FrancophonIA/ELRC3.0 huggingface dataset:
English: Entacapone blocks an enzyme that is involved in the break down of levodopa in the body called catechol-O-methyl transferase (COMT).
Slovenian: Entakapon blokira encim, imenovan katehol-O-metiltransferaza (COMT), ki sodeluje pri razgradnji levodope v telesu.
English: Comtan should not be used together with other medicines that belong to the group ‘monoamine oxidase inhibitors' (a type of antidepressant).
Slovenian: Zdravilo Comtan se ne sme jemati hkrati z drugimi zdravili, ki spadajo v skupino zaviralcev monoaminooksidaze (vrste antidepresivov).
English: The full EPAR for Comtan is available here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) z zdravilo Comtan je na voljo tukaj.
English: Comtan can only be used with conventional combinations of levodopa.
Slovenian: Zdravilo Comtan se lahko uporablja le s standardnimi kombinacijami levodope.
English: Comtan is used when these fluctuations cannot be treated with the standard levodopacontaining combination alone.
Slovenian: Zdravilo Comtan se uporablja, kadar nihanj ne moremo zdraviti samo s standardno kombinacijo, ki vsebuje levodopo.
English: Comtan is used together with levodopa (either a combination of levodopa and benserazide or a combination of levodopa and carbidopa) when the patient is having ‘fluctuations' towards the end of the period between two doses of their medication.
Slovenian: Zdravilo Comtan se uporablja skupaj z levodopo (bodisi v kombinaciji z levodopo in benserazidom ali kombinaciji z levodopo in karbidopo), kadar bolnik doživlja „nihanja“ proti koncu obdobja med dvema odmerkoma zdravil.
English: Comtan is only used in combination either with levodopa and benserazide or with levodopa and carbidopa.
Slovenian: Zdravilo Comtan se uporablja samo v kombinaciji z levodopo in benserazidom oziroma levodopo in karbidopo.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Comtan's benefits are greater than its risks as an adjunct to standard preparations of levodopa/benserazide or levodopa/carbidopa for use in patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Comtan kot dodatka k standardnima kombinacijama levodope/benserazida oziroma levodope/karbidope za zdravljenje bolnikov s Parkinsonovo boleznijo in motoričnimi nihanji ob koncu delovanja odmerka, ki jih ne moremo stabilizirati z navedenimi kombinacijami, večje od z njim povezanih tveganj.
English: What is Comtan used for?
Slovenian: Za kaj se zdravilo Comtan uporablja?
English: How does Comtan work?
Slovenian: Kako zdravilo Comtan deluje?
English: What is Comtan?
Slovenian: Kaj je zdravilo Comtan?
English: How has Comtan been studied?
Slovenian: Kako je bilo zdravilo Comtan raziskano?
English: How is Comtan used?
Slovenian: Kako se zdravilo Comtan uporablja?
English: * Antigenic mass ELISA units.
Slovenian: * ELISA enote mase antigena
English: - L. interrogans serogroup Canicola serovar Portland-vere (strain Ca-12-000)
Slovenian: --1 - serološka skupina L. interrogans serovar Canicola Portland-vere (sev Ca-12-000)
English: - L. kirschneri serogroup Grippotyphosa serovar Dadas (strain Gr-01-005)
Slovenian: - serološka skupina L. interrogans Grippotyphosa serovar Dadas (sev Gr-01-005)
English: EMEA Number
Slovenian: EMEA številka Izmišljeno ime Jakost
English: Not applicable
Slovenian: Ovojnina
English: List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, applicant in the Member States
Slovenian: Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila,
English: United Kingdom TEVA Pharma B.V. Computerweg 10,
Slovenian: Velika Britanija TEVA Pharma B.V.
English: Belgium TEVA Pharma B.V. Computerweg 10,
Slovenian: Computerweg 10,
English: Ocular use vial (glass)
Slovenian: Okularna uporaba viala (steklena)
English: The improvement in patients' vision was maintained for at least three years.
Slovenian: Izboljšanje vida bolnikov se je ohranilo vsaj tri leta.
English: Luxturna (voretigene neparvovec)
Slovenian: Luxturna (voretigen neparvovek)
English: An information package for patients and their carers will also be provided.
Slovenian: Na voljo bo tudi informacijsko gradivo za bolnike in njihove negovalce.
English: The type of virus used in this medicine (adeno-associated virus) does not cause disease in humans.
Slovenian: Vrsta virusa, uporabljenega v tem zdravilu (adeno-povezan virus), ne povzroča bolezni pri ljudeh.
English: Patients were considered to have passed the test if they completed the route within 3 minutes and bumped into no more than 3 obstacles.
Slovenian: Bolniki so preskus opravili, če so pot končali v treh minutah in se niso zaleteli v več kot tri ovire.
English: What measures are being taken to ensure the safe and effective use of Luxturna?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Luxturna?
English: Luxturna will only be available from centres where the educational programme is in place.
Slovenian: Zdravilo Luxturna bo na voljo samo v centrih, kjer se izvaja izobraževalni program.
English: This was considered an important clinical benefit, taking into account the lack of authorised treatments for this progressive, degenerative condition.
Slovenian: To je bilo ocenjeno kot pomembna klinična korist, pri čemer se je upoštevalo pomanjkanje odobrenih zdravljenj za to napredujoče degenerativno stanje.
English: Therefore, the European Medicines Agency decided that Luxturna's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Luxturna večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: In addition, the company will have to follow-up all patients who received Luxturna in the main studies for 15 years, in order to characterise the long-term effectiveness and safety of the medicine, and establish a registry to collect long-term safety data in patients treated with Luxturna.
Slovenian: Poleg tega bo morala družba spremljati vse bolnike, ki so v glavnih študijah prejemali zdravilo Luxturna 15 let, da bi opredelila dolgoročno učinkovitost in varnost zdravila ter vzpostavila register za zbiranje dolgoročnih podatkov o varnosti pri bolnikih, ki so bili zdravljeni z zdravilom Luxturna.
English: Further information on the orphan designations can be found on the European Medicines Agency's website ema.europa.eu/medicines/human/orphandesignations.
Slovenian: Nadaljnje informacije glede določitve zdravila sirote lahko najdete na spletni strani Evropske agencije za zdravila ema.europa.eu/medicines/human/orphan-designations.
English: As for all medicines, data on the use of Luxturna are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Luxturna stalno spremljajo.
English: This helps the cells in the retina to function better, slowing down the progression of the disease.
Slovenian: To pripomore k boljšemu delovanju celic v mrežnici, kar upočasnjuje napredovanje bolezni.
English: Inherited retinal dystrophy is rare, and Luxturna was designated an ‘orphan medicine' (a medicine used in rare diseases) for two forms of the disease on various dates (retinitis pigmentosa: 28 July 2015; Leber's congenital amaurosis: 2 April 2012).
Slovenian: Dedna mrežnična distrofija je redka, zato je bilo zdravilo Luxturna določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih boleznih) za dve obliki bolezni na dva različna datuma (za retinitis pigmentoso: 28. julija 2015 in za Leberjevo kongenitalno amavrozo:2. aprila 2012).
English: Other information about Luxturna
Slovenian: Druge informacije o zdravilu Luxturna
English: Further information on Luxturna can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/luxturna.
Slovenian: Nadaljnje informacije o zdravilu Luxturna so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/luxturna.
English: The main measure of effectiveness was how well patients performed in a mobility test, where they were required to navigate a route with turns and obstacles under various light settings.
Slovenian: Glavno merilo učinkovitosti je bilo, kako dobro so bolniki opravili preskus mobilnosti, pri katerem so morali krmariti po poti z zavoji in ovirami pri različnih nastavitvah svetlobe.
English: Additionally, 13 of the 21 patients (62%) treated with Luxturna passed the mobility test at the lowest light level of 1 lux (similar to conditions of a poorly lit pavement at night), while none of the patients not given the medicine were able to do so.
Slovenian: Poleg tega je 13 od 21 (62 %) bolnikov, zdravljenjih z zdravilom Luxturna, uspešno opravilo preskus mobilnosti na najnižji stopnji osvetljenosti en luks (podobno kot pri slabo osvetljenem pločniku ponoči), medtem ko nobeden od bolnikov, ki niso prejemali tega zdravila, tega ni mogel storiti.
English: Why is Luxturna authorised in the EU?
Slovenian: Zakaj je zdravilo Luxturna odobreno v EU?
English: What is Luxturna and what is it used for?
Slovenian: Kaj je zdravilo Luxturna in za kaj se uporablja?
English: Side effects reported with Luxturna are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Luxturna, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: What benefits of Luxturna have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Luxturna izkazalo v študijah?
English: An overview of Luxturna and why it is authorised in the EU
Slovenian: Pregled zdravila Luxturna in zakaj je odobreno v EU
English: Luxturna has been shown to improve patients' vision and ability to move around obstacles, particularly in dim light, and is expected to improve their quality of life.
Slovenian: Za zdravilo Luxturna je bilo dokazano, da izboljšuje vid bolnikov in njihovo sposobnost, da se premikajo okoli ovir, zlasti pri šibki svetlobi, in se pričakuje, da bo izboljšalo njihovo kakovost življenja.
English: The safety of Luxturna was considered acceptable and side effects manageable.
Slovenian: Varnost zdravila Luxturna je bila ocenjena kot sprejemljiva, neželeni učinki pa obvladljivi.
English: Luxturna must not be used in patients with eye infection or inflammation.
Slovenian: Zdravilo Luxturna ne sme uporabljati pri bolnikih z očesno okužbo ali vnetjem očesa.
English: Patients should start receiving immunosuppressant medicines (medicines that reduce the activity of the immune system, the body's natural defences) 3 days before Luxturna is injected into the first eye, to lower the risk of the medicine being rejected by the body, and this treatment should continue for 14 days after injection.
Slovenian: Bolniki morajo začeti prejemati imunosupresivna zdravila (zdravila, ki zavirajo delovanje imunskega sistema, naravnega obrambnega mehanizma telesa) tri dni preden se zdravilo Luxturna injicira v prvo oko, da se zmanjša tveganje, da telo zavrne zdravilo.
English: What are the risks associated with Luxturna?
Slovenian: Kakšna tveganja so povezana z zdravilom Luxturna?
English: For more information about using Luxturna, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Luxturna 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 Luxturna have also 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 Luxturna upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: The second eye should be treated at least 6 days after the first.
Slovenian: V drugo oko se injicira najmanj 6 dni po injiciranju v prvo.
English: Luxturna is a medicine that is used to treat adults and children with loss of vision due to inherited retinal dystrophy, a rare genetic disorder of the retina (the light sensitive membrane at the back of the eye).
Slovenian: Luxturna je zdravilo, ki se uporablja za zdravljenje odraslih in otrok z izgubo vida zaradi dedne mrežnične distrofije, tj. redke genetske okvare mrežnice (na svetlobo občutljive membrane na očesnem ozadju).
English: Luxturna is given as a single injection into the back of each eye, under the retina.
Slovenian: Zdravilo Luxturna se daje kot enkratna injekcija v zadnji del vsakega očesa pod mrežnico.
English: After one year of treatment, patients treated with Luxturna improved their scores by 1.8 points, while patients who were not given Luxturna improved their scores by 0.2 points, meaning that patients treated with Luxturna were able to move better along the route.
Slovenian: Po enem letu zdravljenja so bolniki, zdravljeni z zdravilom Luxturna, izboljšali svoje rezultate za 1,8 točke, medtem ko so bolniki, ki tega zdravila niso prejemali, svoj rezultat izboljšali za 0,2 točke.
English: Luxturna contains the active substance voretigene neparvovec and is a type of advanced therapy medicine called a ‘gene therapy product'.
Slovenian: Zdravilo Luxturna vsebuje učinkovino voretigen neparvovek in je vrsta zdravila za napredno zdravljenje, imenovano „zdravilo za gensko zdravljenje“.
English: The most common side effects with Luxturna (which may affect more than 1 in 20 people) are conjunctival hyperaemia (increased blood supply to the eye, leading to redness of the eye), cataract (clouding of the lens of the eye) and increased pressure inside the eye. For the full list of side effects of Luxturna, see the package leaflet.
Slovenian: Najpogostejši neželeni učinki zdravila Luxturna (ki lahko prizadenejo več kot 1 osebo od 20) so veznična hiperemija (povečana oskrba očesa s krvjo, ki povzroča pordelost očesa), katarakta (zamegljenost očesne leče) in povečan pritisk znotraj očesa.
English: Luxturna can only be used while patients still have enough functioning cells left in the retina and when the disease is caused by mutations (changes) in the gene RPE65.
Slovenian: Zdravilo Luxturna se lahko uporablja samo, če imajo bolniki še vedno dovolj delujočih celic v mrežnici in če so bolezen povzročile mutacije (spremembe) gena RPE65.
English: RPE65 is responsible for the production of an enzyme called all-trans retinyl isomerase, which is necessary for the normal functioning of retinal cells.
Slovenian: Gen RPE65 je odgovoren za tvorjenje encima, imenovanega vse-trans-retinil izomeraza, ki je potreben za normalno delovanje celic mrežnice.
English: Luxturna was investigated in one main study involving 31 patients with inherited retinal dystrophy due to RPE65 mutations.
Slovenian: Zdravilo Luxturna je bilo raziskano v eni glavni študiji, v katero je bilo vključenih 31 bolnikov z dedno mrežnično distrofijo zaradi mutacij gena RPE65.
English: When Luxturna is injected into the eye the virus carries the RPE65 gene into the retinal cells and enables them to produce the missing enzyme.
Slovenian: Ko se zdravilo Luxturna injicira v oko, virus prenese gen RPE65 v celice mrežnice in jim omogoči tvorjenje manjkajočega encima.
English: Luxturna can only be obtained with a prescription and treatment should be given by a surgeon experienced in performing eye surgery.
Slovenian: Predpisovanje in izdaja zdravila Luxturna je le na recept, zdravljenje z njim pa mora uvesti kirurg z izkušnjami z izvajanjem operativnih posegov na očeh.
English: Luxturna consists of a virus that contains normal copies of the RPE65 gene.
Slovenian: Zdravilo Luxturna sestoji iz virusa, ki vsebuje normalne kopije gena RPE65.
English: The company that markets Luxturna will set up an educational programme and prepare educational material aimed at doctors and pharmacists expected to use and handle Luxturna, in order to ensure the correct use of the medicine and minimise the risks associated with the medicine and its administration.
Slovenian: Družba, ki trži zdravilo Luxturna, bo za zagotovitev njegove pravilne uporabe in zmanjšanje tveganja, povezanega s tem zdravilom in njegovo uporabo, vzpostavila izobraževalni program in pripravila izobraževalno gradivo za zdravnike in farmacevte, za katere se pričakuje, da bodo uporabljali zdravilo Luxturna in rokovali z njim.
English: How is Luxturna used?
Slovenian: Kako se zdravilo Luxturna uporablja?
English: How does Luxturna work?
Slovenian: Kako zdravilo Luxturna deluje?
English: OTHER SPECIAL WARNING(S):
Slovenian: DRUGA POSEBNA OPOZORILA:
English: See situations in which this product should never be used in section 2.
Slovenian: Glejte v poglavju 2, v katerih primerih se to zdravilo ne sme nikoli uporabljati.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Slovenian: Informacije o zdravilu lahko pristojni organi države članice v sodelovanju z referenčno državo članico naknadno dopolnijo, kot je primerno, po postopkih iz Poglavja 4 Naslova III Direktive 2001/83/ES.
English: [This statement below should be strongly emphasised (e.g. capitalized, bold letters or use of colours), the visual details of the warning on the outer and immediate packaging should be agreed with NCAs and be subject to a user test taking into account the "Guideline on the Readability of the labelling and package leaflet on medicinal products for human use" within 1 month from the Commission Decision.]
Slovenian: [Spodnje besedilo je treba močno poudariti (npr. velike tiskane črke, krepko poudarjene črke ali uporaba barv), vizualne podrobnosti opozorila na zunanji in primarni ovojnini morajo biti dogovorjene z nacionalnimi pristojnimi organi in biti predmet preverjanja berljivosti, ob upoštevanju smernice "Guideline on the Readability of the labelling and package leaflet on medicinal products for human use", v 1 mesecu od sklepa Komisije.]
English: These amendments to the relevant sections of the Summary of Product Characteristics and package leaflet are the outcome of the referral procedure.
Slovenian: Spremembe zadevnih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo so rezultat napotitvenega postopka.
English: MAHs of HES solution for infusion should amend the product information (insertion, replacement or deletion of the text, as appropriate) to reflect the wording as provided below, and in conjunction to the Scientific conclusions:
Slovenian: Imetniki dovoljenj za promet z zdravili, ki vsebujejo hidroksietilškrob (HES) v raztopini za infundiranje, morajo spremeniti informacije o zdravilu (vstaviti, zamenjati ali izbrisati besedilo, kot je primerno), tako da bodo odražale besedilo, ki je navedeno spodaj, in v povezavi z znanstvenimi ugotovitvami:
English: SEE ALL CONTRAINDICATIONS IN THE SMPC.
Slovenian: ZA VSE KONTRAINDIKACIJE GLEJTE POVZETEK
English: DO NOT USE IN SEPSIS, RENAL IMPAIRMENT, OR CRITICALLY ILL PATIENTS.
Slovenian: NE UPORABLJAJTE PRI SEPSI, OKVARI LEDVIC ALI KRITIČNO BOLNIH BOLNIKIH.
English: Warning Do not use in sepsis (severe generalised infection), renal impairment, or critically ill patients.
Slovenian: Opozorilo Ne uporabljajte pri sepsi (huda splošna okužba), ledvični okvari ali kritično bolnih bolnikih.
English: SUMMARY OF PRODUCT CHARACTERISTICS [This statement below should be added in a black box at the top of the SmPC.]
Slovenian: POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA [Spodnje besedilo je treba dodati v črnem okvirju na vrhu povzetka glavnih značilnosti zdravila.]
English: Contraindications Do not use in sepsis, renal impairment, or critically ill patients.
Slovenian: Kontraindikacije Ne uporabljajte pri sepsi, okvari ledvic ali kritično bolnih bolnikih.
English: PACKAGE LEAFLET [This statement below should be added in a black box at the top of the package leaflet.]
Slovenian: NAVODILO ZA UPORABO [Spodnje besedilo je treba dodati v črnem okvirju na vrhu navodila za uporabo.]
English: Further information on Poxaconazole AHCL can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/posaconazole-ahcl.
Slovenian: Nadaljnje informacije za zdravilo Posaconazole AHCL so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/posaconazole-ahcl.
English: It is used in patients whose infection is severe or in patients with weakened immune systems, when medicines applied topically (directly on the thrush) are unlikely to work.
Slovenian: Uporablja se pri bolnikih s hudo okužbo ali pri tistih z oslabljenim imunskim sistemom, kadar je malo verjetno, da bi zdravila nanešena topično (neposredno na soor) učinkovala.
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Noxafil, and do not need to be repeated for Posaconazole AHCL.
Slovenian: Študije o koristih in tveganjih učinkovine pri odobrenih načinih uporabe so že bile izvedene z referenčnim zdravilom Noxafil, zato jih ni treba ponoviti za zdravilo Posaconazole AHCL.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Posaconazole AHCL has been shown to have comparable quality and to be bioequivalent to Noxafil.
Slovenian: Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Posaconazole AHCL primerljivo raven kakovosti in je bioekvivalentno zdravilu Noxafil.
English: Because Posaconazole AHCL 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 Posaconazole AHCL generično zdravilo in je bioekvivalentno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: Posaconazole AHCL is available as an oral suspension (40 mg/ml) which is taken with a meal or nutritional supplement.
Slovenian: Zdravilo Posaconazole AHCL je na voljo v obliki peroralne suspenzije (40 mg/ml), ki se jemlje z obrokom ali prehranskimi dopolnili.
English: Posaconazole AHCL is also used to prevent invasive fungal infections in patients whose immune system is weakened because of treatments they are receiving for blood or bone marrow cancers or medicines used in haematopoietic stem cell transplantation (a procedure where the patient's bone marrow is replaced by stem cells from a donor to form new bone marrow).
Slovenian: Zdravilo Posaconazole AHCL se uporablja tudi za preprečevanje invazivnih gliviih okužb pri bolnikih, katerih imunski sistem je oslabljen zaradi zdravljenja, ki ga prejemajo za rakava obolenja krvi ali kostnega mozga, ali zdravil, ki se uporabljajo pri presaditvi hematopoetskih matičnih celic (postopku, pri katerem se bolnikov kostni mozeg nadomesti z izvornimi celicami darovalca, ki tvorijo nov kostni mozeg).
English: Side effects reported with Posaconazole AHCL are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Posaconazole AHCL, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Posaconazole AHCL is an antifungal medicine used to treat adults with the following fungal diseases, when treatments with other antifungal medicines (amphotericin B, itraconazole or fluconazole) cannot be tolerated or have failed:
Slovenian: Posaconazole AHCL je protiglivično zdravilo, ki se uporablja za zdravljenje odraslih z naslednjimi glivičnimi obolenji, kadar so bila zdravljenja z drugimi protiglivičnimi zdravili (amfotericinom B, itrakonazolom ali flukonazolom) neuspešna ali jih bolnik ni mogel prenašati:
English: • chromoblastomycosis and mycetoma (long-term fungal infections of the skin or the tissue just below the skin, usually caused by fungal spores infecting wounds due to thorns or splinters),
Slovenian: • kromoblastomikoze in micetoma (dolgotrajnih glivnih okužb kože in podkožnega tkiva, ki ju navadno povzročajo glivične spore, ki okužijo rane, nastale zaradi trnov ali trsk),