FrancophonIA/ELRC3.0 huggingface dataset:
English: By attaching to interleukin-5, mepolizumab blocks its action and thereby reduces the numbers of eosinophils.
Estonian: Interleukiin-5ga seondudes blokeerib mepolisumaab selle toime ja vähendab seega eosinofiilide sisaldust.
English: The benefits of Nucala in severe eosinophilic asthma that is not well controlled by previous treatment have been shown in three main studies, in which it was compared with a placebo (dummy) injection.
Estonian: Nucala kasulikkust raske eosinofiilse astma korral, mis ei allunud piisavalt varasemale ravile, tõendati kolmes põhiuuringus, milles ravimit võrreldi platseebo (näiva ravimi) süstega.
English: An additional study was carried out in children aged 6 years to 11 years which showed that a dose of 40 mg Nucala given under the skin produced comparable levels of active substance in the body to those seen with standard doses in adults.
Estonian: Veel ühes uuringus, milles osalesid 6-11-aastased lapsed, tõendati, et subkutaanne Nucala 40 mg annus tekitas organismis täiskasvanute standardannustega võrreldava toimeainesisalduse.
English: In eosinophilic asthma, symptoms are associated with having too many eosinophils (a type of white blood cell) in the blood and in phlegm in the lungs.
Estonian: Eosinofiilse astma sümptomid on seotud eosinofiilide (teatud tüüpi leukotsüüdid ehk valged verelibled) liigse sisaldusega veres ja kopsusekreedis.
English: For the full list of side effects and restrictions with Nucala, see the package leaflet.
Estonian: Nucala kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: The main measure of effectiveness in these studies was the number of severe attacks (exacerbations) of asthma that occurred during treatment, which was reduced by about half in patients given Nucala.
Estonian: Nendes uuringutes oli efektiivsuse põhinäitaja ravi ajal tekkinud raskete astmahoogude (ägenemiste) arv, mis vähenes Nucalaga ravitud patsientidel ligikaudu poole võrra.
English: How is Nucala used?
Estonian: Kuidas Nucalat kasutatakse?
English: The first study involved 616 adults and adolescents given Nucala every 4 weeks for a year, in addition to their regular asthma medicines.
Estonian: osales 616 täiskasvanut ja noorukit, kellele manustati Nucalat aasta jooksul iga 4 nädala järel lisaks tavapärastele astmaravimitele.
English: Over half (37 of 69) of the patients given Nucala were able to reduce their daily corticosteroid dose by more than 50% to a dose of 5 mg or less, and 10 of them were able to stop corticosteroids altogether, compared with about a third of those given placebo (22 of 66, of whom 5 were able to stop corticosteroids).
Estonian: Üle pooltel Nucalaga ravitud patsientidest (37 patsiendil 69st) oli võimalik ööpäevast kortikosteroidiannust vähendada üle 50% võrra (annuseni 5 mg või vähem) ning 10 patsienti said kortikosteroidide kasutamise täielikult lõpetada.
English: How does Nucala work?
Estonian: Kuidas Nucala toimib?
English: Nucala is an asthma medicine used to treat patients aged 6 years and above with a particular type of asthma called eosinophilic asthma.
Estonian: Nucala on astmaravim, mida kasutatakse vähemalt 6-aastaste eosinofiilse astmaga (teatud tüüpi astma) patsientide raviks.
English: The active substance in Nucala, mepolizumab, is a type of protein called a monoclonal antibody, which attaches to a specific substance in the body.
Estonian: Nucala toimeaine mepolisumaab on monoklonaalne antikeha ehk teatud tüüpi valk, mis seondub organismis spetsiifilise ainega.
English: The recommended dose is 100 mg in patients aged 12 years and above, and 40 mg in patients aged 6 to 11 years.
Estonian: Vähemalt 12-aastastel patsientidel on soovitatav annus 100 mg ning 6-11-aastastel 40 mg. Nucala on ette nähtud pikaajaliseks raviks.
English: What benefits of Nucala have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Nucala kasulikkus?
English: The third study involved 135 mostly adult patients with eosinophilic asthma severe enough to need regular treatment by mouth with corticosteroids (potent anti-inflammatory medicines such as prednisone and prednisolone), and the main measure of effectiveness was how much the corticosteroid dose could be reduced using Nucala for 24 weeks compared with placebo.
Estonian: Kolmandas uuringus osales 135 patsienti (peamiselt täiskasvanud), kes vajasid eosinofiilse astma raskuse tõttu regulaarset ravi suukaudsete kortikosteroididega (tugevad põletikuvastased ravimid, näiteks prednisoon ja prednisoloon).
English: Nucala is available as a solution in a prefilled pen or syringe or as a powder that comes in a vial and is made up into an injection.
Estonian: Nucalat turustatakse lahusena eeltäidetud pensüstlas või süstlas või süstelahuse pulbrina viaalis.
English: An overview of Nucala and why it is authorised in the EU
Estonian: Ülevaade ravimist Nucala ja ELis müügiloa väljastamise põhjendus
English: Nucala is intended for long-term treatment.
Estonian: Nucala on retseptiravim.
English: Mepolizumab attaches to a substance called interleukin-5 which encourages the production and survival of eosinophils.
Estonian: Mepolisumaab seondub eosinofiilide teket ja organismis püsimist soodustava ainega interleukiin-5.
English: Nucala contains the active substance mepolizumab.
Estonian: Nucala sisaldab toimeainena mepolisumaabi.
English: Nucala can only be obtained with a prescription and should be prescribed by a doctor experienced in identifying and treating severe eosinophilic asthma.
Estonian: Ravi peab määrama raske eosinofiilse astma diagnoosimises ja ravis kogenud arst.
English: Reactions at the site of injection and back pain are common, affecting up to 1 patient in 10.
Estonian: Sagedad kõrvalnähud (võivad esineda kuni 1 patsiendil 10st) on ka süstekoha reaktsioonid ja seljavalu.
English: Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands
Estonian: Nucala (mepolisumaab) EMA/466146/2019
English: In very rare cases depression may develop.
Estonian: Väga harvadel juhtudel võib tekkida depressioon.
English: All horses should be revaccinated every three months to maintain immunity.
Estonian: Kõiki hobuseid tuleb immuunsuse säilitamiseks iga kolme kuu järel uuesti vaktsineerida.
English: This summary was last updated in September 2007.
Estonian: Kokkuvõtte viimane uuendus: 09-2007.
English: Horses from four months of age should receive a second injection after four weeks.
Estonian: Hobused alates nelja kuu vanusest peavad saama nelja nädala pärast ka teise süsti.
English: The effectiveness of Equilis StrepE has been studied in safety studies and one main field study.
Estonian: Equilis StrepE efektiivsust uuriti ohutusuuringutes ja ühes põhilises väliuuringus.
English: The horses had not had any disease including strangles in the past and had never been vaccinated.
Estonian: Hobustel ei olnud varem haigusi, sealhulgas nõletõbe esinenud ning neid ei oldud kunagi vaktsineeritud.
English: This is the first vaccine to be licensed for horses in the EU against strangles.
Estonian: See on esimene Euroopa Liidus litsentseeritud vaktsiin hobuste nõletõve vastu.
English: The vaccine is provided together with the solvent, applicator and a syringe with needle.
Estonian: Vaktsiini turustatakse koos lahusti, aplikaatori ja nõelaga süstlaga.
English: Information on the prescription status of this product may be found on the label/outer package.
Estonian: Teave näidustuste kohta selle toote kasutamiseks on esitatud sildil/välispakendil.
English: This is a highly contagious disease and a common bacterial infection in horses.
Estonian: See on hobustel väga nakkav haigus ja levinud bakteriaalne infektsioon.
English: They also had fewer abscesses and fewer lymph nodes affected.
Estonian: Neil oli ka vähem abstsesse ja haigusest oli mõjutatud vähem lümfisõlmi.
English: In case of accidental self-injection, which can cause inflammation with severe pain and swelling, seek medical advice immediately and show the Package Leaflet or the label to the doctor, even if only a small amount has been injected.
Estonian: Juhuslikul enesele süstimisel, mis võib tekitada põletikku koos tugeva valu ja tursega, pöörduda kohe arsti poole ja näidata ravimi pakendi infolehte või etiketti, isegi kui on süstitud väike kogus.
English: No adjuvant or preservative is included.
Estonian: Vaktsiin ei sisalda adjuvante ega säilitusaineid.
English: The highly contagious and common disease caused by this bacterium is commonly called ‘strangles'.
Estonian: Seda väga nakkavat ja levinud haigust, mida põhjustab kõnealune bakter, nimetatakse nõletõveks.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) EQUILIS StrepE EPAR summary for the public
Estonian: EUROOPA AVALIK HINDAMISARUANNE EQUILIS StrepE Kokkuvõte üldsusele
English: Only healthy horses which are at risk of infection should be vaccinated.
Estonian: Vaktsineerida võib ainult terveid hobuseid, kellel on nakatumisoht.
English: After injection, swelling will develop at the injection site within four hours and the injection site may become warm or painful.
Estonian: Pärast süsti tekib süstekohal nelja tunni jooksul turse ning süstekoht võib muutuda soojaks või valulikuks.
English: An increase in body temperature of up to 2°C may occur on the day of vaccination.
Estonian: Vaktsineerimispäeval võib kehatemperatuur tõusta kuni 2 °C võrra.
English: Equilis StrepE is a vaccine.
Estonian: Equilis StrepE on vaktsiin.
English: In rare cases, loss of appetite, fever and shivering may be observed.
Estonian: Harvadel juhtudel võib täheldada isutust, palavikku ja külmavärinaid.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Equilis StrepE to Intervet International B.V. on 7 May 2004.
Estonian: Euroopa Komisjon väljastas Equilis StrepE müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, ettevõttele Intervet International B.V.
English: Equilis StrepE is only for use in healthy horses that are at risk of S. equi infection due to contact with horses from areas where the bacterium is known to be present.
Estonian: Equilis StrepE on ette nähtud kasutamiseks ainult tervetel hobustel, kellel on S. equi nakkuse oht kokkupuutumise tõttu sellisest piirkonnast pärit hobustega, kus seda bakterit teadaolevalt esineb.
English: The bacterium strain included in Equilis StrepE has had some genes removed, so that it grows less well inside the horse's body and is less likely to cause disease.
Estonian: Vaktsiinis Equilis StrepE sisalduvast bakteritüvest on teatavad geenid eemaldatud, et halvendada selle kasvamist hobuse organismis ja vähendada haiguse tekitamise tõenäosust.
English: The vaccine is given as a 0.2-ml injection into the inside of the upper lip.
Estonian: Vaktsiini manustatakse 0,2 ml süstina ülamoka siseküljele.
English: The reaction is greatest at two to three days after injection, but the area affected should not be larger than 3 by 8 cm.
Estonian: Kõnealune reaktsioon on tugevaim kahe-kolme päeva möödumisel süstist, kuid kahjustatud piirkond ei tohiks olla suurem kui 3 x 8 cm. Turse peaks kaduma kolme nädala jooksul ega tohiks mõjutada hobuse isu ega põhjustada talle ebamugavust.
English: In very rare cases an abscess and discharge may develop at the injection site, and the lymph nodes in the head may enlarge, which may be painful for a short while.
Estonian: Väga harvadel juhtudel võib süstekohal tekkida abstsess ja eritis ning pea lümfisõlmed võivad suureneda, mis võib põhjustada mõnda aega valu.
English: The studies demonstrated that Equilis StrepE is effective in the active immunisation of horses from 4 months of age against Streptococcus equi to reduce clinical signs and occurrence of lymph node abscesses.
Estonian: Uuringud näitasid, et Equilis StrepE on efektiivne alates nelja kuu vanuste hobuste aktiivseks immuniseerimiseks Streptococcus equi vastu, et vähendada lümfisõlmede abstsessi kliinilisi tunnuseid ja ilmnemist.
English: When a horse is given the vaccine, the immune system recognises the bacteria as ‘foreign' and makes antibodies against them.
Estonian: Kui hobune saab vaktsiini, peab immuunsüsteem nõrgestatud viirusi võõrasteks ja produtseerib nende vastu antikehi.
English: Other information about Equilis StrepE:
Estonian: Muu teave Equilis StrepE kohta
English: Equilis StrepE contains small amounts of a type of bacterium called S. equi.
Estonian: Equilis StrepE sisaldab väheses koguses bakteritüve S. equi.
English: Equilis StrepE reduces the clinical signs of disease and the occurrence of lymph node abscesses (collections of pus).
Estonian: Equilis StrepE vähendab kliinilisi haigusnähte ja lümfisõlmede abstsesside (mädapaisete) tekkimist.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Equilis StrepE exceed the risks for immunisation of horses against S. equi to reduce clinical signs and occurrence of lymph node abscesses, and recommended that Equilis StrepE be given a marketing authorisation.
Estonian: Veterinaarravimite komitee otsustas, et Equilis StrepE kasulikkus selle kasutamisel hobuste immuniseerimiseks S. equi vastu lümfisõlmede abstsesside kliiniliste nähtude ja esinemise vähendamiseks on suurem kui sellega kaasnevad riskid, ning soovitas anda Equilis StrepE-le müügiloa.
English: Equilis StrepE is a vaccine which contains the active substance live deletion mutant Streptococcus equi bacteria.
Estonian: Equilis StrepE on vaktsiin, mis sisaldab toimeainena elusat nõrgestatud muteerunud Streptococcus equi tüve.
English: In the future, the immune system will be able to produce antibodies more quickly when it is again exposed to the bacteria.
Estonian: Kui siis immuunsüsteem uuesti viirustega kokku puutub, on see võimeline antikehi kiiremini produtseerima.
English: Equilis StrepE is used to vaccinate horses against the respiratory disease caused by the bacteria Streptococcus equi.
Estonian: Equilis StrepE-d kasutatakse hobuste vaktsineerimiseks bakteri Streptococcus equi põhjustatud hingamisteede haiguse vastu.
English: as the local and systemic reactions observed after single, repeated dose and overdose treatment were considered acceptable.
Estonian: näitavad, et Equilis StrepE on hobustele alates nelja kuu vanusest ohutu, sest pärast ühekordset või korduvat annust ja üleannustamisega ravi täheldatud paikseid ja süsteemseid reaktsioone peeti vastuvõetavaks.
English: Fewer of the horses receiving Equilis StrepE had symptoms of strangles.
Estonian: Hobuste seas, kellele manustati Equilis StrepE-d, esines vähem nõletõve sümptomeid.
English: In strangles, the lymph nodes in the head can become large enough to block the airway, causing the horse to have difficulty breathing.
Estonian: Nõletõve puhul võivad pea lümfisõlmed suureneda niivõrd, et takistavad hingamisteid ja tekitavad hobusel hingamisraskusi.
English: Why has Equilis StrepE been approved?
Estonian: Miks Equilis StrepE heaks kiideti?
English: What is Equilis StrepE?
Estonian: Mis on Equilis StrepE?
English: How has Equilis StrepE been studied?
Estonian: Kuidas Equilis StrepE efektiivsust uuriti?
English: What is the risk associated with Equilis StrepE?
Estonian: Millised on Equilis StrepE-ga kaasnevad riskid?
English: How does Equilis StrepE work?
Estonian: Kuidas Equilis StrepE toimib?
English: What benefit has Equilis StrepE shown during the studies?
Estonian: Milles seisneb uuringute põhjal Equilis StrepE kasulikkus?
English: Equilis StrepE is available as a lyophilisate (freeze-dried pellet) which is made up into a suspension for injection.
Estonian: Equilis StrepE-d turustatakse lüofilisaadina (külmkuivatatud graanul) süstesuspensiooni valmistamiseks.
English: What is Equilis StrepE used for?
Estonian: Milleks Equilis StrepE-d kasutatakse?
English: The company presented results of studies on the quality, safety and effectiveness of the medicine.
Estonian: Ettevõte esitas ravimi kvaliteedi-, ohutus- ja efektiivsusuuringute tulemused.
English: What is Ogivri?
Estonian: Mis on Ogivri?
English: The study measured the number of patients who responded to treatment.
Estonian: Uuringus hinnati ravivastusega patsientide arvu.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom structure (called an antigen) that is found on certain cells in the body.
Estonian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom immuunrakke hävitama vähirakke.
English: Withdrawal of the marketing authorisation application for Ogivri (trastuzumab) EMA/564631/2017
Estonian: Müügiloa taotluse tagasivõtmise teave: Ogivri (trastusumaab) EMA/564631/2017
English: Two studies were carried out in healthy volunteers to investigate whether Ogivri produces the same levels of the active substance in the body as the reference medicine Herceptin and therefore has the same effect.
Estonian: Kahes uuringus, milles osalesid terved vabatahtlikud, uuriti, kas Ogivri tekitab organismis sama toimeainesisalduse nagu võrdlusravim Herceptin ja kas ravimil on seega sama toime.
English: Ogivri is a medicine that contains the active substance trastuzumab.
Estonian: Ogivri on ravim, mis sisaldab toimeainena trastusumaabi.
English: On 3 August 2017, Mylan S.A.S.
Estonian: Mylan S.A.S.
English: How does Ogivri work?
Estonian: Kuidas Ogivri toimib?
English: Withdrawal of the marketing authorisation application for Ogivri (trastuzumab)
Estonian: Müügiloa taotluse tagasivõtmise teave: Ogivri (trastusumaab)
English: This means that it was intended to be highly similar to a biological medicine (the ‘reference medicine') already authorised in the European Union called Herceptin.
Estonian: See tähendab, et Ogivri pidi olema sarnane bioloogilise ravimiga (võrdlusravimiga) Herceptin, millel juba on Euroopa Liidus müügiluba.
English: In a third study, Ogivri in combination with a taxane was compared with Herceptin used in combination with a taxane in 500 patients with metastatic breast cancer whose tumour cells overexpressed HER2.
Estonian: Kolmandas uuringus võrreldi Ogivri ja teatava taksaani kombinatsioonravi Herceptini ja teatava taksaani kombinatsioonraviga 500 metastaatilise rinnavähiga patsiendil, kelle kasvajarakkudes esines HER2 üleekspressioon.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it was withdrawing the application because a GMP certificate for the manufacturing site of the product could not be obtained in the time available.
Estonian: Ettevõtte kirjas, milles ta teatab Euroopa Ravimiametile oma taotluse tagasivõtmisest, märgib ettevõte, et võtab taotluse tagasi, sest ei suutnud ettenähtud aja jooksul hankida ravimi tootmiskoha jaoks hea tootmistava sertifikaati.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not provided enough documentation to support the application for Ogivri.
Estonian: Seetõttu oli inimravimite komitee müügiloa taotluse tagasivõtmise ajal arvamusel, et ettevõte ei ole esitanud piisavalt andmeid ravimi Ogivri taotluse toetuseks.
English: Ogivri was developed as a ‘biosimilar' medicine.
Estonian: Ogivri töötati välja bioloogiliselt sarnase ravimina.
English: Trastuzumab also stops HER2 producing signals that cause the tumour cells to grow.
Estonian: Trastusumaab peatab ka HER2 signaalid, mis stimuleerivad vähirakkude kasvu.
English: The company informed the CHMP that the withdrawal does not impact ongoing clinical trials with Ogivri.
Estonian: Ettevõte teatas inimravimite komiteele, et taotluse tagasivõtmine ei mõjuta praegu Ogivri kliinilistes uuringutes osalevaid patsiente.
English: The CHMP's main concern was the lack of a valid certificate confirming that the manufacturing facility of the product complies with good manufacturing practice (GMP) requirements.
Estonian: Inimravimite komitee väljendas kahtlust peamiselt selle suhtes, et ravimi tootmiskohal puudus hea tootmistava nõuetele vastavust kinnitav sertifikaat.
English: Ogivri was to be used only when the cancer has been shown to ‘overexpress HER2': this means that the cancer produces a protein called HER2 in large quantities on the surface of the tumour cells, which makes the tumour cells grow more quickly.
Estonian: Ogivrit kavatseti kasutada üksnes HER2 üleekspressiooniga vähi ravis (kui kasvajarakkude pinnal tekib palju valku HER2, mis stimuleerib kasvajarakkude kiiret kasvu).
English: Ogivri was expected to be used to treat early and metastatic breast cancer and metastatic gastric (stomach) cancer.
Estonian: Ogivrit kavatseti kasutada varases staadiumis metastaatilise rinnavähi ja metastaatilise maovähi raviks.
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 Ogivri could not have been approved for the treatment of breast cancer and gastric cancer.
Estonian: Tuginedes esitatud andmete analüüsile, nägi komitee taotluse tagasivõtmise ajal põhjust ettevaatlikkuseks ja oli esialgsel seisukohal, et ravimi Ogivri kasutamist rinnavähi ja maovähi raviks ei ole võimalik heaks kiita.
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific
Estonian: Ogivri ja Herceptini toimeaine trastusumaab on monoklonaalne antikeha (teatud valk), mis tunneb ära teatud antigeeni (organismi teatud rakkudel leiduva spetsiifilise struktuuri) ja seondub sellega.
English: Trastuzumab has been designed to attach to HER2.
Estonian: Trastusumaab seondub valguga HER2.
English: What was Ogivri expected to be used for?
Estonian: Milleks kavatseti Ogivrit kasutada?
English: It was to be available as a powder to be made up into a solution for infusion (drip) into a vein.
Estonian: Seda kavatseti turustada veenisiseselt manustatava infusioonilahuse (veeni tilgutatava lahuse) pulbrina.
English: officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ogivri, for the treatment of breast cancer and gastric cancer.
Estonian: teatas 3. augustil 2017 ametlikult inimravimite komiteele oma soovist võtta tagasi ravimi Ogivri müügiloa taotlus.
English: By attaching to HER2, trastuzumab activates cells of the immune system, which then kill the tumour cells.
Estonian: HER2-ga seondudes aktiveerib trastusumaab teatud
English: SCIENTIFIC CONCLUSIONS FOR AMENDMENT OF THE PRODUCT INFORMATION
Estonian: TEADUSLIKUD JÄRELDUSED TOOTEINFO MUUTMISEKS
English: During the CHMP meeting of February 2005, discussions on cardiovascular safety took place.
Estonian: Inimtervishoius kasutatavate ravimite komitee 2005. aasta veebruari koosolekul toimus arutelu kardiovaskulaarse ohutuse teemal.
English: - recommended follow up measures to further investigate the safety of celecoxib.
Estonian: - soovitas rakendada tselekoksiibi ohutuse edasiseks täiendavaks uurimiseks järelmeetmeid.
English: Between November 2004 and June 2005, the MAH made oral explanations to the CHMP on cardiovascular and skin safety aspects for Onsenal on 18 January, 15 February, and 25 May 2005.
Estonian: Ajavahemikul 2004. aasta novembrist 2005. aasta juunini andis müügiloa hoidja inimtervishoius kasutatavate ravimite komiteele suuliselt selgitusi Onsenali kardiovaskulaarse ja nahaohutuse aspektide kohta 18. jaanuaril, 15. veebruaril ja 25. mail 2005.
English: These data resulted in the worldwide withdrawal of Vioxx (rofecoxib) from the market on 30 September 2004 by the MAH and raised questions regarding the cardiovascular safety of other Cox-2 inhibitors.
Estonian: Nende andmete tulemusena kõrvaldas müügiloa hoidja Vioxx'i (rofekoksiib) 30. septembril 2004 müügilt kogu maailmas ning tõstatus küsimus teiste Cox-2 inhibiitorite kardiovaskulaarse ohutuse kohta.
English: The CHMP confirmed changes to the Product Information already introduced through the annual reassessment adopted in April 2005 further to the February USR and requested further changes.
Estonian: Inimtervishoius kasutatavate ravimite komitee kinnitas muutused, mis olid tooteinfosse sisse viidud juba aprillis 2005 veebruarikuise ohutuspiirangu alusel vastu võetud II tüüpi muudatuse kaudu, ning taotles edasiste muutuste tegemist.