natgillin/translations-raw huggingface dataset:
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. 
pedijatrijskih bolesnika bilo je uključeno u nekontrolirano podispitivanje u ukupnom prosječnom trajanju od 3,1 godine pa do 4,4 godine.
Package leaflet: Information for the user Zavesca 100 mg capsules 
Uputa o lijeku: Informacija za korisnika Zavesca 100 mg kapsule miglustat
Zavesca is only used when a patient is considered unsuitable for treatment with enzyme replacement therapy. 
Zavesca se primjenjuje samo kada se bolesnik smatra nepodobnim za enzimsko nadomjesno liječenje.
They could be signs of peripheral neuropathy, due to side effects of Zavesca or they could be due to existing conditions. 
To mogu biti znakovi periferne neuropatije, koji se javljaju zbog nuspojava Zavesce ili su se javili zbog postojeće bolesti.
Other studies revealed changes in sperm parameters (motility and morphology) consistent with an observed reduction in fertility. 
Ostala su ispitivanja otkrila promjene u parametrima sperme (pokretljivost i morfologija) sukladne opažanjima smanjene plodnosti.
Peripheral neuropathy seems to be more common in patients with type 1 Gaucher disease compared to the general population. 
Čini se da je periferna neuropatija češća u bolesnika s Gaucherovom bolesti tipa 1 u usporedbi s ostalom populacijom.
Miglustat is mainly eliminated by renal excretion, with urinary recovery of unchanged drug accounting for 70-80% of the dose. 
Miglustat se uglavnom eliminira kroz bubrege, pri čemu se u urinu pronašlo 70-80% doze neizmijenjenog lijeka.
In patients included in the clinical trial, 40%-50% of patients had platelet counts below the lower limit of normal at baseline. 
Kod bolesnika uključenih u kliničko ispitivanje, 40%-50% bolesnika broj trombocita na početku bio je ispod donje granice normale.
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. 
Razlog za te pretrage je taj što što su neki bolesnici, dok su uzimali Zavescu, osjećali trnce ili obamrlost u šakama i stopalima ili im se smanjila tjelesna težina.
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 Zavesca (see section 4). 
npr. na jednu kapsulu (100 mg) jednom ili dvaput dnevno, ako imate proljev dok uzimate Zavescu (vidjeti dio 4).
The most common adverse reactions reported in clinical studies with Zavesca were diarrhoea, flatulence, abdominal pain, weight loss and tremor (see section 4.4). 
Najčešće nuspojave zabilježene u kliničkim ispitivanjima sa Zavescom bile su proljev, flatulencija, bol u trbuhu, gubitak težine i tremor (vidjeti dio 4.4).
This study was conducted over a 6-month randomised comparison period followed by 18 months extension where all patients received Zavesca monotherapy. 
To je ispitivanje provedeno u 6-mjesečnom randomiziranom komparativnom razdoblju nakon čega je slijedilo 18 mjesečno produljenje u kojem su svi bolesnici primali monoterapiju Zavescom.
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). 
≥ 1/100 < 1/10, manje često: ≥ 1/1000 do < 1/100, rijetko: ≥ 1/10 000 do < 1/1000, vrlo rijetko:
The kinetics of miglustat appear to be dose linear and time independent. 
Pokazalo se da je kinetika miglustata linearno ovisna o dozi a neovisna o vremenu.
Gaucher disease is an inherited metabolic disorder caused by a failure to degrade glucosylceramide resulting in lysosomal storage of this material and widespread pathology. 
Gaucherova bolest je nasljedni poremećaj metabolizma uzrokovan nemogućnošću razgradnje glukozilceramida posljedica čega su pohranjivanje tog materijala u lizosomima i raširena patologija.
Zavesca has negligible influence on the ability to drive and use machines. 
Zavesca zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
Adverse reactions were generally of mild to moderate severity and occurred with similar frequency across indications and dosages tested. 
Nuspojave su uglavnom bile blage do umjerene težine i javljale su se sličnom učestalošću kod svih ispitivanih indikacija i doziranja.
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. 
Pedijatrijska populacija Kod nekih pedijatrijskih bolesnika s Niemann-Pickovom bolesti tipa C zabilježeno je smanjenje rasta u ranoj fazi liječenja miglustatom kada početno smanjeno dobivanje na težini može biti popraćeno smanjenjem rasta ili ono može uslijediti kasnije.
Administration of miglustat to male and female Sprague-Dawley rats by oral gavage for 2 years at dose levels of 30, 60 and 180 mg/kg/day resulted in an increased incidence of testicular interstitial cell (Leydig cell) hyperplasia and adenomas in male rats at all dose levels. 
Primjena miglustata kod muških i ženskih Sprague-Dawley štakora oralnom sondom tijekom 2 godine u dozama od 30, 60 i 180 mg/kg/dan za rezultat je imala povećanu incidenciju hiperplazije testikularnih intersticijskih stanica (Leydigovih stanica) i adenome u muških štakora pri svim razinama doza.
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, 
Nadalje učinci zabilježeni u životinja pri dozama koje su uzrokovale razine izloženosti slične ili malo više od kliničkih razina izloženosti, bili su: promjene na limfoidnim organima u svih ispitanih vrsta, promjene vrijednosti transaminaza, vakuolizacija štitnjače i gušterače, katarakta, nefropatije i promjene miokarda u štakora.
Contraceptive measures should be used by women of childbearing potential. 
Metode kontracepcije trebaju koristiti i žene u razdoblju plodnosti.
There is limited experience with the use of Zavesca in Niemann-Pick type C disease patients under the age of 4 years. 
Postoji ograničeno iskustvo u primjeni Zavesce kod bolesnika s Niemann-Pickovom bolesti tipa C, mlađih od 4 godine.
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. 
Zavesca je ispitivana na indikacijama kod kojih su neki događaji zabilježeni kao nuspojave, poput neuroloških i neurofizioloških simptoma/znakova, kognitivne disfunkcije i trombocitopenije mogli biti posljedica bolesti od koje se bolesnik liječi.
Zavesca contains the active substance miglustat which belongs to a group of medicines that affect metabolism. 
Zavesca sadrži djelatnu tvar miglustat koja pripada skupini lijekova koji djeluju na metabolizam.
Cases of peripheral neuropathy have been reported in patients treated with Zavesca with or without concurrent conditions such as vitamin B12 deficiency and monoclonal gammopathy. 
Kod bolesnika liječenih Zavescom zabilježeni su slučajevi periferne neuropatije prisutne samostalno ili praćene stanjima kao što su, pomanjkanje vitamina B12 i monoklonalna gamopatija.
Miglustat is an inhibitor of glucosylceramide synthase, the enzyme responsible for the first step in the synthesis of most glycolipids. 
Miglustat je inhibitor glukozilceramid sintaze, enzima odgovornog za prvi korak u sintezi večine glikolipida.
A No Observed Effect Level (NOEL) was not established and the effect was not dose dependent. 
nije ustanovljena i učinak nije bio ovisan o dozi.
Zavesca 100 mg capsules 
Zavesca 100 mg kapsule
- If you have any further questions, please ask your doctor or pharmacist. 
Ako imate dodatnih pitanja, obratite se svom liječniku ili ljekarniku.
Zavesca is a white 100 mg capsule with “OGT 918” printed in black on the cap and “100” printed in black on the body. 
Zavesca je bijela kapsula od 100 mg sa “OGT 918” otisnutim crnom bojom na kapici i “100” otisnutim crnom bojom na tijelu.
Zavesca has not been evaluated in patients with a history of significant gastrointestinal disease, including inflammatory bowel disease. 
Zavesca nije procjenjivana kod bolesnika s težom gastrointestinalnom bolesti u anamnezi, uključujući i upalnu bolest crijeva.
It is not known if miglustat is secreted in breast milk. 
Nije poznato izlučuje li se miglustat u majčino mlijeko.
Until further information is available, before seeking to conceive, male patients should cease Zavesca and maintain reliable contraceptive methods for a further 3 months. 
Do dostupnosti daljnjih informacija, prije pokušaja začeća djeteta, muški bolesnici trebaju prekinuti uzimanje Zavesce i primjenjivati pouzdane metode kontracepcije daljnja 3 mjeseca.
If you have Niemann-Pick type C disease, fats such as glycosphingolipids build up in the cells of your brain. 
Ako imate Niemann-Pickovu bolest tipa C, masti kao što su glikosfingolipidi nakupljaju se u stanicama
Studies in the rat have shown that miglustat adversely affects spermatogenesis and sperm parameters, and reduces fertility (see sections 4.6 and 5.3). 
Ispitivanja na štakorima su pokazala da miglustat štetno djeluje na spermatogenezu i parametre sperme, te da umanjuje plodnost (vidjeti dijelove 4.6 i 5.3).
In 11 clinical trials in different indications 247 patients were treated with Zavesca at dosages of 50200 mg t.i.d. 
U 11 kliničkih ispitivanja s različitim indikacijama 247 bolesnika je liječeno Zavescom u dozama od 50200 mg triput dnevno, u prosječnom trajanju od 2,1 godine.
Temporary dose reduction to 100 mg once or twice a day may be necessary in some patients because of diarrhoea. 
Kod nekih će bolesnika možda biti potrebno privremeno smanjenje doze na 100 mg jednom ili dvaput dnevno, zbog proljeva.
Sodium starch glycollate, Povidone (K30), Magnesium stearate. 
Natrijev škroboglikolat, Povidon (K30), Magnezijev stearat
Male patients should use reliable birth control methods during their treatment with Zavesca, and for 3 months after finishing treatment. 
Muški bolesnici trebaju primjenjivati pouzdane metode kontracepcije tijekom liječenja Zavescom, te tijekom 3 mjeseca nakon završetka liječenja.
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). 
< 30 ml/min/1,73 m2) se ne preporučuje (vidjeti dijelove 4.4 i 5.2).
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
U slučaju bilo kakvih pitanja u vezi s primjenom ovoga lijeka, obratite se svojem liječniku ili ljekarniku.
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2) 
Lijek se izdaje na ograničeni recept (vidjeti Prilog I: Sažetak opisa svojstava lijeka, dio 4.2)
Psychiatric disorders Common 
Psihijatrijski poremećaji Često
Zavesca works by inhibiting the enzyme called ‘glucosylceramide synthase' which is responsible for the first step in the synthesis of most glycosphingolipids. 
Zavesca djeluje kao inhibitor enzima 'glukozilceramid sintaze', odgovornog za prvi korak u sintezi većine glikosfingolipida.
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). 
Ispitivanja na štakorima su pokazala da miglustat štetno djeluje na parametre sperme (mobilnost i morfologiju), te umanjuje plodnost (vidjeti dijelove 4.4 i 5.3).
The benefit to the patient of treatment with Zavesca should be evaluated on a regular basis (see section 
Potrebno je redovito procjenjivati korist za bolesnika od liječenja Zavescom (vidjeti dio 4.4).
Depression, insomnia, libido decreased Nervous system disorders Very common 
Depresija, nesanica, oslabljen libido
The active substance is miglustat 100 mg. 
Djelatna tvar je miglustat 100 mg.
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. 
Uobičajena doza Zavesce u odraslih bolesnika bila je 200 mg triput dnevno, a kod pedijatrijskih bolesnika je bila prilagođena veličini površine tijela.
The inhibitory action on glucosylceramide synthase forms the rationale for substrate reduction therapy in Gaucher disease. 
Inhibitorsko djelovanje na glukozilceramid sintazu podloga je za liječenje sa smanjenjem supstrata kod
• Zavesca is used to treat mild to moderate type 1 Gaucher disease in adults. 
• Zavesca se primjenjuje za liječenje blage do umjerene Gaucherove bolesti tipa 1 u odraslih.
Do not drive or use any tools or machines if you feel dizzy. 
Ako osjećate omaglicu nemojte voziti niti raditi sa strojem.
Nausea, vomiting, abdominal distension/discomfort, constipation, dyspepsia 
Mučnina, povraćanje, abdominalna distenzija/nelagoda, konstipacija,
The recommended starting dose for the treatment of adult patients with type 1 Gaucher disease is 100 mg three times a day. 
Preporučena početna doza za liječenje odraslih bolesnika s Gaucherovom bolesti tipa 1 je 100 mg triput dnevno.
Most serious side effects: 
Najozbiljnije nuspojave
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. 
Između početka i kraja ispitivanja uočeno je malo prosječno smanjenje hemoglobina [-0,95 g/dL (95% CI: -1,38, -0,53)]i broja trombocita [-44,1 × 109/L
6.6 Special precautions for disposal 
6.6 Posebne mjere opreza za zbrinjavanje
Zavesca 100 mg capsules Miglustat 
Zavesca 100 mg kapsule miglustat
Dosage in type 1 Gaucher disease 
Doziranje kod Gaucherove bolesti tipa 1
There are no pharmacokinetic data available in patients with liver impairment or in the elderly (> 70 years). 
Nema dostupnih farmakokinetičkih podataka za bolesnike s oštećenjem funkcije jetre ili za starije bolesnike
Do not breastfeed while you are taking Zavesca. 
Nemojte dojiti tijekom uzimanja Zavesce.
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. 
Gaucherovom bolesti tipa 1, Fabrijevom bolesti, kod bolesnika zaraženih HIV-om, te kod odraslih, adolescenata i djece s Niemann-Pickovom bolesti tipa C ili Gaucherovom bolesti tipa
In patients with an adjusted creatinine clearance of 50-70 ml/min/1.73 m2, administration should commence at a dose of 100 mg twice daily in patients with type 1 Gaucher disease and at a dose of 200 mg twice daily (adjusted for body surface area in patients below the age of 12) in patients with Niemann-Pick type C disease. 
Kod bolesnika s prilagođenim klirensom kreatinina od 50-70 ml/min/1,73 m2, primjenu treba početi s dozom od 100 mg dvaput dnevno u bolesnika s Gaucherovom bolesti tipa 1, te dozom od 200 mg dvaput dnevno (prilagođeno površini tijela u bolesnika mlađih od 12 godina) u bolesnika s
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). 
C treba redovito ocjenjivati, npr. svakih 6 mjeseci; nastavak liječenja treba ponovo procijeniti nakon najmanje 1 godine liječenja Zavescom (vidjeti dio 4.4).
Zavesca is indicated for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease. 
Zavesca je indicirana za peroralno liječenje odraslih bolesnika s blagom do umjerenom Gaucherovom bolesti tip 1.
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 
D UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU
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. 
koji su najmanje 3 godine primali ERT a koji su zadovoljavali kriterij stabilne bolesti od najmanje 2 godine.
Zavesca has been administered at doses of up to 3000 mg/day for up to six months in HIV positive patients during clinical trials. 
Zavesca je u kliničkim ispitivanjima kod HIV pozitivnih bolesnika primjenjivana u dozama do 3000 mg/dan tijekom šest mjeseci.
Administration of miglustat to male and female CD1 mice by oral gavage at dose levels of 210, 420 and 840/500 mg/kg/day (dose reduction after half a year) for 2 years resulted in an increased incidence of inflammatory and hyperplastic lesions in the large intestine in both sexes. 
420 i 840/500 mg/kg/dan (smanjenje doze nakon pola godine) za rezultat je imala povećanu incidenciju upalnih i hiperplastičnih lezija u debelom crijevu kod oba spola.
Musculoskeletal and connective tissue disorders Common 
dispepsija Poremećaji mišićno-koštanog sustava i vezivnog tkiva
Due to limited experience, Zavesca should be used with caution in patients with renal or hepatic impairment. 
Zbog ograničenog iskustva, kod bolesnika s poremećajem funkcije bubrega ili jetre, Zavescu treba koristiti oprezno.
The recommended dose for the treatment of adolescent patients (12 years of age and above) with Niemann-Pick type C disease is 200 mg three times a day. 
Pedijatrijska populacija Preporučena doza za liječenje adolescentnih bolesnika (12 godina i starijih) s Niemann-Pickovom bolesti tipa C je 200 mg triput dnevno.
How to store Zavesca 
Kako čuvati Zavescu
Other possible side effects are muscular spasms or weakness, fatigue chills and malaise, depression, difficulty sleeping, forgetfulness, and less libido. 
Ostale moguće nuspojave su grčevi u mišićima ili slabost, umor, zimica ili malaksalost, depresija,
• For type 1 Gaucher disease: For adults, the usual dose is one capsule (100 mg) three times a day (morning, afternoon and evening). 
• Za Gaucherovu bolest tipa 1: za odrasle je uobičajena doza jedna kapsula (100 mg) tri puta dnevno
How to take Zavesca 
Kako uzimati Zavescu
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. 
C treba redovito ocjenjivati, npr. svakih 6 mjeseci; nastavak liječenja treba ponovo procijeniti nakon najmanje 1 godine liječenja Zavescom.
Marketing Authorisation Holder: 
Nositelj odobrenja za stavljanje lijeka u promet:
Dosage in Niemann-Pick type C disease 
Doziranje kod Niemann-Pickove bolesti tipa C
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. 
godine bili liječeni ERT-om, u tri skupine liječenja: nastavak liječenja imiglucerazom, imiglucerazom u kombinaciji sa Zavescom, ili prelazak na Zavescu.
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. 
12-mjesečno nekomparativno ispitivanje, a 22 bolesnika su završila ispitivanje.
A total daily dose of 300 mg Zavesca administered in three divided doses was used in the above two studies. 
U gornja dva ispitivanja primijenjena je ukupna dnevna doza Zavesce od 300 mg u tri pojedinačne doze.
1.Separate at perforations 2.Peel back paper at arrows 3.Push product through foil 
Ogulite crni papir kod strelica 3. Gurnite lijek kroz foliju
Each capsule contains 100 mg miglustat. 
Jedna kapsula sadržava 100 mg miglustata.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
PRILOG II. A. PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET
Bone manifestations of type 1 Gaucher disease were evaluated in 3 open-label clinical studies in patients treated with miglustat 100 mg t.i.d. 
Manifestacije Gaucherove bolesti tipa 1 na kosti ocjenjivane su u 3 otvorena klinička ispitivanja u bolesnika liječenih miglustatom 100 mg triput dnevno u trajanju do 2 godine (n = 72).
If you take more capsules than you were told to, consult your doctor immediately. 
Smjesta se obratite svom liječniku ako ste uzeli više kapsula nego
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. 
primijećena je distocija, porasli su gubitci nakon implantacije i došlo je do povećane incidencije vaskularnih anomalija kod kunića.
Mild reductions in platelet counts without association with bleeding were observed in patients with type 1 Gaucher disease who were switched from ERT to Zavesca. 
Kod bolesnika s Gaucherovom bolesti tipa 1 primijećena su mala smanjenja broja trombocita, a koja nisu povezana s krvarenjem, u bolesnika koji su s ERT prešli na Zavescu.
Each capsule contains 100 mg miglustat 
Jedna kapsula sadržava 100 mg miglustata
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. 
savjetuje se muškim bolesnicima da prije pokušaja začeća djeteta prekinu uzimanje Zavesce i primjenjuju pouzdane metode kontracepcije daljnja 3 mjeseca.
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. 
U nekih je bolesnika došlo do smanjenja broja trombocita i do povećanja aktivnosti hitotriozidaze što ukazuje na to da monoterapija
You must use effective birth control while taking Zavesca. 
Dok uzimate Zavescu morate primjenjivati učinkovitu kontracepciju.
The pharmacokinetics of miglustat is similar in adult type 1 Gaucher disease patients and Niemann-Pick type C disease patients when compared to healthy subjects. 
Farmakokinetika miglustata slična je onoj u odraslih bolesnika s Gaucherovom bolesti tipa 1 i Niemann
LIST OF EXCIPIENTS PHARMACEUTICAL FORM AND CONTENTS 
OBLIK I SADRŽAJ
ANNEX II 
PRILOG III.
Common effects - may affect up to 1 in 10 people Common side effects of treatment include headache, dizziness, paraesthesia (tingling or numbness), abnormal coordination, hypoaesthesia (reduced sensation to touch), dyspepsia (heartburn), nausea (feeling sick), constipation and vomiting, swelling or discomfort in the abdomen (stomach) and thrombocytopenia (reduced levels of blood platelets).The neurological symptoms and thrombocytopenia could be due to the underlying disease. 
Česte nuspojave liječenja uključuju glavobolju, omaglicu, paresteziju (trnci ili obamrlost), nenormalnu koordinaciju, hipoesteziju (oslabljen osjet na dodir), dispepsiju (žgaravica), mučninu, zatvor i povraćanje,
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. 
Najčešće nuspojave su proljev, flatulencija (vjetrovi), bol u trbuhu, gubitak težine i smanjen tek.
Therapy should be directed by physicians who are knowledgeable in the management of Gaucher disease or Niemann-Pick type C disease, as appropriate. 
4.2 Doziranje i način primjene Liječenje trebaju voditi liječnici s odgovarajućim iskustvom u liječenju Gaucherove bolesti ili Niemann
Name and address of the manufacturer responsible for batch release Actelion Manufacturing GmbH 
Nazivi i adresa proizvođača odgovornog za puštanje serije lijeka u promet
Mild reductions in platelet counts without association to bleeding were observed in some patients with Niemann-Pick type C disease treated with Zavesca. 
Kod nekih bolesnika s Niemann-Pickovom bolesti tipa C liječenih Zavescom primijećena su mala smanjenja broja trombocita, a koja nisu povezana s krvarenjem.
SPECIAL STORAGE CONDITIONS 
POPIS POMOĆNIH TVARI