natgillin/translations-raw huggingface dataset:
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.
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.
The company will continue with its ongoing compassionate use programmes pending discussions with national authorities that have already granted approval for compassionate use.
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.
Withdrawal of the marketing authorisation application for Radicava (edaravone) EMA/293450/2019
Umik vloge za pridobitev dovoljenja za promet z zdravilom Radicava (edaravon) EMA/293450/2019
Radicava is a medicine that contains the active substance edaravone.
Zdravilo Radicava je zdravilo, ki vsebuje učinkovino edaravon.
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).
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).
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.
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.
When patients in the placebo group were later switched to Radicava there was no noticeable effect.
Ko so bolniki v skupini, ki je prejemala placebo, kasneje prešli na jemanje zdravila Radicava, ni bilo opaznega učinka.
Withdrawal of the marketing authorisation application for Radicava (edaravone)
Umik vloge za pridobitev dovoljenja za promet z zdravilom Radicava (edaravon)
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.
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.
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.
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.
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.
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.
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.
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.
The company informed the CHMP that the withdrawal does not have any impact on ongoing clinical trials.
Podjetje je odbor CHMP obvestilo, da umik vloge nima nobenih posledic za klinična preskušanja, ki trenutno potekajo.
It was to be available as a solution for infusion (drip) into a vein.
Na voljo naj bi bilo v obliki raztopine za infundiranje (kapalne infuzije) v veno.
What was Radicava expected to be used for?
Za kaj naj bi se zdravilo Radicava uporabljalo?
What were the reasons given by the company for withdrawing the application?
Kakšni so bili razlogi podjetja za umik vloge?
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.
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.
What did the company present to support its application?
Katero dokumentacijo je podjetje predložilo v podporo svoji vlogi?
What is Radicava?
Kaj je zdravilo Radicava?
At the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Radicava could not have been approved.
Odbor CHMP je v času umika vloge izrazil določene zadržke in je začasno menil, da zdravila Radicava ni mogoče odobriti.
The Committee noted that the main study did show significant improvements in ALSFRS-R scores in patients receiving Radicava compared with those receiving placebo.
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.
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.
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.
Radicava was expected to be used to treat patients with amyotrophic lateral sclerosis (ALS).
Zdravilo Radicava naj bi se uporabljalo za zdravljenje bolnikov z amiotrofično lateralno sklerozo.
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.
Zato je odbor ob umiku vloge menil, da koristi zdravila Radicava zaradi pomanjkanja dokazov o učinkovitosti ne odtehtajo z njim povezanih tveganj.
Radicava was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 19 June 2015 for ALS.
Zdravilo Radicava je bilo 19. junija 2015 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni) za amiotrofično lateralno sklerozo.
(ALSFRS-R).
lestvici ALSFRS-R (dopolnjeni funkcijski ocenjevalni lestvici za bolnike z ALS).
The company presented results from a main study of 137 patients with ALS who received either Radicava or placebo (a dummy treatment).
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
How does Radicava work?
Kako zdravilo Radicava deluje?
This testing should be provided free of charge.
To testiranje je treba zagotoviti brezplačno;
• Educational material for the physician.
• izobraževalno gradivo za zdravnike,
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:
Države članice morajo zagotoviti, da se izvajajo vsi spodaj opisani pogoji ali omejitve v zvezi z varno in učinkovito uporabo zdravila na njihovem ozemlju:
• The risk of formation of anti-C1INH antibodies and therefore the potential risk of formation of neutralising antibodies.
• tveganje tvorbe protiteles anti-C1INH in s tem morebitno tveganje za tvorjenje nevtralizirajočih protiteles.
The patient card should contain the following key elements:
Kartica za bolnika mora vsebovati naslednje ključne elemente:
o IgE testing should be repeated once a year or after 10 treatments, whichever occurs first.
o se mora testiranje na protitelesa IgE ponoviti enkrat na leto ali po 10 zdravljenjih, kar je prej.
The patients should receive a patient card that documents the negative result.
Bolniki morajo prejeti kartico bolnika, na kateri je naveden negativni rezultat;
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.
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;
• The patient card should include an area where patients can record the date and dose of every treatment by Ruconest (highlighting every tenth treatment)
• 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);
• 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.
• 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;
• 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.
• 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;
The educational material for the prescriber should include information on the following key elements:
Izobraževalno gradivo za zdravnike, ki predpisujejo zdravilo, mora vsebovati informacije o naslednjih ključnih elementih:
• 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.
• opozorilo, naj imajo kartico pri sebi in jo vedno pokažejo vsakemu zdravstvenemu delavcu, ki jih zdravi zaradi akutnih napadov dednega angioedema.
• 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.
• 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;
In addition, IgE testing should be repeated if symptoms of rabbit allergy develop.
Poleg tega je treba ponoviti testiranje IgE, če se razvijejo simptomi alergije na kunce:
• The Marketing Authorisation Holder (MAH) should ensure that, at launch, all Healthcare Professionals who are expected to prescribe Ruconest are provided with an Educational pack.
• imetnik dovoljenja za promet z zdravilom mora zagotoviti, da ob začetku dajanja zdravila v promet vsi zdravstveni delavci, ki naj bi predpisovali zdravilo Ruconest, prejmejo izobraževalno gradivo.
• The patient card should include an area where patients can record the results of their last IgE anti Rabbit (dander) and the date of the test
• kartica bolnika mora vsebovati prostor, kjer lahko bolniki zabeležijo rezultate svojega zadnjega testa protiteles IgE proti kunčjemu epiteliju (prhljaju) in datum testa;
• The potential risk of an immune complex-mediated type III hypersensitivity reaction due to the formation of antibodies directed against Host Related Impurities (HRI).
• morebitno tveganje preobčutljivostne reakcije tipa III, povzročene z imunskimi kompleksi, zaradi tvorbe protiteles proti nečistotam, povezanim z gostiteljem (HRI).
o Information about the appropriate methodology to be used for laboratory testing of serum IgE antibodies against rabbit epithelium (dander)
o informacije o ustrezni metodologiji, ki se uporablja za laboratorijsko testiranje seruma protiteles IgE proti kunčjemu epiteliju (prhljaju);
• That patients with clinical evidence of cow's milk allergy may have antibodies cross reacting with the rabbit milk impurities in Ruconest.
• da imajo lahko bolniki s klinično dokazano alergijo na kravje mleko protitelesa, ki povzročijo navzkrižno reakcijo z nečistotami kunčjega mleka v zdravilu Ruconest;
• That they are receiving Ruconest for treatment of acute attack of hereditary angioedema
• da prejemajo zdravilo Ruconest za zdravljenje akutnih napadov dednega angioedema;
• That Ruconest is derived from milk of transgenic rabbits and contains trace of rabbit proteins
• da je zdravilo Ruconest pridobljeno iz mleka transgenskih kuncev in vsebuje sledove kunčjih beljakovin;
• a reminder that IgE anti rabbit (dander) testing should be repeated once a year or after 10 treatments, whichever occurs first.
• opomnik, da se mora testiranje na protitelesa IgE proti kunčjemu epiteliju (prhljaju) ponoviti enkrat na leto ali po 10 zdravljenjih, kar je prej.
• The fact that Ruconest is derived from milk of transgenic rabbits and contains trace of rabbit proteins (Host Related Impurities, HRI).
• dejstva, da se zdravilo Ruconest pridobiva iz mleka transgenskih kuncev in vsebuje sledove kunčjih beljakovin (nečistot, povezanih z gostiteljem, HRI - Host Related Impurities);
• That Ruconest is contra indicated in all patients with known or suspected rabbit allergy or with positive serum IgE antibodies against rabbit dander due to the risk of major allergic reactions, therefore:
• da je zdravilo Ruconest kontraindicirano pri vseh bolnikih z znano alergijo na kunce ali sumu nanjo ali s pozitivnim serumom protiteles IgE proti kunčjemu prhljaju zaradi tveganja močnih alergijskih reakcij, zaradi česar:
• That Ruconest should be initiated under the guidance and supervision of a physician experienced in the diagnosis and treatment of hereditary angioedema and should be administered by a health care professional.
• da je treba zdravilo Ruconest uvesti po navodilih in pod nadzorom zdravnika, ki ima izkušnje z diagnosticiranjem in zdravljenjem dednega angioedema, ter da mora zdravilo dati zdravstveni delavec;
• Copies of the patient card to be given to patients before they receive Ruconest
• izvode kartice za bolnika, ki jo mora bolnik prejeti pred začetkom jemanja zdravila Ruconest.
• That they have been tested negative for IgE anti rabbit (dander) within the last year.
• da so bili rezultati testiranja na protitelesa IgE proti kunčjemu epiteliju (prhljaju) v zadnjem letu negativni;
Advice about the immunogenicity laboratory testing program for detecting these antibodies for following up suspected immune complex-mediated disease, and about the procedure to follow for the collection and shipment of a blood sample to the company's central laboratory.
Nasvet glede laboratorijskega programa testiranja imunogenosti za odkrivanje teh protiteles za spremljanje morebitnih bolezni, povzročenih z imunskimi kompleksi, in glede postopka, ki ga je treba upoštevati pri zbiranju in odpremi vzorca krvi v osrednji laboratorij podjetja.
o Before initiating treatment with Ruconest all patients should be tested for the presence of IgE antibodies against rabbit epithelium (dander).
o je treba pred začetkom zdravljenja z zdravilom Ruconest vse bolnike testirati na prisotnost protiteles IgE proti kunčjemu epiteliju (prhljaju).
Advice about the immunogenicity laboratory testing program for these antibodies provided by the company for following up suspected emergence of neutralising antibodies and information about the procedure to follow for the collection and shipment of a blood sample to the company's central laboratory.
Nasvet glede laboratorijskega programa testiranja imunogenosti za ta protitelesa, ki ga zagotovi podjetje za spremljanje morebitnega pojava nevtralizirajočih protiteles, in glede postopka, ki ga je treba upoštevati, za zbiranje in odpremo vzorca krvi v osrednji laboratorij podjetja.
• Summary of Product Characteristics and Patient Information Leaflet for Ruconest
• povzetek glavnih značilnosti zdravila in navodilo za uporabo za zdravilo Ruconest,
Only patients who have been shown to have negative test results should be treated with Ruconest.
Z zdravilom Ruconest se sme zdraviti samo bolnike z negativnimi rezultati testa.
There were three treatment studies and one prevention study.
Izvedli so tri študije zdravljenja in eno študijo preventivnega zdravljenja.
Most of the patients in these two studies were infected with human immunodeficiency virus (HIV).
Večina bolnikov v teh dveh študijah je bila okuženih z virusom humane imunske pomanjkljivosti (HIV).
The European Commission granted a marketing authorisation valid throughout the European Union for Mycamine on 25 April 2008.
Evropska komisija je dovoljenje za promet z zdravilom Mycamine, veljavno po vsej Evropski uniji, odobrila dne 25. aprila 2008.
This checklist will remind prescribers how to use the medicine safely.
Ta seznam bo predpisovalce zdravila opominjal, kako zdravilo varno uporabljati.
Mycamine is used in babies, children and adults in the following situations:
Zdravilo Mycamine se uporablja pri dojenčkih, otrocih in odraslih v naslednjih primerih:
Mycamine is given once a day as an infusion lasting around one hour.
Zdravilo Mycamine se daje enkrat dnevno kot infuzija, ki traja približno eno uro.
What measures are being taken to ensure the safe use of Mycamine?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Mycamine ?
It works by interfering with the production of an essential component of the fungal cell wall called 1,3 β D glucan.
Deluje tako, da vpliva na tvorbo osnovne komponente celične stene glive, imenovane 1,3-β-D-glukan.
Fungal cells treated with Mycamine have incomplete or defective cell walls, making them fragile and unable to grow.
Celice gliv, ki so izpostavljene zdravilu Mycamine, imajo nepopolne ali okvarjene celične stene, zaradi česar so krhke in ne morejo rasti.
The main measure of effectiveness was the number of patients who did not develop a fungal infection during treatment or the following four weeks.
Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih se ni razvila glivična okužba med samim zdravljenjem ali v naslednjih štirih tednih.
The company that makes Mycamine will ensure that prescribers in all Member States receive a checklist before the launch of the medicine.
Družba, ki proizvaja zdravilo Mycamine, bo zagotovila, da bodo predpisovalci zdravila v vseh državah članicah še pred pričetkom trženja zdravila prejeli kontrolni seznam ob predpisovanju.
Mycamine should only be used after careful assessment of its risks and benefits, particularly in patients who have existing liver problems.
Zdravilo Mycamine je treba uporabljati izključno na podlagi skrbne ocene njegovih tveganj in koristi, zlasti pri bolnikih z obstoječimi težavami z jetri.
In all three studies, the main measure of effectiveness was the number of patients in whom treatment was successful, based on an improvement in symptoms and eradication of the fungus at the end of treatment.
V vseh treh študijah je bilo glavno merilo učinkovitosti število bolnikov, pri katerih je bilo zdravljenje uspešno, kar se je pokazalo v obliki izboljšanja simptomov in izkoreninjenja glive ob koncu zdravljenja.
The effectiveness of Mycamine has been studied in four main studies, in which it was compared with other antifungal medicines.
Učinkovitost zdravila Mycamine so preučevali v štirih glavnih študijah, v katerih so ga primerjali z drugimi protiglivičnimi zdravili.
EPAR summary for the public micafungin
Povzetek EPAR za javnost mikafungin
This is a summary of the European public assessment report (EPAR) for Mycamine.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Mycamine.
What benefit has Mycamine shown during the studies?
Kakšne koristi je zdravilo Mycamine izkazalo med študijami?
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Mycamine.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Mycamine, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Other information about Mycamine
Druge informacije o zdravilu Mycamine:
The dose depends on what it is being used for, the patient's weight, and the response to treatment.
Odmerek je odvisen od namena, bolnikove telesne mase in odziva na zdravljenje.
The most common side effects with Mycamine (seen in between 1 and 10 patients in 100) are leucopenia (low levels of leucocytes, a type of white blood cell), neutropenia (low levels of neutrophils, a type of white blood cell), anaemia (low red blood cell counts), hypokalaemia (low blood potassium levels), hypomagnesaemia (low blood magnesium levels), hypocalcaemia (low blood calcium levels), headache, phlebitis (inflammation of a vein), nausea (feeling sick), vomiting, diarrhoea, abdominal (tummy) pain, signs of liver problems in the blood (increased levels of alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase or bilirubin), rash, pyrexia (fever) and rigors (shaking chills).
Najpogostejši neželeni učinki (opaženi pri 1 do 10 bolnikih od 100 bolnikov) so levkopenija (nizka raven levkocitov, vrste belih krvničk), nevtropenija (nizka raven nevtrofilov, vrste belih krvničk), anemija (nizka raven rdečih krvničk), hipokaliemija (nizka raven kalija v krvi), hipomagneziemija (nizka raven magnezija v krvi), hipokalciemija (nizka raven kalcija v krvi), glavobol, flebitis (vnetje ven), navzeja (slabost), bruhanje, driska, bolečine v trebuhu, znaki težav z jetri v krvi (povečane ravni alkalne fosfataze, aspartat-aminotransferaze, alanin-aminotransferaze ali bilirubina), izpuščaj, pireksija (povišana telesna temperature) in tresenje.
It contains the active substance micafungin.
Vsebuje zdravilno učinkovino mikafungin.
What is the risk associated with Mycamine?
Kakšna tveganja so povezana z zdravilom Mycamine?
In the two studies of oesophageal candidiasis, around 90% of the patients were successfully treated with Mycamine, fluconazole or caspofungin.
V dveh študijah kandidoze požiralnika je bilo okrog 90 % bolnikov uspešno zdravljenih z zdravilom Mycamine, flukonazolom ali kaspofunginom.
Mycamine is not recommended for use in patients who have severe problems with their liver, who have long-term liver disease or who are taking other medicines that could harm the liver or the DNA.
Uporaba zdravila Mycamine ni priporočljiva pri bolnikih, ki imajo hude težave z jetri, dolgotrajno bolezen jeter ali ki prejemajo druga zdravila, ki bi lahko škodovala jetrom ali DNA.
Treatment with Mycamine should be initiated by a doctor who has experience managing fungal infections, and after considering official or national guidance on the use of antifungal medicines.
Zdravljenje z zdravilom Mycamine mora uvesti zdravnik z izkušnjami pri zdravljenju glivičnih okužb ob upoštevanju uradnih oziroma nacionalnih smernic za uporabo protiglivičnih zdravil.