FrancophonIA/ELRC3.0 huggingface dataset:
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 Repaglinide Accord.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: This is a summary of the European public assessment report (EPAR) for Repaglinide Accord.
Estonian: See on ravimi Repaglinide Accord Euroopa avaliku hindamisaruande kokkuvõte.
English: Repaglinide Accord is a ‘generic medicine'.
Estonian: Repaglinide Accord on geneeriline ravim.
English: If patients are transferred from another anti-diabetes medicine, the recommended starting dose is 1 mg.
Estonian: Kui patsienti raviti enne muu diabeediravimiga, mis vahetatakse välja Repaglinide Accordi vastu, on soovitatav algannus 1 mg.
English: The CHMP concluded that, in accordance with EU requirements, Repaglinide Accord has been shown to have comparable quality and to be bioequivalent to the reference medicine.
Estonian: Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud Repaglinide Accordi võrdväärne kvaliteet ja bioekvivalentsus võrdlusravimiga.
English: EPAR summary for the public repaglinide
Estonian: Kokkuvõte üldsusele repagliniid
English: Because Repaglinide Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Estonian: Et Repaglinide Accord on geneeriline ravim ja võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: It is used together with diet and exercise to lower blood glucose (sugar) levels in patients whose hyperglycaemia (high blood glucose levels) cannot be controlled by diet, weight reduction and exercise.
Estonian: Repaglinide Accordi kasutatakse koos dieedi ja kehalise koormusega, et vähendada vere glükoosisisaldust (nn veresuhkrut) patsientidel, kelle hüperglükeemiat (vere liigset glükoosisisaldust) ei ole võimalik ainuüksi dieedi, kehakaalu alandamise ja kehaliste harjutustega reguleerida.
English: Because Repaglinide Accord is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine.
Estonian: Et Repaglinide Accord on geneeriline ravim, piirdusid uuringud katsetega, milles näidati selle bioekvivalentsust võrdlusravimitega.
English: Repaglinide Accord helps the pancreas to produce more insulin at mealtimes and is used to control type 2 diabetes.
Estonian: Repaglinide Accord soodustab insuliini tekkimist kõhunäärmes söögi ajal ning seda kasutatakse II tüüpi diabeedi raviks.
English: Therefore, the CHMP's view was that, as for NovoNorm, the benefit outweighs the identified risk.
Estonian: Seetõttu otsustas inimravimite komitee, et nagu ka NovoNormi korral, on Repaglinide Accordi kasulikkus suurem kui sellega kaasnevad riskid.
English: Repaglinide Accord may also be used with metformin (another anti-diabetes medicine) in type 2 diabetes patients whose blood glucose levels are not satisfactorily controlled on metformin alone.
Estonian: Repaglinide Accordi tohib kasutada ka koos metformiiniga (samuti diabeediravim) II tüüpi diabeediga patsientidel, kellel ravi ainult metformiiniga ei anna rahuldavaid tulemusi.
English: Repaglinide Accord is used in patients who have type 2 diabetes (non-insulin-dependent diabetes).
Estonian: Repaglinide Accordi kasutatakse II tüüpi diabeediga (insuliinisõltumatu suhkurtõvega) patsientide raviks.
English: Repaglinide Accord can also be used for type 2 diabetes patients whose
Estonian: Repaglinide Accordi saab kasutada ka nende II tüüpi
English: What are the benefits and risks of Repaglinide Accord?
Estonian: Milles seisneb Repaglinide Accordi kasulikkus ja mis riskid ravimiga kaasnevad?
English: What is Repaglinide Accord?
Estonian: Mis on Repaglinide Accord?
English: Why has Repaglinide Accord been approved?
Estonian: Miks Repaglinide Accord heaks kiideti?
English: How is Repaglinide Accord used?
Estonian: Kuidas Repaglinide Accordi kasutatakse?
English: How has Repaglinide Accord been studied?
Estonian: Kuidas Repaglinide Accordi uuriti?
English: What is Repaglinide Accord used for?
Estonian: Milleks Repaglinide Accordi kasutatakse?
English: blood glucose levels are usually controlled well on diet, but are experiencing temporary loss of blood glucose control.
Estonian: diabeediga patsientide ravimiseks, kellel saab glükoosi sisaldust veres tavaliselt reguleerida dieediga, kuid mis dieediga reguleerimisele ajuti siiski ei allu.
English: How does Repaglinide Accord work?
Estonian: Kuidas Repaglinide Accord toimib?
English: 3 NHBA (Neisserial Heparin Binding Antigen), NadA (Neisseria adhesin A), fHbp (factor H binding protein)
Estonian: 3 NHBA (Neisseriaalne hepariini siduv antigeen), NadA (Neisseria adhesiin A), fHbp (faktor H-d siduv valk)
English: 1 produced in E. coli cells by recombinant DNA technology 2 adsorbed on aluminium hydroxide (0.5 mg Al3+)
Estonian: 1 toodetud E. coli rakkudes rekombinantse DNA-tehnoloogia abil 2 adsorbeeritud alumiiniumhüdroksiidile (0,5 mg Al³+)
English: Outer membrane vesicles (OMV) from Neisseria meningitidis group B strain NZ98/254 measured as amount of total protein containing the PorA P1.4 2
Estonian: välismembraani vesiikulid (OMV, outer membrane vesicles) B-grupi Neisseria meningitidis'e tüvest NZ98/254 mõõdetuna poriini (PorA P1,4) sisaldavate valkude koguhulgana 2
English: Recombinant Neisseria meningitidis group B fHbp fusion protein 1, 2, 3
Estonian: rekombinantne B-grupi Neisseria meningitidis'e fHbp-fusioonvalk 1, 2, 3
English: --1 One dose (0.5 ml) contains: Recombinant Neisseria meningitidis group B NHBA fusion protein 1, 2, 3
Estonian: _ _1 Üks annus (0,5 ml) sisaldab: rekombinantne B-grupi Neisseria meningitidis'e NHBA-fusioonvalk 1, 2, 3
English: 10 pre-filled syringes with needles
Estonian: 10 nõeltega süstlit
English: Recombinant Neisseria meningitidis group B NadA protein 1, 2, 3
Estonian: rekombinantne B-grupi Neisseria meningitidis'e NadA-valk 1, 2, 3
English: 1 pre-filled syringe with needles
Estonian: 1 nõeltega süstel
English: Treatment is usually continued for 2 years.
Estonian: Ravi kestab tavaliselt 2 aastat.
English: The name of the medicine was changed to Granupas on 15 May 2014.
Estonian: Ravimi nimetus muudeti Granupaseks 15. mail 2014.
English: What measures are being taken to ensure the safe and effective use of Granupas?
Estonian: Mis meetmed võetakse, et tagada Granupase ohutu ja efektiivne kasutamine?
English: The first of these involved 166 patients with tuberculosis aged between 15 to 30 years.
Estonian: Esimeses osales 166 tuberkuloosiga patsienti vanuses 15-30 aastat.
English: The recommended dose for adults is one sachet three times a day.
Estonian: Soovitatav annus täiskasvanutele on üks kotike kolm korda ööpäevas.
English: A risk management plan has been developed to ensure that Granupas is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Granupase võimalikult ohutu kasutamine.
English: What is Granupas and what is it used for?
Estonian: Mis on Granupas ja milleks seda kasutatakse
English: They should be given a total of 150 mg per kilogram body weight every day, split into two doses.
Estonian: Neile tuleb manustada kokku 150 mg kehamassi kg kohta ööpäevas, jagatuna kaheks annuseks.
English: The benefits in combination with other tuberculosis treatments were shown in published studies presented by the company, two of which were considered to be the main studies for the application.
Estonian: Kasulikkust kombinatsioonis teiste tuberkuloosiravimitega tõendati ettevõtte avaldatud uuringutes, millest kaht peetakse taotluse seisukohalt põhiuuringuteks.
English: Other information about Granupas
Estonian: Muu teave Granupase kohta
English: The European Commission granted a marketing authorisation valid throughout the European Union for Para-aminosalicylic acid Lucane on 7 April 2014.
Estonian: Euroopa Komisjon andis para-aminosalitsüülhappe Lucane müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 7. aprillil 2014.
English: Why is Granupas approved?
Estonian: Miks Granupas heaks kiideti?
English: The most common side effects with Granupas (which may affect up to 1 in 10 people) are abdominal pain (stomach ache), vomiting, nausea, bloating, diarrhoea and soft stools, giddiness, disturbance in gait and balance, and allergic skin reactions and rash.
Estonian: Granupase kõige sagedamad kõrvalnähud (võivad esineda kuni 1 patsiendil 10st) on kõhuvalu, oksendamine, iiveldus, kõhupuhitus, kõhulahtisus ja pehme väljaheide, peapööritus, kõnnaku- ja tasakaaluhäired, allergilised nahareaktsioonid ning lööve.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Granupas can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Estonian: Harvikravimite komitee arvamuse kokkuvõte Granupase kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Granupas must not be taken by patients with severely reduced kidney function.
Estonian: Granupast ei tohi võtta neerutalitluse raske häirega patsiendid.
English: In children and adolescents, the daily dose depends on their weight.
Estonian: Lastel ja noorukitel sõltub ööpäevane annus kehamassist.
English: The full EPAR and risk management plan summary for Granupas can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst ja riskijuhtimiskava kokkuvõte Granupase kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Granupas's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Inimravimite komitee otsustas, et Granupase kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: In the second main study involving 341 patients aged over 12 years, PAS in combination with isoniazid was compared with isoniazid alone.
Estonian: Teises põhiuuringus, milles osales 341 patsienti vanuses üle 12 aasta, võrreldi paraaminosalitsüülhappe ja isoniasiidi kombinatsiooni ainult isoniasiidiga.
English: Multi-drug resistance is when the bacteria causing tuberculosis (Mycobacterium tuberculosis) are resistant to treatment with at least isoniazid and rifampicin, two standard tuberculosis medicines.
Estonian: Multiresistentsus tähendab, et tuberkuloosi põhjustavad bakterid (Mycobacterium tuberculosis) on resistentsed vähemalt isoniasiid- ja rifampitsiinravi suhtes (tavapärased tuberkuloosiravimid).
English: It is not intended to provide practical advice on how to use Granupas.
Estonian: Hindamisaruandes ei anta Granupase kasutamise praktilisi nõuandeid.
English: It is used in combination with other medicines to treat adults and children from 28 days of age who have multi-drug resistant tuberculosis when combinations without this medicine cannot be used, either because the disease is resistant to them or because of their side effects.
Estonian: Seda kasutatakse kombinatsioonis teiste ravimitega multiresistentse tuberkuloosiga täiskasvanute ja vähemalt 28-päevaste laste raviks, kui haigustekitaja resistentsuse või ravimite kõrvalnähtude tõttu ei saa kombinatsioone ilma selle ravimita kasutada.
English: This is a summary of the European public assessment report (EPAR) for Granupas.
Estonian: See on ravimi Granupas Euroopa avaliku hindamisaruande kokkuvõte.
English: PAS has been used for many years in the EU for the combination treatment of tuberculosis.
Estonian: Para-aminosalitsüülhapet on kasutatud Euroopa Liidus aastaid tuberkuloosi kombineeritud ravis.
English: The applicant also provided published data on the doses of PAS to be used in children.
Estonian: Taotleja esitas ka andmed para-aminosalitsüülhappe annuste kohta kasutamiseks lastel.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Granupas, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati Granupase omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: The patients were treated for 3 months with either PAS or another medicine called streptomycin, or with a combination of PAS and streptomycin, and then followed up for 3 extra months.
Estonian: Patsiente raviti 3 kuud kas paraaminosalitsüülhappe või streptomütsiiniga või para-aminosalitsüülhappe ja streptomütsiini kombinatsiooniga ning jälgiti seejärel veel 3 kuud.
English: What are the risks associated with Granupas?
Estonian: Mis riskid Granupasega kaasnevad?
English: Granupas is a tuberculosis medicine that contains the active substance para-aminosalicylic acid (PAS).
Estonian: Granupas on tuberkuloosiravim, mis sisaldab toimeainena para-aminosalitsüülhapet (PAS).
English: PAS is similar to a chemical (para-aminobenzoic acid) that is used by the bacteria to make folic acid needed for new bacteria to grow.
Estonian: Para-aminosalitsüülhape sarnaneb keemilise ainega (paraaminobensoehape), mida bakterid kasutavad uute bakterite kasvuks vajaliku foolhappe tootmiseks.
English: Because the number of patients with tuberculosis is low in the EU, the disease is considered ‘rare', and Granupas was designated an ‘orphan medicine' (a medicine used in rare diseases) on 17 December
Estonian: Et Euroopa Liidus on tuberkuloosiga patsiente vähe ja see haigus esineb harva, nimetati Granupas 17. detsembril 2010 harvikravimiks.
English: Previously known as Para-aminosalicylic acid Lucane
Estonian: Varasem nimetus Para-aminosalitsüülhape Lucane.
English: A dosing spoon is used to measure small doses for young children.
Estonian: Väikeste annuste mõõtmiseks väikelastele kasutatakse mõõtelusikat.
English: For practical information about using Granupas, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Granupase kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: How is Granupas used?
Estonian: Kuidas Granupast kasutatakse?
English: How does Granupas work?
Estonian: Kuidas Granupas toimib?
English: By interfering and taking the place of this chemical in the processes that make folic acid, para-aminosalicylic acid reduces the amount of folic acid produced and thereby stops or slows the growth of M. tuberculosis.
Estonian: Seda protsessi häirides ja selles para-aminobensoehapet asendades vähendab para-aminosalitsüülhape toodetava foolhappe kogust ja peatab või aeglustab sellega bakteri M. tuberculosis kasvu.
English: For the full list of all side effects reported with Granupas, see the package leaflet.
Estonian: Granupase kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: The Committee also noted that the World Health Organization continues to recommend PAS as an option to be used in combination with other medicines for treating multi-drug resistant tuberculosis.
Estonian: Inimravimite komitee märkis samuti, et Maailma Terviseorganisatsioon jätkab para-aminosalitsüülhappe soovitamist multiresistentse tuberkuloosi raviks kombinatsioonis teiste ravimitega.
English: The active substance, PAS, is a ‘bacteriostatic agent', which means that it works by stopping the growth of M. tuberculosis bacteria.
Estonian: Toimeaine para-aminosalitsüülhape on bakteriostaatiline aine, mis tähendab, et selle toime peatab bakteri M. tuberculosis kasvu.
English: For more information about treatment with Granupas, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Granupasega toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: PAS had been widely used in the past for combination treatment but was largely discontinued due to adverse effects on the stomach.
Estonian: Para-aminosalitsüülhapet on varem laialdaselt kasutatud kombineeritud ravis, kuid selle kasutamine katkestati sageli mao kõrvalnähtude tõttu.
English: The Committee noted that the active substance, PAS, has been shown to be beneficial when used in combination with other medicines to treat tuberculosis and that it helps reduce the emergence of resistance to other medicines.
Estonian: Inimravimite komitee märkis, et on tõendatud toimeaine para-aminosalitsüülhappe kasulikkus, kui seda kasutatakse kombinatsioonis teiste tuberkuloosiravimitega, ja see aitab vähendada resistentsuse teket teiste ravimite suhtes.
English: In addition, the PAS-isoniazid combination helped reduce the emergence of resistance to isoniazid: after 1 year, while 47% of patients in the isoniazid-only group had resistant bacteria the figure was only 8% in the combination group.
Estonian: Peale selle aitas para-aminosalitsüülhappe ja isoniasiidi kombinatsioon vähendada resistentsuse teket isoniasiidi suhtes: 1 aasta möödudes oli patsiente, kellel esinesid resistentsed bakterid, ainult isoniasiidi saanute rühmas 47% ja kombineeritud ravi rühmas ainult 8%.
English: After 12 months, 90% of patients in the combination group did not have the bacteria in their phlegm compared with 51% of patients given a comparable dose of isoniazid alone.
Estonian: 12 kuu möödudes oli patsiente, kellel ei esinenud rögas baktereid, kombinatsioonravi rühmas 90% ja raviks ainult võrreldavaid isoniasiidi annuseid saanute rühmas 51%.
English: What benefits of Granupas have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Granupase kasulikkus?
English: PAS in combination with streptomycin also helped reduce the emergence of resistance to streptomycin: in 89% of patients receiving the combination the bacteria remained responsive to streptomycin, compared with 21% of patients who were given only streptomycin.
Estonian: Para-aminosalitsüülhape kombinatsioonis streptomütsiiniga aitas samuti vähendada streptomütsiiniresistentsuse teket: Patsiente, kellel jäid bakterid streptomütsiini suhtes tundlikuks, oli kombinatsioonravi rühmas 89% ja ainult streptomütsiini saanute rühmas 21%.
English: The CHMP noted that Granupas contains gastro-resistant granules, designed to allow PAS to reach the intestine without being released in the stomach, and thus reduce the potential for side effects.
Estonian: Inimravimite komitee märkis, et Granupas sisaldab gastroresistentseid graanuleid, mis võimaldavad para-aminosalitsüülhappel jõuda soolde maos vabanemata, vähendades sellega võimalikke kõrvalnähte.
English: para-aminosalicylic acid
Estonian: Granupas para-aminosalitsüülhape
English: Granupas can only be obtained with a prescription.
Estonian: Granupas on retseptiravim.
English: At the end of the 6 months, 87% of patients on the combination had improvements in their chest x-rays compared with 56% of patients in the group taking PAS alone.
Estonian: Patsiente, kellel ilmnes 6 kuu möödudes kopsuröntgeniuuringus seisundi paranemine, oli 87% kombinatsioonravi rühmas ja 56% nende patsientidest rühmas, kes said raviks ainult para-aminosalitsüülhapet.
English: In addition,33% of patients in the combination group had no bacteria detected in their phlegm (sputum) compared with 8% in the PAS group.
Estonian: Peale selle oli patsiente, kellel ei tuvastatud rögas baktereid, kombineeritud ravi rühmas 33% ja para-aminosalitsüülhappe rühmas 8%.
English: It is available as 4 g sachets containing ‘gastroresistant' granules that allow the active substance to reach the intestine without being released in the stomach, thus reducing side effects in the stomach.
Estonian: Need võimaldavad toimeainel jõuda soolde maos vabanemata, vähendades sellega kõrvalnähte.
English: Miglustat Gen.Orph received a marketing authorisation valid throughout the EU on 10 November 2017.
Estonian: Miglustat Gen.Orph on saanud müügiloa, mis kehtib kogu ELis, 10. novembril 2017.
English: Further information on Miglustat Gen.Orph can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/miglustat-genorph.
Estonian: Lisateave ravimi Miglustat Gen.Orph kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/miglustat-genorph.
English: Miglustat Gen.Orph (miglustat)
Estonian: Miglustat Gen.Orph (miglustaat)
English: What measures are being taken to ensure the safe and effective use of Miglustat Gen.Orph?
Estonian: Mis meetmed võetakse, et tagada ravimi Miglustat Gen.Orph ohutu ja efektiivne kasutamine?
English: The European Medicines Agency concluded that, in accordance with EU requirements, Miglustat Gen.Orph has been shown to have comparable quality and to be bioequivalent to Zavesca.
Estonian: Euroopa Ravimiamet järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Miglustat Gen.Orph võrreldav kvaliteet ja bioekvivalentsus ravimiga Zavesca.
English: This means that Miglustat Gen.Orph contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Zavesca.
Estonian: See tähendab, et Miglustat Gen.Orph sisaldab sama toimeainet ja toimib samamoodi nagu võrdlusravim Zavesca, millel juba on ELis müügiluba.
English: For more information about using Miglustat Gen.Orph, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet ravimi Miglustat Gen.Orph kasutamise kohta saate pakendi infolehelt või küsige oma arstilt või apteekrilt.
English: Studies on the benefits and risks of the active substance in Gaucher disease have already been carried out with the reference medicine, Zavesca, and do not need to be repeated for Miglustat Gen.Orph.
Estonian: Võrdlusravimiga Zavesca on juba tehtud toimeaine kasulikkuse ja riski uuringud kasutamisel Gaucher' tõve ravis ning neid ei ole vaja ravimiga Miglustat Gen.Orph korrata.
English: Side effects reported with Miglustat Gen.Orph are carefully evaluated and any necessary action taken to protect patients.
Estonian: Ravimi Miglustat Gen.Orph kõrvalnähte hinnatakse hoolikalt ja patsientide kaitseks võetakse vajalikke meetmeid.
English: Because Miglustat Gen.Orph is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Estonian: Et Miglustat Gen.Orph on geneeriline ravim ja võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: Miglustat Gen.Orph is intended for long-term use.
Estonian: Miglustat Gen.Orph on ette nähtud pikaajaliseks kasutamiseks.
English: What is Miglustat Gen.Orph and what is it used for?
Estonian: Mis on Miglustat Gen.Orph ja milleks seda kasutatakse?
English: As for every medicine, the company provided studies on the quality of Miglustat Gen.Orph.
Estonian: Nagu iga ravimi korral, esitas ettevõte ravimi Miglustat Gen.Orph kvaliteedi uuringud.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Miglustat Gen.Orph have been included in the summary of product characteristics and the package leaflet.
Estonian: Ravimi Miglustat Gen.Orph ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Therefore, the Agency's view was that, as for Zavesca, the benefit of Miglustat Gen.Orph outweighs the identified risk and it can be authorised for use in the EU.
Estonian: Seetõttu on amet arvamusel, et nagu ka Zavesca korral, ületab ravimi Miglustat Gen.Orph kasulikkus sellega kaasnevad riskid ja ravimi kasutamise võib ELis heaks kiita.
English: Miglustat Gen.Orph is used to treat the neurological symptoms of the disease (symptoms affecting the brain and nerves).
Estonian: Ravimiga Miglustat Gen.Orph ravitakse haiguse neuroloogilisi sümptomeid (aju- ja närvisümptomid).