natgillin/translations-raw huggingface dataset:
Lower limb oedema, Hypertension, +Embolism and thrombosis 
hipertenzija, +embolizem in tromboza napadi rdečice,
Capecitabine Accord 300 mg film-coated tablets are white to off white, oblong shaped, biconvex, film-coated tablets of 14.6 mm in length and 6.7 mm in width, debossed with ‘300' on one side and plain on other side. 
Kapecitabin Accord 300 mg filmsko obložene tablete so bele ali kremne bele barve, podolgovate oblike, bikonveksne, filmsko obložene tablete dolžine 14,6 mm in debeline 6,7 mm z vtisnjeno oznako “300” na eni strani in brez oznake na drugi strani.
Capecitabine Accord 150 mg film-coated tablets Capecitabine Accord 300 mg film-coated tablets Capecitabine Accord 500 mg film-coated tablets capecitabine 
Navodilo za uporabo: informacije za uporabnika Kapecitabin Accord 150 mg filmsko obložene tablete Kapecitabin Accord 300 mg filmsko obložene tablete Kapecitabin Accord 500 mg filmsko obložene tablete kapecitabin
Eye disorders 
bolečina v ušesih
Capecitabine Accord 150 mg film-coated tablets capecitabine 
Kapecitabin Accord 150 mg filmsko obložene tablete kapecitabin
Capecitabine Accord 150 mg film-coated tablets The film-coated tablets are light peach colored, oblong shaped, biconvex, 11.4 mm in length and 5.3 mm in width, debossed with ‘150' on one side and plain on other side. 
Kapecitabin Accord 150 mg filmsko obložene tablete Filmsko obložene tablete so svetlo breskove barve, podolgovate oblike, bikonveksne, dolžine 11,4 mm in debeline 5,3 mm z vtisnjeno oznako »150« na eni strani in brez oznake na drugi strani.
Capecitabine Accord 300 mg film-coated tablets 
Kapecitabin Accord 300 mg filmsko obložene tablete
Coumarin-derivative anticoagulation 
Antikoagulantno zdravljenje s kumarinskimi derivati:
During capecitabine monotherapy, no adjustment of the starting dose is needed. 
Starejši bolniki Zanje prilagajanje začetnega odmerka pri samostojnem zdravljenju z zdravilom kapecitabin ni potrebno.
The analysis for the secondary endpoint of RFS supports these results with a HR of 0.78 (95% CI=[0.67; 0.92]; p=0.0024) for XELOX vs. 5-FU/LV. 
Analiza preživetja brez ponovitve bolezni (sekundarni cilj preskušanja) te rezultate podpira; razmerje ogroženosti je bilo 0,78 za shemo XELOX v primerjavi s 5-FU/LV (95-% interval zaupanja
Given as monotherapy, the recommended starting dose for capecitabine in the adjuvant treatment of colon cancer, in the treatment of metastatic colorectal cancer or of locally advanced or metastatic breast cancer is 1250 mg/m2 administered twice daily (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 14 days followed by a 7-day rest period. 
Priporočeni začetni odmerek kapecitabina v kombinaciji z docetakselom za zdravljenje metastatskega raka dojk je 1.250 mg/m2 dvakrat na dan 14 dni, sledi 7-dnevni premor, odmerek docetaksela pa je 75 mg/m2 vsake 3 tedne v obliki enourne intravenske infuzije.
Capecitabine Accord 300 mg film-coated tablets The film-coated tablets are white to off white, oblong shaped, biconvex, 14.6 mm in length and 6.7 mm in width, debossed with ‘300' on one side and plain on other side. 
Kapecitabin Accord 300 mg filmsko obložene tablete Filmsko obložene tablete so svetlo breskove barve, podolgovate oblike, bikonveksne, dolžine 14,6 mm in debeline 6,7 mm z vtisnjeno oznako »300« na eni strani in brez oznake na drugi strani.
Grade 1 hand-foot syndrome is defined as numbness, dysesthesia/paresthesia, tingling, painless swelling or erythema of the hands and/or feet and/or discomfort which does not disrupt the patient's normal activities. 
mravljinčenje, neboleče otekanje ali rdečina rok in nog ali obojih okončin oziroma kot neugodje, ki ne vpliva na bolnikove normalne dejavnosti.
A. 
meseca).
Eye pain, Visual impairment, Vision blurred 
poslabšan vid, zamegljen vid
Full dose 1000 mg/m2 
Polni odmerek 1.250 mg/m2
Capecitabine is contraindicated in patients with severe renal impairment (creatinine clearance below 30 ml/min [Cockcroft and Gault] at baseline). 
Zdravilo kapecitabin je kontraindicirano pri bolnikih s hudo ledvično okvaro (očistek kreatinina pod
Dose modifications applied should be applied for the precipitating adverse event as necessary (see section 
Odmerke prilagajamo, kot je to potrebno (glejte poglavje 4.2) glede na neželeni dogodek, ki je povzročil dehidracijo.
• have diarrhoea 
• imate drisko,
Also contains lactose, see the package leaflet for further information. 
Za nadaljnje informacije glejte navodilo za uporabo.
Ophthalmologic complications 
Oftalmološki neželeni učinki:
• vein inflammation 
glivična okužba,
Paraesthesia, Dysaesthesia, Peripheral neuropathy, Peripheral sensory neuropathy, Dysgeusia, Headache 
periferna senzorična nevropatija, disgevzija, glavobol nevtrotoksičnost,
Capecitabine Accord 500 mg film-coated tablets capecitabine 
Kapecitabin Accord 500 mg filmsko obložene tablete kapecitabin
• Diarrhoea: if you have an increase of 4 or more bowel movements compared to your normal bowel movements each day or any diarrhoea at night. 
• Driska: če pogostnost dnevnih iztrebljanj preseže število, ki je za vas običajno, za štiri ali več,
Folinic acid/folic acid 
Folinska/folna kislina:
Titanium dioxide (E171) 
Filmska obloga hipromeloza (6cps) smukec titanov dioksid (E171)
Abdominal distension, 
• utrujenost,
Diabetes, Hypokalaemia, Appetite disorder, Malnutrition, Hypertriglyceridaemia 
Presnovne in prehranske motnje anoreksija dehidracija, zmanjšanje telesne mase sladkorna bolezen, hipokaliemija, motnje apetita, podhranjenost, hipertrigliceridemija
Capecitabine Accord 300 mg film-coated tablets capecitabine 
Kapecitabin Accord 300 mg filmsko obložene tablete kapecitabin
Febrile neutropenia, Pancytopenia, Granulocytopenia, Thrombocytopenia, Leukopenia, Haemolytic anaemia, International Normalised Ratio (INR) increased/Prothrombin time prolonged 
hemolitična anemija, zvišano internacionalno normalizirano razmerje/podaljšan protrombinski čas
• if you have severely low levels of white cells or platelets in the blood (leucopenia, neutropenia or thrombocytopenia) 
• če ste noseči ali dojite, • če imate izredno nizko raven belih krvnih celic ali krvnih ploščic v krvi (levkopenija,
Starting Dose 
Zdravljenje Začetni odmerek
In these trials, 603 patients were randomised to treatment with capecitabine (1250 mg/m2 twice daily for 2 weeks followed by a 1-week rest period and given as 3-week cycles). 
V teh študijah so 603 randomizirane bolnike zdravili s kapecitabinom v tritedenskem ciklu jemanja 1.250 mg/m2/dvakrat na dan 14 dni, čemur je sledil enotedenski premor,
Data from a randomised clinical study (Souglakos et al, 2012) comparing FOLFIRI + bevacizumab with XELIRI + bevacizumab showed no significant differences in PFS or OS between treatments. 
Podatki iz randomizirane klinične študije (Souglakos s sodelavci, 2012), ki je primerjala FOLFIRI +
Herpes viral infection, Nasopharyngitis, Lower respiratory tract infection 
Infekcijske in parazitske bolezni okužba z virusom herpesa, nazofaringitis, okužba spodnjih dihal sepsa, okužba sečil,
An analysis of safety data in patients ≥ 60 years of age treated with capecitabine monotherapy and an analysis of patients treated with capecitabine plus docetaxel combination therapy showed an increase in the incidence of treatment-related grade 3 and 4 adverse reactions and treatment-related serious adverse reactions compared to patients < 60 years of age. 
in tistih, ki so prejemali kapecitabin v kombinaciji z docetakselom, je pokazala, da je pogostnost z zdravljenjem povezanih neželenih učinkov stopnje 3 in 4 ter z zdravljenjem povezanih resnih neželenih učinkov večja kot pri bolnikih, mlajših od 60 let.
• unusual bleeding from the vagina swelling (oedema), chills and rigors 
• neobičajna krvavitev iz vagine,
Table 5 Summary of related ADRs reported in patients treated with capecitabine monotherapy 
Povzetek z zdravljenjem povezanih neželenih učinkov, o katerih so poročali pri bolnikih, zdravljenih z monoterapijo kapecitabina Organski sistem Zelo pogosti Vse stopnje
Capecitabine Accord 150 mg film-coated tablets Each film-coated tablet contains 7 mg anhydrous lactose. 
Pomožna snov z znanim učinkom Kapecitabin Accord 150 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 7 mg brezvodne laktoze.
Muskuloskeletal and connective tissue disorders 
Bolezni mišično skeletnega sistema in vezivnega tkiva mialgija, artralgija,
Common side effects (may affect up to 1 in 10 people) include: 
Pogosti neželeni učinki (pojavijo se pri do 1 od 10 bolnikov) vključujejo:
How to store Capecitabine Accord 
Shranjevanje zdravila Kapecitabin Accord
- The active substance is capecitabine. 
Kapecitabin lahko povzroči drisko.
25.5 months 
25,5 meseca p = 0,45
Dysphagia, Rectal haemorrhage, Abdominal pain lower, Oral dysaesthesia, Paraesthesia oral, Hypoaesthesia oral, 
oralna disestezija, oralna parestezija, oralna hipestezija, nelagodje v trebuhu
STATEMENT OF ACTIVE SUBSTANCE(S) 
Stopnja toksičnosti*
646; 715) in patients treated with 5-FU-containing regimens. 
interval zaupanja; 646; 715).
Intestinal obstruction, Ascites, Enteritis, Gastritis, Dysphagia, Abdominal pain lower, Oesophagitis, Abdominal discomfort, 
Bolezni prebavil zaprtje, dispepsija krvavitev iz zgornjih prebavil, razjede v ustih, gastritis, abdominalna distenzija, gastroezofagealna refluksna bolezen,
- metastatic colorectal cancer (see section 5.1). 
bolnikov (klinična preskušanja metastatskega kolorektalnega raka in metastatskega raka dojk, 2 faze III in 5 faze II).
5-fluorouracil intravenous bolus/infusion, each on Days 1 and 2, every 2 weeks 
FOLFOX-4 ali FOLFOX-4 + bevacizumab oksaliplatin 85 mg/m2 intravensko 2 h oksaliplatin 1. dan, vsake 2 tedna levkovorin 1. in 2. dan, vsake 2 tedna
Gastrooesophageal reflux disease, Colitis, Blood in stool 
disfagija, bolečina v spodnjem delu trebuha, ezofagitis, nelagodje v trebuhu, gastroezofagealna refluksna bolezen, kolitis, kri v blatu
Insomnia, Depression 
depresija stanje zmedenosti,
Oxaliplatin on Day 1, every 3 weeks capecitabine oral twice daily for 2 weeks (followed by 1 week off- treatment) 
XELOX ali XELOX + bevacizumab oksaliplatin 130 mg/m2 intravensko 2 h oksaliplatin 1. dan, vsake 3 tedne kapecitabin peroralno dvakrat na dan 2 tedna (sledi 1-tedenski premor)
- ECF: epirubicin (50 mg/ m2 as a bolus on day 1 every 3 weeks), cisplatin (60 mg/m2 as a two hour infusion on day 1 every 3 weeks) and 5-FU (200 mg/m2 daily given by continuous infusion via a central line). 
- ECF: epirubicin (50 mg/m2 kot bolus 1. dan vsake 3 tedne), cisplatin (60 mg/m2 v 2-urni infuziji 1. dan vsake 3 tedne) in 5-FU (200 mg/m2 na dan v kontinuirani infuziji skozi centralni venski kateter); - ECX: epirubicin (50 mg/m2 kot bolus 1. dan vsake 3 tedne), cisplatin (60 mg/m2 v 2-urni infuziji 1. dan vsake 3 tedne) in kapecitabin (625 mg/m2 dvakrat na dan neprekinjeno); - EOF: epirubicin (50 mg/m2 kot bolus 1. dan vsake 3 tedne), oksaliplatin (130 mg/m2 v 2-urni infuziji 1. dan vsake tri tedne) in 5-FU (200 mg/m2 na dan v kontinuirani infuziji skozi centralni venski kateter); - EOX: epirubicin (50 mg/m2 kot bolus 1. dan vsake 3 tedne), oksaliplatin (130 mg/m2 v 2-urni infuziji 1. dan vsake tri tedne) in kapecitabin (625 mg/m2 dvakrat na dan neprekinjeno).
This leaflet was last revised in 
Seznam neželenih učinkov, prikazan v preglednicah
Flushing, Hypotension, Hypertensive crisis, Hot flush, Phlebitis 
hipotenzija, hipertenzivna kriza,
Gastroesophageal reflux disease, Oral pain, 
Infekcijske in parazitske bolezni herpes zoster, okužba sečil, oralna kandidoza,
• vertigo, ear pain 
• vrtoglavica, bolečina v ušesih,
(listed in section 6) 
(navedeno v poglavju 6).
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10 november 2017 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 10. november 2017
185 Bureaux de la Colline 92213 Saint Cloud Cedex France 
185 Bureaux de la Colline 92213 Saint Cloud Cedex Francija
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1232/001 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/17/1232/001
Body surface area (m²) 
Površina telesa (m2)
The greatest prevalence was observed between 6 and 12 months. 
Največjo prevalenco so opazili med 6 in
Titanium dioxide (E171). 
Ovoj kapsule želatina, titanov dioksid (E171).
for an average duration of 2.1 years. 
Povprečno zdravljenje je trajalo 2,1 leto.
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). 
Neželeni učinki zdravila iz kliničnih preskušanj in spontanega poročanja, ki so se pojavili pri > 1 % bolnikov, so navedeni v spodnji preglednici, razvrščeni po organskem sistemu in pogostnosti (zelo pogosti: ≥ 1/10, pogosti: ≥ 1/100 < 1/10, občasni: ≥1/1.000 do <1/100, redki: ≥1/10.000 do <1/1.000,
PHARMACEUTICAL FORM Hard capsule. 
FARMACEVTSKA OBLIKA trda kapsula
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, ali starostnike (> 70 let).
If you take more Miglustat Gen.Orph than you should If you take more capsules than you were told to, consult your doctor immediately. 
Če ste vzeli večji odmerek zdravila Miglustat Gen.Orph , kot bi smeli Če ste vzeli več kapsul, kot vam je bilo naročeno, se takoj posvetujte z zdravnikom.
Very common effects may affect more than 1 in 10 people. 
Zelo pogosti neželeni učinki se lahko pojavijo pri več kot 1 od 10 bolnikov.
The tests will help the doctor decide whether these effects are due to your disease or other existing conditions, or due to side effects of Miglustat Gen.Orph (see section 4 for further details). 
Te preiskave bodo zdravniku v pomoč pri presoji, ali so ti učinki posledica vaše bolezni ali drugega obstoječega stanja ali posledica neželenih učinkov zdravila Miglustat Gen.Orph (za dodatne informacije glejte poglavje 4).
Your doctor may reduce your dose, e.g., to one capsule (100 mg) once or twice a day, if you suffer from diarrhoea when taking Miglustat Gen.Orph (see section 4). 
Vaš zdravnik lahko zmanjša vaš odmerek, npr. na eno kapsulo (100 mg) enkrat ali dvakrat dnevno, če imate med jemanjem zdravila Miglustat Gen.Orph drisko (glejte poglavje 4).
Tell your doctor if you are taking medicines containing imiglucerase, which are sometimes used at the same time as Miglustat Gen.Orph. 
Obvestite zdravnika, če jemljete zdravila, ki vsebujejo imiglucerazo, ki se včasih jemljejo skupaj z zdravilom Miglustat Gen.Orph.
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. 
V odprto, neprimerjalno, 2-letno študijo je bilo vključenih 42 bolnikov z Gaucherjevo boleznijo tipa 1, ki so vsaj 3 leta prejemali ERT in so vsaj 2 leti izpolnjevali merila stabilne bolezni.
They may lower the amount of Miglustat Gen.Orph in your body. 
Ta zdravila lahko znižajo količino zdravila Miglustat Gen.Orph v vašem telesu.
Box of 12 blisters, each blister containing 7 capsules providing a total of 84 capsules. 
Škatla z 12 pretisnimi omoti, vsak pretisni omot vsebuje 7 kapsul, skupaj torej 84 kapsul.
If you forget to take Miglustat Gen.Orph Take the next capsule at the usual time. 
Če ste pozabili vzeti zdravilo Miglustat Gen.Orph Kapsulo vzemite ob običajnem času.
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 Gen.Orph 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 Gen.Orph skupaj s hrano ali začasno znižate svoj odmerek.
Don't stop taking Miglustat Gen.Orph without talking to your doctor. 
Ne prenehajte uporabljati zdravila Miglustat Gen.Orph, ne da se o tem pogovorite z zdravnikom.
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,
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 1 do
Miglustat Gen.Orph 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 Gen.Orph smemo uporabljati samo za zdravljenje bolnikov, za katere encimsko nadomestno zdravljenje ni primerno (glejte poglavji 4.4 in 5.1).
• For type 1 Gaucher disease: for adults, the usual dose is one capsule (100 mg) three times a day (morning, afternoon and evening). 
• Za Gaucherjevi bolezni tipa 1: za odrasle je običajni odmerek ena kapsula (100 mg) trikrat dnevno (zjutraj, popoldne, zvečer).
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, 
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)].
Polyamide/aluminium/PVC/Aluminium blister supplied as a box of 12 blisters, each blister containing 7 capsules providing a total of 84 capsules. 
Pretisni omot iz poliamida/aluminija/PVC/aluminija, 12 pretisnih omotov na škatlo, vsak pretisni omot vsebuje 7 kapsul, skupaj 84 kapsul.
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 4.4).
Use of Miglustat Gen.Orph in patients with severe renal impairment (creatinine clearance < 30 ml/min/1.73 m2) is not recommended. 
Uporabe zdravila Miglustat Gen.Orph pri bolnikih s hudo okvarjenim delovanjem ledvic (očistek kreatinina < 30 ml/min/1,73 m2) ne priporočamo.
Miglustat Gen.Orph can be taken with or without food. 
Zdravilo Miglustat Gen.Orph se lahko jemlje s hrano ali brez nje.
They could be signs of peripheral neuropathy, due to side effects of Miglustat Gen.Orph or they could be due to existing conditions. 
To so morda znaki periferne nevropatije, ki nastanejo zaradi neželenih učinkov zdravila Miglustat Gen.Orph, morda pa so vzrok zanje obstoječe bolezni.
What Miglustat Gen.Orph is and what it is used for 2. 
Kaj je zdravilo Miglustat Gen.Orph in za kaj ga uporabljamo 2.
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 Miglustat Gen.Orph. 
Razlog za te preiskave je, da so nekateri bolniki med jemanjem zdravila Miglustat Gen.Orph izkusili omrtvičenost ali mravljinčenje v rokah in stopalih ali zmanjšanje telesne mase.
What you need to know before you take Miglustat Gen.Orph 3. 
Kaj morate vedeti, preden boste vzeli zdravilo Miglustat Gen.Orph 3.
Your doctor will perform some tests before and during treatment with Miglustat Gen.Orph to assess this (see section 2). 
Vaš zdravnik bo to ocenil z nekaj preskusi pred zdravljenjem z zdravilom Miglustat Gen.Orph in med zdravljenjem (glejte poglavje 2).
In 11 clinical trials in different indications 247 patients were treated with miglustat at dosages of 50200 mg t.i.d. 
V 11 kliničnih preskušanjih z različnimi indikacijami so 247 bolnikov zdravili z miglustatom z odmerki 50-200 mg trikrat dnevno.
• Miglustat Gen.Orph is also used to treat progressive neurological symptoms in NiemannPick type C disease in adults and in children. 
• Zdravilo Miglustat Gen.Orph se uporablja tudi za zdravljenje progresivnih nevroloških simptomov pri Niemann-Pickovi bolezni tipa C pri odraslih in otrocih.
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. 
V nekontrolirano podštudijo je bilo za celokupno povprečno obdobje 3,1 leta in do 4,4 let vključenih 12 pediatričnih bolnikov.
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). 
Pogosti neželeni učinki vključujejo glavobol, omotičnost, parestezije (mravljinčenje ali omrtvičenost), nenormalno koordinacijo, hipoestezijo (zmanjšana zmožnost čutenja na dotik), dispepsijo (zgago), navzeo (občutek slabosti), zaprtje in bruhanje, oteklost trebuha ali nelagodje v trebuhu in trombocitopenijo (zmanjšanje števila trombocitov).
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 zdravnika..
Miglustat Gen.Orph has negligible influence on the ability to drive and use machines. 
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Miglustat Gen.Orph ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Growth should be monitored in paediatric and adolescent patients during treatment with Miglustat Gen.Orph; the benefit/risk balance should be re-assessed on an individual basis for continuation of therapy. 
Med zdravljenjem z zdravilom Miglustat Gen.Orph je treba spremljati rast pediatričnih bolnikov in mladostnikov; razmerje med koristmi in tveganji je treba ponovno oceniti posamično za vsakega bolnika pred nadaljevanjem zdravljenja.
Common effects may affect up to 1 in 10 people. 
Pogosti neželeni učinki se lahko pojavijo pri največ 1 od 10 bolnikov.
NAME OF THE MARKETING AUTHORISATION HOLDER Gen.Orph (logo) 
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Gen.Orph (logo)
Miglustat Gen.Orph works by inhibiting the enzyme called ‘glucosylceramide synthase' which is responsible for the first step in the synthesis of most glycosphingolipids. 
Zdravilo Miglustat Gen.Orph deluje tako, da zavira delovanje encima, ki se imenuje 'glukozilceramid sintaza', ki je odgovoren za prvi korak sinteze večine glikosfingolipidov.
Miglustat Gen.Orph should not be taken during breast-feeding. 
Zdravilo Miglustat Gen.Orph se ne sme jemati v času dojenja.
4.4 Special warnings and precautions for use 
4.4 Posebna opozorila in previdnostni ukrepi Tremor
What Miglustat Gen.Orph is and what it is used for 
Kaj je zdravilo Miglustat Gen.Orph in za kaj ga uporabljamo
There was no drug-related increase in tumor incidence in male or female rats in any other organ. 
Drugih z zdravilom povezanih povišanj incidenc tumorjev katerega koli drugega organa pri samcih ali samicah podgan ni bilo.
The benefit of treatment with Miglustat Gen.Orph 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 Gen.Orph. 
Koristi zdravljenja z zdravilom Miglustat Gen.Orph pri nevroloških manifestacijah pri bolnikih z Niemann- Pickovo 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 Gen.Orph.
Miglustat Gen.Orph is only used when a patient is considered unsuitable for treatment with enzyme replacement therapy. 
Miglustat Gen.Orph se jemlje le, kadar bolnik za encimsko nadomestno zdravljenje ni primeren.
What Miglustat Gen.Orph contains - The active substance is miglustat 100 mg. - The other ingredients are sodium starch glycolate (type A), povidone (K30), magnesium stearate, gelatin, titanium dioxide (E171). 
- Druge sestavine zdravila so natrijev karboksimetilškrob (tip A), povidon (K30), magnezijev stearat, želatina, titanov dioksid (E171).