natgillin/translations-raw huggingface dataset:
Cases of peripheral neuropathy have been reported in patients treated with miglustat with or without concurrent conditions such as vitamin B12 deficiency and monoclonal gammopathy.
Pri bolnikih, zdravljenih z miglustatom, s sočasnim stanjem, kot sta pomanjkanje vitamina B12 in monoklonska gamopatija ali brez teh stanj, so opazili primere periferne nevropatije.
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 Gaucherjeve bolezni tipa 1 na kosteh so bile ocenjene v 3 odprtih kliničnih preskušanjih pri bolnikih, zdravljenih z miglustatom 100 mg trikrat dnevno do 2 leti (n = 72).
There is limited experience with the use of miglustat in Niemann-Pick type C disease patients under the age of 4 years.
Izkušenj z zdravljenjem z zdravilom miglustat a pri bolnikih z Niemann-Pickovo boleznijo tipa C, starih pod 4 leta, je malo.
Miglustat Dipharma 100 mg hard capsules
Miglustat Dipharma 100 mg trde kapsule
See section 4.
Odmerjanje 200
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 izguba telesne mase in diareja ter, pri višjih odmerkih,
Leukopenia and neutropenia have also been observed in a similar group of patients receiving 800 mg/day or higher dose.
Pri podobni skupini bolnikov, ki so jemali 800 mg/dan ali več, so opazili levkopenijo in nevtropenijo.
Black iron oxide (E172) Potassium Hydroxide Shellac
Tiskarsko črnilo črn železov oksid (E172) kalijev hidroksid šelak propilenglikol (E1520)
Miglustat Dipharma 100 mg hard capsules miglustat
Miglustat Dipharma 100 mg trde kapsule miglustat
How to store Miglustat Dipharma 6.
Shranjevanje zdravila Miglustat Dipharma 6.
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 1 Gaucherjevo bolezen tipa 1: Za odrasle je običajni odmerek ena kapsula (100 mg) trikrat dnevno (zjutraj, popoldne, zvečer).
Male patients should use reliable birth control methods during their treatment with Miglustat Dipharma and for 3 months after finishing treatment.
Moški bolniki morajo med jemanjem zdravila Miglustat Dipharma in 3 mesece po končanju zdravljenja uporabljati zanesljivo obliko kontracepcije.
Twenty-one patients completed 24 months of miglustat treatment.
Enaindvajset bolnikov je zaključilo 24
Hepatic impairment Miglustat has not been evaluated in patients with hepatic impairment.
Okvarjeno delovanje jeter Zdravila Miglustat Dipharma pri bolnikih z okvarjenim delovanjem jeter niso ovrednotili.
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 bela neprozorna kapsula, ki ima v črni barvi na pokrovčku natisnjeno
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.
840/500 mg/kg/dan (zmanjšanje odmerka na pol leta) je povzročilo povišano incidenco vnetnih in hiperplastičnih lezij v debelem črevesu pri obeh spolih.
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).
Enzyme Replacement Therapy) pri bolnikih z Gaucherjevo boleznijo tipa 1, ki predhodno niso bili zdravljeni, niso bile opravljene, ni dokazov, da bi bil miglustat učinkovitejši ali varnejši kot ERT. ERT
Each capsule contains 100 mg miglustat
Ena kapsula vsebuje 100 mg miglustata
The patients were switched to monotherapy with miglustat 100 mg t.i.d.
Bolniki so prešli na monoterapijo z miglustatom 100 mg trikrat dnevno.
Mild reductions in platelet counts without association to bleeding were observed in some patients with Niemann-Pick type C disease treated with miglustat.
Pri nekaterih bolnikih z Niemann-Pickovo boleznijo tipa C, zdravljenih z zdravilom miglustat, so opazili blago zmanjšanje števila trombocitov, ki ni bilo povezano s krvavitvami.
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.
Najbolj pogosti neželeni učinki so driska, flatulenca (vetrovi), bolečine v trebuhu, izguba telesne mase in zmanjšanje apetita.
How to take Miglustat Dipharma
Kako jemati zdravilo Miglustat Dipharma
adjusted for body surface area resulted in Cmax and AUCτ values which were approximately two fold those attained after 100 mg t.i.d.
mg trikrat dnevno pri otrocih, prilagojeno na površino telesa, je povzročilo vrednosti Cmax in AUCτ, ki so bile približno dvakratne od tistih, pridobljenih po odmerku 100 mg trikrat dnevno pri bolnikih z Gaucherjevo boleznijo tipa 1, kar je skladno z farmakokinetiko miglustata, linearno z odmerkom.
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).
Pogosti neželeni učinki vključujejo glavobol, omotičnost, parestezije (mravljinčenje ali omrtvičenost), nenormalno koordinacijo, hipoestezijo (zmanjšana zmožnost čutenja na dotik), dispepsijo (zgago),
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 encimskega nadomestnega zdravljenja z imiglucerazo pri bolnikih z Gaucherjevo boleznijo tipa 1 povzroči znižanje izpostavljenosti miglustatu
You must use effective birth control while taking Miglustat Dipharma.
V času jemanja zdravila Miglustat Dipharma morate uporabljati učinkovite metode preprečitve zanositve.
Do not breast-feed while you are taking Miglustat Dipharma.
V času jemanja zdravila Miglustat Dipharma ne smete dojiti.
Talk to your doctor or pharmacist before taking Miglustat Dipharma
Pred začetkom jemanja zdravila Miglustat Dipharma se posvetujte z zdravnikom ali farmacevtom
• Always take this medicine exactly as your doctor has told you.
Pri jemanju tega zdravila natančno upoštevajte navodila zdravnika.
Miglustat has been used in clinical trials at doses ten times higher than the recommended dose: this caused decreases in white blood cells and other side effects similar to those described in section 4.
V kliničnih preizkušanjih so miglustat jemali v odmerkih, ki so bili 10-krat višji kot priporočen odmerek.
Weight loss, decreased appetite
Presnovne in prehranske motnje Zelo pogosto izguba telesne mase, zmanjšan apetit
He or she may reduce the dose of Miglustat Dipharma or recommend other medicines to help control side effects.
Kadar neželeni učinki povzročajo skrbi ali neprijetnosti, se posvetujte s svojim zdravnikom, ki vam bo morda znižal odmerek zdravila Miglustat Dipharma ali, za nadzor nad neželenimi učinki, priporočil druga zdravila.
Mild reductions in platelet counts without association with bleeding were observed in patients with type 1 Gaucher disease who were switched from ERT to miglustat.
Gaucherjevo boleznijo tipa 1, ki so prešli z zdravljenja z ERT na miglustat, so opazili blago zmanjšanje števila trombocitov, ki ni bilo povezano s krvavitvami.
Package leaflet: Information for the user Miglustat Dipharma 100 mg hard capsules miglustat
Navodilo za uporabo Miglustat Dipharma 100 mg trde kapsule miglustat
How to store Miglustat Dipharma
Shranjevanje zdravila Miglustat Dipharma
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).
Pri bolnikih s prilagojenim očistkom kreatinina 50-70 ml/min/1.73 m2
Fatigue, asthenia, chills and malaise
glavobol, omotičnost
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.
Pediatrična populacija Priporočeni odmerek za zdravljenje mladostnikov (starih 12 let in več) z Niemann-Pickovo boleznijo tipa C
You should not take Miglustat Dipharma if you are pregnant or thinking of becoming pregnant.
Če ste noseči ali nameravate zanositi, zdravila Miglustat Dipharma ne smete jemati.
Description of selected adverse reactions
Seznam neželenih učinkov v obliki preglednice
Why not?
Zakaj ne?
What should I do?
Kaj naj storim?
The medicine you are looking for may be:
Zdravilo, ki ga iščete, je morda:
The Agency will reply in the same language.
Agencija bo nanje odgovorila v istem jeziku.
Fees are adjusted each year for inflation.
Pristojbine se vsako leto prilagodijo inflaciji.
13 February 2017
13. februar 2017
• still in development and not yet authorised;
• še vedno v razvoju in še ni odobreno;
These frequently asked questions are also available in all EU languages.
Ta pogosto zastavljena vprašanja so prav tako na voljo v vseh jezikih EU.
The European Medicines Agency does not control:
Evropska agencija za zdravila ne nadzoruje:
These are not always on the same days as the national holidays in the United Kingdom or other Member States.
Prazniki niso vedno na isti dan kot državni prazniki v Združenem kraljestvu ali drugih državah članicah.
Frequently asked questions EMA/527628/2011
Pogosta vprašanja EMA/527628/2011
• authorised through national procedures and not centrally through EMA.
• bilo odobreno z nacionalnim postopkom in ne centralno prek agencije EMA.
The Agency's normal business hours are 9.00am to 5.30pm, Monday to Friday.
Običajni delovni čas agencije je od ponedeljka do petka od 9:00 do 17:30.
Citizens can submit questions to the Agency in any official EU language.
Državljani lahko vprašanja agenciji pošljejo v katerem koli uradnem jeziku EU.
Each member and expert make an annual declaration of their financial interests.
Vsak član in strokovnjak predloži letno izjavo o finančnih interesih.
No, EMA does not directly fund research.
Ne, agencija EMA ne financira raziskav neposredno.
Sales are dealt with at a national level.
Prodaja se ureja na nacionalni ravni.
The Agency is closed for holidays on various days throughout the year.
Agencija je zaprta ob praznikih na različne dneve v letu.
Questions about pricing, sales and patents
Vprašanja o cenah, prodaji in patentih
These are publicly available.
Izjave so javno dostopne.
Frequently asked questions
Pogosta vprašanja
How is the financial transparency of patient and consumer organisations evaluated?
Kako se vrednoti finančna preglednost organizacij bolnikov in potrošnikov?
• searching by keyword;
• iskanjem po ključni besedi (keyword);
• not classified as a medicine but as a medical device or a nutritional supplement, both of which are authorised at national level.
• ni razvrščeno kot zdravilo, ampak kot medicinski pripomoček ali prehransko dopolnilo, ki se odobri na nacionalni ravni.
The Agency's Management Board is also made up of representatives of Member States and members nominated by the European Commission.
Upravni odbor agencije prav tako sestavljajo predstavniki držav članic in člani, ki jih imenuje Evropska komisija.
There are also two routes to allow companies to gain authorisation in more than one country: the mutual-recognition procedure and the decentralised procedure.
Obstajata tudi dva načina za pridobitev dovoljenja za promet z zdravilom v več kot eni državi: postopek z medsebojnim priznavanjem in decentralizirani postopek.
Each organisation is re-evaluated every two years.
Organizacije so ovrednotene na vsaki dve leti.
The Agency's old acronym of 'EMEA' should not be used any longer.
Stara okrajšava za agencijo „EMEA“ se ne uporablja več.
Can the Agency fund my work?
Ali lahko agencija financira moje delo?
Most of the members of the Agency's six scientific committees are nominated by the Member States or the European Commission.
Večino članov v šestih znanstvenih odborih agencije imenujejo države članice ali Evropska komisija.
How can I get hold of a medicine that is not yet authorised?
Kako lahko dobim zdravila, ki še niso odobrena?
This document provides answers to the most frequently asked questions received by the European Medicines Agency (EMA).If the answer to your question is not here, please use our online form: Send a question to EMA.
V tem dokumentu so odgovori na pogosta vprašanja, naslovljena na Evropsko agencijo za zdravila (EMA).Če ne najdete odgovora na svoje vprašanje, uporabite naš spletni obrazec: Pošljite vprašanje agenciji EMA.
The Agency is not responsible for patents on medicines: issues regarding patent law are not within the Agency's remit.
Ne. Agencija ni odgovorna za patente za zdravila: vprašanja glede patentne zakonodaje ne spadajo med njene pristojnosti.
Are all medicines approved via the Agency?
So vsa zdravila odobrena prek agencije?
Please give as much background information as possible to help us answer your query effectively.
Prosimo, navedite čim več podatkov, saj vam bomo tako lažje odgovorili na vprašanje.
These documents can be found on the webpages of the respective committees.
Ti dokumenti so na voljo na spletnih straneh zadevnih odborov.
Decisions on pricing and reimbursement are made at a national level following negotiations between governments and marketing authorisation holders.
Odločitve o ceni in povračilih se sprejemajo na nacionalni ravni po pogajanjih med vladami in imetniki dovoljenj za promet z zdravili.
Is the Agency's website available in languages other than English?
Ali je spletna stran agencije na voljo tudi v drugih jezikih poleg angleščine?
This is a set of documents that explains the scientific conclusion reached by the Agency's Committees at the end of the evaluation process.
To je vrsta dokumentov, v katerih so predstavljeni znanstveni zaključki, do katerih pridejo odbori agencije ob koncu postopka vrednotenja.
• browsing the A-to-Z list of human or veterinary medicines evaluated by the Agency;
• brskanjem po abecednem seznamu (A-to-Z list) humanih ali veterinarskih zdravil, ki jih je ovrednotila agencija;
Some content is translated into other official European Union (EU) languages, including public summaries and product information in European public assessment reports (EPARs), question-and-answer documents for the public, information on recruitment, work programmes and summaries of the annual report.
Nekatere vsebine se prevajajo v druge uradne jezike Evropske unije (EU), vključno z javnimi povzetki in informacijami o zdravilih v evropskih javnih poročilih o oceni zdravila (EPAR), dokumenti z vprašanji in odgovori za javnost, informacijami o zaposlovanju, delovnimi programi in s povzetki letnega poročila.
These spontaneous reports of suspected side effects by healthcare professionals, patients or carers are used to continuously monitor the safety of medicines on the market and to ensure that their benefits continue to outweigh their risks.
Ta spontana poročila o domnevnih neželenih učinkih od zdravstvenih delavcev, bolnikov ali skrbnikov se uporabljajo za stalno spremljanje varnosti zdravil v prometu in zagotavljanje, da koristi zdravil še vedno odtehtajo tveganja.
However, some medicines can be supplied to individual patients under special conditions before they have been authorised.
Vendar se lahko nekatera zdravila uporabijo pri določenih bolnikih pod posebnimi pogoji, preden pridobijo dovoljenje za promet.
The Agency also recommends that you report any suspected side effects to the national competent authority.
Agencija prav tako priporoča, da vse domnevne neželene učinke prijavite pristojnemu nacionalnemu organu.
Journalists and other representatives of the press should contact our press office directly at press@ema.europa.eu.
Novinarji in drugi predstavniki medijev naj svoja vprašanja naslovijo neposredno naši službi za stike z javnostjo na naslovu press@ema.europa.eu.
The European Commission follows the opinion of the Agency in almost all cases.
Skoraj v vseh primerih upošteva mnenje agencije.
The Agency has a role in preparing scientific opinions on the quality, safety and efficacy of herbal medicines, to help harmonise this information across the EU.
Agencija pripravi znanstvena mnenja o kakovosti, varnosti in učinkovitosti zdravil rastlinskega izvora, s čimer prispeva k usklajevanju teh informacij po vsej EU.
My medicine has been evaluated by the Agency but is not available in my country.
Agencija je moje zdravilo ovrednotila, vendar ni na voljo v moji državi.
Food supplements are evaluated at national level, usually by the authorities that deal with food safety and labelling.
Prehranski dodatki se vrednotijo na nacionalni ravni; običajno je to v pristojnosti organov, odgovornih za varnost hrane in označevanje.
• browsing by therapeutic area or type of medicine.
• brskanjem po terapevtskih področjih ali vrsti zdravila (type of medicine).
The search is currently only available in English.
Iskanje je trenutno mogoče samo v angleškem jeziku.
A medicine that is authorised in the EU might not be authorised or marketed in countries outside the EU.
Zdravilo, ki je odobreno v EU, morda ni odobreno ali se ne trži v državah zunaj EU.
The European Medicines Agency charges pharmaceutical companies fees for the services it provides.
Evropska agencija za zdravila farmacevtskim družbam za svoje storitve zaračunava pristojbine.
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.
Člani upravnega odbora agencije in znanstvenih odborov ter strokovnjaki in zaposleni v agenciji ne smejo opravljati pridobitne dejavnosti ali imeti kakršnih koli drugih interesov na področju farmacevtske industrije, ki bi lahko vplivali na njihovo nepristranskost.
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.
Glavna odgovornost agencije je, da z izvajanjem znanstvenih vrednotenj zdravil za humano in veterinarsko uporabo varuje in spodbuja zdravje ljudi in živali.
These are also published on EMA's homepage.
Utrinki so objavljeni tudi na spletni strani agencije EMA.
These include clinical trials and compassionate-use programmes, which Member Sates regulate.
To vključuje klinična preskušanja in programe sočutne uporabe, ki jih urejajo države članice.
How are the Agency's committee members selected?
Kako se izbirajo člani odborov agencije?
If appropriate, please give the type of organisation you represent (e.g. patient organisation, pharmaceutical company, etc.)
Po potrebi navedite tudi vrsto organizacije, ki jo predstavljate (npr. organizacija bolnikov, farmacevtska družba itd.).
How can I search for a medicine on the Agency's website?
Kako lahko poiščem zdravilo na spletni strani agencije?
Currently, most of the information on the Agency's website is only available in English.
Trenutno je večina informacij na spletni strani agencije na voljo samo v angleškem jeziku.
They are not usually evaluated by medicines regulatory authorities, unless they contain a substance that has pharmacological activity or make a medicinal claim.
Regulativni organi za zdravila jih običajno ne vrednotijo, razen če vsebujejo snov, ki je farmakološko aktivna, ali če je zdravilna.
The Agency requires every patient and consumer organisation that it works with to provide financial statements, including details on donors and their contributions.
Vsaka organizacija bolnikov in potrošnikov, ki sodeluje z agencijo, mora predložiti svoje računovodske izkaze, vključno s podatki o donacijah in prispevkih.
What does the Agency not control?
Česa agencija ne nadzoruje?
How are fees organised at the Agency?
Kako so organizirane pristojbine pri agenciji?
To help us direct your query to the right people within the Agency, please indicate whether you are making your enquiry for personal reasons (e.g. a patient or carer, a student, a researcher, a healthcare professional, etc.) or on behalf of an organisation.
Da bomo vaše vprašanje napotili na pravo osebo v agenciji, vas prosimo, da navedete, ali postavljate vprašanje iz osebnih razlogov (npr. bolnik ali negovalec, študent, raziskovalec, zdravnik itd.) ali v imenu organizacije.
If you wish to use an acronym for the Agency, use 'EMA'.
Če želite agencijo poimenovati s kratico, za to uporabite izraz „EMA“.
During the evaluation procedure, the Agency publishes information relevant to the evaluation timetable in the agenda and minutes of the meetings of its relevant scientific committees.
Agencija med postopkom vrednotenja objavlja informacije glede razporeda vrednotenja v dnevnih redih in zapisniki sej zadevnih znanstvenih odborov.
Why can I not find information about a particular medicine on your website?
Zakaj na spletni strani ne najdem informacij o določenem zdravilu?
To stay up to date with the latest news, features and publications from the Agency, you can subscribe to our RSS feeds or follow EMA on Twitter.
Zadnje novice, objave in publikacije agencije lahko spremljate s prijavo na naše novice RSS ali s sledenjem agenciji EMA na Twitterju.
The Agency is also not in a position to provide medical advice or to confirm whether your symptoms are being caused by your medicine.
Prav tako ne more zagotoviti zdravniškega nasveta ali potrditi, ali simptome povzroča vaše zdravilo.
The Agency publishes the rules on these fees, including a list of the fees charged for each type of procedure.
Agencija objavlja pravilnik o pristojbinah, v katerem je seznam pristojbin za vsako posamezno vrsto postopka.
Can you recommend a medical specialist for my condition?
Ali mi lahko priporočite specialista za mojo bolezen?
The Agency is not involved in recruiting volunteers for clinical trials.
Agencija ne sodeluje pri naboru prostovoljcev za klinična preskušanja.
Medicines cannot be placed on the market without authorisation.
Zdravilo se ne sme dati v promet brez dovoljenja.
Questions about the Agency's website
Vprašanja o spletni strani agencije
Please note that this is an unofficial acronym.
Vendar je to samo neuradna kratica.
The Agency publishes information about all the medicines it assesses as a European public assessment report (EPAR).
Agencija informacije o vseh zdravilih, ki jih vrednoti, objavlja v obliki evropskega javnega poročila o oceni zdravila (EPAR).
In addition you may be eligible to take part in a clinical trial.
Poleg tega ste morda primerni za sodelovanje v kliničnem preskušanju.
The Agency does not have any commercial interests and does not get involved in the distribution of medicines.
Ne. Agencija nima nikakršnih trgovinskih interesov in ne sodeluje pri distribuciji zdravil.
This means that medicines that have received a central marketing authorisation via the Agency may not be available in all European Union (EU) Member States.
To pomeni, da zdravila, ki so bila odobrena s centraliziranim postopkom agencije, morda niso na voljo v vseh državah članicah Evropske unije (EU).
What does the Agency do?
Kaj dela agencija?
Does the Agency control advertising of medicines?
Ali agencija nadzira oglaševanje zdravil?
Can the Agency tell me when a medicine will be approved?
Ali lahko agencija napove, kdaj bo zdravilo odobreno?
The Agency is not involved in these decisions and does not have any information on pricing or reimbursement arrangements in Member States.
Agencija ne sodeluje pri sprejemanju teh odločitev in nima nobenih podatkov o dogovorih glede cene ali povračil v posameznih državah članicah.