natgillin/translations-raw huggingface dataset:
Limited data in patients with Fabry disease and impaired renal function showed that CL/F decreases with decreasing renal function.
Malo podatkov za bolnike s Fabryjevo boleznijo in okvarjenim delovanjem ledvic je pokazalo, da se CL/F s slabšanjem ledvičnega delovanja zmanjšuje.
Weight loss has been reported in 55% of patients using miglustat.
O izgubi telesne mase pri uporabi miglustata so poročali pri približno 55 % bolnikov.
- the other ingredients are sodium starch glycolate (type A), povidone (K-29/32), magnesium stearate, gelatin, purified water, titanium dioxide (E171), printing ink (shellac glaze, iron oxide black (E172), propylene glycol and concentrated ammonia solution)
- druge sestavine zdravila so natrijev karboksimetilškrob (tipa A), povidon (K-29/32),magnezijev stearat, želatina, prečiščena voda, titanov dioksid (E171), tiskarsko črnilo (glazura šelaka, črni železov oksid (E172), propilenglikol in koncentrirana raztopina amoniaka).
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.
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.
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.
Odprta, neprimerjalna dvoletna študija z vključenimi 42 bolniki z Gaucherjevo boleznijo tipa 1, ki so vsaj tri leta prejemali ERT in so izpolnjevali merila za bolezen, stabilno vsaj dve leti.
Limited data suggest that co-administration of miglustat 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).
Malo podatkov kaže, da lahko sočasna uporaba miglustata in nadomestka encima z imiglucerazo pri bolnikih z Gaucherjevo boleznijo tipa 1 povzroči znižanje izpostavljenosti miglustatu (v majhni študiji z vzporednimi skupinami so opažali približno znižanje za 22 % Cmax in 14 % AUC).
In some patients there were reductions in platelet count and increases in chitotriosidase activity indicating that miglustat monotherapy may not maintain the same control of disease activity in all patients.
Pri nekaterih bolnikih je prišlo do zmanjšanja koncentracije trombocitov in povečanja aktivnosti hitotriozidaze, kar kaže, da monoterapija z miglustatom morebiti ne zadostuje za vzdrževanje enakega nadzora nad boleznijo pri vseh bolnikih.
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.
Use of Yargesa in patients with severe renal impairment (creatinine clearance < 30 ml/min/1.73 m2) is not recommended.
Uporabe zdravila Yargesa pri bolnikih s hudo okvarjenim delovanjem ledvic (očistek kreatinina < 30 ml/min/1,73 m2) ne priporočamo.
The capsules are presented in a PVC and polychlorotrifluoroethylene (PCTFE) blister sealed with aluminium foil.
Kapsule so v PVC in poliklorotrifluoroetilenskem (PCTFE) pretisnem omotu, zavarjenem z aluminijasto folijo.
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, zato podatkov ne moremo ekstrapolirati pod to območje.
This means a daily maximum of six capsules (600 mg).
To pomeni največ šest kapsul zdravila dnevno (600 mg).
If you stop taking Yargesa
Če ste prenehali jemati zdravilo Yargesa
UNIQUE IDENTIFIER - HUMAN READABLE DATA PC: {number}
EDINSTVENA OZNAKA - V BERLJIVI OBLIKI PC: {številka}
In some patients, temporary dose reduction may be necessary.
Pri nekaterih bolnikih bo morda treba začasno znižati odmerek.
Reduced growth has been reported in some paediatric patients with Niemann-Pick type C disease in the early phase of treatment with miglustat where the initial reduced weight gain may be accompanied or followed by reduced height gain.
Pri nekaterih pediatričnih bolnikih z Niemann-Pickovo boleznijo tipa C so poročali o zmanjšani rasti v zgodnji fazi zdravljenja z miglustatom, kjer lahko manjša rast spremlja začetno zmanjšano pridobitev teže ali ji sledi.
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 Yargesa together with food, or to temporarily reduce your dose.
Če boste imeli drisko, vam bo morda zdravnik svetoval, da spremenite prehrano tako, da zmanjšate vnos laktoze in ogljikovih hidratov, kot je saharoza (namizni sladkor), ali ne jemljete zdravila Yargesa skupaj s hrano ali začasno znižate odmerek.
Overall the data show that treatment with Yargesa 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 Yargesa zmanjša napredovanje klinično značilnih nevroloških simptomov pri bolnikih z Niemann-Pickovo boleznijo tipa C.
Tremor 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.
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.
The hard capsule consists of an opaque white cap and body with “708” printed in black on the body.
Trda kapsula je sestavljena iz neprozornega belega pokrovčka in telesa kapsule, na katerem je s črno barvo natisnjeno „708“.
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, cataracts, nephropathy and myocardial changes in rats.
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.
Capsule content sodium starch glycolate (Type A) povidone (K-29/32) magnesium stearate
Vsebina kapsule natrijev karboksimetilškrob (tipa A), povidon (K-29/32), magnezijev stearat
Yargesa should not be taken during breast-feeding.
Zdravila Yargesa se ne sme jemati v času dojenja.
Breast-feeding It is not known if miglustat is secreted in breast milk.
Ni znano, ali se miglustat izloča v materino mleko.
Yargesa may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable (see sections 4.4 and 5.1).
Zdravilo Yargesa smemo uporabljati samo za zdravljenje bolnikov, za katere encimsko nadomestno zdravljenje ni primerno (glejte poglavji 4.4 in 5.1).
If you have Niemann-Pick type C disease, fats such as glycosphingolipids build up in the cells of your brain.
Če imate Niemann-Pickovo bolezen tipa C, se v celicah vaših možganov kopičijo maščobe kot so glikosfingolipidi.
Repeated-dose toxicity studies in rats showed effects on the seminiferous epithelium of the testes.
Študije toksičnosti pri večkratnem odmerjanju na podganah so pokazale učinke na semenski epitelij v modih.
Miglustat affected embryo/foetal survival in rats and rabbits, dystocia was reported, postimplantation losses were increased, and an increased incidence of vascular anomalies occurred in rabbits.
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.
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 %.
While the numbers of subjects with mild and moderate renal impairment were very small, the data suggest an approximate decrease in CL/F of 40% and 60% respectively, in mild and moderate renal impairment (see section 4.2).
Medtem ko je bilo število bolnikov z blago in zmerno okvarjenim delovanjem ledvic zelo majhno, podatki kažejo na zmanjšanje CL/F za približno 40 % pri blago in 60 % pri zmerno okvarjenem delovanju ledvic (glejte poglavje 4.2).
Growth should be monitored in paediatric and adolescent patients during treatment with Yargesa; the benefit/risk balance should be re-assessed on an individual basis for continuation of therapy.
Med zdravljenjem z zdravilom Yargesa je treba spremljati rast pediatričnih bolnikov in mladostnikov; razmerje med koristmi in tveganji je treba ponovno oceniti posamično za vsakega bolnika pred nadaljevanjem zdravljenja.
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 %.
The most common serious adverse reaction reported with miglustat treatment in clinical studies 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 section 4.4).
Do not drive or use any tools or machines if you feel dizzy.
Če ste omotični, ne vozite in ne upravljajte nobenega orodja ali strojev.
Although no direct comparisons with Enzyme Replacement Therapy (ERT) have been performed in treatment-naive patients with type 1 Gaucher disease, there is no evidence of miglustat having an efficacy or safety advantage over ERT. ERT is the standard of care for patients who require treatment for type 1 Gaucher disease (see section 5.1).
Čeprav neposredne primerjave z zdravljenjem z encimskim nadomestnim zdravljenjem (ERTEnzyme Replacement Therapy) pri bolnikih z Gaucherevo boleznijo tipa 1, ki predhodno niso bili zdravljeni, niso bile opravljene, ni dokazov, da bi bil miglustat učinkovitejši ali varnejši kot ERT. ERT je standardna oskrba za bolnike, ki potrebujejo zdravljenje Gaucherjeve bolezni tipa 1 (glejte poglavje 5.1).
- the active substance is miglustat.
- zUčinkovina je miglustat.
Gaucher disease is an inherited metabolic disorder caused by a failure to degrade glucosylceramide resulting in lysosomal storage of this material and widespread pathology.
Gaucherjeva bolezen je dedna presnovna motnja, ki jo povzroča neuspešna razgradnja glukozilceramida, kar povzroči shranjevanje te snovi v lizosomih in razširjeno patologijo.
The main effects common to all species were weight loss and diarrhoea, and, at higher doses, damage to the gastrointestinal mucosa (erosions and ulceration).
Glavni učinki, skupni vsem vrstam, so bili hujšanje in driska ter pri višjih odmerkih poškodbe sluznice prebavil (erozije in ulceracije).
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, mrzlica in splošno slabo počutje, depresija, težave s spanjem, pozabljivost in zmanjšan libido.
Yargesa 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 Yargesa 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).
In type 1 Gaucher disease, a substance called glucosylceramide is not removed from your body.
Pri Gaucherjevi bolezni tipa 1 se snov, imenovana glukozilceramid, ne odstranjuje iz telesa.
Niemann-Pick type C disease
Niemann-Pickova bolezen tipa C
• For type 1 Gaucher disease: For adults, the usual dose is one capsule (100 mg) three times a day (morning, afternoon and evening).
• Za 1 Gaucherjevo bolezen tipa 1: Za odrasle je običajni odmerek ena kapsula (100 mg) trikrat dnevno (zjutraj, popoldne, zvečer).
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.
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 miglustata med obroki ali jemanju zdravil proti driski, na primer loperamida, ali obojega.
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.
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 in pri odraslih, mladoletnikih in otrocih z Niemann-Pickovo boleznijo tipa C ali Gaucherjevo boleznijo tipa 3.
Pack size: 84 x 1 capsules.
Velikost pakiranja: 84 x 1 kapsula.
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 Yargesa.
Razlog za te preiskave je, da so nekateri bolniki med jemanjem zdravila Yargesa izkusili omrtvičenost ali mravljinčenje v rokah in stopalih ali zmanjšanje telesne mase.
There are no pharmacokinetic data available in patients with liver impairment, in children or adolescents with type 1 Gaucher disease 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).
Peripheral neuropathy seems to be more common in patients with type 1 Gaucher disease compared to the general population.
Kaže, da je periferna nevropatija pogostejša pri bolnikih z Gaucherjevo boleznijo tipa 1 kot pri splošni populaciji.
Do not take Yargesa - if you are allergic to miglustat or any of the other ingredients of this medicine (listed in section 6)
Kaj morate vedeti, preden boste vzeli zdravilo Yargesa Ne jemljite zdravilaYargesa: - če ste alergični na miglustat ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
In 11 clinical trials in different indications 247 patients were treated with miglustat at dosages of 50-200 mg t.i.d.
V 11 kliničnih preskušanjih z različnimi indikacijami so 247 bolnikov zdravili z zdravilom Yargesa z odmerki 50-200 mg trikrat dnevno.
Monitoring of platelet counts is recommended in these patients.
Zato se pri teh bolnikih priporoča spremljanje števila trobocitov.
If your diarrhoea does not respond to these measures, or if you have any other abdominal complaint, consult your doctor.
Če driska po teh ukrepih ne bo izzvenela ali če imate še druge prebavne težave, se o tem posvetujte z zdravnikom.
In addition, inhibitory action on a non-lysosomal glycosylceramidase has been demonstrated experimentally in vitro.
Poleg tega je bilo zaviralno delovanje na nelizosomalni glikozilceramidazi dokazana eksperimentalno in vitro.
Capsule shell gelatin purified water titanium dioxide (E171)
titanov dioksid (E171)
The most common adverse reactions reported in clinical studies 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 driska, flatulenca, bolečina v trebuhu, izguba telesne mase in tremor (glejte poglavje 4.4).
A No Observed Effect Level (NOEL) was not established and the effect was not dose dependent.
Ravni brez opaženega učinka (NOEL - ˝No Observed Effect Level˝) niso ugotovili,
• Yargesa is also used to treat progressive neurological symptoms in Niemann-Pick type C disease in adults and in children.
• Zdravilo Yargesa se uporablja tudi za zdravljenje progresivnih nevroloških simptomov pri Niemann-Pickovi bolezni tipa C pri odraslih in otrocih.
Nerve conduction studies abnormal
Preiskave Pogosto nenormalne študije prevodnosti živcev
If you do get any of these effects, please seek medical advice from your doctor as soon as possible.
Če opazite katerega koli od teh učinkov, čim prej obvestite svojega zdravnika.
If you do lose some weight when you start treatment with Yargesa don't worry.
Če po začetku zdravljenja z zdravilom Yargesa izgubite nekaj telesne mase, to ni razlog za zaskrbljenost.
Due to limited experience, Yargesa should be used with caution in patients with renal or hepatic impairment.
Zaradi malo izkušenj moramo zdravilo Yargesa pri bolnikih z okvarjenim delovanjem ledvic ali jeter uporabljati previdno.
Yargesa is only used when a patient is considered unsuitable for treatment with enzyme replacement therapy.
Yargesa se jemlje le, kadar bolnik za encimsko nadomestno zdravljenje ni primeren.
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 sukraza-izomaltaza v prebavilih, kar povzroči zmanjšano absorpcijo disaharidov iz hrane.
The benefit to the patient of treatment with Yargesa should be evaluated on a regular basis (see section 4.4).
Koristi zdravljenja z zdravilom Yargesa je treba pri bolnikih redno preverjati (glejte poglavje 4.4).
The efficacy of Yargesa in children and adolescents aged 0-17 years with type 1 Gaucher disease has not been established.
Pediatrična populacija Učinkovitost zdravila Yargesa pri otrocih in mladostnikih, starih od 0 do 17 let, z Gaucherjevo boleznijo tipa 1, še ni bila dokazana.
Peripheral neuropathy, ataxia, amnesia, paraesthesia, hypoaesthesia, headache, dizziness
Pogosto periferna nevropatija, ataksija, amnezija, parestezije, hipoestezija, glavobol, omotičnost
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 z okužbo z virusom HIV.
• 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).
There was no drug-related increase in tumour incidence in any other organ.
Drugih z zdravilom povezanih povišanj incidenc tumorjev katerega koli organa ni bilo.
They could be signs of peripheral neuropathy, due to side effects of Yargesa or they could be due to existing conditions.
To so morda znaki periferne nevropatije, ki nastanejo zaradi neželenih učinkov zdravilaYargesa, morda pa so vzrok zanje druge obstoječe bolezni.
Most serious side effects
Najresnejši neželeni učinki
There is a close relationship between renal function and clearance of miglustat, and exposure to miglustat is markedly increased in patients with severe renal impairment (see section 5.2).
Delovanje ledvic močno vpliva na očistek miglustata, izpostavljenost miglustatu je opazno višja pri bolnikih s hudo okvarjenim delovanjem ledvic (glejte poglavje 5.2).
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 število trombocitov [-44,1 × 109/l (95-odstotni IZ: -57,6, -30,7)].
EU/1/17/1176/001
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/17/1176/001
Contraceptive measures should be used by women of childbearing potential.
Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo.
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.
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 teka.
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 × 109/l.
Take the next capsule at the usual time.
Če ste pozabili vzeti zdravilo Yargesa Kapsulo vzemite ob običajnem času.
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 proučevali 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.
This leaflet was last revised in
Navodilo je bilo nazadnje revidirano dne <{MM/LLLL}> <{mesec LLLL}>.
Male patients should maintain reliable contraceptive methods while taking Yargesa.
Bolniki moškega spola naj v času jemanja zdravila Yargesa uporabljajo zanesljive kontracepcijske metode.
Changes in lactation were observed in female rats in a 1-year study.
V enoletni študiji so opazili spremembe pri dojenju pri podganjih samicah.
Yargesa contains the active substance miglustat which belongs to a group of medicines that affect metabolism.
Zdravilo Yargesa vsebuje učinkovino miglustat, ki spada v skupino zdravil, ki vplivajo na presnovo.
Do not give this medicine to children and adolescents (below 18 years old) with type 1 Gaucher disease because it is not known if it works in this disease.
Tega zdravila ne dajajte otrokom in mladostnikom (mlajšim od 18 let) z Gaucherjevo boleznijo tipa 1,
The benefit of treatment with Yargesa 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 reappraised after at least 1 year of treatment with Yargesa.
Koristi zdravljenja z zdravilom Yargesa 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 Yargesa.
Miglustat is an inhibitor of glucosylceramide synthase, the enzyme responsible for the first step in the synthesis of most glycolipids.
Miglustat je zaviralec glukozilceramid-sintaze, ki je odgovoren za prvi korak v sintezi večine glikolipidov.
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).
In patients with type 1 Gaucher disease, monitoring of platelet counts is recommended.
Pri bolnikih z Gaucherjevo boleznijo tipa 1 se priporoča nadziranje števila trombocitov.
NAME OF THE MARKETING AUTHORISATION HOLDER Piramal Critical Care B.V.
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Piramal Critical Care B.V.