FrancophonIA/ELRC3.0 huggingface dataset:
English: Seroquel XR can also continue to be used as add-on to ongoing treatment for major depressive episodes in patients with major depressive disorder who have had sub-optimal response to treatment with other antidepressants.
Slovenian: Zdravilo Seroquel XR se lahko prav tako še naprej uporablja kot dopolnilno zdravljenje k obstoječemu zdravljenju velikih depresivnih epizod pri bolnikih z veliko depresivno motnjo, ki so imeli suboptimalni odziv na zdravljenje z drugimi antidepresivi.
English: • treatment of moderate to severe manic episodes in bipolar disorder and major depressive episodes in bipolar disorder;
Slovenian: • zdravljenje zmernih do hudih maničnih epizod pri bipolarni motnji in velikih depresivnih epizod pri bipolarni motnji;
English: • prevention of recurrence of manic or depressed episodes in patients with bipolar disorder who previously responded to quetiapine treatment.
Slovenian: • preprečevanje ponovnega pojava maničnih ali depresivnih epizod pri bolnikih z bipolarno motnjo, ki so se predhodno odzvali na zdravljenje s kvetiapinom.
English: On 22 May 2014, the European Medicines Agency completed a review of Seroquel and Seroquel XR.
Slovenian: Evropska agencija za zdravila je 22. maja 2014 zaključila pregled zdravil Seroquel in Seroquel XR.
English: Seroquel XR can also be used as add-on treatment in major depression.
Slovenian: Zdravilo Seroquel XR se lahko uporablja tudi kot dopolnilno zdravljenje pri hudi depresiji.
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Slovenian: Odbor CHMP je na podlagi predloženih podatkov in znanstvene razprave v odboru menil, da je treba uskladiti povzetke glavnih značilnosti zdravila, označevanje in navodilo za uporabo po vsej EU.
English: Seroquel and Seroquel XR are also marketed under other trade names.
Slovenian: Zdravili Seroquel in Seroquel XR se tržita tudi pod drugimi trgovskimi imeni.
English: Seroquel and Seroquel XR are authorised in the EU via national procedures.
Slovenian: Zdravili Seroquel in Seroquel XR sta bili v EU odobreni po nacionalnih postopkih.
English: Seroquel and Seroquel XR are antipsychotic medicines that contain the active substance quetiapine.
Slovenian: Zdravili Seroquel in Seroquel XR sta antipsihotika, ki vsebujeta zdravilno učinkovino kvetiapin.
English: Why were Seroquel and Seroquel XR reviewed?
Slovenian: Zakaj sta bili zdravili Seroquel in Seroquel XR pregledani?
English: What are Seroquel and Seroquel XR?
Slovenian: Kaj sta zdravili Seroquel in Seroquel XR?
English: On 12 June 2013, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Seroquel and Seroquel XR in the EU.
Slovenian: Da bi uskladili dovoljenja za promet z zdraviloma Seroquel in Seroquel XR v EU, je Evropska komisija 12. junija 2013 zadevo napotila na odbor CHMP.
English: Seroquel and Seroquel XR were identified by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) as needing harmonisation.
Slovenian: Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh) je ugotovila, da je za zdravili Seroquel in Seroquel XR potrebno usklajevanje.
English: EMA/206629/2016 EMEA/H/C/000609
Slovenian: EU/1/05/314/001
English: The use of Kepivance should be supervised by a doctor who has experience in anticancer therapy.
Slovenian: Zdravljenje z zdravilom Kepivance lahko izvaja samo zdravnik z izkušnjami pri zdravljenju raka.
English: The main measure of effectiveness was the number of days during which patients experienced severe oral
Slovenian: Glavna končna točka glede učinkovitosti v študiji je bilo število dni, ko so bolniki imeli hud oralni mukozitis (3./4.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Slovenian: 5550 Airport Boulevard Boulder, Colorado 80301 ZDA
English: Three doses are given on three consecutive days before myeloablative therapy, finishing 24 to 48 hours before the therapy.
Slovenian: Prve tri odmerke je treba uporabiti pred mieloablacijsko terapijo, in sicer tako, da bolnik dobi tretji odmerek v 24 do 48 urah pred mieloablacijsko radiokemoterapijo.
English: It contains the active substance
Slovenian: Kaj vsebuje navodilo
English: Palifermin is very similar to a natural growth factor found in the body called keratinocyte growth factor (KGF).
Slovenian: Palifermin deluje enako kot keratinocitni rastni dejavnik (KGF), ki v majhni količini naravno nastaja v človeškem telesu.
English: Kepivance is a powder that is made up into a solution for injection.
Slovenian: 6 vial s praškom za raztopino za injiciranje
English: Kepivance stimulates the growth of the epithelial cells, helping to reduce the incidence, severity and duration of oral mucositis in cancer patients undergoing intensive therapy.
Slovenian: Zdravilo Kepivance uporabljamo za zmanjšanje pogostosti, trajanja in izrazitosti simptomov oralnega mukozitisa.
English: Patients receiving Kepivance also reported less mouth and throat soreness with improved swallowing, drinking, eating and talking.
Slovenian: V klinični študiji 3. faze so bolniki, ki so dobivali palifermin, doživeli pomembne koristi v zvezi s samoopisanim izidom bolečin v ustih in žrelu ter njihovim vplivom na požiranje, pitje, hranjenje in govorjenje.
English: The study involved 281 adults who were receiving chemotherapy to treat multiple myeloma (a type of blood cancer), but without any radiotherapy.
Slovenian: V študiji (n = 281) so bili bolniki z multiplim mielomom pred avtologno presaditvijo krvotvornih matičnih celic deležni pripravljalne terapije z melfalanom (200 mg/m2).
English: Kepivance is used in adults who are likely to develop severe mucositis because they have blood cancer, and are being treated with myeloablative chemotherapy (medicines to destroy the bone marrow) in combination with radiotherapy (treatment with radiation) and an autologous haematopoietic stem-cell transplant (a transplant of their own blood-producing cells).
Slovenian: Za zdravljenje vašega krvnega raka morda dobivate kemoterapijo, radioterapijo in presaditev avtolognih hematopoetskih matičnih celic (krvotvornih celic iz vašega lastnega organizma).
English: In the main study, the patients receiving chemotherapy and radiotherapy had severe oral mucositis for a shorter time if they received Kepivance (3.7 days, on average) than if they received placebo (10.4 days, on average).
Slovenian: Poleg tega so pri bolnikih, ki so prejemali palifermin pred in po kemoterapiji, opazili večjo incidenco okužb (49,5 %), kot pri bolnikih, ki so prejemali placebo (24,6 %).
English: Other information about Kepivance:
Slovenian: Preiskave zelo pogosti:
English: Kepivance should not be used in people who may be hypersensitive (allergic) to palifermin, proteins produced by Escherichia coli (a bacterium) or any of the other ingredients.
Slovenian: - če ste alergični na palifermin, beljakovine, pridobljene iz bakterije Escherichia coli ali katerokoli drugo sestavino tega zdravila (navedeno v poglavju 6).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Kepivance on 25 October 2005.
Slovenian: Datum prve odobritve: 25. oktober 2005 Datum zadnjega podaljšanja: 23. september 2010
English: For the full list of all side effects reported with Kepivance, see the package leaflet.
Slovenian: Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: The most common side effects with Kepivance (seen in more than 1 patient in 10) are dysgeusia (taste disturbances), increased levels of lipase and amylase (enzymes used in digestion), hypertrophy (increase in the number or size of cells) or discoloration of the mouth and tongue, rash, pruritus (itching), erythema (redness), arthralgia (joint pain), oedema (swelling), pain and pyrexia (fever).
Slovenian: Učinkovitost in varnost palifermina so ugotavljali v randomizirani, dvojno slepi, s placebom kontrolirani študiji bolnikov s hematološkimi malignomi (ne-Hodgkinov limfom (NHL), Hodgkinova bolezen, akutna mieloična levkemija (AML), akutna limfatična levkemija (ALL), kronična mieloična levkemija (KML), kronična limfatična levkemija (KLL) ali multipli mielom).
English: How does Kepivance work?
Slovenian: Kepivance.
English: The remaining three doses are given on three consecutive days after myeloablative therapy, with the first dose given on the day of the stem-cell transplant.
Slovenian: Mediani čas do pojava je bil približno 6 dni po prvih 3 zaporednih dnevnih odmerkih zdravila Kepivance; mediano so trajali približno 5 dni.
English: Epithelial cells in the mouth are normally replaced by the body every few days.
Slovenian: Običajni odmerek zdravila Kepivance je 60 mikrogramov na kilogram telesne mase na dan.
English: At the request of the CHMP, the company carried out a further study comparing two schedules of Kepivance with placebo.
Slovenian: Nobena od zgornjih dveh shem odmerjanja ni pokazala statistično značilnih rezultatov v primerjavi s placebom.
English: The active substance in Kepivance, palifermin, is a growth factor that stimulates the ‘epithelial' cells that line the mouth and gastrointestinal tract to grow and develop.
Slovenian: V zdravilu Kepivance je rastni faktor, ki spodbuja proliferacijo epitelijskih celic z eksprimiranimi receptorji KGF.
English: Palifermin is produced by a method known as ‘recombinant DNA technology': it is made by a bacterium that has received a gene (DNA), which makes it able to produce palifermin.
Slovenian: Palifermin je humani keratinocitni rastni faktor (KGF - keratinocyte growth factor), pridobljen s tehnologijo rekombinantne DNA iz Escherichia coli.
English: It is given as an injection into a vein for a total of six doses.
Slovenian: Tak odmerek boste dobili v intravenski injekciji (injekciji v veno).
English: This document is a summary of the European Public Assessment Report (EPAR) for Kepivance.
Slovenian: stopnja po lestvici Svetovne zdravstvene organizacije [SZO]).
English: This summary was last updated in 03-2016.
Slovenian: Navodilo je bilo nazadnje revidirano dne
English: However, in the study of patients receiving chemotherapy without radiation, there was no difference in the severity of mucositis between the patients receiving placebo and those receiving either schedule of Kepivance.
Slovenian: V študiji za presojo potencialne kancerogenosti na transgenskih rasH miših niso opažali, da bi se incidence neoplastičnih lezij povečale v zvezi z zdravljenjem.
English: What is the risk associated with Kepivance?
Slovenian: Možno tveganje za človeški zarodek in plod ni znano.
English: For more information about treatment with Kepivance, read the package leaflet (also part of the EPAR).
Slovenian: Za informacije o pripravi in dajanju zdravila Kepivance glejte informacije za zdravstveno osebje na koncu teh navodil.
English: In patients receiving chemotherapy and radiotherapy, the cells are not replaced as quickly, which leads to the development of mucositis.
Slovenian: Hematološki malignomi nimajo eksprimiranih receptorjev KGF, toda bolnike, zdravljene s kemoterapijo in/ali radioterapijo, bolj ogrožajo sekundarni tumorji.
English: The full EPAR for Kepivance can be found here.
Slovenian: Če predložitev PSUR in posodobitev RMP sovpadata, se lahko predložita sočasno.
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
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: Kepivance has been compared with placebo (a dummy treatment) in one main study in 212 adults receiving chemotherapy and radiotherapy for a blood cancer (mostly non-Hodgkin's lymphoma).
Slovenian: Pojavnost hudega (3. in 4. stopnje) oralnega mukozitisa v treh skupinah je bila 36,8-% v skupini s placebom, 38,3-% v skupini, ki je palifermin prejemala pred/po KT, in 23,9-% v skupini, ki je palifermin prejemala pred KT, pri tem pa ni bilo statistično značilnih razlik.
English: This study is still ongoing.
Slovenian: Ta študija še poteka.
English: The studies will include children below 2 years of age, for whom there are currently no data.
Slovenian: Študije bodo vključevale tudi otroke, mlajše od 2 let, saj zanje trenutno ni podatkov.
English: Brineura cerliponase alfa
Slovenian: Brineura cerliponaza alfa
English: A patient's final score was the sum of the two scores.
Slovenian: Bolnikova končna ocena je seštevek obeh ocen.
English: The treatment can continue for as long as the patient benefits from it.
Slovenian: Zdravljenje se nadaljuje tako dolgo, dokler je za bolnika koristno.
English: What measures are being taken to ensure the safe and effective use of Brineura?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Brineura?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore concluded that Brineura's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Brineura večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: It is not intended to provide practical advice on how to use Brineura.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: This is a summary of the European public assessment report (EPAR) for Brineura.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Brineura.
English: This is because it has not been possible to obtain complete information about Brineura due to the rarity of the disease.
Slovenian: Do tega je prišlo zato, ker zaradi redkosti bolezni ni bilo mogoče pridobiti vseh informacij o njem.
English: In a study in which 23 children (average age of 4 years) were treated with Brineura for almost a year, 20 of them (87%) did not experience the 2-point decline in movement and language skills seen historically in patients not receiving treatment.
Slovenian: V študiji pri 23 otrocih (povprečne starosti 4 leta), ki so se zdravili z zdravilom Brineura skoraj eno leto, 20 otrok (87 %) ni imelo upada za 2 točki pri motoričnih in govornih funkcijah, kot se je pokazalo pri bolnikih, ki zdravila niso prejemali.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Brineura can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Slovenian: Povzetek mnenja Odbora za zdravila sirote o zdravilu Brineura je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: With regard to its safety, the data do not reveal any unacceptable concerns.
Slovenian: V zvezi s podatki ni bilo nobenih nesprejemljivih zadržkov glede varnosti zdravila.
English: Brineura has been authorised under ‘exceptional circumstances'.
Slovenian: Zdravilo Brineura je pridobilo dovoljenje za promet „v izjemnih okoliščinah“.
English: To reduce the risk of infusion-related reactions, patients may be given other medicines before or during treatment with Brineura or the infusion may be slowed down.
Slovenian: Za zmanjšanje tveganja za pojav reakcij, povezanih z infuzijo, lahko bolniki pred zdravljenjem z zdravilom Brineura ali med njim prejemajo druga zdravila ali pa se hitrost infundiranja upočasni.
English: Other information about Brineura
Slovenian: Druge informacije o zdravilu Brineura
English: The rating was done by doctors who gave patients individual scores for movement and language skills (where 0 means most severe and 3 is normal).
Slovenian: Ocenjevanje so izvedli zdravniki, ki so bolnikom dali posamične ocene za motorične in govorne funkcije (kjer ocena 0 pomeni skrajno resno, ocena 3 pa normalno stanje).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Brineura have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Brineura upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: The active substance in Brineura, cerliponase alfa, is a copy of TPP1 and is used as a replacement for the missing enzyme.
Slovenian: Zdravilna učinkovina zdravila Brineura, cerliponaza alfa, je kopija TPP1 in se uporablja kot nadomestilo za manjkajoči encim.
English: For more information about treatment with Brineura, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Brineura preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Since Brineura has been approved under exceptional circumstances, the company that markets it will provide further data from studies on the safety of Brineura, including the risk of allergic reactions when used long-term, and on its long-term effectiveness in delaying or stopping worsening of movement and language skills.
Slovenian: Ker je zdravilo Brineura pridobilo dovoljenje za promet v izjemnih okoliščinah, bo družba, ki ga trži, priskrbela nadaljnje podatke iz študij o varnosti zdravila Brineura, vključno s podatki o tveganju za alergijske reakcije pri dolgotrajni uporabi in o dolgotrajni učinkovitosti pri odložitvi ali zaustavitvi poslabšanja motoričnih in govornih funkcij.
English: The medicine is infused directly into the brain in order to bypass the blood-brain barrier, a protective barrier that separates the blood stream from the brain, and prevents substances such as medicines, from entering brain tissue.
Slovenian: Zdravilo se infundira neposredno v možgane, da obide krvno-možgansko pregrado, zaščitno pregrado, ki loči krvni obtok od možganov in prepreči snovem, kot so zdravila, da bi prišla v možgansko tkivo.
English: The most common side effects with Brineura (which may affect more than 1 in 5 people) are fever, low levels of protein in CSF (the fluid in the brain and spinal cord), abnormalities in ECG (a test of the heart's activity), vomiting, upper respiratory tract infections (nose and throat infections), and hypersensitivity (allergic) reactions.
Slovenian: Najpogostejši neželeni učinki zdravila Brineura (ki se lahko pojavijo pri več kot 1 bolniku od 5) so zvišana telesna temperatura, zmanjšana vrednost beljakovin v CSF (cerebrospinalnem likvorju in hrbtenjači), nenormalnosti na EKG (testu aktivnosti srca), bruhanje, okužbe zgornjih dihal (nosu in žrela) in preobčutljivostne (alergijske) reakcije.
English: It must also not be given to patients who have had a shunt implanted to drain extra fluid from the brain.
Slovenian: Ne sme se dajati tudi bolnikom, ki imajo vsajen šant za odvajanje odvečne tekočine iz možganov.
English: Because the number of patients with CLN2 is low, the disease is considered ‘rare', and Brineura was designated an ‘orphan medicine' (a medicine used in rare diseases) on 13 March 2013.
Slovenian: Ker je bolnikov s CLN2 malo, velja ta bolezen za redko, zato je bilo zdravilo Brineura 13. marca 2013 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: In a follow-up study the benefits of Brineura lasted for another year, with the results showing the disease could be delayed in the majority of patients.
Slovenian: V kontrolni študiji so koristi zdravila Brineura trajale še eno leto, pri čemer so rezultati pri večini bolnikov kazali na odložitev napredovanja bolezni.
English: The full EPAR for Brineura 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 Brineura je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The company that markets Brineura will ensure that all healthcare professionals expected to use this medicine are provided with training material on how to use it and how to avoid problems with the device such as infection or blockage.
Slovenian: Družba, ki trži zdravilo Brineura, bo za vse zdravstvene delavce, za katere se pričakuje, da bodo uporabljali to zdravilo, priskrbela izobraževalno gradivo o tem, kako uporabljati zdravilo in kako se izogniti težavam pri uporabi pripomočka, kot sta okužba ali zamašitev.
English: Why is Brineura approved?
Slovenian: Zakaj je bilo zdravilo Brineura odobreno?
English: Available data show that Brineura helps slow the decline in movement and language skills in patients with CLN2, a condition for which there are no other treatments.
Slovenian: Razpoložljivi podatki kažejo, da zdravilo Brineura pomaga upočasniti upad motoričnih in govornih funkcij pri bolnikih s CLN2, boleznijo, za katero ni na voljo drugih možnosti zdravljenja.
English: What are the risks associated with Brineura?
Slovenian: Kakšna tveganja so povezana z zdravilom Brineura?
English: Brineura is infused directly into the brain.
Slovenian: Zdravilo Brineura se daje z infundiranjem neposredno v možgane.
English: What benefits of Brineura have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Brineura izkazalo v študijah?
English: Brineura is a medicine for treating neuronal ceroid lipofuscinosis type 2 (CLN2 disease), an inherited condition in children that leads to progressive brain damage.
Slovenian: Zdravilo Brineura se uporablja za zdravljenje bolnikov z nevronsko ceroidno lipofuscinozo tipa 2 (CLN2), dedno boleznijo pri otrocih, ki povzroči hitro napredujočo okvaro možganov.
English: For the full list of all side effects reported with Brineura, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Brineura, glejte navodilo za uporabo.
English: Patients with CLN2 lack an enzyme required for normal brain development called tripeptidyl-peptidase1 (TPP1).
Slovenian: Bolniki s CLN2 imajo pomanjkanje encima, ki se imenuje tripeptidil-peptidaza-1 (TPP1) in je potreben za normalen razvoj možganov.
English: What is Brineura and what is it used for?
Slovenian: Kaj je zdravilo Brineura in za kaj se uporablja?
English: What information is still awaited for Brineura?
Slovenian: Katere informacije o zdravilu Brineura še pričakujemo?
English: For practical information about using Brineura, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Brineura naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Brineura contains the active substance cerliponase alfa.
Slovenian: Zdravilo Brineura vsebuje zdravilno učinkovino cerliponaza alfa.
English: Brineura must not be given to patients who have experienced life-threatening hypersensitivity (allergic) reactions with Brineura and whose symptoms re-occurred when Brineura was given again.
Slovenian: Zdravilo Brineura se ne sme dajati bolnikom, ki so imeli življenje ogrožajočo alergijsko reakcijo na zdravilo Brineura in pri katerih se simptomi ob ponovni uporabi zdravila Brineura ponovijo.
English: Finally, patients must not be given Brineura while there are any problems with the device, such as leakage or infection.
Slovenian: Zdravilo Brineura pa se tudi ne sme dajati, kadar imajo bolniki kakršne koli težave s pripomočkom, kot sta puščanje ali okužba.
English: Before the first infusion, the patient will need to have surgery to implant a device, which runs from the outside of the skull through to the fluid cavity in the brain where the medicine is delivered to.
Slovenian: Pred prvim infundiranjem je treba operativno vsaditi pripomoček, ki poteka od zunanje strani lobanje do prostora z likvorjem v možganih, kamor se daje zdravilo.