FrancophonIA/ELRC3.0 huggingface dataset:
English: Coetzee et al, 2007, Journal of Veterinary Pharmacology & Therapeutics, 30, 4, 305-319.
Slovenian: Coetzee et al, 2007, Journal of Veterinary Pharmacology & Therapeutics, 30, 4, 305-319. 2 Plasma concentrations of sodium salicylate in nursery pigs treated orally.. Paterson AR et al, Journal of Swine Health and Production, 2007; 15(3):146-151
English: The CVMP concluded that Solacyl 100% powder for oral solution was essentially similar to the reference product, Natrium salicylaat 100%.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je menil, da je zdravilo Solacyl 100%, prašek za peroralno raztopino, v bistvu podoben referenčnemu zdravilu Natrium salicylaat 100%.
English: No PSURs were submitted as the product is not yet marketed.
Slovenian: To zdravilo se še ne trži, tako da niso bila predložena niti periodična poročila o varnosti zdravila.
English: NA-Salicylaat, 100%, powder for solution for oral administration and NA-Salicylaat, 80% WSP
Slovenian: NA-Salicylaat, 100%, prašek za peroralno raztopino in NA-Salicylaat, 80% WSP
English: Powder for oral solution
Slovenian: Prašek za peroralno raztopino
English: 4.9 Amounts to be administered and administration route In calves, the dose administered should be amended to read 40 mg/kg once daily.
Slovenian: Priporočeni odmerek za teleta naj se spremeni v 40 mg/kg enkrat dnevno.
English: SOLACYL 100 %, powder for oral solution for calves and pigs
Slovenian: SOLACYL 100 %, prašek za peroralno raztopino za teleta in prašiče
English: Given this outcome together with published data on the pharmacokinetics of sodium salicylate in calves and significant variation in individual pig concentrations post treatment2, the MAHs should justify that therapeutic concentrations are established and maintained following oral use of the drug through water medication and submit all available data that could substantiate the posology and dosage regimen of sodium salicylate when given orally to calves and pigs, together with a thorough discussion of the these data.
Slovenian: Upoštevajoč to dejstvo in objavljene podatke o farmakokinetiki natrijevega salicilata pri teletih ter pomembne razlike v koncentracijah po zdravljenju pri posameznih prašičih2, morajo imetniki dovoljenj za promet ustrezno utemeljiti, da so terapevtske koncentracije določene in se vzdržujejo tudi po peroralni uporabi zdravila
English: NA-SALICYLAAT, 100%, powder for solution for oral administration
Slovenian: NA-SALICYLAAT, 100 %, prašek za peroralno raztopino
English: SOLACYL 100 %, powder for oral solution for calves and pigs 4.2 Indications for use, specifying the target species Calves: supportive treatment of pyrexia in acute respiratory disease, in combination with appropriate (e.g. anti-infective) therapy if necessary.
Slovenian: SOLACYL 100 %, prašek za peroralno raztopino za teleta in prašiče 4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Teleta: pomožno zdravljenje pireksije pri akutnih obolenjih dihal, po potrebi v kombinaciji z ustrezno terapijo (na primer z zdravili za zdravljenje okužb).
English: 4.2 Indications for use, specifying the target species Pigs: to promote recovery of respiration and to reduce coughing in respiratory tract infections with concurrent antibiotic therapy.
Slovenian: 4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Prašiči: za pospeševanje okrevanja pri obolenjih dihal in blažitev kašlja pri okužbah dihal v kombinaciji s sočasno terapijo z antibiotiki.
English: NA-Salicylaat, 100%, powder for solution for oral administration 4.2 Indications for use, specifying the target species Calves: supportive treatment of pyrexia in acute respiratory disease, in combination with appropriate (e.g. anti-infective) therapy if necessary.
Slovenian: NA-Salicylaat, 100%, prašek za peroralno raztopino 4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Teleta: pomožno zdravljenje pireksije pri akutnih obolenjih dihal, po potrebi v kombinaciji z ustrezno terapijo (na primer z zdravili za zdravljenje okužb).
English: 4.2 Indications for use, specifying the target species Calves: supportive treatment of pyrexia in acute respiratory disease, in combination with appropriate (e.g. anti-infective) therapy if necessary.
Slovenian: 4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Teleta: pomožno zdravljenje pireksije pri akutnih obolenjih dihal, po potrebi v kombinaciji z ustrezno terapijo (na primer z zdravili za zdravljenje okužb).
English: 2 years.
Slovenian: 2 leta
English: These effects may be partly related to maternal toxicity.
Slovenian: Ti učinki so lahko delno povezani s toksičnostjo pri materi.
English: Your doctor will tell you how long your treatment will last.
Slovenian: Zdravnik vam bo povedal, kako dolgo bo zdravljenje trajalo.
English: The average half-life is 6-7 hours.
Slovenian: Povprečni razpolovni čas je 6-7 ur.
English: In such case, your doctor may decide to conduct further investigations.
Slovenian: V takem primeru se bo zdravnik morda odločil za dodatne preiskave.
English: These findings were considered to be secondary to debilitation.
Slovenian: Te ugotovitve veljajo za sekundarne za oslabitvijo.
English: The greatest prevalence was observed between 6 and 12 months.
Slovenian: Največjo prevalenco so opazili med 6 in 12 meseci.
English: The mechanism for this effect is unknown.
Slovenian: Mehanizem tega učinka ni znan.
English: Body surface area (m2)
Slovenian: Površina telesa (m2)
English: You should swallow the whole capsule with a glass of water.
Slovenian: Kapsulo morate pogoltniti celo in splakniti s kozarcem vode.
English: Effects on spermatogenesis
Slovenian: Učinek na spermatogenezo
English: It is used to treat two conditions:
Slovenian: Uporablja se za zdravljenje dveh bolezni:
English: Adult
Slovenian: Odrasli
English: To remove the capsule:
Slovenian: Odstranitev kapsule:
English: These effects occurred at exposure levels similar to those in patients, but showed reversibility.
Slovenian: Ti učinki so se pojavili pri ravneh izpostavljenosti, podobnih tistim pri bolnikih, a so bili reverzibilni.
English: SN: {number}
Slovenian: SN: {številka}
English: 29 patients continued in the extension period.
Slovenian: V podaljšanju je nadaljevalo 29 bolnikov.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 March 2017
Slovenian: Datum prve odobritve: 22 marec 2017
English: If you have a problem with your kidneys you may receive a lower starting dose.
Slovenian: Če imate težave z ledvicami, lahko dobite manjši začetni odmerek.
English: Capsule Size: 4 (14.3 mm x 5.3 mm)
Slovenian: Velikost kapsule: 4 (14,3 mm x 5,3 mm)
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 web-portal.
Slovenian: Zahteve glede predložitve redno posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: At present, there is insufficient clinical experience in these patients to provide dosing recommendations.
Slovenian: Za sedaj nimamo dovolj kliničnih izkušenj s temi bolniki, da bi lahko podali priporočila glede odmerjanja.
English: Absolute bioavailability has not been determined.
Slovenian: Absolutna biološka uporabnost ni bila ugotovljena.
English: In healthy subjects miglustat is rapidly absorbed.
Slovenian: Pri zdravih osebah se miglustat hitro absorbira.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
English: Recommended dose 200 mg three times a day 200 mg twice a day 100 mg three times a day 100 mg twice a day 100 mg once a day
Slovenian: Priporočeni odmerek 200 mg trikrat dnevno 200 mg dvakrat dnevno 100 mg trikrat dnevno 100 mg dvakrat dnevno 100 mg enkrat dnevno
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Slovenian: Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: NN: {number}
Slovenian: NN: {številka}
English: Maximum plasma concentrations are reached about 2 hours after dose.
Slovenian: Najvišje koncentracije v plazmi dosega približno dve uri po odmerku.
English: Apparent oral clearance (CL/F) is 230 ± 39 ml/min.
Slovenian: Navidezni peroralni očistek (CL/F) je 230 ± 39 ml/min.
English: Dosing in patients under the age of 12 years should be adjusted on the basis of body surface area as illustrated below:
Slovenian: Odmerjanje pri bolnikih, starih manj kot 12 let, je treba prilagoditi na podlagi površine telesa, kot je prikazano spodaj:
English: There are no adequate data from the use of miglustat in pregnant women.
Slovenian: Ustreznih podatkov o uporabi miglustata pri nosečnicah ni.
English: Tremor usually began within the first month, and in many cases resolved during treatment after between 1 and 3 months.
Slovenian: Tremor se je običajno pojavil v prvem mesecu zdravljenja in v mnogih primerih izzvenel v času zdravljenja med 1. in 3. mesecem.
English: They may lower the amount of Yargesa in your body.
Slovenian: Ta zdravila lahko znižajo količino zdravila Yargesa v vašem telesu.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1176/001
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/17/1176/001
English: No acute symptoms of overdose have been identified.
Slovenian: Prepoznali niso nobenih akutnih simptomov prevelikega odmerjanja.
English: The apparent volume of distribution of miglustat is 83 l. Miglustat does not bind to plasma proteins.
Slovenian: Navidezni volumen porazdelitve miglustata je 83 l. Miglustat se ne veže na beljakovine v plazmi.
English: It starts to build up in certain cells of the body's immune system.
Slovenian: Namesto tega se kopiči v določenih celicah imunskega sistema.
English: Most patients get one or more of these side effects, usually at the start of treatment or at intervals during treatment.
Slovenian: Pri večini bolnikov se pojavi eden ali več teh neželenih učinkov, običajno na začetku zdravljenja ali občasno med zdravljenjem.
English: for an average duration of 2.1 years.
Slovenian: Povprečno zdravljenje je trajalo 2,1 leti.
English: Six patients had miglustat treatment prematurely discontinued for potential disease worsening, as defined in the study.
Slovenian: Šest bolnikov je predčasno zaključilo zdravljenje zaradi možnega poslabšanja bolezni, kot je bilo opredeljeno v študiji.
English: Patients with chronic diarrhoea or other persistent gastrointestinal events that do not respond to these interventions should be investigated according to clinical practice.
Slovenian: Bolnike s kronično drisko ali drugimi trdovratnimi prebavnimi težavami, ki se na te ukrepe ne odzovejo, je treba preiskati skladno s klinično prakso.
English: If you are pregnant, breast feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Slovenian: Znotraj vsake pogostnostne skupine so neželeni učinki našteti po padajoči resnosti.
English: These data suggest a decrease in CL/F by at least 70% in patients with severe renal impairment.
Slovenian: Ti podatki kažejo na zmanjšanje CL/F za vsaj 70 % pri bolnikih s hudo okvarjenim delovanjem ledvic.
English: Among the 41 patients enrolled in the trial 14 patients were treated with Yargesa for more than 3 years.
Slovenian: Med 41 bolniki, vključenimi v preskušanje, je bilo 14 bolnikov zdravljenih z zdravilom Yargesa več kot 3 leta.
English: Concomitant administration of food decreases the rate of absorption (Cmax was decreased by 36% and tmax delayed 2 hours), but has no statistically significant effect on the extent of absorption of miglustat (AUC decreased by 14%).
Slovenian: Sočasno jemanje s hrano zniža raven absorpcije (Cmax se je znižal za 36 % in tmax podaljšal za dve uri), vendar nima statistično značilnega učinka na absorpcijo miglustata (AUC se je znižala za 14 %).
English: Yargesa has negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Yargesa ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: In some cases the doctor may prescribe anti-diarrhoeal medicines such as loperamide.
Slovenian: V nekaterih primerih bo zdravnik lahko predpisal zdravilo proti driski, na primer loperamid.
English: Leukopenia and neutropenia have also been observed in a similar group of patients receiving 800 mg/day or higher dose.
Slovenian: Levkopenijo in nevtropenijo so opazili pri podobni skupini bolnikov, ki so jemali 800 mg/dan ali več.
English: Thirteen patients discontinued treatment due to an adverse event.
Slovenian: Trinajst bolnikov je zdravljenje zaključilo zaradi neželenega učinka.
English: The terminal half-life of radioactivity in plasma was 150 h suggesting the presence of one or more metabolites with very long half-life.
Slovenian: Končna razpolovna doba radioaktivnosti v plazmi je bila 150 h, kar kaže na prisotnost enega ali več presnovkov z zelo dolgo razpolovno dobo.
English: The tests will help the doctor decide whether these effects are due to your disease or other existing conditions, or due to side effects of Yargesa (see section 4 for further details).
Slovenian: Te preiskave bodo zdravniku v pomoč pri presoji, ali so ti učinki posledica vaše bolezni ali drugega obstoječega stanja ali posledica neželenih učinkov zdravila Yargesa (za dodatne informacije glejte poglavje 4).
English: In case of overdose general medical care is recommended.
Slovenian: Ravnanje Pri prevelikem odmerjanju se priporoča splošna zdravstvena nega.
English: Do not stop taking Yargesa without talking to your doctor.
Slovenian: Ne prenehajte uporabljati zdravilaYargesa, ne da se o tem pogovorite z zdravnikom.
English: This study also indicated that miglustat has no or limited effect on the pharmacokinetics of imiglucerase.
Slovenian: Ta študija je tudi pokazala, da miglustat nima ali ima le majhen učinek na farmakokinetiko imigluceraze.
English: The systemic exposure at the lowest dose was below or comparable to that observed in humans (based on AUC0-∞) at the recommended human dose.
Slovenian: Sistemska izpostavljenost pri najnižjem odmerku je bila pod tisto, ki so jo opazili pri ljudeh (na podlagi AUC0-∞) ob priporočenem odmerjanju, ali primerljiva z njo.
English: Your doctor can give you more information.
Slovenian: Več informacij lahko dobite pri zdravniku.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: Yargesa can be taken with or without food.
Slovenian: Zdravilo Yargesa se lahko jemlje s hrano ali brez nje.
English: Miglustat did not show any potential for mutagenic or clastogenic effects in the standard battery of genotoxicity tests.
Slovenian: Miglustat ni pokazal nobenega potenciala za mutagene ali klastogene učinke v standardnem nizu testov genotoksičnosti.
English: There were no events of bone crisis, avascular necrosis or fracture during the treatment period.
Slovenian: Ni bilo primerov kostne krize, avaskularne nekroze ali zloma v času zdravljenja.
English: Most cases are mild and disappear quite quickly.
Slovenian: Večina neželenih učinkov je blagih in kmalu izzvenijo.
English: Adverse reactions from clinical trials and spontaneous reporting, occurring in >1% of patients, are listed in the table below by system organ class and frequency (very common: ≥ 1/10, common: ≥ 1/100 < 1/10, uncommon: ≥1/1,000 to <1/100, rare: ≥1/10,000 to <1/1,000, very rare: <1/10,000).
Slovenian: Neželeni učinki zdravila iz kliničnih preskušanj in spontanega poročanja, ki so se pojavili pri > 1 % bolnikov, so navedeni v spodnji preglednici, razvrščeni po organskem sistemu in pogostnosti (zelo pogosti: ≥ 1/10, pogosti: ≥ 1/100 < 1/10, občasni: ≥1/1.000 do <1/100, redki: ≥1/10.000 do <1/1.000,
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Slovenian: • na zahtevo Evropske agencije za zdravila; • ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
English: Twenty-one patients completed 24 months of miglustat treatment.
Slovenian: Enaindvajset bolnikov je zaključilo 24-mesečno zdravljenje z miglustatom.
English: Mechanistic studies revealed a rat specific mechanism which is considered to be of low relevance for humans.
Slovenian: Študije mehanizmov so pokazale mehanizem, specifičen za podgano, ki je običajno majhnega pomena za človeka.
English: Miglustat crosses the placenta and should not be used during pregnancy.
Slovenian: Miglustat prehaja skozi placento in ga med nosečnostjo ne smemo uporabljati.
English: The kinetics of miglustat appear to be dose linear and time independent.
Slovenian: Kinetika miglustata je videti linearno odvisna od odmerka in neodvisna od časa.
English: Clinical benefit has been assessed at 24 and 36 months in 13 patients.
Slovenian: Po 24 in 36 mesecih so pri 13 bolnikih ocenili klinično korist.
English: Both data sets included paediatric, adolescent and adult patients with an age range of 1 year to 43 years.
Slovenian: Oba niza podatkov sta vključevala pediatrične bolnike, mladostnike in odrasle bolnike, pri čemer je bil starostni razpon od 1 do 43 let.
English: Miglustat is mainly eliminated by renal excretion, with urinary recovery of unchanged drug accounting for 70-80% of the dose.
Slovenian: Miglustat se pretežno izloča skozi ledvice, pri čemer znaša rekuperacija nespremenjenega zdravila v urinu 70-80 % odmerka.
English: The clinical trial included 29 adult and juvenile patients in a 12-month controlled period, followed by extension therapy for an average total duration of 3.9 years and up to 5.6 years.
Slovenian: V klinično preskušanje je bilo vključenih 29 odraslih bolnikov in mladostnikov v 12-mesečnem kontroliranem obdobju, ki mu je sledil podaljšek zdravljenja s povprečnim skupnim trajanjem 3,9 let in do 5,6 let.
English: Following administration of a single dose of 100 mg 14C-miglustat to healthy volunteers, 83% of the radioactivity was recovered in urine and 12% in faeces.
Slovenian: Po uporabi enega odmerka 100 mg14C-miglustata pri zdravih prostovoljcih je bilo 83 % radioaktivno označenega zdravila izločenega z urinom in 12 % z blatom.
English: Tell your doctor if you are taking medicines containing imiglucerase, which are sometimes used at the same time as Yargesa.
Slovenian: Obvestite zdravnika, če jemljete zdravila, ki vsebujejo imiglucerazo, ki se včasih jemljejo skupaj z zdravilomYargesa.
English: Of these, 18 patients at baseline were within established therapeutic goals for liver and spleen volume, haemoglobin levels, and platelet counts, and 16 patients remained within all these therapeutic goals at Month 24.
Slovenian: Med njimi je bilo 18 bolnikov ob izhodišču znotraj uveljavljenih terapevtskih ciljev za volumen jeter in vranice, ravni hemoglobina in število trombocitov, 16 bolnikov pa je ostalo znotraj vseh teh terapevtskih ciljev v 24. mesecu.
English: Dose reduction may ameliorate the tremor, usually within days, but discontinuation of treatment may sometimes be required.
Slovenian: Običajno lahko znižanje odmerka tremor v nekaj dneh zmanjša, včasih pa je potrebna prekinitev zdravljenja.
English: Other studies revealed changes in sperm parameters (motility and morphology) consistent with an observed reduction in fertility.
Slovenian: Druge študije so odkrile spremembe v parametrih spermijev (gibljivost in morfologija), skladne z opažanim zmanjšanjem plodnosti.
English: Over the range of data available, no significant relationships or trends were noted between miglustat pharmacokinetic parameters and demographic variables (age, BMI, gender or race).
Slovenian: V območju razpoložljivih podatkov ni opaziti pomembnih razmerij ali usmeritev med farmakokinetičnimi parametri miglustata in demografskimi spremenljivkami (starost, indeks telesne mase, spol ali rasa).
English: For children less than 12 years old, your doctor will adjust the dose for Niemann-Pick type C disease.
Slovenian: Za otroke, stare manj kot 12 let, bo zdravnik odmerek prilagodil za Niemann-Pickovo bolezen tipa C.
English: Rouboslaan 32 (ground floor) 2252 TR, Voorschoten
Slovenian: Rouboslaan 32 (ground floor) 2252 TR, Voorschoten Nizozemska
English: Several metabolites were identified in urine and faeces.
Slovenian: V urinu in blatu so bili identificirani številni presnovki.
English: Gastrointestinal disturbances
Slovenian: Gastrointestinalne motnje
English: What Yargesa is and what it is used for
Slovenian: Kaj je zdravilo Yargesa in za kaj ga uporabljamo
English: Separate at perforations
Slovenian: Ločite po perforaciji.
English: The tremor often disappears without needing to stop the treatment.
Slovenian: Tremor pogosto izgine brez potrebe prekinitve zdravljenja z zdravilom Yargesa.
English: In type 1 Gaucher disease, these tremors were described as an exaggerated physiological tremor of the hands.
Slovenian: Pri Gaucherjevi bolezni tipa 1 so bili ti tremorji so opisovali kot pretirano fiziološko tresenje rok.
English: The efficacy and safety of miglustat has not been specifically evaluated in patients with severe Gaucher disease.
Slovenian: Učinkovitost in varnost miglustata nista bili posebej ocenjeni pri bolnikih s hudo Gaucherjevo boleznijo.
English: Niemann-Pick type C disease is a very rare, invariably progressive and eventually fatal neurodegenerative disorder characterised by impaired intracellular lipid trafficking.
Slovenian: Niemann-Pickova bolezen tipa C je zelo redka, vedno progresivna in končno smrtna nevrodegenerativna bolezen, za katero je značilno zmanjšano intracelično prehajanje maščob.
English: Data to support safety and efficacy of Yargesa in Niemann-Pick type C disease come from a prospective open-label clinical trial and a retrospective survey.
Slovenian: Podatki, ki podpirajo varnost in učinkovitost zdravila Yargesa pri Niemann-Pickovi bolezni tipa C so bili zbrani v prospektivnem odprtem kliničnem preskušanju in v retrospektivni analizi.
English: The metabolite accounting for this has not been identified, but may accumulate and reach concentrations exceeding those of miglustat at steady state.
Slovenian: Presnovek, ki to povzroča, ni bil opredeljen, vendar se lahko kopiči in doseže koncentracije, ki presežejo koncentracije miglustata v stanju dinamičnega ravnovesja.
English: When compared to the measurements at 6 months, disease control was unchanged after 18 and 24 months of miglustat monotherapy (20 and 6 patients, respectively).
Slovenian: V primerjavi z meritvami pri šestih mesecih je bil nadzor bolezni po 18 in 24 mesecih monoterapije z miglustatom nespremenjen (20 oziroma 6 bolnikov).