natgillin/translations-raw huggingface dataset:
- The other ingredients are magnesium stearate, gelatine, titanium dioxide (E171), printing ink (consisting of black iron oxide (E172), propylene glycol (E1520) potassium hydroxide, shellac). 
Svaka tvrda kapsula sadrži 100 mg miglustata. drugi sastojci su magnezijev stearat, želatina, titanijev dioksid (E171) i tinta za označavanje (koja se sastoji od željezovog oksida, crnog (E172), propilenglikola (E1520), kalijeva hidroksida i šelaka).
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. 
Gaucherovom bolesti tipa 3 bila je 31,4-67,2% koncentracije u plazmi.
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 Dipharma (see section 4). 
Liječnik može smanjiti Vašu dozu, npr. na jednu kapsulu (100 mg) jednom ili dvaput dnevno ako imate proljev dok uzimate
Male patients should maintain reliable contraceptive methods while taking Miglustat Dipharma. 
Muški bolesnici trebaju primjenjivati pouzdane metode kontracepcije dok uzimaju Miglustat Dipharma.
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). 
Korist od liječenja miglustat kod neuroloških manifestacija u bolesnika s Niemann-Pickovom bolesti tipa C treba redovito ocjenjivati, npr. svakih 6 mjeseci; nastavak liječenja treba ponovo procijeniti nakon najmanje 1 godine liječenja miglustat (vidjeti dio 4.4).
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 adenoma u muških štakora pri svim razinama doza.
Pack size of 84x1 capsules in perforated unit dose blisters. 
Veličina pakiranja od 84x1 kapsula u perforiranim blisterima s jediničnim dozama.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP {VRSTA/TIP}
There is limited experience with the use of miglustat in Niemann-Pick type C disease patients under the age of 4 years. 
Postoji ograničeno iskustvo u primjeni Miglustat Dipharma kod bolesnika s Niemann-Pickovom bolesti tipa C, mlađih od 4 godine.
These data suggest a decrease in CL/F by at least 70% in patients with severe renal impairment. 
CL/F za najmanje 70% u bolesnika s teškim poremećajem funkcije bubrega.
Miglustat Dipharma is a white opaque 100 mg capsule with “DPH02” printed in black on the top and “100” printed in black on the body. 
Miglustat Dipharma je bijela neprozirna kapsula od 100 mg s oznakom „DPH02” otisnutom crnom bojom na kapici i oznakom „100” otisnutom crnom bojom na tijelu kapsule.
Other medicines and Miglustat Dipharma 
Drugi lijekovi i Miglustat Dipharma
The inhibitory action on glucosylceramide synthase forms the rationale for substrate reduction therapy in Gaucher disease. 
Inhibitorno djelovanje na glukozilceramid sintazu daje razlog za liječenje smanjenjem supstrata kod Gaucherove bolesti.
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. 
Bijele, neprozirne kapsule (veličine 4, 14,3 ± 0,3 mm) s oznakom „DPH02” otisnutom crnom bojom na kapici i oznakom „100” otisnutom crnom bojom na tijelu kapsule.
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. 
Uobičajena doza miglustat u odraslih bolesnika bila je 200 mg triput dnevno, a kod pedijatrijskih bolesnika je bila prilagođena veličini površine tijela.
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).
Package leaflet: Information for the user Miglustat Dipharma 100 mg hard capsules miglustat 
Uputa o lijeku: Informacije za korisnika Miglustat Dipharma 100 mg tvrde kapsule miglustat
Miglustat Dipharma works by inhibiting the enzyme called ‘glucosylceramide synthase' which is responsible for the first step in the synthesis of most glycosphingolipids. 
Miglustat Dipharma djeluje kao inhibitor enzima 'glukozilceramid sintaze', odgovornog za prvi korak u sintezi većine glikosfingolipida.
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 je u kliničkim ispitivanjima kod HIV pozitivnih bolesnika primjenjivan u dozama do 3000 mg/dan tijekom najviše šest mjeseci.
Do not drive or use any tools or machines if you feel dizzy. 
Ako osjećate omaglicu nemojte voziti niti raditi sa alatima i strojevima.
In 11 clinical trials in different indications 247 patients were treated with miglustat at doses of 50-200 mg t.i.d. 
U 11 kliničkih ispitivanja s različitim indikacijama 247 bolesnika je liječeno miglustatom u dozama od 50 - 200 mg triput dnevno, u prosječnom trajanju od 2,1 godine.
Common side 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). 
Česte nuspojave liječenja uključuju glavobolju, omaglicu, paresteziju (trnci ili obamrlost), poremećenu koordinaciju, hipoesteziju (oslabljen osjet na dodir), dispepsiju (žgaravica), mučninu, zatvor i povraćanje, oticanje ili nelagodu u abdomenu (trbuhu) i trombocitopeniju (smanjenje broja trombocita).
Black iron oxide (E172) Potassium Hydroxide Shellac 
Tinta za označavanje željezov oksid, crni (E172) kalijev hidroksid šelak propilenglikol (E1520)
Miglustat Dipharma may make you feel dizzy. 
Miglustat Dipharma može uzrokovati omaglicu.
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. 
Niemann-Pickova bolest tipa C Korist od liječenja miglustat kod neuroloških manifestacija u bolesnika s Niemann-Pickovom bolesti tipa C treba redovito ocjenjivati, npr. svakih 6 mjeseci; nastavak liječenja treba ponovo procijeniti nakon najmanje 1 godine liječenja miglustat.
Contents of the pack and other information What Miglustat Dipharma contains 
Sadržaj pakiranja i druge informacije Što Miglustat Dipharma sadrži djelatna tvar je miglustat.
The benefit to the patient of treatment with miglustat should be evaluated on a regular basis (see section 4.4). 
Potrebno je redovito procjenjivati korist za bolesnika od liječenja Miglustat Dipharma (vidjeti dio 4.4).
If you stop taking Miglustat Dipharma 
Ako prestanete uzimati Miglustat Dipharma
What you need to know before you take Miglustat Dipharma 3. 
Što morate znati prije nego počnete uzimati Miglustat Dipharma
Male patients should use reliable birth control methods during their treatment with Miglustat Dipharma and for 3 months after finishing treatment. 
Muški bolesnici trebaju primjenjivati pouzdane metode kontracepcije tijekom liječenja lijekom Miglustat Dipharma te još 3 mjeseca nakon završetka liječenja.
The apparent volume of distribution of miglustat is 83 L. Miglustat does not bind to plasma proteins. 
Prividni volumen distribucije miglustata je 83 l.
Due to limited experience, miglustat should be used with caution in patients with renal or hepatic impairment. 
Zbog ograničenog iskustva, kod bolesnika s poremećajem funkcije bubrega ili jetre, miglustat treba koristiti oprezno.
Miglustat Dipharma 100 mg hard capsules 
Miglustat Dipharma 100 mg tvrde kapsule
If you forget to take Miglustat Dipharma 
Ako ste zaboravili uzeti Miglustat Dipharma
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. 
Preporučena doza za liječenje adolescentnih bolesnika (12 godina i starijih) s Niemann-Pickovom bolesti tipa C je 200 mg triput dnevno.
29 patients continued in the extension period. 
Dvadeset i devet bolesnika nastavilo je s liječenjem u produljenom razdoblju nastavka ispitivanja.
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. 
uključeno je u ovo 12-mjesečno nekomparativno ispitivanje, a 22 bolesnika završila su ispitivanje.
Limited data in patients with Fabry disease and impaired renal function showed that CL/F decreases with decreasing renal function. 
Ograničeni podatci za bolesnike s Fabryjevom bolesti i poremećajem funkcije bubrega pokazuju da
Miglustat Dipharma 100 mg hard capsules miglustat 
Miglustat Dipharma 100 mg tvrde kapsule miglustat
In patients with an adjusted creatinine clearance of 30-50 ml/min/1.73 m2, administration should commence at a dose of 100 mg once daily in patients with type 1 Gaucher disease and at a dose of 100 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 30-50 ml/min/1,73 m2, primjenu treba početi s dozom od 100 mg jednom dnevno u bolesnika s Gaucherovom bolesti tipa 1, te dozom od 100 mg dvaput dnevno (prilagođeno površini tijela u bolesnika mlađih od 12 godina) u bolesnika s Niemann
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
Of these patients, 132 had type 1 Gaucher disease, and 40 had Niemann-Pick type C disease. 
Gaucherovu bolest tipa 1, a 40 je imalo Niemann-Pickovu bolest tipa
Each capsule contains 100 mg miglustat. 
Jedna kapsula sadrži 100 mg miglustata.
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 što Vam je propisano.
If any of these side effects cause problems, consult your doctor. 
Ako Vam bilo koja od tih nuspojava potraje, obratite se Vašem liječniku.
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 miglustat, or switch to miglustat. 
godine bili liječeni ERT-om, u tri skupine liječenja: nastavak liječenja imiglucerazom, imiglucerazom u kombinaciji s miglustatom, ili prelazak na miglustat.
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 učinci zajednički svim vrstama bili su gubitak tjelesne težine i proljev, a pri višim dozama,
Check with your doctor or pharmacist if you are not sure.For typer 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 (ujutro, popodne i navečer).
Bone manifestations of type 1 Gaucher disease were evaluated in 3 open-label clinical trials in patients treated with miglustat 100 mg t.i.d. 
Manifestacije Gaucherove bolesti tipa 1 na kostima ocjenjivane su u 3 otvorena klinička ispitivanja u bolesnika liječenih miglustatom 100 mg triput dnevno u trajanju do 2 godine (n = 72).
Nausea, vomiting, abdominal distension/discomfort, constipation, dyspepsia 
Mučnina, povraćanje, abdominalna distenzija/nelagoda,
Each capsule contains 100 mg miglustat 
Jedna kapsula sadrži 100 mg miglustata
Hepatic impairment Miglustat has not been evaluated in patients with hepatic impairment. 
Miglustat nije procjenjivan kod bolesnika s oštećenjem funkcije jetre.
Do not breast-feed while you are taking Miglustat Dipharma. 
Nemojte dojiti tijekom uzimanja lijeka Miglustat Dipharma
• Miglustat Dipharma is used to treat mild to moderate type 1 Gaucher disease in adults. 
Primjenjuje se za liječenje dvije bolesti: • Miglustat Dipharma se primjenjuje za liječenje blage do umjerene Gaucherove bolesti tipa 1 u odraslih
Musculoskeletal and connective tissue disorders Common 
konstipacija, dispepsija Poremećaji mišićno-koštanog sustava i vezivnog tkiva
How to take Miglustat Dipharma 
Kako uzimati Miglustat Dipharma
How to store Miglustat Dipharma 
Kako čuvati Miglustat Dipharma
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). 
Miglustat Dipharma je indiciran za peroralno liječenje odraslih bolesnika s blagom do umjerenom Gaucherovom bolesti tipa 1. Miglustat Dipharma se smije koristiti samo u liječenju bolesnika kod kojih enzimska nadomjesna terapija nije prikladna (vidjeti dijelove 4.4 i 5.1).
Until further information is available, before seeking to conceive, male patients should cease Miglustat Dipharma and maintain reliable contraceptive methods for a further 3 months. 
Do dostupnosti daljnjih informacija, prije pokušaja začeća djeteta, muški bolesnici trebaju prekinuti uzimanje lijeka Miglustat
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
You must use effective birth control while taking Miglustat Dipharma. 
Dok uzimate Miglustat Dipharma morate primjenjivati učinkovitu kontracepciju.
Very common side 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.
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. 
Nadalje učinci zabilježeni u životinja pri dozama koje su uzrokovale razine izloženosti slične ili umjereno više od kliničkih razina izloženosti,
The pivotal trial of miglustat was conducted in patients unable or unwilling to receive ERT. Reasons for not receiving ERT included the burden of intravenous infusions and difficulties in venous access. 
Ključno ispitivanje miglustata provedeno je na bolesnicima koji nisu mogli ili nisu željeli primati
adjusted for body surface area resulted in Cmax and AUCτ values which were approximately two fold those attained after 100 mg t.i.d. 
Doziranje u djece od 200 mg triput dnevno prilagođeno veličini površine tijela dalo je vrijednosti Cmax i AUCτ koje su približno dvostruke od onih dobivenih nakon 100 mg triput dnevno u bolesnika s Gaucherovom bolesti tipa 1, što je sukladno farmakokinetici miglustata linearno ovisnoj o dozi.
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
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. 
muškim bolesnicima se savjetuje da prije pokušaja začeća djeteta prekinu uzimanje lijeka Miglustat
How to take Miglustat Dipharma 4. 
Miglustat Dipharma (vidjeti dio 4).
Pharmaceutical Form 
(Zaštićeno) ime Doza Farmaceutski oblik Put primjene
Package size 
Unutarnje pakiranje Veličina pakiranj a
Why not? 
Zašto nije?
What should I do? 
Što mi je činiti?
These are publicly available. 
One su javno dostupne.
The medicine you are looking for may be: 
Lijek koji tražite možda je:
The Agency will reply in the same language. 
Agencija će odgovoriti na tom istom jeziku.
The Agency's normal business hours are 9.00am to 5.30pm, Monday to Friday. 
Radno vrijeme Agencije je od 9.00 do 17.30 od ponedjeljka do petka.
No, EMA does not directly fund research. 
Ne, EMA ne financira istraživanja izravno.
Each organisation is re-evaluated every two years. 
Svaka organizacija ponovno se procjenjuje svake dvije godine.
Fees are adjusted each year for inflation. 
Naknade se svake godine prilagođavaju inflaciji.
When is the Agency open? 
Kada je Agencija otvorena?
The Agency is closed for holidays on various days throughout the year. 
Agencija je zatvorena na blagdane različitih dana tijekom godine.
Each EPAR includes a summary for the public 
Svaki EPAR uključuje sažetak za javnost
The European Medicines Agency does not control: 
Europska agencija za lijekove ne kontrolira sljedeće:
What acronym should I use for the Agency? 
Koji akronim mogu upotrijebiti za Agenciju?
Questions about pricing, sales and patents 
Pitanja o cijenama, prodaji i patentima
These are not always on the same days as the national holidays in the United Kingdom or other Member States. 
To nisu uvijek isti datumi, kao što su primjerice nacionalni praznici u Ujedinjenoj Kraljevini ili drugim državama članicama.
Each member and expert make an annual declaration of their financial interests. 
Svaki član i stručni suradnik daje godišnju izjavu o svojim financijskim interesima.
However, some medicines can be supplied to individual patients under special conditions before they have been authorised. 
Međutim, neki se lijekovi mogu dostaviti pojedinim bolesnicima pod posebnim okolnostima prije nego što su odobreni.
• still in development and not yet authorised; 
• još je u razvoju i dosad nije odobren;
Please note that this is an unofficial acronym. 
Napominjemo da je to neslužbena kratica.
Journalists and other representatives of the press should contact our press office directly at press@ema.europa.eu. 
Novinari i drugi predstavnici tiska moraju se obratiti izravno našoj službi za tisak na press@ema.europa.eu.
• authorised through national procedures and not centrally through EMA. 
• odobren nacionalnim postupkom, a ne centraliziranim postupkom putem EMA-e.
The Agency's old acronym of 'EMEA' should not be used any longer. 
Prijašnja kratica Agencije „EMEA”, više se ne smije upotrebljavati.
The members of the Agency's Management Board and scientific committees, and its experts and staff are not permitted to have financial or other interests in the pharmaceutical industry that could affect their impartiality. 
Članovima Upravnog odbora Agencije i znanstvenih odbora, njihovim stručnim članovima i osoblju nije dozvoljeno da imaju financijske ili druge interese u farmaceutskoj industriji koji bi mogli utjecati na njihovu nepristranost.
• not classified as a medicine but as a medical device or a nutritional supplement, both of which are authorised at national level. 
• nije kategoriziran kao lijek nego kao medicinsko pomagalo/uređaj ili prehrambeni dodatak, a oboje se odobrava na nacionalnoj razini.
• browsing by therapeutic area or type of medicine. 
• pregledavanjem terapijskog područja ili vrste lijeka.
The Agency has no control over these decisions. 
Agencija nema kontrolu nad tim odlukama.
These frequently asked questions are also available in all EU languages. 
Ta često postavljana pitanja dostupna su i na drugim jezicima Europske unije.
How is the financial transparency of patient and consumer organisations evaluated? 
Kako se procjenjuje financijska transparentnost bolesnika i organizacija potrošača?
These documents can be found on the webpages of the respective committees. 
Ti se dokumenti mogu naći na internetskim stranicama navedenih odbora.
These are also published on EMA's homepage. 
To se također objavljuje na EMA-inoj početnoj stranici.
How are the Agency's committee members selected? 
Kako se biraju članovi odbora Agencije?
Can the Agency fund my work? 
Može li Agencija financirati moj rad?
There are also two routes to allow companies to gain authorisation in more than one country: the mutual-recognition procedure and the decentralised procedure. 
Postoje i dva načina na koje tvrtke mogu dobiti odobrenje u više od jednoj državi: postupak međusobnog priznavanja lijeka i decentralizirani postupak.
If appropriate, please give the type of organisation you represent (e.g. patient organisation, pharmaceutical company, etc.) 
Ako je odgovarajuće, navedite vrstu organizacije koju predstavljate (npr. udruga bolesnika, farmaceutska tvrtka, itd.).
EMA/527628/2011 Rev. 1 Directorate 
EMA/527628/2011 Rev.
The European Medicines Agency charges pharmaceutical companies fees for the services it provides. 
Europska medicinska agencija naplaćuje naknade farmaceutskim tvrtkama za usluge koje pruža.
Citizens can submit questions to the Agency in any official EU language. 
Građani mogu postavljati pitanja upućena Agenciji na bilo kojem jeziku Europske unije.
• searching by keyword; 
• pretraživanjem po ključnoj riječi;
Sales are dealt with at a national level. 
To se rješava na nacionalnoj razini.
The Agency's main responsibility is the protection and promotion of public and animal health, by carrying out scientific evaluations of medicines for human and veterinary use. 
Glavni zadatak Agencije jest zaštita i promicanje zdravlja ljudi i životinja davanjem znanstvenih ocjena lijekova za humanu i veterinarsku upotrebu.
The Agency does not have any commercial interests and does not get involved in the distribution of medicines. 
Agencija nema nikakvih komercijalnih interesa i ne uključuje se u distribuciju lijekova.
Can you recommend a medical specialist for my condition? 
Možete li mi preporučiti medicinskog specijalista za moje stanje?
The Agency's Management Board is also made up of representatives of Member States and members nominated by the European Commission. 
Upravni odbor Agencije također čine predstavnici država članica i članovi koje je imenovala Europska komisija.
Most of the members of the Agency's six scientific committees are nominated by the Member States or the European Commission. 
Većinu članova šest odbora Agencije imenuju države članice ili Europska komisija.