natgillin/translations-raw huggingface dataset:
Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in škatli poleg oznake »EXP/Uporabno do«.
In type 1 Gaucher disease, these tremors were described as an exaggerated physiological tremor of the hands.
Te tremorje so opisovali kot pretirano fiziološko tresenje rok.
In patients included in the clinical trial, 40%-50% of patients had platelet counts below the lower limit of normal at baseline.
Pri bolnikih, vključenih v klinično preskušanje, je 40 % - 50% bolnikov imelo število trombocitov pod spodnjo mejo normalnega ob izhodišču.
In the first 6 months in patients who were switched to miglustat, liver and spleen organ volumes and haemoglobin levels were unchanged.
Pri bolnikih, ki so prešli na miglustat, se prvih 6 mesecev volumna jeter in vranice ter ravni hemoglobina niso spremenili.
In vitro, glucosylceramide synthase is inhibited by miglustat with an IC50 of 20-37 μM.
Glukozilceramid-sintazo in vitro zavira miglustat z IC50, ki je 20-37 µM.
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.).
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).
Eighteen patients then continued to receive miglustat under an optional extended treatment protocol.
18 bolnikov je nato nadaljevalo z jemanjem miglustata v neobveznem podaljšanem programu zdravljenja.
No patient showed rapid deterioration of type 1 Gaucher disease following the switch to miglustat monotherapy.
Noben od bolnikov ni kazal hitrega poslabšanja stanja Gaucherjeve bolezni tipa 1 po prehodu na monoterapijo z miglustatom.
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:
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:
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.
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.
The efficacy of miglustat in children and adolescents aged 0-17 years with type 1 Gaucher disease has not been established.
Učinkovitost zdravila miglustat pri otrocih in mladostnikih, starih od 0 do 17 let, z Gaucherjevo boleznijo tipa 1 še ni bila dokazana.
- The active substance is miglustat.
- Učinkovina je miglustat.
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.
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.
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.
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.
Capsule content Magnesium stearate
Vsebina kapsule magnezijev stearat
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.
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.
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.
Študija je vključevala klinično serijo 66 bolnikov, zdravljenih z zdravilom miglustat, izven kliničnega preskušanja s povprečnim trajanjem 1,5 let.
Weight loss has been reported in 55% of patients.
Opis izbranih neželenih učinkov O izgubi telesne mase so poročali pri približno 55 % bolnikov.
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).
Zdravilo Miglustat Dipharma smemo uporabljati samo za zdravljenje bolnikov, za katere encimsko nadomestno zdravljenje ni primerno (glejte poglavji 4.4 in 5.1).
The most abundant metabolite in urine was miglustat glucuronide accounting for 5% of the dose.
V urinu je bilo največ presnovka miglustat glukuronida, ki je predstavljal 5 %
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%.
Po 12 mesecih je bilo povprečno zmanjšanje volumna jeter 12.1 % in povprečno zmanjšanje volumna vranice 19.0 %.
After 3 years of continuous miglustat treatment, mean reductions in liver and spleen organ volume were 17.5% and 29.6%, respectively.
Po treh letih stalnega jemanja miglustata je bilo povprečno zmanjšanje volumna jeter 17.5 % in vranice 29.6 %.
In 11 clinical trials in different indications 247 patients were treated with miglustat at doses of 50-200 mg t.i.d.
V 11 kliničnih preskušanjih z različnimi indikacijami so 247 bolnikov zdravili z miglustatom z odmerki 50-200 mg trikrat dnevno.
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.
Bele neprozorne (velikost 4, 14.3 ± 0.3 mm) kapsule, ki imajo v črni barvi na pokrovčku natisnjeno "DPH02", na ovoju pa "100".
100 mg three times a day 100 mg twice a day
200 mg trikrat dnevno 200 mg trikrat dnevno 100 mg trikrat dnevno 100 mg trikrat dnevno 100 mg enkrat dnevno
Miglustat Dipharma should not be taken during breast-feeding.
Zdravilo Miglustat Dipharma se ne sme jemati v času dojenja.
Contents of the pack and other information What Miglustat Dipharma contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Miglustat Dipharma
Use of Miglustat Dipharma in patients with severe renal impairment (creatinine clearance < 30 ml/min/1.73 m2) is not recommended.
Uporabe zdravila Miglustat Dipharma pri bolnikih s hudo okvarjenim delovanjem ledvic (očistek kreatinina < 30 ml/min/1.73 m2) ne priporočamo.
If you take more capsules than you were told to, consult your doctor immediately.
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.
What you need to know before you take Miglustat Dipharma 3.
Kaj morate vedeti, preden boste vzeli zdravilo Miglustat Dipharma 3.
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.
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)].
• if you suffer from liver disease
• če imate ledvično bolezen • če imate jetrno bolezen.
Your doctor will perform some tests before and during treatment with Miglustat Dipharma to assess this (see section 2).
Vaš zdravnik bo to ocenil z nekaj preiskavami pred zdravljenjem z zdravilom Miglustat Dipharma in med zdravljenjem (glejte poglavje 2).
They could be signs of peripheral neuropathy, due to side effects of Miglustat Dipharma or they could be due to existing conditions.
To so morda znaki periferne nevropatije, ki nastanejo zaradi neželenih učinkov zdravila Miglustat Dipharma, morda pa so vzrok zanje obstoječe bolezni.
The mechanism is most likely inhibition of intestinal disaccharidases such as sucrase-isomaltase in the gastrointestinal tract leading to reduced absorption of dietary disaccharides.
Mehanizem je najverjetneje inhibicija disaharidaz v črevesju, kot je saharaza-izomaltaza v prebavilih, kar povzroči zmanjšano absorpcijo disaharidov iz hrane.
The most common serious adverse reaction reported with miglustat treatment in clinical trials was peripheral neuropathy (see section 4.4).
Najpogostejši resni neželeni učinek, o katerem so poročali pri zdravljenju z miglustatom v kliničnih študijah, je bila periferna nevropatija (glejte poglavje 4.4).
What you need to know before you take Miglustat Dipharma Do not take Miglustat Dipharma:
Kaj morate vedeti, preden boste vzeli zdravilo Miglustat Dipharma Ne jemljite zdravila Miglustat Dipharma:
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.
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
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.
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.
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.
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.
The most common adverse reactions reported in clinical trials with miglustat were diarrhoea, flatulence, abdominal pain, weight loss and tremor (see section 4.4).
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).
Miglustat has been administered at doses of up to 3000 mg/day for up to six months in HIV positive patients during clinical trials.
Miglustat so v kliničnih preskušanjih uporabljali v odmerkih do 3000 mg/dan do šest mesecev pri bolnikih s HIV.
• Miglustat Dipharma is also used to treat progressive neurological symptoms in NiemannPick type C disease in adults and in children.
• Zdravilo Miglustat Dipharma se uporablja tudi za zdravljenje progresivnih nevroloških simptomov pri Niemann-Pickovi bolezni tipa C pri odraslih in otrocih.
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).
• 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).
Depression, insomnia, libido decreased
Pogosto depresija, nespečnost, zmanjšan libido
What Miglustat Dipharma is and what it is used for 2.
Kaj je zdravilo Miglustat Dipharma in za kaj ga uporabljamo 2.
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.
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.
Miglustat Dipharma is only used when a patient is considered unsuitable for treatment with enzyme replacement therapy.
Miglustat Dipharma se jemlje le, kadar bolnik za encimsko nadomestno zdravljenje ni primeren.
Pack size of 84 capsules in non-perforated blisters.
Velikost pakiranja po 84 kapsul v neperforiranih pretisnih omotih.
If you do lose some weight when you start treatment with Miglustat Dipharma don't worry.
Če po začetku zdravljenja z zdravilom Miglustat Dipharma izgubite nekaj telesne mase, to ni razlog za zaskrbljenost.
The neurological symptoms and thrombocytopenia could be due to the underlying disease.
Nevrološki simptomi in trombocitopenija so lahko posledica bolezni, zaradi katere se zdravite.
A mean increase in haemoglobin concentration of 0.26 g/dl and a mean platelet count increase of 8.29 × 109/l were observed.
Opažali so povprečno povišanje koncentracije hemoglobina za 0.26 g/dl ter povprečno povečanje koncentracije trombocitov za 8.29 x 109/l.
The benefit to the patient of treatment with miglustat should be evaluated on a regular basis (see section 4.4).
Koristi zdravljenja z zdravilom miglustat je treba pri bolnikih redno preverjati (glejte poglavje 4.4).
Both data sets included paediatric, adolescent and adult patients with an age range of 1 year to 43 years.
Oba niza podatkov sta vključevala pediatrične bolnike, mladostnike in odrasle bolnike, pri čemer je bil starostni razpon od
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.
Gaucherjevo boleznijo tipa 3 predstavljala 31,4-67,2 % koncentracije v plazmi.
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.
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.
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).
Pri več kot 80 % bolnikov so na začetku zdravljenja ali občasno med zdravljenjem opažali neželene dogodke na prebavila, zlasti diarejo (glejte poglavje 4.8).
What Miglustat Dipharma looks like and contents of the pack
Izgled zdravila Miglustat Dipharma in vsebina pakiranja
If you do get any of these effects reported above, please seek medical advice from your doctor as soon as possible.
Če opazite katerega koli od teh učinkov, čim prej obvestite zdravnika.
Miglustat Dipharma works by inhibiting the enzyme called ‘glucosylceramide synthase' which is responsible for the first step in the synthesis of most glycosphingolipids.
Zdravilo Miglustat Dipharma deluje tako, da zavira delovanje encima, ki se imenuje 'glukozilceramid sintaza', ki je odgovoren za prvi korak sinteze večine glikosfingolipidov.
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).
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
What Miglustat Dipharma is and what it is used for
Kaj je zdravilo Miglustat Dipharma in za kaj ga uporabljamo
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.
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.
Studies in the rat have shown that miglustat adversely affects spermatogenesis and sperm parameters and reduces fertility (see sections 4.6 and 5.3).
Študije na podganah so pokazale, da miglustat neželeno vpliva na spermatogenezo in parametre spermijev ter zmanjšuje plodnost (glejte poglavji 4.6 in 5.3).
The usual dose of miglustat in adult patients was 200 mg t.i.d., and was adjusted according to body surface area in paediatric patients.
Običajni odmerek zdravila miglustat pri odraslih bolnikih je bil 200 mg trikrat dnevno, ustrezno prilagojen na površino telesa pri pediatričnih bolnikih.
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).
Študije na podganah so pokazale, da miglustat negativno vpliva na parametre spermijev (gibljivost in obliko), s čimer zmanjša plodnost (glejte poglavji 4.4 in 5.3).
Pharmacotherapeutic group: Other alimentary tract and metabolism products, various alimentary tract and metabolism products.
Farmakoterapevtska skupina: Druga zdravila za bolezni prebavil in presnove, razna zdravila za bolezni prebavil in presnove.
Miglustat Dipharma contains the active substance miglustat which belongs to a group of medicines that affect metabolism.
Zdravilo Miglustat Dipharma vsebuje učinkovino miglustat, ki spada v skupino zdravil, ki vplivajo na presnovo.
• monitoring of blood platelet counts
• nadziranje števila trombocitov v krvi.
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 (see section 4.4).
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 (glejte poglavje 4.4).
Male patients should maintain reliable contraceptive methods while taking Miglustat Dipharma (see sections 4.4 and 5.3).
Moški morajo ves čas uporabe zdravila Miglustat Dipharma uporabljati zanesljiv način kontracepcije (glejte poglavji 4.4 in 5.3).
100 mg once a day
je 200 mg trikrat dnevno.
Twenty-eight patients with mild to moderate type 1 Gaucher disease were enrolled in this 12-month non-comparative study, and 22 patients completed the study.
V 12-mesečno neprimerjalno študijo so vključili 28 bolnikov z blago do zmerno obliko Gaucherjeve bolezni tipa 1, študijo je zaključilo 22 bolnikov.
In addition, inhibitory action on a non-lysosomal glycosylceramidase has been demonstrated experimentally in vitro.
Poleg tega je bilo eksperimentalno in vitro dokazano zaviralno delovanje na ne-lizosomalno glikozilceramidazo.
Adverse events observed included granulocytopenia, dizziness and paraesthesia.
Opažani neželeni dogodki so bili granulocitopenija, omotičnost in parestezije.
Due to limited experience, miglustat should be used with caution in patients with renal or hepatic impairment.
Posebne populacije Zaradi malo izkušenj moramo zdravilo miglustat pri bolnikih z okvarjenim delovanjem ledvic ali jeter uporabljati previdno.
The recommended dose for the treatment of adult patients with Niemann-Pick type C disease is 200 mg three times a day.
Priporočeni odmerek za zdravljenje odraslih in bolnikov z Niemann-Pickovo boleznijo tipa C je 200 mg trikrat dnevno.
How to take Miglustat Dipharma 4.
Kako jemati zdravilo Miglustat Dipharma 4.
Other medicines and Miglustat Dipharma
Druga zdravila in zdravilo Miglustat Dipharma
Most serious side effects
Najresnejši neželeni učinki:
Other possible side effects are muscular spasms or weakness, fatigue, chills and malaise, depression, difficulty sleeping, forgetfulness and reduced libido.
Drugi možni neželeni učinki so mišični krči ali slabost, utrujenost, mrzlice in splošno slabo počutje,
Sometimes your doctor will need to reduce the dose or stop Miglustat Dipharma treatment to stop the tremor.
Lahko se zgodi, da bo moral vaš zdravnik, da bi odpravil tremor, znižati vaš odmerek zdravila Miglustat Dipharma ali prekiniti zdravljenje z njim.
Until further information is available, it is advised that before seeking to conceive, male patients should cease Miglustat Dipharma and maintain reliable contraceptive methods for 3 months thereafter.
Dokler ne bo na voljo več informacij, je treba moškim svetovati, da pred poskusi zaploditve prenehajo uporabljati zdravilo Miglustat Dipharma in še 3 mesece potem uporabljajo zanesljivo metodo kontracepcije.
Peripheral neuropathy, ataxia, amnesia, paraesthesia, hypoaesthesia headache, dizziness
Pogosto periferna nevropatija, ataksija, amnezija, parestezije, hipoestezija,
If you stop taking Miglustat Dipharma
Če ste prenehali jemati zdravilo Miglustat Dipharma
There was a mean increase of 22.2 × 109/l in platelet count, and a mean increase of 0.95 g/dl in haemoglobin concentration.
Povprečno povečanje koncentracije trombocitov je bilo 22.2 x 109/l, povprečno povišanje koncentracije hemoglobina pa 0,95 g/dl.
• Miglustat Dipharma is used to treat mild to moderate type 1 Gaucher disease in adults.
• Zdravilo Miglustat Dipharma se uporablja za zdravljenje blage do zmerne Gaucherjeve bolezni tipa 1 pri odraslih.
There are no pharmacokinetic data available in patients with liver impairment or in the elderly (> 70 years).
Na voljo ni nobenih farmakokinetičnih podatkov za bolnike z okvarjenim delovanjem jeter, otroke ali mladostnike z Gaucherjevo boleznijo tipa 1 ali starostnike (> 70 let).
Dosage in type 1 Gaucher disease
Odmerjanje pri Gaucherjevi bolezni tipa 1
Pack size of 84x1 capsules in perforated unit dose blisters.
Velikost pakiranja po 84 x 1 kapsula v perforiranih deljivih pretisnih omotih s posameznimi odmerki.
Miglustat Dipharma is indicated for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease.
Zdravilo Miglustat Dipharma je indicirano za peroralno zdravljenje odraslih bolnikov z blago do zmerno obliko Gaucherjeve bolezni tipa 1.
Elderly There is no experience with the use of miglustat in patients over the age of 70.
Ni izkušenj z zdravljenjem bolnikov, starih več kot 70 let, z zdravilom miglustat.
- The other ingredients are magnesium stearate, gelatine, titanium dioxide (E171), printing ink (consisting of black iron oxide (E172), propylene glycol (E1520) potassium hydroxide, shellac).
- Pomožne snovi so magnezijev stearat, želatina, titanov dioksid (E171), tiskarska črnilo
Male patients should maintain reliable contraceptive methods while taking Miglustat Dipharma.
Učinek na spermatogenezo Bolniki moškega spola naj v času jemanja zdravila Miglustat Dipharma uporabljajo zanesljive kontracepcijske metode.
Miglustat Dipharma may make you feel dizzy.
Zaradi zdravila Miglustat Dipharma ste lahko omotični.
Do not take a double dose to make up for a forgotten dose.
Če ste pozabili vzeti zdravilo Miglustat Dipharma Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
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.
ki so vsaj 3 leta prejemali ERT in so vsaj 2 leti izpolnjevali merila stabilne bolezni.