentoksüfülliini ja selles osales kokku 70 patsienti.
English: The only study in this indication with a positive outcome contains significant methodological deficiencies which preclude any conclusion on the efficacy of the product.
Estonian: Ainus positiivse lõpptulemusega uuring sel näidustusel sisaldab olulisi metoodilisi puudusi, mis välistavad järeldused ravimi efektiivsuse kohta.
English: The Feher study (1985) used the Rivermead scale, which has shown high validity and reliability in assessment of motor function in stroke patients.
Estonian: Uuringus Feher (1985) kasutati Rivermeadi skaalat, mis on näidanud suurt valiidsust ja usaldusväärsust insuldiga patsientide motoorse funktsiooni hindamisel.
English: In both studies, tolperisone is given to a very heterogeneous population as part of a rehabilitation program, so it is not possible to isolate the effect of tolperisone from the effect of other interventions and therefore this data does not support the evidence of efficacy in this particular indication.
Estonian: Mõlemas uuringus manustati tolperisooni väga heterogeensele populatsioonile taastusravi programmi vältel, mistõttu ei saa isoleerida tolperisooni toimet muude ravimite toimest ning seetõttu ei tõenda need andmed efektiivsust sel konkreetsel näidustusel.
English: In addition, all patients started by receiving doses above the approved dose.
Estonian: Lisaks said kõik patsiendid algusest peale heakskiidetud annusest suuremaid annuseid.