FrancophonIA/ELRC3.0 huggingface dataset:
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 Zavesca 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 Zavesca skupaj s hrano ali začasno znižate svoj odmerek.
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: The reason for these tests is that some patients have had tingling or numbness in the hands and feet, or a decrease in body weight, while taking Zavesca.
Slovenian: Razlog za te preiskave je, da so nekateri bolniki med jemanjem zdravila Zavesca izkusili omrtvičenost ali mravljinčenje v rokah in stopalih ali zmanjšanje telesne mase.
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: Tremor 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: The main effects common to all species were weight loss and diarrhoea, and, at higher doses, damage to the gastrointestinal mucosa (erosions and ulceration).
Slovenian: Glavni učinki, skupni vsem vrstam, so bili hujšanje in diareja ter, pri višjih odmerkih, poškodbe sluznice prebavil (erozije in ulceracije).
English: Eighteen patients then continued to receive Zavesca under an optional extended treatment protocol.
Slovenian: 18 bolnikov je nato nadaljevalo z jemanjem zdravila Zavesca v neobveznem podaljšanem programu 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 zajcih, poročali so o distociji, povečale so se izgube po implantaciji in povečala se je incidenca žilnih nepravilnosti pri zajcih.
English: An open-label, non comparative, 2-year study enrolled 42 patients with type 1 Gaucher disease, who had received a minimum of 3 years of ERT and who fulfilled criteria of stable disease for at least 2 years.
Slovenian: Odprta, neprimerjalna, 2-letna študija z vključenimi 42 bolniki z Gaucherjevo boleznijo tipa 1, ki so vsaj 3 leta prejemali ERT in so izpolnjevali kriterije bolezni, stabilne vsaj 2 leti.
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: V stanju dinamičnega ravnovesja je koncentracija miglustata v cerebrospinalni tekočini šestih bolnikov z Gaucherjevo bolezijo tipa 3 predstavljala 31,4-67,2 % koncentracije v plazmi.
English: No patient showed rapid deterioration of type 1 Gaucher disease following the switch to Zavesca monotherapy.
Slovenian: Noben od bolnikov ni kazal hitrega poslabšanja stanja Gaucherjeve bolezni vrste 1 po prehodu na monoterapijo z zdravilom Zavesca.
English: In some patients there were reductions in platelet count and increases in chitotriosidase activity indicating that Zavesca monotherapy may not maintain the same control of disease activity in all patients.
Slovenian: Pri nekaterih bolnikih je prišlo do zmanjšanja koncentracije trombocitov in povečanja aktivnosti hitotriozidaze, kar kaže, da monoterapija z zdravilom Zavesca morebiti ne zadostuje za vzdrževanje enakega nadzora nad boleznijo pri vseh bolnikih.
English: - if you suffer from liver disease
Slovenian: - če imate ledvično bolezen - če imate jetrno bolezen
English: In the first 6 months in patients who were switched to Zavesca, liver and spleen organ volumes and haemoglobin levels were unchanged.
Slovenian: Pri bolnikih, ki so prešli na zdravilo Zavesca, se prvih 6 mesecev volumna jeter in vranice ter ravni hemoglobina niso spremenili.
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: Blood and lymphatic system disorders Common
Slovenian: Bolezni krvi in limfatičnega sistema
English: In addition, inhibitory action on a non-lysosomal glycosylceramidase has been demonstrated experimentally in vitro.
Slovenian: Poleg tega je bilo zaviralno delovanje na ne-lizosomalni glikozilceramidazi dokazana eksperimentalno in vitro.
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 rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7)
English: Zavesca has negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Zavesca ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Limited data suggest that co-administration of Zavesca and enzyme replacement with imiglucerase in patients with type 1 Gaucher disease may result in decreased exposure to miglustat (approximate reductions of 22% in Cmax and 14% in AUC were observed in a small parallel-group study).
Slovenian: Malo podatkov kaže, da lahko sočasna uporaba zdravil Zavesca in nadomestka encima z imiglucerazo pri bolnikih z Gaucherjevo boleznijo tipa 1 povzroči znižanje izpostavljenosti miglustatu (v majhni študiji s paralelnimi skupinami so opažali približna znižanja 22 % Cmax in 14 % AUC).
English: Contents of the pack and other information What Zavesca contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Zavesca
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 Zavesca, or switch to Zavesca.
Slovenian: V drugi odprti kontrolirani študiji so v tri skupine zdravljenja naključno razporedili 36 bolnikov, ki so se že vsaj 2 leti zdravili z ERT: nadaljevanje zdravljenja z imiglucerazo, kombinacija imigluceraze in zdravila Zavesca ali prehod na zdravilo Zavesca.
English: These effects occurred at exposure levels similar to those in patients, but showed reversibility.
Slovenian: podobnih tistim pri bolnikih, a so bili reverzibilni.
English: The survey included a case series of 66 patients treated with Zavesca outside of the clinical trial for a mean duration of 1.5 years.
Slovenian: Študija je vključevala klinično serijo 66 bolnikov, zdravljenih z zdravilom Zavesca, izven kliničnega preskušanja s povprečnim trajanjem 1,5 let.
English: Peripheral neuropathy seems to be more common in patients with type 1 Gaucher disease compared to the general population.
Slovenian: Kaže, da je periferna nevropatija pogostejša pri bolnikih z Gaucherjevo boleznijo tipa 1 v primerjavi s splošno populacijo.
English: When compared to the measurements at 6 months, disease control was unchanged after 18 and 24 months of Zavesca 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 zdravilom Zavesca nespremenjen (20 oz. 6 bolnikov).
English: If you do lose some weight when you start treatment with Zavesca don't worry.
Slovenian: Če po začetku zdravljenja z zdravilom Zavesca izgubite nekaj telesne mase, to ni razlog za zaskrbljenost.
English: These data suggest a decrease in CL/F by at least 70% in patients with severe renal impairment.
Slovenian: CL/F za vsaj 70 % pri bolnikih s hudo okvarjenim delovanjem ledvic.
English: Growth should be monitored in paediatric and adolescent patients during treatment with Zavesca; the benefit/risk balance should be re-assessed on an individual basis for continuation of therapy.
Slovenian: Med zdravljenjem z zdravilom Zavesca 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: LIST OF EXCIPIENTS PHARMACEUTICAL FORM AND CONTENTS
Slovenian: SEZNAM POMOŽNIH SNOVI FARMACEVTSKA OBLIKA IN VSEBINA
English: After 3 years of continuous Zavesca treatment, mean reductions in liver and spleen organ volume were 17.5% and 29.6%, respectively.
Slovenian: Po treh letih stalnega jemanja zdravila Zavesca je bilo povprečno zmanjšanje volumna jeter 17,5 % in vranice 29,6 %.
English: The most common serious adverse reaction reported with Zavesca treatment in clinical studies was peripheral neuropathy (see section 4.4).
Slovenian: Najpogostejši resni neželeni učinek, o katerem so poročali pri zdravljenju z zdravilom Zavesca v kliničnih študijah, je bila periferna nevropatija (glejte poglavje section 4.4).
English: Do not drive or use any tools or machines if you feel dizzy.
Slovenian: Če ste omotični, ne vozite in ne upravljajte z nobenim orodjem ali stroji.
English: Gelatin, Titanium dioxide (E171).
Slovenian: Ovoj kapsule želatina, titanov dioksid (E171).
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 Zavesca between meals, and/or to anti-diarrhoeal medicinal products such as loperamide.
Slovenian: V klinični praksi so opažali prebavne dogodke, ki jih je izzval miglustat, in ki so ustrezali individualni spremembi prehrane (na primer zmanjšanju vnosa saharoze, laktoze in drugih ogljikovih hidratov), jemanju zdravila Zavesca med obroki ali jemanju zdravil proti diareji, na primer loperamida, ali obojega.
English: Zavesca 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 Zavesca smemo uporabljati samo za zdravljenje bolnikov, za katere encimsko nadomestno zdravljenje ni primerno (glejte poglavji 4.4 in 5.1).
English: Your doctor will perform some tests before and during treatment with Zavesca to assess this (see section 2).
Slovenian: Vaš zdravnik bo to ocenil z nekaj preskusi pred zdravljenjem z zdravilom Zavesca in med zdravljenjem (glejte poglavje 2).
English: Ask your pharmacist how to throw away medicines you no longer take.
Slovenian: O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom.
English: Box of 4 blister strips, each blister strip containing 21 capsules providing a total of 84 capsules.
Slovenian: Škatla s 4 pretisnimi omoti, vsak pretisni omot vsebuje 21 kapsul, skupaj torej 84 kapsul.
English: They could be signs of peripheral neuropathy, due to side effects of Zavesca or they could be due to existing conditions.
Slovenian: To so morda znaki periferne nevropatije, ki nastanejo zaradi neželenih učinkov zdravila Zavesca, morda pa so vzrok zanje obstoječe bolezni.
English: Zavesca 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 Zavesca je indicirano za zdravljenje progresivne nevrološke manifestacije pri odraslih bolnikih in pediatričnih bolnikih z Niemann-Pickovo boleznijo vrste C (glejte poglavji 4.4, in 5.1).
English: Zavesca should not be taken during breast-feeding.
Slovenian: Zdravila Zavesca se ne sme jemati v času dojenja.
English: If your diarrhoea does not respond to these measures, or if you have any other abdominal complaint, consult your doctor.
Slovenian: Če driska po teh ukrepih ne bo izzvenela ali če imate še druge prebavne težave, se o tem posvetujte s svojim zdravnikom.
English: Take the next capsule at the usual time.
Slovenian: Če ste pozabili vzeti zdravilo Zavesca Kapsulo vzemite ob običajnem času.
English: • Zavesca is also used to treat progressive neurological symptoms in Niemann-Pick type C disease in adults and in children.
Slovenian: • Zdravilo Zavesca se uporablja tudi za zdravljenje progresivnih nevroloških simptomov pri Niemann-Pickovi bolezni tipa C pri odraslih in otrocih.
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 število trombocitov [-44,1 × 109/l (95-odstotni IZ: -57,6, -30,7)].
English: Further effects seen in animals at doses that result in exposure levels similar to or moderately higher than the clinical exposure level were: changes in lymphoid organs in all species tested, transaminase changes, vacuolation of thyroid and pancreas,
Slovenian: Poleg tega so tu še učinki, zabeleženi pri živalih pri odmerkih, ki povzročijo ravni izpostavljenosti, ki so podobne ali malo višje kot klinične ravni izpostavljenosti: spremembe v limfoidnih organih pri vseh testiranih vrstah, spremembe vrednosti transaminaz, vakuolizacija ščitnice in trebušne slinavke, katarakte, nefropatija ter spremembe miokarda pri podganah.
English: Very common effects - may affect more than 1 in 10 people The most common side effects are diarrhoea, flatulence (wind), abdominal (stomach) pain, weight loss and decreased appetite.
Slovenian: Zelo pogosti neželeni učinki - pojavijo se lahko pri več kot 1 od 10 bolnikov Najbolj pogosti neželeni učinki so driska, flatulenca (vetrovi), bolečine v trebuhu, izguba telesne mase in zmanjšanje apetita.
English: If you do get any of these effects, please seek medical advice from your doctor as soon as possible.
Slovenian: Če opazite katerega koli od teh učinkov, čim prej obvestite zdravnika.
English: What you need to know before you take Zavesca Do not take Zavesca
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Zavesca Ne jemljite zdravila Zavesca:
English: Use of Zavesca in patients with severe renal impairment (creatinine clearance < 30 ml/min/1.73 m2) is not recommended.
Slovenian: Uporabe Zavesce pri bolnikih s hudo okvarjenim delovanjem ledvic (očistek kreatinina < 30 ml/min/1,73 m2) ne priporočamo.
English: The most common adverse reactions reported in clinical studies with Zavesca 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 zdravilom Zavesca, so bili driska, flatulenca, bolečina v trebuhu, izguba telesne mase in tremor (glejte poglavje 4.4).
English: The benefit of treatment with Zavesca 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 Zavesca.
Slovenian: Koristi zdravljenja z zdravilom Zavesca 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 Zavesca.
English: Zavesca 100 mg capsules
Slovenian: Zavesca 100 mg kapsule
English: Sometimes your doctor will need to reduce the dose or stop Zavesca treatment to stop the tremor.
Slovenian: Lahko se zgodi, da bo moral vaš zdravnik, da bi odpravil tremor, znižati vaš odmerek zdravila Zavesca ali prekiniti zdravljenje z njim.
English: ACLAR/ALU blister strips supplied as a box of 4 blister strips, each blister strip containing 21 capsules providing a total of 84 capsules.
Slovenian: ACLAR/ALU pretisni omoti, štirje pretisni omoti na škatlo, vsak pretisni omot vsebuje 21 kapsul, skupaj 84 kapsul.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET
English: In 11 clinical trials in different indications 247 patients were treated with Zavesca at dosages of 50200 mg t.i.d.
Slovenian: V 11 kliničnih preskušanjih z različnimi indikacijami so 247 bolnikov zdravili z zdravilom Zavesca z odmerki 50-200 mg trikrat dnevno.
English: The recommended starting dose for the treatment of adult patients with type 1 Gaucher disease is 100 mg three times a day.
Slovenian: Priporočeni začetni odmerek za zdravljenje odraslih bolnikov z Gaucherjevo boleznijo tipa 1 je 100 mg trikrat dnevno.
English: Zavesca is only used when a patient is considered unsuitable for treatment with enzyme replacement therapy.
Slovenian: Zavesca se jemlje le, kadar bolnik za encimsko nadomestno zdravljenje ni primeren.
English: Until further information is available, it is advised that before seeking to conceive, male patients should cease Zavesca and maintain reliable contraceptive methods for 3 months thereafter.
Slovenian: Dokler ne bo na voljo več informacij, je treba moškim svetovati, da pred zaploditvijo prenehajo uporabljati zdravilo Zavesca in še 3 mesece potem uporabljajo zanesljivo metodo kontracepcije.
English: Zavesca 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: Zdravilo Zavesca 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: Capsule, hard White capsules with “OGT 918” printed in black on the cap and “100” printed in black on the body.
Slovenian: Bele kapsule, ki imajo v črni barvi na pokrovčku natisnjeno "OGT 918", na ovoju pa "100".
English: Studies in animals have shown reproductive toxicity, including dystocia (see section 5.3).
Slovenian: Študije na živalih so pokazale vpliv na sposobnost razmnoževanja, vključno z distocijo (glejte 5.3).
English: Male patients should maintain reliable contraceptive methods while taking Zavesca.
Slovenian: Bolniki moškega spola naj v času jemanja zdravila Zavesca uporabljajo zanesljive kontracepcijske metode.
English: The inhibitory action on glucosylceramide synthase forms the rationale for substrate reduction therapy in Gaucher disease.
Slovenian: Zaviralno delovanje na glukozilceramid-sintazo je podlaga za zdravljenje z zmanjšanjem substrata pri Gaucherjevi bolezni.
English: If you get a slight tremor, usually trembling hands, seek medical advice from your doctor as soon as possible.
Slovenian: Če med zdravljenjem z zdravilom Zavesca izkusite blag tremor, običajno tresenje rok, to čim prej sporočite zdravniku.
English: Sodium starch glycollate, Povidone (K30), Magnesium stearate.
Slovenian: povidon (K30), magnezijev stearat.
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 učinke na prebavila, zlasti diarejo (glejte poglavje 4.8).
English: The benefit of treatment with Zavesca 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 Zavesca, (see section 4.4).
Slovenian: Koristi zdravljenja z zdravilom Zavesca 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 Zavesca (glejte poglavje 4.4).
English: Zavesca has been administered at doses of up to 3000 mg/day for up to six months in HIV positive patients during clinical trials.
Slovenian: Zdravilo Zavesca so v kliničnih preskušanjih uporabljali v odmerkih do 3000 mg/dan do šest mesecev pri bolnikih s HIV.
English: Male patients should maintain reliable contraceptive methods while taking Zavesca (see sections 4.4 and 5.3).
Slovenian: Moški morajo ves čas uporabe zdravila Zavesca uporabljati zanesljiv način kontracepcije (glejte poglavji 4.4 in 5.3).
English: Due to limited experience, Zavesca should be used with caution in patients with renal or hepatic impairment.
Slovenian: Posebne populacije Zaradi malo izkušenj moramo zdravilo Zavesca pri bolnikih z okvarjenim delovanjem ledvic ali jeter uporabljati previdno.
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Zavesca Vsebina pakiranja in dodatne informacije
English: Studies in the rat have shown that miglustat adversely affects sperm parameters (motility and morphology) thereby reducing fertility (see sections 4.4 and 5.3).
Slovenian: Plodnost Študije pri podganah so pokazale, da miglustat negativno vpliva na parametre sperme (gibljivost in obliko), s čimer zmanjša plodnost (glejte poglavji 4.4 in 5.3).
English: In addition 12 paediatric patients were enrolled in an uncontrolled substudy for an overall average duration of 3.1 years and up to 4.4 years.
Slovenian: nekontrolirano podštudijo je bilo za celokupno povprečno obdobje 3,1 leta in do 4,4 let vključenih 12 pediatričnih bolnikov.
English: Zavesca works by inhibiting the enzyme called ‘glucosylceramide synthase' which is responsible for the first step in the synthesis of most glycosphingolipids.
Slovenian: Zdravilo Zavesca deluje tako, da zavira delovanje encima, ki se imenuje 'glukozilceramid sintaza', ki je odgovoren za prvi korak sinteze večine glikosfingolipidov.
English: Other possible side effects are muscular spasms or weakness, fatigue chills and malaise, depression, difficulty sleeping, forgetfulness, and less libido.
Slovenian: Drugi možni neželeni učinki so mišični krči ali slabost, utrujenost, mrzlice in splošno slabo počutje,
English: Peripheral neuropathy, ataxia, amnesia, paraesthesia, hypoaesthesia, headache, dizziness
Slovenian: Pogosto periferna nevropatija, ataksija, amnezija, parestezije, hipoestezija, glavobol,
English: There is no experience with the use of Zavesca in patients over the age of 70.
Slovenian: Ni izkušenj z zdravljenjem bolnikov, starih več kot 70 let, z zdravilom Zavesca.
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),
English: Use in patients with severe renal impairment (creatinine clearance < 30 ml/min/1.73 m2) is not recommended (see sections 4.4 and 5.2).
Slovenian: Pickovo boleznijo tipa C. Uporabe pri bolnikih s hudo okvarjenim delovanjem ledvic (očistek kreatinina < 30 ml/min/1,73 m2) ne priporočamo (glejte poglavji 4.4 in 5.2).
English: Twenty-one patients completed 24 months of miglustat treatment.
Slovenian: 24-mesečno zdravljenje z miglustatom.
English: The usual dose of Zavesca in adult patients was 200 mg t.i.d., and was adjusted according to body surface area in paediatric patients.
Slovenian: Običajni odmerek zdravila Zavesca pri odraslih bolnikih je bil 200 mg trikrat dnevno, ustrezno prilagojen na površino telesa pri pediatričnih bolnikih.