FrancophonIA/ELRC3.0 huggingface dataset:
English: Hepatic impairment Miglustat has not been evaluated in patients with hepatic impairment.
Croatian: Miglustat nije procjenjivan kod bolesnika s oštećenjem funkcije jetre.
English: Do not breast-feed while you are taking Miglustat Dipharma.
Croatian: Nemojte dojiti tijekom uzimanja lijeka Miglustat Dipharma
English: • Miglustat Dipharma is used to treat mild to moderate type 1 Gaucher disease in adults.
Croatian: Primjenjuje se za liječenje dvije bolesti: • Miglustat Dipharma se primjenjuje za liječenje blage do umjerene Gaucherove bolesti tipa 1 u odraslih
English: Musculoskeletal and connective tissue disorders Common
Croatian: konstipacija, dispepsija Poremećaji mišićno-koštanog sustava i vezivnog tkiva
English: How to take Miglustat Dipharma
Croatian: Kako uzimati Miglustat Dipharma
English: How to store Miglustat Dipharma
Croatian: Kako čuvati Miglustat Dipharma
English: 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).
Croatian: 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).
English: 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.
Croatian: Do dostupnosti daljnjih informacija, prije pokušaja začeća djeteta, muški bolesnici trebaju prekinuti uzimanje lijeka Miglustat
English: 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.
Croatian: Farmakokinetika miglustata slična je onoj u odraslih bolesnika s Gaucherovom bolesti tipa 1 i
English: You must use effective birth control while taking Miglustat Dipharma.
Croatian: Dok uzimate Miglustat Dipharma morate primjenjivati učinkovitu kontracepciju.
English: 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.
Croatian: Najčešće nuspojave su proljev, flatulencija (vjetrovi), bol u trbuhu, gubitak težine i smanjen tek.
English: 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.
Croatian: Nadalje učinci zabilježeni u životinja pri dozama koje su uzrokovale razine izloženosti slične ili umjereno više od kliničkih razina izloženosti,
English: 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.
Croatian: Ključno ispitivanje miglustata provedeno je na bolesnicima koji nisu mogli ili nisu željeli primati
English: adjusted for body surface area resulted in Cmax and AUCτ values which were approximately two fold those attained after 100 mg t.i.d.
Croatian: 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.
English: Therapy should be directed by physicians who are knowledgeable in the management of Gaucher disease or Niemann-Pick type C disease, as appropriate.
Croatian: 4.2 Doziranje i način primjene Liječenje trebaju voditi liječnici s odgovarajućim iskustvom u liječenju Gaucherove bolesti ili
English: 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.
Croatian: muškim bolesnicima se savjetuje da prije pokušaja začeća djeteta prekinu uzimanje lijeka Miglustat
English: How to take Miglustat Dipharma 4.
Croatian: Miglustat Dipharma (vidjeti dio 4).
English: Pharmaceutical Form
Croatian: (Zaštićeno) ime Doza Farmaceutski oblik Put primjene
English: Package size
Croatian: Unutarnje pakiranje Veličina pakiranj a
English: No.
Croatian: Ne.
English: Why not?
Croatian: Zašto nije?
English: What should I do?
Croatian: Što mi je činiti?
English: These are publicly available.
Croatian: One su javno dostupne.
English: The medicine you are looking for may be:
Croatian: Lijek koji tražite možda je:
English: The Agency will reply in the same language.
Croatian: Agencija će odgovoriti na tom istom jeziku.
English: The Agency's normal business hours are 9.00am to 5.30pm, Monday to Friday.
Croatian: Radno vrijeme Agencije je od 9.00 do 17.30 od ponedjeljka do petka.
English: No, EMA does not directly fund research.
Croatian: Ne, EMA ne financira istraživanja izravno.
English: Each organisation is re-evaluated every two years.
Croatian: Svaka organizacija ponovno se procjenjuje svake dvije godine.
English: Fees are adjusted each year for inflation.
Croatian: Naknade se svake godine prilagođavaju inflaciji.
English: When is the Agency open?
Croatian: Kada je Agencija otvorena?
English: The Agency is closed for holidays on various days throughout the year.
Croatian: Agencija je zatvorena na blagdane različitih dana tijekom godine.
English: Each EPAR includes a summary for the public
Croatian: Svaki EPAR uključuje sažetak za javnost
English: The European Medicines Agency does not control:
Croatian: Europska agencija za lijekove ne kontrolira sljedeće:
English: What acronym should I use for the Agency?
Croatian: Koji akronim mogu upotrijebiti za Agenciju?
English: Questions about pricing, sales and patents
Croatian: Pitanja o cijenama, prodaji i patentima
English: These are not always on the same days as the national holidays in the United Kingdom or other Member States.
Croatian: To nisu uvijek isti datumi, kao što su primjerice nacionalni praznici u Ujedinjenoj Kraljevini ili drugim državama članicama.
English: Each member and expert make an annual declaration of their financial interests.
Croatian: Svaki član i stručni suradnik daje godišnju izjavu o svojim financijskim interesima.
English: However, some medicines can be supplied to individual patients under special conditions before they have been authorised.
Croatian: Međutim, neki se lijekovi mogu dostaviti pojedinim bolesnicima pod posebnim okolnostima prije nego što su odobreni.
English: • still in development and not yet authorised;
Croatian: • još je u razvoju i dosad nije odobren;
English: Please note that this is an unofficial acronym.
Croatian: Napominjemo da je to neslužbena kratica.
English: Journalists and other representatives of the press should contact our press office directly at press@ema.europa.eu.
Croatian: Novinari i drugi predstavnici tiska moraju se obratiti izravno našoj službi za tisak na press@ema.europa.eu.
English: • authorised through national procedures and not centrally through EMA.
Croatian: • odobren nacionalnim postupkom, a ne centraliziranim postupkom putem EMA-e.
English: The Agency's old acronym of 'EMEA' should not be used any longer.
Croatian: Prijašnja kratica Agencije „EMEA”, više se ne smije upotrebljavati.
English: 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.
Croatian: 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.
English: • not classified as a medicine but as a medical device or a nutritional supplement, both of which are authorised at national level.
Croatian: • nije kategoriziran kao lijek nego kao medicinsko pomagalo/uređaj ili prehrambeni dodatak, a oboje se odobrava na nacionalnoj razini.
English: • browsing by therapeutic area or type of medicine.
Croatian: • pregledavanjem terapijskog područja ili vrste lijeka.
English: The Agency has no control over these decisions.
Croatian: Agencija nema kontrolu nad tim odlukama.
English: These frequently asked questions are also available in all EU languages.
Croatian: Ta često postavljana pitanja dostupna su i na drugim jezicima Europske unije.
English: How is the financial transparency of patient and consumer organisations evaluated?
Croatian: Kako se procjenjuje financijska transparentnost bolesnika i organizacija potrošača?
English: These documents can be found on the webpages of the respective committees.
Croatian: Ti se dokumenti mogu naći na internetskim stranicama navedenih odbora.
English: These are also published on EMA's homepage.
Croatian: To se također objavljuje na EMA-inoj početnoj stranici.
English: How are the Agency's committee members selected?
Croatian: Kako se biraju članovi odbora Agencije?
English: Can the Agency fund my work?
Croatian: Može li Agencija financirati moj rad?
English: There are also two routes to allow companies to gain authorisation in more than one country: the mutual-recognition procedure and the decentralised procedure.
Croatian: Postoje i dva načina na koje tvrtke mogu dobiti odobrenje u više od jednoj državi: postupak međusobnog priznavanja lijeka i decentralizirani postupak.
English: If appropriate, please give the type of organisation you represent (e.g. patient organisation, pharmaceutical company, etc.)
Croatian: Ako je odgovarajuće, navedite vrstu organizacije koju predstavljate (npr. udruga bolesnika, farmaceutska tvrtka, itd.).
English: EMA/527628/2011 Rev. 1 Directorate
Croatian: EMA/527628/2011 Rev.
English: The European Medicines Agency charges pharmaceutical companies fees for the services it provides.
Croatian: Europska medicinska agencija naplaćuje naknade farmaceutskim tvrtkama za usluge koje pruža.
English: Citizens can submit questions to the Agency in any official EU language.
Croatian: Građani mogu postavljati pitanja upućena Agenciji na bilo kojem jeziku Europske unije.
English: • searching by keyword;
Croatian: • pretraživanjem po ključnoj riječi;
English: Sales are dealt with at a national level.
Croatian: To se rješava na nacionalnoj razini.
English: 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.
Croatian: Glavni zadatak Agencije jest zaštita i promicanje zdravlja ljudi i životinja davanjem znanstvenih ocjena lijekova za humanu i veterinarsku upotrebu.
English: The Agency does not have any commercial interests and does not get involved in the distribution of medicines.
Croatian: Agencija nema nikakvih komercijalnih interesa i ne uključuje se u distribuciju lijekova.
English: Can you recommend a medical specialist for my condition?
Croatian: Možete li mi preporučiti medicinskog specijalista za moje stanje?
English: The Agency's Management Board is also made up of representatives of Member States and members nominated by the European Commission.
Croatian: Upravni odbor Agencije također čine predstavnici država članica i članovi koje je imenovala Europska komisija.
English: Most of the members of the Agency's six scientific committees are nominated by the Member States or the European Commission.
Croatian: Većinu članova šest odbora Agencije imenuju države članice ili Europska komisija.
English: 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.
Croatian: Neki sadržaji prevedeni su i na druge službene jezike Europske unije (EU), uključujući sažetke za javnost i informacije o lijekovima u Europskim javnim izvješćima o procjeni lijeka (EPAR), dokumente s pitanjima i odgovorima za javnost, informacije o zapošljavanju, radne programe i sažetke godišnjih izvješća.
English: What does the Agency not control?
Croatian: Što Agencija ne kontrolira?
English: 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.
Croatian: Kako biste saznali najnovije vijesti, komentare i publikacije Agencije, možete se pretplatiti na naše RSS sadržaje ili pratiti EMA-u na Twitteru.
English: Following a positive recommendation from the Agency, the European Commission takes around two months to approve a medicine.
Croatian: Poslije pozitivne preporuke Agencije, Europskoj komisiji treba otprilike dva mjeseca da odobri lijek.
English: The search is currently only available in English.
Croatian: Pretraživanje je trenutačno dostupno samo na engleskome jeziku.
English: The Agency is not involved in recruiting volunteers for clinical trials.
Croatian: Agencija nije uključena u novačenje dobrovoljaca za klinička ispitivanja.
English: What does the Agency do?
Croatian: Što radi Agencija?
English: How can I get hold of a medicine that is not yet authorised?
Croatian: Kako mogu doći do lijeka za koje još nije dano odobrenje?
English: Is the Agency's website available in languages other than English?
Croatian: Postoje li mrežne stranice Agencije i na drugim jezicima osim engleskoga?
English: How can I keep up to date with the Agency's opinions?
Croatian: Kako mogu pratiti aktualna mišljenja Agencije?
English: 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.
Croatian: Takve spontane prijave sumnji na nuspojavu koje upute zdravstveni radnici, bolesnici ili njegovatelji koriste se za kontinuirano praćenje sigurnosti primjene lijekova na tržištu te za osiguravanje da njihova dobrobit i dalje premašuje rizike.
English: My medicine has been evaluated by the Agency but is not available in my country.
Croatian: Moj je lijek Agencija ocijenila, ali još nije dostupan u mojoj zemlji.
English: Can the Agency tell me when a medicine will be approved?
Croatian: Može li mi Agencija reći kada će lijek biti odobren?
English: This is a set of documents that explains the scientific conclusion reached by the Agency's Committees at the end of the evaluation process.
Croatian: To je skup dokumenata koji objašnjavaju znanstveni zaključak odbora Agencije na kraju postupka davanja ocjene.
English: The Agency publishes the rules on these fees, including a list of the fees charged for each type of procedure.
Croatian: Pravila za te naknade Agencija objavljuje svake godine, uključujući popis svih naknada koje se naplaćuju za svaku vrstu postupka.
English: How are fees organised at the Agency?
Croatian: Kako su u Agenciji organizirane naknade?
English: The European Patent Office may be able to provide information on a specific patent.
Croatian: Europski ured za patente može Vam dati informacije o određenom patentu.
English: They are not evaluated by the Agency.
Croatian: Njih ne ocjenjuje Agencija.
English: Medicines cannot be placed on the market without authorisation.
Croatian: Lijekovi se ne mogu naći na tržištu, a da nisu odobreni.
English: The Agency requires every patient and consumer organisation that it works with to provide financial statements, including details on donors and their contributions.
Croatian: Agencija zahtijeva da svaki bolesnik i organizacija za zaštitu potrošača s kojom surađuje podnesu financijsko izvješće uključujući detalje o donatorima i njihovim prilozima.
English: The Agency also recommends that you report any suspected side effects to the national competent authority.
Croatian: Agencija također preporučuje da svaku sumnju na nuspojave prijavite nadležnom nacionalnom tijelu.
English: Questions about competing interests and transparency
Croatian: Pitanja o tržišnom natjecanju i transparentnosti
English: In addition you may be eligible to take part in a clinical trial.
Croatian: Osim toga, možda ste pogodni za sudjelovanje u kliničkom ispitivanju.
English: Currently, most of the information on the Agency's website is only available in English.
Croatian: Trenutačno je većina informacija na mrežnim stranicama Agencije dostupna samo na engleskom jeziku.
English: Frequently asked questions EMA/527628/2011
Croatian: EMA/527628/2011
English: 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.
Croatian: Za vrijeme postupka ocjenjivanja, Agencija objavljuje informacije koje se odnose na raspored ocjenjivanja i datume o sastancima njezinih relevantnih znanstvenih odbora.
English: Questions about the Agency's website
Croatian: Pitanja o mrežnim stranicama Agencije
English: The European Commission follows the opinion of the Agency in almost all cases.
Croatian: U gotovo svim slučajevima Europska komisija slijedi mišljenje Agencije.
English: If you wish to use an acronym for the Agency, use 'EMA'.
Croatian: Želite li umjesto „Agencija” upotrijebiti kraticu, možete upotrijebiti „EMA”.
English: A medicine that is authorised in the EU might not be authorised or marketed in countries outside the EU.
Croatian: Lijek koji je odobren u EU-u možda nije odobren ili na tržištu u zemljama izvan EU-a.
English: No, the Agency is unable to recommend academic courses in regulatory affairs, medicine or any other discipline.
Croatian: Ne, Agencija ne može preporučiti studijske predmete u području regulatornih poslova, u medicini ili nekoj drugoj disciplini.
English: If you would like to take part in a clinical trial, you should discuss it with your doctor or nurse, who may be able to refer you for a suitable trial.
Croatian: Želite li sudjelovati kliničkom ispitivanju, morate o tome razgovarati sa svojim liječnikom ili medicinskom sestrom koja vas možda može uputiti u odgovarajuće ispitivanje.
English: Does the Agency control advertising of medicines?
Croatian: Kontrolira li Agencija reklamiranje lijekova?
English: For the Committee for Advanced Therapies, the Committee (CAT) for Orphan Medicinal Products (COMP) and the Paediatric Committee (PDCO), EMA publishes monthly meeting reports in the week following the committee's plenary meeting.
Croatian: Za Odbor za napredne terapije (Committee for Advanced Therapies, CAT), Odbor za lijekove za liječenje rijetkih i teških bolesti (Committee for Orphan Medicinal Products, COMP) i Pedijatrijski odbor (Paediatric Committee, PDCO), EMA objavljuje mjesečna izvješća u tjednu koji slijedi nakon plenarnog sastanka odbora.
English: Food supplements are evaluated at national level, usually by the authorities that deal with food safety and labelling.
Croatian: Dodaci prehrani ocjenjuju se na nacionalnoj razini, obično ih ocjenjuju nadležna tijela koja se bave sigurnošću hrane i označavanjem.
English: The Agency publishes the names of the actives substance of medicines currently under evaluation but cannot say when the medicines will be approved.
Croatian: Agencija objavljuje nazive djelatnih tvari lijekova koji su trenutačno u postupku ocjenjivanja, ali ne može reći kada će lijekovi biti odobreni.
English: They are not usually evaluated by medicines regulatory authorities, unless they contain a substance that has pharmacological activity or make a medicinal claim.
Croatian: Uglavnom ih ne ocjenjuju medicinska regulatorna tijela, osim kad sadrže tvar koja ima farmakološko djelovanje ili predstavljaju medicinski problem.
English: If you are experiencing a side effect or think you may be experiencing one, you should seek advice from a doctor or pharmacist.
Croatian: Ako osjećate nuspojavu ili mislite da je osjećate, morate potražiti savjet liječnika ili ljekarnika.
English: The Agency also supervises the safety of medicines in the EU after they have been authorised.
Croatian: Agencija također nadzire sigurnost primjene lijekova u EU-u nakon njihova odobravanja.
English: The Agency is also unable to give any financial assistance to patients who are trying to get hold of a medicine.
Croatian: Agencija također ne može pružiti nikakvu financijsku pomoć bolesnicima koji pokušavaju doći do lijeka.
English: Contact the medicines regulatory authorities in these countries to get more information on the availability of medicines in their territories.
Croatian: Obratite se medicinskom regulatornom tijelu u tim zemljama kako biste dobili više informacija o dostupnosti lijeka na njihovom teritoriju.
English: For the Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Risk Assessment Committee (PRAC), EMA publishes meeting highlights with evaluation outcomes of major public interest on the Friday following their monthly plenary meetings.
Croatian: Za Odbor za lijekove za humanu uporabu (CHMP) i Odbor za ocjenu rizika na području farmakovigilancije (PRAC), EMA objavljuje glavne točke sastanaka s rezultatima ocjenjivanja od najvećeg javnog interesa nakon njihovih mjesečnih plenarnih sastanaka, a to je petkom.
English: • food supplements;
Croatian: • dodatke prehrani
English: 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.
Croatian: Zadatak Agencije je pripremiti znanstvena mišljenja o kakvoći, sigurnosti primjene i djelotvornosti biljnih lijekova kako bi se olakšalo usklađivanje tih informacija na prostoru Europske unije.
English: The Agency publishes information about all the medicines it assesses as a European public assessment report (EPAR).
Croatian: Informacije o svim lijekovima koje ocjenjuje, Agencija objavljuje u obliku Europskog javnog izvješća o procjeni lijeka (EPAR).
English: How can I get onto a clinical trial?
Croatian: Kako se mogu uključiti u kliničko ispitivanje?
English: The Agency is not responsible for patents on medicines: issues regarding patent law are not within the Agency's remit.
Croatian: Agencija nije odgovorna za pitanja o lijekovima s obzirom na zakon o patentima jer to nije u djelokrugu Agencije.
English: For information on clinical trials, talk to your doctor or nurse.
Croatian: Za informacije o kliničkim ispitivanjima obratite se svom liječniku ili medicinskoj sestri.
English: The Agency also publishes a monthly newsletter called 'human medicines highlights', which provides key information on the Agency's recent activities on human medicines.
Croatian: Agencija također objavljuje mjesečna priopćenja (newsletter) pod nazivom „Human Medicines Highlights” (najvažnije novosti o lijekovima za primjenu u ljudi) u kojem se objavljuju ključne informacije o najnovijim aktivnostima Agencije s obzirom na te lijekove.
English: How can I search for a medicine on the Agency's website?
Croatian: Kako mogu pronaći lijek na mrežnim stranicama Agencije?
English: Decisions on pricing and reimbursement are made at a national level following negotiations between governments and marketing authorisation holders.
Croatian: Odluke o cijenama i naknadama donose se na nacionalnoj razini nakon pregovora me]u vladama i nositeljima odobrenja za stavljanje lijeka u promet.
English: • homoeopathic medicines;
Croatian: • homeopatske lijekove
English: You can do this either by talking to a healthcare professional, or in some cases, you can report the side effects directly to the national competent authority using online patient reporting forms or by telephone.
Croatian: To možete učiniti tako da se obratite zdravstvenom radniku ili, u nekim slučajevima, nuspojavu možete prijaviti izravno nadležnom nacionalnom tijelu putem obrazaca objavljenih na internetu ili telefonom.
English: No, the Agency is unable to supply pens, mugs or other items branded with the Agency's logo.
Croatian: Ne, Agencija Vam ne može poslati kemijske olovke, šalice ili druge predmete s logotipom Agencije.