FrancophonIA/ELRC3.0 huggingface dataset:
English: Opioid-naïve patients because of the risk of life-threatening respiratory depression.
Slovenian: Uporaba Rapinyla je zaradi tveganja življenjsko nevarne depresije dihanja kontraindicirana pri bolnikih, ki še niso prejemali opioidov.
English: Rapinyl 400 microgram sublingual tablets
Slovenian: Rapinyl 400 mikrogramske podjezične tablete
English: 50 microgram sublingual tablet is a white pentagon-shaped tablet 100 microgram sublingual tablet is a white round tablet 200 microgram sublingual tablet is a white oval-shaped tablet 300 microgram sublingual tablet is a white triangle-shaped tablet 400 microgram sublingual tablet is a white diamond-shaped tablet 600 microgram sublingual tablet is a white “D”-shaped tablet 800 microgram sublingual tablet is a white capsule-shaped tablet
Slovenian: 600 mikrogramska podjezična tableta je bela tableta v obliki črke D. 800 mikrogramska podjezična tableta je bela tableta v obliki kapsule.
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Slovenian: Sklep o seznamu vprašanj
English: EU (MA) Number
Slovenian: Številka (EU) dovoljenja za promet z zdravilom
English: Netherlands Sanofi-Aventis Netherlands B.V.
Slovenian: Nizozemska Sanofi-Aventis Netherlands B.V.
English: Annex I List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, Marketing Authorisation Holders in the Member States
Slovenian: Priloga I Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila,
English: Five main studies were carried out.
Slovenian: Opravljenih je bilo pet glavnih študij.
English: Further information on Imvanex can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/imvanex.
Slovenian: Nadaljnje informacije za zdravilo Imvanex so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/imvanex.
English: It is not yet known how long the protection will last.
Slovenian: Ni pa znano, kako dolgo zaščita traja.
English: Smallpox was officially declared eradicated in 1980 with the last known case of the disease occurring in 1977.
Slovenian: Črne koze so bile leta 1980 uradno razglašene za izkoreninjeno bolezen, zadnji znani primer bolezni pa je iz leta 1977.
English: This vaccine will be used when it is considered necessary to protect against smallpox in accordance with official recommendations.
Slovenian: To cepivo se bo uporabljalo, ko se bo ocenilo, da je potrebna zaščita pred črnimi kozami v skladu z uradnimi priporočili.
English: Imvanex (live modified vaccinia ankara virus)
Slovenian: Imvanex (živ modificiran virus vakcinija Ankara)
English: Vaccines work by ‘teaching' the immune system how to defend itself against a disease.
Slovenian: Cepiva delujejo tako, da imunski sistem „naučijo“, kako naj se brani pred boleznijo.
English: The most common side effects with Imvanex (which may affect more than 1 in 10 people) are headache, nausea, myalgia (muscle pain), tiredness and injection site reactions (pain, redness, swelling, hardening and itching).
Slovenian: Najpogostejši neželeni učinki zdravila Imvanex (ki se lahko pojavijo pri več kot 1 od 10 oseb) so glavobol, siljenje na bruhanje, mialgija (bolečine v mišicah), utrujenost in reakcije na mestu injiciranja (bolečina, rdečina, oteklina, zatrdlina in srbečica).
English: When the person comes into contact again with this or a similar virus, these antibodies together with other components of the immune system will be able to kill the viruses and help protect against the disease.
Slovenian: Ko je oseba ponovno izpostavljena temu ali podobnemu virusu, ta protitelesa skupaj z drugimi mehanizmi imunskega sistema uničijo virus in pripomorejo k zaščiti pred boleznijo.
English: What measures are being taken to ensure the safe and effective use of Imvanex?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Imvanex?
English: Imvanex received a marketing authorisation valid throughout the EU on 31 July 2013.
Slovenian: Za zdravilo Imvanex je bilo 31. julija 2013 izdano dovoljenje za promet, veljavno po vsej EU.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Imvanex 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 Imvanex upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Since Imvanex has been authorised under exceptional circumstances, the company that markets Imvanex will provide data on the vaccine's benefits and risks from observational studies in patients who are given the vaccine, and if ever there is an outbreak of the disease in the future.
Slovenian: Ker je zdravilo Imvanex pridobilo dovoljenje za promet v izjemnih okoliščinah, bo podjetje, ki ga trži, zagotovilo podatke o koristih in tveganjih cepiva, pridobljene z opazovalnimi študijami pri bolnikih, ki so prejeli cepivo, in ob morebitnem izbruhu bolezni v prihodnosti.
English: As for all medicines, data on the use of Imvanex are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Imvanex stalno spremljajo.
English: The studies involved over 2,000 adults, including patients with HIV and atopic dermatitis (an itchy skin condition caused by an overactive immune system) and people who had been vaccinated against smallpox in the past.
Slovenian: V teh študijah je sodelovalo več kot 2 000 odraslih, med katerimi so bili bolniki z virusom HIV in atopijskim dermatitisom (srbečimi kožnimi izpuščaji zaradi čezmerno dejavnega imunskega sistema) ter posamezniki, ki so v preteklosti že bili cepljeni proti črnim kozam.
English: Imvanex has been authorised under ‘exceptional circumstances'.
Slovenian: Zdravilo Imvanex je pridobilo dovoljenje za promet v „izjemnih okoliščinah“.
English: For more information about using Imvanex, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Imvanex glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: An overview of Imvanex and why it is authorised in the EU
Slovenian: Pregled zdravila Imvanex in zakaj je odobreno v EU
English: When a person is given the vaccine, the immune system recognises the virus in the vaccine as ‘foreign' and makes antibodies against it.
Slovenian: Ko oseba prejme cepivo, imunski sistem prepozna virus v cepivu kot „tujek“ in začne proti njemu tvoriti protitelesa.
English: Imvanex must not be used in patients who are hypersensitive (allergic) to the active substance or any of the substances found at trace levels, such as chicken protein, benzonase and gentamicin.
Slovenian: Zdravilo Imvanex se ne sme uporabljati pri bolnikih, ki so preobčutljivi za (alergični na) učinkovino ali katero koli drugo sestavino, ki je prisotna v sledeh, na primer na piščančje beljakovine, benzonazo in gentamicin.
English: Other information about Imvanex
Slovenian: Druge informacije o zdravilu Imvanex
English: Side effects reported with Imvanex are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Imvanex, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Imvanex would therefore be beneficial for people who cannot be given vaccines containing replicating viruses, such as patients with a weakened immune system.
Slovenian: Zdravilo Imvanex bi bilo zato koristno za osebe, pri katerih se ne smejo uporabiti cepiva z virusi, ki se podvajajo, na primer za bolnike z oslabljenim imunskim sistemom.
English: Vaccines containing vaccinia viruses were effective in the campaign to eradicate smallpox.
Slovenian: Cepiva, ki vsebujejo viruse vakcinija, so bila učinkovita v okviru prizadevanj za izkoreninjenje črnih koz.
English: A subsequent study in 433 people who had not been vaccinated before found that the level of protective antibodies after vaccination with Imvanex was at least as high as with a conventional smallpox vaccine.
Slovenian: Naknadna študija pri 433 ljudeh, ki pred tem niso bili cepljeni, je pokazala, da je bila po cepljenju z zdravilom Imvanex koncentracija zaščitnih protiteles vsaj tako visoka kot pri običajnem cepivu proti črnim kozam.
English: Why is Imvanex authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Imvanex odobreno v EU?
English: What is Imvanex and what is it used for?
Slovenian: Kaj je zdravilo Imvanex in za kaj se uporablja?
English: What benefits of Imvanex have been shown in studies?
Slovenian: Kakšne koristi zdravila Imvanex so se pokazale v študijah?
English: It contains a live modified form of the vaccinia virus called ‘vaccinia Ankara', which is related to the smallpox virus.
Slovenian: Vsebuje živo modificirano obliko virusa vakcinija, ki se imenuje „vakcinija Ankara“ in je soroden virusu črnih koz.
English: Two of the studies specifically looked at the effectiveness of Imvanex as a booster.
Slovenian: V dveh študijah so se osredotočili predvsem na učinkovitost zdravila Imvanex kot poživitvenega cepljenja.
English: Imvanex contains a modified form of the vaccinia virus called vaccinia Ankara, which does not cause disease in humans and cannot replicate (reproduce) in human cells.
Slovenian: Zdravilo Imvanex vsebuje modificirano obliko virusa vakcinija, imenovanega vakcinija Ankara, ki ne povzroča bolezni pri ljudeh in se v človeških celicah ne more podvajati.
English: The vaccinia virus in Imvanex cannot replicate in human cells and hence is less likely to cause side effects than conventional smallpox vaccines.
Slovenian: Virus vakcinija v zdravilu Imvanex se v človeških celicah ne more podvajati, zato je manj možnosti za neželene učinke kot pri običajnih cepivih proti črnim kozam.
English: If a booster dose is necessary for those who have been vaccinated against smallpox in the past, a single 0.5 ml dose should be given except for patients with a weakened immune system (the body's natural defences) who should receive two booster doses, with the second dose given at least 28 days after the first.
Slovenian: Če je pri posameznikih, ki so v preteklosti že bili cepljeni proti črnim kozam, potreben poživitveni odmerek, je treba dati en 0,5-mililitrski odmerek oziroma dva poživitvena odmerka, kadar gre za bolnike z oslabljenim imunskim sistemom (naravnim obrambnim mehanizmom telesa), pri čemer je drugi odmerek treba dati najmanj 28 dni po prvem.
English: What are the risks associated with Imvanex?
Slovenian: Kakšna tveganja so povezana z zdravilom Imvanex?
English: Imvanex is a vaccine used to protect against smallpox in adults.
Slovenian: Zdravilo Imvanex je cepivo, ki se uporablja za zaščito odraslih pred črnimi kozami.
English: What information is still awaited for Imvanex?
Slovenian: Katere informacije o zdravilu Imvanex še pričakujemo?
English: The European Medicines Agency considered that Imvanex is effective at triggering the production of antibodies against smallpox to a level that provides protection at least as high as that from conventional smallpox vaccines.
Slovenian: Evropska agencija za zdravila je menila, da zdravilo Imvanex učinkovito sproži tvorjenje protiteles proti črnim kozam in da je njihova koncentracija dovolj visoka, da zagotavlja vsaj tolikšno zaščito kot običajna cepiva proti črnim kozam.
English: Imvanex was shown in studies to be effective at triggering the production of antibodies to a level expected to provide protection against smallpox.
Slovenian: Študije so pokazale, da zdravilo Imvanex učinkovito sproži tvorjenje protiteles v koncentracijah, ki naj bi zagotavljale zaščito pred črnimi kozami.
English: How does Imvanex work?
Slovenian: Kako zdravilo Imvanex deluje?
English: Because of its similarity to the smallpox virus, antibodies produced against this virus are also expected to protect against smallpox.
Slovenian: Ker je podoben virusu črnih koz, naj bi protitelesa, ki se tvorijo proti virusu vakcinija Ankara, ščitila tudi pred virusom črnih koz.
English: This is because it has not been possible to obtain complete information about Imvanex due to the rarity of the disease.
Slovenian: To pomeni, da zaradi redkosti bolezni ni bilo mogoče pridobiti vseh podatkov o zdravilu.
English: Imvanex is given by injection under the skin, preferably in the upper arm. People who have not been previously vaccinated against smallpox should receive two 0.5 ml doses, with the second dose given at least 28 days after the first.
Slovenian: Posamezniki, ki še niso bili cepljeni proti črnim kozam, morajo prejeti dva odmerka po 0,5 ml, pri čemer je drugi odmerek treba dati najmanj 28 dni po prvem.
English: How is Imvanex used?
Slovenian: Kako se zdravilo Imvanex uporablja?
English: • Bioequivalence vis-à-vis an EU reference medicinal product has been demonstrated, based on relevant data, in accordance with the requirements of Article 10 of Directive 2001/83/EC (e.g. a bioequivalence study conducted vis-à-vis the EU reference medicinal product).
Slovenian: • Biološka enakovrednost z referenčnim zdravilom, odobrenim v EU, je bila dokazana z ustreznimi podatki v skladu z zahtevami člena 10 Direktive 2001/83/ES (npr. primerjalne študije biološke enakovrednosti z referenčnim zdravilom, odobrenim v EU).
English: For the suspension of the marketing authorisations referred to in annex IB to be lifted, the competent authorities of the EU Member States shall ensure that the below condition has been completed by the marketing authorisation holder(s)
Slovenian: Za preklic začasnega umika dovoljenj za promet z zdravilom, navedenih v Prilogi IB, morajo pristojni organi držav članic Evropske unije zagotoviti, da je/so imetnik(-i) dovoljenj(a) za promet z zdravilom izpolnil(-i) naslednji pogoj:
English: Annex III Condition for lifting the suspension of the marketing authorisations
Slovenian: Priloga III
English: It is available as tablets (15, 30 and 45 mg).
Slovenian: Na voljo je v obliki tablet (15, 30 in 45 mg).
English: The tablets should be swallowed with water.
Slovenian: Tablete je treba pogoltniti z vodo.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Sepioglin on 9 March 2012.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Sepioglin, veljavno po vsej Evropski uniji, odobrila dne 9. marca 2012.
English: The full EPAR for Sepioglin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Sepioglin je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What are the benefits and risks of Sepioglin?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Sepioglin?
English: Treatment with Sepioglin should be reviewed after three to six months, and discontinued in patients who are not deriving sufficient benefit.
Slovenian: Zdravljenje z zdravilom Sepioglin je treba ponovno oceniti po treh do šest mesecih in ga pri bolnikih, ki od njega nimajo zadostne koristi, prekiniti.
English: This means that Sepioglin is similar to a ‘reference medicine' already authorised in the European Union (EU) called Actos.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Actos.
English: EPAR summary for the public pioglitazone
Slovenian: Povzetek EPAR za javnost pioglitazon
English: For more information about treatment with Sepioglin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Sepioglin preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: This is a summary of the European public assessment report (EPAR) for Sepioglin.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Sepioglin.
English: The active substance in Sepioglin, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Slovenian: Zdravilna učinkovina zdravila Sepioglin, pioglitazon, poveča občutljivost celic (maščevja, mišic in jeter) za insulin, kar pomeni, da telo bolje izrablja insulin, ki ga proizvaja.
English: It is used in addition to diet and exercise.
Slovenian: Uporablja se kot dodatek k ustrezni prehrani in telesni vadbi.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Sepioglin.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Sepioglin, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The Committee recommended that Sepioglin be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Sepioglin odobri dovoljenje za promet.
English: Because Sepioglin 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 Sepioglin generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
English: The CHMP concluded that, in accordance with EU requirements, Sepioglin has been shown to have comparable quality and to be bioequivalent to Actos.
Slovenian: CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Sepioglin primerljivo raven kakovosti kot zdravilo Actos ter da mu je biološko enakovredno.
English: Sepioglin is used to treat type 2 diabetes in adults (aged 18 years or over), particularly those who are overweight.
Slovenian: Zdravilo Sepioglin se uporablja za zdravljenje sladkorne bolezni tipa 2 pri odraslih (starejših od 18 let), zlasti tistih s prekomerno telesno maso.
English: Sepioglin is a ‘generic medicine'.
Slovenian: Zdravilo Sepioglin je „generično zdravilo“.
English: This dose may need to be increased after one or two weeks to up to 45 mg once a day if better blood glucose (sugar) control is needed.
Slovenian: Priporočeni začetni odmerek zdravila Sepioglin je 15 ali 30 mg enkrat na dan. Odmerek bo po enem ali dveh tednih morda treba povečati do 45 mg enkrat na dan, če je potreben boljši nadzor glukoze (sladkorja) v krvi.
English: Sepioglin is a medicine that contains the active substance pioglitazone.
Slovenian: Sepioglin je zdravilo, ki vsebuje zdravilno učinkovino pioglitazon.
English: Because Sepioglin is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Actos.
Slovenian: Ker je zdravilo Sepioglin generično zdravilo, so bile študije pri bolnikih omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Actos.
English: Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Slovenian: Sladkorna bolezen tipa 2 je bolezen, pri kateri trebušna slinavka ne tvori dovolj insulina za vzdrževanje primerne ravni glukoze v krvi ali pri kateri ga telo ne more učinkovito izrabljati.
English: Other information about Sepioglin
Slovenian: Druge informacije o zdravilu Sepioglin:
English: Therefore, the CHMP's view was that, as for Actos, the benefit outweighs the identified risk.
Slovenian: Zato je CHMP menil, da njegove koristi, tako kot pri zdravilu Actos, odtehtajo znana tveganja.
English: Sepioglin should not be used in patients on dialysis (a blood clearance technique used in people with kidney disease).
Slovenian: Zdravilo Sepioglin se ne sme uporabljati pri bolnikih na dializi (tehniki čiščenja krvi, uporabljeni pri bolnikih z obolenjem ledvic).
English: Why has Sepioglin been approved?
Slovenian: Zakaj je bilo zdravilo Sepioglin odobreno?
English: At subsequent reviews prescribers should confirm that benefits to patients are maintained.
Slovenian: Pri vseh nadaljnjih pregledih morajo zdravniki, ki zdravilo predpisujejo, preveriti, ali zdravilo še vedno zagotavlja enake koristi.
English: Sepioglin can also be used together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin.
Slovenian: Zdravilo se lahko uporablja tudi skupaj z insulinom pri bolnikih, pri katerih bolezen ni zadostno nadzorovana zgolj z insulinom in za katere metformin ni primeren.
English: Sepioglin is used on its own in patients for whom metformin (another antidiabetes medicine) is not suitable.
Slovenian: Zdravilo Sepioglin se uporablja kot samostojno zdravilo pri bolnikih, za katere metformin (drugo zdravilo proti sladkorni bolezni) ni primerno.
English: Sepioglin can also be used in combination with metformin in patients who are not satisfactorily controlled on metformin alone, or with a sulphonylurea (another type of antidiabetes medicine) when metformin is not suitable (‘dual therapy').
Slovenian: Lahko se uporablja tudi v kombinaciji z metforminom pri bolnikih, pri katerih zgolj z metforminom ni mogoče doseči zadovoljivega nadzora, ali v kombinaciji s sulfonilsečnino (drugo vrsto zdravila proti sladkorni bolezni), če metformin ni primeren (zdravljenje z dvema zdraviloma).
English: Sepioglin can also be used together with both metformin and a sulphonylurea in patients who are not satisfactorily controlled despite dual therapy by mouth (‘triple therapy').
Slovenian: Zdravilo Sepioglin se lahko uporablja tudi skupaj z metforminom in sulfonilsečnino hkrati pri bolnikih, pri katerih nadzor ni zadosten kljub dvojnemu peroralnemu zdravljenju (zdravljenje s tremi zdravili).
English: How has Sepioglin been studied?
Slovenian: Kako je bilo zdravilo Sepioglin raziskano?
English: What is Sepioglin used for?
Slovenian: Za kaj se zdravilo Sepioglin uporablja?
English: What is Sepioglin?
Slovenian: Kaj je zdravilo Sepioglin?
English: How does Sepioglin work?
Slovenian: Kako zdravilo Sepioglin deluje?
English: How is Sepioglin used?
Slovenian: Kako se zdravilo Sepioglin uporablja?
English: (Invented) name Strength Pharmaceutical Form Route of Administration
Slovenian: Številka EU Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina vsebina velikost pakiranja
English: 10 µg + 20 µg
Slovenian: 10 mcg + 20 mcg Raztopina za injiciranje
English: 1 pre-filled pen + 1 pre-filled pen
Slovenian: 1 napolnjen injekcijski peresnik + 1 napolnjen injekcijski peresnik
English: Solution for injection
Slovenian: 2 napolnjena injekcijska peresnika
English: This summary was last updated in 09-2015.
Slovenian: Povzetek je bil nazadnje posodobljen 09-2015.
English: nonacog alfa
Slovenian: nonakog alfa
English: The European Commission granted a marketing authorisation valid throughout the European Union for BeneFIX on 27 August 1997.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom BeneFIX, veljavno po vsej Evropski uniji, izdala 27. avgusta 1997.
English: The full EPAR for BeneFIX can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo BeneFIX je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What measures are being taken to ensure the safe and effective use of BeneFIX?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila BeneFIX?