FrancophonIA/ELRC3.0 huggingface dataset:
English: What is Clopidogrel Apotex used for?
Slovenian: Za kaj se zdravilo Clopidogrel Apotex uporablja?
English: How does Clopidogrel Apotex work?
Slovenian: Kako zdravilo Clopidogrel Apotex deluje?
English: How is Clopidogrel Apotex used?
Slovenian: Kako se zdravilo Clopidogrel Apotex uporablja?
English: Invented name Strength Pharmaceutical form Route of administration Packaging
Slovenian: Številka EU Zaščiteno ime Jakost
English: The side effects that were seen, which mainly affected the gut, did not raise major concerns and were considered mild and manageable.
Slovenian: Opaženi neželeni učinki, ki so prizadeli predvsem črevesje, niso vzbudili večjih pomislekov in so bili ocenjeni kot blagi in obvladljivi.
English: What measures are being taken to ensure the safe and effective use of Xermelo?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Xermelo?
English: These enzymes are needed for the production of serotonin.
Slovenian: Ti encimi so potrebni za tvorbo serotonina.
English: The European Medicines Agency therefore decided that Xermelo's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Xermelo večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
English: This is a summary of the European public assessment report (EPAR) for Xermelo.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Xermelo.
English: The effects of Xermelo were seen from about 3 weeks after starting treatment.
Slovenian: Učinki zdravila Xermelo so bili vidni po približno 3 tednih zdravljenja.
English: The commonest side effect severe enough to cause treatment to be stopped is abdominal pain.
Slovenian: Najpogostejši neželeni učinek, ki je dovolj hud, da povzroči prekinitev zdravljenja, so bolečine v trebuhu.
English: Although small, this reduction was considered significant given that patients view the frequency of bowel movements as a symptom with an important impact on their quality of life.
Slovenian: Zmanjšanje je bilo sicer majhno, vendar ocenjeno kot pomembno, saj se bolnikom pogostnost odvajanja blata zdi simptom, ki pomembno vpliva na kakovost njihovega življenja.
English: Other information about Xermelo
Slovenian: Druge informacije o zdravilu Xermelo
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Xermelo 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 Xermelo je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The most common side effects with Xermelo (which may affect more than 1 in 10 people) are abdominal (belly) pain, increases in the liver enzyme gamma-glutamyl transferase, and tiredness, and are usually mild or moderate.
Slovenian: Najpogostejši neželeni učinki zdravila Xermelo (ki se lahko pojavijo pri več kot 1 bolniku od 10) so bolečine v trebuhu, zvišanje jetrnega encima gama-glutamiltransferaze in utrujenost, ki so ponavadi blagi do zmerni.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xermelo have 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 Xermelo upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: Xermelo was compared with placebo (a dummy treatment) and the main measure of effectiveness was the change in average number of daily bowel movements over the 12 weeks of the study.
Slovenian: Zdravilo Xermelo so primerjali s placebom (zdravilom brez zdravilne učinkovine), glavno merilo učinkovitosti pa je bila sprememba povprečnega števila odvajanj blata na dan v 12 tednih študije.
English: Carcinoid syndrome occurs when certain tumours produce and release too much of a substance called serotonin into the blood.
Slovenian: Do karcinoidnega sindroma pride, kadar določeni tumorji proizvajajo in v kri sproščajo preveč snovi, imenovane serotonin.
English: The excess serotonin can cause severe diarrhoea as well as other symptoms such as flushing of the face and cramps.
Slovenian: Odvečni serotonin lahko povzroča hudo drisko in druge simptome, kot so vročinski oblivi obraza in krči.
English: Because the number of patients with carcinoid syndrome is low, the disease is considered ‘rare', and Xermelo was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 October 2009.
Slovenian: Ker je bolnikov s karcinoidnim sindromom malo, velja ta bolezen za redko, zato je bilo zdravilo Xermelo 8. oktobra 2009 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: What benefits of Xermelo have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Xermelo izkazalo v študijah?
English: For more information about treatment with Xermelo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Xermelo preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: At the start, patients given Xermelo had an average of 6.1 bowel movements per day, and this went down over the 12 weeks to an average of 4.7 per day, a reduction of 1.4 movements.
Slovenian: Na začetku so bolniki, ki so prejemali zdravilo Xermelo, odvajali blato povprečno 6,1-krat na dan, v 12 tednih pa se je to zmanjšalo na 4,7-krat na dan, kar je zmanjšanje za 1,4 odvajanja.
English: What is Xermelo and what is it used for?
Slovenian: Kaj je zdravilo Xermelo in za kaj se uporablja?
English: What are the risks associated with Xermelo?
Slovenian: Kakšna tveganja so povezana z zdravilom Xermelo?
English: The benefits of adding Xermelo to treatment have been shown in one main study involving 135 patients with carcinoid syndrome whose diarrhoea had not been fully controlled with somatostatin analogues alone.
Slovenian: Koristi dodajanja zdravila Xermelo obstoječemu zdravljenju so dokazali v eni glavni študiji, ki je vključevala 135 bolnikov s karcinoidnim sindromom, pri katerih driska ni bila popolnoma nadzorovana samo z analogi somatostatina.
English: Why is Xermelo approved?
Slovenian: Zakaj je bilo zdravilo Xermelo odobreno?
English: For practical information about using Xermelo, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Xermelo naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: The full EPAR for Xermelo 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 Xermelo je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Xermelo is used together with other medicines, called somatostatin analogues, when those medicines are not sufficient on their own to control the diarrhoea.
Slovenian: Zdravilo Xermelo se uporablja skupaj z drugimi zdravili, imenovanimi analogi somatostatina, kadar ta zdravila sama ne zadoščajo za obvladovanje driske.
English: It is not intended to provide practical advice on how to use Xermelo.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: By blocking the enzymes, telotristat reduces the production of serotonin in patients with carcinoid syndrome, and so relieves the symptoms of the condition.
Slovenian: Telotristat z zaviranjem encimov zmanjša nastajanje serotonina pri bolnikih s karcinoidnim sindromom in tako lajša simptome tega stanja.
English: For the full list of all side effects and restrictions with Xermelo, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Xermelo glejte navodilo za uporabo.
English: The active substance in Xermelo, telotristat, blocks the action of enzymes called L-tryptophan hydroxylases.
Slovenian: Zdravilna učinkovina v zdravilu Xermelo, telotristat, zavira delovanje encimov, imenovanih L-triptofanhidroksilaze.
English: Doctors may consider stopping treatment if patients do not benefit after 12 weeks.
Slovenian: Če zdravilo bolniku po 12 tednih še ne koristi, lahko zdravnik razmisli o prekinitvi zdravljenja.
English: Patients taking placebo were having an average of 5.2 bowel movements daily at the start, which fell to an average of 4.6 movements daily, a fall of 0.6 movements.
Slovenian: Bolniki, ki so prejemali placebo, so na začetku blato odvajali 5,2-krat, nato pa se je število zmanjšalo na 4,6 odvajanj na dan, kar je zmanjšanje za 0,6.
English: Xermelo contains the active substance telotristat.
Slovenian: Zdravilo Xermelo vsebuje zdravilno učinkovino telotristat.
English: Xermelo has been shown to produce a reduction in the number of bowel movements suffered by patients with carcinoid syndrome not fully controlled with other medicines.
Slovenian: Dokazali so, da zdravilo Xermelo povzroči zmanjšanje števila odvajanj blata, kar je stanje, ki se pojavi pri bolnikih s karcinoidnim sindromom, ki ni popolnoma nadzorovano z drugimi zdravili.
English: It is available as tablets containing 250 mg of telotristat and the recommended dose is one tablet three times a day.
Slovenian: Na volje je v obliki tablet, ki vsebujejo 250 mg telotristata, priporočeni odmerek pa je ena tableta trikrat na dan. Odmerek zdravila je morda treba zmanjšati pri bolnikih z lažjo ali zmerno okvaro jeter.
English: Xermelo is a medicine used to treat adults with severe diarrhoea associated with a condition called carcinoid syndrome.
Slovenian: Zdravilo Xermelo se uporablja za zdravljenje hude driske, povezane s stanjem, imenovanim karcinoidni sindrom, pri odraslih.
English: How does Xermelo work?
Slovenian: Kako zdravilo Xermelo deluje?
English: Xermelo can only be obtained with a prescription.
Slovenian: Predpisovanje in izdaja zdravila Xermelo je le na recept.
English: How is Xermelo used?
Slovenian: Kako se zdravilo Xermelo uporablja?
English: 29 May 2019
Slovenian: 29. maj 2019
English: Doctors use this scale to rate how well patients can talk, breath, eat and perform other normal activities.
Slovenian: Zdravniki to lestvico uporabljajo za merjenje, kako dobro lahko bolniki govorijo, dihajo, jedo in opravljajo druga običajna opravila.
English: However, the study involved only a small number of patients and there was not enough evidence of improvements in other important measures, such as those related to survival, breathing and muscle strength.
Slovenian: Vendar je bilo v študijo vključeno le manjše število bolnikov, prav tako pa ni bilo dovolj dokazov o izboljšavah v zvezi z drugimi pomembnimi ukrepi, na primer v zvezi s preživetjem, dihanjem in močjo mišic.
English: Radicava was expected to be used to slow down the worsening of the disease in patients who can still perform normal daily activities.
Slovenian: Zdravilo Radicava naj bi se uporabljajo za upočasnitev poslabšanja bolezni pri bolnikih, ki lahko še vedno opravljajo običajna vsakodnevna opravila.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that the withdrawal was based on the Committee's provisional opinion on the study data.
Slovenian: Podjetje je v dopisu, s katerim je agencijo obvestilo o umiku vloge, navedlo, da umik temelji na začasnem mnenju odbora o podatkih študije.
English: Given the clear need for further evidence of Radicava's effectiveness, the Committee considered the possibility of a conditional approval, which would allow the company to provide more data at a later stage.
Slovenian: Ker je jasno, da so potrebni dodatni dokazi o učinkovitosti zdravila Radicava, je odbor razmislil o možnosti izdaje pogojnega dovoljenja za promet, ki bi podjetju omogočilo, da pozneje predloži več podatkov.
English: The company will continue with its ongoing compassionate use programmes pending discussions with national authorities that have already granted approval for compassionate use.
Slovenian: Bo pa nadaljevalo sedanje programe sočutne uporabe zdravila, dokler bodo potekale razprave z nacionalnimi organi, ki so že izdali dovoljenje za programe sočutne uporabe zdravila.
English: Withdrawal of the marketing authorisation application for Radicava (edaravone) EMA/293450/2019
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Radicava (edaravon) EMA/293450/2019
English: Radicava is a medicine that contains the active substance edaravone.
Slovenian: Zdravilo Radicava je zdravilo, ki vsebuje učinkovino edaravon.
English: On 24 May 2019, Mitsubishi Tanabe Pharma GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Radicava intended for the treatment of amyotrophic lateral sclerosis (ALS).
Slovenian: Podjetje Mitsubishi Tanabe Pharma GmbH je 24. maja 2019 uradno obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Radicava, namenjenim zdravljenju amiotrofične lateralne skleroze (ALS).
English: ALS is a disease of the nervous system, where nerve cells in the brain and spinal cord that control voluntary movement gradually deteriorate, causing loss of muscle function and paralysis.
Slovenian: Amiotrofična lateralna skleroza je bolezen živčnega sistema, pri kateri živčne celice v možganih in hrbtenjači, ki nadzorujejo prostovoljno gibanje, postopoma propadajo, kar povzroči izgubo delovanja mišic in paralizo.
English: When patients in the placebo group were later switched to Radicava there was no noticeable effect.
Slovenian: Ko so bolniki v skupini, ki je prejemala placebo, kasneje prešli na jemanje zdravila Radicava, ni bilo opaznega učinka.
English: Withdrawal of the marketing authorisation application for Radicava (edaravone)
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Radicava (edaravon)
English: The Committee considered the merits of such a study but had some objections, including the fact that the treatment for ALS had changed significantly over the past few years, rendering comparisons difficult.
Slovenian: Odbor je proučil prednosti tovrstne študije, vendar je imel določene zadržke, med drugim zaradi dejstva, da se je zdravljenje amiotrofične lateralne skleroze v zadnjih letih močno spremenilo, zaradi česar je bilo težko narediti primerjave.
English: During the evaluation, the CHMP consulted a group of experts in the field to obtain their views on the study results, the proposed registry and the patient population that could potentially benefit from treatment with Radicava.
Slovenian: Med ocenjevanjem se je odbor posvetoval s skupino izvedencev, da bi pridobil njihova mnenja o rezultatih študije, predlaganem registru in populaciji bolnikov, ki bi jim lahko zdravljenje z zdravilom Radicava koristilo.
English: The CHMP was also concerned about the duration of any benefits from Radicava, noting that 24 weeks (a cut-off point in the main study) was too short and that data from the extension phase of the study were difficult to interpret.
Slovenian: Odbor je bil zaskrbljen tudi zaradi trajanja koristi zdravila Radicava, saj je menil, da je 24 tednov (mejna točka v glavni študiji) premalo in da je podatke iz podaljšane faze študije težko tolmačiti.
English: Furthermore, the CHMP noted important differences between the two groups which could have influenced the final results - such as the fact that a higher number of patients in the Radicava group had less severe disease.
Slovenian: Poleg tega je ugotovil pomembne razlike med obema skupinama, ki bi lahko vplivale na končne rezultate, kot je na primer dejstvo, da je bilo v skupini, ki je prejemala zdravilo Radicava, več bolnikov z manj hudo obliko bolezni.
English: The company informed the CHMP that the withdrawal does not have any impact on ongoing clinical trials.
Slovenian: Podjetje je odbor CHMP obvestilo, da umik vloge nima nobenih posledic za klinična preskušanja, ki trenutno potekajo.
English: It was to be available as a solution for infusion (drip) into a vein.
Slovenian: Na voljo naj bi bilo v obliki raztopine za infundiranje (kapalne infuzije) v veno.
English: What was Radicava expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Radicava uporabljalo?
English: What were the reasons given by the company for withdrawing the application?
Slovenian: Kakšni so bili razlogi podjetja za umik vloge?
English: The exact way Radicava works in patients with ALS is not known but it is thought to neutralise oxygencontaining molecules known as ‘free radicals', which have been linked to nerve damage in patients with ALS.
Slovenian: Čeprav natančen način delovanja zdravila Radicava pri bolnikih z amiotrofično lateralno sklerozo ni znan, naj bi zdravilo nevtraliziralo molekule, ki vsebujejo kisik, imenovane „prosti radikali“, ki jih povezujejo s poškodbo živcev pri bolnikih s to boleznijo.
English: What did the company present to support its application?
Slovenian: Katero dokumentacijo je podjetje predložilo v podporo svoji vlogi?
English: What is Radicava?
Slovenian: Kaj je zdravilo Radicava?
English: At the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Radicava could not have been approved.
Slovenian: Odbor CHMP je v času umika vloge izrazil določene zadržke in je začasno menil, da zdravila Radicava ni mogoče odobriti.
English: The Committee noted that the main study did show significant improvements in ALSFRS-R scores in patients receiving Radicava compared with those receiving placebo.
Slovenian: Odbor je opozoril, da je glavna študija pri bolnikih, ki so prejemali zdravilo Radicava, pokazala bistvene izboljšave na lestvici ALSFRS-R v primerjavi s tistimi, ki so prejemali placebo.
English: The company proposed a registry study whereby patients treated with Radicava could be compared with patients who received other treatments for ALS in the past.
Slovenian: Podjetje je predlagalo študijo registra bolnikov, pri kateri bi lahko bolnike, ki so jih zdravili z zdravilom Radicava, primerjali z bolniki, ki so v preteklosti prejemali druga zdravila za zdravljenje amiotrofične lateralne skleroze.
English: Radicava was expected to be used to treat patients with amyotrophic lateral sclerosis (ALS).
Slovenian: Zdravilo Radicava naj bi se uporabljalo za zdravljenje bolnikov z amiotrofično lateralno sklerozo.
English: At the time of the withdrawal, the Committee was of the opinion that, because of lack of proven effectiveness, the benefits of Radicava did not outweigh its risks.
Slovenian: Zato je odbor ob umiku vloge menil, da koristi zdravila Radicava zaradi pomanjkanja dokazov o učinkovitosti ne odtehtajo z njim povezanih tveganj.
English: Radicava was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 19 June 2015 for ALS.
Slovenian: Zdravilo Radicava je bilo 19. junija 2015 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni) za amiotrofično lateralno sklerozo.
English: (ALSFRS-R).
Slovenian: lestvici ALSFRS-R (dopolnjeni funkcijski ocenjevalni lestvici za bolnike z ALS).
English: The company presented results from a main study of 137 patients with ALS who received either Radicava or placebo (a dummy treatment).
Slovenian: Podjetje je predstavilo rezultate glavne študije, v kateri je sodelovalo 137 bolnikov z amiotrofično lateralno sklerozo, ki so prejemali bodisi zdravilo Radicava bodisi placebo (zdravilo brez učinkovine) V študiji so proučevali, kako so se bolnikovi simptomi spremenili v 24 tednih na standardni ocenjevalni
English: How does Radicava work?
Slovenian: Kako zdravilo Radicava deluje?
English: This testing should be provided free of charge.
Slovenian: To testiranje je treba zagotoviti brezplačno;
English: • Educational material for the physician.
Slovenian: • izobraževalno gradivo za zdravnike,
English: The Member States must ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented in their national territory:
Slovenian: Države članice morajo zagotoviti, da se izvajajo vsi spodaj opisani pogoji ali omejitve v zvezi z varno in učinkovito uporabo zdravila na njihovem ozemlju:
English: • The risk of formation of anti-C1INH antibodies and therefore the potential risk of formation of neutralising antibodies.
Slovenian: • tveganje tvorbe protiteles anti-C1INH in s tem morebitno tveganje za tvorjenje nevtralizirajočih protiteles.
English: The patient card should contain the following key elements:
Slovenian: Kartica za bolnika mora vsebovati naslednje ključne elemente:
English: o IgE testing should be repeated once a year or after 10 treatments, whichever occurs first.
Slovenian: o se mora testiranje na protitelesa IgE ponoviti enkrat na leto ali po 10 zdravljenjih, kar je prej.
English: The patients should receive a patient card that documents the negative result.
Slovenian: Bolniki morajo prejeti kartico bolnika, na kateri je naveden negativni rezultat;
English: o A protocol for performing a skin prick test (SPT) with Ruconest and an intravenous test dosing schedule in patients with a negative skin prick test, including criteria for interpreting results, for patients with clinical features of cow's milk allergy.
Slovenian: o protokol za izvedbo kožnega vbodnega testa (SPT - Skin Prick Test) z zdravilom Ruconest in načrt intravenskega testnega odmerjanja pri bolnikih z negativnim kožnim vbodnim testom, vključno z merili za interpretacijo rezultatov, za bolnike s kliničnimi znaki alergije na kravje mleko;
English: • The patient card should include an area where patients can record the date and dose of every treatment by Ruconest (highlighting every tenth treatment)
Slovenian: • kartica za bolnika mora vsebovati prostor, kjer lahko bolnik zabeleži datum in odmerek vsakega zdravljenja z zdravilom Ruconest (pri čemer jasno označi vsako deseto zdravljenje);
English: • Prior to launch of the product in the Member State, the national competent authority shall agree the content and format of the educational material with the Marketing Authorisation Holder.
Slovenian: • pred začetkom dajanja zdravila v promet v državi članici se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovoriti o vsebini in obliki izobraževalnega gradiva;
English: • The importance of monitoring for clinical signs and symptoms of hypersensitivity and that patients should alert their doctor if they develop such symptoms during or after receiving Ruconest.
Slovenian: • pomen spremljanja kliničnih znakov in simptomov preobčutljivosti in da morajo bolniki opozoriti svojega zdravnika, če razvijejo takšne simptome med prejemanjem ali po prejemu zdravila Ruconest;
English: The educational material for the prescriber should include information on the following key elements:
Slovenian: Izobraževalno gradivo za zdravnike, ki predpisujejo zdravilo, mora vsebovati informacije o naslednjih ključnih elementih:
English: • That they should be asked to carry the card and always show it to any health care professional treating them for acute attacks of hereditary angioedema.
Slovenian: • opozorilo, naj imajo kartico pri sebi in jo vedno pokažejo vsakemu zdravstvenemu delavcu, ki jih zdravi zaradi akutnih napadov dednega angioedema.
English: • The need to inform patients about the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis, and that they should alert their physician if these symptoms occur.
Slovenian: • obveznost informiranja bolnika o zgodnjih znakih preobčutljivostnih reakcij, ki vključujejo koprivnico, splošno urtikarijo, stiskanje v prsih, hropenje, hipotenzijo in anafilakso, in da morajo na te simptome opozoriti svojega zdravnika, če se pojavijo;