FrancophonIA/ELRC3.0 huggingface dataset:
English: What evidence supports the use of willow herb medicines?
Slovenian: Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo zel vrbovca?
English: For more information about treatment with willow herb medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravili, ki vsebujejo zel vrbovca, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
English: What are the risks associated with willow herb medicines?
Slovenian: Kakšna tveganja so povezana z zdravili, ki vsebujejo zel vrbovca?
English: For practical information about using willow herb medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o njihovi uporabi naj bolniki preberejo navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujejo z zdravnikom ali farmacevtom.
English: 14 July 2017 EMA/463868/2017
Slovenian: 14. julij 2017 EMA/463868/2017
English: More information can be found here.
Slovenian: Dodatne informacije so na voljo tukaj.
English: The review of Zinbryta has been initiated at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.
Slovenian: Pregled zdravila Zinbryta se je začel na zahtevo Evropske komisije v skladu s členom 20 Uredbe (ES) št. 726/2004.
English: • If an adequate therapeutic response has not been achieved, discontinuation of therapy should be considered.
Slovenian: • Če ni bil dosežen ustrezen terapevtski odziv, je treba razmisliti o prekinitvi zdravljenja.
English: These were forwarded to the European Commission (EC), which on 14 July 2017 issued a provisional legally binding decision applicable in all EU Members States.
Slovenian: Priporočila so bila predložena Evropski komisiji, ki je 14. julija 2017 izdala začasno pravno zavezujočo odločbo, ki velja za vse države članice EU.
English: • Patients should be informed about the potential risk of serious liver problems and how to recognise them.
Slovenian: • Bolnike je treba seznaniti z morebitnim tveganjem za resne težave z jetri in kako jih prepoznati.
English: The final stage of the review procedure is the adoption by the European Commission of a legally binding decision applicable in all EU Member States.
Slovenian: Končna faza postopka pregleda je pravno zavezujoča odločba, ki jo sprejme Evropska komisija in je veljavna v vseh državah članicah EU.
English: Healthcare professionals have been informed in writing about the provisional measures to be followed by doctors.
Slovenian: Zdravstveni delavci so bili pisno obveščeni o začasnih ukrepih, ki jih morajo izvajati zdravniki.
English: As a precaution, changes have been made to the way the medicine is used while this review is ongoing:
Slovenian: Kot previdnostni ukrep so bile uvedene spremembe v načinu uporabe zdravila v času, ko pregled poteka:
English: If you are being given Zinbryta and have any questions or concerns, speak to your doctor or pharmacist.
Slovenian: Če prejemate zdravilo Zinbryta in imate kakršna koli vprašanja ali pomisleke, se pogovorite z zdravnikom ali farmacevtom.
English: During the review, the PRAC made a set of provisional recommendations to protect public health.
Slovenian: Medtem ko pregled poteka, je odbor PRAC pripravil vrsto začasnih priporočil za zaščito javnega zdravja.
English: Once the review is concluded, EMA will communicate further and provide updated guidance to patients and healthcare professionals.
Slovenian: Po koncu pregleda bo agencija EMA sporočila še več informacij ter bolnikom in zdravstvenim delavcem posredovala posodobljena navodila.
English: • Patients who already have liver injury will not be treated with this medicine.
Slovenian: • Bolniki, ki že imajo poškodbe jeter, se s tem zdravilom ne bodo zdravili.
English: Once the PRAC review is concluded, any further recommendations will be forwarded to the Committee for Medicinal Products for Human Use (CHMP), responsible for evaluating medicines for human use, which will adopt a final opinion.
Slovenian: Ko bo odbor PRAC zaključil pregled, bodo vsa nadaljnja priporočila posredovana Odboru za zdravila za uporabo v humani medicini (CHMP), odgovornemu za ovrednotenje zdravil za uporabo v humani medicini, ki bo sprejel končno mnenje.
English: The risk of liver damage with the medicine was already known at time of its approval in the EU, and several measures were in place to manage this risk, including the requirement to monitor liver function and provide educational materials to healthcare professionals and patients on the risk of liver damage.
Slovenian: Tveganje za poškodbe jeter zaradi zdravila je bilo v času njegove odobritve v EU že znano, in za obvladovanje tega tveganja je bilo uvedenih že več ukrepov, vključno z zahtevo po spremljanju delovanja jeter in posredovanju izobraževalnega gradiva zdravstvenim delavcem in bolnikom glede tveganja za poškodbe jeter.
English: • If you are already being treated with this medicine, your doctor will check whether you should continue or switch to an alternative treatment.
Slovenian: • Če se že zdravite s tem zdravilom, bo vaš zdravnik preveril, ali se boste še naprej zdravili z njim ali pa boste zdravilo zamenjali.
English: The review is being carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines.
Slovenian: Pregled opravlja Odbor za ocenjevanje tveganja na področju farmakovigilance (PRAC), ki je odgovoren za presojo varnostnih vprašanj o zdravilih za uporabo v humani medicini.
English: • While on treatment with this medicine, you should contact your doctor immediately if you develop any symptoms of liver problems, such as unexplained nausea (feeling sick), vomiting, abdominal pain, tiredness, loss of appetite, yellowing of the skin and eyes and dark urine.
Slovenian: • Med zdravljenjem s tem zdravilom se takoj obrnite na zdravnika, če se pojavijo simptomi težav z jetri, kot so nepojasnjena slabost (siljenje na bruhanje), bruhanje, bolečine v trebuhu, utrujenost, izguba apetita, rumeno obarvanje kože in oči ter temen urin.
English: Serum transaminase and bilirubin levels should be monitored at least monthly, and more frequently if clinically indicated, during treatment and for up to 4 months after the last dose.
Slovenian: Koncentracije serumskih transaminaz in bilirubina je treba spremljati vsaj enkrat mesečno oziroma pogosteje, če je klinično indicirano, in sicer med zdravljenjem in še do štiri mesece po zadnjem odmerku.
English: • Further information will also be provided once the review is concluded.
Slovenian: • Po zaključku pregleda bodo na voljo dodatne informacije.
English: • You should not stop treatment before speaking to your doctor.
Slovenian: • Zdravila ne prenehajte jemati, dokler se ne posvetujete z zdravnikom.
English: This medicine was authorised in the EU in July 2016 to treat adults with relapsing forms of multiple sclerosis (a disease in which inflammation damages the protective sheath around the nerve cells in the brain and spinal cord).
Slovenian: To zdravilo je bilo v EU odobreno julija 2016 za zdravljenje odraslih z recidivno obliko multiple skleroze (bolezni, pri kateri vnetje poškoduje zaščitno ovojnico okrog živčnih celic v možganih in hrbtenjači).
English: Relapsing means that the patient has flare-ups of the symptoms.
Slovenian: Recidivna pomeni, da imajo bolniki ponovne izbruhe simptomov.
English: • Prior to treatment initiation, ALT, AST and bilirubin levels should be measured.
Slovenian: • Pred uvedbo zdravljenja je treba izmeriti koncentracije ALT, AST in bilirubina.
English: • Healthcare professionals should review promptly any patients who are currently taking Zinbryta to assess whether this medicine continues to be appropriate for them.
Slovenian: • Zdravstveni delavci morajo takoj pregledati vse bolnike, ki trenutno jemljejo zdravilo Zinbryta, in oceniti, ali je zdravilo še naprej primerno zanje.
English: In case of signs and symptoms suggestive of hepatic injury, the patient should be promptly referred to a hepatologist.
Slovenian: Če se pojavijo znaki in simptomi, ki kažejo na poškodbe jeter, je treba bolnika nemudoma napotiti k hepatologu.
English: Restrictions are provisional measures while review of liver safety is ongoing
Slovenian: Omejitve so začasni ukrepi v času, ko poteka pregled varnosti za jetra.
English: If you have signs of liver injury, your doctor will refer you to a liver specialist.
Slovenian: Če imate znake poškodb jeter, vas bo zdravnik napotil k specialistu za bolezni jeter.
English: These provisional measures have been taken, as a precaution, to ensure that Zinbryta continues to be used as safely as possible while a review of its liver safety is ongoing.
Slovenian: Ti začasni ukrepi so bili sprejeti kot previdnostni ukrep, in sicer za zagotovitev, da se zdravilo Zinbryta v času pregleda varnosti za jetra še naprej uporablja čim varneje.
English: • Once the review of Zinbryta is concluded, further information will be provided.
Slovenian: • Po zaključenem pregledu zdravila Zinbryta bodo na voljo dodatne informacije.
English: The safety of the multiple sclerosis medicine Zinbryta is being reviewed.
Slovenian: Varnost zdravila za multiplo sklerozo Zinbryta se pregleduje.
English: • Your doctor will test your liver function at least monthly, and check for signs and symptoms of liver injury.
Slovenian: • Zdravnik bo vsaj enkrat mesečno preverjal delovanje vaših jeter ter vas pregledal glede znakov in simptomov poškodb jeter.
English: • In addition, the medicine has been contraindicated in patients with pre-existing hepatic disease or hepatic impairment.
Slovenian: • Poleg tega je bila uvedena kontraindikacija pri bolnikih z obstoječo jetrno boleznijo ali jetrno okvaro.
English: EMA restricts use of multiple sclerosis medicine Zinbryta
Slovenian: Agencija EMA omejuje uporabo zdravila za multiplo sklerozo Zinbryta
English: • Further details on these provisional measures have been provided in writing to healthcare professionals and the product information has been updated accordingly.
Slovenian: • Zdravstveni delavci so v pisni obliki prejeli več podrobnosti o začasnih ukrepih, v skladu s tem pa so bile posodobljene tudi informacije o zdravilu.
English: • Cases of liver injury with Zinbryta have occurred early after treatment initiation, following repeated treatment courses and several months after discontinuation.
Slovenian: • Primeri poškodb jeter med zdravljenjem z zdravilom Zinbryta so se pojavili kmalu po začetku zdravljenja, po večkratnih ciklih zdravljenja in več mesecev po prenehanju.
English: Doctors should continue to monitor the liver function of patients receiving the medicine and closely watch patients for signs and symptoms of liver injury.
Slovenian: Zdravniki morajo pri bolnikih, ki prejemajo zdravilo, še naprej spremljati delovanje jeter ter jih skrbno opazovati glede znakov in simptomov poškodb jeter.
English: In addition, patients with liver injury must not be given the medicine.
Slovenian: Poleg tega se zdravilo ne sme dajati bolnikom s poškodbami jeter.
English: Zinbryta is a medicine used to treat adults with relapsing forms of multiple sclerosis.
Slovenian: Zdravilo Zinbryta se uporablja za zdravljenje odraslih z recidivno obliko multiple skleroze.
English: • Treatment initiation is not recommended in patients with concurrent autoimmune conditions other than multiple sclerosis and in patients with serum transaminases (ALT or AST) that are at least twice the upper limit of normal (≥ 2 times the ULN).
Slovenian: • Uvedba zdravljenja ni priporočljiva pri bolnikih, ki imajo poleg multiple skleroze še druga sočasna avtoimunska stanja, in pri bolnikih z vrednostmi serumskih transaminaz (ALT ali AST), ki so vsaj dvakratnik zgornje meje normalne vrednosti (≥ 2-krat ULN).
English: The review of Zinbryta started after the death from liver injury (fulminant liver failure) of a patient involved in an ongoing observational study, as well as four cases of serious liver injury.
Slovenian: Pregled zdravila Zinbryta se je začel po smrti zaradi poškodb jeter (fulminantne jetrne odpovedi) pri bolniku, vključenem v potekajočo opazovalno študijo, in po štirih primerih resnih poškodb jeter.
English: • All patients on Zinbryta should also be monitored for signs and symptoms of hepatic injury during treatment.
Slovenian: • Vse bolnike, ki se zdravijo z zdravilom Zinbryta, je treba med zdravljenjem spremljati glede znakov in simptomov poškodb jeter.
English: • The ongoing safety review was triggered following the death from fulminant liver failure of a patient who was treated with Zinbryta in an ongoing observational study, as well as four cases of serious liver injury.
Slovenian: • Potekajoči pregled varnosti je bil sprožen po smrti zaradi fulminantne jetrne odpovedi pri bolniku, ki se je zdravil z zdravilom Zinbryta v potekajoči opazovalni študiji, in po štirih primerih resnih poškodb jeter.
English: • As a precaution and while the review is ongoing, Zinbryta's use has been restricted to adult patients with highly active relapsing disease despite a full and adequate course of treatment with at least one disease modifying therapy (DMT) or with rapidly evolving severe relapsing multiple sclerosis who are unsuitable for treatment with other DMTs.
Slovenian: • Kot previdnostni ukrep v času, ko pregled poteka, je bila uporaba zdravila Zinbryta omejena na odrasle bolnike z visoko aktivno recidivno multiplo sklerozo, ki je prisotna kljub celovitemu in primernemu zdravljenju z vsaj enim zdravilom, ki spreminja potek bolezni (DMT), in na odrasle bolnike s hitro napredujočo hudo recidivno multiplo sklerozo, ki niso primerni za zdravljenje z drugimi zdravili DMT.
English: Starting treatment with Zinbryta is not recommended for patients with autoimmune diseases other than multiple sclerosis and caution should be used when giving Zinbryta together with medicines that can damage the liver.
Slovenian: Uvedba zdravljenja z zdravilom Zinbryta ni priporočena pri bolnikih, ki imajo poleg multiple skleroze še druge avtoimunske bolezni, pri dajanju zdravila Zinbryta skupaj z zdravili, ki lahko poškodujejo jetra, pa je potrebna previdnost.
English: • Zinbryta treatment is not recommended in multiple sclerosis patients who have autoimmune diseases other than multiple sclerosis.
Slovenian: • Zdravljenje z zdravilom Zinbryta ni priporočeno pri bolnikih, ki imajo poleg multiple skleroze še druge avtoimunske bolezni.
English: The European Medicines Agency (EMA) has provisionally restricted the use of the multiple sclerosis medicine Zinbryta (daclizumab) to patients with highly active relapsing disease that has failed to respond to certain other treatment, and to patients with rapidly evolving relapsing disease who cannot be treated with other medicines.
Slovenian: Evropska agencija za zdravila (EMA) je začasno omejila uporabo zdravila za multiplo sklerozo Zinbryta (daklizumab) na bolnike z visoko aktivno recidivno boleznijo, ki se ni odzvala na določena druga zdravila, in na bolnike s hitro napredujočo recidivno boleznijo, ki se ne morejo zdraviti z drugimi zdravili.
English: • Caution is recommended before giving Zinbryta in combination with medicinal products of known hepatotoxic potential, including non-prescription medicines and herbal supplements.
Slovenian: • Pred dajanjem zdravila Zinbryta v kombinaciji z zdravili z znanim hepatotoksičnim potencialom, vključno z zdravili brez recepta in zeliščnimi dodatki, je potrebna previdnost.
English: • The use of Zinbryta has been restricted to patients with highly active relapsing disease that has failed to respond to other treatment, and to patients with rapidly evolving relapsing disease who cannot be treated with other medicines.
Slovenian: • Uporaba zdravila Zinbryta (daklizumab) je bila omejena na bolnike z visoko aktivno recidivno boleznijo, ki se ni odzvala na druga zdravila, in na bolnike s hitro napredujočo recidivno boleznijo, ki se ne morejo zdraviti z drugimi zdravili.
English: • Speak to you doctor or pharmacist before you start taking any other medicines, including medicines obtained without a prescription and herbal supplements.
Slovenian: • Preden začnete jemati druga zdravila, vključno z zdravili brez recepta in zeliščnimi dodatki, se posvetujte z zdravnikom ali farmacevtom.
English: The patient's response and the need for further treatment should be evaluated after three months.
Slovenian: Odziv bolnika in potrebo po nadaljnjem zdravljenju je treba oceniti po treh mesecih.
English: If treatment needs to be stopped for any reason, the dose should be decreased gradually.
Slovenian: Če je treba zdravljenje iz katerega koli razloga prekiniti, je treba odmerek zmanjševati postopoma.
English: Further information on Oprymea can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Več informacij o zdravilu Oprymea 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 Oprymea?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Oprymea?
English: The prolonged-release tablets must not be chewed, divided or crushed, and should be taken around the same time every day.
Slovenian: Tablete s podaljšanim sproščanjem se ne smejo žvečiti, razdeliti ali zdrobiti, vzeti jih je treba vsak dan ob isti uri.
English: Oprymea received a marketing authorisation valid throughout the EU on 12 September 2008.
Slovenian: Za zdravilo Oprymea je bilo 12. septembra 2008 izdano dovoljenje za promet, veljavno po vsej EU.
English: Oprymea tablets should be swallowed with water.
Slovenian: Tablete zdravila Oprymea je treba pogoltniti z vodo.
English: Oprymea (pramipexole)
Slovenian: Oprymea (pramipeksol)
English: The company also carried out a study that showed that it is ‘bioequivalent' to the reference medicine.
Slovenian: Družba je izvedla tudi študijo, ki je pokazala, da je zdravilo „bioekvivalentno“ referenčnemu zdravilu.
English: Oprymea is used when a specific cause for the disorder cannot be identified.
Slovenian: Zdravilo Oprymea se uporablja, kadar ni mogoče odkriti posebnega vzroka za motnjo.
English: What are the benefits and risks of Oprymea?
Slovenian: Kakšne so koristi in tveganja zdravila Oprymea?
English: Oprymea must be given less frequently in patients who have problems with their kidneys.
Slovenian: Zdravilo Oprymea je treba dajati manj pogosto pri bolnikih, ki imajo težave z ledvicami.
English: Oprymea is a medicine used to treat the symptoms of the following diseases:
Slovenian: Oprymea je zdravilo za zdravljenje simptomov naslednjih obolenj:
English: Other information about Oprymea
Slovenian: Druge informacije o zdravilu Oprymea
English: It is available as immediate-release tablets (0.088 mg, 0.18 mg, 0.35 mg, 0.7 mg and 1.1 mg) and prolonged-release tablets (0.26 mg, 0.52 mg, 1.05 mg, 1.57 mg, 2.1 mg, 2.62 mg and 3.15 mg).
Slovenian: Zdravilo je na voljo v obliki tablet s takojšnjim sproščanjem (0,088 mg, 0,18 mg, 0,35 mg, 0,7 mg in 1,1 mg) in tablet s podaljšanim sproščanjem (0,26 mg, 0,52 mg, 1,05 mg, 1,57 mg, 2,1 mg, 2,62 mg in 3,15 mg).
English: As for every medicine, the company provided studies on the quality of Oprymea.
Slovenian: Tako kot za vsako zdravilo je družba predložila študije o kakovosti zdravila Oprymea.
English: An overview of Oprymea and why it is authorised in the EU
Slovenian: Pregled zdravila Oprymea in zakaj je odobreno v EU
English: • moderate to severe restless-legs syndrome, a disorder where the patient has uncontrollable urges to move the limbs to stop uncomfortable, painful or odd sensations in the body, usually at night.
Slovenian: • zmernega do hudega sindroma nemirnih nog, tj. motnje, pri kateri ima bolnik nenadzorovano potrebo po premikanju okončin, da se prenehajo neprijetni, boleči ali nenavadni občutki v telesu, navadno ponoči.
English: Because Oprymea 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 Oprymea generično zdravilo in je bioekvivalentno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: Oprymea can be used either on its own or in combination with levodopa (another medicine for Parkinson's disease), at any stage of disease including the later stages when levodopa starts becoming less effective;
Slovenian: Zdravilo Oprymea se lahko uporablja bodisi samostojno bodisi v kombinaciji z levodopo (drugim zdravilom za zdravljenje Parkinsonove bolezni) v katerem koli stadiju bolezni, vključno s poznim stadijem, ko začne učinek levodope popuščati;
English: This means that Oprymea contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Sifrol (also known as Mirapexin).
Slovenian: To pomeni, da vsebuje enako učinkovino in deluje na enak način kot „referenčno zdravilo“, ki je že odobreno v EU in se imenuje Sifrol (imenovano tudi Mirapexin).
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Sifrol, and do not need to be repeated for Oprymea.
Slovenian: Študije o koristih in tveganjih učinkovine pri odobrenih načinih uporabe so že bile izvedene z referenčnim zdravilom Sifrol, zato jih ni treba ponoviti za zdravilo Oprymea.
English: Oprymea is a ‘generic medicine'.
Slovenian: Zdravilo Oprymea je „generično zdravilo“.
English: As for all medicines, data on the use of Oprymea are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Oprymea stalno spremljajo.
English: The recommended starting dose is one 0.088 mg tablet, but, if needed, this can be increased every four to seven days to reduce symptoms further, to a maximum of three 0.18 mg tablets.
Slovenian: Priporočeni začetni odmerek je ena 0,088-miligramska tableta, vendar se po potrebi lahko poveča vsake štiri do sedem dni za dodatno lajšanje simptomov na največ tri 0,18-miligramske tablete.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Oprymea has been shown to have comparable quality and to be bioequivalent to Sifrol.
Slovenian: Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Oprymea primerljivo raven kakovosti in je bioekvivalentno z zdravilom Sifrol.
English: Side effects reported with Oprymea are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Oprymea, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Oprymea 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 Oprymea upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: What is Oprymea and what is it used for?
Slovenian: Kaj je zdravilo Oprymea in za kaj se uporablja?
English: Why is Oprymea authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Oprymea odobreno v EU?
English: The prolonged-release tablets are not suitable for restless-legs syndrome.
Slovenian: Tablete s podaljšanim sproščanjem niso primerne za zdravljenje sindroma nemirnih nog.
English: For more information about using Oprymea, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Oprymea glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: For restless-legs syndrome, Oprymea immediate-release tablets should be taken once a day, two to three hours before going to bed.
Slovenian: Pri sindromu nemirnih nog je treba tablete zdravila Oprymea s takojšnjim sproščanjem jemati enkrat na dan, dve do tri ure pred spanjem.