FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP had concerns related to the manufacture of the medicine, including the control of impurities and the testing of the finished product.
Slovenian: CHMP je imel pomisleke glede proizvodnje zdravila, vključno z nadzorom nečistot in testiranjem končnega izdelka.
English: The CHMP also had concerns about the main study, citing, among other things, the lack of a comparator medicine.
Slovenian: CHMP je imel tudi pomisleke glede glavne študije, citiranja in med drugim tudi pomanjkanja primerjalnega zdravila.
English: The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Slovenian: Vlogo so umaknili po tem, ko je CHMP ocenil začetno dokumentacijo, ki jo je predložila družba, in pripravil seznam vprašanj.
English: On the whole, the evidence for effectiveness in the indication applied for was limited and there were some safety concerns with the medicine, including side effects caused by the reduced activity of circulating cortisol, fluid and mineral disturbances (particularly reduced potassium levels in blood and increased blood pressure in some patients) and thickening of the womb in some female patients.
Slovenian: Na splošno je bil dokaz učinkovitosti pri indikaciji, navedeni v vlogi, omejen, bilo pa je tudi nekaj varnostnih zadržkov v zvezi z zdravilom, vključno z neželenimi učinki zaradi zmanjšanega delovanja kortizola v obtoku, motenj tekočin in mineralov (še posebej zmanjšane ravni kalija v krvi in povišanega krvnega tlaka pri nekaterih bolnikih) in odebelitve maternice pri nekaterih bolnicah.
English: On 23 March 2015, FGK Representative Service GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Corluxin, intended for the treatment of Cushing's syndrome.
Slovenian: Družba FGK Representative Service GmbH je dne 23. marca 2015 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Corluxin, namenjenim zdravljenju Cushingovega sindroma.
English: Patients with Cushing's syndrome can have ‘central' weight gain (affecting the face and torso but not the limbs), growth of fat above the collar bone and the back of the neck, a roundish face, easy bruising, excessive growth of coarse hair on the face, weakening of the muscles and bones, depression, diabetes and high blood pressure.
Slovenian: Pri bolnikih s Cushingovim sindromom se lahko pojavijo „centralno“ pridobivanje telesne mase (na obrazu in trupu, vendar ne na okončinah), nakopičenje maščobe nad ključnico in zadnjo stranjo vratu, okrogel obraz, nagnjenost k modricam, prekomerna rast grobih dlak na obrazu, slabenje mišic in kosti, depresija, sladkorna bolezen in visok krvni tlak.
English: By blocking these receptors, mifepristone is expected to reduce the effects of the excess cortisol circulating in the body, thereby alleviating the symptoms of the disease.
Slovenian: Z zaviranjem teh receptorjev naj bi mifepriston zmanjšal učinke povečanih ravni kortizola v telesu in tako ublažil simptome bolezni.
English: Withdrawal of the marketing authorisation application for Corluxin (mifepristone)
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Corluxin (mifepriston)
English: Corluxin is a medicine containing the active substance mifepristone.
Slovenian: Corluxin je zdravilo, ki vsebuje zdravilno učinkovino mifepriston.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21 May 2015
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555
English: The active substance in Corluxin, mifepristone, is known to block receptors for cortisol known as glucocorticoid (GR-II) receptors.
Slovenian: Za zdravilno učinkovino v zdravilu Corluxin, mifepriston, je znano, da zavira receptorje za kortizol, imenovane glukokortikoidni receptorji (GR-II).
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Corluxin in the proposed indication did not outweigh its risks.
Slovenian: Zato je CHMP v času umika vloge menil, da koristi zdravila Corluxin pri predlagani indikaciji ne odtehtajo z njim povezanih tveganj.
English: The company informed the CHMP that, at the time of the withdrawal, there were no ongoing clinical trials or compassionate use programmes for Corluxin.
Slovenian: Družba je obvestila CHMP, da v času umika vloge niso potekala nobena klinična preskušanja ali programi sočutne uporabe zdravila Corluxin.
English: Withdrawal of the marketing authorisation application for Corluxin (mifepristone) EMA/261739/2015
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Corluxin (mifepriston) EMA/386096/2015
English: What is Corluxin?
Slovenian: Kaj je zdravilo Corluxin?
English: Corluxin was to be used to treat Cushing's syndrome in patients who cannot have surgery or for whom surgery has failed.
Slovenian: Zdravilo Corluxin naj bi se uporabljalo za zdravljenje Cushingovega sindroma pri bolnikih, pri katerih kirurški poseg ni mogoč ali ni bil uspešen.
English: At the time of the withdrawal, the CHMP was of the provisional opinion that Corluxin could not be approved for use in the broad indication the company applied for, which was the “treatment of adult patients with endogenous Cushing's syndrome for whom surgery is not an option or for whom surgery has failed.”
Slovenian: V času umika je CHMP začasno menil, da zdravila Corluxin ni mogoče odobriti za uporabo pri široki indikaciji, za katero je zaprosila družba, tj. za zdravljenje odraslih bolnikov z endogenim Cushingovim sindromom, pri katerih kirurški poseg ni mogoč ali ni bil uspešen.
English: What was Corluxin expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Corluxin uporabljalo?
English: How is Corluxin expected to work?
Slovenian: Kako naj bi zdravilo Corluxin delovalo?
English: Cushing's syndrome is a disease characterised by an excess production of the hormone cortisol by the adrenal glands, two glands situated above the kidneys.
Slovenian: Cushingov sindrom je bolezen, pri kateri nadledvični žlezi, tj. žlezi, ki se nahajata nad ledvicami, tvorita čezmerne količine hormona kortizola.
English: Annex IV
Slovenian: Dodatek IV
English: Communication Plan
Slovenian: Načrt sporočanja
English: The harmonised date for release of the letter is of 15 working days following the European Commission decision.
Slovenian: Usklajeni datum za objavo sporočila je 15 delovnih dni po odločitvi Evropske komisije.
English: The MAHs should inform healthcare professionals on the outcome of this review on nimesulide via a “Direct Healthcare Professional Communication” (DHPC) as agreed by the CHMP.
Slovenian: Imetniki dovoljenj za promet z zdravilom morajo zdravstvene strokovnjake obvestiti o izidu pregleda nimesulida z „neposrednim obvestilom za zdravstvene delavce“, kot je bilo dogovorjeno z CHMP.
English: CONDITIONS OF THE MARKETING AUTHORISATIONS National Competent Authorities, coordinated by the Reference Member State where applicable, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Slovenian: POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM Pristojni nacionalni organi, ki jih usklajuje referenčna država članica, kjer je potrebno, zagotovijo, da imetniki dovoljenj za promet z zdravilom izpolnijo naslednje pogoje:
English: Condition of the marketing authorisations
Slovenian: Pogoj dovoljenja za promet z zdravilom
English: EMEA/457286/2008-EN
Slovenian: EMEA/457286/2008-SL
English: London, August 2008 EMEA/457286/2008
Slovenian: London, avgust 2008 EMEA/457286/2008
English: The CVMP Opinion was adopted on 12 December 2007 and the subsequent Commission Decision on 11 March 2008.
Slovenian: Mnenje Odbora za zdravila za uporabo v veterinarski medicini je bilo sprejeto dne 12. decembra 2007, Odločba Komisije pa dne 11. marca 2008.
English: o The Periodic Safety Update Reports for at least the last 3 years.
Slovenian: o Periodičnih poročilao varnosti zdravila najmanj za zadnja tri leta.
English: The established withdrawal periods are safe and can be retained.
Slovenian: 5. so vzpostavljene karence varne in se lahko obdržijo.
English: The CVMP started the referral procedure during its meeting of 10-12 July 2007.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini je z napotitvenim postopkom začel na seji, ki je potekala od 10. do 12. julija 2007.
English: The Marketing Authorisation Holders were requested in a list of questions to provide:
Slovenian: Imetniki dovoljenj za promet z zdravilom so bili s seznamom vprašanj pozvani k predložitvi:
English: • Justification of the withdrawal period, in case the recommended dose should increase.
Slovenian: • Utemeljitve obdobja karence v primeru priporočenega povečanja odmerka.
English: On 11 July 2007, France presented to the EMEA a referral under Article 35 of Directive 2001/82/EC, as amended, concerning Tribrissen Oral Paste for Horses (including associated names) and authorised products for which this product served as a reference product, containing trimethoprim and sulfadiazine as active ingredient.
Slovenian: Francija je dne 11. julija 2007 Evropski agenciji za zdravila predložila napotitev v skladu s členom 35 Direktive 2001/82/ES, kakor je bila spremenjena, za zdravilo Tribrissen, peroralna pasta za konje, (in z njim povezana imena) ter odobrena zdravila, za katera je to zdravilo predstavljalo referenčno zdravilo in ki vsebujejo zdravilni učinkovini trimetoprim in sulfadiazin.
English: o Part I Summary of the dossier, including the Summary of Product Characteristics, the expert reports and the quantitative and qualitative composition of the product; o If applicable, Part IV Efficacy information, including information on pharmacokinetics, pharmacodynamics and anti-microbial resistance data.
Slovenian: o Dela 1, povzetka dokumentacije, vključno s povzetkom glavnih značilnosti zdravila, strokovnimi poročili ter kakovostno in količinsko sestavo zdravila; o če je smiselno, Dela 4, podatki o učinkovitosti, vključno s podatki o farmakokinetiki, farmakodinamiki in odpornosti proti mikrobom.
English: France considered that the dosing regime of the product is not correct.
Slovenian: Francija je menila, da način odmerjanja zdravila ni primeren.
English: • Justification of the recommended dose for each of the indications claimed in relation to efficacy and potential selection of antimicrobial resistant bacteria.
Slovenian: • Utemeljitve priporočenih odmerkov za vsako posamezno navedeno indikacijo glede učinkovitosti in potencialne izbire bakterij, odpornih proti mikrobom.
English: Having assessed the responses, the CVMP concluded that:
Slovenian: Po proučitvi predloženih odgovorov je Odbor za zdravila za uporabo v veterinarski medicini sklenil, da:
English: Marketing Authorisation Holders submitted written responses, defending the authorised dose of 1x30 mg/kg body weight per day for all indications but suggesting a higher dose may be required in the case of salmonellosis.
Slovenian: Imetniki dovoljenj za promet z zdravilom so predložili pisne odgovore, v katerih so zagovarjali odobrene odmerke 1x30 mg/kg telesne mase na dan za vse indikacije, so pa predlagali večji odmerek v primeru indikacije salmoneloze.
English: The CVMP recommended varying the Marketing Authorisations of the concerned veterinary medicinal products in accordance with the conclusions where applicable.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini je priporočil spremembo dovoljenj za promet z zadevnimi zdravili v skladu s sprejetimi sklepi.
English: Neither the Periodic Safety Update Reports of the products nor the literature presented included reports of lack of efficacy in the field.
Slovenian: Poročil o neustrezni učinkovitosti na terenu ni bilo ne v periodičnih poročilih o varnosti zdravila niti v predloženi literaturi.
English: It considered that this may lead to lack of efficacy and furthering resistance development in target pathogens, which could possibly lead to risks to human health where zoonotic bacteria are concerned.
Slovenian: Prepričana je, da lahko tako odmerjanje zmanjša učinkovitost in še poveča odpornost ciljnih patogenov, kar bi lahko ogrozilo zdravje ljudi, predvsem kadar gre za bakterije zoonoze.
English: There is no documented evidence of problems relating to lack of efficacy or any change in the resistance situation of the relevant target pathogens that would constitute a concern relating to animal or human health.
Slovenian: 2. do zdaj ni nobenih dokumentiranih dokazov o težavah zaradi slabše učinkovitosti ali kakršnih koli sprememb odpornosti glavnih ciljnih patogenov, ki bi pomenili zadržke zaradi tveganja za zdravje živali ali ljudi;
English: OPINION FOLLOWING AN ARTICLE 35 REFERRAL FOR VETERINARY MEDICINAL PRODUCTS WHICH CONTAIN THE ACTIVE SUBSTANCES TRIMETHOPRIM AND SULFADIAZINE
Slovenian: KI VSEBUJEJO ZDRAVILNI UČINKOVINI TRIMETOPRIM IN SULFADIAZIN
English: The efficacy of a dose of 1x30 mg/kg body weight per day to be administered over a maximum period of 5 days has been substantiated for all indications, except for salmonellosis.
Slovenian: 1. je bila učinkovitost odmerka 1x30 mg/kg telesne mase na dan, ki se daje največ pet zaporednih dni,
English: The use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies.
Slovenian: 3. ni bilo mogoče določiti primernega odmerka za zdravljenje salmonelaze; 4. mora uporaba zdravila temeljiti na testiranju občutljivosti in upoštevati uradno in lokalno protimikrobno politiko;
English: No dose could be established for the treatment of salmonellosis.
Slovenian: ustrezno potrjena za vse indikacije, razen za salmonelozo;
English: Treatment continued for up to two years.
Slovenian: Zdravljenje se je nadaljevalo do dve leti.
English: The side effects are similar in adults and in children.
Slovenian: Neželeni učinki so podobni pri odraslih in otrocih.
English: The site of injection should be changed each week.
Slovenian: Mesto injiciranja je treba vsak teden zamenjati.
English: The main measure of effectiveness was the number of patients whose disability got worse.
Slovenian: Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih se je prizadetost poslabšala.
English: Further information on Avonex can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/avonex.
Slovenian: Nadaljnje informacije za zdravilo Avonex so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/avonex.
English: • patients who have had a single attack of demyelination, when this is severe enough to need treatment with injectable corticosteroids (anti-inflammatory medicines).
Slovenian: • bolnikov, ki so doživeli en demielinizacijski napad, če je bil ta dovolj resen, da je potrebno zdravljenje z intravenoznimi kortikosteroidi (protivnetnimi zdravili).
English: Avonex is a medicine used to treat:
Slovenian: Avonex je zdravilo, ki se uporablja za zdravljenje:
English: These side effects decrease with continued treatment.
Slovenian: Ti neželeni učinki se z nadaljevanjem zdravljenja zmanjšujejo.
English: • patients with relapsing multiple sclerosis (MS).
Slovenian: • bolnikov s ponavljajočo se multiplo sklerozo (MS).
English: The European Medicines Agency decided that Avonex's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Avonex večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: Avonex received a marketing authorisation valid throughout the EU on 13 March 1997.
Slovenian: Za zdravilo Avonex je bilo 13. marca 1997 izdano dovoljenje za promet, veljavno po vsej EU.
English: What measures are being taken to ensure the safe and effective use of Avonex?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Avonex?
English: Other information about Avonex
Slovenian: Druge informacije o zdravilu Avonex
English: In adults (aged 18 years or over), the recommended dose of Avonex is 30 micrograms, given by injection into a muscle once a week.
Slovenian: Pri odraslih (starejših od 18 let) je priporočeni odmerek zdravila Avonex 30 mikrogramov, ki se injicira v mišico enkrat na teden.
English: As for all medicines, data on the use of Avonex are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Avonex stalno spremljajo.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Avonex 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 Avonex upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Avonex has been compared with placebo (a dummy treatment) in two main studies.
Slovenian: Zdravilo Avonex so primerjali s placebom (zdravilom brez učinkovine) v dveh glavnih študijah.
English: The second study involved 383 adults who had experienced a single attack of demyelination and compared the ability of Avonex and placebo to reduce the risk of a second attack.
Slovenian: Druga študija je vključevala 383 odraslih, ki so doživeli en demielinizacijski napad, v njej pa so primerjali sposobnost zdravila Avonex in placeba za zmanjševanje tveganja za pojav drugega napada.
English: The most common side effects with Avonex (which may affect more than 1 in 10 people) are headache, flu-like symptoms, pyrexia (fever), chills and sweating.
Slovenian: Najpogostejši neželeni učinki zdravila Avonex (ki se lahko pojavijo pri več kot 1 od 10 oseb) so glavobol, gripi podobni simptomi, pireksija (povišana telesna temperatura), mrzlica in potenje.
English: The estimated risk of having a second attack of demyelination was lower in the patients taking Avonex than in the patients taking placebo: with Avonex, the risk was 21% in two years and 35% in three years, whereas the risk with placebo was 39% in two years and 50% in three years.
Slovenian: Ocenjeno tveganje za pojav drugega demielinizacijskega napada je bilo manjše pri bolnikih, ki so se zdravili z zdravilom Avonex, kot pri bolnikih, zdravljenih s placebom: pri bolnikih, zdravljenih z zdravilom Avonex, je bilo tveganje v dveh letih 21 %, v treh letih pa 35 %, medtem ko je bilo tveganje pri bolnikih, ki so prejemali placebo, v dveh letih 39 %, v treh letih pa 50 %.
English: Side effects reported with Avonex are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Avonex, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Avonex must not be used in patients who have severe depression or have thoughts of suicide.
Slovenian: Zdravilo Avonex se ne sme uporabljati pri bolnikih, ki imajo hudo depresijo ali samomorilne misli.
English: In relapsing MS, the patient has attacks (relapses) between periods with no symptoms.
Slovenian: Pri ponavljajoči se multipli sklerozi ima bolnik napade (relapse) med obdobji brez simptomov.
English: Avonex slows the progression of disability and reduces the number of relapses;
Slovenian: Zdravilo Avonex upočasnjuje napredovanje prizadetosti in zmanjšuje pogostost relapsov;
English: In MS, the immune system (the body's natural defences) malfunctions and attacks parts of the central nervous system (the brain, spinal cord and optic nerve [nerve that sends signals from the eye to the brain]), causing inflammation that damages the nerves and the insulation around them.
Slovenian: Pri multipli sklerozi imunski sistem (naravni obrambni mehanizem telesa) ne deluje pravilno in napade dele osrednjega živčnega sistema (možgane, hrbtenjačo in vidni živec [živec, ki pošilja signale iz očesa v možgane]), kar povzroča vnetje, ki poškoduje živce in ovojnico okoli njih.
English: MS is a disease in which inflammation damages the protective insulation around nerves (demyelination) as well as the nerves themselves.
Slovenian: Multipla skleroza je bolezen, pri kateri vnetje poškoduje zaščitno ovojnico okoli živcev (demielinizacija) in živce same.
English: This can only be done with the pre-filled syringe, when it is fitted with a special device that attaches onto the syringe and only allows the lower dose of Avonex to be injected.
Slovenian: To je mogoče le z napolnjeno injekcijsko brizgo, če je opremljena s posebnim pripomočkom, ki se pritrdi nanjo in omogoča injiciranje manjšega odmerka zdravila Avonex.
English: To help patients adjust to treatment, the doctor may recommend that patients start with a lower dose once a week before increasing to the full dose.
Slovenian: V pomoč bolnikom pri privajanju na zdravljenje lahko zdravnik priporoči, da se zdravljenje pred prehodom na polni odmerek začne s polovičnim odmerkom enkrat na teden.
English: The active substance in Avonex is the protein interferon beta-1a, one of a group of interferons that can be naturally produced by the body to help it fight against viruses and other attacks.
Slovenian: Učinkovina zdravila Avonex je beljakovina interferon beta-1a, ki je ena od skupin interferonov, ki jih lahko telo naravno ustvari za obrambo pred okužbami, ki jih povzročajo virusi, in drugimi napadi.
English: Each syringe and pen contains 30 micrograms of interferon beta-1a.
Slovenian: Vsaka injekcijska brizga in injekcijski peresnik vsebuje 30 mikrogramov interferona beta-1a.
English: Why is Avonex authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Avonex odobreno v EU?
English: An overview of Avonex and why it is authorised in the EU
Slovenian: Pregled zdravila Avonex in zakaj je odobreno v EU
English: For more information about using Avonex, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Avonex glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: What benefits of Avonex have been shown in studies?
Slovenian: Kakšne koristi zdravila Avonex so se pokazale v študijah?
English: What is Avonex and what is it used for?
Slovenian: Kaj je zdravilo Avonex in za kaj se uporablja?
English: What are the risks associated with Avonex?
Slovenian: Kakšna tveganja so povezana z zdravilom Avonex?
English: The exact way that Avonex works in MS is not yet known but the active substance, interferon beta-1a, seems to calm down the immune system, and prevents relapses of MS.
Slovenian: Natančen način delovanja zdravila Avonex pri multipli sklerozi še ni popolnoma znan, vendar se zdi, da učinkovina, interferon beta-1a, pomirja imunski sistem in preprečuje realpse multiple skleroze.
English: After two years, 22% of the patients who were treated with Avonex and 35% of the patients treated with placebo had a worsening of disability.
Slovenian: Po dveh letih se je prizadetost poslabšala pri 22 % bolnikov, ki so se zdravili z zdravilom Avonex, in 35 % bolnikov, ki so prejemali placebo.
English: Avonex treatment should be stopped in patients who develop progressive (worsening) MS.
Slovenian: Zdravljenje z zdravilom Avonex je treba prekiniti pri bolnikih, pri katerih se je razvila progresivna (napredujoča) multipla skleroza.
English: Patients can inject Avonex themselves once they have been trained.
Slovenian: Bolniki si lahko po ustreznem usposabljanju zdravilo Avonex injicirajo sami.
English: Avonex is available as a solution for injection in a pre-filled syringe or pre-filled pen.
Slovenian: Zdravilo Avonex je na voljo v obliki raztopine za injiciranje v napolnjeni injekcijski brizgi ali napolnjenem injekcijskem peresniku.