FrancophonIA/ELRC3.0 huggingface dataset:
English: It should also not be used in patients with diabetic ketoacidosis (high levels of ketones [acids] in the blood), in patients with severe liver problems or in patients also taking gemfibrozil (a medicine used to reduce blood fat levels).
Slovenian: Uporabljati se ne sme tudi pri bolnikih z diabetično ketoacidozo (visoko koncentracijo ketonov [kislin] v krvi), bolnikih z hudimi težavami z jetri ali bolnikih, ki jemljejo tudi gemfibrozil (zdravilo, ki se uporablja za zniževanje ravni maščob v krvi).
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Prandin's benefits are greater than its risks for the treatment of type 2 diabetes.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Prandin za zdravljenje sladkorne bolezni tipa 2 večje od z njim povezanih tveganj.
English: The most common side effects with Prandin (seen in between 1 and 10 patients in 100) are hypoglycaemia (low blood glucose levels), abdominal (tummy) pain and diarrhoea.
Slovenian: Najpogostejši neželeni učinki zdravila Prandin (opaženi pri 1 do 10 bolnikih izmed 100) so hipoglikemija (nizka koncentracija glukoze v krvi), bolečine v trebuhu in driska.
English: This dose may need to be increased after one or two weeks.
Slovenian: Priporočeni začetni odmerek je 0,5 mg. Odmerek bo morda treba po enem ali dveh tednih povečati.
English: It should also not be used in patients with type 1 (insulin-dependent) diabetes who do not have any ‘C-peptide' in their blood (a marker of type 1 diabetes).
Slovenian: Prav tako ga ne smejo uporabljati bolniki s sladkorno boleznijo tipa 1 (od insulina odvisno sladkorno bolezen), ki nimajo nobenega C-peptida v krvi (označevalca sladkorne bolezni tipa 1).
English: The studies measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c) which gives an indication of how well the blood glucose is controlled.
Slovenian: V študijah so merili vrednost snovi v krvi, imenovane glikirani hemoglobin (HbA1c), ki je pokazatelj stopnje uravnavanja glukoze v krvi.
English: For the full list of all side effects seen with Prandin, see the Package Leaflet.
Slovenian: Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Prandin, glejte navodilo za uporabo.
English: In all studies, Prandin led to a decrease in the level of HbA1c, which showed that blood glucose levels had been controlled to a similar level to that seen with the comparator medicines.
Slovenian: V vseh študijah je zdravilo Prandin povzročilo znižanje vrednosti HbA1c, kar kaže, da so bile koncentracije glukoze v krvi uravnane v podobnem obsegu kot pri primerjalnih zdravilih.
English: Prandin is used in patients who have type 2 diabetes (non-insulin-dependent diabetes).
Slovenian: Zdravilo Prandin se uporablja pri bolnikih s sladkorno boleznijo tipa 2 (sladkorno boleznijo, ki ni odvisna od insulina).
English: It is used together with diet and exercise to lower blood glucose (sugar) levels in patients whose hyperglycaemia (high blood glucose levels) cannot be controlled by diet, weight reduction and exercise.
Slovenian: Uporablja se skupaj z dieto in telesno dejavnostjo za znižanje glukoze (sladkorja) v krvi pri bolnikih, pri katerih hiperglikemije (visoke koncentracije glukoze v krvi) ni mogoče uravnavati z dieto, zmanjšanjem telesne mase in telesno dejavnostjo.
English: Prandin helps the pancreas to produce more insulin at mealtimes and is used to control type 2 diabetes.
Slovenian: Zdravilo Prandin pomaga trebušni slinavki, da tvori več insulina ob obrokih in se uporablja za uravnavanje sladkorne bolezni tipa 2.
English: Prandin can also be used for type 2 diabetes patients whose blood glucose levels are usually controlled well on diet, but are experiencing temporary loss of blood glucose control.
Slovenian: Zdravilo Prandin se lahko uporabi tudi pri bolnikih s sladkorno boleznijo tipa 2, pri katerih so koncentracije glukoze v krvi običajno dobro uravnane z dieto, vendar občasno doživijo izgubo nadzora nad glukozo v krvi.
English: Prandin may also be used with metformin (another anti-diabetes medicine) in type 2 diabetes patients whose blood glucose levels are not satisfactorily controlled on metformin alone.
Slovenian: Zdravilo Prandin se lahko uporablja tudi z metforminom (drugim antidiabetičnim zdravilom) pri bolnikih s sladkorno boleznijo tipa 2, pri katerih koncentracije glukoze v krvi ni mogoče zadovoljivo uravnavati samo z metforminom.
English: Prandin produced a good insulin response to a meal within 30 minutes of being dosed in type 2 diabetes patients, leading to a blood glucose-lowering effect throughout the meal.
Slovenian: Pri bolnikih s sladkorno boleznijo tipa 2 se je v 30 minutah po odmerku zdravila Prandin pojavil dober odziv insulina na obrok, kar je povzročilo znižanje glukoze v krvi v celotnem obdobju obroka.
English: The full EPAR for Prandin is available here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Prandin je na voljo tukaj.
English: How does Prandin work?
Slovenian: Kako zdravilo Prandin deluje?
English: What is Prandin used for?
Slovenian: Za kaj se uporablja zdravilo Prandin?
English: What is Prandin?
Slovenian: Kaj je zdravilo Prandin?
English: How is Prandin used?
Slovenian: Kako se zdravilo Prandin uporablja?
English: How has Prandin been studied?
Slovenian: Kako je bilo zdravilo Prandin raziskano?
English: The full list is available in the Package Leaflet.
Slovenian: Za celoten seznam glejte navodilo za uporabo.
English: This overview was last updated in 06-2019
Slovenian: Pregled je bil nazadnje posodobljen 06-2019.
English: Further information on Miglustat Dipharma can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/miglustat-dipharma.
Slovenian: Nadaljnje informacije o zdravilu Miglustat Dipharma so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/ziextenzo.
English: Miglustat Dipharma received a marketing authorisation valid throughout the EU on 18 February 2019.
Slovenian: Za zdravilo Miglustat Dipharma je bilo 18. februarja 2019 izdano dovoljenje za promet, veljavno po vsej Evropski uniji.
English: These include loss of coordination, problems with ‘saccadic' (rapid) eye movements that can lead to impaired vision, delayed development, difficulty swallowing, decreased muscle tone, fits and learning difficulties.
Slovenian: Med njimi so izguba koordinacije, težave s „sakadnim“ (hitrim) gibanjem oči, ki lahko vodi v motnje vida, zapoznel razvoj, težave pri požiranju, zmanjšan mišični tonus, epileptični napadi in učne težave.
English: The company also carried out a study that showed that it is ‘bioequivalent' to the reference medicine.
Slovenian: Izvedlo je tudi študijo, ki je pokazala, da je zdravilo „bioekvivalentno“ referenčnemu zdravilu.
English: • adults (aged 18 years and above) with mild to moderate type-1 Gaucher disease.
Slovenian: • odraslih (starejših od 18 let) z blago do zmerno obliko Gaucherjeve bolezni tipa-1.
English: What measures are being taken to ensure the safe and effective use of Miglustat Dipharma?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Miglustat Dipharma?
English: Because Miglustat Dipharma is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Miglustat Dipharma generično zdravilo in je bioekvivalentno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: Miglustat Dipharma is used to treat the neurological symptoms of the disease (symptoms affecting the brain and nerves).
Slovenian: Zdravilo Miglustat Dipharma se uporablja za zdravljenje nevroloških simptomov bolezni (simptomov, ki prizadenejo možgane in živce).
English: • patients of all ages with Niemann-Pick type-C disease, a potentially fatal disease in which glycosphingolipids build up within cells in the brain and elsewhere in the body.
Slovenian: • bolnikov vseh starosti z Niemann-Pickovo boleznijo tipa-C, ki je lahko smrtna in pri kateri se glikosfingolipidi kopičijo v celicah v možganih in drugod v telesu.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Miglustat Dipharma has been shown to have comparable quality and to be bioequivalent to Zavesca.
Slovenian: Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Miglustat Dipharma primerljivo raven kakovosti kot referenčno zdravilo Zavesca ter da mu je bioekvivalentno.
English: Side effects reported with Miglustat Dipharma are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Miglustat Dipharma, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: As for every medicine, the company provided studies on the quality of Miglustat Dipharma.
Slovenian: Tako kot za vsako zdravilo, je podjetje predložilo študije o kakovosti zdravila Miglustat Dipharma.
English: Studies on the benefits and risks of the active substance in Gaucher disease have already been carried out with the reference medicine, Zavesca, and do not need to be repeated for Miglustat Dipharma.
Slovenian: Študije o koristih in tveganjih učinkovine pri Gaucherjevi bolezni so že bile izvedene z referenčnim zdravilom Zavesca, zato jih ni treba ponoviti za zdravilo Miglustat Dipharma.
English: This enzyme is involved in the first step of the production of glucosylceramide.
Slovenian: Ta encim sodeluje na prvi stopnji tvorbe glukozilceramida.
English: Miglustat Dipharma is used in patients who cannot receive the standard treatment of enzymereplacement therapy (ERT);
Slovenian: Zdravilo Miglustat Dipharma se uporablja pri bolnikih, ki ne morejo prejemati običajnega encimskega nadomestnega zdravljenja (ERT);
English: An overview of Miglustat Dipharma and why it is authorised in the EU
Slovenian: Pregled zdravila Miglustat Dipharma in zakaj je odobreno v EU
English: As for all medicines, data on the use of Miglustat Dipharma are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Miglustat Dipharma stalno spremljajo.
English: For more information about using Miglustat Dipharma, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij o uporabi zdravila Miglustat Dipharma glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Miglustat Dipharma have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Miglustat Dipharma upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: Miglustat Dipharma is used to treat the following patients:
Slovenian: Zdravilo Miglustat Dipharma se uporablja za zdravljenje naslednjih bolnikov:
English: Miglustat Dipharma is intended for long-term use.
Slovenian: Zdravilo Miglustat Dipharma je namenjeno za dolgotrajno uporabo.
English: Both diseases cause a build-up of fatty substances called glycosphingolipids in the body.
Slovenian: Obe bolezni povzročata kopičenje maščobnih snovi, imenovanih glikosfingolipidi, v telesu.
English: By preventing the enzyme from working, miglustat can reduce the production of glucosylceramide in cells, thereby reducing the symptoms of type-1 Gaucher disease.
Slovenian: Miglustat lahko s preprečevanjem delovanja encima zmanjša tvorbo glukozilceramida v celicah in s tem zmanjša simptome Gaucherjeve bolezni tipa-1.
English: What are the benefits and risks of Miglustat Dipharma?
Slovenian: Kakšne so koristi in tveganja zdravila Miglustat Dipharma?
English: This means that Miglustat Dipharma contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Zavesca.
Slovenian: To pomeni, da vsebuje enako učinkovino in deluje na enak način kot „referenčno zdravilo“, ki je že odobreno v EU in se imenuje Zavesca.
English: What is Miglustat Dipharma and what is it used for?
Slovenian: Kaj je zdravilo Miglustat Dipharma in za kaj se uporablja?
English: Patients with this disease lack an enzyme called glucocerebrosidase, which results in a glycosphingolipid called glucosylceramide building up in different parts of the body, such as the spleen, liver and bones.
Slovenian: Bolnikom s to boleznijo primanjkuje encima, imenovanega glukocerebrozidaza, zaradi česar se glikosfingolipid, imenovan glukozilceramid, kopiči v različnih delih telesa, kot so vranica, jetra in kosti.
English: Miglustat Dipharma is available as 100 mg capsules to be taken by mouth.
Slovenian: Zdravilo Miglustat Dipharma je na voljo v obliki 100-miligramskih kapsul, ki se jemljejo peroralno.
English: Why is Miglustat Dipharma authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Miglustat Dipharma odobreno v EU?
English: Miglustat Dipharma is a ‘generic medicine'.
Slovenian: Zdravilo Miglustat Dipharma je „generično zdravilo“.
English: For Niemann-Pick type-C disease, it is two capsules three times a day for patients aged 12 years and over; in younger patients, the dose depends on their weight and height.
Slovenian: Priporočeni začetni odmerek za Gaucherjevo bolezen tipa-1 je ena kapsula trikrat na dan. Priporočeni začetni odmerek za Niemann-Pickovo boleznijo tipa-C sta dve kapsuli trikrat na dan za bolnike, starejše od 12 let; odmerek pri mlajših bolnikih je odvisen od njihove telesne mase in višine.
English: Other information about Miglustat Dipharma
Slovenian: Druge informacije o zdravilu Miglustat Dipharma
English: The medicine can only be obtained with a prescription and treatment should be supervised by doctors who are experienced in the management of Gaucher disease.
Slovenian: Predpisovanje in izdaja zdravila Miglustat Dipharma je le na recept, zdravljenje z njim pa mora nadzorovati zdravnik, ki ima izkušnje z zdravljenjem bolnikov z Gaucherjevo boleznijo.
English: Miglustat Dipharma is used to treat two inherited diseases that affect the way the body handles fats.
Slovenian: Zdravilo Miglustat Dipharma se uporablja za zdravljenje dveh dednih bolezni, ki vplivata na način presnove maščob v telesu.
English: The active substance in Miglustat Dipharma, miglustat, blocks an enzyme called glucosylceramide synthase.
Slovenian: Učinkovina zdravila Miglustat Dipharma, miglustat, preprečuje delovanje encima, imenovanega glukozilceramidsintaza.
English: Therefore, the Agency's view was that, as for Zavesca, the benefit of Miglustat Dipharma outweighs the identified risk and it can be authorised for use in the EU.
Slovenian: Zato je menila, da koristi zdravila Miglustat Dipharma enako kot pri zdravilu Zavesca odtehtajo znana tveganja in da se zdravilo lahko odobri v EU.
English: How does Miglustat Dipharma work?
Slovenian: Kako zdravilo Miglustat Dipharma deluje?
English: How has Miglustat Dipharma been studied?
Slovenian: Kako je bilo zdravilo Miglustat Dipharma raziskano?
English: How is Miglustat Dipharma used?
Slovenian: Kako se zdravilo Miglustat Dipharma uporablja?
English: [the below currently approved indications should be deleted (specific wording of the indication may vary from product to product)]
Slovenian: [spodaj navedene trenutno odobrene indikacije je treba izbrisati (natančna navedba indikacije se lahko od zdravila do zdravila razlikuje)]
English: • Symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia)
Slovenian: • Simptomatsko zdravljenje kronične patološke kognitivne in nevrosenzorične okvare pri starejših (izključujoč Alzheimerjevo bolezen in druge oblike demence)
English: • Prophylaxis of migraine headache All references to the above mentioned indications should be deleted from the remaining relevant sections of the summaries of product characteristics.
Slovenian: • Preprečevanje migrenskega glavobola Vse sklice na zgoraj navedene indikacije je treba izbrisati iz preostalih ustreznih poglavij povzetkov glavnih značilnosti zdravila.
English: A. Summary of Product Characteristics
Slovenian: A. Povzetek glavnih značilnosti zdravila
English: All references to the above mentioned indications should be deleted from the relevant sections of the package leaflets.
Slovenian: Vse sklice na zgoraj navedene indikacije je treba izbrisati iz ustreznih poglavij navodil za uporabo.
English: • Ancillary treatment of intermittent claudication in symptomatic peripheral arterial occlusive disease (PAOD Stage II)
Slovenian: • Pomožno zdravljenje intermitentne klavdikacije pri simptomatski periferni arterijski okluzivni bolezni (PAOD stadij II)
English: • Acute retinopathies of vascular origin
Slovenian: • Akutne retinopatije žilnega izvora
English: • Ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin
Slovenian: • Pomožno zdravljenje zmanjšane ostrine vida in motenj vidnega polja, za katere se domneva, da so žilnega izvora
English: Annex III Amendments to relevant sections of the summaries of product characteristics and package leaflets
Slovenian: Popravki ustreznih poglavij povzetkov glavnih značilnosti zdravila in navodil za uporabo
English: • Ancillary treatment of Raynaud's syndrome
Slovenian: • Pomožno zdravljenje Raynaudovega sindroma
English: B. Package Leaflet
Slovenian: Priloga III
English: The PRAC therefore revised the indication accordingly.
Slovenian: PRAC je v skladu s to ugotovitvijo ustrezno spremenil indikacijo.
English: This was reflected in the product information in order to adequately inform healthcare providers and patients.
Slovenian: Ta sprememba je bila vključena v informacije o zdravilu, da bodo zdravstveni delavci in bolniki z njo ustrezno seznanjeni.
English: PRAC recommendation
Slovenian: Priporočilo odbora PRAC
English: The PRAC considered that the clinical development data on acipimox was very limited and noted that no clinical outcome studies were conducted.
Slovenian: PRAC je menil, da so podatki o acipimoksu iz kliničnega razvoja zelo omejeni, in ugotovil, da niso bile opravljene nobene študije o kliničnem izidu.
English: Nevertheless, the PRAC considered that the efficacy of acipimox in lowering blood lipids in patients with some forms of hyperlipoproteinaemia is demonstrated.
Slovenian: Kljub temu pa je menil, da je bila učinkovitost acipimoksa pri zniževanju ravni lipidov v krvi pri bolnikih z določenimi oblikami hiperlipoproteinemije dokazana.
English: As a result of the review, the PRAC recommended the suspension of the marketing authorisations of these products.
Slovenian: Na podlagi pregleda je PRAC priporočil začasni umik dovoljenj za promet s temi zdravili.
English: The PRAC also noted that according to the experts, the current data available did not have any major impact on the safety profile of acipimox.
Slovenian: Prav tako je PRAC upošteval, da po mnenju izvedencev trenutno razpoložljivi podatki ne vplivajo bistveno na varnostni profil acipimoksa.
English: The safety data available for acipimox, including data on nicotinic acid obtained from HPS2-THRIVE, showed that the safety profile of acipimox is well characterised.
Slovenian: Podatki o varnosti, ki so na voljo za acipimoks, vključno s podatki o nikotinski kislini, pridobljenimi v študiji HPS2-THRIVE, kažejo, da je varnostni profil acipimoksa dobro opredeljen.
English: Following the conclusion of these procedures, the PRAC was of the view that the concerns regarding the combination products may also be of relevance for the mono-component products and the Danish Health and Medicines Authority therefore initiated a review under Article 31 of Directive 2001/83/EC to assess the impact of the HPS2-THRIVE data on the benefitrisk balance of these products and to give its recommendation on whether their marketing authorisations should be maintained, varied, suspended or revoked and if the supply of the medicinal product should be prohibited.
Slovenian: Po zaključku teh postopkov je PRAC menil, da bi lahko varnostni pomisleki v zvezi s kombiniranimi zdravili veljali tudi za enokomponentna zdravila, zaradi česar je danski organ, pristojen za zdravstvo in zdravila, sprožil pregled v skladu s členom 31 Direktive 2001/83/ES, da bi ocenili, kako podatki iz študije HPS2-THRIVE vplivajo na razmerje med tveganji in koristmi teh zdravil, in da bi podali priporočilo o tem, ali naj se njihova dovoljenja za promet ohranijo, spremenijo, začasno umaknejo ali prekličejo in ali naj se prepove oskrba s temi zdravili.
English: Having considered the matter, the PRAC therefore recommended the variation of the marketing authorisations for acipimox-containing medicinal products.
Slovenian: Potem ko je PRAC preučil zadevo, je priporočil spremembo dovoljenj za promet z zdravili, ki vsebujejo acipimoks.
English: On 19 December 2012, the European Medicines Agency was made aware of preliminary results from a large randomised clinical study (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events - HPS2-THRIVE) designed to assess the incremental benefit of extended release nicotinic acid (ERN)/laropiprant (LRPT) versus placebo in over 25,673 high-risk patients.
Slovenian: Evropska agencija za zdravila je bila dne 19. decembra 2012 seznanjena s predhodnimi rezultati obsežne randomizirane klinične študije (Študija zaščite srca 2 - zdravljenje HDL za zmanjšanje pojavnosti vaskularnih dogodkov - HPS2-THRIVE), ki je bila zasnovana za oceno dodatnih koristi nikotinske kisline s podaljšanim sproščanjem (ERN)/laropipranta (LRPT) v primerjavi s placebom pri več kot 25 673 bolnikih z visokim tveganjem.
English: • The PRAC considered that the available safety data identified a potential risk of muscle toxicity, for which a warning was added to the product information.
Slovenian: • PRAC je menil, da so razpoložljivi podatki o varnosti razkrili možno tveganje za toksične učinke na mišice, zaradi česar so v informacije o zdravilu dodali opozorilo.
English: Most identified adverse events are already reflected in the acipimox product information and the PRAC considered that the available data did not identify any new safety information which impacts the benefit-risk balance of acipimox, with the exception of a potential risk of muscle toxicity, which was addressed by adding a warning to the product information.
Slovenian: Večina znanih neželenih dogodkov je že obravnavana v informacijah o zdravilu za acipimoks, poleg tega pa je PRAC menil, da razpoložljivi podatki niso razkrili nobenih novih varnostnih informacij, ki bi vplivale na razmerje med tveganji in koristmi acipimoksa, z izjemo možnega tveganja za toksične učinke na mišice, v zvezi s katerim so v informacije o zdravilu vključili opozorilo.
English: A review of all available data was undertaken by the Pharmacovigilance Risk Assessment Committee (PRAC) to assess the above safety concerns and their impact on the benefit-risk balance of the centrally authorised combination products Tredaptive, Trevaclyn and Pelzont.
Slovenian: Odbor za oceno tveganja na področju farmakovigilance (PRAC) je pregledal vse razpoložljive podatke, da bi ocenil zgoraj omenjene pomisleke glede varnosti in njihov vpliv na razmerje med tveganji in koristmi kombiniranih zdravil Tredaptive, Trevaclyn in Pelzont, ki so bila odobrena po centraliziranem postopku.
English: The PRAC also agreed that acipimox should not be indicated for increasing HDL-C or for cardiovascular prevention in line with the recent data casting doubts on the association between elevating HDL-C levels and reducing the risk of cardiovascular disease.
Slovenian: PRAC se je tudi strinjal, da acipimoks ne sme biti indiciran za zviševanje ravni holesterola HDL ali za preprečevanje srčnožilnih bolezni, saj najnovejši podatki vzbujajo dvome o povezavi med višjimi ravnmi holesterola HDL in manjšim tveganjem za srčno-žilne bolezni.