FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor if you are taking medicines containing imiglucerase, which are sometimes used at the same time as Miglustat Dipharma.
Slovenian: Obvestite zdravnika, če jemljete zdravila, ki vsebujejo imiglucerazo, ki se včasih jemljejo skupaj z zdravilom Miglustat Dipharma.
English: The kinetics of miglustat appears to be dose linear and time independent.
Slovenian: Kinetika miglustata je videti linearno odvisna od odmerka in neodvisna od časa.
English: Tabulated list of adverse reactions 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: 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 učinka ali ima le majhen učinek na farmakokinetiko imigluceraze.
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: They may lower the amount of Miglustat Dipharma in your body.
Slovenian: Ta zdravila lahko znižajo količino zdravila Miglustat Dipharma v vašem telesu.
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 specifično ocenjeni pri bolnikih s hudo Gaucherjevo boleznijo.
English: Your doctor may reduce your dose, e.g., to one capsule (100 mg) once or twice a day, if you suffer from diarrhoea when taking Miglustat Dipharma (see section 4).
Slovenian: Vaš zdravnik lahko zmanjša vaš odmerek, npr. na eno kapsulo (100 mg) enkrat ali dvakrat dnevno, če imate med jemanjem zdravila Miglustat Dipharma drisko (glejte poglavje 4).
English: This study was conducted over a 6-month randomised comparison period followed by 18 months extension where all patients received miglustat monotherapy.
Slovenian: To študijo so izpeljali prek 6-mesečnega randomiziranega primerjalnega obdobja, ki mu je sledilo 18-mesečno podaljšanje, v katerem so vsi bolniki prejemali monoterapijo z miglustatom.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreeed subsequent updates of the RMP.
Slovenian: • Načrt za obvladovanje tveganj (RMP) Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: Miglustat is mainly eliminated by renal excretion, with urinary recovery of unchanged substance 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: A second open, controlled study randomised 36 patients who had received a minimum of 2 years of treatment with ERT, into three treatment groups: continuation with imiglucerase, imiglucerase in combination with miglustat, or switch to miglustat.
Slovenian: V drugi odprti kontrolirani študiji so 36 bolnikov, ki so se že vsaj 2 leti zdravili z ERT, naključno razporedili v tri skupine zdravljenja: nadaljevanje zdravljenja z imiglucerazo, kombinacija imigluceraze in miglustata ali prehod na miglustat.
English: Data to support safety and efficacy of miglustat 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 miglustat pri Niemann-Pickovi bolezni tipa C so bili zbrani v prospektivnem odprtem kliničnem preskušanju in v retrospektivni analizi.
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 6 mesecih je bil nadzor bolezni po 18 in 24 mesecih monoterapije z miglustatom nespremenjen (20 oz. 6 bolnikov).
English: Miglustat Dipharma can be taken with or without food.
Slovenian: Zdravilo Miglustat Dipharma se lahko jemlje s hrano ali brez nje.
English: PCTFE/PVC and Aluminium blister containing 12 (perforated unit dose) or 21 (non-perforated) capsules.
Slovenian: Pretisni omot PCTFE/PVC in aluminija, ki vsebuje 12 (perforiranih, s posameznimi odmerki) ali 21 (neperforiranih) kapsul.
English: In a pooled analysis of uncontrolled data, bone mineral density Z-scores at the lumbar spine and femoral neck increased by more than 0.1 units from baseline in 27 (57%) and 28 (65%) of the patients with longitudinal bone density measurements.
Slovenian: V zbrani analizi nekontroliranih podatkov so se vrednosti Z mineralne gostote kosti ledvene hrbtenice in vratu stegnenice povečale za več kot 0.1 enoto od izhodišča pri 27 (57 %) in 28 (65 %) bolnikov pri vzdolžni smeri merjenja gostote kosti.
English: Approximately 37% of patients in clinical trials in type 1 Gaucher disease, and 58% of patients in a clinical trial in Niemann-Pick type C disease reported tremor on treatment.
Slovenian: Približno 37 % bolnikov v kliničnih preskušanjih z Gaucherjevo boleznijo tipa 1 in 58 % bolnikov v kliničnih preskušanjih z Niemann-Pickovo boleznijo tipa C je poročalo o tremorju med zdravljenjem.
English: Do not stop taking Miglustat Dipharma without talking to your doctor.
Slovenian: Ne prenehajte jemati zdravila Miglustat Dipharma, ne da se o tem pogovorite z zdravnikom.
English: Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in škatli poleg oznake »EXP/Uporabno do«.
English: In type 1 Gaucher disease, these tremors were described as an exaggerated physiological tremor of the hands.
Slovenian: Te tremorje so opisovali kot pretirano fiziološko tresenje rok.
English: In patients included in the clinical trial, 40%-50% of patients had platelet counts below the lower limit of normal at baseline.
Slovenian: Pri bolnikih, vključenih v klinično preskušanje, je 40 % - 50% bolnikov imelo število trombocitov pod spodnjo mejo normalnega ob izhodišču.
English: In the first 6 months in patients who were switched to miglustat, liver and spleen organ volumes and haemoglobin levels were unchanged.
Slovenian: Pri bolnikih, ki so prešli na miglustat, se prvih 6 mesecev volumna jeter in vranice ter ravni hemoglobina niso spremenili.
English: In vitro, glucosylceramide synthase is inhibited by miglustat with an IC50 of 20-37 μM.
Slovenian: Glukozilceramid-sintazo in vitro zavira miglustat z IC50, ki je 20-37 µM.
English: Based on mg/kg/day and corrected for differences in faecal excretion, the doses corresponded to 8, 16 and 33/19 times the highest recommended human dose (200 mg t.i.d.).
Slovenian: Odmerki, ki temeljijo na mg/kg/dan in korekciji zaradi razlik pri izločanju fecesa, ustrezajo 8, 16 in 33/19-kratnem najvišjem priporočenem odmerku pri človeku (200 mg trikrat dnevno).
English: Eighteen patients then continued to receive miglustat under an optional extended treatment protocol.
Slovenian: 18 bolnikov je nato nadaljevalo z jemanjem miglustata v neobveznem podaljšanem programu zdravljenja.
English: No patient showed rapid deterioration of type 1 Gaucher disease following the switch to miglustat monotherapy.
Slovenian: Noben od bolnikov ni kazal hitrega poslabšanja stanja Gaucherjeve bolezni tipa 1 po prehodu na monoterapijo z miglustatom.
English: Since some patients have had tingling or numbness in the hands and feet, or a decrease in body weight, while taking Miglustat Dipharma, your doctor will perform the following tests before treatment and during treatment with Miglustat Dipharma:
Slovenian: Ker so nekateri bolniki med jemanjem zdravila Miglustat Dipharma imeli mravljinčenje ali otrplost v rokah in stopalih ali zmanjšanje telesne mase, bo pred zdravljenjem in med zdravljenjem z Miglustat Dipharma opravil naslednje preiskave:
English: Data in severe renal impairment are limited to two patients with creatinine clearance in the range 18 - 29 ml/min and cannot be extrapolated below this range.
Slovenian: Podatki za hudo okvarjeno delovanje ledvic so omejeni na dva bolnika, ki sta imela očistek kreatinina v območju 1829 ml/min, in podatkov ne moremo ekstrapolirati pod to območje.
English: The efficacy of miglustat in children and adolescents aged 0-17 years with type 1 Gaucher disease has not been established.
Slovenian: Učinkovitost zdravila miglustat pri otrocih in mladostnikih, starih od 0 do 17 let, z Gaucherjevo boleznijo tipa 1 še ni bila dokazana.
English: - The active substance is miglustat.
Slovenian: - Učinkovina je miglustat.
English: The capsules are presented in PCTFE/PVC and Aluminium blister, ain pack size of 84 capsules in non-perforated blisters and 84x1 capsules in perforated unit dose blisters.
Slovenian: Kapsule so predstavljene v pretisnih omotih PCTFE/PVC in aluminija, v velikosti pakiranja po 84 kapsul v neperforiranih pretisnih omotih in 84 x 1 kapsula v perforiranih deljivih pretisnih omotih s posameznimi odmerki.
English: If you have diarrhoea, your doctor may ask you to change your diet to reduce your lactose and carbohydrate intake such as sucrose (cane sugar), or not to take Miglustat Dipharma together with food, or to temporarily reduce your dose.
Slovenian: Če boste imeli drisko, vam bo morda zdravnik svetoval, da spremenite svojo prehrano tako, da zmanjšate vnos laktoze in ogljikovih hidratov, kot je saharoza (namizni sladkor), ali ne jemljete zdravila Miglustat Dipharma skupaj s hrano ali začasno znižate svoj odmerek.
English: Capsule content Magnesium stearate
Slovenian: Vsebina kapsule magnezijev stearat
English: Overall the data show that treatment with miglustat can reduce the progression of clinically relevant neurological symptoms in patients with Niemann-Pick type C disease.
Slovenian: Na splošno so podatki pokazali, da lahko zdravljenje z zdravilom miglustat zmanjša napredovanje klinično značilnih nevroloških simptomov pri bolnikih z Niemann-Pickovo boleznijo tipa C.
English: The survey included a case series of 66 patients treated with miglustat outside of the clinical trial for a mean duration of 1.5 years.
Slovenian: Študija je vključevala klinično serijo 66 bolnikov, zdravljenih z zdravilom miglustat, izven kliničnega preskušanja s povprečnim trajanjem 1,5 let.
English: Weight loss has been reported in 55% of patients.
Slovenian: Opis izbranih neželenih učinkov O izgubi telesne mase so poročali pri približno 55 % bolnikov.
English: Miglustat Dipharma may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable (see sections 4.4 and 5.1).
Slovenian: Zdravilo Miglustat Dipharma smemo uporabljati samo za zdravljenje bolnikov, za katere encimsko nadomestno zdravljenje ni primerno (glejte poglavji 4.4 in 5.1).
English: The most abundant metabolite in urine was miglustat glucuronide accounting for 5% of the dose.
Slovenian: V urinu je bilo največ presnovka miglustat glukuronida, ki je predstavljal 5 %
English: At 12 months, there was a mean reduction in liver organ volume of 12.1% and a mean reduction in spleen volume of 19.0%.
Slovenian: Po 12 mesecih je bilo povprečno zmanjšanje volumna jeter 12.1 % in povprečno zmanjšanje volumna vranice 19.0 %.
English: After 3 years of continuous miglustat treatment, mean reductions in liver and spleen organ volume were 17.5% and 29.6%, respectively.
Slovenian: Po treh letih stalnega jemanja miglustata je bilo povprečno zmanjšanje volumna jeter 17.5 % in vranice 29.6 %.
English: In 11 clinical trials in different indications 247 patients were treated with miglustat at doses of 50-200 mg t.i.d.
Slovenian: V 11 kliničnih preskušanjih z različnimi indikacijami so 247 bolnikov zdravili z miglustatom z odmerki 50-200 mg trikrat dnevno.
English: White opaque (size 4, 14.3 ± 0.3 mm) capsules with “DPH02” printed in black on the cap and “100” printed in black on the body.
Slovenian: Bele neprozorne (velikost 4, 14.3 ± 0.3 mm) kapsule, ki imajo v črni barvi na pokrovčku natisnjeno "DPH02", na ovoju pa "100".
English: 100 mg three times a day 100 mg twice a day
Slovenian: 200 mg trikrat dnevno 200 mg trikrat dnevno 100 mg trikrat dnevno 100 mg trikrat dnevno 100 mg enkrat dnevno
English: Miglustat Dipharma should not be taken during breast-feeding.
Slovenian: Zdravilo Miglustat Dipharma se ne sme jemati v času dojenja.
English: Contents of the pack and other information What Miglustat Dipharma contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Miglustat Dipharma
English: Use of Miglustat Dipharma in patients with severe renal impairment (creatinine clearance < 30 ml/min/1.73 m2) is not recommended.
Slovenian: Uporabe zdravila Miglustat Dipharma pri bolnikih s hudo okvarjenim delovanjem ledvic (očistek kreatinina < 30 ml/min/1.73 m2) ne priporočamo.
English: If you take more capsules than you were told to, consult your doctor immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Miglustat Dipharma, kot bi smeli Če ste vzeli več kapsul, kot vam je bilo naročeno, se takoj posvetujte z zdravnikom.
English: What you need to know before you take Miglustat Dipharma 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Miglustat Dipharma 3.
English: Small mean reductions in haemoglobin [-0.95 g/dL (95% CI: -1.38, -0.53)] and platelet count [-44.1 × 109/L (95% CI: -57.6, -30.7)] were observed between baseline and end of study.
Slovenian: Med izhodiščem in koncem študije so opazili majhno povprečno zmanjšanje hemoglobina [-0.95 g/dl (95-odstotni IZ: -1.38, -0.53)] in števila trombocitov [- 44.1 × 109/l (95-odstotni IZ: -57.6, -30.7)].
English: • if you suffer from liver disease
Slovenian: • če imate ledvično bolezen • če imate jetrno bolezen.
English: Your doctor will perform some tests before and during treatment with Miglustat Dipharma to assess this (see section 2).
Slovenian: Vaš zdravnik bo to ocenil z nekaj preiskavami pred zdravljenjem z zdravilom Miglustat Dipharma in med zdravljenjem (glejte poglavje 2).
English: They could be signs of peripheral neuropathy, due to side effects of Miglustat Dipharma or they could be due to existing conditions.
Slovenian: To so morda znaki periferne nevropatije, ki nastanejo zaradi neželenih učinkov zdravila Miglustat Dipharma, morda pa so vzrok zanje obstoječe bolezni.
English: The mechanism is most likely inhibition of intestinal disaccharidases such as sucrase-isomaltase in the gastrointestinal tract leading to reduced absorption of dietary disaccharides.
Slovenian: Mehanizem je najverjetneje inhibicija disaharidaz v črevesju, kot je saharaza-izomaltaza v prebavilih, kar povzroči zmanjšano absorpcijo disaharidov iz hrane.
English: The most common serious adverse reaction reported with miglustat treatment in clinical trials was peripheral neuropathy (see section 4.4).
Slovenian: Najpogostejši resni neželeni učinek, o katerem so poročali pri zdravljenju z miglustatom v kliničnih študijah, je bila periferna nevropatija (glejte poglavje 4.4).
English: What you need to know before you take Miglustat Dipharma Do not take Miglustat Dipharma:
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Miglustat Dipharma Ne jemljite zdravila Miglustat Dipharma:
English: Growth should be monitored in paediatric and adolescent patients during treatment with Miglustat Dipharma; the benefit/risk balance should be re-assessed on an individual basis for continuation of therapy.
Slovenian: Med zdravljenjem z zdravilom miglustat je treba spremljati rast pediatričnih bolnikov in mladostnikov; razmerje med koristmi in tveganji je treba ponovno oceniti posamično za vsakega bolnika pred nadaljevanjem zdravljenja
English: Miglustat affected embryo/foetal survival in rats and rabbits, dystocia was reported, post-implantation losses were increased, and an increased incidence of vascular anomalies occurred in rabbits.
Slovenian: Miglustat je vplival na preživetje zarodkov/plodov pri podganah in kuncih, poročali so o distociji, povečale so se izgube po implantaciji in povečala se je incidenca žilnih nepravilnosti pri kuncih.
English: Pharmacokinetic parameters of miglustat were assessed in healthy subjects, in a small number of patients with type 1 Gaucher disease, Fabry disease, HIV-infected patients, and in adults, adolescents and children with Niemann-Pick type C disease or type 3 Gaucher disease.
Slovenian: 5.2 Farmakokinetične lastnosti Farmakokinetične parametre miglustata so ovrednotili pri zdravih osebah, pri majhnem številu bolnikov z Gaucherjevo boleznijo tipa 1, pri bolnikih s Fabryjevo boleznijo, pri bolnikih, okuženih z virusom HIV, ter pri odraslih, mladoletnikih in otrocih z Niemann-Pickovo boleznijo tipa C ali Gaucherjevo boleznijo tipa 3.
English: The most common adverse reactions reported in clinical trials with miglustat were diarrhoea, flatulence, abdominal pain, weight loss and tremor (see section 4.4).
Slovenian: Najpogostejši neželeni učinki, o katerih so poročali v kliničnih študijah z miglustatom, so bili diareja, flatulenca, bolečina v trebuhu, izguba telesne mase in tremor (glejte poglavje 4.4).
English: Miglustat has been administered at doses of up to 3000 mg/day for up to six months in HIV positive patients during clinical trials.
Slovenian: Miglustat so v kliničnih preskušanjih uporabljali v odmerkih do 3000 mg/dan do šest mesecev pri bolnikih s HIV.
English: • Miglustat Dipharma is also used to treat progressive neurological symptoms in NiemannPick type C disease in adults and in children.
Slovenian: • Zdravilo Miglustat Dipharma se uporablja tudi za zdravljenje progresivnih nevroloških simptomov pri Niemann-Pickovi bolezni tipa C pri odraslih in otrocih.
English: For Niemann-Pick type C disease: For adults and adolescents (over 12 years old), the usual dose is two capsules (200 mg) three times a day (morning, afternoon and evening).
Slovenian: • Za Niemann-Pickovo bolezen tipa C: Za odrasle in mladostnike (stare več kot 12 let) je običajni odmerek dve kapsuli (200 mg) trikrat dnevno (zjutraj, popoldan in zvečer).
English: Depression, insomnia, libido decreased
Slovenian: Pogosto depresija, nespečnost, zmanjšan libido
English: What Miglustat Dipharma is and what it is used for 2.
Slovenian: Kaj je zdravilo Miglustat Dipharma in za kaj ga uporabljamo 2.
English: Miglustat has been studied in indications where certain events reported as adverse reactions, such as neurological and neuropsychological symptoms/signs, cognitive dysfunction and thrombocytopenia could also be due to the underlying conditions.
Slovenian: Miglustat so preučevali v zvezi z indikacijami, pri katerih bi bili lahko nekateri neželeni učinki, kot so nevrološki in nevropsihološki simptomi/znaki, kognitivna disfunkcija in trombocitopenija, tudi posledica bolezni, zaradi katere se bolnik zdravi.
English: Miglustat Dipharma is only used when a patient is considered unsuitable for treatment with enzyme replacement therapy.
Slovenian: Miglustat Dipharma se jemlje le, kadar bolnik za encimsko nadomestno zdravljenje ni primeren.
English: Pack size of 84 capsules in non-perforated blisters.
Slovenian: Velikost pakiranja po 84 kapsul v neperforiranih pretisnih omotih.
English: If you do lose some weight when you start treatment with Miglustat Dipharma don't worry.
Slovenian: Če po začetku zdravljenja z zdravilom Miglustat Dipharma izgubite nekaj telesne mase, to ni razlog za zaskrbljenost.
English: The neurological symptoms and thrombocytopenia could be due to the underlying disease.
Slovenian: Nevrološki simptomi in trombocitopenija so lahko posledica bolezni, zaradi katere se zdravite.
English: A mean increase in haemoglobin concentration of 0.26 g/dl and a mean platelet count increase of 8.29 × 109/l were observed.
Slovenian: Opažali so povprečno povišanje koncentracije hemoglobina za 0.26 g/dl ter povprečno povečanje koncentracije trombocitov za 8.29 x 109/l.
English: The benefit to the patient of treatment with miglustat should be evaluated on a regular basis (see section 4.4).
Slovenian: Koristi zdravljenja z zdravilom miglustat je treba pri bolnikih redno preverjati (glejte poglavje 4.4).
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
English: At steady state, the concentration of miglustat in cerebrospinal fluid of six type 3 Gaucher disease patients was 31.4-67.2% of that in plasma.
Slovenian: Gaucherjevo boleznijo tipa 3 predstavljala 31,4-67,2 % koncentracije v plazmi.
English: The benefit of treatment with miglustat for neurological manifestations in patients with Niemann-Pick type C disease should be evaluated on a regular basis, e.g. every 6 months; continuation of therapy should be re-appraised after at least 1 year of treatment with miglustat.
Slovenian: Koristi zdravljenja z zdravilom miglustat pri nevroloških manifestacijah pri bolnikih z NiemannPickovo boleznijo tipa C je treba redno preverjati, npr. vsakih 6 mesecev; za nadaljevanje terapije se je treba ponovno odločiti po vsaj 1-letnem zdravljenju z zdravilom miglustat.
English: Gastrointestinal events, mainly diarrhoea, have been observed in more than 80% of patients, either at the outset of treatment or intermittently during treatment (see section 4.8).
Slovenian: Pri več kot 80 % bolnikov so na začetku zdravljenja ali občasno med zdravljenjem opažali neželene dogodke na prebavila, zlasti diarejo (glejte poglavje 4.8).
English: What Miglustat Dipharma looks like and contents of the pack
Slovenian: Izgled zdravila Miglustat Dipharma in vsebina pakiranja
English: If you do get any of these effects reported above, please seek medical advice from your doctor as soon as possible.
Slovenian: Če opazite katerega koli od teh učinkov, čim prej obvestite zdravnika.
English: Miglustat Dipharma works by inhibiting the enzyme called ‘glucosylceramide synthase' which is responsible for the first step in the synthesis of most glycosphingolipids.
Slovenian: Zdravilo Miglustat Dipharma deluje tako, da zavira delovanje encima, ki se imenuje 'glukozilceramid sintaza', ki je odgovoren za prvi korak sinteze večine glikosfingolipidov.
English: Miglustat Dipharma is indicated for the treatment of progressive neurological manifestations in adult patients and paediatric patients with Niemann-Pick type C disease (see sections 4.4, and 5.1).
Slovenian: Zdravilo Miglustat Dipharma je indicirano za zdravljenje progresivne nevrološke manifestacije pri odraslih bolnikih in pediatričnih bolnikih z Niemann-Pickovo boleznijo vrste C (glejte poglavji 4.4, in
English: What Miglustat Dipharma is and what it is used for
Slovenian: Kaj je zdravilo Miglustat Dipharma in za kaj ga uporabljamo
English: In clinical practice, miglustat-induced gastrointestinal events have been observed to respond to individualised diet modification (for example reduction of sucrose, lactose and other carbohydrate intake), to taking miglustat between meals, and/or to anti-diarrhoeal medicinal products such as loperamide.
Slovenian: odzvale na individualno spremembo prehrane (na primer na zmanjšanje vnosa saharoze, laktoze in drugih ogljikovih hidratov), jemanje miglustata med obroki in/ali na jemanje zdravil proti diareji, na primer loperamida.